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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
The effect of socioeconomic deprivation on corneal graft survival in the United Kingdom.
OBJECTIVE: To investigate the effect of socioeconomic deprivation on cornea graft survival in the United Kingdom. DESIGN: Retrospective cohort study. PARTICIPANTS: All the recipients (n = 13,644) undergoing their first penetrating keratoplasty (PK) registered on the United Kingdom Transplant Registry between April 1999 and March 2011 were included. METHODS: Data of patients' demographic details, indications, graft size, corneal vascularization, surgical complication, rejection episodes, and postoperative medication were collected at the time of surgery and 1, 2, and 5 years postoperatively. Patients with endophthalmitis were excluded from the study. Patients' home postcodes were used to determine the socioeconomic status using a well-validated deprivation index in the United Kingdom: A Classification of Residential Neighborhoods (ACORN). Kaplan-Meier survival and Cox proportional hazards regression were used to evaluate the influence of ACORN categories on 5-year graft survival, and the Bonferroni method was used to adjust for multiple comparisons. MAIN OUTCOME MEASURES: Patients' socioeconomic deprivation status and corneal graft failure. RESULTS: A total of 13,644 patients received their first PK during the study periods. A total of 1685 patients (13.36%) were lost to follow-up, leaving 11,821 patients (86.64%) for analysis. A total of 138 of the 11,821 patients (1.17%) developed endophthalmitis. The risk of graft failure within 5 years for the patients classified as hard-pressed was 1.3 times that of the least deprived (hazard ratio, 1.3; 95% confidence interval, 1.1-1.5; P = 0.003) after adjusting for confounding factors and indications. There were no statistically significant differences between the causes of graft failure and the level of deprivation (P = 0.14). CONCLUSIONS: Patients classified as hard-pressed had an increased risk of graft failure within 5 years compared with the least deprived patients.
Global emergency medicine: A scoping review of the literature from 2020
Objective: The objective was to identify, screen, highlight, review, and summarize some of the most rigorously conducted and impactful original research (OR) and review articles (RE) in global emergency medicine (EM) published in 2020 in the peer-reviewed and gray literature. Methods: A broad systematic search of peer-reviewed publications related to global EM indexed on PubMed and in the gray literature was conducted. The titles and abstracts of the articles on this list were screened by members of the Global Emergency Medicine Literature Review (GEMLR) Group to identify those that met our criteria of OR or RE in the domains of disaster and humanitarian response (DHR), emergency care in resource-limited settings (ECRLS), and EM development. Those articles that met these screening criteria were then scored using one of three scoring templates appropriate to the article type. Those articles that scored in the top 5% then underwent in-depth narrative summarization. Results: The 2020 GEMLR search initially identified 35,970 articles, more than 50% more than last year’s search. From these, 364 were scored based on their full text. Nearly three-fourths of the scored articles constituted OR, of which nearly three-fourths employed quantitative research methods. Nearly 10% of the articles identified this year were directly related to COVID-19. Research involving ECRLS again constituted most of the articles in this year’s review, accounting for more than 60% of the literature scored. A total of 20 articles underwent in-depth narrative critiques. Conclusions: The number of studies relevant to global EM identified by our search was very similar to that of last year. Revisions to our methodology to identify a broader range of research were successful in identifying more qualitative research and studies related to DHR. The number of COVID-19–related articles is likely to continue to increase in subsequent years.
Antibiotic prescribing rate after optimal near-patient C-reactive protein testing in acutely ill children presenting to ambulatory care (ARON project): protocol for a cluster-randomized pragmatic trial
IntroductionChildren become ill quite often, mainly because of infections, most of which can be managed in the community. Many children are prescribed antibiotics which contributes to antimicrobial resistance and reinforces health-seeking behaviour. Point-of-care C reactive protein (POC CRP) testing, prescription guidance and safety-netting advice can help safely reduce antibiotic prescribing to acutely ill children in ambulatory care as well as save costs at a systems level.Methods and analysisThe ARON (Antibiotic prescribing Rate after Optimal Near-patient testing in acutely ill children in ambulatory care) trial is a pragmatic cluster randomized controlled superiority trial with a nested process evaluation and will assess the clinical and cost effectiveness of a diagnostic algorithm, which includes a standardised clinical assessment, a POC CRP test, and safety-netting advice, in acutely ill children aged 6 months to 12 years presenting to ambulatory care. The primary outcome is antibiotic prescribing at the index consultation; secondary outcomes include clinical recovery, reconsultation, referral/admission to hospital, additional testing, mortality and patient satisfaction. We aim to recruit a total sample size of 6111 patients. All outcomes will be analysed according to the intent-to-treat approach. We will use a mixed-effect logistic regression analysis to account for the clustering at practice level.Ethics and disseminationThe study will be conducted in compliance with the principles of the Declaration of Helsinki (current version), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. Ethics approval for this study was obtained on 10 November 2020 from the Ethics Committee Research of University Hospitals Leuven under reference S62005. We will ensure that the findings of the study will be disseminated to relevant stakeholders other than the scientific world including the public, healthcare providers and policy-makers. The process evaluation that is part of this trial may provide a basis for an implementation strategy. If our intervention proves to be clinically and cost-effective, it will be essential to educate physicians about introducing the diagnostic algorithm including POC CRP testing and safety-netting advice in their daily practice.Trial registration numberClinicalTrials.gov Identifier: NCT04470518. Protocol V.2.0 date 2 October 2020. (Pre-results)
Development of methodological guidance, publication standards and training materials for realist and meta-narrative reviews: the RAMESES (Realist And Meta-narrative Evidence Syntheses – Evolving Standards) project
BackgroundThere is growing interest in theory-driven, qualitative and mixed-method approaches to systematic review, such as realist and meta-narrative review. These approaches offer the potential to expand the knowledge base in policy-relevant areas. However, the quality of such reviews can be difficult to assess.ObjectivesThe aim of this project was to produce methodological guidance, publication standards and training resources for those seeking to undertake realist and/or meta-narrative reviews.Methods/designWe (1) collated and summarised existing literature on the principles of good practice in realist and meta-narrative systematic reviews; (2) considered the extent to which these principles had been followed by published and in-progress reviews, thereby identifying how rigour may have been lost and how existing methods could be improved; (3) used an online Delphi method with an interdisciplinary panel of experts from academia and policy, to produce a draft set of methodological steps and publication standards; (4) produced training materials with learning objectives linked to these steps; (5) refined these standards and training materials prospectively on real reviews in progress, capturing methodological and other challenges as they arose; (6) synthesised expert input, evidence review and real-time problem analysis into more definitive guidance and standards; and (7) disseminated outputs to audiences in academia and policy.ResultsAn important element of this study was the establishment of an e-mail mailing list to bring together researches in the field (www.jiscmail.ac.uk/RAMESES). Our literature review identified 35 and nine realist and meta-narrative reviews respectively. Analysis and discussion within the project team produced a summary of the published literature, and common questions and challenges into briefing materials for the Delphi panel, comprising 37 and 33 members (for realist and meta-narrative reviews respectively). Within three rounds this panel had reached a consensus on 19 (realist) and 20 (meta-narrative) key publication standards, with an overall response rate of 90% and 91% respectively. The Realist And Meta-narrative Evidence Syntheses – Evolving Standards (RAMESES) publication standards for realist syntheses and meta-narrative reviews were published in open-access journals and quickly became highly accessed. The RAMESES quality standards and training materials drew together the following sources of data: (1) personal expertise as researchers and trainers; (2) data from the Delphi panels; (3) feedback from participants at training sessions we ran; and (4) comments made on RAMESES mailing list. The quality standards and training materials are freely available online (www.ramesesproject.org).DiscussionThe production of these standards and guidance drew on multiple sources of knowledge and expertise, and a high degree of a consensus was achieved despite ongoing debate among researchers about the overall place of these methodologies in the secondary research toolkit. As with all secondary research methods, guidance on quality assurance and uniform reporting is an important step towards improving quality and consistency of studies. We anticipate that as more reviews are undertaken, further refinement will be needed to the publication and quality standards and training materials.LimitationsThe project’s outputs are not definitive and in the future updating and further development is likely to be needed.ConclusionAn initial set of publication standards, quality standards and training materials have been produced for researchers, users and funders of realist or meta-narrative reviews. As realist and meta-narrative reviews are relatively new approaches to evidence synthesis, methodological development is needed for both review approaches.FundingThe National Institute for Health Research Health Services and Delivery Research programme.
Preventable deaths from SARS-CoV-2 in England and Wales: a systematic case series of coroners' reports during the COVID-19 pandemic.
OBJECTIVES: To examine coroners' Prevention of Future Deaths (PFDs) reports to identify deaths involving SARS-CoV-2 that coroners deemed preventable. DESIGN: Consecutive case series. SETTING: England and Wales. PARTICIPANTS: Patients reported in 510 PFDs dated between 01 January 2020 and 28 June 2021, collected from the UK's Courts and Tribunals Judiciary website using web scraping to create an openly available database: https://preventabledeathstrackernet/. MAIN OUTCOME MEASURES: Concerns reported by coroners. RESULTS: SARS-CoV-2 was involved in 23 deaths reported by coroners in PFDs. Twelve deaths were indirectly related to the COVID-19 pandemic, defined as those that were not medically caused by SARS-CoV-2, but were associated with mitigation measures. In 11 cases, the coroner explicitly reported that COVID-19 had directly caused death. There was geographical variation in the reporting of PFDs; most (39%) were written by coroners in the North West of England. The coroners raised 56 concerns, problems in communication being the most common (30%), followed by failure to follow protocols (23%). Organisations in the National Health Service were sent the most PFDs (51%), followed by the government (26%), but responses to PFDs by these organisations were poor. CONCLUSIONS: PFDs contain a rich source of information on preventable deaths that has previously been difficult to examine systematically. Our openly available tool (https://preventabledeathstracker.net/) streamlines this process and has identified many concerns raised by coroners that should be addressed during the government's inquiry into the handling of the COVID-19 pandemic, so that mistakes made are less likely to be repeated. STUDY PROTOCOL PREREGISTRATION: https://osf.io/bfypc/.
Registration of health and medical research.
Registration of health and medical research is an effective way of improving the transparency and credibility of evidence. Registration involves pre-specifying the research objectives, design, methods and analytic plan on a publicly accessible repository before conducting the study. Registration can reduce bias and improve the transparency and credibility of research findings. Registration is mandated for clinical trials, but it is also relevant to systematic reviews, observational and preclinical experimental research. This paper describes how researchers can register their research and outlines possible barriers and challenges in doing so. Widespread adoption of research registration can reduce research waste and improve evidence-informed clinical and policy decision making.
Are some feasibility studies more feasible than others? A review of the outcomes of feasibility studies on the ISRCTN registry
Background: Feasibility studies are often conducted before committing to a randomised controlled trial (RCT), yet there is little published evidence to inform how useful feasibility studies are, especially in terms of adding or reducing waste in research. This study attempted to examine how many feasibility studies demonstrated that the full trial was feasible and whether some feasibility studies were inherently likely to be feasible or not feasible, based on the topic area and/or research setting. Methods: Keyword searches were conducted on the International Standard Randomised Controlled Trials Number (ISRCTN) registry to identify all completed feasibility studies which had been conducted in the UK. Results: A total of 625 records from the 1933 identified were reviewed before it became evident that it would be futile to continue. Of 329 feasibility studies identified, 160 had a known outcome (49%), 133 (83%) trials were deemed to be feasible and only 27 (17%) were reported to be non-feasible. There were therefore too few studies to allow the intended comparison of differences in non-feasible studies by topic and/or setting. Conclusions: There were too few studies reported as non-feasible to draw any useful conclusions on whether topic and/or setting had an effect. However, the high feasibility rate (83%) may suggest that non-feasible studies are subject to publication bias or that many feasible studies are redundant and may be adding waste to the research pathway.
Early Positive Approaches to Support (E-PAtS) for Families of Young Children With Intellectual Disability: A Feasibility Randomised Controlled Trial
Background: Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS.Methods: This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to <6 years old) with intellectual disability were recruited at research sites and allocated to intervention (E-PAtS and usual practise) or control (usual practise) on a 1:1 basis at cluster (family) level. Data were collected at baseline and 3 and 12 months' post-randomisation. The following feasibility outcomes were assessed: participant recruitment rates and effectiveness of recruitment pathways; retention rates; intervention adherence and fidelity; service provider recruitment rates and willingness to participate in a future trial; barriers and facilitating factors for recruitment, engagement, and intervention delivery; and feasibility of collecting outcome measures.Results: Seventy-four families were randomised to intervention or control (n = 37). Retention rates were 72% at 12 months post-randomisation, and completion of the proposed primary outcome measure (WEMWBS) was 51%. Recruitment of service provider organisations and facilitators was feasible and intervention implementation acceptable. Adherence to the intervention was 76% and the intervention was well-received by participants; exploratory analyses suggest that adherence and attendance may be associated with improved well-being. Health economic outcome measures were collected successfully and evidence indicates that linkage with routine data would be feasible in a future trial.Conclusions: The E-PAtS Feasibility RCT has demonstrated that the research design and methods of intervention implementation are generally feasible. Consideration of the limitations of this feasibility trial and any barriers to conducting a future definitive trial, do however, need to be considered by researchers.Clinical Trial Registration:https://www.isrctn.com, identifier: ISRCTN70419473.
Testing the short-term effectiveness of primary care referral to online weight loss programmes: A randomised controlled trial.
Guidelines ask health professionals to offer brief advice to encourage weight loss for people living with obesity. We tested whether referral to one of three online programmes could lead to successful weight loss. A total of 528 participants aged ≥18 years with a body mass index of ≥30 kg/m2 were invited via a letter from their GP. Participants were randomised to one of three online weight loss programmes (NHS Weight Loss Plan, Rosemary Online or Slimming World Online) or to a control group receiving no intervention. Participants self-reported weight at baseline and 8 weeks. The primary outcome was weight change in each of the active intervention groups compared with control. We also compared the proportion of participants losing ≥5% or ≥10% of body weight. For Rosemary, Online mean weight loss was modestly greater than control (-1.5 kg [95% confidence interval (CI) -2.3 to -0.6]) and more than three times as many participants in this group lost ≥5% (relative risk [RR] = 3.64, 95% CI: 1.63-8.1). For Slimming World, mean weight loss was not significantly different from control (-0.8 kg [95%CI -1.7 to 0.1]), twice as many participants lost ≥5% (RR = 2.70, 1.17-6.23). There was no significant difference in weight loss for participants using the NHS Weight Loss Plan (-0.4 kg, [95% CI -1.3 to 0.5]), or the proportion losing ≥5% (RR = 2.09, 0.87-5.01). Only one of three online weight loss programmes was superior to no intervention and the effect size modest among participants living with obesity.
Long-term oral prednisolone exposure in primary care for bullous pemphigoid: Population-based study
Background Oral prednisolone is the mainstay treatment for bullous pemphigoid, an autoimmune blistering skin disorder affecting older people. Treatment with moderate-to-high doses is often initiated in secondary care, but then continued in primary care. Aim To describe long-term oral prednisolone prescribing in UK primary care for adults with bullous pemphigoid from 1998 to 2017. Design and setting A prospective cohort study using routinely collected data from the Clinical Practice Research Datalink, a primary care database containing the healthcare records for over 17 million people in the UK. Method Oral prednisolone exposure was characterised in terms of the proportion of individuals with incident bullous pemphigoid prescribed oral prednisolone following their diagnosis, and the duration and dose of prednisolone. Results In total, 2312 (69.6%) of 3322 people with bullous pemphigoid were prescribed oral prednisolone in primary care. The median duration of exposure was 10.6 months (interquartile range [IQR] 3.4-24.0). Of prednisolone users, 71.5% were continuously exposed for >3 months, 39.7% for >1 year, 14.7% for >3 years, 5.0% for >5 years, and 1.7% for >10 years. The median cumulative dose was 2974 mg (IQR 1059-6456). Maximum daily doses were ≥10 mg/day in 74.4% of prednisolone users, ≥20 mg/day in 40.7%, ≥30 mg/day in 18.2%, ≥40 mg/day in 6.6%, ≥50 mg/day in 3.8%, and ≥60 mg/day in 1.9%. Conclusion A high proportion of people with incident bullous pemphigoid are treated with oral prednisolone in UK primary care. Action is required by primary and second care services to encourage use of steroid-sparing alternatives and, where switching is not possible, ensure prophylactic treatments and proactive monitoring of potential side effects are in place.
Deaths from cardiovascular disease involving anticoagulants: a systematic synthesis of coroners' case reports.
BACKGROUND: The global burden of cardiovascular disease (CVD) is forecast to increase, and anticoagulants will remain important medicines for its management. Coroners' Prevention of Future Death reports (PFDs) provide valuable insights that may enable safer and more effective use of these agents. AIM: To identify CVD-related PFDs involving anticoagulants. DESIGN AND SETTING: Retrospective observational study of coronial case reports in England and Wales between 2013 and 2019. METHOD: We screened 3037 PFDs for eligibility and included PFDs where CVD and an anticoagulant caused or contributed to the death. We descriptively analysed included cases and used content analysis to assess concerns raised by coroners and who responded to them. RESULTS: We identified 113 cardiovascular disease-related PFDs involving anticoagulants. Warfarin (36%), enoxaparin (11%), and rivaroxaban (11%) were the most common anticoagulants reported. Concerns most frequently raised by coroners included poor systems (31%), poor communication (25%), and failures to keep accurate medical records (25%). These concerns were most often directed to NHS trusts (29%), hospitals (10%), and general practices (8%). Nearly two-thirds (60%) of PFDs had not received responses from such organisations, which are mandatory under regulation 28 of the Coroners' (Investigations). We created a publicly available tool, https://preventabledeathstracker.net/, which displays coroners' reports in England and Wales to streamline access and identify important lessons to prevent future deaths. CONCLUSION: National organisations, healthcare professionals, and prescribers should take actions to address the concerns of coroners' in PFDs to improve the safe use of anticoagulants in patients with cardiovascular disease.
The diagnostic accuracy of HbA1c , compared to the oral glucose tolerance test, for screening for type 2 diabetes mellitus in Africa-a systematic review and meta-analysis.
OBJECTIVE: To assess the diagnostic accuracy of HbA1c , compared to fasting plasma glucose (FPG) and the oral glucose tolerance test (OGTT), in screening for type 2 diabetes (T2D) in Africa. METHODS: We systematically searched databases for studies that compared the HbA1C to either the OGTT, or the FPG for T2D diagnosis were included. The QUADAS 2 tool was used for assessing the quality of included studies. We used the split component synthesis (SCS) method for the meta-analysis of diagnostic accuracy studies to pool the studies for meta-analysis of sensitivity and specificity, primarily at the HbA1C ≥48mmol/mol (6.5%) cut-off and at other cut-offs. We assessed heterogeneity using the I2 statistic and publication bias using Doi plots. RESULTS: Eleven studies, from seven African countries, with 12925 participants, were included. Against the OGTT, HbA1C ≥48mmol/mol (6.5%) had a pooled sensitivity of 57.7% (95%CI 43.4-70.9) and specificity of 92.3% (95%CI 83.9 - 96.5). Against the FPG, HbA1C ≥48mmol/mol (6.5%) had a pooled sensitivity of 64.5% (95%CI 50.5 - 76.4) and specificity of 94.3% (95%CI 87.9 - 97.5). The highest sensitivity for HbA1C , against the OGTT, was at the 42mmol/mol (6.0%) cut off. CONCLUSION: In Africa, the HbA1C ≥48mmol/mol (6.5%) cut-off may miss almost half of the individuals with T2D based on blood glucose measures.
Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): study protocol
Background In the UK, postnatal depression is more common in British South Asian women than White Caucasion women. Cognitive–behavioural therapy (CBT) is recommended as a first-line treatment, but there is little evidence for the adaptation of CBT for postnatal depression to ensure its applicability to different ethnic groups. Aims To evaluate the clinical and cost-effectiveness of a CBT-based positive health programme group intervention in British South Asian women with postnatal depression. Method We have designed a multicentre, two-arm, partially nested, randomised controlled trial with 4- and 12-month follow-up, comparing a 12-session group CBT-based intervention (positive health programme) plus treatment as usual with treatment as usual alone, for British South Asian women with postnatal depression. Participants will be recruited from primary care and appropriate community venues in areas of high South Asian density across the UK. It has been estimated that randomising 720 participants (360 into each group) will be sufficient to detect a clinically important difference between a 55% recovery rate in the intervention group and a 40% recovery rate in the treatment-as-usual group. An economic analysis will estimate the cost-effectiveness of the positive health programme. A qualitative process evaluation will explore barriers and enablers to study participation and examine the acceptability and impact of the programme from the perspective of British South Asian women and other key stakeholders.