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Outcome reporting in randomised controlled trials and meta-analyses of appendicitis treatments in children: a systematic review

机译：儿童阑尾炎治疗的随机对照试验和荟萃分析的结果报告：系统评价

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Background Acute appendicitis is the most common surgical emergency in children. Despite this, there is no core outcome set (COS) described for randomised controlled trials (RCTs) in children with appendicitis and hence no consensus regarding outcome selection, definition and reporting. We aimed to identify outcomes currently reported in studies of paediatric appendicitis. Methods Using a defined, sensitive search strategy, we identified RCTs and systematic reviews (SRs) of treatment interventions in children with appendicitis. Included studies were all in English and investigated the effect of one or more treatment interventions in children with acute appendicitis or undergoing appendicectomy for presumed acute appendicitis. Studies were reviewed and data extracted by two reviewers. Primary (if defined) and all other outcomes were recorded and assigned to the core areas ‘Death’, ‘Pathophysiological Manifestations’, ‘Life Impact’, ‘Resource Use’ and ‘Adverse Events’, using OMERACT Filter 2.0. Results A total of 63 studies met the inclusion criteria reporting outcomes from 51 RCTs and nine SRs. Only 25 RCTs and four SRs defined a primary outcome. A total of 115 unique and different outcomes were identified. RCTs reported a median of nine outcomes each (range 1 to 14). The most frequently reported outcomes were wound infection (43 RCTs, nine SRs), intra-peritoneal abscess (41 RCTs, seven SRs) and length of stay (35 RCTs, six SRs) yet all three were reported in just 25 RCTs and five SRs. Common outcomes had multiple different definitions or were frequently not defined. Although outcomes were reported within all core areas, just one RCT and no SR reported outcomes for all core areas. Outcomes assigned to the ‘Death’ and ‘Life Impact’ core areas were reported least frequently (in six and 15 RCTs respectively). Conclusions There is a wide heterogeneity in the selection and definition of outcomes in paediatric appendicitis, and little overlap in outcomes used across studies. A paucity of studies report patient relevant outcomes within the ‘Life Impact’ core area. These factors preclude meaningful evidence synthesis, and pose challenges to designing prospective clinical trials and cohort studies. The development of a COS for paediatric appendicitis is warranted.
机译：背景急性阑尾炎是儿童最常见的外科急症。尽管如此，尚无描述阑尾炎患儿随机对照试验（RCT）的核心结果集（COS），因此在结果选择，定义和报告方面尚无共识。我们旨在确定目前在小儿阑尾炎研究中报告的结局。方法使用明确的敏感搜索策略，我们确定了阑尾炎患儿的RCT和治疗干预措施的系统评价（SR）。所包括的研究全部为英文，调查了一种或多种治疗干预措施对急性阑尾炎或因假定的急性阑尾炎而接受阑尾切除术的儿童的效果。两名研究者对研究进行了审查并提取了数据。使用OMERACT Filter 2.0记录了主要（如果已定义）和所有其他结果，并分配到了“死亡”，“病理生理表现”，“生命影响”，“资源使用”和“不良事件”等核心区域。结果共有63项研究符合纳入标准，报告了51项RCT和9项SR的结果。只有25个RCT和4个SR定义了主要结果。总共鉴定出115种独特和不同的结果。 RCT报告中位数为9个结局（范围1至14）。报告最频繁的结局是伤口​​感染（43个RCT，9个SR），腹腔脓肿（41个RCT，7个SR）和住院时间（35个RCT，6个SR），但仅在25个RCT和5个SR中报告了全部三个。 。共同的结果有多个不同的定义，或者经常没有定义。尽管在所有核心领域都报告了结果，但只有一项RCT和没有SR报告了所有核心领域的结果。分配给“死亡”和“生命影响”核心领域的结果被报告的频率最低（分别在六个和15个RCT中）。结论小儿阑尾炎结局的选择和定义存在广泛的异质性，并且跨研究使用的结局很少重叠。少数研究报告了“生命影响”核心领域中患者的相关结局。这些因素妨碍了有意义的证据综合，并给设计前瞻性临床试验和队列研究带来了挑战。有必要为小儿阑尾炎开发COS。

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