Validación para utilización en Colombia de la escala EORTC QLQ C-30 para evaluación de la calidad de vida de los pacientes con cáncer

Autores/as

  • Ricardo Sánchez Pedraza Instituto Nacional de Cancerología, Bogotá D. C., Colombia - Instituto de Investigaciones Clínicas, Facultad de Medicina, Universidad Nacional de Colombia, Bogotá D. C., Colombia
  • Adriana Valderamar Instituto Nacional de Cancerología, Bogotá D. C., Colombia

DOI:

https://doi.org/10.35509/01239015.128

Palabras clave:

Calidad de vida, Neoplasia, Estudios de Validación, Confiabilidad, Validez

Resumen

Objetivo: Validar la versión colombiana de la escala EORTC QLQC-30 para medir calidad de vida en pacientes con diagnóstico de cáncer en Colombia.

Métodos: La validez de la escala se determinó usando métodos de análisis factorial  exploratorio y confirmatorio. Adicionalmente, para medir la validez de criterio concurrente se utilizaron análisis de correlación entre dominios de las escalas EORTC QLQC-30 y FACIT-G. Para evaluar la confiabilidad se efectuaron análisis de consistencia interna (se usaron coeficientes Alfa de Cronbach, Omega de McDonald y GLB), así como análisis de medidas repetidas (confiabilidad test-retest).

Resultados: En el estudio se incluyó un total de 486 pacientes ubicados en el Instituto Nacional de Cancerología en Colombia. Tanto el modelo estándar de 14 dominios como una solución empírica con cinco dominios (Físico, Psicológico, Debilidad, Socioeconómico y Puntaje Global) demostraron tener una adecuada representatividad del constructo. La correlación entre dominios del EORTC QLQC-30 y del FACT-G mostró valores bajos en el dominio relacionado con funcionamiento social. La correlación entre medidas repetidas tuvo valores de correlación-concordancia entre 0,51 y 0,8; los límites de acuerdo de Bland y Altman estuvieron entre -38 y 43 alrededor de un valor esperado de cero. Los valores de Alfa de Cronbach, GLB y Omega de McDonald tuvieron valores de 0,94 – 0,96 y 0,93 respectivamente.

Conclusión: La escala EORTC QLQC-30 es un instrumento válido y confiable para medir calidad de vida en pacientes con cáncer en Colombia.

Palabras clave: Calidad de vida. Neoplasia. Estudios de Validación. Confiabilidad. Validez.

Referencias bibliográficas

Lee SJ, Earle CC, Weeks JC. Outcomes research in oncology: history, conceptual framework, and trends in the literature. J Natl Cancer Inst. 2000;92(3):195-204. https://doi.org/10.1093/jnci/92.3.195

Bottomley A, Quinten C, Coens C, Martinelli F, Mauer M, Maringwa J, et al. Making better use of existing cancer data: Patient Reported Outcomes and Behavioural Evidence: a new international initiative. Eur J Cancer Care (Engl). 2009;18(2):1057. https://doi.org/10.1111/j.1365-2354.2009.01092.x

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, et al. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. Lancet Oncol. 2016;17(11):e510-e4.

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(5):365-76. https://doi.org/10.1093/jnci/85.5.365

Aaronson NK, Bullinger M, Ahmedzai S. A modular approach to quality-of-life assessment in cancer clinical trials. Recent Results Cancer Res. 1988;111:231-49. https://doi.org/10.1007/978-3642-83419-6_27

Valderas JM, Alonso J. Patient reported outcome measures: a model-based classification system for research and clinical practice. Qual Life Res. 2008;17(9):1125-35. https://doi.org/10.1007/s11136-008-9396-4

Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol. 2007;25(32):5121-7. https://doi.org/10.1200/JCO.2007.12.4784

Hjollund NHI, Valderas JM, Kyte D, Calvert MJ. Health Data Processes: A Framework for Analyzing and Discussing Efficient Use and Reuse of Health Data With a Focus on Patient-Reported Outcome Measures. J Med Internet Res. 2019;21(5):e12412. https://doi.org/10.2196/12412

Calvert M, Kyte D, Price G, Valderas JM, Hjollund NH. Maximising the impact of patient reported outcome assessment for patients and society. BMJ. 2019;364:k5267. https://doi.org/10.1136/bmj.k5267

Greenhalgh J, Gooding K, Gibbons E, Dalkin S, Wright J, Valderas J, et al. How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis. J Patient Rep Outcomes. 2018;2:42. https://doi.org/10.1186/s41687-018-0061-6

Cheng KK, Yeung RM. Impact of mood disturbance, sleep disturbance, fatigue and pain among patients receiving cancer therapy. Eur J Cancer Care (Engl). 2013;22(1):70-8. https://doi.org/10.1111/j.1365-2354.2012.01372.x

Cleeland CS. Symptom burden: multiple symptoms and their impact as patient-reported outcomes. J Natl Cancer Inst Monogr. 2007(37):16-21. https://doi.org/10.1093/jncimonographs/lgm005

Cella D, Nowinski CJ. Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system. Arch Phys Med Rehabil. 2002;83(12 Suppl 2):S10-7. https://doi.org/10.1053/apmr.2002.36959

Sanchez R, Ballesteros M, Arnold BJ. Validation of the FACT-G scale for evaluating quality of life in cancer patients in Colombia. Qual Life Res. 2011;20(1):19-29. https://doi.org/10.1007/s11136-010-9727-0

Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, et al. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008;19(12):2053-60. https://doi.org/10.1093/annonc/mdn417

Cheng JX, Liu BL, Zhang X, Zhang YQ, Lin W, Wang R, et al. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011;11:56. https://doi.org/10.1186/1471-2288-11-56

Cerezo O, Onate-Ocana LF, Arrieta-Joffe P, Gonzalez-Lara F, Garcia-Pasquel MJ, Bargallo-Rocha E, et al. Validation of the Mexican-Spanish version of the EORTC QLQ-C30 and BR23 questionnaires to assess health-related quality of life in Mexican women with breast cancer. Eur J Cancer Care (Engl). 2012;21(5):684-91. https://doi.org/10.1111/j.13652354.2012.01336.x

Tomaszewski KA, Puskulluoglu M, Biesiada K, Bochenek J, Nieckula J, Krzemieniecki K. Validation of the polish version of the EORTC QLQ-C30 and the QLQ-OG25 for the assessment of health-related quality of life in patients with esophagi-gastric cancer. J Psychosoc Oncol. 2013;31(2):191-203. https://doi.org/10.1080/07347332.2012.761323

Tan ML, Idris DB, Teo LW, Loh SY, Seow GC, Chia YY, et al. Validation of EORTC QLQ-C30 and QLQ-BR23 questionnaires in the measurement of quality of life of breast cancer patients in Singapore. Asia Pac J Oncol Nurs. 2014;1(1):22-32. https://doi.org/10.4103/2347-5625.135817

Viada C. Validation of the Proposed Reduced Quality of Life Questionnaire to the EORTC QLQ-C30 in Cubans Patients with Cancer. Value Health. 2014;17(7):A651. https://doi.org/10.1016/j.jval.2014.08.2369

Magaji BA, Moy FM, Roslani AC, Law CW, Sagap I. Psychometric Validation of the Malaysian Chinese Version of the EORTC QLQ-C30 in Colorectal Cancer Patients. Asian Pac J Cancer Prev. 2015;16(18):8107-12. https://doi.org/10.7314/APJCP.2015.16.18.8107

Muller K, Karrer S, Szeimies RM, Steinbauer J, Kohl E, Steinbauer D, et al. Quality of life assessment in patients with nonmelanoma skin cancer - psychometric validation of the EORTC QLQ-C30 questionnaire. J Dtsch Dermatol Ges. 2017;15(11):1090-100. https://doi.org/10.1111/ddg.13357

Sánchez R, Venegas M, Otero J, Sánchez O. Transcultural adaptation of two scales used to measure quality of life among cancer patients in Colombia: EORTC QLQ-C30 and QLQ-BR23. Rev Colomb Cancerol. 2009;13(4):205-12. https://doi.org/10.1016/S0123-9015(09)70119-2

Fayers P, Bottomley A, Group EQoL, Quality of Life U. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002;38(Suppl 4):S125-33. https://doi.org/10.1016/S09598049(01)00448-8

MacCallum RC, Widaman KF, Preacher KJ, Hong S. Sample Size in Factor Analysis: The Role of Model Error. Multivariate Behav Res. 2001;36(4):611-37. https://doi.org/10.1207/S15327906MBR3604_06

Schreiber JB. Core reporting practices in structural equation modeling. Res Social Adm Pharm. 2008;4(2):83-97. https://doi.org/10.1016/j.sapharm.2007.04.003

Schreiber JB. Update to core reporting practices in structural equation modeling. Res Social Adm Pharm. 2017;13(3):634-43. https://doi.org/10.1016/j.sapharm.2016.06.006

Revelle W. psych: Procedures for Psychological, Psychometric, and Personality Research2018 12 december 2019. Available from: https://CRAN.R-project.org/package=psych.

Dinno A. paran: Horn’s Test of Principal Components/Factors2018 12 december 2019. Available from: https://CRAN.R-project.org/package=paran.

Fox J. polycor: Polychoric and Polyserial Correlations. 2019.

Epskmap S. semPlot: Path Diagrams and Visual Analysis of Various SEM Packages2019 12 december 2019. Available from: https:// CRAN.R-project.org/package=semPlot.

Rosseel Y. lavaan: An R package for structural equation modeling. Journal of Statistical Software. 2012;42(2):1-36. https://doi.org/10.18637/jss.v048.i02

Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Dominguez Dominguez MA, Lainez Milagro N, Manterola Burgaleta A, et al. The EORTC quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol. 2008;61(8):949-54. https://doi.org/10.4321/S000406142008000800017

Blazeby JM, Fayers P, Conroy T, Sezer O, Ramage J, Rees M, et al. Validation of the European Organization for Research and Treatment of Cancer QLQ-LMC21 questionnaire for assessment of patient-reported outcomes during treatment of colorectal liver metastases. Br J Surg. 2009;96(3):291-8. https://doi.org/10.1002/bjs.6471

Chie WC, Chang KJ, Huang CS, Kuo WH. Quality of life of breast cancer patients in Taiwan: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and EORTC QLQ-BR23. Psychooncology. 2003;12(7):729-35. https://doi.org/10.1002/pon.727

Chie WC, Hong RL, Lai CC, Ting LL, Hsu MM. Quality of life in patients of nasopharyngeal carcinoma: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and the EORTC QLQ-H&N35. Qual Life Res. 2003;12(1):93-8. https://doi.org/10.1023/A:1022070220328

Chie WC, Yang CH, Hsu C, Yang PC. Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. Qual Life Res. 2004;13(1):257-62. https://doi.org/10.1023/B:QURE.0000015295.74812.06

Demirci S, Eser E, Ozsaran Z, Tankisi D, Aras AB, Ozaydemir G, et al. Validation of the Turkish versions of EORTC QLQ-C30 and BR23 modules in breast cancer patients. Asian Pac J Cancer Prev. 2011;12(5):1283-7.

Fredheim OM, Borchgrevink PC, Saltnes T, Kaasa S. Validation and comparison of the health-related quality-of-life instruments EORTC QLQ-C30 and SF-36 in assessment of patients with chronic nonmalignant pain. J Pain Symptom Manage. 2007;34(6):65765. https://doi.org/10.1016/j.jpainsymman.2007.01.011

Groenvold M, Klee MC, Sprangers MA, Aaronson NK. Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient observer agreement. J Clin Epidemiol. 1997;50(4):441-50. https://doi.org/10.1016/S0895-4356(96)00428-3

Hoopman R, Muller MJ, Terwee CB, Aaronson NK. Translation and validation of the EORTC QLQ-C30 for use among Turkish and Moroccan ethnic minority cancer patients in the Netherlands. Eur J Cancer. 2006;42(12):1839-47. https://doi.org/10.1016/j.ejca.2005.08.047

Huang CC, Lien HH, Sung YC, Liu HT, Chie WC. Quality of life of patients with gastric cancer in Taiwan: validation and clinical application of the Taiwan Chinese version of the EORTC QLQ-C30 and EORTC QLQ-STO22. Psychooncology. 2007;16(10):945-9. https://doi.org/10.1002/pon.1158

Kobayashi K, Takeda F, Teramukai S, Gotoh I, Sakai H, Yoneda S, et al. A cross-validation of the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) for Japanese with lung cancer. Eur J Cancer. 1998;34(6):810-5. https://doi.org/10.1016/S0959-8049(97)00395-X

Montazeri A, Harirchi I, Vahdani M, Khaleghi F, Jarvandi S, Ebrahimi M, et al. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): translation and validation study of the Iranian version. Support Care Cancer. 1999;7(6):400-6. https://doi.org/10.1007/s005200050300

Perwitasari DA, Atthobari J, Dwiprahasto I, Hakimi M,Gelderblom H, Putter H, et al. Translation and validation of EORTC QLQ-C30 into Indonesian version for cancer patients in Indonesia. Jpn J Clin Oncol. 2011;41(4):519-29. https://doi.org/10.1093/jjco/hyq243

Singer S, Wollbruck D, Wulke C, Dietz A, Klemm E, Oeken J, et al. Validation of the EORTC QLQ-C30 and EORTC QLQ-H&N35 in patients with laryngeal cancer after surgery. Head Neck. 2009;31(1):64-76. https://doi.org/10.1002/hed.20938

Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, et al. Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res. 2004;13(4):863-8. https://doi.org/10.1023/ B:QURE.0000021692.81214.70

Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW, et al. Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. J Clin Epidemiol. 2016;69:79-88. https://doi.org/10.1016/j.jclinepi.2015.08.007

Gundy CM, Fayers PM, Groenvold M, Petersen MA, Scott NW, Sprangers MA, et al. Comparing higher order models for the EORTC QLQ-C30. Qual Life Res. 2012;21(9):1607-17. https://doi.org/10.1007/s11136-011-0082-6

Nunes NA. The quality of life of Brazilian patients in palliative care: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 PAL (EORTC QLQ-C15-PAL). Support Care Cancer. 2014;22(6):1595600. https://doi.org/10.1007/s00520-014-2119-1

Zhao H, Kanda K. Testing psychometric properties of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30). J Epidemiol. 2004;14(6):193-203. https://doi.org/10.2188/jea.14.193

Trizano-Hermosilla I, Alvarado JM. Best Alternatives to Cronbach’s Alpha Reliability in Realistic Conditions: Congeneric and Asymmetrical Measurements. Front Psychol. 2016;7:769. https://doi.org/10.3389/fpsyg.2016.00769

Cómo citar

[1]
Sánchez Pedraza, R. y Valderamar, A. 2020. Validación para utilización en Colombia de la escala EORTC QLQ C-30 para evaluación de la calidad de vida de los pacientes con cáncer. Revista Colombiana de Cancerología. 24, 2 (may 2020), 61–71. DOI:https://doi.org/10.35509/01239015.128.

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26-05-2020

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