Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion.

INTRODUCTION: Detection of adverse reactions to drugs and biologic agents is an important component of regulatory approval and post-market safety evaluation. Real-world data, including insurance claims and electronic health records data, are increasingly used for the evaluation of potential safety outcomes; however, there are different types of data elements available within these data resources, impacting the development and performance of computable phenotypes for the identification of adverse events (AEs) associated with a given therapy. OBJECTIVE: To evaluate the utility of different types of data elements to the performance of computable phenotypes for AEs. METHODS: We used intravenous immunoglobulin (IVIG) as a model therapeutic agent and conducted a single-center, retrospective study of 3897 individuals who had at least one IVIG administration between 1 January 2014 and 31 December 2019. We identified the potential occurrence of four different AEs, including two proximal AEs (anaphylaxis and heart rate alterations) and two distal AEs (thrombosis and hemolysis). We considered three different computable phenotypes: (1) an International Classification of Disease (ICD)-based phenotype; (2) a phenotype-based on EHR-derived contextual information based on structured data elements, including laboratory values, medication administrations, or vital signs; and (3) a compound phenotype that required both an ICD code for the AE in combination with additional EHR-derived structured data elements. We evaluated the performance of each of these computable phenotypes compared with chart review-based identification of AEs, assessing the positive predictive value (PPV), specificity, and estimated sensitivity of each computable phenotype method. RESULTS: Compound computable phenotypes had a high positive predictive value for acute AEs such as anaphylaxis and bradycardia or tachycardia; however, few patients had both ICD codes and the relevant contextual data, which decreased the sensitivity of these computable phenotypes. In contrast, computable phenotypes for distal AEs (i.e., thrombotic events or hemolysis) frequently had ICD codes for these conditions in the absence of an AE due to a prior history of such events, suggesting that patient medical history of AEs negatively impacted the PPV of computable phenotypes based on ICD codes. CONCLUSIONS: These data provide evidence for the utility of different structured data elements in computable phenotypes for AEs. Such computable phenotypes can be used across different data sources for the detection of infusion-related adverse events.

Caring for adolescents and young adults with attention-deficit/hyperactivity disorder in primary care: seizing opportunities to address youth mental health needs.

PURPOSE OF REVIEW: To provide primary care providers (PCPs) with updated practical guidance around the assessment and management of attention-deficit/hyperactivity disorder (ADHD) in adolescents and young adults (AYA). RECENT FINDINGS: Of the three different presentations of ADHD delineated in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the Predominantly Inattentive presentation is the most common among AYA. Multiple rating scales exist to assist clinicians in identifying ADHD symptoms and monitoring treatment effects. Importantly, ADHD frequently persists into adulthood with negative impacts in many life domains if left untreated. It is important for PCPs to provide support for AYA as they transition to adulthood, as treatment adherence often drops sharply at that time, and, once treatment is discontinued, it is rarely restarted. Further, clinicians should be aware of the negative psychological, behavioral, and social impacts that COVID-19 has had on AYA with ADHD. SUMMARY: AYA with ADHD often seek care first from PCPs. However, diagnosis and management of ADHD among AYA are challenging, and many clinicians feel ill-equipped, creating concern that many youth may go undiagnosed and untreated. Despite these long-standing challenges, recent advances have opened up critical opportunities for PCPs to proactively address ADHD in primary care settings and make a profound impact on youth as they seek to realize their full potential.