Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple Myeloma.

Autor: Murugappan MN; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (U.S. FDA), Silver Spring, MD, USA. Meena.Murugappan@fda.hhs.gov.; Department of Pharmaceutical Care and Health Systems, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA. Meena.Murugappan@fda.hhs.gov.; Oncology Center of Excellence, Food and Drug Administration, Building 22, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Meena.Murugappan@fda.hhs.gov., King-Kallimanis BL; LUNGevity Foundation, Chicago, IL, USA., Bhatnagar V; Oncology Center for Excellence (U.S. FDA), Silver Spring, MD, USA., Kanapuru B; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (U.S. FDA), Silver Spring, MD, USA., Farley JF; Department of Pharmaceutical Care and Health Systems, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA., Seifert RD; Department of Pharmacy Practice and Pharmaceutical Sciences, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA., Stenehjem DD; Department of Pharmacy Practice and Pharmaceutical Sciences, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA., Chen TY; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (U.S. FDA), Silver Spring, MD, USA., Horodniceanu EG; Oncology Center for Excellence (U.S. FDA), Silver Spring, MD, USA., Kluetz PG; Oncology Center for Excellence (U.S. FDA), Silver Spring, MD, USA.
Jazyk: angličtina
Zdroj: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation [Qual Life Res] 2023 Aug; Vol. 32 (8), pp. 2281-2292. Date of Electronic Publication: 2023 Mar 20.
DOI: 10.1007/s11136-023-03390-5
Abstrakt: Purpose: The objective of this retrospective study was to determine the feasibility of measuring frailty using patient responses to relevant EORTC QLQ-C30 items as proxy criteria for the Fried Frailty Phenotype, in a cohort of patients with Relapsed/Refractory Multiple Myeloma (RRMM).
Methods: Data were pooled from nine Phase III randomized clinical trials submitted to the FDA for regulatory review between 2010 and 2021, for the treatment of RRMM. Baseline EORTC QLQ-C30 responses were used to derive a patient-reported frailty phenotype (PRFP), based on the Fried definition of frailty. PRFP was assessed for internal consistency reliability, structural validity, and known groups validity.
Results: This study demonstrated the feasibility of adapting patient responses to relevant EORTC QLQ-C30 items to serve as proxy Fried frailty criteria. Selected items were well correlated with one another and PRFP as a whole demonstrated adequate internal consistency reliability and structural validity. Known groups analysis demonstrated that PRFP could be used to detect distinct comorbidity levels and distinguish between different functional profiles, with frail patients reporting more difficulty in walking about, washing/dressing, and doing usual activities, as compared to their pre-frail and fit counterparts. Among the 4928 patients included in this study, PRFP classified 2729 (55.4%) patients as fit, 1209 (24.5%) as pre-frail, and 990 (20.1%) as frail.
Conclusion: Constructing a frailty scale from existing PRO items commonly collected in cancer trials may be a patient-centric and practical approach to measuring frailty. Additional psychometric evaluation and research is warranted to further explore the utility of such an approach.
(© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
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