Health and Quality of Life Outcomes | |
Translation and validation of the Chinese version of the quality of life radiation therapy instrument and the head & neck module (QOL-RTI/H&N) | |
Dong-hai Li2  Juan Sun3  Qian Xu5  Chuan-wei Mo5  Yan Liu1  Li-zhi Liu7  Yong Su4  Mo-fa Gu4  Zhen-wen Qiu2  Xin-lin Chen6  | |
[1] The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong province, China;The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong province, China;School of Human Social Science, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong province, China;Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong province, China;Department of Biostatistics and Preventive Medicine, School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong province, China;Department of biostatistics, School of Public Health, Southern Medical University, Guangzhou, Guangdong province, China;Department of Radiology, State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong province, China | |
关键词: Validation; Translation; N; QOL-RTI/H& Quality of Life; Head and neck cancer; | |
Others : 814964 DOI : 10.1186/1477-7525-12-51 |
|
received in 2013-10-23, accepted in 2014-04-08, 发布年份 2014 | |
【 摘 要 】
Background
To translate and validate the Chinese version of the Quality Of Life Radiation Therapy Instrument and the Head & Neck Module (QOL-RTI/H&N), a disease-specific scale to measure quality of life (QOL) for patients with head and neck cancer (HNC) who received radiotherapy.
Methods
The QOL-RTI/H&N was translated and validated according to the standard process: a translation and back-translation procedure, pilot testing and a validation study. HNC patients were enrolled from the Cancer Center of Sun Yat-sen University and assessed using the QOL-RTI/H&N, QLQ-C30 and QLQ-H&N35. Reliability (internal consistency reliability, split-half reliability and test-retest reliability), validity (content validity, construct validity, criterion validity and discriminant validity), and responsiveness analysis were performed to evaluate the psychometric characteristics of the QOL-RTI/H&N.
Results
A total of 238 patients (99.2%) completed the questionnaire. Item RTI23 had 16.0% missing data. Other items had low percentages of missing data (0.4% or 0.8%) or no missing data. The average time to finish the scale was 9.8 minutes. Cronbach's alpha of the domains ranged from 0.41 to 0.77. The split-half reliability coefficients ranged from 0.43 to 0.77. All of the intra-class correlation coefficients were equal to or greater than 0.8. All of the item-own domain correlation coefficients were greater than those of the item-other domain. Confirmatory factor analysis showed that Comparative Fit Index, Normed Fit Index and Non-Normed Fit Index were equal to 1.00. Root Mean Square Error of Approximation was 0.01, with 90% CI (0.00, 0.10). The domain scores of the QOL-RTI/H&N were significantly correlated with those of the QLQ-C30 or QLQ-H&N3. All domain scores of patients in different radiotherapy stages were statistically significant (P < 0.05), apart from the speech domain.
Conclusions
The Chinese version of the QOL-RTI/H&N is a valid, reliable and responsive scale to measure QOL in HNC patients and can be used to assess the effects of radiotherapy treatment on these patients.
【 授权许可】
2014 Chen et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20140710052308260.pdf | 580KB | download | |
Figure 2. | 89KB | Image | download |
Figure 1. | 50KB | Image | download |
【 图 表 】
Figure 1.
Figure 2.
【 参考文献 】
- [1]Parkin DM, Bray F, Ferlay J, Pisani P: Global cancer statistics, 2002. CA Cancer J Clin 2005, 55(2):74-108.
- [2]World Health Organization: GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. 2012. [http://globocan.iarc.fr/Pages/fact_sheets_population.aspx webcite]
- [3]Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D: Global cancer statistics. CA Cancer J Clin 2011, 61(2):69-90.
- [4]Cooper JS, Fu K, Marks J, Silverman S: Late effects of radiation therapy in the head and neck region. Int J Radiat Oncol Biol Phys 1995, 31(5):1141-1164.
- [5]Lee SH, Kim TH, Kim JY, Park SY, Pyo HR, Shin KH, Kim DY, Kim JY, Cho KH: Evaluation of parotid gland function following intensity modulated radiation therapy for head and neck cancer. Cancer Res Treat 2006, 38(2):84-91.
- [6]Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J: The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res 2008, 17(2):179-193.
- [7]Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JCJM: 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):365-376.
- [8]Bjordal K, Ahlner-Elmqvist M, Tollesson E, Jensen AB, Razavi D, Maher EJ, Kaasa S: Development of a European Organization for Research and Treatment of Cancer (EORTC) questionnaire module to be used in quality of life assessments in head and neck cancer patients. Acta Oncol 1994, 33(8):879-885.
- [9]Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, Biörklund A, de Leeuw JRJ, Fayers PM, Jannert M: Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol 1999, 17(3):1008-1008.
- [10]Wan Leung S, Lee TF, Chien CY, Chao PJ, Tsai WL, Fang FM: Health-related Quality of life in 640 head and neck cancer survivors after radiotherapy using EORTC QLQ-C30 and QLQ-H&N35 questionnaires. BMC Cancer 2011, 11:128. BioMed Central Full Text
- [11]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. BioMed Central Full Text
- [12]Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J: The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 1993, 11(3):570-579.
- [13]Dapueto JJ, Francolino C, Servente L, Chang CH, Gotta I, Levin R, Abreu Mdel C: Evaluation of the Functional Assessment of Cancer Therapy-General (FACT-G) Spanish Version 4 in South America: classic psychometric and item response theory analyses. Health Qual Life Outcomes 2003, 1:32. BioMed Central Full Text
- [14]Johnson DJ, Casey L, Noriega B: A pilot study of patient quality of life during radiation therapy treatment. Qual Life Res 1994, 3(4):267-272.
- [15]Trotti A, Johnson DJ, Gwede C, Casey L, Sauder B, Cantor A, Pearlman J: Development of a head and neck companion module for the quality of life-radiation therapy instrument (QOL-RTI). Int J Radiat Oncol Biol Phys 1998, 42(2):257-261.
- [16]Browman GP, Levine MN, Hodson DI, Sathya J, Russell R, Skingley P, Cripps C, Eapen L, Girard A: The Head and Neck Radiotherapy Questionnaire: a morbidity/quality-of-life instrument for clinical trials of radiation therapy in locally advanced head and neck cancer. J Clin Oncol 1993, 11(5):863-872.
- [17]Hassan SJ, Weymuller EA: Assessment of quality of life in head and neck cancer patients. Head & neck 1993, 15(6):485-496.
- [18]Morton RP, Witterick IJ: Rationale and development of a quality-of-life instrument for head-and-neck cancer patients. Am J Otolaryngol 1995, 16(5):284.
- [19]Rathmell AJ, Ash DV, Howes M, Nicholls J: Assessing quality of life in patients treated for advanced head and neck cancer. Clin Oncol 1991, 3(1):10-16.
- [20]Terrell JE, Nanavati KA, Esclamado RM, Bishop JK, Bradford CR, Wolf GT: Head and neck cancer–specific quality of life: Instrument validation. Arch Otolaryngol Head Neck Surg 1997, 123(10):1125.
- [21]Yang Z, Meng Q, Luo J, Lu Q, Li X, Li G, Wan C: Development and validation of the simplified Chinese version of EORTC QLQ-H&N35 for patients with head and neck cancer. Support Care Cancer 2012, 20(7):1555-1564.
- [22]Lo PSY, Lo SK, Tong MCF, Ku PKM, Leung SF, Hasselt AC: Quality-of-life measurement in patients undergoing radiation therapy for head and neck cancer: a Hong Kong experience. J Oncol Manag 2004, 13(6):13-23.
- [23]Takahashi T, Hondo M, Nishimura K, Kitani A, Yamano T, Yanagita H, Osada H, Shinbo M, Honda N: Evaluation of quality of life and psychological response in cancer patients treated with radiotherapy. Radiat Med 2008, 26(7):396-401.
- [24]Janda M, Johnson D, Woelfl H, Trimmel M, Bressmann T, Schröckmayr H, Widder J, Trotti A: Measurement of quality of life in head and neck cancer patients utilizing the quality of life radiation therapy questionnaire. Strahlenther Onkol 2002, 178(3):153-158.
- [25]Bullinger M, Alonso J, Apolone G, Leplège A, Sullivan M, Wood-Dauphinee S, Gandek B, Wagner A, Aaronson N, Bech P: Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment. J Clin Epidemiol 1998, 51(11):913-923.
- [26]Gandek B, Ware JE: Methods for validating and norming translations of health status questionnaires: the IQOLA project approach. J Clin Epidemiol 1998, 51(11):953-959.
- [27]Khoshnevisan A, Yekaninejad MS, Ardakani SK, Pakpour AH, Mardani A, Aaronson NK: Translation and validation of the EORTC brain cancer module (EORTC QLQ-BN20) for use in Iran. Health Qual Life Outcomes 2012, 10:54. BioMed Central Full Text
- [28]Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P: Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes 2013, 11(1):166. BioMed Central Full Text
- [29]Jöreskog KG, Sörbom D: Lisrel 8: Structural Equation Modeling with the SIMPLIS Command Language [M]. Chicago: Scientific Software International; 1996:1-226.
- [30]Marx RG, Menezes A, Horovitz L, Jones EC, Warren RF: A comparison of two time intervals for test-retest reliability of health status instruments. J Clin Epidemiol 2003, 56(8):730-735.
- [31]Jöreskog KG, Goldberger AS: Estimation of a model with multiple indicators and multiple causes of a single latent variable. J Am Stat Assoc 1975, 70(351a):631-639.
- [32]Thompson B, Daniel LG: Factor analytic evidence for the construct validity of scores: A historical overview and some guidelines. Educ Psychol Meas 1996, 56(2):197-208.
- [33]Lix LM, Osman BA, Adachi JD, Towheed T, Hopman W, Davison KS, Leslie WD: Measurement equivalence of the SF-36 in the canadian multicentre osteoporosis study. Health Qual Life Outcomes 2012, 10(1):29. BioMed Central Full Text
- [34]Schreiber JB, Nora A, Stage FK, Barlow EA, King J: Reporting structural equation modeling and confirmatory factor analysis results: a review. J Educ Res 2006, 99(6):323-338.
- [35]McDonald RP, Ho M-HR: Principles and practice in reporting structural equation analyses. Psychol Methods 2002, 7(1):64-82.
- [36]Brosseau-Liard PE: RMSEA with nonnormal Data: A comparison of two robust corrections. Multivar Behav Res 2013, 48(1):150-151.
- [37]Sloan JA, Cella D, Hays RD: Clinical significance of patient-reported questionnaire data: another step toward consensus. J Clin Epidemiol 2005, 58(12):1217-1219.
- [38]Bonomi AE, Patrick DL, Bushnell DM, Martin M: Validation of the United States' version of the World Health Organization Quality of Life (WHOQOL) instrument. J Clin Epidemiol 2000, 53(1):1-12.
- [39]Skevington SM, Gunson KS, Óconnell KA: Introducing the WHOQOL-SRPB BREF: developing a short-form instrument for assessing spiritual, religious and personal beliefs within quality of life. Qual Life Res 2013, 22(5):1073-1083.