Assessing Usual Care in Clinical Trials
Year: 2014
Type: article
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.
Institutions: University of Pittsburgh, Yale University, University of North Carolina at Chapel Hill, Columbia University, University of Missouri–Kansas City, University of Miami, RAND Corporation, Harvard University, Ragon Institute of MGH, MIT and Harvard, Massachusetts General Hospital, University of California, Los Angeles
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: green
Awards: G1033683653, G1469232840, BEHAVIORAL MANAGEMENT AND STRESS RESPONSES IN HIV/AIDS, G185513119, G2046965509, HIV THERAPY ADHERENCE AND VIRAL RESISTANCE IN DRUG USERS, Contingent Reinforcement of Compliance in Drug Users, G2851072695, Cornell Clinical Trials Unit, Peer & Pager Support to Enhance Antiretroviral Adherence, ADHERENCE TO HAART AMONG INCARCERATED SUBSTANCE USERS, Novel approaches to monitoring and utilizing adherence to HIV therapy in Africa, ADHERENCE TO PROTEASE INHIBITORS IN HIV, ADULT ACTG CENTRAL GROUP, Understanding and Improving Adherence in HIV Disease, SERODISCORDANT COUPLES, MEDICAL ADHERENCE AND HIV RISK, HIV PROTEASE INHIBITOR RESISTANCE AND ADHERENCE, Improving Adherence to Antiretroviral Therapy, ADHERENCE TO ANTIRETROVIRAL THERAPY: A CONTROLLED TRIAL, G749807406, A TRAINING INTERVENTION TO ENHANCE ADHERENCE TO HAART, G7622767975, ART Adherence: Observed Therapy and Enhanced Counseling, Behavioral Interventions for the Dually Diagnosed, G9000023130, G9000277732, Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials Unit, The University of North Carolina Center for AIDS Research, HIV Center for Clinical and Behavioral Studies, Multi-Site Collaborative Study for Adherence Virologic and Clinical Outcomes
OpenAlex ID: W2143174274