| dc.description.abstract | In this paper, we discuss the development of an adverse events (AEs) questionnaire for the registration and documentation of adverse events (AEs) in a clinical trial with nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of pain in canine cancer patients. The aim of the research project is to assess the usefulness of robenacoxib in comparison to carprofen in the palliative treatment of canine cancer patients. The assessment of the treatment efficacy is done by scoring quality of life (QoL), pain and AEs. In literature, QoL scoring systems en pain scoring systems can be easily found (Lynch, 2010) (Iliopoulou, 2013) (Lavan, 2013). But in most clinical trials, AEs are recorded spontaneously or by interviewing owners (Edamura, 2012) (Vial, 2012) (Flor, 2013). We developed an AE questionnaire owners can fill out at home every week during the treatment period. The research question of this thesis is whether we succeeded in developing an AE questionnaire for the clinical trial with NSAIDs. During the development of the AE questionnaire another research question emerged. Namely, if the AE questionnaire might also be useful for owners with canine cancer patients undergoing chemotherapy at the Clinic of Companion Animals at the University of Utrecht.
In order to create the AE questionnaire, a selection of expected AEs in treatment with NSAIDs was made. This selection is based upon the mechanisms of action of NSAIDs and the known AEs reported by the European Medicines Agency (European Medicines Agency, 2011). We adapted the VCOG CTCAE v1.1, a grading system for AEs observed during chemotherapy in cats and dogs (Veterinary Cooperative Oncology Group, 2011). After translation and a first review, the developed questionnaire was tested twice. The first time its adequacy was tested in a group of canine patients without AEs. The second time its adequacy was tested in a group of canine cancer patients treated with chemotherapy. Based upon the first test, the final version of the AE was formed. Finally, owners of the second test group were asked for feedback on the AE questionnaire. In both tests, we find that owners think that the AE questionnaire we developed is clear and easy to fill out. The results of the survey reported that owners do not think that filling out the AE questionnaire is time consuming. But only 50% (4/8) of the owners think the AE questionnaire has added value.
In this study, we find that the AE questionnaire is adequate for the use in the research project with NSAIDs. However, we believe that the AE questionnaire should be adapted before it can be used in a clinical setting with canine cancer patients undergoing chemotherapy. | |
