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随机对照试验中运动疗法治疗多种慢性病患者的招募率和保留率:系统评价和荟萃分析。

Recruitment and retention rates in randomised controlled trials of exercise therapy in people with multimorbidity: a systematic review and meta-analysis.

机构信息

Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, 5230, Odense M, Denmark.

Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Region Zealand, 4200, Slagelse, Denmark.

出版信息

Trials. 2021 Jun 14;22(1):396. doi: 10.1186/s13063-021-05346-x.

Abstract

AIM

To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise therapy in people with multimorbidity.

DATA SOURCES

MEDLINE, EMBASE, CINAHL and CENTRAL from 1990 to April 20, 2020.

STUDY SELECTION

RCTs including people with multimorbidity comparing exercise therapy with a non-exposed comparator group reporting at least one of the following outcomes: physical function, health-related quality of life, depression symptoms, or anxiety symptoms.

DATA EXTRACTION AND SYNTHESIS

Recruitment rates (proportion of people randomised/proportion of people eligible), retention rates (proportion of people providing the outcomes of interest/proportion randomised) and differential retention rates (difference in proportion of people providing the outcomes in the intervention group and comparator group) were calculated. Meta-analysis using a random-effects model was used to estimate pooled proportions. Methodological quality was assessed using Cochrane ´Risk of Bias tool 2.0´ for individual studies, and the GRADE approach was used to assess the overall quality of the evidence.

RESULTS

Twenty-three RCTs with 3363 people were included. The pooled prevalence for recruitment rate was 75% (95%CI 66 to 84%). The pooled prevalence for retention rate was 90% (95%CI 86 to 94%) at the end of the intervention (12 weeks; interquartile range (IQR) (12 to 12)). Meta-regression analyses showed that increasing age and including a higher proportion of people with hypertension was associated with lower retention rates. Retention rates did not differ between the intervention and comparator groups. The overall quality of the evidence was deemed very low.

CONCLUSION

Three in four eligible people with multimorbidity were randomised to RCTs using exercise therapy, of which nine out of 10 provided end of treatment outcomes with no difference seen between the intervention and comparison groups. However, the results must be interpreted with caution due to large differences between the included studies.

TRIAL REGISTRATION

ClinicalTrials.gov CRD42020161329 . Registered on 28 April 2020.

摘要

目的

量化招募、保留和差异保留率以及与评估多种疾病患者运动疗法效果的随机对照试验(RCT)相关的试验、参与者和干预特征。

数据来源

1990 年至 2020 年 4 月 20 日期间,MEDLINE、EMBASE、CINAHL 和 CENTRAL。

研究选择

RCT 纳入了患有多种疾病的患者,将运动疗法与非暴露对照进行比较,报告了以下至少一项结果:身体功能、健康相关生活质量、抑郁症状或焦虑症状。

数据提取和综合

计算了招募率(随机分配的人数/符合条件的人数比例)、保留率(提供感兴趣结果的人数/随机分配的人数比例)和差异保留率(干预组和对照组提供结果的人数比例差异)。使用随机效应模型进行荟萃分析以估计汇总比例。使用 Cochrane“风险偏倚工具 2.0”评估个体研究的方法学质量,并使用 GRADE 方法评估证据的总体质量。

结果

纳入了 23 项 RCT,涉及 3363 人。招募率的汇总患病率为 75%(95%CI 66 至 84%)。干预结束时(12 周;四分位距(IQR)(12 至 12))的保留率汇总患病率为 90%(95%CI 86 至 94%)。元回归分析表明,年龄增加和包括更高比例的高血压患者与保留率降低相关。干预组和对照组之间的保留率没有差异。证据的总体质量被认为是极低的。

结论

患有多种疾病的符合条件的人中,有四分之三被随机分配到使用运动疗法的 RCT 中,其中十分之九的人在治疗结束时提供了结果,干预组和对照组之间没有差异。然而,由于纳入研究之间存在很大差异,因此必须谨慎解释结果。

试验注册

ClinicalTrials.gov CRD42020161329。于 2020 年 4 月 28 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7c60/8204443/b49f8ae3d674/13063_2021_5346_Fig1_HTML.jpg

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