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

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: 1. 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 fo...
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Ethics and economics Source Type: research