家庭医学和初级保健的临床试验方法。

IF 1.7 Q4 PRIMARY HEALTH CARE
Robert Mash, Bolatito B Fatusin, Edith Madela-Mntla, Christopher Butler
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引用次数: 0

摘要

本文概述了博士或早期职业研究人员临床试验的基本特征。世界卫生组织最近强调需要更高质量的临床试验,更多地在低收入和中等收入国家进行试验,以及初级保健,更多地与患者和社区接触,并采用创新的试验设计。在撒哈拉以南非洲,初级保健研究人员需要超越准实验和前后对照设计,进行随机临床试验。本文描述了随机对照试验的关键方法学要求:假设、设计、设置、招募、随机化、样本量、干预、评估、结果、解释和外推。我们还讨论了伦理和组织良好的试验方面,这些试验尊重研究参与者,参与协作过程,具有适当的治理和透明的结果传播。最后,我们概述了创新设计,如阶梯楔形,临床试验网络和自适应平台设计。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical trial methods for family medicine and primary care.

This article outlines the essential features of clinical trials for doctoral or early career researchers. The World Health Organization has recently emphasised the need for higher quality clinical trials, more trials from low- and middle-income countries, as well as primary care, more engagement with patients and communities and adoption of innovative trial designs. In sub-Saharan Africa, primary care researchers need to move beyond quasi-experimental and before-and-after designs to conduct randomised clinical trials. The article describes the key methodological requirements of a randomised controlled trial: the hypothesis, design, setting, recruitment, randomisation, sample size, intervention, assessment, results, interpretation and extrapolation. We also discuss the aspects of ethical and well-organised trials that respect study participants, engage with collaborative processes, have appropriate governance and transparent dissemination of results. Finally, we outline innovative designs such as step-wedge, clinical trial networks and adaptive platform designs.

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来源期刊
CiteScore
3.30
自引率
10.00%
发文量
81
审稿时长
15 weeks
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