title: Assessing usual care in clinical trials.
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 Multisite Adherence Collaboration in HIV (MACH 14), a multisite 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.
authors.affiliation: University of Pittsburgh, PA, USA jae001@pitt.edu.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Erlen
authors.affiliation: University of Pittsburgh, PA, USA.
authors.forename: Lisa K
authors.initials: LK
authors.lastname: Tamres
authors.affiliation: Yale University, New Haven, CT, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Reynolds
authors.affiliation: University of North Carolina, Chapel Hill, USA.
authors.forename: Carol E
authors.initials: CE
authors.lastname: Golin
authors.affiliation: Yale University, New Haven, CT, USA.
authors.forename: Marc I
authors.initials: MI
authors.lastname: Rosen
authors.affiliation: Columbia University, New York, NY, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Remien
authors.affiliation: University of Missouri-Kansas City School of Medicine, USA.
authors.forename: Julie W
authors.initials: JW
authors.lastname: Banderas
authors.affiliation: University of Miami, Coral Gables, FL, USA.
authors.forename: Neil
authors.initials: N
authors.lastname: Schneiderman
authors.affiliation: RAND Corporation, Santa Monica, CA, USA.
authors.forename: Glenn
authors.initials: G
authors.lastname: Wagner
authors.affiliation: Massachusetts General Hospital Center for Global Health, Boston, USA Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA Harvard Medical School, Boston, MA, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Bangsberg
authors.affiliation: University of California Los Angeles School of Dentistry, USA.
authors.forename: Honghu
authors.initials: H
authors.lastname: Liu
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D055118:Medication Adherence; D011787:Quality of Health Care
keywords: HIV; adherence; control condition; intervention; usual care