Harmonized Outcome Measures for Use in Non–Small Cell Lung Cancer Patient Registries and Clinical Practice

Authors:
Martin J. Edelman Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania;

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Daniel P. Raymond Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio;

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Dwight H. Owen Division of Medical Oncology, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio;

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Michelle B. Leavy OM1, Inc, Boston, Massachusetts;

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Kari Chansky Cancer Research and Biostatistics, Seattle, Washington;

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Sriram Yennu Department of Palliative Care, Rehabilitation, & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas;

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Felix G. Fernandez Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia;

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Carolyn J. Presley Division of Medical Oncology, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio;

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Tithi Biswas Department of Radiation Oncology, Case Western Reserve University, University Hospitals Seidman Cancer Center, Cleveland, Ohio;

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Gwendolyn P. Quinn Department of Population Health, New York University School of Medicine, New York, New York;

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Matthew B. Schabath Department of Cancer Epidemiology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida;

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Seth Sheffler-Collins American Association for Cancer Research, Philadelphia, Pennsylvania; and

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Laura Chu Product Development, Personalized Healthcare Data Science, Genentech, Inc, South San Francisco, California.

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Richard E. Gliklich OM1, Inc, Boston, Massachusetts;

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Volume/Issue:
Volume 19: Issue 13
Online Publication Date:
13 Aug 2021
DOI:
https://doi.org/10.6004/jnccn.2021.7021
Restricted access

Background: Lung cancer is the leading cause of cancer-related death in the United States and globally, and many questions exist about treatment options. Harmonizing data across registries and other data collection efforts would yield a robust data infrastructure to help address many research questions. The purpose of this project was to develop a minimum set of patient and clinician relevant harmonized outcome measures that can be collected in non–small cell lung cancer (NSCLC) patient registries and clinical practice. Methods: Seventeen lung cancer registries and related efforts were identified and invited to submit outcome measures. Representatives from medical specialty societies, government agencies, health systems, health information technology groups, patient advocacy organizations, and industry formed a stakeholder panel to categorize the measures and harmonize definitions using the Agency for Healthcare Research and Quality’s supported Outcome Measures Framework (OMF). Results: The panel reviewed 66 outcome measures and identified a minimum set of 8 broadly relevant measures in the OMF categories of patient survival, clinical response, events of interest, and resource utilization. The panel harmonized definitions for the 8 measures through in-person and virtual meetings. The panel did not reach consensus on 1 specific validated instrument for capturing patient-reported outcomes. The minimum set of harmonized outcome measures is broadly relevant to clinicians and patients and feasible to capture across NSCLC disease stages and treatment pathways. A pilot test of these measures would be useful to document the burden and value of the measures for research and in clinical practice. Conclusions: By collecting the harmonized measures consistently, registries and other data collection systems could contribute to the development research infrastructure and learning health systems to support new research and improve patient outcomes.

Submitted August 24, 2020; final revision received January 8, 2021; accepted for publication January 28, 2021.

Published online August 13, 2021.

Author contributions: Study concept and design: All authors. Data acquisition: All authors. Data analysis and interpretation: All authors. Manuscript preparation: Leavy, Gliklich. Critical revision: All authors.

Disclosures: Dr. Owen has disclosed receiving consulting fees from L&M Policy Research and theMednet; serving on an advisory board for AstraZeneca; and receiving institutional research support from Bristol-Myers Squibb, Merck, Palobiofarma, Genentech, and AbbVie. Ms. Leavy and Dr. Gliklich have disclosed being employed by and stockholders of OM1, which has received funding from the Agency for Healthcare Research and Quality for this work. Dr. Presley has disclosed being a Paul Calabresi Scholar supported by the OSU K12 Training Grant for Clinical Faculty Investigators (5 K12 CA133250–09). Mr. Sheffler-Collins has disclosed being employed by AACR, which receives funding from Amgen, AstraZeneca, Boehringer Ingelheim, Pfizer, Merck, Novartis, Genentech, H3 Biomedicine, and Janssen to support Project GENIE. Ms. Chu has disclosed being an employee of Genentech/Roche and owning stock in Roche. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Funding: This project was funded under Contract HHSA290201400004C from the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services (HHS). The authors of this manuscript are responsible for its content. Statements in the manuscript do not necessarily represent the official views of or imply endorsement by AHRQ or HHS. This work was supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund under Interagency Agreement #16-566R-16.

Correspondence: Michelle B. Leavy, MPH, OM1, Inc., 800 Boylston Street, Suite 1410, Boston, MA 02199. Email: mleavy@om1.com

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Print ISSN:
1540-1405
Online ISSN:
1540-1413
Publisher:
National Comprehensive Cancer Network
Cover Journal of the National Comprehensive Cancer Network
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Copyright:
Copyright © 2021 by the National Comprehensive Cancer Network 2021
Page Numbers:
8
Article Category:
Research Article
Received:
24 Aug 2020
Accepted:
28 Jan 2021
Print Publication Date:
01 Dec 2021
Online Publication Date:
13 Aug 2021

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