Preliminary development of a questionnaire measuring patient views of participation in clinical trials.

Journal: BMC research notes

Volume: 12

Issue: 1

Year of Publication: 2020

Affiliated Institutions:  Department of Family Medicine, Michigan State University College of Human Medicine, Michigan Street NE, Grand Rapids, MI, , USA. arnetzju@msu.edu. Department of Family Medicine, Michigan State University College of Human Medicine, Michigan Street NE, Grand Rapids, MI, , USA. Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI, USA. Department of Psychiatry, Wayne State University School of Medicine, Detroit, MI, USA. Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, MI, USA.

Abstract summary 

This study aimed to develop a questionnaire for measuring patient perceptions of participating in clinical trials. Development was based on earlier research on patient views of involvement in medical care and a literature review. Patients were recruited from an ongoing clinical trial focused on cardiovascular illness and from an outpatient psychiatry department. Factor analysis was conducted on a pilot version of the questionnaire in 2016 and on a revised version in 2017.A total of 53 patients were recruited for the pilot study and 55 were recruited for the main study, substantially below the goal of 100 participants. Factor analysis revealed six factors measuring aspects of patients' perceptions of participating in clinical trials, including motivation, risks and benefits, the nature of the trial itself, and practical considerations, such as cost and convenience. Inter-scale correlations ranged between 0.06 and 0.64, indicating acceptable scale independence. Reliability scores (Cronbach's alphas) ranged from 0.62 to 0.85. Factor analysis results were somewhat unstable, with shared variance for several items across scales. This is likely due to the small sample sizes. In larger, more diverse patient samples, this questionnaire can be useful for measuring and incorporating patients' views into the design and execution of clinical trials.

Authors & Co-authors:  Arnetz Judith J Sudan Sukhesh S Goetz Courtney C Arnetz Bengt B Gowland Laura L Manji Suzanne S Ghosh Samiran S

Study Outcome 

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Statistics
Citations :  Allison M. Can web 2.0 reboot clinical trials? Nat Biotechnol. 2009;27(10):895–902. doi: 10.1038/nbt1009-895.
Authors :  7
Identifiers
Doi : 667
SSN : 1756-0500
Study Population
Male,Female
Mesh Terms
Cardiovascular Diseases
Other Terms
Clinical trials;Factor analysis;Patients;Psychometric evaluation;Questionnaire
Study Design
Study Approach
Country of Study
Publication Country
England