Explanation and Elaboration Document for the STROBE‐Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology—Veterinary Extension

The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement was first published in 2007 and again in 2014. The purpose of the original STROBE was to provide guidance for authors, reviewers, and editors to improve the comprehensiveness of reporting; however, STROBE has a unique focus on observational studies. Although much of the guidance provided by the original STROBE document is directly applicable, it was deemed useful to map those statements to veterinary concepts, provide veterinary examples, and highlight unique aspects of reporting in veterinary observational studies. Here, we present the examples and explanations for the checklist items included in the STROBE‐Vet statement. Thus, this is a companion document to the STROBE‐Vet statement methods and process document (JVIM_14575 “Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology—Veterinary (STROBE‐Vet) Statement” undergoing proofing), which describes the checklist and how it was developed.     

Issues of reporting in observational studies in veterinary medicine

Observational studies are common in veterinary medicine; the results may be used to inform decision-making, future research, or as inputs to systematic reviews or risk assessment. To be of use, the results must be published, all of the outcomes that were assessed must be included in the publication, and the research (methods and results) must be reported in sufficient detail that the reader can evaluate the internal and external validity. In human healthcare, concerns about the completeness of reporting – and evidence that poor reporting is associated with study results – have led to the creation of reporting guidelines; these include the STROBE statement for observational studies.     

A SURVEY OF RADIOLOGISTS AND REFERRING VETERINARIANS REGARDING IMAGING REPORTS

An imaging report is a vital communication tool between a radiologist and clinician. In a field where in‐person communication may not be readily available, it is imperative that the report clearly relays pertinent clinical information in a timely manner. The purpose of this observational study was to describe and compare opinions and expectations of small animal general practitioners, veterinary specialists, and veterinary radiologists regarding the imaging report. Online surveys were distributed, and data were collected from 202 veterinary clinicians and 123 veterinary radiologists. The majority (89%) of clinicians were satisfied with their imaging reports and stated that they read the radiology report as soon as it was available (92%). Just less than half (48%) of clinicians indicated it was standard of care that a board‐certified veterinary radiologist read all imaging studies. Radiologists and clinicians agreed that a clinical history (98% and 94%, respectively) and clinical question (82% and 68%, respectively) were needed to generate a good radiology report. Fifty‐five percent to 70% of clinicians prefer red bulleted reports, which included incidental findings (96%); while radiologists slightly favored prose reporting (37–46%). Clinicians found it helpful when additional imaging (86%), medical (71%), and surgical recommendations (73%) were made. About one‐third of specialists who had been in practice for >11 years thought they were better able to interpret imaging for their own specialty than the radiologist. Clinicians voiced discontentment with reports that were not completed in a timely manner or did not give a prioritized differential list. Further studies are warranted to provide a more in‐depth evaluation of veterinary radiology reporting structure and style.     

The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety by Modifying the CONSORT Statement†

The conduct of randomized controlled trials in livestock with production, health and food‐safety outcomes presents unique challenges that may not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2‐day consensus meeting was held on 18–19 November 2008 in Chicago, IL, USA, to achieve the objective. Prior to the meeting, a Web‐based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food‐safety researchers, livestock‐production specialists, journal editors, assistant editors and associate editors. Prior to the meeting, the attendees completed a Web‐based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22‐item checklist. Fourteen items were modified from the CONSORT checklist and an additional sub‐item was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health and food‐safety outcomes.     

Acute lung injury and acute respiratory distress syndromes in veterinary medicine: consensus definitions: The Dorothy Russell Havemeyer Working Group on ALI and ARDS in Veterinary Medicine

Background: As veterinary medicine has become more sophisticated, with greater numbers of veterinary patients receiving intensive care, more patients with an acute respiratory distress (ARDS)‐like syndrome have been recognized. Methods: A consensus definition meeting was held for the purpose of developing veterinary‐specific definitions for acute lung injury (ALI) and ARDS. Results/conclusions: Three clinically based definitions for acute lung injury and acute respiratory distress‐like syndromes occurring in veterinary patients were described. Neonatal equine respiratory distress syndrome (NERDS) was defined separately due to the specific requirement for primary developmental surfactant dysfunction and lack of an inflammatory component. Five diagnostic criteria categories were established for Veterinary ALI/ARDS (Vet ALI/ARDS) with 4 required and a fifth highly recommended criteria. A strong consensus was reached that onset of respiratory distress must have been acute and that known risk factors must be present. Additional criteria included evidence of pulmonary capillary leak with no evidence of increased pulmonary capillary pressure, evidence of inefficient gas exchange and, finally, evidence of inflammation. Some features of ALI/ARDS in the neonatal horse were recognized as unique, therefore, equine neonatal ALI/ARDS (EqNALI/EqNARDS) was similarly defined but with a graded gas exchange inefficiency table to allow for normal developmental changes in gas exchange. Use of these definitions in planning prospective studies of these problems in veterinary patients should allow for more direct comparisons of studies and clinical trials, with a larger goal of improving outcome in veterinary patients.     

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration†

Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest that similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996, with a revised edition published in 2001. The CONSORT statement consists of a 22‐item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies; the use of deliberate challenge models in some trials and the common use of non‐clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies.     

ASVCP guidelines: quality assurance for point‐of‐care testing in veterinary medicine

Point‐of‐care testing (POCT) refers to any laboratory testing performed outside the conventional reference laboratory and implies close proximity to patients. Instrumental POCT systems consist of small, handheld or benchtop analyzers. These have potential utility in many veterinary settings, including private clinics, academic veterinary medical centers, the community (eg, remote area veterinary medical teams), and for research applications in academia, government, and industry. Concern about the quality of veterinary in‐clinic testing has been expressed in published veterinary literature; however, little guidance focusing on POCT is available. Recognizing this void, the ASVCP formed a subcommittee in 2009 charged with developing quality assurance (QA) guidelines for veterinary POCT. Guidelines were developed through literature review and a consensus process. Major recommendations include (1) taking a formalized approach to POCT within the facility, (2) use of written policies, standard operating procedures, forms, and logs, (3) operator training, including periodic assessment of skills, (4) assessment of instrument analytical performance and use of both statistical quality control and external quality assessment programs, (5) use of properly established or validated reference intervals, (6) and ensuring accurate patient results reporting. Where possible, given instrument analytical performance, use of a validated 1_3s control rule for interpretation of control data is recommended. These guidelines are aimed at veterinarians and veterinary technicians seeking to improve management of POCT in their clinical or research setting, and address QA of small chemistry and hematology instruments. These guidelines are not intended to be all‐inclusive; rather, they provide a minimum standard for maintenance of POCT instruments in the veterinary setting.     

ACVIM consensus statement on the treatment of immune‐mediated hemolytic anemia in dogs

Immune‐mediated hemolytic anemia (IMHA) causes severe anemia in dogs and is associated with considerable morbidity and mortality. Treatment with various immunosuppressive and antithrombotic drugs has been described anecdotally and in previous studies, but little consensus exists among veterinarians as to the optimal regimen to employ and maintain after diagnosis of the disease. To address this inconsistency and provide evidence‐based guidelines for treatment of IMHA in dogs, we identified and extracted data from studies published in the veterinary literature. We developed a novel tool for evaluation of evidence quality, using it to assess study design, diagnostic criteria, explanation of treatment regimens, and validity of statistical methods. In combination with our clinical experience and comparable guidelines for humans afflicted with autoimmune hemolytic anemia, we used the conclusions of this process to make a set of clinical recommendations regarding treatment of IMHA in dogs, which we refined subsequently by conducting several iterations of Delphi review. Additionally, we considered emerging treatments for IMHA in dogs and highlighted areas deserving of future research. Comments were solicited from several professional bodies to maximize clinical applicability before the recommendations were submitted for publication. The resulting document is intended to provide clinical guidelines for management of IMHA in dogs. These guidelines should be implemented pragmatically, with consideration of animal, owner, and veterinary factors that may vary among cases.     

Veterinary students as elite performers: preliminary insights

The KPMG 'Mega Study' (Brown JP, Silverman JD. The current and future market for veterinarians and veterinary medical services in the United States. J Am Vet Med Assoc 215:161-183, 1999) and other studies (Cron WL, Slocum JV, Goodnight DB, Volk JO. Impact of management practices and business behaviors on small animal veterinarians' incomes. J Am Vet Med Assoc 217:332-338, 1999; Lewis RE. Non-technical Competencies Underlying Career Success as a Veterinarian: A New Model for Selecting and Training Veterinary Students. Minneapolis: Personnel Decisions, 2002) concur that improvement in veterinary practitioner performance is necessary. Improvement in practitioners' non-technical competencies is considered most vital. Little research exists that identifies underlying psychological factors harbored by veterinary students that inhibit ability to achieve sustained maximum professional performance. Left unaddressed, these same characteristics may lead to coping behaviors that disrupt or, in the worst cases, lead to voluntary or involuntary termination of professional careers. Several performance-related characteristics and interpersonal dynamics are investigated in this study that provide preliminary evidence for the long-term shortcomings addressed in previous veterinary practice management literature. Pedagogical recommendations for addressing these student psychological characteristics are submitted for consideration.     

Illness Severity Scores in Veterinary Medicine: What Can We Learn?

Illness severity scores are gaining increasing popularity in veterinary medicine. This article discusses their applications in both clinical medicine and research, reviews the caveats pertaining to their use, and discusses some of the issues that arise in appropriate construction of a score. Illness severity scores can be used to decrease bias and confounding and add important contextual information to research by providing a quantitative and objective measure of patient illness. In addition, illness severity scores can be used to benchmark performance, and establish protocols for triage and therapeutic management. Many diagnosis‐specific and diagnosis‐independent veterinary scores have been developed in recent years. Although score use in veterinary research is increasing, the scores available are currently underutilized, particularly in the context of observational studies. Analysis of treatment effect while controlling for illness severity by an objective measure can improve the validity of the conclusions of observational studies. In randomized trials, illness severity scores can be used to demonstrate effective randomization, which is of particular utility when group sizes are small. The quality of veterinary scoring systems can be improved by prospective multicenter validation. The prevalence of euthanasia in companion animal medicine poses a unique challenge to scores based on a mortality outcome.     

A dose‐finding study with a novel water‐soluble formulation of paclitaxel for the treatment of malignant high‐grade solid tumours in dogs

A new formulation of water‐soluble paclitaxel (Paccal® Vet) has been developed for canine cancer patients, without the need for pre‐medication (traditionally required in non‐water‐soluble paclitaxel formulations). The objective of the study was to determine a clinically safe and efficacious dose of Paccal Vet and to estimate progression‐free and overall survival and to evaluate single‐dose pharmacokinetics in tumour‐bearing dogs. A positive risk:benefit ratio was established for Paccal Vet administered at 150 mg m^–2 intravenous (IV) for three or more treatment cycles. Preliminary efficacy was demonstrated by best objective response rate (86%), median time to response (14 days) and median progression‐free survival (131 days). Paccal Vet was associated with expected adverse events (AE) (e.g. myelosuppression), however the majority were transient, clinically silent and manageable. This is the first clinical report of a water‐soluble formulation of paclitaxel suggesting successful administration and being safely used without pre‐medication in dogs.     

Update on Canine and Feline Blood Donor Screening for Blood‐Borne Pathogens

An update on the 2005 American College of Veterinary Internal Medicine (ACVIM) Consensus Statement on blood donor infectious disease screening was presented at the 2015 ACVIM Forum in Indianapolis, Indiana, followed by panel and audience discussion. The updated consensus statement is presented below. The consensus statement aims to provide guidance on appropriate blood‐borne pathogen testing for canine and feline blood donors in North America.     

Recommendations for designing and conducting veterinary clinical pathology biologic variation studies

The recent creation of a veterinary clinical pathology biologic variation website has highlighted the need to provide recommendations for future studies of biologic variation in animals in order to help standardize and improve the quality of published information and to facilitate review and selection of publications as standard references. The following recommendations are provided in the format and order commonly found in veterinary publications. A checklist is provided to aid in planning, implementing, and evaluating veterinary studies on biologic variation (Appendix  S1 ). These recommendations provide a valuable resource for clinicians, laboratorians, and researchers interested in conducting studies of biologic variation and in determining the quality of studies of biologic variation in veterinary laboratory testing.     

The veterinary pharmacovigilance program of the APVMA

This paper provides an overview of the Australian Pesticides and Veterinary Medicines Authority's (APVMA) Adverse Experience Reporting Program for veterinary medicines (AERP Vet). It outlines the history of the AERP Vet and how the program investigates adverse experience reports received from veterinarians, product registrants and members of the public. The benefits to veterinarians of such a program are highlighted and include the ability to trust in the safety, quality and efficacy of the veterinary drugs that they handle and administer daily.