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一项在英国国民保健制度(NHS)环境下,针对已患有心血管疾病或存在高风险的患者使用复方药的经济性评价方案:RUPEE(NHS)研究。

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.

机构信息

BresMed Ireland, Dublin 24, Ireland.

College of Health and Life Science, Brunel University London, London, UK.

出版信息

BMJ Open. 2018 Mar 14;8(3):e013063. doi: 10.1136/bmjopen-2016-013063.

DOI:10.1136/bmjopen-2016-013063
PMID:29540403
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5857692/
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.

摘要

简介

“多药物联合用药降低心血管事件风险”(UMPIRE)试验是一项随机对照临床试验,旨在评估在已患有心血管疾病(CVD)或有高风险患有 CVD 的人群中,使用多药联合用药策略对遵医嘱用药的影响。“研究 UMPIRE 试验在英国国民保健署(NHS)中的经济评估过程(RUPEE-NHS)”旨在利用 UMPIRE 试验和其他相关数据,估算 NHS 中多药联合用药策略预防 CVD 的潜在健康经济效益。本文介绍了 UK UMPIRE 参与者中,增加对多药联合用药的依从性对健康经济影响的建模经济评估设计。

方法和分析

根据国际药物经济学和结果研究学会以及医学决策制定学会的建模指南建议,对已发表的 CVD 模型进行了综述,以确定最合适的建模方法和结构。在电子数据库 MEDLINE 和 EMBASE 中进行了综述。从 57 项研究中确定了 40 个 CVD 模型,其中大多数经济模型为健康状态转移队列模型和个体水平模拟模型。与临床专家讨论了这些发现,以确认方法和结构。确定个体模拟方法是捕捉 CVD 风险人群异质性的最合适方法。RUPEE-NHS 将利用 UMPIRE 试验中关于依从性的数据来估计多药联合用药策略的长期成本效益。

传播

评估结果将在开放获取的科学和医疗保健政策期刊以及国家和国际会议上展示。我们还将向 NHS 政策制定者和制药公司介绍调查结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b08/5857692/f77eaf2e35c1/bmjopen-2016-013063f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b08/5857692/00802e32c255/bmjopen-2016-013063f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b08/5857692/f77eaf2e35c1/bmjopen-2016-013063f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b08/5857692/00802e32c255/bmjopen-2016-013063f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b08/5857692/f77eaf2e35c1/bmjopen-2016-013063f02.jpg

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What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice.服用他汀类药物的患者中,有症状的副作用真正由药物引起的比例是多少?对随机安慰剂对照试验进行系统评价以帮助个体患者做出选择。
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Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trial.固定剂量联合策略对 CVD 患者或高危患者的依从性及相关风险因素的影响:UMPIRE 随机临床试验。
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