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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