Experiences of involving patients and the public as partners in randomised clinical trials: a qualitative evidence scoping review protocol.

The scoping review described in this protocol aims to review the evidence to understand the experience of relevant parties when involving patients and the public at any stage of randomised controlled trial; specifically exploring what worked well and what could be improved.

Objectives

- To review the evidence reporting the experience of trial teams of PPI at any stage of trials.

- To review the evidence reporting the experience of patients, and/or the public of PPI at any stage of trials.

- To identify research gaps within existing evidence of experiences of trial teams and patients/public partners of PPI at any stage of trials.

Methods

A scoping review adopting the Joanna Brigg Institute (JBI) methodology will be conducted. Studies eligible in the review will adopt the Population, Concept and Context (PCC) framework.

- Population : Trial teams, patients, and/or public partners.

- Concept : The phenomenon of interest is trial teams’, patients’, and/or public partners’ experience (as captured using qualitative methods) of PPI at any stage of trials.

- Context : Any stages of trials (from design to dissemination) in any country.

Result structure:

A PRISMA-scr diagram will be used to report the scoping review process. Descriptive statistics will be used to describe the participant and trial characteristics of the included studies. A narrative summary using thematic synthesis will be undertaken to report relevant parties’ experiences of involvement in trials. We will thematically synthesise the findings following steps recommended by Thomas and Harden:coding, development of descriptive themes and analytical themes. Qualitative data management software (e.g NVivo, Citavi) may be used to facilitate data organisation.