Skip to main content
Article
Assessing Usual Care in Clinical Trials
OHSU-PSU School of Public Health Faculty Publications and Presentations
  • Judith A. Erlen, University of Pittsburgh School of Nursing
  • Lisa K. Tamres, University of Pittsburgh School of Nursing
  • 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, UMKC School of Medicine
  • Neil Schneiderman, University of Miami
  • Glenn Wagner, RAND Corporation
  • David Bangsberg, Portland State University
  • Honghu Liu, University of California Los Angeles
Document Type
Post-Print
Publication Date
3-1-2015
Subjects
  • AIDS (Disease) -- Patients -- Clinical trials,
  • Clinical trials -- Methodology,
  • Antiretroviral therapy
Physical Description
9 pages
Abstract

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.

Description

David Bangsberg was affiliated with MGH Center for Global Health; Ragon Institute of MGH, MIT, and Harvard; Harvard Medical School, at the time of writing.

This is the author's final manuscript; published in final edited form as West J Nurs Res. 2015 March ; 37(3): 288–298. doi:10.1177/0193945914526001.

DOI
10.1177/0193945914526001
Persistent Identifier
http://archives.pdx.edu/ds/psu/18446
Citation Information
238. Erlen JA, Tamres LK, Reynolds N, Golin CE, Rosen MI, Remien RH, Banderas JW, Schneiderman N, Wagner G, Bangsberg DR, Liu H. Assessing Usual Care in Clinical Trials. West J Nurs Res. 2014 Mar 12. PubMed PMID: 24622154