EditorialImproving the Reporting of Clinical Case Series
Section snippets
Proportions of a population with variable follow-up
One of the more common statements made in a clinical case series is one such as “In 28% of patients with some disease (e.g., uveitis) followed for a mean of some time (e.g., 9 months, range 3 months-5 years), some complication (e.g., elevated intraocular pressure) occurred.” Although at face value, the statement seems reasonable, it actually conveys little or no information and may convey misleading information. As shown in Figure 1, two very different event curves both are consistent with this
Small studies
A third problem present in clinical case series is the overinterpretation of small studies. This problem is not restricted to uncontrolled case series but also may affect underpowered clinical trials. One example is a small clinical trial that suggested a new treatment was ineffective for preventing relapse of uveitis because there was no significant difference in the proportion relapsing between the treatment group (30%) and the placebo group (50%, P = .66).18 The problem with this study was
Conclusion
Uncommon diseases may not be easily amenable to investigation in adequately powered randomized controlled clinical trials. The disease may not be judged to be important enough for the large amount of funding required for a large multicenter clinical trial, and the sample size may not be easily achievable. No one center or small group of collaborating centers may have enough patients to conduct a large epidemiologic study. A new treatment may be being used and pilot data needed. Thus, case
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Supported in part by grant EY 00405 from the National Eye Institute, National Institutes of Health, Bethesda, MD.
The Editors-in-Chief of the American Journal of Ophthalmology, Archives of Ophthalmology, and Ophthalmology have reviewed the manuscript, and with the approval of the author, have included this manuscript in the Editorship series of these three journals.