Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument

Espinoza-Zamora, José Ramiro; Portilla-Espinosa, César Miguel; Labardini-Méndez, J; Eduardo, Cervera; Niesvisky, Ruben; Oñate‐Ocaña, Luis F.

doi:10.1007/s00277-014-2290-y

Cited by 10 publications

(20 citation statements)

References 26 publications

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“…Sexual problems in particular were also reported by patients with newly diagnosed disease pretransplantation . The same was observed for financial difficulties, present in newly diagnosed samples, samples with mixed disease stages and studies reporting baseline evaluation of SCT patients . A high prevalence of fatigue was also reported in these studies .…”

Section: Discussionsupporting

confidence: 63%

Prevalence of symptoms in patients with multiple myeloma: a systematic review and meta‐analysis

Ramsenthaler

Kane

Gao

et al. 2016

European J of Haematology

122

107

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Objectives: Multiple myeloma (MM) is an incurable haematological disease. Due to novel agents, overall survival has improved in this group, yet there are no systematic reviews to understand the symptom profiles resulting from disease and treatment-related toxicities. We aimed to synthesise data on the prevalence of symptoms in patients with MM. Methods: A systematic database and grey literature search were conducted in six databases. Random-effects meta-analysis with inverse variance weighting to pool prevalence data was performed. Results: Thirty-six studies were included of which 34 studies (N = 3023) provided data for meta-analysis. Twenty-seven distinct symptoms were reported, with the majority of studies focusing on pain (n = 27), fatigue (n = 19) and problems with functioning (n = 15). The most prevalent symptoms were fatigue (98.8%, 95% CI 98.1-99.2%), pain (73%, 39.9-91.7), constipation (65.2%, 22.9-92.2) and tingling in the hands/feet with 53.4% (0.4-99.7). The most common problems were decreased physical functioning (98.9%, 98.2-99.3), decreased cognitive functioning (80.2%, 40-96.1) and financial difficulties (78.4%, 39.1-95.4). These problems were present in newly diagnosed to advanced disease stage. Conclusions: Optimal quality of life and good symptom management in this incurable disease can only be achieved by routinely assessing symptoms throughout the disease trajectory.

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Section: Discussionsupporting

confidence: 63%

Prevalence of symptoms in patients with multiple myeloma: a systematic review and meta‐analysis

Ramsenthaler

Kane

Gao

et al. 2016

European J of Haematology

122

107

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“…Cronbach's alpha >0.7 for all the scales except Nausea and vomiting with alpha value 0.356 and cognitive (0.597)…”

Section: Resultsmentioning

confidence: 94%

“…Correlation between item and own scale >0.3 (0.3‐0.7). Good discriminant validity in majority of scales…”

Section: Resultsmentioning

confidence: 99%

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Haematological malignancy: Are we measuring what is important to patients? A systematic review of quality‐of‐life instruments

Goswami

Khatib

Salek

2019

European J of Haematology

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The wide range of health‐related quality‐of‐life (HRQoL) instruments used in haematology makes it challenging for haematologists and other care team members in practice to select, use and understand the scoring system and finally interpret the results. The main objectives of this study were to: (a) provide a comprehensive list of quality‐of‐life issues important to patients suffering from haematological malignancies, identified through the literature; (b) provide a list of health‐related quality‐of‐life (HRQoL) instruments used in haematological malignancies in both daily clinical practice and research; and (c) evaluate the relevance and comprehensibility of the identified instruments in haematological malignancies. Systematic literature review of two databases, followed by addition of articles by manual searching, was carried out. The articles focusing on the primary studies, which have used semi‐structured/structured interviews or surveys to identify issues important to HM patients, and other studies describing the results of testing measurement properties, such as reliability, validity and responsiveness of the instruments currently used to evaluate the HRQoL in different HMs, were included. Fifty‐seven studies reported development and validation of 30 HRQoL instruments, which have been used in haematology. Twenty‐four studies were identified using qualitative methods to report HRQoL issues and symptoms from a patient's perspective. No identified instrument captured all the issues identified from the qualitative studies. None of the instruments reviewed appeared to have been developed for use in clinical practice and specifically for patients with HM, except MyPOS. Furthermore, measurement properties were established, largely, in clinical trial scenarios. There is a need for development of a new HRQoL instrument entirely based on involvement of patients with haematological malignancies.

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“…Furthermore, this review also reports that a barrier to using patient-reported outcomes (PRO) in clinical practice is the diversity of such instruments. The oncology generic instruments like EORTC QLQ-C30, FACT-G (Stead et al, 1999;Cella et al, 2012) and their disease specific modules, such as EORTC QLQ-MY20, EORTC QLQ-CML24, FACT-Leu (Cocks et al, 2007;Kontodimopoulos et al, 2012;Jones et al, 2013;Efficace et al, 2014;Espinoza-Zamora et al, 2015) which are currently used have been developed and validated to be used in clinical trials. Only one instrument, MYPOS has been recently developed and validated to be used in clinical practice specific for myeloma and Abbreviations: ALL, acute lymphoid leukemia; AML, acute myeloid leukemia; ANHL, aggressive non-Hodgkin lymphoma; CLL, chronic lymphoid leukemia; CML, chronic myeloid leukemia; CVI, content validity index; CVR, content validity ratio; EMA, european medicines agency; EORTC QLQ C-30, european organization for the research and treatment of cancer quality of life questionnaire -core 30; EORTC QLQ MY-20, european organization for the research and treatment of cancer quality of life questionnaire -myeloma 20; EORTC QLQ-CML24, european organization for the research and treatment of cancer quality of life questionnaire -chronic myeloid leukaemia-24; FACT-G, functional assessment of cancer therapy: general; FACT-Leu, functional assessment of cancer therapy: leukemia; FDA, food and drug administration; HL, hodgkin lymphoma; HM, hematological malignancy; HM-PRO, hematological malignancy patientreported outcome measure; HRQoL, health-related quality of life; ICC, intra-class correlation; I-CVI, item-content validity index; INHL, indolent non-Hodgkin lymphoma.…”

Section: Introductionmentioning

confidence: 99%

Development of a Novel Hematological Malignancy Specific Patient-Reported Outcome Measure (HM-PRO): Content Validity

Goswami

Oliva

Ionova³

et al. 2020

Front. Pharmacol.

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Background: The quality of life of patients at all stages of hematological malignancy is greatly affected by the disease and its treatment. There is a wide range of healthrelated quality of life (HRQoL) issues important to these patients. Any new instrument developed to measure HRQoL of such patients should be content valid, i.e., the items should be comprehensively relevant to the patients and their health condition. The aim of the present study was to examine content validity of a hematological malignancy specific patient reported outcome measure (HM-PRO) developed for use in routine clinical practice. Methods: Following literature review and semi-structured interviews, the generated themes and sub-themes were discussed to develop the prototype version of the HM-PRO. A 4-step approach was used for content validation: initial testing and cognitive interviewing; item rating; content validity panel meeting; final field testing and cognitive interviewing. Additional questions related to patients' perception of recall period and preferred sentence structure (i.e., question or statement) of the items were also asked during cognitive interviews. Results: The content analysis of 129 transcribed semi-structured interviews resulted in the prototype version of the instrument consisting of 58 items grouped into two parts: Part A (impact/HRQoL-34 items) and Part B (signs and symptoms-24 items). The initial testing showed intra-class correlation coefficient (ICC) of >0.8 for both Part A and Part B. Item rating for language clarity, completeness, relevance, and response scale by experts and patients showed content validity index for scales average >0.8 for both Part A and Part B, except 0.64 for relevance for Part A by the patient panel. The final testing of the revised version of the instrument showed the Cronbach's alpha value of

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Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument

Cited by 10 publications

References 26 publications

Prevalence of symptoms in patients with multiple myeloma: a systematic review and meta‐analysis

Prevalence of symptoms in patients with multiple myeloma: a systematic review and meta‐analysis

Haematological malignancy: Are we measuring what is important to patients? A systematic review of quality‐of‐life instruments

Development of a Novel Hematological Malignancy Specific Patient-Reported Outcome Measure (HM-PRO): Content Validity

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