Development and validation of a Patient-Reported Oral Mucositis Symptom (PROMS) scale.

BACKGROUND AND OBJECTIVE 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. 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 quality of life. MATERIALS AND METHODS The PROMS scale was compared with previously validated tools measuring quality of life (Functional Assessment of Cancer Therapy--Bone Marrow Transplant), symptoms of depression (Center for Epidemiologic Studies Depression Scale), psychological well-being (Affect Balance Scale) and stressful life events, as well as an objective, clinician-rated assessment of oral mucositis (Visual Analogue Scale--Oral Mucositis Assessment Scale). Thirty-four patients who were to undergo allogeneic bone marrow transplantation at Princess Margaret Hospital in Toronto, Ontario, were enrolled in this validation study. RESULTS The PROMS scale had high internal reliability, as well as good convergent and discriminant validity relative to subjective measures of well-being. Longitudinal assessments showed that changes in PROMS scores were strongly correlated with changes in clinical assessment of oral mucositis over the first 2 weeks after transplantation, when the onset of oral mucositis typically occurs and the lesions are most severe. CONCLUSIONS Oral mucositis in patients who have undergone bone marrow transplantation can be quantified reliably with the easily administered PROMS scale. The PROMSscale provides a valid measure of the impact of oral mucositis on the oral-health-related quality of life of patients affected by this malady.