Veterinary Randomized Clinical Trial Reporting: A Review of the Small Animal Literature

The randomized clinical trial (RCT) is a valuable research method for the evaluation of new treatment and prevention regimens in veterinary medicine. Reporting of clinical trials in other disciplines has not been complete. Without complete information on the conduct and results of a clinical trial, readers cannot optimize their use of the information presented. This report represents an objective review of randomized clinical trials in the veterinary small animal literature from 1986 to 1990. Results indicate that RCT reports in the small animal veterinary literature are incomplete. The importance of reporting on particular aspects of RCT research is described.     

Using clinical audits to identify practitioner learning needs

Clinical audits are used in medicine to monitor practice performance, provide practice feedback, and identify learning needs. Although relatively new to veterinary practice, they hold promise as personal learning needs assessment tools. Continuing veterinary medical education providers are in a unique position to assist practitioners in the design, implementation, and evaluation of clinical audits. This paper discusses the types, the interpretation, and the potential uses of data from clinical audits in the veterinary setting and links audits to continuing veterinary medical education.     

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges

Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even misleading unless the study design and reporting are carried out with care. Herein, we offer some perspective on several emerging challenges associated with RCTs, including use of composite endpoints, the reporting of different forms of risk, analysis in the presence of missing data, and issues of reporting and safety assessment. These topics are explored in the context of previously reported veterinary internal medicine studies as well as through illustrative examples with hypothetical data sets. Moreover, many insights germane to RCTs in veterinary internal medicine can be drawn from the wealth of experience with RCTs in the human medical field. A better understanding of the issues presented here can help improve the design, interpretation, and reporting of veterinary RCTs.     

New chemotherapy agents in veterinary medicine.

Several anticancer drugs have been added to the therapeutic armamentarium in recent years. Some of these agents are traditional drugs with a long history of use in human oncology. Increased sophistication in clinical trial design in veterinary oncology has allowed the incorporation of agents previously viewed as excessively toxic. Other agents have been developed more recently. This article summarizes the veterinary experience with two older alkylating agents, lomustine and streptozocin, and newer compounds ifosfamide and gemcitabine. The published literature regarding veterinary use of these agents is limited, and the reader is advised to contact a veterinary oncologist for current guidelines when contemplating use of these agents.     

Emergency medicine clerkship: a joining of private-practice referral veterinary medicine with an academic institution

Novel approaches to the clinical training of veterinary students in many disciplines are being sought by veterinary colleges. In 2004, the University of Florida College of Veterinary Medicine approached the Small Animal Department and Florida Veterinary Specialists (FVS) in Tampa with a proposal to jointly design and run an elective clerkship in emergency medicine. The program would focus on providing increased emergency case exposure in a real-world environment to interested third- and fourth-year veterinary students. The purpose would be to better prepare these students for emergent cases while increasing their overall level of clinical confidence. This article reviews in detail the clerkship structure, its objectives, and the logistics of training and support at FVS. In this instance, the academic-private institution partnership has been successful in providing effective learning for veterinary students over the last three years. This clerkship structure may serve as a template for other institutions exploring alternatives to the traditional clinical training of veterinary students.     

4种藏兽药组方抗腹泻作用研究

试验旨在了解4种藏兽药提取物抗细菌性腹泻病的效果,指导兽医临床治疗该类疾病。采用K-B纸片扩散法和肉汤微量稀释法检测纤毛婆婆纳、松萝、苦参、独一味4种藏兽药提取物对维氏气单胞菌、金黄色葡萄球菌、痢疾志贺氏菌、屎肠球菌、中间耶尔森氏菌、黏质沙雷氏菌、大肠杆菌、铜绿假单胞菌、肺炎克雷伯、肠沙门氏菌肠亚种、粪肠球菌、阪崎肠杆菌、普通变形杆菌、阴沟肠杆菌阴沟亚种14种常见致泻性菌的抑菌效果,再利用正交设计软件对纤毛婆婆纳、苦参、松萝和独一味4味藏兽药进行组方优选,同时利用临床分离菌布利丹沙门氏菌建立小鼠细菌性腹泻模型。根据4种藏兽药优选组方的LD₅₀将组方分为高（0.060 g/mL）、中（0.030 g/mL）、低（0.020 g/mL） 3个剂量组对建立的小鼠细菌性模型进行治疗。结果表明,4种藏兽药对大部分试验致泻性细菌有很好的抑制作用,其中松萝对所有试验菌都有较好的抑制作用,4种藏兽药的优选组方高剂量对小鼠细菌性腹泻表现出最好的治疗作用,有利于临床该类疾病的治疗。     

兽用化学药品血药浓度法生物等效性试验技术指导原则简述

血药浓度法生物等效性试验是兽药生物等效性研究的重要方法。为科学规范兽用化学药品生物等效性研究,保障兽药安全、有效、质量可控,在已发布实施的《兽用化学药品生物等效性试验指导原则》基础上,农业农村部兽药评审中心参考相关最新技术指导原则,结合国内兽药研究现状,修订发布了《兽用化学药品血药浓度法生物等效性试验技术指导原则》。本文针对该指导原则的适用范围、试验设计的内容进行阐述,旨在加强研发单位或相关临床试验机构对此指导原则的理解,对生物等效性试验的有效开展提供指导与帮助。     

Conduct,Oversight, and Ethical Considerations of Clinical Trials in Companion Animals with Cancer: Report of a Workshop on Best Practice Recommendations

Development of effective and safe treatments for companion animals with cancer requires the collaboration of numerous animal health professionals and the full engagement of animal owners. Establishing ‘Best Practice Recommendations’ for clinical trials in veterinary oncology represents an important step toward meeting the goal of rigorous clinical trial design and conduct that is required to establish valid evidence. Likewise, optimizing patient welfare and owner education and advocacy is crucial to meet the unique ethical obligations to both owners and animals enrolled in these clinical trials and to ensure trust in the team conducting the research. To date, ‘Best Practice Recommendations’ for clinical trial conduct have not been reported for veterinary oncology. This document summarizes the consensus of a workshop held in November, 2014 to identify relevant ethical principles and to ensure responsible conduct of clinical research in companion animals with cancer. It is intended as a working document that will be updated as advances in science and ethical considerations require. To the extent possible, existing guidelines for the conduct and oversight of clinical trials in humans have been adapted for veterinary trials to avoid duplicative effort and to facilitate integration of clinical trials such that translational research with benefits for both companion animals and humans are encouraged.     

Rationale for hyperbaric oxygen therapy in traumatic injury and wound care in small animal veterinary practice

Hyperbaric oxygen therapy is in wide use in human medicine around the world. Although hyperbaric oxygen therapy is available for veterinary use, it is still significantly underutilised. The physical principles, gas laws and physiologic mechanisms by which hyperbaric oxygen therapy is therapeutic, especially in traumatic injuries and complicated wound care, are discussed. Then, considerations are offered for the implementation of hyperbaric oxygen therapy in veterinary practices. Finally, a review of clinical indications for veterinary practices, including a presentation of select literature, is provided. Applying hyperbaric oxygen therapy in an earlier and more consistent manner could improve short- and long-term outcomes in complicated wounds. The authors also hope this information may stimulate interest in the design of future, prospective studies for the various clinical situations described.     

Information-seeking behaviors of first-semester veterinary students: a preliminary report

Although emphasis in veterinary education is increasingly being placed on the ability to find, use, and communicate information, studies on the information behaviors of veterinary students or professionals are few. Improved knowledge in this area will provide valuable information for course and curriculum planning and the design of information resources. This article describes a survey of the information-seeking behaviors of first-semester veterinary students at Purdue University. A survey was administered as the first phase of a progressive semester-long assignment for a first semester DVM course in systemic mammalian physiology. The survey probed for understanding of the scientific literature and its use for course assignments and continuing learning. The survey results showed that students beginning the program tended to use Google for coursework, although some also used the resources found through the Purdue libraries' Web sites. On entering veterinary school, they became aware of specific information resources in veterinary medicine. They used a small number of accepted criteria to evaluate the Web site quality. This study confirms the findings of studies of information-seeking behaviors of undergraduate students. Further studies are needed to examine whether those behaviors change as students learn about specialized veterinary resources that are designed to address clinical needs as they progress through their training.     

Clinical Evaluation of Methods of Treatment

Veterinary clinicians can make a significant contribution to the knowledge of the practical value of using alternative treatment methods by conducting clinical trials. By following a logical sequence of steps the clinician can design and participate in a clinical trial in his clinic without interfering with his normal practice. The successive stages of a field trial were presented along with an example to demonstrate the application of the principles involved. These stages are: design and planning, implementation, collection of data, and analysis of data.

The veterinary clinician who initiates clinical trials to answer questions plaguing him provides two services to the veterinary profession. First, he helps answer questions facing private practitioners throughout the profession. Second, he can demonstrate that not all research must be done in a laboratory setting isolated from “real world” complications. Seeing the results that can be derived from individual practicing veterinarians participating in clinical trials should act as a stimulus to other veterinarians to logically organize the data coming from their practices.

     

Evidence‐Based Medicine: The Design and Interpretation of Noninferiority Clinical Trials in Veterinary Medicine

Noninferiority trials are clinical studies designed to demonstrate that an investigational drug is at least as effective as an established treatment within a predetermined margin. They are conducted, in part, because of ethical concerns of administering a placebo to veterinary patients when an established effective treatment exists. The use of noninferiority trial designs has become more common in veterinary medicine with the increasing number of established veterinary therapeutics and the desire to eliminate potential pain or distress in a placebo‐controlled study. Selecting the appropriate active control and an a priori noninferiority margin between the investigational and active control drug are unique and critical design factors for noninferiority studies. Without reliable historical knowledge of the disease response in the absence of treatment and of the response to the selected active control drug, proper design and interpretation of a noninferiority trial is not possible. Despite the appeal of conducting noninferiority trials to eliminate ethical concerns of placebo‐controlled studies, there are real limitations and possible ethical conundrums associated with noninferiority trials. The consequences of incorrect study conclusions because of poor noninferiority trial design need careful attention. Alternative trial designs to typical noninferiority studies exist, but these too have limitations and must also be carefully considered.     

Development, advances and applications of diagnostic ultrasound in animals

Ultrasound has many industrial applications but it was first introduced as a medical diagnostic aid in the 1940s with its first veterinary application, the detection of ovine pregnancy, being reported in 1966. Since then, improvements in equipment quality combined with an increased awareness of the benefits of ultrasound as an imaging technique have led to its widespread use in the veterinary field. Recent advances in computer technology have significantly influenced equipment design and the miniaturization of transducers allows intra-operative and intra-vascular applications. Software advances have improved the ability to manipulate and process data, leading to an increased amount of information being obtained from each examination and the advent of 'remote diagnosis'. Ultrasound guided interventional techniques can now be used for diagnostic or therapeutic purposes. Many of these developments have been introduced by equipment manufacturers but have found specific applications in the veterinary field. Ultrasound is currently employed in a very diverse range of situations, not just as a diagnostic tool in the routine clinical workup of a range of species, but also for disease screening, conservation projects, commercial services, herd management and clinical research.     

Training students to appraise the quality of scientific literature

Implementing evidence-based veterinary medicine (EBVM) into clinical practice requires not only the ability to retrieve, interpret, and apply the results of published scientific studies, but also the ability to critically evaluate the quality of the literature. These skills, however, are not widely taught in the veterinary curriculum. The objective of this study was to test a literature evaluation form (LEF) designed to assist veterinary students in appraising the quality of literature on animal reproduction and to compare their ability to do so with that of students who were provided with a control form (CF). The 68 participants were in their fifth year of study and attended a clinical rotation at the Clinic for Animal Reproduction. Students in the LEF group determined the quality of two scientific papers, considering statements about study design, information content, and objectivity, and determined rating points to obtain an overall score. Participants using the CF ranked the quality of the article without the assistance of the quality assessment form. The LEF group was able to more correctly assess the quality of the literature and the variability of the chosen evidence levels was higher in the CF group. The questionnaire was found to be a useful tool for the systematic assessment of the quality of publications within a reasonable period of time. Seventy-eight per cent of the participants agreed that the LEF helps them evaluate the quality and validity of biomedical scientific information. We conclude that courses that introduce EBVM should be taught in the first semesters of the veterinary curriculum so that students can develop competence in defining a clinical problem, retrieving information from the literature, and developing independent critical thinking.     

Quality documentation challenges for veterinary clinical pathology laboratories

An increasing number of veterinary laboratories worldwide have obtained or are seeking certification based on international standards, such as the International Organization for Standardization/International Electrotechnical Commission 17025. Compliance with any certification standard or quality management system requires quality documentation, an activity that may present several unique challenges in the case of veterinary laboratories. Research specifically addressing quality documentation is conspicuously absent in the veterinary literature. This article provides an overview of the quality system documentation needed to comply with a quality management system with an emphasis on preparing written standard operating procedures specific for veterinary laboratories. In addition, the quality documentation challenges that are unique to veterinary clinical pathology laboratories are critically evaluated against the existing quality standards and discussed with respect to possible solutions and/or recommended courses of action. Documentation challenges include the establishment of quality requirements for veterinary tests, the use or modification of human analytic methods for animal samples, the limited availability of quality control materials satisfactory for veterinary clinical pathology laboratories, the limited availability of veterinary proficiency programs, and the complications in establishing species-specific reference intervals.     

高通量测序技术在兽医临床中的应用

高通量测序技术可一次同时测定几十万到几百万条核酸分子序列,在兽医临床上已被应用到畜禽疾病诊断、疾病监测、致病机理研究、耐药性分析等相关工作中.本综述结合应用实例对高通量测序技术在兽医临床的研究进展进行系统阐述,总结了高通量测序技术在兽医临床应用中的局限性和解决措施,并展望了高通量测序技术在兽医临床的应用前景.     

中兽药前处理及提取车间布局设计的分析与建议

中兽药是兽医用药的重要组成部分,兽用中药制剂的质量与中药材前处理及中药提取工艺密切相关。文章从车间布局、设施设备和车间环境要求等方面详细分析了《兽药生产质量管理规范》对中药前处理车间和中药提取车间的要求,并结合生产实际提出中药前处理车间和中药提取车间的设计建议,给兽药企业中药前处理车间和提取车间GMP改造提供参考,以期在设计和建造中降低企业成本,满足兽用中药提取物及中药制剂达到安全、有效、稳定、可控的质量要求。     

Statistical principles of "good clinical practice" in veterinary medicine--a position paper for planning, implementation and evaluation of empirical studies

The complexity of the design, conduct, analysis and evaluation of empirical studies necessitates a high degree of interdisciplinary collaboration in all areas of research. In order to make sure that no essential harmonisation is missed among the plenitude of processes, it has become common to provide direction on the essential operating procedures in so called "Good ... Practice" guidelines in recent years. In pharmaceutical research on human medicinal products guidelines on Good Clinical Practice have been an integral part of research and development in industry, academia, and the regulatory authorities for a long time. On the other hand, in the development and registration of pharmaceuticals for veterinary use such procedures are not yet established to this extent in Germany. Notwithstanding there being a lot of regulations on specialised subjects. This paper tries to summarise the current state of the discussion and to give an overview on the important points in the design, conduct, analysis and reporting of veterinary clinical studies mainly from an biometrical point of view.