Innovative use of self-controlled methods for the evaluation of waning effectiveness of the COVID-19 monovalent third dose: comparison with a test-negative design.

Background: Waning vaccine effectiveness (VE) evaluations are affected by multiple biases, many of which could be implicitly adjusted by using self-controlled methods.

Methods: We used a self-controlled risk interval (SCRI) design to evaluate waning COVID-19 monovalent third dose effectiveness against laboratory-confirmed SARS-CoV-2 medically-attended infections (cases) and hospitalizations with COVID-19 discharge diagnosis among Veterans Health Administration enrollees who received a third dose 15 December 2021-31 August 2022. We used weeks 3-8 post-third dose as reference interval, representing the period of peak VE.

Association between imaging surveillance compliance and long-term outcomes after endovascular abdominal aortic aneurysm repair at Veterans Affairs hospitals.

Objective: To assess the association between compliance with guideline-recommended annual imaging surveillance after endovascular aortic aneurysm repair (EVAR) and long-term outcomes.

Methods: Veterans who underwent EVAR between January 1, 2000, and December 31, 2023, in US Department of Veterans Affairs facilities were examined retrospectively. The exposure was imaging surveillance compliance, defined as at least one imaging study (computed tomography, ultrasound examination, or magnetic resonance imaging) per year after EVAR.

Imaging Surveillance Adherence After Endovascular Abdominal Aortic Aneurysm Repair at VA Hospitals.

Importance: Guidelines recommend annual imaging surveillance after endovascular abdominal aortic aneurysm repair (EVAR). How these guidelines translate into practice among veterans remains poorly described.

Objective: To characterize post-EVAR surveillance among veterans.

Coronary and Cerebrovascular Events and Exacerbation of Existing Conditions After Laboratory-Confirmed Influenza Infection Among US Veterans: A Self-Controlled Case Series Study.

Background: Influenza may contribute to coronary/cerebrovascular events and exacerbate underlying conditions.

Methods: We used self-controlled case series (SCCS) design to analyze data from US Veterans ≥18 years with coronary/cerebrovascular or exacerbation event +/-1 year of lab-confirmed influenza (LCI) during 2010-2018. We estimated the incidence ratio (IR) (95% CI) of the event for risk interval (Days 1-7 post-LCI) versus control interval (all other times +/-1 year of LCI) with fixed-effects conditional Poisson regression.

Hypertension Control During the Coronavirus Disease 2019 Pandemic: A Cohort Study Among US Veterans.

Design: Retrospective cohort study.

Objective: We sought to examine whether disruptions in follow-up intervals contributed to hypertension control.

Background: Disruptions in health care were widespread during the coronavirus disease 2019 pandemic.

Effectiveness of Sotrovimab in Preventing COVID-19-Related Hospitalizations or Deaths Among US Veterans During Omicron BA.1.

Background: The real-world clinical effectiveness of sotrovimab in preventing coronavirus disease 2019 (COVID-19)-related hospitalization or mortality among high-risk patients diagnosed with COVID-19, particularly after the emergence of the Omicron variant, needs further research.

Method: Using data from the US Department of Veterans Affairs (VA) health care system, we adopted a target trial emulation design in our study. Veterans aged ≥18 years, diagnosed with COVID-19 between December 1, 2021, and April 4, 2022, were included.

Excess mortality in US Veterans during the COVID-19 pandemic: an individual-level cohort study.

Background: Most analyses of excess mortality during the COVID-19 pandemic have employed aggregate data. Individual-level data from the largest integrated healthcare system in the US may enhance understanding of excess mortality.

Methods: We performed an observational cohort study following patients receiving care from the Department of Veterans Affairs (VA) between 1 March 2018 and 28 February 2022.

Tixagevimab/cilgavimab for preventing COVID-19 during the Omicron surge: retrospective analysis of National Veterans Health Administration electronic data.

Little is known regarding the effectiveness of tixagevimab/cilgavimab in preventing SARS-CoV-2 infection in vaccinated immunocompromised patients, particularly after the emergence of the Omicron variant. In this retrospective cohort study with exact matching and propensity score adjustment within the U.S.

Absolute and relative excess mortality across demographic and clinical subgroups during the COVID-19 pandemic: an individual-level cohort study from a nationwide healthcare system of US Veterans.

Background: Most analyses of excess mortality during the COVID-19 pandemic have employed aggregate data. Individual-level data from the largest integrated healthcare system in the US may enhance understanding of excess mortality.

Methods: We performed an observational cohort study following patients receiving care from the Department of Veterans Affairs (VA) between 1 March 2018 and 28 February 2022.

Excess Mortality Among Patients in the Veterans Affairs Health System Compared With the Overall US Population During the First Year of the COVID-19 Pandemic.

Importance: During the first year of the COVID-19 pandemic, there was a substantial increase in the rate of death in the United States. It is unclear whether those who had access to comprehensive medical care through the Department of Veterans Affairs (VA) health care system had different death rates compared with the overall US population.

Objective: To quantify and compare the increase in death rates during the first year of the COVID-19 pandemic between individuals who received comprehensive medical care through the VA health care system and those in the general US population.

Effectiveness of mRNA COVID-19 vaccines against Omicron and Delta variants in a matched test-negative case-control study among US veterans.

Objective: To estimate the effectiveness of messenger RNA (mRNA) booster doses during the period of Delta and Omicron variant dominance.

Design: We conducted a matched test-negative case-control study to estimate the vaccine effectiveness (VE) of three and two doses of mRNA vaccines against infection (regardless of symptoms) and against COVID-19-related hospitalisation and death.

Setting: Veterans Health Administration.

Relative effectiveness of booster vs. 2-dose mRNA Covid-19 vaccination in the Veterans Health Administration: Self-controlled risk interval analysis.

Objective: To estimate relative effectiveness of the booster mRNA Covid-19 vaccination versus the 2-dose primary series for both Delta and Omicron variants with self-controlled study design.

Methods: We used the Veterans Health Administration (VHA) Corporate Data Warehouse to identify U.S.

Real-world Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Newly Treated Korean Patients With Asthma: A Retrospective Cohort Study.

Purpose: Although asthma treatment guidelines recommend regular inhaled medication, real-world treatment patterns and outcomes in South Korea have not been examined. We examined real-world treatment patterns and outcomes among patients treated for asthma in South Korea.

Methods: This retrospective cohort study utilized data from the South Korean National Health Insurance database (2013-2016).

Coverage and Estimated Effectiveness of mRNA COVID-19 Vaccines Among US Veterans.

Importance: Effectiveness of mRNA vaccinations in a diverse older population with high comorbidity is unknown.

Objectives: To describe the scope of the COVID-19 vaccination rollout among US veterans, and to estimate mRNA COVID-19 vaccine effectiveness (VE) as measured by rates of SARS-CoV-2 infection.

Design, Setting, And Participants: This matched test-negative case-control study was conducted using SARS-CoV-2 test results at Veterans Health Administration sites from December 14, 2020, to March 14, 2021.

Real-World Experience with Lifitegrast Ophthalmic Solution (Xiidra) in the US and Canada: Retrospective Study of Patient Characteristics, Treatment Patterns, and Clinical Effectiveness in 600 Patients with Dry Eye Disease.

Purpose: This study evaluated real-world treatment of dry eye disease (DED) with lifitegrast.

Patients And Methods: Ophthalmologists and optometrists treating patients with DED were invited to participate through a healthcare provider (HCP)-based panel. HCPs completed a provider survey and contributed data toward a chart review for up to five qualifying patients with DED who initiated lifitegrast ophthalmic solution (index date) between 01/01/2017 (US) or 01/01/2018 (Canada) and 06/30/2019.

Treatment of metastatic castration resistant prostate cancer with radium-223: a retrospective study at a US tertiary oncology center.

Background: Guidelines for optimal sequencing of radium-223 and chemotherapy for metastatic castration resistant prostate cancer (mCRPC) do not exist. This study evaluated treatment patterns and overall survival (OS) among patients with mCRPC treated with radium-223 in an academic clinical setting.

Methods: A retrospective study was conducted of bone metastases-predominant mCRPC patients treated with radium-223.

Public health impact of Rotarix vaccination among commercially insured children in the United States.

Background: This study (NCT01915888) assessed public health impact of Rotarix, GSK [RV1] vaccination.

Methods: Children born between 2007-2011 were identified from Truven Commercial Claims and Encounters Databases and observed until earlier of plan disenrollment or five years old. Children receiving one or two doses of RV1 during the vaccination window were assigned to incomplete and complete vaccination cohorts, respectively.

Public Health Impact of Complete and Incomplete Rotavirus Vaccination among Commercially and Medicaid Insured Children in the United States.

Background: This study (NCT01682005) aims to assess clinical and cost impacts of complete and incomplete rotavirus (RV) vaccination.

Methods: Beneficiaries who continuously received medical and pharmacy benefits since birth were identified separately in Truven Commercial Claims and Encounters (2000-2011) and Truven Medicaid Claims (2002-2010) and observed until the first of end of insurance eligibility or five years. Infants with ≥1 RV vaccine within the vaccination window (6 weeks-8 months) were divided into completely and incompletely vaccinated cohorts.

A retrospective chart review of drug treatment patterns and clinical outcomes among patients with metastatic or recurrent soft tissue sarcoma refractory to one or more prior chemotherapy treatments.

Background: Limited clinical data on real-world practice patterns are available for patients with metastatic/relapsed soft tissue sarcomas (STS). The primary objective of this study was to evaluate treatment patterns in patients with metastatic/relapsed STS following failure of prior chemotherapy by examining data collected from 2000 to 2011 from a major tertiary academic cancer center in the United States.

Methods: Medical records, including community-based referral records, from a tertiary cancer center for adult patients with metastatic/relapsed STS with confirmed disease progression who commenced second-line treatment between January 1, 2000 and February 4, 2011, and with at least 3 months of follow-up data following second-line treatment initiation, were retrospectively reviewed.

Impact of early versus late systemic lupus erythematosus diagnosis on clinical and economic outcomes.

Background And Objectives: Systemic lupus erythematosus (SLE) is a multisystem complex autoimmune disease that often mimics symptoms of other illnesses, which complicates the ability of healthcare providers to make the diagnosis. The objective of this study was to assess clinical outcomes, resource utilization, and costs between patients with earlier versus later SLE diagnosis.

Methods: Patients aged 18-64 years were identified from a large US commercial claims database between January 2000 and June 2010.

Angiogenesis inhibitor therapies for advanced renal cell carcinoma: toxicity and treatment patterns in clinical practice from a global medical chart review.

The aim of this study was to assess the treatment patterns and safety of sunitinib, sorafenib and bevacizumab in real-world clinical settings in US, Europe and Asia. Medical records were abstracted at 18 community oncology clinics in the US and at 21 tertiary oncology centers in US, Europe and Asia for 883 patients ≥ 18 years who had histologically/cytologically confirmed diagnosis of advanced RCC and received sunitinib (n=631), sorafenib (n=207) or bevacizumab (n=45) as first-line treatment. No prior treatment was permitted.

Systematic literature review and meta-analysis of the efficacy and safety of prescription opioids, including abuse-deterrent formulations, in non-cancer pain management.

Objective: This study was conducted to compare safety and efficacy outcomes between opioids formulated with technologies designed to deter or resist tampering (i.e., abuse-deterrent formulations [ADFs]) and non-ADFs for commonly prescribed opioids for treatment of non-cancer pain in adults.

Safety and treatment patterns of angiogenesis inhibitors in patients with advanced renal cell carcinoma in Spain.

Objective: To examine real-world safety and treatment patterns of angiogenesis inhibitors for advanced renal cell carcinoma (aRCC) using observational data from two Spanish hospitals.

Methods: A retrospective medical record review was performed for 93 patients with a histological diagnosis of aRCC who received sunitinib, sorafenib, bevacizumab or temsirolimus as first-line angiogenesis inhibitor therapy, between January 2005 and September 2010 at two Spanish hospitals. Data were collected on adverse events (AEs), dosing to calculate relative dose intensity (RDI), treatment modifications and reasons for modifications.

The cost-effectiveness of initial treatment of multiple myeloma in the U.S. with bortezomib plus melphalan and prednisone versus thalidomide plus melphalan and prednisone or lenalidomide plus melphalan and prednisone with continuous lenalidomide maintenance treatment.

The outlook for transplant-ineligible multiple myeloma patients has improved enormously over recent years with the incorporation of new agents into standard regimens. Novel regimens combine melphalan and prednisone (MP) with bortezomib (VMP), with thalidomide (MPT), and with lenalidomide with (MPR-R) and without (MPR) lenalidomide maintenance. The efficacy, safety, and cost-effectiveness of these regimens have not yet been compared; therefore, we conducted a pharmacoeconomic analysis using data from randomized controlled trials versus MP.

Resource utilization and costs following hospitalization of patients with chronic heart failure in the US.

Background: Despite advances in its management and the identification of preventable risk factors, heart failure (HF) is a growing health problem in the US. The objective of this study was to describe treatment patterns, medical resource utilization and costs following hospitalization for chronic HF for patients stratified by age.

Methods: Patients with at least one hospitalization with chronic HF were identified in a US commercial insurance claims database from 2004-2008.