《严重过敏反应急救指南》临床问题与结局指标的收集和确定

目的: 确定纳入《严重过敏反应急救指南》的临床问题与结局指标。方法: 由指南指导委员会7位临床医学、药学及护理学专家参考国际指南指导项目组起草、修订拟纳入指南的临床问题与结局指标初稿。临床问题分为背景问题与前景问题,其中背景问题在专家共识组共22位临床专家修订后直接纳入指南范围,前景问题与结局指标将通过三轮德尔菲法对共识组临床专家咨询形成终稿。研究在方法学家全程监督下完成,并通过分析积极系数、变异系数与分值频率等指标进行质量控制。结果: 问题征集初拟共纳入34个前景问题、6个背景问题及6个结局指标,背景问题经专家组修订后直接纳入指南。使用德尔菲法(Delphi method)对前景问题与结局指标的重要程度进行分级后,最终确定28个关键前景问题及6个结局指标纳入指南范围。其中,4个结局指标为关键性结局,其余2个为重要结局,纳入的28个关键前景问题分为严重过敏反应的诊断、救治准备、救治措施及救治后的管理四个部分,另有5个重要问题和1个次要问题此次未纳入指南,供指南修订或更新时参考或讨论。研究中专家响应的积极程度高,积极系数为100%;前景问题的共识程度高,4分及以上的问卷频率均≥0.75;结局指标中,病死率及疾病严重程度的共识程度高,变异系数≤15%。结论: 在全面严谨的信息收集基础上,以德尔菲法的方式确定了需要纳入《严重过敏反应急救指南》的临床问题与结局指标为该指南的后续制定工作奠定了基础。

Selecting and defining the clinical questions and outcomes of Guideline for the Emergency Treatment of Anaphylaxis

Objective: To select and define the clinical questions and outcomes of Guideline for the Emergency Treatment of Anaphylaxis. Methods: A draft including clinical questions, which could be divided into foreground questions and background questions, and outcomes was drawn and revised by the secretary group for the guideline referring to the present guidelines with the guidance of a panel consisting of 7 experienced clinical medicine, pharmacy and nursing experts. Foreground questions and outcomes of the draft were voted into a final version after three rounds of counsels of 22 experienced medicine, pharmacy and nursing clinical experts using Delphi method including 3 rounds of inquiry. And the background questions were directly included in the guideline after the 22 experts’ thorough revising. The research was carried out under the supervision of methodologists. Active coefficient, coefficient of variation and the frequencies of each score were calculated for quality control. Results: The draft of 34 foreground questions, 6 background questions and 6 outcomes was finally drawn up after thorough selecting and consulting. The 6 background questions revised by the clinical experts were all included. After three rounds of Delphi method, 28 pivotal clinical questions covering the diagnosis, preparation for the treatment, treatment and administration after the treatment, and 6 outcomes were defined and included for the guideline. The rest of the foreground questions, 4 of which were recognized as essential and 2 as important, were excluded from the guideline and left for further revising or updating. As for the outcomes, 4 of them were recognized as critical and the rest as important. The experts contributing to the research were active as the active coefficient reached 100%, and the degree of consensus was fine as the frequencies of the feedback scoring equal to or greater than 4 for all the 28 foreground questions included were greater than 75% and the result was settled in the first round. And 2 outcomes, fatality rate and severity, reached a higher degree of consensus with coefficient of variation less than 15%. Conclusion: After thorough and rigorous selecting, the clinical questions and outcomes to be included in the Guideline for the Emergency Treatment of Anaphylaxis were finally selected and defined via Delphi method, guiding the future development of the guidelines.