Best practices for patient authorship and involvement in pharmaceutical industry peer-reviewed publications: systematic literature review and qualitative evidence synthesis

Background Patient authorship and involvement in peer-reviewed publications is an increasing and evolving practice across the pharmaceutical industry, however implementation remains inconsistent and there is a need for specific and comprehensive guidelines. Methods This practice-informed systematic literature review and qualitative evidence synthesis searched the peer-reviewed and grey literature (1 Jan 2018–1 June 2025) for meta-research, thought leadership, or commentaries about patient involvement in publications. Qualitative extractions were split into three datasets of best practices, gaps, and recommendations. Best practice codes were then categorised and synthesised into evidence-based best practices using meta-aggregative pragmatic inquiry and mapped to the stages of the publication lifecycle. As secondary, a priori analyses, a subset of codes relating to conflicting topics from the codebook generated using the best practice dataset were then deductively applied to the gaps and recommendations datasets and analysed for interpretation and expansion of concepts using reflexive thematic analysis. Results A total of 166 peer-reviewed literature and grey literature records were included in the reviewed, resulting in a synthesis of 66 best practices for patient involvement in peer-reviewed publications across and beyond the publication lifecycle. Two conflicting best practice topics required secondary analysis, namely the discourse on how patient authors should be identified and affiliated and if patient authors can be remunerated. Conclusions Here we establish and propose an evidence-based framework of best practices for patient authorship and involvement in pharmaceutical industry peer-reviewed publications to improve consistency and standardisation. Further consensus is needed on topics of patient author affiliations and remuneration. Systematic review registration PROSPERO. CRD420251030982.