An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT).

ABSTRACT:

Background

It is the investigator's responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that participants often have a poor understanding of the concepts which are key to ensuring valid informed consent, such as randomisation and risks/discomforts. Paper-based participant information leaflets and informed consent forms (PIL/ICFs) are becoming longer and are often too complex for many participants. Multimedia interventions and enhanced PIL/ICFs have been trialled in an attempt to improve participants' understanding of various aspects of research studies. However, there is insufficient empirical evidence to determine how effective such interventions are. This proto

SUBMITTER: O'Sullivan L 

PROVIDER: S-EPMC8762861 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature