International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15.
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.
Regional Centre for Excellence in Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, Norway. marianne.j.hjermstad@ntnu.no.|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.
Marianne J
MJ
Hjermstad
Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.|Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
Mia
M
Bergenmar
Oslo University Hospital, Oslo, Norway.
Kristin
K
Bjordal
University of Leeds, Leeds, LS2 9JT, UK.
Sheila E
SE
Fisher
University of Leipzig, Leipzig, Germany.
Dirk
D
Hofmeister
Department of Psychology, University Paris Saint Denis, Paris, France.
Sébastien
S
Montel
University of Athens, Athens, Greece.
Ourania
O
Nicolatou-Galitis
Rehabilitation Unit, Department of Quality of Life, Istituto Nazionale Tumori "Fondazione G. Pascale"-IRCCS, Naples, Italy.
Monica
M
Pinto
Department of Oral and Maxillofacial Surgery, Academic Medical Center University of Amsterdam, Amsterdam, Netherlands.
Judith
J
Raber-Durlacher
Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre, Mainz, Germany.
Susanne
S
Singer
Department of Medical Education, Jagiellonian University Medical College, Krakow, Poland.
Iwona M
IM
Tomaszewska
Department of Anatomy, Jagiellonian University Medical College, Krakow, Poland.
Krzysztof A
KA
Tomaszewski
Department of Otolaryngology-Head and Neck Surgery, VU University Medical Center, Amsterdam, Netherlands.
Irma
I
Verdonck-de Leeuw
Department of Oral and Maxillofacial Surgery, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.|Department of Oral Pathology and Oral Medicine, School of Dental Medicine, Tel Aviv University, Tel Aviv, Israel.
Noam
N
Yarom
Patricia Ritchie Centre, University of Sydney, Sydney, Australia.|Osman Consulting Pty LTD, Sydney, Australia.
Julie B
JB
Winstanley
Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Oslo, Norway.
Bente B
BB
Herlofson
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009909:Oral Health / Q000592:standards*; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D054928:Validation Studies as Topic; D055815:Young Adult
EORTC QLQ-C30; Oral health; Patient reported outcomes; QLQ-OH15; Quality of life; Validation study