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BACKGROUND: There is a policy drive in NHS maternity services to improve open disclosure with harmed families and limited information on how better practice can be achieved. OBJECTIVES: To identify critical factors for improving open disclosure from the perspectives of families, doctors, midwives and services and to produce actionable evidence for service improvement. DESIGN: A three-phased, qualitative study using realist methodology. Phase 1: two literature reviews: scoping review of post-2013 NHS policy and realist synthesis of initial programme theories for improvement; an interview study with national stakeholders in NHS maternity safety and families. Phase 2: in-depth ethnographic case studies within three NHS maternity services in England. Phase 3: interpretive forums with study participants. A patient and public involvement strategy underpinned all study phases. SETTING: National recruitment (study phases 1 and 3); three English maternity services (study phase 2). PARTICIPANTS: We completed n = 142 interviews, including 27 with families; 93 hours of ethnographic observations, including 52 service and family meetings over 9 months; and interpretive forums with approximately 69 people, including 11 families. RESULTS: The policy review identified a shift from viewing injured families as passive recipients to active contributors of post-incident learning, but a lack of actionable guidance for improving family involvement. The realist synthesis found weak evidence of the effectiveness of open disclosure interventions in the international maternity literature, but some improvements with organisation-wide interventions. Recent evidence was predominantly from the United Kingdom. The research identified and explored five key mechanisms for open disclosure: meaningful acknowledgement of harm; involvement of those affected in reviews/investigations; support for families' own sense-making; psychological safely of skilled clinicians (doctors and midwives); and knowing th

BACKGROUND: Open Disclosure (OD) is open and timely communication about harmful events arising from health care with those affected. It is an entitlement of service-users and an aspect of their recovery, as well as an important dimension of service safety improvement. Recently, OD in maternity care in the English National Health Service has become a pressing public issue, with policymakers promoting multiple interventions to manage the financial and reputational costs of communication failures. There is limited research to understand how OD works and its effects in different contexts. METHODS: Realist literature screening, data extraction, and retroductive theorisation involving two advisory stakeholder groups. Data relevant to families, clinicians, and services were mapped to theorise the relationships between contexts, mechanisms, and outcomes. From these maps, key aspects for successful OD were identified. RESULTS: After realist quality appraisal, 38 documents were included in the synthesis (22 academic, 2 training guidance, and 14 policy report). 135 explanatory accounts were identified from the included documents (with n = 41 relevant to families; n = 37 relevant to staff; and n = 37 relevant to services). These were theorised as five key mechanism sets: (a) meaningful acknowledgement of harm, (b) opportunity for family involvement in reviews and investigations, (c) possibilities for families and staff to make sense of what happened, (d) specialist skills and psychological safety of clinicians, and (e) families and staff knowing that improvements are happening. Three key contextual factors were identified: (a) the configuration of the incident (how and when identified and classified as more or less severe); (b) national or state drivers, such as polices, regulations, and schemes, designed to promote OD; and (c) the organisational context within which these these drivers are recieived and negotiated. CONCLUSIONS: This is the first review to theorise how OD works

Patients and families are entitled to an open disclosure and discussion of healthcare incidents affecting them. This reduces distress and contributes to learning for safety improvement. Complex barriers prevent effective disclosure and continue in the English NHS, despite a legal duty of candour. NHS maternity services are the focus of significant efforts to improve this. There is limited understanding of how, and to what effect, they are achieving this. METHODS AND ANALYSIS: A 27-month, three-phased realist evaluation identifying the critical factors contributing to improvements in the disclosure and discussion of incidents with affected families. The evaluation asks 'what works, for whom, in what circumstances, in why respects and why?'.Phase 1: establish working hypotheses of key factors and outcomes of interventions improving disclosure and discussion, by realist literature review and in-depth realist interviews with key stakeholders (n=approximately 20]Phase 2: refine or overturn hypotheses, by ethnographic case-study analysis using triangulated qualitative methods (non-participant observation, interviews (n=12) and documentary analysis) in up to 4 purposively sampled NHS trusts.Phase 3: consider hypotheses and design outputs during seven interpretive forums. ETHICS AND DISSEMINATION: Phase 1 study approval by King's College London's Ethics Panel (BDMRESC 22033) and National Research Ethical Approval for Phases 2-3 (IRASID:262197) (CAG:20/CAG/0121) (REC:20/LO/1152). Study sponsorship by King's College London (HS&DR 17/99/85).Findings to be disseminated through tailored management briefings; clinician and family guidance (written and video); lay summaries, academic papers, and report with outputs tailored to maximise academic and societal impact. Views of women/family groups are represented throughout.