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

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  1. Ecological momentary assessments (EMAs) did not improve responsiveness of patient-reported outcomes on quality of life

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  2. More than one-third of Cochrane reviews had gift authors, whereas ghost authorship was rare

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  3. Half of Cochrane reviews were published more than 2 years after the protocol

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  4. Unlike ROC analysis, a new IRT method identified clinical thresholds unbiased by disease prevalence

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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 (I2 = 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.

OriginalsprogEngelsk
TidsskriftJournal of Clinical Epidemiology
Vol/bind123
Sider (fra-til)27-38
Antal sider12
ISSN0895-4356
DOI
StatusUdgivet - jul. 2020

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

ID: 59777420