Kidney Function Decline After COVID-19 Infection.

Importance: COVID-19 infection has been associated with acute kidney injury. However, its possible association with long-term kidney function is not well understood.

Objective: To investigate whether kidney function decline accelerated after COVID-19 compared with after other respiratory tract infections.

Prior Local Therapy and First-Line Apalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of the SPARTAN Randomized Clinical Trial.

Importance: Preclinical studies suggest that exposure to prostate-directed local therapy (LT) may influence the efficacy of subsequent systemic therapy including androgen receptor pathway inhibitors. However, there is insufficient clinical evidence to support this premise in patients with nonmetastatic castrate-resistant prostate cancer (nmCRPC).

Objective: To determine whether exposure to prior prostate-directed LT (radical prostatectomy [RP], radiation therapy [RT], or both) played any effect-modifying role in the treatment effect of apalutamide on metastasis-free survival (MFS) and overall survival (OS) in patients with nmCRPC.

Core Concepts in Pharmacoepidemiology: Quantitative Bias Analysis.

Pharmacoepidemiological studies provide important information on the safety and effectiveness of medications, but the validity of study findings can be threatened by residual bias. Ideally, biases would be minimized through appropriate study design and statistical analysis methods. However, residual biases can remain, for example, due to unmeasured confounders, measurement error, or selection into the study.

Improving the Validity of Non-Interventional Comparative Effectiveness Research by Basing Study Design on a Specified Existing Randomised Controlled Trial.

This issue of AJE includes three articles (two reporting original analyses and one systematic review) in which non-interventional studies used an existing randomized controlled trial (RCT) as a reference standard to both inform non-interventional study design, and to benchmark results against. This commentary provides a brief background on the challenges of non-interventional comparative effectiveness research, before elaborating on (i) the potential benefits and challenges of basing non-interventional study design on a specified existing RCT, and (ii) the distinction between designing analysis based upon a specified existing RCT and studies based solely upon a hypothetical target trial. Finally, a number of recommendations for the conduct and reporting of non-interventional studies based upon existing RCTs are provided.

Comparison of oral anticoagulants for stroke prevention in atrial fibrillation using the UK clinical practice research Datalink Aurum: A reference trial (ARISTOTLE) emulation study.

Background: Stroke prevention guidance for patients with atrial fibrillation (AF) uses evidence generated from randomised controlled trials (RCTs). However, applicability to patient groups excluded from trials remains unknown. Real-world patient data provide an opportunity to evaluate outcomes in a trial analogous population of direct oral anticoagulants (DOACs) users and in patients otherwise excluded from RCTs; however, there remains uncertainty on the validity of methods and suitability of the data.

Cardiorenal effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers among people underrepresented in trials: analysis of routinely collected data with emulation of a reference trial (ONTARGET).

Cardiovascular disease is a leading cause of death globally. Angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB), compared in the ONTARGET trial (Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial), each prevent cardiovascular disease. However, trial results may not be generalizable, and their effectiveness in underrepresented groups is unclear.

Discovery of a monoclonal, high-affinity CD8 T-cell clone following natural hepatitis C virus infection.

CD8 T cells recognizing their cognate antigen are typically recruited as a polyclonal population consisting of multiple clonotypes with varying T-cell receptor (TCR) affinity to the target peptide-major histocompatibility complex (pMHC) complex. Advances in single-cell sequencing have increased accessibility toward identifying TCRs with matched antigens. Here we present the discovery of a monoclonal CD8 T-cell population with specificity for a hepatitis C virus (HCV)-derived human leukocyte antigen (HLA) class I epitope (HLA-B*07:02 GPRLGVRAT) which was isolated directly ex vivo from an individual with an episode of acutely resolved HCV infection.

Systemic Fluoroquinolone Use and Risk of Uveitis or Retinal Detachment.

Importance: Fluoroquinolone use has been associated with increased risk of uveitis and retinal detachment in noninterventional studies, but the findings have been conflicting and causality is unclear.

Objective: To estimate the association of systemic fluoroquinolone use with acute uveitis or retinal detachment, using multiple analyses and multiple databases to increase the robustness of results.

Design, Setting, And Participants: This cohort study used data from the Clinical Practice Research Datalink Aurum and GOLD UK primary care records databases, which were linked to hospital admissions data.

Deep Learning-Based Identification of Intraocular Pressure-Associated Genes Influencing Trabecular Meshwork Cell Morphology.

Purpose: Genome-wide association studies have recently uncovered many loci associated with variation in intraocular pressure (IOP). Artificial intelligence (AI) can be used to interrogate the effect of specific genetic knockouts on the morphology of trabecular meshwork cells (TMCs) and thus, IOP regulation.

Design: Experimental study.

Shared Decision Making in Hallux Valgus Surgery: A Prospective Observational Study.

Patient-physician communication has the potential to improve outcomes and satisfaction through the shared decision-making process (SDM). This study aims to assess the relationship between perception of SDM and demographic, clinical, and patient-reported outcomes in patients undergoing Hallux Valgus (HV) correction. A prospective analysis of 306 patients scheduled for HV surgery was completed.

Association Between Fluoroquinolone Use and Hospitalization With Aortic Aneurysm or Aortic Dissection.

Importance: Fluoroquinolone use has been associated with increased hospitalization with aortic aneurysm or dissection in noninterventional studies, but the reason for this observed association is unclear.

Objective: To determine the association between fluoroquinolone use and aortic aneurysm or dissection using multiple study designs and multiple databases to increase the robustness of findings.

Design, Setting, And Participants: Cohort and case-crossover studies were conducted separately in 2 databases of UK primary care records.

Living alone and mental health: parallel analyses in UK longitudinal population surveys and electronic health records prior to and during the COVID-19 pandemic.

Background: People who live alone experience greater levels of mental illness; however, it is unclear whether the COVID-19 pandemic had a disproportionately negative impact on this demographic.

Objective: To describe the mental health gap between those who live alone and with others in the UK prior to and during the COVID-19 pandemic.

Methods: Self-reported psychological distress and life satisfaction in 10 prospective longitudinal population surveys (LPSs) assessed in the nearest pre-pandemic sweep and three periods during the pandemic.

Case mix-based changes in health status: A prospective study of elective surgery patients in Vancouver, Canada.

Introduction: Hospital activity is often measured using diagnosis-related groups, or case mix groups, but this information does not represent important aspects of patients' health outcomes. This study reports on case mix-based changes in health status of elective (planned) surgery patients in Vancouver, Canada.

Data And Methods: We used a prospectively recruited cohort of consecutive patients scheduled for planned inpatient or outpatient surgery in six acute care hospitals in Vancouver.

Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study.

Introduction: Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018.

Objectives: To investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions.

Methods: A multi-database, times series study of females of childbearing potential (12-55 years) was conducted using electronic medical records from five countries/regions (01.

The molecular characteristics of non-small cell lung cancer in the Northern Territory's Top End.

Aim: Indigenous Australians with lung cancer have poorer survival than non-Indigenous Australians. The reasons for the disparity are not fully understood and this study hypothesized that there may be a difference in the molecular profiles of tumors. The aim of this study, therefore, was to describe and compare the characteristics of non-small cell lung cancer (NSCLC) in the Northern Territory's Top End, between Indigenous and non-Indigenous patients, and describe the molecular profile of tumors in the two groups.

Correction: Incidence of Lyme disease in the United Kingdom and association with fatigue: A population-based, historical cohort study.

[This corrects the article DOI: 10.1371/journal.pone.

Association between household composition and severe COVID-19 outcomes in older people by ethnicity: an observational cohort study using the OpenSAFELY platform.

Background: Ethnic differences in the risk of severe COVID-19 may be linked to household composition. We quantified the association between household composition and risk of severe COVID-19 by ethnicity for older individuals.

Methods: With the approval of NHS England, we analysed ethnic differences in the association between household composition and severe COVID-19 in people aged 67 or over in England.

Cohort Comparison of Radiographic Correction and Complications Between Minimal Invasive and Open Lapidus Procedures for Hallux Valgus.

Background: The Lapidus procedure corrects hallux valgus first ray deformity. First tarsometatarsal (TMT) fusion in patients with hallux valgus deformity using minimally invasive surgery (MIS) is a new technique, but comparative outcomes between MIS and open techniques have not been reported. This study compares the early radiographic results and complications of the MIS with the open procedure in a single-surgeon practice.

Comparative effectiveness of ChAdOx1 versus BNT162b2 covid-19 vaccines in health and social care workers in England: cohort study using OpenSAFELY.

Objective: To compare the effectiveness of the BNT162b2 mRNA (Pfizer-BioNTech) and the ChAdOx1 (Oxford-AstraZeneca) covid-19 vaccines against infection and covid-19 disease in health and social care workers.

Design: Cohort study, emulating a comparative effectiveness trial, on behalf of NHS England.

Setting: Linked primary care, hospital, and covid-19 surveillance records available within the OpenSAFELY-TPP research platform, covering a period when the SARS-CoV-2 Alpha variant was dominant.

Arthroscopic Versus Open Ankle Arthrodesis: A 5-Year Follow Up.

Background: End-stage ankle arthritis has long been managed surgically with open ankle arthrodesis (OAA). Since the first published report in 1983, arthroscopic ankle arthrodesis (AAA) has been thought to be associated with improved patient-reported outcome measures (PROMs) and fewer complications. The purpose of the present study was to compare the long-term PROMs, major complications, and reoperations for these 2 approaches at up to 15 years of follow-up.