| Description: |
Background . Mycetoma is a chronic, subcutaneous infection that causes local tissue destruction, leading to deformity, disability, and social stigma. Safe and effective treatments for mycetoma are urgently needed, however there is currently no systematic measure that allows objective clinical assessment of disease severity and activity. This makes it difficult to accurately assess the effectiveness of treatments and draw comparison between studies. Methods . A modified Delphi study was conducted involving a panel of 23 mycetoma experts from 5 continents, to establish consensus on the structure, wording and content of a clinical scoring system for mycetoma. Three rounds of anonymous surveys were conducted between August 2023 and May 2024. Consensus was defined as 65-85% agreement and strong consensus as >85%. Findings . The final version of the MASS consisted of 20 items, 14 pertaining to disease severity and 6 to disease activity, grouped into objective clinical features, patient-reported measures and investigations. Consensus was achieved for 19 of the 20 items, and strong consensus for 14. Interpretation . The MASS is the first clinical scoring system for mycetoma derived from a consensus approach. This will allow more accurate evaluation of response to treatment for patients if it is adopted into routine clinical practice by healthcare workers across mycetoma endemic regions. It will also serve an important function as a research tool, for use in prospective clinical studies and comparative drug trials. |