US Real-World Effectiveness Study of Nirmatrelvir/Ritonavir in Preventing Hospitalization of High-Risk COVID-19 Patients.

Purpose: We describe nirmatrelvir/ritonavir (NMV/r) effectiveness in preventing hospitalization among COVID-19 patients at high risk of severe disease.

Methods: An ongoing US population-based observational cohort study with retrospective and prospective collection of national electronic healthcare data collected from the US Optum® deidentified COVID-19 Electronic Health Record dataset during December 22, 2021-July 20, 2022. Participants were ≥12 years old; had a positive SARS-CoV-2 test, COVID-19 diagnosis, or NMV/r prescription; and were at high risk of severe COVID-19 based on demographic/clinical characteristics.

Factors associated with receipt of systemic anticancer treatment for locally advanced or metastatic urothelial carcinoma in England: a population-based study.

Introduction: Systemic anticancer therapy for locally advanced or metastatic urothelial carcinoma (la/mUC) is associated with efficacy benefits, including longer overall survival (OS), but many patients remain untreated. This observational, real-world, national study aimed to investigate factors associated with receiving systemic anticancer therapy for la/mUC in England.

Patients And Methods: Adults diagnosed with la/mUC between 2013 and 2019 were identified in the National Cancer Registration Dataset and followed until March 2021.

Health Care Disparities, Social Determinants of Health, and Emotional Impacts in Patients with Ulcerative Colitis: Results from a Global Ulcerative Colitis Narrative Patient Survey.

Background: The Ulcerative Colitis (UC) Narrative global survey assessed aspects of living with UC. This analysis aimed to identify health care disparities, social determinants of health, and emotional impacts related to UC disease management, patient experience, and quality of life.

Methods: The survey was conducted by The Harris Poll from August 2017 to February 2018 among adults with UC.

Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms' Fit for Purpose for Safety Outcomes.

Introduction: Electronic health record (EHR) or medical claims-based algorithms (i.e., operational definitions) can be used to define safety outcomes using real-world data.

Disease-Specific Health Disparities: A Targeted Review Focusing on Race and Ethnicity.

Background: Wide disparities in health status exist in the United States across race and ethnicity, broadly driven by social determinants of health-most notably race and ethnic group differences in income, education, and occupational status. However, disparities in disease frequency or severity remain underappreciated for many individual diseases whose distribution in the population varies. Such information is not readily accessible, nor emphasized in treatment guidelines or reviews used by practitioners.

Multimethod quantitative benefit-risk assessment of treatments for moderate-to-severe osteoarthritis.

Objective: Demonstrate how benefit-risk profiles of systemic treatments for moderate-to-severe osteoarthritis (OA) can be compared using a quantitative approach accounting for patient preference.

Study Design And Setting: This study used a multimethod benefit-risk modelling approach to quantifiably compare treatments of moderate-to-severe OA. In total four treatments and placebo were compared.

Identifying Valid Algorithms for Number of Lines of Anti-Neoplastic Therapy in the Danish National Patient Registry Among Patients with Advanced Ovarian, Gastric, Renal Cell, Urothelial, and Non-Small Cell Lung Cancer Attending a Danish University Hospital.

Purpose: To develop algorithms to identify number of lines of anti-neoplastic therapy per patient based on the Danish National Patient Registry (DNPR) and identify which algorithm has the highest percentage agreement with a reference standard of documentation in medical records.

Patients And Methods: We included 179 patients diagnosed between January 1, 2012, and December 31, 2016, with stage II, III, or IV urothelial cell carcinoma or stage III or IV epithelial ovarian cancer, gastric adenocarcinoma, renal cell carcinoma, or non-small cell lung cancer (NSCLC). We developed two algorithms for number of lines of anti-neoplastic therapy based on dates and treatment codes (eg, "treatment with cisplatin" or "cytostatic treatment") in the DNPR.

Exploring patient preference heterogeneity for pharmacological treatments for chronic pain: A latent class analysis.

Background: Several pharmaceutical treatments for chronic pain caused by osteoarthritis (OA) and chronic low back pain (CLBP) are available or currently under development, each associated with different adverse events (AEs) and efficacy profiles. It is therefore important to understand what trade-offs patients are willing to make when choosing between treatments.

Methods: A discrete-choice experiment (DCE) was conducted with 437 adults with chronic pain caused by OA and/or CLBP.

Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design.

Interest in real-world data (RWD) and real-world evidence (RWE) to expedite and enrich the development of new biopharmaceutical products has proliferated in recent years, spurred by the 21st Century Cures Act in the United States and similar policy efforts in other countries, willingness by regulators to consider RWE in their decisions, demands from third-party payers, and growing concerns about the limitations of traditional clinical trials. Although much of the recent literature on RWE has focused on potential regulatory uses (e.g.

Treatment and Survival in Advanced Non-Small Cell Lung Cancer, Urothelial, Ovarian, Gastric and Kidney Cancer: A Nationwide Comprehensive Evaluation.

Purpose: Few studies have described real-world treatment patterns and survival before the widespread use of immune checkpoint inhibitors (ICIs). We aimed to describe anti-cancer treatment including the use of programmed cell death-1 and ligand-1 (PD-1/PD-L1) ICIs and overall survival (OS) in advanced cancer patients as a benchmarking real-world standard before widespread use of ICIs.

Patients And Methods: Using nationwide Danish medical registries, we assembled cohorts of Danish patients with advanced non-small cell lung cancer (NSCLC) (n=12,283), urothelial carcinoma (n=2504), epithelial ovarian cancer (n=1466), gastric adenocarcinoma (n=1457), and renal cell carcinoma (RCC) (n=1261) diagnosed between 1/1/2013 and 31/12/2017.

High-dose corticosteroid use and risk of hospitalization for infection in patients treated with immune checkpoint inhibitors--A nationwide register-based cohort study.

High-dose corticosteroids have been associated with increased risk of serious infection in patients with metastatic melanoma treated with immune checkpoint inhibitors targeting cytotoxic T-lymphocyte antigen 4. This potential association needs to be examined further among patients with other cancer types and for other immune checkpoint inhibitors. We examined whether receipt of high-dose corticosteroids was associated with increased rates of hospitalization for infection among 981 Danish renal, urothelial, and lung cancer patients followed from first administration of programmed death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1) immune checkpoint inhibitors.

Patients' and caregivers' maximum acceptable risk of death for non-curative gene therapy to treat Duchenne muscular dystrophy.

Background: Gene therapy offers an etiologically targeted treatment for genetic disorders. Little is known about the acceptance of mortality risk among patients with progressive, fatal conditions. We assessed patients' and caregivers' maximum acceptable risk (MAR) of mortality for gene therapy when used to treat Duchenne muscular dystrophy (DMD).

A real-world study on characteristics, treatments and outcomes in US patients with advanced stage ovarian cancer.

Background: Detailed epidemiologic descriptions of large populations of advanced stage ovarian cancer patients have been lacking to date. This study aimed to describe the patient characteristics, treatment patterns, survival, and incidence rates of health outcomes of interest (HOI) in a large cohort of advanced stage ovarian cancer patients in the United States (US).

Methods: This cohort study identified incident advanced stage (III/IV) ovarian cancer patients in the US diagnosed from 2010 to 2018 in the HealthCore Integrated Research Database (HIRD) using a validated predictive model algorithm.

Development of predictive models to identify advanced-stage cancer patients in a US healthcare claims database.

Background: Although healthcare databases are a valuable source for real-world oncology data, cancer stage is often lacking. We developed predictive models using claims data to identify metastatic/advanced-stage patients with ovarian cancer, urothelial carcinoma, gastric adenocarcinoma, Merkel cell carcinoma (MCC), and non-small cell lung cancer (NSCLC).

Methods: Patients with ≥1 diagnosis of a cancer of interest were identified in the HealthCore Integrated Research Database (HIRD), a United States (US) healthcare database (2010-2016).

Priorities when deciding on participation in early-phase gene therapy trials for Duchenne muscular dystrophy: a best-worst scaling experiment in caregivers and adult patients.

Purpose: Several gene therapy trials for Duchenne muscular dystrophy initiated in 2018. Trial decision making is complicated by non-curative, time-limited benefits; the progressive, fatal course; and high unmet needs. Here, caregivers and patients prioritize factors influencing decision making regarding participation in early-phase gene therapy trials.

Is black always the opposite of white? An investigation on the comprehension of antonyms in people with schizophrenia and in healthy participants.

The present investigation sought to expand our understanding of the cognitive processes underlying the recognition of antonyms and to evaluate whether these processes differed in patients with schizophrenia and in healthy controls. Antonymy is the most robust of the lexico-semantic relations and is relevant to both the mental organization of the lexicon and the organization of coherent discourse, as attested by the resurgence of interest in antonymy in the linguistic and psychological domains. In contrast, the vast literature on semantic processing in schizophrenia almost ignored antonymy.

Prevalence, Patient Characteristics, and Pharmacological Treatment of Children, Adolescents, and Adults Diagnosed With ADHD in Sweden.

Objective: The objective of this study was to describe the epidemiology of diagnosed ADHD and the pharmacological treatment of patients with ADHD in Sweden. Specifically, this study estimates the prevalence of patients with a newly registered diagnosis of ADHD over a 5-year period, and the prevalence of all patients with a registered ADHD diagnoses over a 6-year period in Sweden.

Method: Two population-based registries were used as data sources for this study; the National Patient Register (NPR) and the Prescribed Drug Register (PDR).

Is the comprehension of idiomatic sentences indeed impaired in paranoid Schizophrenia? A window into semantic processing deficits.

Schizophrenia patients have been reported to be more impaired in comprehending non-literal than literal language since early studies on proverbs. Preference for literal rather than figurative interpretations continues to be documented. The main aim of this study was to establish whether patients are indeed able to use combinatorial semantic processing to comprehend literal sentences and both combinatorial analysis, and retrieval of pre-stored meanings to comprehend idiomatic sentences.

[Oral hypoglycemic drugs in chronic kidney disease: which limitations in the clinical setting].

A large amount of recent epidemiological studies have shown the worldwide growth on the incidence and prevalence of diabetes mellitus type II (DM2), especially in industrialized countries where DM2 is the most frequent cause of chronic kidney disease. Diabetic nephropathy progression to ESRD (End Stage Renal Disease) may be slowed down only with a tight glycemic control, since no hypoglycemic drugs have been shown to possess renoprotective effects. Treatment with oral hypoglycemic agents should be closely and regularly monitored in patients with diabetic nephropathy since the decline of renal function below 60 ml/min of glomerular filtration rate (GFR) could cause multiple pharmacokinetic alterations.

Role of pharmacoepidemiology studies in addressing pharmacovigilance questions: a case example of pancreatitis risk among ulcerative colitis patients using mesalazine.

Purpose: Well-designed pharmacoepidemiology studies address several limitations of postmarketing spontaneous reports in regard to signal evaluation. This study evaluated a signal of disproportionate reporting of acute pancreatitis cases observed in patients with ulcerative colitis (UC) treated with MMX Multi Matrix System® (MMX®) mesalazine and demonstrated how inherent limitations of postmarketing reports were overcome.

Methods: Adults with UC who were new users of MMX mesalazine or another branded mesalazine (controlled-release, delayed-release, or extended-release mesalazine; balsalazide disodium; olsalazine sodium; sulfasalazine; or sulfasalazine delayed-release) were identified from a large US administrative healthcare claims database.

Nonmedical use of prescription ADHD stimulant medications among adults in a substance abuse treatment population: early findings from the NAVIPPRO surveillance system.

Objective: To examine nonmedical use (NMU) of prescription ADHD stimulants among adults evaluated for substance abuse treatment.

Method: 147,816 assessments from the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) system (10/01/2009 through 03/31/2012) examined NMU prevalence, routes of administration (ROA), and diversion sources.

Results: Past 30-day NMU for prescription stimulants (1.

Descriptive comparison of drug treatment-persistent, -nonpersistent, and nondrug treatment patients with newly diagnosed attention deficit/hyperactivity disorder in Germany.

Background: Attention deficit/hyperactivity disorder (ADHD) is a heterogeneous behavioral disorder commonly found in children, with serious lifetime health and social consequences for both children and their parents. Public awareness of ADHD in Germany has increased in the past decade, but little is known about the costs of treating newly diagnosed patients in clinical practice.

Objective: This study aimed to describe the resource utilization and treatment costs of patients aged 6 to 17 years with newly diagnosed ADHD, using patient data from a German sickness fund, and to quantify resource utilization by drug treatment and treatment persistence.

Nonmedical Use and Diversion of ADHD Stimulants Among U.S. Adults Ages 18-49: A National Internet Survey.

Objective: Evaluate nonmedical use (NMU) of ADHD prescription stimulants (Ritalin(®), Adderall(®), Adderall(®) XR, Concerta(®), and Vyvanse(®)) in a U.S. adult general population sample.