Sponsor
This research was supported by the multi-site adherence collaboration in HIV (MACH14) grant R01MH078773 from the National Institute of Mental Health (NIMH), Office on AIDS. The original grants of individual participating studies are: R01DA11869, MH54907, 2R01NR04749, R01NR04749, MH68197, R01 DA13826, K23MH01862, MH01584, R01 AI41413, R01 MH61173, NIH/ NIAID AI38858, AI069419, K02 DA017277, R01DA15215, NIMH P01 MH49548, MH58986, RO1MH61695, CC99-SD003, CC02-SD-003 and R01DA015679.
Document Type
Post-Print
Publication Date
3-2015
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.
DOI
10.1177/0193945914526001
Persistent Identifier
http://archives.pdx.edu/ds/psu/18446
Citation Details
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
Included in
Clinical Trials Commons, Immune System Diseases Commons, Infectious Disease Commons, Virus Diseases Commons
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.