Design for validation of acute myocardial infarction cases in Mini‐Sentinel

Abstract

Purpose To describe the Acute Myocardial Infarction (AMI) Validation project, a test case for health outcome validation within the FDA-funded Mini-Sentinel pilot program. Methods The project consisted of four parts: (1) case identification: developing an ICD9-based algorithm to identify hospitalized AMI patients within the Mini-Sentinel Distributed Database; (2) chart retrieval: establishing procedures that ensured patient privacy (collection and transfer of minimum necessary amount of information, and redaction of direct identifiers to validate potential cases of AMI; (3) abstraction and adjudication: trained nurse abstractors gathered key data using a standardized form with cardiologist adjudication; and (4) calculation of the positive predictive value of the constructed algorithm. Results Key decision points included: (1) breadth of the AMI algorithm; (2) centralized vs. distributed abstraction; and (3) approaches to maintaining patient privacy and to obtaining charts for public health purposes. We used an algorithm limited to ICD9 codes 410.x0-410.x1. Centralized data abstraction was performed due to the modest number of charts requested (<155). The project’s public health status accelerated chart retrieval in most instances. Conclusions We have established a process to validate AMI within Mini-Sentinel, which may be used for other health outcomes. Challenges include: (1) ensuring that only minimum necessary data is transmitted by Data Partners for centralized chart review; (2) establishing procedures to maintain data privacy while still allowing for timely access to medical charts; and (3) securing access to charts for public health uses that do not require IRB approval while maintaining patient privacy.

Study of Cardiovascular Health Outcomes in the Era of Claims Data

“…A high PPV means that a large proportion of cases identified by selected diagnostic codes meets study criteria for an event. In-patient diagnostic codes for many common cardiovascular diseases (CVD), including myocardial infarction (MI), heart failure (HF), and stroke, have high PPVs 5–7 , and these codes are often used without further review as primary outcomes. Of course, hospitalization data fail to detect out-patient events and out-of-hospital deaths.…”

The organizational structure and governing principles of the Food and Drug Administration's Mini‐Sentinel pilot program

“…When it is necessary to verify that electronic health data accurately identify exposures or outcomes of interest, Data Partners may share information concerning individuals with other health service organizations that have provided services to those individuals. This may involve an insurer identifying relevant plan members and then obtaining medical records (stripped of direct identifiers) from clinics or hospitals to facilitate validation of an exposure or health outcome of interest to the FDA . Data Partners must clearly identify and segregate data received from these outside sources and refrain from using that outside source data for any other purposes.…”

Does fair anonymization exist?

“…12 Frequently, when researchers ask for an anonymized excerpt from a medical treatment database they request a waiver for obtaining informed consent and the ethics board usually gives it to them. In one recent public health study, IRBs (Institutional Review Boards) refused to provide only seven of 153 (4.6%) of the requested medical records and insisted that patient consent was required (Cutrona et al 2012). The author is a member in a regional medical REC (Research Ethics Committee) and his own personal experiences bear this out.…”