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Designing a field trial of an equine grass sickness vaccine: a questionnaire-based feasibility study

机译:设计马草病疫苗的田间试验:基于问卷调查的可行性研究

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摘要

Without an experimental model of Equine Grass Sickness (EGS), a randomised controlled field trial (RCT) represents the only method of evaluating the efficacy of Clostridium botulinum type C vaccination in preventing naturally occurring disease. Clinical trial feasibility is an important aspect of preliminary work undertaken prior to initiating RCTs, estimating parameters that are important for study design. This cross-sectional study aimed to assess the feasibility of conducting a nationwide RCT of a candidate vaccine for EGS based on responses from a sample of British equine veterinary practices (n = 119/284).Seventy-three percent of practices had attended ≥ 1 EGS case within the preceding two years (median four cases), and 51.3% regularly attended recurrently affected premises. Veterinary surgeons had greater confidence diagnosing acute/subacute EGS based solely on history and clinical signs compared to chronic EGS. Ninety-one percent of respondents (n = 103/113) considered the proposed RCT to be important/very important to equine veterinary research. Ninety-one percent of respondents (n = 102/112) indicated preparedness to assist in owner recruitment and 92.9% (n = 104/112) indicated willingness to participate in a RCT. The most frequent reasons for practices declining to participate were low incidence of EGS (n = 4), did not believe clients would wish to participate (n = 3) and amount of paperwork/data collection involved (n = 2). There was considerable support amongst participating veterinary practices for a RCT evaluating the efficacy of Clostridium botulinum vaccination for the prevention of EGS in Britain. Substantial proportions of participating practices would be prepared to participate in the RCT and regularly attended EGS-affected premises that would meet trial inclusion criteria.
机译:没有马匹草病(EGS)的实验模型,随机对照的田间试验(RCT)代表了评估C型肉毒梭菌疫苗预防自然疾病预防效果的唯一方法。临床试验的可行性是启动RCT之前进行的初步工作的重要方面,该阶段评估对研究设计很重要的参数。这项横断面研究旨在根据英国马兽医实践(n = 119/284)的样本评估在全国范围内对EGS候选疫苗进行RCT的可行性。73%的实践参加了≥1前两年内发生了EGS案件(中位数为4例),有51.3%的人定期去了经常受影响的场所。与慢性EGS相比,仅根据病史和临床体征,兽医对诊断急性/亚急性EGS的信心更大。 91%的受访者(n = 103/113)认为拟议的RCT对马兽医研究很重要/非常重要。 91%(n = 102/112)的受访者表示愿意协助所有者招募,而92.9%(n = 104/112)表示愿意参加RCT。拒绝参与实践的最常见原因是EGS发生率低(n = 4),不相信客户希望参与(n = 3)和涉及的文书工作/数据收集量(n = 2)。在英国的参与兽医实践中,有一项关于评估肉毒梭菌疫苗预防EGS有效性的RCT获得了相当大的支持。愿意参加RCT的人员比例将相当大,并定期参加符合EGS标准的受EGS影响的场所。

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