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一项基于证据的干预措施的演变,该措施旨在改善初级保健中患有多种疾病且用药过多的老年人的处方开具情况并减少多重用药(SPPiRE)。

The evolution of an evidence based intervention designed to improve prescribing and reduce polypharmacy in older people with multimorbidity and significant polypharmacy in primary care (SPPiRE).

作者信息

McCarthy Caroline, Moriarty Frank, Wallace Emma, Smith Susan M

机构信息

HRB Centre for Primary Care Research and RCSI Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.

出版信息

J Comorb. 2020 Sep 14;10:2235042X20946243. doi: 10.1177/2235042X20946243. eCollection 2020 Jan-Dec.

Abstract

INTRODUCTION

By the time an intervention is ready for evaluation in a definitive RCT the context of the evidence base may have evolved. To avoid research waste, it is imperative that intervention design and evaluation is an adaptive process incorporating emerging evidence and novel concepts. The aim of this study is to describe changes that were made to an evidence based intervention at the protocol stage of the definitive RCT to incorporate emerging evidence.

METHODS

The original evidence based intervention, a GP delivered web guided medication review, was modified in a five step process:Identification of core components of the original intervention.Literature review.Modification of the intervention.Pilot study.Final refinements. A framework, developed in public health research, was utilised to describe the modification process.

RESULTS

The population under investigation changed from older people with a potentially inappropriate prescription (PIP) to older people with significant polypharmacy, a proxy marker for complex multimorbidity. An assessment of treatment priorities and brown bag medication review, with a focus on deprescribing were incorporated into the original intervention. The number of repeat medicines was added as a primary outcome measure as were additional secondary patient reported outcome measures to assess treatment burden and attitudes towards deprescribing.

CONCLUSIONS

A framework was used to systematically describe how and why the original intervention was modified, allowing the new intervention to build upon an effective and robustly developed intervention but also to be relevant in the context of the current evidence base.

摘要

引言

当一项干预措施准备好在确定性随机对照试验(RCT)中进行评估时,证据基础的背景可能已经发生了变化。为避免研究资源浪费,干预措施的设计和评估必须是一个适应性过程,纳入新出现的证据和新颖概念。本研究的目的是描述在确定性RCT的方案阶段,基于证据的干预措施为纳入新出现的证据而做出的改变。

方法

最初基于证据的干预措施是由全科医生提供的网络指导药物审查,通过以下五个步骤进行修改:确定原始干预措施的核心组成部分;文献综述;干预措施的修改;试点研究;最终完善。采用公共卫生研究中开发的一个框架来描述修改过程。

结果

研究人群从有潜在不适当处方(PIP)的老年人转变为有大量多种药物治疗的老年人,这是复杂多重疾病的一个替代指标。对治疗优先级的评估和棕色纸袋药物审查(重点是减少用药)被纳入原始干预措施。重复用药数量被添加为主要结局指标,还增加了额外的患者报告的次要结局指标,以评估治疗负担和对减少用药的态度。

结论

使用一个框架系统地描述了原始干预措施是如何以及为何被修改的,使新的干预措施既能建立在一个有效且经过充分发展的干预措施基础上,又能与当前的证据基础相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69db/7493276/a94cdad09bec/10.1177_2235042X20946243-fig1.jpg

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