Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years.

Background: Active monitoring of safety outcomes following COVID-19 vaccination is critical to understand vaccine safety and can provide early detection of rare outcomes not identified in pre-licensure trials. We present findings from an early warning rapid surveillance system in three large commercial insurance databases including more than 16 million vaccinated individuals.

Methods: We evaluated 17 outcomes of interest following COVID-19 vaccination among individuals aged 12-64 years in Optum, HealthCore, and CVS Health databases from December 11, 2020, through January 22, 2022, January 7, 2022, and December 31, 2021, respectively.

The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines.

Background: Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in children 6-23 months of age during the 2013-14 and 2014-15 influenza seasons.

Methods: Using claims data and a self-controlled risk interval design, we compared the febrile seizure rate in a risk interval (0-1 days) versus control interval (14-20 days).

Validation of febrile seizures identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program.

Background: The Sentinel Initiative was established in 2008 to monitor the safety of FDA-regulated medical products. We evaluated the positive predictive value (PPV) of ICD-9 codes for post-vaccination febrile seizures to identify optimal algorithms for use in post-market safety surveillance.

Methods: We identified ICD-9 diagnosis codes for fever and seizures in the emergency department or inpatient setting after vaccinations of interest from July 1, 2010 to June 30, 2011.

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools.

Purpose: To pilot use of the US Food and Drug Administration's (FDA's) Sentinel System data and analytic tools by a non-FDA stakeholder through the Innovation in Medical Evidence Development and Surveillance system of the Reagan Udall Foundation. We evaluated the US FDA 2010 proton pump inhibitor (PPI) class label change that warned of increased risk of bone fracture, to use PPIs for the lowest dose and shortest duration, and to manage bone status for those at risk for osteoporosis.

Methods: The cohort consisted of adults aged 18 years or older prescribed PPIs without fracture risk factors.

Occurrence of hemolytic reactions on the same day as immune globulin product administrations during 2008 to 2014.

Background: Hemolytic reactions (HRs) are rare serious adverse events after immune globulin (IG) use. Our large claims-based study evaluated occurrence of same-day hemolysis after administration of different IG products and potential risk factors, during the 2008 to 2014 study period.

Study Design And Methods: We conducted a retrospective cohort study using a large commercial administrative database.

Occurrence of acute renal failure on the same day as immune globulin product administrations during 2008 to 2014.

Background: Acute renal failure (ARF) is a rare serious adverse event after immune globulin (IG) use. Our large claims-based study evaluated occurrence of same-day ARF after administration of different IGs and ascertained potential risk factors, during the 2008 to 2014 study period.

Study Design And Methods: A retrospective cohort study was conducted using a large commercial administrative database.

Aggressive End-of-Life Care for Metastatic Cancer Patients Younger Than Age 65 Years.

Background: Aggressive medical care at the end of life can be harmful to patients and families, but its prevalence in use among younger cancer patients is unknown. The goal of the study was to report on the use of aggressive care and hospice services for patients younger than age 65 years.

Methods: Using the HealthCore Integrated Research Database, we analyzed patients who died between 2007 and 2014 with metastatic lung (n = 12 764), colorectal (n = 5207), breast (n = 5855), pancreatic (n = 3397), or prostate (n = 1508) cancer.

Initiation of Trastuzumab by Women Younger Than 64 Years for Adjuvant Treatment of Stage I-III Breast Cancer.

Studies have reported disparities by age and race in the initiation of adjuvant trastuzumab for the initial treatment of older women with early-stage breast cancer, but less is known about its initiation in younger patients. Therefore, we assessed temporal trends and clinical and demographic factors associated with trastuzumab initiation in a large, population-based cohort of patients aged <64 years in 5 states. Using a cancer registry and claims-linked data set of 13,398 women with incident invasive breast cancer from 2006 to 2011, we identified 934 patients aged <64 years with HER2-positive stage I-III breast cancer.

Evaluation of optic neuritis following human papillomavirus vaccination.

To assess the relationship between human papillomavirus (HPV) vaccination and occurrence of optic neuritis (ON) and to evaluate a claims-based algorithm for identification of ON. Females of 9-26 year olds in the HealthCore's Integrated Research Database (HIRD) with and without claims evidence of HPV vaccination between 2007 and 2012 were included in this study. Potential ON cases were identified using the claims-based algorithm, positive predictive value (PPV) was determined using medical chart review.

Endocrine therapy initiation, discontinuation and adherence and breast imaging among 21-gene recurrence score assay-eligible women under age 65.

Background: Aside from chemotherapy utilization, limited data are available on the relationship between gene expression profiling (GEP) testing and breast cancer care. We assessed the relationship between GEP testing and additional variables and the outcomes of endocrine therapy initiation, discontinuation and adherence, and breast imaging exams in women under age 65 years.

Methods: Data from five state cancer registries were linked with claims data and GEP results.

Use of Quantile Regression to Determine the Impact on Total Health Care Costs of Surgical Site Infections Following Common Ambulatory Procedures.

Objective: To determine the impact of surgical site infections (SSIs) on health care costs following common ambulatory surgical procedures throughout the cost distribution.

Background: Data on costs of SSIs following ambulatory surgery are sparse, particularly variation beyond just mean costs.

Methods: We performed a retrospective cohort study of persons undergoing cholecystectomy, breast-conserving surgery, anterior cruciate ligament reconstruction, and hernia repair from December 31, 2004 to December 31, 2010 using commercial insurer claims data.

Quality of Care Provided by Board-Certified Versus Non-Board-Certified Psychiatrists and Neurologists.

Purpose: To examine associations between board certification of psychiatrists and neurologists and quality-of-care measures, using multilevel models controlling for physician and patient characteristics, and to assess feasibility of linking physician information with patient records to construct quality measures from electronic claims data.

Method: The authors identified quality measures and matched claims data from 2006 to 2012 with 942 board-certified (BC) psychiatrists, 868 non-board-certified (nBC) psychiatrists, 963 BC neurologists, and 328 nBC neurologists. Using the matched data, they identified psychiatrists who treated at least one patient with a schizophrenia diagnosis, and neurologists attending patients discharged with a principal diagnosis of ischemic stroke, and analyzed claims from these patients.

Bidirectional Data Collaborations in Distributed Research.

Introduction: The need for collaborations with bidirectional data exchange within and across distributed research networks has increased.

Currently Existing Activities: This commentary will present currently publically available activities including the Sentinel Initiative, the Patient-Centered Outcomes Research Network (PCORnet), and the NIH Research Collaboratory.

Current Technical And Governance Challenges: Even with the advances made in this arena, several technical and governance challenges remain including the evolution of clinically rich data sources and modes of care, availability of longitudinal data resources through data linkage, and the processes to share data and link data resources while ensuring privacy and proprietary control of data.

Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females.

After the Food and Drug Administration (FDA) licensed quadrivalent human papillomavirus vaccine (HPV4) in 2006, reports suggesting a possible association with venous thromboembolism (VTE) emerged from the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink. Our objective was to determine whether HPV4 increased VTE risk. The subjects were 9-26-year-old female members of five data partners in the FDA's Mini-Sentinel pilot project receiving HPV4 during 2006-2013.

Adoption of Gene Expression Profiling for Breast Cancer in US Oncology Practice for Women Younger Than 65 Years.

Background: A number of practice guidelines incorporate the use of gene expression profiling (GEP) tests for early-stage, hormone receptor-positive, HER2-negative breast tumors. Few studies describe factors associated with GEP testing in US oncology practice. We assessed the relationship between clinical, demographic, and group-level socioeconomic variables and test use in women younger than 65 years.

Febrile Seizures After 2010-2011 Trivalent Inactivated Influenza Vaccine.

Objectives: In the Post-Licensure Rapid Immunization Safety Monitoring Program, we examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) during the 2010-2011 influenza season, adjusted for concomitant diphtheria tetanus acellular pertussis-containing vaccines (DTaP). Assuming children would receive both vaccines, we examined whether same-day TIV and PCV13 vaccination was associated with greater FS risk when compared with separate-day vaccination.

Methods: We used a self-controlled risk interval design, comparing the FS rate in a risk interval (0-1 days) versus control interval (14-20 days).

Population-based study of the effect of gene expression profiling on adjuvant chemotherapy use in breast cancer patients under the age of 65 years.

Background: Gene expression profiling (GEP) testing can help to predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy for breast cancer (BC). However, no prior US studies have evaluated the relation between GEP testing and the use of adjuvant chemotherapy by women treated in a general oncology practice.

Methods: Eligible patients were women under the age 65 of years who were newly diagnosed with their first stage I or II, hormone receptor-positive BC between 2006 and 2011 (n = 9405).

Provider Patient-Sharing Networks and Multiple-Provider Prescribing of Benzodiazepines.

Background: Prescription benzodiazepine overdose continues to cause significant morbidity and mortality in the US. Multiple-provider prescribing, due to either fragmented care or "doctor-shopping," contributes to the problem.

Objective: To elucidate the effect of provider professional relationships on multiple-provider prescribing of benzodiazepines, using social network analytics.

Identification of Stevens-Johnson syndrome and toxic epidermal necrolysis in electronic health record databases.

Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) carry a high mortality risk. While identifying clinical and genetic risk factors for these conditions has been hindered by their rarity, large electronic health databases hold promise for identifying large numbers of cases for study, especially with the introduction in 2008 of ICD-9 codes more specific for these conditions.

Objective: The objective of this study is to estimate the validity of ICD-9 codes for ascertaining SJS/TEN in 12 collaborating research units in the USA, covering almost 60 million lives.

Immune globulins and same-day thrombotic events as recorded in a large health care database during 2008 to 2012.

Background: Thrombotic events (TEs) are rare and serious adverse events after administration of immune globulin (IG) products. Our study evaluated the occurrence of same-day TEs for different IG products and ascertained potential risk factors.

Study Design And Methods: This retrospective cohort study utilized HealthCore's Integrated Research Database (HIRD) to assess individuals exposed to IGs during 2008 to 2012.

Intussusception risk after rotavirus vaccination in U.S. infants.

Background: International postlicensure studies have identified an increased risk of intussusception after vaccination with the second-generation rotavirus vaccines RotaTeq (RV5, a pentavalent vaccine) and Rotarix (RV1, a monovalent vaccine). We studied this association among infants in the United States.

Methods: The study included data from infants 5.

Validation of anaphylaxis in the Food and Drug Administration's Mini-Sentinel.

Purpose: We aim to develop and validate the positive predictive value (PPV) of an algorithm to identify anaphylaxis using health plan administrative and claims data. Previously published PPVs for anaphylaxis using International Classification of Diseases, ninth revision, Clinical Modification (ICD-9-CM) codes range from 52% to 57%.

Methods: We conducted a retrospective study using administrative and claims data from eight health plans.

Hyperimmune globulins and same-day thrombotic adverse events as recorded in a large healthcare database during 2008-2011.

Thrombotic events (TEs) are rare serious complications following administration of hyperimmune globulin (HIG) products. Our retrospective claims-based study assessed occurrence of same-day TEs following administration of HIGs during 2008-2011 and examined potential risk factors using HealthCore's Integrated Research Database (HIRD(SM) ) and laboratory testing of products' procoagulant Factor XIa activity by U.S.