A core outcome set for clinical trials in acute diarrhoea
A core outcome set for clinical trials in acute diarrhoea
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DOI：
10.1136/archdischild-2014-307403
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发表时间：
2015-04-01
影响因子：
5.2
通讯作者：
Szajewska, Hania
中科院分区：
文献类型：
--
作者：
Karas, Jacek;Ashkenazi, Shai;Szajewska, Hania
目的核心结果集是临床研究中应测量内容的基线，因此应作为应收集和报告内容的指南。成立于2012年的儿科肠内营养临床试验结局指标共识小组一致认为，需要就一组核心结局达成共识，并商定应在临床试验中测量和报告的定义。为了实现这一目标，六个工作组（WG）成立，包括工作组急性腹泻，其主要目标是制定一个核心的结果集急性diarrheum.Methods的试验第一步确定如何公布的结果有关急性腹泻的报告。第二个重点是确定在临床试验中测量哪些结果的方法。第三项研究采用两阶段问卷研究，使用德尔菲技术为临床医生和家长定义临床重要的结局。结果对于治疗研究，五个最重要的结局指标是腹泻持续时间、脱水程度、住院需要（或住院患者的住院时间）、48小时内康复的患者比例和不良反应。预防性核心结果集包括预防腹泻，预防脱水，预防住院和不良反应。结论治疗和预防的结果集可以推荐用于胃肠炎患者在未来的试验。他们设想的目标是减少研究的异质性和简化研究的可比性。工作组的下一步是确定如何衡量核心数据集所包含的成果。
Objective Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea.Methods The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents.Results For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects.Conclusions The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set.