Development and evaluation of a scalable alternative to chart review for phenotype case adjudication using standardized structured data from electronic health records

Objective Chart review as the current gold standard for phenotype evaluation cannot support observational research at scale. It is expensive, time-consuming, and variable. We aimed to evaluate the ability of structured data to support efficient patient status ascertainment and develop a standardized and scalable alternative to chart review. Methods We developed Knowledge-Enhanced Electronic Patient Profile Review system (KEEPER) that extracts a patient’s structured data elements relevant to a given phenotype and presents them in a standardized fashion that follows clinical reasoning principles. We evaluated its performance compared to manual chart review for four conditions (diabetes type I, acute appendicitis, end stage renal disease and chronic obstructive lung disease) using randomized two-period, two-sequence crossover design. Inter-method agreement, inter-rater agreement, accuracy, and review duration were measured. Results Ascertaining patient status with KEEPER was twice as fast compared to manual chart review. 88.1% of the patients were classified concordantly using full chart and KEEPER, but agreement varied depending on the condition. Pairs of clinicians agreed in classification of patient status in 91.2% of the cases when using KEEPER compared to 76.3% when using full chart. Patient classification aligned with the gold standard in 88.1% and 86.9% of the cases respectively. Conclusion This proof-of-concept study demonstrated that structured data can be used for efficient patient ascertainment if are limited to only relevant subset and organized according to the clinical reasoning principles. A system that implements these principles can achieve similar accuracy and higher inter-rater reliability compared to chart review at a fraction of time. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by the US National Institutes of Health grant R01 LM006910. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: We obtained an approval to conduct this research from the Columbia University Medical Center institutional review board (IRB-AAAS6414). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The data used in this study are protected health information and are not available