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Table 5 Appraisal of the validity of the studies included for review using the AOTA scale

From: Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic review

Study Level of Evidence Sample size Internal validity Possible threats to internal validity External validity Possible threats to external validity
Pollak [44] IV A 2-Moderate Unblinded B-Moderate Treatment may not represents current practice: - Participants had to have toenails that the investigators believed were capable of regrowth - Onychomycosis must have been dermatophyte-caused - Patients may not be representative of the diabetic population: - Patients were not allowed to participants if they had abnormal laboratory results - Detail of diabetic population not provided (age, sex ratio, coexisting medical conditions, use of other medications etc.
Albreski [45] II B 3-Low Unblinded Duration of diabetes different between groups More people in the itraconazole group received insulin compared with palliative group B-Moderate Patients may not be representative of the diabetic population: - Participants were excluded if they were taking certain medication, such as medication for high cholesterol, which patients with diabetes are likely to be on - Only one female assessed
Brenner [43] IV B 3-Low Unblinded Attrition Patients were allowed to use other antifungal agents for coexisting tinea pedis Patients received also received nail care treatment B-Moderate Patients may not be representative of the diabetic population: - Patients had to have a good history of scheduled podiatric medical visits for nail care, be in good general health have good pulses.
Farkas [46] IV A 2-Moderate Unblinded Attrition A-High nil
Gupta [42] II B 1-High nil A-High nil
Sadighha [41] IV C 2-Moderate Unblinded Selection criteria not clearly stated B-Moderate Patients may not be representative of the diabetic population: - Detail of diabetic population not provided (age, sex ratio, coexisting medical conditions, use of other medications etc.)
  1. For consistency, the NHMRC study design classification system was used instead of the AOTA study design classification system