Department of Pediatrics, Medical University of Warsaw, Warsaw, Poland.
Department of Pediatrics, West China Second University Hospital, Chengdu, China.
PLoS One. 2020 May 29;15(5):e0228824. doi: 10.1371/journal.pone.0228824. eCollection 2020.
Routine use of probiotics during antibiotic therapy in children remains a subject of discussion. To facilitate synthesis of individual study results and guideline formulation, it is important to assess predefined, similar, and clinically important outcomes. Core outcome sets are a proposed solution for this issue. The aim of this review was to document choice, design, and heterogeneity of outcomes in studies that assessed the effects of probiotics used for the prevention of antibiotic-associated adverse events in children.
A scoping literature search covering three major databases was performed. Studies that evaluated oral probiotics' use concomitant with antibiotic therapy in children were included. Data on outcome definitions, measurement instruments, and follow-up were extracted. The outcomes were assigned to predefined core areas and domains. Data were analyzed descriptively.
Thirty-seven studies were included in this review. Diarrhea, the most commonly reported outcome, had diagnostic criteria clearly defined only in 21 studies. In total, 16 different definitions of diarrhea were identified. Diarrhea duration, severity, and etiology were reported in 9, 4, and 7 studies, respectively. Twenty studies assessed gastrointestinal symptoms other than diarrhea. Seven studies reported outcomes related to resource use or the economic impact of the intervention. Only 2 studies assessed outcomes related to life impact. None of the studies predefined adverse events of probiotic use.
Identified outcomes were characterized by substantial heterogeneity. The majority of outcomes were not designed to evaluate endpoints of real-life relevance. Results from this review suggest the need for a new core outcome set consisting of outcomes important for decision-making.
在儿童抗生素治疗期间常规使用益生菌仍然是一个讨论的话题。为了便于综合个别研究结果和制定指南，评估预先定义的、相似的和临床上重要的结局非常重要。核心结局集是解决这个问题的一种方法。本综述的目的是记录评估益生菌用于预防儿童抗生素相关不良事件的效果的研究中选择、设计和结局的异质性。
对三个主要数据库进行了广泛的文献检索。纳入了评估儿童口服益生菌与抗生素治疗同时使用的研究。提取了结局定义、测量工具和随访的数据。将结局分配到预先定义的核心领域和域。数据进行了描述性分析。
本综述共纳入 37 项研究。腹泻是最常报告的结局，但只有 21 项研究明确界定了其诊断标准。总共确定了 16 种不同的腹泻定义。9 项研究报告了腹泻持续时间、严重程度和病因，4 项研究报告了胃肠道症状，7 项研究报告了与资源利用或干预的经济影响相关的结局。只有 2 项研究评估了与生活影响相关的结局。没有研究预先定义益生菌使用的不良事件。
确定的结局具有显著的异质性。大多数结局的设计不是为了评估实际相关的终点。本综述的结果表明需要制定一个新的核心结局集，包括对决策有重要意义的结局。
