International healthcare experts' consensus on the key requirements of a potential international patient safety learning system: a modified online Delphi study

BackgroundDespite widespread recognition that patient safety learning can transcend national boundaries, no international patient safety learning system (PSLS) currently exists. There is no expert consensus on the purpose, key requirements, or feasibility of such a system. ObjectiveTo gain consensus from an international panel of healthcare experts regarding the key requirements and feasibility of a potential international PSLS, with or without an incident reporting function. MethodsA two-round modified online Delphi study was conducted with 21 international healthcare experts in patient safety and learning systems, representing all six continents. The study was informed by a prior systematic literature review and semi-structured key-informant interviews with safety-critical industry experts. Panellists rated statements on a 9-point Likert-like scale. Consensus was defined a priori as [≥]70% agreement (ratings 7-9) with an interquartile range (IQR) [≤]2.00. A post-hoc threshold of [≥]80% was applied to identify the strongest areas of consensus. ResultsOf 73 experts invited, 21 completed round one (29% response rate) and 15 completed round two (71% retention). Across two rounds, 103 statements were evaluated; consensus was achieved on 85 (83%) at the [≥]80% threshold across all four domains: purposes (15/19 statements); key functions and features (17/22); patient safety incidents and criteria for international concern (19/24 combined); and enablers and challenges (34/38). The panel endorsed a proposed framework for an international PSLS and generated novel consensus-based lists of patient safety incidents and criteria for determining what should be shared internationally. ConclusionsInternational healthcare experts broadly agree on the purposes, key functions, and feasibility of an international PSLS. The consensus-derived framework provides a foundation for future feasibility research and potential pilot implementation. Validation with frontline end-users is an essential next step. KEY MESSAGESO_ST_ABSWhat is already known on this topicC_ST_ABSNational patient safety learning systems vary considerably in design, governance, and the degree to which they generate actionable learning, and no international system currently exists to enable systematic cross-border sharing and learning from patient safety data. What this study addsThis is the first Delphi study to establish international expert consensus on the purposes, key functions and features, and feasibility of an international Patient Safety Learning System (PSLS), producing novel consensus-based lists of patient safety incidents relevant to international sharing and criteria for determining what constitutes a risk of international concern. How this study might affect research, practice or policyThe proposed framework and consensus-derived criteria provide a starting point for feasibility research and potential pilot implementation by organisations such as the World Health Organization (WHO), in alignment with the Global Patient Safety Action Plan 2021-2030. The findings also highlight the structural prerequisites -- including a standardised international taxonomy, governance frameworks, and equitable participation mechanisms -- that must be addressed before implementation can proceed.