title: Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation.
abstract: OBJECTIVE
  To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants.
  
  
  METHODS
  We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format.
  
  
  METHODS
  The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages.
  
  
  METHODS
  The primary outcome measure was reliability and validity of the questionnaire.
  
  
  RESULTS
  Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education.
  
  
  CONCLUSIONS
  We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants.
authors: Medical Research Council Unit, Fajara, The Gambia Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.
authors: Muhammed O
authors: MO
authors: Afolabi
authors: Medical Research Council Unit, Fajara, The Gambia.
authors: Kalifa
authors: K
authors: Bojang
authors: Medical Research Council Unit, Fajara, The Gambia Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.
authors: Umberto
authors: U
authors: D'Alessandro
authors: Research, Publications & Library Services, World Health Organization-Regional Office for Africa, Brazzaville, Congo.
authors: Martin O C
authors: MO
authors: Ota
authors: The Jenner Institute, University of Oxford, Oxford, UK.
authors: Egeruan B
authors: EB
authors: Imoukhuede
authors: Clinical Sciences Department, Institute of Tropical Medicine, Antwerp, Belgium Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.
authors: Raffaella
authors: R
authors: Ravinetto
authors: Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
authors: Heidi J
authors: HJ
authors: Larson
authors: Faculty of Medicine, University of Southampton, Southampton, UK.
authors: Nuala
authors: N
authors: McGrath
authors: Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.
authors: Daniel
authors: D
authors: Chandramohan
mesh_terms: D000293:Adolescent; D000328:Adult; D001296:Audiovisual Aids; D032882:Comprehension; D005260:Female; D005714:Gambia; D006801:Humans; D007258:Informed Consent; D000067010:Literacy; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Ethics (see Medical Ethics); Medical Ethics