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本文引用的文献

1
Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy.试验设计者和荟萃分析者的选择性偏倚可能会影响干预效果的结论。
J Clin Epidemiol. 2017 Nov;91:95-110. doi: 10.1016/j.jclinepi.2017.07.014. Epub 2017 Aug 24.
2
Pharmaceutical companies' policies on access to trial data, results, and methods: audit study.制药公司获取试验数据、结果和方法的政策:审计研究。
BMJ. 2017 Jul 26;358:j3334. doi: 10.1136/bmj.j3334.
3
Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study.在 Cochrane 综述中纳入的 20920 项随机对照试验中,研究随时间推移而出现的报告质量差和方法学不足的演变:研究中的研究。
BMJ. 2017 Jun 8;357:j2490. doi: 10.1136/bmj.j2490.
4
Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis.临床试验中的多种结果和分析给解释和研究综合带来了挑战。
J Clin Epidemiol. 2017 Jun;86:39-50. doi: 10.1016/j.jclinepi.2017.05.007. Epub 2017 May 18.
5
A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.一种利用ClinicalTrials.gov评估核心结局集纳入情况的方法学途径:类风湿性关节炎随机对照试验综述的结果
BMJ. 2017 May 17;357:j2262. doi: 10.1136/bmj.j2262.
6
Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS.针对相同病症的类似干预措施的临床试验和系统评价并不认为类似结果很重要:一项关于艾滋病毒/艾滋病的案例研究。
J Clin Epidemiol. 2017 Apr;84:85-94. doi: 10.1016/j.jclinepi.2017.02.005. Epub 2017 Feb 27.
7
Update on Trial Registration 11 Years after the ICMJE Policy Was Established.ICMJE政策制定11年后的试验注册最新情况。
N Engl J Med. 2017 Jan 26;376(4):383-391. doi: 10.1056/NEJMsr1601330.
8
Data Sharing - Is the Juice Worth the Squeeze?数据共享——挤出来的汁值得吗?
N Engl J Med. 2016 Oct 27;375(17):1608-1609. doi: 10.1056/NEJMp1610336.
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Trial Reporting in ClinicalTrials.gov - The Final Rule.ClinicalTrials.gov 中的试验报告 - 最终规则。
N Engl J Med. 2016 Nov 17;375(20):1998-2004. doi: 10.1056/NEJMsr1611785. Epub 2016 Sep 16.
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The Yale Open Data Access (YODA) Project--A Mechanism for Data Sharing.耶鲁开放数据访问(YODA)项目——一种数据共享机制。
N Engl J Med. 2016 Aug 4;375(5):403-5. doi: 10.1056/NEJMp1607342.

标准的设计和测量方法将使临床研究具有可重复性和实用性。

Standards for design and measurement would make clinical research reproducible and usable.

机构信息

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205.

出版信息

Proc Natl Acad Sci U S A. 2018 Mar 13;115(11):2590-2594. doi: 10.1073/pnas.1708273114.

DOI:10.1073/pnas.1708273114
PMID:29531086
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5856499/
Abstract

We find standards useful in everyday life and in science, although we do not always follow them. Adopting new standards can be expensive, so there may be a strong incentive to maintain the rather than adopt new standards. The scientific community has many standards encompassing both doing clinical research and reporting it, including standards for design and measurement. Although existing research standards have improved both research and its reporting, we need to unify existing standards and to fill the gaps between steps throughout the research process. Existing gaps include implementation of standards and links between standards for study registration (to know about all studies undertaken), study protocols (to identify the preplanned study design and methods), data collection (to assess outcomes that are important and comparable across studies), dissemination of findings (to know the results of previous studies), data sharing (to make best use of existing data), and evidence synthesis (to draw appropriate conclusions from the body of evidence). The scientific community must work together to harmonize existing standards, to ensure that standards are kept up to date, to check that standards are followed, and to develop standards where they are still needed. A unified system of standards will make our work more reproducible.

摘要

我们在日常生活和科学中都发现标准很有用,尽管我们并不总是遵循它们。采用新标准可能代价高昂,因此,维持旧标准而不采用新标准可能会有强烈的动机。科学界有许多涵盖临床研究和报告的标准,包括设计和测量标准。尽管现有的研究标准已经提高了研究及其报告的质量,但我们需要统一现有的标准,并填补研究过程中各个步骤之间的差距。现有的差距包括标准的实施以及研究注册(了解所有进行的研究)、研究方案(确定预先计划的研究设计和方法)、数据收集(评估重要且可在研究间比较的结果)、研究结果的传播(了解先前研究的结果)、数据共享(充分利用现有数据)和证据综合(从证据体中得出适当的结论)之间的标准链接。科学界必须共同努力,协调现有的标准,确保标准得到更新,检查标准是否得到遵守,并在仍需要标准的地方制定标准。一个统一的标准体系将使我们的工作更具可重复性。