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Table 1 The guidance for reporting involvement of patients and the public (GRIPP2-short form) checklist

From: Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study

Section and topic

Item

Reported on page no

Aims

This study sought to develop international consensus on a core outcome set for informed consent for therapy for adults over 18 years with capacity to consent for themselves

3–4

Methods

An experienced patient partner was recruited to the research team from the SEHSCT Research & development department. They served to ensure patient involvement throughout the COS development process. They were involved in refining the research questions and helped draft the PPI strategy which was built into the study ethical approval. This facilitated the SAG to budget for specific elements of COS development and make decisions regarding PPI involvement at each stage

5–13

Study results

PPI contributed to the study in numerous ways, including; The patient partner provided feedback on the initial findings from our systematic review [27] of patient experiences which helped to define a long list of outcomes to be brought forward to the semi-structured interview stage of the COS. They provided lay feedback on the generation and wording of the Delphi Survey questions. Additionally, expert patient opinion was sought from the COMET PoPPIE group for feedback on patient engagement summary videos prior to release. Outcomes from the Delphi that were brought forward to consensus were discussed with the Royal college of surgeons of England Patient liaison group of patient experts

14–22

Discussion and conclusion

At all stages we were open minded to the lay perspective. The role of patient during the semi-structured interviews was not simply to reflect the long list of items generated from systematic reviews. At each stage considerable time was taken by the SAG to reflect on the patient perspective. The time taken in developing the long list minimised ambiguity or queries during later stages of the process

21–23

Reflection/critical perspective

The PPI in this mixed method study was considered and integrated as far as possible into the methods from the very beginning according to best available evidence from the COMET initiative. In the absence of any funding or direct link with major research organisations the COS was developed as per our protocol with consideration given to all elements based on time and resource to maximise patient engagement. A decision to omit patients in the consensus webinars was carefully considered by the SAG which was highlighted in both ethical approval documents and a priori protocol design based upon best available guidance. Since the publication of more recent documents [28] outlining strategies to optimise Patient and public engagement, direct involvement of patients in consensus meetings would be a future consideration

23