Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy

BACKGROUND. An impediment to mucositis research has been the lack of an acc epted, validated scoring system. The objective of this study was to design, test, and validate a new scoring system for mucositis that can be used eas ily, is reproducible, and provides an accurate system for research applicat ions. METHODS. A panel of experts, convened to design an objective, simple, and r eproducible assessment tool to evaluate mucositis with specific application to multicenter clinical trials, developed a scale that measured objective and subjective indicators of mucositis. Nine centers participated in the st udy's validation. Paired investigators at each center evaluated patients re ceiving chemotherapy or head and neck radiation. Objective measures of muco sitis evaluated ulceration/ pseudomembrane formation and erythema. Subjecti ve outcomes of mouth pain, ability to swallow, and function were measured. Analgesia use for mouth sensitivity was recorded. RESULTS. One hundred eight chemotherapy and 56 radiation therapy patients w ere evaluated. Seventy-eight percent of chemotherapy patients and 64% of ra diation therapy patients had clinically significant mucositis. Cumulative d aily mucositis scores demonstrated a high correlation among observers. Usin g area under the curve analysis, it was found that for chemotherapy patient s, the highest correlations (correlation coefficient > 0.92) occurred for t he scores that selected the three highest daily values over the course of m ucositis assessment. High interobserver correlations were noted for patient s receiving radiation therapy. Objective mucositis scores demonstrated stro ng correlation with symptoms. CONCLUSIONS. The scoring system evaluated was easily used, showed high inte robserver reproducibility, was responsive over time, and measured those ele ments deemed to be associated with mucositis. The use of concomitant sympto matic measurements appeared to be unnecessary. Cancer 1999;85:2103-13. (C) 1999 American Cancer Society.