'Real-world' clinical trials in diabetes care: meaningful or meaningless?

IF 0.4 Q4 ENDOCRINOLOGY & METABOLISM British Journal of Diabetes Pub Date : 2021-12-06 DOI:10.15277/bjd.2021.317
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Abstract

So-called 'real-world' studies seem increasingly popular in diabetes care, as are the economic evaluations in secondary literature based upon them. The term is usually used for pharmacoepidemiological uncontrolled observational studies of different designs. Interpretation of the study findings is, however, badly undermined by the very reasons that the randomised controlled blinded study was invented – namely, non-medication study effects and biases in investigator selection and behaviour. In diabetes studies, glucose control seems particularly susceptible to such effects, perhaps through changes in patient motivation and education. Further, insulin studies are heavily influenced by baseline factors such as the site of starting insulin, the health circumstances of the patient at the time and the clinician involved. It is rare to see these issues adequately addressed or attempts made to understand their influence. In this article an attempt is made to discuss some of the issues further.
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糖尿病护理的“现实世界”临床试验:有意义还是无意义?
所谓的“真实世界”研究似乎在糖尿病护理中越来越受欢迎,二手文献中基于它们的经济评估也是如此。该术语通常用于不同设计的药物流行病学非控制观察性研究。然而,对研究结果的解释被发明随机对照盲法研究的原因严重破坏了——即非药物研究的影响和研究者选择和行为的偏见。在糖尿病研究中,血糖控制似乎特别容易受到这种影响,可能是由于患者动机和教育的改变。此外,胰岛素研究在很大程度上受到基线因素的影响,如开始使用胰岛素的地点、患者当时的健康状况和参与的临床医生。很少看到这些问题得到充分解决,也很少有人试图理解它们的影响。本文试图进一步讨论其中的一些问题。
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来源期刊
British Journal of Diabetes
British Journal of Diabetes ENDOCRINOLOGY & METABOLISM-
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16.70%
发文量
15
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