Search

Background: Dominant conceptualisations of access to health care are limited, framed in terms of speed and supply. The Candidacy Framework offers a more comprehensive approach, identifying diverse influences on how access is accomplished., Aim: To characterise how the Candidacy Framework can explain access to general practice - an increasingly fraught area of public debate and policy., Design and Setting: Qualitative review guided by the principles of critical interpretive synthesis., Method: We conducted a literature review using an author-led approach, involving iterative analytically guided searches. Articles were eligible for inclusion if they related to the context of general practice, without geographical or time limitations. Key themes relating to access to general practice were extracted and synthesised using the Candidacy Framework., Results: A total of 229 articles were included in the final synthesis. The seven features identified in the original Candidacy Framework are highly salient to general practice. Using the lens of candidacy demonstrates that access to general practice is subject to multiple influences that are highly dynamic, contingent, and subject to constant negotiation. These influences are socioeconomically and institutionally patterned, creating risks to access for some groups. This analysis enables understanding of the barriers to access that may exist, even though general practice in the UK is free at the point of care, but also demonstrates that a Candidacy Framework specific to this setting is needed., Conclusion: The Candidacy Framework has considerable value as a way of understanding access to general practice, offering new insights for policy and practice. The original framework would benefit from further customisation for the distinctive setting of general practice., (© The Authors.)

Introduction: Despite increasing incidence of impacted fetal head at cesarean birth and associated injury, it is unclear which techniques are most effective for prevention and management. A high quality evidence review in accordance with international reporting standards is currently lacking. To address this gap, we aimed to identify, assess, and synthesize studies comparing techniques to prevent or manage impacted fetal head at cesarean birth prior to or at full cervical dilatation., Material and Methods: We searched MEDLINE, Emcare, Embase and Cochrane databases up to 1 January 2023 (PROSPERO: CRD420212750016). Included were randomized controlled trials (any size) and non-randomized comparative studies (n ≥ 30 in each arm) comparing techniques or adjunctive measures to prevent or manage impacted fetal head at cesarean birth. Following screening and data extraction, we assessed risk of bias for individual studies using RoB2 and ROBINS-I, and certainty of evidence using GRADE. We synthesized data using meta-analysis where appropriate, including sensitivity analyses excluding data published in potential predatory journals or at risk of retraction., Results: We identified 24 eligible studies (11 randomized and 13 non-randomized) including 3558 women, that compared vaginal disimpaction, reverse breech extraction, the Patwardhan method and/or the Fetal Pillow®. GRADE certainty of evidence was low or very low for all 96 outcomes across seven reported comparisons. Pooled analysis mostly showed no or equivocal differences in outcomes across comparisons of techniques. Although some maternal outcomes suggested differences between techniques (eg risk ratio of 3.41 [95% CI: 2.50-4.66] for uterine incision extension with vaginal disimpaction vs. reverse breech extraction), these were based on unreliable pooled estimates given very low GRADE certainty and, in some cases, additional risk of bias introduced by data published in potential predatory journals or at risk of retraction., Conclusions: The current weaknesses in the evidence base mean that no firm recommendations can be made about the superiority of any one impacted fetal head technique over another, indicating that high quality training is needed across the range of techniques. Future studies to improve the evidence base are urgently required, using a standard definition of impacted fetal head, agreed maternal and neonatal outcome sets for impacted fetal head, and internationally recommended reporting standards., (© 2024 The Author(s). Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Objectives: The impact of incident investigations in improving patient safety may be linked to the quality of risk controls recommended in investigation reports. We aimed to identify the range and apparent strength of risk controls generated from investigations into serious incidents, map them against contributory factors identified in investigation reports, and characterize the nature of the risk controls proposed., Methods: We undertook a content analysis of 126 action plans of serious incident investigation reports from a multisite and multispeciality UK hospital over a 3-year period to identify the risk controls proposed. We coded each risk control against the contributory factor it aimed to address. Using a hierarchy of risk controls model, we assessed the strength of proposed risk controls. We used thematic analysis to characterize the nature of proposed risk controls., Results: A substantial proportion (15%) of factors identified in investigation reports as contributing to serious incidents were not addressed by identifiable risk controls. Of the 822 proposed risk controls in action plans, most (74%) were assessed as weak, typically focusing on individualized interventions-even when the problems were organizational or systemic in character. The following 6 broad approaches to risk controls could be identified: improving individual or team performance; defining, standardizing, or reinforcing expected practice; improving the working environment; improving communication; process improvements; and disciplinary actions., Conclusions: The identified shortfalls in the quality of risk controls following serious incident investigations-including a 15% mismatch between contributory factors and aligned risk controls and 74% of proposed risk controls centering on weaker interventions-represent significant gaps in translating incident investigations into meaningful systemic improvements. Advancing the quality of risk controls after serious incident investigations will require involvement of human factors specialists in their design, a theory-of-change approach, evaluation, and curation and sharing of learning, all supported by a common framework., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: System problems, known as operational failures, can greatly affect the work of GPs, with negative consequences for patient and professional experience, efficiency, and effectiveness. Many operational failures are tractable to improvement, but which ones should be prioritised is less clear., Aim: To build consensus among GPs and patients on the operational failures that should be prioritised to improve NHS general practice., Design and Setting: Two modified Delphi exercises were conducted online among NHS GPs and patients in several regions across England., Method: Between February and October 2021, two modified Delphi exercises were conducted online: one with NHS GPs, and a subsequent exercise with patients. Over two rounds, GPs rated the importance of a list of operational failures ( n = 45) that had been compiled using existing evidence. The resulting shortlist was presented to patients for rating over two rounds. Data were analysed using median scores and interquartile ranges. Consensus was defined as 80% of responses falling within one value below and above the median., Results: Sixty-two GPs responded to the first Delphi exercise, and 53.2% ( n = 33) were retained through to round two. This exercise yielded consensus on 14 failures as a priority for improvement, which were presented to patients. Thirty-seven patients responded to the first patient Delphi exercise, and 89.2% ( n = 33) were retained through to round two. Patients identified 13 failures as priorities. The highest scoring failures included inaccuracies in patients' medical notes, missing test results, and difficulties referring patients to other providers because of problems with referral forms., Conclusion: This study identified the highest-priority operational failures in general practice according to GPs and patients, and indicates where improvement efforts relating to operational failures in general practice should be focused., (© The Authors.)

Background: High-quality antenatal care is important for ensuring optimal birth outcomes and reducing risks of maternal and fetal mortality and morbidity. The COVID-19 pandemic disrupted the usual provision of antenatal care, with much care shifting to remote forms of provision. We aimed to characterise what quality would look like for remote antenatal care from the perspectives of those who use, provide and organise it., Methods: This UK-wide study involved interviews and an online survey inviting free-text responses with: those who were or had been pregnant since March 2020; maternity professionals and managers of maternity services and system-level stakeholders. Recruitment used network-based approaches, professional and community networks and purposively selected hospitals. Analysis of interview transcripts was based on the constant comparative method. Free-text survey responses were analysed using a coding framework developed by researchers., Findings: Participants included 106 pregnant women and 105 healthcare professionals and managers/stakeholders. Analysis enabled generation of a framework of the domains of quality that appear to be most relevant to stakeholders in remote antenatal care: efficiency and timeliness; effectiveness; safety; accessibility; equity and inclusion; person-centredness and choice and continuity. Participants reported that remote care was not straightforwardly positive or negative across these domains. Care that was more transactional in nature was identified as more suitable for remote modalities, but remote care was also seen as having potential to undermine important aspects of trusting relationships and continuity, to amplify or create new forms of structural inequality and to create possible risks to safety., Conclusions: This study offers a provisional framework that can help in structuring thinking, policy and practice. By outlining the range of domains relevant to remote antenatal care, this framework is likely to be of value in guiding policy, practice and research., Competing Interests: Competing interests: TD is Vice President of the Royal College of Obstetricians and Gynaecologists. RJM has previously received BP monitors from Omron Healthcare for research purposes and is working with them on a telemonitoring system., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: We have read and understood BMJ policy on competing interests and declare: MD-W is currently undertaking evaluative work for the Care Quality Commission. She is an unpaid director and founder of THIS Labs. CS gave oral evidence to the House of Lords Science and Technology Committee Inquiry into Clinical Academics and the NHS. She is employed by the University of Cambridge, is an honorary consultant at Cambridge University Hospitals NHS Foundation Trust, and is director of studies in clinical medicine at Selwyn College, Cambridge. MM is an employee of The BMJ and has acted in various advisory roles for the health service including for the Welsh government. KP has no interests to declare.

Background: Problems in intrapartum electronic fetal monitoring with cardiotocography (CTG) remain a major area of preventable harm. Poor understanding of the range of influences on safety may have hindered improvement. Taking an interdisciplinary perspective, we sought to characterise the everyday practice of CTG monitoring and the work systems within which it takes place, with the goal of identifying potential sources of risk., Methods: Human factors/ergonomics (HF/E) experts and social scientists conducted 325 hours of observations and 23 interviews in three maternity units in the UK, focusing on how CTG tasks were undertaken, the influences on this work and the cultural and organisational features of work settings. HF/E analysis was based on the Systems Engineering Initiative for Patient Safety 2.0 model. Social science analysis was based on the constant comparative method., Results: CTG monitoring can be understood as a complex sociotechnical activity, with tasks, people, tools and technology, and organisational and external factors all combining to affect safety. Fetal heart rate patterns need to be recorded and interpreted correctly. Systems are also required for seeking the opinions of others, determining whether the situation warrants concern, escalating concerns and mobilising response. These processes may be inadequately designed or function suboptimally, and may be further complicated by staffing issues, equipment and ergonomics issues, and competing and frequently changing clinical guidelines. Practice may also be affected by variable standards and workflows, variations in clinical competence, teamwork and situation awareness, and the ability to communicate concerns freely., Conclusions: CTG monitoring is an inherently collective and sociotechnical practice. Improving it will require accounting for complex system interdependencies, rather than focusing solely on discrete factors such as individual technical proficiency in interpreting traces., Competing Interests: Competing interests: TD: research and innovation lead for PROMPT Maternity Foundation., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Clinical tools for use in practice-such as medicine reconciliation charts, diagnosis support tools and track-and-trigger charts-are endemic in healthcare, but relatively little attention is given to how to optimise their design. User-centred design approaches and co-design principles offer potential for improving usability and acceptability of clinical tools, but limited practical guidance is currently available. We propose a framework (FRamework for co-dESign of Clinical practice tOols or 'FRESCO') offering practical guidance based on user-centred methods and co-design principles, organised in five steps: (1) establish a multidisciplinary advisory group; (2) develop initial drafts of the prototype; (3) conduct think-aloud usability evaluations; (4) test in clinical simulations; (5) generate a final prototype informed by workshops. We applied the framework in a case study to support co-design of a prototype track-and-trigger chart for detecting and responding to possible fetal deterioration during labour. This started with establishing an advisory group of 22 members with varied expertise. Two initial draft prototypes were developed-one based on a version produced by national bodies, and the other with similar content but designed using human factors principles. Think-aloud usability evaluations of these prototypes were conducted with 15 professionals, and the findings used to inform co-design of an improved draft prototype. This was tested with 52 maternity professionals from five maternity units through clinical simulations. Analysis of these simulations and six workshops were used to co-design the final prototype to the point of readiness for large-scale testing. By codifying existing methods and principles into a single framework, FRESCO supported mobilisation of the expertise and ingenuity of diverse stakeholders to co-design a prototype track-and-trigger chart in an area of pressing service need. Subject to further evaluation, the framework has potential for application beyond the area of clinical practice in which it was applied., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: The Safety Case is a regulatory technique that requires organisations to demonstrate to regulators that they have systematically identified hazards in their systems and reduced risks to being as low as reasonably practicable. It is used in several high-risk sectors, but only in a very limited way in healthcare. We examined the first documented attempt to apply the Safety Case methodology to clinical pathways., Methods: Data are drawn from a mixed-methods evaluation of the Safer Clinical Systems programme. The development of a Safety Case for a defined clinical pathway was a centrepiece of the programme. We base our analysis on 143 interviews covering all aspects of the programme and on analysis of 13 Safety Cases produced by clinical teams., Results: The principles behind a proactive, systematic approach to identifying and controlling risk that could be curated in a single document were broadly welcomed by participants, but was not straightforward to deliver. Compiling Safety Cases helped teams to identify safety hazards in clinical pathways, some of which had been previously occluded. However, the work of compiling Safety Cases was demanding of scarce skill and resource. Not all problems identified through proactive methods were tractable to the efforts of front-line staff. Some persistent hazards, originating from institutional and organisational vulnerabilities, appeared also to be out of the scope of control of even the board level of organisations. A particular dilemma for organisational senior leadership was whether to prioritise fixing the risks proactively identified in Safety Cases over other pressing issues, including those that had already resulted in harm., Conclusions: The Safety Case approach was recognised by those involved in the Safer Clinical Systems programme as having potential value. However, it is also fraught with challenge, highlighting the limitations of efforts to transfer safety management practices to healthcare from other sectors., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Large-scale improvement programmes are a frequent response to quality and safety problems in health systems globally, but have mixed impact. The extent to which they meet criteria for programme quality, particularly in relation to transparency of reporting and evaluation, is unclear., Aim: To identify large-scale improvement programmes focused on intrapartum care implemented in English National Health Service maternity services in the period 2010-2023, and to conduct a structured quality assessment., Methods: We drew on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidance to inform the design and reporting of our study. We identified relevant programmes using multiple search strategies of grey literature, research databases and other sources. Programmes that met a prespecified definition of improvement programme, that focused on intrapartum care and that had a retrievable evaluation report were subject to structured assessment using selected features of programme quality., Results: We identified 1434 records via databases and other sources. 14 major initiatives in English maternity services could not be quality assessed due to lack of a retrievable evaluation report. Quality assessment of the 15 improvement programmes meeting our criteria for assessment found highly variable quality and reporting. Programme specification was variable and mostly low quality. Only eight reported the evidence base for their interventions. Description of implementation support was poor and none reported customisation for challenged services. None reported reduction of inequalities as an explicit goal. Only seven made use of explicit patient and public involvement practices, and only six explicitly used published theories/models/frameworks to guide implementation. Programmes varied in their reporting of the planning, scope and design of evaluation, with weak designs evident., Conclusions: Poor transparency of reporting and weak or absent evaluation undermine large-scale improvement programmes by limiting learning and accountability. This review indicates important targets for improving quality in large-scale programmes., Competing Interests: Competing interests: TJD: Research and Innovation lead for PROMPT Maternity Foundation and has a part-time appointment at NHS Resolution where he leads on a Safety Action within the Maternity Incentive Scheme., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Despite their widespread use, the evidence base for the effectiveness of quality improvement collaboratives remains mixed. Lack of clarity about 'what good looks like' in collaboratives remains a persistent problem. We aimed to identify the distinctive features of a state-wide collaboratives programme that has demonstrated sustained improvements in quality of care in a range of clinical specialties over a long period., Design: Qualitative case study involving interviews with purposively sampled participants, observations and analysis of documents., Setting: The Michigan Collaborative Quality Initiatives programme., Participants: 38 participants, including clinicians and managers from 10 collaboratives, and staff from the University of Michigan and Blue Cross Blue Shield of Michigan., Results: We identified five features that characterised success in the collaboratives programme: learning from positive deviance; high-quality coordination; high-quality measurement and comparative performance feedback; careful use of motivational levers; and mobilising professional leadership and building community. Rigorous measurement, securing professional leadership and engagement, cultivating a collaborative culture, creating accountability for quality, and relieving participating sites of unnecessary burdens associated with programme participation were all important to high performance., Conclusions: Our findings offer valuable learning for optimising collaboration-based approaches to improvement in healthcare, with implications for the design, structure and resourcing of quality improvement collaboratives. These findings are likely to be useful to clinicians, managers, policy-makers and health system leaders engaged in multiorganisational approaches to improving quality and safety., Competing Interests: Competing interests: The Michigan Quality Collaboratives are supported by Blue Cross and Blue Shield of Michigan. MJE receives salary support from Blue Cross and Blue Shield of Michigan as well as the NIH and the Michigan DHHS. DAC, GLK and MJE’s institution (University of Michigan) receives a partial salary paid for by the Blue Cross Blue Shield of Michigan Value Partnerships for the Michigan Surgical Quality Collaborative. GLK, DAC and MJE are employed by the Michigan Surgical Quality Collaborative. MJE and JBD were interviewed as participants in the study., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objective: To investigate the hypothesis that risk factors in addition to an abnormal fetal heart rate pattern (aFHRp) are independently associated with adverse neonatal outcomes of labour., Design: Observational prospective cohort study., Setting: 17 UK maternity units., Sample: 585 291 pregnancies between 1988 and 2000 inclusive., Methods: Adjusted odds ratios (OR) with 95% confidence intervals (95% CI) were estimated from multivariable logistic regression., Main Outcome Measures: Adverse neonatal outcome at term (5-minute Apgar score <7, and a composite measure comprising 5-minute Apgar score <7, resuscitation by intubation and/or perinatal death)., Results: Analysis was based on 302 137 vaginal births at 37-42 weeks inclusive. We found a higher odds of Apgar score at 5 minutes <7 with suspected fetal growth restriction (OR 1.34, 95% CI 1.16-1.53), induction of labour (OR 1.41, 95% CI 1.25-1.58), nulliparity (OR 1.48, 95% CI 1.34-1.63), booking body mass index ≥30 (OR 1.18, 95% CI 1.02-1.37), maternal age <25 (OR 1.23, 95% CI 1.10-1.39), black ethnicity (OR 1.21, 95% CI 1.03-1.43), early-term birth at 37-38 weeks (OR 1.13, 95% CI 1.02-1.25), late-term birth at 41-42 weeks (OR 1.14, 95% CI 1.01-1.28), use of oxytocin (OR 1.27, 95% CI 1.14-1.41), maternal pyrexia (OR 1.87, 95% CI 1.46-2.40), aFHRp and presence of meconium (aFHRp without meconium: OR 2.40, 95% CI 2.15-2.69; meconium without aFHRp: OR 2.20, 195% CI.94-2.49; both aFHRp and meconium: OR 4.26, 95% CI 3.74-4.87). The results were similar when the composite adverse outcome was considered., Conclusions: A range of risk factors, including suspicion of fetal growth restriction, maternal pyrexia and presence of meconium, are implicated in poor birth outcomes in addition to aFHRp. Interpretation of the fetal heart rate pattern alone is insufficient as a basis for decisions about escalation and intervention., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Objective: We aimed to explore the experiences and perspectives of pregnant women, antenatal healthcare professionals, and system leaders to understand the impact of the implementation of remote provision of antenatal care during the COVID-19 pandemic and beyond., Methods: We conducted a qualitative study involving semi-structured interviews with 93 participants, including 45 individuals who had been pregnant during the study period, 34 health care professionals, and 14 managers and system-level stakeholders. Analysis was based on the constant comparative method and used the theoretical framework of candidacy., Results: We found that remote antenatal care had far-reaching effects on access when understood through the lens of candidacy. It altered women's own identification of themselves and their babies as eligible for antenatal care. Navigating services became more challenging, often requiring considerable digital literacy and sociocultural capital. Services became less permeable, meaning that they were more difficult to use and demanding of the personal and social resources of users. Remote consultations were seen as more transactional in character and were limited by lack of face-to-face contact and safe spaces, making it more difficult for women to make their needs - both clinical and social - known, and for professionals to assess them. Operational and institutional challenges, including problems in sharing of antenatal records, were consequential. There were suggestions that a shift to remote provision of antenatal care might increase risks of inequities in access to care in relation to every feature of candidacy we characterised., Conclusion: It is important to recognise the implications for access to antenatal care of a shift to remote delivery. It is not a simple swap: it restructures many aspects of candidacy for care in ways that pose risks of amplifying existing intersectional inequalities that lead to poorer outcomes. Addressing these challenges through policy and practice action is needed to tackle these risks.

Introduction: This study assessed views, understanding and current practices of maternity professionals in relation to impacted fetal head at cesarean birth, with the aim of informing a standardized definition, clinical management approaches and training., Material and Methods: We conducted a survey consultation including the range of maternity professionals who attend emergency cesarean births in the UK. Thiscovery, an online research and development platform, was used to ask closed-ended and free-text questions. Simple descriptive analysis was undertaken for closed-ended responses, and content analysis for categorization and counting of free-text responses. Main outcome measures included the count and percentage of participants selecting predefined options on clinical definition, multi-professional team approach, communication, clinical management and training., Results: In total, 419 professionals took part, including 144 midwives, 216 obstetricians and 59 other clinicians (eg anesthetists). We found high levels of agreement on the components of an impacted fetal head definition (79% of obstetricians) and the need for use of a multi-professional approach to management (95% of all participants). Over 70% of obstetricians deemed nine techniques acceptable for management of impacted fetal head, but some obstetricians also considered potentially unsafe practices appropriate. Access to professional training in management of impacted fetal head was highly variable, with over 80% of midwives reporting no training in vaginal disimpaction., Conclusions: These findings demonstrate agreement on the components of a standardized definition for impacted fetal head, and a need and appetite for multi-professional training. These findings can inform a program of work to improve care, including use of structured management algorithms and simulation-based multi-professional training., (© 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Introduction: A common neurosurgical condition, chronic subdural haematoma (cSDH) typically affects older people with other underlying health conditions. The care of this potentially vulnerable cohort is often, however, fragmented and suboptimal. In other complex conditions, multidisciplinary guidelines have transformed patient experience and outcomes, but no such framework exists for cSDH. This paper outlines a protocol to develop the first comprehensive multidisciplinary guideline from diagnosis to long-term recovery with cSDH. Methods: The project will be guided by a steering group of key stakeholders and professional organisations and will feature patient and public involvement. Multidisciplinary thematic working groups will examine key aspects of care to formulate appropriate, patient-centered research questions, targeted with evidence review using the GRADE framework. The working groups will then formulate draft clinical recommendations to be used in a modified Delphi process to build consensus on guideline contents. Conclusions: We present a protocol for the development of a multidisciplinary guideline to inform the care of patients with a cSDH, developed by cross-disciplinary working groups and arrived at through a consensus-building process, including a modified online Delphi., Competing Interests: No competing interests were disclosed., (Copyright: © 2023 Stubbs DJ et al.)

Background: Implementation of national multiprofessional training for managing the obstetric emergency of impacted fetal head (IFH) at caesarean birth has potential to improve quality and safety in maternity care, but is currently lacking in the UK., Objectives: To evaluate a training package for managing IFH at caesarean birth with multiprofessional maternity teams., Methods: The training included an evidence-based lecture supported by an animated video showing management of IFH, followed by hands-on workshops and real-time simulations with use of a birth simulation trainer, augmented reality and management algorithms. Guided by the Kirkpatrick framework, we conducted a multimethod evaluation of the training with multiprofessional maternity teams. Participants rated post-training statements about relevance and helpfulness of the training and pre-training and post-training confidence in their knowledge and skills relating to IFH (7-point Likert scales, strongly disagree to strongly agree). An ethnographer recorded sociotechnical observations during the training. Participants provided feedback in post-training focus groups., Results: Participants (N=57) included 21 midwives, 25 obstetricians, 7 anaesthetists and 4 other professionals from five maternity units. Over 95% of participants agreed that the training was relevant and helpful for their clinical practice and improving outcomes following IFH. Confidence in technical and non-technical skills relating to managing IFH was variable before the training (5%-92% agreement with the pre-training statements), but improved in nearly all participants after the training (71%-100% agreement with the post-training statements). Participants and ethnographers reported that the training helped to: (i) better understand the complexity of IFH, (ii) recognise the need for multiprofessional training and management and (iii) optimise communication with those in labour and their birth partners., Conclusions: The evaluated training package can improve self-reported knowledge, skills and confidence of multiprofessional teams involved in management of IFH at caesarean birth. A larger-scale evaluation is required to validate these findings and establish how best to scale and implement the training., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The National Health Service (NHS) in England has introduced a range of policy measures aimed at fostering greater openness, transparency and candour about quality and safety. We draw on the findings of an evaluation of the implementation of these policies in NHS organisations, with the aim of identifying key implications for policy and practice., Methods: We undertook a mixed-methods policy evaluation, comprising four substudies: a longitudinal analysis of data from surveys of NHS staff and service users; interviews with senior stakeholders in NHS provider organisations and the wider system; a survey of board members of NHS provider organisations and organisational case studies across acute, community and mental health, and ambulance services., Results: Our findings indicate a mixed picture of progress towards improving openness in NHS organisations, influenced by organisational history and memories of past efforts, and complicated by organisational heterogeneity. We identify four features that appear to be necessary conditions for sustained progress in improving openness: (1) authentic integration into organisational mission is crucial in making openness a day-to-day concern; (2) functional and effective administrative systems are vital; (3) these systems must be leavened by flexibility and sensitivity in implementation and (4) a spirit of continuous inquiry, learning and improvement is required to avoid the fallacy that advancing openness can be reduced to a time-limited project. We also identify four persistent challenges in consolidating and sustaining improvement: (1) a reliance on goodwill and discretionary effort; (2) caring for staff, patients and relatives who seek openness; (3) the limits of values-driven approaches on their own and (4) the continued marginality of patients, carers and families., Conclusions: Variation in policy implementation offers important lessons on how organisations can better deliver openness, transparency and candour. These lessons highlight practical actions for policymakers, managers and senior clinicians.

Background: People with dementia and other forms of cognitive impairment form a substantial proportion of patients admitted to hospitals, but problems in their care are persistent. One widely proposed improvement approach involves the use of systems using visual identifiers to help staff quickly recognise people with suspected dementia, with the goal of supporting more personalised care. The aim of this paper is to identify the identifier systems in use and staff perceptions of their strengths and weaknesses., Methods: We undertook an online survey of staff providing care for people with dementia in acute and mental health hospitals across the United Kingdom. The questionnaire covered different types of visual identifier systems for dementia. It used categorical and open-response questions to access staff views of their use in practice. Responses were analysed using descriptive statistics, and the Framework approach for free-text answers., Results: 162 responses were received from staff in at least 48 hospitals. Of these, 128 had direct experience of using visual identifier systems. They reported that multiple identifier systems are in use, including schemes with national scope and locally developed approaches. Most respondents reported that more than one system is in use in their hospital. Different types of identifier were seen to have different strengths and weaknesses. Respondents had a broadly positive view of identifiers, but highlighted risks including lack of reliable and consistent use (linked to competing pressures on staff time), lack of staff training, uncertainty about patient and family views, and unclear consent processes., Conclusions: Our study suggests that a wide range of identifier systems is in use in UK hospitals, with many hospitals using more than one. Further consideration should be given to ensuring that multiple perspectives-including those of patients and carers-are drawn on in optimising their design, resolving ethical issues and supporting implementation., (© 2022 The Authors. International Journal of Older People Nursing published by John Wiley & Sons Ltd.)

Objective: Central venous access devices (CVADs), often known as central lines, are important for delivering medically complex care in children, and are increasingly used for children living at home. Central line-associated bloodstream infection (CLABSI) is a serious, life-threatening complication. Although the physical consequences of CLABSIs are well documented, families' views and experiences of CLABSI are poorly understood., Design: Qualitative study using semistructured interviews with participants from 11 families of a child living at home with a CVAD., Participants: Parents of children aged 4-12 years living at home with a CVAD. Four fathers and nine mothers participated in interviews., Results: The risk of CLABSI is a constant fear for families of a child with a CVAD. Though avoiding infection is a key priority for families, it is not the only one: maintaining a sense of 'normal life' is another goal. Infection prevention and control require much work and expertise on the part of families, contributing significantly to families' physical and emotional workload., Conclusions: Living with the risk of CLABSI poses additional burdens that impact on the physical and emotional well-being of families. Services to better support families to manage these burdens are needed., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Background: Workplace programmes to test staff for asymptomatic COVID-19 infection have become common, but raise a number of ethical challenges. In this article, we report the findings of a consultation that informed the development of an ethical framework for organisational decision-making about such programmes., Methods: We conducted a mixed-method consultation - a survey and semi-structured interviews during November-December 2020 in a UK case study organisation that had introduced asymptomatic testing for all staff working on-site in its buildings. Analysis of closed-ended survey data was conducted descriptively. An analysis approach based on the Framework Method was used for the open-ended survey responses and interview data. The analyses were then integrated to facilitate systematic analysis across themes. Inferences were based on the integrated findings and combined with other inputs (literature review, ethical analysis, legal and public health guidance, expert discussions) to develop an ethical framework., Results: The consultation involved 61 staff members from the case study organisation (50 survey respondents and 11 interview participants). There was strong support for the asymptomatic testing programme: 90% of the survey respondents viewed it as helpful or very helpful. Open-ended survey responses and interviews gave insight into participants' concerns, including those relating to goal drift, risk of false negatives, and potential negative impacts for household members and people whose roles lacked contractual and financial stability. Integration of the consultation findings and the other inputs identified the importance of a whole-system approach with appropriate support for the key control measure of isolation following positive tests. The need to build trust in the testing programme, for example through effective communication from leaders, was also emphasised., Conclusions: The consultation, together with other inputs, informed an ethical framework intended to support employers. The framework may support organisational decision-making in areas ranging from design and operation of the programme through to choices about participation. The framework is likely to benefit from further consultation and refinement in new settings., (© 2022. The Author(s).)

Background: Serious incident (SI) investigations aim to identify factors that caused or could have caused serious patient harm. This study aimed to use the Human Factors Analysis and Classification System (HFACS) to characterise the contributory factors identified in SI investigation reports., Methods: We performed a content analysis of 126 investigation reports from a multi-site NHS trust. We used a HFACS-based framework that was modified through inductive analysis of the data., Results: Using the modified HFACS framework, 'unsafe actions' were the most commonly identified hierarchical level of contributory factors in investigation reports, which were identified 282 times across 99 (79%) incidents. 'Preconditions to unsafe acts' (identified 223 times in 91 (72%) incidents) included miscommunication and environmental factors. Supervisory factors were identified 73 times across 40 (31%) incidents, and organisational factors 115 times across 59 (47%) incidents. We identified 'extra-organisational factors' as a new HFACS level, though it was infrequently described., Conclusions: Analysis of SI investigation reports using a modified HFACS framework allows important insights into what investigators view as contributory factors. We found an emphasis on human error but little engagement with why it occurs. Better investigations will require independence and professionalisation of investigators, human factors expertise, and a systems approach., (© Royal College of Physicians 2022. All rights reserved.)

Introduction: At least one in four people treated by the primary care improving access to psychological therapies (IAPT) programme in England experiences distressing psychotic experiences (PE) in addition to common mental disorder (CMD). These individuals are less likely to achieve recovery. IAPT services do not routinely screen for nor offer specific treatments for CMD including PE. The Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences study will evaluate the clinical and cost-effectiveness of an enhanced training for cognitive behavioural therapists that aims to address this clinical gap., Methods and Analysis: This is a multisite, stepped-wedge cluster randomised controlled trial. The setting will be IAPT services within three mental health trusts. The participants will be (1) 56-80 qualified IAPT cognitive behavioural therapists and (2) 600 service users who are triaged as appropriate for cognitive behavioural therapy in an IAPT service and have PE according to the Community Assessment of Psychic Experiences-Positive 15-items Scale. IAPT therapists will be grouped into eight study clusters subsequently randomised to the control-intervention sequence. We will obtain pseudonymous clinical outcome data from IAPT clinical records for eligible service users. We will invite service users to complete health economic measures at baseline, 3, 6, 9 and 12-month follow-up. The primary outcome will be the proportion of patients with common mental disorder psychotic experiences who have recovered by the end of treatment as measured by the official IAPT measure for recovery., Ethics and Dissemination: The study received the following approvals: South Central-Berkshire Research Ethics Committee on 28 April 2020 (REC reference 20/SC/0135) and Health Research Authority (HRA) on 23 June 2020. An amendment was approved by the Ethics Committee on 01 October 2020 and HRA on 27 October 2020. Results will be made available to patients and the public, the funders, stakeholders in the IAPT services and other researchers., Trial Registration Number: ISRCTN93895792., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Importance: The Centers for Medicare & Medicaid Services (CMS) Hospital Compare star ratings are widely used summaries of hospital quality that can influence patient choice and organizational reputation., Objective: To identify the changes in hospital ratings and rankings associated with alternative methodological choices in the calculation of the 2021 CMS Hospital Compare star ratings., Design Setting and Participants: This cross-sectional study used publicly available 2021 Hospital Compare data for 3339 US hospitals from the October 2020 data release. Change in apparent hospital performance was assessed, arising when plausible alternatives to current methods are used for calculating star ratings in relation to individual measure standardization, domain derivation, and domain weighting. Three example changes were examined in detail, with more comprehensive changes considered using Monte Carlo simulation. Changes in centile of hospital ranks and in star rating overall were examined, as well as separately in CMS peer groupings defined by the number of reported quality domains., Main Outcomes and Measures: Proportion of hospitals receiving a different star rating under the alternative technical specifications than under the current (2021) CMS approach and mean absolute change in centile rank of hospitals under alternative technical specifications compared with the current (2021) CMS approach., Results: A total of 3339 US hospitals were included in the analysis. Of the specific changes to current specifications considered, the alternative method of standardization was associated with the most substantial changes, with 55.4% (95% CI, 53.7%-57.1%) of hospitals having their star rating reclassified. The change in domain weights was associated with the smallest differences, but even that resulted in reclassification of the star rating in approximately 1 in 4 (24.5%; 95% CI, 23.0%-26.0%) hospitals. In the simulation study, which covered a range of possible changes, on average half of hospitals (51.8%; IQR, 44.2%-59.7%) were assigned a different star rating from that produced by the current specification, usually into an adjacent star category., Conclusions and Relevance: In this cross-sectional study of data on US hospitals, CMS Hospital Compare star ratings were found to be highly sensitive to how performance ratings are calculated, demonstrating the need for transparent justification of the technical approaches used in calculating composite performance ratings., Competing Interests: Conflict of Interest Disclosures: Dr Barclay reported honorarium from The Lancet for acting as a statistical reviewer outside the submitted work. Prof Dixon-Woods reported honorarium from the Centers for Medicare & Medicaid Services outside the submitted work. No other disclosures were reported., (Copyright 2022 Barclay ME et al. JAMA Health Forum.)

New models of data governance for health data are a focus of growing interest in an era of challenge to the social licence. In this article, we reflect on what the data trust model, which is founded on principles of participatory governance, can learn from experiences of involving and engagement of members of the public and participants in the governance of large-scale biobanks. We distinguish between upstream and ongoing governance models, showing how they require careful design and operation if they are to deliver on aspirations for deliberation and participation. Drawing on this learning, we identify a set of considerations important to future design for data trusts as they seek to ensure just, proportionate and fair governance. These considerations relate to the timing of involvement of participants, patterns of inclusion and exclusion, and responsiveness to stakeholder involvement and engagement. We emphasise that the evolution of governance models for data should be matched by a commitment to evaluation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Asymptomatic COVID-19 testing programmes are being introduced in higher education institutions, but stakeholder views regarding the acceptability of mandating or incentivizing participation remain little understood. A mixed-method study (semi-structured interviews and a survey including open and closed questions) was undertaken in a case study university with a student testing programme. Survey data were analysed descriptively; analysis for interviews was based on the framework method. Two hundred and thirty-nine people participated in the study: 213 in the survey (189 students, 24 staff), and 26 in interviews (19 students, 7 staff). There was majority (62%) but not universal support for voluntary participation, with a range of concerns expressed about the potentially negative effects of mandating testing. Those who supported mandatory testing tended to do so on the grounds that it would protect others. There was also majority (64%) opposition to penalties for refusing to test. Views on restricting access to face-to-face teaching for non-participants were polarized. Three-quarters (75%) supported incentives, though there were some concerns about effectiveness and unintended consequences. Participants emphasized the importance of communication about the potential benefits of testing. Preserving the voluntariness of participation in student asymptomatic testing programmes is likely to be the most ethically sound policy unless circumstances change., (© 2022 The Authors. Bioethics published by John Wiley & Sons Ltd.)

Objectives: Those who work in health care organisations are a potentially valuable source of information about safety concerns, yet failures of voice are persistent. We propose the concept of 'voiceable concern' and offer an empirical exploration., Methods: We conducted a qualitative study involving 165 semi-structured interviews with a range of staff (clinical, non-clinical and at different hierarchical levels) in three hospitals in two countries. Analysis was based on the constant comparative method., Results: Our analysis shows that identifying what counts as a concern, and what counts as a occasion for voice by a given individual, is not a straightforward matter of applying objective criteria. It instead often involves discretionary judgement, exercised in highly specific organisational and cultural contexts. We identified four influences that shape whether incidents, events and patterns were classified as voiceable concerns: certainty that something is wrong and is an occasion for voice; system versus conduct concerns, forgivability and normalisation. Determining what counted as a voiceable concern is not a simple function of the features of the concern; also important is whether the person who noticed the concern felt it was voiceable by them., Conclusions: Understanding how those who work in health care organisations come to recognise what counts as a voiceable concern is critical to understanding decisions and actions about speaking out. The concept of a voiceable concern may help to explain aspects of voice behaviour in organisations as well as informing interventions to improve voice.

Candidacy, a construct describing how people's eligibility for care is negotiated between themselves and services, has received limited attention in the context of mental health care. In addition, candidacy research has only rarely studied the views of carers and health professionals. In this article, we use concepts relating to candidacy to enable a theoretically informed examination of experiences of access to secondary mental health services during the first wave of the COVID-19 pandemic in England. We report a qualitative study of the views and experiences of service users, carers, and healthcare professionals. Analysis of 65 in-depth interviews was based on the constant comparative method. We found that wide-ranging service changes designed to address the imperatives of the pandemic were highly consequential for people's candidacy. Macro-level changes, including increased emphasis on crisis and risk management and adapted risk assessment systems, produced effects that went far beyond restrictions in the availability of services: they profoundly re-structured service users' identification of their own candidacy, including perceptions of what counted as a problem worthy of attention and whether they as individuals needed, deserved, and were entitled to care. Services became less permeable, such that finding a point of entry to those services that remained open required more work of service users and carers. Healthcare professionals were routinely confronted by complex decisions and ethical dilemmas about provision of care, and their implicit judgements about access may have important implications for equity. Many of the challenges of access exposed by the pandemic related to pre-existing resource deficits and institutional weaknesses in care for people living with mental health difficulties. Overall, these findings affirm the value of the construct of candidacy for explaining access to mental healthcare, but also enable deepened understanding of the specific features of candidacy, offering enduring learning and implications for policy and practice., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Although problems that impair task completion - known as operational failures - are an important focus of concern in primary care, they have remained little studied., Aim: To quantify the time GPs spend on different activities during clinical sessions; to identify the number of operational failures they encounter; and to characterise the nature of operational failures and their impact for GPs., Design and Setting: Mixed-method triangulation study with 61 GPs in 28 NHS general practices in England from December 2018 to December 2019., Method: Time-motion methods, ethnographic observations, and interviews were used., Results: Time-motion data on 7679 GP tasks during 238 hours of practice in 61 clinical sessions suggested that operational failures were responsible for around 5.0% (95% confidence interval [CI] = 4.5% to 5.4%) of all tasks undertaken by GPs and accounted for 3.9% (95% CI = 3.2% to 4.5%) of clinical time. However, qualitative data showed that time-motion methods, which depend on pre-programmed categories, substantially underestimated operational failures. Qualitative data also enabled further characterisation of operational failures, extending beyond those measured directly in the time-motion data (for example, interruptions, deficits in equipment/supplies, and technology) to include problems linked to GPs' coordination role and weaknesses in work systems and processes. The impacts of operational failures were highly consequential for GPs' experiences of work., Conclusion: GPs experience frequent operational failures, disrupting patient care, impairing experiences of work, and imposing burden in an already pressurised system. This better understanding of the nature and impact of operational failures allows for identification of targets for improvement and indicates the need for coordinated action to support GPs., (© The Authors.)

Employee voice is an important source of organizational intelligence about possible problems in quality and patient safety, but effective systems for encouraging and supporting those who seek to speak up have remained elusive. In the English National Health Service, a novel role known as the 'Freedom to Speak Up Guardian' has been introduced to address this problem. We critically examine the role and its realization in practice, drawing on semi-structured interviews with 51 key individuals, including Guardians, clinicians, managers, policymakers, regulators and others. Operationalizing the new role in organizations was not straightforward, since it had to sit in a complex set of existing systems and processes. One response was to seek to bound the scope of Guardians, casting them in a signposting or coordinating role in relation to quality and safety concerns. However, the role proved hard to delimit, not least because the concerns most frequently voiced in practice differed in character from those anticipated in the role's development. Guardians were tasked with making sense of and dealing with issues that could not always straightforwardly be classified, deflected to the right system or escalated to the appropriate authority. Our analysis suggests that the role's potential contribution might be understood less as supporting whistleblowers who bear witness to clear-cut wrongdoing, and more as helping those with lower-level worries to construct their concerns and what to do with them. These findings have implications for how voice is understood, imagined and addressed in healthcare organizations.

Healthcare organisations' responses to concerns and complaints often fall short of the expectations of patients and staff who raise them, and substandard responses to concerns and complaints have been implicated in organisational failures. Informed by Habermas's systems theory, we offer new insights into the features of organisations' responses to concerns and complaints that give rise to these problems. We draw on a large qualitative dataset, comprising 88 predominantly narrative interviews with people raising and responding to concerns and complaints in six English NHS organisations. In common with past studies, many participants described frustrations with systems and processes that seemed ill-equipped to deal with concerns of the kinds they raised. Departing from existing analyses, we identify the influence of functional rationality, as conceptualised by Habermas, and embodied in procedures, pathways and scripts for response, in producing this dissatisfaction. Functionally rational processes were well equipped to deal with simple, readily categorised concerns and complaints. They were less well placed to respond adequately to concerns and complaints that were complex, cross-cutting, or irreducible to predetermined criteria for redress and resolution. Drawing on empirical examples and on Habermas's theory of communicative action, we offer suggestions for alternative and supplementary approaches to responding to concerns and complaints that might better address both the expectations of complainants and the improvement of services., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The importance of employee voice-speaking up and out about concerns-is widely recognised as fundamental to patient safety and quality of care. However, failures of voice continue to occur, often with disastrous consequences. In this article, we argue that the enduring sociological concepts of the informal organisation and formal organisation offer analytical purchase in understanding the causes of such problems and how they can be addressed. We report a qualitative study involving 165 interviews across three healthcare organisations in two high-income countries. Our analysis emphasises the interdependence of the formal and informal organisation. The formal organisation describes codified and formalised elements of structures, procedures and processes for the exercise of voice, but participants often found it frustrating, ambiguous, and poorly designed. The informal organisation-the informal practices, social connections, and methods for making decisions that are key to coordinating organisational activity-could facilitate voice through its capacity to help people to understand complex processes, make sense of their concerns, and frame them in ways likely to prompt an appropriate organisational response. Sometimes the informal organisation compensated for gaps, ambiguities and inconsistencies in formal policies and systems. At the same time, the informal organisation had a dark side, potentially subduing voice by creating informal hierarchies, prioritising social cohesion, and providing opportunities for retaliation. The formal and the informal organisation are not exclusive or independent: they interact with and mutually reinforce each other. Our findings have implications for efforts to improve culture and processes in relation to voice in healthcare organisations, pointing to the need to address deficits in the formal organisation, and to the potential of building on strengths in the informal organisation that are crucial in supporting voice., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Reducing avoidable harm in maternity services is a priority globally. As well as learning from mistakes, it is important to produce rigorous descriptions of 'what good looks like'., Objective: We aimed to characterise features of safety in maternity units and to generate a plain language framework that could be used to guide learning and improvement., Methods: We conducted a multisite ethnography involving 401 hours of non-participant observations 33 semistructured interviews with staff across six maternity units, and a stakeholder consultation involving 65 semistructured telephone interviews and one focus group., Results: We identified seven features of safety in maternity units and summarised them into a framework, named For Us (For Unit Safety). The features include: (1) commitment to safety and improvement at all levels, with everyone involved; (2) technical competence, supported by formal training and informal learning; (3) teamwork, cooperation and positive working relationships; (4) constant reinforcing of safe, ethical and respectful behaviours; (5) multiple problem-sensing systems, used as basis of action; (6) systems and processes designed for safety, and regularly reviewed and optimised; (7) effective coordination and ability to mobilise quickly. These features appear to have a synergistic character, such that each feature is necessary but not sufficient on its own: the features operate in concert through multiple forms of feedback and amplification., Conclusions: This large qualitative study has enabled the generation of a new plain language framework-For Us-that identifies the behaviours and practices that appear to be features of safe care in hospital-based maternity units., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: The Covid-19 pandemic has imposed extraordinary strains on healthcare workers. But, in contrast with acute settings, relatively little attention has been given to those who work in mental health settings. We aimed to characterise the experiences of those working in English NHS secondary mental health services during the first wave of the pandemic., Methods: The design was a qualitative interview-based study. We conducted semi-structured, remote (telephone or online) interviews with 35 members of staff from NHS secondary (inpatient and community) mental health services in England. Analysis was based on the constant comparative method., Results: Participants reported wide-ranging changes in the organisation of secondary mental health care and the nature of work in response to the pandemic, including pausing of all services deemed to be "non-essential", deployment of staff across services to new and unfamiliar roles, and moves to remote working. The quality of participants' working life was impaired by increasing levels of daily challenge associated with trying to provide care in trying and constrained circumstances, the problems of forging new ways of working remotely, and constraints on ability to access informal support. Participants were confronted with difficult dilemmas relating to clinical decision-making, prioritisation of care, and compromises in ability to perform the therapeutic function of their roles. Other dilemmas centred on trying to balance the risks of controlling infection with the need for human contact. Many reported features of moral injury linked to their perceived failures in providing the quality or level of care that they felt service users needed. They sometimes sought to compensate for deficits in care through increased advocacy, taking on additional tasks, or making exceptions, but this led to further personal strain. Many experienced feelings of grief, helplessness, isolation, distress, and burnout. These problems were compounded by sometimes poor communication about service changes and by staff feeling that they could not take time off because of the potential impact on others. Some reported feeling poorly supported by organisations., Conclusions: Mental health workers faced multiple adversities during the pandemic that were highly consequential for their wellbeing. These findings can help in identifying targets for support.

Background: Practical methods for facilitating process improvement are needed to support high quality, safe care. How best to specify (identify and define) process improvements - the changes that need to be made in a healthcare process - remains a key question. Methods for doing so collaboratively, rapidly and remotely offer much potential, but are under-developed. We propose an approach for engaging diverse stakeholders remotely in a consensus-building exercise to help specify improvements in a healthcare process, and we illustrate the approach in a case study., Methods: Organised in a five-step framework, our proposed approach is informed by a participatory ethos, crowdsourcing and consensus-building methods: (1) define scope and objective of the process improvement; (2) produce a draft or prototype of the proposed process improvement specification; (3) identify participant recruitment strategy; (4) design and conduct a remote consensus-building exercise; (5) produce a final specification of the process improvement in light of learning from the exercise. We tested the approach in a case study that sought to specify process improvements for the management of obstetric emergencies during the COVID-19 pandemic. We used a brief video showing a process for managing a post-partum haemorrhage in women with COVID-19 to elicit recommendations on how the process could be improved. Two Delphi rounds were then conducted to reach consensus., Results: We gathered views from 105 participants, with a background in maternity care (n = 36), infection prevention and control (n = 17), or human factors (n = 52). The participants initially generated 818 recommendations for how to improve the process illustrated in the video, which we synthesised into a set of 22 recommendations. The consensus-building exercise yielded a final set of 16 recommendations. These were used to inform the specification of process improvements for managing the obstetric emergency and develop supporting resources, including an updated video., Conclusions: The proposed methodological approach enabled the expertise and ingenuity of diverse stakeholders to be captured and mobilised to specify process improvements in an area of pressing service need. This approach has the potential to address current challenges in process improvement, but will require further evaluation.

Objectives: To explore the experiences of service users, carers and staff seeking or providing secondary mental health services during the COVID-19 pandemic., Design: Qualitative interview study, codesigned with mental health service users and carers., Methods: We conducted semistructured, telephone or online interviews with a purposively constructed sample; a lived experience researcher conducted and analysed interviews with service users. Analysis was based on the constant comparison method., Setting: National Health Service (NHS) secondary mental health services in England between June and August 2020., Participants: Of 65 participants, 20 had either accessed or needed to access English secondary mental healthcare during the pandemic; 10 were carers of people with mental health difficulties; 35 were members of staff working in NHS secondary mental health services during the pandemic., Results: Experiences of remote care were mixed. Some service users valued the convenience of remote methods in the context of maintaining contact with familiar clinicians. Most participants commented that a lack of non-verbal cues and the loss of a therapeutic 'safe space' challenged therapeutic relationship building, assessments and identification of deteriorating mental well-being. Some carers felt excluded from remote meetings and concerned that assessments were incomplete without their input. Like service users, remote methods posed challenges for clinicians who reported uncertainty about technical options and a lack of training. All groups expressed concern about intersectionality exacerbating inequalities and the exclusion of some service user groups if alternatives to remote care are lost., Conclusions: Though remote mental healthcare is likely to become increasingly widespread in secondary mental health services, our findings highlight the continued importance of a tailored, personal approach to decision making in this area. Further research should focus on which types of consultations best suit face-to-face interaction, and for whom and why, and which can be provided remotely and by which medium., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Postpartum haemorrhage (PPH) is an obstetric emergency requiring prompt and accurate response. PPH emergency kits containing equipment and medications can facilitate this kind of intervention, but their design and contents vary, potentially introducing risk of confusion or delay. Designs may be suboptimal, and relying on localised kit contents may result in supply chain costs, increased waste and missed opportunities for economies of scale. This study aims to characterise contextual influences on current practice in relation to PPH kits and to describe the range of kits currently employed in UK maternity units., Methods and Analysis: This mixed-methods study comprises two phases. The first will use field observations and semistructured interviews to research PPH kits in a small number (3-5) of maternity units that will be selected to represent diversity. Analysis will be conducted both using an established human factors and ergonomics framework and using the constant comparative method for qualitative data analysis. The second phase will use a research and development platform (Thiscovery) to conduct a crowdsourced photography-based audit of PPH kits currently in use in the UK. Participants will tag images to indicate which objects have been photographed. Quantitative analysis will report the frequency of inclusion of each item in kits and the content differences between kit and unit types. All maternity units in the UK will be invited to take part, with additional targeted recruitment strategies used, if necessary, to ensure that the final sample includes different maternity unit types, sizes and PPH kit types. Study results will inform future work to develop consensus on effective PPH kit designs., Ethics and Dissemination: Approval has been received from the UK Health Research Authority (project ID 274147). Study results will be reported through the research institute's website, presented at conferences and published in peer-reviewed journals., Competing Interests: Competing interests: TD is a paid speaker for Ferring Pharmaceuticals and Royal College of Obstetricians and Gynaecologists., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Measurement is an indispensable element of most quality improvement (QI) projects, but it is undertaken to variable standards. We aimed to characterise challenges faced by clinical teams in undertaking measurement in the context of a safety QI programme that encouraged local selection of measures., Methods: Drawing on an independent evaluation of a multisite improvement programme (Safer Clinical Systems), we combined a qualitative study of participating teams' experiences and perceptions of measurement with expert review of measurement plans and analysis of data collected for the programme. Multidisciplinary teams of frontline clinicians at nine UK NHS sites took part across the two phases of the programme between 2011 and 2016., Results: Developing and implementing a measurement plan against which to assess their improvement goals was an arduous task for participating sites. The operational definitions of the measures that they selected were often imprecise or missed important details. Some measures used by the teams were not logically linked to the improvement actions they implemented. Regardless of the specific type of data used (routinely collected or selected ex novo), the burdensome nature of data collection was underestimated. Problems also emerged in identifying and using suitable analytical approaches., Conclusion: Measurement is a highly technical task requiring a degree of expertise. Simply leveraging individual clinicians' motivation is unlikely to defeat the persistent difficulties experienced by clinical teams when attempting to measure their improvement efforts. We suggest that more structural initiatives and broader capability-building programmes should be pursued by the professional community. Improving access to, and ability to use repositories of validated measures, and increasing transparency in reporting measurement attempts, is likely to be helpful., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Operational failures, defined as inadequacies or errors in the information, supplies, or equipment needed for patient care, are known to be highly consequential in hospital environments. Despite their likely relevance for GPs' experiences of work, they remain under-explored in primary care., Aim: To identify operational failures in the primary care work environment and to examine how they influence GPs' work., Design and Setting: Qualitative interview study in the East of England., Method: Semi-structured interviews were conducted with GPs ( n = 21). Data analysis was based on the constant comparison method., Results: GPs reported a large burden of operational failures, many of them related to information transfer with external healthcare providers, practice technology, and organisation of work within practices. Faced with operational failures, GPs undertook 'compensatory labour' to fulfil their duties of coordinating and safeguarding patients' care. Dealing with operational failures imposed significant additional strain in the context of already stretched daily schedules, but this work remained largely invisible. In part, this was because GPs acted to fix problems in the here-and-now rather than referring them to source, and they characteristically did not report operational failures at system level. They also identified challenges in making process improvements at practice level, including medicolegal uncertainties about delegation., Conclusion: Operational failures in primary care matter for GPs and their experience of work. Compensatory labour is burdensome with an unintended consequence of rendering these failures largely invisible. Recognition of the significance of operational failures should stimulate efforts to make the primary care work environment more attractive., (©The Authors.)

Background: New opportunities to record, collate, and analyze routine patient data have prompted optimism about the potential of learning health systems. However, real-life examples of such systems remain rare and few have been exposed to study. We aimed to examine the views of design stakeholders on designing and implementing a US-based registry-enabled care and learning system for cystic fibrosis (RCLS-CF)., Methods: We conducted a two-phase qualitative study with stakeholders involved in designing, implementing, and using the RCLS-CF. First, we conducted semi-structured interviews with 19 program personnels involved in design and delivery of the program. We then undertook 11 follow-up interviews. Analysis of interviews was based on the constant comparative method, supported by NVivo software., Results: The organizing principle for the RCLS-CF was a shift to more partnership-based relationships between patients and clinicians, founded in values of co-production, and facilitated by technology-enabled data sharing. Participants proposed that, for the system to be successful, the data it collects must be both clinically useful and meaningful to patients and clinicians. They suggested that the prerequisites included a technological infrastructure capable of supporting data entry and joint decision-making in an accessible way, and a set of social conditions, including willingness from patients and clinicians alike to work together in new ways that build on the expertise of both parties. Follow-up interviews highlighted some of the obstacles, including technical challenges and practical constraints on refiguring relationships between clinicians and patients., Conclusions: The values and vision underlying the RCLS-CF were shared and clearly and consistently articulated by design stakeholders. The challenges to realization were often not at the level of principle, but were both practical and social in character. Lessons from this study may be useful to other systems looking to harness the power of "big data" registries, including patient-reported data, for care, research, and quality improvement.

Simulation can offer researchers access to events that can otherwise not be directly observed, and in a safe and controlled environment. How to use simulation for the study of how to improve the quality and safety of healthcare remains underexplored, however. We offer an overview of simulation-based research (SBR) in this context. Building on theory and examples, we show how SBR can be deployed and which study designs it may support. We discuss the challenges of simulation for healthcare improvement research and how they can be tackled. We conclude that using simulation in the study of healthcare improvement is a promising approach that could usefully complement established research methods., Competing Interests: Competing interests None declared.

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following interests: TD is employed by NHS Resolution as a senior maternity adviser and is a trustee of the PROMPT Maternity Foundation, a UK based charity that undertakes research and provides multiprofessional training. TD is partially funded by the PROMPT Maternity Foundation on a secondment basis from North Bristol NHS Trust. CWHY has previously been partially funded by the PROMPT Maternity Foundation. BL provides legal advice to doctors and hospitals. MDW and EL are research collaborators of TD. DP, EL, and MDW are supported by the Health Foundation’s grant to the University of Cambridge for The Healthcare Improvement Studies (THIS) Institute. MDW is a National Institute for Health Research (NIHR) senior investigator (NF-SI-0617-10026).