scholarly journals A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
S. A. Moore ◽  
◽  
A. O’Kell ◽  
H. Borghese ◽  
R. Garabed ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Working Group ◽  
Best Practice ◽  
One Health ◽  
The United States ◽  
Ethical Review ◽  
Guidance Document ◽  
Regulatory Review ◽  
Protocol Review ◽  
Health Alliance

AbstractHarmonized institutional processes and reviewer training are vital to maintain integrity and ethical rigor of the veterinary clinical research pipeline and are a prerequisite to future work that might establish centralized or single-site ethical and regulatory review to ease initiation of multi-center studies. Funded by a CTSA One Health Alliance (COHA) pilot award, a diverse working group of veterinary clinicians and institutional representatives was convened in February 2020 to develop a guidance document detailing broadly agreed upon practices for ethical review and approval of veterinary clinical studies conducted in the United States.The working group defined key areas of need for consensus, developed a set of associated guidelines, and circulated these for review by COHA’s fifteen member institutions. Six focus areas were identified by the working group and included vital items of protocol review, composition of the review committee, post-approval monitoring and adverse event reporting, consideration of special circumstances such as satellite sites and the use of healthy veterinary subjects in research, and the informed consent process.This document outlines a broadly agreed-upon framework through which to approach vital items associated with veterinary clinical study protocol review and approval. These approaches represent current best practice in the review and approval of veterinary clinical studies, and can serve as a guidance for veterinary clinician-scientists and regulatory experts, to ensure robust and ethically conducted studies that can contribute to the advancement of both animal and human health.

Rules for the Rulemakers

2019 ◽  
Author(s):  
Jeffrey Beck
Keyword(s):  
Working Group ◽  
Best Practice ◽  
Guidance Document ◽  
Practice Recommendations ◽  
The Way

Maximal flexibility of rules, or ease of reuse — choose one. The tighter the rules, the more consistent documents will be and the easier it will be to reuse them, but only if the rules are reasonable enough to be adopted. (If all the data creators ignore the rules, reuse doesn’t get easier.) JATS4R (JATS for Reuse) is a NISO working group devoted to optimizing the reusability of scholarly content by developing best-practice recommendations for tagging content in JATS XML. The group has devoted particular attention to the flexibility/reuse tradeoff for rules on attribute use and controlled values, and we eventually decided that we needed some rules for ourselves, on how to write rules for attributes in our recommendations. In the process of developing our guidance document for writing rules for attribute values in our recommendations, we learned (or at least articulated) some things along the way.

scholarly journals Recommendations for Ethical Review of Veterinary Clinical Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Jessica A. Bertout ◽  
Philippe J. R. Baneux ◽  
Carol K. Robertson-Plouch
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Best Practices ◽  
United States Of America ◽  
Clinical Studies ◽  
Animal Studies ◽  
The United States ◽  
Animal Research ◽  
Laboratory Animals ◽  
Ethical Review

Ethical review of both human and animal research is critical to ensuring that studies are conducted with due regard to the welfare and safety of enrolled subjects and to the integrity of the data. However, differences exist in laws, policies, and best practices between human and animal studies. Ethical review is required for most human studies. While the laws and standards are clear for humans and for laboratory animals, the laws and standards for clinical research for client-owned animals are not as well-defined. Here, we discuss gaps in ethical review of clinical animal research in the United States of America and propose expanded functions for veterinary clinical studies committees as a solution.

Business: The Electronic Health Record: Front Line Experience

2011 ◽  
Vol 21 (1) ◽  
pp. 18-22
Author(s):  
Rosemary Griffin
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Electronic Health Record ◽  
Financial Incentives ◽  
Best Practice ◽  
Health Care Systems ◽  
The United States ◽  
Health Record ◽  
Health Trends ◽  
Electronic Health

National legislation is in place to facilitate reform of the United States health care industry. The Health Care Information Technology and Clinical Health Act (HITECH) offers financial incentives to hospitals, physicians, and individual providers to establish an electronic health record that ultimately will link with the health information technology of other health care systems and providers. The information collected will facilitate patient safety, promote best practice, and track health trends such as smoking and childhood obesity.

Best practice for chronic oedema in community settings: what can we learn?

2020 ◽  
Vol 25 (12) ◽  
pp. 610-614
Author(s):  
Garry Cooper-Stanton
Keyword(s):  
Service Provision ◽  
Best Practice ◽  
Evidence Base ◽  
Community Services ◽  
Guidance Document ◽  
Community Settings ◽  
Tissue Viability ◽  
Delivery Of Care ◽  
Specialist Nurses ◽  
The Uk

There are various opportunities and challenges in the delivery of care to those diagnosed with chronic oedema/lymphoedema. Service provision is not consistent within the UK, and non-specialist nurses and other health professionals may be called on to fill the gaps in this area. The latest best practice guidance on chronic oedema is directed at community services that care for people within their own homes in primary care. This guide was developed in order to increase awareness, knowledge and access to an evidence base. Those involved in its creation cross specialist fields (lymphoedema and tissue viability), resulting in the document covering a number of areas, including an explanation of chronic oedema, its assessment and management and the association between chronic oedema and wet legs. The document complements existing frameworks on the condition and its management and also increases the available tools within chronic oedema management in the community. The present article provides an overview of the guidance document and discusses its salient features.

A proposal to leverage high-quality veterinary diagnostic laboratory large data streams for animal health, public health, and One Health

2021 ◽  
pp. 104063872110030
Author(s):  
Craig N. Carter ◽  
Jacqueline L. Smith
Keyword(s):  
Public Health ◽  
Data Streams ◽  
One Health ◽  
Animal Health ◽  
Disease Outbreaks ◽  
Large Data ◽  
Health Impact ◽  
The United States ◽  
Zoonotic Diseases ◽  
Diagnostic Laboratory

Test data generated by ~60 accredited member laboratories of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) is of exceptional quality. These data are captured by 1 of 13 laboratory information management systems (LIMSs) developed specifically for veterinary diagnostic laboratories (VDLs). Beginning ~2000, the National Animal Health Laboratory Network (NAHLN) developed an electronic messaging system for LIMS to automatically send standardized data streams for 14 select agents to a national repository. This messaging enables the U.S. Department of Agriculture to track and respond to high-consequence animal disease outbreaks such as highly pathogenic avian influenza. Because of the lack of standardized data collection in the LIMSs used at VDLs, there is, to date, no means of summarizing VDL large data streams for multi-state and national animal health studies or for providing near-real-time tracking for hundreds of other important animal diseases in the United States that are detected routinely by VDLs. Further, VDLs are the only state and federal resources that can provide early detection and identification of endemic and emerging zoonotic diseases. Zoonotic diseases are estimated to be responsible for 2.5 billion cases of human illness and 2.7 million deaths worldwide every year. The economic and health impact of the SARS-CoV-2 pandemic is self-evident. We review here the history and progress of data management in VDLs and discuss ways of seizing unexplored opportunities to advance data leveraging to better serve animal health, public health, and One Health.

scholarly journals Consensus for the General Use of Equine Water Treadmills for Healthy Horses

Animals ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 305
Author(s):  
Kathryn Nankervis ◽  
Carolyne Tranquille ◽  
Persephone McCrae ◽  
Jessica York ◽  
Morgan Lashley ◽  
...  
Keyword(s):  
Working Group ◽  
Best Practice ◽  
Treadmill Exercise ◽  
Good Practice ◽  
Belt Speed ◽  
Research Programmes ◽  
Potential Benefits ◽  
Water Treadmill ◽  
Selection Of

Water treadmill exercise has become popular in recent years for the training and rehabilitation of equine athletes. In 2019, an equine hydrotherapy working group was formed to establish what was commonly considered to be best practice in the use of the modality. This article describes the process by which general guidelines for the application of water treadmill exercise in training and rehabilitation programmes were produced by the working group. The guidelines describe the consensus reached to date on (1) the potential benefits of water treadmill exercise, (2) general good practice in water treadmill exercise, (3) introduction of horses to the exercise, (4) factors influencing selection of belt speed, water depth and duration of exercise, and (5) monitoring movement on the water treadmill. The long-term goal is to reach a consensus on the optimal use of the modality within a training or rehabilitation programme. Collaboration between clinicians, researchers and experienced users is needed to develop research programmes and further guidelines regarding the most appropriate application of the modality for specific veterinary conditions.

Article Commentary: Defining New Directions for More Effective Management of Surgical Pain in the United States: Highlights of the Inaugural Surgical Pain Congress™

2014 ◽  
Vol 80 (3) ◽  
pp. 219-228 ◽  
Author(s):  
Girish P. Joshi ◽  
David E. Beck ◽  
Roger Hill Emerson ◽  
Thomas M. Halaszynski ◽  
Jonathan S. Jahr ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Pain Management ◽  
Best Practice ◽  
Task Force ◽  
Unmet Need ◽  
The United States ◽  
Cost Of Care ◽  
Inaugural Meeting ◽  
Surgical Pain ◽  
Wide Range

Despite advances in pharmacologic options for the management of surgical pain, there appears to have been little or no overall improvement over the last two decades in the level of pain experienced by patients. The importance of adequate and effective surgical pain management, however, is clear, because inadequate pain control 1) has a wide range of undesirable physiologic and immunologic effects; 2) is associated with poor surgical outcomes; 3) has increased probability of readmission; and 4) adversely affects the overall cost of care as well as patient satisfaction. There is a clear unmet need for a national surgical pain management consensus task force to raise awareness and develop best practice guidelines for improving surgical pain management, patient safety, patient satisfaction, rapid postsurgical recovery, and health economic outcomes. To comprehensively address this need, the multidisciplinary Surgical Pain Congress™ has been established. The inaugural meeting of this Congress (March 8 to 10, 2013, Celebration, Florida) evaluated the current surgical pain management paradigm and identified key components of best practices.

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