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.
Bibliographical noteFunding Information:
Following reimbursements, fees and funding have been received by the authors in the last three years and have been declared in the competing interest section. WL, CR, RGF, HAV, KM, MP and JP have received fees for acting as a consultant for Boehringer Ingelheim (WL, KM, MP: consultancy during development and approval of imepitoin; CR: pain consultancy; RGF, JP, HAV: consultancy pre and post launch of imepitoin). AT has been an advisor for Boehringer Ingelheim. SFMB, HAV and AT have been responsible principal investigator of several research studies concerning imepitoin financed by Boehringer Ingelheim. SFMB, HAV, JP, HP, MB, CR and AF received speaking fees from Boehringer Ingelheim. HP received consulting and speaking fees and funding for a collaborative project from Eisai Co. LTD. HAV received funding for a collaborative project from Desitin and Nestlé Purina Research. AF and LDR received reimbursements from Boehringer Ingelheim. LDR has received consulting and speaking fees from Vetoquinol. MP has received consultant fees for Aratana. The other authors declared that they have no competing interests.
The authors are grateful to all owners of epileptic pets and veterinary colleagues who have inspired the group to create consensus statements. We would especially like to thank Professor Simon Shorvon for the critical review of the consensus statements. His great insight has been immensely helpful. The authors also would like to thank the research office for assessing the manuscript according to the Royal Veterinary College’s code of good research practice (Authorisation Number – CCS_ 01026). This study was not financially supported by any organization or grant.
© 2015 Potschka et al.
- Epileptic seizure