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Facets of physical function assessed by patient-reported outcome measures in oncology research

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Abstract

Purpose

The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure.

Methods

As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a “card sort” activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item.

Results

The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation.

Conclusion

Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials.

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Data availability

Due to the small sample sizes included in qualitative studies, sharing transcripts or other data could identify an individual. Therefore, these data are not publicly available.

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Acknowledgements

We would like to extend our gratitude to the panel members who generously shared their valuable insights and expertise. Their contributions have been instrumental in the evolution of how we understand the measurement of physical function, and we are deeply grateful for their time and effort in engaging in meaningful discussions. Panel members included Claudio Battaglini, Vishal Bhatnagar, Nicki Bush, Alicyn Campbell, Cynthia Chauhan, Lori Denison, Amylou Dueck, Shana Harrington, Roxanne Jensen, Hanna Sanoff, and Siva Sundaresan. The authors would also like to acknowledge Liz Wing for editorial support.

Funding

This work was supported by the U.S. Food & Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) (Contract 75F40120C00069). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

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Authors and Affiliations

  1. Center for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St., Durham, NC, 27701, USA

    Theresa Coles, Rebecca Fillipo, Kate Plyler, Alexy Hernandez, Debra M. Henke, Cara Arizmendi, Bryce B. Reeve & Kevin Weinfurt

  2. AstraZeneca, Evinova, Durham, NC, USA

    Cara Arizmendi

  3. Medical Center Library, Duke University School of Medicine, Durham, NC, USA

    Sarah Cantrell

  4. Department of Surgery, Duke University School of Medicine, Durham, NC, USA

    Sandhya Lagoo-Deenadayalan

  5. Department of Neurosurgery, Duke University School of Medicine, Durham, NC, USA

    C. Rory Goodwin

  6. Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University School of Medicine, Durham, NC, USA

    Thomas W. LeBlanc

  7. Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Washington D.C., MD, USA

    Erica G. Horodniceanu & Vishal Bhatnagar

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  1. Theresa Coles
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Contributions

TC contributed to conceptualization, funding acquisition, methodology, interpretation of results, and writing of the original draft. RF, KP, AH, and DH contributed to data collection, analysis, interpretation of results, and writing, reviewing and editing of the manuscript. CA and SC: data collection and writing, reviewing, and editing of the manuscript. SL-D, RG, TL, VB, and EH contributed to interpretation of results and writing, reviewing, and editing of the manuscript. BR contributed to methodology, interpretation of results, and writing, reviewing, and editing of the manuscript. KW contributed to conceptualization, methodology, interpretation of results, and writing, reviewing, and editing of the manuscript.

Corresponding author

Correspondence to Theresa Coles.

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Conflicts of Interest

TC has research funding from Merck and Pfizer, a prior consulting agreement with Regenxbio and received a speaking honorarium from ISPOR. CA was a fellow at Duke (2021–2023) funded by AstraZeneca and is now an employee at AstraZeneca (2023-present).CRG is a consultant for Stryker and Medtronic. BBR had a consulting role with Novartis. TWL has received honoraria for consulting/advisory boards from AbbVie, Agilix, Agios/Servier, Apellis, Astellas, AstraZeneca, BlueNote, BMS/Celgene, Genentech, GSK, Lilly, Meter Health, Novartis, and Pfizer; speaking related honoraria from AbbVie, Agios, Astellas, BMS/Celgene, Incyte, and Rigel; equity interest in Dosentrx (stock options in a privately-held company); royalties from UpToDate; research funding from the AbbVie, American Cancer Society, AstraZeneca, BMS, Deverra Therapeutics, Duke University, GSK, Jazz Pharmaceuticals, and Seattle Genetics. TWL is a Scholar in Clinical Research of the Leukemia & Lymphoma Society. All other authors have no disclosures.

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Coles, T., Fillipo, R., Plyler, K. et al. Facets of physical function assessed by patient-reported outcome measures in oncology research. Qual Life Res (2024). https://doi.org/10.1007/s11136-024-03640-0

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