Patient-reported frailty phenotype (PRFP) vs. International Myeloma Working Group frailty index (IMWG FI) proxy: A comparison between two approaches to measuring frailty.

INTRODUCTION: Frailty assessments may help to identify patients at highest risk for treatment-related toxicity, early treatment discontinuation due to toxicity, and death in Multiple Myeloma. We aimed to compare the patient-reported frailty phenotype (PRFP) and a modified version of the International Myeloma Working Group frailty index (IMWG FI) in terms of their strengths, limitations, and classification of frailty in a cohort of patients with relapsed/refractory multiple myeloma (RRMM). MATERIALS AND METHODS: Data were pooled from six RRMM Phase 3 randomized clinical trials submitted to the Food and Drug Administration for regulatory review between 2010 and 2021. Patients were classified as fit, intermediate fit/pre-frail, or frail using both PRFP and the IMWG FI proxy. Agreement between the two approaches in classification of patient frailty was assessed using weighted Cohen's kappa. A contingency table and Venn diagram were generated to analyze overlap in categorization of patient frailty across the different severity groups. Descriptive statistics were used to summarize and compare the clinical and demographic characteristics of patients categorized as frail by PRFP vs. IMWG FI proxy. RESULTS: Of the 2,750 patients included in this analysis, IMWG FI proxy classified 16.4% (452) patients as frail, 28.1% (772) as intermediate fit/pre-frail, and 55.5% (1,526) as fit. Meanwhile, PRFP classified 21.7% (597) of patients as frail, 24.5% (675) as intermediate fit/pre-frail, and 53.8% (1478) as fit. Fair agreement was observed between PRFP and IMWG FI proxy (weighted Cohen's Kappa = 0.34 [0.31-0.37]). On average, patients who were categorized as frail by IMWG FI proxy were older and had higher Charlson Comorbidity Index scores than patients classified as frail by PRFP. In contrast, patients who were classified as frail by PRFP had worse EORTC QLQ-C30 Physical Functioning subscale summary scores as compared to patients in the IMWG FI proxy frail group (median score of 40 vs. 47 out of 100). DISCUSSION: Our analysis found fair concordance between IMWG FI proxy and PRFP. This demonstrates that while both frailty models measure the same underlying construct, the variables that constitute each approach may result in differing frailty categorizations for the same patient. Further prospective studies are needed to establish and compare the predictive and prognostic abilities of the different frailty indices in MM.

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

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.

Pharmacogenomics education, research and clinical implementation in the state of Minnesota.

Several healthcare organizations across Minnesota have developed formal pharmacogenomic (PGx) clinical programs to increase drug safety and effectiveness. Healthcare professional and student education is strong and there are multiple opportunities in the state for learners to gain workforce skills and develop advanced competency in PGx. Implementation planning is occurring at several organizations and others have incorporated structured utilization of PGx into routine workflows. Laboratory-based and translational PGx research in Minnesota has driven important discoveries in several therapeutic areas. This article reviews the state of PGx activities in Minnesota including educational programs, research, national consortia involvement, technology, clinical implementation and utilization and reimbursement, and outlines the challenges and opportunities in equitable implementation of these advances.

Reprint of: Examining Medicare Part D Medication Therapy Management program in the context of mental health.

OBJECTIVES: To describe and compare the delivery of medication therapy management (MTM) between Medicare beneficiaries with and without mental health conditions. DESIGN: Nationally representative cross-sectional study that used a 20% random sample of 2014 Medicare Parts A, B, and D data merged with a 100% sample of 2014 MTM data. SETTING AND PARTICIPANTS: Medicare beneficiaries continuously enrolled in Parts A, B, and D in 2014 were included in this study. Comprehensive medication review (CMR) use and MTM delivery were examined among a subset of 825,003 MTM-enrolled beneficiaries. OUTCOME MEASURES: Predisposing, enabling, and need characteristics were selected on the basis of the Andersen Behavioral Model of Health Services Use. Descriptive, bivariable, and multivariable logistic regression statistics were used to determine associations between beneficiary characteristics and MTM delivery. RESULTS: A total of 3,016,620 (43%) and 3,997,105 beneficiaries (57%) were categorized into mental health and nonmental health cohorts, respectively. MTM enrollment in the mental health cohort was significantly higher than that in the nonmental health cohort (17.4% vs. 7.5%, P < 0.001). However, once enrolled, a greater proportion of beneficiaries in the nonmental health cohort received CMRs (19.3% vs. 17.7%, P < 0.001). Patients in the mental health cohort were more likely to have hospitalization (22% vs. 9.2%, P < 0.001) or emergency department visit (25.2% vs. 11.5%, P < 0.001) and used more medications in 2014 (16 % vs. 12%, P < 0.001). The proportion of patients in the mental health cohort receiving a CMR in 2014 that had at least 1 medication-related problem (MRP) identified and resolved was higher than that of patients in the nonmental health cohort (24.8% vs. 20.6%, P < 0.001). CONCLUSION: Although patients with mental health conditions are more often enrolled into MTM, they are less likely to receive a CMR once enrolled. Given that this population has higher medical complexity and a higher MRP burden following a CMR, opportunities exist for pharmacists to enhance MTM delivery in this population.

Examining Medicare Part D Medication Therapy Management program in the context of mental health.

OBJECTIVES: To describe and compare the delivery of medication therapy management (MTM) between Medicare beneficiaries with and without mental health conditions. DESIGN: Nationally representative cross-sectional study that used a 20% random sample of 2014 Medicare Parts A, B, and D data merged with a 100% sample of 2014 MTM data. SETTING AND PARTICIPANTS: Medicare beneficiaries continuously enrolled in Parts A, B, and D in 2014 were included in this study. Comprehensive medication review (CMR) use and MTM delivery were examined among a subset of 825,003 MTM-enrolled beneficiaries. OUTCOME MEASURES: Predisposing, enabling, and need characteristics were selected on the basis of the Andersen Behavioral Model of Health Services Use. Descriptive, bivariable, and multivariable logistic regression statistics were used to determine associations between beneficiary characteristics and MTM delivery. RESULTS: A total of 3,016,620 (43%) and 3,997,105 beneficiaries (57%) were categorized into mental health and nonmental health cohorts, respectively. MTM enrollment in the mental health cohort was significantly higher than that in the nonmental health cohort (17.4% vs. 7.5%, P < 0.001). However, once enrolled, a greater proportion of beneficiaries in the nonmental health cohort received CMRs (19.3% vs. 17.7%, P < 0.001). Patients in the mental health cohort were more likely to have hospitalization (22% vs. 9.2%, P < 0.001) or emergency department visit (25.2% vs. 11.5%, P < 0.001) and used more medications in 2014 (16 % vs. 12%, P < 0.001). The proportion of patients in the mental health cohort receiving a CMR in 2014 that had at least 1 medication-related problem (MRP) identified and resolved was higher than that of patients in the nonmental health cohort (24.8% vs. 20.6%, P < 0.001). CONCLUSION: Although patients with mental health conditions are more often enrolled into MTM, they are less likely to receive a CMR once enrolled. Given that this population has higher medical complexity and a higher MRP burden following a CMR, opportunities exist for pharmacists to enhance MTM delivery in this population.