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

Affiliations

¹ 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.
² Department of Pharmaceutical Care and Health Systems, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA. Meena.Murugappan@fda.hhs.gov.
³ Oncology Center of Excellence, Food and Drug Administration, Building 22, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Meena.Murugappan@fda.hhs.gov.
⁴ LUNGevity Foundation, Chicago, IL, USA.
⁵ Oncology Center for Excellence (U.S. FDA), Silver Spring, MD, USA.
⁶ Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (U.S. FDA), Silver Spring, MD, USA.
⁷ Department of Pharmaceutical Care and Health Systems, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA.
⁸ Department of Pharmacy Practice and Pharmaceutical Sciences, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA.
⁹ Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (U.S. FDA), Silver Spring, MD, USA.

PMID: 36935467
PMCID: PMC10025057
DOI: 10.1007/s11136-023-03390-5

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

Meena N Murugappan et al. Qual Life Res. 2023 Aug.

. 2023 Aug;32(8):2281-2292.

doi: 10.1007/s11136-023-03390-5. Epub 2023 Mar 20.

Authors

Affiliations

¹ 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.
² Department of Pharmaceutical Care and Health Systems, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA. Meena.Murugappan@fda.hhs.gov.
³ Oncology Center of Excellence, Food and Drug Administration, Building 22, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Meena.Murugappan@fda.hhs.gov.
⁴ LUNGevity Foundation, Chicago, IL, USA.
⁵ Oncology Center for Excellence (U.S. FDA), Silver Spring, MD, USA.
⁶ Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (U.S. FDA), Silver Spring, MD, USA.
⁷ Department of Pharmaceutical Care and Health Systems, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA.
⁸ Department of Pharmacy Practice and Pharmaceutical Sciences, University of Minnesota - College of Pharmacy, Minneapolis, MN, USA.
⁹ Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (U.S. FDA), Silver Spring, MD, USA.

PMID: 36935467
PMCID: PMC10025057
DOI: 10.1007/s11136-023-03390-5

Abstract

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.

Keywords: Frailty; Geriatric oncology; Multiple myeloma; Patient-reported outcomes.

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Conflict of interest statement

All authors declare that they have no conflicts of interest to disclose.

Figures

**Fig. 1**
Confirmatory Factor Analysis Results for the Patient-Reported Frailty Phenotype (PRFP). The values in-between the arrows from Frailty to each item are the standardized regression coefficients or ‘factor loadings’, an indicator of the strength of the relationship between an item and the underlying construct (frailty). R² values are displayed to the left of each item box, representing the variance of each item explained by frailty. R² values > 0.5 are generally preferred [46]. Coefficients adjacent to the error circles on the right represent variance in each item explained by factors other than frailty. It is generally desirable to have more of the variance in each item explained by the construct of interest (in this case frailty) rather than by error/ factors other than frailty

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

LinkOut - more resources

Full Text Sources

Medical