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Vol. 74, No. 1
ISSN: 1488-2159
February 2008


Development and Validation of a Patient-Reported Oral Mucositis Symptom (PROMS) Scale


• Jennifer A. Kushner, DDS, MSc, FRCD(C) •
• Herenia P. Lawrence, DDS, MSc, PhD •
• Irit Shoval, DDS, MSc, FRCD(C) •
• Thomas L. Kiss , MD, FRCPC •
• Gerald M. Devins, PhD, C Psych •
• Linda Lee, DDS, MSc, Dipl ABOP, FRCD(C) •
• Howard C. Tenenbaum, DDS, Dip Perio, PhD, FRCD(C) •

A b s t r a c t

Oral mucositis, a painful condition with potentially life-threatening sequelae, often develops in association with allogeneic bone marrow transplantation. This condition has an adverse impact on the oral-health-related quality of life of patients undergoing marrow transplantation therapy.

Objective: The purpose of this study was to create and validate a Patient-Reported Oral Mucositis Symptom (PROMS) scale. This scale allows evaluation of symptoms of oral mucositis that threaten patients' quality of life.

Materials and Methods: The internal reliability of the new PROMS scale was examined with Cronbach's α, and its validity was determined by correlation with previously validated tools measuring quality of life (Functional Assessment of Cancer Therapy—Bone Marrow Transplant, FACT-BMT), symptoms of depression (Center for Epidemiologic Studies Depression Scale, CES-D), psychological well-being (Affect Balance Scale, ABS) and stressful life events (SLE), as well as an objective, clinician-rated assessment of the severity of oral mucositis (Visual Analogue Scale—Oral Mucositis Assessment Scale, VAS-OMAS). Thirty four patients who were to undergo allogeneic bone marrow transplantation at Princess Margaret Hospital in Toronto, Ontario, were enrolled. The FACT-BMT and SLE scales were administered at baseline, at the time of discharge from hospital and on day 60 after the transplant procedure. The CES-D, ABS and PROMS scales were administered at baseline, on days 7, 14, 21 and 28, at discharge and on day 60. The VAS-OMAS determinations of the extent of ulceration and erythema in the mouth were scored separately on days 3, 7, 10, 14, 17, 21, 24 and 28 after the transplant procedure.

Results: PROMS showed high internal reliability (Cronbach's α = 0.86 to 0.98) and good convergent and discriminant validity when correlated with other measures of subjective well-being and clinician-rated severity of oral mucositis. Longitudinal analyses showed that changes in PROMS scores were strongly correlated with changes in the clinical assessments of oral mucositis over the first 2 weeks after bone marrow transplantation, when the onset of oral mucositis typically occurs and the lesions are most severe. Spearman's correlation coefficients for mean changes in PROMS and VAS-OMAS scores for erythema and ulceration relative to baseline were 0.72 and 0.72 on day 7 (p < 0.01) and 0.57 and 0.52 (p < 0.01) on day 14, respectively.

Conclusions: The severity of oral mucositis reported by patients who have undergone bone marrow transplantation can be reliably quantified with the easily administered PROMS scale. The PROMS scale is a valid measure of the impact of oral mucositis on the oral-health-related quality of life of these patients and is a potentially useful measure for patients with other types of cancer who are subject to this malady. The PROMS scale could be used in future studies to assess the effectiveness of new treatments for oral mucositis and to predict clinical outcomes from the patient's perspective.


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