Limitations in the literature regarding Mohs surgery and staged excision for melanoma: A critical review of quality and data reporting.

BACKGROUND AND OBJECTIVES: The literature supporting Mohs micrographic surgery and staged excision in treating primary cutaneous melanoma is growing but has not been critically reviewed for bias.

METHODS: Articles concerning Mohs micrographic surgery and staged excision for melanoma were assessed using modified "Risk of Bias in Non-randomized Studies of Interventions" (ROBINS-I) criteria, which measures bias in 7 categories.

RESULTS: Forty-seven of 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. 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 1 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 designs are necessary to improve the quality of future research.