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

dc.contributor.author

Coles, Theresa

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Fillipo, Rebecca

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Plyler, Kate

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Hernandez, Alexy

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Henke, Debra M

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Arizmendi, Cara

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Cantrell, Sarah

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Lagoo-Deenadayalan, Sandhya

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Rory Goodwin, C

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LeBlanc, Thomas W

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Horodniceanu, Erica G

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Bhatnagar, Vishal

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Reeve, Bryce B

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Weinfurt, Kevin

dc.date.accessioned

2024-05-29T17:35:57Z

dc.date.available

2024-05-29T17:35:57Z

dc.date.issued

2024-04

dc.description.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.
dc.identifier

10.1007/s11136-024-03640-0

dc.identifier.issn

0962-9343

dc.identifier.issn

1573-2649

dc.identifier.uri

https://hdl.handle.net/10161/30744

dc.language

eng

dc.publisher

Springer Science and Business Media LLC

dc.relation.ispartof

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

dc.relation.isversionof

10.1007/s11136-024-03640-0

dc.rights.uri

https://creativecommons.org/licenses/by-nc/4.0

dc.subject

Cancer

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Delphi panel

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Patient-reported outcomes

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Physical function

dc.title

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

dc.type

Journal article

duke.contributor.orcid

Coles, Theresa|0000-0003-2941-8999

duke.contributor.orcid

Fillipo, Rebecca|0000-0003-1467-7971

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Cantrell, Sarah|0000-0003-2694-7836

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LeBlanc, Thomas W|0000-0002-0546-7895

duke.contributor.orcid

Reeve, Bryce B|0000-0002-6709-8714

duke.contributor.orcid

Weinfurt, Kevin|0000-0002-0624-7448

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Duke

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School of Medicine

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Trinity College of Arts & Sciences

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Pediatrics

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Psychiatry & Behavioral Sciences

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Radiation Oncology

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Duke Cancer Institute

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Psychology & Neuroscience

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Duke Clinical Research Institute

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