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Table 3 Feedback from workshop

From: Formalising the induction of patient and public involvement contributors on trial oversight committees

To Improve To Include To Consider
Terminology
•Use “plain English” not “lay language”
•Provide definitions of key terms
•Make language used more consistent throughout (e.g. standard of care vs current treatment)
Additional Sections
•Glossary/jargon buster
•Signposting for further information (in person or via additional resources)
•Supporting/encouraging the distribution of results and implementation into standard practice where possible
•Advice on getting your voice heard in meetings/teleconferences
•Implications of committee membership on personal benefits/taxes (in relation to honorariums)
•Encouragement to bring other skills to the group rather than “just” a PPI Contributor
•Breakdown of the individual members of
the committees and whether they’re independent or not
•Duration of the committee membership, anticipated workload & how to leave the committee
•Access to the protocol and PIS/ICF
•Information on what research or trials will have been conducted in the lead up to this study
•Why PPI is important
•Confidentiality and how to deal with the media
Terminology
•"Patient Representative” is an inappropriate title for some situations (e.g. people with HIV or parents/carers of children)
•Clarification of the meaning of “involvement” and “engagement”
Formatting
•Ensure consistency of visual style
•Re-ordering of the sections: introduction to trials, then the CTU, then trial specific information
Pre-Requisites
•Does the CTU require PPI Contributors to have GCP training?
•Indemnity insurance - are PPI Contributors covered by the CTU’s policies?
Language Choices
•Give clearer description of remit of this role to reduce uncertainty (e.g. remove “not expected to … “)
•Sentence length is too long for plain English in some sections
•Academic language is still used throughout - needs to be simplified
Layout
•"Pick and Mix” design where trial teams can choose which sections to include
•Highlight “essential” and “optional” sections
Existing Sections
•Detail the additional visit/testing burden on participants on the study compared to standard of care
•Give more details of the aims and objectives of the study under consideration in the trial specific section
•Provide links to existing documents and resources rather than creating new material
•Include examples of the tasks PPI Contributors may be asked to participate in
•Clarify which committees see raw data broken down by treatment group
Future Additional Resources
•Trial-specific guidance on the role and remit of each committee, to be agreed by all members of the committee to ensure consistency throughout the CTU
•Future iterations to include multimedia to make the document more accessible (e.g. to those with visual impairments)
•Implementation of a “Scientific Mentor” role to provide ongoing support regarding clinical aspects of the study
•Similar induction pack to be created for researchers to assist them in supporting their PPI Contributors
•Guidance for pre-trial groups such as protocol review boards
Clarification
•Differentiation between the role and remit of each oversight committee
•Whether PPI Contributors have voting rights and how they are weighted compared to the other members
•Involvement outside of the committee: may be asked to attend conferences to discuss the study
•Whether Contributors can join multiple committees
General
•Advise trial teams that a member of the PPI Group reviews the document completed by the Study Team before it’s distributed to PPI Contributors
•Make it clear to investigators that the acceptable levels of risk taken by patients will vary from group to group
•Emphasise that the PPI Contributor’s role is to focus on patient safety and wellbeing
•Highlight that the role may adapt and change over time as the study progresses
•Integrate the NIHR National Standards for PPI
Format
•Bullet points make the text easy to read
•It is good to have clear sections marked for trial teams to add in specific data to personalise the pack
•Keep the pack as short as possible to avoid overwhelming but provide signposting to additional resources