Evaluation of an audio-visual informed consent procedure in a diagnostic tuberculosis trial

Evaluation of an audio-visual informed consent procedure in a diagnostic tuberculosis trial
Luis Gómez Paciello, Floryn Schippers, Ana Aguiar, Cecile Magis
European Respiratory Journal, January 2023
Abstract
Background
In line with the End Tuberculosis (TB) Strategy of the World Health Organization a diagnostic study, PriNose NCT0440732, has started in Paraguayan prisons. Due to high illiteracy among persons deprived of liberty (PDL) and low educational attainment, an audio-visual message was developed and incorporated in the informed consent (IC) procedure. The aim of this study is evaluating the experience and thoughts on the IC procedure in a vulnerable population from multiple viewpoints.
Objectives
Evaluation of the participants’ thoughts and experience on the IC procedure. 2. Evaluation of the user experience of the IC procedure.
Methods
Inclusion strategy: convenience sampling by face-to-face request, directly after completion of the IC procedure of the PriNose study. Separate written ICs were obtained. Semi-structured interview guides with 11 integrated true/false questions and Likert scales were used for in depth face-to-face interviews with respectively the PDL and the volunteers, lasting on average 22 minutes. Cyclic thematic inductive analysis with open and axial coding of data in ATLAS.ti v.22 followed.
Results
A total of 22 PDL and 4 volunteers, (Males; mean age: 31.8 years (Sd: 11.8)), were included from penitentiary institution ‘Emboscada’. Preliminary data analysis presented 3 main themes: improving disease knowledge, importance of selfcare in relation to health and level of information comprehension. Final analysis and interpretation will follow soon.