In addition, the harvest process fails to adequately incorporate an agreed upon adverse event terminology, and many hospital systems are reluctant to release this protected information even in a blinded fashion. What these data collection agencies can excel at is the amassing of enormous amounts of numeric data elements such as vital signs, drug usage, and dosage (including inhaled anesthesia concentrations) and demographic elements such as age at surgery and sex, lengths of stay, and certain very specific care elements that are documented discretely.2 The recent publication “Reference Values for Noninvasive Blood Pressure in Children During Anesthesia: A Multicentered Retrospective Observational Cohort Study” by de Graaff et al3 is an excellent example of using “big data” harvesting to analyze these discrete data without the bias of relying upon human-based administrative procedural coding that most frequently occurs post hoc by nonclinical personnel abstracting information from clinical records for the purposes of hospital billing.
Another element you raise is the sharing of data and outcomes across multiple institutions. Assuming hospital systems have a business agreement and are on the same EMR platform (such as EPIC), it is sometimes possible for there to be a seamless transmission of data from one institution to another, but in practice, this has proved to be less than ideal and to date there is no way for competing EMR platforms such as EPIC and Cerner to communicate effectively. In addition, there has been a reluctance on the part of EMR platforms and some medical registries to directly communicate data because of concerns about data integrity and accuracy in the medical records being transmitted without any sort of auditing of the data for clinical accuracy.
The authors wholeheartedly agree with your suggestion of revisiting the “Common Rule” regulations to allow for better long-term outcome assessment, particularly in a field such as congenital cardiac disease where outcomes are properly measured across decades and multiple institutions.