Adaptation of the Systematic Review Framework to the Assessment of Toxicological Test Methods: Challenges and Lessons Learned With the Zebrafish Embryotoxicity Test
Adaptation of the Systematic Review Framework to the Assessment of Toxicological Test Methods: Challenges and Lessons Learned With the Zebrafish Embryotoxicity Test
复制标题
系统审查框架对毒理学测试方法评估的适应：斑马鱼胚胎毒性测试的挑战和经验教训
作者：
M. Stephens;Sevcan Gül Akgün;S. Hoffmann;R. D. de Vries;B. Flick;T. Hartung;M. Lalu;A. Maertens;H. Witters;Robert A. Wright;K. Tsaioun
摘要系统评价方法是通过对相关科学证据进行结构化、一致性和透明的检查来解决特定问题的一种手段。这种方法已被用于临床医学的优势，并正在适应用于其他学科。虽然已经探索了毒理学的一些应用，特别是危害识别，但据我们所知，目前的预备研究是第一次尝试将其应用于毒理学试验方法的评估。作为我们的测试案例，我们选择了斑马鱼胚胎毒性试验（ZET）的发育毒性和它的哺乳动物对应物，标准的哺乳动物产前发育毒性研究，重点审查如何以及ZET预测存在或不存在的化学诱导的产前发育毒性在哺乳动物研究中观察到的。一个跨学科小组编写了一份系统性审查协议，并在整个试点阶段根据需要对其进行了调整。最终方案已注册，并将指导主要研究（系统性综述），主要研究将执行方案以全面回答综述问题。本预备性研究的目的是将系统评价方法转化为毒理学试验方法性能的评估。因此，报告侧重于所遇到的方法问题，而主要研究报告将报告实质性调查结果。这些涉及许多系统性综述步骤，但主要是搜索和选择证据。将学到的经验教训应用于这些挑战不仅可以改进我们的主要研究，而且可能对其他寻求使用系统性评价方法来比较毒理学测试方法的人有所帮助。最后，我们提出了一系列建议，这些建议如果被采纳，将有助于提高已发表文献的质量，并使毒理学研究的系统评价更快，更容易。
Abstract Systematic review methodology is a means of addressing specific questions through structured, consistent, and transparent examinations of the relevant scientific evidence. This methodology has been used to advantage in clinical medicine, and is being adapted for use in other disciplines. Although some applications to toxicology have been explored, especially for hazard identification, the present preparatory study is, to our knowledge, the first attempt to adapt it to the assessment of toxicological test methods. As our test case, we chose the zebrafish embryotoxicity test (ZET) for developmental toxicity and its mammalian counterpart, the standard mammalian prenatal development toxicity study, focusing the review on how well the ZET predicts the presence or absence of chemical-induced prenatal developmental toxicity observed in mammalian studies. An interdisciplinary team prepared a systematic review protocol and adjusted it throughout this piloting phase, where needed. The final protocol was registered and will guide the main study (systematic review), which will execute the protocol to comprehensively answer the review question. The goal of this preparatory study was to translate systematic review methodology to the assessment of toxicological test method performance. Consequently, it focused on the methodological issues encountered, whereas the main study will report substantive findings. These relate to numerous systematic review steps, but primarily to searching and selecting the evidence. Applying the lessons learned to these challenges can improve not only our main study, but may also be helpful to others seeking to use systematic review methodology to compare toxicological test methods. We conclude with a series of recommendations that, if adopted, would help improve the quality of the published literature, and make conducting systematic reviews of toxicological studies faster and easier over time.
机械验证。
DOI：
10.14573/altex.2013.2.119
发表时间：
2013
期刊：
ALTEX
影响因子：
--
作者：
Hartung,Thomas;Hoffmann,Sebastian;Stephens,Martin
通讯作者：
Stephens,Martin
影响因子：
11.8
作者：
Morgan RL;Thayer KA;Bero L;Bruce N;Falck-Ytter Y;Ghersi D;Guyatt G;Hooijmans C;Langendam M;Mandrioli D;Mustafa RA;Rehfuess EA;Rooney AA;Shea B;Silbergeld EK;Sutton P;Wolfe MS;Woodruff TJ;Verbeek JH;Holloway AC;Santesso N;Schünemann HJ
通讯作者：
Schünemann HJ
影响因子：
11.8
作者：
Whaley P;Halsall C;Ågerstrand M;Aiassa E;Benford D;Bilotta G;Coggon D;Collins C;Dempsey C;Duarte-Davidson R;FitzGerald R;Galay-Burgos M;Gee D;Hoffmann S;Lam J;Lasserson T;Levy L;Lipworth S;Ross SM;Martin O;Meads C;Meyer-Baron M;Miller J;Pease C;Rooney A;Sapiets A;Stewart G;Taylor D
通讯作者：
Taylor D