Developing core principles for sharing Information about potential intervention benefits and harms in patient information leaflets using a modified Delphi Survey

Svobodova, Martina ORCID: https://orcid.org/0000-0001-7949-4039, Hale, Rachel ORCID: https://orcid.org/0000-0003-4248-0391, Hood, Kerenza ORCID: https://orcid.org/0000-0002-5268-8631, Gillies, Katie, Bostock, Jennifer, Bower, Peter, Edwards, Adrian ORCID: https://orcid.org/0000-0002-6228-4446, Rawlinson, Sarah, Treweek, Shaun and Howick, Jeremy 2021. Developing core principles for sharing Information about potential intervention benefits and harms in patient information leaflets using a modified Delphi Survey. [Online]. OSF Preprints: OSF. Available at: https://osf.io/upnf4/

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Abstract

Patients need to be informed about potential risks of taking part in clinical trials. A problem is that there are no standards telling researchers or ethics committees how these risks need to be communicated. Our background research suggests that the way harms are communicated can actually increase the risks of the harms occurring. Over half of our sample of 250,000 patients who took placebo pills (like sugar pills) in clinical trials reported some negative side effect (like pain or nausea but also more serious things). The aim of this study is to understand what information about trial harms and benefits stakeholders consider to be important for ‘principled participant information leaflets’ or ‘PrinciPILs’ to contain. The stakeholders will include patients, ethics committee members, industry representatives, medico-legal experts, psychologists, and trial managers.

Item Type:	Website Content
Date Type:	Publication
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Uncontrolled Keywords:	clinical trial; delphi; harm; harm and benefit; patient information; patient information leaflet; patient information sheet; risk communication; survey
Publisher:	OSF
Funders:	Medical Research Council UK
Last Modified:	06 Jan 2024 02:22
URI:	https://orca.cardiff.ac.uk/id/eprint/141653

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