Browsing by Author "Henke, Debra M"
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Item Open Access Facets of physical function assessed by patient-reported outcome measures in oncology research.(Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2024-04) Coles, Theresa; Fillipo, Rebecca; Plyler, Kate; Hernandez, Alexy; Henke, Debra M; Arizmendi, Cara; Cantrell, Sarah; Lagoo-Deenadayalan, Sandhya; Rory Goodwin, C; LeBlanc, Thomas W; Horodniceanu, Erica G; Bhatnagar, Vishal; Reeve, Bryce B; Weinfurt, KevinPurpose
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.Item Open Access How do patients interpret and respond to a novel patient-reported eastern cooperative oncology group performance status (ECOG)?(Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2024-06) Fillipo, Rebecca; Leblanc, Thomas W; Plyler, Katelyn E; Arizmendi, Cara; Henke, Debra M; Coles, TheresaPurpose
Performance status is an important concept in oncology, but is typically clinician-reported. Efforts are underway to include patient-reported measures in cancer care, which may improve patient symptoms, quality of life and overall survival. The purpose of this study was to gain a preliminary understanding of how patients determined their physical performance status based on a novel patient-reported version of the Eastern Cooperative Oncology Group Performance Status (ECOG) scale.Methods
We conducted qualitative interviews, including concept elicitation and cognitive interviewing as part of the Patient Reports of Physical Functioning Study (PROPS) to investigate how participants selected their answers to a novel patient-reported ECOG. Participants were administered the patient-reported ECOG and asked to describe devices and modifications used to keep up with daily activities.Results
Participants generally understood the ECOG as intended. Participants with recent changes in status had some difficulty selecting an answer. Most participants used modifications and assistive devices in their daily lives but did not incorporate these into their rational for the ECOG.Conclusion
The potential benefits of a patient-reported ECOG are numerous and this study demonstrates that participants were able to understand and answer the patient-reported ECOG as intended. We recommend future evaluation for the most-appropriate recall period, whether to include modifications in the ECOG instructions, and if increasing the number of response options to the patient-reported ECOG may improve confidence when providing an answer.