In May 2023, the US Food and Drug Administration (FDA) initially approved an AS01_E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) for adults aged ≥60 years. The approval was expanded in June 2024 to include adults 50–59 years of age at increased risk for RSV-associated lower respiratory tract disease. In this paper, we describe the protocol of a postmarketing safety study evaluating the association between adjuvanted RSVPreF3 and new-onset Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis (ADEM) and atrial fibrillation (AF) among adults ≥50 years of age in the USA and provide our rationale for key methodological decisions.

The potential associations between adjuvanted RSVPreF3 and GBS, ADEM and AF will be evaluated using secondary healthcare data and the self-controlled risk interval (SCRI) design. Data from five research partners in the USA spanning August 2023 through June 2030 will be used for the conduct of yearly monitoring queries and, sample size permitting, SCRI analyses. Claims-based definitions for new-onset outcomes (first diagnosis in 365 days) are: ≥1 inpatient diagnosis for GBS and ADEM; ≥1 inpatient or ≥2 ambulatory/emergency diagnoses for AF. The primary risk and control windows are 1–42 and 43–84 days, respectively, for GBS and ADEM; and 1–8 and 9–16 days for AF. SCRI analyses for GBS and ADEM will include chart-confirmed cases. SCRI analyses for AF will adjust for the positive predictive value obtained from validation against charts. Conditional Poisson regression will be used to calculate incidence rate ratios.

This study was approved by the Institutional Review Boards (IRB) of Harvard Pilgrim Health Care Institute; WIRB-Copernicus Group, Inc and its affiliates (collectively, ‘WCG’); WCG IRB, Inc; and Sterling IRB, with Federal Wide Assurance (FWA) numbers FWA00000100, FWA00033319 and FWA00025632, respectively, for all participating research partners. Study results will be shared with the US FDA and publicly disseminated through national or international clinical or scientific conferences and peer-reviewed publications.

This protocol has been registered in the Heads of Medicines Agencies–European Medicines Agency Real World Data Catalogues (EUPAS1000000486).

To examine inpatient benzodiazepine receptor agonists prescribing patterns and assess how hospitalisation affects use at discharge.

Subanalysis of the WEsleep trial, a cluster-randomised controlled single-centre study conducted at Amsterdam University Medical Center (Amsterdam UMC) (two locations) between July 2023 and March 2024. Twelve departments (six medical, six surgical) were matched and randomised to intervention or standard care. On intervention wards, multiple measures to improve sleep were implemented, including minimising nighttime disruptions.

Amsterdam UMC, across medical and surgical hospital departments.

Adult patients admitted for ≥2 nights (medical) or undergoing elective non-cardiac surgery in a surgical department.

Benzodiazepine use was classified as no use, pre-admission use or new in-hospital initiation. Prescribing patterns were summarised descriptively according to type, timing, indication and discharge status.

Of 746 patients, 187 (25%) used benzodiazepines: 80 (43%) had pre-admission use, and 107 (57%) were newly initiated during their hospital stay. Among pre-admission users, two discontinued and five had adjustments at discharge. Among newly initiated users, 94 (88%) had their benzodiazepine discontinued at discharge. Approximately half of pre-admission prescriptions and one-third of in-hospital prescriptions lacked a documented indication.

Although most newly initiated benzodiazepine treatments were discontinued during hospitalisation, pre-existing use was rarely reassessed and nearly 10% of new users were discharged with a prescription. Structured deprescribing protocols, better documentation of indications and improved discharge planning are needed to promote safer and more rational benzodiazepine use.

NCT05683483.

In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.

We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.

This study has been reviewed and approved by the local ethical review body, ‘The Medical Ethics Committee Leiden The Hague Delft’, under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.

NCT06719245. Dutch trial registry: NL87196.058.24

To examine the association between friendly community environments and depressive symptoms among older adults in China and to investigate the potential mediating roles of happiness and confidence in this association.

A nationally representative longitudinal study employing the parallel mediation model to estimate the direct association. Bootstrapping procedures were employed to test the hypothesised mediating effects.

The China Family Panel Studies (CFPS) database, a nationally representative survey.

The analytical sample comprised 3182 individuals aged 60 years or older from the CFPS 2016, 2018 and 2020 waves.

Depressive symptoms were measured using an eight-item version of the Center for Epidemiologic Studies Depression Scale. Higher scores indicated more depressive symptoms. Friendly community environment, happiness and confidence were assessed using corresponding survey items.

The analysis revealed a significant direct negative association was observed between friendly community environments and depressive symptoms (β=–0.062, 95% CI –0.092 to –0.035, p

Friendly community environments are negatively associated with depressive symptoms among older adults in China, primarily by enhancing happiness and confidence in life. To promote healthy ageing, it is crucial to create comfortable, clean and convenient community environments tailored to the older adult population.

Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.

The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).

The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.

NCT06581965.

The hospital-at-home (HaH) model has gained traction as a viable alternative to traditional inpatient care, allowing patients to receive care in their own homes. Despite its growing popularity, there is a lack of comprehensive research addressing effectiveness, safety and factors critical to the successful implementation of HaH programmes. We conducted a scoping review to comprehensively map and summarise the evidence on both admission avoidance and early-supported discharge up until now.

A scoping review of randomised controlled trials (RCTs), conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews (PRISMA-ScR) guidelines.

Ovid MEDLINE, Embase, CINAHL and Web of Science were systematically searched up to July 2024

We included English-language RCTs published from 2005 onwards, involving adults (≥18 years) receiving acute care at home who would otherwise require hospital admission. Eligible studies evaluated admission avoidance or early supported discharge within HaH settings for acutely ill patients. Studies focusing on outpatient care, non-acute conditions or interventions not aligning with the widely accepted HaH definition were excluded. COVID-19-related studies were also excluded to avoid context-specific bias.

Two reviewers independently extracted data on study characteristics, interventions and outcomes including mortality, length of stay, escalation rates, costs and patient and caregiver satisfaction. Implementation facilitators and barriers were also collected. Discrepancies were resolved by a third reviewer. Results were synthesised descriptively in accordance with PRISMA-ScR guidelines.

Nine RCTs were identified. The review shows that the HaH model is at least as safe as usual care, with lower or comparable mortality rates. Length of stay varied, with some studies reporting longer stays in the HaH group due to cautious clinical practices. Cost analyses often indicate lower healthcare costs with staffing as the largest expense. Patient and caregiver satisfaction was high, but essential implementation factors were not clearly addressed.

The HaH model represents a promising alternative to acute inpatient care for suitable patients. Future research should focus on conducting larger RCTs, expanding the range of conditions suitable for HaH. Despite favourable clinical outcomes, substantial implementation barriers remain underexplored in current RCTs. This underscores the need to identify strategies for successful implementation, including the integration of technological advancements and qualitative insights into patient and caregiver experiences.