Economic evaluations performed alongside randomized implementation trials in clinical settings: a systematic review.

BACKGROUND: Economic evaluations alongside implementation trials compare the outcomes and costs of competing implementation strategies to identify the most efficient strategies. The aims of this systematic review were to investigate how economic evaluations are performed in randomized implementation trials in clinical settings and to assess the quality of these evaluations. METHODS: A systematic literature review was conducted on 23 March 2023 to identify studies that reported on economic evaluations embedded in randomized implementation trials in clinical settings. A systematic search was applied across seven databases, and references of relevant reviews were screened for additional studies. The Drummond Checklist was used to assess the quality and risk of bias of included economic evaluations. Study characteristics and quality assessments were tabulated and described. RESULTS: Of the 6,550 studies screened for eligibility, 10 met the inclusion criteria. Included studies were published between 1990 and 2022 and from North America, the United Kingdom, Europe, and Africa. Most studies were conducted in the primary and out-patient care setting. Implementation costs included materials, staffing, and training, and the most common approach to collecting implementation costs was obtaining expense and budget reports. Included studies scored medium to high in terms of economic methodological quality. CONCLUSIONS: Economic evidence is particularly useful for healthcare funders and service providers to inform the prioritization of implementation efforts in the context of limited resources and competing demands. The relatively small number of studies identified may be due to lack of guidance on how to conduct economic evaluations alongside implementation trials and the lack of standardized terminology used to describe implementation strategies in clinical research. We discuss these methodological gaps and present recommendations for embedding economic evaluations in implementation trials. First, reporting implementation strategies used in clinical trials and aligning these strategies with implementation outcomes and costs are an important advancement in clinical research. Second, economic evaluations of implementation trials should follow guidelines for standard clinical trial economic evaluations and adopt an appropriate costing and data collection approach. Third, hybrid trial designs are recommended to generate evidence for effective and cost-effective implementation strategies alongside clinical effectiveness and cost-effectiveness. TRIAL REGISTRATION: The review was prospectively registered with PROSPERO (CRD42023410186).

What is the best way to evaluate social prescribing? A qualitative feasibility assessment for a national impact evaluation study in England.

OBJECTIVES: Despite significant investment in social prescribing in England over the last decade, we still do not know if it works, or how models of social prescribing fit within wider health and care policy and practice. This study explores current service delivery structures and assesses the feasibility of a national evaluation of the link worker model. METHODS: Semi-structured interviews were conducted between May and September 2020, with 25 key informants from across social prescribing services in England. Participants included link workers, voluntary, community and social enterprise staff, and those involved in policy and decision-making for social prescribing services. Interview and workshop transcripts were analysed thematically, adopting a framework approach. RESULTS: We found differences in how services are provided, including by individual link workers, and between organisations and regions. Standards, referral pathways, reporting, and monitoring structures differ or are lacking in voluntary services as compared to clinical services. People can self-refer to a link worker or be referred by a third party, but the lack of standardised processes generated confusion in both public and professional perceptions of the link worker model. We identified challenges in determining the appropriate outcomes and outcome measures needed to assess the impact of the link worker model. CONCLUSIONS: The current varied service delivery structures in England poses major challenges for a national impact evaluation. Any future rigorous evaluation needs to be underpinned with national standardised outcomes and process measures which promote uniform data collection.

Clinical effectiveness of pharmacological interventions for managing chronic migraine in adults: a systematic review and network meta-analysis.

BACKGROUND: Chronic migraine can be a profoundly disabling disorder that may be treated with preventive medications. However, uncertainty remains as to which preventive medication is the most effective. We present a network meta-analysis to determine the effectiveness and rank of preventive drugs for chronic migraine in adults. METHODS: We identified, reviewed, and extracted data from randomised controlled trials (RCTs) of preventive drugs for chronic migraine with at least 200 participants. Data were analysed using network meta-analysis. FINDINGS: We included 12 RCTs of six medications (Eptinezumab, Erenumab, Fremanezumab, Galcanezumab, Onabotulinumtoxin A, and Topiramate) compared to placebo or each other. All drugs effectively reduced monthly headache and migraine days compared with placebo. The most effective drug for monthly headache days was Eptinezumab 300mg, with a mean difference of -2.46 days, 95% Credible Interval (CrI): -3.23 to -1.69. On the Surface Under the Cumulative Ranking Area (SUCRA) analysis, the probability that Eptinezumab 300mg was ranked highest was 0.82. For monthly migraine days, the most effective medication was Fremanezumab-monthly, with a mean difference: -2.77 days, 95% CrI: -3.36 to -2.17, and 0.98 probability of being ranked the highest. All included drugs, except Topiramate, improved headache-related quality of life. No eligible studies were identified for the other common preventive oral medications such as Amitriptyline, Candesartan, and Propranolol. The main reasons were that the studies did not define chronic migraine, were undertaken before the definition of chronic migraine, or were too small. INTERPRETATION: All six medications were more effective than the placebo on monthly headache and migraine days. The absolute differences in the number of headache/migraine days are, at best, modest. No evidence was found to determine the relative effectiveness of the six included drugs with other oral preventive medications. REGISTRATION: PROSPERO (number CRD42021265990).

In which context and for whom can interventions improve leadership of surgical trainees, surgeons and surgical teams and why: a realist review protocol.

Background: Improving effective leadership of individuals, groups, and healthcare organisations is essential for improving surgical performance and indirectly improving health outcomes for patients. Numerous systematic reviews have been conducted which seek to determine the effectiveness of specific leadership interventions across a range of disciplines and healthcare outcomes. The purpose of this realist review is to systematically synthesise the literature which examines in which context and for whom leadership interventions improve leadership of surgeons, surgical teams, and trainees. Methods: Several approaches will be used to iteratively search the scientific and grey literature to identify relevant evidence. Selected articles will inform the development of a programme theory that seeks to explain in which context and for whom interventions can improve leadership of surgical trainees, surgeons, and surgical teams. Next, empirical studies will be searched systematically in order to test and, where necessary, refine the theory. Once theoretical saturation has been achieved, recommendations for advancing leadership in surgery will be developed. Stakeholder and patient and public consultations will contribute to the development of the programme theory. The review will be written up according to the Realist And Meta-narrative Evidence Synthesis: Evolving Standards publication standards. No ethical review will be required for the conduct of this realist review. Discussion: The knowledge gained from this review will provide evidence-based guidance for those planning or designing leadership interventions in surgery. The recommendations will help policymakers, educationalists, healthcare providers, and those delivering or planning leadership development programmes across the surgical disciplines to design interventions that are acceptable to the surgical community and successful in improving surgical leadership.PROSPERO registration: CRD42021230709.

How do leadership development activities need to be designed in order to improve the leadership of surgeons, surgical teams and surgical trainees? Leadership is seen to be an important skill for those working in healthcare. Healthcare systems therefore, invest a lot of money into the development of the leadership of surgeons, surgical teams, and surgical trainees. Leadership development activities include leadership courses and programmes, mentoring and coaching, feedback activities, and simulation training. To date there is no agreement on what makes leadership development activities effective or not. We also do not know whether they work for certain people or professionals more than others. It is important to find out what interventions are best, in order to spend money on leadership development effectively. This protocol describes our plan to develop a theory explaining in which context and for whom leadership development activities work and why. We will develop the theory based on the existing literature and through discussions with experts in the field. To make the results more reliable, we will search databases systematically and the different stages of the review will be checked by two people. Results will feed into further research where we collect 'real world' data on leadership development activities that take place in the National Health Service (NHS) and whether they work and why. Our study will also provide guidance for those who are planning or designing leadership development activities for surgeons, surgical teams and surgical trainees.

Advancing leadership in surgery: a realist review of interventions and strategies to promote evidence-based leadership in healthcare.

BACKGROUND: Healthcare systems invest in leadership development of surgeons, surgical trainees, and teams. However, there is no agreement on how interventions should be designed, or what components they must contain to be successful. The objective of this realist review was to generate a programme theory explaining in which context and for whom surgical leadership interventions work and why. METHODS: Five databases were systematically searched, and articles screened against inclusion considering their relevance. Context-mechanism-outcome configurations (CMOCs) and fragments of CMOCs were identified. Gaps in the CMOCs were filled through deliberation with the research team and stakeholder feedback. We identified patterns between CMOCs and causal relationships to create a programme theory. RESULTS: Thirty-three studies were included and 19 CMOCs were developed. Findings suggests that interventions for surgeons and surgical teams improve leadership if timely feedback is delivered on multiple occasions and by trusted and respected people. Negative feedback is best provided privately. Feedback from senior-to-junior or peer-to-peer should be delivered directly, whereas feedback from junior-to-senior is preferred when delivered anonymously. Leadership interventions were shown to be most effective for those with awareness of the importance of leadership, those with confidence in their technical surgical skills, and those with identified leadership deficits. For interventions to improve leadership in surgery, they need to be delivered in an intimate learning environment, consider implementing a speak-up culture, provide a variety of interactive learning activities, show a genuine investment in the intervention, and be customised to the needs of surgeons. Leadership of surgical teams can be best developed by enabling surgical teams to train together. CONCLUSIONS: The programme theory provides evidence-based guidance for those who are designing, developing and implementing leadership interventions in surgery. Adopting the recommendations will help to ensure interventions are acceptable to the surgical community and successful in improving surgical leadership. TRIAL REGISTRATION: The review protocol is registered with PROSPERO (CRD42021230709).

Surgical implementation gap: an interrupted time series analysis with interviews examining the impact of surgical trials on surgical practice in England.

OBJECTIVES: Landmark studies published near the turn of the 21st century found an implementation gap concerning the effect of evidenced-based findings on clinical practice. The current study examines the uptake of six trials that produced actionable findings to describe the effects of evidence on practice and the reasons for those effects. DESIGN: A sequential, explanatory mixed methods study was conducted. First, a quantitative study assessed whether actionable findings from large, publicly funded elective surgical trials influenced practice. Subsequently, qualitative interviews were conducted to explain the quantitative findings. SETTING: Changes in NHS-funded practice were tracked across hospitals in England. Interviews were conducted online. DATA AND PARTICIPANTS: The six surgical trials were funded and published by England's National Institute for Health Research's Health Technology Assessment programme between 2006 and 2015. Quantitative time series analyses used data about the frequencies or proportions of relevant surgical procedures conducted in England between 2001 and 2020. Subsequently, qualitative interviews were conducted with 25 participants including study authors, surgeons and other healthcare staff in the supply chain. Transcripts were coded to identify major temporal events and Consolidated Framework for Implementation Research (CFIR) domains/constructs that could influence implementation. Findings were synthesised by clinical area. RESULTS: The quantitative analyses reveal that practice changed in accordance with findings for three trials. In one trial (percutaneous vs nasogastric tube feed after stroke), the change took a decade to occur. In another (patella resurfacing), change anticipated the trial findings. In the third (abdominal aortic aneurysm repair), changes tracked the evolving evidence base. In the remaining trials (two about varicose veins and one about gastric reflux), practice did not change in line with findings. For varicose veins, the results were superseded by a further trial. For gastric reflux, surgical referrals declined as medical treatment increased. The exploratory qualitative analysis informed by CFIR found that evidence from sources apart from the trial in question was mentioned as a reason for non-adoption in the three trials where evidence did not affect practice and in the trial where uptake was delayed. There were no other consistent patterns in the qualitative data. CONCLUSION: While practice does not always change in the direction indicated by clinical trials, our results suggest that individuals, official committees and professional societies do assimilate trial evidence. Decision-makers seem to respond to the totality of evidence such that there are often plausible reasons for not adopting the evidence of any one trial in isolation.

Investigating informed choice in screening programmes: a mixed methods analysis.

BACKGROUND: Screening programmes aim to identify individuals at higher risk of developing a disease or condition. While globally, there is agreement that people who attend screening should be fully informed, there is no consensus about how this should be achieved. We conducted a mixed methods study across eight different countries to understand how countries address informed choice across two screening programmes: breast cancer and fetal trisomy anomaly screening. METHODS: Fourteen senior level employees from organisations who produce and deliver decision aids to assist informed choice were interviewed, and their decision aids (n = 15) were evaluated using documentary analysis. RESULTS: We discovered that attempts to achieve informed choice via decision aids generate two key tensions (i) between improving informed choice and increasing uptake and (ii) between improving informed choice and comprehensibility of the information presented. Comprehensibility is fundamentally at tension with an aim of being fully informed. These tensions emerged in both the interviews and documentary analysis. CONCLUSION: We conclude that organisations need to decide whether their overarching aim is ensuring high levels of uptake or maximising informed choice to participate in screening programmes. Consideration must then be given to all levels of development and distribution of information produced to reflect each organisation's aim. The comprehensibility of the DA must also be considered, as this may be reduced when informed choice is prioritised.

Is the assumption of waning of treatment effect applied consistently across NICE technology appraisals? A case-study focusing on disease-modifying therapies for treatment of multiple sclerosis.

OBJECTIVES: Whether the effects of therapies may wane over time is a matter of debate, especially when considering their long-term cost-effectiveness. Here, we examined how the assumption of the waning of treatment effect was applied across the National Institute for Health and Care Excellence (NICE) appraisals for disease-modifying therapies (DMTs) used in multiple sclerosis. METHODS: We undertook a document analysis following a search of the NICE website. The inclusion criteria of the study were as follows: all publicly available documents related to completed appraisals for DMTs (period: January 2000 to July 2021). The exclusion criteria of the study were as follows: all documents that did not meet the inclusion criteria, especially pertaining to drugs used in other disease areas. We extracted information about the waning of treatment effect assumption as considered by companies, assessment groups, and appraisal committees, and we analyzed trends over time. RESULTS: We reviewed fifteen appraisals that reported guidance on sixteen DMTs. Irrespective of the drugs' mechanism of action or their pharmaceutical nature, there was substantial variation in the modalities when the assumption of waning was implemented. We noted the recent preference to use all-cause discontinuation as a proxy. This heterogeneity did not appear to affect acceptance of the DMTs (all but one were recommended for use across the National Health System (NHS)). CONCLUSIONS: Modeling the long-term effect of therapies is challenging, especially given the limited follow-up duration of related trials. This generates recurrent debates on the presence of waning of treatment efficacy and heterogeneity across appraisals. More refined recommendations obtained by consensus among stakeholders could help to achieve greater consistency in decision making.

The Effectiveness of Interventions for the Prevention or Treatment of Paternal Perinatal Anxiety: A Systematic Review.

Background: The worldwide prevalence of paternal perinatal anxiety (PPA) ranges between 3.4% and 25.0% antenatally, and 2.4% and 51.0% postnatally. Experiencing PPA can adversely impact the individual, partners, and infants. Research concerning PPA is lagging and fragmented compared to research for new mothers. Objectives: To establish the effectiveness of prevention or treatment interventions for PPA in adults identifying as male. Data sources: We completed searches of Medline, EMBASE, PsycINFO and Web of Science from inception to 2 December 2021, as well as hand searches of references from relevant papers. Search selection and data extraction: Randomised controlled trials delivering prevention or treatment interventions and reporting anxiety outcomes for new/expectant fathers in the perinatal mental health period were included. Our review follows the PRISMA reporting guidelines. One reviewer independently screened 5170 titles/abstracts; second reviewers screened 50%. Two reviewers independently screened full text, extracted data, and conducted risk of bias assessments. Synthesis: Cochrane's collaboration tool 2 was used to assess quality. Primarily results are synthesised narratively, a post-hoc sub-group analysis was completed on four studies using the same outcome measure. Main results: Twelve of the 5170 studies fulfilled the inclusion criteria. Studies used psychoeducational or practical skills interventions. Interventions mostly involved couple-dyads and three studies assessed PPA as a primary outcome. Included interventions were prevention-based; no treatment interventions were found. Father-only interventions consistently reported a significant reduction of PPA. Conclusions: Systematic searching yielded no treatment interventions, highlighting a substantial gap in the evidence base. Within a limited and heterogenous sample, no studies targeted diagnosed PPA. Evidence suggested father-focused interventions may be effective in preventing PPA, regardless of the intervention delivery mode or intervention content. However, consistency between study design and options within the field are lacking compared to interventions available for mothers.

Perioperative oxygen therapy: a protocol for an overview of systematic reviews and meta-analyses.

BACKGROUND: Oxygen is routinely given to patients during and after surgery. Perioperative oxygen administration has been proposed as a potential strategy to prevent and treat hypoxaemia and reduce complications, such as surgical site infections, pulmonary complications and mortality. However, uncertainty exists as to which strategies in terms of amount, delivery devices and timing are clinically effective. The aim of this overview of systematic reviews and meta-analyses is to answer the research question, 'For which types of surgery, at which stages of care, in which sub-groups of patients and delivered under what conditions are different types of perioperative oxygen therapy clinically effective?'. METHODS: We will search key electronic databases (MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, CENTRAL, Epistemonikos, PROSPERO, the INAHTA International HTA Database and DARE archives) for systematic reviews and randomised controlled trials comparing perioperative oxygen strategies. Each review will be mapped according to type of surgery, surgical pathway timepoints and clinical comparison. The highest quality reviews with the most comprehensive and up-to-date coverage of relevant literature will be chosen as anchoring reviews. Standardised data will be extracted from each chosen review, including definition of oxygen therapy, summaries of interventions and comparators, patient population, surgical characteristics and assessment of overall certainty of evidence. For clinical outcomes and adverse events, the overall pooled findings and results of subgroup and sensitivity analyses (where available) will be extracted. Trial-level data will be extracted for surgical site infections, mortality, and potential trial-level effect modifiers such as risk of bias, outcome definition and type of surgery to facilitate quantitative data analysis. This analysis will adopt a multiple indication review approach with panoramic meta-analysis using review-level data and meta-regression using trial-level data. An evidence map will be produced to summarise our findings and highlight any research gaps. DISCUSSION: There is a need to provide a panoramic overview of systematic reviews and meta-analyses describing peri-operative oxygen practice to both inform clinical practice and identify areas of ongoing uncertainty, where further research may be required. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021272361.

Public health intelligence challenges for local public health authorities responding to disease outbreaks: a mixed-methods systematic review protocol.

Background: Information management capacity is crucial for controlling risks from health emergencies. But little is known about how sub-national public health bodies overcome public health intelligence challenges when responding to disease outbreaks. This paper describes a protocol for a mixed-methods systematic review to fill this knowledge gap. In addition to describing the evidence base and characterising public health intelligence responses, it will explore reported facilitators and barriers to response. Methods: Research on sub-national Public Health Intelligence disease outbreak responses will be synthesised. The review will be limited to articles published in English, during or after 2019. Key electronic databases will be searched for peer-reviewed, primary research studies. Two reviewers will independently screen articles for relevance. Articles that refer to a public health intelligence response to a propagated disease outbreak by a sub-national Public Health Authority will be included. Quality assessment of included articles will be undertaken using published tools. Data integration will be by the Pillar Integration Process (PIP). Discussion: This review will describe and synthesise the recent literature on sub-national Public Health Authorities' responses to propagated disease outbreaks. The systematic design will limit bias and the inclusion of data from quantitative, qualitative and mixed-methods studies will ensure relevant evidence is considered regardless of the methodology used to produce it. The review is part of a larger research project which aims to explore the role of sub-national public health intelligence during the COVID-19 pandemic and investigate how public health intelligence preparedness could be improved in the future. This could provide information to support the development of training, preparedness indicators and/or ways of implementing directives. PROSPERO registration: CRD42022308042 (08/02/2022).

What are the information challenges for local public health services responding to an outbreak of disease? Useful information is vital for planning public health activities. This means good information management is very important during an outbreak of disease. But little is known about how local public health bodies overcome challenges in this area. Examples of challenges could include not receiving sufficient data and/or not having enough staff to analyse it. This paper describes planned research based on a review of the literature. We want to know how local public health bodies have collected, analysed and provided useful information during disease outbreaks and what makes it easier or harder for them to do this. To make the results more reliable, the review will take a structured approach. Two people will work on some stages to check each other's work. We will search databases of research articles to find any kind of study that describes information challenges for local public health organisations during a disease outbreak. Specific criteria will be used to judge which studies to include. To be included, studies must be about a disease that spreads from person-to-person, and they must have been published in or after 2019. Included studies will be summarised. Results will feed into further research on how local public health bodies could be better prepared for disease outbreaks in the future.

Paragons, Mavericks and Innovators-A typology of orthopaedic surgeons' professional identities. A comparative case study of evidence-based practice.

Clinical guidelines, as vehicles for evidence-based practice (EBP) attempt to standardize health-care practice, reduce variation and increase quality. However, their use for surgery has been contested, and often resisted. This article examines professional responses to EBP in hip replacement surgery using data from case study observations and interviews in three English orthopaedic departments. A professional identity perspective is adopted to explain how standardization through EBP, represents an empirical phenomenon around which surgeons enact their identities as Paragons, Mavericks or Innovators, to enhance legitimacy and stratify themselves in their response to EBP. Attention is drawn to variation between Paragon surgeons working in university (teaching) hospitals and Maverick and Innovator types located in general hospitals, and the ways this interacts with adoption of EBP. The typology shows how practice variation is related to surgeons' tendencies to align to characteristic types, with distinct social processes, power and prestige, and which are in turn influenced by organizational context. The dynamics of EBP and professional identity continues to limit attempts to standardize surgical practice. The typology contributes to the understanding of failures to follow EBP, as associated with the identities individuals create and negotiate, and with identity narratives used to legitimize differing responses to EBP.

Association between vitamin D supplementation or serum vitamin D level and susceptibility to SARS-CoV-2 infection or COVID-19 including clinical course, morbidity and mortality outcomes? A systematic review.

OBJECTIVE: To systemically review and critically appraise published studies of the association between vitamin D supplementation or serum vitamin D level and susceptibility to SARS-CoV-2 infection or COVID-19, including clinical course, morbidity and mortality outcomes. DESIGN: Systematic review. DATA SOURCES: MEDLINE (OVID), Embase (OVID), Cochrane Central Register of Controlled Trials, MedRxiv and BioRxiv preprint databases. COVID-19 databases of the WHO, Cochrane, CEBM Oxford and Bern University up to 10 June 2020. STUDY SELECTION: Studies that assessed vitamin D supplementation and/or low serum vitamin D in patients acutely ill with, or at risk of, severe betacoronavirus infection (SARS-CoV, MERS-CoV, SARS-CoV-2). DATA EXTRACTION: Two authors independently extracted data using a predefined data extraction form and assessed risk of bias using the Downs and Black Quality Assessment Checklist. RESULTS: Searches elicited 449 papers, 59 studies were eligible full-text assessment and 4 met the eligibility criteria of this review. The four studies were narratively synthesised and included (1) a cross-sectional study (n=107) suggesting an inverse association between serum vitamin D and SARS-CoV-2; (2) a retrospective cohort study (348 598 participants, 449 cases) in which univariable analysis showed that vitamin D protects against COVID-19; (3) an ecological country level study demonstrating a negative correlation between vitamin D and COVID-19 case numbers and mortality; and (4) a case-control survey (n=1486) showing cases with confirmed/probable COVID-19 reported lower vitamin D supplementation. All studies were at high/unclear risk of bias. CONCLUSION: There is no robust evidence of a negative association between vitamin D and COVID-19. No relevant randomised controlled trials were identified and there is no robust peer-reviewed published evidence of association between vitamin D levels and severity of symptoms or mortality due to COVID-19. Guideline producers should acknowledge that benefits of vitamin D supplementation in COVID-19 are as yet unproven despite increasing interest.

Advancing clinical leadership to improve the implementation of evidence-based practice in surgery: a longitudinal mixed-method study protocol.

BACKGROUND: Clinical leadership is fundamental in facilitating service improvements in healthcare. Few studies have attempted to understand or model the different approaches to leadership which are used when promoting the uptake and implementation of evidence-based interventions. This research aims to uncover and explain how distributed clinical leadership can be developed and improved to enhance the use of evidence in practice. In doing so, this study examines implementation leadership in orthopaedic surgery to explain leadership as a collective endeavour which cannot be separated from the organisational context. METHODS: A mixed-method study consisting of longitudinal and cross-sectional interviews and an embedded social network analysis will be performed in six NHS hospitals. A social network analysis will be undertaken in each hospital to uncover the organisational networks, the focal leadership actors and information flows in each organisation. This will be followed by a series of repeated semi-structured interviews, conducted over 4 years, with orthopaedic surgeons and their professional networks. These longitudinal interviews will be supplemented by cross-sectional interviews with the national established surgical leaders. All qualitative data will be analysed using a constructivist grounded theory approach and integrated with the quantitative data. The participant narratives will enrich the social network to uncover the leadership configurations which exist, and how different configurations of leadership are functioning in practice to influence implementation processes and outcomes. DISCUSSION: The study findings will facilitate understanding about how and why different configurations of leadership develop and under what organisational conditions and circumstances they are able to flourish. The study will guide the development of leadership interventions that are grounded in the data and aimed at advancing leadership for service improvement in orthopaedics. The strength of the study lies in the combination of multi-component, multi-site, multi-agent methods to examine leadership processes in surgery. The findings may be limited by the practical challenges of longitudinal qualitative data collection, such as ensuring participant retention, which need to be balanced against the theoretical and empirical insights generated through this comprehensive exploration of leadership across and within a range of healthcare organisations.

COVID-19 in cardiac arrest and infection risk to rescuers: A systematic review.

BACKGROUND: There may be a risk of COVID-19 transmission to rescuers delivering treatment for cardiac arrest. The aim of this review was to identify the potential risk of transmission associated with key interventions (chest compressions, defibrillation, cardiopulmonary resuscitation) to inform international treatment recommendations. METHODS: We undertook a systematic review comprising three questions: (1) aerosol generation associated with key interventions; (2) risk of airborne infection transmission associated with key interventions; and (3) the effect of different personal protective equipment strategies. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the World Health Organization COVID-19 database on 24th March 2020. Eligibility criteria were developed individually for each question. We assessed risk of bias for individual studies, and used the GRADE process to assess evidence certainty by outcome. RESULTS: We included eleven studies: two cohort studies, one case control study, five case reports, and three manikin randomised controlled trials. We did not find any direct evidence that chest compressions or defibrillation either are or are not associated with aerosol generation or transmission of infection. Data from manikin studies indicates that donning of personal protective equipment delays treatment delivery. Studies provided only indirect evidence, with no study describing patients with COVID-19. Evidence certainty was low or very low for all outcomes. CONCLUSION: It is uncertain whether chest compressions or defibrillation cause aerosol generation or transmission of COVID-19 to rescuers. There is very limited evidence and a rapid need for further studies. Review registration: PROSPERO CRD42020175594.

How are evidence and knowledge used in orthopaedic decision-making? Three comparative case studies of different approaches to implementation of clinical guidance in practice.

BACKGROUND: The uptake and use of clinical guidelines is often insufficient to change clinical behaviour and reduce variation in practice. As a consequence of diverse organisational contexts, the simple provision of guidelines cannot ensure fidelity or guarantee their use when making decisions. Implementation research in surgery has focused on understanding what evidence exists for clinical practice decisions but limits understanding to the technical, educational and accessibility issues. This research aims to identify where, when and how evidence and knowledge are used in orthopaedic decision-making and how variation in these factors contributes to different approaches to implementation of clinical guidance in practice. METHODS: We used in-depth case studies to examine guideline implementation in real-life surgical practice. We conducted comparative case studies in three English National Health Service hospitals over a 12-month period. Each in-depth case study consisted of a mix of qualitative methods including interviews, observations and document analysis. Data included field notes from observations of day-to-day practice, 64 interviews with NHS surgeons and staff and the collection of 121 supplementary documents. RESULTS: Case studies identified 17 sources of knowledge and evidence which influenced clinical decisions in elective orthopaedic surgery. A comparative analysis across cases revealed that each hospital had distinct approaches to decision-making. Decision-making is described as occurring as a result of how 17 types of knowledge and evidence were privileged and of how they interacted and changed in context. Guideline implementation was contingent and mediated through four distinct contextual levels. Implementation could be assessed for individual surgeons, groups of surgeons or the organisation as a whole, but it could also differ between these levels. Differences in how evidence and knowledge were used contributed to variations in practice from guidelines. CONCLUSION: A range of complex and competing sources of evidence and knowledge exists which influence the working practices of healthcare professionals. The dynamic selection, combination and use of each type of knowledge and evidence influence the implementation and use of clinical guidance in practice. Clinical guidelines are a fundamental part of practice, but represent only one type of evidence influencing clinical decisions. In the orthopaedic speciality, other distinct sources of evidence and knowledge are selected and used which impact on how guidelines are implemented. New approaches to guideline implementation need to appreciate and incorporate this diverse range of knowledge and evidence which influences clinical decisions and to take account of the changing contexts in which decisions are made.

It's hard to play ball: A qualitative study of knowledge exchange and silo effects in public health.

BACKGROUND: Partnerships in public health form an important component of commissioning and implementing services, in England and internationally. In this research, we examine the views of staff involved in a City-wide health improvement programme which ran from 2009 to 2013 in England. We examine the practicalities of partnership work in community settings, and we describe some of barriers faced when implementing a large, multi-organisation health improvement programme. METHODS: Qualitative, semi-structured interviews were performed. Purposive sampling was used to identify potential participants in the programme: programme board of directors, programme and project managers and intervention managers. Interviews were conducted one-to-one. We conducted a thematic analysis using the 'one sheet of paper' technique. This involved analysing data deductively, moving from initial to axial coding, developing categories and then identifying emerging themes. RESULTS: Fifteen interviews were completed. Three themes were identified. The first theme reflects how poor communication approaches hindered the ability of partnerships to deliver their aims and objectives in a range of ways and for a range of reasons. Our second theme reflects how a lack of appropriate knowledge exchange hindered decision-making, affected trust and contributed to protectionist approaches to working. This lack of shared, and communicated, understanding of what type of knowledge is most appropriate and in which circumstance made meaningful knowledge exchange challenging for decision-making and partnership-working in the City-wide health improvement programme. Theme three demonstrates how perceptions about silos in partnership-working could be problematic, but silos themselves were at times beneficial to partnerships. This revealed a mismatch between rhetoric and a realistic understanding of what components of the programme were functional and which were more hindrance than help. DISCUSSION: There were high expectations placed on the concept of what partnership work was, or how it should be done. We found our themes to be interdependent, and reflective of the 'dynamic fluid process' discussed within the knowledge mobilisation literature. We contend that reframing normal and embedded processes of silos and silo-working already in use might ease resistance to some knowledge exchange processes and contribute to better long-term functioning of public health partnerships.

Incorporation of a health economic modelling tool into public health commissioning: Evidence use in a politicised context.

This paper explores how commissioners working in an English local government authority (LA) viewed a health economic decision tool for planning services in relation to diabetes. We conducted 15 interviews and 2 focus groups between July 2015 and February 2016, with commissioners (including public health managers, data analysts and council members). Two overlapping themes were identified explaining the obstacles and enablers of using such a tool in commissioning: a) evidence cultures, and b) system interdependency. The former highlighted the diverse evidence cultures present in the LA with politicians influenced by the 'soft' social care agendas affecting their local population and treating local opinion as evidence, whilst public health managers prioritised the scientific view of evidence informed by research. System interdependency further complicated the decision making process by recognizing interlinking with departments and other disease groups. To achieve legitimacy within the commissioning arena health economic modelling needs to function effectively in a highly politicised environment where decisions are made not only on the basis of research evidence, but on grounds of 'soft' data, personal opinion and intelligence. In this context decisions become politicised, with multiple opinions seeking a voice. The way that such decisions are negotiated and which ones establish authority is of importance. We analyse the data using Larson's (1990) discursive field concept to show how the tool becomes an object of research push and pull likely to be used instrumentally by stakeholders to advance specific agendas, not a means of informing complex decisions. In conclusion, LA decision making is underpinned by a transactional business ethic which is a further potential 'pull' mechanism for the incorporation of health economic modelling in local commissioning.

Has Metal-On-Metal Resurfacing Been a Cost-Effective Intervention for Health Care Providers?-A Registry Based Study.

BACKGROUND: Total hip replacement for end stage arthritis of the hip is currently the most common elective surgical procedure. In 2007 about 7.5% of UK implants were metal-on-metal joint resurfacing (MoM RS) procedures. Due to poor revision performance and concerns about metal debris, the use of RS had declined by 2012 to about a 1% share of UK hip procedures. This study estimated the lifetime cost-effectiveness of metal-on-metal resurfacing (RS) procedures versus commonly employed total hip replacement (THR) methods. METHODOLOGY/PRINCIPAL FINDINGS: We performed a cost-utility analysis using a well-established multi-state semi-Markov model from an NHS and personal and social services perspective. We used individual patient data (IPD) from the National Joint Registry (NJR) for England and Wales on RS and THR surgery for osteoarthritis recorded from April 2003 to December 2012. We used flexible parametric modelling of NJR RS data to guide identification of patient subgroups and RS devices which delivered revision rates within the NICE 5% revision rate benchmark at 10 years. RS procedures overall have an estimated revision rate of 13% at 10 years, compared to <4% for most THR devices. New NICE guidance now recommends a revision rate benchmark of <5% at 10 years. 60% of RS implants in men and 2% in women were predicted to be within the revision benchmark. RS devices satisfying the 5% benchmark were unlikely to be cost-effective compared to THR at a standard UK willingness to pay of £20,000 per quality-adjusted life-year. However, the probability of cost effectiveness was sensitive to small changes in the costs of devices or in quality of life or revision rate estimates. CONCLUSION/SIGNIFICANCE: Our results imply that in most cases RS has not been a cost-effective resource and should probably not be adopted by decision makers concerned with the cost effectiveness of hip replacement, or by patients concerned about the likelihood of revision, regardless of patient age or gender.