Immunotherapies have improved cancer outcomes, but have a unique profile of immune-related adverse events (irAEs). Biorepositories have been established to collect data and samples to help improve our understanding of irAEs, however identifying patients who are eligible for these biorepositories in a timely fashion can be challenging. The goal of this study is to determine if an informatics system for automated irAE detection can improve registration to a prospective irAE biorepository (NCT04242095). The informatics system automatically "reads" participants' electronic health records (EHRs) and determines whether that patient may be experiencing an irAE. The main questions it aims to answer are:
* Is it feasible to implement an informatics system for daily analysis of EHR data to detect irAEs? * Does the automated irAE detection system improve registration rates to an irAE biorepository at our institution following an eligible irAE?
Researchers will compare standard irAE monitoring to informatics-assisted irAE monitoring to see if using the informatics system increases the registration rate and improves data entry efficiency and quality.
Participants will:
* Be randomly assigned to standard monitoring or informatics-assisted monitoring for irAE detection. * Have their EHR reviewed to collect demographic, medical, and cancer treatment history. * Be monitored for irAEs through daily automated analysis of their EHR data for up to 12 months or until registration in the biorepository.
Received or receiving a regimen containing one or more immuno-oncology therapeutics
None
Parallel
Informatics system for eligibility monitoring
Other interventionA daily automated data query of eligible subjects will collect EHR data, and our informatics system will be run on these data behind our institution's secure firewall. The daily list of subjects identified by the informatics system as having a new irAE will be accessed by the Alliance irAE biorespository study team at Dana-Farber/Brigham Cancer Center for review.
Standard eligibility monitoring
Other interventionReporting of an eligible event to the biorepository study staff by the treating clinician and EHR review by the study staff.
Feasibility
Feasibility is defined as successfully connecting the informatics system to subjects' relevant EHR data, carrying out inferencing on the records, and reporting newly identified automatically extracted irAEs in a tabular format daily for a minimum of 1 week. Feasibility is defined at the patient-level.
Registration
Registration rate is the proportion of subjects who are registered onto a prospective irAE biopository at Dana Farber/Brigham Cancer Center. Patients are eligible for biorepository registration within 96 hours of a severe (grade 3-4) irAE.
Time to data entry
Time to data entry is defined as the time from first evidence of an irAE in the EHR until the data is first entered into the irAE biorespository clinical data management system.
irAE capture rate
irAE capture rate is defined as the proportion of subjects who experienced a severe irAE that were registered onto the prospective irAE biorepository. The occurrence of a severe irAE will be determined by dual expert clinician review of the EHR of enrolled patients.
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Brigham and Women's Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
