A New Statistical Approach for Quality of Life Questionnaires in the Assessment of Non-Small-Cell Lung Cancer Cuban Patients
Cancer Research Journal
Volume 2, Issue 1, January 2014, Pages: 1-8
Received: Dec. 6, 2013;
Published: Jan. 30, 2014
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Carmen Viada, Center of Molecular Immunology (CIM), Havana, Cuba
Javier Ballesteros, University of the Basque Country UPV/EHU, Leioa, Spain; Centre for Biomedical Network Research on Mental Health (CIBERSAM), Spain
Martha Fors, National Coordinating Center for Clinical Trials (CENCEC), Havana, Cuba
Patricia Luaces, Center of Molecular Immunology (CIM), Havana, Cuba
Liset Sánchez, Center of Molecular Immunology (CIM), Havana, Cuba
Bárbara Wilkinson, Center of Molecular Immunology (CIM), Havana, Cuba
Aymara Fernández, Center of Molecular Immunology (CIM), Havana, Cuba
Camilo Rodríguez, Center of Molecular Immunology (CIM), Havana, Cuba
Tania Crombet, Center of Molecular Immunology (CIM), Havana, Cuba
Objectives: To evaluate the dimensionality and item characteristics of the European Organization for the Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and the lung cancer module (QLQ-LC13) and explore the possibility of reduction of the scales. Methods: We analyzed the answers recorded for the QLQ-C30 and QLQ-LC13 in patients diagnosed with non-small-cell lung cancer (NSCLC) participating in 4 Cuban multicenter clinical trials. We assessed the dimensionality underlying both scales with a Mokken nonparametric item response analysis. We used the parametric Samejima’s graded response model to assess the item characteristics; we also conducted a conﬁrmatory factor analysis (CFA) to test the dimensionality of both scales. Taking into account the previous results we compared different reduced scales using the Receiver Operator Curves (ROC Analysis). Results: 873 patients with NSCLC that completed the EORTC QLQ-C30 and 840 patients that completed the QLQ-LC13 were included. Mokken analysis of both scales resulted in 1-dimensional scales. All items showed scalability indices over 0.30. The overall scalability for the QLQ-C30 was 0.43, deﬁning a medium scale according to Mokken’s criteria, while the overall scalability of the QLQ-LC13 was 0.44. Unconstrained Samejima’s graded response models showed appropriate ﬁt, with most items of both scales presenting pertinent difﬁculty and discrimination parameters. The results of the CFA supported an underlying 1-dimensional latent structure for perceived quality of life (QLQ-C30 comparative ﬁt index [CFI]=0.98; root-mean-square error of approximation [RMSEA]=0.05; QLQ-LC13 CFI=0.99 and RMSEA=0.04). All factor loadings were above 0.30. Conclusions: The QLQ-C30 and the QLQ-LC13 represent in patients with lung cancer a 1-dimensional structure of patient-perceived quality of life. All the reduced scales had similar performance compared with both original scales.
A New Statistical Approach for Quality of Life Questionnaires in the Assessment of Non-Small-Cell Lung Cancer Cuban Patients, Cancer Research Journal.
Vol. 2, No. 1,
2014, pp. 1-8.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC 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.
Niezgoda HE, Pater JL. A validation study of the domains of the core EORTC quality of life questionnaire. Qual Life Res 1993; 2(5): 319-25.
Nicklasson M, Bergman B. Validity, reliability and clinical relevance of EORTC QLQ-C30 and LC13 in patients with chest malignancies in a palliative setting. Qual Life Res 2007; 16(6):1019-28.
Osoba D, Zee B, Pater J, Warr D, Kaizer L, Latreille J. Psychometric properties and responsiveness of the EORTC Quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. Qual Life Res 1994; 3(5):353-64.
Uwer L, Rotonda C, Guillemin F, Miny J, Kaminsky MC, Mercier M, Tournier-Rangeard L, Leonard I, Montcuquet P, Rauch P, Conroy T. Responsiveness of EORTC QLQ-C30, QLQ-CR38 and FACT-C quality of life questionnaires in patients with colorectal cancer. Health Qual Life Outcomes 2011; 9:70 [URL http://www.hqol.com/content/9/1/70].
Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). European Organisation for Research and Treatment of Cancer, Brussels 2001.
Rodriguez PC, Neninger E, García B, Popa X, Viada C, Luaces P, González G, Lage A, Montero E, Crombet T. Safety, immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor (EGF) based cancer vaccine in advanced non small cell lung cancer (NSCLC) patients. J Immune Based Ther Vaccines 2011, 9:7 (doi: 10.1186/1476-8518-9-7).
Rodríguez PC, Rodríguez G, González G, Lage A: Clinical development and Perspectives of CIMAvaxEGF, Cuban vaccine for non-small-cell lung cancer therapy. MEDICC Rev 2010; 12(1):17-23.
González G, Crombet T, Catalá M, Mirabal V, Hernández JC, González Y, Marinello P, Guillén G, Lage A: A novel cancer vaccine composed of human-recombinant epidermal growth factor linked to a carrier protein: report of a pilot clinical trial. Ann Oncol 1998; 9(4):431-5.
González G,Crombet T, Torres F, Catalá M, Alfonso L, Osorio M, Neninger E, García B, Mulet A, Pérez R, Lage R: Epidermal growth factor-based cancer vaccine for non-small-cell lung cancer therapy. Ann Oncol 2003,14(3):461-6.
R Core Team. R: a language and environment for statistical computing. R Foundation for Statistical Computing. Vienna, Austria, 2013. [URL http://www.R-project.org/]
van der Ark. Mokken scale analysis in R. Journal of Statistical Software 2007; 20(11):1-19. [URL http://www.jstatsoft.org/v20/i11/]
van der Ark. New developments in Mokken scale analysis in R. Journal of Statistical Software 2012; 48(5):1-27. [URL http://www.jstatsoft.org/v48/i05/]
Rizopoulos D. ltm: an R package for latent variable modeling and item response theory analysis. Journal of Statistical Software 2006; 17(5):1-25. [URL http://www.jstatsoft.org/v17/i05/]
Rosseel Y. lavaan: an R package for structural equation modeling. Journal of Statistical Software 2012; 48(2):1-36. [URL http://www.jstatsoft.org/v48/i02/]
Gundy CM, Fayers PM, Groenvold M, Petersen MA, Scott NW, Sprangers MAG, Velikova G, Aaronson NK. Comparing higher order models for he EORTC QLQ-C30. Qual Life Res 2012; 21:1607-17. [DOI 10.1007/s11136-011-0082-6]
Arraras JI, Suárez J, Arias de la Vega F, Vera R, Asín G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011; 13(1):50-6. [DOI 10.1007/s12094-011-0616-y].
Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Domínguez Domínguez MA, Lainez Milagro N, Manterola Burgaleta A, Martínez Lopez E, Romero Rojano P, Martínez Aguillo M.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.
Scott NW, Fayers PM, Bottomley A, Aaronson NK, de Graeff A, Groenvold M, Koller M, Petersen MA, Sprangers MA; EORTC and the Quality of Life Cross-Cultural Meta-Analysis Group. Comparing translations of the EORTC QLQ-C30 using differential item functioning analyses. Qual Life Res 2006; 15(6):1103-15.
Bjorner JB, Petersen MA, Groenvold M, Aaronson N, Ahlner-Elmqvist M, Arraras JI, Brédart A, Fayers P, Jordhoy M, Sprangers M, Watson M, Young T; European Organisation for Research and Treatment of Cancer Quality of Life Group. Use of item response theory to develop a shortened version of the EORTC QLQ-C30 emotional functioning scale. Qual Life Res 2004; 13(10):1683-97.
Petersen MA, Groenvold M, Aaronson N, Blazeby J, Brandberg Y, de Graeff A, Fayers P, Hammerlid E, Sprangers M, Velikova G, Bjorner JB: European Organisation for Research and Treatment of Cancer Quality of Life Group. Item response theory was used to shorten EORTC QLQ-C30 scales for use in palliative care. J Clin Epidemiol 2006; 59(1):36-44.
Teckle P, Peacock S, McTaggart-Cowan H, van der Hoek K, Chia S, Melosky B, Gelmon K. The ability of cancer-specific and generic preference-based instruments to discriminate across clinical and self-reported measures of cancer severities. Health Qual Life Outcomes 2011; 9:106. [URL http://www.hqlo.com/content/9/1/106]
Kim SH, Jo M-W, Kim H-J, Ahn J-H. Mapping EORTC QLQ-C30 onto EQ-5D for the assessment of cancer patients. Health Qual Life Outcomes 2012; 10:151. [URL http://www.hqlo.com/contents/10/1/151]