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Psychometric properties of the Chilean version of the quality of life questionnaire for multiple myeloma

Propriedades psicométricas da versão chilena do questionário de qualidade de vida para mieloma múltiplo

ABSTRACT

Objectives:

To evaluate the internal consistency and construct validity of the QLQ-MY20 for assessing the quality of life in multiple myeloma survivors in Chile.

Methods:

This was a cross-sectional study conducted between March 2020 and December 2022. It involved 118 individuals from two public hospitals. The QLQ-C30 and QLQ-MY20 questionnaires were used. Internal consistency was assessed using Cronbach’s alpha(α), and construct validity was evaluated through hypothesis testing (Mann-Whitney and Spearman correlation).

Results:

The average age of participants was 67.2 years (SD=9.2). Internal consistency for the complete scale was α=0.779, for the “disease symptoms” dimension α=0.671, for the “side effects of treatments” dimension α=0.538, and for the “future perspective” dimension α=0.670. Four of the five construct validity hypotheses were confirmed: women, individuals with worse performance status, those with pain, and those with worse fatigue showed more symptoms.

Conclusions:

The Chilean version of the QLQ-MY20 demonstrates adequate internal consistency and construct validity.

Descriptors
Multiple Myeloma; Quality of Life; Validation Study; Psychometrics; Pain.

RESUMO

Objetivos:

Avaliar consistência interna e validade de construto do QLQ-MY20 para avaliação da qualidade de vida em sobreviventes de mieloma múltiplo no Chile.

Métodos:

Estudo transversal, realizado entre março de 2020 e dezembro de 2022. Participaram 118 pessoas de dois hospitais públicos. Foram utilizados questionários QLQ-C30 e QLQ-MY20. A consistência interna foi avaliada com alfa de Cronbach(α) e a validade de construto através de testes de hipóteses (Mann Whitney e correlação de Spearman).

Resultados:

A idade média dos participantes era de 67,2 (DP=9,2) anos. Consistência interna para escala completa (α=0,779), dimensão “sintomas da doença” (α=0,671), dimensão “efeitos colaterais dos tratamentos” (α=0,538) e dimensão “perspectiva de futuro” (α=0,670). Quatro das cinco hipóteses de validade de construto foram confirmadas: as mulheres apresentaram mais sintomas, assim como pessoas com pior estado de desempenho, com dor e com maior fadiga.

Conclusões:

A versão chilena do QLQ-MY20 apresenta consistência interna adequada e validade de construto.

Descritores
Mieloma Múltiplo; Qualidade de Vida; Estudo de Validação; Psicometria; Dor.

RESUMEN

Objetivos:

Evaluar consistencia interna y validez de constructo del QLQ-MY20 para valoración de calidad de vida en sobrevivientes de mieloma múltiple en Chile.

Métodos:

Estudio transversal, realizado entre marzo 2020 y diciembre 2022. Participaron 118 personas de dos hospitales públicos. Se utilizaron los cuestionarios QLQ-C30 y QLQ-MY20. Fueron evaluadas la consistencia interna con alfa de Cronbach (α) y validez de constructo mediante pruebas de hipótesis (Mann Whitney y correlación de Spearman).

Resultados:

El promedio de edad de los participantes era 67,2 (DE=9,2) años. Consistencia interna para escala completa (α=0,779), dimensión “síntomas de la enfermedad” (α=0,671), dimensión “efectos secundarios de los tratamientos” (α=0,538) y dimensión “perspectiva de futuro” (α=0,670). Se comprobaron cuatro de las cinco hipótesis de la validez de constructo: presentaron más síntomas las mujeres, personas con peor performance estatus, con dolor y con peor fatiga.

Conclusiones:

La versión chilena del QLQ-MY20 presenta adecuada consistencia interna y validez de constructo.

Descriptores
Mieloma Múltiple; Calidad de Vida; Estudios de Validación; Psicometría; Dolor.

INTRODUCTION

Multiple Myeloma (MM) is a neoplasm of plasma cells, accounting for 10% of hematological neoplasms(11 Siegel RL, Miller KD, Jemal A. Cancer Statistics: 2017. CA Cancer J Clin. 2017;67(1):7-30. https://doi.org/10.3322/caac.21387
https://doi.org/10.3322/caac.21387...
). It is primarily diagnosed in older adults, with the median age at diagnosis in Chile’s public system being 65 years. However, a third of diagnosed patients are under 60 years old(22 Peña C, Rojas C, Rojas H, Soto P, Cardemil D, Aranda S, et al. Survival of 1,103 Chilean patients with multiple myeloma receiving different therapeutic protocols from 2000 to 2016. Rev Med Chile. 2018;146(7):869-75. https://doi.org/10.4067/s0034-98872018000700869
https://doi.org/10.4067/s0034-9887201800...
). In Chile, epidemiological data collected in the Second National Cancer Surveillance Report 2020 estimated the incidence of MM, by gender, at 4.3 cases per 100,000 inhabitants per year in men and 3.2 cases per 100,000 inhabitants per year in women, for the period from 2003-2010. This period saw 853 new cases reported annually and a prevalence of 2207 cases over five years(33 Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71:209-49. https://doi.org/10.3322/caac.21660
https://doi.org/10.3322/caac.21660...
). Both in Chile and in Latin America(44 Peña C, Riva E, Schutz N, Tarín-Arzaga L, Martínez-Cordero H, Bove V, et al. Different outcomes for transplant-eligible newly diagnosed multiple myeloma patients in Latin America according to the public versus private management: a GELAMM study. Leuk Lymphoma 2020;61(13):3112-9. https://doi.org/10.1080/10428194.2020.1804558
https://doi.org/10.1080/10428194.2020.18...
), the diagnosis is often made in more advanced stages of the disease, which tends to have higher morbidity and mortality compared to cohorts from developed countries(55 Conte G, Figueroa G, Lois V, Cabrera ME, León A, García H, et al. Mieloma múltiple en Chile: características clínicas y sobrevida. Rev Med Chile 2007;135:1111-7. https://doi.org/10.4067/S0034-98872007000900003
https://doi.org/10.4067/S0034-9887200700...
). Advances in screening and new therapeutic options, however, have improved survival rates, and health-related quality of life (HRQoL) has become an important therapeutic goal(66 Fayers PM, Machin D, (eds). Quality of life: the assessment, analysis, and interpretation of patient-reported outcomes. 2nd ed. West Sussex UK: Wiley; 2007.).

Patients diagnosed with MM have shown significant improvements in overall survival, leading to a considerable number of older people living with the disease(77 Hevroni G, Korde N. Examining health related quality of life outcomes in multiple myeloma: past and future perspectives. Semin Oncol. 2022;49(1):94-102. https://doi.org/10.1053/j.seminoncol.2022.01.002
https://doi.org/10.1053/j.seminoncol.202...
). However, due to the effects of the disease itself and its treatments, patients experience deterioration in physical function, emotional and psychological well-being, social well-being, and work capability(88 LeBlanc MR, Bryant AL, LeBlanc TW, Yang Q, Sellars E, Chase CC, et al. A cross-sectional observational study of health-related quality of life in adults with multiple myeloma. Support Care Cancer. 2022;30(6):5239-48. https://doi.org/10.1007/s00520-022-06943-5
https://doi.org/10.1007/s00520-022-06943...
). Additionally, they suffer from a significant symptom burden, such as fatigue and pain, which can significantly affect their quality of life, especially in older individuals(99 Kontodimopoulos N, Samartzis A, Papadopoulos AA, Niakas D. Reliability and validity of the Greek QLQ-C30 and QLQ-MY20 for measuring quality of life in patients with multiple myeloma. Scient World J. 2012:842867. https://doi.org/10.1100/2012/842867
https://doi.org/10.1100/2012/842867...
).

Survivors of MM experience substantial long-term quality of life issues and are second only to lung cancer patients in terms of the worst HRQoL across all cancer types(1010 Nicol JL, Woodrow C, Cunningham BJ, Mollee P, Weber N, Smith MD, et al. An individualized exercise intervention for people with multiple myeloma-study protocol of a randomized waitlist-controlled trial. Curr Oncol. 2022;29(2):901-23. https://doi.org/10.3390/curroncol29020077
https://doi.org/10.3390/curroncol2902007...
). It has also been shown that MM patients have the lowest HRQoL scores compared to patients with other hematological cancers(1111 Li X, Liu J, Chen M, Gu J, Huang B, Zheng D, et al. Health-related quality of life of patients with multiple myeloma: a real-world study in China. Cancer Med. 2020;9:7896-913. https://doi.org/10.1002/cam4.3391
https://doi.org/10.1002/cam4.3391...
). Traditionally, studies in onco-hematology have considered objective clinical outcome measures, such as clinical response or survival. However, both patients and clinical researchers now argue that subjective outcome measures, such as HRQoL, should also be considered(1212 Espinoza-Zamora JR, Portilla-Espinosa CM, Labardini-Méndez JR, Cervera E, Niesvisky R, Oñate-Ocaña LF. Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument. Ann Hematol. 2015;94(6):1017-24. https://doi.org/10.1007/s00277-014-2290-y
https://doi.org/10.1007/s00277-014-2290-...
).

Considering the relevant and specific problems related to MM, the European Organization for Research and Treatment of Cancer Quality of Life Group (EORTC)(1313 Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. https://doi.org/10.1093/jnci/85.5.365
https://doi.org/10.1093/jnci/85.5.365...
) created and validated the specific module Quality of Life Questionnaire for Myeloma (QLQ-MY20)(1414 Cocks K, Cohen D, Wisløff F, Sezer O, Lee S, Hippe E, et al. EORTC Quality of Life Group. an international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer. 2007;43(11):1670-8. https://doi.org/10.1016/j.ejca.2007.04.022
https://doi.org/10.1016/j.ejca.2007.04.0...
). The QLQ-MY20 questionnaire has been validated in many countries(99 Kontodimopoulos N, Samartzis A, Papadopoulos AA, Niakas D. Reliability and validity of the Greek QLQ-C30 and QLQ-MY20 for measuring quality of life in patients with multiple myeloma. Scient World J. 2012:842867. https://doi.org/10.1100/2012/842867
https://doi.org/10.1100/2012/842867...
,1212 Espinoza-Zamora JR, Portilla-Espinosa CM, Labardini-Méndez JR, Cervera E, Niesvisky R, Oñate-Ocaña LF. Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument. Ann Hematol. 2015;94(6):1017-24. https://doi.org/10.1007/s00277-014-2290-y
https://doi.org/10.1007/s00277-014-2290-...
,1515 Ahmadzadeh A, Yekaninejad MS, Saffari M, Pakpour AH, Aaronson NK. Reliability and Validity of an Iranian Version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Patients with Multiple Myeloma: the EORTC QLQ-MY20. Asian Pac J Cancer Prev. 2016;17(1):255-9. https://doi.org/10.7314/apjcp.2016.17.1.255
https://doi.org/10.7314/apjcp.2016.17.1....
-1616 Malta JS, Silveira LP, Drummond PLM, Costa NL, Santos RMM, Reis IA, et al. Validity and reliability of the QLQ-MY20 module for assessing the health-related quality of life in Brazilians with multiple myeloma. Curr Med Res Opin. 2021;37(7):1163-69. https://doi.org/10.1080/03007995.2021.1929136
https://doi.org/10.1080/03007995.2021.19...
) and is relevant in the clinical management of MM patients, as it has the potential to improve treatment outcomes(1717 Mathew A, Farooqui HH, Kumar L. Quality of life assessment & out-of-pocket expenditure in multiple myeloma: an observational study. Indian J Med Res. 2021;154(6):823-32. https://doi.org/10.4103/ijmr.IJMR_4028_20
https://doi.org/10.4103/ijmr.IJMR_4028_2...
). The questionnaire is available in a Spanish version translated for Chile, but its psychometric properties have yet to be evaluated. Validating the QLQ-MY20 questionnaire for the Chilean population will allow for the assessment of the perceived quality of life and health status by patients in relation to their disease. Furthermore, HRQoL research is currently gaining more importance as it is a relevant outcome in clinical studies, alongside survival, treatment efficacy, and patient adaptation to their disease.

OBJECTIVE

To evaluate the internal consistency and construct validity of the QLQ-MY20 questionnaire for assessing Health-Related Quality of Life (HRQoL) in survivors of multiple myeloma in Chile.

METHODS

Ethical Considerations

This study was conducted in accordance with national and international ethical guidelines and was approved by the Scientific Ethics Committee of the Metropolitan East Health Service on 3rd of March 2020, with their opinion attached to this submission. All participants gave their informed consent in writing.

Study Design

This was an observational, cross-sectional validation study. The study was conducted between March 2020 and December 2022 in two public hospitals in Chile located in Santiago (Hospital del Salvador) and Viña del Mar (Hospital Gustavo Fricke). Reporting guidelines for validation studies from COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) were followed(1818 Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19(4):539-49. https://doi.org/10.1007/s11136-010-9606-8
https://doi.org/10.1007/s11136-010-9606-...
).

Population and Setting

The study population consisted of adult survivors of MM, who were patients at two Chilean public hospitals, regularly attending Hematology and Physical Medicine and Rehabilitation services, and were in different stages of the disease. A total of 118 individuals were enrolled. The sample was of a consecutive type. Recruitment was carried out by five health clinical professionals (one hematologist and four physiotherapists) who conducted face-to-face interviews to apply the scales.

Exclusion criteria included patients with another associated neoplasm, critically ill patients, those with cognitive impairment or illiteracy (insufficient understanding of Spanish), and individuals with any hearing or cognitive impairment that prevented them from responding to the questionnaires. For the evaluation of cognitive dimensions, the abbreviated mini-mental test was used(1919 Jiménez D, Lavados M, Rojas P, Henríquez C, Silva F, Guillón M. Evaluación del minimental abreviado de la evaluación funcional del adulto mayor (EFAM) como screening para la detección de demencia en la atención primaria. Rev Med Chile 2017;145(7):862-8. https://doi.org/10.4067/s0034-98872017000700862
https://doi.org/10.4067/s0034-9887201700...
).

The sample size was estimated based on the primary objective of the study. Statistical literature suggests a minimum of 5 participants per questionnaire item(2020 Field A. Descobrindo a estatística usando o SPSS. Porto Alegre: Artmed; 2009.); thus, considering the questionnaire has 20 items, it was estimated that a minimum of 100 individuals should be evaluated. All adults who met the eligibility criteria were evaluated until the desired sample size was achieved.

Study Protocol

For the execution of this study, the EORTC Quality of Life Group authorized the use of their questionnaires, providing the Spanish version. The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, nausea, and vomiting); and a global health scale. Additionally, it incorporates six individual items assessing symptoms that cancer patients may experience, such as dyspnea, loss of appetite, sleep disorders, constipation, and diarrhea(1313 Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. https://doi.org/10.1093/jnci/85.5.365
https://doi.org/10.1093/jnci/85.5.365...
). Each item is rated on a scale from 1 to 4 (1=not at all, 2=a little, 3=quite a bit, 4=very much). For the final calculation, the scores of the 30 items are summed and divided by 30, yielding a quality of life score ranging from 0 (very poor) to 100 (excellent) for the functional dimensions. For the symptom dimension, a higher score corresponds to a higher level of symptom burden, with 100 interpreted as “maximum symptom burden” and 0 as “no symptoms”(1313 Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. https://doi.org/10.1093/jnci/85.5.365
https://doi.org/10.1093/jnci/85.5.365...
). The EORTC QLQ-C30 has been validated for Chile in patients diagnosed with breast cancer(2121 Irarrázaval ME, Rodríguez PF, Fasce G, Silva FW, Waintrub H, Torres C, et al. Calidad de vida en cáncer de mama: validación del cuestionario BR23 en Chile. Rev Med Chile, 2013;141:723-4. https://doi.org/10.4067/S0034-98872013000600006
https://doi.org/10.4067/S0034-9887201300...
).

The EORTC QLQ-MY20 was developed as a supplement to the EORTC QLQ-C30 to assess the quality of life of patients with MM(1313 Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. https://doi.org/10.1093/jnci/85.5.365
https://doi.org/10.1093/jnci/85.5.365...
). It consists of 20 questions grouped into four dimensions assessing “future perspective” (3 items), “disease symptoms” (6 items), “treatment side effects” (10 items), and a single item on “body image”(1414 Cocks K, Cohen D, Wisløff F, Sezer O, Lee S, Hippe E, et al. EORTC Quality of Life Group. an international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer. 2007;43(11):1670-8. https://doi.org/10.1016/j.ejca.2007.04.022
https://doi.org/10.1016/j.ejca.2007.04.0...
). Responses are scored on a four-point scale, ranging from “1=not at all” to “4=very much”. Scores are linearly transformed to a 0-100 scale. Higher scores in the body image and future perspective scales represent better outcomes, while higher scores in the symptoms and side effects scales indicate worse outcomes. For HRQoL assessment, the EORTC group recommends using both questionnaires. For calculating and estimating the scores of both instruments, a detailed manual provided by the EORTC group was used, available on the EORTC website(2222 Fayers PM. EORTC QLQ-C30 Scoring Manual. 3rd edition. Brussels: EORTC; 2001.).

Information was collected from clinical records regarding sociodemographic variables (age, gender, education, marital status, institution) and clinical variables (cancer treatments received, nutritional status, smoking habits, alcohol consumption, and presence of vertebral fractures). Additionally, fatigue was assessed with the Brief Fatigue Inventory(2323 Lorca LA, Sacomori C, Puga B. Propiedades psicométricas del inventario breve de fatiga en personas tratadas por neoplasias hematológicas en Chile. Rev Med Chile, 2016;144:894-9. https://doi.org/10.4067/S0034-98872016000700010
https://doi.org/10.4067/S0034-9887201600...
), and performance status with the ECOG (Eastern Cooperative Oncology Group)(2424 Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol [Internet]. 1982[cited 2023 Sep 01];5(6):649-55. Available from: https://pubmed.ncbi.nlm.nih.gov/7165009/
https://pubmed.ncbi.nlm.nih.gov/7165009/...
).

Analysis of Results and Statistics

The data were tabulated in Excel and analyzed using SPSS software version 20. Descriptive statistical methods such as frequency, mean, median, and interquartile range were used. Internal consistency was measured using Cronbach’s alpha (α), where values of α>0.70 were considered to indicate high internal consistency, and values between 0.5 and 0.7 were considered as indicating moderate internal consistency(2525 Streiner DL. Being inconsistent about consistency: when coefficient alpha does and doesn’t matter. J Pers Assess. 2003;80(3):217-22. https://doi.org/10.1207/S15327752JPA8003_01
https://doi.org/10.1207/S15327752JPA8003...
-2626 Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018;27(5):1147-57. https://doi.org/10.1007/s11136-018-1798-3
https://doi.org/10.1007/s11136-018-1798-...
). The normality of the data was tested with the Kolmogorov-Smirnov test and a normal curve graph for observing symmetry and kurtosis.

For the analysis of construct validity, hypothesis tests were conducted using the Mann-Whitney U test to determine how well the QLQ-MY20 could discriminate between independent patient subgroups. Five hypotheses were proposed, expecting that the “disease symptoms” and “treatment side effects” dimensions would present higher scores in [1] women; [2] those with worse performance status; [3] those with pain; [4] those with the presence of fractures; and [5] those with moderate/severe fatigue. For the “body image” dimension, better scores were expected in men. For the “future perspective” dimension, better scores were expected in men and in people without pain, with mild fatigue, and without fractures.

In this study, performance status was categorized as good (ECOG: 0-1) and poor (ECOG: 2-3). For the fatigue variable, the cutoff point given by item 3 of the instrument was used, with the following categorization: individuals without fatigue or with mild fatigue (scores from 0 to 3) and individuals with moderate or severe fatigue (scores from 4 to 10).

Finally, to identify clinical differences and overlaps, correlation analyses were performed between the dimensions of the QLQ-MY20 and the QLQ-C30, using Pearson’s correlation test. A 95% confidence level was established for all analyses.

RESULTS

Sample Characterization

This study involved 118 patients (Table 1). The average age was 67.2 years (SD=9.2; Median=68; Minimum value=41; Maximum value=86). The majority were men (51.6%). Regarding treatments, most were treated with chemotherapy (n=116; 98.3%); 42 individuals (35.6%) received radiotherapy, and only two (1.7%) underwent hematopoietic stem cell transplantation. Additionally, 54 individuals had experienced vertebral fractures (45.8%). Furthermore, 37 individuals (31.3%) presented with a performance status (ECOG 2 and 3) and were unable to take care of their work, needing to be in bed at least 50% of the time. The most frequent comorbidities were isolated musculoskeletal disorders (24.6%) and those associated with other comorbidities. The “moderate” level of fatigue was the most prevalent, observed in 66 participants (55.9%), and the majority reported pain in some part of the body (88.9%).

Table 1
Characteristics of Patients with Multiple Myeloma from Santiago and Viña del Mar, Chile (N=118)

Quality of Life Characterization

Regarding the characterization of the dimensions of health-related quality of life (Table 2), it is possible to identify that the functional dimensions with the lowest scores were role functioning, social functioning, global health, and future perspective. Meanwhile, among the items related to cancer-related symptoms, those with the greatest impact on quality of life were insomnia, pain, fatigue, and financial difficulties. The symptoms of nausea and diarrhea showed a floor effect (16.7% and 33.3%, respectively).

Table 2
Characterization of the Quality of Life Dimensions in Patients with Multiple Myeloma from Santiago and Viña del Mar, Chile (N=118)

Table 2 describes the specific aspects related to the Health-Related Quality of Life (HRQoL) of multiple myeloma (MY 20). It is noteworthy that, in terms of symptoms associated with MM, the dimension that showed the greatest impact was “disease symptoms” (Median=33.3%) compared to “treatment side effects” (Median=23.3%). As for the functional dimensions, “future perspective” (Median=66.7%) showed a greater impact than “body image” (Median=100%), with the latter dimension exhibiting a tendency towards a ceiling effect.

Psychometric Properties of the QLQ-MY20

The internal consistency of both questionnaires and each dimension was moderate (Table 2). A high Cronbach’s alpha of 0.779 was obtained for the total QLQ-MY20 questionnaire.

Regarding the hypothesis tests for construct validity, four out of the five proposed hypotheses were confirmed. When comparing the QLQ-MY20 scores between men and women (Figure 1), it was identified that women had significantly lower “body image” scores (p=0.041) and higher scores in symptomatology (“disease symptoms” and “treatment side effects”; p=0.007 and p=0.041, respectively).

Figure 1
Comparison of EORTC QLQ-MY20 Scores Between Men and Women

Patients with poor performance status (ECOG 2 and 3) significantly exhibited more “disease symptoms” and “treatment side effects” compared to patients with a good ECOG performance status (0 and 1) - See Figure 2.

Figure 2
Comparison of EORTC QLQ-MY20 Scores Based on Performance Status (ECOG)

Individuals with pain had higher scores for “disease symptoms” (p<0.001), “treatment side effects” (p=0.001), and lower “future perspective” (p<0.001) compared to those who did not report experiencing pain.

Patients with moderate/severe fatigue presented higher scores for “disease symptoms” (p=0.009), “treatment side effects” (p=0.035) compared to individuals without fatigue or with mild fatigue.

There was no statistically significant difference between individuals with and without vertebral fractures regarding the dimensions of the QLQ-MY20 (p>0.05).

Finally, most of the dimensions of the QLQ-MY20 were significantly correlated with the dimensions of the QLQ-C30 (Table 3). The strongest correlations were for the “disease symptoms” dimension of the QLQ-MY20 with the fatigue dimension (Spearman’s rho=0.594) and pain dimension (Spearman’s rho=0.663). Higher scores for “disease symptoms” and “treatment side effects” were associated with worse scores in physical functioning, role functioning, emotional, social, cognitive functioning, and global health (negative correlations, Spearman’s rho between -0.236 and -0.443).

Table 3
Correlations between the dimensions of the EORTC QLQ-MY20 and EORTC QLQ-C30 among patients with multiple myeloma from Santiago and Viña del Mar, Chile (N=118)

DISCUSSION

This study identified that the Chilean Spanish version of the QLQ-MY20 questionnaire for the assessment of Health-Related Quality of Life (HRQoL) demonstrated good results in terms of internal consistency and construct validity. Overall, the psychometric properties of the QLQ-MY20 were strong, similar to the data reported in other validation studies of the questionnaire(99 Kontodimopoulos N, Samartzis A, Papadopoulos AA, Niakas D. Reliability and validity of the Greek QLQ-C30 and QLQ-MY20 for measuring quality of life in patients with multiple myeloma. Scient World J. 2012:842867. https://doi.org/10.1100/2012/842867
https://doi.org/10.1100/2012/842867...
,1212 Espinoza-Zamora JR, Portilla-Espinosa CM, Labardini-Méndez JR, Cervera E, Niesvisky R, Oñate-Ocaña LF. Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument. Ann Hematol. 2015;94(6):1017-24. https://doi.org/10.1007/s00277-014-2290-y
https://doi.org/10.1007/s00277-014-2290-...
,1515 Ahmadzadeh A, Yekaninejad MS, Saffari M, Pakpour AH, Aaronson NK. Reliability and Validity of an Iranian Version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Patients with Multiple Myeloma: the EORTC QLQ-MY20. Asian Pac J Cancer Prev. 2016;17(1):255-9. https://doi.org/10.7314/apjcp.2016.17.1.255
https://doi.org/10.7314/apjcp.2016.17.1....
-1616 Malta JS, Silveira LP, Drummond PLM, Costa NL, Santos RMM, Reis IA, et al. Validity and reliability of the QLQ-MY20 module for assessing the health-related quality of life in Brazilians with multiple myeloma. Curr Med Res Opin. 2021;37(7):1163-69. https://doi.org/10.1080/03007995.2021.1929136
https://doi.org/10.1080/03007995.2021.19...
). Internal consistency showed adequate values for the complete questionnaire and moderate consistency for each dimension. The moderate internal consistency obtained for some scales may be a result of the small number of items in each domain and the heterogeneity of the studied population, rather than due to the low internal consistency of the items(2626 Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018;27(5):1147-57. https://doi.org/10.1007/s11136-018-1798-3
https://doi.org/10.1007/s11136-018-1798-...
).

Regarding construct validity, the results mostly met expectations, with 4 out of 5 hypothesis tests being confirmed. Low performance status was associated with worse HRQoL. Previous studies have also linked functional status to lower levels of functioning, higher symptom levels, and poorer quality of life(1111 Li X, Liu J, Chen M, Gu J, Huang B, Zheng D, et al. Health-related quality of life of patients with multiple myeloma: a real-world study in China. Cancer Med. 2020;9:7896-913. https://doi.org/10.1002/cam4.3391
https://doi.org/10.1002/cam4.3391...
,2727 Kiely F, Cran A, Finnerty D, O’Brien T. Self-Reported quality of life and symptom burden in ambulatory patients with multiple myeloma on disease-modifying treatment. Am J Hosp Palliat Care. 2017;34(7):671-6. https://doi.org/10.1177/1049909116646337
https://doi.org/10.1177/1049909116646337...
). In a German study, functional status, assessed with ECOG, was the strongest determinant of HRQoL(2828 Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, et al. Real-world evaluation of health-related quality of life in patients with multiple myeloma from Germany. Clin Lymphoma Myeloma Leuk. 2021;21(2):e160-e175. https://doi.org/10.1016/j.clml.2020.10.002
https://doi.org/10.1016/j.clml.2020.10.0...
).

Concerning fatigue, it was confirmed that higher levels were associated with worse HRQoL. Fatigue, along with the reduction of physical functioning and breathing difficulties experienced by people with MM, has been known to contribute to poor HRQoL(1111 Li X, Liu J, Chen M, Gu J, Huang B, Zheng D, et al. Health-related quality of life of patients with multiple myeloma: a real-world study in China. Cancer Med. 2020;9:7896-913. https://doi.org/10.1002/cam4.3391
https://doi.org/10.1002/cam4.3391...
,2929 Koutoukidis DA, Land J, Hackshaw A, Heirich M, McCourt O, Beeken RJ, et al. Fatigue, quality of life and physical fitness following an exercise intervention in multiple myeloma survivors (MASCOT): an exploratory randomised Phase 2 trial utilising a modified Zelen design. Br J Cancer 2020;123:187-95. https://doi.org/10.1038/s41416-020-0866
https://doi.org/10.1038/s41416-020-0866...
). Additionally, fatigue has been linked to greater deterioration of daily activities, shorter disease-free progression, and overall survival(2929 Koutoukidis DA, Land J, Hackshaw A, Heirich M, McCourt O, Beeken RJ, et al. Fatigue, quality of life and physical fitness following an exercise intervention in multiple myeloma survivors (MASCOT): an exploratory randomised Phase 2 trial utilising a modified Zelen design. Br J Cancer 2020;123:187-95. https://doi.org/10.1038/s41416-020-0866
https://doi.org/10.1038/s41416-020-0866...
).

In this study, patients who reported experiencing pain had higher scores for the two symptom dimensions and lower scores for future perspective compared to those without pain. Bone pain is a significant symptom in MM(3030 Diaz-delCastillo M, Chantry AD, Lawson MA, Heegaard A. Multiple myeloma: a painful disease of the bone marrow. Semin Cell Dev Biol 2021;112:49-58. https://doi.org/10.1016/j.semcdb.2020.10.006
https://doi.org/10.1016/j.semcdb.2020.10...
). Even when the disease is stabilized, 63% of patients report moderate or severe pain, and 80% report that pain affects their daily lives(3131 Jespersen E, Nielsen LK, Larsen RF, Möller S, Jarlbæk L. Everyday living with pain: reported by patients with multiple myeloma. Scand J Pain 2020;21(1):127-34. https://doi.org/10.1515/sjpain-2020-0087
https://doi.org/10.1515/sjpain-2020-0087...
). Pain can be present at different stages of the disease and may manifest as: bone pain induced by myeloma, peripheral neuropathic pain induced by chemotherapy, post-herpetic neuralgia induced by post-transplant immune depression, and pain in cancer survivors(3232 Shi H, Ren H, Tian Y, Chen Z, Xu C, Lu L, et al. Pain as a risk factor of depression and anxiety symptoms with multiple myeloma during maintenance therapy. Front Psychol. 2022;13:1015497. https://doi.org/10.3389/fpsyg.2022.1015497
https://doi.org/10.3389/fpsyg.2022.10154...
).

Regarding gender, women experienced worse HRQoL than men in the dimensions of symptoms and body image. This finding, which has been reported previously, indicates that female gender, along with older age, predicts worse HRQoL in people with MM(3333 Despiége N, Toubou C, Flinois A, Saba G, Suzan F, Gonzalez-McQuire S, et al. Health-related quality of life of patients with multiple myeloma treated in routine clinical practice in France. Clin Lymphoma Myeloma Leuk 2019;19:e13-28. https://doi.org/10.1016/j.clml.2018.08.019
https://doi.org/10.1016/j.clml.2018.08.0...
). Additionally, a meta-analysis showed that, in general, men have higher levels of body appreciation compared to women, although the effect size was small(3434 He J, Sun S, Zickgraf HF, Lin Z, Fan X. Meta-analysis of gender differences in body appreciation. Body Image. 2020;33:90-100. https://doi.org/10.1016/j.bodyim.2020.02.011
https://doi.org/10.1016/j.bodyim.2020.02...
).

The only hypothesis not confirmed in this study was the influence of vertebral fractures on HRQoL, as there was no statistically significant difference between individuals with and without vertebral fractures. This result differs from the original validation study(1414 Cocks K, Cohen D, Wisløff F, Sezer O, Lee S, Hippe E, et al. EORTC Quality of Life Group. an international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer. 2007;43(11):1670-8. https://doi.org/10.1016/j.ejca.2007.04.022
https://doi.org/10.1016/j.ejca.2007.04.0...
) and the Iranian study(1515 Ahmadzadeh A, Yekaninejad MS, Saffari M, Pakpour AH, Aaronson NK. Reliability and Validity of an Iranian Version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Patients with Multiple Myeloma: the EORTC QLQ-MY20. Asian Pac J Cancer Prev. 2016;17(1):255-9. https://doi.org/10.7314/apjcp.2016.17.1.255
https://doi.org/10.7314/apjcp.2016.17.1....
). A possible explanation is that the patients in this study were in better functional conditions, and those with fractures needing rehabilitation are promptly referred to a structured program existing in both participating institutions. Furthermore, patients can access technical aids and orthoses if required, which aims to enhance functioning and limit dependence.

In terms of the correlations between the QLQ-C30 and QLQ-MY20, the results support the construct validity. Scales that are conceptually correlated showed high correlations, while scales with less in common demonstrated lower correlations. This indicates that both questionnaires are robust and capable of providing reliable and precise descriptions of the HRQoL of patients with MM.

In this study, using the QLQ-C30 questionnaire, the dimensions most affected were role functioning, social functioning, and global health, which is similar to results obtained in other studies(99 Kontodimopoulos N, Samartzis A, Papadopoulos AA, Niakas D. Reliability and validity of the Greek QLQ-C30 and QLQ-MY20 for measuring quality of life in patients with multiple myeloma. Scient World J. 2012:842867. https://doi.org/10.1100/2012/842867
https://doi.org/10.1100/2012/842867...
,1212 Espinoza-Zamora JR, Portilla-Espinosa CM, Labardini-Méndez JR, Cervera E, Niesvisky R, Oñate-Ocaña LF. Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument. Ann Hematol. 2015;94(6):1017-24. https://doi.org/10.1007/s00277-014-2290-y
https://doi.org/10.1007/s00277-014-2290-...
,3535 Ramsenthaler C, Kane P, Gao W, Siegert RJ, Edmonds PM, Schey SA, et al. Prevalence of symptoms in patients with multiple myeloma: a systematic review and meta-analysis. Eur J Haematol. 2016;97:416-29. https://doi.org/10.1111/ejh.12790
https://doi.org/10.1111/ejh.12790...
). Regarding the symptom-related dimensions, fatigue, pain, insomnia, and financial problems were identified as having a greater impact on HRQoL, findings that are also described in other studies(1717 Mathew A, Farooqui HH, Kumar L. Quality of life assessment & out-of-pocket expenditure in multiple myeloma: an observational study. Indian J Med Res. 2021;154(6):823-32. https://doi.org/10.4103/ijmr.IJMR_4028_20
https://doi.org/10.4103/ijmr.IJMR_4028_2...
,3636 Osborne TR, Ramsenthaler C, Wolf-Linder S, Schey SA, Siegert RJ, Edmonds PM, et al. Understanding what matters most to people with multiple myeloma: a qualitative study of views on quality of life. BMC Cancer. 2014;14:496. https://doi.org/10.1186/1471-2407-14-496
https://doi.org/10.1186/1471-2407-14-496...
). It has been reported that insomnia is common in most MM patients(1111 Li X, Liu J, Chen M, Gu J, Huang B, Zheng D, et al. Health-related quality of life of patients with multiple myeloma: a real-world study in China. Cancer Med. 2020;9:7896-913. https://doi.org/10.1002/cam4.3391
https://doi.org/10.1002/cam4.3391...
), affecting caregivers and family members as well, and exacerbates other symptoms such as fatigue and pain(3737 Induru RR, Walsh D. Cancer-related insomnia. Am J Hosp Palliat Care. 2014;31:777-85. https://doi.org/10.1177/1049909113508302
https://doi.org/10.1177/1049909113508302...
). Although the Chilean health system provides guaranteed access to MM treatment, some patients reported that due to the disease, loss of income and returning to work were challenging. Additionally, a significant percentage needed to cover extra expenses for transportation to hospital visits and for care.

Regarding the QLQ-MY20, participants in this study experienced a greater impact in the “disease symptoms” dimension, similar to the validation study of the Greek version(99 Kontodimopoulos N, Samartzis A, Papadopoulos AA, Niakas D. Reliability and validity of the Greek QLQ-C30 and QLQ-MY20 for measuring quality of life in patients with multiple myeloma. Scient World J. 2012:842867. https://doi.org/10.1100/2012/842867
https://doi.org/10.1100/2012/842867...
). In the “future perspective” dimension, a significant percentage were concerned about their future health and afraid of dying. The body image dimension, especially among men, did not appear to be greatly affected, aligning with what was reported in another study(3434 He J, Sun S, Zickgraf HF, Lin Z, Fan X. Meta-analysis of gender differences in body appreciation. Body Image. 2020;33:90-100. https://doi.org/10.1016/j.bodyim.2020.02.011
https://doi.org/10.1016/j.bodyim.2020.02...
).

Study Limitations

One limitation was the lack of access to complete treatment duration records, which prevented the control of this variable. Additionally, it was not possible to perform a concurrent validity analysis due to the absence of a comparable instrument.

Contributions to Nursing, Health, or Public Policy

This instrument, available in Spanish, will be useful for analyzing the clinical outcomes and HRQoL of patients with multiple myeloma who receive nursing care. Measuring HRQoL is crucial for guiding patient treatment in a comprehensive, systematic, and scientific manner.

CONCLUSIONS

The Chilean version of the QLQ-MY20 questionnaire demonstrates adequate internal consistency and construct validity, making it a robust tool for assessing HRQoL in adult survivors of MM. Therefore, it is recommended for clinical application. The promotion and maintenance of quality of life should be integrated as objectives of clinical care and as criteria for systematic evaluation. An intervention model aimed at improving HRQoL to facilitate interdisciplinary rehabilitation in MM survivors is suggested. Additionally, future studies should investigate the instrument’s responsiveness in detecting changes in HRQoL related to different stages of the disease and following treatments.

AVAILABILITY OF DATA AND MATERIAL

https://doi.org/10.48331/scielodata.KZR5M3

ACKNOWLEDGMENT

The authors thank all the patients who gave their valuable time participating in this study.

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Edited by

EDITOR IN CHIEF: Antonio José de Almeida Filho
ASSOCIATE EDITOR: Ana Fátima Fernandes

Publication Dates

  • Publication in this collection
    03 May 2024
  • Date of issue
    2024

History

  • Received
    12 Sept 2023
  • Accepted
    25 Nov 2023
Associação Brasileira de Enfermagem SGA Norte Quadra 603 Conj. "B" - Av. L2 Norte 70830-102 Brasília, DF, Brasil, Tel.: (55 61) 3226-0653, Fax: (55 61) 3225-4473 - Brasília - DF - Brazil
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