Nieves Prior1, Eduardo Remor2, Elia Pérez-Fernández3, Magdalena Caminoa4, Carmen Gómez-Traseira4, Francisco Gayá5, Anne Aabom6, Werner Aberer7, Stephen Betschel8, Isabelle Boccon-Gibod9, Laurence Bouillet9, Anette Bygum6, Dorottya Csuka10, Henriette Farkas10, Maria Gomide11, Anete Grumach11, Iris Leibovich12, Alejandro Malbran13, Dumitru Moldovan14, Eniko Mihaly14, Krystyna Obtulowicz15, Cecilia Perpén13, Adriane Peveling-Oberhag16, Grzegorz Porebski15, Celine Rayonne Chavannes8, Avner Reshef12, Petra Staubach16, Michaela Wiednig7, Teresa Caballero17. 1. Allergy Department, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain. Electronic address: nivprior@gmail.com. 2. Faculty of Psychology, Universidad Autónoma, Madrid, Spain. 3. Research Unit, Hospital Universitario Fundación Alcorcón, Madrid, Spain. 4. Allergy Department, Hospital La Paz Institute for Health Research (IdiPaz), Madrid, Spain. 5. Research Unit, Hospital La Paz Institute for Health Research Institute (IdiPAZ), Madrid, Spain. 6. Department of Dermatology and Allergy Centre and OPEN Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. 7. Department of Dermatology, Medical University, Graz, Austria. 8. Division of Allergy and Clinical Immunology St. Michael's Hospital, Toronto, Canada. 9. National Reference Centre for Angioedème (CREAK), Internal Medicine Department, Grenoble University Hospital Joseph Fourier University of Medicine, Grenoble, France. 10. National Angioedema Center 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary. 11. Faculty of Medicine ABC, Sao Paulo, Brazil. 12. Allergy, Clinical Immunology and Angioedema Unit, Chaim Sheba Medical Center, Tel Hashomer, Israel. 13. Unidad de Alergia, Asma e Inmunología Clínica, Buenos Aires, Argentina. 14. Department of Allergology-Immunology, Mures County Hospital, Tìrgu-Mureş Romania. 15. Department of Clinical and Environmental Allergology, Jagiellonian University, Krakow, Poland. 16. Department of Dermatology, University Medical Center Mainz, Mainz, Germany. 17. Allergy Department, Hospital La Paz Institute for Health Research (IdiPaz), Madrid, Spain; Biomedical Research Network on Rare Diseases (CIBERER, U754), Madrid, Spain.
Abstract
BACKGROUND: Hereditary angioedema due to C1 inhibitor deficiency (C1-INH-HAE) may affect health-related quality of life (HRQoL). A specific HRQoL questionnaire for adult patients with C1-INH-HAE, the HAE-QoL, has recently been developed in Spain. OBJECTIVE: The objective of this study was to perform a cross-cultural validation and psychometric study of the HAE-QoL in an international setting. METHODS: Cross-cultural adaptation of the Spanish HAE-QoL draft version and an international rating phase with experts were performed. The resultant version of the HAE-QoL, a clinical questionnaire, and Short Form 36-item Health Survey Version 2.0 (SF-36v2) were pilot tested internationally. Item reduction was based on both descriptive and exploratory factor analysis. Psychometric properties were assessed. RESULTS: Cross-cultural adaptation of the HAE-QoL was performed in 18 countries. The draft version of the HAE-QoL was pilot tested in 332 patients, and accurate data were obtained from 290 patients from 11 countries. The reduction process resulted in a new version with 25 items and 7 dimensions (treatment difficulties, physical functioning and health, disease-related stigma, emotional role and social functioning, concern about offspring, perceived control over illness, and mental health). Strong psychometric properties were observed (Cronbach's α 0.92; test-retest reliability 0.87). Convergent validity showed mild to moderate correlations with SF-36v2 physical and mental component summaries (0.45 and 0.64, respectively) and with SF-36v2 dimensions (P < .004). HAE-QoL scores discriminated significantly among severity groups (median: asymptomatic 133.5 vs severe 84.0; P < .001); between patients with and without long-term prophylaxis (median: 101 vs 90; P = .001); and between patients with and without psychiatric and/or psychological care (median: 74 vs 103; P ≤ .001). CONCLUSIONS: The HAE-QoL, currently available in 18 languages, showed good reliability and validity evidence.
BACKGROUND:Hereditary angioedema due to C1 inhibitor deficiency (C1-INH-HAE) may affect health-related quality of life (HRQoL). A specific HRQoL questionnaire for adult patients with C1-INH-HAE, the HAE-QoL, has recently been developed in Spain. OBJECTIVE: The objective of this study was to perform a cross-cultural validation and psychometric study of the HAE-QoL in an international setting. METHODS: Cross-cultural adaptation of the Spanish HAE-QoL draft version and an international rating phase with experts were performed. The resultant version of the HAE-QoL, a clinical questionnaire, and Short Form 36-item Health Survey Version 2.0 (SF-36v2) were pilot tested internationally. Item reduction was based on both descriptive and exploratory factor analysis. Psychometric properties were assessed. RESULTS: Cross-cultural adaptation of the HAE-QoL was performed in 18 countries. The draft version of the HAE-QoL was pilot tested in 332 patients, and accurate data were obtained from 290 patients from 11 countries. The reduction process resulted in a new version with 25 items and 7 dimensions (treatment difficulties, physical functioning and health, disease-related stigma, emotional role and social functioning, concern about offspring, perceived control over illness, and mental health). Strong psychometric properties were observed (Cronbach's α 0.92; test-retest reliability 0.87). Convergent validity showed mild to moderate correlations with SF-36v2 physical and mental component summaries (0.45 and 0.64, respectively) and with SF-36v2 dimensions (P < .004). HAE-QoL scores discriminated significantly among severity groups (median: asymptomatic 133.5 vs severe 84.0; P < .001); between patients with and without long-term prophylaxis (median: 101 vs 90; P = .001); and between patients with and without psychiatric and/or psychological care (median: 74 vs 103; P ≤ .001). CONCLUSIONS: The HAE-QoL, currently available in 18 languages, showed good reliability and validity evidence.
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