Glenn T Werneburg, Florian Wagenlehner, J Quentin Clemens, Chris Harding, Marcus J Drake
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The definition aligns with guidance from regulatory bodies for approval of UTI drugs. Implementation of a reference standard definition in the design and reporting of future investigations will allow better research design and interpretability within and outside the urology field. The new reference standard resolves some issues and offers a suitable way to unify methodology, and hence increase the potential strength of research in this area. There are some limitations and challenges for implementation, such as difficulties in establishing sensitivity and specificity values for the various settings in which the definition will be used. The inclusion of \"probable\" and \"possible\" UTI categories could be a problem in studies that require dichotomous outcomes. Nonetheless, the reference standard should be recommended until new developments become available, notably a more specific UTI biomarker than pyuria. Approaches to standardized diagnosis of catheter-associated UTIs remain unresolved. PATIENT SUMMARY: A new research definition for urinary tract infection (UTI) has been developed. Use of a single standardized definition in research will help in better design of research studies and comparison of results. 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Despite the high clinical relevance of UTI, there is high variability in definitions in the literature, making interpretation and comparison of research studies difficult, and even impossible in some cases. A recent Delphi consensus study generated a new reference standard definition for UTI that incorporates symptoms, pyuria, and urine culture results. This definition allows for designation of systemic involvement, and no longer categorizes UTIs as complicated or uncomplicated. The definition aligns with guidance from regulatory bodies for approval of UTI drugs. Implementation of a reference standard definition in the design and reporting of future investigations will allow better research design and interpretability within and outside the urology field. The new reference standard resolves some issues and offers a suitable way to unify methodology, and hence increase the potential strength of research in this area. 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引用次数: 0
摘要
尿路感染(UTI)是人类最常见的细菌感染之一。在抗生素耐药性不断增加的背景下,许多研究人员都在努力提高对尿路感染的病理生理认识、诊断和治疗。尽管UTI 与临床高度相关,但文献中的定义却存在很大差异,这就给研究解释和比较带来了困难,在某些情况下甚至是不可能的。最近的一项德尔菲共识研究为 UTI 制定了一个新的参考标准定义,其中包括症状、脓尿和尿培养结果。该定义允许指定全身受累情况,不再将尿毒症分为复杂性和非复杂性。该定义与监管机构批准 UTI 药物的指南相一致。在未来调查的设计和报告中采用参考标准定义将使泌尿科领域内外的研究设计和可解释性得到改善。新的参考标准解决了一些问题,为统一方法论提供了合适的途径,从而提高了该领域研究的潜在实力。但在实施过程中也存在一些局限性和挑战,如在使用该定义的不同环境中确定敏感性和特异性值存在困难。在需要二分结果的研究中,纳入 "可能 "和 "可能 "的 UTI 类别可能会造成问题。尽管如此,在有新的发展,尤其是比脓尿更特异的 UTI 生物标记物出现之前,仍应推荐使用该参考标准。导管相关性尿毒症的标准化诊断方法仍悬而未决。患者摘要:尿路感染(UTI)的新研究定义已经制定。在研究中使用单一的标准化定义将有助于更好地设计研究和比较研究结果。虽然新定义有助于减少尿路感染研究报告中的差异,但它也有一些局限性,在广泛应用之前可能还需要克服一些挑战。
Towards a Reference Standard Definition of Urinary Tract Infection for Research.
Urinary tract infection (UTI) is among the most common human bacterial infections. In the context of increasing antibiotic resistance, there are many research efforts to improve the pathophysiological understanding, diagnosis, and treatment of UTI. Despite the high clinical relevance of UTI, there is high variability in definitions in the literature, making interpretation and comparison of research studies difficult, and even impossible in some cases. A recent Delphi consensus study generated a new reference standard definition for UTI that incorporates symptoms, pyuria, and urine culture results. This definition allows for designation of systemic involvement, and no longer categorizes UTIs as complicated or uncomplicated. The definition aligns with guidance from regulatory bodies for approval of UTI drugs. Implementation of a reference standard definition in the design and reporting of future investigations will allow better research design and interpretability within and outside the urology field. The new reference standard resolves some issues and offers a suitable way to unify methodology, and hence increase the potential strength of research in this area. There are some limitations and challenges for implementation, such as difficulties in establishing sensitivity and specificity values for the various settings in which the definition will be used. The inclusion of "probable" and "possible" UTI categories could be a problem in studies that require dichotomous outcomes. Nonetheless, the reference standard should be recommended until new developments become available, notably a more specific UTI biomarker than pyuria. Approaches to standardized diagnosis of catheter-associated UTIs remain unresolved. PATIENT SUMMARY: A new research definition for urinary tract infection (UTI) has been developed. Use of a single standardized definition in research will help in better design of research studies and comparison of results. Although the new definition will help in reducing the variability in UTI research reports, it has some limitations and there may be challenges to overcome before it is widely used.
期刊介绍:
European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU).
EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.