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

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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.

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Data availability

Data are not available due to legal restrictions which prevent the U.S. Food and Drug Administration from sharing sponsor-submitted data with third parties. Custom code generated using R programming software for statistical analyses in this manuscript can be shared upon request.

Abbreviations

EORTC QLQ-C30:

European Organization for Research and Treatment of Cancer Quality of Life 30-item Questionnaire

RRMM:

Relapsed/Refractory Multiple Myeloma

PRFP:

Patient-reported frailty phenotype

CGA:

Comprehensive Geriatric Assessment

PRO:

Patient-reported outcomes

PROMIS:

Patient-reported outcomes measurement information system

FACIT:

Functional assessment of chronic illness therapy

FDA - U.S.:

Food and Drug Administration

CFA:

Confirmatory factor analysis

WLSMV:

Weighted least square means and variances

RMSEA:

Root mean square error of approximation

CFI:

Comparative fit index

SRMR:

Standardized root mean square residual

TLI:

Tucker Lewis Index

CCI:

Charlson Comorbidity Index

EQ-5D:

EuroQol-5 Dimension

ECOG PS:

Eastern Cooperative Oncology Group Performance Status

ISS:

International staging system

IMWG:

International Myeloma Working Group

HRQoL:

Health-related quality of life

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Acknowledgements

This work was supported in part by an appointment to the Research Fellowship Program at the Center for Drug Evaluation and Research—Office of New Drugs, U.S. Food and Drug Administration, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and FDA.

Funding

This work was supported by Oak Ridge Institute for Science and Education

Author information

Authors and 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 N. Murugappan & Ting-Yu Chen

  2. LUNGevity Foundation, Chicago, IL, USA

    Bellinda L. King-Kallimanis

  3. Oncology Center for Excellence (U.S. FDA), Silver Spring, MD, USA

    Vishal Bhatnagar, Erica G. Horodniceanu & Paul G. Kluetz

  4. Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (U.S. FDA), Silver Spring, MD, USA

    Bindu Kanapuru

  5. Department of Pharmaceutical Care and Health Systems, University of Minnesota – College of Pharmacy, Minneapolis, MN, USA

    Meena N. Murugappan & Joel F. Farley

  6. Department of Pharmacy Practice and Pharmaceutical Sciences, University of Minnesota – College of Pharmacy, Minneapolis, MN, USA

    Randall D. Seifert & David D. Stenehjem

  7. Oncology Center of Excellence, Food and Drug Administration, Building 22, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA

    Meena N. Murugappan

Authors
  1. Meena N. Murugappan
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  2. Bellinda L. King-Kallimanis
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  3. Vishal Bhatnagar
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  4. Bindu Kanapuru
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  5. Joel F. Farley
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  6. Randall D. Seifert
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  7. David D. Stenehjem
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  8. Ting-Yu Chen
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  9. Erica G. Horodniceanu
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  10. Paul G. Kluetz
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Contributions

Conceptualization: MNM; Methodology: MNM; Formal analysis and investigation: MNM; Writing - original draft preparation: MNM, Writing - review and editing: BLK-K, VB, BK, JFF, RDS, DDS, T-YC, EGH, PGK; Supervision: PGK

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Correspondence to Meena N. Murugappan.

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Murugappan, M.N., King-Kallimanis, B.L., Bhatnagar, V. et al. Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple Myeloma. Qual Life Res 32, 2281–2292 (2023). https://doi.org/10.1007/s11136-023-03390-5

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  • DOI: https://doi.org/10.1007/s11136-023-03390-5

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