Cohort Definition Name : Earliest event of Neonatal Thrombocytopenia (NT), less than 1 year old
Contributor name : Nathan Hal’, ‘Azza Shoaibi’
Contributor OrcId : 0000-0002-6976-2594’
Logic Description : Earliest occurrence of Neonatal Thrombocytopenia indexed on diagnosis date, for the first time in history limited to patients less than 1 years old, cohort exit is the end of continuous observation
Recommended study application : target
Assertion statement : This cohort definition was executed on at least one real person-level observational health data source and resulted in a cohort with at least 1 person.
Target Clinical Description : Fetal and neonatal alloimmune thrombocytopenia (FNAIT), also known as fetomaternal alloimmune thrombocytopenia and neonatal alloimmune thrombocytopenia (NT), is a rare disease caused by human platelet antigen (HPA) incompatibility between mother and fetus. In FNAIT, maternal IgG antibodies against fetal HPA cross the placenta and destroy fetal and neonatal platelets resulting in thrombocytopenia. Low platelet counts correlate with an increased risk of bleeding with intracranial hemorrhage (ICH) being the most severe complication. In pregnancies with no prior ICH, risk of ICH is estimated to be 7% among women not receiving IVIG. In pregnancies with prior ICH, the risk is 79%. In the proposed Phase 3 open-label interventional study, Nipocalimab will be studied in patients with a history of FNAIT in a prior pregnancy without ICH for the prevention of adverse outcomes of death, severe bleeds (ICH, non-ICH), or neonatal nadir platelet count <50 x 109/L (birth to 4 weeks)(primary endpoint).
Evaluation conclusion : We developed a prevalent cohort definition for Neonatal Thrombocytopenia (NT) using a concept set of 1 concept which incorporated all those found from the literature review, the analysis of PHOEBE, and orphan concepts in cohort diagnostics as a proxy for fetal and neonatal alloimmune thrombocytopenia (FNAIT). We performed the evaluation across a network of claim data sources and 1 EHR US data source. The data sources are: IBM® MarketScan® Commercial Database (CCAE), Optum’s longitudinal EHR repository (Optum EHR), Optum’s Clinformatics® Data Mart (DOD), IBM® MarketScan® Multi-State Medicaid Database (MDCD), IBM® MarketScan® Medicare Supplemental Database (MDCR), Japan Claims Database (JMDC), Clinical Practice Research Datalink (CPRD) , IQVIA® Australia Longitudinal Patient Data (LPD) database (Australia), IQVIA® Disease Analyzer (DA) France database (France), QVIA® Disease Analyzer (DA) Germany database (Germany), IQVIA® Adjudicated Health Plan Claims Data (formerly PharMetrics Plus) - US database (PharMetrics), IQVIA® Ambulatory EMR (EMR). The algorithm retrieves subjects from only 6 databases . This definition uses a broad set of concepts that capture neonatal thrombocytopenia and its descendants across six databases. Using this definition for neonatal thrombocytopenia as opposed to a more restrictive definition, such as “fetal neonatal alloimmune thrombocytopenia” provides a generalizable phenotype for neonates with this condition without relying on linkage to their mothers. This singular cohort definition was deemed to have sufficient performance the analytical use. As illustrated in Cohort Diagnostics, subjects had characteristics that are consistent with the clinical description of the disease. In specific, respiratory distress syndrome was common in about one third of NT patients at the time of index. Cholecalciferol was administered in 38% at time of index, in 26% of patients within 1-30 days post-index, and in 44% of patients 31-365 days post-index. No clear or extremely common traits were identified any time prior to index date. Additionally. fluorine administration and a condition occurrence of apnea were both present in slightly less than one fourth of patients at time of index. The majority of patients were indexed durring an inpatient visit.
Imported to the OHDSI Phenotype Library. It may be expected to be found with id = 1017 in the next release. Thank you