Susanne Singer1, Cecilie Delphin Amdal2, Eva Hammerlid3, Iwona M Tomaszewska4, Joaquim Castro Silva5, Hisham Mehanna6, Marcos Santos7, Johanna Inhestern8, Christine Brannan9, Noam Yarom10, Amy Fullerton11, Monica Pinto12, Juan I Arraras13, Naomi Kiyota14, Pierluigi Bonomo15, Allen C Sherman16, Ingo Baumann17, Razvan Galalae18, Loreto Fernandez Gonzalez19, Ourania Nicolatou-Galitis20, Zeinab Abdel-Hafeez21, Judith Raber-Durlacher22, Claudia Schmalz23, Paola Zotti24, Andreas Boehm25, Dirk Hofmeister26, Sanja Krejovic Trivic27, Suat Loo28, Wei-Chu Chie29, Kristin Bjordal30, Bente Brokstad Herlofson31, Vincent Grégoire32, Lisa Licitra33. 1. Division of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Centre of Johannes Gutenberg University, Mainz, Germany. 2. Department of Oncology, Oslo University Hospital, Oslo, Norway. 3. Department of Otolaryngology and Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg University, Gothenburg, Sweden. 4. Department of Medical Didactics, Jagiellonian University Medical College, Krakow, Poland. 5. Department of Otolaryngology, Head and Neck Surgery, Instituto Português de Oncologia Francisco Gentil do Porto, Porto, Portugal. 6. Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham, United Kingdom. 7. Radiation Oncology Department, Brasilia University Hospital, Brasilia, Brazil. 8. Clinic of Otorhinolaryngology, Jena University Hospital, Jena, Germany. 9. Lynda Jackson Macmillan Centre, East & North Hertfordshire NHS Trust incorporating Mount Vernon Cancer Centre, Northwood, United Kingdom. 10. Oral Medicine Unit, Sheba Medical Center, Tel-Hashomer, Israel and School of Dental Medicine, Tel Aviv University, Tel Aviv, Israel. 11. Department of Speech, Language and Hearing Sciences, College of Public Health and Health Professions, University of Florida, Gainesville, Florida. 12. Supportive Care Department, Istituto Nazionale Tumori -IRCCS- Fondazione G. Pascale, Naples, Italy. 13. Oncology Departments, Complejo Hospitalario de Navarra, Pamplona, Spain. 14. Department of Medical Oncology and Hematology, Kobe University Hospital Cancer Center, Kobe, Japan. 15. Radiation Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. 16. Behavioral Medicine Division, Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences, Little Rock, Arkansas. 17. Department of Otolaryngology, Head and Neck Surgery, University of Heidelberg, Heidelberg, Germany. 18. Department of Radiation Oncology, EVK Gelsenkirchen, University Duisburg-Essen, Gelsenkirchen, Germany. 19. Research and Teaching Unit, Instituto Oncológico Fundación Arturo López Pérez, Santiago, Chile. 20. Clinic of Hospital Dentistry, Dental Oncology Unit, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece. 21. Department of Clinical Oncology, Ain Shams-University, Cairo, Egypt. 22. Department of Oral and Maxillofacial Surgery, Amsterdam University Medical Center (location AMC) and Department of Oral Medicine ACTA, University of Amsterdam and VU University, Amsterdam, The Netherlands. 23. Department of Radiation Therapy, University Hospital Schleswig-Holstein, Kiel, Germany. 24. Department of Psychology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy. 25. Department of Otolaryngology Head and Neck Surgery, St. Georg Hospital, Leipzig, Germany. 26. Department of Medical Psychology, University Hospital Leipzig, Leipzig, Germany. 27. Clinic of Otorhinolaryngology and Maxillofacial Surgery, Faculty of Medicine, University of Belgrade, Belgrade, Serbia. 28. Department of Oncology, Colchester Hospital University NHS Foundation Trust, Colchester, United Kingdom. 29. Department of Family Medicine, Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan. 30. Department of Research Support Services, Oslo University Hospital, and University of Oslo, Oslo, Norway. 31. Department of Oral Surgery and Oral Medicine, University of Oslo, and Department of Otorhinolaryngology - Head and Neck Surgery Division for Head, Neck and Reconstructive Surgery, Oslo University Hospital, Oslo, Norway. 32. Radiation Oncology Dept & Center for Molecular Imaging and Experimental Radiotherapy, Université Catholique de Louvain and St-Luc University Hospital, Brussels, Belgium. 33. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milano, and University of Milan, Milan, Italy.
Abstract
BACKGROUND: We validated the new European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43). METHODS: We enrolled 812 patients with head and neck cancer from 18 countries. Group 1 completed the questionnaire before therapy, and 3 and 6 months later. In group 2 (survivors), we determined test-retest reliability using intraclass correlation coefficients (ICC). Internal consistency was assessed using Cronbach's Alpha, the scale structure with confirmatory factor analysis, and discriminant validity with known-group comparisons. RESULTS: Cronbach's alpha was >0.70 in 10 of the 12 multi-item scales. All standardized factor loadings exceeded 0.40. The ICC was >0.70 in all but two scales. Differences in scale scores between known-groups were >10 points in 17 of the 19 scales. Sensitivity to change was found to be sufficient in 18 scales. CONCLUSIONS: Evidence supports the reliability and validity of the EORTC QLQ-HN43 as a measure of quality of life.
BACKGROUND: We validated the new European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43). METHODS: We enrolled 812 patients with head and neck cancer from 18 countries. Group 1 completed the questionnaire before therapy, and 3 and 6 months later. In group 2 (survivors), we determined test-retest reliability using intraclass correlation coefficients (ICC). Internal consistency was assessed using Cronbach's Alpha, the scale structure with confirmatory factor analysis, and discriminant validity with known-group comparisons. RESULTS: Cronbach's alpha was >0.70 in 10 of the 12 multi-item scales. All standardized factor loadings exceeded 0.40. The ICC was >0.70 in all but two scales. Differences in scale scores between known-groups were >10 points in 17 of the 19 scales. Sensitivity to change was found to be sufficient in 18 scales. CONCLUSIONS: Evidence supports the reliability and validity of the EORTC QLQ-HN43 as a measure of quality of life.
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