Afolabi Muhammed Olanrewaju, Rennie Stuart, Hallfors Denise Dion, Kline Tracy, Zeitz Susannah, Odongo Frederick S, Amek Nyaguara O, Luseno Winnie K
Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.
Department of Social Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
BMJ Open. 2018 Jul 12;8(7):e021613. doi: 10.1136/bmjopen-2018-021613.
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.
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.
The questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya.
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.
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.
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.
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.
对最初在研究环境中开发的一份问卷进行改编和验证，以用于在不同文化和语言的研究环境中评估对同意信息的理解。
改编过程包括为三个研究组分别开发和定制一份问卷，该问卷紧密仿照先前经过验证的问卷。两位生物伦理学家和原始问卷的开发者对三份改编后的问卷初稿进行了进一步审查，以评估其表面效度和内容效度。随后，将修订后的问卷编程为音频计算机格式，并由研究参与者翻译成三种广泛使用的语言：卢奥语、斯瓦希里语和英语，然后再进行回译。
该问卷在肯尼亚西部农村地区锡亚县的青少年、他们的父母和年轻人中进行了验证。
向235名参与者发放了由封闭式、多项选择题和开放式问题组成的25项改编问卷，其中包括107名青少年、92名父母和36名年轻人。在首次发放问卷2至4周后，对74名青少年、年轻人和父母进行了重测。
主要结果测量包括上限/下限分析，以识别回答极端的问题，以及项目层面的相关性，以确定重测关系。鉴于数据格式，对二分法项目进行四分相关分析，对有序项目进行多分相关分析。定性验证评估包括由技术专家对改编后的工具进行表面效度和内容效度评估。
上限/下限分析显示，有8个问题项目，一个或多个组中超过80%的人回答正确；而对于9个问题，包括所有7个开放式问题，回答正确的比例不到20%。大多数问题项目的重测相关性估计为中度到强，表明具有时间稳定性。
我们的研究表明，对知情同意理解问卷进行跨文化改编和验证是可行的。然而，需要进一步研究来开发一种工具，该工具可以估计可量化的理解阈值，从而作为需要采取干预措施来提高理解的客观指标。
