Prognostic factors associated with failure of total elbow replacement: a protocol for analysis of National Joint Registry data in England

Introduction
Understanding the prognostic factors associated with the failure of total elbow replacement (TER) is crucial for informing patients about risks and enabling shared decision-making regarding TER as a definitive management option. This protocol outlines the planned analysis of National Joint Registry (NJR) data to investigate prognostic factors for TER failure.

Methods and analysis
The primary analysis will use the NJR elbow dataset, including all eligible patients who underwent TER surgery between April 2012 and December 2023. To incorporate ethnicity and comorbidities as potential prognostic factors, the NJR will be linked to the National Health Service (NHS) England Hospital Episode Statistics-Admitted Patient Care (HES-APC) data for a secondary analysis. The analysis will adhere to the REporting recommendations for tumour MARKer prognostic studies guidelines. The primary outcome under investigation is TER failure, defined as requiring revision surgery. Initially, the overall prognosis of TER will be examined using unadjusted net implant failure via the Kaplan-Meier method. The list of potential prognostic factors to be investigated in this study has been informed by a systematic review on this topic, input from patient and public involvement and engagement (PPIE) groups and a survey shared with healthcare professionals providing TER services. The relationship between each potential prognostic factor and failure will be assessed using univariable regression methods. Based on the findings from our systematic review, the univariable association will also be adjusted for age, sex and indication for TER surgery using multivariable regression methods. The extent of missing data will be reported, and the reasons for missing data will be explored. A very high degree of data completeness is expected, and a complete case analysis will be performed as the primary analysis. Multiple imputations will be considered as a sensitivity analysis.

Ethics and dissemination
The NJR research committee approved this analysis, and the NHS Health Research Authority tool guidance dictates that the secondary use of such data for research does not require approval from a research ethics committee. The results from this analysis will be published in a peer-reviewed journal and presented at scientific conferences.

Trial registration number
NCT06760585.

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RSV Vaccine Shows Real-World Effectiveness in Older Adults

Respiratory syncytial virus (RSV) vaccine effectiveness was approximately 75% for preventing acute respiratory infection among adults aged 60 years or older in a case-control study assessing real-life outcomes among approximately 780 000 people. This performance was comparable with efficacy in clinical trials, the researchers reported in JAMA Network Open.

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Alkaptonuria

This case report describes a man in his 50s with progressive blue-gray discoloration of sun-exposed areas, including the nose, cheeks, ears, and hands.

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Concerns About Crisis Pregnancy Center Analysis

To the Editor The analysis by Desai et al regarding crisis pregnancy center (CPC) websites is substantially flawed. The following are major areas of concern: lack of a case definition, double counting, construal of keywords as advertising services, and erroneous interpretations and assertions.

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Risk of myocardial infarction and stroke following microbiologically confirmed urinary tract infection: a self-controlled case series study using linked electronic health data

Objectives
The inflammatory response from acute infection may trigger cardiovascular events. We aimed to estimate associations between microbiologically confirmed urinary tract infections (UTIs) and first acute myocardial infarction (MI) and stroke.

Design
We used a self-controlled case series, with risk periods 1–7, 8–14, 15–28 and 29–90 days after UTI. Included individuals experienced the outcome and exposure of interest and acted as their own controls.

Setting
We used individually linked general practice, hospital admission and microbiology data for the population of Wales held by the Secure Anonymised Information Linkage databank.

Participants
Included individuals were Welsh residents aged over 30 years with a record of a hospital admission for MI or stroke (outcomes) and evidence of a microbiologically confirmed UTI (exposure) during the study period of 1 January 2010 to 31 December 2020.

Main outcome measures
The primary outcome was acute MI or stroke identified using the International Classification of Disease V.10 codes from inpatient diagnoses recorded in the Patient Episode Database for Wales. We used Poisson regression to estimate incidence rate ratios (IRRs) and 95% CIs for MI and stroke during predefined risk periods, compared with baseline periods.

Results
During the study period, 51 660 individuals had a hospital admission for MI, of whom 2320 (4.5%) had 3900 microbiologically confirmed UTIs, and 58 150 had a hospital admission for stroke, of whom 2840 (4.9%) had 4600 microbiologically confirmed UTIs. There were 120 MIs during risk periods and 2190 during baseline periods, with an increased risk of MI for 1–7 days following UTI (IRR 2.49, 95% CI (1.65 to 3.77)). There were 200 strokes during risk periods and 2640 during baseline periods, with an increased risk of stroke for 1–7 days following UTI (IRR 2.34, 95% CI (1.61 to 3.40)).

Conclusions
UTI may be a trigger for MI or stroke. Further work is needed to understand mechanisms and test interventions to reduce the risk of cardiovascular events among people with UTIs in primary care.

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Study protocol to assess clinical outcomes of breast cancer and its relationship with access to healthcare in Brazil–BREAST trial (BRaziLian outcomE for metAStatic breasT cancer): a prospective observational study in HER2-negative/hormone receptor-positive metastatic disease

Introduction
Breast cancer survival rates in low-income and middle-income countries significantly differ from those in high-income countries, indicating limited access to first-line systemic therapy for advanced and metastatic tumours. Recent studies have demonstrated the benefits of combining cyclin-dependent kinase 4 and 6 inhibitors (CDK 4/6) with endocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. However, in Brazil, the population faces limited access to these drugs, particularly in the public healthcare system.

Methods and analysis
This prospective observational study will enrol 300 female patients from 20 cancer centres across Brazil, divided into two groups based on healthcare coverage: those treated in the public healthcare system (group 1) and those treated in the private healthcare system (group 2). The use or non-use of CDK 4/6 inhibitors is not dictated by the study protocol but rather reflects real-world treatment decisions made by attending physicians. Patients will be followed for 24 months, stratified according to CDK 4/6 inhibitor usage. The project aims to assess health inequities by evaluating the prognosis of patients treated in the public versus private healthcare systems. Outcomes include progression-free survival (PFS), overall survival (OS), quality of life and cost-effectiveness. Kaplan-Meier curves will be used to analyse PFS and OS, while the Cox proportional hazards frailty model will be employed to compare outcomes between healthcare systems, adjusting for prognostic variables.

Ethics and dissemination
The study protocol was approved by the Ethics Committee of the HCor Research Institute (Hospital do Coracão/Associacão Beneficente Síria), which served as the central ethics board for the trial (study number: CAAE 42538621.5.1001.0060; approval letter number: 4.571.507; date: 3 March 2021). All participating centres also obtained approval from their respective local ethics committees prior to patient enrolment: Ethics Committee of Hospital de Câncer de Barretos—Fundacão Pio XII; Ethics Committee of Universidade Estadual de Campinas—UNICAMP; Ethics Committee of Faculdade de Minas Muriaé—FAMINAS; Ethics Committee of Hospital Santa Paula—SP; Ethics Committee of Hospital Alemão Oswaldo Cruz—SP; Ethics Committee of Hospital Regional do Câncer de Presidente Prudente—HRCPP; Ethics Committee of Instituto Brasileiro de Controle do Câncer—IBCC/Oncologia Clínica—SP; Ethics Committee of Instituto de Medicina Integral Prof. Fernando Figueira—IMIP/PE; Ethics Committee of Hospital São Rafael; Ethics Committee of Universidade Federal de São Paulo—UNIFESP; Ethics Committee of Hospital Geral de Fortaleza—HGF; Ethics Committee of Casa de Saúde Santa Marcelina; Ethics Committee of Centro Universitário FMABC; Ethics Committee of Liga Norte Riograndense Contra o Câncer; Ethics Committee of Hospital Mãe de Deus/Associacão Educadora São Carlos—AESC; and Ethics Committee of Instituto do Câncer Brasil—ICB. All patients will provide written informed consent. Study findings will be disseminated through scientific publications and presented to a broad range of stakeholders, including patients, physicians, the general public and policymakers.

Trial registration number
ClinicalTrials.gov identifier: NCT05559528—BRaziLian outcomE for metAStatic breasT cancer (BREAST).

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Partnership Model of Regionalized Care for Congenital Heart Disease in Resource-Limited Settings: Results From the ASSIST Project

Circulation, Ahead of Print. BACKGROUND:Equal access to care for patients with congenital heart disease (CHD) remains unrealized globally. The ASSIST project (Academic Medical Hospitals–Local Institutions collaboration) is an ongoing national quality initiative implemented in low-resource settings in China attempting to reduce gaps in access to CHD care. This study sought to evaluate its feasibility and effectiveness.METHODS:Shanghai Children’s Medical Center, an academic medical center, has partnered with 4 local hospitals in low-resource regions to enhance local CHD programs since 2021. Comparison was made between patients receiving treatments in these 4 local hospitals before (2013–2020) versus after the ASSIST project (2021–2024). In addition, contemporaneous patients receiving treatments in Shanghai Children’s Medical Center (2021–2024) were compared with the post-ASSIST cohort of patients. The primary outcome was a composite of postoperative mortality and multiorgan dysfunction. A key secondary outcome was delayed treatment, defined as an interval of more than 6 months between the time of surgery and the time when the clinicians recommended surgery at the initial presentation.RESULTS:The analysis cohort included 11 895 pediatric patients (median age, 2.0 years [25th–75th percentile 0.7–5.0]; 5933 female [49.9%]), with 3333 cases in the pre-ASSIST group, 1566 in the post-ASSIST group, and 6996 in the Shanghai Children’s Medical Center group. Lower family educational attainment (odds ratio, 1.50 [95% CI 1.21–1.85];P

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Exercise Intolerance and Response to Training in Patients With Postacute Sequelae of SARS-CoV2 (Long COVID): A Scientific Statement From the American Heart Association

Circulation, Ahead of Print. The postacute sequelae of SARS-CoV-2, also known as Long COVID, may affect 10% to 25% of individuals diagnosed with SARS-CoV-2. More than 100 symptoms have been reported among patients with Long COVID, but almost all patients report severe fatigue, orthostatic intolerance, shortness of breath, and reductions in exercise tolerance. Emerging data suggest that cardiovascular deconditioning plays a major role in the development of this syndrome and that reductions in functional capacity among patients with Long COVID are comparable to reductions seen among individuals with cardiovascular deconditioning resulting from bed rest. Concern has been raised about the use of exercise training as part of the management strategy for patients with Long COVID. However, exercise training appropriately tailored to the patient with cardiovascular deconditioning may be an effective strategy to facilitate improvement in symptoms. This American Heart Association scientific statement provides a concise yet comprehensive overview of mechanisms contributing to development of Long COVID and methods by which exercise training may be applied to this unique patient population to alleviate symptoms and improve quality of life. In addition, methods of reintroducing exercise and return to play among athletes affected by COVID-19 are discussed.

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