Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto Street, Pittsburgh, PA 15261, USA.
Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto Street, Pittsburgh, PA 15261, USA.
J Clin Epidemiol. 2016 Mar;71:3-10. doi: 10.1016/j.jclinepi.2015.10.014. Epub 2015 Nov 5.
Patient care decisions demand high-quality research. To assist those decisions, numerous observational studies are being performed. Are the standards and guidelines to assess observational studies consistent and actionable? What policy considerations should be considered to ensure decision makers can determine if an observational study is of high-quality and valid to inform treatment decisions?
Based on a literature review and input from six experts, we compared and contrasted nine standards/guidelines using 23 methodological elements involved in observational studies (e.g., study protocol, data analysis, and so forth).
Fourteen elements (61%) were addressed by at least seven standards/guidelines; 12 of these elements disagreed in the approach. Nine elements (39%) were addressed by six or fewer standards/guidelines. Ten elements (43%) were not actionable in at least one standard/guideline that addressed the element.
The lack of observational study standard/guideline agreement may contribute to variation in study conduct; disparities in what is considered credible research; and ultimately, what evidence is adopted. A common set of agreed on standards/guidelines for conducting observational studies will benefit funders, researchers, journal editors, and decision makers.
患者护理决策需要高质量的研究。为了辅助这些决策，正在进行大量的观察性研究。评估观察性研究的标准和指南是否一致且可行？为了确保决策者能够确定观察性研究的质量和有效性，以告知治疗决策，应考虑哪些政策考虑因素？
基于文献回顾和六位专家的意见，我们使用涉及观察性研究的 23 个方法学要素（例如研究方案、数据分析等）比较和对比了九项标准/指南。
至少有七项标准/指南涵盖了 14 个要素（61%）；其中 12 个要素的处理方法不一致。有 9 个要素（39%）被六个或更少的标准/指南涵盖。在至少一个涵盖该要素的标准/指南中，有 10 个要素（43%）不可操作。
缺乏观察性研究标准/指南的一致性可能导致研究实施的差异；对可信研究的看法存在差异；最终影响所采用的证据。一套针对观察性研究的通用标准/指南将使资助者、研究人员、期刊编辑和决策者受益。
