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The Centre for Evidence-Based Medicine (CEBM) at Oxford University develops, promotes and disseminates better evidence for health care.
Intravenous immunoglobulin treatment in childhood encephalitis (IgNiTE): a randomised controlled trial
OBJECTIVE: To investigate whether intravenous immunoglobulin (IVIG) improves neurological outcomes in children with encephalitis when administered early in the illness. DESIGN: Phase 3b multicentre, double-blind, randomised placebo-controlled trial. SETTING: Twenty-one hospitals in the UK. PARTICIPANTS: Children aged 6 months to 16 years with a diagnosis of acute or subacute encephalitis, with a planned sample size of 308. INTERVENTION: Two doses (1 g/kg/dose) of either IVIG or matching placebo given 24-36 hours apart, in addition to standard treatment. MAIN OUTCOME MEASURE: The primary outcome was a 'good recovery' at 12 months after randomisation, defined as a score of≤2 on the Paediatric Glasgow Outcome Score Extended. SECONDARY OUTCOME MEASURES: The secondary outcomes were clinical, neurological, neuroimaging and neuropsychological results, identification of the proportion of children with immune-mediated encephalitis, and IVIG safety data. RESULTS: 18 participants were recruited from 12 hospitals and randomised to receive either IVIG (n=10) or placebo (n=8) between 23 December 2015 and 26 September 2017. The study was terminated early following withdrawal of funding due to slower than anticipated recruitment, and therefore did not reach the predetermined sample size required to achieve the primary study objective; thus, the results are descriptive. At 12 months after randomisation, 9 of the 18 participants (IVIG n=5/10 (50%), placebo n=4/8 (50%)) made a good recovery and 5 participants (IVIG n=3/10 (30%), placebo n=2/8 (25%)) made a poor recovery. Three participants (IVIG n=1/10 (10%), placebo n=2/8 (25%)) had a new diagnosis of epilepsy during the study period. Two participants were found to have specific autoantibodies associated with autoimmune encephalitis. No serious adverse events were reported in participants receiving IVIG. CONCLUSIONS: The IgNiTE (ImmunoglobuliN in the Treatment of Encephalitis) study findings support existing evidence of poor neurological outcomes in children with encephalitis. However, the study was halted prematurely and was therefore underpowered to evaluate the effect of early IVIG treatment compared with placebo in childhood encephalitis. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT02308982; ICRCTN registry ISRCTN15791925.
Private prescribing of controlled opioids in England, 2014-2021: a retrospective observational study.
BACKGROUND: Trends in NHS opioid prescribing have been well published, yet trends in private prescribing of opioids have not been widely established. AIM: To assess trends and geographical variation in controlled opioids prescribed by private prescribers in England. DESIGN AND SETTING: This was a retrospective observational study in English primary health care. METHOD: Data on Schedule 2 and 3 controlled opioids ('controlled opioids') were obtained from the NHS Business Services Authority (BSA) using Freedom of Information (FOI) requests between 1 January 2014 and 30 November 2021. Absolute counts and rates of the number of items dispensed per cumulative number of registered private prescribers were calculated and stratified over time, by opioid type, and geographical region. RESULTS: This study found that 128 341 items of controlled opioids were prescribed by private prescribers in England between January 2014 and November 2021, which decreased by 50% from 23 339 items (4.09 items/prescriber) in 2014 to 11 573 items (1.49 items/prescriber) in 2020. Methadone (36%, n = 46 660) was the most common controlled opioid prescribed privately, followed by morphine (18%, n = 22 543), buprenorphine (16%, n = 20 521), and oxycodone (12%, n = 15 319). Prescriptions were highest in London (74%, n = 94 438), followed by the South-East of England (7%, n = 9237). A proportion of items (n = 462; 0.36%) were prescribed by 'unidentified doctors' where the prescription is not readily attributable to an individual prescriber by the BSA. CONCLUSION: Controlled opioids prescribed by private prescribers in England decreased and were primarily prescribed in London. To ensure patient safety, the monitoring and surveillance of controlled opioids dispensed privately should continue and items linked to 'unidentified doctors' should be addressed further.
Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial.
IMPORTANCE: Pregnancy hypertension results in adverse cardiac remodeling and higher incidence of hypertension and cardiovascular diseases in later life. OBJECTIVE: To evaluate whether an intervention designed to achieve better blood pressure control in the postnatal period is associated with lower blood pressure than usual outpatient care during the first 9 months postpartum. DESIGN, SETTING, AND PARTICIPANTS: Randomized, open-label, blinded, end point trial set in a single hospital in the UK. Eligible participants were aged 18 years or older, following pregnancy complicated by preeclampsia or gestational hypertension, requiring antihypertensive medication postnatally when discharged. The first enrollment occurred on February 21, 2020, and the last follow-up, November 2, 2021. The follow-up period was approximately 9 months. INTERVENTIONS: Participants were randomly assigned 1:1 to self-monitoring along with physician-optimized antihypertensive titration or usual postnatal care. MAIN OUTCOMES AND MEASURES: The primary outcome was 24-hour mean diastolic blood pressure at 9 months postpartum, adjusted for baseline postnatal blood pressure. RESULTS: Two hundred twenty participants were randomly assigned to either the intervention group (n = 112) or the control group (n = 108). The mean (SD) age of participants was 32.6 (5.0) years, 40% had gestational hypertension, and 60% had preeclampsia. Two hundred participants (91%) were included in the primary analysis. The 24-hour mean (SD) diastolic blood pressure, measured at 249 (16) days postpartum, was 5.8 mm Hg lower in the intervention group (71.2 [5.6] mm Hg) than in the control group (76.6 [5.7] mm Hg). The between-group difference was -5.80 mm Hg (95% CI, -7.40 to -4.20; P
Trends in diagnostic tests ordered for children: a retrospective analysis of 1.7 million laboratory test requests in Oxfordshire, UK from 2005 to 2019.
OBJECTIVE: To better understand testing patterns in children, we measured temporal trends in paediatric testing from 2005 to 2019 in Oxfordshire, UK. DESIGN: Descriptive study of population-based secondary data. SETTING: Oxfordshire University Hospitals National Health Service Trust laboratories. PARTICIPANTS: Children aged 0-15 years in Oxfordshire who received at least one blood test. MAIN OUTCOME MEASURES: We estimated average annual percentage changes (AAPCs) in test use using joinpoint regression models. Temporal changes in age-adjusted rates in test use were calculated overall and stratified by healthcare setting, sex, and age. RESULTS: Between 2005 and 2019, 1 749 425 tests were performed among 113 607 children. Overall test use declined until 2012, when test rates appeared to increase (AAPC 1.5%, 95% CI -0.8% to 3.9%). Most tests were performed in inpatient settings, where testing rates stayed steady (AAPC -0.6%, 95% CI -2.1% to 0.9%). Increases were highest in females, those aged 6-15 years and in the outpatient setting. The greatest increase in testing was for vitamin D (AAPC 26.5%), followed by parathyroid hormone (9.8%), iron studies (9.3%), folate (8.4%), vitamin B12 (8.4%), HbA1c (8.0%), IgA (7.9%) and coeliac (7.7%). CONCLUSIONS: After an initial decline, laboratory test use by children in Oxfordshire demonstrated an apparent increase since 2012. Test use increased in outpatient and general practice settings, however remained steady in inpatient settings. Further research should examine the root causes and implications for test increases, and whether these increases are warranted. We encourage clinicians to consider the individual and systemic implications of performing blood tests in children.
External validation of clinical severity scores to guide referral of paediatric acute respiratory infections in resource-limited primary care settings
Accurate and reliable guidelines for referral of children from resource-limited primary care settings are lacking. We identified three practicable paediatric severity scores (the Liverpool quick Sequential Organ Failure Assessment (LqSOFA), the quick Pediatric Logistic Organ Dysfunction-2, and the modified Systemic Inflammatory Response Syndrome) and externally validated their performance in young children presenting with acute respiratory infections (ARIs) to a primary care clinic located within a refugee camp on the Thailand-Myanmar border. This secondary analysis of data from a longitudinal birth cohort study consisted of 3010 ARI presentations in children aged ≤ 24 months. The primary outcome was receipt of supplemental oxygen. We externally validated the discrimination, calibration, and net-benefit of the scores, and quantified gains in performance that might be expected if they were deployed as simple clinical prediction models, and updated to include nutritional status and respiratory distress. 104/3,010 (3.5%) presentations met the primary outcome. The LqSOFA score demonstrated the best discrimination (AUC 0.84; 95% CI 0.79–0.89) and achieved a sensitivity and specificity > 0.80. Converting the scores into clinical prediction models improved performance, resulting in ~ 20% fewer unnecessary referrals and ~ 30–50% fewer children incorrectly managed in the community. The LqSOFA score is a promising triage tool for young children presenting with ARIs in resource-limited primary care settings. Where feasible, deploying the score as a simple clinical prediction model might enable more accurate and nuanced risk stratification, increasing applicability across a wider range of contexts.
The advantages and challenges experienced with the implementation and delivery of community paramedicine programmes: A qualitative reflexive thematic analysis
Objective: This study aims to investigate the experiences of individuals involved in implementing and delivering community paramedicine programmes across several different regions internationally, in order to identify key themes that can inform ongoing development and introduction of community paramedicine programmes. Methods: In this study, participants were enlisted through convenience sampling and a snowballing method. They responded to a custom survey emphasising open-ended responses. We employed a qualitative reflexive thematic analysis, utilising an inductive coding technique at the semantic/explicit level. This approach allowed us to discern themes from the participants’ accounts of the programme's implementation and delivery, along with their perceptions of its strengths and challenges. Results: Data was collected from 29 participants engaged in the development or delivery of community paramedicine programmes spanning seven countries. Five themes were created: (1) community drives the need, which emphasises the importance of community engagement and flexible response to health needs; (2) working with others, which underscores the necessity of collaboration with stakeholders for integration and relationship maintenance; (3) promotion and communication, focusing on clarifying roles and countering misconceptions; (4) recruitment and support of community paramedics, highlighting the significance of experienced paramedic recruitment and providing support for staff retention; and (5) research and evaluation, stressing the importance of data sharing for patient care and programme evaluation. These themes demonstrate the significance of community-centred approaches, interprofessional practice, and programme evaluation in community paramedicine. Conclusion: This study highlights the significance of community-centred approaches, interprofessional practice, and programme evaluation in community paramedicine. These findings can inform policymakers and practitioners in the development and implementation of community paramedicine programmes, ultimately improving the health and well-being of communities across different regions internationally.
Relationship Between Clinician Language and the Success of Behavioral Weight Loss Interventions : A Mixed-Methods Cohort Study.
BACKGROUND: International guidelines recommend that primary care clinicians recognize obesity and offer treatment opportunistically, but there is little evidence on how clinicians can discuss weight and offer treatment in ways that are well received and effective. OBJECTIVE: To examine relationships between language used in the clinical visit and patient weight loss. DESIGN: Mixed-methods cohort study. SETTING: 38 primary care clinics in England participating in the Brief Intervention for Weight Loss trial. PARTICIPANTS: 246 patients with obesity seen by 87 general practitioners randomly sampled from the intervention group of the randomized clinical trial. MEASUREMENTS: Conversation analysis of recorded discussions between 246 patients with obesity and 87 clinicians regarding referral to a 12-week behavioral weight management program offered as part of the randomized clinical trial. Clinicians' interactional approaches were identified and their association with patient weight loss at 12 months (primary outcome) was examined. Secondary outcomes included patients' agreement to attend weight management, attendance, loss of 5% body weight, actions taken to lose weight, and postvisit satisfaction. RESULTS: Three interactional approaches were identified on the basis of clinicians' linguistic and paralinguistic practices: creating a sense of referrals as "good news" related to the opportunity of the referral (n = 62); "bad news," focusing on the harms of obesity (n = 82); or neutral (n = 102). Outcome data were missing from 57 participants, so weighted analyses were done to adjust for missingness. Relative to neutral news, good news was associated with increased agreement to attend the program (adjusted risk difference, 0.25 [95% CI, 0.15 to 0.35]), increased attendance (adjusted risk difference, 0.45 [CI, 0.34 to 0.56]), and weight change (adjusted difference, -3.60 [CI, -6.58 to -0.62]). There was no evidence of differences in mean weight change comparing bad and neutral news, and no evidence of differences in patient satisfaction across all 3 approaches. LIMITATIONS: Data were audio only, so body language and nonverbal cues could not be assessed. There is potential for selection bias and residual confounding. CONCLUSION: When raising the topic of excess weight in clinical visits, presenting weight loss treatment as a positive opportunity is associated with greater uptake of treatment and greater weight loss. PRIMARY FUNDING SOURCE: National Institute for Health and Care Research School for Primary Care Research and the Foundation for the Sociology of Health and Illness.
Cochrane review of electronic cigarettes for smoking cessation
Supplementary tables 1-10 for the update to the Cochrane review of electronic cigarettes for smoking cessation. Once accepted the DOI for the publication will be: 10.1002/14651858.CD010216.pub8
Electronic cigarettes for smoking cessation
November 2023 Supplementary tables 1-10 for the update to the Cochrane Review of electronic cigarettes for smoking cessation. All are word files. The
Electronic cigarettes for smoking cessation
Supplementary tables 1-10 for the update to the Cochrane review of electronic cigarettes for smoking cessation. Once accepted the DOI for the publication will be: 10.1002/14651858.CD010216.pub8 I would like a DOI to link to the supplementary tablesWord documents. November 2023.
Cochrane living review of electronic cigarettes for smoking cessation
Supplementary tables 1-10 for the update to the Cochrane review of electronic cigarettes for smoking cessation. Once accepted the DOI for the publication will be: 10.1002/14651858.CD010216.pub8 I would like a DOI to link to the supplementary tablesWord documents. November 2023.
Fitting in or belonging: emerging findings from a realist evaluation of social prescribing link workers in primary care
BACKGROUND: Social prescribing link workers are being employed in primary care through the Additional Roles Reimbursement Scheme. AIM: To understand and explain how the link worker role is being implemented and sustained in primary care. METHOD: As part of a realist evaluation, we observed link workers in practices in different parts of England and interviewed patients and professionals. Data have been coded and are being developed into statements that explain how context interacts with mechanisms leading to intended and unintended outcomes. RESULTS: Our first work package (WP) involved data collection from seven sites in England. For this WP, we interviewed 61 patients and 94 professionals (link workers, GPs, and members of the voluntary-community sector). 'Boundaries' is a key concept within the data. It can describe whether and how link workers draw limits around their role. This can affect the breadth of their work, as they attempt to gain credibility and acceptance within a practice. Boundaries can shape how far link workers feel they belong rather than having to fit into a practice. This may shape their ability to support patients with their psychosocial needs. CONCLUSION: Dominance of a medical model approach to service delivery may not be conducive to uncovering and supporting people with their non-medical problems, or to promoting a wider understanding of health. Tensions between fitting into a setting dominated by medical discourse and practices, compared to feeling they belong, is something that link workers can encounter when providing social prescribing services in primary care.
Preventable deaths involving falls in England and Wales, 2013-22: a systematic case series of coroners' reports.
BACKGROUND: Falls in older people are common, leading to significant harm including death. Coroners have a duty to report cases where action should be taken to prevent future deaths, but dissemination of their findings remains poor. OBJECTIVE: To identify preventable fall-related deaths, classify coroner concerns and explore organisational responses. DESIGN: A retrospective systematic case series of coroners' Prevention of Future Deaths (PFD) reports, from July 2013 (inception) to November 2022. SETTING: England and Wales. METHODS: Reproducible data collection methods were used to web-scrape and read PFD reports. Demographic information, coroner concerns and responses from organisations were extracted and descriptive statistics used to synthesise data. RESULTS: Five hundred and twenty-seven PFDs (12.5% of PFDs) involved a fall that contributed to death. These deaths predominantly affected older people (median 82 years) in the community (72%), with subsequent death in hospital (70.8%). A high proportion of cases experienced fractures (51.6%), major bleeding (35.9%) or head injury (38.7%). Coroners frequently raised concerns regarding falls risks assessments (20.9%), failures in communication (20.3%) and documentation issues (17.5%). Only 56.7% of PFDs received a response from organisations to whom they were addressed. Organisations tended to produce new protocols (58.5%), improve training (44.6%) and commence audits (34.3%) in response to PFDs. CONCLUSIONS: One in eight preventable deaths in England and Wales involved a fall. Addressing concerns raised by coroners should improve falls prevention and care following falls especially for older adults, but the poor response rate may indicate that lessons are not being learned. Wider dissemination of PFD findings may help reduce preventable fall-related deaths in the future.
Comparative effectiveness of sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in patients on kidney replacement therapy: observational study using the OpenSAFELY-UKRR and SRR databases.
BACKGROUND: Due to limited inclusion of patients on kidney replacement therapy (KRT) in clinical trials, the effectiveness of coronavirus disease 2019 (COVID-19) therapies in this population remains unclear. We sought to address this by comparing the effectiveness of sotrovimab against molnupiravir, two commonly used treatments for non-hospitalised KRT patients with COVID-19 in the UK. METHODS: With the approval of National Health Service England, we used routine clinical data from 24 million patients in England within the OpenSAFELY-TPP platform linked to the UK Renal Registry (UKRR) to identify patients on KRT. A Cox proportional hazards model was used to estimate hazard ratios (HRs) of sotrovimab versus molnupiravir with regards to COVID-19-related hospitalisations or deaths in the subsequent 28 days. We also conducted a complementary analysis using data from the Scottish Renal Registry (SRR). RESULTS: Among the 2367 kidney patients treated with sotrovimab (n = 1852) or molnupiravir (n = 515) between 16 December 2021 and 1 August 2022 in England, 38 cases (1.6%) of COVID-19-related hospitalisations/deaths were observed. Sotrovimab was associated with substantially lower outcome risk than molnupiravir {adjusted HR 0.35 [95% confidence interval (CI) 0.17-0.71]; P = .004}, with results remaining robust in multiple sensitivity analyses. In the SRR cohort, sotrovimab showed a trend toward lower outcome risk than molnupiravir [HR 0.39 (95% CI 0.13-1.21); P = .106]. In both datasets, sotrovimab had no evidence of an association with other hospitalisation/death compared with molnupiravir (HRs ranged from 0.73 to 1.29; P > .05). CONCLUSIONS: In routine care of non-hospitalised patients with COVID-19 on KRT, sotrovimab was associated with a lower risk of severe COVID-19 outcomes compared with molnupiravir during Omicron waves.