Albrecht Joerg, Meves Alexander, Bigby Michael
Department of Medicine and Division of Dermatology, John Stroger Hospital of Cook County, Chicago, Illinois 60612, USA.
Int J Dermatol. 2009 Jun;48(6):592-7. doi: 10.1111/j.1365-4632.2009.04031.x.
Case reports and case series are often the first line of clinical evidence in the medical literature and, until stronger evidence becomes available, are the only guidance to new therapies.
To determine how case reports and case series are reported, what kind of information is provided, and what the authors conclude.
All case reports and series (n < or = 10 patients) that described new or innovative therapies were selected from the online version of the Archives of Dermatology published from January 1998 to June 2001. Data were extracted according to a predefined protocol.
Sixty-two case reports and 38 case series were identified. Four of the 100 articles reported treatment failure; 25 reports (40%) and 19 series (50%) concluded that the treatment was efficacious or useful. Systemic treatment was used in 28 reports (45%) and 19 series (50%). Twelve series (32%) reported treatment of consecutive patients. Follow-up could not be assessed in seven case reports (11%). Sixteen reports (26%) and 15 series (39%) reported patients' experiences; 14 reports (23%) and 10 series (26%) indicated some consent.
This small survey confirms a strong publication bias that favors positive results, exaggerated claims of efficacy and safety, underreporting of patient-centered outcomes, and inadequate reporting of consent. We hope to stimulate a discussion of the quality standards for reporting single cases and case series, and of how information from case reports can be used best to improve patient care.
病例报告和病例系列通常是医学文献中临床证据的首要来源,并且在有更有力的证据出现之前,是新疗法的唯一指导依据。
确定病例报告和病例系列是如何报告的,提供了何种信息,以及作者得出了什么结论。
从1998年1月至2001年6月出版的《皮肤病学文献》网络版中选取所有描述新的或创新疗法的病例报告和病例系列(患者数n≤10)。数据按照预先定义的方案提取。
共识别出62篇病例报告和38个病例系列。100篇文章中有4篇报告了治疗失败;25篇报告(40%)和19个系列(50%)得出治疗有效或有用的结论。28篇报告(45%)和19个系列(50%)使用了全身治疗。12个系列(32%)报告了连续患者的治疗情况。7篇病例报告(11%)无法评估随访情况。16篇报告(26%)和15个系列(39%)报告了患者的体验;14篇报告(23%)和10个系列(26%)表明获得了某种同意。
这项小型调查证实了一种强烈的发表偏倚,即倾向于阳性结果、对疗效和安全性的夸大宣称、以患者为中心结局的报告不足以及同意情况的报告不充分。我们希望引发关于报告单个病例和病例系列的质量标准,以及如何最好地利用病例报告中的信息来改善患者护理的讨论。