Developing principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey.

ABSTRACT:

Background

The way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and can cause subjective 'nocebo' harms. This study aimed to develop principles to improve the composition of information about potential trial intervention benefits and harms within PILs so that variability and avoidable harms are reduced.

Methods

We conducted a two-round modified online Delphi survey, followed by a consensus meeting. For the first round of the survey, 27 statements were developed based on previous research and relevant guidance from the UK, the USA and the World Health Organization. Participants included members from each of the following stakeholder groups: patient and public representatives, research ethics com

SUBMITTER: Svobodova M 

PROVIDER: S-EPMC9548137 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature