Evaluating the quality of rosacea studies: implications for the patient and physician

BACKGROUND: Patients suffering from rosacea may experience frequent blushing and flushing, erythema, telangiectasia, and/or rhinophyma. In an attempt to find effective treatments, many studies have been performed. OBJECTIVE: It is important to be able to evaluate the quality of clinical trials where agents have been used to treat rosacea, and to compare the effectiveness of the different therapies used for this indication. METHODS: The reports on the efficacy and safety of the different drug therapies were evaluated using predetermined criteria. We searched MEDLINE (1966-2002) for studies where rosacea was treated with the various therapies. The criteria used to assess the quality of the studies were: randomization, blinding (double, single, or open), aims clearly defined, prior sample size calculation, whether inclusion and/or exclusion criteria were outlined, baseline comparison of patient characteristics and demographics, interventions and efficacy parameters defined, compliance assessed, statistical analysis performed including intention-to-treat evaluation of efficacy of therapy. RESULTS: Using the above-mentioned criteria, each study was rated in order to determine the quality of the clinical trial. The maximum score a study could attain was 20. To determine if high-quality studies are cited more often than the lower-quality papers, the number of times a study had been cited since its publication was measured. We found 13 of the 42 studies scored greater than 14; these studies were rated as high-quality studies. There was no significant association between high-quality papers and the number of times they had been cited, suggesting that other factors are also taken into consideration when a given study is cited. CONCLUSION: It is important for investigators and clinicians to be aware of the parameters that count towards designing a high-quality protocol since such studies are more likely to reflect efficacy rates that are accurate. Furthermore, it is essential that when a study is written up, the pertinent information regarding the design of the trial and the manner in which it was conducted are conveyed to the reader.