(B-213) Integrating the Patient Perspective Within Real-World Evidence: A Case Study Linking Routinely Collected Patient-Reported Outcomes and Electronic Health Records from Mass General Brigham Healthcare System

Background: Regulators and reimbursement bodies recognize the importance of integrating patient perspectives into assessments of novel therapies. Traditionally, patient-centric evidence is generated from clinical trials or prospective data collection, which are often limited by low consent rates, small sample sizes, and limited generalizability. Integrating Patient Reported Outcomes Measures (PROMs), which capture self-reported symptoms, quality of life, and functional status, into routine healthcare offers new opportunities to combine patient centric and clinical data to augment understanding of real-world health outcomes.

Objectives: To assess how routinely collected PROMs linked to electronic health records (EHR) data may enhance understanding of the holistic burden of disease and therapeutic decision-making through an ovarian cancer case study.

Methods: EHR data from the Mass General Brigham (MGB) Research Patient Data Registry were linked with MGB PROMs data, which includes patient-reported quality of life instruments systematically deployed to patients of participating specialty departments to improve quality of care by incorporating patient experience into clinical decision-making. Adult patients with ovarian cancer initiating a novel therapy after July 1, 2018, were identified in the EHR data. Patients were followed from therapy initiation (index date) until the earliest of death, loss to follow up, or end of data availability. The availability and completeness of five PROMs of interest (two EORTC and three PROMIS instruments) were assessed pre- and post-index.

Results: Among 264 ovarian cancer patients starting a novel therapy identified in the EHR, 60% had at least one PROM of interest. PROMs were available for 48% of patients pre-index and 44% post-index, with an annualized average of 9.5 PROMs per person (SD 14.2) during follow-up. The average interval between PROMs was 3 months. One-third (33%) of patients had PROMs both pre- and post-index. The frequency of PROMs capture was higher when deployed as part of a series post-surgery.

Conclusions: Over half of the ovarian cancer patients had at least one PROM of interest, highlighting the feasibility of leveraging PROMs to assess holistic disease burden. A subset of patients had frequent, sequential measures, demonstrating the potential to efficiently generate longitudinal patient-reported data linked to clinical data. Understanding the clinical context for PROMs collection is essential for accurate data interpretation. Increased use of PROMs in usual care, linking these measures to routinely collected healthcare data, offers significant potential to enrich our understanding of the patient experience in relation to clinical decisions.