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临床试验中多发性硬化症康复干预措施的参与者多样性:范围综述。

Participant diversity in clinical trials of rehabilitation interventions for people with multiple sclerosis: A scoping review.

机构信息

School of Rehabilitation Therapy, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.

Health Sciences Program, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.

出版信息

Mult Scler. 2023 Aug;29(9):1149-1157. doi: 10.1177/13524585231189670.

DOI:10.1177/13524585231189670
PMID:37555491
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10413778/
Abstract

BACKGROUND

The selection and description of participants in clinical trials enables health care providers to determine generalizability of findings to the populations they serve. Limited diversity of participants in trials restricts evidence-based decision-making.

OBJECTIVES

To determine the extent to which diverse participants are being included in clinical trials of rehabilitation interventions for people with multiple sclerosis (MS).

METHODS

We conducted a scoping review of MS rehabilitation trials published since January 2002 using MEDLINE, CINAHL, and Web of Science. Covidence was used to facilitate the review. Article selection required randomized control design, a rehabilitation intervention, and a functional status outcome. Data extracted included details of intervention(s), outcomes, and participant selection and description using a social determinants of health framework.

RESULT

A total of 243 studies were included. Exercise interventions and impairment-focused outcomes were most common. Most studies used only a MS Clinic for recruitment. Common exclusion criteria were physical or mental comorbidities, disability, age, and cognitive impairment. Participant age and sex were reported for almost all trials; reporting of other social determinants of health was atypical.

CONCLUSION

MS rehabilitation trials have used limited recruitment methods, restricted samples, and reported few participant descriptors. Changes are required to enhance participant diversity and the descriptions of participant characteristics.

摘要

背景

临床试验中对参与者的选择和描述使医疗保健提供者能够确定研究结果在他们所服务的人群中的普遍性。试验中参与者的多样性有限限制了循证决策。

目的

确定在多发性硬化症(MS)康复干预临床试验中纳入多样性参与者的程度。

方法

我们使用 MEDLINE、CINAHL 和 Web of Science 对自 2002 年 1 月以来发表的 MS 康复试验进行了范围审查。Covidence 用于促进审查。文章选择需要随机对照设计、康复干预和功能状态结果。使用健康的社会决定因素框架提取的数据包括干预措施、结果以及参与者选择和描述的详细信息。

结果

共纳入 243 项研究。运动干预和以损伤为中心的结局最为常见。大多数研究仅使用 MS 诊所进行招募。常见的排除标准是身体或精神合并症、残疾、年龄和认知障碍。几乎所有试验都报告了参与者的年龄和性别;对健康的其他社会决定因素的报告并不典型。

结论

MS 康复试验使用了有限的招募方法、限制了样本量,并报告了很少的参与者描述符。需要进行更改以增强参与者的多样性和参与者特征的描述。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac7d/10413778/06c2897e78f0/10.1177_13524585231189670-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac7d/10413778/06c2897e78f0/10.1177_13524585231189670-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac7d/10413778/06c2897e78f0/10.1177_13524585231189670-fig1.jpg

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Social determinants of health in multiple sclerosis.多发性硬化症的社会决定因素。
Nat Rev Neurol. 2022 Dec;18(12):723-734. doi: 10.1038/s41582-022-00735-5. Epub 2022 Nov 11.
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