The protocol for this scoping review is registered with the OSF Registries [25]. The protocol is reported in line with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) reporting checklist (adapted for scoping review protocol; Checklist 1) [26].

The review team comprises pharmacy and biomedical researchers, simulation educators, and patient advocates with lived experience of Sjögren disease. This interdisciplinary team ensures methodological rigor, experiential relevance, and real-world applicability throughout the review.

This scoping review followed the methodological framework originally proposed by Arksey and O’Malley [22] and further refined by Levac et al [23]. Elements of JBI guidance for scoping reviews were also incorporated to strengthen reporting transparency and methodological rigor. The review is reported in accordance with the PRISMA-ScR checklist (Checklist 1) [26,27]. The review question guiding this scoping review is “How has patient and public involvement been implemented in clinical, translational, and preclinical research relating to autoimmune and inflammatory ocular diseases?”

This protocol was codeveloped through an ongoing researcher-patient partnership established in May 2021, using a cocreation through consultation approach [28]. Patient advocates contributed to defining the research question, refining eligibility criteria, and shaping the methodological approach. Previous collaborative activities included co-design of educational resources for health care professionals and the public, development of a dedicated Sjögren information webpage, and codevelopment of Ireland’s first PPI survey for people living with Sjögren disease to identify research and care priorities. These activities formed part of an ongoing researcher-patient partnership and cocreation program previously described by Doyle et al [7,28]. This foundation of sustained co-design ensures that the scoping review reflects real-world concerns, lived experience, and patient-defined priorities from its inception. Patient partners will also codevelop dissemination materials, including lay summaries and visual outputs for patient advocacy communities.

For the purposes of this review, PPI is defined as the active involvement of patients, carers, advocacy groups, or members of the public in the design, conduct, analysis, or dissemination of research, rather than participation solely as research participants. Eligible forms of involvement will include consultation exercises, priority-setting activities, co-design approaches, advisory roles, collaborative partnerships, and coproduction activities. Studies describing participants solely as research participants, without evidence of involvement in shaping the research process will be excluded.

Peer-reviewed studies describing or evaluating PPI within clinical, translational, or preclinical research relating to autoimmune or inflammatory ocular diseases will be eligible for inclusion. Studies will be required to report explicit patient or public involvement in at least one stage of the research process, including research priority setting, study design, conduct, analysis, or dissemination. Gray literature, conference abstracts, editorials, and studies without clearly defined PPI components will be excluded.

A systematic search of the MEDLINE (via Ovid), Embase (via Ovid), and CINAHL databases was conducted to identify studies describing PPI in autoimmune and inflammatory ocular disease research. These databases were selected in consultation with an information specialist to ensure broad coverage of biomedical, clinical, and nursing literature relevant to the review question.

The search strategy combined controlled vocabulary terms (eg, MeSH and Emtree headings) and free-text keywords relating to PPI, autoimmune or inflammatory disease, and ocular or eye conditions. Search concepts were combined using Boolean operators (AND and OR), with search syntax adapted for each database. Truncation, phrase searching, and database-specific subject headings were used where appropriate to optimize retrieval.

Searches were conducted from database inception to March 2025. Searches were limited to English-language studies involving human participants. Reference lists of eligible studies will also be screened to identify additional relevant publications.

Gray literature was excluded because the review aimed to focus on peer-reviewed studies providing sufficiently detailed descriptions of PPI approaches and research processes. Full search strategies for all databases are provided in Multimedia Appendix 1.

Reporting of the search strategy was informed by relevant elements of the PRISMA-S (Preferred Reporting Items for Systematic Reviews and Meta-Analyses literature search extension) guidance for literature searches.

Search results will be imported into Covidence for deduplication and screening. Prior to formal screening, the eligibility criteria and data charting form will be piloted on a purposive sample of records to ensure consistency in interpretation and application. Title and abstract screening will be conducted by one reviewer in keeping with the exploratory nature of scoping review methodology. Full-text screening will be undertaken independently by 2 reviewers, with disagreements resolved through discussion and consensus.

The data charting form was developed iteratively by the review team and refined following pilot extraction of a sample of studies. This iterative approach was consistent with the exploratory objectives of scoping review methodology.

Extracted information will include the author and year of publication, country and setting, disease focus, type of research, study design, participants involved in PPI activities, stage and type of involvement, reported PPI activities and approaches, and reported impacts, challenges, enabling factors, and reflections relating to PPI.

For the purposes of this review, stages of involvement will include activities relating to research priority setting, study design, conduct, analysis, interpretation, and dissemination.

Levels of involvement will be categorized using established PPI reporting and involvement frameworks, including INVOLVE and GRIPP2 (Guidance for Reporting Involvement of Patients and the Public) guidance [29], and classified as consultation, collaboration, or coproduction where sufficient detail is provided by study authors.

Data extraction will be conducted by 1 reviewer using the prepiloted charting form. Extracted data and categorization decisions will be reviewed collaboratively within the research team to support consistency and clarity. The final data charting form is provided in Multimedia Appendix 2.

Extracted data will be synthesized using narrative and thematic synthesis approaches. Study characteristics and PPI activities will be summarized descriptively in tables. Narrative synthesis will be used to compare how PPI has been implemented across different autoimmune and inflammatory ocular disease contexts and across clinical, translational, and preclinical research domains.

Thematic synthesis will be conducted using a deductive-inductive approach. Initial coding will be informed by recognized PPI reporting frameworks, including GRIPP2 short form categories relating to aims of involvement, methods, stages of involvement, reported outcomes, and reflections on PPI processes. Additional inductive coding will be undertaken to identify emerging themes relating to challenges, enabling factors, impacts, and approaches to involvement across studies.

Themes will be iteratively reviewed and refined through discussion within the research team to support consistency of interpretation. Comparisons will be made across studies to explore similarities and differences in how PPI is implemented and reported across research domains and disease areas.

Consistent with scoping review methodology, the synthesis will aim to map and characterize patterns of PPI rather than formally evaluate intervention effectiveness. Formal critical appraisal will not be undertaken, consistent with the exploratory objectives of scoping review methodology.

As this scoping review involved analysis of published literature and did not involve collection of primary research data, formal research ethics committee approval was not required in accordance with institutional guidance for literature-based research. PPI contributors participated as research partners in the development of the protocol rather than as research participants. Contributors were involved in refining the research question, eligibility criteria, and dissemination planning through collaborative discussions and review meetings. No personal or sensitive data were collected from contributors for research purposes. Patient partners were supported in accordance with Royal College of Surgeons in Ireland (RCSI) PPI guidance, and reimbursement for involvement activities was provided through the RCSI PPI Ignite seed funding scheme.