Table 2 Operational Definitions

Operational definitions

Comprehension Level: the level of participant understanding and recall of the information they were given through the consent document. Assessment is based on the Comprehension Test administered two weeks into the study. Comprehension was categorized into three levels [high :75 % or greater; medium: between 50 % and 75 %; low: 50 % or less ] adapted from earlier studies [3]. Its components included Recall and Understanding.

Recall: success in selecting or remembering the correct statement

Understanding: correctness of interpretations of statements presented

Study Recruitment rate: Recruitment rate is the proportion (percentage) of participants who voluntarily decide to participate in the study out of those who were approached to take part.

Study Compliance (or Retention) rate: Measures compliance to follow-up and appointments as directed in the visit before. Compliance rate refers to the proportion (percentage) of participant that attended their appointment at the specified time divided by the number of participants who were given an appointment and agreed to come.

Quality of informed consent process assessment: a measure of the quality of consent process concerning information adequacy, participant perception and satisfaction of the process, and the situation of decision making during the recruitment process. Scoring levels were the same as for comprehension.