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Assessing Usual Care in Clinical Trials
Western Journal of Nursing Research (2015)
  • Judith A. Erlen, University of Pittsburgh
  • Lisa K. Tamres, University of Pittsburgh
  • Nancy Reynolds, Yale University
  • Carol E. Golin, University of North Carolina at Chapel Hill
  • Marc I. Rosen, Yale University
  • Robert H. Remien, Columbia University
  • Julie W. Banderas, University of Missouri-Kansas City
  • Neil Schneiderman, University of Miami
  • Glenn J. Wagner, RAND Corporation
  • David R. Bangsberg, Portland State University
  • Honghu H. Liu, University of California, Los Angeles
Researchers designing clinical trials often specify usual care received by participants as the control condition expecting that all participants receive usual care regardless of group assignment. The assumption is that the groups in the study are affected similarly. We describe the assessment of usual care within the 16 studies in MACH 14, a multi-site collaboration on adherence to antiretroviral therapy. Only five of the studies in MACH 14 assessed usual care. Assessment protocols varied as did the timing and frequency of assessments. All usual care assessments addressed patient education focused on HIV, HIV medications, and medication adherence. Our findings support earlier work that calls for systematic assessments of usual care within the study design, inclusion of descriptions of usual care in reports of the study, and the influence of usual care on the experimental condition in clinical trials.
Publication Date
March, 2015
Publisher Statement
At the time of publication David Bangsberg was affiliated with the Harvard Medical School.
Citation Information
Erlen JA, Tamres LK, Reynolds N, Golin CE, Rosen MI, Remien RH, Banderas JW, Schneiderman N, Wagner G, Bangsberg DR, Liu H. 2015. Assessing Usual Care in Clinical Trials. West J Nurs Res. 37(3):288-98