Maintenance of certification in dermatology2what we know, what we don’t To the Editor: The Federation of State Medical Boards (FSMB) appreciates the article about the value of lifelong learning and the overview of the FSMB’s Maintenance of Licensure (MOL) initiative.1 As several state medical boards begin to study the implementation of MOL, it is important to recognize that our recommendations do not include, as the article suggests, a ‘‘proctored examination.’’ The MOL framework adopted in 2010 by FSMB’s member boards does not require physicians to take examinations to comply with MOL. While an exam may be an option that some physicians wish to utilize to demonstrate their knowledge and skills in their area of practice, we do not believe such an exam should be mandatory to renew a state medical license. Humayun J. Chaudhry, DO, MACP President and CEO, Federation of State Medical Boards, Euless, Texas Funding sources: None. Conflicts of interest: None declared. Correspondence to: Drew Carlson, Director of Communications, Federation of State Medical Boards, 400 Fuller Wiser Road, Suite 300, Euless, TX 76039 E-mail: [email protected] REFERENCE 1. Stratman E, Kirsner RS, Horn TD. Maintenance of Certification in dermatology: What we know, what we don’t. J Am Acad Dermatol 2013;69:1.e1-11. http://dx.doi.org/10.1016/j.jaad.2013.09.015

Comment on ‘A double-blind, randomized, placebo-controlled trial of adalimumab in the treatment of cutaneous sarcoidosis’ To the Editor: Recently, the University of Ottawa’s Division of Dermatology (Canada) reviewed ‘‘A double-blind, randomized, placebo-controlled trial of adalimumab in the treatment of cutaneous sarcoidosis’’ by Pariser et al1 during our monthly journal club. While we commend the authors on several fronts, the conclusion of the article seems disconnected from the data presented. This is the first randomized control trial of any type for the treatment of cutaneous sarcoidosis and adds to the literature by attempting to guide management 950

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through evidence-based research. Pariser et al took a significant risk in designing a trial to treat patients with proven sarcoidosis with a drug and a class of drugs that have induced more cases of sarcoidosis than the number of patients included in this study (15 patients). As the study states, at least 8 cases of adalimumab-induced sarcoidosis and at least 47 cases of tumor necrosis factor (TNF)- inhibitor-induced sarcoidosis have been reported. Yet, cutaneous sarcoidosis can be exceedingly difficult to manage with a limited number of therapeutic options that demonstrate measurable responses. Therefore, any trial of treatment for this difficult disease is valuable. From a statistical point of view, we have several concerns with regard to this article. First, the trial was designed with one primary outcome and 12 secondary outcomes. In any given study with the gold standard of P # .05, there is a 1 in 20 chance that an outcome will show significance due to chance. In this article, 1 in 13 outcomes showed statistical significance (a secondary outcome not the primary). Therefore, it is plausible that this single significant secondary outcome could be due to chance from simply having a large number of secondary outcomes. Second, and related, only 1 Pvalue in 11 outcomes was included in Table III: Efficacy evaluations at week 12. We calculated the Pvalue for the primary outcome as .6 using the chisquared method. This does not suggest any effect in using adalimumab in cutaneous sarcoidosis when assessing the primary outcome and the favorable appearing results (5 ‘‘responders’’ in treatment group versus 1 ‘‘responder’’ in control group) could be due to chance. Third, a minor point, the abstract states that the trial had 16 patients; however, there were only 15 patients. Finally, this study does not include an intention-to-treat analysis (ITT), an analysis that includes all randomized patients in the group to which they were assigned independent of adherence, treatment received, and subsequent withdrawals. ITT is generally a more conservative estimate of treatment effect. The authors could argue that due to the small size and relatively compliant group, this analysis was unnecessary; nevertheless, providing an ITT would better inform the readers. With regard to the safety of adalimumab in the treatment of cutaneous sarcoidosis, the article concludes in the abstract and body that the treatment is safe. The trial, however, was not powered or designed to comment on safety. Although a table of the adverse events was provided, no analysis was J AM ACAD DERMATOL

Maintenance of certification in dermatology--what we know, what we don't.

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