ABSTRACT

1. Patient Attitudes Regarding Willingness to Participate in Clinical Research: Results from the Patient Attitude Survey Study (PASS) Lala R. Hussain, Tiffany Lindman, Greg Whittington, Kendra Thompson, Kelly Carrico, Timothy L. Wiemken, and Ruth M. Carrico Division of Infectious Diseases, University of Louisville METHODS ABSTRACT RESULTS RESULTS Background: Clinical trials are the cornerstone for the development of new, effective treatments and interventions with a high level of evidence. Recruiting and retaining adequate numbers of patients in clinical studies is one of the primary challenges in clinical research. Although understanding patient attitudes regarding participation in clinical research is important, there is minimal knowledge in this area. The objective of this study was to examine patient attitudes towards participation in clinical research. METHODS: A 32-item self-administered, anonymous survey was randomly distributed to 94 participants enrolled in a multicenter prospective randomized clinical trial titled: Rapid Empiric Treatment with Oseltamivir Study (RETOS). The survey was developed addressing most relevant issues affecting patients’ willingness to participate in clinical research based on a review of the literature. These included: (1) attitudes towards clinical trials, (2) beliefs regarding healthcare professionals that conduct research, and (3) motivation for enrolling in trials. RESULTS: Completed questionnaires were returned from 36 participants. Regarding attitudes towards participating in clinical trials, 39% had positive attitude and 53% felt neutral. About 74% of respondents indicated that they trust healthcare professionals that conduct medical research. Overall, 86% of respondents strongly felt their participation would contribute to medical research, benefit future patients, and avoid delays in improving medicine. CONCLUSION: A key observation from the study suggests that an altruistic motivation for taking part in the trial was recognized by participants. Research teams trying to recruit patients for clinical research may be more successful if they consider the altruistic views of patients during the consent process. Investigators should clearly articulate the societal benefits of their research project to potential subjects. Study design:A 32-item anonymous survey was utilized to elicit attitudes regarding participating in clinical research. Each question was measured on a five-point agree-disagree scale. Major question domains included: (1) attitudes towards medical research, (2) beliefs with respect to the research personnel, and (3) motivation for enrolling in trials. • Study population: Between November 2011 and March 2012, 94 subjects enrolled in a multicenter prospective randomized clinical trial, Rapid Empiric Treatment with Oseltamivir Study (RETOS), were randomly selected to participate in PASS. • The survey was mailed to 94 subjects enrolled in RETOS. Study data was managed using REDCap electronic data capture tools hosted at University of Louisville Clinical and Translational Research Support Center.5 • Study definition: Attitude refers to a person’s thoughts and feelings towards an object or subject with a related pattern of behavior with regards to the object or subject. • Statistical Analysis: Descriptive analysis were conducted using RStudio v0.96.6,7 Responses across all questions were examined by percentages. CONCLUSIONS • Overall, patients have positive attitude toward medical research. • A key observation from the study suggests that an altruistic motivation for taking part in the trial was recognized by participants. • Research teams trying to recruit patients for clinical research may be more successful if they consider the altruistic views of patients during the consent process. • Investigators should clearly articulate the societal benefits of their research project to potential subjects. RESULTS Completed questionnaires were returned from 36 participants. Table 1 below depicts the basic demographic characteristics of the study sample. Table 1: Demographic characteristics of the study sample included in the PASS Study INTRODUCTION • The majority of advances in medicine are achieved through clinical research studies where new drugs, treatments or innovations are carefully studied on human subjects in an ethical and controlled environment. • Recruitment and retention of human subjects is critical to the outcome and success of clinical research.1 • Response rates to invitations to participate in all types of research have dramatically declined over the past decade.2 • Shortages in the number of participants involved in clinical research can result in prolonged trial duration, early termination of studies, compromised generalizability of the finings, increased cost, and delays in the development and adoption of new treatments.3,4 • Although understanding patient attitudes regarding participation in clinical research is important, there is minimal knowledge in this area. REFERENCES • Hersher, R., Clinicians call for greater transparency in trial recruitment. Nat Med, 2012. 18(2): p. 186. • Hunter, J., Corcoran, K., Appealing to Altruism is Not Enough: Motivators for Participating in Health Services Research. J Empir Res Hum Res Ethics, 2012. 7(3): p. 84-90. • Mapstone, J., D. Elbourne, and I. Roberts, Strategies to improve recruitment to research studies. Cochrane Database Syst Rev, 2007(2): p. MR000013. • Peters-Lawrence, M.H., et al., Clinical trial implementation and recruitment: Lessons learned from the early closure of a randomized clinical trial. Contemporary Clinical Trials, 2012. 33(2): p. 291-297. • Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81. • R Development Core Team (2012). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-project.org/. • Simon Urbanek and Jeffrey Horner (2011). Cairo: R graphics device using cairographics library for creating high-quality bitmap (PNG, JPEG, TIFF), vector (PDF, SVG, PostScript) and display (X11 and Win32) output.. R package version 1.5-1. http://CRAN.R-project.org/package=Cairo OBJECTIVE The objective of this study was to examine patient attitudes towards participation in clinical research.