Development of a Conceptual Model of the Patient Experience in Small Cell Lung Cancer: A Qualitative Interview Study.

Introduction: Small cell lung cancer (SCLC) is a subtype of lung cancer, the second most common cancer diagnosis worldwide. Currently, there is little published qualitative research that provides insight into the disease-related symptoms and impacts that are relevant to patients living with SCLC as directly reported by patients themselves.

Methods: This qualitative, cross-sectional, noninterventional, descriptive study included concept elicitation interviews with participants diagnosed with SCLC and the development of a conceptual model of clinical treatment benefit.

Oncology drugs and added benefit: insights from 3 European health technology assessment agencies on the role of efficacy endpoints.

Objective: This study aimed to understand the impact of different efficacy endpoints on reimbursement decisions made by health technology assessment (HTA) bodies.

Materials And Methods: European Medicines Agency (EMA) oncology product marketing authorizations were screened to identify products that completed review by 3 HTA bodies during 2016-2019: United Kingdom's National Institute for Health and Care Excellence, Germany's Gemeinsamer Bundesausschuss, and France's Haute Autorité de Santé. Each decision's endpoint information, including overall survival (OS) and progression-free survival (PFS), was extracted.

Collection of Post-treatment PRO Data in Oncology Clinical Trials.

As patient-reported outcome (PRO) measures are being included more frequently in oncology clinical trials, regulatory and health technology assessment agencies have begun to request long-term, post-treatment PRO data to supplement traditional survival/progression endpoints. These data may be collected as part of cohort extension or registry studies to describe long-term outcomes of study participants after concluding their cancer treatment. While post-treatment PRO data may be expected to satisfy regulatory and payer expectations, significant practical barriers exist for the efficient incorporation of these data into oncology clinical trials, such as subject attrition, protocol deviations, and treatment crossover.

Treatment and persistence with oral anticoagulants among newly diagnosed patients with non-valvular atrial fibrillation: a retrospective observational study in a US commercially insured and Medicare Advantage population.

Objectives: With the approval of new non-vitamin K antagonist oral anticoagulants for stroke prevention in non-valvular atrial fibrillation (NVAF), it is anticipated that their introduction may change NVAF treatment patterns; however, there is limited supporting real-world evidence. This study investigated guideline-recommended oral anticoagulation (OAC) treatment and persistence in newly diagnosed patients with NVAF to understand demographic and clinical characteristics.

Design: Retrospective observational administrative claims study in the USA.

Comparison of claims vs patient-reported adherence measures and associated outcomes among patients with nonvalvular atrial fibrillation using oral anticoagulant therapy.

Objective: To compare oral anticoagulant (OAC) adherence among patients with nonvalvular atrial fibrillation (NVAF) using patient-reported and claims-based measures, and to evaluate the effect of OAC adherence on health care costs and patient satisfaction with OAC therapy.

Methods: This was a hybrid US observational study consisting of a longitudinal cohort survey followed by linkage and analysis of respondents' administrative claims data. Patients with NVAF receiving warfarin, dabigatran, rivaroxaban, or apixaban completed an initial survey and follow-up surveys at 4, 8, and 12 months.

Health Care Resource Utilization and Costs Among Newly Diagnosed and Oral Anticoagulant-Naive Nonvalvular Atrial Fibrillation Patients Treated with Dabigatran or Warfarin in the United States.

Background: Warfarin has a long history of use to reduce the risk of stroke in patients with atrial fibrillation (AF), but it requires frequent laboratory monitoring to maintain international normalized ratio levels in the therapeutic range. Dabigatran, a novel oral anticoagulant (OAC), has demonstrated efficacy in reducing the risk of stroke and systemic embolism and does not require laboratory monitoring.

Objective: To compare health care resource utilization (HCRU) and costs of OAC-naive patients newly diagnosed with nonvalvular atrial fibrillation (NVAF), using dabigatran or warfarin.

All-cause mortality and use of antithrombotics within 90 days of discharge in acutely ill medical patients.

Conflicting evidence exists regarding predictors of and antithrombotic benefit on mortality in hospitalised acutely-ill medical patients. We compared mortality risk within 90 days post-discharge among medically ill patients who did and did not receive antithrombotics. This retrospective claims analysis included patients ≥ 40 years with nonsurgical hospitalisation ≥ 2 days between 2005 and 2009 using the HealthCore Integrated Research Database.

Cardiovascular-related healthcare resource utilization and costs in patients with hypertension switching from metoprolol to nebivolol.

Background: The prevalence of hypertension is increasing in the United States and the associated costs are soaring. Despite the many treatment options, only approximately 50% of Americans with hypertension achieve optimal control. Patients receiving nebivolol, a third-generation beta-blocker, have fewer adverse events and better treatment persistence compared with patients receiving other antihypertensive agents.

Association between anticoagulant treatment duration and risk of venous thromboembolism recurrence and bleeding in clinical practice.

Introduction: This retrospective observational study examined whether anticoagulant treatment duration varies by risks of venous thromboembolism (VTE) recurrence and bleeding.

Materials And Methods: VTE patients naïve to anticoagulants were identified from the HealthCore Integrated Research Database between 06/01/2007 and 09/30/2011 and categorized into three groups: provoked, cancer-related, and unprovoked VTE. Treatment duration was from initiation to discontinuation of anticoagulation, based on a 60-day gap in prescription fill unless there was an international normalized ratio test every 42 days.

Characteristics affecting oral anticoagulant therapy choice among patients with non-valvular atrial fibrillation: a retrospective claims analysis.

Background: Dabigatran is one of the three newer oral anticoagulants (OACs) recently approved in the United States for stroke prevention in non-valvular atrial fibrillation (NVAF) patients. The objective of this study was to identify patient, healthcare provider, and health plan factors associated with dabigatran versus warfarin use among NVAF patients.

Methods: Administrative claims data from patients with ≥ 2 NVAF medical claims in the HealthCore Integrated Research Database between 10/1/2009 and 10/31/2011 were analyzed.

Thromboprophylaxis patterns, risk factors, and outcomes of care in the medically ill patient population.

Introduction: Medically ill, hospitalized patients are at increased risk for venous thromboembolism (VTE) after discharge. This study aimed to examine thromboprophylaxis patterns, risk factors, and post-discharge outcomes.

Methods: This was a retrospective claims analysis involving administrative claims data and in-patient data abstracted from a sample of hospital charts.

A retrospective study of patients' out-of-pocket costs for granulocyte colony-stimulating factors.

Objective: With rising healthcare costs, there is an increasing concern with the burden of out-of-pocket costs on cancer patients. This study examined patients' out-of-pocket expenditures for granulocyte colony-stimulating factors, pegfilgrastim and filgrastim, which are given to cancer patients receiving myelosuppressive chemotherapy and have been shown to decrease the incidence of febrile neutropenia.

Methods: Adult patients who received chemotherapy and granulocyte colony-stimulating factors in the outpatient setting in the United States between January 2007 and June 2010 were evaluated using medical and pharmacy claims data from two healthcare data sources, the MarketScan(®) Commercial and Medicare Supplemental Databases and the HealthCore Integrated Research Database(SM).

Antithrombotic medication use and bleeding risk in medically ill patients after hospitalization.

Background: Hospitalized medically ill patients receiving antithrombotic medications experience increased risk of bleeding. We examined antithrombotic use, bleeding rates, and associated risk factors at 30 days post discharge.

Methods: This retrospective database analysis included nonsurgical patients aged ≥40 years hospitalized for ≥2 days during 2005 to 2009.