Potschka Heidrun, Fischer Andrea, Löscher Wolfgang, Patterson Ned, Bhatti Sofie, Berendt Mette, De Risio Luisa, Farquhar Robyn, Long Sam, Mandigers Paul, Matiasek Kaspar, Muñana Karen, Pakozdy Akos, Penderis Jacques, Platt Simon, Podell Michael, Rusbridge Clare, Stein Veronika, Tipold Andrea, Volk Holger A
Department of Pharmacology, Toxicology and Pharmacy, Ludwig-Maximillians-University, Königinstr. 16, 80539, Munich, Germany.
Service Neurology at the Centre for Clinical Veterinary Medicine, Ludwig-Maximilians-University, Veterinärstr. 13, 80539, Munich, Germany.
BMC Vet Res. 2015 Aug 28;11:177. doi: 10.1186/s12917-015-0465-y.
Common criteria for the diagnosis of drug resistance and the assessment of outcome are needed urgently as a prerequisite for standardized evaluation and reporting of individual therapeutic responses in canine epilepsy. Thus, we provide a proposal for the definition of drug resistance and partial therapeutic success in canine patients with epilepsy. This consensus statement also suggests a list of factors and aspects of outcome, which should be considered in addition to the impact on seizures. Moreover, these expert recommendations discuss criteria which determine the validity and informative value of a therapeutic trial in an individual patient and also suggest the application of individual outcome criteria. Agreement on common guidelines does not only render a basis for future optimization of individual patient management, but is also a presupposition for the design and implementation of clinical studies with highly standardized inclusion and exclusion criteria. Respective standardization will improve the comparability of findings from different studies and renders an improved basis for multicenter studies. Therefore, this proposal provides an in-depth discussion of the implications of outcome criteria for clinical studies. In particular ethical aspects and the different options for study design and application of individual patient-centered outcome criteria are considered.
作为对犬癫痫个体治疗反应进行标准化评估和报告的前提条件,迫切需要耐药性诊断和结果评估的通用标准。因此,我们针对犬癫痫患者的耐药性定义和部分治疗成功提供了一项提议。本共识声明还提出了一系列结果相关的因素和方面,除了对癫痫发作的影响外,这些也应予以考虑。此外,这些专家建议讨论了决定个体患者治疗试验有效性和信息价值的标准,并提出了个体结果标准的应用。就通用指南达成一致不仅为未来优化个体患者管理奠定了基础,也是设计和实施具有高度标准化纳入和排除标准的临床研究的前提。相应的标准化将提高不同研究结果的可比性,并为多中心研究提供更好的基础。因此,本提议深入讨论了结果标准对临床研究的影响。特别考虑了伦理方面以及以个体患者为中心的结果标准在研究设计和应用中的不同选择。