Key Points for Designing and Reporting Helicobacter pylori Therapeutic Trials: A Personal View
Key Points for Designing and Reporting Helicobacter pylori Therapeutic Trials: A Personal View
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DOI：
10.1111/j.1523-5378.2011.00890.x
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发表时间：
2011-10-01
期刊：
影响因子：
4.4
通讯作者：
Suarez, David
中科院分区：
文献类型：
--
作者：
Calvet, Xavier;Gisbert, Javier P.;Suarez, David
背景和目标：本文的目的是提供一个方法论框架，并回顾充分设计试验以评估幽门螺杆菌感染新疗法的关键方面。方法：非系统文献综述。结果和结论：关于文章的设计，我们建议为未来的试验选择幽门螺杆菌没有显着主要耐药性的药物，并在进行随机试验之前通过试点研究评估治疗方法。该手稿定义了试验前后所需的幽门螺杆菌诊断测试的数量和类型如何取决于测试的设置和可靠性。它推荐了治疗前后幽门螺杆菌检测的最佳方法和时机。其他建议包括使用当前的标准治疗作为新疗法的比较，确定抗生素敏感性（只要有用和可能），使用足够的随机化和分配隐藏但不一定是盲法，并进行意向治疗和符合方案分析。此外，我们还提供了报告和讨论研究结果的基本技巧。
Background & objectives: The aim of this document is to provide a methodological framework and to review key aspects for adequately designing trials to evaluate new treatments for Helicobacter pylori infection.Methods: Non-systematic literature review.Results & conclusions: Regarding the design of the article, we suggest selecting for future trials drugs to which H. pylori has no significant primary resistances and evaluating therapies with pilot studies before engaging in randomized trials. The manuscript defines how the number and type of H. pylori diagnostic tests necessary before and after the trial depend on the setting and reliability of the tests. It recommends the best methods and timing for H. pylori testing before and after therapy. Other recommendations are using current standard treatments as comparators of new therapies, determining antibiotic sensitivity - whenever useful and possible - using adequate randomization and allocation concealment but not necessarily blinding, and performing an intention-to-treat and a per-protocol analysis. In addition, we give basic tips for reporting and discussing study results.