Lessons learned from a multi-data source research collaboration: The mirabegron post-authorization safety study program.

Background: Many factors contribute to developing and conducting a successful multi-data source, non-interventional, post-authorization safety study (NI-PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide useful insights to others considering similar studies.

Objectives: We discuss challenges and key methodological and organizational factors that led to the delivery of a successful post-marketing requirement (PMR)/PASS program investigating the risk of cardiovascular and cancer events among users of mirabegron, an oral medication for the treatment of overactive bladder.

Systematic Literature Review of Risk Factors for Poor Outcomes Among Adults With Respiratory Syncytial Virus Infection in High-Income Countries.

Unlabelled: Identification of risk factors for severe respiratory syncytial virus (RSV) disease in adults could facilitate their appropriate vaccine recommendations. We conducted a systematic literature review (last 10 years in PubMed/Embase) to identify quantitative estimates of risk factors for severe RSV infection outcomes in high-income countries. Severe outcomes from RSV infection included hospitalization, excess mortality, lower respiratory tract infection, or a composite measure: severe RSV, which included these outcomes and others, such as mechanical ventilation and extended hospital stay.

Validation of an ICD-10 case-finding algorithm for endometrial cancer in US insurance claims.

Purpose: To evaluate the positive predictive value (PPV) of an endometrial cancer case finding algorithm using International Classification of Disease 10th revision Clinical Modification (ICD-10-CM) diagnosis codes from US insurance claims for implementation in a planned post-marketing safety study. Two algorithm variants were evaluated.

Methods: Provisional incident endometrial cancer cases were identified from 2016 through 2020 among women aged ≥50 years.

Distribution of gestational age at birth by maternal and infant characteristics in U.S. birth certificate data: Informing gestational age assumptions when clinical estimates are not available.

Purpose: We aimed to describe the distribution of gestational age at birth (GAB) to inform the estimation of GAB when clinical or obstetric estimates are not available for perinatal pharmacoepidemiology studies.

Methods: We estimated GAB (median, mode, mean, and standard deviation) and percentage born at each gestational week in groups based on plurality and other variables for live births in CDC's U.S.

Surgical Management of Hidradenitis Suppurativa: Factors Associated with Postoperative Complications and Disease Recurrence.

Unlabelled: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Treatment of HS remains challenging, and surgical procedures commonly follow attempts of conservative therapy. To date, a consensus regarding the optimal surgical technique has not been reached, and the implications of conservative therapy on future surgical outcomes have yet to be studied.

Clinical trial and detection of SARS-CoV-2 by a commercial breath analysis test based on Terahertz technology.

Public health threats such as the current COVID-19 pandemics have required prompt action by the local, national, and international authorities. Rapid and noninvasive diagnostic methods may provide on-site detection and immediate social isolation, used as tools to rapidly control virus spreading. Accordingly, the aim of the present study was to evaluate a commercial breath analysis test (TERA.

Efficacy and acceptability of using wearable activity trackers in older adults living in retirement communities: a mixed method study.

Background: Wearable activity trackers hold the potential for enhancing health and fitness, but the use of wearable activity trackers has remained largely unexplored in older adults. The purpose of the current study was to examine the effectiveness and acceptability of wearable activity trackers for promoting physical activity (PA) in older adults living in retirement communities.

Methods: Forty older adult participants (mean age = 85.

Endoscopic Inferior Meatal Antrostomy for Antrochoanal Polyps: A Long-Term Follow-Up.

Background: Endoscopic middle meatal antrostomy (EMMA) is considered the standard approach for surgical management of antrochoanal polyps (ACPs). Recently, an endoscopic inferior meatal antrostomy (EIMA) approach for clearing lesions in the maxillary sinus was described. In this study, we compared the long-term outcome of patients with ACP following surgical treatment using one of these 2 approaches (EIMA or EMMA).

Perinatal pharmacoepidemiology: How often are key methodological elements reported in publications?

Purpose: Publications provide important information for clinicians, researchers, and patients. Key methodological elements must be reported for maximum transparency. We identified key methodological elements necessary for fully understanding perinatal pharmacoepidemiology research and quantified the proportion of studies that reported these elements in a sample of publications.

Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study.

Introduction: During clinical trials, mirabegron, a β3-adrenoreceptor agonist, was associated with increased vital signs vs placebo in patients with overactive bladder.

Objective: The purpose of this study was to compare incidence rates of adverse cardiovascular (CV) outcomes following mirabegron or antimuscarinic use.

Methods: We conducted an observational post-marketing safety study utilising real-world data.

Birth prevalence of phenylalanine hydroxylase deficiency: a systematic literature review and meta-analysis.

Background: Phenylalanine hydroxylase (PAH) deficiency is an autosomal recessive disorder that results in elevated concentrations of phenylalanine (Phe) in the blood. If left untreated, the accumulation of Phe can result in profound neurocognitive disability. The objective of this systematic literature review and meta-analysis was to estimate the global birth prevalence of PAH deficiency from newborn screening studies and to estimate regional differences, overall and for various clinically relevant Phe cutoff values used in confirmatory testing.

Endoscopic treatment of ectopic teeth in the maxillary sinus.

Background: Ectopic teeth in maxillary sinus is rare and are usually removed via sub-labial trans-canine fossa approach (SLCFA). The aim of our study was to present our experience with extraction of ectopic teeth in the maxillary sinus via transnasal endoscopic approach (TEA).

Material And Methods: Rhinologists were asked to share their experience in the management of ectopic teeth in the maxillary sinus.

A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder.

Objective: This post-authorization safety study (EU PAS Register Number: EUPAS16088) was designed to compare the incidence of cancer outcomes in patients treated with mirabegron versus antimuscarinic medications.

Methods: Cohorts of mirabegron initiators during 2012-2018 were propensity-score matched to antimuscarinic medication initiators within real-world data sources (Danish National Registers, Swedish National Registers, Clinical Practice Research Datalink [UK], Optum [US], and Humana [US]). Incident cancer cases were identified during follow-up from direct linkage to cancer registers or validated through medical record review or through physician questionnaires.

The Role of Congenital Cytomegalovirus Infection in Adverse Birth Outcomes: A Review of the Potential Mechanisms.

Human cytomegalovirus (CMV) is a major cause of nonhereditary adverse birth outcomes, including hearing and visual loss, neurologic deficits, and intrauterine growth retardation (IUGR), and may contribute to outcomes such as stillbirth and preterm delivery. However, the mechanisms by which CMV could cause adverse birth outcomes are not fully understood. This study reviewed proposed mechanisms underlying the role of CMV in stillbirth, preterm birth, and IUGR.

Validation of cardiovascular outcomes and risk factors in the Clinical Practice Research Datalink in the United Kingdom.

Purpose: Strategies to identify and validate acute myocardial infarction (AMI) and stroke in primary-care electronic records may impact effect measures, but to an unknown extent. Additionally, the validity of cardiovascular risk factors that could act as confounders in studies on those endpoints has not been thoroughly assessed in the United Kingdom Clinical Practice Research Datalink's (CPRD's) GOLD database. We explored the validity of algorithms to identify cardiovascular outcomes and risk factors and evaluated different outcome-identification strategies using these algorithms for estimation of adjusted incidence rate ratios (IRRs).

Clinical pharmacist input on HIV management may improve antiretroviral prescribing for psychiatric patients.

Purpose: The results of a study to determine the difference in HIV management with clinical pharmacist input in an adult psychiatric hospitalized patient population are reported.

Methods: Single-center, retrospective study of patients admitted to a psychiatric hospital on antiretroviral (ARV) medication(s) from October 2016 to March 2017 (phase I: no pharmacist involvement), October 2017 to March 2018 (phase II: partial pharmacist involvement), and November 2018 to January 2019 (phase III: consistent pharmacist involvement). Patients were excluded if less than 18 years of age, pregnant, incarcerated, or taking ARV medication(s) for non-HIV indications.

[NEW ANALGESIC PROTOCOL FOR THE TREATMENT OF PAIN AND ANXIETY IN PEDIATRIC BURN PATIENTS - DEVELOPMENT, IMPLEMENTATION AND FIRST RESULTS].

Introduction: Burns are one of the most common and painful injuries among babies and children. The pain endured during and in between treatment can be minimized with sedation. These sedations, however, are not without side effects and risks.

Relation of in-utero exposure to antiepileptic drugs to pregnancy duration and size at birth.

Background: The associations of individual antiepileptic drugs (AEDs) with pregnancy duration and size at birth, and potential dose relations, are not well characterized.

Methods: This cohort study used nationwide Swedish register data (1996-2013). Adjusting for smoking, epilepsy and other AED indications, we used linear and quantile regression to explore associations with pregnancy duration, and birth weight, length, and head circumference (the last three operationalized as z-scores).

Does the Beta-Lactam Matter? Nafcillin versus Cefazolin for Methicillin-Susceptible Staphylococcus aureus Bloodstream Infections.

Background: Antistaphylococcal penicillins have historically been regarded as the drugs of choice for methicillin-susceptible Staphylococcus aureus (MSSA) bloodstream infections (BSI). However, recent outcomes data compared to cefazolin treatment are conflicting.

Objective: This study compared treatment failure and adverse effects associated with nafcillin and cefazolin for MSSA BSI.

Surgical Technique for Nasal Cleft Repair.

Background: Congenital nasal cleft is a very rare yet challenging deformity to reconstruct. Atypical craniofacial clefts that involve the nasal ala are designated as number 1 and number 2 under the Tessier classification system. These clefts typically present as notches in the medial one-third of either nasal ala and may be accompanied by a malpositioned cartilaginous framework.