Provision of COVID-19 Self-Test Kits to Patients for Distribution to Social Contacts: A Randomized Clinical Trial.

Importance: Widespread and equitable access to testing remains critical to controlling the COVID-19 pandemic, which has disproportionately affected medically underserved communities.

Objective: To determine whether secondary distribution of COVID-19 self-test (ST) kits, in which an individual distributes ST kits to contacts in their social networks, increases COVID-19 testing.

Design, Setting, And Participants: The COVID-19 Self-Testing Through Rapid Network Distribution study was a randomized clinical trial conducted between May 2021 and September 2023 at 4 federally qualified health centers serving medically underserved populations in Philadelphia, Pennsylvania.

Towards precision medicine in clinical trials for the treatment of urologic chronic pelvic pain syndrome: lessons from the MAPP Research Network.

Randomized clinical trials have resulted in few approved therapies for the treatment of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, collectively referred to as urologic chronic pelvic pain syndrome. Heterogenous patient populations, mismatches of treatments to patient phenotypes, non-specific outcomes and use of standard study designs not leveraging phenotypic heterogeneity might have contributed to the inability of previous trials to demonstrate existing efficacy. The Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network has identified important phenotypic characteristics associated with differential symptom severity and treatment responsiveness.

Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial.

Background: Psoriatic arthritis (PsA) is a multi-domain, inflammatory disease impacting joints, soft tissues, and skin; tumor necrosis factor inhibitors (TNFi) are typically the first biologic following inadequate response (IR) to conventional therapies. Although guidance is lacking on therapy selection after initial TNFi failure, data suggest TNFi-IR PsA patients may benefit from switching to a different mechanism of action (MOA) vs. cycling to another TNFi.

Cost Analysis of a Scalable Clinician Communication Intervention to Increase HPV Vaccine Initiation.

Background And Objective: For a previous longitudinal cluster randomized controlled trial (2018-2019), we randomized 48 primary care pediatric practices to online communication training vs usual care. Online communication training reduced missed opportunities (MOs) for initial human papillomavirus (HPV) vaccination at well-child care (WCC) visits by 6.8 percentage points among children aged 11-17 years.

A Bundled, Practice-Based Intervention to Increase HPV Vaccination.

Background And Objectives: Human papillomavirus (HPV) vaccination rates are suboptimal, and missed vaccination opportunities are common. We hypothesized that a bundled intervention improves missed HPV vaccination opportunities.

Methods: We used a pre-post design to assess differences in HPV vaccine missed opportunities (visits when vaccine-eligible adolescents are not vaccinated).

Relationship of Sex and Diagnosis With Symptoms and Illness Impact in Urologic Chronic Pelvic Pain; A Mapp Network Analysis.

Objective: To assess differences in clinical presentation and illness impact in men and women presenting with urologic chronic pelvic pain syndrome (UCPPS) and between men diagnosed with interstitial cystitis/bladder pain syndrome (IC/BPS) or chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

Methods: 356 men and 605 women from six sites across the United States were assessed using a comprehensive set of demographic, symptom, and illness impact measures. Multivariable regression analyses examined differences between men and women and between men previously diagnosed with CP/CPPS or IC/BPS.

Modulation of circulating free testosterone fraction by testosterone, dihydrotestosterone, and estradiol during testosterone replacement therapy.

Background: Testosterone, estradiol, and dihydrotestosterone share common ligand binding sites on sex hormone binding globulin and albumin. It is unknown whether and how changes in testosterone, dihydrotestosterone, and estradiol concentrations during testosterone replacement therapy affect free testosterone fraction.

Objective: To determine the effect of changes in testosterone, dihydrotestosterone, and estradiol concentrations on free testosterone fraction during testosterone replacement therapy of men with hypogonadism.

University of Pennsylvania Telehealth Research Center of Excellence.

Drawing from insights from communication science and behavioral economics, the University of Pennsylvania Telehealth Research Center of Excellence (Penn TRACE) is designing and testing telehealth strategies with the potential to transform access to care, care quality, outcomes, health equity, and health-care efficiency across the cancer care continuum, with an emphasis on understanding mechanisms of action. Penn TRACE uses lung cancer care as an exemplar model for telehealth across the care continuum, from screening to treatment to survivorship. We bring together a diverse and interdisciplinary team of international experts and incorporate rapid-cycle approaches and mixed methods evaluation in all center projects.

Comparison of Sales From Vending Machines With 4 Different Food and Beverage Messages: A Randomized Trial.

Importance: Point-of-sale food messaging can encourage healthier purchases, but no studies have directly compared multiple interventions in the field.

Objective: To examine which of 4 food and beverage messages would increase healthier vending machine purchases.

Design, Setting, And Participants: This randomized trial assessed 13 months (February 1, 2019, to February 29, 2020) of vending sales data from 267 machines and 1065 customer purchase assessments from vending machines on government property in Philadelphia, Pennsylvania.

Comparative Effectiveness of Perioperative Antibiotic Regimens to Prevent Surgical Site Infections in Pediatric Liver Transplant Recipients.

Background: Surgical site infections (SSIs) are a common complication in liver transplant (LT) recipients. Lack of pediatric prophylaxis guidelines results in variation in preventative antibiotic regimens.

Methods: We performed a retrospective observational study of LT recipients <18 years old using a merged data set that included data from the Pediatric Health Information System and the United Network for Organ Sharing between 2006 and 2017.

Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease.

Objective: To evaluate whether the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a responsive instrument in psoriatic arthritis (PsA) and whether it differentiates between axial and peripheral disease activity in PsA.

Methods: Individuals with PsA initiating therapy in a longitudinal cohort study based in the United States were included. Axial PsA (axPsA), most often also associated with peripheral disease, was defined as fulfillment of the Assessment of Spondyloarthritis international Society axial spondyloarthritis classification criteria or presence of axial disease imaging features.

Marshall Joffe's Contributions to Causal Inference, Biostatistics, and Epidemiology.

We pay tribute to Marshall Joffe, PhD, and his substantial contributions to the field of causal inference with focus in biostatistics and epidemiology. By compiling narratives written by us, his colleagues, we not only present highlights of Marshall's research and their significance for causal inference but also offer a portrayal of Marshall's personal accomplishments and character. Our discussion of Marshall's research notably includes (but is not limited to) handling of posttreatment variables such as noncompliance, employing G-estimation for treatment effects on failure-time outcomes, estimating effects of time-varying exposures subject to time-dependent confounding, and developing a causal framework for case-control studies.

Effects of 4 Interpretive Front-of-Package Labeling Systems on Hypothetical Beverage and Snack Selections: A Randomized Clinical Trial.

Importance: Policymakers and researchers have proposed a variety of interpretative front-of-package food labeling systems, but it remains unclear which is most effective at encouraging people to choose healthier foods and beverages, including among people with less education.

Objective: To test the effects of 4 interpretative front-of-package food labeling systems on the healthfulness of beverage and snack selections, overall and by education level.

Design, Setting, And Participants: This randomized clinical trial of a national sample of US adults 18 years and older was conducted online from November 16 to December 3, 2022.

Missed Opportunities for Adolescent Immunizations at Well-Care Visits During the COVID-19 Pandemic.

Purpose: The Coronavirus Disease 2019 pandemic disrupted healthcare, but the impact on vaccination missed opportunities (MOs, vaccine-eligible visits without vaccination) is unknown. We evaluated pandemic-related trends in MOs at adolescent well-care visits for three vaccines: human papillomavirus; quadrivalent meningococcal conjugate; and tetanus, diphtheria, and acellular pertussis (Tdap).

Methods: We analyzed electronic health record data from 24 pediatric primary care practices in 13 states from 1/1/2018 to 12/31/2021.

Research and scholarly methods: Propensity scores.

Propensity score methods are increasingly used as a tool to control for confounding bias in pharmacoepidemiologic studies. The propensity score is a dimension reducing balancing score, creating treatment and reference groups that have comparable distributions of measured covariates. The purpose of this methods review is to provide an overview of the use of propensity score methods, including a summary of important data assumptions, various applications of the propensity score, and how to evaluate covariate balance.

Predictors of Male Sexual Dysfunction in Urologic Chronic Pelvic Pain Syndrome (UCPPS), Other Chronic Pain Syndromes, and Healthy Controls in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network.

Background: Sexual dysfunction (SD), including erectile (ED) and ejaculatory dysfunction, is associated with diminished quality of life (QoL) in men with UCPPS (chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and/or interstitial cystitis/bladder pain syndrome (IC/BPS)).

Aim: We sought to compare SD among male patients with UCPPS, other chronic pain conditions (positive controls, PC), and healthy controls (HC) without chronic pain, and to evaluate the association of comorbidities, psychosocial factors, and urologic factors of SD in all 3 groups.

Methods: Baseline data from male UCPPS participants, PC (irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia) and HC enrolled in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network Epidemiology and Phenotyping Study were included in the analysis.

Clinical impact of a modified lung allocation score that mitigates selection bias.

Background: The Lung Allocation Score (LAS) is used in the U.S. to prioritize lung transplant candidates.