TY - JOUR
T1 - Treatment effect sizes vary in randomized trials depending on the type of outcome measure
AU - Berthelsen, Dorthe B.
AU - Ginnerup-Nielsen, Elisabeth
AU - Juhl, Carsten
AU - Lund, Hans
AU - Henriksen, Marius
AU - Hróbjartsson, Asbjørn
AU - Nielsen, Sabrina M.
AU - Voshaar, Marieke
AU - Christensen, Robin
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
KW - Effect size
KW - Meta-epidemiology
KW - Meta-Research
KW - Patient-involvement
KW - Patient-reported outcome measures
KW - Physical therapy
KW - n/a OA procedure
UR - http://www.scopus.com/inward/record.url?scp=85083336939&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2019.10.016
DO - 10.1016/j.jclinepi.2019.10.016
M3 - Review article
C2 - 32217079
AN - SCOPUS:85083336939
SN - 0895-4356
VL - 123
SP - 27
EP - 38
JO - Journal of clinical epidemiology
JF - Journal of clinical epidemiology
ER -