Development and validation of QOL-E© instrument for the assessment of health-related quality of life in myelodysplastic syndromes

Olíva, Esther Natalie; Nobile, Francesco; Dimitrov, Borislav D.

doi:10.2478/s11536-013-0196-z

Cited by 18 publications

(25 citation statements)

References 32 publications

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“… Oliva and colleagues (2013) developed and evaluated the validity of the QOL-E in three phases: a development phase, a pilot study phase with 52 patients with myelodysplastic syndromes (MDS), and a third phase evaluating the validity of the instrument in 147 patients with MDS. Validity and reliability results from the second and third phases of the study are presented in Table 3 .…”

Section: Resultsmentioning

confidence: 99%

“…A total of 12 articles ( Aaronson et al., 1993 ; Stalfelt and Wadman, 1993 ; Watson et al., 1996 ; Groenvold et al., 1997 ; Alibhai et al., 2007 ; Cella et al., 2012 ; Oliva et al., 2013 ; Shih et al., 2013 ; Lorgelly et al., 2017 ; Goswami et al., 2019 ) presenting psychometric properties of validity and/or reliability for ten QOL instruments are presented in this review. Of these, eight articles evaluated seven instruments (AML-QOL, FACT-F, FACT-Leu, EORTC QLQ-Leu, LIP, HM-PRO, and QOL-E) in patients with AML or disease states related to and inclusive of AML.…”

Section: Discussionmentioning

confidence: 99%

“…Articles that evaluated instruments in more specific populations tended to have smaller sample sizes, with a median of 113 patients (range, 35-388) ( Stalfelt and Wadman, 1993 ; Watson et al., 1996 ; Alibhai et al., 2007 ; Cella et al., 2012 ; Oliva et al., 2013 ; Goswami et al., 2019 ; Buckley et al., 2020 ; Peipert et al., 2020 ). Articles that evaluated instruments in broader patient populations tended to have larger sample sizes, with a median of 991.5 patients (range, 95–2,295) ( Aaronson et al., 1993 ; Groenvold et al., 1997 ; Shih et al., 2013 ; Lorgelly et al., 2017 ).…”

Section: Discussionmentioning

confidence: 99%

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Validated Instruments of Quality of Life (QOL) in Patients With Acute Myeloid Leukemia (AML) and Other Cancers

et al. 2020

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Introduction: Acute myeloid leukemia (AML) can negatively impact quality of life (QOL). Few QOL instruments are specific to and have been validated in AML. This review aims to identify QOL instruments that have been validated in patients with AML and other cancers and summarize their psychometric properties reported in published literature. A literature review search was performed using PubMed and OVID (Biosis, Embase, MEDLINE) databases through June 25, 2020. Search terms included: QOL, health-related QOL, patient-reported outcomes and validity, reliability, validated, tools, instruments, testretest, and leukemia myeloid acute, leukemia, myeloid, acute, acute myeloid leukemia. Articles were included if they focused on cancer and reported psychometric properties that could be extracted. Abstracts and their references were reviewed for inclusion. Results: Twelve evaluating ten instruments were included. Functional Assessment of Cancer Therapy Leukemia (FACT-Leu) showed internal consistency (IC) of a = 0.86 to >0.9, correlation with EQ-5D-3L of r > 0.50, correlation with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-Leu of r = 0.29-0.63, test-retest reliability of k = 0.861. FACT-F showed correlations with EORTC QLQ-C30 of r = 0.40-0.83. Hematological Malignancy Patient-Reported Outcome (HM-PRO) showed intraclass correlation coefficient (ICC) of 0.94-0.98. EORTC-8D and EQ-5D-3L showed ICC = 0.595, correlations with each other of r = 0.137-0.634 and with EORTC QLQ-C30 of r = 0.651-0.917. EORTC QLQ-C30 showed person separation reliability of 0.47 to 0.90 and patient-observer agreement of 0.85. Life Ingredient Profile (LIP) showed IC of a = 0.29-0.77 and test-retest reliability of k = 0.42-1.0. QOL-E showed correlation with FACT-general of R = 0.71, internal validity of a = 0.7, and test-retest reliability of standardized Cronbach's a = 0.7-0.92. EORTC QLQ-Leu showed IC of a = 0.6-0.79. The Acute Myeloid Leukemia-Quality of Life (AML-QOL) instrument showed IC of a = 0.72, correlations with EORTC QLQ-30 of magnitudes r = 0.59-0.72, and test-retest reliability of ICC = 0.52-0.91.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Validated Instruments of Quality of Life (QOL) in Patients With Acute Myeloid Leukemia (AML) and Other Cancers

et al. 2020

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“…QoL during treatment was assessed using the MDS‐specific, health‐related QoL instrument QOL‐E© version 2 , which was completed at baseline and at 8, 12, 24, and 52 weeks' follow‐up. The QOL‐E© questionnaire comprises two items concerning general perceptions of well‐being, and 26 items addressing physical, functional, social, sexual, fatigue, and disease‐specific domains.…”

Section: Methodsmentioning

confidence: 99%

Early lenalidomide treatment for low and intermediate‐1 International Prognostic Scoring System risk myelodysplastic syndromes with del(5q) before transfusion dependence

et al. 2015

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Lenalidomide is approved for the treatment of transfusion‐dependent (TD) del(5q) myelodysplastic syndromes (MDS). However, few data are available in patients with transfusion‐independent (TI) del(5q) MDS. In the first, observational, part of this 2‐part study, we assessed the impact of transfusion dependence on overall survival (OS) and non‐leukemic death in untreated del(5q) MDS patients who were TD (n = 136), TI with hemoglobin (Hb) ≥10 mg/dL (n = 88), or TI with Hb <10 mg/dL (n = 96). In the second, interventional, part we assessed the quality‐of‐life (QoL) benefits and clinical efficacy of lenalidomide (10 mg/day) in 12 patients with TI del(5q) MDS and Hb <10 mg/dL. In the untreated population, OS was significantly longer in TI than in TD patients (TI [Hb ≥10 g/dL], 108 months; TI [Hb <10 g/dL], 77 months; TD, 44 months). Transfusion dependence also negatively impacted non‐leukemic death rates. In the interventional part of the study, baseline Hb levels were found to correlate significantly with physical (R = 0.666, P = 0.035) and fatigue (R = 0.604, P = 0.049) QoL scores. Median physical QoL scores improved significantly after 12 weeks' treatment with lenalidomide (+12.5; P = 0.020). Evaluable TI patients experienced early increases in Hb levels, and all attained an erythroid response. Our findings suggest that TI patients with moderate anemia may benefit from early treatment with lenalidomide.

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“…In parallel, the US FDA confirmed its interest in using PROMs, in particular the PROM version of the US FDA/EMA-approved products for the treatment of MDS and AML since 2000Evidence table with description of the selection of PROMs MDS and AML patients Validated in MDS and AML patients 33Abbreviations: AML, acute myeloid leukemia; HRQOL, health-related quality of life; MDS, myelodysplastic syndromes; PROM, patient-reported outcomes measure. QUALMS), 44 Q OL-E,45 and the AML-QOL 15 are in the development and validation stages and could fit into today's management landscape.Our study does have some limitations. The search strategy was aimed at covering studies published and indexed in Medline or Embase.…”

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confidence: 99%

Patient‐reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis

Stauder

Lambert

Desruol‐Allardin

et al. 2020

European J of Haematology

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This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. AbstractObjectives: This study aims to describe the use of patient-reported outcome measures (PROMs) in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) studies and the PROMs landscape. Methods:A comprehensive literature review was performed in Medline/Embase (since 2000) and ClinicalTrials.gov (since 2013) to identify PROMs used in MDS and AML clinical studies. Additionally, PROMs included in approved drug labels since 2000 were reviewed. Results: Overall, 112 different PROMs were used in 168 published MDS studies and 152 PROMs were used in 172 AML studies. From ClinicalTrials.gov, 16 different PROMs were used in 22 ongoing registered studies in MDS, and 24 were reported in 41 AML studies. The most frequently used PROMs were cancer-specific (eg, EORTC QLQ-C30, FACT-An) or generic (SF-36, EQ-5D) instruments, whereas MDS-and AML-specific instruments (eg, QUALMS and QOL-E in MDS; FACT-Leu and EORTC QLQ-Leu in AML) were used in a minority of studies. Two EMA-approved drugs for MDS included PROMs in their label. EORTC QLQ-C30 is by far the most frequently used cancer-specific PROM in both MDS and AML studies. Conclusions: This research indicated an underuse of AML/MDS-specific PROMs for these two indications in clinical studies and labeling claims. However, AML/MDSspecific instruments in development might be considered in future studies. K E Y W O R D S acute myeloid leukemia, myelodysplastic syndromes, quality of life | 477 STAUDER ET Al.

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Development and validation of QOL-E© instrument for the assessment of health-related quality of life in myelodysplastic syndromes

Abstract: Abstract

Cited by 18 publications

References 32 publications

Validated Instruments of Quality of Life (QOL) in Patients With Acute Myeloid Leukemia (AML) and Other Cancers

Validated Instruments of Quality of Life (QOL) in Patients With Acute Myeloid Leukemia (AML) and Other Cancers

Early lenalidomide treatment for low and intermediate‐1 International Prognostic Scoring System risk myelodysplastic syndromes with del(5q) before transfusion dependence

Patient‐reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis

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