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A Study Design to Harmonize Patient-Reported Outcomes Across Data Sets

Authors :
Brittany A. McKelvey
Alexandra Berk
Lynda Chin
Stacie Hudgens
Ian Kudel
Ronan C. O'Hagan
Amila Patel
Julie Scott
Hillary Stires
Sam Wang
Debra Wujcik
Mark Stewart
Jeff Allen
Source :
JCO Clinical Cancer Informatics.
Publication Year :
2023
Publisher :
American Society of Clinical Oncology (ASCO), 2023.

Abstract

PURPOSE Using patient-reported outcomes (PROs) provides important insights from the patient's perspective and can be valuable to monitor and manage treatment-related adverse events during cancer treatment. Additionally, the digital administration of PROs (electronic PROs [ePROs]) provides real-time updates to clinical care teams on treatment-related symptoms in-between clinic visits. However, given the variability in the methodology and timing of the data collection, using and harmonizing these data across different systems remains challenging. Identifying data elements to capture and operating procedures for harmonization across ePRO tools will expedite efforts to generate relevant and robust data on use of ePRO data in clinical care. METHODS Friends of Cancer Research assembled a consortium of project partners from key health care sectors to align on a framework for ePRO data capture across ePRO tools and assessment of the impact of ePRO data capture on patient outcomes. RESULTS We identified challenges and opportunities to align ePRO data capture across ePRO tools and aligned on key data elements for assessing the impact of ePRO data capture on patient care and outcomes. Ultimately, we proposed a study protocol to leverage ePRO data for symptom and adverse event management to measure real-world effectiveness of ePRO tool implementation on patient care and outcomes. CONCLUSION This work provides considerations for harmonizing ePRO data sets and a common framework to align across multiple ePRO tools to assess the value of ePROs for improving patient outcomes. Future efforts to interpret evidence and evaluate the impact of ePRO tools on patient outcomes will be aided by improved alignment across studies.

Subjects

Subjects :
General Medicine

Details

ISSN :
24734276
Database :
OpenAIRE
Journal :
JCO Clinical Cancer Informatics
Accession number :
edsair.doi...........e16307ceaaf53ed8d7a23de541901e67