Journal of Clinical Epidemiology
Volume 63, Issue 10 , Pages 1110-1117, October 2010

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

  • Paula M. Frew

      Affiliations

    • Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, USA
    • Emory Center for AIDS Research, Atlanta, GA, USA
    • The Hope Clinic of the Emory Vaccine Center, Decatur, GA, USA
    • Department of Behavioral Sciences and Health Education and the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA
    • Corresponding Author InformationCorresponding author. The Department of Medicine, Division of Infectious Disease, The Hope Clinic of the Emory Vaccine Center, 603 Church Street, Decatur, GA 30030, USA. Tel.: 404-712-8546; fax: 404-712-9017.
    • ,
  • Su-I. Hou

      Affiliations

    • Department of Health Promotion and Behavior, College of Public Health, The University of Georgia, Athens, GA, USA
    • ,
  • Marsha Davis

      Affiliations

    • Department of Health Promotion and Behavior, College of Public Health, The University of Georgia, Athens, GA, USA
    • ,
  • Kayshin Chan

      Affiliations

    • The Hope Clinic of the Emory Vaccine Center, Decatur, GA, USA
    • ,
  • Takeia Horton

      Affiliations

    • The Hope Clinic of the Emory Vaccine Center, Decatur, GA, USA
    • ,
  • Justin Shuster

      Affiliations

    • The Hope Clinic of the Emory Vaccine Center, Decatur, GA, USA
    • ,
  • Brooke Hixson

      Affiliations

    • The Hope Clinic of the Emory Vaccine Center, Decatur, GA, USA
    • ,
  • Carlos del Rio

      Affiliations

    • Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, USA
    • Emory Center for AIDS Research, Atlanta, GA, USA
    • The Hope Clinic of the Emory Vaccine Center, Decatur, GA, USA
    • Department of Behavioral Sciences and Health Education and the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA

Accepted 20 December 2009. published online 22 March 2010.

Abstract 

Objective

We developed the Clinical Research Involvement Scales (CRIS) to assess the willingness to participate in a clinical trial.

Study Design and Setting

Diverse populations (N=919) aged 18 years or older 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 time points, resulted in the 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 to 0.918. Confirmatory factor analysis verified item–factor relationships and determined construct and convergent validity (root mean square error of approximation=0.068; comparative fit index=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.

Keywords: HIV, psychometrics, HIV vaccines, Patient selection, African Americans, Women, Recruitment

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 Sources of support: 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).

PII: S0895-4356(09)00387-4

doi:10.1016/j.jclinepi.2009.12.002

Journal of Clinical Epidemiology
Volume 63, Issue 10 , Pages 1110-1117, October 2010

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