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Usual Care as the Control Group in Clinical Trials of Nonpharmacologic Interventions

¹ Pulmonary and Critical Care Unit and ² Biostatistics Center, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts

Correspondence and requests for reprints should be addressed to B. Taylor Thompson, M.D., Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114. E-mail tthompson1{at}partners.org

ABSTRACT

We discuss the pros and cons of including usual care as a control arm in clinical trials of nonpharmacologic interventions. 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. 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. 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. Examples of the latter include pragmatic effectiveness trials of clinical pathways or protocolized-care versus usual-care practices. 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.

Key Words: clinical trials • human experimentation • human subjects protection • control group selection