Facets of physical function assessed by patient-reported outcome measures in oncology research.
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2024-04
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Abstract
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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.Type
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Coles, Theresa, Rebecca Fillipo, Kate Plyler, Alexy Hernandez, Debra M Henke, Cara Arizmendi, Sarah Cantrell, Sandhya Lagoo-Deenadayalan, et al. (2024). 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. 10.1007/s11136-024-03640-0 Retrieved from https://hdl.handle.net/10161/30744.
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Scholars@Duke
Theresa Marie Coles
Theresa Coles, Ph.D., is a health outcomes methodologist with a focus on measuring and evaluating patient-reported outcomes (PROs) and other clinical outcomes assessments (COAs), integrating PRO measures in clinical care, and improving interpretation of patient-centered outcome scores for use in healthcare delivery and clinical research settings to inform decision making.
My research program is comprised of 3 pillars:
- Enhance the assessment of physical function and related concepts to inform decision-making
- Improve interpretability of PRO scores
- Design and implement screeners to improve patient-centered care by measuring what matters
Rebecca Fillipo
Sarah Cantrell
Sarah Cantrell (she/her/hers) is the Associate Director for Research & Education at the Medical Center Library & Archives, and is responsible for developing, implementing, and evaluating the Library's research and education programs. She is also the liaison to the Graduate Medical Education programs. Sarah is currently on the steering committee of the Evidence-Based Practice for Health Sciences Librarians workshop, and co-director of the Evidence-Based Practice for the Medical Librarian course at the University of North Carolina at Chapel Hill School of Information and Library Science. Sarah served as a Co-Director of Duke's national Evidence-Based Practice (EBP) workshop for clinicians and librarians from 2019 to 2024. Before joining Duke, she worked at Walter Reed National Military Medical Center in Bethesda, MD, where she established a Clinical Librarian Program and joined inpatient care teams for teaching rounds, providing real-time evidence-based decision support and teaching at the point of care. Prior to WRNMMC, she was the Education Services Coordinator and Instruction Librarian at Georgetown University Medical Center's Dahlgren Memorial Library in Washington, DC.
- MLIS, Library & Information Studies, University of Wisconsin Madison
- BA, English Literature, University of Wisconsin Madison
Sandhya Anand Lagoo-Deenadayalan
Thomas William LeBlanc
I am a medical oncologist, palliative care physician, and patient experience researcher, and serve as Chief Patient Experience and Safety Officer for the Duke Cancer Institute, as well as the Director of Outcomes Research in the Division of Hematologic Malignancies and Cellular Therapy. My clinical practice focuses on the care of patients with hematologic malignancies, with a particular emphasis on myeloid conditions and acute leukemias including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPNs / MPDs, CML, PV, ET, MF), as well as rarer and related diseases like BPDCN.
As founding Director of the Duke Cancer Patient Experience Research Program (CPEP), my research investigates common issues faced by people with cancer, including issues of symptom burden, quality of life, psychological distress, prognostic understanding, and treatment decision-making. This work aims to improve patients' experiences living with serious illnesses like blood cancers, including the integration of specialist palliative care services to provide an extra layer of support along with their comprehensive cancer care. More broadly, our team in CPEP conducts various studies of patient experience and outcomes issues in oncology, including retrospective chart review studies, comparative effectiveness work, prospective observational studies and registries, and qualitative research, along with efforts to facilitate the integration of patient-generated health data (PGHD) into routine cancer care processes, such as with electronic patient-reported outcome measures (ePROs) and other mobile health interventions (mHealth). Our team has conducted and participated in several pivotal clinical trials of palliative care integration into cancer care, including among patients with AML, those undergoing stem cell transplantation, and those receiving treatment for advanced lung cancer.
This work has led to recognition as an "Inspirational Leader under 40" by the American Academy of Hospice and Palliative Medicine (AAHPM), "Fellow" status from the Academy in 2016, the 2018 international "Clinical Impact Award" from the European Association for Palliative Care, and the AAHPM "Early Career Investigator" award in 2020. I served as 2017-18 Chair of the ASCO Ethics Committee, and Chaired the Scientific Review Committee of the NIH/NINR-funded Palliative Care Research Cooperative Group through June 2023 (PCRC; www.palliativecareresearch.org). I have served on various national guideline panels for AML and for palliative/supportive care issues in oncology, and was inducted as a Fellow of the American Society of Clinical Oncology (FASCO) in 2021, then served as the Chair of the Education Program of the ASCO 2024 annual meeting. To date I have published over 240 Medline-indexed articles, and several chapters in prominent textbooks of oncology and palliative medicine.
Kevin Phillip Weinfurt
Kevin P. Weinfurt, PhD, is Professor and Vice Chair of Faculty in the Department of Population Health Sciences at Duke University Medical Center and a faculty member of the Duke Clinical Research Institute. He holds secondary appointment as a Professor of Psychology and Neuroscience, Professor of Psychiatry and Behavioral Sciences, Professor of Biostatistics and Bioinformatics, and a Faculty Associate of the Trent Center for Bioethics, Humanities & History of Medicine. Dr. Weinfurt also co-directs the Center for Health Measurement at Duke and is co-director of the Clinical Research Training Program (Masters degree offered through the School of Medicine). Dr. Weinfurt worked as a Special Governmental Employee for the U.S. Food and Drug Administration for four years, helping to create the Patient-Focused Drug Development guidance series. He is also a member of the Secretary's Advisory Committee for Human Research Protections.
Dr. Weinfurt conducts research on measuring patient-reported outcomes, medical decision making, and bioethics. In addition to conducting research, Dr. Weinfurt has taught undergraduate courses in introductory psychology, judgment and decision making, and the psychology of medical decision making; and graduate courses in multivariate statistics, patient-reported outcomes, and research ethics.
Areas of Expertise: Bioethics, Health Measurement, Health Services Research, and Health Behavior
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