Co-production of guidance and resources to implement principled participant information leaflets (PrinciPILs).

Background

The way information about potential benefits and harms of trial is presented within participant information leaflets (PILs) varies widely and may cause unnecessary 'nocebo' effects. The Medical Research Council (MRC) funded a project that developed seven principles to reduce this variation. However, guidance has not been produced to facilitate the implementation of the principles. Stakeholder involvement is recommended to optimise the way these principles are disseminated and explained. To co-produce recommendations for developing: (1) user-friendly guidance for users of the principles; and (2) resources that support the implementation of the principles.

Methods

We held a co-production workshop with representation from the following professional groups: the Health Research Authority (HRA), research ethics committee members, and trial managers. Two rounds of discussions focused on generating recommendations for guidance and resources that support the implementation of the seven principles. Extensive low inference style ethnographic notes were taken, and the data were analysed thematically using deductive codes. The data was collected on October 14, 2022.

Results

25 participants attended a hybrid workshop. Participants recommended that both researchers designing PILs and research ethics committee members should use the principles, and that that they should be simple, mention both benefits and harms explicitly, include examples of visual representations, and provide the evidence base for the principles.

Conclusions

We were able to co-produce recommendations for developing and implementing the seven principles within PILs. These recommendations can now be implemented to reduce unexplained variation in the way potential benefits and harms are shared within PILs.

Trial participants need to know about the potential benefits and harms of trial interventions to make an informed decision about whether to take part in a clinical trial. Yet the way they are told about these benefits and harms varies widely. We developed seven principles that can reduced this variability. We held a workshop with members of ethics committees and other stakeholders to develop the best way to implement the principles. 25 participants attended the workshop, and we were able to make useful recommendations that will improve the way trial participants are told about risks and benefits of trial treatments.

Informations de copyright

Copyright: © 2023 Jacob N et al.

Déclaration de conflit d'intérêts

No competing interests were disclosed.