Methodologic issues in the use of bleeding as an outcome in transfusion medicine studies
Methodologic issues in the use of bleeding as an outcome in transfusion medicine studies
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DOI：
10.1046/j.1537-2995.2003.00418.x
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发表时间：
2003-06-01
期刊：
影响因子：
2.9
通讯作者：
Rebulla, P
中科院分区：
文献类型：
--
作者：
Heddle, NM;Cook, RJ;Rebulla, P
背景：对血小板减少的患者进行预防性的血小板输注是为了防止出血。血小板输注的益处经常通过测量计数增量来评估；然而，最近使用了出血评估，因为它是一种更具临床相关性的结果衡量标准。本研究的目的是确定将出血作为结果衡量标准的血小板输注触发研究，比较和对比用于记录出血和分析出血结果的方法，并确定和讨论当出血作为研究结果时需要考虑的方法学问题。研究设计和方法：进行系统性搜索以确定血小板输注触发研究。对相关文献进行综述，以确定出血数据是如何获取和分析的，并确定方法学方面的考虑。结果：确定了7篇符合预先定义的入选标准的文章。用于记录出血的方法包括图表回顾和临床评估。评估的频率和执行评估的人员类型各不相同。确定了四种分析方法：描述性；比较至少有一次出血的患者的比例；比较患者有出血的天数占总出血风险天数的比例；以及事件发生时间(首次出血)分析。结论：设计一项以出血为结果衡量标准的临床研究时，应考虑的方法学问题包括尽量减少对出血的记录和分类的偏见，以及选择适合所问问题的分析方法。还确定了开发有效和可靠的出血量表的必要性。
BACKGROUND: Prophylactic platelet transfusions are given to thrombocytopenic patients to prevent bleeding. The benefit of platelet transfusions has frequently been assessed by measuring the count increment; however, more recently, an assessment of bleeding has been used because it is a more clinically relevant outcome measure. The purpose of this study was to identify platelet transfusion trigger studies that used bleeding as an outcome measure, compare and contrast methods used to document bleeding and analyze bleeding outcomes, and identify and discuss methodologic issues to consider when bleeding is used as a study outcome.STUDY DESIGN AND METHODS: A systematic search to identify platelet transfusion trigger studies was performed. Relevant articles were reviewed to identify how bleeding data was captured and analyzed, and methodologic considerations were identified.RESULTS: Seven articles meeting the predefined entry criteria were identified. Methods used to document bleeding included chart review and clinical assessment. The frequency of assessment and the type of personnel performing the assessment were variable. Four approaches to analysis were identified: descriptive; comparison of the proportions of patients having at least one bleed; comparison of patient days with bleeding expressed as a proportion of the total days at risk of bleeding; and time-to-event (first bleed) analysis.CONCLUSION: Methodologic issues for consideration when designing a clinical study with bleeding as the outcome measure included approaches to minimize bias in the documentation and classification of bleeding and selection of an analysis approach that is appropriate to the question being asked. The need for development of a valid and reliable bleeding scale was also identified.