PrinciPIL
Research type
Research Study
Full title
PrinciPIL: Developing Core Principles for Sharing Information about Potential Intervention Benefits and Harms in Patient Information Leaflets
IRAS ID
305945
Contact name
Jeremy Howick
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Presentation of potential trial participation harms and benefits in patient information leaflets (PILs) varies, with trial benefits sometimes not being mentioned. This can cause information-induced adverse events (‘nocebo effects’). Because guidance regarding the best way to present potential trial participation benefits and harms does not exist, scarce resources are also wasted, with every PI having to negotiate their own method (reinventing the wheel). We propose to develop and test a method for presenting information about potential trial benefits and harms that considers patient, doctor and research ethics committee member views. We have undertaken a survey with stakeholders including patients, research ethics committee members, clinicians, medico-legal experts, regulators, and clinical trial managers to understand their views about how the information about trial participation harms and benefits should be communicated. Using the principles identified in the survey, we will design patient information leaflets (PILs) for five trials. We will call these ‘PrinciPILs’. We will test these PrinciPILs to see whether they reduce side effects. Using the Study within a TRial methodology (SWAT), we will compare PrinciPILs with standard PILs in 5 host trials. We will test whether patients exposed to PrinciPILs had fewer negative side effects.The main outputs from our study will be a report on effects of using PrinciPILs and guidelines designing them. We also expect our findings will be useful outside trials and in clinical practice, where clinicians also need to present information about harms and benefits of interventions to patients.
PrinciPILs will be valuable even if they do not reduce information induced adverse events. This is because PrinciPILs will be generated using the transparent methodology described above, whereas currently the way in which trial benefits and harms are presented in PILs is more ad hoc, dependent on the trial team, and not based on an agreed ethical rationale.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0040
Date of REC Opinion
21 Feb 2022
REC opinion
Further Information Favourable Opinion