Tacrolimus and pimecrolimus for atopic dermatitis: where do they fit in?
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Biomedical subjects
Publications and source records attributed to Michael Bigby.
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BACKGROUND AND OBJECTIVES: Case reports and case series are often the first evidence of innovative treatment, but clinical trials need to follow to substantiate this evidence. The objective of this article was to evaluate case reports or case series describing innovative treatment concerning their impact. METHODS: Case reports and case series (n < or = 10) from a high-impact journal, The Lancet, published from 1 January 1996 to 30 June 1997, were evaluated according to predefined criteria. To assess publication impact, Pubmed, Science Citation Index, the Register of Current Controlled Clinical Trials, and the Cochrance Controlled Clinical Trials Register were searched. RESULTS: Sixty-four case reports and 39 case series were identified. They were cited in average 17 times (median 6,5; range 0-336). Twenty-Four follow-up trials were identified, nine in the register of current controlled clinical trials. CONCLUSION: Case reports and case series can be well received, and have significant influence on subsequent literature and possibly on clinical practice. Many were followed by clinical trials. Often, though, they report rare conditions for which trials may not be feasible, and more or less explicitly transfer established treatment into other conditions. Overall, there is a strong publication bias favoring positive results, and opportunity should be created for publication of follow-up reports.
BACKGROUND: There is wide variation in the objective visual variables used to measure atopic eczema severity in clinical trials, making comparison and interpretation of results difficult. OBJECTIVE: To provide a rationale for simplifying and standardizing objective atopic eczema scoring by investigating which visual variables provide the best measure of disease severity from the patient's perspective. SETTING: The dermatology outpatient department at the Queen's Medical Centre, University Hospital in Nottingham, and 5 local general practices. PATIENTS: One hundred eighty individuals with atopic eczema. INTERVENTIONS: Clinical examination with scoring of 7 clinical signs and disease extent, followed by regression analyses of visual variable scores against a patient-rated measure of current disease severity. RESULTS: Objective measurements account for only a quarter of the variation in patient-rated disease severity. Three clinical signs were independent predictors of patient-rated disease severity: excoriations, erythema, and edema/papulation. Disease extent measurements do not reflect patient-rated disease severity in a linear manner, with mean severity scores increasing little above 30% body surface area involvement. CONCLUSIONS: From the patient's perspective, the measurement of 3 clinical signs-excoriations, erythema, and edema/papulation-provides as much information about current atopic eczema severity as more complex scoring systems that measure multiple clinical signs and disease extent. The simplicity of the Three Item Severity score, a previously published atopic eczema score based on measurement of these 3 clinical signs, makes it a suitable tool for research studies or clinical practice.
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