Objective To estimate the real world effectiveness of modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine against mpox infection. Design Emulation of a target trial. Setting Linked databases in Ontario, Canada. Participants 9803 men aged ≥18 years with a history of being tested for syphilis and a laboratory confirmed bacterial sexually transmitted infection (STI) in the previous year, or who

Objective To assess efficacy and safety of laughter exercise in patients with symptomatic dry eye disease. Design Non-inferiority randomised controlled trial. Setting Recruitment was from clinics and community and the trial took place at Zhongshan Ophthalmic Center, Sun Yat-sen University, the largest ophthalmic centre in China, between 18 June 2020 to 8 January 2021. Participants People with symptomatic

Objective To provide a comprehensive assessment of various fractionation schemes in radiation therapy for breast cancer, with a focus on side effects, cosmesis, quality of life, risks of recurrence, and survival outcomes. Design Systematic review and meta-analysis. Data sources Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (from inception to 23 October 2023). Study selection

This article discusses definitions of the effect of vaccines across outcomes of interest, from individual level to contacts of vaccinated people to population level. The focus is on the outcome evaluated in an observational study on the effectiveness of mpox vaccine in the context of potential outcomes that could have been measured. When evaluating how well a vaccine works, two categories of outcomes

Objective To provide a baseline comparative assessment of the main epidemiological features of prostate cancer in European populations as background for the proposed EU screening initiatives. Design Population based study. Setting 26 European countries, 19 in the EU, 1980-2017. National or subnational incidence data were extracted from population based cancer registries from the International Agency

Objective To investigate associations between long term residential exposure to road traffic noise and particulate matter with a diameter <2.5 µm (PM2.5) and infertility in men and women. Design Nationwide prospective cohort study. Setting Denmark. Participants 526 056 men and 377 850 women aged 30-45 years, with fewer than two children, cohabiting or married, and residing in Denmark between 2000 and

Predicting future outcomes of patients is essential to clinical practice, with many prediction models published each year. Empirical evidence suggests that published studies often have severe methodological limitations, which undermine their usefulness. This article presents a step-by-step guide to help researchers develop and evaluate a clinical prediction model. The guide covers best practices in

Objective To compare the risk of dementia associated with sodium-glucose cotransporter-2 (SGLT-2) inhibitors versus dipeptidyl peptidase-4 (DPP-4) inhibitors in adults aged 40-69 years with type 2 diabetes. Design Population based cohort study. Setting Korean National Health Insurance Service data, 2013-21. Participants 110 885 propensity score matched pairs of adults with type 2 diabetes aged 40-69

Objective To evaluate the comparative effectiveness and acceptability of oral monotherapy using psychedelics and escitalopram in patients with depressive symptoms, considering the potential for overestimated effectiveness due to unsuccessful blinding. Design Systematic review and Bayesian network meta-analysis. Data sources Medline, Cochrane Central Register of Controlled Trials, Embase, PsycINFO,

Objectives To estimate age standardised suicide rate ratios in male and female physicians compared with the general population, and to examine heterogeneity across study results. Design Systematic review and meta-analysis. Data sources Studies published between 1960 and 31 March 2024 were retrieved from Embase, Medline, and PsycINFO. There were no language restrictions. Forward and backwards reference

Objective To assess the clinical benefit and actionability of molecular targets for genome targeted cancer drugs recommended for clinical practice by the National Comprehensive Cancer Network (NCCN). Design Cross sectional study. Participants/setting Genome targeted cancer drugs recommended by NCCN guidelines in the advanced setting. Main outcome measures Molecular target actionability was assessed

Objective To quantify global intakes of sugar sweetened beverages (SSBs) and trends over time among children and adolescents. Design Population based study. Setting Global Dietary Database. Population Children and adolescents aged 3-19 years in 185 countries between 1990 and 2018, jointly stratified at subnational level by age, sex, parental education, and rural or urban residence. Results In 2018

Objective To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis. Design Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS). Setting 16 public orthopaedic and neurosurgical clinics in Norway. Participants Patients aged 18-80 years with symptomatic

Objective To evaluate the personal protective effects of wearing versus not wearing surgical face masks in public spaces on self-reported respiratory symptoms over a 14 day period. Design Pragmatic randomised superiority trial. Setting Norway. Participants 4647 adults aged ≥18 years: 2371 were assigned to the intervention arm and 2276 to the control arm. Interventions Participants in the intervention

Objectives To quantify prevalence, harms, and NHS costs in England of problematic oral non-steroidal anti-inflammatory drug (NSAID) prescribing in high risk groups. Design Population based cohort and economic modelling study. Setting Economic models estimating patient harm associated with NSAID specific hazardous prescribing events, and cost to the English NHS, over a 10 year period, were combined

Objective To compare the effectiveness of intraosseous versus intravenous vascular access in the treatment of adult patients with out-of-hospital cardiac arrest. Design Cluster randomised controlled trial. Setting The VICTOR (Venous Injection Compared To intraOsseous injection during resuscitation of patients with out-of-hospital cardiac arrest) trial involved emergency medical service agencies with

Objective To evaluate the effectiveness of a clinical decision support system (CDSS) in improving the use of guideline accordant antihypertensive treatment in primary care settings in China. Design Pragmatic, open label, cluster randomised trial. Setting 94 primary care practices in four urban regions of China between August 2019 and July 2022: Luoyang (central China), Jining (east China), and Shenzhen

Objectives To evaluate the risk of major congenital anomalies according to infection with or vaccination against covid-19 during the first trimester of pregnancy. Design Prospective Nordic registry based study. Setting Sweden, Denmark, and Norway. Participants 343 066 liveborn singleton infants in Sweden, Denmark, and Norway, with an estimated start of pregnancy between 1 March 2020 and 14 February

Objective To examine trends in long term (>6 months) vaping among adults in England. Design Population based study. Setting England. Participants 179 725 adults (≥18 years) surveyed between October 2013 and October 2023. Main outcome measures Time trends in prevalence of long term vaping using logistic regression, overall and by vaping frequency (daily or non-daily), and main type of device used (disposable

Objectives To assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson’s disease. Design Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial. Setting The speech and language therapy interventions were delivered in outpatient or home settings between 26

Objective To evaluate the effectiveness of behavioural interventions that include motivational interviewing on physical activity outcomes in adults. Design Systematic review and meta-analysis. Study selection A search of seven databases for randomised controlled trials published from inception to 1 March 2023 comparing a behavioural intervention including motivational interviewing with a comparator

Objective To investigate the incidence of cardiovascular disease (CVD) overall and by age, sex, and socioeconomic status, and its variation over time, in the UK during 2000-19. Design Population based study. Setting UK. Participants 1 650 052 individuals registered with a general practice contributing to Clinical Practice Research Datalink and newly diagnosed with at least one CVD from 1 January 2000

Objectives To evaluate the comparative effectiveness of sodium-glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and dipeptidyl peptidase-4 (DPP-4) inhibitors in preventing hyperkalemia in people with type 2 diabetes in routine clinical practice. Design Population based cohort study with active-comparator, new user design. Setting Claims data from Medicare

Objectives To assess the efficacy and safety of colchicine versus placebo on reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient ischaemic attack within the first three months of symptom onset (CHANCE-3). Design Multicentre, double blind, randomised, placebo controlled trial. Setting 244 hospitals in China between 11 August 2022 and 13 April 2023.

Objective To compare the effectiveness and safety of nab-paclitaxel, cisplatin, and capecitabine (nab-TPC) with gemcitabine and cisplatin as an alternative first line treatment option for recurrent or metastatic nasopharyngeal carcinoma. Design Phase 3, open label, multicentre, randomised trial. Setting Four hospitals located in China between September 2019 and August 2022. Participants Adults (≥18

Objective To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction. Design A multicentre, open label, randomised controlled trial. Setting Eight hospitals in Sweden, 2017-23. Participants 717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were

Objectives To estimate the burden, trends, and inequalities of type 1 diabetes mellitus (T1DM) among older adults at global, regional, and national level from 1990 to 2019. Design Population based study. Population Adults aged ≥65 years from 21 regions and 204 countries and territories (Global Burden of Disease and Risk Factors Study 2019) from 1990 to 2019. Main outcome measures Primary outcomes were

Objective To assess the effect of different antiplatelet strategies on clinical outcomes after coronary artery bypass grafting. Design Five year follow-up of randomised Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Grafting (DACAB) trial. Setting Six tertiary hospitals in China; enrolment between July 2014 and November 2015; completion of five year follow-up from August 2019

Objectives To evaluate whether providing family physicians with feedback on their antibiotic prescribing compared with that of their peers reduces antibiotic prescriptions. To also identify effects on antibiotic prescribing from case-mix adjusted feedback reports and messages emphasising antibiotic associated harms. Design Pragmatic, factorial randomised controlled trial. Setting Primary care physicians

Objective To evaluate the efficacy and safety of tislelizumab added to chemotherapy as first line (primary) treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma compared with placebo plus chemotherapy. Design Randomised, double blind, placebo controlled, phase 3 study. Setting 146 medical centres across Asia, Europe, and North America, between 13 December 2018 and 28 February

Objective To evaluate the association between antibiotic use during pregnancy or early infancy and the risk of neurodevelopmental disorders in children. Design Nationwide population based cohort study and sibling analysis. Setting Korea’s National Health Insurance Service mother-child linked database, 2008-21. Participants All children live born between 2009 and 2020, followed up until 2021 to compare

Objectives To determine the effect of labour epidural on severe maternal morbidity (SMM) and to explore whether this effect might be greater in women with a medical indication for epidural analgesia during labour, or with preterm labour. Design Population based study. Setting All NHS hospitals in Scotland. Participants 567 216 women in labour at 24+0 to 42+6 weeks’ gestation between 1 January 2007

Objectives To replicate previous analyses on the effectiveness of the English human papillomavirus (HPV) vaccination programme on incidence of cervical cancer and grade 3 cervical intraepithelial neoplasia (CIN3) using 12 additional months of follow-up, and to investigate effectiveness across levels of socioeconomic deprivation. Design Observational study. Setting England, UK. Participants Women aged

Objective To examine the association between prescriber workforce exit, long term opioid treatment discontinuation, and clinical outcomes. Design Quasi-experimental difference-in-differences study Setting 20% sample of US Medicare beneficiaries, 2011-18. Participants People receiving long term opioid treatment whose prescriber stopped providing office based patient care or exited the workforce, as

Objectives To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. Design The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial. Setting 34 UK hospitals. Participants 405 women of reproductive age undergoing conservative

Objective To examine the association of ultra-processed food consumption with all cause mortality and cause specific mortality. Design Population based cohort study. Setting Female registered nurses from 11 US states in the Nurses’ Health Study (1984-2018) and male health professionals from all 50 US states in the Health Professionals Follow-up Study (1986-2018). Participants 74 563 women and 39 501

Objective To compare the effectiveness of three commonly prescribed oral antidiabetic drugs added to metformin for people with type 2 diabetes mellitus requiring second line treatment in routine clinical practice. Design Cohort study emulating a comparative effectiveness trial (target trial). Setting Linked primary care, hospital, and death data in England, 2015-21. Participants 75 739 adults with

Objective To determine the efficacy of psilocybin as an antidepressant compared with placebo or non-psychoactive drugs. Design Systematic review and meta-analysis. Data sources Five electronic databases of published literature (Cochrane Central Register of Controlled Trials, Medline, Embase, Science Citation Index and Conference Proceedings Citation Index, and PsycInfo) and four databases of unpublished

Objectives To answer a national research priority by comparing the risk-benefit and costs associated with reverse total shoulder replacement (RTSR) and anatomical total shoulder replacement (TSR) in patients having elective primary shoulder replacement for osteoarthritis. Design Population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England. Setting

Objective To investigate the potential association between prenatal opioid exposure and the risk of neuropsychiatric disorders in children. Design Nationwide birth cohort study. Setting From 1 January 2009 to 31 December 2020, birth cohort data of pregnant women in South Korea linked to their liveborn infants from the National Health Insurance Service of South Korea were collected. Participants All

Objective To determine whether the combined use of glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors is associated with a decreased risk of major adverse cardiovascular events and serious renal events compared with either drug class alone among patients with type 2 diabetes, and to assess the effect of the combination on the individual components

Objective To investigate risks of multiple adverse outcomes associated with use of antipsychotics in people with dementia. Design Population based matched cohort study. Setting Linked primary care, hospital and mortality data from Clinical Practice Research Datalink (CPRD), England. Population Adults (≥50 years) with a diagnosis of dementia between 1 January 1998 and 31 May 2018 (n=173 910, 63.0% women)

The risk prediction model for kidney failure and death in people with chronic kidney disease (CKD) presented in the linked study is a super learner. A super learner is an algorithm that repeatedly splits the data into training and test sets and then chooses the best performing model from a list of candidate prediction models. This article describes why and how the super learner was implemented in the

Objective To train and test a super learner strategy for risk prediction of kidney failure and mortality in people with incident moderate to severe chronic kidney disease (stage G3b to G4). Design Multinational, longitudinal, population based, cohort study. Settings Linked population health data from Canada (training and temporal testing), and Denmark and Scotland (geographical testing). Participants

Objective To determine whether a single low dose of esketamine administered after childbirth reduces postpartum depression in mothers with prenatal depression. Design Randomised, double blind, placebo controlled trial with two parallel arms. Setting Five tertiary care hospitals in China, 19 June 2020 to 3 August 2022. Participants 364 mothers aged ≥18 years who had at least mild prenatal depression

Objective To determine how a large scale, multicomponent, pharmacy based intervention to reduce proton pump inhibitor (PPI) overuse affected prescribing patterns, healthcare utilization, and clinical outcomes. Design Difference-in-difference study. Setting US Veterans Affairs Healthcare System, in which one regional network implemented the overuse intervention and all 17 others served as controls.

Objective To investigate whether use of glucagon-like peptide 1 (GLP1) receptor agonists is associated with increased risk of thyroid cancer. Design Scandinavian cohort study. Setting Denmark, Norway, and Sweden, 2007-21. Participants Patients who started GLP1 receptor agonist treatment were compared with patients who started dipeptidyl peptidase 4 (DPP4) inhibitor treatment, and in an additional analysis

Objectives To examine how the lifetime risks of atrial fibrillation and of complications after atrial fibrillation changed over time. Design Danish, nationwide, population based cohort study. Setting Population of Denmark from 1 January 2000 to 31 December 2022. Participants 3.5 million individuals (51.7% women and 48.3% men) who did not have atrial fibrillation at 45 years of age or older were followed

Objective To develop and externally validate a prediction model for severe cisplatin associated acute kidney injury (CP-AKI). Design Multicenter cohort study. Setting Six geographically diverse major academic cancer centers across the US. Participants Adults (≥18 years) receiving their first dose of intravenous cisplatin, 2006-22. Main outcome measures The primary outcome was CP-AKI, defined as a twofold

Objectives To determine the strength and nature of the association between delirium and incident dementia in a population of older adult patients without dementia at baseline. Design Retrospective cohort study using large scale hospital administrative data. Setting Public and private hospitals in New South Wales, Australia between July 2001 and March 2020. Participants Data were extracted for 650 590

Objective To assess the risk of intracranial meningioma associated with the use of selected progestogens. Design National case-control study. Setting French National Health Data System (ie, Système National des Données de Santé ). Participants Of 108 366 women overall, 18 061 women living in France who had intracranial surgery for meningioma between 1 January 2009 and 31 December 2018 (restricted inclusion

Objectives To evaluate the effectiveness of safeguards to prevent large language models (LLMs) from being misused to generate health disinformation, and to evaluate the transparency of artificial intelligence (AI) developers regarding their risk mitigation processes against observed vulnerabilities. Design Repeated cross sectional analysis. Setting Publicly accessible LLMs. Methods In a repeated cross

Generative artificial intelligence (AI) is advancing rapidly and has the potential to greatly improve many aspects of society, including health. The risks of potentially harmful consequences, however, necessitate effective oversight and mitigation measures. This article highlights distinct forms of health related risks of generative AI, with corresponding options for mitigating risk. Although artificial

Objective To synthesise evidence of the effectiveness of community based complex interventions, grouped according to their intervention components, to sustain independence for older people. Design Systematic review and network meta-analysis. Data sources Medline, Embase, CINAHL, PsycINFO, CENTRAL, clinicaltrials.gov, and International Clinical Trials Registry Platform from inception to 9 August 2021

Objective To examine and interpret trends in UK cancer incidence and mortality for all cancers combined and for the most common cancer sites in adults aged 35-69 years. Design Retrospective secondary data analysis. Data sources Cancer registration data, cancer mortality and national population data from the Office for National Statistics, Public Health Wales, Public Health Scotland, Northern Ireland

Objective To compare the effectiveness of cervical pessary and vaginal progesterone in the prevention of adverse perinatal outcomes and preterm birth in pregnant women of singletons with no prior spontaneous preterm birth at less than 34 weeks’ gestation and who have a short cervix of 35 mm or less. Design Open label, multicentre, randomised, controlled trial. Setting 20 hospitals and five obstetric

Objective To measure and compare the scope of US insurers’ policies for prior authorization (PA), a process by which insurers assess the necessity of planned medical care, and to quantify differences in PA across insurers, physician specialties, and clinical service categories. Design Cross sectional analysis. Setting PA policies for five insurers serving most of the beneficiaries covered by privately

Objective To evaluate the diagnostic accuracy and safety of using magnetically guided capsule endoscopy with a detachable string (ds-MCE) for detecting and grading oesophagogastric varices in adults with cirrhosis. Design Prospective multicentre diagnostic accuracy study. Setting 14 medical centres in China. Participants 607 adults (>18 years) with cirrhosis recruited between 7 January 2021 and 25

Objectives To evaluate the added benefit and revenues of oncology drugs, explore their association, and investigate potential discrepancies between added benefit and revenues across different approval pathways of the European Medicines Agency (EMA). Design Retrospective cohort study. Setting Oncology drugs and their indications approved by the EMA between 1995 and 2020. Main outcome measures Added

Objective To evaluate the existing meta-analytic evidence of associations between exposure to ultra-processed foods, as defined by the Nova food classification system, and adverse health outcomes. Design Systematic umbrella review of existing meta-analyses. Data sources MEDLINE, PsycINFO, Embase, and the Cochrane Database of Systematic Reviews, as well as manual searches of reference lists from 2009