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[null,null,"This Excel workbook contains the Evidence Map  on \nEVIDENCE MAP OF PRO INSTRUMENTS USED IN HYPERLIPIDAEMIA SINCE 1960"]
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[null,null,"How this Evidence Map was generated"]
[null,null,"We searched heoro.com on the 5th December 2017 with the following field settings:"]
[null,null,"Disease: Hyperlipidaemia AND Study type: PRO tools"]
[null,null,"The search identified a total of XXX relevant abstracts published since 1960, which were  segmented with the following standard heoro.com fields:"]
[null,null,null,"Locations - the geographical setting of the study, or, where this is unknown, the authors' location."]
[null,null,null,"Disease - Underlying diseases identified within the study population"]
[null,null,null,"Interventions - the interventions evaluated in the study, if any."]
[null,null,null,"PRO tools - the PRO intruments that were cited in the title or abstract."]
[null,null,null,"Study methodology - the type of study that was conducted, e.g. clinical trial, observational, systematic review."]
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[null,null,"In addition the following publication date segmentations are used:"]
[null,null,null,"1960 to 1999, 2000 to 2004, 2005 to 2009, 2010 to 2014, 2015 to 2017"]
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[null,null,"All data in this Evidence Map is taken from the heoro.com database"]
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[null,null,"Details of the PubMed search strategy used to populate the heoro.com database can be found here."]
[]
[null,null,"Contact us:"]
[null,null,"Address: Crystallise Ltd. Unit 21, Thames Enterpise Centre, Thames Industrial Park, East Tilbury, Essex, UK RM18 8RH"]
[null,null,"Tel: +44 (0)1375 488020"]
[null,null,"Email: alison.martin@crystallise.com"]

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[{"$f":"COUNT(A2:A988)","v":71},"Full citation","DOI","Authors","Title","Abstract","Citation","Locations","Year","Diseases","Interventions","PROtools","Subpopulations","Study types","Study methodologies","LocationsTags","SubpopulationsTags","DiseaseTags","InterventionsTags","StudytypesTags","StudyMethodologyTags","PROtoolTags","DateBand","C1","C2","C3","C4","C5"]
[1,"Anonymous (1991). \"Prevalence of risk factors for heart disease in OXCHECK trial: implications for screening in primary care. Imperial Cancer Research Fund OXCHECK Study Group.\" Bmj 302(6784): 1057-1060.",null,"Anonymous","Prevalence of risk factors for heart disease in OXCHECK trial: implications for screening in primary care. Imperial Cancer Research Fund OXCHECK Study Group","OBJECTIVE: To describe the outcome of offering health checks systematically to a general practice adult population,in terms of age and sex specific prevalence of risk factors,follow up workload,and selective screening of cholesterol concentration. DESIGN: Descriptive analysis of data obtained by postal questionnaire and by personal interview and clinical examination by a trained nurse. SUBJECTS: 2205 patients aged 35-64 who attended for a health check in 1989-90 from an invited random sample of 2777 patients from five urban general practices in Bedfordshire. RESULTS: Overall,almost three quarters of patients (78% of men,68% of women) needed specific advice or follow up. Smoking,a high fat diet,and being overweight (body mass index greater than or equal to 25 kg/m2) were common characteristics exhibited by 35%,31%,and 55% respectively of men and 24%,18%,and 48% of women. The total cholesterol concentration was greater than or equal to 6.5 mmol/l in 37% of patients and greater than or equal to 8 mmol/l in 8%. In terms of workload 13% needed dietary advice only,15% needed only follow up of hyperlipidaemia or hypertension,and 9% needed advice on smoking only. A further 35% needed follow up for a combination of risk factors. The proportion of patients in whom cholesterol concentration would be measured if a selective screening policy were adopted would vary from 29% to 71%,according to different criteria,but (particularly in men) no combination would be much better than random testing as a means to detect patients with a total cholesterol concentration greater than or equal to 8 mmol/l. CONCLUSIONS: If the entire adult population of a practice is offered health checks systematically the acceptance rate is lower and the follow up workload higher than previously understood. The resource implications depend on the age and sex of patients screened and the selective criteria adopted for cholesterol measurement. Health checks are only the beginning of a successful preventive programme--the challenge is to provide effective intervention and follow up.",null,"Unknown",1991,"Unknown","None","Unknown",null,null,"Cohort"]
[2,"Abs,R.,et al. (1999). \"GH replacement in 1034 growth hormone deficient hypopituitary adults: demographic and clinical characteristics,dosing and safety.\" Clin Endocrinol (Oxf) 50(6): 703-713.",null,"Abs,R.,et al.","GH replacement in 1034 growth hormone deficient hypopituitary adults: demographic and clinical characteristics,dosing and safety","OBJECTIVE: Long-term experience of growth hormone (GH) replacement therapy in a large population of hypopituitary adults with GH deficiency (GHD) is limited,and safety surveillance is clearly essential. KIMS,the Pharmacia & Upjohn International Metabolic Database,is a long-term,open,outcomes research programme of hypopituitary adult patients with GHD who are treated in a conventional clinical setting. PATIENTS: The present analysis encompasses data from 1034 hypopituitary adult GHD patients treated with GH for a total of 818 patient years. RESULTS: Prior to GH therapy,the KIMS patient population exhibited an increased prevalence of obesity,diabetes mellitus (in females) and hyperlipidaemia,compared with normal populations described in published studies. Quality of life,assessed using a disease-specific questionnaire (QoL-AGHDA),was also reduced in KIMS patients. The maintenance dose of GH was significantly higher in patients who were receiving GH prior to enrolment into KIMS (non-naive patients) compared with patients who commenced GH at the time of enrolment (naive patients). In addition,dose of GH correlated significantly with body weight in the former group of patients. Analysis of serum levels of IGF-I indicated that overtreatment with GH was markedly more common in non-naive than in naive patients. The frequency of adverse events in KIMS patients was no higher than that reported in patients receiving placebo in previous clinical trials. Recurrence of pituitary or CNS tumours was reported in six patients,a rate consistent with data from control series. Three deaths were reported,none of which was obviously associated with GH treatment. CONCLUSIONS: Our data,drawn from a large population of hypopituitary adults treated with GH for a total of more than 800 patient years,confirm previous reports that untreated GHD in hypopituitary adults is associated with a number of important clinical problems. In addition,the results suggest that there has been a shift in recent years from determination of GH dose on the basis of body weight to dose titration of individual patients,and indicate that the latter technique has important advantages. The data provide further evidence that GH replacement therapy is well-tolerated in adults. However,it is possible that some adverse events may not become evident over the time scale covered by the present analysis,and continued surveillance therefore remains mandatory.",null,"Belgium",1999,"Various","Various","Qol-AGHDA",null,null,"Cohort"]
[3,"Agewall,S.,et al. (1995). \"A randomized study of quality of life during multiple risk factor intervention in treated hypertensive men at high cardiovascular risk.\" J Hypertens 13(12 Pt 1): 1471-1477.",null,"Agewall,S.,et al.","A randomized study of quality of life during multiple risk factor intervention in treated hypertensive men at high cardiovascular risk","OBJECTIVE: To examine the effect on quality of life in hypertensive men of a multiple risk factor intervention programme compared with that of usual care. DESIGN: A prospective,open,randomized,parallel-group study with allocation either to a comprehensive multiple risk factor modification programme or to usual care. SETTING: An outpatient clinic in a city hospital. PATIENTS: Five hundred and eight treated hypertensive men,aged 50-72 years,with at least one of the following: serum cholesterol > or = 6.5 mmol/l,smoking habit or diabetes mellitus. INTERVENTION: Nutritional advice,behavioural treatment principles and drug therapy. MAIN OUTCOME MEASURES: Minor symptoms evaluation profile (MSEP) was used to measure change in quality of life. RESULTS: The intervention programme led to sustained effects on lifestyle-related variables such as hypercholesterolaemia,body mass index and smoking habits,whereas diastolic blood pressure and HbA1c remained unchanged. The change in the MSEP during follow-up did not differ between the intervention and the usual care groups. There was a close relationship between the measurements of the three MSEP dimensions at baseline and at follow-up (P < 0.0001). None of the potential risk factors measured at entry was significantly associated with change in the three MSEP dimensions during follow-up. CONCLUSION: The multiple risk factor intervention programme directed towards smoking habits,hypercholesterolaemia and the metabolic control of diabetes mellitus in treated hypertensive men at high cardiovascular risk was not associated with an impaired quality of life compared with that in a control group. The method used,the MSEP,has previously been found to be a reliable method with good validity,and this study's results provide further evidence of its validity.",null,"Sweden",1995,"Hypertension","Dietary,Behavioural/Education,Unknown","MSEP",null,null,"RCT"]
[4,"Angelico,F.,et al. (2003). \"Attitudes and approach to cardiovascular risk factors in Italy: results of an electronic questionnaire survey.\" Public Health 117(4): 242-249.",null,"Angelico,F.,et al.","Attitudes and approach to cardiovascular risk factors in Italy: results of an electronic questionnaire survey","BACKGROUND: The advent of computer-based technology has led to innovative epidemiological research methods to exploit the advantages of computer-mediated communications. The aim of the present study was to develop and evaluate a self-administered electronic questionnaire for acquiring information on cardiovascular health,knowledge and behaviours in a representative,stratified sample of the Italian population. METHODS: We report information on the attitudes and approach to cardiovascular disease prevention in a representative sample of Italian families who were interviewed at home by electronic questionnaires. The panel of families is currently used for national opinion polls and marketing surveys. Electronic questionnaires were filled out by 1683 males and 1736 females during a weekend period. RESULTS: Two-thirds of respondents reported having their blood pressure measured while only half reported having blood lipid and glucose tests over the previous 2 years. Prevalence of reported hypertension,hypercholesterolaemia,diabetes and smoking were 15.2,13.0,9.8 and 37.1% in men and 10.1,8.1,2.6 and 28.0% in women,respectively. More than 50% of hypertensives and diabetics were on drug treatment,while only 20% of subjects reporting hyperlipidaemia were on medication. CONCLUSIONS: The results suggest the usefulness of self-administered electronic questionnaires for acquiring quick,low-cost and high response rate information in epidemiological surveys.",null,"Italy",2003,"Unknown","None","Unknown",null,null,"Survey"]
[5,"Avorn,J.,et al. (2002). \"Measuring the cost-effectiveness of lipid-lowering drugs in the elderly: the outcomes research and economic analysis components of the PROSPER trial.\" Control Clin Trials 23(6): 757-773.",null,"Avorn,J.,et al.","Measuring the cost-effectiveness of lipid-lowering drugs in the elderly: the outcomes research and economic analysis components of the PROSPER trial","Little information exists to quantify the functional status and economic consequences of lipid-lowering therapy in elderly patients. We describe the design of the cost-effectiveness component of the first large,randomized,placebo-controlled trial of lipid-lowering therapy in subjects aged 70 years or older. The PROspective Study of Pravastatin in the Elderly at Risk has randomized 5804 men and women 70-82 years old,with existing vascular disease or related risk factors,to receive 40 mg/d of pravastatin or placebo. The cost-effectiveness study will be based on within-trial observations of differences between the two study arms in rates of myocardial infarction,stroke and related vascular disease outcomes (including vascular dementia). In addition to comparing within-trial clinical outcomes,we will model the projected changes in life expectancy and cardiovascular outcome rates that would be seen with lifelong use of the drug,based on the risk reduction rates seen in the trial as well as baseline observational data from the three countries where the trial is being conducted (Scotland,Ireland and the Netherlands). A state transition (Markov) model will be constructed to estimate the likely states of health,functional status and health care resource utilization (including lipid-lowering drug costs) in a cohort of elderly patients with versus without pravastatin therapy over a series of 1-year cycles until death. In addition,a standard measure of utility (the Health Utilities Index) will be administered to all study subjects to permit calculation of quality-adjusted life-years gained with this regimen. This approach will make it possible to go beyond the calculation of a single endpoint for each subject,and to translate the trial findings into definitions of effectiveness and outcomes that will be relevant to the ongoing debate concerning how best to relate the benefits of such medications to their costs.",null,"USA",2002,"Unknown","Pravastatin","Unknown",null,null,"RCT"]
[6,"Bahat,G.,et al. (2015). \"Observational cohort study on correlates of mortality in older community-dwelling outpatients: The value of functional assessment.\" Geriatr Gerontol Int 15(11): 1219-1226.",null,"Bahat,G.,et al.","Observational cohort study on correlates of mortality in older community-dwelling outpatients: The value of functional assessment","AIM: To analyze correlates of mortality with admission features/factors in older community-dwelling outpatients. METHOD: This is an observational cohort study including 608 patients aged >60 years admitted to the geriatrics outpatient clinics of a university hospital. On admission,demographic characteristics,history of smoking-alcohol consumption,individual comorbidities,individual drugs,number of comorbidities,number of drugs and the components of comprehensive geriatric assessment (functional status,nutritional status,depression and cognition screening) of the patients were recorded. Survival status was assessed through the related official website. The relationship between mortality and recorded parameters were analyzed individually by univariate analyses. Consequently,stepwise forward Cox regression analysis was carried out to detect independent correlates for mortality (for those variables statistically significantly related to mortality.) RESULTS: The mean age was 73.8 +/- 6.9 years. 66.6% of participants were female. The mean follow-up time was 40.4 +/- 25.3 months. The mortality rate was 17.8%. Correlates of mortality were calculated using univariate analysis. They were age,sex,nutritional status,activities of daily living (ADL),instrumental ADL,diabetes mellitus (P < 0.001 for all),suspected dementia (P = 0.002),hyperlipidemia (P = 0.048) and total number of diseases (P = 0.025). Independent correlates of mortality were advanced age (HR 1.10,95% CI 1.06-1.13; P < 0.001,low ADL score (HR 1.22,95% CI 1.12-1.32; P < 0.001),the presence of diabetes (HR 2.64,95% CI 1.78-3.91,P < 0.001),male sex (HR 1.68,95% CI 1.13-2.49; P = 0.01) and suspected dementia (HR 1.51,95% CI 1.02-2.22; P < 0.05). CONCLUSION: In the present study--taking many factors into consideration--the variables associated with mortality were advanced age,low ADL score,presence of diabetes,male sex and suspected dementia. Functional status emerged as the second most significant factor associated with higher mortality--after advanced age. The present study highlights the importance of functional assessment in geriatric outpatient clinics.",null,"Turkey",2015,"Unknown","None","ADL",null,null,"Cohort"]
[7,"Berglund,G.,et al. (2000). \"Long-term outcome of the Malmo preventive project: mortality and cardiovascular morbidity.\" J Intern Med 247(1): 19-29.",null,"Berglund,G.,et al.","Long-term outcome of the Malmo preventive project: mortality and cardiovascular morbidity","OBJECTIVES: To analyse the effects on mortality and cardiovascular morbidity in a population-based sample,invited to an intervention programme incorporating a baseline screening examination and treatment programmes for subjects with cardiovascular risk factors,high alcohol intake and,in women,suspicion of breast cancer on mammography. SETTING: Section of Preventive Medicine,Department of Medicine,University Hospital,Malmo,Sweden. SUBJECTS: Birth cohorts (aged 32-51 years) invited to screening examination (men = 9. 923; women = 4.422) were compared to birth cohorts not invited (men = 6.655; women = 4.290). Mean participation rate in the invited cohorts was 71% (range 64-78%). SCREENING EXAMINATION: Between 1974 and 1992 a baseline screening including a physical examination,blood pressure,a questionnaire regarding,e.g. family history,lifestyle,and socio-economic factors,laboratory tests of serum cholesterol,triglycerides,gamma-glutamyl-transferase,blood glucose before and after an oral glucose load,as well as a mammography examination in women,was performed. INTERVENTIONS: Subjects with hypertension; hyperlipidaemia; diabetes or glucose intolerance; high alcohol intake; or,in women,suspicion of breast cancer were referred to special outpatient clinics. MAIN OUTCOME MEASURES: Total and cause-specific mortality,nonfatal myocardial infarction,and stroke,from the screening examination until the end of 1995,was followed in both the intervention and control groups,using national and/or local registries. RESULTS: Total mortality did not differ significantly between the intervention group and control group. Cause-specific deaths were also similar except for 'other' deaths amongst men being significantly lower in the intervention group,mainly due to a lower mortality from 'other' causes (suicide,alcohol related deaths) in men under 40 years of age at baseline. Women under 40 years of age had a significantly lower mortality from cancer in the intervention group than in the control group. Nonfatal myocardial infarction and stroke did not differ between intervention and control group in either sex. Within the invited birth cohorts,nonparticipants had a higher total and cause-specific mortality. CONCLUSIONS: Risk factor screening for major diseases such as cardiovascular disease,alcohol abuse,diabetes mellitus and breast cancer,and subsequent treatment of the detected risk factors/diseases - The Malmo Preventive Project - did not reduce total mortality in the intervention group as a whole. In subjects under 40 years of age at entry,total mortality was lower in the intervention group than in the control group. In men,this seemed to be due to a reduction of alcohol-related deaths,whilst in women death from cancer was reduced.",null,"Sweden",2000,"Hypertension,Hyperlipidemia,Diabetes,Various","Patient Management","Unknown",null,null,"Cohort"]
[8,"Bloemenkamp,D. G.,et al. (2003). \"Functional health and well-being of relatively young women with peripheral arterial disease is decreased but stable after diagnosis.\" J Vasc Surg 38(1): 104-110.",null,"Bloemenkamp,D. G.,et al.","Functional health and well-being of relatively young women with peripheral arterial disease is decreased but stable after diagnosis","OBJECTIVE: This study was undertaken to investigate the extent to which health-related quality of life (HQOL) is reduced in young women with peripheral arterial disease (PAD) compared with age-matched and gender-matched control subjects. Moreover,potential determinants of HQOL in young women with PAD were studied,ie,traditional cardiovascular risk factors,location of stenosis and time since diagnosis. METHODS: This was a population-based case-control study. Subjects were 208 young (<50 years) women with PAD diagnosed at angiography and 471 population-based age-matched and gender-matched control subjects. All participants completed the RAND-36 questionnaire,which produces a HQOL profile. The questionnaire contains 36 items that assess 8 domains of HQOL. Each domain is given a mean score ranging from 0 to 100,with higher scores indicative of better quality of life. RESULTS: PAD had a deleterious effect on HQOL in young women. Ability to deal with the physical requirements of daily life was affected,and physical capabilities limited activity to a considerable extent. Mean differences observed for 2 domains,ie,Physical functioning and Role-physical,were -25.1 (95% confidence interval [CI],-28.8,-21.4) and -22.5 (95% CI,-28.9,-16.0). Within the group of young women with PAD,HQOL did not depend on age,smoking,hypercholesterolemia,or education. However,women with hyperglycemia,hypertension,or increased body mass index scored lower on 1 or more domains of RAND-36. Location of stenosis was also related to HQOL; patients with more proximal stenosis scored slightly higher on the domain Physical functioning,compared with women with more distal stenosis. Time (0-10 years) between diagnosis (1990-1999) and when RAND-36 was filled out (2000) is related to score on the Mental health domain; score increases over time. Scores on the other 7 domains of HQOL showed no significant relation to duration of disease. CONCLUSION: Quality of life in young women with PAD was statistically significant diminished for all domains of RAND-36 in comparison with HQOL in healthy age-matched control subjects. HQOL of patients with recently diagnosed PAD is comparable to that of patients in whom the diagnosis was made several years previously. Effective therapy might stabilize,albeit not improve,quality of life in this specific patient population.",null,"The Netherlands",2003,"Various","None","SF-36",null,null,"Case Control"]
[9,"Broekhuizen,K.,et al. (2015). \"An economic evaluation alongside a randomized controlled trial evaluating an individually tailored lifestyle intervention compared with usual care in people with familial hypercholesterolemia.\" BMC Res Notes 8: 317.",null,"Broekhuizen,K.,et al.","An economic evaluation alongside a randomized controlled trial evaluating an individually tailored lifestyle intervention compared with usual care in people with familial hypercholesterolemia","BACKGROUND: Cost-effectiveness analyses provide insight in the use of lifestyle interventions. To evaluate the cost-effectiveness of a lifestyle intervention compared to usual care in people with Familial Hypercholesterolemia,340 people with FH were randomized to the intervention or control group. LDL cholesterol,quality of life and costs were measured at 0 and 12 months. Cost-effectiveness analyses were performed from a healthcare perspective using bootstrapping techniques. RESULTS: Non-significant decreases in LDL cholesterol and quality of life were found. The mean between-group difference in costs was euro-237 (95% CI -1,386 to 130). The incremental cost-effectiveness ratios were 1,729 per 1 mmol/l LDL cholesterol and 145,899 per QALY gained. Assumed that the small non-significant decrease in LDL cholesterol is attributed to the intervention,the probability of cost-effectiveness of the intervention compared to usual care was 91% per 1 mmol/l LDL cholesterol reduction and 75% per QALY gained at a ceiling ratio of euro20,000. CONCLUSIONS: The intervention is not cost-effective. TRIAL REGISTRATION: NTR1899,date 07-07-2009.",null,"The Netherlands",2015,"Familial Hypercholesterolemia","Behavioural/Education","Unknown",null,null,"RCT"]
[10,"Buchwald,H.,et al. (1993). \"Perception of quality of life before and after disclosure of trial results: a report from the Program on the Surgical Control of the Hyperlipidemias (POSCH).\" Control Clin Trials 14(6): 500-510.",null,"Buchwald,H.,et al.","Perception of quality of life before and after disclosure of trial results: a report from the Program on the Surgical Control of the Hyperlipidemias (POSCH)","The Program on the Surgical Control of the Hyperlipidemias (POSCH) was a randomized controlled clinical trial designed to ascertain whether cholesterol lowering induced by the partial ileal bypass operation would favorably affect overall mortality and the mortality and morbidity due to coronary heart disease. The trial results provided strong clinical and coronary arteriographic support for the beneficial effects of lipid modification for the reduction of atherosclerosis progression. At the same time,the surgery-assigned group experienced diarrhea and an increased incidence of kidney stones and gallstones compared to the control-assigned group. Identical quality of life determinations were performed in the POSCH study population shortly before disclosure of the trial results to the patients and shortly thereafter. The purpose of this dual assessment was to evaluate the effect of knowledge of outcomes on the patients' subjective evaluation of quality of life. The primary instrument utilized for analysis of the perception of quality of life in POSCH was the McMasters Health Index Questionnaire (MHIQ). In addition,four study-specific questions were asked of the trial patients. The results for the MHIQ before disclosure of trial results showed a difference (p = 0.07) favoring the control-assigned group (diet-treated),for the social function index of the MHIQ. After disclosure of the trial results,the difference was larger (p < 0.05). For the four study-specific questions,all differences favored the control-assigned group (p < 0.01) before and after disclosure of the trial results,with the exception of satisfaction with randomization allocation in the surgery-assigned group (p = 0.08). The intragroup MHIQ indices before and after disclosure of the trial results showed no suggestive significant differences,except in the surgery-assigned group,in which there was an improvement in the emotional function index after disclosure of the trial results (p = 0.03). The intragroup responses to the study-specific questions before and after disclosure of the trial results again showed no significant differences,except in the surgery-assigned group,in which there was an improvement in patient satisfaction with randomization allocation after disclosure of the trial results (p = 0.04).(ABSTRACT TRUNCATED AT 400 WORDS)",null,"USA",1993,"Coronary Heart Disease","Bariatrics","MHIQ",null,null,"RCT"]
[11,"Busetto,L.,et al. (2012). \"Determinants of health-related quality of life in morbid obese candidates to gastric banding.\" Eat Weight Disord 17(2): e93-100.",null,"Busetto,L.,et al.","Determinants of health-related quality of life in morbid obese candidates to gastric banding","OBJECTIVE: To analyse determinants of self reported health-related quality of life (HR-QoL) in morbid obese patients candidates to laparoscopic adjustable gastric banding (LAGB). METHODS: Determinants of HR-QoL were investigated in 383 morbid obese patients (82 M and 301 F) with BMI>/=40 kg/m(2) (BMI>/=35 kg/m(2) if complicated obesity) and age 18-60 years. HR-QoL was determined with the SF-36 questionnaire. Determinants of the two summary measures of SF-36 (physical component and mental component) were analysed by stepwise multiple linear regression analysis with age,BMI,physical comorbidites,mental comorbidites and eating behaviour disorders as independent variables. Physical comorbities (diabetes,hypertension,hypertriglyceridemia,low HDL,sleep apnea and osteoarthritis) were coded as present or absent on the basis of simple diagnostic clinical criteria; mental comorbidities (depression) and eating behaviour disorders (binge eating,sweet eating and nibbling) on the basis of an unstructured clinical interview. RESULTS: Mean age was 38.8+/-10.2 years and mean BMI was 41.5+/-5.4 kg/m(2). Scores in the eight SF-36 subscales were lower in women than in men and lower than in the general Italian population. However,18.4-43.5% of the participants had HR-QoL levels above the normative values,depending on the scale. In both genders,low scores in the mental component of the SF-36 were associated to the presence of depression and eating behaviour disorders and not to physical comorbidities or BMI levels. Low physical self-perceived well being was associated to high BMI levels in men and to depression,hypertension and hypertriglyceridemia in women. CONCLUSION: HR-QoL was poor in morbid obese candidates to LAGB,particularly in women,and was negatively affected more by mental comorbidites and eating behaviour disorders than by physical comorbidities or BMI levels.",null,"Italy",2012,"Diabetes,Hypertension,Hypertriglyceridemia,Various","Bariatrics","SF-36",null,null,"Survey"]
[12,"Carlsson,C. M.,et al. (2002). \"Health-related quality of life and long-term therapy with pravastatin and tocopherol (vitamin E) in older adults.\" Drugs Aging 19(10): 793-805.",null,"Carlsson,C. M.,et al.","Health-related quality of life and long-term therapy with pravastatin and tocopherol (vitamin E) in older adults","INTRODUCTION: Concerns about the effects of HMG-CoA reductase inhibitors ('statins') on health-related quality of life may contribute to their underuse in older adults with and at risk for cardiovascular disease. These concerns also may prevent clinicians from enrolling older patients in clinical trials assessing the efficacy of statins as a preventive therapy for Alzheimer's disease. OBJECTIVE: To determine the effects of pravastatin and tocopherol (vitamin E),alone and in combination,on health-related quality of life in older adults. STUDY DESIGN: Double-blind,randomised,placebo-controlled,crossover study. PARTICIPANTS: Forty-one community-dwelling men and women aged > or = 70 years with low-density lipoprotein-cholesterol (LDL-C) > or = 3.62 mmol/L (140 mg/dl) participated. METHODS: Subjects received pravastatin for 6 months then pravastatin plus tocopherol for an additional 6 months (group 1),or tocopherol for 6 months then pravastatin plus tocopherol for an additional 6 months (group 2). Dosages were pravastatin 20 mg daily and tocopherol 400 IU daily. MAIN OUTCOME MEASURES: The following health-related quality-of-life measures were assessed at baseline,after 6 months and after 1 year: health perception,depression,physical function,cognitive function and sleep behaviour. In addition,data on adverse effects and laboratory abnormalities were obtained. RESULTS: Pravastatin reduced levels of total cholesterol (-21%,p < 0.001) and LDL-C (-29%,p < 0.001). Health-related quality-of-life scores,physical adverse effects,muscle enzyme levels and liver function tests did not change after 12 months of therapy with pravastatin,tocopherol or their combination. CONCLUSION: Both pravastatin and tocopherol have a good safety profile,are well tolerated and do not adversely affect health-related quality of life in older patients with hypercholesterolaemia. Given the significant beneficial cardiovascular effects of statin therapy in older adults and the potential role of statins in prevention of Alzheimer's disease,concerns about adverse effects on quality of life should not deter use of these medications in this population.",null,"USA",2002,"Cardiovascular Disease","Pravastatin,Dietary","Unknown",null,null,"RCT"]
[13,"Chomistek,A. K.,et al. (2015). \"Healthy lifestyle in the primordial prevention of cardiovascular disease among young women.\" J Am Coll Cardiol 65(1): 43-51.",null,"Chomistek,A. K.,et al.","Healthy lifestyle in the primordial prevention of cardiovascular disease among young women","BACKGROUND: Overall mortality rates from coronary heart disease (CHD) in the United States have declined in recent decades,but the rate has plateaued among younger women. The potential for further reductions in mortality rates among young women through changes in lifestyle is unknown. OBJECTIVES: The aim of this study was to estimate the proportion of CHD cases and clinical cardiovascular disease (CVD) risk factors among young women that might be attributable to poor adherence to a healthy lifestyle. METHODS: A prospective analysis was conducted among 88,940 women ages 27 to 44 years at baseline in the Nurses' Health Study II who were followed from 1991 to 2011. Lifestyle factors were updated repeatedly by questionnaire. A healthy lifestyle was defined as not smoking,a normal body mass index,physical activity >/= 2.5 h/week,television viewing </= 7 h/week,diet in the top 40% of the Alternative Healthy Eating Index-2010,and 0.1 to 14.9 g/day of alcohol. To estimate the proportion of CHD and clinical CVD risk factors (diabetes,hypertension,and hypercholesterolemia) that could be attributed to poor adherence to a healthy lifestyle,we calculated the population-attributable risk percent. RESULTS: During 20 years of follow-up,we documented 456 incident CHD cases. In multivariable-adjusted models,nonsmoking,a healthy body mass index,exercise,and a healthy diet were independently and significantly associated with lower CHD risk. Compared with women with no healthy lifestyle factors,the hazard ratio for CHD for women with 6 lifestyle factors was 0.08 (95% confidence interval: 0.03 to 0.22). Approximately 73% (95% confidence interval: 39% to 89%) of CHD cases were attributable to poor adherence to a healthy lifestyle. Similarly,46% (95% confidence interval: 43% to 49%) of clinical CVD risk factor cases were attributable to a poor lifestyle. CONCLUSIONS: Primordial prevention through maintenance of a healthy lifestyle among young women may substantially lower the burden of CVD.",null,"USA",2015,"Coronary Heart Disease","none","Unknown",null,null,"Cohort"]
[14,"Clark,M.,et al. (1997). \"Development and evaluation of a computer-based system for dietary management of hyperlipidemia.\" J Am Diet Assoc 97(2): 146-150.",null,"Clark,M.,et al.","Development and evaluation of a computer-based system for dietary management of hyperlipidemia","OBJECTIVE: To describe the development of a computer-based system for dietary management of hyperlipidemia and to evaluate its efficacy for lowering plasma cholesterol level. DESIGN: Using a stepwise approach,we developed and tested a three-part self-management system in five consecutive clinical studies. Each study assessed plasma cholesterol levels before and after dietary intervention using the system. These studies enabled progressive refinement of (a) a food frequency questionnaire used to assess food intake in the preceding month; (b) computer-generated progress reports,based on questionnaire responses,offering dietary change subgoals and strategies for change; and (c) a dietary workbook providing detailed information on how to achieve goals. SUBJECTS/SETTING: Persons with hyperlipidemia (n=814) were enrolled from worksite and clinical settings in the San Francisco Bay area of California. The attrition rate after randomization was 5%. INTERVENTION: Elements of the dietary intervention evolved in response to the results of five clinical studies. In each study,patients underwent a form of baseline assessment of dietary intake followed by counseling/instruction by various means. Follow-up dietary assessments were provided at specific intervals to facilitate subjects' progress toward their dietary goals. A dietary workbook provided the detailed instruction required to implement the recommendations contained in the periodic progress reports. STATISTICAL ANALYSES PERFORMED: Changes in plasma cholesterol level were measured by paired and unpaired t tests. The relationship between the reported reduction in dietary fat and cholesterol level assessed by food frequency questionnaires and the directly measured change in plasma cholesterol level was measured by multiple linear regression. RESULTS: The three major elements of the final computerized system (food frequency questionnaires,computer-generated progress reports,and dietary workbook) were developed and refined in the course of the five clinical studies. Reductions in total plasma cholesterol level of 5.0% to 6.5% achieved by participants in all five studies were consistent with self-reported reductions in intake of dietary saturated fat and cholesterol. Therefore,the computerized self-management system appears to be an effective tool for reducing plasma cholesterol levels. APPLICATIONS/CONCLUSIONS: A computer-based system for dietary self-management of hyperlipidemia,implemented by mail,was effective in short-term studies. This self-management system can potentially provide health-promoting services to large numbers of people at low cost.",null,"USA",1997,"Hyperlipidemia","Dietary","Unknown",null,null,"RCT"]
[15,"Cohen,J.,et al. (1998). \"Near-patient testing for serum cholesterol: attitudes of general practitioners and patients,appropriateness,and costs.\" Med J Aust 168(12): 605-609.",null,"Cohen,J.,et al.","Near-patient testing for serum cholesterol: attitudes of general practitioners and patients,appropriateness,and costs","OBJECTIVE: To determine the attitudes of general practitioners (GPs) and patients to near-patient testing (NPT) for serum cholesterol level,the appropriateness of NPT,and cost compared with testing in a specialist pathology laboratory. DESIGN: A descriptive survey of registered Category 5 general practices in Victoria,1994. Matched questionnaires were completed by GPs providing NPT and patients being tested. PARTICIPANTS: 13 GPs performing NPT and 206 patients having NPT. RESULTS: Thirteen of the 17 Victorian Category 5-accredited practices participated in this study (77%),and 203 of the 260 GP questionnaires and 206 of the 260 patient questionnaires were returned. NPT of serum cholesterol level was found to be appropriately used by GPs,and recommended management guidelines for lowering cholesterol level were followed. Both GPs and patients strongly supported the role of NPT in general practice on the basis of convenience,issues of patient care,quality,efficiency and cost,but GPs felt the registration and quality assurance fees were unreasonably high. We identified potential cost savings for patients and the Health Insurance Commission with NPT of cholesterol level by GPs compared with testing at specialist pathology laboratories. CONCLUSIONS: NPT appears to be of benefit to both GPs and patients and to provide cost savings. However,the registration charges and quality assurance fees for NPT laboratories may be limiting GPs' use of NPT.",null,"Australia",1998,"Unknown","None","Unknown",null,null,"Survey"]
[16,"Davidson,M.,et al. (2017). \"The burden of familial chylomicronemia syndrome: interim results from the IN-FOCUS study.\" Expert Rev Cardiovasc Ther 15(5): 415-423.",null,"Davidson,M.,et al.","The burden of familial chylomicronemia syndrome: interim results from the IN-FOCUS study","BACKGROUND: Familial Chylomicronemia Syndrome (FCS) is a rare genetic disorder that is caused by a decrease or an absence of lipoprotein lipase activity. FCS is characterized by marked accumulation of chylomicrons and extreme hypertriglyceridemia,which have major effects on both physical and mental health. To date,there have been no systematic efforts to characterize the impact of chylomicronemia on FCS patients' lives. In particular,the impact of FCS on the burden of illness (BoI) and quality of life (QoL) has not been fully described in the literature. METHODS: IN-FOCUS was a comprehensive web-based research survey of patients with FCS focused on capturing the BoI and impact on QoL associated with FCS. Sixty patients from the US diagnosed with FCS participated. Patients described multiple symptoms spanning across physical,emotional and cognitive domains. RESULTS: Patients on average cycled through 5 physicians of varying specialty before being diagnosed with FCS,reflecting a lengthy journey to diagnosis Nearly all respondents indicated that FCS had a major impact on BoI and QoL and significantly influenced their career choice and employment status,and caused significant work loss due to their disease. CONCLUSION: FCS imparts a considerable burden across multiple domains with reported impairment on activities of daily living and QoL.",null,"USA",2017,"Familial chylomicronemia syndrome","none","Unknown",null,null,"Survey"]
[17,"de Jongh,S.,et al. (2003). \"Quality of life,anxiety and concerns among statin-treated children with familial hypercholesterolaemia and their parents.\" Acta Paediatr 92(9): 1096-1101.",null,"de Jongh,S.,et al.","Quality of life,anxiety and concerns among statin-treated children with familial hypercholesterolaemia and their parents","AIM: To assess the quality of life,anxiety and concerns among statin-treated children with familial hypercholesterolaemia (FH) and their parents. METHODS: 69 FH children on statin therapy and 87 parents (51 families) participated in this study. Quality of life of the children,and anxiety levels of both the children and their parents,were investigated using self-report questionnaires. In addition,a questionnaire was designed to evaluate FH-specific concerns of these children and their parents on six different topics: 1,knowledge about FH; 2,experience of the disease; 3,family communication; 4,screening; 5,diet; and 6,experience of medication therapy. RESULTS: FH children and their parents reported no problems with regard to quality of life and anxiety. In contrast,the FH survey showed specific FH-related concerns. One-third of the children thought that FH can be cured,and 44% of the children suffered from the fact they have FH,but taking medication makes them feel safer (62%). The majority of the children kept a low cholesterol diet and more than 50% took care not to eat too much fat. Almost 38% of the parents experienced FH as a burden to their family and 79% suffered because their child had FH. CONCLUSION: These findings show that statin-treated children with FH and their parents did not report affected psychosocial functioning,but did show specific FH-related concerns.",null,"The Netherlands",2003,"Familial hypercholesterolemia","none","Unknown",null,null,"Survey"]
[18,"Delahanty,L. M.,et al. (2002). \"Medical nutrition therapy for hypercholesterolemia positively affects patient satisfaction and quality of life outcomes.\" Ann Behav Med 24(4): 269-278.",null,"Delahanty,L. M.,et al.","Medical nutrition therapy for hypercholesterolemia positively affects patient satisfaction and quality of life outcomes","Following a heart-healthy diet to lower cholesterol levels is often assumed to be difficult,to be burdensome,and to have a negative impact on quality of life (QOL). The purpose of this study was to evaluate the impact of medical nutrition therapy (MNT) versus usual care (UC) for hypercholesterolemia on patient satisfaction and QOL. Ninety ambulatory care patients (60 men and 30 women),age 28 to 66,were randomly assigned to receive either MNT from dietitians using a National Cholesterol Education Program-based protocol or UC from their physicians. Patients who received MNT reported no difference in QOL related to the taste or enjoyment of food compared with UC patients. However,the MNT group reported initial improvements in QOL related to the convenience and cost of following a low-fat diet when compared with the UC group. The MNT group also reported significant and lasting improvements in perceived QOL related to self-care compared with the UC group. MNT patients were more satisfied with the interaction at visits,knowledge and ability to manage their cholesterol,eating habits,appearance,time spent exercising,and life in general. Moreover,MNT patients did not report any negative impact related to following a low-fat diet in regard to feeling restricted by diet; interference with lifestyle activities; or difficulty planning,purchasing,or preparing meals or eating away from home. Contrary to popular belief there is no apparent reduction but rather an improvement in some measures of QOL and patient satisfaction with MNT for hypercholesterolemia.",null,"USA",2002,"Hypercholesterolemia","Dietary","Unknown",null,null,"RCT"]
[19,"Delahanty,L. M.,et al. (2001). \"Clinical and cost outcomes of medical nutrition therapy for hypercholesterolemia: a controlled trial.\" J Am Diet Assoc 101(9): 1012-1023.",null,"Delahanty,L. M.,et al.","Clinical and cost outcomes of medical nutrition therapy for hypercholesterolemia: a controlled trial","OBJECTIVE: To compare the results and cost-effectiveness of a cholesterol lowering protocol implemented by registered dietitians with cholesterol lowering advice by physicians. DESIGN: Six month randomized controlled trial,cost-effectiveness analysis. Subjects included 90 ambulatory care patients (60 men,30 women),age range 21 to 65 years,with hypercholesterolemia and not taking hypolipidemic drugs. Patients were randomly assigned to receive medical nutrition therapy (MNT) from dietitians using a NCEP based lowering protocol or usual care (UC) from physicians. Outcome measures were plasma lipid profiles,dietary intake,weight,activity,patient satisfaction,and costs of MNT. Changes from baseline for each variable of interest were compared between treatment groups using analysis of covariance controlling for baseline value of the variable and gender. RESULTS: MNT achieved a 6% decrease in total and LDL cholesterol levels at 3 and 6 months compared with a 1% increase and a 2% decrease in both values at 3 and 6 months with UC (P<.001 and P<.05,respectively). Weight loss (1.9 vs 0 kg,P<.001) and dietary intake of saturated fat (7% of energy vs 10%,P<.001) were better in the MNT than the UC group. The additional costs of MNT were $217 per patient to achieve a 6% reduction in cholesterol and $98 per patient to sustain the reduction. The cost-effectiveness ratio for MNT was $36 per 1% decrease in cholesterol and LDL level. APPLICATIONS/CONCLUSIONS: MNT from registered dietitians is a reasonable investment of resources because it results in significantly better lipid,diet,activity,weight,and patient satisfaction outcomes than UC.",null,"USA",2001,"Hypercholesterolemia","Dietary","Unknown",null,null,"RCT"]
[20,"Dubisar,B. M.,et al. (2004). \"Adverse effects of atypical antipsychotic agents and their effects on quality of life.\" Pharmacotherapy 24(7): 843-847.",null,"Dubisar,B. M.,et al.","Adverse effects of atypical antipsychotic agents and their effects on quality of life","STUDY OBJECTIVES: To determine how axis III metabolic disturbances associated with atypical antipsychotic agents (weight gain,diabetes mellitus,and hyperlipidemia) affect patients' quality of life by comparing perceived quality of life of patients taking these agents who developed the disorders with those who did not develop them. A secondary objective was to compare patients' assessments of their quality of life with assessments made of the same patients by their treating psychiatrists. DESIGN: Analysis of questionnaire results. PATIENTS: Thirty three patients hospitalized at a Missouri Department of Mental Health long-term care psychiatric facility after January 1,1990. MEASUREMENTS AND MAIN RESULTS: Participating patients independently completed the \"long\" form of the Quality of Life Enjoyment and Satisfaction Questionnaire. The psychiatrists who treated these patients completed the Physical Health-Activities section of the same questionnaire,based on their assessments of their patients' quality of life. Fifteen patients had a diagnosed axis III metabolic disturbance. For the group with these comorbid illnesses,the mean score on overall life satisfaction and contentment was 3.6 (fair to good). The corresponding value for the group without these comorbid diseases was 4.538 (good to very good). Psychiatrists' assessments of their patients' quality of life were less positive than the patients' own assessments,regardless of the existence of comorbid disease. CONCLUSION: Patients receiving atypical antipsychotic drugs had a perceived high quality of life and were satisfied with a variety of aspects of their lives. However,metabolic disturbances had a significant,detrimental effect on patients' perceived quality of life.",null,"USA",2004,"Unknown","None","Q-LES-Q",null,null,"Survey"]
[21,"Einvik,G.,et al. (2010). \"The influence of long-term awareness of hyperlipidemia and of 3 years of dietary counseling on depression,anxiety,and quality of life.\" J Psychosom Res 68(6): 567-572.",null,"Einvik,G.,et al.","The influence of long-term awareness of hyperlipidemia and of 3 years of dietary counseling on depression,anxiety,and quality of life","OBJECTIVE: The purpose of this study is to investigate the long-term effects of participation in a cardiovascular screening program and of dietary counseling on self-reported psychosocial outcomes and health concerns. METHODS: High-risk subjects (n=563) with hyperlipidemia from the Oslo Diet and Antismoking Study (1972-1977) were reexamined after 25 years and randomly assigned to a new 3-year prospective 2x2 factorial placebo-controlled study in 1997 of n-3 polyunsaturated fatty acids and/or dietary counseling. Hospital Anxiety and Depression Scale (HADS),Life Satisfaction Index (LSI),and a new questionnaire on health concerns and behavior in response to risk information were collected at the 25-year follow-up. Hospital Anxiety and Depression Scale and LSI were evaluated at the end of the 3-year Diet and Omega-3 Intervention Trial on atherosclerosis (DOIT) in 505 subjects. RESULTS: Twenty-five years after the screening program,HADS-anxiety was similar to the Norwegian norms (3.3 vs. 3.5),while HADS-depression was significantly lower (3.6 vs. 4.1,P<.01). Patients reported that 25 years of awareness of hyperlipidemia had influenced health concerns through a moderate change in diet habits,some restriction in life conduct,but an improvement of the total life situation. After a novel 3-year intervention in DOIT,there was no difference between the dietary counseling and control group with regard to anxiety,depression,or life satisfaction,but HADS-anxiety increased significantly (4.0 vs. 3.3,P<.001) in both groups. CONCLUSION: Compared to the general population,screening-positive subjects did not have increased mental distress 25 years after screening,and beneficial health behavior persisted. Dietary counseling did not affect psychosocial outcomes.",null,"Norway",2010,"Hyperlipidemia","None","HADS,LSI",null,null,"RCT"]
[22,"Erhardt,L. R. and F. D. Hobbs (2007). \"A global survey of physicians' perceptions on cholesterol management: the From The Heart study.\" Int J Clin Pract 61(7): 1078-1085.",null,"Erhardt,L. R. and F. D. Hobbs","A global survey of physicians' perceptions on cholesterol management: the From The Heart study","AIMS: Guidelines for cardiovascular disease (CVD) prevention cite high levels of low-density lipoprotein cholesterol (LDL-C) as a major risk factor and recommend LDL-C goals for various risk groups. Lifestyle changes are advised as first-line treatment for patients with high cholesterol,and statins are recommended in high-risk patients. The From The Heart study investigated current practice for the diagnosis and treatment of high cholesterol,and attitudes towards management of the condition. METHODS: Physicians were randomly selected from 10 countries,and completed a confidential,semi-structured questionnaire. RESULTS: Of 2790 physicians agreeing to participate,750 (27%) responded. Physicians rated CVD as the leading cause of death,although physicians (80%) perceived that cancer was the most feared illness among patients. Physicians (71%) believed smoking to be the greatest CVD risk factor,while only 50% thought high cholesterol was the greatest risk. Most physicians (81%) used guidelines to set cholesterol goals,primarily their national guidelines (34%) or the National Cholesterol Education Program Adult Treatment Panel III guidelines (24%). Although only 47% of patients reached and maintained their cholesterol goals,61% of physicians believed that a sufficient number of patients achieved goals,and 53% did not feel frustrated that they could not always effectively treat patients with CVD. CONCLUSION: Results indicate discrepancies between guideline recommendations and clinical practice. Although physicians appreciate the risk of CVD,the importance of achieving healthy cholesterol levels for CVD prevention does not seem to be widely endorsed. There is a need for improved communication regarding the importance of cholesterol lowering and investigation of initiatives to improve goal achievement among physicians.",null,"Sweden",2007,"Cardiovascular disease","none","Unknown",null,null,"Survey"]
[23,"Feldman,W. (1990). \"How serious are the adverse effects of screening?\" J Gen Intern Med 5(5 Suppl): S50-53.",null,"Feldman,W.","How serious are the adverse effects of screening?","The adverse effects of screening are not commonly studied. False-positive tests lead to discomfort,costs,and risks from additional diagnostic and therapeutic procedures. False-negative tests lead to a sense of security and delays in seeking medical help when symptoms develop. Labeling an individual with a false-positive test,or with a true-positive test for which there is no evidence that intervention makes a difference,e.g.,intervention on an 80-year-old asymptomatic woman with hypercholesterolemia,can have a markedly negative impact on the quality of life. Interpreting statistical abnormalities out of clinical context,e.g.,lending importance to a multiphasic blood screen showing \"high\" alkaline phosphatase in a teenager,leads to unnecessary costs and anxiety. The cost of screening programs that may not have been shown to do more good than harm is already having an impact on the resources available to diagnose and treatment symptomatic persons. Premature implementation of unproved screening programs will continue to decrease physician and public confidence in prevention.",null,"Canada",1990,"Unknown","None","Unknown",null,null,"Narrative Review"]
[24,"Flannery,J. and A. Raulerson (2000). \"Hypercholesterolemia: a look at low-cost treatment and treatment adherence.\" J Am Acad Nurse Pract 12(11): 462-466.",null,"Flannery,J. and A. Raulerson","Hypercholesterolemia: a look at low-cost treatment and treatment adherence","PURPOSE: To determine whether a positive cholesterol-lowering effect could be achieved with a psyllium dose of 6 grams per day instead of the usual 10 grams per day as advocated by other researchers. DATA SOURCES: Randomized trial of 46 males and females with hypercholesterolemia; multivariate analysis of variance with repeated measures on 1 factor done on 28 subjects (18 in treatment group,10 in control group) remaining after 16 weeks of treatment. CONCLUSIONS: Lipoprotein analysis at 2,8,and 16 weeks indicated that a daily dose of 6 grams of psyllium hydrophilic mucilloid did not significantly affect serum total cholesterol nor low-density lipoproteins in either men or women with hypercholesterolemia. The effects of psyllium on hypercholesterolemia appear to be dose dependent. PRACTICE IMPLICATIONS: Although it is a low cost option,the addition of psyllium to the diet has unpleasant side-effects,including abdominal distention,flatulence,and discomfort. Because these side effects are troublesome,the lowest effective dose of psyllium may be an important factor in improving treatment adherence.",null,"USA",2000,"Hypercholesterolemia","Herbal","Unknown",null,null,"RCT"]
[25,"Flodgren,G.,et al. (2015). \"Interactive telemedicine: effects on professional practice and health care outcomes.\" Cochrane Database Syst Rev 9: Cd002098.",null,"Flodgren,G.,et al.","Interactive telemedicine: effects on professional practice and health care outcomes","BACKGROUND: Telemedicine (TM) is the use of telecommunication systems to deliver health care at a distance. It has the potential to improve patient health outcomes,access to health care and reduce healthcare costs. As TM applications continue to evolve it is important to understand the impact TM might have on patients,healthcare professionals and the organisation of care. OBJECTIVES: To assess the effectiveness,acceptability and costs of interactive TM as an alternative to,or in addition to,usual care (i.e. face-to-face care,or telephone consultation). SEARCH METHODS: We searched the Effective Practice and Organisation of Care (EPOC) Group's specialised register,CENTRAL,MEDLINE,EMBASE,five other databases and two trials registers to June 2013,together with reference checking,citation searching,handsearching and contact with study authors to identify additional studies. SELECTION CRITERIA: We considered randomised controlled trials of interactive TM that involved direct patient-provider interaction and was delivered in addition to,or substituting for,usual care compared with usual care alone,to participants with any clinical condition. We excluded telephone only interventions and wholly automatic self-management TM interventions. DATA COLLECTION AND ANALYSIS: For each condition,we pooled outcome data that were sufficiently homogenous using fixed effect meta-analysis. We reported risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes,and mean differences (MD) for continuous outcomes. MAIN RESULTS: We included 93 eligible trials (N = 22,047 participants),which evaluated the effectiveness of interactive TM delivered in addition to (32% of studies),as an alternative to (57% of studies),or partly substituted for usual care (11%) as compared to usual care alone.The included studies recruited patients with the following clinical conditions: cardiovascular disease (36),diabetes (21),respiratory conditions (9),mental health or substance abuse conditions (7),conditions requiring a specialist consultation (6),co morbidities (3),urogenital conditions (3),neurological injuries and conditions (2),gastrointestinal conditions (2),neonatal conditions requiring specialist care (2),solid organ transplantation (1),and cancer (1).Telemedicine provided remote monitoring (55 studies),or real-time video-conferencing (38 studies),which was used either alone or in combination. The main TM function varied depending on clinical condition,but fell typically into one of the following six categories,with some overlap: i) monitoring of a chronic condition to detect early signs of deterioration and prompt treatment and advice,(41); ii) provision of treatment or rehabilitation (12),for example the delivery of cognitive behavioural therapy,or incontinence training; iii) education and advice for self-management (23),for example nurses delivering education to patients with diabetes or providing support to parents of very low birth weight infants or to patients with home parenteral nutrition; iv) specialist consultations for diagnosis and treatment decisions (8),v) real-time assessment of clinical status,for example post-operative assessment after minor operation or follow-up after solid organ transplantation (8) vi),screening,for angina (1).The type of data transmitted by the patient,the frequency of data transfer,(e.g. telephone,e-mail,SMS) and frequency of interactions between patient and healthcare provider varied across studies,as did the type of healthcare provider/s and healthcare system involved in delivering the intervention.We found no difference between groups for all-cause mortality for patients with heart failure (16 studies; N = 5239; RR:0.89,95% CI 0.76 to 1.03,P = 0.12; I(2) = 44%) (moderate to high certainty of evidence) at a median of six months follow-up. Admissions to hospital (11 studies; N = 4529) ranged from a decrease of 64% to an increase of 60% at median eight months follow-up (moderate certainty of evidence). We found some evidence of improved quality of life (five studies; N = 482; MD:-4.39,95% CI -7.94 to -0.83; P < 0.02; I(2) = 0%) (moderate certainty of evidence) for those allocated to TM as compared with usual care at a median three months follow-up. In studies recruiting participants with diabetes (16 studies; N = 2768) we found lower glycated haemoglobin (HbA1c %) levels in those allocated to TM than in controls (MD -0.31,95% CI -0.37 to -0.24; P < 0.00001; I(2)= 42%,P = 0.04) (high certainty of evidence) at a median of nine months follow-up. We found some evidence for a decrease in LDL (four studies,N = 1692; MD -12.45,95% CI -14.23 to -10.68; P < 0.00001; I(2 =) 0%) (moderate certainty of evidence),and blood pressure (four studies,N = 1770: MD: SBP:-4.33,95% CI -5.30 to -3.35,P < 0.00001; I(2) = 17%; DBP: -2.75 95% CI -3.28 to -2.22,P < 0.00001; I(2) = 45% (moderate certainty evidence),in TM as compared with usual care.Seven studies that recruited participants with different mental health and substance abuse problems,reported no differences in the effect of therapy delivered over video-conferencing,as compared to face-to-face delivery. Findings from the other studies were inconsistent; there was some evidence that monitoring via TM improved blood pressure control in participants with hypertension,and a few studies reported improved symptom scores for those with a respiratory condition. Studies recruiting participants requiring mental health services and those requiring specialist consultation for a dermatological condition reported no differences between groups. AUTHORS' CONCLUSIONS: The findings in our review indicate that the use of TM in the management of heart failure appears to lead to similar health outcomes as face-to-face or telephone delivery of care; there is evidence that TM can improve the control of blood glucose in those with diabetes. The cost to a health service,and acceptability by patients and healthcare professionals,is not clear due to limited data reported for these outcomes. The effectiveness of TM may depend on a number of different factors,including those related to the study population e.g. the severity of the condition and the disease trajectory of the participants,the function of the intervention e.g.,if it is used for monitoring a chronic condition,or to provide access to diagnostic services,as well as the healthcare provider and healthcare system involved in delivering the intervention.",null,"UK",2015,"Cardiovascular Disease,Diabetes,Various","Patient Management","Unknown",null,null,"Systematic Review"]
[26,"Gourley,G. K.,et al. (2001). \"Development and validation of the pharmaceutical care satisfaction questionnaire.\" Am J Manag Care 7(5): 461-466.",null,"Gourley,G. K.,et al.","Development and validation of the pharmaceutical care satisfaction questionnaire","The development and validation of a survey instrument to assess consumer satisfaction with pharmacy services is discussed. The Pharmaceutical Care Satisfaction Questionnaire (PCSQ) is a 30-item instrument administered by someone other than the pharmacist that uses a Likert scale to score respondents' answers. The PCSQ is written approximately at a seventh grade reading level. Following initial development,the PCSQ was administered to 360 consumers in ambulatory pharmacies and to 311 patients in a multicenter hyperlipidemia outcomes study. The Cronbach coefficient alpha was .94 for the consumer data,with a 64.8% variance accounted for by the 4-factor solution. A coefficient alpha of .84 was found on all 30 items in the hyperlipidemia study,with a variance of 63.78% in control patients and 60.16% in treatment patients. The PCSQ is easy to administer and score,with minimal cost. Unlike other satisfaction surveys,the PCSQ contains patient evaluations regarding outcomes of care. A primary limitation of the PCSQ is that it is a newly developed instrument that needs to be used in more studies to strengthen its validity.",null,"USA",2001,"Unknown","None","PCSQ",null,null,"Survey"]
[27,"Hollman,G.,et al. (2002). \"Quality of life in patients with familial hypercholesterolaemia.\" J Intern Med 251(4): 331-337.",null,"Hollman,G.,et al.","Quality of life in patients with familial hypercholesterolaemia","OBJECTIVES: The primary aim of this study was to analyse quality of life in adult patients with familial hypercholesterolaemia (FH),a genetic disorder with increased risk of coronary heart disease (CHD). Secondary aims were to find explanatory factors for quality of life and anxiety. DESIGN: A descriptive cross-sectional design was used. SETTING: Outpatients from lipid clinics at two university hospitals in Sweden were included. Patients with heterozygous FH and a randomly selected control group participated by filling out questionnaires. SUBJECTS: Two hundred and eighty patients with heterozygous FH above 18 years of age were asked,and 212 of whom 185 were free of overt CHD,participated. Of a control group of 2980 persons 1485 were included for comparison. METHODS: We used Likert-type questionnaires: the Quality of Life Index (QLI) consisting of four subscales,the Hospital Anxiety and Depression Scale (HAD),the Mastery Scale measuring coping and a questionnaire on health and lipids constructed for FH patients. RESULTS: Patients with FH were significantly more satisfied with overall quality of life 21.8 +/- 0.3 (SEM) vs. controls 21.1 +/- 0.1 and this was also the case in three of four subscales,all differences P < 0.05. Anxiety about getting CHD was expressed amongst 86% of the patients with FH. CONCLUSIONS: Quality of life amongst patients with FH was at least as good as in controls but they were worried about getting CHD.",null,"Sweden",2002,"Familial hypercholesterolemia","None","HADS,QLI,Mastery Scale",null,null,"Cohort"]
[28,"Hollman,G.,et al. (2003). \"Familial hypercholesterolaemia and quality of life in family members.\" Prev Med 36(5): 569-574.",null,"Hollman,G.,et al.","Familial hypercholesterolaemia and quality of life in family members","BACKGROUND: Awareness of genetic disease in the family may influence quality of life. The purpose of this study was to describe quality of life among nonaffected members of families with familial hypercholesterolaemia. All were aware of the risk for coronary heart disease. Their quality of life was compared with a reference group and with the patients with familial hypercholesterolaemia themselves. METHODS: Names of family members (n = 129) were given by the patients with familial hypercholesterolaemia. A randomly selected reference group (n = 1485) and patients with familial hypercholesterolaemia (n = 185) were included for comparison. They all completed the questionnaire Quality of Life Index,the Hospital Anxiety and Depression Scale,and the Mastery Scale measuring coping. Family members and patients with familial hypercholesterolaemia also completed a questionnaire on health and lipids. RESULTS: Family members were more satisfied with family life,mean 22.1 +/- 3.5 (SD),and psychological/spiritual life,22.9 +/- 4.0,than the reference group,21.4 +/- 4.3 and 21.1 +/- 4.8,respectively; this was particularly expressed among partners,P < 0.05. Of family members,91% were anxious about the patient with familial hypercholesterolaemia developing coronary heart disease. CONCLUSIONS: Family members have as good a quality of life as members of the reference group,but they were anxious about the patient with familial hypercholesterolaemia developing coronary heart disease.",null,"Sweden",2003,"Hypercholesterolemia","None","HADS,QLI,Mastery Scale",null,null,"Case Control"]
[29,"Hovingh,G. K.,et al. (2016). \"Identification and management of patients with statin-associated symptoms in clinical practice: A clinician survey.\" Atherosclerosis 245: 111-117.",null,"Hovingh,G. K.,et al.","Identification and management of patients with statin-associated symptoms in clinical practice: A clinician survey","BACKGROUND AND AIMS: Discontinuation of statin therapy by patients with hypercholesterolemia because of the onset of side-effects (statin-associated symptoms [SAS]) increases the risk of cardiovascular morbidity and mortality. We aimed to understand how patients with SAS,particularly those with statin-associated muscle symptoms (SAMS),are identified and managed in the outpatient setting. METHODS: A web-based survey involving 60 clinicians in each of 12 countries and 90 clinicians in the US was conducted. Clinicians answered questions about the diagnostic criteria,estimated incidence of SAS,and choice of treatment for patients with SAS. RESULTS: Overall,810 clinicians (78% cardiologists) completed the survey. An average of 72% of patients with potential SAS were reported to present with muscle-related symptoms (range across countries [RAC] 50-87%) that could be SAMS. Clinicians took a range of steps to confirm SAMS in these patients,including discontinuation of statin (average 59%; RAC 48-67%); re-challenge with >/= 2 statins (average 74%; RAC 60-85%); modification of statin regimen (average 76%; RAC 65-85%); or a combination of these steps. Overall,6% of patients with hypercholesterolemia were estimated to eventually have SAS (RAC 2-12%). In patients with SAS,on average 52% continued to receive a low-dose statin,usually with other lipid-lowering therapies (LLT). Of the remaining 49%,38% received alternative LLT only; 11% did not receive any LLT. CONCLUSION: There is some consistency and stringency in clinical practice for identifying patients with SAS; however,a structured work-up for identification,followed by a defined therapeutic algorithm,may improve their management.",null,"The Netherlands",2016,"Unknown","None","Unknown",null,null,"Survey"]
[30,"Hupp,J. A.,et al. (2007). \"Results of a single center vascular screening and education program.\" J Vasc Surg 46(2): 182-187; discussion 188-189.",null,"Hupp,J. A.,et al.","Results of a single center vascular screening and education program","BACKGROUND: Vascular screening events have become a popular way to increase vascular awareness. Most screenings programs involve multiple locations on a single date and do not explore the local impact of screening. We evaluated the economic and community impact of the Dare to C.A.R.E. (DTC) program,a large,single center,continuous vascular screening and education program in Annapolis,Maryland. METHODS: Between July 2000 and July 2006,DTC was offered free to the public for those over 60 or over 50 with risk factors of hypertension,diabetes,smoking,or elevated cholesterol. DTC consisted of a 2-hour educational lecture,completing a risk factor questionnaire,and testing blood pressure,carotid duplex,abdominal aortic aneurysm (AAA) ultrasound,and pedal pulse/ankle-brachial index (ABI). Mild disease (MD) was defined as 1% to 39% carotid stenosis or an ABI between .7 and .95; intermediate disease (ID) as carotid stenosis >or=40%,AAA >or=3 cm,or an ABI <or=0.7; and severe disease (SD) as carotid stenosis >or=60%,AAA >or=5 cm,or an ABI <or=0.5. Results were discussed with the participants and forwarded to their primary physicians. Questionnaire data and screening results were analyzed and local hospital data was examined to determine the effects of screening. RESULTS: A total of 12,055 screenings were performed in DTC,439 were excluded due to age less than 40 or repeat visits,leaving 11,616 unique patients for this report. Participation grew from 189 in 2000 to over 6400 in 2005. Age ranged from 40 to 95 (median 65 years) and females comprised 58.7%. Demographics included past smokers (51.3%),current smokers (7.3%),diabetes mellitus (10.6%),hypertension (46.7%),hyperlipidemia (49.4%),and prior myocardial infarction (MI) (11.9%). 47% participants had evidence of at least mild disease (MD) with intermediate disease (ID) found in 6.9% and severe disease (SD) found in 2.2% of patients screened. Statistical analysis showed a greater prevalence of ID and SD in patients with risk factors. Diabetes alone doubled the prevalence of disease in all age groups. Over 340 hospital vascular cases were identified in DTC patients in the first 5 years of the program. CONCLUSIONS: The Dare to C.A.R.E. vascular screening and education program is an effective way to detect early and significant vascular disease. It has a powerful effect on procedural and testing volumes.",null,"USA",2007,"Hypertension,Diabetes","Behavioural/Education","Unknown",null,null,"Cohort"]
[31,"Jansen,R.,et al. (2000). \"Factors influencing efficacy of nitrate therapy for stable angina pectoris: a multiple linear regression analysis.\" Angiology 51(12): 1007-1012.",null,"Jansen,R.,et al.","Factors influencing efficacy of nitrate therapy for stable angina pectoris: a multiple linear regression analysis","In an open-label self-controlled study of 1,350 patients with stable angina pectoris (SAP),we previously demonstrated that 50 mg of isosorbide mononitrate (ISMN) slow release formulation once daily not only provided a better antianginal effect but also a better quality of life (QOL) than did the daily administration of multiple small doses of the compound. It is unknown whether certain patient characteristics contribute to this benefit. The objective of this article was to determine what independent factors contribute to this benefit. Multiple linear regression analysis was performed on the data from these 1,350 patients. Quality of life was assessed by the Marquis QOL-questionnaire for patients with angina and included the domains of immobility,pain,and psychological distress. For the purpose of this study,overall QOL was calculated as the pooled sums of the domain scores and expressed as mean scores on an ordinal scale of 10. Age did not influence the beneficial effect of nitrate therapy on QOL. Neither did gender,rhythmic disturbances,peripheral artery disease,or the concomitant use of calcium channel blockers or beta blockers. New York Heart Association (NYHA) angina classification was an independent variable: patients with a NYHA class I or II benefited less than did patients with NYHA III or IV (p = 0.02). Obese patients as well as hypertensive patients benefited less (p = 0.04 and 0.02),and smokers tended to benefit less also (p = 0.08). In contrast,hypercholesterolemia and diabetes mellitus improved the beneficial effect of nitrates on QOL (p = 0.03 and 0.05). The authors conclude that patients with coronary artery disease (CAD) and concomitant diabetes mellitus or hypercholesterolemia,a category particularly prone to early endothelial dysfunction and thus dysfunctional endogenous nitric oxide (NO) production,may benefit more from NO-donor therapy than patients without such concomitant conditions.",null,"The Netherlands",2000,"Various","Various","MQOLQ",null,null,"Cohort"]
[32,"Johannigman,M. J.,et al. (2010). \"Medication therapy management and condition care services in a community-based employer setting.\" Am J Health Syst Pharm 67(16): 1362-1367.",null,"Johannigman,M. J.,et al.","Medication therapy management and condition care services in a community-based employer setting","PURPOSE: A program in which health-system pharmacists and pharmacy technicians provide medication therapy management (MTM),wellness,and condition care (disease management) services under contract with local businesses is described. SUMMARY: The health-system pharmacy department's Center for Medication Management contracts directly with company benefits departments for defined services to participating employees. The services include an initial wellness and MTM session and,for certain patients identified during the initial session,ongoing condition care. The initial appointment includes a medication history,point-of-care testing for serum lipids and glucose,body composition analysis,and completion of a health risk assessment. The pharmacist conducts a structured MTM session,reviews the patient's test results and risk factors,provides health education,discusses opportunities for cost savings,and documents all activities on the patient's medication action plan. Eligibility for the condition care program is based on a diagnosis of diabetes,hypertension,asthma,heart failure,or hyperlipidemia or elevation of lipid or glucose levels. Findings are summarized for employers after the initial wellness screening and at six-month intervals. Patients receiving condition care sign a customized contract,establish goals,attend up to four MTM sessions per year,and track their information on a website; employers may offer incentives for participation. When pharmacists recommend adjustments to therapy or cost-saving changes,it is up to patients to discuss these with their physician. A survey completed by each patient after the initial wellness session has indicated high satisfaction. Direct cost savings related to medication changes have averaged $253 per patient per year. Total cost savings to companies in the first year of the program averaged $1011 per patient. For the health system,the program has been financially sustainable. Key laboratory values indicate positive clinical outcomes. CONCLUSION: A business model in which health-system pharmacists provide MTM and condition care services for company employees has demonstrated successful outcomes in terms of patient satisfaction,cost savings,and clinical benefits.",null,"USA",2010,"Diabetes,Hypertension,Various,Hyperlipidemia","Patient Management","Unknown",null,null,"Case Control"]
[33,"Kannan,H.,et al. (2008). \"Economic and humanistic outcomes associated with comorbid type-2 diabetes,high cholesterol,and hypertension among individuals who are overweight or obese.\" J Occup Environ Med 50(5): 542-549.",null,"Kannan,H.,et al.","Economic and humanistic outcomes associated with comorbid type-2 diabetes,high cholesterol,and hypertension among individuals who are overweight or obese","OBJECTIVE: To assess the association of diabetes,hypertension,and high cholesterol with economic and humanistic outcomes among overweight or obese individuals. METHODS: Data were from the 2006 National Health and Wellness Survey and were limited to overweight or obese adults (BMI > 27). Outcomes assessed include the SF-8,resource use,and the Work Productivity and Activity Impairment questionnaire. Independent effects of comorbid conditions were determined using linear regression models. RESULTS: Significant associations between comorbid conditions and outcomes were noted. Comorbid conditions had significant independent effects on outcomes. The presence of all three comorbid conditions was the strongest correlate of work productivity loss (B = 13.992) and activity impairment (B = 13.397) and had the strongest negative association with SF-8 physical (B = -8.239) and mental summary scores (B = -2.605). CONCLUSION: Among,overweight or obese individuals,comorbid conditions are associated with greater productivity loss,resource use,and poorer quality of life.",null,"USA",2008,"Diabetes,Hypertension,Hypercholesterolemia","None","SF-8,WPAI",null,null,"Survey"]
[34,"Kayikcioglu,M. and L. Tokgozoglu (2017). \"The rationale and design of the national familial hypercholesterolemia registries in Turkey: A-HIT1 and A-HIT2 studies.\" Turk Kardiyol Dern Ars 45(3): 261-267.",null,"Kayikcioglu,M. and L. Tokgozoglu","The rationale and design of the national familial hypercholesterolemia registries in Turkey: A-HIT1 and A-HIT2 studies","OBJECTIVE: Familial hypercholesterolemia (FH) is a genetic disease characterized by extremely high levels of cholesterol,leading to premature atherosclerosis. Although many countries have already addressed the burden of FH by means of national registries,Turkey has no national FH registry or national screening program to detect FH. Creation of a series of FH registries is planned as part of Turkish FH Initiative endorsed by the Turkish Society of Cardiology to meet this need. This article provides detailed information on the rationale and design of the first 2 FH registries (A-HIT1 and A-HIT2). METHODS: A-HIT1 is a nationwide survey of adult homozygous FH (HoFH) patients undergoing low-density lipoprotein (LDL) apheresis (LA) in Turkey. A-HIT1 will provide insight into the clinical status of HoFH patients undergoing LA. Primary objective of this cross-sectional study is to identify how HoFH patients on LA are managed. Inclusion criteria are age >12 years,diagnosis of HoFH,and regular LA treatment. All available apheresis centers were electronically invited to participate in the study. The principal physicians of each center will respond to a questionnaire regarding their attitude toward LA. For each patient,another questionnaire will be used to collect data on clinical status,medication use,and disease data. In addition,patients will be asked to complete self-report questionnaires that provide information on quality of life,disease-related anxiety,and depression. A-HIT2 is a registry of adult FH patients presenting at outpatient clinics. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 statistical regions in Turkey based on the EU NUTS classification. Sites specializing in cardiology,internal medicine,and endocrinology were invited to participate. The primary objective of this cross-sectional study is to determine clinical status and management of patients in Turkey diagnosed with FH. Eligibility for screening was defined as having LDL-cholesterol level >160 mg/dL. Inclusion criteria are age >18 years and diagnosis as possible FH (total score of >2 according to Dutch Lipid Clinic Network criteria). In addition to measuring clinical status of patients,a short survey to assess patient level of disease awareness will also be administered. CONCLUSION: A-HIT1 and A-HIT2 are the first nationwide FH registries in Turkey and will provide important information on the management of Turkish FH patients. In addition,it is planned that they will guide establishment of a national policy for the diagnosis and treatment of FH in Turkey.",null,"Turkey",2017,"Familial Hypercholesterolemia","None","Unknown",null,null,"Survey"]
[35,"Kimball, A. B., et al. (2011). \"Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: Subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial.\" Am J Clin Dermatol 12(1): 51-62.",null,"Kimball, A. B., et al.","Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: Subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial","BACKGROUND: Psoriasis is associated with a variety of major physical and mental co-morbidities. OBJECTIVE: To assess the incremental burden of co-morbidities on patient-reported outcomes and evaluate the efficacy and safety of adalimumab in psoriasis patients with co-morbidities. STUDY DESIGN: Data were obtained from the initial 16-week, double-blind treatment period of REVEAL (Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis triAL), a randomized, multicenter, phase III clinical trial. INTERVENTION: Patients with moderate to severe psoriasis were randomized in a 2 : 1 ratio to receive adalimumab 80 mg (two 40 mg injections administered subcutaneously) at baseline followed by one 40 mg injection every other week from week 1 to week 15 or placebo. MAIN OUTCOME MEASURES: Clinical severity (Psoriasis Area and Severity Index [PASI]) and patient-reported outcomes (Dermatology Life Quality Index [DLQI], Short Form 36 [SF-36] health survey, Work Productivity and Activity Impairment [WPAI] questionnaire) were assessed during the trial. The effect of selected co-morbidities (i.e. hypertension, psoriatic arthritis, hyperlipidemia, obesity, depression, other forms of arthritis, diabetes mellitus, and other cardiovascular diseases) on patient-reported outcomes was evaluated using multivariate analysis of covariance models. Subgroup analyses were performed by co-morbidity type to statistically compare the clinical efficacy, patient-reported outcome benefits, and safety of adalimumab with placebo in the presence of these conditions. RESULTS: Study co-morbidities were each independently associated with significantly greater impairment on at least one general patient-reported outcome measured at baseline (all p < 0.05), with the exception of hyperlipidemia. During the 16-week study, adalimumab patients demonstrated significantly greater PASI 75 response rates (defined as a reduction of at least 75% in PASI scores from baseline) compared with placebo patients for all co-morbidity subgroups. Adalimumab provided consistent improvements in DLQI, SF-36 Physical Component Summary and Mental Component Summary scores, and WPAI total scores from baseline to week 16 within co-morbidity subgroups. Rates of serious adverse events (AEs), serious infectious AEs, and AEs leading to discontinuation were comparable between adalimumab and placebo for patients with co-morbidities. CONCLUSIONS: Co-morbidities were associated with additionally impaired health-related quality of life and work productivity in patients with psoriasis. Adalimumab significantly improved efficacy and patient-reported outcomes and was well tolerated in patients with co-morbidities.",null,"USA",2011,"Various","Various","PASI,DLQI,SF-36,WPAI",null,null,"RCT"]
[36,"Kimura, T. and J. Nakamura (2004). \"Health-related quality of life in outpatients of a psychosomatic medicine clinic: a pilot survey in Japan.\" Tokai J Exp Clin Med 29(4): 135-141.",null,"Kimura, T. and J. Nakamura","Health-related quality of life in outpatients of a psychosomatic medicine clinic: a pilot survey in Japan","The objective of this study is to clarify the difference of health-related quality of life (HRQoL) profiles by disease category with the SF-36 questionnaires, and to examine the possibility of application for a longitudinal study. A number of subjects was 536, specifically 127 men and 409 women. For all of the eight domains, Cronbach's alpha exceeded 0.7. Categories in which all of the domains were approximately equal to the national standard included hypertension, neck and shoulders syndrome, diabetes, hyperlipidemia and cardiac disease. Bodily pain was especially lower in gastrointestinal disorder, spondylopathy and hemopathy. Patients with mental disorder had lower scores in all domains. Categories in which 5-7 of the eight domains had lower scores included arthropathy, asthma, chronic hepatitis, autonomic imbalance, 'ovariopathy and hysteropathy' and chronic rheumatism. No significant change was found between the first and second scores in hypertension as a representative of the high HRQoL categories. In mental disorder as a representative of the low HRQoL categories, however, five of the eight domains increased significantly. We concluded that a target disease should be chosen among subjects with low HRQoL scores before an intervention to assess its effectiveness. Or subjects with high HRQoL scores can be examined to determine whether they keep the same level of HRQoL.",null,"Japan",2004,"Hypertension,Diabetes,Hyperlipidemia,Coronary Heart Disease,Various","None","SF-36",null,null,"Survey"]
[37,"Lalonde, L., et al. (1999). \"Conventional and chained standard gambles in the assessment of coronary heart disease prevention and treatment. Canadian Collaborative Cardiac Assessment Group.\" Med Decis Making 19(2): 149-156.",null,"Lalonde, L., et al.","Conventional and chained standard gambles in the assessment of coronary heart disease prevention and treatment. Canadian Collaborative Cardiac Assessment Group","The authors compared the abilities of descriptive and valuational health-related quality-of-life measures to discriminate healthy participants (n=39) from those on diets for dyslipidemia (n=35) and angina patients (n=30). On the rating scale, the time tradeoff, and the General Health Perception subscale of the SF-36 Health Survey, the participants with dyslipidemia or angina reported lower mean scores than the healthy participants. No differences were detected between these groups on conventional or chained standard gamble (SG) scales. The distribution of the conventional and the chained SG scores was very skewed, with the vast majority of scores being equal or very close to the maximum score. It is concluded that in this study the discriminant ability of the chained SG was comparable to that of the conventional SG and inferior to descriptive and non-risky valuational scaling techniques. This may be explained by the distortion of probabilities, by a misunderstanding of the SG chained assessment, and by a strong certainty effect.",null,"Canada",1999,"Hyperlipidemia,Various","None","SF-36",null,null,"Survey"]
[38,"Lederle, F. A. and E. M. Rogers (1990). \"Lowering the cost of lowering the cholesterol: a formulary policy for lovastatin.\" J Gen Intern Med 5(6): 459-463.",null,"Lederle, F. A. and E. M. Rogers","Lowering the cost of lowering the cholesterol: a formulary policy for lovastatin","OBJECTIVES: To describe a medical center policy designed to contain the cost of using the lipid-lowering drug lovastatin in a primary care setting, to examine the effect of the policy on cost containment, and to examine physician acceptance of the policy. SETTING: A Veterans Affairs medical center. INTERVENTIONS: The policy made lovastatin available to physicians when failure of therapy with diet and two first-line drugs was documented on an order form. The form also contained educational information including prices and recommended niacin as the drug treatment of first choice for most patients. DESIGN: To evaluate the effect of the policy, lipid-lowering drug use at the medical center was compared with that at a similar center that did not restrict lovastatin use, and with lipid-lowering drug use in the United States as a whole. A written questionnaire was used to survey physician reaction to the policy. RESULTS: The use of lovastatin as a percentage of total lipid-lowering drug use at the center with the lovastatin policy was one-fourth that at the other center or nationwide, and the use of niacin was four times greater (p less than 0.0001). The estimated savings in drug costs to the center with the lovastatin policy due to these differences was more than $30,000 per year. In the survey of physicians affected by the policy (n = 78, response rate = 100%), less than one-fourth viewed it unfavorably, and 90% favored this policy over restricting the drug to a subspecialty clinic. CONCLUSION: The authors' experience indicates that a formulary policy that permits limited use of an expensive drug in a primary care setting can contain costs in a way that is acceptable to physicians. A policy of this type could be useful to the increasing number of health care provider organizations that cover the cost of outpatient medications.",null,"USA",1990,"Unknown","Lovastatin","Unknown",null,null,"Survey"]
[39,"Leren, T. P., et al. (2008). \"Diagnosis of familial hypercholesterolemia in general practice using clinical diagnostic criteria or genetic testing as part of cascade genetic screening.\" Community Genet 11(1): 26-35.",null,"Leren, T. P., et al.","Diagnosis of familial hypercholesterolemia in general practice using clinical diagnostic criteria or genetic testing as part of cascade genetic screening","BACKGROUND: Too few familial hypercholesterolemia (FH) patients are diagnosed. The most cost-effective strategy to diagnose FH is to examine first-degree relatives of already diagnosed patients. This is referred to as cascade genetic screening. METHODS AND RESULTS: One thousand eight hundred and five first-degree relatives of index patients with molecularly defined FH consented to cascade genetic screening by the use of molecular genetic testing. Of these, 44.8% were mutation carriers and 55.2% were noncarriers. Only 44.2% of the mutation carriers were on lipid-lowering drugs at the time of genetic testing. Of these, only 9.4% had a value for total serum cholesterol below 5 mM. Among adult mutation carriers who were not on lipid-lowering treatment at the time of genetic testing, reductions in total serum cholesterol and low-density lipoprotein cholesterol of 18.4% (p < 0.0001) and 25.3% (p < 0.0001), respectively, were observed 6 months after genetic testing. It is assumed that this improvement in the lipid profile is due to a definite diagnosis obtained by molecular genetic testing. By using the results of genetic testing as the gold standard for diagnosis of FH, data from a questionnaire filled out by the relatives showed that the use of clinical criteria to diagnose FH in general practice had a sensitivity of 46.2% and a specificity of 88.0%. CONCLUSIONS: The use of clinical diagnostic criteria to diagnose FH in general practice identifies only approximately 50% of FH patients. Molecular genetic testing as part of cascade genetic screening is an efficient tool to diagnose patients, leading to significant improvement in the lipid profile. It should therefore be implemented in clinical medicine.",null,"Norway",2008,"Familial Hypercholesterolemia","None","Unknown",null,null,"Cohort"]
[40,"Liu, Z. L., et al. (2011). \"Chinese herbal medicines for hypercholesterolemia.\" Cochrane Database Syst Rev (7): Cd008305.",null,"Liu, Z. L., et al.","Chinese herbal medicines for hypercholesterolemia","BACKGROUND: Hypercholesterolemia is an important key contributory factor for ischemic heart disease and is associated with age, high blood pressure, a family history of hypercholesterolemia, and diabetes. Chinese herbal medicines have been used for a long time as lipid-lowering agents. OBJECTIVES: To assess the effects of Chinese herbal medicines on hypercholesterolemia. SEARCH STRATEGY: We searched the following databases: The Cochrane Library (issue 8, 2010), MEDLINE (until July 2010), EMBASE (until July 2010 ), Chinese BioMedical Database (until July 2010), Traditional Chinese Medical Literature Analysis and Retrieval System (until July 2010), China National Knowledge Infrastructure (until July 2010), Chinese VIP Information (until July 2010), Chinese Academic Conference Papers Database and Chinese Dissertation Database (until July 2010), and Allied and Complementary Medicine Database (until July 2010). SELECTION CRITERIA: We considered randomized controlled clinical trials in hypercholesterolemic participants comparing Chinese herbal medicines with placebo, no treatment, and pharmacological or non-pharmacological interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. We resolved any disagreements with this assessment through discussion and a decision was achieved based by consensus. We assessed trials for the risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting and other sources of bias. MAIN RESULTS: We included 22 randomized trials (2130 participants). The mean treatment duration was 2.3 +/- 1.3 months (ranging from one to six months). Twenty trials were conducted in China and 18 trials were published in Chinese. Overall, the risk of bias of included trials was high or unclear. Five different herbal medicines were evaluated in the included trials, which compared herbs with conventional medicine in six comparisons (20 trials), or placebo (two trials). There were no outcome data in any of the trials on cardiovascular events and death from any cause. One trial each reported well-being (no significant differences) and economic costs. No serious adverse events were observed. Xuezhikang was the most commonly used herbal formula investigated. A significant effect on total cholesterol (two trial, 254 participants) was shown in favor of Xuezhikang when compared with inositol nicotinate (mean difference (MD) -0.90 mmol/L, 95% confidence interval (CI) -1.13 to -0.68) . AUTHORS' CONCLUSIONS: Some herbal medicines may have cholesterol-lowering effects. Our findings have to be interpreted with caution due to high or unclear risk of bias of the included trials.",null,"China",2011,"Hypercholesterolemia","Herbal","Unknown",null,null,"Systematic Review"]
[41,"MacLeod, H. M. and E. M. McNally (2008). \"A pilot study of a family history risk assessment tool for cardiovascular disease.\" J Genet Couns 17(5): 499-507.",null,"MacLeod, H. M. and E. M. McNally","A pilot study of a family history risk assessment tool for cardiovascular disease","This study evaluated the effectiveness of using a family history questionnaire to ascertain patients and families at-risk for inherited cardiovascular disease. A questionnaire composed of 21 questions was developed based on the experience of a cardiovascular genetic counselor. This questionnaire was administered to 39 patients at a University-based cardiology practice reflecting general and specialized aspects of cardiovascular medicine. Using the number and degree of relatedness of relatives reported and limited age of onset information participants were ranked into three familial risk categories. Thirty-nine patients participated in this pilot study. Of the 39 patients, six Mendelian diseases were identified. All individuals surveyed in this study were found to be at high and/or moderate risk for at least one disease based on the family history questionnaire. Twenty-five out of 39 participants (64.1%) were found to be at high risk for at least one cardiovascular disease, and thirty-three out of 39 participants (84.6%) were found to be at moderate risk for at least one disease. A family history of arrhythmia disorders, hypertension, hyperlipidemia, coronary artery disease and diabetes were more likely to be associated with a personal history in family histories of both moderate and high risk. Family history questionnaires in cardiology clinics can be a cost-effective tool for identifying patients and families who are in the greatest need of genetic evaluation and genetic counseling services.",null,"USA",2008,"Hypertension,Hyperlipidemia,Coronary Heart Disease,Diabetes,Various","Unknown","Unknown",null,null,"Survey"]
[42,"Mann, B. S., et al. (2014). \"Association between drug insurance cost sharing strategies and outcomes in patients with chronic diseases: a systematic review.\" PLoS One 9(3): e89168.",null,"Mann, B. S., et al.","Association between drug insurance cost sharing strategies and outcomes in patients with chronic diseases: a systematic review","BACKGROUND: Prescription drugs are used in people with hypertension, diabetes, and cardiovascular disease to manage their illness. Patient cost sharing strategies such as copayments and deductibles are often employed to lower expenditures for prescription drug insurance plans, but the impact on health outcomes in these patients is unclear. OBJECTIVE: To determine the association between drug insurance and patient cost sharing strategies on medication adherence, clinical and economic outcomes in those with chronic diseases (defined herein as diabetes, hypertension, hypercholesterolemia, coronary artery disease, and cerebrovascular disease). METHODS: Studies were included if they examined various cost sharing strategies including copayments, coinsurance, fixed copayments, deductibles and maximum out-of-pocket expenditures. Value-based insurance design and reference based pricing studies were excluded. Two reviewers independently identified original intervention studies (randomized controlled trials, interrupted time series, and controlled before-after designs). MEDLINE, EMBASE, Cochrane Library, CINAHL, and relevant reference lists were searched until March 2013. Two reviewers independently assessed studies for inclusion, quality, and extracted data. Eleven studies, assessing the impact of seven policy changes, were included: 2 separate reports of one randomized controlled trial, 4 interrupted time series, and 5 controlled before-after studies. FINDINGS: Outcomes included medication adherence, clinical events (myocardial infarction, stroke, death), quality of life, healthcare utilization, or cost. The heterogeneity among the studies precluded meta-analysis. Few studies reported the impact of cost sharing strategies on mortality, clinical and economic outcomes. The association between patient copayments and medication adherence varied across studies, ranging from no difference to significantly lower adherence, depending on the amount of the copayment. CONCLUSION: Lowering cost sharing in patients with chronic diseases may improve adherence, but the impact on clinical and economic outcomes is uncertain.",null,"Canada",2014,"Hypertension,Diabetes,Cardiovascular Disease","None","Unknown",null,null,"Systematic Review"]
[43,"Matsumura, J. S., et al. (2013). \"The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II).\" J Vasc Surg 58(1): 73-83.e71.",null,"Matsumura, J. S., et al.","The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II)","OBJECTIVE: Angioplasty and stenting are options for revascularization of symptomatic femoral popliteal disease. Although angioplasty alone is effective in short lesions, longer lesions are often treated with stents. Multiple overlapping stents are expensive and may be associated with stent fracture. This trial evaluated the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery. METHODS: Patients with lesions >4 cm and <18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protege EverFlex Self-Expanding Peripheral Stent System (Covidien, Plymouth, Minn). The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. These were compared with published performance goals. A preplanned analysis was conducted for the primary effectiveness end points at 1 year. Follow-up, including history, ankle-brachial index, patient-reported outcomes, duplex ultrasound assessment, and radiographs, is planned through 3 years. There was core laboratory review of angiograms, ultrasound scans, and plain radiographs. A subgroup of patients was studied with graded treadmill testing. RESULTS: The study enrolled 287 patients (66% male; mean age, 68 years) with stenotic, restenotic, or occluded lesions of the SFA at 44 investigational sites in the United States and Europe. Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%), and prior SFA intervention (41%). The mean lesion length measured by the core laboratory was 89 mm. The mean normal-to-normal lesion length measured by sites was 110 mm. A total of 303 stents were implanted, and 95% of patients received a single stent. No major adverse events occurred at 30 days. At 1 year, primary outcome of duplex ultrasound stent patency was 67.7% in evaluable patients, and among 1-year secondary outcomes, the mean ankle-brachial index increased by 0.25. Walking Improvement Questionnaire scores improved in pain by 33.7, distance by 37.1, speed by 18.6, and stair climbing by 24.7. The Kaplan-Meier estimate of primary patency was 77.2%, primary assisted patency was 86.9%, and secondary patency was 87.3%. Rutherford clinical category improved in 83.5% of patients. Stent fracture rate was 0.4%. Matched absolute claudication distance was 412 feet greater and was not statistically different in this subgroup of 29 individuals. CONCLUSIONS: The results of DURABILITY II (StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol Stent SYstem II) suggest that a new single stent strategy is safe and effective for the treatment of long lesions of the SFA and proximal popliteal arteries at 1 year.",null,"USA",2013,"Various","Various","WIQ",null,null,"Clinical Trial"]
[44,"Mehler, P. S., et al. (2001). \"Russian immigrant cardiovascular risk assessment.\" J Health Care Poor Underserved 12(2): 224-235.",null,"Mehler, P. S., et al.","Russian immigrant cardiovascular risk assessment","Immigration from the former Soviet Union has been increasing. In 1990, there were 454,000 Russian immigrants living in the United States. Lifestyle habits prevalent in Russia, including smoking, alcoholism, and little preventive health, are compelling medical and economic reasons to understand the health status of this population. This study identified a cohort of Russian-born subjects living in Denver to characterize their cardiovascular risk profile. Using a risk assessment questionnaire, 204 Russian immigrants were screened. Seventy-one percent had Medicaid insurance; 14 percent were medically indigent. Those aged 55 to 64 years had a higher prevalence of hyperlipidemia (p < 0.04) and hypertension (p < 0.03) than U.S. counterparts; those age 20 to 34 and 65 to 74 years had a higher prevalence of hypertension (p < 0.00001). Almost half of the participants had two or more cardiac risk factors. Cardiac risk factor identification and intervention programs may help to reduce the health care costs for these patients.",null,"USA",2001,"unknown","Unknown","Unknown",null,null,"Cohort"]
[45,"Mold, J. W., et al. (1998). \"Outcomes of an insurance company-sponsored multichannel chemistry screening initiative.\" J Fam Pract 47(2): 110-117.",null,"Mold, J. W., et al.","Outcomes of an insurance company-sponsored multichannel chemistry screening initiative","BACKGROUND: The use of serum chemistry panels as screening tests has been studied in a variety of clinical and nonclinical settings. None of the studies, however, has attempted to carefully examine any potential harm done to participants, and none has measured the impact on health-related quality of life. METHODS: Consenting participants in an insurance company-sponsored screening initiative completed a questionnaire before and 6 months after having blood drawn for a 25-item chemistry panel and a lipid profile; for men older than 50, a prostate-specific antigen (PSA) test was also done. The prescreening questionnaire included demographic and health information. The postscreening questionnaire included questions about specific outcomes. Included in both questionnaires were single-item measures of self-rated health and self-rated worry about health, and the 17-item Duke Health Profile (DUKE), a measure of health-related quality of life. Various outcomes were examined, including the numbers of new diagnoses, numbers and types of new treatment recommendations, change in self-reported health and worry, and change in DUKE subscale scores. Participants who were potentially helped and those who were potentially harmed by the serum chemistry panels screening program were identified and further characterized. RESULTS: Of the 2249 subjects who satisfactorily completed both questionnaires, 2012 (89%) had at least one abnormal test result, but only 985 of these (49%) remembered having discussed their test results with a physician. A total of 342 individuals received new treatment advice. However, 29 (10%) of them indicated that they would be \"somewhat unlikely\" to \"very unlikely\" to follow it. Following the intervention questionnaire, there were statistically significant average decrements in the General Health, Physical Health, and Pain subscales of the DUKE for participants with abnormal results. Self-rated health status did not change but level of worry about health increased significantly. At least 250 (11%) subjects were potentially helped by the screening initiative, but at least 574 (26%) were potentially harmed by it. CONCLUSIONS: The use of serum chemistry panels as screening tests in nonclinical settings should probably be discouraged, since health-related quality of life is not improved and the intervention may harm more individuals than it benefits.",null,"USA",1998,"Unknown","Unknown","DHP",null,null,"Survey"]
[46,"Nieuwkerk, P. T., et al. (2012). \"Intervention to improve adherence to lipid-lowering medication and lipid-levels in patients with an increased cardiovascular risk.\" Am J Cardiol 110(5): 666-672.",null,"Nieuwkerk, P. T., et al.","Intervention to improve adherence to lipid-lowering medication and lipid-levels in patients with an increased cardiovascular risk","Low levels of statin adherence may compromise treatment outcomes. The aim of this study was to investigate whether nurse-led cardiovascular risk-factor counseling could improve statin adherence and lipid levels without increasing patients' anxiety. Patients with indications for statin therapy for primary or secondary prevention of cardiovascular disease were randomly assigned to receive routine care or extended care (EC) at baseline and at months 3, 9, and 18. Patients in the EC group received a personalized risk-factor passport, showing modifiable and unmodifiable individual risk factors and a graphical presentation of their calculated absolute 10-year cardiovascular disease risk as well as the target risk that could be reached if all modifiable risk factors were optimally treated. Lipid levels were assessed at each visit. Carotid intima-media thickness was measured at baseline and at month 18. Adherence, anxiety, quality of life, symptoms, and smoking status were assessed using a self-administered questionnaire at each visit. A total of 201 patients were included in the study. Statin adherence was significantly higher (p <0.01) and anxiety was significantly lower (p <0.01) in the EC group than in the routine care group. Low-density lipoprotein cholesterol was statistically significantly lower in the EC group than in the routine group (2.66 vs 3.00 mmol/L, respectively, p = 0.024) in primary prevention patients only. Intima-media thickness improved significantly from baseline (p <0.01) in all patients, irrespective of group assignment. In conclusion, cardiovascular risk-factor counseling resulted in improved lipid profiles in primary prevention patients and higher levels of adherence to statins and lower levels of anxiety in all patients.",null,"The Netherlands",2012,"Cardiovascular Disease","Patient Management","Unknown",null,null,"RCT"]
[47,"Nishijima, H., et al. (2007). \"Effects of exercise in overweight Japanese with multiple cardiovascular risk factors.\" Med Sci Sports Exerc 39(6): 926-933.",null,"Nishijima, H., et al.","Effects of exercise in overweight Japanese with multiple cardiovascular risk factors","PURPOSE: The effects of exercise in subjects with multiple cardiovascular risk factors (RF) have never been tested in a large-scale randomized controlled trial. The favorable results from our observational study led to this randomized controlled trial. METHODS: The participants, recruited from a community, were overweight, with two of the following three risk factors: hypertension, hyperlipidemia, or glucose intolerance (N=561; 44% male; mean age (SD) 67 (6); mean BMI 26.4 (2.0)). All participants received a standard health exam with counseling, followed by randomization. The intervention group (INT) was to exercise two to four times per week for 6 months at a fitness club. RESULTS: Dropout rate was 11% for INT and 10% for the controls. INT exercised an average of 2.6 times per week. Among primary outcome measures, there was a marginally significant between-group difference in changes in systolic blood pressure (intervention minus control, -2.46 mm Hg). Reductions in LDL cholesterol (-1.9 mg.dL) and hemoglobin A1c (-0.042%) were not significant. Among secondary outcomes, between-group differences were significantly greater (P<0.05) for INT in mean body weight (-1.60 kg), waist circumference (-1.8 cm), triglyceride (-7 mg.dL), hsCRP (-0.063 mg.L), and estimated VO2peak (2.0 mL.kg.min). All directional mean RF changes consistently favored INT. A cardiovascular risk reduction estimated from the changes in RF was about 24%. A greater improvement was also found in health-related quality-of-life measures (SF-36) in INT. No difference was found in the adverse event rate. CONCLUSIONS: Exercising an average of 2.6 times per week for 6 months produced a significant improvement in cardiovascular risk profile in subjects with multiple cardiovascular risk factors through cumulative results of modest yet pervasive changes in all conventional risk factors, without increased adverse effects.",null,"Japan",2007,"Hypertension,Hyperlipidemia,Various","Behavioural/Education","Unknown",null,null,"RCT"]
[48,"Ock, M., et al. (2015). \"Estimating quality-adjusted life-year loss due to noncommunicable diseases in Korean adults through to the year 2040.\" Value Health 18(1): 61-66.",null,"Ock, M., et al.","Estimating quality-adjusted life-year loss due to noncommunicable diseases in Korean adults through to the year 2040","OBJECTIVES: To estimate the loss in quality-adjusted life-years (QALYs) in Korean adults due to 13 noncommunicable diseases (NCDs) in 2010 and predict changes in QALY loss through to the year 2040. METHODS: Thirteen NCDs (hypertension, diabetes mellitus, hyperlipidemia, stroke, myocardial infarction, angina, arthritis, osteoporosis, asthma, allergic rhinitis, atopic dermatitis, cataract, and depression) were selected from the Korean Community Health Survey 2010. The EuroQol five-dimensional questionnaire index from the Korean Community Health Survey 2010 and the Korean valuation set were used to estimate utility weights according to sex, age, and disease. Morbidity data were also obtained from the Korean Community Health Survey 2010. Mortality data according to disease and life expectancy were retrieved from the Korean Statistical Information Service. To predict future QALY loss, future population projection data from the Korean Statistical Information Service were used as substitutes for 2010 population size. RESULTS: Among the assessed 13 NCDs, the largest total QALY loss was for hypertension (513,113 QALYs; units are omitted hereafter), followed by arthritis (509,317) and stroke (431,049). The largest QALY loss due to mortality was stroke (306,733), whereas the largest QALY loss due to morbidity was arthritis (502,513). By applying the middle estimate of future population, the largest increase in total QALY loss between 2010 and 2040 was for hypertension (840,582), followed by stroke (719,076) and diabetes mellitus (474,607). CONCLUSIONS: Hypertension, arthritis, and stroke are important in terms of total QALY loss, which will continuous to increase because of aging. These results could be used to develop cost-effective interventions that reduce the burden of NCDs.",null,"South Korea",2015,"Hypertension,Diabetes,Hyperlipidemia,Stroke,Coronary Heart Disease,Various","None","EQ-5D",null,null,"Survey"]
[49,"Paulos, C. P., et al. (2005). \"Impact of a pharmaceutical care program in a community pharmacy on patients with dyslipidemia.\" Ann Pharmacother 39(5): 939-943.",null,"Paulos, C. P., et al.","Impact of a pharmaceutical care program in a community pharmacy on patients with dyslipidemia","BACKGROUND: Inappropriate use of medications is a significant problem in health care today. A possible solution to this problem may be achieved through better control of patients' drug therapy. OBJECTIVE: To design a pharmaceutical care program for dyslipidemic patients within a community pharmacy setting that provides education in the areas of medication compliance and lifestyle modifications, while emphasizing the importance of achieving cholesterol goals to ensure improvement in quality of life. METHODS: Patients at an outpatient pharmacy volunteered to be surveyed for 16 weeks. Although both the intervention and control groups were surveyed, the randomly selected intervention group was interviewed more frequently and more comprehensively. Cholesterol, triglycerides, glucose, weight, risk factors, drug-related problems (DRPs), and quality of life were measured via a survey at the onset of the study and continually measured until the study's conclusion. RESULTS: In the intervention group, 26 DRPs were detected, of which 24 were resolved; in the control group, 26 DRPs were detected, of which 5 were resolved. When comparing initial and final blood cholesterol levels in the intervention group, the mean decrease was 27.0 +/- 41.1 mg/dL (p = 0.0266); in the control group, the average blood cholesterol level decreased by a mean of 1.4 +/- 37.2 mg/dL (p = 0.6624). In the intervention group, the triglyceride level decreased an average of 50.5 +/- 80.3 mg/dL (p = 0.0169), while the control group experienced a mean triglyceride level increase of 29.6 +/- 118.5 mg/dL (p = 0.1435). As a result of the intervention, the quality of life in the intervention group was improved. CONCLUSIONS: Short-term pharmaceutical care plans developed in a retail pharmacy within the proper setting may contribute to improved blood lipid values, cardiovascular disease risk factors, and patients' quality of life.",null,"Chile",2005,"unknown","Patient Management","Unknown",null,null,"RCT"]
[50,"Santanello, N. C., et al. (1997). \"Effect of pharmacologic lipid lowering on health-related quality of life in older persons: results from the Cholesterol Reduction in Seniors Program (CRISP) Pilot Study.\" J Am Geriatr Soc 45(1): 8-14.",null,"Santanello, N. C., et al.","Effect of pharmacologic lipid lowering on health-related quality of life in older persons: results from the Cholesterol Reduction in Seniors Program (CRISP) Pilot Study","OBJECTIVE: To determine the effect of lovastatin therapy on health-related quality of life in older persons. DESIGN: A prospective, randomized, double blind clinical trial. SETTING: Four university medical center research clinics. PARTICIPANTS: There were 431 men and women, primarily 65 years of age or older, with low density lipoprotein levels greater than 159 mg/dL and less than 221 mg/dL. Exclusion criteria included a Mini-Mental state score less than 24 or presence of recent cardiovascular events or other serious chronic disease likely to shorten survival. INTERVENTION: All participants were administered the National Cholesterol Education Program step one diet and were then randomized to placebo, 20 mg lovastatin, or 40 mg lovastatin. MEASUREMENTS: Areas of health-related quality of life assessed in the Cholesterol Reduction in Seniors Program (CRISP) included: (1) physical functioning, (2) sleep behavior, (3) social support, (4) depression, (5) cognitive function, and (6) health perception. Three global change questions asked the patients to judge change in general health since starting the study diet or the study medication and change in ability to function or care for self. Although some patients were followed for a total of 12 months, all participants were followed for 6 months, and 6-month data have been used for the primary analysis in this paper. RESULTS: Patients treated with 20 mg of lovastatin had a 17% and 24% reduction in total cholesterol and LDL-cholesterol, respectively. Patients treated with the 40-mg lovastatin dose achieved reductions of 20% for total cholesterol and 28% for LDL-cholesterol. Complaints of possible adverse events were remarkably similar in the two active treatment groups and the placebo group. At 6 months of follow-up there were no statistically significant differences found in mean change scores from baseline between treatment groups on the health-related quality of life measures (physical functioning, sleep, social support, depression, cognitive function scales, health perception) or global questions. CONCLUSIONS: This study demonstrates that lovastatin was extremely well tolerated in an older cohort, both with regard to symptoms and to health-related quality of life.",null,"USA",1997,"Various","Lovastatin","Unknown",null,null,"RCT"]
[51,"Schlenk, E. A., et al. (1998). \"Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36.\" Qual Life Res 7(1): 57-65.",null,"Schlenk, E. A., et al.","Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36","The purpose of this report is to examine health-related quality of life (HRQoL) as measured by the Medical Outcomes Study Short Form-36, across patient populations with chronic disorders and to compare quality of life (QoL) in these subjects with normative data on healthy persons. Six studies, within the Center for Research in Chronic Disorders at the University of Pittsburgh School of Nursing, in patients with urinary incontinence, prostate cancer, chronic obstructive pulmonary disease (COPD), acquired immune deficiency syndrome (AIDS), fibromyalgia and hyperlipidaemia provided the data for analysis. The results demonstrated that not only did the prostate cancer and hyperlipidaemia patients have the highest QoL across the chronic disorders, but their QoL was comparable to normative data on healthy persons. Homebound, elderly, incontinent patients had the lowest QoL for physical functioning, whereas patients hospitalized with AIDS had the lowest QoL in general health and social functioning. Patients with COPD had the lowest QoL in role-physical, role-emotional and mental health. Patients with fibromyalgia had the lowest QoL in bodily pain and vitality. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia generally had lower QoL. Prostate cancer and hyperlipidaemia patients had QoL comparable to normative data. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia had more variability for role-emotional. AIDS patients had more variability on physical functioning, bodily pain and social functioning compared to the normative data. These data suggest that patients with various chronic disorders may have QoL that is lower in most domains compared to a healthy population. However, there may be differences in the domains affected as well as the extent of variation across specific chronic disorders.",null,"USA",1998,"Various,Hyperlipidemia","None","SF-36",null,null,"Survey"]
[52,"Seed, M. and M. R. Weir (1999). \"Double-masked comparison of the quality of life of hypercholesterolemic men treated with simvastatin or pravastatin. International Quality of Life Multicenter Group.\" Clin Ther 21(10): 1758-1770.",null,"Seed, M. and M. R. Weir","Double-masked comparison of the quality of life of hypercholesterolemic men treated with simvastatin or pravastatin. International Quality of Life Multicenter Group","The efficacy, safety, and impact on quality of life of once-daily treatment with simvastatin 20 mg and pravastatin 40 mg were compared in a multinational, randomized, double-masked trial involving 387 men 21 to 72 years of age with primary mild-to-moderate hypercholesterolemia. The trial consisted of a 12-week baseline period, which included 6 weeks of single-masked placebo administration, and a 12-week double-masked active treatment period. Throughout the trial, patients were maintained on a standard lipid-lowering diet. Efficacy variables were plasma lipid levels and a measurement of health-related quality of life evaluated by means of a self-administered questionnaire (the Nottingham Health Profile [NHP]) and other questionnaires related to general health, sexual function, and stress/life events. Clinic visits were scheduled at study entry (week -12), at initiation and week 5 of placebo (weeks -6 and -1, respectively); at randomization (week 1, day 1); and after 4, 8, and 12 weeks of active treatment. At each visit, blood samples were collected for determination of lipid levels and the NHP, the principal measure of health-related quality of life, was administered. Primary safety measures were adverse events and laboratory test results. All statistical comparisons were two-sided, and significance was defined as P< or =0.05 except for the NHP questionnaire, which was P< or =0.01. Treatment with simvastatin 20 mg/d for 12 weeks (n = 194) resulted in significantly greater reductions in plasma total cholesterol and low-density lipoprotein cholesterol levels (25.7% and 33.6%, respectively) compared with pravastatin 40 mg/d for 12 weeks (n = 193) (19.0% and 26.3%, respectively) (P<0.001). No detrimental effects on health-related quality-of-life measurements were reported with either drug. A small but statistically significant improvement in emotional reaction from baseline (P<0.001) was observed after 12 weeks of treatment with simvastatin. At least 75% of simvastatin-treated patients indicated no change in response from baseline on NHP domain scores; these findings were similar to those for pravastatin-treated patients. The differences in the changes in lipid profiles between the 2 treatment groups were not associated with any observed differences in tolerability or health-related quality-of-life measures.",null,"UK",1999,"Hypercholesterolemia","Simvastatin","NHP",null,null,"RCT"]
[53,"Shams, T., et al. (2017). \"Baseline Quality of Life and Risk of Stroke in the ALLHAT Study (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial).\" Stroke 48(11): 3078-3085.",null,"Shams, T., et al.","Baseline Quality of Life and Risk of Stroke in the ALLHAT Study (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial)","BACKGROUND AND PURPOSE: The visual analogue scale is a self-reported, validated tool to measure quality of life (QoL). Our purpose was to determine whether baseline QoL predicted strokes in the ALLHAT study (Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial) and evaluate determinants of poststroke change in QoL. In the ALLHAT study, among the 33 357 patients randomized to treatment arms, 1525 experienced strokes; 1202 (79%) strokes were nonfatal. This study cohort includes 32 318 (97%) subjects who completed the baseline visual analogue scale QoL estimate. METHODS: QoL was measured on a visual analogue scale and adjusted using a Torrance transformation (transformed QoL [TQoL]). Kaplan-Meier curves and adjusted proportional hazards analyses were used to estimate the effect of TQoL on the risk of stroke, on a continuous scale (0-1) and by quartiles (</=0.81, >0.81</=0.89, >0.89</=0.95, >0.95). We analyzed the change from baseline to first poststroke TQoL using adjusted linear regression. RESULTS: After adjusting for multiple stroke risk factors, the hazard ratio for stroke events for baseline TQoL was 0.93 (95% confidence interval, 0.89-0.98) per 0.1 U increase. The lowest baseline TQoL quartile had a 20% increased stroke risk (hazard ratio=1.20 [95% confidence interval, 1.00-1.44]) compared with the reference highest quartile TQoL. Poststroke TQoL change was significant within all treatment groups (P</=0.001). Multivariate regression analysis revealed that baseline TQoL was the strongest predictor of poststroke TQoL with similar results for the untransformed QoL. CONCLUSIONS: The lowest baseline TQoL quartile had a 20% higher stroke risk than the highest quartile. Baseline TQoL was the only factor that predicted poststroke change in TQoL. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000542.",null,"USA",2017,"Various","Unknown","VAS",null,null,"RCT"]
[54,"Shayani, V., et al. (2012). \"Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years.\" Postgrad Med 124(4): 181-188.",null,"Shayani, V., et al.","Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years","BACKGROUND: The objective of this analysis is to report interim, 2-year results for morbidly obese patients who have undergone laparoscopic adjustable gastric banding in the LAP-BAND AP(R) EXperience (APEX) trial. METHODS: The APEX trial is an ongoing, multicenter, prospective, open-label, 5-year study of the LAP-BAND AP(R) System (LBAP) in 517 morbidly obese patients at 50 clinical centers in the United States. Last observation carried forward was used in the analyses of change in body weight and comorbid conditions, and observed data were analyzed for the Obesity and Weight-Loss Quality of Life (OWLQOL) questionnaire. Changes in body weight, percent weight loss, percent excess weight loss, body mass index (BMI), OWLQOL score, remission or improvement in obesity-related comorbid conditions, and adverse events were reported. RESULTS: At baseline, 81.5% of patients were female, and 85.8% were white. The mean age was 42.5 years, and the mean BMI was 44.0 kg/m(2). More than 85% of patients had >/= 1 obesity-related comorbidity. At 2 years, the mean BMI change was -8.5 kg/m(2), and the mean percent weight loss was -19.3%. Responses to all questions on the OWLQOL questionnaire had a mean improvement of 54% (range, 26%-67%) at 2 years. Obesity-related comorbid conditions were remitted or improved in the majority of patients at 2 years, including type 2 diabetes mellitus (96%), hypertension (91%), gastroesophageal reflux disease (91%), hyperlipidemia (77%), obstructive sleep apnea (86%), depression (75%), and osteoarthritis (93%). The LBAP and its implantation were well tolerated, with 19.1% and 6.0% of patients reporting device-related adverse events or serious device-related adverse events, respectively. CONCLUSION: The LBAP safely and effectively facilitated weight loss in morbidly obese patients, with clinically meaningful improvements in quality of life and obesity-related comorbidities. The durability of these results will be further described with additional follow-up through 5 years. TRIAL REGISTRATION: www.ClinicalTrials.gov identifier NCT00501085.",null,"USA",2012,"Various","Bariatrics","OWLQOL",null,null,"Clinical Trial"]
[55,"Shephard, M. D., et al. (2009). \"Evaluation of a training program for device operators in the Australian Government's Point of Care Testing in General Practice Trial: issues and implications for rural and remote practices.\" Rural Remote Health 9(3): 1189.",null,"Shephard, M. D., et al.","Evaluation of a training program for device operators in the Australian Government's Point of Care Testing in General Practice Trial: issues and implications for rural and remote practices","INTRODUCTION: From September 2005 to February 2007 the Australian Government funded the Point of Care Testing (PoCT) in General Practice Trial, a multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost-effectiveness and satisfaction of PoCT in General Practice. In total, 53 practices (23 control and 30 intervention) based in urban, rural or remote locations across three states (South Australia [SA], New South Wales [NSW] and Victoria [VIC]) participated in the Trial. Control practices had pathology testing performed by their local laboratory, while intervention practices conducted pathology testing by PoCT. In total, 4968 patients (1958 control and 3010 intervention) participated in the Trial. The point-of-care (PoC) tests performed by intervention practices were: haemoglobin A1c (HbA1c) and urine albumin:creatinine ratio (ACR) on patients with diabetes, total cholesterol, triglyceride and high density lipoprotein (HDL) cholesterol on patients with hyperlipidaemia, and international normalised ratio (INR) on patients on anticoagulant therapy. Three PoCT devices measured these tests: the Siemens DCA 2000 (Siemens HealthCare Diagnostics, Melbourne, VIC, Australia) for HbA1c and urine ACR; Point of Care Diagnostics Cholestech LDX analyser (Point of Care Diagnostics; Sydney, NSW, Australia) for lipids; and the Roche CoaguChek S (Roche Diagnostics; Sydney, NSW, Australia) for INR. Point-of-care testing in the General Practice Trial was underpinned by a quality management framework which included an on-going training and competency program for PoCT device operators. This article describes the design, implementation and results of the training and competency program. METHODS: An education and training resource package was developed for the Trial consisting of a training manual, a set of A3 laminated posters and a CD ROM. Five initial training workshops were held for intervention practices from each geographic region between August and October 2005 at three centres - Adelaide (SA), Bendigo (VIC) and Dubbo (NSW). These workshops combined theoretical training in the principles and practice of PoCT with 'hands on' practical training delivered in interactive small group sessions. At the completion of training, practice staff undertook a written and practical competency assessment and received a certificate of competency as a qualified device operator. Following each initial training workshop, practice staff completed a short satisfaction survey. Five refresher training workshops covering all geographic regions were delivered during late August 2006, coinciding with the 12 month point of the live phase of the Trial. At the completion of the Trial in February 2007, device operators completed a further questionnaire. RESULTS: Sixty device operators from 31 practices completed training and competency assessment as part of the Initial Training Workshop series. A further 20 device operators from 12 of the practices were trained in the 12 month period after the initial workshops; 19 of these staff were from rural or remote practices. In total 80 device operators comprising 74 practice staff and six GPs from 31 practices were trained and received competency certificates as part of Trial. In all, 19 device operators left the Trial either through personal resignation from an existing practice or because their practice withdrew from the Trial; the majority (84%) were from rural and remote practices. A total of 42 device operators from 25 practices attended refresher training in the second half of 2006. Results from the satisfaction questionnaire completed by device operators following the initial training workshops showed there was unanimous agreement that the posters were useful for the conduct of daily PoCT and practical training in small groups was satisfactory as a training method. The quality and appropriateness of the PoCT training resources and the workshop overall was rated as either good or excellent by all respondents (100% and 78%, respectively). The responses by device operators to the post-Trial satisfaction questionnaire found a high level of satisfaction with PoCT across all geographic regions. Device operators from remote practices had the highest satisfaction levels for quality of training, usefulness of the training manual, ease of use of devices, confidence in the accuracy of PoCT results and preference for PoCT over laboratory testing. The usefulness of the posters for conducting PoCT achieved the highest satisfaction rating among operators from all three geographic regions. However the highest staff turnover rates and the highest number of requests for training of additional staff were from rural and remote practices. CONCLUSION: The methods established for the implementation and delivery of training and competency assessment for the PoCT in General Practice Trial were appropriate and effective. Results of the evaluation showed rural and remote practices have a greater need for training and support compared to their urban counterparts and may require more flexible training options to cater for much higher rates of staff turnover.",null,"Australia",2009,"Diabetes,Hyperlipidemia","Behavioural/Education","Unknown",null,null,"Survey"]
[56,"Shibley, M. C. and C. B. Pugh (1997). \"Implementation of pharmaceutical care services for patients with hyperlipidemias by independent community pharmacy practitioners.\" Ann Pharmacother 31(6): 713-719.",null,"Shibley, M. C. and C. B. Pugh","Implementation of pharmaceutical care services for patients with hyperlipidemias by independent community pharmacy practitioners","OBJECTIVE: To implement and evaluate pharmaceutical care services for patients with hyperlipidemias in the community pharmacy setting, to evaluate the results of a pharmaceutical care training process for pharmacists by using an assessment quiz, and to measure patient outcomes resulting from provision of pharmaceutical care to patients with hyperlipidemia. DESIGN: A prospective study was conducted over a 1-year period. Patients served as their own controls. SETTING: Two independent community pharmacies in Richmond, Virginia. PARTICIPANTS: Twenty-five adult patients with confirmed dyslipidemias completed the study. INTERVENTIONS: Study pharmacists assessed each patient and assisted in setting therapeutic goals; patients also completed a visit with a registered dietitian. Drug therapy recommendations were made to physicians by the pharmacist when appropriate. Follow-up was scheduled with the pharmacist to ensure positive outcomes and reduce adverse effects. MAIN OUTCOME MEASURES: Fasting lipoprotein profiles were measured initially and at 6 and 12 months. The SF-36 survey, the MacKeigan-Larson satisfaction survey, and a patient opinion survey were administered initially and at the conclusion of the study. RESULTS: Total cholesterol and low-density lipoprotein cholesterol values were significantly decreased at 12 months compared with either the baseline or 6-month values (p < 0.02). Significant improvement was found in several domains of the surveys; quality of life, patient satisfaction with pharmacy services, and patient opinions on the role of the pharmacist improved after the intervention. CONCLUSIONS: Pharmaceutical care may positively affect lipid values, quality of life, and patient satisfaction.",null,"USA",1997,"Hyperlipidemia","Patient Management","SF-36,MKLSS",null,null,"Clinical Trial"]
[57,"Sipetic, S., et al. (2013). \"The burden of disease preventable by risk factor reduction in Serbia.\" Vojnosanit Pregl 70(5): 445-451.",null,"Sipetic, S., et al.","The burden of disease preventable by risk factor reduction in Serbia","BACKGROUND/AIM: Reliable and comparable analysis of health risks is an important component of evidence-based and preventive programs. The aim of this study was to analyze the impact of the most relevant avoidable risk factors on the burden of the selected conditions in Serbia. METHODS: Attributable fractions were calculated from the survey information on the prevalence of a risk factor and the relative risk of dying if exposed to a risk factor. The population-attributable risks were applied to deaths, years of life lost due to premature mortality (YLL), years of life with disability (YLD) and disability adjusted life years (DALY). RESULTS: More than 40% of all deaths and of the total YLL are attributable to cigarette smoking, overweight, physical inactivity, inadequate intake of fruit and vegetables, hypertension and high blood cholesterol. Alcohol consumption has in total a beneficial effect. According to the percent of DALY for the selected conditions attributable to the observed risk factors, their most harmful effects are as follows: alcohol consumption on road traffic accidents; cigarette smoking on lung cancer; physical inactivity on cerebrovascular disease (CVD), ischemic heart disease (IHD) and colorectal cancer; overweight on type 2 diabetes; hypertension on renal failure and CVD; inadequate intake of fruit and vegetables on IHD and CVD, and high blood cholesterol on IHD. CONCLUSIONS: This study shows that a high percentage of disease and injury burden in Serbia is attributable to avoidable risk factors, which emphasizes the need for improvement of relevant preventive strategies and programs at both individual and population levels. Social preferences should be determined for a comprehensive set of conditions and cost effectiveness analyses of potential interventions should be carried out. Furthermore, positive measures, derived from health, disability and quality of life surveys, should be included.",null,"Serbia",2013,"Unknown","None","Unknown",null,null,"Survey"]
[58,"Smets, E. M., et al. (2008). \"Health-related quality of life of children with a positive carrier status for inherited cardiovascular diseases.\" Am J Med Genet A 146a(6): 700-707.",null,"Smets, E. M., et al.","Health-related quality of life of children with a positive carrier status for inherited cardiovascular diseases","Familial hypercholesterolemia, hypertrophic cardiomyopathy, and long QT Syndrome are genetic cardiovascular conditions which may lead to sudden cardiac death at a young age. Preventive measures include lifestyle modifications, medications, and/or cardiac devices. Hence, identification of carrier children can protect them for the potentially life threatening consequences at a young age. Yet, informing children about their genetic risk status and subjecting them to treatment may have negative consequences. This preliminary study aimed to explore (1) how the health-related quality of life of carrier children compares to the quality of life of Dutch children in general; and (2) to what extent the carrier children's quality of life and their parents' perception thereof concur. Our method involved carrier children (n = 35), aged between 8 and 18 years, and their parents (n = 37) who completed a self-report questionnaire. Children's health-related quality of life was assessed with a children and parent version of the KIDSCREEN. Dutch reference data were available from a representative national sample. Our results show no statistically significant differences in scores between carrier children and the reference group. Also, no differences were found between carrier children and their parents' ratings, with the exception of the scale \"psychological well being\". Parents rated their child's psychological well being significantly lower. We identified no problems with the well-being of carrier children as compared to a representative sample of peers. This may offer some initial reassurance to those who have concerns about the implications of genetically testing children for one of these cardiovascular conditions. Yet, attention to possible problems in these children remains warranted.",null,"The Netherlands",2008,"Familial Hypercholesterolemia,Various","None","KIDSCREEN",null,null,"Survey"]
[59,"Spence, J. D., et al. (1995). \"Combination therapy with colestipol and psyllium mucilloid in patients with hyperlipidemia.\" Ann Intern Med 123(7): 493-499.",null,"Spence, J. D., et al.","Combination therapy with colestipol and psyllium mucilloid in patients with hyperlipidemia","OBJECTIVE: To test whether combining psyllium mucilloid with half the usual dose of colestipol reduces the adverse effects associated with colestipol and maintains or increases its efficacy in the treatment of hyperlipidemia. This strategy might make bile acid sequestrants, which are seldom used because they cause adverse effects such as bloating and constipation, more tolerable and less expensive. DESIGN: A randomized, parallel-group, double-blind, controlled trial. SETTING: An outpatient clinic in a tertiary care hospital. PATIENTS: 121 patients who had moderate primary hypercholesterolemia (total cholesterol level > 6 mmol/L and < 8 mmol/L; triglyceride level < 3 mmol/L) after following a low-fat diet for 1 year (National Cholesterol Education Program Step Two diet). INTERVENTION: 5 g of cellulose placebo; 5 g of colestipol; 2.5 g of colestipol plus 2.5 g of psyllium; or 5 g of psyllium three times daily before meals for 10 weeks. MAIN OUTCOME MEASURES: At baseline and at weeks 4 and 10, fasting blood lipid levels and apoprotein concentrations were measured and a quality-of-life instrument was completed. RESULTS: A combination of 2.5 g of psyllium and 2.5 g of colestipol was better tolerated than and as effective as either 5 g of colestipol alone or 5 g of psyllium alone. The combination therapy and colestipol alone did not differ significantly with respect to changes in individual lipid values. The ratio of total cholesterol to high-density lipoprotein cholesterol (HDL) was reduced by 18.2% (95% CI, 12.3% to 24%) with the combination therapy; by 10.6% (CI, 2.0% to 15.4%) with colestipol alone; by 6.1% (CI, 1.5% to 10.6%) with psyllium alone; and by 0.1% (CI, -4.8% to 7%) with placebo (P = 0.0002). Combination therapy reduced the ratio of total cholesterol to HDL significantly more than did colestipol alone or psyllium alone (P < 0.05). CONCLUSIONS: These findings suggest that adding psyllium to half the usual dose of bile acid sequestrant resins maintains the efficacy and improves the tolerability of these resins.",null,"Canada",1995,"Hyperlipidemia","Herbal,Colestipol","Unknown",null,null,"RCT"]
[60,"Stasiewski, E., et al. (2015). \"Mental symptoms and quality of life in lipoprotein apheresis patients in comparison to hemodialysis patients, platelet donors and normal population.\" Atheroscler Suppl 18: 233-240.",null,"Stasiewski, E., et al.","Mental symptoms and quality of life in lipoprotein apheresis patients in comparison to hemodialysis patients, platelet donors and normal population","BACKGROUND: Despite the fact that extracorporeal methods such as lipoprotein apheresis (LA) and hemodialysis (HD) are highly effective in improving the physical status of patients, these treatment options may possibly harm the psychological status and the health related quality of life (HRQL). METHODS: The occurrences of anxiety, depression and the HRQL of 111 study participants treated with LA (n = 41), HD (n = 41) or undergoing plateletpheresis (PD) (n = 29) were compared to the normal population (NP), using standardized questionnaires (anxiety and depression: Hospital Anxiety and Depression Scale (HADS), heart-focused anxiety: Cardiac Anxiety Questionnaire (CAQ) and HRQL: Short-Form Health Survey (SF-12)). Additionally, the subjective mental and physical stress of study participants was evaluated. RESULTS: LA females had a significantly elevated HADS-A score compared to PD and NP. Additionally, there was a trend toward higher HADS-A scores in the LA group compared to the HD group in females. In HD males HADS-A and -D scores increased compared to PD and NP. The CAQ revealed a significant increase in the CAQ-Fear scale in LA compared to HD and PD participants. The CAQ-Avoidance score showed significantly increased scores in LA and HD patients compared to PD and NP. In the CAQ-Attention scale the LA patients also showed significantly increased scores compared to PD and NP. The increased psychological symptoms were associated with significantly lower levels of objective and subjective HRQL in LA and HD patients compared to PD and NP. CONCLUSIONS: LA and HD patients had similarly increased presence of psychological symptoms with concurrent decreased quality of life compared to PD and the normal population, which may affect the outcome of the LA patients. Therefore, early psychosomatic screening and probable psychosomatic treatment should be performed.",null,"Germany",2015,"Unknown","Various,Lipoprotein Apheresis","HADS,CAQ,SF-12",null,null,"Survey"]
[61,"Stewart, P. M., et al. (2016). \"Exploring Inpatient Hospitalizations and Morbidity in Patients With Adrenal Insufficiency.\" J Clin Endocrinol Metab 101(12): 4843-4850.",null,"Stewart, P. M., et al.","Exploring Inpatient Hospitalizations and Morbidity in Patients With Adrenal Insufficiency","CONTEXT: Patients with adrenal insufficiency (AI) (primary AI [PAI], secondary AI due to a pituitary disorder [PIT] and congenital adrenal hyperplasia [CAH]) have reduced life expectancy; however, the underlying explanation remains unknown. OBJECTIVE: To evaluate characteristics, comorbidities, and hospitalizations in AI patients. DESIGN: Retrospective observational. SETTING AND POPULATION: Using a United States-based national payer database comprising of more than 108 million members, strict inclusion criteria including diagnostic codes and steroid prescription records were used to identify 10 383 adults with AI; 1014 with PAI, 8818 with PIT, and 551 with CAH. Patients were matched 1:1 to controls, based on age (+/-5 y), gender, insurance, and region and followed for more than 12 months. INTERVENTION: None. MAIN OUTCOME MEASURES: Demographic variables, comorbidities (diabetes mellitus [DM] types 1 and 2, depression, anxiety, hyperlipidemia, hypertension) and hospitalization incidence. RESULTS: Compared with controls, patients with AI had higher odds of DM, hypertension, hyperlipidaemia, depression, and anxiety, ranging from an odds ratio (OR) of 1.51 for hyperlipidaemia in PAI to 3.85 for DM in CAH. Odds of having DM (OR, 3.85; 95% confidence interval, 2.52-5.90) or anxiety (OR, 2.99; 95% confidence interval, 2.02-4.42) compared with controls were highest in CAH, whereas depression was highest in PAI and PIT (OR, 2.40 and 2.55). ORs of hyperlipidaemia and hypertension (OR, 1.98 and 2.24) were highest in the PIT cohort. Inpatient admissions were more frequent in PAI (4.64:1; P < .0001) and PIT (4.00:1; P < .0001) than controls; infection was the most common cause for admission. CONCLUSION: Patients with AI carry a significant metabolic and psychiatric burden, with higher risk of comorbidities and hospital admissions than matched controls.",null,"UK",2016,"Various","none","Unknown",null,null,"Cohort"]
[62,"Steyn, K., et al. (1996). \"Apolipoprotein B levels and related factors in a rural white South African community--the CORIS study. Coronary Risk Factor Study.\" S Afr Med J 86(4): 359-364.",null,"Steyn, K., et al.","Apolipoprotein B levels and related factors in a rural white South African community--the CORIS study. Coronary Risk Factor Study","OBJECTIVE: In a survey of the Coronary Risk Factor Study (CORIS), apolipoprotein B (apoB) levels were determined to ascertain their impact on coronary heart disease (CHD) risk. Other CHD risk factors associated with apoB were also identified. DESIGN: Cross-sectional analytical study, which included CHD risk factor and dietary questionnaires, electrocardiography, anthropometric and blood pressure measurements, and a blood sample for a lipid profile. SETTING AND PARTICIPANTS: The three districts of Riversdale, Robertson and Swellendam in the south-western Cape; a 25% random sample of 1,528 white respondents aged 15-68 years. RESULTS: Men tended to have higher mean apoB levels than women. Classification of CHD risk by apoB levels and total cholesterol (TC) levels did not correspond, as only 61% of men and 58.5% of women were classified in the same risk categories. Respondents in the highest apoB risk category reported a medical history of hypercholesterolaemia and hypertension more frequently than those in lower categories. There was a significant increase from the low to the high apoB risk category of TC, low-density lipoprotein (LDL) cholesterol, triglyceride levels, body mass index and percentage body fat. Using stepwise multiple regression, 84.9% of the variation in apoB of men and 85.8% in apoB of women were accounted for by significantly associated variables. CONCLUSION: Although apoB may be a better predictor of CHD than TC or LDL cholesterol concentrations, its easy approximation with the formula (TC-HDLC)/2 + 20, high cost, measurement variability and an approach in management similar to that for raised TC discourage its routine use in the screening of patients for CHD.",null,"South Africa",1996,"Coronary Heart Disease","Unknown","Unknown",null,null,"Cohort"]
[63,"Tatlock, S., et al. (2017). \"Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection.\" Value Health 20(3): 430-440.",null,"Tatlock, S., et al.","Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection","BACKGROUND: Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, significantly reduces low-density lipoprotein cholesterol, but requires subcutaneous injections rather than oral pills. To measure patients' acceptance of this treatment modality, a new patient-reported outcome, the Injection-Treatment Acceptance Questionnaire (I-TAQ), was developed. OBJECTIVES: To psychometrically evaluate the I-TAQ with patients at high risk of cardiovascular events receiving alirocumab. METHODS: The 22-item, 5-domain I-TAQ was administered cross-sectionally to 151 patients enrolled in alirocumab clinical trials. Item response distributions, factor and multitrait analyses, interitem correlations, correlations with an existing measure of acceptance (convergent validity), and comparison of known-groups were performed to assess the I-TAQ's psychometric properties. RESULTS: Completion rates were high, with no patients missing more than two items and 91.4% missing no data. All items displayed high ceiling effects (>30%) because of high treatment acceptance. Factor analysis supported the a priori hypothesized item-domain structure with good fit indices (root mean square error approximation = 0.070; comparative fit index = 0.988) and high factor loadings. All items demonstrated item convergent validity (item-scale correlation >/=0.40), except for the side effects domain, which was limited by small numbers (n = 46). Almost all items correlated most highly with the domain to which they were assigned (item discriminant validity). Internal reliability was acceptable for all domains (Cronbach alpha range 0.72-0.88) and convergent validity was supported by a logical pattern of correlations with the Chronic Treatment Acceptance Questionnaire. CONCLUSIONS: These findings provide initial evidence of validity and reliability for the I-TAQ in patients treated with subcutaneous alirocumab. The I-TAQ could prove to be a valuable patient-reported outcome for therapies requiring subcutaneous injection.",null,"UK,USA",2017,"unknown","Alirocumab","I-TAQ",null,null,"Cohort"]
[64,"Tonstad, S. (1996). \"Familial hypercholesterolaemia: a pilot study of parents' and children's concerns.\" Acta Paediatr 85(11): 1307-1313.",null,"Tonstad, S.","Familial hypercholesterolaemia: a pilot study of parents' and children's concerns","OBJECTIVE: To assess psychosocial concerns of families with familial hypercholesterolaemia. METHODS: One-hundred-and-fifty-four single or pairs of parents of children age 6 - 16 years responded to a specifically designed questionnaire. One child from each family was interviewed. RESULTS: Eleven percent of parents thought that their quality of life would have been better had they not known about the disease. None agreed totally that they wished the diagnosis had not been made. However, 20% reported familial conflicts and 8% that their child's emotional or social life had been adversely affected. Conflicts and adverse effects were associated with higher scores on the Child Behaviour Checklist (CBCL). Among the children, worry about cardiovascular disease (affirmed by 22%) was related to male sex and CBCL score. RELEVANCE: Most families do not indicate that they have experienced psychosocial problems due to familial hypercholesterolaemia. Parental ratings of the child's behavioural adjustment may identify vulnerable children.",null,"Norway",1996,"Familial Hypercholesterolemia","none","Unknown",null,null,"Survey"]
[65,"Tsai, W. L., et al. (2004). \"Impact of obesity on medical problems and quality of life in Taiwan.\" Am J Epidemiol 160(6): 557-565.",null,"Tsai, W. L., et al.","Impact of obesity on medical problems and quality of life in Taiwan","Little is known about the impact of obesity on medical problems and quality of life for people in the Asia-Pacific region. This January 2002-June 2003 cross-sectional study surveyed 6,318 Taiwanese (3,540 men and 2,778 women) visiting health screening centers in southern Taiwan. The authors used the body mass index classification endorsed by the World Health Organization for people in this region. Information was collected on 15 medical problems and quality of life outcomes, measured by the Medical Outcomes Study Short Form 36 questionnaire. After adjustment for age, lifestyle, and sociodemographic factors, and after comparison of subjects with those not overweight or obese (reference group), an increasing trend of body mass index effects based on this reference category was observed on hypertension, hypercholesterolemia, hypertriglyceridemia, type II diabetes, hyperuricemia, pulmonary function impairment, fatty liver disease, and osteoarthritis in both sexes (p <0.01). Concerning quality of life, an increasing trend of body mass index effects was also observed on the outcomes physical functioning and bodily pain for both sexes and role limitation due to physical problems for women (p <0.05). Specifically, only the physical functioning domain, including daily activities such as climbing stairs, bending, walking, or some moderate activities, was significantly associated with obesity and was limited to class II obesity.",null,"Taiwan",2004,"Hypertension,Hypercholesterolemia,Hypertriglyceridemia,Diabetes,various","none","SF-36",null,null,"Survey"]
[66,"Usher-Smith, J. A., et al. (2007). \"Evaluation of the cost savings and clinical outcomes of switching patients from atorvastatin to simvastatin and losartan to candesartan in a Primary Care setting.\" Int J Clin Pract 61(1): 15-23.",null,"Usher-Smith, J. A., et al.","Evaluation of the cost savings and clinical outcomes of switching patients from atorvastatin to simvastatin and losartan to candesartan in a Primary Care setting","This study was carried out in a Primary Care practice in the UK to assess the clinical and practical implications, cost savings and patients' perspective of switching to generic drugs. In the 70 patients switched from atorvastatin to simvastatin there was no significant change in mean total cholesterol 4 months after the switch (4.07 +/- 0.55 mmol/L prior to the switch and 4.10 +/- 0.73 mmol/L post-switch) and only one patient switched back because of side effects. One hundred and fifteen patients were switched from losartan to candesartan. Seven switched back but in those that remained on candesartan there was a small, significant (p = 0.0006), reduction in blood pressure after the switch (138.9/78.7 +/- 13.2/7.0 to 136.3/76.1 +/- 14.7/8.4 mmHg). No adverse events attributable to the switch were reported in either group and the net annualised savings for the year 2005-2006 were 12,715.58 pounds for the statin and 13,374.40 pounds for the antihypertensive switch, respectively.",null,"UK",2007,"unknown","Various,Simvastatin","Unknown",null,null,"Cohort"]
[67,"Weir, M. R., et al. (1996). \"Comparison of the effects on quality of life and of the efficacy and tolerability of lovastatin versus pravastatin. The Quality of Life Multicenter Group.\" Am J Cardiol 77(7): 475-479.",null,"Weir, M. R., et al.","Comparison of the effects on quality of life and of the efficacy and tolerability of lovastatin versus pravastatin. The Quality of Life Multicenter Group","This multicenter study compared the effects of lovastatin (40 mg) and pravastatin (40 mg) on quality of life. Men, aged 20 to 65 years old, with primary hypercholesterolemia (types IIa and IIb) were eligible for enrollment if baseline low-density lipoprotein cholesterol met the first National Cholesterol Education Program adult treatment guidelines. Eligible patients were enrolled into a 6-week diet baseline period, followed by a 6-week diet-plus-placebo period. Patients whose low-density lipoprotein cholesterol still met National Cholesterol Education Program guidelines for drug therapy were randomized into the double-blind, active-treatment period to receive either lovastatin 40 mg or pravastatin 40 mg/day for 12 weeks. Clinic visits were scheduled every 4 weeks and included complete serum lipid profiles, monitoring of adverse experiences, and patient completion of health-related quality-of-life questionnaires. The primary end point of the study was the change in quality of life, as measured by the Nottingham Health Profile (part 1) after 12 weeks of treatment. Secondary end points included responses to a general health question from the National Health and Nutrition Examination Survey, sexual function questions from the Medical Outcomes Study, and stress/life event questions from the National Institutes of Health Post-Coronary Artery Bypass Grafting Study. No significant differences between the 2 groups were observed in tolerability, health-related quality-of-life measures, or changes in lipid profiles.",null,"USA",1996,"Hypercholesterolemia","Lovastatin,Pravastatin","NHP,NHANES",null,null,"RCT"]
[68,"Williams, P. T. and B. A. Franklin (2015). \"Incident diabetes mellitus, hypertension, and cardiovascular disease risk in exercising hypercholesterolemic patients.\" Am J Cardiol 116(10): 1516-1520.",null,"Williams, P. T. and B. A. Franklin","Incident diabetes mellitus, hypertension, and cardiovascular disease risk in exercising hypercholesterolemic patients","Exercise may be an important treatment for hypercholesterolemic patients, particularly in statin users who are at increased diabetes risk. We therefore used Cox proportional hazard analyses to compare running and walking dose (metabolic equivalent hours/day [MET-h/d]) to diabetes, hypertension, and cardiovascular disease (CVD) risk in hypercholesterolemic patients. There were 60 diabetic- and 373 CVD-related deaths during a 10.1-year mortality surveillance of 6,688 hypercholesterolemic patients. In addition, there were 177 incident nonfatal diabetes, 815 incident nonfatal hypertensions, and 323 incident nonfatal CVD events during a 6.4-year follow-up of 6,971 hypercholesterolemic patients who supplied follow-up questionnaires. Fatal and nonfatal diabetes risk decreased 26% (p = 0.002) and 19% (p </=0.0001) per MET-h/d, respectively, and relative to <1.07 MET-h/d decreased 35% (p = 0.19) and 55% (p </=0.0001), respectively, for 1.8 to 3.6 MET-h/d and 73% (p = 0.02) and 71% (p </=0.0001), respectively, for >/=3.6 MET-h/d. Fatal and nonfatal CVD risk decreased 8% (p = 0.008) and 3% (p = 0.22) per MET-h/d, respectively, and relative to <1.07 MET-h/d decreased 10% (p = 0.45) and 36% (p = 0.008) for 1.8 to 3.6 MET-h/d, respectively, and 37% (p = 0.009) and 26% (p = 0.10), respectively, for >/=3.6 MET-h/d. Incident hypertension risk decreased 4% (p = 0.01) per MET-h/d, and relative to <1.07 MET-h/d decreased 29% (p = 0.002) for 1.8 to 3.6 MET-h/d and 31% (p = 0.001) for >/=3.6 MET-h/d. In conclusion, running and walking for exercise lowers diabetes, hypertension, and CVD risk in hypercholesterolemic patients and should more than compensate for the purported 9% increase in diabetes risk from statin use. By preventing morbidity and mortality for a specific existing medical condition, some exercise expenses may qualify for flexible spending account expenditures in hypercholesterolemic patients when prescribed by a physician.",null,"USA",2015,"Diabetes,Hypertension,Cardiovascular Disease","none","Unknown",null,null,"Cohort"]
[69,"Willich, S. N., et al. (2004). \"Economic evaluation of a compliance-enhancing intervention in patients with hypercholesterolemia: design and baseline results of the Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study.\" Am Heart J 148(6): 1060-1067.",null,"Willich, S. N., et al.","Economic evaluation of a compliance-enhancing intervention in patients with hypercholesterolemia: design and baseline results of the Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study","BACKGROUND: Previous studies investigating the effectiveness of compliance programs in patients with cardiovascular risk factors have been inconclusive and have not included economic analyses. The primary aim of this Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study is to determine the long-term cost-effectiveness of a compliance-enhancing intervention in patients with hypercholesterolemia (HC). Secondary objectives include the assessment of compliance, cardiovascular events, and health-related quality of life. STUDY DESIGN: A total of 7598 patients (56% men, age 60 +/- 10 years, and 44% women, 64 +/- 10 years) with HC requiring statin therapy according to the Second Joint European Guidelines were recruited at presentation to 1961 primary care physicians in Germany. Patients were randomized to rosuvastatin therapy with or without a compliance-enhancing program (including standardized contacts between the study center and patients, 9 mailings, 6 telephone calls, and access to a Web page and hotline) for 12 months. Following the intervention phase, there will be a 24-month observational period with patients receiving usual care. Baseline and 6-monthly follow-up assessments are to be obtained from patients and their physicians using standardized questionnaires to evaluate medical and economic parameters. Cumulative direct and indirect disease-related costs (including resource utilization for ambulatory, hospital, rehabilitative, and nursing care, medication, physiotherapy, and transportation, and loss of productivity) will be compared applying a societal perspective. CONCLUSIONS: The results of this ORBITAL study will provide a basis to develop cost-effective compliance strategies and eventually improve medical care for patients with HC.",null,"Germany",2004,"Hypercholesterolemia","Rosuvastatin","Unknown",null,null,"RCT"]
[70,"Wink, J., et al. (2002). \"Effect of very-low-dose niacin on high-density lipoprotein in patients undergoing long-term statin therapy.\" Am Heart J 143(3): 514-518.",null,"Wink, J., et al.","Effect of very-low-dose niacin on high-density lipoprotein in patients undergoing long-term statin therapy","BACKGROUND: A low level of high-density lipoprotein (HDLC) is a proven risk factor for coronary artery disease. Niacin raises HDLC levels, but it is infrequently used because of its side effect profile. Niacin's side effects are dose related. This study tests the hypothesis that very low-dose niacin, in conjunction with long-term statin therapy, will improve the lipid profile by significantly raising the level of HDLC, with fewer side effects than traditional doses of niacin. METHODS: Fifty patients undergoing stable statin therapy for 3 months were blindly randomized to receive either placebo or niacin 50 mg administered by mouth 2 times daily for 3 months. Patients with diabetes and active smokers were excluded. Each patient completed a questionnaire regarding current medical problems, medications, and lifestyle before and after the therapy. Patients were questioned about any possible side effects that occurred during the medication trial. The primary end points were change in HDLC level and patient-reported side effects. RESULTS: Thirty-nine patients completed the study. Very low-dose niacin added to statin therapy increased the mean HDLC, 2.1 mg/dL in niacin group (standard error of the mean, 0.767) versus -0.56 mg/dL for placebo group (standard error of the mean-.816, P =.0246 by analysis of variance). Five patients receiving niacin, versus 2 patients receiving placebo, had episodes of flushing. No major side effects were noted. No patients stopped the study medication as a result of side effects. CONCLUSIONS: The addition of very low-dose niacin to statin therapy increased HDLC cholesterol significantly, while avoiding the side effects that are associated with traditional doses of niacin therapy.",null,"USA",2002,"Coronary Heart Disease","Dietary","Unknown",null,null,"RCT"]
[71,"Winkelmann, B. R., et al. (2001). \"Rationale and design of the LURIC study--a resource for functional genomics, pharmacogenomics and long-term prognosis of cardiovascular disease.\" Pharmacogenomics 2(1 Suppl 1): S1-73.",null,"Winkelmann, B. R., et al.","Rationale and design of the LURIC study--a resource for functional genomics, pharmacogenomics and long-term prognosis of cardiovascular disease","BACKGROUND AND AIM: Coronary artery disease (CAD), arterial hypertension and Type 2 diabetes mellitus are common polygenetic disorders which have a major impact on public health. Disease prevalence and progression to cardiovascular complications, such as myocardial infarction (MI), stroke or heart failure, are the product of environment and gene interaction. The LUdwigshafen RIsk and Cardiovascular Health (LURIC) study aims to provide a well-defined resource for the study of environmental and genetic risk factors, and their interactions, and the study of functional relationships between gene variation and biochemical phenotype (functional genomics) or response to medication (pharmacogenomics). Long-term follow-up on clinical events will allow us to study the prognostic importance of common genetic variants (polymorphisms) and plasma biomarkers. SETTING: Cardiology unit in tertiary care medical centre in south-west Germany. STUDY DESIGN: Prospective cohort study of individuals with and without cardiovascular disease at baseline. PATIENTS AND METHODS: LURIC is an ongoing prospective study of currently > 3300 individuals in whom the cardiovascular and metabolic phenotypes CAD, MI, dyslipidaemia, hypertension, metabolic syndrome and diabetes mellitus have been defined or ruled out using standardised methodologies in all study participants. Inclusion criteria for LURIC were: German ancestry (limitation of genetic heterogeneity) clinical stability (except for acute coronary syndromes [ACSs]) availability of a coronary angiogram (this inclusion criterium was waived for family members provided that they met all other inclusion and exclusion criteria) Exclusion criteria were: any acute illness other than ACSs any chronic disease where non-cardiac disease predominated a history of malignancy within the past five years. Exclusion criteria were pre-specified in order to minimise the impact of concomitant non-cardiovascular disease on intermediate biochemical phenotypes or on clinical prognosis (limitation of clinical heterogeneity). A standardised personal and family history questionnaire and an extensive laboratory work-up (including glucose tolerance testing in non-diabetics and objective assessment of smoking exposure by determination of cotinine plasma levels) was obtained from all individuals after informed consent. A total of 115 ml of fasting venous blood was sampled for the determination of a pre-specified wide range of intermediate biochemical phenotypes in serum, plasma or whole blood, for leukocyte DNA extraction and immortalisation of B-lymphocytes. Biochemical phenotypes measured included markers of endothelial dysfunction, inflammation, oxidative status, coagulation, lipid metabolism and flow cytometric surface receptor expression of lympho-, mono- and thrombocytes. In addition, multiple aliquots of blood samples were stored for future analyses. RESULTS: A total of 3500 LURIC baseline measurements were performed in 3316 individuals between July 1997 and January 2000. The baseline examination was repeated within a median of 35 days in 5% of study participants (n = 166, including a third examination in 18 after a median of 69 days) for pharmacogenomic assessment of lipid-lowering therapy and for quality control purposes. A five-year follow-up on major clinical events (death, any cardiovascular event including MI, stroke and revascularisation, malignancy and any hospitalisation) is ongoing. The clinical phenotypes prevalent at baseline in the cohort of 2309 men (70%) with a mean age of 62 +/- 11 years and 1007 women (30%), mean age 65 +/- 10 years, were angiographically-documented CAD in 2567 (79%), MI in 1368 (41%), dyslipidaemia in 2050 (62%) with hypercholesterolaemia > or = 240 mg/dl (27%), hypertriglyceridaemia > or = 150 mg/dl (44%) and HDL-cholesterol < or = 35 mg/dl (38%) in individuals not treated with lipid-lowering agents, systemic hypertension in 1921 (58%), metabolic syndrome in 1591 (48%), Type 2 diabetes in 1063 (32%) and obesity defined by body mass index > or = 30 kg/m2 in 770 (23%). Control patients in whom CAD had been ruled out angiographically were five years younger than those with CAD (59 +/- 12 and 64 +/- 10 years, respectively; p < 0.001), twice as often females (48% compared to 25% females in the CAD group, p < 0.001) and had significantly less cardiovascular risk factors than individuals with CAD. The prevalence of specific cardiovascular risk subsets in LURIC, such as the elderly (> or = 75 years), was 375 (11%), while 213 (6%) were young adults (< 45 years) and 904 (27%) were postmenopausal women (90% of all females). A low risk status (< or = 1 out of the four traditional risk factors: dyslipidaemia, smoking, hypertension and diabetes mellitus) was identified in 314 (9%) individuals of the entire cohort (5% in CAD and 26% in controls, p < 0.001) and 97 (3%) carried none of the four risk factors (1% in CAD and 9% in controls, p < 0.001). (ABSTRACT TRUNCATED)",null,"Germany",2001,"Coronary Heart Disease,Diabetes,Various","none","Unknown",null,null,"Cohort"]

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[]
["Acronym","Full name","Type of PRO tool (if relevant)"]
["15D",null,"General"]
["ABC","Activities-specific Balance Confidence Scal","Symptom"]
["AUA-SI","American Urological Association Symptom Index","Complication"]
["BAI","Beck Anxiety Inventory","Comorbidity"]
["BDI","Beck Depression Inventory","Comorbidity"]
["BFS","Bruera Global Fatigue Severity Scale ","Symptom"]
["BHS","Beck Hopelessness Scale","Comorbidity"]
["BiFS","Bidimensional Fatigue Scale","Symptom"]
["BIS","Body Image Scale","Treatment"]
["BPI","Brief Pain Inventory","Symptom"]
["BSFI","Brief Sexual Function Inventory","Complication"]
["BSI","Brief Symptom Inventory","Symptom"]
["BSP-PC","Bononian Satisfaction Profile-Prostate Cancer","Treatment"]
["CARDI","Colon and Ano-Rectal Distress Inventory","Complication"]
["CARES-SF","Cancer Rehabilitation Evaluation System Short Form","Treatment"]
["CARIQ","Colon and Ano-Rectal Impact Questionnaire","Complication"]
["CAVIPRES-30","Prostate cancer-specific instrument","Disease"]
["CCCI","Coping with Cancer Instrument ","General"]
["CCFIS","Cleveland Clinic Fecal Incontinence Score","Complication"]
["CES-D","Center for Epidemiological Studies-Depression Scale","Comorbidity"]
["CHAMPS","Community Healthy Activities Model Program for Seniors","General"]
["CILFS","Cancer Interference with Life and Family Scale","Carer"]
["Cleary-30","Cleary 30-item questionnaire","General"]
["CLSS","Core Lower Urinary Tract Symptom Score","Symptom"]
["COIN","Collection of Indirect and Nonmedical Direct Costs","Costs"]
["CPQ","Cologne Patient Questionnaire","General"]
["CQOLC"," Caregiver Quality of Life Index-Cancer","Carer"]
["CSQ-8","Customer Satisfaction Questionnaire","Treatment"]
["CTCAE","Common Terminology Criteria for Adverse Events","Complication"]
["CTS","Cancer Treatment Scale","Treatment"]
["CUF","Changes in Urinary Function","Symptom"]
["DASS-21"," Depression, Anxiety and Stress Scale","Comorbidity"]
["DUKE","Duke Health Profile","General"]
["ED-EQoL","Erectile Dysfunction effect on QoL","Complication"]
["EMPK","Erfassung multipler psychischer Konstrukte","General"]
["EORTC QLQ-C30","European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30","General"]
["EORTC QLQ-INFO25","European Organisation for Research and Treatment of Cancer Information Module","Knowledge"]
["EORTC QLQ-PR25","European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate","Disease"]
["EORTC QLQ-PRT23","European Organization for Research and Treatment of Cancer Quality of Life -Proctitis","Complication"]
["EORTC-8D","European Organization for Research and Treatment of Cancer Utility index","Utility"]
["EPIC","Expanded Prostate Cancer Index Composite","Disease"]
["EPInv","Eysenck Personality Inventory","General"]
["EQ-5D","EuroQol Quality of Life","Utility"]
["EQ-VAS","EQ-5D Visual Analogue Scale","Utility"]
["ESAS","Edmonton Symptom Assessment Scale","Symptom"]
["FACIT-F","Functional Assessment of Chronic Illness Therapy - Fatigue Scale","Symptom"]
["FACT-F","Functional Assessment of Cancer Therapy: Fatigue ","Symptom"]
["FACT-G","Functional Assessment of Cancer Therapy-General","Treatment"]
["FACT-P","Functional Assessment of Cancer Therapy-Prostate","Disease"]
["FACT-TOI","Functional Assessment of Cancer Therapy-Treatment Outcome Index","Treatment"]
["FAIT-U","Functional Assessment of Incontinence Therapy-Urinary","Complication"]
["FAPSI-8","FACT Advanced Prostate Symptom Index-8","Disease"]
["FCRI","Fear of Cancer Recurrence Inventory","Disease"]
["FFQ","Food Frequency Questionnaire","General"]
["FLIC","Functional Living Index-Cancer","General"]
["GHI","General Health Index","General"]
["GISEQ","Gastrointestinal Side Effects Questionnaire","Complication"]
["HADS","Hospital Anxiety and Depression Scale","Comorbidity"]
["HCP","Healthcare professional"]
["HIFU","High intensity focused ultrasound"]
["HSC","Hopkins Symptom Checklist","Symptom"]
["HSQ","Health Status Questionnaire ","General"]
["HUI","Health Utility Index","Utility"]
["IBDQ","Inflammatory Bowel Disease Questionnaire","Complication"]
["ICIQ","International Consultation on Incontinence Modular Questionnaire","Complication"]
["ICI-SF","IPSS bother score and incontinence questionnaire","Complication"]
["ICSQ","International Continence Society Questionnaire","Complication"]
["IES","Impact of Event Scale","Complication"]
["IIEF","International Index of Erectile Function-5","Complication"]
["IIQ","Incontinence Impact Questionnaire","Complication"]
["IOC","Impact of Cancer","General"]
["IPAQ","International Physical Activity Questionnaire","General"]
["IPSS","International Prostate Symptom Score","Disease"]
["I-QoL","Incontinence Quality of Life Instrument","Complication"]
["ISvI","Insomnia Severity Index","Symptom"]
["ISyI","Incontinence Symptom Index ","Complication"]
["JOL","Joy-Of-Life Questionnaire","General"]
["KHQ","King's Health Questionnaire","General"]
["KUJ","Knowledge of cancer, Understanding treatment choices and Judgement of survival scale","Treatment"]
["LASA","Linear analog self-assessment scale","General"]
["LENT","Late Effects in Normal Tissues","Treatment"]
["LENT-SOMA","Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic scales","Treatment"]
["MASPC","Memorial Anxiety Scale for Prostate Cancer","Comorbidity"]
["MFI","Multidimensional Fatigue Inventory","Symptom"]
["MHI","Mental Health Index","Comorbidity"]
["MKLSS","MacKeigan-Larsonn Satisfaction Survey"]
["MMAC","Mini-Mental Adjustment to Cancer","Disease"]
["MOS-MHI","MOS Mental Health Index","Comorbidity"]
["MOS-SP","MOS Sexual Problems ","Complication"]
["MOS-SSS","Medical Outcomes Study Social Support Survey","Social"]
["MPQ-PPI","McGill Pain Questionnaire Present Pain Intensity","Symptom"]
["MQOLQ","Marquis Quality Of Life Questionnaire"]
["MSAS","Memorial Symptom Assessment Scale","Symptom"]
["MUDI","Male Urogenital Distress Inventory","Complication"]
["MUSIQ"," Male Urinary Symptom Impact Questionnaire","Complication"]
["MYCWB","Measure Yourself Concerns and Well-Being","General"]
["NHP","Nottingham Health Profile ","General"]
["NPS","Numeric Pain Scale","Symptom"]
["OSGA","Ottery's Subjective Global Assessment","General"]
["PAIS","Psychological Adjustment to Illness Self-report Scale","General"]
["PBQ","Prostate Brachytherapy Questionnaire","Treatment"]
["PCIn","Prostate Cancer Index ","Disease"]
["PCKQ","Prostate Cancer Knowledge Questionnaire","Knowledge"]
["PC-QoL","Prostate cancer- Quality of Life","Disease"]
["PCRT-PCQoL","Prostate Cancer Radiotherapy Quality of Life Questionnaire","Treatment"]
["PCSI","Prostate Cancer Symptom Indices","Symptom"]
["PCSQLI","Prostate Cancer Specific Quality of Life Instrument","Disease"]
["PCTO-Q","Prostate Cancer Treatment Outcome Questionnaire","Treatment"]
["PDEi","Phosphodiesterase inhibitors"]
["PGI-I","Patient Global Impression of Improvement","Treatment"]
["PHQ-9","Patient Health Questionnaire","Comorbidity"]
["POMS","Profile of Mood States","Comorbidity"]
["PORPUS","Patient-Oriented Prostate Utility Scale","Disease"]
["PORT","Prostate Outcomes Research Team prostate cancer treatment complication profile","Treatment"]
["POSAS","Patient and Observer Scar Assessment Questionnair","Treatment"]
["PPB","Physical Performance Battery","Symptom"]
["PPP","Prostate Cancer Patient & Partner questionnaire","Disease"]
["PROMIS","Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue Short Form","Symptom"]
["PROSQoLI ","Prostate cancer Quality of Life ","Disease"]
["PSM-G","Prostate-specific instrument","Disease"]
["PSS"," Perceived Stress Scale","General"]
["PSSR","Prostate Symptom Self-Report","Disease"]
["PVP","PatientViewpoint","General"]
["QLACS","Quality of Life in Adult Cancer Survivors","General"]
["QLI","Quality of Life Index","General"]
["QOL-CS","Quality of Life - Cancer Survivor","General"]
["QOLM-P14","Quality of Life Module-Prostate 14","Disease"]
["QUFW94","Prostate cancer specific symptom questionnaire","Disease"]
["QWB","Quality of Well-Being Scale","General"]
["R-FAS","Rectal Function Assessment Score","Complication"]
["RMS","Royal Marsden Scale","Treatment"]
["RS","Rating Scale","Utility"]
["RSCL","Rotterdam Symptom Checklist","General"]
["RT-ARD","Condensed Anorectal Dysfunction Score","Complication"]
["RTOG-EORTC-SS","Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema","Complication"]
["SActQ"," Sexual Activity questionnaire","Complication"]
["SAQ","Sexual Adjustment Questionnaire","Complication"]
["SCL-90","Symptom Checklist-90","Symptom"]
["SCN-SF34","Supportive Care Needs Survey-SF34 Revised","Social"]
["SF-12","Medical Outcomes Study Short Form Health Survey-12","Utility"]
["SF-36","Medical Outcomes Study Short Form Health Survey SF-36","Utility"]
["SF-8","Medical Outcome Study 8-Item Short-Form Health Survey","Utility"]
["SFI","Sexual function Index","Complication"]
["SFQ","Sapporo Medical University Sexual Function Questionnaire","Complication"]
["SFQ","Sexuality Follow-up Questionnaire","Complication"]
["SG","Standard Gamble","Utility"]
["SHIM","Sexual Health Inventory for Men","Complication"]
["SIP","Sickness Impact Profile","General"]
["SOC","Sense of Coherence ","General"]
["SQLU","Selby's QL Uniscale","General"]
["SSQ","Subjective Significance Questionnaire","General"]
["STAI","State-Trait Anxiety Inventory","Comorbidity"]
["STAR","Symptom Tracking and Reporting","Symptom"]
["SUPPH","Strategies Used by Patients to Promote Health","General"]
["SWBS","Spiritual Well-Being Scale","General"]
["SWLS","Satisfaction With Life Scale","General"]
["SWOG-QLQ","Southwest Oncology Group Quality of Life Questionnaire","General"]
["TIBI-P","Total Illness Burden Index-Prostate","Comorbidity"]
["TOI","Trial Outcome Index","Treatment"]
["TTO","Time Trade-Off","Utility"]
["UCLA-PCI","UCLA Prostate Cancer Index","Disease"]
["UCLA-SFS","University of California-Los Angeles Sexual Functioning Scale","Complication"]
["UFQ-RP","Urinary Function Questionnaire for men after RP","Complication"]
["U-Titer","U-Titer","Utility"]
["UWIN","Urgency, weak stream, incomplete emptying and nocturia","Complication"]
["VAS","Visual analogue scale","General"]
["VRS","Verbal Rating Scale","General"]
["WHO-Pain","WHO Pain Score","Symptom"]
["WHO-PS","WHO Performance Status","General"]
["WHOQOL","World Health Organization Quality of Life scale","General"]
["WHOQOL-BREF","World Health Organization Quality of Life scale-BREF","General"]
["WHOQOL-OLD","World Health Organization Quality of Life scale for the elderly","General"]
["WOC","Ways of Coping Scale ","General"]
["WSFQ"," Watt's Sexual Function Questionnaire","Complication"]
["WTP","Willingness to Pay","Utility"]

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[null,"3. Click on a cell in the Map, then click the Show",null,null,null,null,null,null,null,"South Africa",0,0,0,1,0,0,0,0]
[null,"Citation button below to see the relevant",null,null,null,null,null,null,null,"South Korea",0,0,0,0,0,0,1,0]
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[null,"See abbreviations",null,null,null,null,null,null,null,"Unknown",0,0,0,1,0,0,0,0]
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[1,"Anonymous (1991). \"Prevalence of risk factors for heart disease in OXCHECK trial: implications for screening in primary care. Imperial Cancer Research Fund OXCHECK Study Group.\" Bmj 302(6784): 1057-1060.",null,"Anonymous","Prevalence of risk factors for heart disease in OXCHECK trial: implications for screening in primary care. Imperial Cancer Research Fund OXCHECK Study Group","OBJECTIVE: To describe the outcome of offering health checks systematically to a general practice adult population,in terms of age and sex specific prevalence of risk factors,follow up workload,and selective screening of cholesterol concentration. DESIGN: Descriptive analysis of data obtained by postal questionnaire and by personal interview and clinical examination by a trained nurse. SUBJECTS: 2205 patients aged 35-64 who attended for a health check in 1989-90 from an invited random sample of 2777 patients from five urban general practices in Bedfordshire. RESULTS: Overall,almost three quarters of patients (78% of men,68% of women) needed specific advice or follow up. Smoking,a high fat diet,and being overweight (body mass index greater than or equal to 25 kg/m2) were common characteristics exhibited by 35%,31%,and 55% respectively of men and 24%,18%,and 48% of women. The total cholesterol concentration was greater than or equal to 6.5 mmol/l in 37% of patients and greater than or equal to 8 mmol/l in 8%. In terms of workload 13% needed dietary advice only,15% needed only follow up of hyperlipidaemia or hypertension,and 9% needed advice on smoking only. A further 35% needed follow up for a combination of risk factors. The proportion of patients in whom cholesterol concentration would be measured if a selective screening policy were adopted would vary from 29% to 71%,according to different criteria,but (particularly in men) no combination would be much better than random testing as a means to detect patients with a total cholesterol concentration greater than or equal to 8 mmol/l. CONCLUSIONS: If the entire adult population of a practice is offered health checks systematically the acceptance rate is lower and the follow up workload higher than previously understood. The resource implications depend on the age and sex of patients screened and the selective criteria adopted for cholesterol measurement. Health checks are only the beginning of a successful preventive programme--the challenge is to provide effective intervention and follow up.",null,"Unknown",1991,"Unknown","None","Unknown",null,null,"Cohort","Unknown",null,"Unknown","None",null,"Cohort","Unknown","1960:1999"]
[2,"Abs,R.,et al. (1999). \"GH replacement in 1034 growth hormone deficient hypopituitary adults: demographic and clinical characteristics,dosing and safety.\" Clin Endocrinol (Oxf) 50(6): 703-713.",null,"Abs,R.,et al.","GH replacement in 1034 growth hormone deficient hypopituitary adults: demographic and clinical characteristics,dosing and safety","OBJECTIVE: Long-term experience of growth hormone (GH) replacement therapy in a large population of hypopituitary adults with GH deficiency (GHD) is limited,and safety surveillance is clearly essential. KIMS,the Pharmacia & Upjohn International Metabolic Database,is a long-term,open,outcomes research programme of hypopituitary adult patients with GHD who are treated in a conventional clinical setting. PATIENTS: The present analysis encompasses data from 1034 hypopituitary adult GHD patients treated with GH for a total of 818 patient years. RESULTS: Prior to GH therapy,the KIMS patient population exhibited an increased prevalence of obesity,diabetes mellitus (in females) and hyperlipidaemia,compared with normal populations described in published studies. Quality of life,assessed using a disease-specific questionnaire (QoL-AGHDA),was also reduced in KIMS patients. The maintenance dose of GH was significantly higher in patients who were receiving GH prior to enrolment into KIMS (non-naive patients) compared with patients who commenced GH at the time of enrolment (naive patients). In addition,dose of GH correlated significantly with body weight in the former group of patients. Analysis of serum levels of IGF-I indicated that overtreatment with GH was markedly more common in non-naive than in naive patients. The frequency of adverse events in KIMS patients was no higher than that reported in patients receiving placebo in previous clinical trials. Recurrence of pituitary or CNS tumours was reported in six patients,a rate consistent with data from control series. Three deaths were reported,none of which was obviously associated with GH treatment. CONCLUSIONS: Our data,drawn from a large population of hypopituitary adults treated with GH for a total of more than 800 patient years,confirm previous reports that untreated GHD in hypopituitary adults is associated with a number of important clinical problems. In addition,the results suggest that there has been a shift in recent years from determination of GH dose on the basis of body weight to dose titration of individual patients,and indicate that the latter technique has important advantages. The data provide further evidence that GH replacement therapy is well-tolerated in adults. However,it is possible that some adverse events may not become evident over the time scale covered by the present analysis,and continued surveillance therefore remains mandatory.",null,"Belgium",1999,"Various","Various","Qol-AGHDA",null,null,"Cohort","Belgium",null,"Various","Various",null,"Cohort","Qol-AGHDA","1960:1999"]
[3,"Agewall,S.,et al. (1995). \"A randomized study of quality of life during multiple risk factor intervention in treated hypertensive men at high cardiovascular risk.\" J Hypertens 13(12 Pt 1): 1471-1477.",null,"Agewall,S.,et al.","A randomized study of quality of life during multiple risk factor intervention in treated hypertensive men at high cardiovascular risk","OBJECTIVE: To examine the effect on quality of life in hypertensive men of a multiple risk factor intervention programme compared with that of usual care. DESIGN: A prospective,open,randomized,parallel-group study with allocation either to a comprehensive multiple risk factor modification programme or to usual care. SETTING: An outpatient clinic in a city hospital. PATIENTS: Five hundred and eight treated hypertensive men,aged 50-72 years,with at least one of the following: serum cholesterol > or = 6.5 mmol/l,smoking habit or diabetes mellitus. INTERVENTION: Nutritional advice,behavioural treatment principles and drug therapy. MAIN OUTCOME MEASURES: Minor symptoms evaluation profile (MSEP) was used to measure change in quality of life. RESULTS: The intervention programme led to sustained effects on lifestyle-related variables such as hypercholesterolaemia,body mass index and smoking habits,whereas diastolic blood pressure and HbA1c remained unchanged. The change in the MSEP during follow-up did not differ between the intervention and the usual care groups. There was a close relationship between the measurements of the three MSEP dimensions at baseline and at follow-up (P < 0.0001). None of the potential risk factors measured at entry was significantly associated with change in the three MSEP dimensions during follow-up. CONCLUSION: The multiple risk factor intervention programme directed towards smoking habits,hypercholesterolaemia and the metabolic control of diabetes mellitus in treated hypertensive men at high cardiovascular risk was not associated with an impaired quality of life compared with that in a control group. The method used,the MSEP,has previously been found to be a reliable method with good validity,and this study's results provide further evidence of its validity.",null,"Sweden",1995,"Hypertension","Dietary,Behavioural/Education,Unknown","MSEP",null,null,"RCT","Sweden",null,"Hypertension","Dietary,Behavioural/Education,Unknown",null,"RCT","MSEP","1960:1999"]
[4,"Angelico,F.,et al. (2003). \"Attitudes and approach to cardiovascular risk factors in Italy: results of an electronic questionnaire survey.\" Public Health 117(4): 242-249.",null,"Angelico,F.,et al.","Attitudes and approach to cardiovascular risk factors in Italy: results of an electronic questionnaire survey","BACKGROUND: The advent of computer-based technology has led to innovative epidemiological research methods to exploit the advantages of computer-mediated communications. The aim of the present study was to develop and evaluate a self-administered electronic questionnaire for acquiring information on cardiovascular health,knowledge and behaviours in a representative,stratified sample of the Italian population. METHODS: We report information on the attitudes and approach to cardiovascular disease prevention in a representative sample of Italian families who were interviewed at home by electronic questionnaires. The panel of families is currently used for national opinion polls and marketing surveys. Electronic questionnaires were filled out by 1683 males and 1736 females during a weekend period. RESULTS: Two-thirds of respondents reported having their blood pressure measured while only half reported having blood lipid and glucose tests over the previous 2 years. Prevalence of reported hypertension,hypercholesterolaemia,diabetes and smoking were 15.2,13.0,9.8 and 37.1% in men and 10.1,8.1,2.6 and 28.0% in women,respectively. More than 50% of hypertensives and diabetics were on drug treatment,while only 20% of subjects reporting hyperlipidaemia were on medication. CONCLUSIONS: The results suggest the usefulness of self-administered electronic questionnaires for acquiring quick,low-cost and high response rate information in epidemiological surveys.",null,"Italy",2003,"Unknown","None","Unknown",null,null,"Survey","Italy",null,"Unknown","None",null,"Survey","Unknown","2000:2004"]
[5,"Avorn,J.,et al. (2002). \"Measuring the cost-effectiveness of lipid-lowering drugs in the elderly: the outcomes research and economic analysis components of the PROSPER trial.\" Control Clin Trials 23(6): 757-773.",null,"Avorn,J.,et al.","Measuring the cost-effectiveness of lipid-lowering drugs in the elderly: the outcomes research and economic analysis components of the PROSPER trial","Little information exists to quantify the functional status and economic consequences of lipid-lowering therapy in elderly patients. We describe the design of the cost-effectiveness component of the first large,randomized,placebo-controlled trial of lipid-lowering therapy in subjects aged 70 years or older. The PROspective Study of Pravastatin in the Elderly at Risk has randomized 5804 men and women 70-82 years old,with existing vascular disease or related risk factors,to receive 40 mg/d of pravastatin or placebo. The cost-effectiveness study will be based on within-trial observations of differences between the two study arms in rates of myocardial infarction,stroke and related vascular disease outcomes (including vascular dementia). In addition to comparing within-trial clinical outcomes,we will model the projected changes in life expectancy and cardiovascular outcome rates that would be seen with lifelong use of the drug,based on the risk reduction rates seen in the trial as well as baseline observational data from the three countries where the trial is being conducted (Scotland,Ireland and the Netherlands). A state transition (Markov) model will be constructed to estimate the likely states of health,functional status and health care resource utilization (including lipid-lowering drug costs) in a cohort of elderly patients with versus without pravastatin therapy over a series of 1-year cycles until death. In addition,a standard measure of utility (the Health Utilities Index) will be administered to all study subjects to permit calculation of quality-adjusted life-years gained with this regimen. This approach will make it possible to go beyond the calculation of a single endpoint for each subject,and to translate the trial findings into definitions of effectiveness and outcomes that will be relevant to the ongoing debate concerning how best to relate the benefits of such medications to their costs.",null,"USA",2002,"Unknown","Pravastatin","Unknown",null,null,"RCT","USA",null,"Unknown","Pravastatin",null,"RCT","Unknown","2000:2004"]
[6,"Bahat,G.,et al. (2015). \"Observational cohort study on correlates of mortality in older community-dwelling outpatients: The value of functional assessment.\" Geriatr Gerontol Int 15(11): 1219-1226.",null,"Bahat,G.,et al.","Observational cohort study on correlates of mortality in older community-dwelling outpatients: The value of functional assessment","AIM: To analyze correlates of mortality with admission features/factors in older community-dwelling outpatients. METHOD: This is an observational cohort study including 608 patients aged >60 years admitted to the geriatrics outpatient clinics of a university hospital. On admission,demographic characteristics,history of smoking-alcohol consumption,individual comorbidities,individual drugs,number of comorbidities,number of drugs and the components of comprehensive geriatric assessment (functional status,nutritional status,depression and cognition screening) of the patients were recorded. Survival status was assessed through the related official website. The relationship between mortality and recorded parameters were analyzed individually by univariate analyses. Consequently,stepwise forward Cox regression analysis was carried out to detect independent correlates for mortality (for those variables statistically significantly related to mortality.) RESULTS: The mean age was 73.8 +/- 6.9 years. 66.6% of participants were female. The mean follow-up time was 40.4 +/- 25.3 months. The mortality rate was 17.8%. Correlates of mortality were calculated using univariate analysis. They were age,sex,nutritional status,activities of daily living (ADL),instrumental ADL,diabetes mellitus (P < 0.001 for all),suspected dementia (P = 0.002),hyperlipidemia (P = 0.048) and total number of diseases (P = 0.025). Independent correlates of mortality were advanced age (HR 1.10,95% CI 1.06-1.13; P < 0.001,low ADL score (HR 1.22,95% CI 1.12-1.32; P < 0.001),the presence of diabetes (HR 2.64,95% CI 1.78-3.91,P < 0.001),male sex (HR 1.68,95% CI 1.13-2.49; P = 0.01) and suspected dementia (HR 1.51,95% CI 1.02-2.22; P < 0.05). CONCLUSION: In the present study--taking many factors into consideration--the variables associated with mortality were advanced age,low ADL score,presence of diabetes,male sex and suspected dementia. Functional status emerged as the second most significant factor associated with higher mortality--after advanced age. The present study highlights the importance of functional assessment in geriatric outpatient clinics.",null,"Turkey",2015,"Unknown","None","ADL",null,null,"Cohort","Turkey",null,"Unknown","None",null,"Cohort","ADL","2015:2018"]
[7,"Berglund,G.,et al. (2000). \"Long-term outcome of the Malmo preventive project: mortality and cardiovascular morbidity.\" J Intern Med 247(1): 19-29.",null,"Berglund,G.,et al.","Long-term outcome of the Malmo preventive project: mortality and cardiovascular morbidity","OBJECTIVES: To analyse the effects on mortality and cardiovascular morbidity in a population-based sample,invited to an intervention programme incorporating a baseline screening examination and treatment programmes for subjects with cardiovascular risk factors,high alcohol intake and,in women,suspicion of breast cancer on mammography. SETTING: Section of Preventive Medicine,Department of Medicine,University Hospital,Malmo,Sweden. SUBJECTS: Birth cohorts (aged 32-51 years) invited to screening examination (men = 9. 923; women = 4.422) were compared to birth cohorts not invited (men = 6.655; women = 4.290). Mean participation rate in the invited cohorts was 71% (range 64-78%). SCREENING EXAMINATION: Between 1974 and 1992 a baseline screening including a physical examination,blood pressure,a questionnaire regarding,e.g. family history,lifestyle,and socio-economic factors,laboratory tests of serum cholesterol,triglycerides,gamma-glutamyl-transferase,blood glucose before and after an oral glucose load,as well as a mammography examination in women,was performed. INTERVENTIONS: Subjects with hypertension; hyperlipidaemia; diabetes or glucose intolerance; high alcohol intake; or,in women,suspicion of breast cancer were referred to special outpatient clinics. MAIN OUTCOME MEASURES: Total and cause-specific mortality,nonfatal myocardial infarction,and stroke,from the screening examination until the end of 1995,was followed in both the intervention and control groups,using national and/or local registries. RESULTS: Total mortality did not differ significantly between the intervention group and control group. Cause-specific deaths were also similar except for 'other' deaths amongst men being significantly lower in the intervention group,mainly due to a lower mortality from 'other' causes (suicide,alcohol related deaths) in men under 40 years of age at baseline. Women under 40 years of age had a significantly lower mortality from cancer in the intervention group than in the control group. Nonfatal myocardial infarction and stroke did not differ between intervention and control group in either sex. Within the invited birth cohorts,nonparticipants had a higher total and cause-specific mortality. CONCLUSIONS: Risk factor screening for major diseases such as cardiovascular disease,alcohol abuse,diabetes mellitus and breast cancer,and subsequent treatment of the detected risk factors/diseases - The Malmo Preventive Project - did not reduce total mortality in the intervention group as a whole. In subjects under 40 years of age at entry,total mortality was lower in the intervention group than in the control group. In men,this seemed to be due to a reduction of alcohol-related deaths,whilst in women death from cancer was reduced.",null,"Sweden",2000,"Hypertension,Hyperlipidemia,Diabetes,Various","Patient Management","Unknown",null,null,"Cohort","Sweden",null,"Hypertension,Hyperlipidemia,Diabetes,Various","Patient Management",null,"Cohort","Unknown","2000:2004"]
[8,"Bloemenkamp,D. G.,et al. (2003). \"Functional health and well-being of relatively young women with peripheral arterial disease is decreased but stable after diagnosis.\" J Vasc Surg 38(1): 104-110.",null,"Bloemenkamp,D. G.,et al.","Functional health and well-being of relatively young women with peripheral arterial disease is decreased but stable after diagnosis","OBJECTIVE: This study was undertaken to investigate the extent to which health-related quality of life (HQOL) is reduced in young women with peripheral arterial disease (PAD) compared with age-matched and gender-matched control subjects. Moreover,potential determinants of HQOL in young women with PAD were studied,ie,traditional cardiovascular risk factors,location of stenosis and time since diagnosis. METHODS: This was a population-based case-control study. Subjects were 208 young (<50 years) women with PAD diagnosed at angiography and 471 population-based age-matched and gender-matched control subjects. All participants completed the RAND-36 questionnaire,which produces a HQOL profile. The questionnaire contains 36 items that assess 8 domains of HQOL. Each domain is given a mean score ranging from 0 to 100,with higher scores indicative of better quality of life. RESULTS: PAD had a deleterious effect on HQOL in young women. Ability to deal with the physical requirements of daily life was affected,and physical capabilities limited activity to a considerable extent. Mean differences observed for 2 domains,ie,Physical functioning and Role-physical,were -25.1 (95% confidence interval [CI],-28.8,-21.4) and -22.5 (95% CI,-28.9,-16.0). Within the group of young women with PAD,HQOL did not depend on age,smoking,hypercholesterolemia,or education. However,women with hyperglycemia,hypertension,or increased body mass index scored lower on 1 or more domains of RAND-36. Location of stenosis was also related to HQOL; patients with more proximal stenosis scored slightly higher on the domain Physical functioning,compared with women with more distal stenosis. Time (0-10 years) between diagnosis (1990-1999) and when RAND-36 was filled out (2000) is related to score on the Mental health domain; score increases over time. Scores on the other 7 domains of HQOL showed no significant relation to duration of disease. CONCLUSION: Quality of life in young women with PAD was statistically significant diminished for all domains of RAND-36 in comparison with HQOL in healthy age-matched control subjects. HQOL of patients with recently diagnosed PAD is comparable to that of patients in whom the diagnosis was made several years previously. Effective therapy might stabilize,albeit not improve,quality of life in this specific patient population.",null,"The Netherlands",2003,"Various","None","SF-36",null,null,"Case Control","The Netherlands",null,"Various","None",null,"Case Control","SF-36","2000:2004"]
[9,"Broekhuizen,K.,et al. (2015). \"An economic evaluation alongside a randomized controlled trial evaluating an individually tailored lifestyle intervention compared with usual care in people with familial hypercholesterolemia.\" BMC Res Notes 8: 317.",null,"Broekhuizen,K.,et al.","An economic evaluation alongside a randomized controlled trial evaluating an individually tailored lifestyle intervention compared with usual care in people with familial hypercholesterolemia","BACKGROUND: Cost-effectiveness analyses provide insight in the use of lifestyle interventions. To evaluate the cost-effectiveness of a lifestyle intervention compared to usual care in people with Familial Hypercholesterolemia,340 people with FH were randomized to the intervention or control group. LDL cholesterol,quality of life and costs were measured at 0 and 12 months. Cost-effectiveness analyses were performed from a healthcare perspective using bootstrapping techniques. RESULTS: Non-significant decreases in LDL cholesterol and quality of life were found. The mean between-group difference in costs was euro-237 (95% CI -1,386 to 130). The incremental cost-effectiveness ratios were 1,729 per 1 mmol/l LDL cholesterol and 145,899 per QALY gained. Assumed that the small non-significant decrease in LDL cholesterol is attributed to the intervention,the probability of cost-effectiveness of the intervention compared to usual care was 91% per 1 mmol/l LDL cholesterol reduction and 75% per QALY gained at a ceiling ratio of euro20,000. CONCLUSIONS: The intervention is not cost-effective. TRIAL REGISTRATION: NTR1899,date 07-07-2009.",null,"The Netherlands",2015,"Familial Hypercholesterolemia","Behavioural/Education","Unknown",null,null,"RCT","The Netherlands",null,"Familial Hypercholesterolemia","Behavioural/Education",null,"RCT","Unknown","2015:2018"]
[10,"Buchwald,H.,et al. (1993). \"Perception of quality of life before and after disclosure of trial results: a report from the Program on the Surgical Control of the Hyperlipidemias (POSCH).\" Control Clin Trials 14(6): 500-510.",null,"Buchwald,H.,et al.","Perception of quality of life before and after disclosure of trial results: a report from the Program on the Surgical Control of the Hyperlipidemias (POSCH)","The Program on the Surgical Control of the Hyperlipidemias (POSCH) was a randomized controlled clinical trial designed to ascertain whether cholesterol lowering induced by the partial ileal bypass operation would favorably affect overall mortality and the mortality and morbidity due to coronary heart disease. The trial results provided strong clinical and coronary arteriographic support for the beneficial effects of lipid modification for the reduction of atherosclerosis progression. At the same time,the surgery-assigned group experienced diarrhea and an increased incidence of kidney stones and gallstones compared to the control-assigned group. Identical quality of life determinations were performed in the POSCH study population shortly before disclosure of the trial results to the patients and shortly thereafter. The purpose of this dual assessment was to evaluate the effect of knowledge of outcomes on the patients' subjective evaluation of quality of life. The primary instrument utilized for analysis of the perception of quality of life in POSCH was the McMasters Health Index Questionnaire (MHIQ). In addition,four study-specific questions were asked of the trial patients. The results for the MHIQ before disclosure of trial results showed a difference (p = 0.07) favoring the control-assigned group (diet-treated),for the social function index of the MHIQ. After disclosure of the trial results,the difference was larger (p < 0.05). For the four study-specific questions,all differences favored the control-assigned group (p < 0.01) before and after disclosure of the trial results,with the exception of satisfaction with randomization allocation in the surgery-assigned group (p = 0.08). The intragroup MHIQ indices before and after disclosure of the trial results showed no suggestive significant differences,except in the surgery-assigned group,in which there was an improvement in the emotional function index after disclosure of the trial results (p = 0.03). The intragroup responses to the study-specific questions before and after disclosure of the trial results again showed no significant differences,except in the surgery-assigned group,in which there was an improvement in patient satisfaction with randomization allocation after disclosure of the trial results (p = 0.04).(ABSTRACT TRUNCATED AT 400 WORDS)",null,"USA",1993,"Coronary Heart Disease","Bariatrics","MHIQ",null,null,"RCT","USA",null,"Coronary Heart Disease","Bariatrics",null,"RCT","MHIQ","1960:1999"]
[11,"Busetto,L.,et al. (2012). \"Determinants of health-related quality of life in morbid obese candidates to gastric banding.\" Eat Weight Disord 17(2): e93-100.",null,"Busetto,L.,et al.","Determinants of health-related quality of life in morbid obese candidates to gastric banding","OBJECTIVE: To analyse determinants of self reported health-related quality of life (HR-QoL) in morbid obese patients candidates to laparoscopic adjustable gastric banding (LAGB). METHODS: Determinants of HR-QoL were investigated in 383 morbid obese patients (82 M and 301 F) with BMI>/=40 kg/m(2) (BMI>/=35 kg/m(2) if complicated obesity) and age 18-60 years. HR-QoL was determined with the SF-36 questionnaire. Determinants of the two summary measures of SF-36 (physical component and mental component) were analysed by stepwise multiple linear regression analysis with age,BMI,physical comorbidites,mental comorbidites and eating behaviour disorders as independent variables. Physical comorbities (diabetes,hypertension,hypertriglyceridemia,low HDL,sleep apnea and osteoarthritis) were coded as present or absent on the basis of simple diagnostic clinical criteria; mental comorbidities (depression) and eating behaviour disorders (binge eating,sweet eating and nibbling) on the basis of an unstructured clinical interview. RESULTS: Mean age was 38.8+/-10.2 years and mean BMI was 41.5+/-5.4 kg/m(2). Scores in the eight SF-36 subscales were lower in women than in men and lower than in the general Italian population. However,18.4-43.5% of the participants had HR-QoL levels above the normative values,depending on the scale. In both genders,low scores in the mental component of the SF-36 were associated to the presence of depression and eating behaviour disorders and not to physical comorbidities or BMI levels. Low physical self-perceived well being was associated to high BMI levels in men and to depression,hypertension and hypertriglyceridemia in women. CONCLUSION: HR-QoL was poor in morbid obese candidates to LAGB,particularly in women,and was negatively affected more by mental comorbidites and eating behaviour disorders than by physical comorbidities or BMI levels.",null,"Italy",2012,"Diabetes,Hypertension,Hypertriglyceridemia,Various","Bariatrics","SF-36",null,null,"Survey","Italy",null,"Diabetes,Hypertension,Hypertriglyceridemia,Various","Bariatrics",null,"Survey","SF-36","2010:2014"]
[12,"Carlsson,C. M.,et al. (2002). \"Health-related quality of life and long-term therapy with pravastatin and tocopherol (vitamin E) in older adults.\" Drugs Aging 19(10): 793-805.",null,"Carlsson,C. M.,et al.","Health-related quality of life and long-term therapy with pravastatin and tocopherol (vitamin E) in older adults","INTRODUCTION: Concerns about the effects of HMG-CoA reductase inhibitors ('statins') on health-related quality of life may contribute to their underuse in older adults with and at risk for cardiovascular disease. These concerns also may prevent clinicians from enrolling older patients in clinical trials assessing the efficacy of statins as a preventive therapy for Alzheimer's disease. OBJECTIVE: To determine the effects of pravastatin and tocopherol (vitamin E),alone and in combination,on health-related quality of life in older adults. STUDY DESIGN: Double-blind,randomised,placebo-controlled,crossover study. PARTICIPANTS: Forty-one community-dwelling men and women aged > or = 70 years with low-density lipoprotein-cholesterol (LDL-C) > or = 3.62 mmol/L (140 mg/dl) participated. METHODS: Subjects received pravastatin for 6 months then pravastatin plus tocopherol for an additional 6 months (group 1),or tocopherol for 6 months then pravastatin plus tocopherol for an additional 6 months (group 2). Dosages were pravastatin 20 mg daily and tocopherol 400 IU daily. MAIN OUTCOME MEASURES: The following health-related quality-of-life measures were assessed at baseline,after 6 months and after 1 year: health perception,depression,physical function,cognitive function and sleep behaviour. In addition,data on adverse effects and laboratory abnormalities were obtained. RESULTS: Pravastatin reduced levels of total cholesterol (-21%,p < 0.001) and LDL-C (-29%,p < 0.001). Health-related quality-of-life scores,physical adverse effects,muscle enzyme levels and liver function tests did not change after 12 months of therapy with pravastatin,tocopherol or their combination. CONCLUSION: Both pravastatin and tocopherol have a good safety profile,are well tolerated and do not adversely affect health-related quality of life in older patients with hypercholesterolaemia. Given the significant beneficial cardiovascular effects of statin therapy in older adults and the potential role of statins in prevention of Alzheimer's disease,concerns about adverse effects on quality of life should not deter use of these medications in this population.",null,"USA",2002,"Cardiovascular Disease","Pravastatin,Dietary","Unknown",null,null,"RCT","USA",null,"Cardiovascular Disease","Pravastatin,Dietary",null,"RCT","Unknown","2000:2004"]
[13,"Chomistek,A. K.,et al. (2015). \"Healthy lifestyle in the primordial prevention of cardiovascular disease among young women.\" J Am Coll Cardiol 65(1): 43-51.",null,"Chomistek,A. K.,et al.","Healthy lifestyle in the primordial prevention of cardiovascular disease among young women","BACKGROUND: Overall mortality rates from coronary heart disease (CHD) in the United States have declined in recent decades,but the rate has plateaued among younger women. The potential for further reductions in mortality rates among young women through changes in lifestyle is unknown. OBJECTIVES: The aim of this study was to estimate the proportion of CHD cases and clinical cardiovascular disease (CVD) risk factors among young women that might be attributable to poor adherence to a healthy lifestyle. METHODS: A prospective analysis was conducted among 88,940 women ages 27 to 44 years at baseline in the Nurses' Health Study II who were followed from 1991 to 2011. Lifestyle factors were updated repeatedly by questionnaire. A healthy lifestyle was defined as not smoking,a normal body mass index,physical activity >/= 2.5 h/week,television viewing </= 7 h/week,diet in the top 40% of the Alternative Healthy Eating Index-2010,and 0.1 to 14.9 g/day of alcohol. To estimate the proportion of CHD and clinical CVD risk factors (diabetes,hypertension,and hypercholesterolemia) that could be attributed to poor adherence to a healthy lifestyle,we calculated the population-attributable risk percent. RESULTS: During 20 years of follow-up,we documented 456 incident CHD cases. In multivariable-adjusted models,nonsmoking,a healthy body mass index,exercise,and a healthy diet were independently and significantly associated with lower CHD risk. Compared with women with no healthy lifestyle factors,the hazard ratio for CHD for women with 6 lifestyle factors was 0.08 (95% confidence interval: 0.03 to 0.22). Approximately 73% (95% confidence interval: 39% to 89%) of CHD cases were attributable to poor adherence to a healthy lifestyle. Similarly,46% (95% confidence interval: 43% to 49%) of clinical CVD risk factor cases were attributable to a poor lifestyle. CONCLUSIONS: Primordial prevention through maintenance of a healthy lifestyle among young women may substantially lower the burden of CVD.",null,"USA",2015,"Coronary Heart Disease","none","Unknown",null,null,"Cohort","USA",null,"Coronary Heart Disease","None",null,"Cohort","Unknown","2015:2018"]
[14,"Clark,M.,et al. (1997). \"Development and evaluation of a computer-based system for dietary management of hyperlipidemia.\" J Am Diet Assoc 97(2): 146-150.",null,"Clark,M.,et al.","Development and evaluation of a computer-based system for dietary management of hyperlipidemia","OBJECTIVE: To describe the development of a computer-based system for dietary management of hyperlipidemia and to evaluate its efficacy for lowering plasma cholesterol level. DESIGN: Using a stepwise approach,we developed and tested a three-part self-management system in five consecutive clinical studies. Each study assessed plasma cholesterol levels before and after dietary intervention using the system. These studies enabled progressive refinement of (a) a food frequency questionnaire used to assess food intake in the preceding month; (b) computer-generated progress reports,based on questionnaire responses,offering dietary change subgoals and strategies for change; and (c) a dietary workbook providing detailed information on how to achieve goals. SUBJECTS/SETTING: Persons with hyperlipidemia (n=814) were enrolled from worksite and clinical settings in the San Francisco Bay area of California. The attrition rate after randomization was 5%. INTERVENTION: Elements of the dietary intervention evolved in response to the results of five clinical studies. In each study,patients underwent a form of baseline assessment of dietary intake followed by counseling/instruction by various means. Follow-up dietary assessments were provided at specific intervals to facilitate subjects' progress toward their dietary goals. A dietary workbook provided the detailed instruction required to implement the recommendations contained in the periodic progress reports. STATISTICAL ANALYSES PERFORMED: Changes in plasma cholesterol level were measured by paired and unpaired t tests. The relationship between the reported reduction in dietary fat and cholesterol level assessed by food frequency questionnaires and the directly measured change in plasma cholesterol level was measured by multiple linear regression. RESULTS: The three major elements of the final computerized system (food frequency questionnaires,computer-generated progress reports,and dietary workbook) were developed and refined in the course of the five clinical studies. Reductions in total plasma cholesterol level of 5.0% to 6.5% achieved by participants in all five studies were consistent with self-reported reductions in intake of dietary saturated fat and cholesterol. Therefore,the computerized self-management system appears to be an effective tool for reducing plasma cholesterol levels. APPLICATIONS/CONCLUSIONS: A computer-based system for dietary self-management of hyperlipidemia,implemented by mail,was effective in short-term studies. This self-management system can potentially provide health-promoting services to large numbers of people at low cost.",null,"USA",1997,"Hyperlipidemia","Dietary","Unknown",null,null,"RCT","USA",null,"Hyperlipidemia","Dietary",null,"RCT","Unknown","1960:1999"]
[15,"Cohen,J.,et al. (1998). \"Near-patient testing for serum cholesterol: attitudes of general practitioners and patients,appropriateness,and costs.\" Med J Aust 168(12): 605-609.",null,"Cohen,J.,et al.","Near-patient testing for serum cholesterol: attitudes of general practitioners and patients,appropriateness,and costs","OBJECTIVE: To determine the attitudes of general practitioners (GPs) and patients to near-patient testing (NPT) for serum cholesterol level,the appropriateness of NPT,and cost compared with testing in a specialist pathology laboratory. DESIGN: A descriptive survey of registered Category 5 general practices in Victoria,1994. Matched questionnaires were completed by GPs providing NPT and patients being tested. PARTICIPANTS: 13 GPs performing NPT and 206 patients having NPT. RESULTS: Thirteen of the 17 Victorian Category 5-accredited practices participated in this study (77%),and 203 of the 260 GP questionnaires and 206 of the 260 patient questionnaires were returned. NPT of serum cholesterol level was found to be appropriately used by GPs,and recommended management guidelines for lowering cholesterol level were followed. Both GPs and patients strongly supported the role of NPT in general practice on the basis of convenience,issues of patient care,quality,efficiency and cost,but GPs felt the registration and quality assurance fees were unreasonably high. We identified potential cost savings for patients and the Health Insurance Commission with NPT of cholesterol level by GPs compared with testing at specialist pathology laboratories. CONCLUSIONS: NPT appears to be of benefit to both GPs and patients and to provide cost savings. However,the registration charges and quality assurance fees for NPT laboratories may be limiting GPs' use of NPT.",null,"Australia",1998,"Unknown","None","Unknown",null,null,"Survey","Australia",null,"Unknown","None",null,"Survey","Unknown","1960:1999"]
[16,"Davidson,M.,et al. (2017). \"The burden of familial chylomicronemia syndrome: interim results from the IN-FOCUS study.\" Expert Rev Cardiovasc Ther 15(5): 415-423.",null,"Davidson,M.,et al.","The burden of familial chylomicronemia syndrome: interim results from the IN-FOCUS study","BACKGROUND: Familial Chylomicronemia Syndrome (FCS) is a rare genetic disorder that is caused by a decrease or an absence of lipoprotein lipase activity. FCS is characterized by marked accumulation of chylomicrons and extreme hypertriglyceridemia,which have major effects on both physical and mental health. To date,there have been no systematic efforts to characterize the impact of chylomicronemia on FCS patients' lives. In particular,the impact of FCS on the burden of illness (BoI) and quality of life (QoL) has not been fully described in the literature. METHODS: IN-FOCUS was a comprehensive web-based research survey of patients with FCS focused on capturing the BoI and impact on QoL associated with FCS. Sixty patients from the US diagnosed with FCS participated. Patients described multiple symptoms spanning across physical,emotional and cognitive domains. RESULTS: Patients on average cycled through 5 physicians of varying specialty before being diagnosed with FCS,reflecting a lengthy journey to diagnosis Nearly all respondents indicated that FCS had a major impact on BoI and QoL and significantly influenced their career choice and employment status,and caused significant work loss due to their disease. CONCLUSION: FCS imparts a considerable burden across multiple domains with reported impairment on activities of daily living and QoL.",null,"USA",2017,"Familial chylomicronemia syndrome","none","Unknown",null,null,"Survey","USA",null,"Familial chylomicronemia syndrome","None",null,"Survey","Unknown","2015:2018"]
[17,"de Jongh,S.,et al. (2003). \"Quality of life,anxiety and concerns among statin-treated children with familial hypercholesterolaemia and their parents.\" Acta Paediatr 92(9): 1096-1101.",null,"de Jongh,S.,et al.","Quality of life,anxiety and concerns among statin-treated children with familial hypercholesterolaemia and their parents","AIM: To assess the quality of life,anxiety and concerns among statin-treated children with familial hypercholesterolaemia (FH) and their parents. METHODS: 69 FH children on statin therapy and 87 parents (51 families) participated in this study. Quality of life of the children,and anxiety levels of both the children and their parents,were investigated using self-report questionnaires. In addition,a questionnaire was designed to evaluate FH-specific concerns of these children and their parents on six different topics: 1,knowledge about FH; 2,experience of the disease; 3,family communication; 4,screening; 5,diet; and 6,experience of medication therapy. RESULTS: FH children and their parents reported no problems with regard to quality of life and anxiety. In contrast,the FH survey showed specific FH-related concerns. One-third of the children thought that FH can be cured,and 44% of the children suffered from the fact they have FH,but taking medication makes them feel safer (62%). The majority of the children kept a low cholesterol diet and more than 50% took care not to eat too much fat. Almost 38% of the parents experienced FH as a burden to their family and 79% suffered because their child had FH. CONCLUSION: These findings show that statin-treated children with FH and their parents did not report affected psychosocial functioning,but did show specific FH-related concerns.",null,"The Netherlands",2003,"Familial hypercholesterolemia","none","Unknown",null,null,"Survey","The Netherlands",null,"Familial Hypercholesterolemia","None",null,"Survey","Unknown","2000:2004"]
[18,"Delahanty,L. M.,et al. (2002). \"Medical nutrition therapy for hypercholesterolemia positively affects patient satisfaction and quality of life outcomes.\" Ann Behav Med 24(4): 269-278.",null,"Delahanty,L. M.,et al.","Medical nutrition therapy for hypercholesterolemia positively affects patient satisfaction and quality of life outcomes","Following a heart-healthy diet to lower cholesterol levels is often assumed to be difficult,to be burdensome,and to have a negative impact on quality of life (QOL). The purpose of this study was to evaluate the impact of medical nutrition therapy (MNT) versus usual care (UC) for hypercholesterolemia on patient satisfaction and QOL. Ninety ambulatory care patients (60 men and 30 women),age 28 to 66,were randomly assigned to receive either MNT from dietitians using a National Cholesterol Education Program-based protocol or UC from their physicians. Patients who received MNT reported no difference in QOL related to the taste or enjoyment of food compared with UC patients. However,the MNT group reported initial improvements in QOL related to the convenience and cost of following a low-fat diet when compared with the UC group. The MNT group also reported significant and lasting improvements in perceived QOL related to self-care compared with the UC group. MNT patients were more satisfied with the interaction at visits,knowledge and ability to manage their cholesterol,eating habits,appearance,time spent exercising,and life in general. Moreover,MNT patients did not report any negative impact related to following a low-fat diet in regard to feeling restricted by diet; interference with lifestyle activities; or difficulty planning,purchasing,or preparing meals or eating away from home. Contrary to popular belief there is no apparent reduction but rather an improvement in some measures of QOL and patient satisfaction with MNT for hypercholesterolemia.",null,"USA",2002,"Hypercholesterolemia","Dietary","Unknown",null,null,"RCT","USA",null,"Hypercholesterolemia","Dietary",null,"RCT","Unknown","2000:2004"]
[19,"Delahanty,L. M.,et al. (2001). \"Clinical and cost outcomes of medical nutrition therapy for hypercholesterolemia: a controlled trial.\" J Am Diet Assoc 101(9): 1012-1023.",null,"Delahanty,L. M.,et al.","Clinical and cost outcomes of medical nutrition therapy for hypercholesterolemia: a controlled trial","OBJECTIVE: To compare the results and cost-effectiveness of a cholesterol lowering protocol implemented by registered dietitians with cholesterol lowering advice by physicians. DESIGN: Six month randomized controlled trial,cost-effectiveness analysis. Subjects included 90 ambulatory care patients (60 men,30 women),age range 21 to 65 years,with hypercholesterolemia and not taking hypolipidemic drugs. Patients were randomly assigned to receive medical nutrition therapy (MNT) from dietitians using a NCEP based lowering protocol or usual care (UC) from physicians. Outcome measures were plasma lipid profiles,dietary intake,weight,activity,patient satisfaction,and costs of MNT. Changes from baseline for each variable of interest were compared between treatment groups using analysis of covariance controlling for baseline value of the variable and gender. RESULTS: MNT achieved a 6% decrease in total and LDL cholesterol levels at 3 and 6 months compared with a 1% increase and a 2% decrease in both values at 3 and 6 months with UC (P<.001 and P<.05,respectively). Weight loss (1.9 vs 0 kg,P<.001) and dietary intake of saturated fat (7% of energy vs 10%,P<.001) were better in the MNT than the UC group. The additional costs of MNT were $217 per patient to achieve a 6% reduction in cholesterol and $98 per patient to sustain the reduction. The cost-effectiveness ratio for MNT was $36 per 1% decrease in cholesterol and LDL level. APPLICATIONS/CONCLUSIONS: MNT from registered dietitians is a reasonable investment of resources because it results in significantly better lipid,diet,activity,weight,and patient satisfaction outcomes than UC.",null,"USA",2001,"Hypercholesterolemia","Dietary","Unknown",null,null,"RCT","USA",null,"Hypercholesterolemia","Dietary",null,"RCT","Unknown","2000:2004"]
[20,"Dubisar,B. M.,et al. (2004). \"Adverse effects of atypical antipsychotic agents and their effects on quality of life.\" Pharmacotherapy 24(7): 843-847.",null,"Dubisar,B. M.,et al.","Adverse effects of atypical antipsychotic agents and their effects on quality of life","STUDY OBJECTIVES: To determine how axis III metabolic disturbances associated with atypical antipsychotic agents (weight gain,diabetes mellitus,and hyperlipidemia) affect patients' quality of life by comparing perceived quality of life of patients taking these agents who developed the disorders with those who did not develop them. A secondary objective was to compare patients' assessments of their quality of life with assessments made of the same patients by their treating psychiatrists. DESIGN: Analysis of questionnaire results. PATIENTS: Thirty three patients hospitalized at a Missouri Department of Mental Health long-term care psychiatric facility after January 1,1990. MEASUREMENTS AND MAIN RESULTS: Participating patients independently completed the \"long\" form of the Quality of Life Enjoyment and Satisfaction Questionnaire. The psychiatrists who treated these patients completed the Physical Health-Activities section of the same questionnaire,based on their assessments of their patients' quality of life. Fifteen patients had a diagnosed axis III metabolic disturbance. For the group with these comorbid illnesses,the mean score on overall life satisfaction and contentment was 3.6 (fair to good). The corresponding value for the group without these comorbid diseases was 4.538 (good to very good). Psychiatrists' assessments of their patients' quality of life were less positive than the patients' own assessments,regardless of the existence of comorbid disease. CONCLUSION: Patients receiving atypical antipsychotic drugs had a perceived high quality of life and were satisfied with a variety of aspects of their lives. However,metabolic disturbances had a significant,detrimental effect on patients' perceived quality of life.",null,"USA",2004,"Unknown","None","Q-LES-Q",null,null,"Survey","USA",null,"Unknown","None",null,"Survey","Q-LES-Q","2000:2004"]
[21,"Einvik,G.,et al. (2010). \"The influence of long-term awareness of hyperlipidemia and of 3 years of dietary counseling on depression,anxiety,and quality of life.\" J Psychosom Res 68(6): 567-572.",null,"Einvik,G.,et al.","The influence of long-term awareness of hyperlipidemia and of 3 years of dietary counseling on depression,anxiety,and quality of life","OBJECTIVE: The purpose of this study is to investigate the long-term effects of participation in a cardiovascular screening program and of dietary counseling on self-reported psychosocial outcomes and health concerns. METHODS: High-risk subjects (n=563) with hyperlipidemia from the Oslo Diet and Antismoking Study (1972-1977) were reexamined after 25 years and randomly assigned to a new 3-year prospective 2x2 factorial placebo-controlled study in 1997 of n-3 polyunsaturated fatty acids and/or dietary counseling. Hospital Anxiety and Depression Scale (HADS),Life Satisfaction Index (LSI),and a new questionnaire on health concerns and behavior in response to risk information were collected at the 25-year follow-up. Hospital Anxiety and Depression Scale and LSI were evaluated at the end of the 3-year Diet and Omega-3 Intervention Trial on atherosclerosis (DOIT) in 505 subjects. RESULTS: Twenty-five years after the screening program,HADS-anxiety was similar to the Norwegian norms (3.3 vs. 3.5),while HADS-depression was significantly lower (3.6 vs. 4.1,P<.01). Patients reported that 25 years of awareness of hyperlipidemia had influenced health concerns through a moderate change in diet habits,some restriction in life conduct,but an improvement of the total life situation. After a novel 3-year intervention in DOIT,there was no difference between the dietary counseling and control group with regard to anxiety,depression,or life satisfaction,but HADS-anxiety increased significantly (4.0 vs. 3.3,P<.001) in both groups. CONCLUSION: Compared to the general population,screening-positive subjects did not have increased mental distress 25 years after screening,and beneficial health behavior persisted. Dietary counseling did not affect psychosocial outcomes.",null,"Norway",2010,"Hyperlipidemia","None","HADS,LSI",null,null,"RCT","Norway",null,"Hyperlipidemia","None",null,"RCT","HADS,LSI","2010:2014"]
[22,"Erhardt,L. R. and F. D. Hobbs (2007). \"A global survey of physicians' perceptions on cholesterol management: the From The Heart study.\" Int J Clin Pract 61(7): 1078-1085.",null,"Erhardt,L. R. and F. D. Hobbs","A global survey of physicians' perceptions on cholesterol management: the From The Heart study","AIMS: Guidelines for cardiovascular disease (CVD) prevention cite high levels of low-density lipoprotein cholesterol (LDL-C) as a major risk factor and recommend LDL-C goals for various risk groups. Lifestyle changes are advised as first-line treatment for patients with high cholesterol,and statins are recommended in high-risk patients. The From The Heart study investigated current practice for the diagnosis and treatment of high cholesterol,and attitudes towards management of the condition. METHODS: Physicians were randomly selected from 10 countries,and completed a confidential,semi-structured questionnaire. RESULTS: Of 2790 physicians agreeing to participate,750 (27%) responded. Physicians rated CVD as the leading cause of death,although physicians (80%) perceived that cancer was the most feared illness among patients. Physicians (71%) believed smoking to be the greatest CVD risk factor,while only 50% thought high cholesterol was the greatest risk. Most physicians (81%) used guidelines to set cholesterol goals,primarily their national guidelines (34%) or the National Cholesterol Education Program Adult Treatment Panel III guidelines (24%). Although only 47% of patients reached and maintained their cholesterol goals,61% of physicians believed that a sufficient number of patients achieved goals,and 53% did not feel frustrated that they could not always effectively treat patients with CVD. CONCLUSION: Results indicate discrepancies between guideline recommendations and clinical practice. Although physicians appreciate the risk of CVD,the importance of achieving healthy cholesterol levels for CVD prevention does not seem to be widely endorsed. There is a need for improved communication regarding the importance of cholesterol lowering and investigation of initiatives to improve goal achievement among physicians.",null,"Sweden",2007,"Cardiovascular disease","none","Unknown",null,null,"Survey","Sweden",null,"Cardiovascular Disease","None",null,"Survey","Unknown","2005:2009"]
[23,"Feldman,W. (1990). \"How serious are the adverse effects of screening?\" J Gen Intern Med 5(5 Suppl): S50-53.",null,"Feldman,W.","How serious are the adverse effects of screening?","The adverse effects of screening are not commonly studied. False-positive tests lead to discomfort,costs,and risks from additional diagnostic and therapeutic procedures. False-negative tests lead to a sense of security and delays in seeking medical help when symptoms develop. Labeling an individual with a false-positive test,or with a true-positive test for which there is no evidence that intervention makes a difference,e.g.,intervention on an 80-year-old asymptomatic woman with hypercholesterolemia,can have a markedly negative impact on the quality of life. Interpreting statistical abnormalities out of clinical context,e.g.,lending importance to a multiphasic blood screen showing \"high\" alkaline phosphatase in a teenager,leads to unnecessary costs and anxiety. The cost of screening programs that may not have been shown to do more good than harm is already having an impact on the resources available to diagnose and treatment symptomatic persons. Premature implementation of unproved screening programs will continue to decrease physician and public confidence in prevention.",null,"Canada",1990,"Unknown","None","Unknown",null,null,"Narrative Review","Canada",null,"Unknown","None",null,"Narrative Review","Unknown","1960:1999"]
[24,"Flannery,J. and A. Raulerson (2000). \"Hypercholesterolemia: a look at low-cost treatment and treatment adherence.\" J Am Acad Nurse Pract 12(11): 462-466.",null,"Flannery,J. and A. Raulerson","Hypercholesterolemia: a look at low-cost treatment and treatment adherence","PURPOSE: To determine whether a positive cholesterol-lowering effect could be achieved with a psyllium dose of 6 grams per day instead of the usual 10 grams per day as advocated by other researchers. DATA SOURCES: Randomized trial of 46 males and females with hypercholesterolemia; multivariate analysis of variance with repeated measures on 1 factor done on 28 subjects (18 in treatment group,10 in control group) remaining after 16 weeks of treatment. CONCLUSIONS: Lipoprotein analysis at 2,8,and 16 weeks indicated that a daily dose of 6 grams of psyllium hydrophilic mucilloid did not significantly affect serum total cholesterol nor low-density lipoproteins in either men or women with hypercholesterolemia. The effects of psyllium on hypercholesterolemia appear to be dose dependent. PRACTICE IMPLICATIONS: Although it is a low cost option,the addition of psyllium to the diet has unpleasant side-effects,including abdominal distention,flatulence,and discomfort. Because these side effects are troublesome,the lowest effective dose of psyllium may be an important factor in improving treatment adherence.",null,"USA",2000,"Hypercholesterolemia","Herbal","Unknown",null,null,"RCT","USA",null,"Hypercholesterolemia","Herbal",null,"RCT","Unknown","2000:2004"]
[25,"Flodgren,G.,et al. (2015). \"Interactive telemedicine: effects on professional practice and health care outcomes.\" Cochrane Database Syst Rev 9: Cd002098.",null,"Flodgren,G.,et al.","Interactive telemedicine: effects on professional practice and health care outcomes","BACKGROUND: Telemedicine (TM) is the use of telecommunication systems to deliver health care at a distance. It has the potential to improve patient health outcomes,access to health care and reduce healthcare costs. As TM applications continue to evolve it is important to understand the impact TM might have on patients,healthcare professionals and the organisation of care. OBJECTIVES: To assess the effectiveness,acceptability and costs of interactive TM as an alternative to,or in addition to,usual care (i.e. face-to-face care,or telephone consultation). SEARCH METHODS: We searched the Effective Practice and Organisation of Care (EPOC) Group's specialised register,CENTRAL,MEDLINE,EMBASE,five other databases and two trials registers to June 2013,together with reference checking,citation searching,handsearching and contact with study authors to identify additional studies. SELECTION CRITERIA: We considered randomised controlled trials of interactive TM that involved direct patient-provider interaction and was delivered in addition to,or substituting for,usual care compared with usual care alone,to participants with any clinical condition. We excluded telephone only interventions and wholly automatic self-management TM interventions. DATA COLLECTION AND ANALYSIS: For each condition,we pooled outcome data that were sufficiently homogenous using fixed effect meta-analysis. We reported risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes,and mean differences (MD) for continuous outcomes. MAIN RESULTS: We included 93 eligible trials (N = 22,047 participants),which evaluated the effectiveness of interactive TM delivered in addition to (32% of studies),as an alternative to (57% of studies),or partly substituted for usual care (11%) as compared to usual care alone.The included studies recruited patients with the following clinical conditions: cardiovascular disease (36),diabetes (21),respiratory conditions (9),mental health or substance abuse conditions (7),conditions requiring a specialist consultation (6),co morbidities (3),urogenital conditions (3),neurological injuries and conditions (2),gastrointestinal conditions (2),neonatal conditions requiring specialist care (2),solid organ transplantation (1),and cancer (1).Telemedicine provided remote monitoring (55 studies),or real-time video-conferencing (38 studies),which was used either alone or in combination. The main TM function varied depending on clinical condition,but fell typically into one of the following six categories,with some overlap: i) monitoring of a chronic condition to detect early signs of deterioration and prompt treatment and advice,(41); ii) provision of treatment or rehabilitation (12),for example the delivery of cognitive behavioural therapy,or incontinence training; iii) education and advice for self-management (23),for example nurses delivering education to patients with diabetes or providing support to parents of very low birth weight infants or to patients with home parenteral nutrition; iv) specialist consultations for diagnosis and treatment decisions (8),v) real-time assessment of clinical status,for example post-operative assessment after minor operation or follow-up after solid organ transplantation (8) vi),screening,for angina (1).The type of data transmitted by the patient,the frequency of data transfer,(e.g. telephone,e-mail,SMS) and frequency of interactions between patient and healthcare provider varied across studies,as did the type of healthcare provider/s and healthcare system involved in delivering the intervention.We found no difference between groups for all-cause mortality for patients with heart failure (16 studies; N = 5239; RR:0.89,95% CI 0.76 to 1.03,P = 0.12; I(2) = 44%) (moderate to high certainty of evidence) at a median of six months follow-up. Admissions to hospital (11 studies; N = 4529) ranged from a decrease of 64% to an increase of 60% at median eight months follow-up (moderate certainty of evidence). We found some evidence of improved quality of life (five studies; N = 482; MD:-4.39,95% CI -7.94 to -0.83; P < 0.02; I(2) = 0%) (moderate certainty of evidence) for those allocated to TM as compared with usual care at a median three months follow-up. In studies recruiting participants with diabetes (16 studies; N = 2768) we found lower glycated haemoglobin (HbA1c %) levels in those allocated to TM than in controls (MD -0.31,95% CI -0.37 to -0.24; P < 0.00001; I(2)= 42%,P = 0.04) (high certainty of evidence) at a median of nine months follow-up. We found some evidence for a decrease in LDL (four studies,N = 1692; MD -12.45,95% CI -14.23 to -10.68; P < 0.00001; I(2 =) 0%) (moderate certainty of evidence),and blood pressure (four studies,N = 1770: MD: SBP:-4.33,95% CI -5.30 to -3.35,P < 0.00001; I(2) = 17%; DBP: -2.75 95% CI -3.28 to -2.22,P < 0.00001; I(2) = 45% (moderate certainty evidence),in TM as compared with usual care.Seven studies that recruited participants with different mental health and substance abuse problems,reported no differences in the effect of therapy delivered over video-conferencing,as compared to face-to-face delivery. Findings from the other studies were inconsistent; there was some evidence that monitoring via TM improved blood pressure control in participants with hypertension,and a few studies reported improved symptom scores for those with a respiratory condition. Studies recruiting participants requiring mental health services and those requiring specialist consultation for a dermatological condition reported no differences between groups. AUTHORS' CONCLUSIONS: The findings in our review indicate that the use of TM in the management of heart failure appears to lead to similar health outcomes as face-to-face or telephone delivery of care; there is evidence that TM can improve the control of blood glucose in those with diabetes. The cost to a health service,and acceptability by patients and healthcare professionals,is not clear due to limited data reported for these outcomes. The effectiveness of TM may depend on a number of different factors,including those related to the study population e.g. the severity of the condition and the disease trajectory of the participants,the function of the intervention e.g.,if it is used for monitoring a chronic condition,or to provide access to diagnostic services,as well as the healthcare provider and healthcare system involved in delivering the intervention.",null,"UK",2015,"Cardiovascular Disease,Diabetes,Various","Patient Management","Unknown",null,null,"Systematic Review","UK",null,"Cardiovascular Disease,Diabetes,Various","Patient Management",null,"Systematic Review","Unknown","2015:2018"]
[26,"Gourley,G. K.,et al. (2001). \"Development and validation of the pharmaceutical care satisfaction questionnaire.\" Am J Manag Care 7(5): 461-466.",null,"Gourley,G. K.,et al.","Development and validation of the pharmaceutical care satisfaction questionnaire","The development and validation of a survey instrument to assess consumer satisfaction with pharmacy services is discussed. The Pharmaceutical Care Satisfaction Questionnaire (PCSQ) is a 30-item instrument administered by someone other than the pharmacist that uses a Likert scale to score respondents' answers. The PCSQ is written approximately at a seventh grade reading level. Following initial development,the PCSQ was administered to 360 consumers in ambulatory pharmacies and to 311 patients in a multicenter hyperlipidemia outcomes study. The Cronbach coefficient alpha was .94 for the consumer data,with a 64.8% variance accounted for by the 4-factor solution. A coefficient alpha of .84 was found on all 30 items in the hyperlipidemia study,with a variance of 63.78% in control patients and 60.16% in treatment patients. The PCSQ is easy to administer and score,with minimal cost. Unlike other satisfaction surveys,the PCSQ contains patient evaluations regarding outcomes of care. A primary limitation of the PCSQ is that it is a newly developed instrument that needs to be used in more studies to strengthen its validity.",null,"USA",2001,"Unknown","None","PCSQ",null,null,"Survey","USA",null,"Unknown","None",null,"Survey","PCSQ","2000:2004"]
[27,"Hollman,G.,et al. (2002). \"Quality of life in patients with familial hypercholesterolaemia.\" J Intern Med 251(4): 331-337.",null,"Hollman,G.,et al.","Quality of life in patients with familial hypercholesterolaemia","OBJECTIVES: The primary aim of this study was to analyse quality of life in adult patients with familial hypercholesterolaemia (FH),a genetic disorder with increased risk of coronary heart disease (CHD). Secondary aims were to find explanatory factors for quality of life and anxiety. DESIGN: A descriptive cross-sectional design was used. SETTING: Outpatients from lipid clinics at two university hospitals in Sweden were included. Patients with heterozygous FH and a randomly selected control group participated by filling out questionnaires. SUBJECTS: Two hundred and eighty patients with heterozygous FH above 18 years of age were asked,and 212 of whom 185 were free of overt CHD,participated. Of a control group of 2980 persons 1485 were included for comparison. METHODS: We used Likert-type questionnaires: the Quality of Life Index (QLI) consisting of four subscales,the Hospital Anxiety and Depression Scale (HAD),the Mastery Scale measuring coping and a questionnaire on health and lipids constructed for FH patients. RESULTS: Patients with FH were significantly more satisfied with overall quality of life 21.8 +/- 0.3 (SEM) vs. controls 21.1 +/- 0.1 and this was also the case in three of four subscales,all differences P < 0.05. Anxiety about getting CHD was expressed amongst 86% of the patients with FH. CONCLUSIONS: Quality of life amongst patients with FH was at least as good as in controls but they were worried about getting CHD.",null,"Sweden",2002,"Familial hypercholesterolemia","None","HADS,QLI,Mastery Scale",null,null,"Cohort","Sweden",null,"Familial Hypercholesterolemia","None",null,"Cohort","HADS,QLI,Mastery Scale","2000:2004"]
[28,"Hollman,G.,et al. (2003). \"Familial hypercholesterolaemia and quality of life in family members.\" Prev Med 36(5): 569-574.",null,"Hollman,G.,et al.","Familial hypercholesterolaemia and quality of life in family members","BACKGROUND: Awareness of genetic disease in the family may influence quality of life. The purpose of this study was to describe quality of life among nonaffected members of families with familial hypercholesterolaemia. All were aware of the risk for coronary heart disease. Their quality of life was compared with a reference group and with the patients with familial hypercholesterolaemia themselves. METHODS: Names of family members (n = 129) were given by the patients with familial hypercholesterolaemia. A randomly selected reference group (n = 1485) and patients with familial hypercholesterolaemia (n = 185) were included for comparison. They all completed the questionnaire Quality of Life Index,the Hospital Anxiety and Depression Scale,and the Mastery Scale measuring coping. Family members and patients with familial hypercholesterolaemia also completed a questionnaire on health and lipids. RESULTS: Family members were more satisfied with family life,mean 22.1 +/- 3.5 (SD),and psychological/spiritual life,22.9 +/- 4.0,than the reference group,21.4 +/- 4.3 and 21.1 +/- 4.8,respectively; this was particularly expressed among partners,P < 0.05. Of family members,91% were anxious about the patient with familial hypercholesterolaemia developing coronary heart disease. CONCLUSIONS: Family members have as good a quality of life as members of the reference group,but they were anxious about the patient with familial hypercholesterolaemia developing coronary heart disease.",null,"Sweden",2003,"Hypercholesterolemia","None","HADS,QLI,Mastery Scale",null,null,"Case Control","Sweden",null,"Hypercholesterolemia","None",null,"Case Control","HADS,QLI,Mastery Scale","2000:2004"]
[29,"Hovingh,G. K.,et al. (2016). \"Identification and management of patients with statin-associated symptoms in clinical practice: A clinician survey.\" Atherosclerosis 245: 111-117.",null,"Hovingh,G. K.,et al.","Identification and management of patients with statin-associated symptoms in clinical practice: A clinician survey","BACKGROUND AND AIMS: Discontinuation of statin therapy by patients with hypercholesterolemia because of the onset of side-effects (statin-associated symptoms [SAS]) increases the risk of cardiovascular morbidity and mortality. We aimed to understand how patients with SAS,particularly those with statin-associated muscle symptoms (SAMS),are identified and managed in the outpatient setting. METHODS: A web-based survey involving 60 clinicians in each of 12 countries and 90 clinicians in the US was conducted. Clinicians answered questions about the diagnostic criteria,estimated incidence of SAS,and choice of treatment for patients with SAS. RESULTS: Overall,810 clinicians (78% cardiologists) completed the survey. An average of 72% of patients with potential SAS were reported to present with muscle-related symptoms (range across countries [RAC] 50-87%) that could be SAMS. Clinicians took a range of steps to confirm SAMS in these patients,including discontinuation of statin (average 59%; RAC 48-67%); re-challenge with >/= 2 statins (average 74%; RAC 60-85%); modification of statin regimen (average 76%; RAC 65-85%); or a combination of these steps. Overall,6% of patients with hypercholesterolemia were estimated to eventually have SAS (RAC 2-12%). In patients with SAS,on average 52% continued to receive a low-dose statin,usually with other lipid-lowering therapies (LLT). Of the remaining 49%,38% received alternative LLT only; 11% did not receive any LLT. CONCLUSION: There is some consistency and stringency in clinical practice for identifying patients with SAS; however,a structured work-up for identification,followed by a defined therapeutic algorithm,may improve their management.",null,"The Netherlands",2016,"Unknown","None","Unknown",null,null,"Survey","The Netherlands",null,"Unknown","None",null,"Survey","Unknown","2015:2018"]
[30,"Hupp,J. A.,et al. (2007). \"Results of a single center vascular screening and education program.\" J Vasc Surg 46(2): 182-187; discussion 188-189.",null,"Hupp,J. A.,et al.","Results of a single center vascular screening and education program","BACKGROUND: Vascular screening events have become a popular way to increase vascular awareness. Most screenings programs involve multiple locations on a single date and do not explore the local impact of screening. We evaluated the economic and community impact of the Dare to C.A.R.E. (DTC) program,a large,single center,continuous vascular screening and education program in Annapolis,Maryland. METHODS: Between July 2000 and July 2006,DTC was offered free to the public for those over 60 or over 50 with risk factors of hypertension,diabetes,smoking,or elevated cholesterol. DTC consisted of a 2-hour educational lecture,completing a risk factor questionnaire,and testing blood pressure,carotid duplex,abdominal aortic aneurysm (AAA) ultrasound,and pedal pulse/ankle-brachial index (ABI). Mild disease (MD) was defined as 1% to 39% carotid stenosis or an ABI between .7 and .95; intermediate disease (ID) as carotid stenosis >or=40%,AAA >or=3 cm,or an ABI <or=0.7; and severe disease (SD) as carotid stenosis >or=60%,AAA >or=5 cm,or an ABI <or=0.5. Results were discussed with the participants and forwarded to their primary physicians. Questionnaire data and screening results were analyzed and local hospital data was examined to determine the effects of screening. RESULTS: A total of 12,055 screenings were performed in DTC,439 were excluded due to age less than 40 or repeat visits,leaving 11,616 unique patients for this report. Participation grew from 189 in 2000 to over 6400 in 2005. Age ranged from 40 to 95 (median 65 years) and females comprised 58.7%. Demographics included past smokers (51.3%),current smokers (7.3%),diabetes mellitus (10.6%),hypertension (46.7%),hyperlipidemia (49.4%),and prior myocardial infarction (MI) (11.9%). 47% participants had evidence of at least mild disease (MD) with intermediate disease (ID) found in 6.9% and severe disease (SD) found in 2.2% of patients screened. Statistical analysis showed a greater prevalence of ID and SD in patients with risk factors. Diabetes alone doubled the prevalence of disease in all age groups. Over 340 hospital vascular cases were identified in DTC patients in the first 5 years of the program. CONCLUSIONS: The Dare to C.A.R.E. vascular screening and education program is an effective way to detect early and significant vascular disease. It has a powerful effect on procedural and testing volumes.",null,"USA",2007,"Hypertension,Diabetes","Behavioural/Education","Unknown",null,null,"Cohort","USA",null,"Hypertension,Diabetes","Behavioural/Education",null,"Cohort","Unknown","2005:2009"]
[31,"Jansen,R.,et al. (2000). \"Factors influencing efficacy of nitrate therapy for stable angina pectoris: a multiple linear regression analysis.\" Angiology 51(12): 1007-1012.",null,"Jansen,R.,et al.","Factors influencing efficacy of nitrate therapy for stable angina pectoris: a multiple linear regression analysis","In an open-label self-controlled study of 1,350 patients with stable angina pectoris (SAP),we previously demonstrated that 50 mg of isosorbide mononitrate (ISMN) slow release formulation once daily not only provided a better antianginal effect but also a better quality of life (QOL) than did the daily administration of multiple small doses of the compound. It is unknown whether certain patient characteristics contribute to this benefit. The objective of this article was to determine what independent factors contribute to this benefit. Multiple linear regression analysis was performed on the data from these 1,350 patients. Quality of life was assessed by the Marquis QOL-questionnaire for patients with angina and included the domains of immobility,pain,and psychological distress. For the purpose of this study,overall QOL was calculated as the pooled sums of the domain scores and expressed as mean scores on an ordinal scale of 10. Age did not influence the beneficial effect of nitrate therapy on QOL. Neither did gender,rhythmic disturbances,peripheral artery disease,or the concomitant use of calcium channel blockers or beta blockers. New York Heart Association (NYHA) angina classification was an independent variable: patients with a NYHA class I or II benefited less than did patients with NYHA III or IV (p = 0.02). Obese patients as well as hypertensive patients benefited less (p = 0.04 and 0.02),and smokers tended to benefit less also (p = 0.08). In contrast,hypercholesterolemia and diabetes mellitus improved the beneficial effect of nitrates on QOL (p = 0.03 and 0.05). The authors conclude that patients with coronary artery disease (CAD) and concomitant diabetes mellitus or hypercholesterolemia,a category particularly prone to early endothelial dysfunction and thus dysfunctional endogenous nitric oxide (NO) production,may benefit more from NO-donor therapy than patients without such concomitant conditions.",null,"The Netherlands",2000,"Various","Various","MQOLQ",null,null,"Cohort","The Netherlands",null,"Various","Various",null,"Cohort","MQOLQ","2000:2004"]
[32,"Johannigman,M. J.,et al. (2010). \"Medication therapy management and condition care services in a community-based employer setting.\" Am J Health Syst Pharm 67(16): 1362-1367.",null,"Johannigman,M. J.,et al.","Medication therapy management and condition care services in a community-based employer setting","PURPOSE: A program in which health-system pharmacists and pharmacy technicians provide medication therapy management (MTM),wellness,and condition care (disease management) services under contract with local businesses is described. SUMMARY: The health-system pharmacy department's Center for Medication Management contracts directly with company benefits departments for defined services to participating employees. The services include an initial wellness and MTM session and,for certain patients identified during the initial session,ongoing condition care. The initial appointment includes a medication history,point-of-care testing for serum lipids and glucose,body composition analysis,and completion of a health risk assessment. The pharmacist conducts a structured MTM session,reviews the patient's test results and risk factors,provides health education,discusses opportunities for cost savings,and documents all activities on the patient's medication action plan. Eligibility for the condition care program is based on a diagnosis of diabetes,hypertension,asthma,heart failure,or hyperlipidemia or elevation of lipid or glucose levels. Findings are summarized for employers after the initial wellness screening and at six-month intervals. Patients receiving condition care sign a customized contract,establish goals,attend up to four MTM sessions per year,and track their information on a website; employers may offer incentives for participation. When pharmacists recommend adjustments to therapy or cost-saving changes,it is up to patients to discuss these with their physician. A survey completed by each patient after the initial wellness session has indicated high satisfaction. Direct cost savings related to medication changes have averaged $253 per patient per year. Total cost savings to companies in the first year of the program averaged $1011 per patient. For the health system,the program has been financially sustainable. Key laboratory values indicate positive clinical outcomes. CONCLUSION: A business model in which health-system pharmacists provide MTM and condition care services for company employees has demonstrated successful outcomes in terms of patient satisfaction,cost savings,and clinical benefits.",null,"USA",2010,"Diabetes,Hypertension,Various,Hyperlipidemia","Patient Management","Unknown",null,null,"Case Control","USA",null,"Diabetes,Hypertension,Various,Hyperlipidemia","Patient Management",null,"Case Control","Unknown","2010:2014"]
[33,"Kannan,H.,et al. (2008). \"Economic and humanistic outcomes associated with comorbid type-2 diabetes,high cholesterol,and hypertension among individuals who are overweight or obese.\" J Occup Environ Med 50(5): 542-549.",null,"Kannan,H.,et al.","Economic and humanistic outcomes associated with comorbid type-2 diabetes,high cholesterol,and hypertension among individuals who are overweight or obese","OBJECTIVE: To assess the association of diabetes,hypertension,and high cholesterol with economic and humanistic outcomes among overweight or obese individuals. METHODS: Data were from the 2006 National Health and Wellness Survey and were limited to overweight or obese adults (BMI > 27). Outcomes assessed include the SF-8,resource use,and the Work Productivity and Activity Impairment questionnaire. Independent effects of comorbid conditions were determined using linear regression models. RESULTS: Significant associations between comorbid conditions and outcomes were noted. Comorbid conditions had significant independent effects on outcomes. The presence of all three comorbid conditions was the strongest correlate of work productivity loss (B = 13.992) and activity impairment (B = 13.397) and had the strongest negative association with SF-8 physical (B = -8.239) and mental summary scores (B = -2.605). CONCLUSION: Among,overweight or obese individuals,comorbid conditions are associated with greater productivity loss,resource use,and poorer quality of life.",null,"USA",2008,"Diabetes,Hypertension,Hypercholesterolemia","None","SF-8,WPAI",null,null,"Survey","USA",null,"Diabetes,Hypertension,Hypercholesterolemia","None",null,"Survey","SF-8,WPAI","2005:2009"]
[34,"Kayikcioglu,M. and L. Tokgozoglu (2017). \"The rationale and design of the national familial hypercholesterolemia registries in Turkey: A-HIT1 and A-HIT2 studies.\" Turk Kardiyol Dern Ars 45(3): 261-267.",null,"Kayikcioglu,M. and L. Tokgozoglu","The rationale and design of the national familial hypercholesterolemia registries in Turkey: A-HIT1 and A-HIT2 studies","OBJECTIVE: Familial hypercholesterolemia (FH) is a genetic disease characterized by extremely high levels of cholesterol,leading to premature atherosclerosis. Although many countries have already addressed the burden of FH by means of national registries,Turkey has no national FH registry or national screening program to detect FH. Creation of a series of FH registries is planned as part of Turkish FH Initiative endorsed by the Turkish Society of Cardiology to meet this need. This article provides detailed information on the rationale and design of the first 2 FH registries (A-HIT1 and A-HIT2). METHODS: A-HIT1 is a nationwide survey of adult homozygous FH (HoFH) patients undergoing low-density lipoprotein (LDL) apheresis (LA) in Turkey. A-HIT1 will provide insight into the clinical status of HoFH patients undergoing LA. Primary objective of this cross-sectional study is to identify how HoFH patients on LA are managed. Inclusion criteria are age >12 years,diagnosis of HoFH,and regular LA treatment. All available apheresis centers were electronically invited to participate in the study. The principal physicians of each center will respond to a questionnaire regarding their attitude toward LA. For each patient,another questionnaire will be used to collect data on clinical status,medication use,and disease data. In addition,patients will be asked to complete self-report questionnaires that provide information on quality of life,disease-related anxiety,and depression. A-HIT2 is a registry of adult FH patients presenting at outpatient clinics. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 statistical regions in Turkey based on the EU NUTS classification. Sites specializing in cardiology,internal medicine,and endocrinology were invited to participate. The primary objective of this cross-sectional study is to determine clinical status and management of patients in Turkey diagnosed with FH. Eligibility for screening was defined as having LDL-cholesterol level >160 mg/dL. Inclusion criteria are age >18 years and diagnosis as possible FH (total score of >2 according to Dutch Lipid Clinic Network criteria). In addition to measuring clinical status of patients,a short survey to assess patient level of disease awareness will also be administered. CONCLUSION: A-HIT1 and A-HIT2 are the first nationwide FH registries in Turkey and will provide important information on the management of Turkish FH patients. In addition,it is planned that they will guide establishment of a national policy for the diagnosis and treatment of FH in Turkey.",null,"Turkey",2017,"Familial Hypercholesterolemia","None","Unknown",null,null,"Survey","Turkey",null,"Familial Hypercholesterolemia","None",null,"Survey","Unknown","2015:2018"]
[35,"Kimball, A. B., et al. (2011). \"Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: Subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial.\" Am J Clin Dermatol 12(1): 51-62.",null,"Kimball, A. B., et al.","Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: Subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial","BACKGROUND: Psoriasis is associated with a variety of major physical and mental co-morbidities. OBJECTIVE: To assess the incremental burden of co-morbidities on patient-reported outcomes and evaluate the efficacy and safety of adalimumab in psoriasis patients with co-morbidities. STUDY DESIGN: Data were obtained from the initial 16-week, double-blind treatment period of REVEAL (Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis triAL), a randomized, multicenter, phase III clinical trial. INTERVENTION: Patients with moderate to severe psoriasis were randomized in a 2 : 1 ratio to receive adalimumab 80 mg (two 40 mg injections administered subcutaneously) at baseline followed by one 40 mg injection every other week from week 1 to week 15 or placebo. MAIN OUTCOME MEASURES: Clinical severity (Psoriasis Area and Severity Index [PASI]) and patient-reported outcomes (Dermatology Life Quality Index [DLQI], Short Form 36 [SF-36] health survey, Work Productivity and Activity Impairment [WPAI] questionnaire) were assessed during the trial. The effect of selected co-morbidities (i.e. hypertension, psoriatic arthritis, hyperlipidemia, obesity, depression, other forms of arthritis, diabetes mellitus, and other cardiovascular diseases) on patient-reported outcomes was evaluated using multivariate analysis of covariance models. Subgroup analyses were performed by co-morbidity type to statistically compare the clinical efficacy, patient-reported outcome benefits, and safety of adalimumab with placebo in the presence of these conditions. RESULTS: Study co-morbidities were each independently associated with significantly greater impairment on at least one general patient-reported outcome measured at baseline (all p < 0.05), with the exception of hyperlipidemia. During the 16-week study, adalimumab patients demonstrated significantly greater PASI 75 response rates (defined as a reduction of at least 75% in PASI scores from baseline) compared with placebo patients for all co-morbidity subgroups. Adalimumab provided consistent improvements in DLQI, SF-36 Physical Component Summary and Mental Component Summary scores, and WPAI total scores from baseline to week 16 within co-morbidity subgroups. Rates of serious adverse events (AEs), serious infectious AEs, and AEs leading to discontinuation were comparable between adalimumab and placebo for patients with co-morbidities. CONCLUSIONS: Co-morbidities were associated with additionally impaired health-related quality of life and work productivity in patients with psoriasis. Adalimumab significantly improved efficacy and patient-reported outcomes and was well tolerated in patients with co-morbidities.",null,"USA",2011,"Various","Various","PASI,DLQI,SF-36,WPAI",null,null,"RCT","USA",null,"Various","Various",null,"RCT","PASI,DLQI,SF-36,WPAI","2010:2014"]
[36,"Kimura, T. and J. Nakamura (2004). \"Health-related quality of life in outpatients of a psychosomatic medicine clinic: a pilot survey in Japan.\" Tokai J Exp Clin Med 29(4): 135-141.",null,"Kimura, T. and J. Nakamura","Health-related quality of life in outpatients of a psychosomatic medicine clinic: a pilot survey in Japan","The objective of this study is to clarify the difference of health-related quality of life (HRQoL) profiles by disease category with the SF-36 questionnaires, and to examine the possibility of application for a longitudinal study. A number of subjects was 536, specifically 127 men and 409 women. For all of the eight domains, Cronbach's alpha exceeded 0.7. Categories in which all of the domains were approximately equal to the national standard included hypertension, neck and shoulders syndrome, diabetes, hyperlipidemia and cardiac disease. Bodily pain was especially lower in gastrointestinal disorder, spondylopathy and hemopathy. Patients with mental disorder had lower scores in all domains. Categories in which 5-7 of the eight domains had lower scores included arthropathy, asthma, chronic hepatitis, autonomic imbalance, 'ovariopathy and hysteropathy' and chronic rheumatism. No significant change was found between the first and second scores in hypertension as a representative of the high HRQoL categories. In mental disorder as a representative of the low HRQoL categories, however, five of the eight domains increased significantly. We concluded that a target disease should be chosen among subjects with low HRQoL scores before an intervention to assess its effectiveness. Or subjects with high HRQoL scores can be examined to determine whether they keep the same level of HRQoL.",null,"Japan",2004,"Hypertension,Diabetes,Hyperlipidemia,Coronary Heart Disease,Various","None","SF-36",null,null,"Survey","Japan",null,"Hypertension,Diabetes,Hyperlipidemia,Coronary Heart Disease,Various","None",null,"Survey","SF-36","2000:2004"]
[37,"Lalonde, L., et al. (1999). \"Conventional and chained standard gambles in the assessment of coronary heart disease prevention and treatment. Canadian Collaborative Cardiac Assessment Group.\" Med Decis Making 19(2): 149-156.",null,"Lalonde, L., et al.","Conventional and chained standard gambles in the assessment of coronary heart disease prevention and treatment. Canadian Collaborative Cardiac Assessment Group","The authors compared the abilities of descriptive and valuational health-related quality-of-life measures to discriminate healthy participants (n=39) from those on diets for dyslipidemia (n=35) and angina patients (n=30). On the rating scale, the time tradeoff, and the General Health Perception subscale of the SF-36 Health Survey, the participants with dyslipidemia or angina reported lower mean scores than the healthy participants. No differences were detected between these groups on conventional or chained standard gamble (SG) scales. The distribution of the conventional and the chained SG scores was very skewed, with the vast majority of scores being equal or very close to the maximum score. It is concluded that in this study the discriminant ability of the chained SG was comparable to that of the conventional SG and inferior to descriptive and non-risky valuational scaling techniques. This may be explained by the distortion of probabilities, by a misunderstanding of the SG chained assessment, and by a strong certainty effect.",null,"Canada",1999,"Hyperlipidemia,Various","None","SF-36",null,null,"Survey","Canada",null,"Hyperlipidemia,Various","None",null,"Survey","SF-36","1960:1999"]
[38,"Lederle, F. A. and E. M. Rogers (1990). \"Lowering the cost of lowering the cholesterol: a formulary policy for lovastatin.\" J Gen Intern Med 5(6): 459-463.",null,"Lederle, F. A. and E. M. Rogers","Lowering the cost of lowering the cholesterol: a formulary policy for lovastatin","OBJECTIVES: To describe a medical center policy designed to contain the cost of using the lipid-lowering drug lovastatin in a primary care setting, to examine the effect of the policy on cost containment, and to examine physician acceptance of the policy. SETTING: A Veterans Affairs medical center. INTERVENTIONS: The policy made lovastatin available to physicians when failure of therapy with diet and two first-line drugs was documented on an order form. The form also contained educational information including prices and recommended niacin as the drug treatment of first choice for most patients. DESIGN: To evaluate the effect of the policy, lipid-lowering drug use at the medical center was compared with that at a similar center that did not restrict lovastatin use, and with lipid-lowering drug use in the United States as a whole. A written questionnaire was used to survey physician reaction to the policy. RESULTS: The use of lovastatin as a percentage of total lipid-lowering drug use at the center with the lovastatin policy was one-fourth that at the other center or nationwide, and the use of niacin was four times greater (p less than 0.0001). The estimated savings in drug costs to the center with the lovastatin policy due to these differences was more than $30,000 per year. In the survey of physicians affected by the policy (n = 78, response rate = 100%), less than one-fourth viewed it unfavorably, and 90% favored this policy over restricting the drug to a subspecialty clinic. CONCLUSION: The authors' experience indicates that a formulary policy that permits limited use of an expensive drug in a primary care setting can contain costs in a way that is acceptable to physicians. A policy of this type could be useful to the increasing number of health care provider organizations that cover the cost of outpatient medications.",null,"USA",1990,"Unknown","Lovastatin","Unknown",null,null,"Survey","USA",null,"Unknown","Lovastatin",null,"Survey","Unknown","1960:1999"]
[39,"Leren, T. P., et al. (2008). \"Diagnosis of familial hypercholesterolemia in general practice using clinical diagnostic criteria or genetic testing as part of cascade genetic screening.\" Community Genet 11(1): 26-35.",null,"Leren, T. P., et al.","Diagnosis of familial hypercholesterolemia in general practice using clinical diagnostic criteria or genetic testing as part of cascade genetic screening","BACKGROUND: Too few familial hypercholesterolemia (FH) patients are diagnosed. The most cost-effective strategy to diagnose FH is to examine first-degree relatives of already diagnosed patients. This is referred to as cascade genetic screening. METHODS AND RESULTS: One thousand eight hundred and five first-degree relatives of index patients with molecularly defined FH consented to cascade genetic screening by the use of molecular genetic testing. Of these, 44.8% were mutation carriers and 55.2% were noncarriers. Only 44.2% of the mutation carriers were on lipid-lowering drugs at the time of genetic testing. Of these, only 9.4% had a value for total serum cholesterol below 5 mM. Among adult mutation carriers who were not on lipid-lowering treatment at the time of genetic testing, reductions in total serum cholesterol and low-density lipoprotein cholesterol of 18.4% (p < 0.0001) and 25.3% (p < 0.0001), respectively, were observed 6 months after genetic testing. It is assumed that this improvement in the lipid profile is due to a definite diagnosis obtained by molecular genetic testing. By using the results of genetic testing as the gold standard for diagnosis of FH, data from a questionnaire filled out by the relatives showed that the use of clinical criteria to diagnose FH in general practice had a sensitivity of 46.2% and a specificity of 88.0%. CONCLUSIONS: The use of clinical diagnostic criteria to diagnose FH in general practice identifies only approximately 50% of FH patients. Molecular genetic testing as part of cascade genetic screening is an efficient tool to diagnose patients, leading to significant improvement in the lipid profile. It should therefore be implemented in clinical medicine.",null,"Norway",2008,"Familial Hypercholesterolemia","None","Unknown",null,null,"Cohort","Norway",null,"Familial Hypercholesterolemia","None",null,"Cohort","Unknown","2005:2009"]
[40,"Liu, Z. L., et al. (2011). \"Chinese herbal medicines for hypercholesterolemia.\" Cochrane Database Syst Rev (7): Cd008305.",null,"Liu, Z. L., et al.","Chinese herbal medicines for hypercholesterolemia","BACKGROUND: Hypercholesterolemia is an important key contributory factor for ischemic heart disease and is associated with age, high blood pressure, a family history of hypercholesterolemia, and diabetes. Chinese herbal medicines have been used for a long time as lipid-lowering agents. OBJECTIVES: To assess the effects of Chinese herbal medicines on hypercholesterolemia. SEARCH STRATEGY: We searched the following databases: The Cochrane Library (issue 8, 2010), MEDLINE (until July 2010), EMBASE (until July 2010 ), Chinese BioMedical Database (until July 2010), Traditional Chinese Medical Literature Analysis and Retrieval System (until July 2010), China National Knowledge Infrastructure (until July 2010), Chinese VIP Information (until July 2010), Chinese Academic Conference Papers Database and Chinese Dissertation Database (until July 2010), and Allied and Complementary Medicine Database (until July 2010). SELECTION CRITERIA: We considered randomized controlled clinical trials in hypercholesterolemic participants comparing Chinese herbal medicines with placebo, no treatment, and pharmacological or non-pharmacological interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. We resolved any disagreements with this assessment through discussion and a decision was achieved based by consensus. We assessed trials for the risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting and other sources of bias. MAIN RESULTS: We included 22 randomized trials (2130 participants). The mean treatment duration was 2.3 +/- 1.3 months (ranging from one to six months). Twenty trials were conducted in China and 18 trials were published in Chinese. Overall, the risk of bias of included trials was high or unclear. Five different herbal medicines were evaluated in the included trials, which compared herbs with conventional medicine in six comparisons (20 trials), or placebo (two trials). There were no outcome data in any of the trials on cardiovascular events and death from any cause. One trial each reported well-being (no significant differences) and economic costs. No serious adverse events were observed. Xuezhikang was the most commonly used herbal formula investigated. A significant effect on total cholesterol (two trial, 254 participants) was shown in favor of Xuezhikang when compared with inositol nicotinate (mean difference (MD) -0.90 mmol/L, 95% confidence interval (CI) -1.13 to -0.68) . AUTHORS' CONCLUSIONS: Some herbal medicines may have cholesterol-lowering effects. Our findings have to be interpreted with caution due to high or unclear risk of bias of the included trials.",null,"China",2011,"Hypercholesterolemia","Herbal","Unknown",null,null,"Systematic Review","China",null,"Hypercholesterolemia","Herbal",null,"Systematic Review","Unknown","2010:2014"]
[41,"MacLeod, H. M. and E. M. McNally (2008). \"A pilot study of a family history risk assessment tool for cardiovascular disease.\" J Genet Couns 17(5): 499-507.",null,"MacLeod, H. M. and E. M. McNally","A pilot study of a family history risk assessment tool for cardiovascular disease","This study evaluated the effectiveness of using a family history questionnaire to ascertain patients and families at-risk for inherited cardiovascular disease. A questionnaire composed of 21 questions was developed based on the experience of a cardiovascular genetic counselor. This questionnaire was administered to 39 patients at a University-based cardiology practice reflecting general and specialized aspects of cardiovascular medicine. Using the number and degree of relatedness of relatives reported and limited age of onset information participants were ranked into three familial risk categories. Thirty-nine patients participated in this pilot study. Of the 39 patients, six Mendelian diseases were identified. All individuals surveyed in this study were found to be at high and/or moderate risk for at least one disease based on the family history questionnaire. Twenty-five out of 39 participants (64.1%) were found to be at high risk for at least one cardiovascular disease, and thirty-three out of 39 participants (84.6%) were found to be at moderate risk for at least one disease. A family history of arrhythmia disorders, hypertension, hyperlipidemia, coronary artery disease and diabetes were more likely to be associated with a personal history in family histories of both moderate and high risk. Family history questionnaires in cardiology clinics can be a cost-effective tool for identifying patients and families who are in the greatest need of genetic evaluation and genetic counseling services.",null,"USA",2008,"Hypertension,Hyperlipidemia,Coronary Heart Disease,Diabetes,Various","Unknown","Unknown",null,null,"Survey","USA",null,"Hypertension,Hyperlipidemia,Coronary Heart Disease,Diabetes,Various","Unknown",null,"Survey","Unknown","2005:2009"]
[42,"Mann, B. S., et al. (2014). \"Association between drug insurance cost sharing strategies and outcomes in patients with chronic diseases: a systematic review.\" PLoS One 9(3): e89168.",null,"Mann, B. S., et al.","Association between drug insurance cost sharing strategies and outcomes in patients with chronic diseases: a systematic review","BACKGROUND: Prescription drugs are used in people with hypertension, diabetes, and cardiovascular disease to manage their illness. Patient cost sharing strategies such as copayments and deductibles are often employed to lower expenditures for prescription drug insurance plans, but the impact on health outcomes in these patients is unclear. OBJECTIVE: To determine the association between drug insurance and patient cost sharing strategies on medication adherence, clinical and economic outcomes in those with chronic diseases (defined herein as diabetes, hypertension, hypercholesterolemia, coronary artery disease, and cerebrovascular disease). METHODS: Studies were included if they examined various cost sharing strategies including copayments, coinsurance, fixed copayments, deductibles and maximum out-of-pocket expenditures. Value-based insurance design and reference based pricing studies were excluded. Two reviewers independently identified original intervention studies (randomized controlled trials, interrupted time series, and controlled before-after designs). MEDLINE, EMBASE, Cochrane Library, CINAHL, and relevant reference lists were searched until March 2013. Two reviewers independently assessed studies for inclusion, quality, and extracted data. Eleven studies, assessing the impact of seven policy changes, were included: 2 separate reports of one randomized controlled trial, 4 interrupted time series, and 5 controlled before-after studies. FINDINGS: Outcomes included medication adherence, clinical events (myocardial infarction, stroke, death), quality of life, healthcare utilization, or cost. The heterogeneity among the studies precluded meta-analysis. Few studies reported the impact of cost sharing strategies on mortality, clinical and economic outcomes. The association between patient copayments and medication adherence varied across studies, ranging from no difference to significantly lower adherence, depending on the amount of the copayment. CONCLUSION: Lowering cost sharing in patients with chronic diseases may improve adherence, but the impact on clinical and economic outcomes is uncertain.",null,"Canada",2014,"Hypertension,Diabetes,Cardiovascular Disease","None","Unknown",null,null,"Systematic Review","Canada",null,"Hypertension,Diabetes,Cardiovascular Disease","None",null,"Systematic Review","Unknown","2010:2014"]
[43,"Matsumura, J. S., et al. (2013). \"The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II).\" J Vasc Surg 58(1): 73-83.e71.",null,"Matsumura, J. S., et al.","The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II)","OBJECTIVE: Angioplasty and stenting are options for revascularization of symptomatic femoral popliteal disease. Although angioplasty alone is effective in short lesions, longer lesions are often treated with stents. Multiple overlapping stents are expensive and may be associated with stent fracture. This trial evaluated the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery. METHODS: Patients with lesions >4 cm and <18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protege EverFlex Self-Expanding Peripheral Stent System (Covidien, Plymouth, Minn). The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. These were compared with published performance goals. A preplanned analysis was conducted for the primary effectiveness end points at 1 year. Follow-up, including history, ankle-brachial index, patient-reported outcomes, duplex ultrasound assessment, and radiographs, is planned through 3 years. There was core laboratory review of angiograms, ultrasound scans, and plain radiographs. A subgroup of patients was studied with graded treadmill testing. RESULTS: The study enrolled 287 patients (66% male; mean age, 68 years) with stenotic, restenotic, or occluded lesions of the SFA at 44 investigational sites in the United States and Europe. Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%), and prior SFA intervention (41%). The mean lesion length measured by the core laboratory was 89 mm. The mean normal-to-normal lesion length measured by sites was 110 mm. A total of 303 stents were implanted, and 95% of patients received a single stent. No major adverse events occurred at 30 days. At 1 year, primary outcome of duplex ultrasound stent patency was 67.7% in evaluable patients, and among 1-year secondary outcomes, the mean ankle-brachial index increased by 0.25. Walking Improvement Questionnaire scores improved in pain by 33.7, distance by 37.1, speed by 18.6, and stair climbing by 24.7. The Kaplan-Meier estimate of primary patency was 77.2%, primary assisted patency was 86.9%, and secondary patency was 87.3%. Rutherford clinical category improved in 83.5% of patients. Stent fracture rate was 0.4%. Matched absolute claudication distance was 412 feet greater and was not statistically different in this subgroup of 29 individuals. CONCLUSIONS: The results of DURABILITY II (StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol Stent SYstem II) suggest that a new single stent strategy is safe and effective for the treatment of long lesions of the SFA and proximal popliteal arteries at 1 year.",null,"USA",2013,"Various","Various","WIQ",null,null,"Clinical Trial","USA",null,"Various","Various",null,"Clinical Trial","WIQ","2010:2014"]
[44,"Mehler, P. S., et al. (2001). \"Russian immigrant cardiovascular risk assessment.\" J Health Care Poor Underserved 12(2): 224-235.",null,"Mehler, P. S., et al.","Russian immigrant cardiovascular risk assessment","Immigration from the former Soviet Union has been increasing. In 1990, there were 454,000 Russian immigrants living in the United States. Lifestyle habits prevalent in Russia, including smoking, alcoholism, and little preventive health, are compelling medical and economic reasons to understand the health status of this population. This study identified a cohort of Russian-born subjects living in Denver to characterize their cardiovascular risk profile. Using a risk assessment questionnaire, 204 Russian immigrants were screened. Seventy-one percent had Medicaid insurance; 14 percent were medically indigent. Those aged 55 to 64 years had a higher prevalence of hyperlipidemia (p < 0.04) and hypertension (p < 0.03) than U.S. counterparts; those age 20 to 34 and 65 to 74 years had a higher prevalence of hypertension (p < 0.00001). Almost half of the participants had two or more cardiac risk factors. Cardiac risk factor identification and intervention programs may help to reduce the health care costs for these patients.",null,"USA",2001,"unknown","Unknown","Unknown",null,null,"Cohort","USA",null,"Unknown","Unknown",null,"Cohort","Unknown","2000:2004"]
[45,"Mold, J. W., et al. (1998). \"Outcomes of an insurance company-sponsored multichannel chemistry screening initiative.\" J Fam Pract 47(2): 110-117.",null,"Mold, J. W., et al.","Outcomes of an insurance company-sponsored multichannel chemistry screening initiative","BACKGROUND: The use of serum chemistry panels as screening tests has been studied in a variety of clinical and nonclinical settings. None of the studies, however, has attempted to carefully examine any potential harm done to participants, and none has measured the impact on health-related quality of life. METHODS: Consenting participants in an insurance company-sponsored screening initiative completed a questionnaire before and 6 months after having blood drawn for a 25-item chemistry panel and a lipid profile; for men older than 50, a prostate-specific antigen (PSA) test was also done. The prescreening questionnaire included demographic and health information. The postscreening questionnaire included questions about specific outcomes. Included in both questionnaires were single-item measures of self-rated health and self-rated worry about health, and the 17-item Duke Health Profile (DUKE), a measure of health-related quality of life. Various outcomes were examined, including the numbers of new diagnoses, numbers and types of new treatment recommendations, change in self-reported health and worry, and change in DUKE subscale scores. Participants who were potentially helped and those who were potentially harmed by the serum chemistry panels screening program were identified and further characterized. RESULTS: Of the 2249 subjects who satisfactorily completed both questionnaires, 2012 (89%) had at least one abnormal test result, but only 985 of these (49%) remembered having discussed their test results with a physician. A total of 342 individuals received new treatment advice. However, 29 (10%) of them indicated that they would be \"somewhat unlikely\" to \"very unlikely\" to follow it. Following the intervention questionnaire, there were statistically significant average decrements in the General Health, Physical Health, and Pain subscales of the DUKE for participants with abnormal results. Self-rated health status did not change but level of worry about health increased significantly. At least 250 (11%) subjects were potentially helped by the screening initiative, but at least 574 (26%) were potentially harmed by it. CONCLUSIONS: The use of serum chemistry panels as screening tests in nonclinical settings should probably be discouraged, since health-related quality of life is not improved and the intervention may harm more individuals than it benefits.",null,"USA",1998,"Unknown","Unknown","DHP",null,null,"Survey","USA",null,"Unknown","Unknown",null,"Survey","DHP","1960:1999"]
[46,"Nieuwkerk, P. T., et al. (2012). \"Intervention to improve adherence to lipid-lowering medication and lipid-levels in patients with an increased cardiovascular risk.\" Am J Cardiol 110(5): 666-672.",null,"Nieuwkerk, P. T., et al.","Intervention to improve adherence to lipid-lowering medication and lipid-levels in patients with an increased cardiovascular risk","Low levels of statin adherence may compromise treatment outcomes. The aim of this study was to investigate whether nurse-led cardiovascular risk-factor counseling could improve statin adherence and lipid levels without increasing patients' anxiety. Patients with indications for statin therapy for primary or secondary prevention of cardiovascular disease were randomly assigned to receive routine care or extended care (EC) at baseline and at months 3, 9, and 18. Patients in the EC group received a personalized risk-factor passport, showing modifiable and unmodifiable individual risk factors and a graphical presentation of their calculated absolute 10-year cardiovascular disease risk as well as the target risk that could be reached if all modifiable risk factors were optimally treated. Lipid levels were assessed at each visit. Carotid intima-media thickness was measured at baseline and at month 18. Adherence, anxiety, quality of life, symptoms, and smoking status were assessed using a self-administered questionnaire at each visit. A total of 201 patients were included in the study. Statin adherence was significantly higher (p <0.01) and anxiety was significantly lower (p <0.01) in the EC group than in the routine care group. Low-density lipoprotein cholesterol was statistically significantly lower in the EC group than in the routine group (2.66 vs 3.00 mmol/L, respectively, p = 0.024) in primary prevention patients only. Intima-media thickness improved significantly from baseline (p <0.01) in all patients, irrespective of group assignment. In conclusion, cardiovascular risk-factor counseling resulted in improved lipid profiles in primary prevention patients and higher levels of adherence to statins and lower levels of anxiety in all patients.",null,"The Netherlands",2012,"Cardiovascular Disease","Patient Management","Unknown",null,null,"RCT","The Netherlands",null,"Cardiovascular Disease","Patient Management",null,"RCT","Unknown","2010:2014"]
[47,"Nishijima, H., et al. (2007). \"Effects of exercise in overweight Japanese with multiple cardiovascular risk factors.\" Med Sci Sports Exerc 39(6): 926-933.",null,"Nishijima, H., et al.","Effects of exercise in overweight Japanese with multiple cardiovascular risk factors","PURPOSE: The effects of exercise in subjects with multiple cardiovascular risk factors (RF) have never been tested in a large-scale randomized controlled trial. The favorable results from our observational study led to this randomized controlled trial. METHODS: The participants, recruited from a community, were overweight, with two of the following three risk factors: hypertension, hyperlipidemia, or glucose intolerance (N=561; 44% male; mean age (SD) 67 (6); mean BMI 26.4 (2.0)). All participants received a standard health exam with counseling, followed by randomization. The intervention group (INT) was to exercise two to four times per week for 6 months at a fitness club. RESULTS: Dropout rate was 11% for INT and 10% for the controls. INT exercised an average of 2.6 times per week. Among primary outcome measures, there was a marginally significant between-group difference in changes in systolic blood pressure (intervention minus control, -2.46 mm Hg). Reductions in LDL cholesterol (-1.9 mg.dL) and hemoglobin A1c (-0.042%) were not significant. Among secondary outcomes, between-group differences were significantly greater (P<0.05) for INT in mean body weight (-1.60 kg), waist circumference (-1.8 cm), triglyceride (-7 mg.dL), hsCRP (-0.063 mg.L), and estimated VO2peak (2.0 mL.kg.min). All directional mean RF changes consistently favored INT. A cardiovascular risk reduction estimated from the changes in RF was about 24%. A greater improvement was also found in health-related quality-of-life measures (SF-36) in INT. No difference was found in the adverse event rate. CONCLUSIONS: Exercising an average of 2.6 times per week for 6 months produced a significant improvement in cardiovascular risk profile in subjects with multiple cardiovascular risk factors through cumulative results of modest yet pervasive changes in all conventional risk factors, without increased adverse effects.",null,"Japan",2007,"Hypertension,Hyperlipidemia,Various","Behavioural/Education","Unknown",null,null,"RCT","Japan",null,"Hypertension,Hyperlipidemia,Various","Behavioural/Education",null,"RCT","Unknown","2005:2009"]
[48,"Ock, M., et al. (2015). \"Estimating quality-adjusted life-year loss due to noncommunicable diseases in Korean adults through to the year 2040.\" Value Health 18(1): 61-66.",null,"Ock, M., et al.","Estimating quality-adjusted life-year loss due to noncommunicable diseases in Korean adults through to the year 2040","OBJECTIVES: To estimate the loss in quality-adjusted life-years (QALYs) in Korean adults due to 13 noncommunicable diseases (NCDs) in 2010 and predict changes in QALY loss through to the year 2040. METHODS: Thirteen NCDs (hypertension, diabetes mellitus, hyperlipidemia, stroke, myocardial infarction, angina, arthritis, osteoporosis, asthma, allergic rhinitis, atopic dermatitis, cataract, and depression) were selected from the Korean Community Health Survey 2010. The EuroQol five-dimensional questionnaire index from the Korean Community Health Survey 2010 and the Korean valuation set were used to estimate utility weights according to sex, age, and disease. Morbidity data were also obtained from the Korean Community Health Survey 2010. Mortality data according to disease and life expectancy were retrieved from the Korean Statistical Information Service. To predict future QALY loss, future population projection data from the Korean Statistical Information Service were used as substitutes for 2010 population size. RESULTS: Among the assessed 13 NCDs, the largest total QALY loss was for hypertension (513,113 QALYs; units are omitted hereafter), followed by arthritis (509,317) and stroke (431,049). The largest QALY loss due to mortality was stroke (306,733), whereas the largest QALY loss due to morbidity was arthritis (502,513). By applying the middle estimate of future population, the largest increase in total QALY loss between 2010 and 2040 was for hypertension (840,582), followed by stroke (719,076) and diabetes mellitus (474,607). CONCLUSIONS: Hypertension, arthritis, and stroke are important in terms of total QALY loss, which will continuous to increase because of aging. These results could be used to develop cost-effective interventions that reduce the burden of NCDs.",null,"South Korea",2015,"Hypertension,Diabetes,Hyperlipidemia,Stroke,Coronary Heart Disease,Various","None","EQ-5D",null,null,"Survey","South Korea",null,"Hypertension,Diabetes,Hyperlipidemia,Stroke,Coronary Heart Disease,Various","None",null,"Survey","EQ-5D","2015:2018"]
[49,"Paulos, C. P., et al. (2005). \"Impact of a pharmaceutical care program in a community pharmacy on patients with dyslipidemia.\" Ann Pharmacother 39(5): 939-943.",null,"Paulos, C. P., et al.","Impact of a pharmaceutical care program in a community pharmacy on patients with dyslipidemia","BACKGROUND: Inappropriate use of medications is a significant problem in health care today. A possible solution to this problem may be achieved through better control of patients' drug therapy. OBJECTIVE: To design a pharmaceutical care program for dyslipidemic patients within a community pharmacy setting that provides education in the areas of medication compliance and lifestyle modifications, while emphasizing the importance of achieving cholesterol goals to ensure improvement in quality of life. METHODS: Patients at an outpatient pharmacy volunteered to be surveyed for 16 weeks. Although both the intervention and control groups were surveyed, the randomly selected intervention group was interviewed more frequently and more comprehensively. Cholesterol, triglycerides, glucose, weight, risk factors, drug-related problems (DRPs), and quality of life were measured via a survey at the onset of the study and continually measured until the study's conclusion. RESULTS: In the intervention group, 26 DRPs were detected, of which 24 were resolved; in the control group, 26 DRPs were detected, of which 5 were resolved. When comparing initial and final blood cholesterol levels in the intervention group, the mean decrease was 27.0 +/- 41.1 mg/dL (p = 0.0266); in the control group, the average blood cholesterol level decreased by a mean of 1.4 +/- 37.2 mg/dL (p = 0.6624). In the intervention group, the triglyceride level decreased an average of 50.5 +/- 80.3 mg/dL (p = 0.0169), while the control group experienced a mean triglyceride level increase of 29.6 +/- 118.5 mg/dL (p = 0.1435). As a result of the intervention, the quality of life in the intervention group was improved. CONCLUSIONS: Short-term pharmaceutical care plans developed in a retail pharmacy within the proper setting may contribute to improved blood lipid values, cardiovascular disease risk factors, and patients' quality of life.",null,"Chile",2005,"unknown","Patient Management","Unknown",null,null,"RCT","Chile",null,"Unknown","Patient Management",null,"RCT","Unknown","2005:2009"]
[50,"Santanello, N. C., et al. (1997). \"Effect of pharmacologic lipid lowering on health-related quality of life in older persons: results from the Cholesterol Reduction in Seniors Program (CRISP) Pilot Study.\" J Am Geriatr Soc 45(1): 8-14.",null,"Santanello, N. C., et al.","Effect of pharmacologic lipid lowering on health-related quality of life in older persons: results from the Cholesterol Reduction in Seniors Program (CRISP) Pilot Study","OBJECTIVE: To determine the effect of lovastatin therapy on health-related quality of life in older persons. DESIGN: A prospective, randomized, double blind clinical trial. SETTING: Four university medical center research clinics. PARTICIPANTS: There were 431 men and women, primarily 65 years of age or older, with low density lipoprotein levels greater than 159 mg/dL and less than 221 mg/dL. Exclusion criteria included a Mini-Mental state score less than 24 or presence of recent cardiovascular events or other serious chronic disease likely to shorten survival. INTERVENTION: All participants were administered the National Cholesterol Education Program step one diet and were then randomized to placebo, 20 mg lovastatin, or 40 mg lovastatin. MEASUREMENTS: Areas of health-related quality of life assessed in the Cholesterol Reduction in Seniors Program (CRISP) included: (1) physical functioning, (2) sleep behavior, (3) social support, (4) depression, (5) cognitive function, and (6) health perception. Three global change questions asked the patients to judge change in general health since starting the study diet or the study medication and change in ability to function or care for self. Although some patients were followed for a total of 12 months, all participants were followed for 6 months, and 6-month data have been used for the primary analysis in this paper. RESULTS: Patients treated with 20 mg of lovastatin had a 17% and 24% reduction in total cholesterol and LDL-cholesterol, respectively. Patients treated with the 40-mg lovastatin dose achieved reductions of 20% for total cholesterol and 28% for LDL-cholesterol. Complaints of possible adverse events were remarkably similar in the two active treatment groups and the placebo group. At 6 months of follow-up there were no statistically significant differences found in mean change scores from baseline between treatment groups on the health-related quality of life measures (physical functioning, sleep, social support, depression, cognitive function scales, health perception) or global questions. CONCLUSIONS: This study demonstrates that lovastatin was extremely well tolerated in an older cohort, both with regard to symptoms and to health-related quality of life.",null,"USA",1997,"Various","Lovastatin","Unknown",null,null,"RCT","USA",null,"Various","Lovastatin",null,"RCT","Unknown","1960:1999"]
[51,"Schlenk, E. A., et al. (1998). \"Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36.\" Qual Life Res 7(1): 57-65.",null,"Schlenk, E. A., et al.","Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36","The purpose of this report is to examine health-related quality of life (HRQoL) as measured by the Medical Outcomes Study Short Form-36, across patient populations with chronic disorders and to compare quality of life (QoL) in these subjects with normative data on healthy persons. Six studies, within the Center for Research in Chronic Disorders at the University of Pittsburgh School of Nursing, in patients with urinary incontinence, prostate cancer, chronic obstructive pulmonary disease (COPD), acquired immune deficiency syndrome (AIDS), fibromyalgia and hyperlipidaemia provided the data for analysis. The results demonstrated that not only did the prostate cancer and hyperlipidaemia patients have the highest QoL across the chronic disorders, but their QoL was comparable to normative data on healthy persons. Homebound, elderly, incontinent patients had the lowest QoL for physical functioning, whereas patients hospitalized with AIDS had the lowest QoL in general health and social functioning. Patients with COPD had the lowest QoL in role-physical, role-emotional and mental health. Patients with fibromyalgia had the lowest QoL in bodily pain and vitality. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia generally had lower QoL. Prostate cancer and hyperlipidaemia patients had QoL comparable to normative data. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia had more variability for role-emotional. AIDS patients had more variability on physical functioning, bodily pain and social functioning compared to the normative data. These data suggest that patients with various chronic disorders may have QoL that is lower in most domains compared to a healthy population. However, there may be differences in the domains affected as well as the extent of variation across specific chronic disorders.",null,"USA",1998,"Various,Hyperlipidemia","None","SF-36",null,null,"Survey","USA",null,"Various,Hyperlipidemia","None",null,"Survey","SF-36","1960:1999"]
[52,"Seed, M. and M. R. Weir (1999). \"Double-masked comparison of the quality of life of hypercholesterolemic men treated with simvastatin or pravastatin. International Quality of Life Multicenter Group.\" Clin Ther 21(10): 1758-1770.",null,"Seed, M. and M. R. Weir","Double-masked comparison of the quality of life of hypercholesterolemic men treated with simvastatin or pravastatin. International Quality of Life Multicenter Group","The efficacy, safety, and impact on quality of life of once-daily treatment with simvastatin 20 mg and pravastatin 40 mg were compared in a multinational, randomized, double-masked trial involving 387 men 21 to 72 years of age with primary mild-to-moderate hypercholesterolemia. The trial consisted of a 12-week baseline period, which included 6 weeks of single-masked placebo administration, and a 12-week double-masked active treatment period. Throughout the trial, patients were maintained on a standard lipid-lowering diet. Efficacy variables were plasma lipid levels and a measurement of health-related quality of life evaluated by means of a self-administered questionnaire (the Nottingham Health Profile [NHP]) and other questionnaires related to general health, sexual function, and stress/life events. Clinic visits were scheduled at study entry (week -12), at initiation and week 5 of placebo (weeks -6 and -1, respectively); at randomization (week 1, day 1); and after 4, 8, and 12 weeks of active treatment. At each visit, blood samples were collected for determination of lipid levels and the NHP, the principal measure of health-related quality of life, was administered. Primary safety measures were adverse events and laboratory test results. All statistical comparisons were two-sided, and significance was defined as P< or =0.05 except for the NHP questionnaire, which was P< or =0.01. Treatment with simvastatin 20 mg/d for 12 weeks (n = 194) resulted in significantly greater reductions in plasma total cholesterol and low-density lipoprotein cholesterol levels (25.7% and 33.6%, respectively) compared with pravastatin 40 mg/d for 12 weeks (n = 193) (19.0% and 26.3%, respectively) (P<0.001). No detrimental effects on health-related quality-of-life measurements were reported with either drug. A small but statistically significant improvement in emotional reaction from baseline (P<0.001) was observed after 12 weeks of treatment with simvastatin. At least 75% of simvastatin-treated patients indicated no change in response from baseline on NHP domain scores; these findings were similar to those for pravastatin-treated patients. The differences in the changes in lipid profiles between the 2 treatment groups were not associated with any observed differences in tolerability or health-related quality-of-life measures.",null,"UK",1999,"Hypercholesterolemia","Simvastatin","NHP",null,null,"RCT","UK",null,"Hypercholesterolemia","Simvastatin",null,"RCT","NHP","1960:1999"]
[53,"Shams, T., et al. (2017). \"Baseline Quality of Life and Risk of Stroke in the ALLHAT Study (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial).\" Stroke 48(11): 3078-3085.",null,"Shams, T., et al.","Baseline Quality of Life and Risk of Stroke in the ALLHAT Study (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial)","BACKGROUND AND PURPOSE: The visual analogue scale is a self-reported, validated tool to measure quality of life (QoL). Our purpose was to determine whether baseline QoL predicted strokes in the ALLHAT study (Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial) and evaluate determinants of poststroke change in QoL. In the ALLHAT study, among the 33 357 patients randomized to treatment arms, 1525 experienced strokes; 1202 (79%) strokes were nonfatal. This study cohort includes 32 318 (97%) subjects who completed the baseline visual analogue scale QoL estimate. METHODS: QoL was measured on a visual analogue scale and adjusted using a Torrance transformation (transformed QoL [TQoL]). Kaplan-Meier curves and adjusted proportional hazards analyses were used to estimate the effect of TQoL on the risk of stroke, on a continuous scale (0-1) and by quartiles (</=0.81, >0.81</=0.89, >0.89</=0.95, >0.95). We analyzed the change from baseline to first poststroke TQoL using adjusted linear regression. RESULTS: After adjusting for multiple stroke risk factors, the hazard ratio for stroke events for baseline TQoL was 0.93 (95% confidence interval, 0.89-0.98) per 0.1 U increase. The lowest baseline TQoL quartile had a 20% increased stroke risk (hazard ratio=1.20 [95% confidence interval, 1.00-1.44]) compared with the reference highest quartile TQoL. Poststroke TQoL change was significant within all treatment groups (P</=0.001). Multivariate regression analysis revealed that baseline TQoL was the strongest predictor of poststroke TQoL with similar results for the untransformed QoL. CONCLUSIONS: The lowest baseline TQoL quartile had a 20% higher stroke risk than the highest quartile. Baseline TQoL was the only factor that predicted poststroke change in TQoL. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000542.",null,"USA",2017,"Various","Unknown","VAS",null,null,"RCT","USA",null,"Various","Unknown",null,"RCT","VAS","2015:2018"]
[54,"Shayani, V., et al. (2012). \"Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years.\" Postgrad Med 124(4): 181-188.",null,"Shayani, V., et al.","Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years","BACKGROUND: The objective of this analysis is to report interim, 2-year results for morbidly obese patients who have undergone laparoscopic adjustable gastric banding in the LAP-BAND AP(R) EXperience (APEX) trial. METHODS: The APEX trial is an ongoing, multicenter, prospective, open-label, 5-year study of the LAP-BAND AP(R) System (LBAP) in 517 morbidly obese patients at 50 clinical centers in the United States. Last observation carried forward was used in the analyses of change in body weight and comorbid conditions, and observed data were analyzed for the Obesity and Weight-Loss Quality of Life (OWLQOL) questionnaire. Changes in body weight, percent weight loss, percent excess weight loss, body mass index (BMI), OWLQOL score, remission or improvement in obesity-related comorbid conditions, and adverse events were reported. RESULTS: At baseline, 81.5% of patients were female, and 85.8% were white. The mean age was 42.5 years, and the mean BMI was 44.0 kg/m(2). More than 85% of patients had >/= 1 obesity-related comorbidity. At 2 years, the mean BMI change was -8.5 kg/m(2), and the mean percent weight loss was -19.3%. Responses to all questions on the OWLQOL questionnaire had a mean improvement of 54% (range, 26%-67%) at 2 years. Obesity-related comorbid conditions were remitted or improved in the majority of patients at 2 years, including type 2 diabetes mellitus (96%), hypertension (91%), gastroesophageal reflux disease (91%), hyperlipidemia (77%), obstructive sleep apnea (86%), depression (75%), and osteoarthritis (93%). The LBAP and its implantation were well tolerated, with 19.1% and 6.0% of patients reporting device-related adverse events or serious device-related adverse events, respectively. CONCLUSION: The LBAP safely and effectively facilitated weight loss in morbidly obese patients, with clinically meaningful improvements in quality of life and obesity-related comorbidities. The durability of these results will be further described with additional follow-up through 5 years. TRIAL REGISTRATION: www.ClinicalTrials.gov identifier NCT00501085.",null,"USA",2012,"Various","Bariatrics","OWLQOL",null,null,"Clinical Trial","USA",null,"Various","Bariatrics",null,"Clinical Trial","OWLQOL","2010:2014"]
[55,"Shephard, M. D., et al. (2009). \"Evaluation of a training program for device operators in the Australian Government's Point of Care Testing in General Practice Trial: issues and implications for rural and remote practices.\" Rural Remote Health 9(3): 1189.",null,"Shephard, M. D., et al.","Evaluation of a training program for device operators in the Australian Government's Point of Care Testing in General Practice Trial: issues and implications for rural and remote practices","INTRODUCTION: From September 2005 to February 2007 the Australian Government funded the Point of Care Testing (PoCT) in General Practice Trial, a multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost-effectiveness and satisfaction of PoCT in General Practice. In total, 53 practices (23 control and 30 intervention) based in urban, rural or remote locations across three states (South Australia [SA], New South Wales [NSW] and Victoria [VIC]) participated in the Trial. Control practices had pathology testing performed by their local laboratory, while intervention practices conducted pathology testing by PoCT. In total, 4968 patients (1958 control and 3010 intervention) participated in the Trial. The point-of-care (PoC) tests performed by intervention practices were: haemoglobin A1c (HbA1c) and urine albumin:creatinine ratio (ACR) on patients with diabetes, total cholesterol, triglyceride and high density lipoprotein (HDL) cholesterol on patients with hyperlipidaemia, and international normalised ratio (INR) on patients on anticoagulant therapy. Three PoCT devices measured these tests: the Siemens DCA 2000 (Siemens HealthCare Diagnostics, Melbourne, VIC, Australia) for HbA1c and urine ACR; Point of Care Diagnostics Cholestech LDX analyser (Point of Care Diagnostics; Sydney, NSW, Australia) for lipids; and the Roche CoaguChek S (Roche Diagnostics; Sydney, NSW, Australia) for INR. Point-of-care testing in the General Practice Trial was underpinned by a quality management framework which included an on-going training and competency program for PoCT device operators. This article describes the design, implementation and results of the training and competency program. METHODS: An education and training resource package was developed for the Trial consisting of a training manual, a set of A3 laminated posters and a CD ROM. Five initial training workshops were held for intervention practices from each geographic region between August and October 2005 at three centres - Adelaide (SA), Bendigo (VIC) and Dubbo (NSW). These workshops combined theoretical training in the principles and practice of PoCT with 'hands on' practical training delivered in interactive small group sessions. At the completion of training, practice staff undertook a written and practical competency assessment and received a certificate of competency as a qualified device operator. Following each initial training workshop, practice staff completed a short satisfaction survey. Five refresher training workshops covering all geographic regions were delivered during late August 2006, coinciding with the 12 month point of the live phase of the Trial. At the completion of the Trial in February 2007, device operators completed a further questionnaire. RESULTS: Sixty device operators from 31 practices completed training and competency assessment as part of the Initial Training Workshop series. A further 20 device operators from 12 of the practices were trained in the 12 month period after the initial workshops; 19 of these staff were from rural or remote practices. In total 80 device operators comprising 74 practice staff and six GPs from 31 practices were trained and received competency certificates as part of Trial. In all, 19 device operators left the Trial either through personal resignation from an existing practice or because their practice withdrew from the Trial; the majority (84%) were from rural and remote practices. A total of 42 device operators from 25 practices attended refresher training in the second half of 2006. Results from the satisfaction questionnaire completed by device operators following the initial training workshops showed there was unanimous agreement that the posters were useful for the conduct of daily PoCT and practical training in small groups was satisfactory as a training method. The quality and appropriateness of the PoCT training resources and the workshop overall was rated as either good or excellent by all respondents (100% and 78%, respectively). The responses by device operators to the post-Trial satisfaction questionnaire found a high level of satisfaction with PoCT across all geographic regions. Device operators from remote practices had the highest satisfaction levels for quality of training, usefulness of the training manual, ease of use of devices, confidence in the accuracy of PoCT results and preference for PoCT over laboratory testing. The usefulness of the posters for conducting PoCT achieved the highest satisfaction rating among operators from all three geographic regions. However the highest staff turnover rates and the highest number of requests for training of additional staff were from rural and remote practices. CONCLUSION: The methods established for the implementation and delivery of training and competency assessment for the PoCT in General Practice Trial were appropriate and effective. Results of the evaluation showed rural and remote practices have a greater need for training and support compared to their urban counterparts and may require more flexible training options to cater for much higher rates of staff turnover.",null,"Australia",2009,"Diabetes,Hyperlipidemia","Behavioural/Education","Unknown",null,null,"Survey","Australia",null,"Diabetes,Hyperlipidemia","Behavioural/Education",null,"Survey","Unknown","2005:2009"]
[56,"Shibley, M. C. and C. B. Pugh (1997). \"Implementation of pharmaceutical care services for patients with hyperlipidemias by independent community pharmacy practitioners.\" Ann Pharmacother 31(6): 713-719.",null,"Shibley, M. C. and C. B. Pugh","Implementation of pharmaceutical care services for patients with hyperlipidemias by independent community pharmacy practitioners","OBJECTIVE: To implement and evaluate pharmaceutical care services for patients with hyperlipidemias in the community pharmacy setting, to evaluate the results of a pharmaceutical care training process for pharmacists by using an assessment quiz, and to measure patient outcomes resulting from provision of pharmaceutical care to patients with hyperlipidemia. DESIGN: A prospective study was conducted over a 1-year period. Patients served as their own controls. SETTING: Two independent community pharmacies in Richmond, Virginia. PARTICIPANTS: Twenty-five adult patients with confirmed dyslipidemias completed the study. INTERVENTIONS: Study pharmacists assessed each patient and assisted in setting therapeutic goals; patients also completed a visit with a registered dietitian. Drug therapy recommendations were made to physicians by the pharmacist when appropriate. Follow-up was scheduled with the pharmacist to ensure positive outcomes and reduce adverse effects. MAIN OUTCOME MEASURES: Fasting lipoprotein profiles were measured initially and at 6 and 12 months. The SF-36 survey, the MacKeigan-Larson satisfaction survey, and a patient opinion survey were administered initially and at the conclusion of the study. RESULTS: Total cholesterol and low-density lipoprotein cholesterol values were significantly decreased at 12 months compared with either the baseline or 6-month values (p < 0.02). Significant improvement was found in several domains of the surveys; quality of life, patient satisfaction with pharmacy services, and patient opinions on the role of the pharmacist improved after the intervention. CONCLUSIONS: Pharmaceutical care may positively affect lipid values, quality of life, and patient satisfaction.",null,"USA",1997,"Hyperlipidemia","Patient Management","SF-36,MKLSS",null,null,"Clinical Trial","USA",null,"Hyperlipidemia","Patient Management",null,"Clinical Trial","SF-36,MKLSS","1960:1999"]
[57,"Sipetic, S., et al. (2013). \"The burden of disease preventable by risk factor reduction in Serbia.\" Vojnosanit Pregl 70(5): 445-451.",null,"Sipetic, S., et al.","The burden of disease preventable by risk factor reduction in Serbia","BACKGROUND/AIM: Reliable and comparable analysis of health risks is an important component of evidence-based and preventive programs. The aim of this study was to analyze the impact of the most relevant avoidable risk factors on the burden of the selected conditions in Serbia. METHODS: Attributable fractions were calculated from the survey information on the prevalence of a risk factor and the relative risk of dying if exposed to a risk factor. The population-attributable risks were applied to deaths, years of life lost due to premature mortality (YLL), years of life with disability (YLD) and disability adjusted life years (DALY). RESULTS: More than 40% of all deaths and of the total YLL are attributable to cigarette smoking, overweight, physical inactivity, inadequate intake of fruit and vegetables, hypertension and high blood cholesterol. Alcohol consumption has in total a beneficial effect. According to the percent of DALY for the selected conditions attributable to the observed risk factors, their most harmful effects are as follows: alcohol consumption on road traffic accidents; cigarette smoking on lung cancer; physical inactivity on cerebrovascular disease (CVD), ischemic heart disease (IHD) and colorectal cancer; overweight on type 2 diabetes; hypertension on renal failure and CVD; inadequate intake of fruit and vegetables on IHD and CVD, and high blood cholesterol on IHD. CONCLUSIONS: This study shows that a high percentage of disease and injury burden in Serbia is attributable to avoidable risk factors, which emphasizes the need for improvement of relevant preventive strategies and programs at both individual and population levels. Social preferences should be determined for a comprehensive set of conditions and cost effectiveness analyses of potential interventions should be carried out. Furthermore, positive measures, derived from health, disability and quality of life surveys, should be included.",null,"Serbia",2013,"Unknown","None","Unknown",null,null,"Survey","Serbia",null,"Unknown","None",null,"Survey","Unknown","2010:2014"]
[58,"Smets, E. M., et al. (2008). \"Health-related quality of life of children with a positive carrier status for inherited cardiovascular diseases.\" Am J Med Genet A 146a(6): 700-707.",null,"Smets, E. M., et al.","Health-related quality of life of children with a positive carrier status for inherited cardiovascular diseases","Familial hypercholesterolemia, hypertrophic cardiomyopathy, and long QT Syndrome are genetic cardiovascular conditions which may lead to sudden cardiac death at a young age. Preventive measures include lifestyle modifications, medications, and/or cardiac devices. Hence, identification of carrier children can protect them for the potentially life threatening consequences at a young age. Yet, informing children about their genetic risk status and subjecting them to treatment may have negative consequences. This preliminary study aimed to explore (1) how the health-related quality of life of carrier children compares to the quality of life of Dutch children in general; and (2) to what extent the carrier children's quality of life and their parents' perception thereof concur. Our method involved carrier children (n = 35), aged between 8 and 18 years, and their parents (n = 37) who completed a self-report questionnaire. Children's health-related quality of life was assessed with a children and parent version of the KIDSCREEN. Dutch reference data were available from a representative national sample. Our results show no statistically significant differences in scores between carrier children and the reference group. Also, no differences were found between carrier children and their parents' ratings, with the exception of the scale \"psychological well being\". Parents rated their child's psychological well being significantly lower. We identified no problems with the well-being of carrier children as compared to a representative sample of peers. This may offer some initial reassurance to those who have concerns about the implications of genetically testing children for one of these cardiovascular conditions. Yet, attention to possible problems in these children remains warranted.",null,"The Netherlands",2008,"Familial Hypercholesterolemia,Various","None","KIDSCREEN",null,null,"Survey","The Netherlands",null,"Familial Hypercholesterolemia,Various","None",null,"Survey","KIDSCREEN","2005:2009"]
[59,"Spence, J. D., et al. (1995). \"Combination therapy with colestipol and psyllium mucilloid in patients with hyperlipidemia.\" Ann Intern Med 123(7): 493-499.",null,"Spence, J. D., et al.","Combination therapy with colestipol and psyllium mucilloid in patients with hyperlipidemia","OBJECTIVE: To test whether combining psyllium mucilloid with half the usual dose of colestipol reduces the adverse effects associated with colestipol and maintains or increases its efficacy in the treatment of hyperlipidemia. This strategy might make bile acid sequestrants, which are seldom used because they cause adverse effects such as bloating and constipation, more tolerable and less expensive. DESIGN: A randomized, parallel-group, double-blind, controlled trial. SETTING: An outpatient clinic in a tertiary care hospital. PATIENTS: 121 patients who had moderate primary hypercholesterolemia (total cholesterol level > 6 mmol/L and < 8 mmol/L; triglyceride level < 3 mmol/L) after following a low-fat diet for 1 year (National Cholesterol Education Program Step Two diet). INTERVENTION: 5 g of cellulose placebo; 5 g of colestipol; 2.5 g of colestipol plus 2.5 g of psyllium; or 5 g of psyllium three times daily before meals for 10 weeks. MAIN OUTCOME MEASURES: At baseline and at weeks 4 and 10, fasting blood lipid levels and apoprotein concentrations were measured and a quality-of-life instrument was completed. RESULTS: A combination of 2.5 g of psyllium and 2.5 g of colestipol was better tolerated than and as effective as either 5 g of colestipol alone or 5 g of psyllium alone. The combination therapy and colestipol alone did not differ significantly with respect to changes in individual lipid values. The ratio of total cholesterol to high-density lipoprotein cholesterol (HDL) was reduced by 18.2% (95% CI, 12.3% to 24%) with the combination therapy; by 10.6% (CI, 2.0% to 15.4%) with colestipol alone; by 6.1% (CI, 1.5% to 10.6%) with psyllium alone; and by 0.1% (CI, -4.8% to 7%) with placebo (P = 0.0002). Combination therapy reduced the ratio of total cholesterol to HDL significantly more than did colestipol alone or psyllium alone (P < 0.05). CONCLUSIONS: These findings suggest that adding psyllium to half the usual dose of bile acid sequestrant resins maintains the efficacy and improves the tolerability of these resins.",null,"Canada",1995,"Hyperlipidemia","Herbal,Colestipol","Unknown",null,null,"RCT","Canada",null,"Hyperlipidemia","Herbal,Colestipol",null,"RCT","Unknown","1960:1999"]
[60,"Stasiewski, E., et al. (2015). \"Mental symptoms and quality of life in lipoprotein apheresis patients in comparison to hemodialysis patients, platelet donors and normal population.\" Atheroscler Suppl 18: 233-240.",null,"Stasiewski, E., et al.","Mental symptoms and quality of life in lipoprotein apheresis patients in comparison to hemodialysis patients, platelet donors and normal population","BACKGROUND: Despite the fact that extracorporeal methods such as lipoprotein apheresis (LA) and hemodialysis (HD) are highly effective in improving the physical status of patients, these treatment options may possibly harm the psychological status and the health related quality of life (HRQL). METHODS: The occurrences of anxiety, depression and the HRQL of 111 study participants treated with LA (n = 41), HD (n = 41) or undergoing plateletpheresis (PD) (n = 29) were compared to the normal population (NP), using standardized questionnaires (anxiety and depression: Hospital Anxiety and Depression Scale (HADS), heart-focused anxiety: Cardiac Anxiety Questionnaire (CAQ) and HRQL: Short-Form Health Survey (SF-12)). Additionally, the subjective mental and physical stress of study participants was evaluated. RESULTS: LA females had a significantly elevated HADS-A score compared to PD and NP. Additionally, there was a trend toward higher HADS-A scores in the LA group compared to the HD group in females. In HD males HADS-A and -D scores increased compared to PD and NP. The CAQ revealed a significant increase in the CAQ-Fear scale in LA compared to HD and PD participants. The CAQ-Avoidance score showed significantly increased scores in LA and HD patients compared to PD and NP. In the CAQ-Attention scale the LA patients also showed significantly increased scores compared to PD and NP. The increased psychological symptoms were associated with significantly lower levels of objective and subjective HRQL in LA and HD patients compared to PD and NP. CONCLUSIONS: LA and HD patients had similarly increased presence of psychological symptoms with concurrent decreased quality of life compared to PD and the normal population, which may affect the outcome of the LA patients. Therefore, early psychosomatic screening and probable psychosomatic treatment should be performed.",null,"Germany",2015,"Unknown","Various,Lipoprotein Apheresis","HADS,CAQ,SF-12",null,null,"Survey","Germany",null,"Unknown","Various,Lipoprotein Apheresis",null,"Survey","HADS,CAQ,SF-12","2015:2018"]
[61,"Stewart, P. M., et al. (2016). \"Exploring Inpatient Hospitalizations and Morbidity in Patients With Adrenal Insufficiency.\" J Clin Endocrinol Metab 101(12): 4843-4850.",null,"Stewart, P. M., et al.","Exploring Inpatient Hospitalizations and Morbidity in Patients With Adrenal Insufficiency","CONTEXT: Patients with adrenal insufficiency (AI) (primary AI [PAI], secondary AI due to a pituitary disorder [PIT] and congenital adrenal hyperplasia [CAH]) have reduced life expectancy; however, the underlying explanation remains unknown. OBJECTIVE: To evaluate characteristics, comorbidities, and hospitalizations in AI patients. DESIGN: Retrospective observational. SETTING AND POPULATION: Using a United States-based national payer database comprising of more than 108 million members, strict inclusion criteria including diagnostic codes and steroid prescription records were used to identify 10 383 adults with AI; 1014 with PAI, 8818 with PIT, and 551 with CAH. Patients were matched 1:1 to controls, based on age (+/-5 y), gender, insurance, and region and followed for more than 12 months. INTERVENTION: None. MAIN OUTCOME MEASURES: Demographic variables, comorbidities (diabetes mellitus [DM] types 1 and 2, depression, anxiety, hyperlipidemia, hypertension) and hospitalization incidence. RESULTS: Compared with controls, patients with AI had higher odds of DM, hypertension, hyperlipidaemia, depression, and anxiety, ranging from an odds ratio (OR) of 1.51 for hyperlipidaemia in PAI to 3.85 for DM in CAH. Odds of having DM (OR, 3.85; 95% confidence interval, 2.52-5.90) or anxiety (OR, 2.99; 95% confidence interval, 2.02-4.42) compared with controls were highest in CAH, whereas depression was highest in PAI and PIT (OR, 2.40 and 2.55). ORs of hyperlipidaemia and hypertension (OR, 1.98 and 2.24) were highest in the PIT cohort. Inpatient admissions were more frequent in PAI (4.64:1; P < .0001) and PIT (4.00:1; P < .0001) than controls; infection was the most common cause for admission. CONCLUSION: Patients with AI carry a significant metabolic and psychiatric burden, with higher risk of comorbidities and hospital admissions than matched controls.",null,"UK",2016,"Various","none","Unknown",null,null,"Cohort","UK",null,"Various","None",null,"Cohort","Unknown","2015:2018"]
[62,"Steyn, K., et al. (1996). \"Apolipoprotein B levels and related factors in a rural white South African community--the CORIS study. Coronary Risk Factor Study.\" S Afr Med J 86(4): 359-364.",null,"Steyn, K., et al.","Apolipoprotein B levels and related factors in a rural white South African community--the CORIS study. Coronary Risk Factor Study","OBJECTIVE: In a survey of the Coronary Risk Factor Study (CORIS), apolipoprotein B (apoB) levels were determined to ascertain their impact on coronary heart disease (CHD) risk. Other CHD risk factors associated with apoB were also identified. DESIGN: Cross-sectional analytical study, which included CHD risk factor and dietary questionnaires, electrocardiography, anthropometric and blood pressure measurements, and a blood sample for a lipid profile. SETTING AND PARTICIPANTS: The three districts of Riversdale, Robertson and Swellendam in the south-western Cape; a 25% random sample of 1,528 white respondents aged 15-68 years. RESULTS: Men tended to have higher mean apoB levels than women. Classification of CHD risk by apoB levels and total cholesterol (TC) levels did not correspond, as only 61% of men and 58.5% of women were classified in the same risk categories. Respondents in the highest apoB risk category reported a medical history of hypercholesterolaemia and hypertension more frequently than those in lower categories. There was a significant increase from the low to the high apoB risk category of TC, low-density lipoprotein (LDL) cholesterol, triglyceride levels, body mass index and percentage body fat. Using stepwise multiple regression, 84.9% of the variation in apoB of men and 85.8% in apoB of women were accounted for by significantly associated variables. CONCLUSION: Although apoB may be a better predictor of CHD than TC or LDL cholesterol concentrations, its easy approximation with the formula (TC-HDLC)/2 + 20, high cost, measurement variability and an approach in management similar to that for raised TC discourage its routine use in the screening of patients for CHD.",null,"South Africa",1996,"Coronary Heart Disease","Unknown","Unknown",null,null,"Cohort","South Africa",null,"Coronary Heart Disease","Unknown",null,"Cohort","Unknown","1960:1999"]
[63,"Tatlock, S., et al. (2017). \"Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection.\" Value Health 20(3): 430-440.",null,"Tatlock, S., et al.","Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection","BACKGROUND: Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, significantly reduces low-density lipoprotein cholesterol, but requires subcutaneous injections rather than oral pills. To measure patients' acceptance of this treatment modality, a new patient-reported outcome, the Injection-Treatment Acceptance Questionnaire (I-TAQ), was developed. OBJECTIVES: To psychometrically evaluate the I-TAQ with patients at high risk of cardiovascular events receiving alirocumab. METHODS: The 22-item, 5-domain I-TAQ was administered cross-sectionally to 151 patients enrolled in alirocumab clinical trials. Item response distributions, factor and multitrait analyses, interitem correlations, correlations with an existing measure of acceptance (convergent validity), and comparison of known-groups were performed to assess the I-TAQ's psychometric properties. RESULTS: Completion rates were high, with no patients missing more than two items and 91.4% missing no data. All items displayed high ceiling effects (>30%) because of high treatment acceptance. Factor analysis supported the a priori hypothesized item-domain structure with good fit indices (root mean square error approximation = 0.070; comparative fit index = 0.988) and high factor loadings. All items demonstrated item convergent validity (item-scale correlation >/=0.40), except for the side effects domain, which was limited by small numbers (n = 46). Almost all items correlated most highly with the domain to which they were assigned (item discriminant validity). Internal reliability was acceptable for all domains (Cronbach alpha range 0.72-0.88) and convergent validity was supported by a logical pattern of correlations with the Chronic Treatment Acceptance Questionnaire. CONCLUSIONS: These findings provide initial evidence of validity and reliability for the I-TAQ in patients treated with subcutaneous alirocumab. The I-TAQ could prove to be a valuable patient-reported outcome for therapies requiring subcutaneous injection.",null,"UK,USA",2017,"unknown","Alirocumab","I-TAQ",null,null,"Cohort","UK,USA",null,"Unknown","Alirocumab",null,"Cohort","I-TAQ","2015:2018"]
[64,"Tonstad, S. (1996). \"Familial hypercholesterolaemia: a pilot study of parents' and children's concerns.\" Acta Paediatr 85(11): 1307-1313.",null,"Tonstad, S.","Familial hypercholesterolaemia: a pilot study of parents' and children's concerns","OBJECTIVE: To assess psychosocial concerns of families with familial hypercholesterolaemia. METHODS: One-hundred-and-fifty-four single or pairs of parents of children age 6 - 16 years responded to a specifically designed questionnaire. One child from each family was interviewed. RESULTS: Eleven percent of parents thought that their quality of life would have been better had they not known about the disease. None agreed totally that they wished the diagnosis had not been made. However, 20% reported familial conflicts and 8% that their child's emotional or social life had been adversely affected. Conflicts and adverse effects were associated with higher scores on the Child Behaviour Checklist (CBCL). Among the children, worry about cardiovascular disease (affirmed by 22%) was related to male sex and CBCL score. RELEVANCE: Most families do not indicate that they have experienced psychosocial problems due to familial hypercholesterolaemia. Parental ratings of the child's behavioural adjustment may identify vulnerable children.",null,"Norway",1996,"Familial Hypercholesterolemia","none","Unknown",null,null,"Survey","Norway",null,"Familial Hypercholesterolemia","None",null,"Survey","Unknown","1960:1999"]
[65,"Tsai, W. L., et al. (2004). \"Impact of obesity on medical problems and quality of life in Taiwan.\" Am J Epidemiol 160(6): 557-565.",null,"Tsai, W. L., et al.","Impact of obesity on medical problems and quality of life in Taiwan","Little is known about the impact of obesity on medical problems and quality of life for people in the Asia-Pacific region. This January 2002-June 2003 cross-sectional study surveyed 6,318 Taiwanese (3,540 men and 2,778 women) visiting health screening centers in southern Taiwan. The authors used the body mass index classification endorsed by the World Health Organization for people in this region. Information was collected on 15 medical problems and quality of life outcomes, measured by the Medical Outcomes Study Short Form 36 questionnaire. After adjustment for age, lifestyle, and sociodemographic factors, and after comparison of subjects with those not overweight or obese (reference group), an increasing trend of body mass index effects based on this reference category was observed on hypertension, hypercholesterolemia, hypertriglyceridemia, type II diabetes, hyperuricemia, pulmonary function impairment, fatty liver disease, and osteoarthritis in both sexes (p <0.01). Concerning quality of life, an increasing trend of body mass index effects was also observed on the outcomes physical functioning and bodily pain for both sexes and role limitation due to physical problems for women (p <0.05). Specifically, only the physical functioning domain, including daily activities such as climbing stairs, bending, walking, or some moderate activities, was significantly associated with obesity and was limited to class II obesity.",null,"Taiwan",2004,"Hypertension,Hypercholesterolemia,Hypertriglyceridemia,Diabetes,various","none","SF-36",null,null,"Survey","Taiwan",null,"Hypertension,Hypercholesterolemia,Hypertriglyceridemia,Diabetes,Various","None",null,"Survey","SF-36","2000:2004"]
[66,"Usher-Smith, J. A., et al. (2007). \"Evaluation of the cost savings and clinical outcomes of switching patients from atorvastatin to simvastatin and losartan to candesartan in a Primary Care setting.\" Int J Clin Pract 61(1): 15-23.",null,"Usher-Smith, J. A., et al.","Evaluation of the cost savings and clinical outcomes of switching patients from atorvastatin to simvastatin and losartan to candesartan in a Primary Care setting","This study was carried out in a Primary Care practice in the UK to assess the clinical and practical implications, cost savings and patients' perspective of switching to generic drugs. In the 70 patients switched from atorvastatin to simvastatin there was no significant change in mean total cholesterol 4 months after the switch (4.07 +/- 0.55 mmol/L prior to the switch and 4.10 +/- 0.73 mmol/L post-switch) and only one patient switched back because of side effects. One hundred and fifteen patients were switched from losartan to candesartan. Seven switched back but in those that remained on candesartan there was a small, significant (p = 0.0006), reduction in blood pressure after the switch (138.9/78.7 +/- 13.2/7.0 to 136.3/76.1 +/- 14.7/8.4 mmHg). No adverse events attributable to the switch were reported in either group and the net annualised savings for the year 2005-2006 were 12,715.58 pounds for the statin and 13,374.40 pounds for the antihypertensive switch, respectively.",null,"UK",2007,"unknown","Various,Simvastatin","Unknown",null,null,"Cohort","UK",null,"Unknown","Various,Simvastatin",null,"Cohort","Unknown","2005:2009"]
[67,"Weir, M. R., et al. (1996). \"Comparison of the effects on quality of life and of the efficacy and tolerability of lovastatin versus pravastatin. The Quality of Life Multicenter Group.\" Am J Cardiol 77(7): 475-479.",null,"Weir, M. R., et al.","Comparison of the effects on quality of life and of the efficacy and tolerability of lovastatin versus pravastatin. The Quality of Life Multicenter Group","This multicenter study compared the effects of lovastatin (40 mg) and pravastatin (40 mg) on quality of life. Men, aged 20 to 65 years old, with primary hypercholesterolemia (types IIa and IIb) were eligible for enrollment if baseline low-density lipoprotein cholesterol met the first National Cholesterol Education Program adult treatment guidelines. Eligible patients were enrolled into a 6-week diet baseline period, followed by a 6-week diet-plus-placebo period. Patients whose low-density lipoprotein cholesterol still met National Cholesterol Education Program guidelines for drug therapy were randomized into the double-blind, active-treatment period to receive either lovastatin 40 mg or pravastatin 40 mg/day for 12 weeks. Clinic visits were scheduled every 4 weeks and included complete serum lipid profiles, monitoring of adverse experiences, and patient completion of health-related quality-of-life questionnaires. The primary end point of the study was the change in quality of life, as measured by the Nottingham Health Profile (part 1) after 12 weeks of treatment. Secondary end points included responses to a general health question from the National Health and Nutrition Examination Survey, sexual function questions from the Medical Outcomes Study, and stress/life event questions from the National Institutes of Health Post-Coronary Artery Bypass Grafting Study. No significant differences between the 2 groups were observed in tolerability, health-related quality-of-life measures, or changes in lipid profiles.",null,"USA",1996,"Hypercholesterolemia","Lovastatin,Pravastatin","NHP,NHANES",null,null,"RCT","USA",null,"Hypercholesterolemia","Lovastatin,Pravastatin",null,"RCT","NHP,NHANES","1960:1999"]
[68,"Williams, P. T. and B. A. Franklin (2015). \"Incident diabetes mellitus, hypertension, and cardiovascular disease risk in exercising hypercholesterolemic patients.\" Am J Cardiol 116(10): 1516-1520.",null,"Williams, P. T. and B. A. Franklin","Incident diabetes mellitus, hypertension, and cardiovascular disease risk in exercising hypercholesterolemic patients","Exercise may be an important treatment for hypercholesterolemic patients, particularly in statin users who are at increased diabetes risk. We therefore used Cox proportional hazard analyses to compare running and walking dose (metabolic equivalent hours/day [MET-h/d]) to diabetes, hypertension, and cardiovascular disease (CVD) risk in hypercholesterolemic patients. There were 60 diabetic- and 373 CVD-related deaths during a 10.1-year mortality surveillance of 6,688 hypercholesterolemic patients. In addition, there were 177 incident nonfatal diabetes, 815 incident nonfatal hypertensions, and 323 incident nonfatal CVD events during a 6.4-year follow-up of 6,971 hypercholesterolemic patients who supplied follow-up questionnaires. Fatal and nonfatal diabetes risk decreased 26% (p = 0.002) and 19% (p </=0.0001) per MET-h/d, respectively, and relative to <1.07 MET-h/d decreased 35% (p = 0.19) and 55% (p </=0.0001), respectively, for 1.8 to 3.6 MET-h/d and 73% (p = 0.02) and 71% (p </=0.0001), respectively, for >/=3.6 MET-h/d. Fatal and nonfatal CVD risk decreased 8% (p = 0.008) and 3% (p = 0.22) per MET-h/d, respectively, and relative to <1.07 MET-h/d decreased 10% (p = 0.45) and 36% (p = 0.008) for 1.8 to 3.6 MET-h/d, respectively, and 37% (p = 0.009) and 26% (p = 0.10), respectively, for >/=3.6 MET-h/d. Incident hypertension risk decreased 4% (p = 0.01) per MET-h/d, and relative to <1.07 MET-h/d decreased 29% (p = 0.002) for 1.8 to 3.6 MET-h/d and 31% (p = 0.001) for >/=3.6 MET-h/d. In conclusion, running and walking for exercise lowers diabetes, hypertension, and CVD risk in hypercholesterolemic patients and should more than compensate for the purported 9% increase in diabetes risk from statin use. By preventing morbidity and mortality for a specific existing medical condition, some exercise expenses may qualify for flexible spending account expenditures in hypercholesterolemic patients when prescribed by a physician.",null,"USA",2015,"Diabetes,Hypertension,Cardiovascular Disease","none","Unknown",null,null,"Cohort","USA",null,"Diabetes,Hypertension,Cardiovascular Disease","None",null,"Cohort","Unknown","2015:2018"]
[69,"Willich, S. N., et al. (2004). \"Economic evaluation of a compliance-enhancing intervention in patients with hypercholesterolemia: design and baseline results of the Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study.\" Am Heart J 148(6): 1060-1067.",null,"Willich, S. N., et al.","Economic evaluation of a compliance-enhancing intervention in patients with hypercholesterolemia: design and baseline results of the Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study","BACKGROUND: Previous studies investigating the effectiveness of compliance programs in patients with cardiovascular risk factors have been inconclusive and have not included economic analyses. The primary aim of this Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study is to determine the long-term cost-effectiveness of a compliance-enhancing intervention in patients with hypercholesterolemia (HC). Secondary objectives include the assessment of compliance, cardiovascular events, and health-related quality of life. STUDY DESIGN: A total of 7598 patients (56% men, age 60 +/- 10 years, and 44% women, 64 +/- 10 years) with HC requiring statin therapy according to the Second Joint European Guidelines were recruited at presentation to 1961 primary care physicians in Germany. Patients were randomized to rosuvastatin therapy with or without a compliance-enhancing program (including standardized contacts between the study center and patients, 9 mailings, 6 telephone calls, and access to a Web page and hotline) for 12 months. Following the intervention phase, there will be a 24-month observational period with patients receiving usual care. Baseline and 6-monthly follow-up assessments are to be obtained from patients and their physicians using standardized questionnaires to evaluate medical and economic parameters. Cumulative direct and indirect disease-related costs (including resource utilization for ambulatory, hospital, rehabilitative, and nursing care, medication, physiotherapy, and transportation, and loss of productivity) will be compared applying a societal perspective. CONCLUSIONS: The results of this ORBITAL study will provide a basis to develop cost-effective compliance strategies and eventually improve medical care for patients with HC.",null,"Germany",2004,"Hypercholesterolemia","Rosuvastatin","Unknown",null,null,"RCT","Germany",null,"Hypercholesterolemia","Rosuvastatin",null,"RCT","Unknown","2000:2004"]
[70,"Wink, J., et al. (2002). \"Effect of very-low-dose niacin on high-density lipoprotein in patients undergoing long-term statin therapy.\" Am Heart J 143(3): 514-518.",null,"Wink, J., et al.","Effect of very-low-dose niacin on high-density lipoprotein in patients undergoing long-term statin therapy","BACKGROUND: A low level of high-density lipoprotein (HDLC) is a proven risk factor for coronary artery disease. Niacin raises HDLC levels, but it is infrequently used because of its side effect profile. Niacin's side effects are dose related. This study tests the hypothesis that very low-dose niacin, in conjunction with long-term statin therapy, will improve the lipid profile by significantly raising the level of HDLC, with fewer side effects than traditional doses of niacin. METHODS: Fifty patients undergoing stable statin therapy for 3 months were blindly randomized to receive either placebo or niacin 50 mg administered by mouth 2 times daily for 3 months. Patients with diabetes and active smokers were excluded. Each patient completed a questionnaire regarding current medical problems, medications, and lifestyle before and after the therapy. Patients were questioned about any possible side effects that occurred during the medication trial. The primary end points were change in HDLC level and patient-reported side effects. RESULTS: Thirty-nine patients completed the study. Very low-dose niacin added to statin therapy increased the mean HDLC, 2.1 mg/dL in niacin group (standard error of the mean, 0.767) versus -0.56 mg/dL for placebo group (standard error of the mean-.816, P =.0246 by analysis of variance). Five patients receiving niacin, versus 2 patients receiving placebo, had episodes of flushing. No major side effects were noted. No patients stopped the study medication as a result of side effects. CONCLUSIONS: The addition of very low-dose niacin to statin therapy increased HDLC cholesterol significantly, while avoiding the side effects that are associated with traditional doses of niacin therapy.",null,"USA",2002,"Coronary Heart Disease","Dietary","Unknown",null,null,"RCT","USA",null,"Coronary Heart Disease","Dietary",null,"RCT","Unknown","2000:2004"]
[71,"Winkelmann, B. R., et al. (2001). \"Rationale and design of the LURIC study--a resource for functional genomics, pharmacogenomics and long-term prognosis of cardiovascular disease.\" Pharmacogenomics 2(1 Suppl 1): S1-73.",null,"Winkelmann, B. R., et al.","Rationale and design of the LURIC study--a resource for functional genomics, pharmacogenomics and long-term prognosis of cardiovascular disease","BACKGROUND AND AIM: Coronary artery disease (CAD), arterial hypertension and Type 2 diabetes mellitus are common polygenetic disorders which have a major impact on public health. Disease prevalence and progression to cardiovascular complications, such as myocardial infarction (MI), stroke or heart failure, are the product of environment and gene interaction. The LUdwigshafen RIsk and Cardiovascular Health (LURIC) study aims to provide a well-defined resource for the study of environmental and genetic risk factors, and their interactions, and the study of functional relationships between gene variation and biochemical phenotype (functional genomics) or response to medication (pharmacogenomics). Long-term follow-up on clinical events will allow us to study the prognostic importance of common genetic variants (polymorphisms) and plasma biomarkers. SETTING: Cardiology unit in tertiary care medical centre in south-west Germany. STUDY DESIGN: Prospective cohort study of individuals with and without cardiovascular disease at baseline. PATIENTS AND METHODS: LURIC is an ongoing prospective study of currently > 3300 individuals in whom the cardiovascular and metabolic phenotypes CAD, MI, dyslipidaemia, hypertension, metabolic syndrome and diabetes mellitus have been defined or ruled out using standardised methodologies in all study participants. Inclusion criteria for LURIC were: German ancestry (limitation of genetic heterogeneity) clinical stability (except for acute coronary syndromes [ACSs]) availability of a coronary angiogram (this inclusion criterium was waived for family members provided that they met all other inclusion and exclusion criteria) Exclusion criteria were: any acute illness other than ACSs any chronic disease where non-cardiac disease predominated a history of malignancy within the past five years. Exclusion criteria were pre-specified in order to minimise the impact of concomitant non-cardiovascular disease on intermediate biochemical phenotypes or on clinical prognosis (limitation of clinical heterogeneity). A standardised personal and family history questionnaire and an extensive laboratory work-up (including glucose tolerance testing in non-diabetics and objective assessment of smoking exposure by determination of cotinine plasma levels) was obtained from all individuals after informed consent. A total of 115 ml of fasting venous blood was sampled for the determination of a pre-specified wide range of intermediate biochemical phenotypes in serum, plasma or whole blood, for leukocyte DNA extraction and immortalisation of B-lymphocytes. Biochemical phenotypes measured included markers of endothelial dysfunction, inflammation, oxidative status, coagulation, lipid metabolism and flow cytometric surface receptor expression of lympho-, mono- and thrombocytes. In addition, multiple aliquots of blood samples were stored for future analyses. RESULTS: A total of 3500 LURIC baseline measurements were performed in 3316 individuals between July 1997 and January 2000. The baseline examination was repeated within a median of 35 days in 5% of study participants (n = 166, including a third examination in 18 after a median of 69 days) for pharmacogenomic assessment of lipid-lowering therapy and for quality control purposes. A five-year follow-up on major clinical events (death, any cardiovascular event including MI, stroke and revascularisation, malignancy and any hospitalisation) is ongoing. The clinical phenotypes prevalent at baseline in the cohort of 2309 men (70%) with a mean age of 62 +/- 11 years and 1007 women (30%), mean age 65 +/- 10 years, were angiographically-documented CAD in 2567 (79%), MI in 1368 (41%), dyslipidaemia in 2050 (62%) with hypercholesterolaemia > or = 240 mg/dl (27%), hypertriglyceridaemia > or = 150 mg/dl (44%) and HDL-cholesterol < or = 35 mg/dl (38%) in individuals not treated with lipid-lowering agents, systemic hypertension in 1921 (58%), metabolic syndrome in 1591 (48%), Type 2 diabetes in 1063 (32%) and obesity defined by body mass index > or = 30 kg/m2 in 770 (23%). Control patients in whom CAD had been ruled out angiographically were five years younger than those with CAD (59 +/- 12 and 64 +/- 10 years, respectively; p < 0.001), twice as often females (48% compared to 25% females in the CAD group, p < 0.001) and had significantly less cardiovascular risk factors than individuals with CAD. The prevalence of specific cardiovascular risk subsets in LURIC, such as the elderly (> or = 75 years), was 375 (11%), while 213 (6%) were young adults (< 45 years) and 904 (27%) were postmenopausal women (90% of all females). A low risk status (< or = 1 out of the four traditional risk factors: dyslipidaemia, smoking, hypertension and diabetes mellitus) was identified in 314 (9%) individuals of the entire cohort (5% in CAD and 26% in controls, p < 0.001) and 97 (3%) carried none of the four risk factors (1% in CAD and 9% in controls, p < 0.001). (ABSTRACT TRUNCATED)",null,"Germany",2001,"Coronary Heart Disease,Diabetes,Various","none","Unknown",null,null,"Cohort","Germany",null,"Coronary Heart Disease,Diabetes,Various","None",null,"Cohort","Unknown","2000:2004"]

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[null,null,{"$f":"SelectedTitle","v":"Angelico,F.,et al."}]
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[]
[]
[]
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[null,null,"PMID",null,null,{"$f":"SelectedPMID","v":"Unknown"},null,null,null,null,null,"DOI",null,{"$f":"SelectedDOI","v":"None"}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," "]
[null,null,"Locations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," "]
[null,null,"Interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," "]
[null,null,"Diseases",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," ",null," ",null,null," "]
[null,null,"PRO tools"]
[null,null,"Sub-populations"]
[null,null,"Study types",null,null,null,null,null,null,"Case control",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," "]
[null,null,"Study methodologies"]
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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"OFFSET($CI$1,0,domainChoice)","v":7},{"$f":"COUNTA(CJ3:CJ513)","v":19},{"$f":"COUNTA(CK3:CK513)","v":15},12,29,0,0,7,null,null,null,null,{"$f":"ADDRESS(2,1,1,1,domainSheet)","v":"studymethodCategories!$A$2"},{"$f":"INDIRECT(CU1)","v":"Unallocated"}]
[null,"Toggle age cut-offs",null,null,null,null,null,null,7,1,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"This year =",{"$f":"YEAR(NOW())","v":2018},null,"Years","Cut","Selected cut state","Start","End",{"$f":"COUNTA(CF3:CF58)","v":5},{"$f":"OFFSET($CI$2,0,domainChoice)","v":"Study methodologies"},"Locations","Interventions","Diseases","PRO tools","subPopulations","Study types","Study methodologies",null,null,null,null,"selected categories"]
[null,null,56,null,null,null,null,null,"Unallocated","Case Control",null,null,null,null,null,null,null,null,null,null,null,"New names","Existing names",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Low year =",{"$f":"MIN($CF$3:$CF$60)","v":1960},null,1960,false,true,1960,1999,{"$f":"IF(CF3<>\"\",_xlfn.CONCAT(CF3,\":\",CG3),\"\")","v":"1960:1999"},{"$f":"OFFSET($CJ$2,0,ROW()-3)","v":"Locations"},"Australia","Alirocumab","Cardiovascular Disease","ADL",null,null,"Case Control",null,null,null,null,{"$f":"OFFSET(INDIRECT($CU$1),ROW()-3,0)","v":"Unallocated"}]
[null,"From",null,null,"To",null,null,null,null,"Case Control",null,null,null,null,null,null,null,null,null,null,null,"C1","C1","Locations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"OFFSET($BY$5,domainChoice,0)","v":"studymethodCategories"},"High year =",{"$f":"MAX(CG3:$CG$60)","v":2018},null,1961,false,null,2000,2004,{"$f":"IF(CF4<>\"\",_xlfn.CONCAT(CF4,\":\",CG4),\"\")","v":"2000:2004"},{"$f":"OFFSET($CJ$2,0,ROW()-3)","v":"Interventions"},"Belgium","Bariatrics","Coronary Heart Disease","CAQ",null,null,"Clinical Trial",null,null,null,null,{"$f":"OFFSET(INDIRECT($CU$1),ROW()-3,0)","v":"Case Control"}]
[null,{"$f":"IF(CF3=\"\",\"\",CF3)","v":1960},null,null,{"$f":"IF(CG3=\"\",\"\",CG3)","v":1999},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C2","C2","Interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1962,false,"Segment count",2005,2009,"2005:2009","Diseases","Canada","Behavioural/Education","Diabetes","DHP",null,null,"Cohort",null,null,null,null,"Clinical Trial"]
[null,{"$f":"IF(CF4=\"\",\"\",CF4)","v":2000},null,null,{"$f":"IF(CG4=\"\",\"\",CG4)","v":2004},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C3","C3","Diseases",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"locationCategories",null,null,null,1963,false,null,2010,2014,"2010:2014","PRO tools","Chile","Colestipol","Familial Hypercholesterolemia","DLQI",null,null,"Narrative Review",null,null,null,null,"Cohort"]
[null,2005,null,null,2009,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C4","C4","Sub-populations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"interventionCategories",null,null,null,1964,false,null,2015,2018,"2015:2018","subPopulations","China","Dietary","Familial chylomicronemia syndrome","EQ-5D",null,null,"RCT",null,null,null,null,"Narrative Review"]
[null,2010,null,null,2014,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C5","C5","PRO tools",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"diseaseCategories",null,null,null,1965,false,null,null,null,"","Study types","Germany","Herbal","Hypercholesterolemia","HADS",null,null,"Survey",null,null,null,null,"RCT"]
[null,2015,null,null,2018,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study types",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"protoolCategories",null,null,null,1966,false,null,null,null,"","Study methodologies","Italy","Lipoprotein Apheresis","Hyperlipidemia","I-TAQ",null,null,"Systematic Review",null,null,null,null,"Survey"]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study methodologies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"subpopulationCategories",null,null,null,1967,false,null,null,null,"",null,"Japan","Lovastatin","Hypertension","KIDSCREEN",null,null,null,null,null,null,null,"Systematic Review"]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Location categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"studytypeCategories",null,null,null,1968,false,null,null,null,"",null,"Norway","None","Hypertriglyceridemia","LSI",null,null,null,null,null,null,null,""]
[null,{"$f":"IF(CF10=\"\",\"\",CF10)","v":""},null,null,{"$f":"IF(CG10=\"\",\"\",CG10)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Intervention categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"studymethodCategories",null,null,null,1969,false,null,null,null,"",null,"Serbia","Patient Management","Stroke","MHIQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Disease categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1970,false,null,null,null,"",null,"South Africa","Pravastatin","Unknown","MKLSS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Sub-populations categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1971,false,null,null,null,"",null,"South Korea","Rosuvastatin","Various","MQOLQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PRO tool categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1972,false,null,null,null,"",null,"Sweden","Simvastatin",null,"MSEP",null,null,null,null,null,null,null,""]
[null,"",null,null,{"$f":"IF(CG14=\"\",\"\",CG14)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study type categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1973,false,null,null,null,"",null,"Taiwan","Unknown",null,"Mastery Scale",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study methodology categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1974,false,null,null,null,"",{"$f":"COLUMN()","v":87},"The Netherlands","Various",null,"NHANES",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1975,false,null,null,null,"",null,"Turkey",null,null,"NHP",null,null,null,null,null,null,null,""]
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