Objective To adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting.
Design The adaptation process involved development and customisation of a questionnaire for each of the three study groups, modelled closely on the previously validated questionnaire. The three adapted draft questionnaires were further reviewed by two bioethicists and the developer of the original questionnaire for face and content validity. The revised questionnaire was subsequently programmed into an audio computerised format, with translations and back translations in three widely spoken languages by the study participants: Luo, Swahili and English.
Setting The questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya.
Participants Twenty-five-item adapted questionnaires consisting of close-ended, multiple-choice and open-ended questions were administered to 235 participants consisting of 107 adolescents, 92 parents and 36 young adults. Test-retest was conducted 2–4 weeks after first questionnaire administration among 74 adolescents, young adults and parents.
Outcome measure Primary outcome measures included ceiling/floor analysis to identify questions with extremes in responses and item-level correlation to determine the test-retest relationships. Given the data format, tetrachoric correlations were conducted for dichotomous items and polychoric correlations for ordinal items. The qualitative validation assessment included face and content validity evaluation of the adapted instrument by technical experts.
Results Ceiling/floor analysis showed eight question items for which >80% of one or more groups responded correctly, while for nine questions, including all seven open-ended questions,<20% responded correctly. Majority of the question items had moderate to strong test-retest correlation estimates indicating temporal stability.
Conclusions Our study demonstrates that cross-cultural adaptation and validation of an informed consent comprehension questionnaire is feasible. However, further research is needed to develop a tool which can estimate a quantifiable threshold of comprehension thereby serving as an objective indicator of the need for interventions to improve comprehension.
- informed consent
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Contributors Design of study: WKL, DDH and MOA; drafting and reviewing questionnaires: DDH, WKL, MOA and SR; acquiring data: WKL, FSO and NOA; analysing data: TK, SZ, DDH, WKL and MOA; writing the manuscript: MOA, SR, DDH, WKL, TK, SZ and NOA.
Funding The research reported in this publication was sponsored by the National Institute of Mental Health and National Institute of Allergy and Infectious Diseases of the National Institutes of Health Under Award Number R01MH102125 (Winfred (Winnie) Luseno, Principal Investigator)
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethical approval was obtained from the Institutional Review Boards of the Pacific Institute for Research and Evaluation (PIRE), USA (IRBNet ID: 601736, Project Code: 0744), and Kenya Medical Research Institute (KEMRI; SSC Protocol No. 2982).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Exclusive use of the data will be maintained by the Principal Investigator (PI), WKL, until the publication of major outputs. Thereafter, following approvals by the institutional review boards of PIRE and KEMRI, deidentified data will made available to the scientific community through requests made to the PI at firstname.lastname@example.org.
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