The likelihood of participation in clinical trials can be measured: the Clinical Research Involvement Scales

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 itemfactor 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.

Time will tell: community acceptability of HIV vaccine research before and after the “Step Study” vaccine discontinuation

“…Reliabilities for the scales for each population were moderately high to very strong, with Cronbach’s α values of 0.740–0.910, close to internal consistency values obtained with similar populations 16,17,28. The values for each scale were “Attitudes” (α = 0.740), “Behavioral Beliefs” (α = 0.849), “Outcome Evaluation” (α = 0.822), “Organizational Involvement” (α = 0.811), and “Social Activism Congruence” (α =0.910).…”

“…The instrument contained additional psychosocial measures from a modified theory of reasoned action, including behavioral beliefs, attitudes, outcome evaluation (eg, perceived risk of study participation and product safety concerns), organizational involvement, normative influences including perceived social stigma, and social activism congruence with the HIV vaccine research cause 17,28,29. Each item on the scale was rated by the study participants on a Likert scale of 1–5, with 1 representing strong agreement and 5 indicating strong disagreement.…”

Venue-Based Recruitment of Women at Elevated Risk for HIV: An HIV Prevention Trials Network Study

“…[46][47][48][49][50] Community partnerships were necessary, not only to identify study communities and venues, but also to establish and maintain the trust of venue owners, management, and potential participants, and also to reduce other structural barriers, such as access to transportation to clinical research sites. It is likely that the substantial ongoing community collaborations, as evidenced by establishment of local community advisory boards and working groups, frequenting of local businesses, and volunteering at community events, was responsible for rapid recruitment and successful identification of a cohort of women at heightened risk for HIV.…”

Exception from informed consent for emergency research

“…In addition to collecting demographic data, participants were asked about their experiences with clinical research, the importance of emergency research, opinions about consent, reason for hospital admission, and exposure to life-threatening trauma requiring blood transfusion. Using a modified version of the Clinical Research Involvement Scales, 19 participants were asked rank statements regarding EFIC in the context of the AVERT Shock Trial and their general willingness to participate in emergency research using a 5-point Likert-type scale (1 = strongly disagree to 5 = strongly agree). Four questions investigated attitudes regarding EFIC and 21 assessed willingness to participate in emergency research.…”