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BEST 协作组临床血小板输注研究报告指南。

A reporting guideline for clinical platelet transfusion studies from the BEST Collaborative.

机构信息

Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.

出版信息

Transfusion. 2013 Jun;53(6):1328-34. doi: 10.1111/j.1537-2995.2012.03906.x. Epub 2012 Sep 25.

DOI:10.1111/j.1537-2995.2012.03906.x
PMID:23003345
Abstract

BACKGROUND

A systematic review of randomized controlled trials and observational studies assessing platelet (PLT) transfusion therapy identified gaps in the descriptions of trial design, variables of the PLT products transfused, and outcomes. We aimed to systematically develop a reporting guideline to aid in designing, reporting, and critiquing PLT trials.

STUDY DESIGN AND METHODS

With the use of expert opinion, a preliminary checklist of 23 items was created. The Delphi method, an iterative forecasting method, was used to achieve consensus among experts to systematically improve upon the preliminary checklist. Items were ranked for inclusion using a 7-point Likert scale from "definitely should not" to "very important to" include. Criteria were established a priori based on the mean score: at least 5.5 accept, 2.6 to 5.4 intermediate, and not more than 2.5 eliminate. Intermediate items were edited and sent out in subsequent rounds for review. Three rounds were undertaken to determine the final checklist.

RESULTS

Initially 33 experts participated, decreasing to 25 by the third round. The preliminary checklist consisted of 23 items spread over four sections: methods and intervention, PLT-specific outcomes, PLT-specific results, and PLT-specific adverse events. After three rounds of the Delphi method, the checklist was expanded and refined to include 30 items. The final checklist was further enhanced by adding an explanatory guide.

CONCLUSION

Use of the Delphi method was successful in finding consensus on items to include in reports of a clinical PLT transfusion study. The final checklist and explanatory guide will be useful for authors and editors to improve the reporting of PLT transfusion trials.

摘要

背景

对评估血小板 (PLT) 输血治疗的随机对照试验和观察性研究进行的系统评价发现,在试验设计、输注的 PLT 产品的变量以及结局的描述方面存在空白。我们旨在系统地制定一份报告指南,以帮助设计、报告和评估 PLT 试验。

研究设计与方法

采用专家意见,初步制定了包含 23 项内容的检查表。德尔菲法是一种迭代预测方法,用于在专家之间达成共识,以系统地改进初步检查表。使用 7 分李克特量表(从“绝对不应”到“非常重要”)对纳入项目进行排名。基于平均得分设定了纳入标准:至少 5.5 分接受,2.6 至 5.4 分中等,不超过 2.5 分淘汰。中间项目在随后的几轮中进行编辑和审查。进行了三轮以确定最终检查表。

结果

最初有 33 名专家参与,到第三轮减少到 25 名。初步检查表包含 23 项,分布在四个部分:方法和干预、PLT 特异性结局、PLT 特异性结果和 PLT 特异性不良事件。经过三轮德尔菲法,检查表得到扩展和完善,包含 30 项内容。通过添加解释性指南,最终检查表得到进一步增强。

结论

使用德尔菲法成功地就报告临床 PLT 输血研究时应包括的项目达成了共识。最终检查表和解释性指南将有助于作者和编辑提高 PLT 输血试验的报告质量。

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