Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
PLoS One. 2019 Mar 15;14(3):e0213802. doi: 10.1371/journal.pone.0213802. eCollection 2019.
Assessing adherence to Early goal-directed therapy (EGDT) is challenging and might account for the negative findings and generalisability of the major trials to a real-life setting. This study was aimed (1) to extract key components of pediatric EGDT guidelines potentially becoming adherence criteria; (2) to classify adherence criteria into complete, clinically important, and feasible; and (3) to compare percent adherence to selected guidelines using the three approaches.
This study started with review of existing evidence to extract key components of pediatric EGDT guidelines. Modified Delphi method was then conducted in two rounds among national experts to identify feasible and/or clinically important criteria. Data from the national prospective multicenter study "Clinical Effectiveness of the Utilization of Bundled Care for Severe Sepsis and Septicemia Children" at King Chulalongkorn Memorial Hospital (KCMH) during 1 June 2012 and 28 February 2014 was used to compare percentage of adherence across the three approaches.
Of 28 components extracted from the review, 10 were identified by the national experts through the Modified Delphi as feasible whereas 8 were identified as clinically important. Thirty-one severe sepsis patients (48.39% male, median age 3.4 years) were reviewed. Sepsis mortality was 9.7%, a significant reduction from 19% and 42% in 2010 and 2007, respectively. Based on the complete adherence criteria, the percent adherence varied from 60.71% to 89.29% (overall mean 76.84%), with lower adherence in the dead than the survived cases (73.81% vs 77.17%; p = 0.55). The percent adherence varied by criteria used: 69.35%, 76.84%, and 84.52% for clinical importance, complete, and feasibility criteria, respectively.
Adherence determination based on selected clinical importance alone might result in an incorrectly estimated clinical benefit of EGDT guidelines, especially in a resource-limited setting. Both clinical importance and feasibility should be integrated into the development of adherence assessment criteria.
评估早期目标导向治疗(EGDT)的依从性具有挑战性,这可能是主要试验在真实环境中得出负面结果和缺乏普遍性的原因。本研究旨在:(1)提取儿科 EGDT 指南的关键组成部分,这些部分可能成为依从性标准;(2)将依从性标准分为完整、临床重要和可行;(3)使用这三种方法比较选择指南的依从性百分比。
本研究首先回顾现有证据,提取儿科 EGDT 指南的关键组成部分。然后,在全国专家中进行了两轮改良 Delphi 法,以确定可行和/或临床重要的标准。2012 年 6 月 1 日至 2014 年 2 月 28 日,在朱拉隆功国王纪念医院(KCMH)进行的全国前瞻性多中心研究“利用捆绑式护理治疗严重脓毒症和败血症儿童的临床效果”的数据用于比较三种方法的依从性百分比。
从综述中提取的 28 个组成部分中,有 10 个被全国专家通过改良 Delphi 法确定为可行,8 个被确定为临床重要。回顾了 31 例严重脓毒症患者(男性占 48.39%,中位年龄 3.4 岁)。脓毒症死亡率为 9.7%,与 2010 年和 2007 年的 19%和 42%相比显著降低。根据完全依从标准,依从性百分比从 60.71%到 89.29%(总体平均 76.84%)不等,死亡患者的依从性低于存活患者(73.81%比 77.17%;p=0.55)。根据使用的标准,依从性百分比分别为临床重要性、完全性和可行性标准的 69.35%、76.84%和 84.52%。
仅基于选择的临床重要性确定依从性可能导致对 EGDT 指南临床获益的不正确估计,特别是在资源有限的环境中。临床重要性和可行性都应纳入依从性评估标准的制定中。