Abstract:
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 testretest 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 openended 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.