【文献阅读1】《interpertation and impac

2021年03月02日

文献阅读

Data can provide evidence that informs payers, clinicians, and patients on how an intervention performs outside the narrow confines of the research setting,

我的翻译：数据提供证据，通知付款人、临床医生、受试者在狭隘的研究设置外面的干预的表现；google:数据可以提供证据，告知付款人，临床医生和患者有关干预措施在研究范围的狭窄范围之外的执行情况的信息，

providing essential information on the longterm safety and effectiveness of a drug in large populations,

在大人群中，提供药物长期安全性和有效性的基础信息；

its economic performance in a naturalistic setting, and for assessment of comparative effectiveness with other treatments.

我的翻译：它经济表现在自然设置上，并且为了评估和其他治疗方案比较药效。google：在自然主义的环境中提高经济表现，并评估与其他方法的相对有效性。

With improvements （in the rigor of methodology ）being applied to real-world studies,along with the increasing availability of higher-quality, larger datasets, the importance of findings from these studies is growing.google：

随着将方法学的严谨性提高到现实世界研究中，随着更高的质量，更大的数据集的能力增加中，发现这些研究的重要性在增长；

These bodies acknowledge the importance [of real-world data in supporting marketed products ]and [their potential role in supporting (life cycle product development/monitoring) and (decision-making for regulation and assessment；)]我的翻译：这些主体认识到真实世界的重要性，在支持生产和生活循环生产发展和管理与评估决定制造上；

google：这些机构认识到现实世界数据在支持上市产品中的重要性，以及它们在支持生命周期产品开发/监视和决策制定以进行监管和评估方面的潜在作用；

A survey of the pharmaceutical and medical devices industry in the European Union and the USA determined that 27% of real-world studies are conducted by industry, performed ‘‘on request’’ by regulatory authorities.

27%的研究是被工厂指挥的，被管理机构执行的一项针对欧盟和美国制药和医疗器械行业的调查确定，现实世界中有27％的研究是由行业进行的，是由监管机构“按要求”执行的[7]；

Real-world data form a key component of healthcare technology assessments used by national and regional bodies。such as the National Institute /for Health and Care Excellence (NICE) /in the UK and Germany’s Institute for Quality and Efficiency /in Health Care (EQWiG), to guide clinical decision-making [8]

真实世界数据在健康技术评估的重要补充，被用在国家和宗教主体；例如 去指导临床决策制定google：真实数据是国家和地区机构使用的医疗技术评估的重要组成部分。

The data from real-world studies are also increasingly utilized by payers.In a US survey, the majority of payers who responded reported using real-world data to guide decision-making, in particular on utilization management and formulary placement [9]

数据更多的被支付者使用，从大量回复的支付者报道使用真实世界数据去指制造决策、管理利用率、处方配置；

Such data usage may have profound effects; for example, the reversal of a decision by the EQWiG that analogue basal insulins showed no benefit over human insulin, which restored market access and premium pricing for insulin glargine in Germany。

数据使用者可以提前发现影响；通过EQWiG的决定的取消 ，展示了基础胰岛素没有超过人类胰岛素的受益，恢复甘精胰岛素的市场评估和费用价格；

google：这样的数据使用可能会产生深远的影响；例如，EQWiG的一项决定被推翻，即基础胰岛素没有显示出优于人胰岛素的优势，从而恢复了德国甘精胰岛素的市场准入和溢价。

The increase （in the number of real-world studies） has resulted in more clinical evidence being available to guide treatment decisions, and can allow assessment of the impacts of off-label use

真实世界的研究数量的增加 导致更多的临床证据能够去指导治疗决策，并且允许评估标签脱离使用影响；在现实世界中研究的数量增加导致有更多的临床证据可用于指导治疗决策，并可以评估非标签使用的影响

In this paper, we review the impact of real-world clinical data andhow their interpretation can assist clinicians to assess clinical evidence appropriately for their own decision-making.

在这篇文章中，我们回顾了真实世界临床数据的影响，并且他们的解释可以如何帮助临床医生去评估临床证据对她们生产决策的适用性；在本文中，我们将回顾现实世界中临床数据的影响，并他们的解释如何帮助临床医生为自己的决策适当评估临床证据

CONCLUSIONSReal-world studies provide important information that can complement and/or even expand the information obtained in RCTs.

真实世界研究提供了重要补充信息，或者甚至是扩大rct中获取的信息；RCTs set the standard for eliminating bias in determiningefficacy and safety of medications, rcts在确定药物有效性和安全性上为了消除偏见设立了标准；but have significant limitations with regard to generalizability to the broad population of patients （with diabetes receiving health care） in diverse clinical practice settings.在复杂的临床实践环境中，糖尿病受到健康关注者，在广泛的患者人口中，有意义重大的限制；中心。普遍性。；

在广泛的接受医保的糖尿病患者人群中但是对于广泛接受医疗保健的糖尿病患者的可推广性有很大的限制在不同的临床实践环境中

Because real—world studies are performed in actual clinical practice settings,they are better able to assess the actual effectiveness and safety of medications as they are used in real-life by patients and clinicians.With improving study designs, methodological advances, and data sources with more comprehensive data elements, the potential for realworld evidence continues to expand.Moreover,the limitations of real-world studies are betterunderstood and can be better addressed.

然而，真实世界研究的局限性可以更好的被理解和解决

Realworld evidence can both generate hypotheses requiring further investigation in RCTs and also provide answers to some research questions that may be impractical to address through RCTs.

真实世界证据可能产生的猜想，要求在rct中更进一步的调查；对于一些通过RCT解决问题可能不切实际的研究问题，提供答案；现实世界的证据都可能产生假设，需要在RCT中进行进一步研究;