Many activities conducted within FDA’s Sentinel System are aimed at gaining a better understanding of the pediatric patient population. These include studies that estimate rates of specific health outcomes, as well as studies that examine prevalent and incident use of medical products, among pediatric patients in the Sentinel System. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity.
This poster describes demographics, enrollment, and health characteristics among pediatric members in the Sentinel Distributed Database. It was presented at the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management.
This analysis includes two reports:
- Report 1: We examined the trends in diagnosis of congenital cytomegalovirus disease (cCMV) or cytomegalovirus infection (CMV). We also assessed clinical characteristics, laboratory tests performed for CMV diagnosis, hearing loss and hematologic outcomes among infants with CMV and those who used valganciclovir/ganciclovir treatment.
- Report 2: We assessed follow-up time and distribution of valganciclovir or ganciclovir treatment in infants with cCMV. We also assessed clinical characteristics, laboratory tests performed for CMV diagnosis, hearing loss and hematologic outcomes among infants with CMV who used valganciclovir/ganciclovir treatment.
The study period includes data from January 1, 2008 through May 31, 2021. We distributed this request to 12 Sentinel Data Partners on December 9, 2021.
The proposed goal of this project is to pilot, via two use cases, the ability to more routinely and broadly understand how FDA might conduct “on-demand quality assurance” for selected vital signs and laboratory results in a within cohort fashion. The first use case will evaluate a cohort of pediatric patients with hypertension. The second use case will evaluate a cohort of new adult users of SGLT-2 inhibitors.
Vital signs and laboratory measures will be evaluated for each use case. Measures will include blood pressure as well as smoking use/status, height, and weight. Laboratory tests will include Hemoglobin A1c and creatinine.
A comparison of the identification using a claims-only phenotype versus a clinical data (e.g., electronic health record based) phenotype will be conducted. Two reports have been posted from the first use case that evaluated a cohort of pediatric patients with hypertension. In the first report, the hypertension algorithm is simplified. The second report utilized a more complex hypertension algorithm to define events of interest. The second use case is still in progress and a final report will be posted when complete.
In this request, we estimated rates of hypertension in a pediatric population within the Sentinel Distributed Database (SDD).
The study period included data from January 1, 2008 to April 30, 2019. We distributed the request to 15 Data Partners on September 26, 2019.
The objective of this request was to identify use of typical and atypical antipsychotics among neonates during inpatient encounters using Hospital Corporation of America (HCA) Healthcare data. HCA's Sentinel data (ETL 3.0) from July 1, 2011 - September 30, 2017 were included in this report. This request was distributed on August 15, 2019.
The purpose of this request was to estimate the number of pediatric patients with respiratory syncytial virus (RSV) and RSV-related events and related preventative services in the Sentinel Distributed Database (SDD). This request contains two reports:
- Report 1 contains estimates of the number of pediatric patients 0 to <24 months of age.
- Report 2 contains estimates of the number of pediatric patients 1 to <24 months of age.
We distributed this request to 16 Data Partners contributing to the SDD on August 7, 2016.
The goal of this request was to estimate the number of prevalent users and dispensings of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) among pediatric populations in the Sentinel Distributed Database (SDD). Data from January 1, 2001 to December 31, 2012 from 15 Data Partners contributing to the SDD were included in this report. This request was distributed on July 1, 2016.
The goal of this request is to describe interleukin-1 (IL-1) and interleukin-6 (IL-6) inhibitor use and occurrence of incident pulmonary arterial hypertension (PAH), interstitial lung disease (ILD), and macrophage activation syndrome (MAS) among an adult cohort with Adult-Onset Still's Disease (AOSD) and a pediatric cohort with Systemic Juvenile Idiopathic Arthritis (SJIA) in the Sentinel Distributed Database (SDD). Report 1 contains estimates of PAH, ILD, and MAS events among adults with AOSD and children with SJIA. Report 2 contains estimates of IL-1/-6 use and occurence of incident PAH, ILD, and MAS events among the two the adult and pediatric cohorts.
Data from October 1, 2015 to March 31, 2018 from 15 Data Partners contributing to the SDD were included in these reports. This request was distributed to Data Partners on August 15, 2018.