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Development and Preliminary Testing of the Perceived Benefit and Burden Scales for Cancer Clinical Trial Participation

Development and Preliminary Testing of the Perceived Benefit and Burden Scales for Cancer... We developed measures of benefits and burdens of research participation in cancer clinical trials using a sequential mixed methods design with a qualitative (n = 32) and quantitative sample (n = 110) of cancer clinical trial participants. Benefit–burden items (22 for benefits, 23 for burdens) were subsequently developed and assessed through cognitive interviewing for content, clarity, and meaning. Preliminary psychometric analyses support the internal consistency reliability and construct validity of Benefit (α = .90) and Burden (α = .87) research participation scales. Item response theory models supported the discrimination ability of the items on the scales. Participants who had thoughts of dropping out had lower Benefit scale scores (p < .001) and higher Burden scores (p < .001) than those who had no thoughts of dropping out, supporting construct validity. With further psychometric testing, the scale can be used to develop appropriate interventions to address recruitment and retention of human participants in clinical research. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Empirical Research on Human Research Ethics SAGE

Development and Preliminary Testing of the Perceived Benefit and Burden Scales for Cancer Clinical Trial Participation

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Publisher
SAGE
Copyright
© The Author(s) 2018
ISSN
1556-2646
eISSN
1556-2654
DOI
10.1177/1556264618764730
Publisher site
See Article on Publisher Site

Abstract

We developed measures of benefits and burdens of research participation in cancer clinical trials using a sequential mixed methods design with a qualitative (n = 32) and quantitative sample (n = 110) of cancer clinical trial participants. Benefit–burden items (22 for benefits, 23 for burdens) were subsequently developed and assessed through cognitive interviewing for content, clarity, and meaning. Preliminary psychometric analyses support the internal consistency reliability and construct validity of Benefit (α = .90) and Burden (α = .87) research participation scales. Item response theory models supported the discrimination ability of the items on the scales. Participants who had thoughts of dropping out had lower Benefit scale scores (p < .001) and higher Burden scores (p < .001) than those who had no thoughts of dropping out, supporting construct validity. With further psychometric testing, the scale can be used to develop appropriate interventions to address recruitment and retention of human participants in clinical research.

Journal

Journal of Empirical Research on Human Research EthicsSAGE

Published: Jul 1, 2018

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