Development of the Preferred Components for Co-Design in Research (PRECISE) Guideline and Checklist: Phase 1 Scoping Review and Preliminary Guidance (Preprint)

BACKGROUND Co-design is a collaborative process spanning the lifecycle of a design project that uses creativity, reflexivity, and iterative learning to support feedback, adaptation, and shared understanding during intervention development. Co-design aims to involve diverse groups, including patients, caregivers, clinicians, administrators, community members, researchers, designers, and policy actors. Evidence suggests co-designed interventions may be more engaging, acceptable, and feasible to implement than those developed using traditional approaches. Despite the growing adoption of co-design, considerable variation remains in how it is understood, implemented, and reported, limiting its potential to support meaningful and equitable improvements in health interventions. OBJECTIVE To map the scope and nature of the literature describing the models, theories, and frameworks (MTFs) used to co-design complex health interventions and synthesize their key characteristics. This review constitutes Phase 1 of the Preferred Components for Co-design in Research (PRECISE) initiative, which aims to enhance conceptual clarity, methodological rigour, and transparency in reporting co-design studies for complex health interventions. METHODS A scoping review was conducted following JBI guidance and reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Seven databases were searched from 1972 to 19 October 2023. Screening and data extraction were done independently and in duplicate. Publications were eligible if they reported co-design, co-production, or co-creation approaches and applied a model, theory, or framework to guide co-design of complex interventions. Extracted data were synthesized descriptively using counts and proportions. RESULTS A total of 130 publications were included. Co-design terminology use was inconsistent: 62.3% of publications used the term “co-design,” 7.7% “co-production”, 6.9% “co-creation”, and 16.2% did not use any co-approach term in their methodology. Among publications using a co-approach term, only 31.2% provided an associated citation. Fewer than two-thirds (60.0%) reported reciprocal collaboration with co-design partners. Among these, “developing the intervention” was the most commonly reported role (89.5%), while involvement in analysis and dissemination was less frequently reported. Reported co-design principles were variable, with "use participatory means" being the most prevalent (93.9%). Regarding MTFs, 70.0% of publications used a design-only MTF (e.g., pre-2021 Medical Research Council framework). Only three studies (2.3%) used a co-only MTF. Nearly half (42.3%) reported using a co + design MTF (e.g., Double Diamond). Of those using a co + design MTF, 67.3% operationalized its elements in the study context. CONCLUSIONS This scoping review reveals significant variability in how co-design is defined, conceptualized, and applied in the development of complex health interventions, with limited use of and application of MTFs. These findings highlight the necessity for clearer conceptual bases and more transparent reporting. As Phase 1 of the PRECISE guideline initiative, this review lays the empirical groundwork for developing reporting standards for co-design research. CLINICALTRIAL The Open Science Framework on June 12, 2023 (osf.io/prd3t).