Mapping the evidence for patient and public involvement and engagement in statistical methodology research: A scoping review protocol.

OBJECTIVE: To identify and map the existing literature on the conduct of patient and public involvement and engagement (PPIE) for statistical methodology. INTRODUCTION: PPIE refers to the consideration of patient and public perspectives into research development, conduct and dissemination and, while commonly integrated in applied healthcare research, it currently remains underutilised in statistical methodology research. Many statistical methodologists lack confidence in conducting PPIE citing barriers such as insufficient training, unclear tasks, and concerns about impact. INCLUSION CRITERIA: This review will examine literature on PPIE in the context of statistical methodology aiming to inform the design or analysis of healthcare research studies and related methodological research domains such as trials methodology and health data science. METHODS: A three-step search strategy, developed with an information specialist and based on JBI guidelines, will identify published and unpublished PPIE literature. This will include database searches, hand-searching key journals, and grey literature searches via search engines. The authors will contact their professional networks to identify additional material. The literature will be screened, selected and extracted by two independent researchers. Results will be presented in an evidence map and using a qualitative, thematic analysis.