Marianne J Hjermstad1,2, Mia Bergenmar3,4, Kristin Bjordal5, Sheila E Fisher6, Dirk Hofmeister7, Sébastien Montel8, Ourania Nicolatou-Galitis9, Monica Pinto10, Judith Raber-Durlacher11, Susanne Singer12, Iwona M Tomaszewska13, Krzysztof A Tomaszewski14, Irma Verdonck-de Leeuw15, Noam Yarom16,17, Julie B Winstanley18,19, Bente B Herlofson20. 1. Regional Centre for Excellence in Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, Norway. marianne.j.hjermstad@ntnu.no. 2. European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University for Science and Technology, Trondheim, Norway. marianne.j.hjermstad@ntnu.no. 3. Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. 4. Department of Oncology, Karolinska University Hospital, Stockholm, Sweden. 5. Oslo University Hospital, Oslo, Norway. 6. University of Leeds, Leeds, LS2 9JT, UK. 7. University of Leipzig, Leipzig, Germany. 8. Department of Psychology, University Paris Saint Denis, Paris, France. 9. University of Athens, Athens, Greece. 10. Rehabilitation Unit, Department of Quality of Life, Istituto Nazionale Tumori "Fondazione G. Pascale"-IRCCS, Naples, Italy. 11. Department of Oral and Maxillofacial Surgery, Academic Medical Center University of Amsterdam, Amsterdam, Netherlands. 12. Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre, Mainz, Germany. 13. Department of Medical Education, Jagiellonian University Medical College, Krakow, Poland. 14. Department of Anatomy, Jagiellonian University Medical College, Krakow, Poland. 15. Department of Otolaryngology-Head and Neck Surgery, VU University Medical Center, Amsterdam, Netherlands. 16. Department of Oral and Maxillofacial Surgery, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel. 17. Department of Oral Pathology and Oral Medicine, School of Dental Medicine, Tel Aviv University, Tel Aviv, Israel. 18. Patricia Ritchie Centre, University of Sydney, Sydney, Australia. 19. Osman Consulting Pty LTD, Sydney, Australia. 20. Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Oslo, Norway.
Abstract
PURPOSE: This international EORTC validation study (phase IV) is aimed at testing the psychometric properties of a quality of life (QoL) module related to oral health problems in cancer patients. METHODS: The phase III module comprised 17 items with four hypothesized multi-item scales and three single items. In phase IV, patients with mixed cancers, in different treatment phases from 10 countries completed the EORTC QLQ-C30, the QLQ-OH module, and a debriefing interview. The hypothesized structure was tested using combinations of classical test theory and item response theory, following EORTC guidelines. Test-retest assessments and responsiveness to change analysis (RCA) were performed after 2 weeks. RESULTS: Five hundred seventy-two patients (median age 60.3, 54 % females) were analyzed. Completion took <10 min for 84 %, 40 % expressed satisfaction that these issues were addressed. Analyses suggested a revision of the phase III hypothesized scale structure. Two items were deleted based on a high degree of item misfit, together with negative patient feedback. The remaining 15 items formed one eight-item scale named OH-QoL score, a two-item information scale, a two-item scale regarding dentures, and three single items (sticky saliva/mouth soreness/sensitivity to food/drink). Face and convergent validity and internal consistency were confirmed. Test-retest reliability (n = 60) was demonstrated as was RCA for patients undergoing chemotherapy (n = 117; p = 0.06). The resulting QLQ-OH15 discriminated between clinically distinct patient groups, e.g., low performance status vs. higher (p < 000.1), and head-and-neck cancer versus other cancers (p < 0.03). CONCLUSION: The EORTC module QLQ-OH15 is a short, well-accepted assessment tool focusing on oral problems and QoL to improve clinical management. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01724333.
PURPOSE: This international EORTC validation study (phase IV) is aimed at testing the psychometric properties of a quality of life (QoL) module related to oral health problems in cancerpatients. METHODS: The phase III module comprised 17 items with four hypothesized multi-item scales and three single items. In phase IV, patients with mixed cancers, in different treatment phases from 10 countries completed the EORTC QLQ-C30, the QLQ-OH module, and a debriefing interview. The hypothesized structure was tested using combinations of classical test theory and item response theory, following EORTC guidelines. Test-retest assessments and responsiveness to change analysis (RCA) were performed after 2 weeks. RESULTS: Five hundred seventy-two patients (median age 60.3, 54 % females) were analyzed. Completion took <10 min for 84 %, 40 % expressed satisfaction that these issues were addressed. Analyses suggested a revision of the phase III hypothesized scale structure. Two items were deleted based on a high degree of item misfit, together with negative patient feedback. The remaining 15 items formed one eight-item scale named OH-QoL score, a two-item information scale, a two-item scale regarding dentures, and three single items (sticky saliva/mouth soreness/sensitivity to food/drink). Face and convergent validity and internal consistency were confirmed. Test-retest reliability (n = 60) was demonstrated as was RCA for patients undergoing chemotherapy (n = 117; p = 0.06). The resulting QLQ-OH15 discriminated between clinically distinct patient groups, e.g., low performance status vs. higher (p < 000.1), and head-and-neck cancer versus other cancers (p < 0.03). CONCLUSION: The EORTC module QLQ-OH15 is a short, well-accepted assessment tool focusing on oral problems and QoL to improve clinical management. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01724333.
Entities:
Keywords:
EORTC QLQ-C30; Oral health; Patient reported outcomes; QLQ-OH15; Quality of life; Validation study
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