Faculty of Life Science and Medicine, Department of Women and Children's Health, King's College London, London, UK
Centre for Team Based Practice and Learning in Health Care, King's College London, London, UK.
BMJ Open. 2022 Feb 3;12(2):e048285. doi: 10.1136/bmjopen-2020-048285.
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.
患者及其家属有权了解影响他们的医疗事故，并对此进行公开披露和讨论。这可以减轻他们的痛苦，并有助于提高安全性。尽管有坦诚的法律义务，但在英国国民保健制度中，仍存在复杂的障碍，阻碍了有效的披露。英国国民保健制度的产科服务是为改善这一状况而做出重大努力的重点。对于这些努力如何以及在何种程度上实现这一目标，人们的理解有限。
这是一项为期 27 个月的、分三个阶段的现实主义评估，旨在确定有助于改善与受影响家庭一起披露和讨论事件的关键因素。该评估提出了“哪些因素有效，对谁有效，在什么情况下有效，在哪些方面有效以及为什么有效”的问题。
第 1 阶段：通过现实主义文献综述和对关键利益相关者（约 20 人）的深入现实主义访谈，建立改善披露和讨论的干预措施的关键因素和结果的工作假设。
第 2 阶段：通过使用三角定性方法（非参与式观察、访谈（12 人）和文献分析）对多达 4 个有目的抽样的 NHS 信托进行民族志案例研究分析，对假设进行修正或推翻。
第 3 阶段：在 7 个解释性论坛中考虑假设和设计产出。
第 1 阶段的研究已获得伦敦国王学院伦理小组（BDMRESC 22033）和第 2-3 阶段的国家研究伦理批准（IRASID：262197）（CAG：20/CAG/0121）（REC：20/LO/1152）。该研究由伦敦国王学院（HS&DR 17/99/85）赞助。
研究结果将通过定制的管理简报、临床医生和家庭指导（书面和视频）、通俗摘要、学术论文以及根据最大限度提高学术和社会影响而定制的报告进行传播。妇女/家庭团体的意见将贯穿始终。
