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Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT)

Bone Marrow Transplantation volume 37, pages 393–401 (2006)Cite this article

Abstract

Oral mucositis (OM) is a frequent complication of myeloablative therapy and HSCT. We evaluated the feasibility, reliability, and validity of a new patient self-reported daily questionnaire on OM and its impact on daily functions. This OM Daily Questionnaire (OMDQ), containing 10 items, was developed for use in palifermin clinical trials. In a phase 3 study, 212 patients received palifermin or placebo for three consecutive days before conditioning and three consecutive days after HSCT. Compliance rates were consistently >80% for most patients. Mouth and throat soreness (MTS) and MTS-Activity Limitations (MTS-AL) (swallowing, drinking, eating, talking, and sleeping) scores on consecutive days were highly correlated (days 7,8=0.70–0.86; test–retest reliability). Correlations among items measuring the same construct ranged between 0.5 and 0.8 (internal consistency reliability). The WHO Oral Toxicity scale was the clinical comparator to assess the criterion, discriminative, and evaluative validities of MTS-related questions. Most correlation coefficients between the WHO and MTS ranged between 0.45 and 0.55. Patients with more severe WHO OM grades had higher MTS mean scores. Changes in MTS scores were similar, but patients detected changes 1–3 days earlier than clinicians. In conclusion, the OMDQ is a feasible, reliable, valid, and responsive patient-reported measure of OM severity.

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Acknowledgements

We are grateful to Dieter Elhardt, PhD and Gary Okano, PhD, for assistance with the conduct of the study; Stephen Sonis, DMD, DMSc, for advice regarding assessment of oral mucositis; Alan Rong, PhD, Moshe Friedman, PhD, and Mon-Gy Chen, MS, for statistical consultations. Additionally, we thank the patients who participated in this study, their families, and all the physicians, nurses, and study coordinators who cared for the patients. Interim results from this study have been presented at ASH 2003, ASCO 2004, and ASBMT 2005. This study was sponsored by Amgen Inc., Thousand Oaks, CA.

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Authors and Affiliations

  1. Cardinal Bernardin Cancer Center, Loyola University, Maywood, IL, USA

    P J Stiff

  2. Forest Laboratories, New York City, NY, USA

    H Erder

  3. Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    W I Bensinger

  4. UCLA David Geffen School of Medicine, Los Angeles, CA, USA

    C Emmanouilides

  5. SUNY Upstate Medical University, Syracuse, NY, USA

    T Gentile

  6. Amgen Inc., Thousand Oaks, CA, USA

    J Isitt & Z J Lu

  7. City of Hope National Medical Center, Duarte, CA, USA

    R Spielberger

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  1. P J Stiff
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  2. H Erder
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Correspondence to P J Stiff.

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Stiff, P., Erder, H., Bensinger, W. et al. Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplant 37, 393–401 (2006). https://doi.org/10.1038/sj.bmt.1705250

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