Limitations in the Literature Regarding Mohs Surgery and Staged Excision for Melanoma: A Critical Review of Quality and Data Reporting.

Abstract Background and Objectives The literature supporting Mohs micrographic surgery (MMS) and staged excision (SE) in treating primary cutaneous melanoma is growing but has not been critically reviewed for bias. Methods Articles concerning MMS/SE for melanoma were assessed using a modified “Risk of Bias in Non-randomized Studies – of Interventions” (ROBINS-I) criteria which measures bias in seven categories. Results 47/48 (97.9%) studies reviewed had serious or critical bias. None were randomized controlled trials. The most frequent cause of critical bias was poorly defined outcomes. The least frequent form of bias observed was change in intervention. Limitations The modified ROBINS-I criteria cannot account for all study limitations, and modification of the criteria leads to some degree of subjectivity. Conclusion The current body of literature suffers from limitations due to serious or critical bias in one or more ROBINS-I criteria. Local recurrence rate definitions are often poorly defined or not defined at all. Longer follow-up times, clear tumor classifications, and prospective, randomized study design are necessary to improve the quality of future research.