目的:在COVID-19大流行的头几个月已经发表了许多系统评价(SRs),临床试验的设计迅速突出了SRs中研究(IfRs)部分的信息含义的重要性。IfR是2020年系统审查和荟萃分析清单的首选报告项目之一,Cochrane手册建议考虑人口,干预,control,结果(PICO)和建议分级,评估,发展,和开发IfR时的评估(等级)域。我们的目的是(1)评估COVID-19治疗的SRs是否包括任何IfR陈述,对于具有IfR语句的SR,(2)检查哪些要素告知了IfR声明。
方法:我们根据2021年5月在EvidenceCOVID-19数据库的LivingOVerview中确定的COVID-19治疗的SR进行了一项综合研究,作为另一个研究项目(CRD42021240423)的一部分。我们将IfR语句定义为至少一个句子,其中包含至少一位信息,这些信息可以为规划未来的研究提供信息。我们在预定义的IfR变量上提取了SR中任何位置的IfR语句,特别是PICO元素,研究设计,和等级域基础的概念。三个作者在试验数据提取表后独立提取数据。我们在每周的讨论中解决了差异,以确保高质量的数据提取。
结果:我们包括326个SR,其中284SR(87.1%)表示IfR。在这284个SR中,201(70.8%)使用首选报告项目进行系统评价和荟萃分析,66(23.2%)使用GRADE。IfR语句(n=284)解决PICO是非结构化的,通常报告“人口”(n=195,68.7%),“干预”(n=242,85.2%),和“结果”(n=127,44.7%),但不是“控制”(n=29,10.2%)。在SRs的IfR陈述中很少报告GRADE领域的概念(n=284):“偏见风险”(n=14,4.9%),“不精确”(n=8,2.8%),“不一致”(n=7,2.5%),“出版偏见”(n=3,1.1%),和“间接性”(n=1,0.4%)。IfR中提到的其他IfR元素是未来研究的“更好报告”(n=17,6.0%)和“临床试验程序标准化”(n=12,4.2%)。
结论:在COVID-19治疗中,几乎90%的SR报告了IfR。关于PICO的IfR声明在SRs中是非结构化的,并且很少报告GRADE基础概念以告知IfR。需要进一步的工作来评估COVID-19以外的普遍性,并更准确地定义应考虑哪些IfR元素,以及如何在干预措施的SR中报告它们。在那之前,考虑PICO元素和GRADE基础概念来推导IfR似乎是一个明智的起点。
OBJECTIVE: Numerous systematic reviews (SRs) have been published in the first months of the COVID-19 pandemic and clinical trials were designed rapidly highlighting the importance of informative implications for research (IfRs) sections in SRs. IfR is one item of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist and the Cochrane Handbook suggests considering population, intervention, control, outcome (PICO) and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) domains when developing IfR. We aimed (1) to assess whether SRs on COVID-19 treatments included any IfR statements and, for SRs with an IfR statement, (2) to examine which elements informed the IfR statement.
METHODS: We conducted a metaresearch study based on SRs on COVID-19 treatment identified in the Living OVerview of the Evidence COVID-19 database in May 2021 as part of another research project (CRD42021240423). We defined an IfR statement as at least one sentence that contained at least one bit of information that could be informative for planning future research. We extracted any IfR statements anywhere in the SRs on predefined IfR variables, in particular PICO elements, study design, and concepts underlying GRADE domains. Three authors extracted data independently after piloting the data extraction form. We resolved discrepancies in weekly discussions to ensure a high-quality data extraction.
RESULTS: We included 326 SRs, of which 284 SRs (87.1%) stated IfR. Of these 284 SRs, 201 (70.8%) reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses and 66 (23.2%) using GRADE. IfR statements (n = 284) addressing PICO were unstructured and commonly reported \'population\' (n = 195, 68.7%), \'intervention\' (n = 242, 85.2%), and \'outcome\' (n = 127, 44.7%) but not \'control\' (n = 29, 10.2%). Concepts underlying GRADE domains were infrequently reported in IfR statements of SRs (n = 284): \'risk of bias\' (n = 14, 4.9%), \'imprecision\' (n = 8, 2.8%), \'inconsistency\' (n = 7, 2.5%), \'publication bias\' (n = 3, 1.1%), and \'indirectness\' (n = 1, 0.4%). Additional IfR elements mentioned in IfR were \'better reporting\' of future studies (n = 17, 6.0%) and \'standardization of procedures in clinical trials\' (n = 12, 4.2%).
CONCLUSIONS: Almost 90% of SRs on COVID-19 treatments reported IfR. IfR statements addressing PICO were unstructured across SRs and concepts underlying GRADE were rarely reported to inform IfR. Further work is needed to assess generalizability beyond COVID-19 and to define more precisely which IfR elements should be considered, and how they should be reported in SRs of interventions. Until then, considering PICO elements and concepts underlying GRADE to derive IfR seems to be a sensible starting point.