Onychomycosis: quality of studies.

OBJECTIVE

The quality of original clinical trial publications pertaining to the use of oral antifungal agents to treat onychomycosis was evaluated using predetermined criteria.

METHODS

The list of studies included in this analysis was determined by conducting a search in Medline. For each clinical trial, two independent reviewers each determined a composite score by evaluating a list of criteria that were felt to represent a good study, for example, randomization and blinding, prior sample size calculated, and treatment regimen clearly explained. A citation count was performed to determine whether higher-quality papers were cited more often than lower-quality papers.

RESULTS

Forty-five studies were included in this quality analysis of study design. Of these, 27 were considered to be "high quality" (score greater than or equal to 11 out of 20). A significant correlation coefficient of 0.997 was found between the two reviewers (P < 0.00001). Higher-quality papers were cited significantly more often than lower-quality papers (P = 0.03).

CONCLUSION

The scale that we use to evaluate the quality of onychomycosis studies has high interrater reliability. According to this scale, many published studies (18 out of 45) pertaining to treatments for onychomycosis do not meet the criteria required to be considered "high quality."