用德尔菲法确定儿科阿奇霉素注射使用的快速建议指南的临床问题与结局指标

目的:旨在通过三轮德尔菲法,确定儿科阿奇霉素注射使用的快速建议指南中需纳入的临床问题与结局指标。方法:通过前期问卷调查、专家咨询并结合临床实践经验,指南指导委员会草拟了27个临床问题和12个结局指标。专家组在会上对其进行重要性评分,同时可进行补充。采用5分制对临床问题"是否有必要在指南中形成推荐意见"进行评分,1至5分重要性递增;采用9分制对结局指标进行评分,1至9分重要性递增。第一轮在会前采用网络投票形式进行,根据一定的共识规则,共识程度低的问题和指标将进入第二、三轮;第二轮在会中采用纸质问卷进行,投票分数在四分位数外和第一轮补充问题的专家填写意见说明;第三轮在会中采用网络投票形式进行,专家根据第二轮匿名反馈结果,对未形成共识和补充的问题与指标进行重新评分。统计分析专家组的基本信息和调查结果,并计算积极系数和协调系数。结果:共24位专家参与调查,专家组的遴选体现了多学科合作性、地域性和权威性。共有22个临床问题(包括适应证、用法用量、不良反应及护理和特殊人群用药)在指南中必须形成推荐意见或说明,5个临床问题需根据证据质量和专家共识决定是否形成推荐意见,形成7个关键结局和5个重要结局。第一轮与第三轮专家积极系数均为100%,且协调系数经第二轮匿名反馈后有所改善,专家的意见逐渐趋近一致。结论:本研究通过三轮德尔菲法问卷形成了儿科阿奇霉素注射使用的快速建议指南的临床问题与结局指标,为后续指南推荐意见的形成和制定打下了良好的基础。

Using Delphi method to determine the questions and outcomes included in the Rapid Advice Guideline for Intravenous Azithromycin in Pediatrics

OBJECTIVE To define the questions and outcomes to be included in the Rapid Advice Guideline for Intravenous Azithromycin in Pediatrics and their importance ranking. METHODS Twenty-seven questions and twelve outcomes were drafted by the steering group, combining with the questionnaire investigation, expert consultation and clinical practice experience. The questions and outcomes were graded by the guideline panel according to the importance, addition was allowed. As for questions, the importance increases from one to five points while one to nine points for outcomes. Based on the consensus rules, the first round was developed online, and the second round was conducted by paper questionnaires to collect the opinions from the experts whose scores were outside the quarterback if they didn't reach consensus. The third round was carried out online again on the meeting according to the anonymous feedback from the second round. The basic information, questionnaire results, enthusiasm indexes and conformity indexes were calculated and analyzed. RESULTS Twenty-four experts were involved in the investigation and the selection of them was considered to be multidisciplinary collaborative, territorial and authoritative. Recommendation of twenty-two questions must be developed in the guideline, including indication, usage and dosage, adverse reaction, nursing and use in specific populations while five questions depended on the quality of evidence and the consensus of experts. Seven outcomes were ranked as "critical outcome" and five as "important outcome". The enthusiasm index of round one and three were both 100%. In the third round, the conformity improved and the experts came to consensus because of the second round investigation. CONCLUSION Through three rounds of Delphi method investigation, questions and outcomes included in the Rapid Advice Guideline for Intravenous Azithromycin in Pediatrics are defined, which gives directions and foundation to the guideline development.