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International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15

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Supportive Care in Cancer Aims and scope Submit manuscript

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.

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Acknowledgments

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.

Author information

Authors and Affiliations

  1. Regional Centre for Excellence in Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, Norway

    Marianne J. Hjermstad

  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

  3. Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden

    Mia Bergenmar

  4. Department of Oncology, Karolinska University Hospital, Stockholm, Sweden

    Mia Bergenmar

  5. Oslo University Hospital, Oslo, Norway

    Kristin Bjordal

  6. University of Leeds, Leeds, LS2 9JT, UK

    Sheila E. Fisher

  7. University of Leipzig, Leipzig, Germany

    Dirk Hofmeister

  8. Department of Psychology, University Paris Saint Denis, Paris, France

    Sébastien Montel

  9. University of Athens, Athens, Greece

    Ourania Nicolatou-Galitis

  10. Rehabilitation Unit, Department of Quality of Life, Istituto Nazionale Tumori “Fondazione G. Pascale”—IRCCS, Naples, Italy

    Monica Pinto

  11. Department of Oral and Maxillofacial Surgery, Academic Medical Center University of Amsterdam, Amsterdam, Netherlands

    Judith Raber-Durlacher

  12. Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre, Mainz, Germany

    Susanne Singer

  13. Department of Medical Education, Jagiellonian University Medical College, Krakow, Poland

    Iwona M. Tomaszewska

  14. Department of Anatomy, Jagiellonian University Medical College, Krakow, Poland

    Krzysztof A. Tomaszewski

  15. Department of Otolaryngology—Head and Neck Surgery, VU University Medical Center, Amsterdam, Netherlands

    Irma Verdonck-de Leeuw

  16. Department of Oral and Maxillofacial Surgery, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel

    Noam Yarom

  17. Department of Oral Pathology and Oral Medicine, School of Dental Medicine, Tel Aviv University, Tel Aviv, Israel

    Noam Yarom

  18. Patricia Ritchie Centre, University of Sydney, Sydney, Australia

    Julie B Winstanley

  19. Osman Consulting Pty LTD, Sydney, Australia

    Julie B Winstanley

  20. Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Oslo, Norway

    Bente B. Herlofson

Authors
  1. Marianne J. Hjermstad
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  2. Mia Bergenmar
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  3. Kristin Bjordal
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  7. Ourania Nicolatou-Galitis
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  8. Monica Pinto
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  9. Judith Raber-Durlacher
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  10. Susanne Singer
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  11. Iwona M. Tomaszewska
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  12. Krzysztof A. Tomaszewski
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  13. Irma Verdonck-de Leeuw
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  14. Noam Yarom
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  15. Julie B Winstanley
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  16. Bente B. Herlofson
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on behalf of the EORTC QoL Group

Corresponding author

Correspondence to Marianne J. Hjermstad.

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Conflicts of interest

The authors declare that they have no conflict of interest.

Financial support

This study was supported by Grant No. 001/2012 from the EORTC Quality of Life Group.

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Hjermstad, M.J., Bergenmar, M., Bjordal, K. et al. International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15. Support Care Cancer 24, 3915–3924 (2016). https://doi.org/10.1007/s00520-016-3216-0

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  • DOI: https://doi.org/10.1007/s00520-016-3216-0

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