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Pragmatic clinical trials evaluate the effectiveness of health interventionsin real-world settings. Spillover arises in a pragmatic trial if the studyintervention affects how scarce resources are allocated between patients in theintervention and comparison groups. This can harm patients assigned to thecontrol group and lead to overestimation of treatment effect. There iscurrently little recognition of this source of bias - which I term"scarcity-mediated spillover" - in the medical literature. In this article, Iexamine what causes spillover and how it may have led trial investigators tooverestimate the effect of patient navigation, AI-based physiological alarms,and elective induction of labor. I also suggest ways to detectscarcity-mediated spillover, design trials that avoid it, and modify clinicaltrial guidelines to address this overlooked source of bias.

Scarcity-Mediated Spillover: An Overlooked Source of Bias in Pragmatic Clinical Trials