Management of impacted fetal head at cesarean birth: A systematic review and meta-analysis.

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 (e.g., 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.

Risk factors for a serious adverse outcome in neonates: a retrospective cohort study of vaginal births.

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.

Definition, management, and training in impacted fetal head at cesarean birth: a national survey of maternity professionals.

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.

What can data trusts for health research learn from participatory governance in biobanks?

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.

Guiding organisational decision-making about COVID-19 asymptomatic testing in workplaces: mixed-method study to inform an ethical framework.

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.

Mixed-methods exploration of views on choice in a university asymptomatic COVID-19 testing programme.

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.

How to specify healthcare process improvements collaboratively using rapid, remote consensus-building: a framework and a case study of its application.

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.

A qualitative study of experiences of NHS mental healthcare workers during the Covid-19 pandemic.

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.

Impacts of Operational Failures on Primary Care Physicians' Work: A Critical Interpretive Synthesis of the Literature.

PURPOSE: Operational failures are system-level errors in the supply of information, equipment, and materials to health care personnel. We aimed to review and synthesize the research literature to determine how operational failures in primary care affect the work of primary care physicians. METHODS: We conducted a critical interpretive synthesis. We searched 7 databases for papers published in English from database inception until October 2017 for primary research of any design that addressed problems interfering with primary care physicians' work. All potentially eligible titles/abstracts were screened by 1 reviewer; 30% were subject to second screening. We conducted an iterative critique, analysis, and synthesis of included studies. RESULTS: Our search retrieved 8,544 unique citations. Though no paper explicitly referred to "operational failures," we identified 95 papers that conformed to our general definition. The included studies show a gap between what physicians perceived they should be doing and what they were doing, which was strongly linked to operational failures-including those relating to technology, information, and coordination-over which physicians often had limited control. Operational failures actively configured physicians' work by requiring significant compensatory labor to deliver the goals of care. This labor was typically unaccounted for in scheduling or reward systems and had adverse consequences for physician and patient experience. CONCLUSIONS: Primary care physicians' efforts to compensate for suboptimal work systems are often concealed, risking an incomplete picture of the work they do and problems they routinely face. Future research must identify which operational failures are highest impact and tractable to improvement.

A modified Delphi study to identify the features of high quality measurement plans for healthcare improvement projects.

BACKGROUND: The design and execution of measurement in quality improvement (QI) initiatives is often poor. Better guidance on "what good looks like" might help to mitigate some of the problems. We report a consensus-building process that sought to identify which features are important to include in QI measurement plans. METHODS: We conducted a three-stage consensus-building approach: (1) identifying the list of features of measurement plans that were potential candidates for inclusion based on literature review and the study team's experience; (2) a two-round modified Delphi exercise with a panel of experts to establish consensus on the importance of these features; and (3) a small in-person consensus group meeting to finalise the list of features. RESULTS: A list of 104 candidate questions was generated. A panel of 19 experts in the Delphi reviewed these questions and produced consensus on retaining 46 questions in the first round and on a further 22 in the second round. Thematic analysis of open text responses from the panellists suggested a number of areas of debate that were explicitly considered by the consensus group. The exercise yielded 74 questions (71% of 104) on which there was consensus in five categories of measurement relating to: design, data collection and management, analysis, action, and embedding. CONCLUSIONS: This study offers a consensus-based view on the features of a good measurement plan for a QI project in healthcare. The results may be of use to QI teams, funders and evaluators, but are likely to require further development and testing to ensure feasibility and usefulness.

Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks.

In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to 'unethical research' and a 'government experimenting on its own people'. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.

Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers.

Public health and service delivery programmes, interventions and policies (collectively, 'programmes') are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that helps determine effectiveness and costs as well as informing design and implementation of future programmes. Such studies might be termed 'opportunistic evaluations', since they are responsive to emergent opportunities rather than being studies of interventions that are initiated or designed by researchers. However, current ethical guidance and registration procedures make little allowance for scenarios where researchers have played no role in the development or implementation of a programme, but nevertheless plan to conduct a prospective evaluation. We explore the limitations of the guidance and procedures with respect to opportunistic evaluations, providing a number of examples. We propose that one key missing distinction in current guidance is moral responsibility: researchers can only be held accountable for those aspects of a study over which they have control. We argue that requiring researchers to justify an intervention, programme or policy that would occur regardless of their involvement prevents or hinders research in the public interest without providing any further protections to research participants. We recommend that trial consent and ethics procedures allow for a clear separation of responsibilities for the intervention and the evaluation.

Learning from high risk industries may not be straightforward: a qualitative study of the hierarchy of risk controls approach in healthcare.

OBJECTIVE: Though healthcare is often exhorted to learn from 'high-reliability' industries, adopting tools and techniques from those sectors may not be straightforward. We sought to examine the hierarchies of risk controls approach, used in high-risk industries to rank interventions according to supposed effectiveness in reducing risk, and widely advocated as appropriate for healthcare. DESIGN: Classification of risk controls proposed by clinical teams following proactive detection of hazards in their clinical systems. Classification was based on a widely used hierarchy of controls developed by the US National Institute for Occupational Safety and Health (NIOSH). SETTING AND PARTICIPANTS: A range of clinical settings in four English NHS hospitals. RESULTS: The four clinical teams in our study planned a total of 42 risk controls aimed at addressing safety hazards. Most (n = 35) could be classed as administrative controls, thus qualifying among the weakest type of interventions according to the HoC approach. Six risk controls qualified as 'engineering' controls, i.e. the intermediate level of the hierarchy. Only risk control qualified as 'substitution', classified as the strongest type of intervention by the HoC. CONCLUSIONS: Many risk controls introduced by clinical teams may cluster towards the apparently weaker end of an established hierarchy of controls. Less clear is whether the HoC approach as currently formulated is useful for the specifics of healthcare. Valuable opportunities for safety improvement may be lost if inappropriate hierarchical models are used to guide the selection of patient safety improvement interventions. Though learning from other industries may be useful, caution is needed.

A qualitative study of participants' views on re-consent in a longitudinal biobank.

BACKGROUND: Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or "biobanks" over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. METHODS: We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. RESULTS: What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. CONCLUSIONS: Participants' perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation.

How Well Is Quality Improvement Described in the Perioperative Care Literature? A Systematic Review.

BACKGROUND: Quality improvement (QI) approaches are widely used across health care, but how well they are reported in the academic literature is not clear. A systematic review was conducted to assess the completeness of reporting of QI interventions and techniques in the field of perioperative care. METHODS: Searches were conducted using Medline, Scopus, the Cochrane Central Register of Controlled Trials, the Cochrane Effective Practice and Organization of Care database, and PubMed. Two independent reviewers used the Template for Intervention Description and Replication (TIDieR) check list, which identifies 12 features of interventions that studies should describe (for example, How: the interventions were delivered [e. g., face to face, internet]), When and how much: duration, dose, intensity), to assign scores for each included article. Articles were also scored against a small number of additional criteria relevant to QI. RESULTS: The search identified 16,103 abstracts from databases and 19 from other sources. Following review, full-text was obtained for 223 articles, 100 of which met the criteria for inclusion. Completeness of reporting of QI in the perioperative care literature was variable. Only one article was judged fully complete against the 11 TIDieR items used. The mean TIDieR score across the 100 included articles was 6.31 (of a maximum 11). More than a third (35%) of the articles scored 5 or lower. Particularly problematic was reporting of fidelity (absent in 74% of articles) and whether any modifications were made to the intervention (absent in 73% of articles). CONCLUSIONS: The standard of reporting of quality interventions and QI techniques in surgery is often suboptimal, making it difficult to determine whether an intervention can be replicated and used to deliver a positive effect in another setting. This suggests a need to explore how reporting practices could be improved.

What is the role of individual accountability in patient safety? A multi-site ethnographic study.

An enduring debate concerns how responsibility for patient safety should be distributed between organisational systems and individual professionals. Though rule-based, calculus-like approaches intended to support a 'just culture' have become popular, they perpetuate an asocial and atomised account. In this article, we use insights from practice theory--which sees organisational phenomena as accomplished in everyday actions, with individual agency and structural conditions as a mutually constitutive, dynamic duality--along with contributions from the political science and ethics literature as a starting point for analysis. Presenting ethnographic data from five hospitals, three in one high-income country and two in low-income countries, we offer an empirically informed, normative rethinking of the role of personal accountability, identifying the collective nature of the healthcare enterprise and the extent to which patient safety depends on contributions from many hands. We show that moral responsibility for actions and behaviours is an irreducible element of professional practice, but that individuals are not somehow 'outside' and separate from 'systems': they create, modify and are subject to the social forces that are an inescapable feature of any organisational system; each element acts on the other. Our work illustrates starkly the structuring effects of the broader institutional and socioeconomic context on opportunities to 'be good'. These findings imply that one of the key responsibilities of organisations and wider institutions in relation to patient safety is the fostering of the conditions of moral community.

Why is patient safety so hard in low-income countries? A qualitative study of healthcare workers' views in two African hospitals.

BACKGROUND: The views of practitioners at the sharp end of health care provision are now recognised as a valuable source of intelligence that can inform efforts to improve patient safety in high-income countries. Yet despite growing policy emphasis on patient safety in low-income countries, little research examines the views of practitioners in these settings. We aimed to give voice to how healthcare workers in two East African hospitals identify and explain the major obstacles to ensuring the safety of patients in their care. METHODS: We conducted in-depth, face to face interviews with healthcare workers in two East African hospitals. Our sample included a total of 57 hospital staff, including nurses, physicians, technicians, clinical services staff, administrative staff and hospital managers. RESULTS: Hospital staff in low-income settings offered broadly encompassing and aspirational definitions of patient safety. They identified obstacles to patient safety across three major themes: material context, staffing issues and inter-professional working relationships. Participants distinguished between the proximal influences on patient safety that posed an immediate threat to patient care, and the distal influences that generated the contexts for such hazards. These included contexts of severe material deprivation, but also the impact of relational factors such as teamwork and professional hierarchies. Structures of authority, governance and control that were not optimally aligned with achieving patient safety were widely reported. CONCLUSIONS: As in high-income countries, the accounts of healthcare workers in low-income countries provide sophisticated and valuable insights into the challenges of patient safety. Though the impact of resource constraints and weak governance structures are particularly marked in low-income countries, the congruence between accounts of health workers in diverse settings suggest that the origins and solutions to patient safety problems are likely to be similar everywhere and are rooted in human factors, resources, culture and behaviour. While additional resources are essential to patient safety improvement in low-income settings, such resources on their own will not be sufficient to secure the changes needed.

The social licence for research: why care.data ran into trouble.

In this article we draw on the concept of a social licence to explain public concern at the introduction of care.data, a recent English initiative designed to extract data from primary care medical records for commissioning and other purposes, including research. The concept of a social licence describes how the expectations of society regarding some activities may go beyond compliance with the requirements of formal regulation; those who do not fulfil the conditions for the social licence (even if formally compliant) may experience ongoing challenge and contestation. Previous work suggests that people's cooperation with specific research studies depends on their perceptions that their participation is voluntary and is governed by values of reciprocity, non-exploitation and service of the public good. When these conditions are not seen to obtain, threats to the social licence for research may emerge. We propose that care.data failed to adequately secure a social licence because of: (i) defects in the warrants of trust provided for care.data, (ii) the implied rupture in the traditional role, expectations and duties of general practitioners, and (iii) uncertainty about the status of care.data as a public good. The concept of a social licence may be useful in explaining the specifics of care.data, and also in reinforcing the more general lesson for policy-makers that legal authority does not necessarily command social legitimacy.