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The Centre for Evidence-Based Medicine (CEBM) at Oxford University develops, promotes and disseminates better evidence for health care.
Postoperative mortality and complications in patients with and without pre-operative SARS-CoV-2 infection: a service evaluation of 24 million linked records using OpenSAFELY.
Surgical decision-making after SARS-CoV-2 infection is influenced by the presence of comorbidity, infection severity and whether the surgical problem is time-sensitive. Contemporary surgical policy to delay surgery is informed by highly heterogeneous country-specific guidance. We evaluated surgical provision in England during the COVID-19 pandemic to assess real-world practice and whether deferral remains necessary. Using the OpenSAFELY platform, we adapted the COVIDSurg protocol for a service evaluation of surgical procedures that took place within the English NHS from 17 March 2018 to 17 March 2022. We assessed whether hospitals adhered to guidance not to operate on patients within 7 weeks of an indication of SARS-CoV-2 infection. Additional outcomes were postoperative all-cause mortality (30 days, 6 months) and complications (pulmonary, cardiac, cerebrovascular). The exposure was the interval between the most recent indication of SARS-CoV-2 infection and subsequent surgery. In any 6-month window,
Trends, variation, and clinical characteristics of recipients of antiviral drugs and neutralising monoclonal antibodies for covid-19 in community settings: retrospective, descriptive cohort study of 23.4 million people in OpenSAFELY.
OBJECTIVE: To ascertain patient eligibility status and describe coverage of antiviral drugs and neutralising monoclonal antibodies (nMAB) as treatment for covid-19 in community settings in England. DESIGN: Retrospective, descriptive cohort study, approved by NHS England. SETTING: Routine clinical data from 23.4 million people linked to data on covid-19 infection and treatment, within the OpenSAFELY-TPP database. PARTICIPANTS: Outpatients with covid-19 at high risk of severe outcomes. INTERVENTIONS: Nirmatrelvir/ritonavir (paxlovid), sotrovimab, molnupiravir, casirivimab/imdevimab, or remdesivir, used in the community by covid-19 medicine delivery units. RESULTS: 93 870 outpatients with covid-19 were identified between 11 December 2021 and 28 April 2022 to be at high risk of severe outcomes and therefore potentially eligible for antiviral or nMAB treatment (or both). Of these patients, 19 040 (20%) received treatment (sotrovimab, 9660 (51%); molnupiravir, 4620 (24%); paxlovid, 4680 (25%); casirivimab/imdevimab, 50 (<1%); and remdesivir, 30 (<1%)). The proportion of patients treated increased from 9% (190/2220) in the first week of treatment availability to 29% (460/1600) in the latest week. The proportion treated varied by high risk group, being lowest in those with liver disease (16%; 95% confidence interval 15% to 17%); by treatment type, with sotrovimab favoured over molnupiravir and paxlovid in all but three high risk groups (Down's syndrome (35%; 30% to 39%), rare neurological conditions (45%; 43% to 47%), and immune deficiencies (48%; 47% to 50%)); by age, ranging from ≥80 years (13%; 12% to 14%) to 50-59 years (23%; 22% to 23%); by ethnic group, ranging from black (11%; 10% to 12%) to white (21%; 21% to 21%); by NHS region, ranging from 13% (12% to 14%) in Yorkshire and the Humber to 25% (24% to 25%) in the East of England); and by deprivation level, ranging from 15% (14% to 15%) in the most deprived areas to 23% (23% to 24%) in the least deprived areas. Groups that also had lower coverage included unvaccinated patients (7%; 6% to 9%), those with dementia (6%; 5% to 7%), and care home residents (6%; 6% to 7%). CONCLUSIONS: Using the OpenSAFELY platform, we were able to identify patients with covid-19 at high risk of severe outcomes who were potentially eligible to receive treatment and assess the coverage of these new treatments among these patients. In the context of a rapid deployment of a new service, the NHS analytical code used to determine eligibility could have been over-inclusive and some of the eligibility criteria not fully captured in healthcare data. However targeted activity might be needed to resolve apparent lower treatment coverage observed among certain groups, in particular (at present): different NHS regions, ethnic groups, people aged ≥80 years, those living in socioeconomically deprived areas, and care home residents.
Protocol for the Pathways Study: a realist evaluation of staff social ties and communication in the delivery of neonatal care in Kenya
IntroductionThe informal social ties that health workers form with their colleagues influence knowledge, skills and individual and group behaviours and norms in the workplace. However, improved understanding of these ‘software’ aspects of the workforce (eg, relationships, norms, power) have been neglected in health systems research. In Kenya, neonatal mortality has lagged despite reductions in other age groups under 5 years. A rich understanding of workforce social ties is likely to be valuable to inform behavioural change initiatives seeking to improve quality of neonatal healthcare.This study aims to better understand the relational components among health workers in Kenyan neonatal care areas, and how such understanding might inform the design and implementation of quality improvement interventions targeting health workers’ behaviours.Methods and analysisWe will collect data in two phases. In phase 1, we will conduct non-participant observation of hospital staff during patient care and hospital meetings, a social network questionnaire with staff, in-depth interviews, key informant interviews and focus group discussions at two large public hospitals in Kenya. Data will be collected purposively and analysed using realist evaluation, interim analyses including thematic analysis of qualitative data and quantitative analysis of social network metrics. In phase 2, a stakeholder workshop will be held to discuss and refine phase one findings.Study findings will help refine an evolving programme theory with recommendations used to develop theory-informed interventions targeted at enhancing quality improvement efforts in Kenyan hospitals.Ethics and disseminationThe study has been approved by Kenya Medical Research Institute (KEMRI/SERU/CGMR-C/241/4374) and Oxford Tropical Research Ethics Committee (OxTREC 519-22). Research findings will be shared with the sites, and disseminated in seminars, conferences and published in open-access scientific journals.
Health visiting in the UK in light of the COVID-19 pandemic experience (RReHOPE): a realist review protocol.
INTRODUCTION: Health visiting services, providing support to under 5s and their families, are organised and delivered in very different ways in different parts of the UK. While there has been attention to the key components of health visiting practice and what works well and how, there is little research on how health visiting services are organised and delivered and how that affects their ability to meet their objectives. The COVID-19 pandemic rapidly disrupted service delivery from March 2020. This realist review aims to synthesise the evidence on changes during the pandemic to identify the potential for improving health visiting services and their delivery. METHODS AND ANALYSIS: This review will follow the RAMESES (Realist And Meta-narrative Evidence Syntheses: Evolving Standards) quality standards and Pawson's five iterative stages to locate existing theories, search for evidence, select literature, extract data, synthesise evidence and draw conclusions. It will be guided by stakeholder engagement with practitioners, commissioners, policymakers, policy advocates and people with lived experience. This approach will consider the emerging strategies and evolving contexts in which the services are delivered, and the varied outcomes for different groups. A realist logic of analysis will be used to make sense of what was happening to health visiting services during and following the pandemic response through the identification and testing of programme theories. Our refined programme theory will then be used to develop recommendations for improving the organisation, delivery and ongoing postpandemic recovery of health visiting services. ETHICS AND DISSEMINATION: General University Ethics Panel approval has been obtained from University of Stirling (reference 7662). Dissemination will build on links to policymakers, commissioners, providers, policy advocates and the public. A range of audiences will be targeted using outputs tailored to each. A final stakeholder event focused on knowledge mobilisation will aid development of recommendations. PROSPERO REGISTRATION NUMBER: CRD42022343117.
Protocol for an OpenSAFELY cohort study collecting patient-reported outcome measures using the TPP Airmid smartphone application and linked big data to quantify the health and economic costs of long COVID (OpenPROMPT)
INTRODUCTION: The impact of long COVID on health-related quality of-life (HRQoL) and productivity is not currently known. It is important to understand who is worst affected by long COVID and the cost to the National Health Service (NHS) and society, so that strategies like booster vaccines can be prioritised to the right people. OpenPROMPT aims to understand the impact of long COVID on HRQoL in adults attending English primary care. METHODS AND ANALYSIS: We will ask people to participate in this cohort study through a smartphone app (Airmid), and completing a series of questionnaires held within the app. Questionnaires will ask about HRQoL, productivity and symptoms of long COVID. Participants will be asked to fill in the questionnaires once a month, for 90 days. Questionnaire responses will be linked, where possible, to participants' existing health records from primary care, secondary care, and COVID testing and vaccination data. Analysis will take place using the OpenSAFELY data platform and will estimate the impact of long COVID on HRQoL, productivity and cost to the NHS. ETHICS AND DISSEMINATION: The Proportionate Review Sub-Committee of the South Central-Berkshire B Research Ethics Committee has reviewed and approved the study and have agreed that we can ask people to take part (22/SC/0198). Our results will provide information to support long-term care, and make recommendations for prevention of long COVID in the future. TRIAL REGISTRATION NUMBER: NCT05552612.
Self-monitoring for improving control of blood pressure in patients with hypertension: a Cochrane intervention review
BACKGROUND: Hypertension is a major risk factor for cardiovascular events with only a minority of people treated to satisfactory levels. There is an increasing body of literature pertaining to the beneficial effect of self-blood pressure monitoring (SBPM) on blood pressure control in hypertensive patients. It is cost-effective, well tolerated, and has been shown to be a better predictor of end organ damage than traditional office blood pressure monitoring (OBPM). The aim of this Cochrane review is to provide an up-to-date assessment on the effectiveness of self-monitoring in the management of hypertension.Is SBPM more efficacious in reducing blood pressure, compared with OBPM or usual care?Is SBPM with additional supports more efficacious in reducing blood pressure, compared with no additional support?Are there any adverse events associated with SBPM, compared with OBPM or usual care? METHODS: All randomised controlled trials of adult patients with a diagnosis of primary hypertension where the intervention of interest is SBPM will be included. Data extraction, analysis and risk of bias assessment will be carried out by two independent authors. Analysis will be based on intention-to-treat (ITT) data from individual trials. RESULTS: Primary outcome measures include change in mean office systolic and/or diastolic BP, change in mean ambulatory blood pressure, the proportion of patients reaching target BP, and adverse events including mortality or cardiovascular morbidity or related to treatment with antihypertensive agents. DISCUSSION: This review will help to determine if self-monitoring of blood pressure, with or without co-interventions, is effective in lowering blood pressure. Results will be available for conference.
Is England facing an opioid epidemic?
The opioid crisis in the United States (US) is one of the most high-profile public health scandals of the 21st century with millions of people unknowingly becoming dependent on opioids. The United Kingdom (UK) had the world’s highest rate of opioid consumption in 2019, and opiate-related drug poisoning deaths have increased by 388% since 1993 in England and Wales. This article explores the epidemiological definitions of public health emergencies and epidemics in the context of opioid use, misuse, and mortality in England, to establish whether England is facing an opioid crisis.
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners' Reports 2013-22.
Medicines cause over 1700 preventable deaths annually in England. Coroners' Prevention of Future Death reports (PFDs) are produced in response to preventable deaths to facilitate change. The information in PFDs may help reduce medicine-related preventable deaths. We aimed to identify medicine-related deaths in coroners' reports and to explore concerns to prevent future deaths. We carried out a retrospective case series of PFDs across England and Wales, dated between 1 July, 2013 and 23 February, 2022, collected from the UK's Courts and Tribunals Judiciary website using web scraping, generating an openly available database: https://preventabledeathstracker.net/ . We used descriptive techniques and content analysis to assess the main outcome criteria: the proportion of PFDs in which coroners reported that a therapeutic medicine or drug of abuse had caused or contributed to a death; the characteristics of included PFDs; coroners' concerns; the recipients of PFDs; and the timeliness of their responses. There were 704 PFDs (18%; 716 deaths) that involved medicines, representing an estimated 19,740 years of life lost (average of 50 years lost per death). Opioids (22%), antidepressants (9.7%), and hypnotics (9.2%) were the most common drugs involved. Coroners expressed 1249 concerns, primarily around the major themes of patient safety (29%) and communication (26%), including minor themes of failures of monitoring (10%) and poor communication between organizations (7.5%). Most expected responses to PFDs (51%; 630/1245) were not reported on the UK's Courts and Tribunals Judiciary website. One in five coroner-reported preventable deaths involved medicines. Addressing coroners' concerns, including problems with patient safety and communication, should reduce harms from medicines. Despite concerns being raised repeatedly, half of the PFD recipients failed to respond, suggesting that lessons are not generally learned. The rich information in PFDs should be used to foster a learning environment in clinical practice that may help reduce preventable deaths. https://doi.org/10.17605/OSF.IO/TX3CS .
ChroniSense National Early Warning Score Study: Comparison Study of a Wearable Wrist Device to Measure Vital Signs in Patients Who Are Hospitalized.
BackgroundWearable devices could be used to continuously monitor vital signs in patients who are hospitalized, but they require validation.ObjectiveThis study aimed to evaluate the clinical validity of the prototype of a semiautomated wearable wrist device (ChroniSense Polso) to measure vital signs and provide National Early Warning Scores (NEWSs).MethodsVital signs and NEWSs measured using the wearable device were compared with standard, nurse-lead manual measurements. We enrolled adult patients (aged ≥18 years) who required vital sign measurements at least every 6 hours in a UK teaching district general hospital. Wearable device measurements were not used for clinical decision-making. The primary outcome was the agreement on the individual National Early Warning parameter scores and vital sign measurements: respiratory rate, oxygen saturation, body temperature, systolic blood pressure, and heart rate. Secondary outcomes were the agreement on the total NEWS, incidence of adverse events, and user acceptance. To compare the wearable device measurements with the standard measurements, we analyzed vital sign measurements by limits of agreement (Bland-Altman analysis) and conducted κ agreement analyses for NEWSs. A user experience survey was conducted with questions about comfort of the wrist device, safety, preference, and use.ResultsWe included 132 participants in the study, with a mean age of 62 (SD 15.81) years; most of them were men (102/132, 77.3%). The highest weighted κ values were found for heart rate (0.69, 95% CI 0.57-0.81 for all 385 measurements) and systolic blood pressure (0.39, 95% CI 0.30-0.47 for all 339 measurements). Weighted κ values were low for respiration rate (0.03, 95% CI -0.001 to 0.05 for all 445 measurements), temperature (0, 95% CI 0-0 for all 231 measurements), and oxygen saturation (-0.11, 95% CI -0.20 to -0.02 for all 187 measurements). Weighted κ using Cicchetti-Allison weights showed κ of 0.20 (95% CI 0.03-0.38) when using all 56 total NEWSs. The user acceptance survey found that approximately half (45/91, 49%) of the participants found it comfortable to wear the device and liked its appearance. Most (85/92, 92%) of them said that they would wear the device during their next hospital visit, and many (74/92, 80%) said that they would recommend it to others.ConclusionsThis study shows the promising use of a prototype wearable device to measure vital signs in a hospital setting. Agreement between the standard measurements and wearable device measurements was acceptable for systolic blood pressure and heart rate, but needed to be improved for respiration rate, temperature, and oxygen saturation. Future studies need to improve the clinical validity of this wearable device. Large studies are required to assess clinical outcomes and cost-effectiveness of wearable devices for vital sign measurement.International registered report identifier (irrid)RR2-10.1136/bmjopen-2018-028219.