International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15
- 467 Downloads
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.
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.
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).
The EORTC module QLQ-OH15 is a short, well-accepted assessment tool focusing on oral problems and QoL to improve clinical management.
ClinicalTrials.gov Identifier: NCT01724333.
KeywordsOral health Quality of life EORTC QLQ-C30 QLQ-OH15 Patient reported outcomes Validation study
This project received financial support from the EORTC Quality of Life Group (QLG) Grant No. 001/2012. We express our gratitude to the EORTC QLG Executive Committee for reviewing and approving the phase IV module development report and manuscript.
Special thanks are also given to the study coordinators at the participating centers and the patients who took part in the study, and to Cand. odont. Petter Wilberg for valuable advice in the preparation of this manuscript.
Compliance with ethical standards
Conflicts of interest
The authors declare that they have no conflict of interest.
This study was supported by Grant No. 001/2012 from the EORTC Quality of Life Group.
- 1.NIH State-of-the-Science Statement on symptom management in cancer: Pain, depression, and fatigue (2002). NIH Consens State Science Statements 19(4): 1–29Google Scholar
- 2.U.S.Department of Health and Human services NIoH. National Cancer Institute: The NCI strategic plan for leading the nation. To eliminate the suffering and death due to cancer (2006). In: U.S.Department of Health and Human services NIoH, ed., Bethesda, MD, US, Free-eBooks.net
- 14.Elad S, Epstein JB, Raber-Durlacher J, Donnelly P, Strahilevitz J (2012) The antimicrobial effect of Iseganan HCl oral solution in patients receiving stomatotoxic chemotherapy: analysis from a multicenter, double-blind, placebo-controlled, randomized, phase III clinical trial. J Oral Pathol Med 41(3):229–234CrossRefPubMedGoogle Scholar
- 16.Multinational Association for Supportive Care in Cancer (MASCC). Evidence-based management strategies for oral complication from cancer treatment. http://www.mascc.org/assets/documents/Oral_Care-Summary-Oral_Complications_Systematic_Reviews.pdf. Accessed November 26, 2015
- 18.Riley P, Glenny AM, Worthington HV, Littlewood A, Clarkson JE, McCabe MG (2015) Interventions for preventing oral mucositis in patients with cancer receiving treatment: oral cryotherapy. Cochrane Database Syst Rev 12:CD0115Google Scholar
- 27.Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al (1993). 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 85(5):365–376 (http://groups.eortc.be/QoL/questionnaires_qlqc30.htm)CrossRefPubMedGoogle Scholar
- 28.DeWolf L, Koller M, Velikova G, Jokovic A, Scott N, Bottomley A (2009) EORTC quality of life group translation procedure, 3rd edn. EORTC Study Group on Quality of Life, Brussels ISBN 978–2–930064-38-3Google Scholar
- 29.Johnson C, Aaronson N, Blazeby J, Bottomley A, Fayers P, Koller M, et al. (2011) Guidelines for developing questionnaire modules, 4th edn. EORTC Quality of Life Group, Brussels ISBN 978–2–930064-413Google Scholar
- 31.Streiner DL, Norman GR (2003) Health measurement scales: a practical guide to their development and use, 3rd edn. Oxford University Press, OxfordGoogle Scholar
- 34.Bjordal K, Ahlner-Elmqvist M, Tollesson E, Jenssen AB, Razavi D, Maher EJ, et al. (1994) 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 patients. Acta Oncol 33:879–885CrossRefPubMedGoogle Scholar
- 36.Sodergren SC, White A, Efficace F, Sprangers M, Fitzsimmons D, Bottomley A, et al. (2014) Systematic review of the side effects associated with tyrosine kinase inhibitors used in the treatment of gastrointestinal stromal tumours on behalf of the EORTC Quality of Life Group. Crit Rev Oncol Hematol 91(1):35–46CrossRefPubMedGoogle Scholar
- 37.Wheelwright S, Darlington AS, Fitzsimmons D, Fayers P, Arraras JI, Bonnetain F, et al. (2013) International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer 109(4):852–858CrossRefPubMedPubMedCentralGoogle Scholar