2021年03月02日
文獻閱讀
Data can provide evidence that informs payers, clinicians, and patients on how an intervention performs outside the narrow confines of the research setting,
我的翻譯：數據提供證據，通知付款人、臨床醫生、受試者在狹隘的研究設置外面的干預的表現；google:數據可以提供證據，告知付款人，臨床醫生和患者有關干預措施在研究范圍的狹窄范圍之外的執行情況的信息，
providing essential information on the longterm safety and effectiveness of a drug in large populations,
在大人群中，提供藥物長期安全性和有效性的基礎信息；
its economic performance in a naturalistic setting, and for assessment of comparative effectiveness with other treatments.
我的翻譯：它經濟表現在自然設置上，并且為了評估和其他治療方案比較藥效。google：在自然主義的環境中提高經濟表現，并評估與其他方法的相對有效性。
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：
隨著將方法學的嚴謹性提高到現實世界研究中，隨著更高的質量，更大的數據集的能力增加中，發現這些研究的重要性在增長；
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；)]我的翻譯：這些主體認識到真實世界的重要性，在支持生產和生活循環生產發展和管理與評估決定制造上；
google：這些機構認識到現實世界數據在支持上市產品中的重要性，以及它們在支持生命周期產品開發/監視和決策制定以進行監管和評估方面的潛在作用；
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%的研究是被工廠指揮的，被管理機構執行的一項針對歐盟和美國制藥和醫療器械行業的調查確定，現實世界中有27％的研究是由行業進行的，是由監管機構“按要求”執行的[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]
真實世界數據在健康技術評估的重要補充，被用在國家和宗教主體；例如 去指導臨床決策制定google：真實數據是國家和地區機構使用的醫療技術評估的重要組成部分。
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]
數據更多的被支付者使用，從大量回復的支付者報道使用真實世界數據去指制造決策、管理利用率、處方配置；
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。
數據使用者可以提前發現影響；通過EQWiG的決定的取消 ，展示了基礎胰島素沒有超過人類胰島素的受益，恢復甘精胰島素的市場評估和費用價格；
google：這樣的數據使用可能會產生深遠的影響；例如，EQWiG的一項決定被推翻，即基礎胰島素沒有顯示出優于人胰島素的優勢，從而恢復了德國甘精胰島素的市場準入和溢價。
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
真實世界的研究數量的增加 導致更多的臨床證據能夠去指導治療決策，并且允許評估標簽脫離使用影響；在現實世界中研究的數量增加導致有更多的臨床證據可用于指導治療決策，并可以評估非標簽使用的影響
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.
在這篇文章中，我們回顧了真實世界臨床數據的影響，并且他們的解釋可以如何幫助臨床醫生去評估臨床證據對她們生產決策的適用性；在本文中，我們將回顧現實世界中臨床數據的影響，并他們的解釋如何幫助臨床醫生為自己的決策適當評估臨床證據
CONCLUSIONSReal-world studies provide important information that can complement and/or even expand the information obtained in RCTs.
真實世界研究提供了重要補充信息，或者甚至是擴大rct中獲取的信息；RCTs set the standard for eliminating bias in determiningefficacy and safety of medications, rcts在確定藥物有效性和安全性上為了消除偏見設立了標準；but have significant limitations with regard to generalizability to the broad population of patients （with diabetes receiving health care） in diverse clinical practice settings.在復雜的臨床實踐環境中，糖尿病受到健康關注者，在廣泛的患者人口中，有意義重大的限制；中心。普遍性。；
在廣泛的接受醫保的糖尿病患者人群中但是對于廣泛接受醫療保健的糖尿病患者的可推廣性有很大的限制在不同的臨床實踐環境中
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，真實世界研究的局限性可以更好的被理解和解決
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.
真實世界證據可能產生的猜想，要求在rct中更進一步的調查；對于一些通過RCT解決問題可能不切實際的研究問題，提供答案；現實世界的證據都可能產生假設，需要在RCT中進行進一步研究;
