The likelihood of participation in clinical trials can be measured: The Clinical Research Involvement Scales (CRIS)

• Type of Material: Article
• Authors: Paula M. Frew, Emory University; Su-I Hou, The University of Georgia; Marsha Davis, The University of Georgia; Kayshin Chan, Emory University; Takeia Horton, Emory University; Justin Shuster, Emory University; Brooke Hixson, Emory University; Carlos Del Rio, Emory University
• Language: English
• Date: 2010-10
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2009 Elsevier Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommerical-NoDerivs 3.0 Unported
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jclinepi.2009.12.002
• Title of Journal or Parent Work: Journal of Clinical Epidemiology
• ISSN: 0895-4356
• Volume: 63
• Issue: 10
• Start Page: 1110
• End Page: 1117
• Grant/Funding Information: Partial support was provided by the Emory Center for AIDS Research (P30 AI050409), the Emory Vaccine Center (U19 AI057266), and the Emory HIV/AIDS Clinical Trials Unit (U01 AI069418).
• Keywords: Women; African Americans; Patient Selection; HIV Vaccines; HIV Psychometrics
• Research Categories: Education, Health; Health Sciences, Epidemiology; Health Sciences, Public Health

Abstract

Objective We developed the Clinical Research Involvement Scales (CRIS) to assess clinical trial willingness-to-participate. Study Design and Setting Diverse populations (N=919) aged ≥ 18 years from Atlanta, Georgia were included in comprehensive testing of the 41-item CRIS instrument. The formative phase focused on item content for the new measures (n=54). Questionnaires from potential vaccine trial participants (n=865) collected at multiple timepoints resulted in evaluation of scale reliability and validity (i.e., attitudes, behavioral and normative beliefs, perceived social support for clinical research participation, social norm compliance, perceptions of the clinical research organization, and perceived relevance of the research endeavor). Results Qualitative testing revealed adequate comprehension and content validity of the initial item set. The subjective norms domain (n=3) initially exhibited poor internal consistency in pilot testing (Cronbach's α = 0.525), yet rewording of the items resulted in consistently stable measurement improvement (Cronbach's α = 0.850). Each of the CRIS subscales demonstrated extremely high reliability, ranging from 0.734 – 0.918. Confirmatory factor analysis verified item-factor relationships and determined construct and convergent validity (RMSEA=.068; CFI=0.835). Conclusions CRIS is a reliable instrument for measuring community attitudes toward participation in biomedical research studies. Results of this study support the use of these scales to recruit diverse populations to clinical trials.