International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV

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; EORTC Quality of Life and the EORTC Head and Neck Cancer Groups

Affiliations

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.

PMID: 30636188
DOI: 10.1002/hed.25609

Clinical Trial

International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV

Susanne Singer et al. Head Neck. 2019 Jun.

. 2019 Jun;41(6):1725-1737.

doi: 10.1002/hed.25609. Epub 2019 Jan 12.

Authors

Affiliations

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.

PMID: 30636188
DOI: 10.1002/hed.25609

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.

Keywords: chemoradiation; head and neck cancer; multimodal therapies; quality of life; validation.

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International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV

Affiliations

International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV

Authors

Affiliations

Abstract

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical