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 PROMS scale provides a valid measure of the impact of oral mucositis on the oral-health-related quality of life of patients affected by this malady.