Levels of Evidence in Cosmetic Surgery: Analysis and Recommendations Using a New CLEAR Classification

Abstract

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Abstract

Background:

The Level of Evidence rating was introduced in 2011 to grade the quality of publications. This system evaluates study design but does not assess several other quality indicators. This study introduces a new “Cosmetic Level of Evidence And Recommendation” (CLEAR) classification that includes additional methodological criteria and compares this new classification with the existing system.

Methods:

All rated publications in the Cosmetic Section of Plastic and Reconstructive Surgery, July 2011 through June 2013, were evaluated. The published Level of Evidence rating (1–5) and criteria relevant to study design and methodology for each study were tabulated. A new CLEAR rating was assigned to each article, including a recommendation grade (A–D). The published Level of Evidence rating (1–5) was compared with the recommendation grade determined using the CLEAR classification.

Results:

Among the 87 cosmetic articles, 48 studies (55%) were designated as level 4. Three articles were assigned a level 1, but they contained deficiencies sufficient to undermine the conclusions. The correlation between the published Level of Evidence classification (1–5) and CLEAR Grade (A–D) was weak ( ρ = 0.11, not significant). Only 41 studies (48%) evaluated consecutive patients or consecutive patients meeting inclusion criteria.

Conclusions:

The CLEAR classification considers methodological factors in evaluating study reliability. A prospective study among consecutive patients meeting eligibility criteria, with a reported inclusion rate, the use of contemporaneous controls when indicated, and consideration of confounders is a realistic goal. Such measures are likely to improve study quality.