![]() We will examine the design considerations for using usual care as a control group in interventional trials and discuss three-arm designs that include two interventional strategies with usual care as a control. Critics argue that such arms, which allow for individualized treatment decisions unrestricted by study protocols or rules, require “no assumptions to determine whether or not an experimental therapy is resulting in harm during a trial” because the experimental arm is being compared with de facto usual care ( 3). Criticism has focused on the absence of a control arm that reflected “best current care” to detect potential harm to research subjects with rapidly fatal diseases ( 2). Recent controversy has centered on control group selection for intensive care unit (ICU) trials of nonpharmacologic interventional strategies, specifically Acute Respiratory Distress Syndrome Network (ARDSnet) studies of low tidal volume ( 1). ![]() Randomized intervention trials can be safely conducted and monitored using two treatments that lie within the range of usual-care practices if both approaches are considered prudent and good care for the target population. Examples of the latter include pragmatic effectiveness trials of clinical pathways or protocolized-care versus usual-care practices. The use of a usual-care arm in a two-arm trial should be considered for trials of investigational drugs or devices, for trials that propose to test interventions that lie well outside usual-care practices, or for trials where the research question per se is to compare a strategy against usual care. The decision to use usual care as the control arm should be based on the nature of the research question and the uniformity of usual-care practices. Usual care is a term used to describe the full spectrum of patient care practices in which clinicians have the opportunity (which is not necessarily seized) to individualize care. We discuss the pros and cons of including usual care as a control arm in clinical trials of nonpharmacologic interventions.
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