A Framework to Promote Implementation of Patient-Reported Outcomes in Institutions Caring for Vulnerable and Underserved Cancer Populations

Anne L R Schuster¹, Norah L Crossnohere², Eric Adjei Boakye³, Rebekah Angove⁴, Billie Baldwin⁵, Esteban A Barreto⁶, Ronald C Chen⁷, Theresa W Gillespie⁸, Betty Hamilton⁹, Nadine Jackson McCleary¹⁰, Maimah Karmo¹¹, Tara Kaufmann¹², William Lee¹³, Vikas Mehta¹⁴, Larissa Meyer¹⁵, Kriti Mittal¹⁶, Leah Owens¹⁷, Rachel Peterson¹⁸, Andrea Pusic¹⁹, Anne Marie Rainey²⁰, Angelique Richardson²¹, Lauren Shapiro²², Bethany Sibbitt²³, Cardinale Smith²⁴, Mary Vargo²⁵, Andrew Vickers²⁶, Michael Brundage²⁷, Claire Snyder²⁸

Affiliations

¹ Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, OH, USA. anne.schuster@osumc.edu.
² Division of General Internal Medicine, Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.
³ Henry Ford Health System, Detroit, MI, USA.
⁴ Patient Advocate Foundation, Hampton, VA, USA.
⁵ MedStar Franklin Square Medical Center, Baltimore, MD, USA.
⁶ Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
⁷ University of Kansas Medical Center, Kansas City, KS, USA.
⁸ Emory University School of Medicine, Atlanta, GA, USA.
⁹ Cleveland Clinic, Cleveland, OH, USA.
¹⁰ Dana-Farber Cancer Institute, Boston, MA, USA.
¹¹ Tiger Lily Foundation, Stone Ridge, VA, USA.
¹² University of Texas at Austin, Austin, TX, USA.
¹³ Carilion Clinic, Roanoke, Virginia, USA.
¹⁴ Montefiore Medical Center, Albert Einstein College of Medicine, New York, NY, USA.
¹⁵ The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁶ University of Massachusetts, Worcester, MA, USA.
¹⁷ Tennessee Oncology, Nashville, TN, USA.
¹⁸ Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁹ Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
²⁰ American Oncology Network, Fort Myers, FL, USA.
²¹ University of California in San Diego, San Diego, CA, USA.
²² University of California-San Francisco, San Francisco, CA, USA.
²³ School of Pharmacy, Cedarville University, Cedarville, OH, USA.
²⁴ Mount Sinai Health System, New York, NY, USA.
²⁵ MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.
²⁶ Memorial Sloan Kettering Cancer Center, New York, NY, USA.
²⁷ Queen's University Cancer Research Institute, Cancer Care and Epidemiology, Kingston, ON, Canada.
²⁸ Departments of Medicine, Oncology, and Health Policy and Management, Johns Hopkins Schools of Medicine and Public Health, Baltimore, MD, USA.

PMID: 38909128
PMCID: PMC12160071 (available on 2026-01-01)
DOI: 10.1007/s40271-024-00703-9

A Framework to Promote Implementation of Patient-Reported Outcomes in Institutions Caring for Vulnerable and Underserved Cancer Populations

Anne L R Schuster et al. Patient. 2025 Jan.

. 2025 Jan;18(1):89-95.

doi: 10.1007/s40271-024-00703-9. Epub 2024 Jun 22.

Authors

Affiliations

¹ Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, OH, USA. anne.schuster@osumc.edu.
² Division of General Internal Medicine, Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.
³ Henry Ford Health System, Detroit, MI, USA.
⁴ Patient Advocate Foundation, Hampton, VA, USA.
⁵ MedStar Franklin Square Medical Center, Baltimore, MD, USA.
⁶ Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
⁷ University of Kansas Medical Center, Kansas City, KS, USA.
⁸ Emory University School of Medicine, Atlanta, GA, USA.
⁹ Cleveland Clinic, Cleveland, OH, USA.
¹⁰ Dana-Farber Cancer Institute, Boston, MA, USA.
¹¹ Tiger Lily Foundation, Stone Ridge, VA, USA.
¹² University of Texas at Austin, Austin, TX, USA.
¹³ Carilion Clinic, Roanoke, Virginia, USA.
¹⁴ Montefiore Medical Center, Albert Einstein College of Medicine, New York, NY, USA.
¹⁵ The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁶ University of Massachusetts, Worcester, MA, USA.
¹⁷ Tennessee Oncology, Nashville, TN, USA.
¹⁸ Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁹ Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
²⁰ American Oncology Network, Fort Myers, FL, USA.
²¹ University of California in San Diego, San Diego, CA, USA.
²² University of California-San Francisco, San Francisco, CA, USA.
²³ School of Pharmacy, Cedarville University, Cedarville, OH, USA.
²⁴ Mount Sinai Health System, New York, NY, USA.
²⁵ MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.
²⁶ Memorial Sloan Kettering Cancer Center, New York, NY, USA.
²⁷ Queen's University Cancer Research Institute, Cancer Care and Epidemiology, Kingston, ON, Canada.
²⁸ Departments of Medicine, Oncology, and Health Policy and Management, Johns Hopkins Schools of Medicine and Public Health, Baltimore, MD, USA.

PMID: 38909128
PMCID: PMC12160071 (available on 2026-01-01)
DOI: 10.1007/s40271-024-00703-9

No abstract available

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Conflict of interest statement

Declarations. Conflict of Interest: Dr. Snyder is currently or has previously received research funding through her institution from Genentech and Pfizer, and consulting fees from Shionogi and Janssen. Dr. Brundage is currently or has previously received research funding through his institution from Genentech and Pfizer. Dr. Schuster receives research funding through her institution from Pfizer. Dr. Crossnohere is currently or has previously received research funding through herinstitution from Genentech and Pfizer, and receives unrelated consulting support from Boehringer Ingelheim. Dr. Hamilton has consulting (ad hoc advisory board) fees from Incyte and Sanofi; she is on the data safety monitoring board for Angiocrine, and Adjudication committee for CSL Behring. Dr. Meyer has research funding from Merck and AstraZeneca. Dr. Mittal has received grant funding from Pfizer, has served in consulting/advisory board role for Bayer, Aveo, Dendreon, Myovant, Fletcher, Curio Science, Janssen, Dedham Group, Astra Zeneca, and has received honoraria from IntrinsiQ, Targeted oncology, Medpage, Aptitude Health, Cardinal Health; none of these activities are related to material in the commentary. Ms. Rainey sits on the board for both the Community Oncology Alliance (COA) and the Association for Community Cancers Centers (ACCC). Dr. Smith reports honoraria from GSK and serves on the advisory board for Elevance Health. Ms. Baldwin and Ms. Owens have no conflicts of interest to disclose. Drs. Adjei Boakye, Angove, Gillespie, Jackson McCleary, Mittal, Kaufmann, Lee, Mehta, Peterson, Richardson, Shapiro, Sibbitt, Vargo, Vickers, have no conflicts of interest to disclose. Data availability: The data supporting the findings of this work are available within the article.

References

1. FDA 2020. Clinical Outcome Assessment (COA): Frequently Asked Questions. Available at: https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently.... Last accessed: February 8, 2022.
1. Haywood KL, de Wit M, Staniszewska S, Morel T, Salek S. Chapter 9 (Part II) Developing Patient-Reported and Relevant Outcome Measures. In: Facey K, Hansen HP, Single ANV (eds). Patient Involvement in Health Technology Assessment. Adis Springer Nature. 2017. DOI 10.1007/978-981-10-4068-9. - DOI
1. FDA. Guidance for industry. Patient-reported outcomes measures: use in medical product development to support labeling claims. 2009: 65132–65133. - PMC - PubMed
1. Acquadro C, Berzon R, Dubois D et al. Incorporating the patient’s perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value in Health 2003; 6 (5): 522–531. - PubMed
1. Greenhalgh J The applications of PROs in clinical practice: what are they, do they work, and why? Quality of Life Research 2009; 18 (1): 115–123. - PubMed

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A Framework to Promote Implementation of Patient-Reported Outcomes in Institutions Caring for Vulnerable and Underserved Cancer Populations

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A Framework to Promote Implementation of Patient-Reported Outcomes in Institutions Caring for Vulnerable and Underserved Cancer Populations

Authors

Affiliations

Conflict of interest statement

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