An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study

Abstract

ObjectiveTo 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.DesignThe 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.SettingThe questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya.ParticipantsTwenty-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 measurePrimary 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.ResultsCeiling/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.ConclusionsOur 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.

Do Our Patients Read Informed Consent Forms?

“…Thus, in future studies, tools such as the Digitised Informed Consent Comprehension Form should be used to measure patient understanding. 7 Agre and Rapkin investigated the effect of informed consent tools, including written and online materials, videos, and booklets, on patient understanding of informed consent. 2 They found that the provision of different media tools did not result in higher patient information status than that of patients informed using routine written tools.…”

Reliability and validity of ICU nurses' knowledge-attitude-practice scale for post-ICU syndrome in critically ill patients

“…Reliability means that the measurement tool re ects the consistency and stability of the measurement results, and the Cronbach's alpha coe cient and the split-half reliability (0.7-0.9) re ect the internal consistency of the questionnaire [18] . Test-retest reliability (> 0.8) re ects the stability of the questionnaire [19] . The Cronbach's alpha coe cients of this questionnaire and each dimension were 0.948, 0.976, 0.966, 0.910, and the split-half reliability was 0.951, indicating that the questionnaire had a good degree of consistency.…”

Development and initial psychometric testing of a scale for ICU nurses' knowledge, belief, and behavior in critically ill patients with post-ICU syndrome

“…Reliability means that the measurement tool re ects the consistency and stability of the measurement results, and the Cronbach's alpha coe cient and the split-half reliability (0.7-0.9) re ect the internal consistency of the scale [18] . retest reliability (> 0.8) re ects the stability of the scale [19] . The Cronbach's alpha coe cients of this scale and each dimension were 0.948, 0.976, 0.966, 0.910, and the split-half reliability was 0.951, indicating that the scale had a good degree of consistency.…”