Table 2 Overview of the 38 documents included in the realist synthesis
Focus of Improvement | Lead Author & Publication Year | National Context | Publication type | Ranking (Relevance) | Ranking (Rigour) | Aims and objectives | Research Design | Improvement/Intervention Specified |
|---|---|---|---|---|---|---|---|---|
Family-Clinician Relations and Care Provision | High-Income countries | Peer- reviewed Research | 1 | 1 | Review of latest published research, guidelines, and best practice points | Evidence Review | Stillbirth Bereavement Care | |
|  | Ellis A. (2016) [60] | Western High-Income Countries | Peer-reviewed Research | 2 | 1 | Synthesis and meta synthesis of parents’ and healthcare workers’ experiences of maternity bereavement care in hospital settings | Systematic Literature Review | Practical learning points to improve research, training and ultimately care of parents who experience late stillbirth (> 24 weeks) |
|  | Downe S. (2013) [61] | UK | Peer-reviewed Research | 2 | 2 | Analysis of parents’ experiences and views of interactions with hospital staff after perinatal death | Qualitative | Care of parents after perinatal bereavement |
| Â | Heazell A. (2013) [62] | International | Conference Proceeding Report | 2 | 2 | Evidence-based summary of international conference proceedings | Evidence Review | Bereavement support after stillbirth |
| Â | Make Births Better (2020) [63] | UK | Research Report | 2 | 2 | Findings on reported access to support after a difficult birth experience. Findings on professional training and service provision for this support | Survey | Birth Trauma Care and Support for Women, Families and Professionals |
|  | Redshaw M. (2014) [64] | UK | Research Report | 3 | 2 | Investigation of parents’ experiences of care after stillbirth or death of their baby after birth, including offering and information of post-mortem and professional support to understand the report | National Survey | Bereavement care after stillbirth or death of a baby after birth |
|  | Stanford S. (2016) [65] | England | Peer-reviewed Article | 1 | 1 | Narrative account of experience of harmful event during maternity care; difficulties with communication and outcomes for women and family | Qualitative | Communication and candour issues, women’s story, and response by a professional college |
Clinical Skills, Training and Post-Incident Support | Bonnema R.A. (2009) [66] | USA | Peer-reviewed Research | 3 | 1 | Post-intervention study of pilot training intervention to evaluate effectiveness of ‘Being Open’ training | Survey | ‘Being Open’ and Breaking Bad News graduate training |
|  | Coughlan B. (2017) [67] | Europe | Peer-reviewed Research | 2 | 1 | Narrative review of phenomenon of ‘second victims’ and remediation systems in maternity services | Evidence Review | ‘Second Victims’ of avoidable adverse events in maternity care |
| Â | Karkowsky C.E. (2016) [68] | USA | Peer-reviewed Research | 3 | 1 | Assessment of trainee-assessed effectiveness of simulation training for breaking bad news situations in obstetrics | Randomised prospective trial | Simulation training with obstetric residents |
| Â | Raemer D.B. (2016) [69] | USA | Peer-reviewed Research | 1 | 1 | Testing of best practice guideline for disclosure and apology to improve communication performance | Randomised Trial | Mixed-realism simulation |
Perinatal Mortality Review (Development & Evaluation) | Bakhbakhi D. (2017b) [59] | England | Peer-reviewed Research | 1 | 1 | Analysis of bereaved parents’ views on involvement in the perinatal mortality review process | Qualitative | Parents' Active Role and ENgagement in The review of their Stillbirth/perinatal death (PARENTS) perinatal mortality review design portfolio |
|  | Bakhbakhi D. (2018) [70] | England | Peer-reviewed Research | 1 | 1 | Exploration of healthcare professionals’ views on acceptability of and support for parent engagement in the perinatal mortality review process | Qualitative | PARENTS perinatal mortality review design portfolio |
| Â | Bakhbakhi D. (2019) [71] | England | Peer-reviewed Research | 1 | 1 | Development of core principles and recommendations for parental engagement in Perinatal Mortality Review Tool | Qualitative | PARENTS perinatal mortality review design portfolio |
| Â | Boyle et al. (2021) [72] | High-income countries | Peer-reviewed Research | 2 | 1 | Investigation of perinatal morality review meeting practices, including the extent of parent engagement, as reported by healthcare professionals in six countries | Survey | Perinatal mortality review meetings |
| Â | Burden C.B. (2018) [73] | England | Report | 2 | 2 | Summary of evidence-based policy recommendations arising from the PARENTS studies | Evidence Summary | PARENTS perinatal mortality review design portfolio |
| Â | Chepkin S. (2019) [30] | England | Research Report | 1 | 2 | First annual report on progress of implementation of the perinatal morality review tool | Thematic Review | Perinatal Morality Review Tool Progress Report |
| Â | Kurinczick J.J. (2020) [34] | England | Progress Report | 1 | 2 | Second annual report of progress of the national perinatal morality review tool | Thematic review | Perinatal Morality Review Tool Progress Report |
|  | Sauvegrain P. (2020) [74] | France | Peer-reviewed Research | 1 | 1 | Examination of effects of implementation of mother’s inclusion in perinatal mortality audit interviews | Mixed methods | District-level Perinatal Mortality Audit |
Organisation or Service Level Pilots & Evaluations | Bennett J.B. (2016) [75] | Scotland | Conference Presentation | 1 | 3 | Summary of principles, requirements, and initial outcomes of the ‘Being Open’ project (for scalability of training package) | Progress Summary | ‘Being Open’ Scotland |
| Â | Gluyas H. (2011) [76] | Australia | Peer-reviewed Research | 2 | 1 | Case study of hospital-level changes following an inquiry to review the quality of obstetric and gynaecological services | Qualitative | Clinical Governance |
|  | Healthcare Improvement Scotland (2016) [77] | Scotland | Resources with evidence of effect | 1 | 2 | Checklists, resources, and outcomes evidence developed for ‘Being Open’ pilot | Qualitative | ‘Being Open’ training and staff support pilot resource |
| Â | Hendrich A. (2014) [78] | USA | Peer-reviewed Research | 1 | 1 | Case study of implementation of full disclosure protocol in 5 pilot sites (one organisation) | Mixed methods | Labour and delivery units |
| Â | Pillinger J.P. (2016) [53] | Ireland | Research Report | 1 | 2 | Process evaluation of implementation of open disclosure pilot programme piloted in 2 acute hospitals (including maternity units) | Qualitative | Trust Pilot Schemes |
| Â | Santos P. (2015) [79] | USA | Peer-reviewed Research | 2 | 1 | Evaluation of a multi-faceted model for managing malpractice in obstetrics, including a disclosure programme | Qualitative | Disclosure Programme |
| Â | Scholefield H. (2007) [49] | England | Peer-reviewed research | 1 | 1 | Organisational case study of improvement in quality and risk management processes in obstetrics, including parent involvement in adverse events | Document analysis | Internal Trust Investigations/Local Review |
National and Regional Interventions, Evaluations & Audits | Care Quality Commission (2016) [50] | England | Research Report | 1 | 2 | Review of processes and systems in NHS Trusts in England on how NHS trusts identify, investigate, and learn from the deaths of people under their care | Mixed methods | NHS Trust Investigations and Reviews of deaths of patients (including maternity units) Local Review |
Care Quality Commission (2019) [51] | England | Research Report | 1 | 2 | Review progress and examples of good practice in implementation of the learning from deaths guidance | Qualitative | Learning from Deaths guidance implementation | |
| Â | Health Safety Investigation Branch (2020) [80] | England | Progress Report | 1 | 2 | Report on progress of engagement of families in independent investigations | Survey | Family involvement in external investigations of serious incidents (including maternity incidents) |
|  | Iedema R.A. (2008a) [6] | Australia | Peer-reviewed Research | 1 | 1 | Determination of which aspects of open disclosure ‘work’ for patients and healthcare staff (including maternity services) | Qualitative | Australian Open Disclosure pilot |
|  | Iedema R.A. (2008b) [54] | Australia | Peer-reviewed Research | 1 | 1 | Exploration of patients’ and family perceptions of Open Disclosure of adverse events that occurred during their health care (including maternity care) | Qualitative | Australian Open Disclosure pilot |
| Â | Kenyon S. (2017) [29] | England | Research Report | 2 | 2 | Examination of local reviews of a random selection of eligible cases reported to the perinatal confidential enquiry on inter-partum and intra-partum related neonatal death, including parent notification and involvement | Thematic review | Trust-based local reviews of inter-partum and intra-partum related neonatal death |
| Â | Magro, M. (2017) [31] | England | Research Report | 1 | 2 | Thematic review of NHSR data to identify the clinical and non-clinical themes from cerebral palsy claim records that resulted in claim compensation and to highlight areas for shared learning and improvement, including family involvement in serious incident reviews | Thematic Review | Serious incident Investigation summaries submitted to NIHR for progression of cerebral palsy claim |
| Â | NHS Improvement (2018) [52] | England | Research Report | 1 | 2 | National consultation (of patients, families, the public, commissioners, providers, and professional bodies) on factors affecting serious incident investigations (including maternity) in NHS Trusts | Mixed methods | Serious Incident Framework Implementation |
| Â | NHS Resolution (2019) [17] | England | Progress Report | 1 | 2 | Analysis of a pragmatic sample of cases of potentially severe brain injured babies reported into year 1 of the Early Notification Scheme, including notification and communication with families | Mixed-Methods Thematic Review | Early Notification Scheme progress report |
| Â | Quinn A.M. (2008) [81] | USA | Peer-reviewed Research | 2 | 1 | Description of origins and outcomes of 3Rs programme for patients, physicians, and programme officers (including maternity) | Qualitative | The 3Rs programme (early disclosure and resolution program) |
| Â | Sakala C. (2013) [82] | USA | Peer-reviewed Research | 3 | 1 | Literature synthesis of policy strategies most likely to mitigate harmful effects of the liability (tort) system for families | Evidence Review | Liability Systems |
| Â | Sorensen R. (2008) [48] | Australia | Peer-reviewed Research | 1 | 1 | Analysis of views on open disclosure of medical errors by health care professionals and managers and identification of workforce and systems capabilities required for embedding disclosure in units | Qualitative | Australian Open Disclosure Pilot |