Previous research found that information about trial benefits and harms within patient information leaflets (PILs) varies widely. Information is often presented in a way that patients neither understand nor want and can even cause 'information induced' harm. In addition, there is currently no guidance for trial investigators informing them how to present information about benefits and harms in a balanced way. This creates confusion and wasted resources, as each trial PI has to spend time deciding how to present information about trial benefits and harms. The primary aim of our project is to overcome these problems.
The main objective is to develop and test 'PrinciPILs', which are PILs that present information about trial participation harms and benefits in a balanced, ethical, and patient- and stakeholder-informed way. Our systematic review found that 'information induced harm' is more common in the following clinical areas: cancer, musculoskeletal conditions and mental and behavioural disorders, and our research will target trials of treatment of these conditions.
Objectives will be achieved in 5 steps:
- Identify stakeholder (patients, research ethics committee members, clinicians, senior trial managers, etc.) views on necessary and potentially harmful information provided to patients to seek consent to participate in trials.
- Identify principles that emerge from (1) to guide PrinciPIL design.
- Develop PrinciPILs for five host trials.
- Embed Studies Within a Trial (SWATs) of PrinciPILs: Measure preliminary effects of PrinciPILs (change in adverse events, recruitment and retention rates), and evaluate process of embedding SWATs of PrinciPILs. We will set up an infrastructure for testing future PrinciPILs within trials of other disease areas.
- Develop and disseminate guidance explaining how to generate PrinciPILs and test PrinciPILs within SWATs
Katie Gillies; firstname.lastname@example.org
Shaun Treweek; email@example.com