Cost-effectiveness of interventions to control cardiovascular diseases and type 2 diabetes mellitus in South Asia: protocol for a systematic review Valuing SF-6D Health States Using a Discrete Choice Experiment Impact of personalized cardiovascular disease risk estimates on physical activity-a randomized controlled trial. The systematic coronary risk evaluation (SCORE) for the prevention of cardiovascular diseases. Does evidence exist for its effectiveness? A systematic review The impact of individualised cardiovascular disease (CVD) risk estimates and lifestyle advice on physical activity in individuals at high risk of CVD: a pilot 2 × 2 factorial understanding risk trial A Markov model of the cost-effectiveness of pharmacist care for diabetes in prevention of cardiovascular diseases: evidence from Kaiser Permanente Northern California. Seeing the forests and the trees—innovative approaches to exploring heterogeneity in systematic reviews of complex interventions to enhance health system decision-making: a protocol Glycated hemoglobin measurement and prediction of cardiovascular disease. 3L, 5L, What the L? A NICE Conundrum Aspirin, Statins, or Both Drugs for the Primary Prevention of Coronary Heart Disease Events in Men: A CostUtility Analysis Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder Association of cardiovascular health screening with mortality, clinical outcomes, and health care cost: a nationwide cohort study. Cost-utility analysis modeling at 2-year follow-up for cervical disc arthroplasty versus anterior cervical discectomy and fusion: A single-center contribution to the randomized controlled trial Eliciting health state utilities for Dupuytren’s contracture using a discrete choice experiment A cardiovascular disease policy model that predicts life expectancy taking into account socioeconomic deprivation Exenatide versus insulin glargine in patients with type 2 diabetes in the UK: a model of long-term clinical and cost outcomes Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials Costs of treating cardiovascular events in Germany: a systematic literature review Probabilistic Sensitivity Analysis Using Monte Carlo Simulation Perceptions of Community Health Workers (CHWs/PS) in the U.S.-Mexico Border HEART CVD Study Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care: study protocol for a randomised controlled trial Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: a randomized controlled trial Methods for comparing the results of different studies.
Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 Background . SF-6D utility weights are conventionally produced using a st and ard gamble ( SG ) . SG-derived weights consistently demonstrate a floor effect not observed with other elicitation techniques . Recent advances in discrete choice methods have allowed estimation of utility weights . The objective was to produce Australian utility weights for the SF-6D and to explore the application of discrete choice experiment ( DCE ) methods in this context . We hypothesized that weights derived using this method would reflect the largely monotonic construction of the SF-6D . Methods . We design ed an online DCE and administered it to an Australia-representative online panel ( n = 1017 ) . A range of specifications investigating nonlinear preferences with respect to additional life expectancy were estimated using a r and om-effects probit model . The preferred model was then used to estimate a preference index such that full health and death were valued at 1 and 0 , respectively , to provide an algorithm for Australian cost-utility analyses . Results . Physical functioning , pain , mental health , and vitality were the largest drivers of utility weights . Combining levels to remove illogical orderings did not lead to a poorer model fit . Relative to international SG-derived weights , the range of utility weights was larger with 5 % of health states valued below zero . Conclusion s. DCEs can be used to investigate preferences for health profiles and to estimate utility weights for multi-attribute utility instruments . Australian cost-utility analyses can now use domestic SF-6D weights . The comparability of DCE results to those using other elicitation methods for estimating utility weights for quality -adjusted life-year calculations should be further investigated AIM Informing a person of their individual risk of developing a disease in the future may be sufficient to provide the person with the impetus to adopt risk reducing behaviours . The aim of this study was to determine if a personalised 10-year cardiovascular disease ( CVD ) risk estimate can increase  physical activity  and other risk reduction behaviours in adults at high risk of CVD . METHODS Pilot 2 × 2 factorial r and omised controlled trial conducted in Oxfordshire , UK including 194 adults at increased CVD risk ( 10-year CVD risk ≥ 20 % ) recruited from four general practice s. Main outcome measure at one month was physical activity measured by accelerometer . RESULTS Median ( IQR ) age was 62.3 ( 54.9 , 66.1 ) years , 67 % were men and 19 % had known diabetes . Mean ( SD ) total accelerometer counts per day was 297 × 10(-3 ) ( 110 × 10(-3 ) ) and activity of moderate or greater intensity was undertaken for 53 ( 22 ) minutes per day . In the 185 ( 95 % ) participants attending follow-up an increase in physical activity was not seen . There was a non-significant 0.5 % ( p = 0.56 ) greater increase in accelerometer counts in those receiving personalised CVD risk estimates . No significant within or between group changes were seen at one month in estimated 10-year CVD risk . A net 7 % decrease in mean LDL cholesterol ( p = 0.004 ) was seen in the intervention group despite similar increases in new prescriptions for lipid lowering therapies . CONCLUSION In adults at increased risk of CVD provision of personalised 10-year CVD risk estimates did not appear to increase physical activity or estimated CVD risk over a one-month period Objectives : The SCORE model predicts the ten-year risk of cardiovascular mortality but it is still unknown whether applying the SCORE in clinical practice subsequently improves cardiovascular disease ( CVD ) outcomes . The objective of this study is to assess the effect of total cardiovascular risk estimation using the SCORE in preventing serious cardiovascular events in European adults without prior CVD . Methods and results : Data sources : eight bibliographical data bases ( 2003 – August 2015 ) , other internet sources and reference lists of articles were checked . This was supplemented by contact with the board members of the European Society of Cardiology ( ESC ) and the authors of the SCORE model . Study eligibility criteria : all prospect i ve studies in any language investigating the effect of using the SCORE on the clinical outcome ( CVD death , major events and adverse outcomes ) in an adult population were examined . Two review ers assessed the studies independently ( titles , abstract s , full texts ) . After removal of duplicates , 5,256 records were screened and 14 full text papers considered . No eligible studies were identified . An extensive literature search revealed no r and omized control trial or other prospect i ve study comparing significant clinical outcomes between groups that used the SCORE and those who did not . Conclusions : The effect of using the SCORE ( with or without subsequent intervention ) on CVD death , all-cause mortality , major CVD events like myocardial infa rct ion and stroke , as well as adverse outcomes , is still unknown . A cluster r and omised controlled trial is warranted to evaluate the use of the SCORE on important outcomes Background There is currently much interest in encouraging individuals to increase physical activity in order to reduce CVD risk . This study has been design ed to determine if personalised CVD risk appreciation can increase physical activity in adults at high risk of CVD . Methods / Design In a 2 × 2 factorial design participants are allocated at r and om to a personalised 10-year CVD risk estimate or numerical CVD risk factor values ( systolic blood pressure , LDL cholesterol and fasting glucose ) and , simultaneously , to receive a brief lifestyle advice intervention targeting physical activity , diet and smoking cessation or not . We aim to recruit 200 participants from Oxfordshire primary care practice s. Eligibility criteria include adults age 40–70 years , estimated 10-year CVD risk ≥20 % , ability to read and write English , no known CVD and no physical disability or other condition reducing the ability to walk . Primary outcome is physical activity measured by ActiGraph accelerometer with biochemical , anthropometrical and psychological measures as additional outcomes . Primary analysis is between group physical activity differences at one month powered to detect a difference of 30,000 total counts per day of physical activity between the groups . Additional analyses will seek to further eluci date the relationship between the provision of risk information , and intention to change behaviour and to determine the impact of both interventions on clinical and anthropometrical measures including fasting and 2 hour plasma glucose , fructosamine , serum cotinine , plasma vitamin C , body fat percentage and blood pressure . Discussion This is a pilot trial seeking to demonstrate in a real world setting , proof of principal that provision of personalised risk information can contribute to behaviour changes aim ed at reducing CVD risk . This study will increase our underst and ing of the links between the provision of risk information and behaviour change and if successful , could be used in clinical practice with little or no modification BACKGROUND It has been demonstrated in previous studies that pharmacist management of patients with type 2 diabetes mellitus ( T2DM ) in the outpatient setting not only improves diabetes-related clinical outcomes such as hemoglobin A1c but also blood pressure ( BP ) , total cholesterol ( TC ) , and quality of life . Improved control of BP and TC has been shown to reduce the risks of cardiovascular disease ( CVD ) , which has placed a heavy economic burden on the health care system . However , no study has evaluated the cost-effectiveness of pharmacist intervention programs with respect to the long-term preventive effects on CVD outcomes among T2DM patients . OBJECTIVES To ( a ) quantify the long-term preventive effects of pharmacist intervention on CVD outcomes among T2DM patients using evidence from a matched cohort study in the outpatient primary care setting and ( b ) assess the relative cost-effectiveness of adding a clinical pharmacist to the primary care team for the management of patients with T2DM based on improvement in CVD risks with the aid of an economic model . METHODS Clinical data between the periods of June 2007 to February 2010 were collected from electronic medical records at 2 separate clinics at Kaiser Permanente ( KP ) Northern California , 1 with primary care physicians only ( control group ) and the other with the addition of a pharmacist ( enhanced care group ) . Patients in the enhanced care group were matched 1:1 with patients in the control group according to baseline characteristics that included age , gender , A1c , and Charlson comorbidity score . The estimated 10-year CVD risk for both groups was calculated by the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) Risk Engine ( version 2 ) based on age , sex , race , smoking status , atrial fibrillation , duration of diabetes , levels of A1c , systolic BP ( SBP ) and TC , and high-density lipoprotein cholesterol ( HDL-C ) observed at 12 months . There was no statistical difference in the baseline clinical inputs to the Risk Engine ( A1c [ P=0.115 ] , SBP [ P=0.184 ] , TC [ P=0.055 ] , and HDL-C [ P=0.475 ] ) between the 2 groups . A Markov model was developed to simulate the estimated CVD outcomes over 10 years and to estimate cost-effectiveness . The final outcomes examined included incremental cost and effectiveness measured by life years and per quality -adjusted life year gained . Both deterministic sensitivity analysis ( SA ) and probabilistic SA were conducted to examine the robustness of the results . RESULTS The estimated risks for coronary heart disease ( CHD ) and stroke ( both nonfatal and fatal ) at the end of the follow-up were consistently lower in the enhanced care group compared with the control group , even though baseline risks in both groups were similar . The absolute risk reduction ( ARR ) between the enhanced care and control groups increased over time . For example , the ARR for nonfatal CHD risk in year 1 was 0.5 % ( 1.2 % vs. 0.7 % ) , whereas the ARR increased to 5.5 % in year 10 ( 14.8 % vs. 9.3 % ) . Similarly , the ARR between the enhanced care and the control groups was calculated as 0.3 % for fatal CHD in year 1 and increased to 4.6 % in year 10 . Results from the Markov model suggest that the enhanced care group was shown to be a dominant strategy ( less expensive and more effective ) compared with the control group in the 10-year evaluation period in the base-case ( average or mean results ) scenario . Sensitivity analysis that took into account the uncertainty in all important variables , such as wage of pharmacists , utility weight ( the degree of preference individuals have for a particular health state or condition ) , response rate to pharmacists ' care , and uncertainty associated with the estimated 10 years of CVD risk , revealed that the relative value of enhanced care was robust to most of the variations in these parameters . Notably , the level of cost-effectiveness measured by net monetary value depends on the time horizon adopted by the payers and the magnitude of CVD risk reduction . The enhanced care group has a higher chance of being considered as a cost-effective strategy when a longer time horizon such as a minimum of 4 to 5 years is adopted . CONCLUSIONS Adding pharmacists to the health care management team for diabetic patients improves the long-term CVD risks . The longer-term CVD risk reductions were shown to be more dramatic than the short-term reduction . A longer time horizon adopted by health plans in managing T2DM patients has a higher probability of making the intervention cost-effective Background To improve quality of care and patient outcomes , health system decision-makers need to identify and implement effective interventions . An increasing number of systematic review s document the effects of quality improvement programs to assist decision-makers in developing new initiatives . However , limitations in the reporting of primary studies and current meta- analysis methods ( including approaches for exploring heterogeneity ) reduce the utility of existing syntheses for health system decision-makers . This study will explore the role of innovative meta- analysis approaches and the added value of enriched and up date d data for increasing the utility of systematic review s of complex interventions . Methods / Design We will use the data set from our recent systematic review of 142 r and omized trials of diabetes quality improvement programs  to evaluate novel approaches for exploring heterogeneity . These will include exploratory methods , such as multivariate meta-regression analyses and all-subsets combinatorial meta- analysis . We will then up date our systematic review to include new trials and enrich the data set by surveying authors of all included trials . In doing so , we will explore the impact of variables not , reported in previous publications , such as details of study context , on the effectiveness of the intervention . We will use innovative analytical methods on the enriched and up date d data set to identify key success factors in the implementation of  quality improvement interventions  for diabetes . Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results . Discussion This study will inform future systematic review s of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta- analysis . It will also result in an up date d comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision-makers in developing interventions to improve outcomes for people with diabetes . Systematic review registration PROSPERO registration no. IMPORTANCE The value of measuring levels of glycated hemoglobin ( HbA1c ) for the prediction of first cardiovascular events is uncertain . OBJECTIVE To determine whether adding information on HbA1c values to conventional cardiovascular risk factors is associated with improvement in prediction of cardiovascular disease ( CVD ) risk . DESIGN , SETTING , AND PARTICIPANTS Analysis of individual-participant data available from 73 prospect i ve studies involving 294,998 participants without a known history of diabetes mellitus or CVD at the baseline assessment . MAIN OUTCOMES AND MEASURES Measures of risk discrimination for CVD outcomes ( eg , C-index ) and reclassification ( eg , net reclassification improvement ) of participants across predicted 10-year risk categories of low ( < 5 % ) , intermediate ( 5 % to < 7.5 % ) , and high ( ≥ 7.5 % ) risk . RESULTS During a median follow-up of 9.9 ( interquartile range , 7.6 - 13.2 ) years , 20,840 incident fatal and nonfatal CVD outcomes ( 13,237 coronary heart disease and 7603 stroke outcomes ) were recorded . In analyses adjusted for several conventional cardiovascular risk factors , there was an approximately J-shaped association between HbA1c values and CVD risk . The association between HbA1c values and CVD risk changed only slightly after adjustment for total cholesterol and triglyceride concentrations or estimated glomerular filtration rate , but this association attenuated somewhat after adjustment for concentrations of high-density lipoprotein cholesterol and C-reactive protein . The C-index for a CVD risk prediction model containing conventional cardiovascular risk factors alone was 0.7434 ( 95 % CI , 0.7350 to 0.7517 ) . The addition of information on HbA1c was associated with a C-index change of 0.0018 ( 0.0003 to 0.0033 ) and a net reclassification improvement of 0.42 ( -0.63 to 1.48 ) for the categories of predicted 10-year CVD risk . The improvement provided by HbA1c assessment in prediction of CVD risk was equal to or better than estimated improvements for measurement of fasting , r and om , or postload plasma glucose levels . CONCLUSIONS AND RELEVANCE In a study of individuals without known CVD or diabetes , additional assessment of HbA1c values in the context of CVD risk assessment provided little incremental benefit for prediction of CVD risk For many years , the National Institute for Health and Care Excellence ( NICE ) has recommended use of the EQ-5D-3L ( 3L ) [ 1 ] and its value set for the UK [ 2 ] . Since 2011 , an exp and ed-level instrument , the EQ-5D-5L ( 5L ) , has been available [ 3 ] and value sets now exist to support its use , including a value set for Engl and [ 4 , 5 ] . This poses a challenge for NICE . Should it recommend the 5L rather than the 3L ? This is neither a trivial nor merely academic matter : the choice of whether to use the 5L ( and English value set ) or the 3L ( and UK value set ) is likely to impact estimates of quality -adjusted life-years ( QALYs ) and incremental cost-effectiveness ratios ( ICERs ) . The size and direction of that impact will depend on the disease and the nature of the health problems . In general , where technologies improve self-reported health , estimates of QALY gains will often be smaller with the 5L [ 6 ] . In contrast , where technologies extend the length of life , estimates of QALY gains will be higher ( to varying degrees ) : each year of additional life is assigned a higher utility . The ultimate impact on health technology assessment ( HTA ) will depend on whether the differences between the 3L and 5L push ICERs from one side of the cost-effectiveness threshold to the other . Given the implication s for NICE ’s technology appraisal process , and other decisions informed by EQ-5D data , the Department of Health for Engl and has called for an independent validation of the 5L value set , given its relevance to policy [ 7 ] . In 2017 , NICE released a ‘ position statement ’ [ 8 ] stating that : The 3L value set continues to be used for reference-case analyses . Where 5L data have been collected , reference-case analyses should calculate utilities by mapping the 5L descriptive system data onto the 3L value set , using the van Hout et al. [ 9 ] mapping function . NICE supports sponsors of prospect i ve clinical studies continuing to use the 5L to collect data on quality of life . A further position statement is planned for August 2018 , to be informed by evidence from various studies underway . These include studies commissioned by the English Department of Health to investigate the implication s for past NICE technology appraisal s had the 5L been used , and to collect 3L and 5L data in parallel to further improve functions for mapping from one to the other . Other studies , funded by the EuroQol Group , are also underway , investigating various aspects of the relationship between the 3L and 5L across disease areas . The 3L and its UK value set has occupied a special place in NICE ’s technology appraisal process since its inception , therefore any transition will inevitably pose challenges ; for example , reconciling potential inconsistencies between past and future decisions . Given that evidence will continue to be su bmi tted using both the 3L and 5L for years to come , if both value sets are able to be used , there is a risk of inconsistency between decisions being made in the future . HTA in other countries may also face similar issues . Given the difficulties with any transition away from the 3L , is there a case for NICE to adopt the 5L as its preferred instrument ? Papers in this issue of Pharmacoeconomics , which are cited in this commentary , address that question by investigating comparative performance of the 3L and 5L Context National guidelines recommend aspirin or statin drugs individually to reduce first coronary heart disease ( CHD )  events , but there are no guidelines about taking both . Contribution The authors used a Markov model to estimate the cost-effectiveness of aspirin , statins , both drugs , or neither in men . In patients with a 10-year risk for CHD of 7.5 % , aspirin alone reduced costs and lengthened life compared with no treatment . Adding a statin cost $ 56200 per additional quality -adjusted life-year at a 7.5 % risk but only $ 42500 at a 10 % risk . Caution s The authors ' analysis was limited to men . Implication s Therapy with aspirin alone is effective and cost-effective in men with an average level of risk for CHD . The addition of a statin is more cost-effective as risk increases . The Editors Aspirin and statin drugs have been shown to be effective for preventing first coronary heart disease ( CHD ) events ( 1 - 3 ) . Systematic review s and meta-analyses suggest that the relative risk reductions with both forms of therapy are similar in magnitude and seem to be independent and relatively constant across the range of underlying risk for CHD ( 2 - 5 ) . The absolute benefit from these treatments seems to be proportional to the patient 's underlying risk for CHD . National treatment guidelines recommend aspirin and statin drugs individually for the primary prevention of cardiovascular events in men who are at increased risk ( 4 , 6 , 7 ) . However , no U.S. guidelines have addressed how these drugs should be used together , and we are unaware of any previous analyses that have reported the cost-effectiveness of these drugs when used in combination for CHD prevention . To help inform clinical and policy decisions about primary CHD prevention , we performed a costutility analysis that examined the use of aspirin therapy , statin therapy , or combination therapy with both drugs in men with various underlying levels of risk for CHD . Methods To examine the cost and utility associated with aspirin and with statin use , we used Microsoft Excel 2002 for Windows ( Microsoft Corp. , Redmond , Washington ) to develop a Markov state-transition model . The model was design ed to simulate cohorts of initially healthy middle-aged men with no history of cardiovascular events and with various levels of 10-year risk for CHD ( Figure 1 ) . Figure 1 . General structure of the Markov model . Base-Case Scenario In our base-case scenario , we compared the effectiveness of 10 years of aspirin therapy , statin therapy , combination therapy with both drugs , and no therapy in 45-year-old men with a 10-year risk for CHD of 7.5 % . After 10 years , both groups adopted the treatment used in the intervention group . Although the differences in therapy were maintained for only 10 years , we examined the effects of these therapies over a lifetime . Model Assumptions All persons were initially healthy and progressed through the model in annual cycles . In each cycle , an individual remained healthy , had an initial cardiovascular event ( angina , myocardial infa rct ion , or stroke ) , experienced adverse effects from therapy ( gastrointestinal bleeding from aspirin or myopathy from statins ) , or died . We assumed that those who had cardiovascular events or adverse events stayed in the subacute state for the remainder of that cycle and then entered a postevent state . Adherence to treatment was assumed to be 100 % in the absence of adverse effects , although the treatment efficacy data were based on the actual rates of adherence in the clinical trials . Persons who had adverse effects from therapy stopped taking the offending medication ; their procession through the model was similar to that of healthy patients after the initial cycle . All costs and outcomes were discounted at 3 % in accordance with current consensus recommendations ( 8) . Model Parameters Model parameters , including base-case values , ranges , and references , are shown in Table 1 ( 1 - 3 , 9 - 29 ) . Table 1 . Base-Case Estimates and Ranges Used in Sensitivity Analyses Noncardiovascular Mortality Age-dependent noncardiovascular mortality rates were estimated from the National Vital Statistics life tables ( 31 ) . Rates were adjusted as the cohort aged over the time horizon of the analysis . Cardiovascular Event Rates Baseline risks for initial cardiovascular events ( myocardial infa rct ion , stroke , angina , and death from CHD ) were drawn from Framingham risk equations by using hypothetical scenarios of nonsmoking , nonhypertensive , nondiabetic men at different levels of risk for CHD ( Appendix Table ) ( 32 ) . Assuming an exponential distribution , we translated these 10-year risks into annual event-related transition probabilities . These probabilities were allowed to change over time to reflect increasing risk for CHD over the time horizon of the analysis . Appendix Table . Sample Baseline Characteristics of 45-Year-Old Men by Risk Level Because we were interested in primary prevention , we did not simulate or examine the details of a patient 's course after a primary , nonfatal event . Instead , we assigned them an increased risk for death , increased costs , and decreased utilities by using data from the literature regarding the average experience of patients after an initial event . The increased relative risk for death after an initial event ( Table 1 ) was drawn from population -based studies in the United Kingdom ( 12 , 16 ) and applied to the general mortality rates from the U.S. life tables to generate the estimated postevent mortality rates . We modified these event rates by assuming that all patients received optimal secondary prevention . Adverse Effects The excess risks for gastrointestinal bleeding with aspirin use and for myopathy with statin use were drawn from systematic review s of r and omized trials and a recent secondary data analysis ( 2 , 26 , 27 ) . Risks for gastrointestinal bleeding and myopathy in untreated patients were assumed to be zero so that only treatment-induced adverse events were counted . Because better data were not available , we estimated the risks for death from aspirin-related gastrointestinal bleeding and statin-induced myopathy and varied them in sensitivity analysis . Patients who had nonfatal adverse effects were not given therapy with alternate agents for primary prevention of CHD . Modeling Stroke Because many r and omized trials of aspirin prophylaxis did not distinguish by stroke type , we had difficulty estimating the precise effect of aspirin on ischemic and hemorrhagic strokes ( 30 ) . To account for this limitation , we used 2 approaches to model the effect of aspirin on stroke . In the base-case analysis , we followed the approach that was used in a recent meta- analysis ( 9 ) by including hemorrhagic stroke and ischemic stroke together in 1 estimate of the effect of aspirin on total stroke ( relative risk for stroke with aspirin , 1.06 ) . In an alternate scenario , we modeled hemorrhagic stroke and ischemic stroke as separate health states . We assumed that aspirin was associated with an excess annual risk of 20 hemorrhagic strokes per 100000 users on the basis of published meta-analyses and that one third of these hemorrhagic strokes would be fatal ( 19 , 30 , 33 ) . We conservatively assumed that aspirin had no effect on ischemic stroke ( 30 ) . The costs and utilities of ischemic stroke and hemorrhagic stroke were also considered separately . Treatment Efficacy We used summary relative risk estimates from existing meta-analyses or relative risks from individual trials to estimate the efficacy of aspirin and statin therapy , either alone or in combination , for preventing CHD events ( 3 , 24 , 29 ) . Where data were limited , we made conservative assumptions . The efficacy of the combined use of aspirin and statins was assumed to be independent on the basis of data from secondary prevention trials ( 5 ) . We did not model the effect of aspirin or statins on initial use of revascularization procedures in the absence of a cardiovascular event . All patients who survived an initial cardiovascular event were assumed to have received secondary preventive therapy with aspirin and a statin or with an alternate agent if  they could not tolerate  aspirin  or  statins . The effect of treatments on all-cause mortality was estimated from meta-analyses of secondary prevention trials ( 18 - 20 ) . Costs We conducted our analysis from the perspective of a third-party payer . State costs ( Table 1 ) , which were derived from data from the published literature and several recent national data bases , are expressed in 2003 dollars . To estimate the costs during the year in which an event occurred , we estimated acute care costs by drawing on data regarding hospital charges from the Healthcare Utilization Project data base and by converting these values to costs . To convert hospital charges to costs , we used the 1999 cost-to-charge ratio value of 0.4501 , which was derived from the Medicare Provider Analysis and Review of short-stay hospitals ( 28 ) . We then used the Medical Consumer Price Index to generate an inflation factor of 1.195 , which was applied to the 1999 cost figure to convert 1999 dollars to 2003 dollars ( 17 ) . In addition to the acute care costs , we assumed that each patient who survived an acute event would also incur one half of the estimated ongoing annual costs of care for the first year . Costs for subsequent years were based on ongoing costs of care that were drawn from the medical literature ( 22 - 25 ) . Drug costs were obtained from the 2003 Red Book average wholesale prices ( 21 ) . For our base-case analysis , we set the annual  statin cost to $ 730 by averaging the Red Book prices of simvastatin ( $ 922 for 10 mg/d ) and lovastatin ( $ 503 for 10 mg/d ) . The base-case cost of aspirin was based on an annual cost of $ 16 for Bayer aspirin ( Bayer Healthcare LLC , Morristown , New Jersey ) . The annual cost of generic aspirin  was estimated at approximately $ 6 ( 21 ) . We varied the costs of each drug over wide ranges in sensitivity analysis . To check our cost estimates , we compared our derived values with other cost estimates Background Limited utility data on patients suffering from overactive bladder ( OAB ) are available in the literature . The objectives of this study were to estimate utility values in patients with OAB using the generic EQ-5D question naire and the OAB-5D disease specific question naire , to investigate the relationship between utilities and symptoms , and to evaluate the sensitivity of the two instruments to changes in symptom severity . Methods Analyses were based on pooled data from three large multicenter r and omized 12-week placebo-controlled trials ( SCORPIO , ARIES , CAPRICORN ) . Patients completed a micturition diary , EQ-5D and OAB-q ( a quality of life question naire from which OAB-5D is derived ) at baseline and at weeks 4 , 8 and 12 . Time trade-off tariffs elicited from UK population were applied to obtain utilities from both instruments . Repeated measures regressions were used to estimate EQ-5D and OAB-5D utilities by micturition frequency and incontinence severity level . As a test of sensitivity of the instruments , utility changes from baseline to week 12 were estimated by symptomatic response ( improvement , stable or worsening ) . Results The sample included 4427 patients . Mean utilities ( ± st and ard deviation ) across all visits were 0.82 ( ±0.21 ) for EQ-5D and 0.86 ( ±0.09 ) for OAB-5D . Correlation between EQ-5D and OAB-5D was 0.34 ( p < 0.0001 ) . Both OAB-5D and EQ-5D utilities increased as OAB symptoms improved . Utility values were similar for severe levels of symptoms , but higher with OAB-5D than with EQ-5D for mild cases . Micturitions and incontinence had similar impact on EQ-5D utilities , but micturitions had greater impact on OAB-5D utilities than incontinence . Changes from baseline in OAB-5D utilities differed significantly according to symptomatic response . Changes in EQ-5D utilities were not significantly associated with changes in micturition frequency and weakly associated with changes in incontinence severity among patients with mild symptoms at baseline . Conclusions This study showed that both EQ-5D and OAB-5D can detect changes in severity of OAB , especially in severe cases . However , OAB-5D is more sensitive than EQ-5D in measuring differences between treatments in milder cases . Both OAB-5D and EQ-5D – although leading to different results –may be useful to derive utilities from clinical trial data and perform cost-effectiveness analyses . Trial registration Clinical Trials NCT00689104 , NCT00662909 , NCT00912964 OBJECTIVE To determine whether a  cardiovascular disease ( CVD ) health screening program is associated with CVD-related health conditions , incidence of cardiovascular events , mortality , healthcare utilization , and costs . METHODS Cohort study of a 3 % r and om sample of all Korea National Health Insurance members 40years of age or older and free of CVD or CVD-related health conditions was conducted . A total 443,337 study participants were followed-up from January 1 , 2005 through December 31 , 2010 . RESULTS In primary analysis , the hazard ratios for CVD mortality , all-cause mortality , incident composite CVD events , myocardial infa rct ion , cerebral infa rct ion , and cerebral hemorrhage comparing participants who attended a screening exam during 2003 - 2004 compared to those who did not were 0.58 ( 95 % CI : 0.53 - 0.63 ) , 0.62 ( 95 % CI : 0.60 - 0.64 ) , 0.82 ( 95 % CI : 0.78 - 0.85 ) , 0.84 ( 95 % CI : 0.75 - 0.93 ) , 0.84 ( 95 % CI : 0.79 - 0.89 ) , and 0.73 ( 95 % CI : 0.67 - 0.80 ) , respectively . Screening attenders had higher rates of newly diagnosed hypertension , diabetes mellitus , and dyslipidemia , lower inpatient days of stay and cost , and lower outpatient cost compared to non-attenders . CONCLUSIONS Participation in CVD health screening was associated with lower rates of CVD , all-cause mortality , and CVD events , higher detection of CVD-related health conditions , and lower healthcare utilization and costs Background Patients with cervical disc herniations result ing in radiculopathy or myelopathy from single level disease have traditionally been treated with Anterior Cervical Discectomy and Fusion ( ACDF ) , yet Cervical Disc Arthroplasty ( CDA ) is a new alternative . Expert suggestion of reduced adjacent segment degeneration is a promising future result of CDA . A cost-utility analysis of these procedures with long-term follow-up has not been previously reported . Methods We review ed single institution prospect i ve data from a r and omized trial comparing single-level ACDF and CDA in cervical disc disease . Both Medicare reimbursement schedules and actual hospital cost data for peri-operative care were separately review ed and analyzed to estimate the cost of treatment of each patient . QALYs were calculated at 1 and 2 years based on NDI and SF-36 outcome scores , and incremental cost effectiveness ratio ( ICER ) analysis was performed to determine relative cost-effectiveness . Results Patients of both groups showed improvement in NDI and SF-36 outcome scores . Medicare reimbursement rates to the hospital were $ 11,747 and $ 10,015 for ACDF and CDA , respectively ; these figures rose to $ 16,162 and $ 13,171 when including physician and anesthesiologist reimbursement . The estimated actual cost to the hospital of ACDF averaged $ 16,108 , while CDA averaged $ 16,004 ( p = 0.97 ) ; when including estimated physicians fees , total hospital costs came to $ 19,811 and $ 18,440 , respectively . The cost/QALY analyses therefore varied widely with these discrepancies in cost values . The ICERs of ACDF vs CDA with Medicare reimbursements were $ 18,593 ( NDI ) and $ 19,940 ( SF-36 ) , while ICERs based on actual total hospital cost were $ 13,710 ( NDI ) and $ 9,140 ( SF-36 ) . Conclusions We confirm the efficacy of ACDF and CDA in the treatment of cervical disc disease , as our results suggest similar clinical outcomes at one and two year follow-up . The ICER suggests that the non-significant added benefit via ACDF comes at a reasonable cost , whether we use actual hospital costs or Medicare reimbursement values , though the actual ICER values vary widely depending upon the CUA modality used . Long term follow-up may illustrate a different profile for CDA due to reduced cost and greater long-term utility scores . It is crucial to note that financial modeling plays an important role in how economic treatment dominance is portrayed Background and purpose An internet-based discrete choice experiment ( DCE ) was conducted to elicit preferences for a wide range of Dupuytren ’s contracture (DC)-related health states . An algorithm was subsequently developed to convert these preferences into health state utilities that can be used to assess DC ’s impact on quality of life and the value of its treatments . Methods Health state preferences for varying levels of DC h and severity were elicited via an internet survey from a sample of the UK adult population . Severity levels were defined using a combination of contractures ( 0 , 45 , or 90 degrees ) in 8 proximal interphalangeal and metacarpophalangeal joints of the index , middle , ring , and little fingers . Right-h and ed , left-h and ed , and ambidextrous respondents indicated which h and was preferable in each of the 10 r and omly-selected h and -pairings comparing different DC severity levels . For consistency across comparisons , anatomically precise digital h and drawings were used . To anchor preferences onto the traditional 0–1 utility scale used in health economic evaluations , unaffected h and s were assigned a utility of 1.0 whereas the utility for a maximally affected h and ( i.e. , all 8 joints set at 90 degrees of contracture ) was derived by asking respondents to indicate what combination of attributes and levels of the EQ-5D-5L profile most accurately reflects the impact of living with such h and . Conditional logistic models were used to estimate indirect utilities , then rescaled to the anchor points on the EQ-5D-5L . Results Estimated utilities based on the responses of 1,745 qualified respondents were 0.49 , 0.57 , and 0.63 for completely affected dominant h and s , non-dominant h and s , or ambidextrous h and s , respectively . Utility for a dominant h and with 90-degree contracture in t h e metacarpophalangeal joints of the ring and little fingers was estimated to be 0.89 . Separately , reducing the contracture of metacarpophalangeal joint for a little finger from 50 to 12 degrees would improve utility by 0.02 . Interpretation DC is associated with substantial utility decre- ments . The algorithms presented herein provide a robust and flexible framework to assess utility for varying degrees of DC severity Objectives A policy model is a model that can evaluate the effectiveness and cost-effectiveness of interventions and inform policy decisions . In this study , we introduce a cardiovascular disease ( CVD ) policy model which can be used to model remaining life expectancy including a measure of socioeconomic deprivation as an independent risk factor for CVD . Design A state transition model was developed using the Scottish Heart Health Extended Cohort ( SHHEC ) linked to Scottish morbidity and death records . Individuals start in a CVD-free state and can transit to three CVD event states plus a non-CVD death state . Individuals who have a non-fatal first event are then followed up until death . Taking a competing risk approach , the cause-specific hazards of a first event are modelled using parametric survival analysis . Survival following a first non-fatal event is also modelled parametrically . We assessed discrimination , validation and calibration of our model . Results Our model achieved a good level of discrimination in each component ( c-statistics for men (women)—non-fatal coronary heart disease ( CHD ) : 0.70 ( 0.74 ) , non-fatal cerebrovascular disease ( CBVD ) : 0.73 ( 0.76 ) , fatal CVD : 0.77 ( 0.80 ) , fatal non-CVD : 0.74 ( 0.72 ) , survival after non-fatal CHD : 0.68 ( 0.67 ) and survival after non-fatal CBVD : 0.65 ( 0.66 ) ) . In general , our model predictions were comparable with observed event rates for a Scottish r and omised statin trial population which has an overlapping follow-up period with SHHEC . After applying a calibration factor , our predictions of life expectancy closely match those published in recent national life tables . Conclusions Our model can be used to estimate the impact of primary prevention interventions on life expectancy and can assess the impact of interventions on inequalities ABSTRACT Objectives : The aim of this study was to evaluate the long-term clinical and economic outcomes associated with exenatide or insulin glargine , added to oral therapy in individuals with type 2 diabetes inadequately controlled with combination oral agents in the UK setting . Methods : A published and vali date d computer simulation model of diabetes was used to project long-term complications , life expectancy , quality -adjusted life expectancy and direct medical costs . Probabilities of diabetes-related complications were derived from published sources . Treatment effects and patient characteristics were extracted from a recent r and omised controlled trial comparing exenatide with insulin glargine . Simulations incorporated published quality of life utilities and UK-specific costs from 2004 . Pharmacy costs for exenatide were based on 20 , 40 , 60 , 80 and 100 % of the US value ( as no price for the UK was available at the time of analysis ) . Future costs and clinical benefits were discounted at 3.5 % annually . Sensitivity analyses were performed . Results : In the base – case analysis exenatide was associated with improvements in life expectancy of 0.057 years and in quality -adjusted life expectancy of 0.442 quality -adjusted life years ( QALYs ) versus insulin glargine . Long-term projections demonstrated that exenatide was associated with a lower cumulative incidence of most cardiovascular disease ( CVD ) complications and CVD-related death than insulin glargine . Using the range of cost values , evaluation results showed that exenatide is likely to fall in a range between dominant ( cost and life saving ) at 20 % of the US price and cost-effective ( with an ICER of £ 22 420 per QALY gained ) at 100 % of the US price , versus insulin glargine . Conclusions : Based on the findings of a recent clinical trial , long-term projections indicated that exenatide is likely to be associated with improvement in life expectancy and quality -adjusted life expectancy compared to insulin glargine . The results from this modelling analysis suggest that that exenatide is likely to represent good value for money by generally accepted st and ards in the UK setting in individuals with type 2 diabetes inadequately controlled on oral therapy Background Patient underst and ing of study information is fundamental to gaining informed consent to take part in a r and omised controlled trial . In order to meet the requirements of research ethics committees , patient information material s can be long and need to communicate complex messages . There is concern that st and ard approaches to providing patient information may deter potential participants from taking part in trials . The Systematic Techniques for Assisting Recruitment to Trials ( MRC-START ) research programme aims to test interventions to improve trial recruitment . The aim of this study was to investigate the effect on recruitment of optimised patient information material s ( with improved readability and ease of comprehension ) compared with st and ard material s. The study was embedded within two primary care trials involving patients with long-term conditions . Methods The Healthlines Study involves two linked trials evaluating a telehealth intervention  in patients with depression ( Healthlines Depression ) or raised cardiovascular disease risk ( Healthlines CVD ) . We conducted two trials of a recruitment intervention , embedded within the Healthlines host trials . Patients identified as potentially eligible in each of the Healthlines trials were r and omised  to receive either the  original patient information material s or optimised versions of these material s. Primary outcomes were the proportion of participants r and omised ( Healthlines Depression ) and the proportion expressing interest in taking part ( Healthlines CVD ) . Results In Healthlines Depression ( n = 1364 ) , 6.3 % of patients receiving the optimised patient information material  s were r and omised into the study compared to 4.0 % in those receiving st and ard material s ( OR = 1.63 , 95 % CI = 1.00 to 2.67 ) . In Healthlines CVD ( n = 671 ) 24.0 % of those receiving optimised patient information material s responded positively to the invitation to participate , compared to 21.9 % in those receiving st and ard material s ( OR = 1.12 , 95 % CI = 0.78 to 1.61 ) . Conclusions Evidence from these two embedded trials suggests limited benefits of optimised patient information material s on recruitment rates , which may only be apparent in some patient population s , with no effects on other outcomes . Further embedded trials are needed to provide a more precise estimate of effect , and to explore further how effects vary by trial context , intervention , and patient population .Trial registration Current Controlled Trials : Healthlines Depression ( IS RCT N27508731 ) on 26 June 2012 ; and Healthlines CVD ( IS RCT N14172341 ) on 5 July Objective This study aims to systematic ally evaluate available evidence regarding direct medical costs of treating cardiovascular ( CV ) events in Germany after 2003 on an individual patient basis and from a payer perspective . The CV events of interest were myocardial infa rct ion ( MI ) , unstable angina , heart failure ( HF ) , stroke , and peripheral artery disease ( PAD ) . Method A systematic literature search was performed in the following data bases according to Preferred Reporting Items for Systematic Review s and Meta- Analysis ( PRISMA ) guidelines - Medline , Embase , Centre for Review s and Dissemination , TIBORDER , and German dissertation data base from January 2003 to October 2013 . Both observational studies and r and omized clinical trials were considered for the review . All values stated in € are inflation adjusted to 2014 € unless stated otherwise . Result This review included 13 articles . For newly occurred MI patients , the average hospitalization costs during the acute phase were reported to be between € 6790 and € 8918 per admission . In the first year after a MI event , direct medical costs were € 13,838–14,792 per patient . Direct medical costs of chronic HF patients were found to be between € 3417 and 5576 per patient per year . Treatment costs increase with disease progression . The average treatment costs  for hospitalized PAD in the acute phase were reported to be € 4963 per admission , € 2535 per patient during month 1–6 after the initial hospitalization , € 1601 in month 7–12 , and € 1390 in month 13–18 . For stroke of all types , total direct medical costs in the 1st year after an event were reported to be € 13,273 per patient . Total direct medical costs during the 1st year after an ischemic stroke event were € 17,399–21,954 per patient , € 6260 in month 13–18 , and € 6496 per year in the subsequent 4 years . Conclusion MI , unstable angina , HF , stroke and PAD have a high financial impact on the German health care system . Treatment costs of these diseases are mostly incurred during the acute phase of events and tend to decrease over time . Hospitalization and rehabilitation costs were two major cost drivers . Medication costs was one of the smallest cost component reported The data for medical decision analyses are often unreliable . Traditional sensitivity analysis --varying one or more probability or utility estimates from baseline values to see if the optimal strategy changes -- is cumbersome if more than two values are allowed to vary concurrently . This paper describes a practical method for probabilistic sensitivity analysis , in which uncertainties in all values are considered simultaneously . The uncertainty in each probability and utility is assumed to possess a probability distribution . For ease of application we have used a parametric model that permits each distribution to be specified by two values : the baseline estimate and a bound ( upper or lower ) of the 95 percent confidence interval . Following multiple simulations of the decision tree in which each probability and utility is r and omly assigned a value within its distribution , the following results are recorded : ( a ) the mean and st and ard deviation of the expected utility of each strategy ; ( b ) the frequency with which each strategy is optimal ; ( c ) the frequency with which each strategy " buys " or " costs " a specified amount of utility relative to the remaining strategies . As illustrated by an application to a previously published decision analysis , this technique is easy to use and can be a valuable addition to the armamentarium of the decision analyst Although prior research has shown that Community Health Workers/Promotores de Salud ( CHW/PS ) can facilitate access to care , little is known about how CHW/PS are perceived in their community . The current study reports the findings of a r and omized telephone survey conducted in a high-risk urban community environment along the U.S.-Mexico border . In preparation for a community-based CHW/PS intervention called the HEART ecological study , the survey aim ed to assess perceptions of CHW/PS , availability and utilization of community re sources ( recreational and nutrition related ) and health behaviors and intentions . A total of 7,155 calls were placed to complete 444 surveys in three zip codes in El Paso , Texas . Results showed that participants felt that healthful community re sources were available , but utilization was low and variable : 35 % reported going to a park , 20 % reported having taken a health class , few reported using a gym ( 12 % ) , recreation center ( 8 % ) , or YMCA/YWCA ( 0.9 % ) . Awareness and utilization of CHW/PS services were low : 20 % of respondents had heard of CHW/PS , with 8 % reporting previous exposure to CHW/PS services . Upon review of a definition of CHW/PS , respondents expressed positive views of CHW/PS and their value in the healthcare system . Respondents who had previous contact with a CHW/PS reported a significantly more positive perception of the usefulness of CHW/PS ( p = 0.006 ) , were more likely to see CHW/PS as an important link between providers and patients ( p = 0.008 ) , and were more likely to ask a CHW/PS for help ( p = 0.009 ) . Participants who utilized CHW/PS services also had significantly healthier intentions to reduce fast food intake . Future research is needed to evaluate if CHW/PS can facilitate utilization of available community re sources such as recreational facilities among Hispanic border residents at risk for CVD Abstract Background Cardiovascular disease ( CVD ) is an important worldwide cause of mortality . In The Netherl and s , CVD is the leading cause of death for women and the second cause of death for men . Recommendations for diagnosis and treatment of CVD are not well implemented in primary care . In this study , we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with ( high risk for ) CVD . Methods / design A two-arm cluster r and omized trial is planned . We offer practice nurses a tailored program to improve adherence to six specific recommendations related to blood pressure and cholesterol target values , risk profiling and lifestyle advice . Practice nurses are offered training and feedback on their motivational interviewing technique and an e-learning program on cardiovascular risk management ( CVRM ) . They are also advised to screen for the presence and severity of depressive symptoms in patients . We also advise practice nurses to use selected E-health options ( selected websites and Twitter-consult ) in patients without symptoms of depression . Patients with mild depressive symptoms are referred to a physical exercise group . We recommend referring patients with major depressive symptoms for assessment and treatment of depressive symptoms if appropriate before starting CVRM .  Data from 900 patients at high risk of CVD or with established CVD will be collected in 30 general practice s in several geographical areas in The Netherl and s. The primary outcome measure is performance of practice nurses in CVRM and reflects application of recommendations for personalized counselling and education of CVRM patients . Patients ’ health-related lifestyles ( physical exercise , diet and smoking status ) will be measured with vali date d question naires and medical record audit will be performed to document estimated CVD risk . Additionally , we will survey and interview participating healthcare professionals for exploration of processes of change . The control practice s will provide usual care . Discussion Tailored interventions can improve healthcare . An underst and ing of the methods to reach the improved healthcare can be improved . This research contributes a share of it . Identification of the determinants of practice and developing implementation interventions were two steps which were completed . The subsequent step was implementation of the tailored intervention program . Trial registration Name trial register : Nederl and s trial registerWeb address of trial register : http://www.trialregister.nl Data of registration : 11 July 2013Number of registration : Background Intensive lifestyle interventions in well-controlled setting s are effective in lowering the risk of chronic diseases such as type 2 diabetes ( T2DM ) and cardiovascular diseases ( CVD ) , but there are still no effective lifestyle interventions for everyday practice . In the Hoorn Prevention Study we aim ed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality , and to motivate changes in lifestyle behaviors . Methods The Hoorn Prevention Study is a parallel group r and omized controlled trial , implemented in the region of West-Friesl and , the Netherl and s. 622 adults with ≥10 % estimated risk of T2DM and /or CVD mortality were r and omly assigned and monitored over a period of 12 months . The intervention group ( n=314 ) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment , provided by trained practice nurses in 12 general practice s. The control group ( n=308 ) received existing health brochures . Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities ( ARIC ) Study , and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation ( SCORE ) formula . Secondary outcomes included lifestyle behavior ( diet , physical activity and smoking ) . The research assistants , the principal investigator and the general practitioners were blinded to group assignment . Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure , adjusted for baseline values . Results 536 ( 86.2 % ) of the 622 participants ( age 43.5 years ) completed the 6-month follow-up , and 502 ( 81.2 % ) completed the 12-month follow-up . The mean baseline T2DM risk was 18.9 % ( SD 8.2 ) and the mean CVD mortality risk was 3.8 % ( SD 3.0 ) . The intervention group participated in a median of 2 sessions . Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up . Conclusions The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population .Trial registration Current Controlled Trials : IS RCT The reader of oral and maxillofacial implant literature is challenged to be cognizant of the quality of clinical research data . The large variety of possible study design s utilized by clinical research ers requires the reader to have a fundamental awareness of the advantages , disadvantages , and limitations of commonly utilized study design s. This article aims to provide the reader with information to make an informed decision regarding the quality of a clinical research paper , so that he or she can judge whether the information presented in any given manuscript was obtained in a manner that truly minimizes bias , in the form of systematic or r and om errors , and whether it warrants serious consideration for clinical decision making . Special consideration is given to scientific literature pertaining to the use of oral and maxillofacial implants . In addition , the reader is presented with a method for placing any single manuscript within a " hierarchy of evidence " enabling an " estimate of confidence " in a particular therapy . By utilizing such methods to appraise the quality of research data , clinicians and patients will be better informed when making treatment-planning decisions
In this sub-set , it was found that method ological differences contributed to variation in utility values .
Direct methods often yielded higher scores than did indirect methods .
Within direct methods , there were no clear trends in head-to-head studies ( st and ard gamble [ SG ] vs time trade-off ) ; but general population respondents often provided lower scores than did patients with the disease when evaluating the same health states with SG methods .
When comparing indirect methods , the EQ-5D typically yielded higher values than the SF-6D , but also showed more sensitivity to differences in health states .
When selecting CVD utility values for an economic model , consideration of the utility elicitation method is important , as this review demonstrates that methodology of choice impacts utility values in CVD
AIMS Utility values inform estimates of the cost-effectiveness of treatment for cardiovascular disease ( CVD ) , but values can vary depending on the method used .
The aim of this systematic literature review ( SLR ) was to explore how methods of elicitation impact utility values for CVD .