Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials.

Objectives: Patient-reported outcome (PRO) data are critical in understanding treatments from the patient perspective in cancer clinical trials. The potential benefits and methodological approaches to the collection of PRO data after treatment discontinuation (eg, because of progressive disease or unacceptable drug toxicity) are less clear. The purpose of this article is to describe the Food and Drug Administration's Oncology Center of Excellence and the Critical Path Institute cosponsored 2-hour virtual roundtable, held in 2020, to discuss this specific issue.

Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.

Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.

Advancing digital health applications: priorities for innovation in real-world evidence generation.

In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a "Fast-Track" regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products.

State variation in effects of state social distancing policies on COVID-19 cases.

Background: The novel coronavirus disease 2019 (COVID-19) sickened over 20 million residents in the United States (US) by January 2021. Our objective was to describe state variation in the effect of initial social distancing policies and non-essential business (NEB) closure on infection rates early in 2020.

Methods: We used an interrupted time series study design to estimate the total effect of all state social distancing orders, including NEB closure, shelter-in-place, and stay-at-home orders, on cumulative COVID-19 cases for each state.

Understanding Use of Real-World Data and Real-World Evidence to Support Regulatory Decisions on Medical Product Effectiveness.

RWE has potential to provide efficient and relevant information on the effectiveness of medical products, complementing the data generated in clinical trials; however, how RWE can support regulatory decision-making is unclear, potentially limiting its use. The objective of this study was to identify and characterize instances where RWE was included in the evidence package to support the effectiveness of a medical product regulated by U.S.

Correction to: Comparing Associations of State Reopening Strategies with COVID-19 Burden.

In the original version of this paper, an author was misidentified. The corrected author listing appears here, and has been updated in the online version.

Comparing Associations of State Reopening Strategies with COVID-19 Burden.

Background: The novel coronavirus disease 2019 (COVID-19) infected over 5 million United States (US) residents resulting in more than 180,000 deaths by August 2020. To mitigate transmission, most states ordered shelter-in-place orders in March and reopening strategies varied.

Objective: To estimate excess COVID-19 cases and deaths after reopening compared with trends prior to reopening for two groups of states: (1) states with an evidence-based reopening strategy, defined as reopening indoor dining after implementing a statewide mask mandate, and (2) states reopening indoor dining rooms before implementing a statewide mask mandate.

Characterizing and assessing antiemetic underuse in patients initiating highly emetogenic chemotherapy.

Background: Patients initiating highly emetic chemotherapy (HEC) are at a 90% risk of chemotherapy-induced nausea and vomiting (CINV). Despite guideline-concordant antiemetic prescribing preventing CINV in up to 80% of patients, studies suggest that guideline-concordant antiemetic regimen use by patients initiating HEC is sub-optimal. However, these studies have been limited to single-site or single-cancer type with limited generalizability.

Value-based arrangements may be more prevalent than assumed.

Objectives: To better understand the prevalence of US value-based payment arrangements (VBAs), their characteristics, and the factors that facilitate their success or act as barriers to their implementation.

Study Design: Surveys were administered to a convenience sample of subject matter experts who were senior representatives from payer organizations and biopharmaceutical manufacturers. These data were supplemented with qualitative interviews in a subsample of survey respondents.

Continuity of Medication Management among Adults with Schizophrenia and Comorbid Cardiometabolic Conditions.

Objectives: Adults with schizophrenia and cardiometabolic conditions may be good candidates for co-management by primary care prescribers and specialists. Associated risks for discontinuity in medication management have not been well-studied. This study examines whether medication adherence, inpatient admissions, and emergency department (ED) visits vary by the number and types of prescribers seen by adults with schizophrenia and cardiometabolic conditions.

Incidence of and Risk Factors for Severe Adverse Events in Elderly Patients Taking Angiotensin-Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers after an Acute Myocardial Infarction.

Study Objective: To assess the incidence of and risk factors associated with severe adverse events in elderly patients who used angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) after an acute myocardial infarction (AMI).

Design: Retrospective cohort study.

Data Sources: Centers for Medicare & Medicaid Services Chronic Conditions Data Warehouse (Medicare service claims database), American Community Survey of the U.

Continuity of medication management in Medicaid patients with chronic comorbid conditions: An examination by mental health status.

Objective: Patients with serious mental illness (SMI) often have comorbid cardiometabolic conditions (CMCs) that may increase the number of prescribers involved in treatment. This study examined whether patients with SMI (depression and schizophrenia) and comorbid CMCs experience greater discontinuity of prescribing than patients with CMCs alone.

Methods: 2009 Medicaid data were used to compare number and types of prescribers (primary care, cardiometabolic, psychiatric, other) in individuals with 1-3 CMCs (diabetes, hypertension, dyslipidemia) alone (n=76.

Prescription Drug Utilization and Reimbursement Increased Following State Medicaid Expansion in 2014.

Background: The Affordable Care Act (ACA) expanded health care and medication insurance coverage through Medicaid expansion in select states. Expansion has the potential to increase the availability of health services to patients, including prescription medications. However, limited studies have examined how expansion affected prescription drug utilization and reimbursement.

The Value of Vedolizumab as Rescue Therapy in Moderate-Severe Crohn's Disease Patients with Adalimumab Non-response in the USA.

Background And Aims: In May 2014, vedolizumab was approved by the Food and Drug Administration for the treatment of moderate-to-severe Crohn's disease. In clinical practice it is typically used in patients who are primary or secondary non-responders to adalimumab [Humira]. We aim to estimate the incremental benefits and costs of using vedolizumab as rescue therapy for adalimumab non-responders.

Who has used internal company documents for biomedical and public health research and where did they find them?

Objective: To describe the sources of internal company documents used in public health and healthcare research.

Methods: We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research.