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Gepubliceerd in: Quality of Life Research 8/2023

20-03-2023

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

Auteurs: Meena N. Murugappan, Bellinda L. King-Kallimanis, Vishal Bhatnagar, Bindu Kanapuru, Joel F. Farley, Randall D. Seifert, David D. Stenehjem, Ting-Yu Chen, Erica G. Horodniceanu, Paul G. Kluetz

Gepubliceerd in: Quality of Life Research | Uitgave 8/2023

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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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Literatuur
11.
go back to reference Corre, R., Greillier, L., Le Caër, H., Audigier-Valette, C., Baize, N., Bérard, H., Falchero, L., Monnet, I., Dansin, E., Vergnenègre, A., Marcq, M., Decroisette, C., Auliac, J.-B., Bota, S., Lamy, R., Massuti, B., Dujon, C., Pérol, M., Daurès, J.-P., … Chouaïd, C. (2016). Use of a comprehensive geriatric assessment for the management of elderly patients with advanced non-small-cell lung cancer: The phase III randomized ESOGIA-GFPC-GECP 08–02 study. Journal of Clinical Oncology, 34(13), 1476–1483. https://doi.org/10.1200/jco.2015.63.5839CrossRefPubMed Corre, R., Greillier, L., Le Caër, H., Audigier-Valette, C., Baize, N., Bérard, H., Falchero, L., Monnet, I., Dansin, E., Vergnenègre, A., Marcq, M., Decroisette, C., Auliac, J.-B., Bota, S., Lamy, R., Massuti, B., Dujon, C., Pérol, M., Daurès, J.-P., … Chouaïd, C. (2016). Use of a comprehensive geriatric assessment for the management of elderly patients with advanced non-small-cell lung cancer: The phase III randomized ESOGIA-GFPC-GECP 08–02 study. Journal of Clinical Oncology, 34(13), 1476–1483. https://​doi.​org/​10.​1200/​jco.​2015.​63.​5839CrossRefPubMed
12.
go back to reference Hall, P. S., Swinson, D., Waters, J. S., Wadsley, J., Falk, S., Roy, R., Tillett, T., Nicoll, J., Cummings, S., Grumett, S. A., Kamposioras, K., Garcia, A., Allmark, C., Marshall, H., Ruddock, S., Katona, E., Velikova, G., Petty, R. D., Grabsch, H. I., & Seymour, M. T. (2019). Optimizing chemotherapy for frail and elderly patients (pts) with advanced gastroesophageal cancer (aGOAC): The GO2 phase III trial. Journal of Clinical Oncology, 37(15_suppl), 4006–4006. https://doi.org/10.1200/JCO.2019.37.15_suppl.4006CrossRef Hall, P. S., Swinson, D., Waters, J. S., Wadsley, J., Falk, S., Roy, R., Tillett, T., Nicoll, J., Cummings, S., Grumett, S. A., Kamposioras, K., Garcia, A., Allmark, C., Marshall, H., Ruddock, S., Katona, E., Velikova, G., Petty, R. D., Grabsch, H. I., & Seymour, M. T. (2019). Optimizing chemotherapy for frail and elderly patients (pts) with advanced gastroesophageal cancer (aGOAC): The GO2 phase III trial. Journal of Clinical Oncology, 37(15_suppl), 4006–4006. https://​doi.​org/​10.​1200/​JCO.​2019.​37.​15_​suppl.​4006CrossRef
13.
go back to reference Li, D., Sun, C.-L., Kim, H., Chung, V., Koczywas, M., Fakih, M., Chao, J., Chien, L., Charles, K., Hughes, S. F. D. S., Trent, M., Roberts, E., Celis, E. S. P. D., Jayani, R., Katheria, V., Moreno, J., Kelly, C., Sedrak, M. S., Hurria, A., & Dale, W. (2020). Geriatric assessment-driven intervention (GAIN) on chemotherapy toxicity in older adults with cancer: A randomized controlled trial. Journal of Clinical Oncology, 38(15_suppl), 12010–12010. https://doi.org/10.1200/JCO.2020.38.15_suppl.12010CrossRef Li, D., Sun, C.-L., Kim, H., Chung, V., Koczywas, M., Fakih, M., Chao, J., Chien, L., Charles, K., Hughes, S. F. D. S., Trent, M., Roberts, E., Celis, E. S. P. D., Jayani, R., Katheria, V., Moreno, J., Kelly, C., Sedrak, M. S., Hurria, A., & Dale, W. (2020). Geriatric assessment-driven intervention (GAIN) on chemotherapy toxicity in older adults with cancer: A randomized controlled trial. Journal of Clinical Oncology, 38(15_suppl), 12010–12010. https://​doi.​org/​10.​1200/​JCO.​2020.​38.​15_​suppl.​12010CrossRef
14.
go back to reference Mohile, S. G., Mohamed, M. R., Culakova, E., Huiwen, Xu., Loh, K. P., Magnuson, A., Flannery, M. A., Ramsdale, E. E., Dunne, R. F., Gilmore, N., Obrecht, S., Patil, A., Plumb, S., Lowenstein, L. M., Janelsins, M. C., Mustian, K. M., Hopkins, J. O., Berenberg, J. L., Gaur, R., & Dale, W. (2020). A geriatric assessment (GA) intervention to reduce treatment toxicity in older patients with advanced cancer: A University of Rochester Cancer Center NCI community oncology research program cluster randomized clinical trial (CRCT). Journal of Clinical Oncology, 38(15_suppl), 12009–12009. https://doi.org/10.1200/JCO.2020.38.15_suppl.12009CrossRef Mohile, S. G., Mohamed, M. R., Culakova, E., Huiwen, Xu., Loh, K. P., Magnuson, A., Flannery, M. A., Ramsdale, E. E., Dunne, R. F., Gilmore, N., Obrecht, S., Patil, A., Plumb, S., Lowenstein, L. M., Janelsins, M. C., Mustian, K. M., Hopkins, J. O., Berenberg, J. L., Gaur, R., & Dale, W. (2020). A geriatric assessment (GA) intervention to reduce treatment toxicity in older patients with advanced cancer: A University of Rochester Cancer Center NCI community oncology research program cluster randomized clinical trial (CRCT). Journal of Clinical Oncology, 38(15_suppl), 12009–12009. https://​doi.​org/​10.​1200/​JCO.​2020.​38.​15_​suppl.​12009CrossRef
18.
go back to reference Mohile, S. G., Mohamed, M. R., Huiwen, Xu., Culakova, E., Loh, K. P., Magnuson, A., Flannery, M. A., Obrecht, S., Gilmore, N., Ramsdale, E., Dunne, R. F., Wildes, T., Plumb, S., Patil, A., Wells, M., Lowenstein, L., Janelsins, M., Mustian, K., Hopkins, J. O., … Dale, W. (2021). Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): A cluster-randomised study. Lancet, 398(10314), 1894–1904. https://doi.org/10.1016/s0140-6736(21)01789-xCrossRefPubMedPubMedCentral Mohile, S. G., Mohamed, M. R., Huiwen, Xu., Culakova, E., Loh, K. P., Magnuson, A., Flannery, M. A., Obrecht, S., Gilmore, N., Ramsdale, E., Dunne, R. F., Wildes, T., Plumb, S., Patil, A., Wells, M., Lowenstein, L., Janelsins, M., Mustian, K., Hopkins, J. O., … Dale, W. (2021). Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): A cluster-randomised study. Lancet, 398(10314), 1894–1904. https://​doi.​org/​10.​1016/​s0140-6736(21)01789-xCrossRefPubMedPubMedCentral
20.
go back to reference O’Donovan, A., & Leech, M. (2020). Personalised treatment for older adults with cancer: The role of frailty assessment. Technical Innovations & Patient Support in Radiation Oncology, 16, 30–38.CrossRef O’Donovan, A., & Leech, M. (2020). Personalised treatment for older adults with cancer: The role of frailty assessment. Technical Innovations & Patient Support in Radiation Oncology, 16, 30–38.CrossRef
23.
24.
go back to reference Abt, N. B., Richmon, J. D., Koch, W. M., Eisele, D. W., & Agrawal, N. (2016). Assessment of the predictive value of the modified frailty index for Clavien-Dindo grade IV critical care complications in major head and neck cancer operations. JAMA Otolaryngology—Head & Neck Surgery, 142(7), 658–664. https://doi.org/10.1001/jamaoto.2016.0707CrossRef Abt, N. B., Richmon, J. D., Koch, W. M., Eisele, D. W., & Agrawal, N. (2016). Assessment of the predictive value of the modified frailty index for Clavien-Dindo grade IV critical care complications in major head and neck cancer operations. JAMA Otolaryngology—Head & Neck Surgery, 142(7), 658–664. https://​doi.​org/​10.​1001/​jamaoto.​2016.​0707CrossRef
28.
go back to reference Efficace, F., Gaidano, G., Petrucci, M. T., Niscola, P., Tognazzi, L., Antonioli, E., Cottone, F., Annibali, O., Tafuri, A., Califano, C., Larocca, A., Potenza, L., Palazzo, G., Fozza, C., Pastore, D., Rigolin, G. M., Offidani, M., Romano, A., Tosi, P., … Cavo, M. (2021). The accuracy of the international myeloma working group frailty score in capturing health-related quality of life profile of patients with relapsed refractory multiple myeloma. Blood, 138(Supplement 1), 115–115. https://doi.org/10.1182/blood-2021-145977CrossRef Efficace, F., Gaidano, G., Petrucci, M. T., Niscola, P., Tognazzi, L., Antonioli, E., Cottone, F., Annibali, O., Tafuri, A., Califano, C., Larocca, A., Potenza, L., Palazzo, G., Fozza, C., Pastore, D., Rigolin, G. M., Offidani, M., Romano, A., Tosi, P., … Cavo, M. (2021). The accuracy of the international myeloma working group frailty score in capturing health-related quality of life profile of patients with relapsed refractory multiple myeloma. Blood, 138(Supplement 1), 115–115. https://​doi.​org/​10.​1182/​blood-2021-145977CrossRef
31.
32.
go back to reference Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., Filiberti, A., Flechtner, H., Fleishman, S. B., Haes, J. C. JMd., Kaasa, S., Klee, M., Osoba, D., Razavi, D., Rofe, P. B., Schraub, S., Sneeuw, K., Sullivan, M., & Takeda, F. (1993). The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376. https://doi.org/10.1093/jnci/85.5.365CrossRefPubMed Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., Filiberti, A., Flechtner, H., Fleishman, S. B., Haes, J. C. JMd., Kaasa, S., Klee, M., Osoba, D., Razavi, D., Rofe, P. B., Schraub, S., Sneeuw, K., Sullivan, M., & Takeda, F. (1993). The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376. https://​doi.​org/​10.​1093/​jnci/​85.​5.​365CrossRefPubMed
36.
go back to reference Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma (FiTNEss). In Clinicaltrials.gov: NCT03720041 Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma (FiTNEss). In Clinicaltrials.gov: NCT03720041
37.
go back to reference Palumbo, A., Bringhen, S., Mateos, M.-V., Larocca, A., Facon, T., Kumar, S. K., Offidani, M., McCarthy, P., Evangelista, A., Lonial, S., Zweegman, S., Musto, P., Terpos, E., Belch, A., Hajek, R., Heinz Ludwig, A., Stewart, K., Moreau, P., Anderson, K., … Rajkumar, V. (2015). Geriatric assessment predicts survival and toxicities in elderly myeloma patients: An International Myeloma Working Group report. Blood, 125(13), 2068–2074. https://doi.org/10.1182/blood-2014-12-615187CrossRefPubMedPubMedCentral Palumbo, A., Bringhen, S., Mateos, M.-V., Larocca, A., Facon, T., Kumar, S. K., Offidani, M., McCarthy, P., Evangelista, A., Lonial, S., Zweegman, S., Musto, P., Terpos, E., Belch, A., Hajek, R., Heinz Ludwig, A., Stewart, K., Moreau, P., Anderson, K., … Rajkumar, V. (2015). Geriatric assessment predicts survival and toxicities in elderly myeloma patients: An International Myeloma Working Group report. Blood, 125(13), 2068–2074. https://​doi.​org/​10.​1182/​blood-2014-12-615187CrossRefPubMedPubMedCentral
39.
go back to reference Murugappan, M. N., King-Kallimanis, B. L., Bhatnagar, V., Kanapuru, B., Chen, T. Y., Horodniceanu, E. G., Singh, H., & Kluetz, P. G. (2021). Leveraging patient-reported outcomes to measure frailty in relapsed/refractory multiple myeloma. Quality of Life Research, 30(Suppl 1), S1–S177. Murugappan, M. N., King-Kallimanis, B. L., Bhatnagar, V., Kanapuru, B., Chen, T. Y., Horodniceanu, E. G., Singh, H., & Kluetz, P. G. (2021). Leveraging patient-reported outcomes to measure frailty in relapsed/refractory multiple myeloma. Quality of Life Research, 30(Suppl 1), S1–S177.
40.
go back to reference Brown, T. A. (2015). Confirmatory factor analysis for applied research (2nd ed.). The Guilford Press. Brown, T. A. (2015). Confirmatory factor analysis for applied research (2nd ed.). The Guilford Press.
41.
go back to reference Weston, R., & Gore, P. A., Jr. (2006). A brief guide to structural equation modeling. The counseling psychologist, 34(5), 719–751.CrossRef Weston, R., & Gore, P. A., Jr. (2006). A brief guide to structural equation modeling. The counseling psychologist, 34(5), 719–751.CrossRef
42.
go back to reference Fayers, P. M., & Machin, D. (2013). Quality of life: The assessment, analysis and interpretation of patient-reported outcomes. John Wiley & Sons. Fayers, P. M., & Machin, D. (2013). Quality of life: The assessment, analysis and interpretation of patient-reported outcomes. John Wiley & Sons.
45.
go back to reference Comrey, A. L., & Lee, H. B. (2013). A first course in factor analysis. Psychology press.CrossRef Comrey, A. L., & Lee, H. B. (2013). A first course in factor analysis. Psychology press.CrossRef
47.
go back to reference Cook, G., Royle, K.-L., Pawlyn, C., Hockaday, A., Shah, V., Kaiser, M. F., Brown, S. R., Gregory, W. M., Anthony Child, J., Davies, F. E., Morgan, G. J., Cairns, D. A., & Jackson, G. H. (2019). A clinical prediction model for outcome and therapy delivery in transplant-ineligible patients with myeloma (UK Myeloma Research Alliance Risk Profile): a development and validation study. The Lancet Haematology, 6(3), e154–e166. https://doi.org/10.1016/S2352-3026(18)30220-5CrossRefPubMedPubMedCentral Cook, G., Royle, K.-L., Pawlyn, C., Hockaday, A., Shah, V., Kaiser, M. F., Brown, S. R., Gregory, W. M., Anthony Child, J., Davies, F. E., Morgan, G. J., Cairns, D. A., & Jackson, G. H. (2019). A clinical prediction model for outcome and therapy delivery in transplant-ineligible patients with myeloma (UK Myeloma Research Alliance Risk Profile): a development and validation study. The Lancet Haematology, 6(3), e154–e166. https://​doi.​org/​10.​1016/​S2352-3026(18)30220-5CrossRefPubMedPubMedCentral
48.
49.
go back to reference Facon, T., Hulin, C., Dimopoulos, M. A., Belch, A., Meuleman, N., & Mohty, M. (2015). A frailty scale predicts outcomes of patients with newly diagnosed multiple myeloma who are ineligible for transplant treated with continuous lenalidomide plus low-dose dexamethasone on the first trial. Blood, 126(23), 4239.CrossRef Facon, T., Hulin, C., Dimopoulos, M. A., Belch, A., Meuleman, N., & Mohty, M. (2015). A frailty scale predicts outcomes of patients with newly diagnosed multiple myeloma who are ineligible for transplant treated with continuous lenalidomide plus low-dose dexamethasone on the first trial. Blood, 126(23), 4239.CrossRef
50.
go back to reference Paolo Milani, S., Rajkumar, V., Merlini, G., Kumar, S., Gertz, M. A., Palladini, G., Lacy, M. Q., Buadi, F. K., Hayman, S. R., Leung, N., Dingli, D., Lust, J. A., Lin, Yi., Kapoor, P., Go, R. S., Hwa, Y. L., Gonsalves, W. I., Zeldenrust, S. R., Kyle, R. A., & Dispenzieri, A. (2016). N-terminal fragment of the type-B natriuretic peptide (NT-proBNP) contributes to a simple new frailty score in patients with newly diagnosed multiple myeloma. American Journal of Hematology, 91(11), 1129–1134. https://doi.org/10.1002/ajh.24532CrossRefPubMedPubMedCentral Paolo Milani, S., Rajkumar, V., Merlini, G., Kumar, S., Gertz, M. A., Palladini, G., Lacy, M. Q., Buadi, F. K., Hayman, S. R., Leung, N., Dingli, D., Lust, J. A., Lin, Yi., Kapoor, P., Go, R. S., Hwa, Y. L., Gonsalves, W. I., Zeldenrust, S. R., Kyle, R. A., & Dispenzieri, A. (2016). N-terminal fragment of the type-B natriuretic peptide (NT-proBNP) contributes to a simple new frailty score in patients with newly diagnosed multiple myeloma. American Journal of Hematology, 91(11), 1129–1134. https://​doi.​org/​10.​1002/​ajh.​24532CrossRefPubMedPubMedCentral
53.
go back to reference Mohile, S. G., Bylow, K., Dale, W., Dignam, J., Martin, K., Petrylak, D. P., Stadler, W. M., & Rodin, M. (2007). A pilot study of the vulnerable elders survey-13 compared with the comprehensive geriatric assessment for identifying disability in older patients with prostate cancer who receive androgen ablation. Cancer, 109(4), 802–810. https://doi.org/10.1002/cncr.22495CrossRefPubMed Mohile, S. G., Bylow, K., Dale, W., Dignam, J., Martin, K., Petrylak, D. P., Stadler, W. M., & Rodin, M. (2007). A pilot study of the vulnerable elders survey-13 compared with the comprehensive geriatric assessment for identifying disability in older patients with prostate cancer who receive androgen ablation. Cancer, 109(4), 802–810. https://​doi.​org/​10.​1002/​cncr.​22495CrossRefPubMed
58.
go back to reference Roydhouse, J. K., King-Kallimanis, B. L., Howie, L. J., Singh, H., & Kluetz, P. G. (2019). Blinding and patient-reported outcome completion rates in US Food and Drug Administration cancer trial submissions, 2007–2017. Journal of the National Cancer Institute, 111(5), 459–464. https://doi.org/10.1093/jnci/djy181CrossRefPubMed Roydhouse, J. K., King-Kallimanis, B. L., Howie, L. J., Singh, H., & Kluetz, P. G. (2019). Blinding and patient-reported outcome completion rates in US Food and Drug Administration cancer trial submissions, 2007–2017. Journal of the National Cancer Institute, 111(5), 459–464. https://​doi.​org/​10.​1093/​jnci/​djy181CrossRefPubMed
Metagegevens
Titel
Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple Myeloma
Auteurs
Meena N. Murugappan
Bellinda L. King-Kallimanis
Vishal Bhatnagar
Bindu Kanapuru
Joel F. Farley
Randall D. Seifert
David D. Stenehjem
Ting-Yu Chen
Erica G. Horodniceanu
Paul G. Kluetz
Publicatiedatum
20-03-2023
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 8/2023
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-023-03390-5

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