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Electronic Patient-Reported Data Capture as a Foundation of Rapid Learning Cancer Care

Abernethy, Amy P. MD*†; Ahmad, Asif MS, MBA; Zafar, S. Yousuf MD, MHS*†; Wheeler, Jane L. MSPH*; Reese, Jennifer Barsky PhD§; Lyerly, H. Kim MD†¶

doi: 10.1097/MLR.0b013e3181db53a4
Comparative Effectiveness

Background: “Rapid learning healthcare” presents a new infrastructure to support comparative effectiveness research. By leveraging heterogeneous datasets (eg, clinical, administrative, genomic, registry, and research), health information technology, and sophisticated iterative analyses, rapid learning healthcare provides a real-time framework in which clinical studies can evaluate the relative impact of therapeutic approaches on a diverse array of measures.

Purpose: This article describes an effort, at 1 academic medical center, to demonstrate what rapid learning healthcare might look like in operation. The article describes the process of developing and testing the components of this new model of integrated clinical/research function, with the pilot site being an academic oncology clinic and with electronic patient-reported outcomes (ePROs) being the foundational dataset.

Research Design: Steps included: feasibility study of the ePRO system; validation study of ePRO collection across 3 cancers; linking ePRO and other datasets; implementation; stakeholder alignment and buy in, and; demonstration through use cases.

Subjects: Two use cases are presented; participants were metastatic breast cancer (n = 65) and gastrointestinal cancer (n = 113) patients at 2 academic medical centers.

Results: (1) Patient-reported symptom data were collected with tablet computers; patients with breast and gastrointestinal cancer indicated high levels of sexual distress, which prompted multidisciplinary response, design of an intervention, and successful application for funding to study the intervention's impact. (2) The system evaluated the longitudinal impact of a psychosocial care program provided to patients with breast cancer. Participants used tablet computers to complete PRO surveys; data indicated significant impact on psychosocial outcomes, notably distress and despair, despite advanced disease. Results return to the clinic, allowing iterative update and evaluation.

Conclusions: An ePRO-based rapid learning cancer clinic is feasible, providing real-time research-quality data to support comparative effectiveness research.

From the *Division of Medical Oncology, Department of Medicine; †Duke Comprehensive Cancer Center; and ‡Department of Medicine, Duke University Health System, Duke University Medical Center (DUMC), Durham, NC; §Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD; and ¶Department of Surgery, Duke University Medical Center (DUMC), Durham, NC.

This project did not have specific funding, but is built from various funded elements. Development of the electronic patient reported outcomes data collection system was funded through an Outcomes Research service agreement with Pfizer, Inc., to evaluate whether e/Tablets are an acceptable and reliable method of patient-reported data collection in the academic oncology setting; Pfizer does not have access to individual data. Computer hardware was funded by Supportive Oncology Services (SOS), Inc. and subsequently by Duke University Hospital and Duke University Health System (DUHS). The wireless system, some programming, and technical support was funded by DUHS. Research pilot studies were funded by the Duke Comprehensive Cancer Center and Duke Cancer Care Research Program. Clinic physicians are paid through DUHS and the Duke Private Diagnostic Clinic, LLC. The sexual intervention study is funded by the American Cancer Society.

Reprints: Amy P. Abernethy, MD, Duke University Medical Center, Box 3436, Durham, NC 27710. E-mail:

© 2010 Lippincott Williams & Wilkins, Inc.