Translating the consent form is the tip of the iceberg: using cognitive interviews to assess the barriers to informed consent in South African health facilities

The increasing digitisation of personal health data has led to an increase in the demand for onward health data. This study sought to develop local language scripts for use in public sector maternity clinics to capture informed consent for onward health data use. The script considered five possible health data uses: 1. Sending of general health information content via mobile phones; 2. Delivery of personalised health information via mobile phones; 3. Use of women's anonymised health data; 4. Use of child's anonymised health data; and 5. Use of data for recontact. Qualitative interviews (n = 54) were conducted among women attending maternity services in three public health facilities in Gauteng and Western Cape, South Africa. Using cognitive interviewing techniques, interviews sought to:(1) explore understanding of the consent script in five South African languages, (2) assess women's understanding of what they were consenting to, and (3) improve the consent script. Multiple rounds of interviews were conducted, each followed by revisions to the consent script, until saturation was reached, and no additional cognitive failures identified. Cognitive failures were a result of: (1) words and phrases that did not translate easily in some languages, (2) cognitive mismatches that arose as a result of different world views and contexts, (3) linguistic gaps, and (4) asymmetrical power relations that influence how consent is understood and interpreted. Study activities resulted in the development of an informed consent script for onward health data use in five South African languages for use in maternity clinics. In the wake of growing digitisation of personal health data, greater scrutiny is needed on the language of informed consent and the processes for soliciting consent in health care facilities. Qualitative interviews using cognitive interviewing techniques were used to develop and refine consent language in English, Sesotho, isiXhosa, isiZulu and Setswana for the onward use of health data among maternity clients in public sector primary health clinics in the Western Cape and Gauteng provinces of South Africa. We found that translation in local languages and addressing individual words and phrases was only one barrier to requesting informed consent. Other barriers were cognitive mismatches between the question intent and how women understood the question, linguistic gaps that were linked to language and identity, and power dynamics that affected how women understood the consent script. Emerging language scripts used "/" to present words in multiple languages; a reflection of the multi-linguistic nature of communities in this context. La numerisation croissante des donnees personnelles de sante a entraine une augmentation de la demande de donnees sanitaires en aval. Cette etude visait a elaborer des scripts en langue locale a utiliser dans les maternites du secteur public afin de recueillir le consentement eclaire pour l'emploi ulterieur des donnees de sante. Le script envisageait cinq utilisations possibles des donnees de sante: 1. envoi de contenus d'informations sanitaires generales au moyen de telephones portables; 2. transmission d'informations sanitaires personnalisees au moyen de telephones portables; 3. utilisation des donnees de sante anonymisees des femmes; 4. utilisation des donnees de sante anonymisees des enfants; et 5. utilisation des donnees en vue de recontacter les patientes. Des entretiens qualitatifs (n = 54) ont ete menes aupres de femmes frequentant les services de maternite dans trois etablissements de sante publique du Gauteng et du Cap-Occidental, en Afrique du Sud. A l'aide de techniques d'entretien cognitif, les entretiens souhaitaient: (1) explorer la comprehension du script recueillant le consentement dans cinq langues sud-africaines, (2) evaluer la comprehension par les femmes de ce a quoi elles consentaient, et (3) ameliorer le script sur le consentement. Plusieurs series d'entretiens ont ete realisees, chacune suivie de revisions du script sur le consentement, jusqu'a ce que la saturation soit atteinte et qu'aucun echec cognitif supplementaire ne soit identifie. Les echecs cognitifs etaient le resultat: (1) de mots et d'expressions qui ne se traduisaient pas facilement dans certaines langues, (2) d'inadequations cognitives causees par differentes visions du monde et differents contextes, (3) de lacunes linguistiques, et (4) de rapports de pouvoir asymetriques qui influencent la maniere dont le consentement est compris et interprete. Les activites de l'etude ont permis de mettre au point un script de recueil du consentement eclaire pour l'emploi ulterieur des donnees sanitaires dans cinq langues sud-africaines a utiliser dans les maternites. La creciente digitalizacion de datos de salud personales ha causado un aumento de la demanda de datos de salud posterior. Este estudio buscaba elaborar un guion de terminologia local para uso en centros de maternidad del sector publico, con el fin de capturar consentimiento informado para el uso de datos de salud posterior. El guion considero cinco posibles usos de datos de salud: 1. Envio de informacion de salud general via telefonos moviles; 2. Entrega de informacion de salud personalizada via telefonos moviles; 3. Uso de datos de salud de mujeres anonimizados; 4. Uso de datos de salud de ninos anonimizados; y 5. Uso de datos para recontacto. Se realizaron entrevistas cualitativas (n = 54) con mujeres que asistieron a servicios de maternidad en tres establecimientos de salud publica en Gauteng y Cabo Occidental, Sudafrica. Utilizando tecnicas de entrevistas cognitivas, las entrevistas buscaban: (1) explorar la comprension del guion de consentimiento en cinco idiomas sudafricanos, (2) evaluar la comprension de las mujeres de lo que estaban consintiendo, y (3) mejorar el guion de consentimiento. Se realizaron multiples rondas de entrevistas, cada una seguida de modificaciones al guion de consentimiento, hasta alcanzar saturacion y no identificar fracasos cognitivos adicionales. Los fracasos cognitivos fueron el resultado de: (1) palabras y frases que no se traducian con facilidad a ciertos idiomas, (2) discordancias cognitivas que surgieron a causa de diferentes cosmovisiones y contextos, (3) brechas linguisticas y (4) relaciones de poder asimetrico que influyen en las maneras de entender e interpretar el consentimiento. Las actividades del estudio produjeron un guion de consentimiento informado para el uso de datos de salud posterior en cinco idiomas sudafricanos para uso en centros de maternidad.