Inappropriate Evaluation of Effect Modifications Based on Categorical Outcomes: A Systematic Review of Randomized Controlled Trials

Akihiro Shiroshita (), Norio Yamamoto, Natsumi Saka, Motohiro Okumura, Hiroshi Shiba and Yuki Kataoka
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Akihiro Shiroshita: Department of Respiratory Medicine, Ichinomiyanishi Hospital, Ichinomiya 494-0001, Japan
Norio Yamamoto: Scientific Research WorkS Peer Support Group (SRWS-PSG), Osaka 541-0043, Japan
Natsumi Saka: Scientific Research WorkS Peer Support Group (SRWS-PSG), Osaka 541-0043, Japan
Motohiro Okumura: Department of Neurology, Jikei University School of Medicine, Tokyo 105-8471, Japan
Hiroshi Shiba: Department of Internal Medicine, Suwa Central Hospital, Chino 391-8503, Japan
Yuki Kataoka: Scientific Research WorkS Peer Support Group (SRWS-PSG), Osaka 541-0043, Japan

IJERPH, 2022, vol. 19, issue 22, 1-9

Abstract: Our meta-epidemiological study aimed to describe the prevalence of reporting effect modification only on relative scale outcomes and inappropriate interpretations of the coefficient of interaction terms in nonlinear models on categorical outcomes. Our study targeted articles published in the top 10 high-impact-factor journals between 1 January and 31 December 2021. We included two-arm, parallel-group, interventional superiority randomized controlled trials to evaluate the effects of modifications on categorical outcomes. The primary outcomes were the prevalence of reporting effect modifications only on relative scale outcomes and that of inappropriately interpreting the coefficient of interaction terms in nonlinear models on categorical outcomes. We included 52 articles, of which 41 (79%) used nonlinear regression to evaluate effect modifications. At least 45/52 articles (87%) reported effect modifications based only on relative scale outcomes, and at least 39/41 (95%) articles inappropriately interpreted the coefficient of interaction terms merely as indices of effect modifications. The quality of the evaluations of effect modifications in nonlinear models on categorical outcomes was relatively low, even in randomized controlled trials published in medical journals with high impact factors. Researchers should report effect modifications of both absolute and relative scale outcomes and avoid interpreting the coefficient of interaction terms in nonlinear regression analyses.

Keywords: effect modification; meta-epidemiological study; nonlinear regression; randomized controlled trial; relative scale outcome (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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