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推进考虑社会背景和人类意愿的“真实世界”试验。

Advancing 'real-world' trials that take account of social context and human volition.

作者信息

Hansen Anders Blædel Gottlieb, Jones Allan

机构信息

Strategic Research and Development Support, Metropolitan University College, Tagensvej 18, Copenhagen N, 2200, Denmark.

Bachelor's Degree in Global Nutrition and Health, Faculty of Health and Technology, Metropolitan University College, Sigurdsgade 26, Copenhagen N, 2200, Denmark.

出版信息

Trials. 2017 Nov 10;18(1):531. doi: 10.1186/s13063-017-2286-8.

DOI:10.1186/s13063-017-2286-8
PMID:29126449
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5681782/
Abstract

BACKGROUND

The recent paper in Trials by Porter and colleagues highlights the utility of applying a critical realism approach in randomised trials, an approach central to the Medical Research Council's (MRC) Framework for the Development and Evaluation of Complex Healthcare Interventions. The MRC framework offers a pragmatic step towards a more open systems approach that bridges randomised evaluation with social context and human agency in an effort to improve the generalisability of trial outcomes.

MAIN BODY

The MRC framework has contributed to the proliferation of a more open systems approach in health research; however, the broader acceptance of the realist approach to health research does not seem to be emulated by norms in research fund allocation, which largely prioritises laboratory-based research.

CONCLUSION

This commentary is simply a plea, to those who make the strategic decisions regarding allocation of research funding, to support all phases of health intervention research in complex systems that contribute to the development of effective, translational and sustainable interventions in the promotion of health.

摘要

背景

波特及其同事近期发表在《试验》杂志上的论文强调了在随机试验中应用批判实在论方法的效用,该方法是医学研究理事会(MRC)复杂医疗保健干预措施开发与评估框架的核心。MRC框架朝着更开放的系统方法迈出了务实的一步,这种方法将随机评估与社会背景和人类能动性联系起来,以提高试验结果的普遍性。

主体

MRC框架推动了健康研究中更开放系统方法的普及;然而,健康研究现实主义方法的更广泛接受似乎并未被研究资金分配规范所效仿,研究资金分配在很大程度上优先考虑基于实验室的研究。

结论

本评论只是向那些做出研究资金分配战略决策的人发出呼吁,支持复杂系统中健康干预研究的所有阶段,这些研究有助于开发促进健康的有效、转化性和可持续干预措施。

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本文引用的文献

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SSM Popul Health. 2017 Dec;3:132-135. doi: 10.1016/j.ssmph.2016.12.005.
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The possibility of critical realist randomised controlled trials.批判实在论随机对照试验的可能性。
Trials. 2017 Mar 21;18(1):133. doi: 10.1186/s13063-017-1855-1.
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Why clinical trial outcomes fail to translate into benefits for patients.为何临床试验结果无法转化为患者的益处。
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Diabet Med. 2016 Dec;33(12):1673-1676. doi: 10.1111/dme.13255. Epub 2016 Oct 6.
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Realist complex intervention science: Applying realist principles across all phases of the Medical Research Council framework for developing and evaluating complex interventions.现实主义复杂干预科学:在医学研究理事会制定和评估复杂干预措施的框架的所有阶段应用现实主义原则。
Evaluation (Lond). 2016 Jul;22(3):286-303. doi: 10.1177/1356389016652743. Epub 2016 Jun 2.
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Can "realist" randomised controlled trials be genuinely realist?“现实主义”随机对照试验能真正做到现实主义吗?
Trials. 2016 Jul 7;17(1):313. doi: 10.1186/s13063-016-1407-0.
8
The three stages of building and testing mid-level theories in a realist RCT: a theoretical and methodological case-example.在实用随机对照试验中构建和检验中层理论的三个阶段:一个理论与方法的案例
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Process evaluation of complex interventions: Medical Research Council guidance.复杂干预措施的过程评估:医学研究委员会指南。
BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.