FDA | Biologics Effectiveness and Safety (BEST)

Outcomes

To identify adverse events (AEs) or health outcomes of interest (HOIs) in health care databases including administrative claims, electronic health records [EHR], and linked claims-EHRs, rule-based algorithms are developed utilizing reimbursement or health care management coding systems as well as clinical and auxiliary data elements. These algorithms may also apply health care settings, demographic and other specific population characteristics, and time criteria. Based on prevalence and clinical characteristics, some of these algorithms may be feasible to be validated by reviewing patients’ medical records. The health outcomes may be employed as outcomes, identification of study populations, or covariates in observational studies depending on the study objectives. The portability of these algorithms across populations and databases depends on the similarities of the populations and databases characteristics.

Most Recent Outcomes Assessments

Title

Date

Identifying Individuals with Diabetes Using Administrative Claims Data: A Code-Based Algorithm

Diabetes Algorithm Report 2020 (pdf)

05/2020

Algorithm, Diabetes Mellitus, Administrative Claims Data, ICD-10-CM, ICD-9-CM, Exclusion Criterion, Covariate Iteration, Population Iteration, Outcome Iteration

Defining Acquired Hemolysis Using Administrative Claims Data: A Case Algorithm

Hemolysis Algorithm Report 2020 (pdf)

05/2020

Algorithm, Hemolysis, Administrative Claims Data, intravenous immunoglobulins, IVIG, FAERS, FDA Adverse Event Reporting System, Outcome Definition, blood derived, blood derived products, acquired hemolysis, ICD-10-CM, ICD-9-CM

Defining Syncope Using Administrative Claims Data: A Case Algorithm

Syncope Algorithm Report 2020 (pdf)

05/2020

Algorithm, Syncope, Administrative Claims Data, ICD-9-CM, ICD-10-CM

Defining Thromboembolic Events Using Administrative Claims Data: A Series of Case Algorithms

TEE Algorithm Report 2020 (pdf)

05/2020

Algorithm, Thromboembolic event, pulmonary embolism, deep vein thrombosis, acute myocardial infarction, stroke, arterial embolism, thrombosis, TEE, ICD-9-CM, ICD-10-CM