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A protocol for an economic evaluation of a polypill in patients with established or at high risk of cardiovascular disease in a UK NHS setting: RUPEE (NHS) study.

ABSTRACT: INTRODUCTION:The 'Use of a Multi-drug Pill in Reducing cardiovascular Events' (UMPIRE) trial was a randomised controlled clinical trial evaluating the impact of a polypill strategy on adherence to indicated medication in a population with established cardiovascular disease (CVD) of or at high risk thereof. The aim of Researching the UMPIRE Processes for Economic Evaluation in the National Health Service (RUPEE NHS) is to estimate the potential health economic impact of a polypill strategy for CVD prevention within the NHS using UMPIRE trial and other relevant data. This paper describes the design of a modelled economic evaluation of the impact of increased adherence to the polypill versus usual care among the UK UMPIRE participants. METHODS AND ANALYSIS:As recommended by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making modelling guidelines, a review of published CVD models was undertaken to identify the most appropriate modelling approach and structure. The review was carried out in the electronic databases, MEDLINE and EMBASE. 40 CVD models were identified from 57 studies, the majority of economic models were health state transition cohort models and individual-level simulation models. The findings were discussed with clinical experts to confirm the approach and structure. An individual simulation approach was identified as the most suitable method to capture the heterogeneity in the population at CVD risk. RUPEE-NHS will use UMPIRE trial data on adherence to estimate the long-term cost-effectiveness of the polypill strategy. DISSEMINATION:The evaluation findings will be presented in open-access scientific and healthcare policy journals and at national and international conferences. We will also present findings to NHS policy makers and pharmaceutical companies.

SUBMITTER: Crossan C

PROVIDER: S-EPMC5857692 | biostudies-other | 2018 Mar

REPOSITORIES: biostudies-other

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A protocol for an economic evaluation of a polypill in patients with established or at high risk of cardiovascular disease in a UK NHS setting: RUPEE (NHS) study.

Crossan Catriona C Dehbi Hakim-Moulay HM Williams Hilarie H Poulter Neil N Rodgers Anthony A Jan Stephen S Thom Simon S Lord Joanne J

BMJ open 20180314 3

<h4>Introduction</h4>The 'Use of a Multi-drug Pill in Reducing cardiovascular Events' (UMPIRE) trial was a randomised controlled clinical trial evaluating the impact of a polypill strategy on adherence to indicated medication in a population with established cardiovascular disease (CVD) of or at high risk thereof. The aim of Researching the UMPIRE Processes for Economic Evaluation in the National Health Service (RUPEE NHS) is to estimate the potential health economic impact of a polypill strateg ...[more]

PMID: 29540403

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Project description:BackgroundNHS Health Check is a national cardiovascular disease (CVD) risk assessment programme for 40-74 year olds in England, in which practitioners should assess and communicate CVD risk, supported by appropriate risk-management advice and goal-setting. This requires effective communication, to equip patients with knowledge and intention to act. Currently, the QRISK®2 10-year CVD risk score is most common way in which CVD risk is estimated. Newer tools, such as JBS3, allow manipulation of risk factors and can demonstrate the impact of positive actions. However, the use, and relative value, of these tools within CVD risk communication is unknown. We will explore practitioner and patient CVD risk perceptions when using QRISK®2 or JBS3, the associated advice or treatment offered by the practitioner, and patients' responses.MethodsRIsk COmmunication in NHS Health Check (RICO) is a qualitative study with quantitative process evaluation. Twelve general practices in the West Midlands of England will be randomised to one of two groups: usual practice, in which practitioners use QRISK®2 to assess and communicate CVD risk; intervention, in which practitioners use JBS3. Twenty Health Checks per practice will be video-recorded (n = 240, 120 per group), with patients stratified by age, gender and ethnicity. Post-Health Check, video-stimulated recall (VSR) interviews will be conducted with 48 patients (n = 24 per group) and all practitioners (n = 12-18), using video excerpts to enhance participant recall/reflection. Patient medical record reviews will detect health-protective actions in the first 12-weeks following a Health Check (e.g., lifestyle referrals, statin prescription). Risk communication, patient response and intentions for health-protective behaviours in each group will be explored through thematic analysis of video-recorded Health Checks (using Protection Motivation Theory as a framework) and VSR interviews. Process evaluation will include between-group comparisons of quantitatively coded Health Check content and post-Health Check patient outcomes. Finally, 10 patients with the most positive intentions or behaviours will be selected for case study analysis (using all data sources).DiscussionThis study will produce novel insights about the utility of QRISK®2 and JBS3 to promote patient and practitioner understanding and perception of CVD risk and associated implications for patient intentions with respect to health-protective behaviours (and underlying mechanisms). Recommendations for practice will be developed.Trial registrationISRCTN ISRCTN10443908 . Registered 7th February 2017.

Project description:ObjectivesTo evaluate potential return on investment of the National Health Service Diabetes Prevention Programme (NHS DPP) in England and estimate which population subgroups are likely to benefit most in terms of cost-effectiveness, cost-savings and health benefits.DesignEconomic analysis using the School for Public Health Research Diabetes Prevention Model.SettingEngland 2015-2016.PopulationAdults aged ≥16 with high risk of type 2 diabetes (HbA1c 6%-6.4%). Population subgroups defined by age, sex, ethnicity, socioeconomic deprivation, baseline body mass index, baseline HbA1c and working status.InterventionsThe proposed NHS DPP: an intensive lifestyle intervention focusing on dietary advice, physical activity and weight loss. Comparator: no diabetes prevention intervention.Main outcome measuresIncremental costs, savings and return on investment, quality-adjusted life-years (QALYs), diabetes cases, cardiovascular cases and net monetary benefit from an NHS perspective.ResultsIntervention costs will be recouped through NHS savings within 12 years, with net NHS saving of £1.28 over 20 years for each £1 invested. Per 100 000 DPP interventions given, 3552 QALYs are gained. The DPP is most cost-effective and cost-saving in obese individuals, those with baseline HbA1c 6.2%-6.4% and those aged 40-74. QALY gains are lower in minority ethnic and low socioeconomic status subgroups. Probabilistic sensitivity analysis suggests that there is 97% probability that the DPP will be cost-effective within 20 years. NHS savings are highly sensitive to intervention cost, effectiveness and duration of effect.ConclusionsThe DPP is likely to be cost-effective and cost-saving under current assumptions. Prioritising obese individuals could create the most value for money and obtain the greatest health benefits per individual targeted. Low socioeconomic status or ethnic minority groups may gain fewer QALYs per intervention, so targeting strategies should ensure the DPP does not contribute to widening health inequalities. Further evidence is needed around the differential responsiveness of population subgroups to the DPP.

Project description:INTRODUCTION:Current international guidelines for cardiac rehabilitation (CR) advocate moderate-intensity exercise training (MISS, moderate-intensity steady state). This recommendation predates significant advances in medical therapy for coronary heart disease (CHD) and may not be the most appropriate strategy for the 'modern' patient with CHD. High-intensity interval training (HIIT) appears to be a safe and effective alternative, resulting in greater improvements in peak oxygen uptake (VO2 peak). To date, HIIT trials have predominantly been proof-of-concept studies in the laboratory setting and conducted outside the UK. The purpose of this multicentre randomised controlled trial is to compare the effects of HIIT and MISS training in patients with CHD attending UK CR programmes. METHODS AND ANALYSIS:This pragmatic study will randomly allocate 510 patients with CHD to 8?weeks of twice weekly HIIT or MISS training at 3 centres in the UK. HIIT will consist of 10 high-intensity (85-90% peak power output (PPO)) and 10 low-intensity (20-25% PPO) intervals, each lasting 1?min. MISS training will follow usual care recommendations, adhering to currently accepted UK guidelines (ie, >20?min continuous exercise at 40-70% heart rate reserve). Outcome measures will be assessed at baseline, 8?weeks and 12?months. The primary outcome for the trial will be change in VO2 peak as determined by maximal cardiopulmonary exercise testing. Secondary measures will assess physiological, psychosocial and economic outcomes. ETHICS AND DISSEMINATION:The study protocol V.1.0, dated 1 February 2016, was approved by the NHS Health Research Authority, East Midlands-Leicester South Research Ethics Committee (16/EM/0079). Recruitment will start in August 2016 and will be completed in June 2018. Results will be published in peer-reviewed journals, presented at national and international scientific meetings and are expected to inform future national guidelines for exercise training in UK CR. TRIAL REGISTRATION NUMBER:NCT02784873; pre-results.

Project description:INTRODUCTION:Half of all deaths in custody are due to natural causes, the most common being cardiovascular disease (CVD). National Health Service Healthchecks should be available to all eligible prisoners; it is not clear who receives them. Mental health issues are common in prisoners and may affect how healthcare interventions should be delivered. Current policy is to offer Healthchecks to those serving over 2 years in prison. OBJECTIVES, METHODS, SETTING AND DESIGN:An observational cross-sectional survey in six male prisons in England between September 2017 and January 2019 in prisoners aged 35-74 to identify who was eligible for a Healthcheck and compare CVD risk data with those that were not, and factors associated with uptake. OUTCOME MEASURES:Characteristics of those accepting a Healthcheck were compared with those declining. Assessments of anxiety and depression were compared with CVD risk factors. RESULTS:1207 prisoners completed a Healthcheck. 21.8% of prisoners were ineligible due to existing comorbidities. 76.4% of those invited took up a Healthcheck, and of those, 12.1% were found to have new significant CVD comorbidity. CVD risk was similar to community levels but this population was 10 years younger. Definite case-level depression or anxiety was present in 20.7% and 18.0%, respectively, of participants. An association was found between ethnicity and those invited (p=0.023, ?=0.1) and accepting (p=0.008, ?=0.1) a Healthcheck. 9.7% of prisoners serving less than 2 years had CVD risk scores of 10% or more, and had similar CVD risk profiles but much higher levels of anxiety (p<0.001, ?=0.2) or depression (p=0.009, ?=0.2) than those serving 2 years or more. CONCLUSION:Cardiovascular risk was comparable with community rates and in some prisons, much higher. Rates of anxiety and depression were high. The national policy for selecting prisoners for Healthchecks may leave many high-risk prisoners without appropriate cardiovascular preventative assessments.

Dataset Information

A protocol for an economic evaluation of a polypill in patients with established or at high risk of cardiovascular disease in a UK NHS setting: RUPEE (NHS) study.

Publications

A protocol for an economic evaluation of a polypill in patients with established or at high risk of cardiovascular disease in a UK NHS setting: RUPEE (NHS) study.

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