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      Humanizing processes after harm part 1: patient safety incident investigations, litigation and the experiences of those affected

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          Abstract

          Background

          There is a growing international policy focus on involving those affected by healthcare safety incidents, in subsequent investigations. Nonetheless, there remains little UK-based evidence exploring how this relates to the experiences of those affected over time, including the factors influencing decisions to litigate.

          Aims

          We aimed to explore the experiences of patients, families, staff and legal representatives affected by safety incidents over time, and the factors influencing decisions to litigate.

          Methods

          Participants were purposively recruited via (i) communication from four NHS hospital Trusts or an independent national investigator in England, (ii) relevant charitable organizations, (iii) social media, and (iv) word of mouth to take part in a qualitative semi-structured interview study. Data were analyzed using an inductive reflexive thematic approach.

          Findings

          42 people with personal or professional experience of safety incident investigations participated, comprising patients and families ( n = 18), healthcare staff ( n = 7), legal staff ( n = 1), and investigators ( n = 16). Patients and families started investigation processes with cautious hope, but over time, came to realize that they lacked power, knowledge, and support to navigate the system, made clear in awaited investigation reports. Systemic fear of litigation not only failed to meet the needs of those affected, but also inadvertently led to some pursuing litigation. Staff had parallel experiences of exclusion, lacking support and feeling left with an incomplete narrative. Importantly, investigating was often perceived as a lonely, invisible and undervalued role involving skilled “work” with limited training, resources, and infrastructure. Ultimately, elusive “organizational agendas” were prioritized above the needs of all affected.

          Conclusions

          Incident investigations fail to acknowledge and address emotional distress experienced by all affected, resulting in compounded harm. To address this, we propose five key recommendations, to: (1) prioritize the needs of those affected by incidents, (2) overcome culturally engrained fears of litigation to re-humanize processes and reduce rates of unnecessary litigation, (3) recognize and value the emotionally laborious and skilled work of investigators (4) inform and support those affected, (5) proceed in ways that recognize and seek to reduce social inequities.

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          Most cited references67

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          Reflecting on reflexive thematic analysis

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            Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough?

            Saturation is a core guiding principle to determine sample sizes in qualitative research, yet little methodological research exists on parameters that influence saturation. Our study compared two approaches to assessing saturation: code saturation and meaning saturation. We examined sample sizes needed to reach saturation in each approach, what saturation meant, and how to assess saturation. Examining 25 in-depth interviews, we found that code saturation was reached at nine interviews, whereby the range of thematic issues was identified. However, 16 to 24 interviews were needed to reach meaning saturation where we developed a richly textured understanding of issues. Thus, code saturation may indicate when researchers have "heard it all," but meaning saturation is needed to "understand it all." We used our results to develop parameters that influence saturation, which may be used to estimate sample sizes for qualitative research proposals or to document in publications the grounds on which saturation was achieved.
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              Epistemic Injustice

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                Author and article information

                Contributors
                URI : https://loop.frontiersin.org/people/2790908/overviewRole: Role:
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                Journal
                Front Health Serv
                Front Health Serv
                Front. Health Serv.
                Frontiers in Health Services
                Frontiers Media S.A.
                2813-0146
                03 January 2025
                2024
                : 4
                : 1473256
                Affiliations
                [ 1 ]Yorkshire and Humber Patient Safety Research Collaboration, Bradford Institute for Health Research , Bradford, United Kingdom
                [ 2 ]York Trials Unit, University of York , York, United Kingdom
                [ 3 ]Health Services Management Centre, University of Birmingham , Birmingham, United Kingdom
                [ 4 ]School of Humanities and Social Sciences, Leeds Beckett University , Leeds, United Kingdom
                [ 5 ]School of Psychology, University of Leeds , Leeds, United Kingdom
                [ 6 ]School of Healthcare, University of Leeds , Leeds, United Kingdom
                [ 7 ]Research and Innovation, Midlands Partnership NHS Foundation Trust , Stafford, United Kingdom
                Author notes

                Edited by: Melissa Baysari, The University of Sydney, Australia

                Reviewed by: Charles Vincent, University of Oxford, United Kingdom

                Adeola Bamgboje-Ayodele, The University of Sydney, Australia

                [* ] Correspondence: Lauren Ramsey l.ramsey@ 123456leeds.ac.uk
                [ † ]

                Present Addresses: Justin Waring, Social Sciences and Humanities, Loughborough University, Loughborough, United Kingdom Jane K. O'Hara, THIS Institute (The Healthcare Improvement Studies Institute), University of Cambridge, Cambridge, United Kingdom

                Article
                10.3389/frhs.2024.1473256
                11739161
                39831148
                15087824-5082-4029-b077-bd17ded2e254
                © 2025 Ramsey, Sheard, Waring, McHugh, Simms-Ellis, Louch, Ludwin and O'Hara.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 30 July 2024
                : 29 October 2024
                Page count
                Figures: 1, Tables: 1, Equations: 0, References: 61, Pages: 12, Words: 0
                Funding
                Funded by: National Institute for Health and Care Research (NIHR) Health Services and Delivery Research Programme
                Award ID: ISRCTN14463242
                Funded by: NIHR Yorkshire and Humber Patient Safety Research Collaboration
                Award ID: NIHR YH PSRC
                The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was funded by the National Institute for Health and Care Research (NIHR) Health Services and Delivery Research Programme (18/10/02; ISRCTN14463242) and supported by the NIHR Yorkshire and Humber Patient Safety Research Collaboration (NIHR YH PSRC). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
                Categories
                Health Services
                Original Research
                Custom metadata
                Patient Safety

                patient safety,patient involvement,staff involvement,healthcare harm,safety investigations,healthcare litigation,qualitative research

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