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Meta 流行病学的争议与讨论。论文 1:随机试验中,因结果测量指标类型的不同,治疗效果的大小存在差异。

Controversy and Debate on Meta-epidemiology. Paper 1: Treatment effect sizes vary in randomized trials depending on the type of outcome measure.

机构信息

The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark; Department of Physiotherapy and Occupational Therapy, University Hospital of Copenhagen, Herlev and Gentofte, Gentofte, Denmark.

出版信息

J Clin Epidemiol. 2020 Jul;123:27-38. doi: 10.1016/j.jclinepi.2019.10.016. Epub 2020 Mar 23.

DOI:10.1016/j.jclinepi.2019.10.016
PMID:32217079
Abstract

OBJECTIVE

To compare estimated treatment effects of physical therapy (PT) between patient-reported outcome measures (PROMs) and outcomes measured in other ways.

STUDY DESIGN AND SETTING

We selected randomized trials of PT with both a PROM and a non-PROM included in Cochrane systematic reviews (CSRs). Two reviewers independently extracted data and risk-of-bias assessments. Our primary outcome was the ratio of odds ratios (RORs), used to quantify how effect varies between PROMs and non-PROMs; an ROR > 1 indicates larger effect when assessed by using PROMs. We used REML-methods to estimate associations of trial characteristics with effects and between-trial heterogeneity.

RESULTS

From 90 relevant CSRs, 205 PT trials were included. The summary ROR across all the comparisons was not statistically significant (ROR, 0.88 [95% CI: 0.70-1.12]; P = 0.30); however, the heterogeneity was substantial (I = 88.1%). When stratifying non-PROMs further into clearly objective non-PROMs (e.g., biomarkers) and other non-PROMs (e.g., aerobic capacity), the PROMs appeared more favorable than did clearly objective non-PROMs (ROR, 1.92 [95% CI: 0.99-3.72]; P = 0.05).

CONCLUSION

Estimated treatment effects based on PROMs are generally comparable with treatment effects measured in other ways. However, in our study, PROMs indicate a more favorable treatment effect compared with treatment effects based on clearly objective outcomes.

摘要

目的

比较患者报告结局测量(PROMs)和其他方式测量的结果在物理治疗(PT)中的估计治疗效果。

研究设计和设置

我们选择了 Cochrane 系统评价(CSRs)中同时包含 PROM 和非 PROM 的 PT 随机试验。两位审稿人独立提取数据和风险偏倚评估。我们的主要结局是比值比(ROR),用于量化 PROM 和非 PROM 之间的效果差异;ROR>1 表示使用 PROM 评估时效果更大。我们使用 REML 方法来估计试验特征与效应之间以及试验间异质性的关联。

结果

从 90 项相关 CSRs 中,纳入了 205 项 PT 试验。所有比较的综合 ROR 无统计学意义(ROR,0.88 [95% CI:0.70-1.12];P=0.30);然而,异质性很大(I=88.1%)。当进一步将非 PROM 细分为明确的客观非 PROM(如生物标志物)和其他非 PROM(如有氧能力)时,PROM 似乎比明确的客观非 PROM 更有利(ROR,1.92 [95% CI:0.99-3.72];P=0.05)。

结论

基于 PROM 的估计治疗效果通常与其他方式测量的治疗效果相当。然而,在我们的研究中,与基于明确客观结局的治疗效果相比,PROM 显示出更有利的治疗效果。

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