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减肥手术的结果报告:一项深入分析,为核心结局集的制定提供信息,即BARIACT研究。

Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study.

作者信息

Hopkins J C, Howes N, Chalmers K, Savovic J, Whale K, Coulman K D, Welbourn R, Whistance R N, Andrews R C, Byrne J P, Mahon D, Blazeby J M

机构信息

University Surgery Unit, University Hospitals Southampton, Southampton, UK.

出版信息

Obes Rev. 2015 Jan;16(1):88-106. doi: 10.1111/obr.12240. Epub 2014 Nov 30.

Abstract

Outcome reporting in bariatric surgery needs a core outcome set (COS), an agreed minimum set of outcomes reported in all studies of a particular condition. The aim of this study was to summarize outcome reporting in bariatric surgery to inform the development of a COS. Outcomes reported in randomized controlled trials (RCTs) and large non-randomized studies identified by a systematic review were listed verbatim and categorized into domains, scrutinizing the frequency of outcome reporting and uniformity of definitions. Ninety studies (39 RCTs) identified 1,088 separate outcomes, grouped into nine domains with most (n = 920, 85%) reported only once. The largest outcome domain was 'surgical complications', and overall, 42% of outcomes corresponded to a theme of 'adverse events'. Only a quarter of outcomes were defined, and where provided definitions, which were often contradictory. Percentage of excess weight loss was the main study outcome in 49 studies, but nearly 40% of weight loss outcomes were heterogeneous, thus not comparable. Outcomes of diverse bariatric operations focus largely on adverse events. Reporting is inconsistent and ill-defined, limiting interpretation and comparison of published studies. Thus, we propose and are developing a COS for the surgical treatment of severe and complex obesity.

摘要

减肥手术的结果报告需要一个核心结局集(COS),即在特定疾病的所有研究中报告的一组商定的最小结局。本研究的目的是总结减肥手术的结果报告,为COS的制定提供信息。通过系统评价确定的随机对照试验(RCT)和大型非随机研究中报告的结局逐字列出,并分类到各个领域,审查结局报告的频率和定义的一致性。90项研究(39项RCT)确定了1088个单独的结局,分为9个领域,其中大多数(n = 920,85%)仅报告过一次。最大的结局领域是“手术并发症”,总体而言,42%的结局对应于“不良事件”主题。只有四分之一的结局有定义,而且所提供的定义往往相互矛盾。49项研究中,超重减轻百分比是主要研究结局,但近40%的体重减轻结局是异质性的,因此无法比较。各种减肥手术的结局主要集中在不良事件上。报告不一致且定义不明确,限制了已发表研究的解释和比较。因此,我们提出并正在制定一项针对重度和复杂性肥胖手术治疗的COS。

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