Minimal Clinically Important Difference for Safe and Simple Novel Acute Ischemic Stroke Therapies
Minimal Clinically Important Difference for Safe and Simple Novel Acute Ischemic Stroke Therapies
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DOI：
10.1161/strokeaha.117.017496
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发表时间：
2017-11-01
期刊：
影响因子：
8.3
通讯作者：
Saver, Jeffrey L.
中科院分区：
文献类型：
--
作者：
Cranston, Jessica S.;Kaplan, Brett D.;Saver, Jeffrey L.
背景和目的-确定最小临床重要差异（MCID）对于评价新的治疗是必不可少的。对于急性缺血性中风，专家调查已经产生了MCID是大大高于MCID观察到的实际专家行为在指南的写作和临床practice. Methods锚定偏差，我们管理的结构化，基于互联网的调查，在美国的学术中风神经学家的横截面。调查答复评估了人口统计学和临床经验，以及MCID的专家判断，即在3个月时实现功能独立的患者比例需要绝对增加，以考虑一种新型、安全的神经保护剂具有临床价值。为了减轻锚定偏差，调查响应框架使用基数1000而不是基数100 patient framework.Results-Survey responses收到来自333名学术中风神经学家中的122名，有23%为女性，72.8%有≥ 6年的实践经验，并且神经血管疾病占> 70%的实践时间的一半以上。应答者-非应答者和连续耐药试验表明，应答者可代表全部专家人群。在受访者中，中位MCID为1.3%（四分位距，0.8%至> 2%holds.Conclusions中风专家对MCID调查的反应受到锚定和中心性偏差的影响。当调查设计考虑到这些因素时，安全的急性缺血性卒中治疗的专家MCID为1.1%至1.5%，与指南编写和临床实践中的实际医生行为雅阁。修订后的MCID值可以指导临床试验设计和资助以及监管机构的决策。
Background and Purpose-Determining the minimal clinically important difference (MCID) is essential for evaluating novel therapies. For acute ischemic stroke, expert surveys have yielded MCIDs that are substantially higher than the MCIDs observed in actual expert behavior in guideline writing and clinical practice, potentially because of anchoring bias.Methods-We administered a structured, internet-based survey to a cross-section of academic stroke neurologists in the United States. Survey responses assessed demographic and clinical experience, and expert judgment of the MCID of the absolute increase needed in the proportion of patients achieving functional independence at 3 months to consider a novel, safe neuroprotective agent as clinically worthwhile. To mitigate anchoring bias, the survey response framework used a base 1000 rather than base 100 patient framework.Results-Survey responses were received from 122 of 333 academic stroke neurologists, there were 23% women, 72.8% had >= 6 years of practice experience, and neurovascular disease accounted for more than half of practice time in >70%. Responder-nonresponder and continuum of resistance tests indicated that responders were representative of the full expert population. Among respondents, the median MCID was 1.3% (interquartile range, 0.8% to >2%).Conclusions-Stroke expert responses to MCID surveys are affected by anchoring and centrality bias. When survey design takes these into account, the expert-derived MCID for a safe acute ischemic stroke treatment is 1.1% to 1.5%, in accord with actual physician behavior in guideline writing and clinical practice. This revised MCID value can guide clinical trial design and grant-funding and regulatory agency decisions.