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.     

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, 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.     

Methodological quality and completeness of reporting in clinical trials conducted in livestock species

Randomized controlled trials (RCTs) are the gold standard for evaluating efficacy of treatments under real world conditions and, as such, it is important that they are conducted with methodological rigour to prevent biased results. Many medical journals have adopted a standard checklist for reporting of RCTs, the CONSORT statement. The objective of this study was to evaluate clinical trials in livestock populations to assess methodological quality and completeness of reporting and to investigate the association between these criteria and treatment effects. A total of 100 clinical trials published between 2006 and 2008 in the English language were randomly selected. For each trial, 2 reviewers independently completed a checklist based on the CONSORT statement and a different 2 reviewers completed a standard template describing the outcomes used and the statistical significance of all reported treatment effects. Disagreements among reviewers were resolved by consensus. The results showed that there were substantive deficiencies in the reporting of many of trial features, both related to methodological quality and completeness of reporting. Details on key features such as randomization, double blinding, and the number of subjects lost to follow-up were reported in only 67, 4, and 62% of trials, respectively. Reporting of random allocation to treatment group was associated with a lower proportion of positive treatments effects within trials, as was reporting of inclusion/exclusion criteria for study subjects, details on the intervention, animal signalment, significance tests of baseline differences for at least one variable, and the methods used to measure all outcomes. The results suggest that there are deficiencies in the current reporting of important features of RCTs conducted in livestock species and that these deficiencies may be associated with biased treatment effects. The creation and adoption of standards for trial reporting in livestock could aid authors, reviewers, and editors in ensuring that necessary trial details are reported in all published trials.     

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.     

Consensus-based reporting standards for diagnostic test accuracy studies for paratuberculosis in ruminants

The Standards for Reporting of Diagnostic Accuracy (STARD) statement (www.stard-statement.org) was developed to encourage complete and transparent reporting of key elements of test accuracy studies in human medicine. The statement was motivated by widespread evidence of bias in test accuracy studies and the finding that incomplete or absent reporting of items in the STARD checklist was associated with overly optimistic estimates of test performance characteristics. Although STARD principles apply broadly, specific guidelines do not exist to account for unique considerations in livestock studies such as herd tests, potential use of experimental challenge studies, a more diverse group of testing purposes and sampling designs, and the widespread lack of an ante-mortem reference standard with high sensitivity and specificity. The objective of the present study was to develop a modified version of STARD relevant to paratuberculosis (Johne's disease) in ruminants. Examples and elaborations for each of the 25 items were developed by a panel of experts using a consensus-based approach to explain the items and underlying concepts. The new guidelines, termed STRADAS-paraTB (Standards for Reporting of Animal Diagnostic Accuracy Studies for paratuberculosis), should facilitate improved quality of reporting of the design, conduct and results of paratuberculosis test accuracy studies which were identified as "poor" in a review published in 2008 in Veterinary Microbiology.     

The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety

The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that might 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 November 18–19, 2008 in Chicago, IL, to achieve the objective. Before 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. Before the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items would 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 subitem 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.     

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.     

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative

Background:  To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors.  Objective:  To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability.  Methods:  The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.  Results:  The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both.  Conclusions:  Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.     

Quality of Reporting of Clinical Trials of Dogs and Cats and Associations with Treatment Effects

Background: To address concerns about the quality of reporting of randomized controlled trials, and the potential for biased treatment effects in poorly reported trials, medical journals have adopted a common set of reporting guidelines, the Consolidated Standards of Reporting Trials (CONSORT) statement, to improve the reporting of randomized controlled trials.
Hypothesis: The reporting of clinical trials involving dogs and cats might not be ideal, and this might be associated with biased treatment effects.
Animals: Dogs and cats used in 100 randomly selected reports of clinical trials.
Methods: Data related to methodological quality and completeness of reporting were extracted from each trial. Associations between reporting of trial features and the proportion of positive treatment effects within trials were evaluated by generalized linear models.
Results: There were substantive deficiencies in reporting of key trial features. An increased proportion of positive treatment effects within a trial was associated with not reporting: the method used to generate the random allocation sequence ( P < .001), the use of double blinding ( P < .001), the inclusion criteria for study subjects ( P = .003), baseline differences between treatment groups ( P = .006), the measurement used for all outcomes ( P = .002), and possible study limitations ( P = .03).
Conclusions and Clinical Importance: Many clinical trials involving dogs and cats in the literature do not report details related to methodological quality and aspects necessary to evaluate external validity. There is some evidence that these deficiencies are associated with treatment effects. There is a need to improve reporting of clinical trials, and guidelines, such as the CONSORT statement, can provide a valuable tool for meeting this need.     

Recommended guidelines for submission, trimming, margin evaluation, and reporting of tumor biopsy specimens in veterinary surgical pathology

Neoplastic diseases are typically diagnosed by biopsy and histopathological evaluation. The pathology report is key in determining prognosis, therapeutic decisions, and overall case management and therefore requires diagnostic accuracy, completeness, and clarity. Successful management relies on collaboration between clinical veterinarians, oncologists, and pathologists. To date there has been no standardized approach or guideline for the submission, trimming, margin evaluation, or reporting of neoplastic biopsy specimens in veterinary medicine. To address this issue, a committee consisting of veterinary pathologists and oncologists was established under the auspices of the American College of Veterinary Pathologists Oncology Committee. These consensus guidelines were subsequently reviewed and endorsed by a large international group of veterinary pathologists. These recommended guidelines are not mandated but rather exist to help clinicians and veterinary pathologists optimally handle neoplastic biopsy samples. Many of these guidelines represent the collective experience of the committee members and consensus group when assessing neoplastic lesions from veterinary patients but have not met the rigors of definitive scientific study and investigation. These questions of technique, analysis, and evaluation should be put through formal scrutiny in rigorous clinical studies in the near future so that more definitive guidelines can be derived.     

Clinical outcome in dogs with nasal tumors treated with intensity-modulated radiation therapy

Intensity-modulated radiation therapy (IMRT) is a valuable tool in human radiation oncology, but information on its use in veterinary medicine is lacking. In this study, 12 dogs with nasal tumors were treated with IMRT at a median radiation dose of 54 Gy. Patient survival times and frequency and severity of side effects on ocular structures, oral mucosa, and skin were recorded. Eight dogs (67%) had resolution of clinical signs during radiation therapy. Median overall survival time was 446 d with a 50% 1-year and a 25% 2-year survival rate. Minimal grade 2 or 3 acute skin toxicity, no grade 2 or 3 late skin toxicity, and no grade 2 or 3 toxicity to oral mucosa or the eye opposite the tumor were identified in the dogs treated with IMRT in this study. The ipsilateral eye could not be routinely spared due to its proximity to the tumor.     

Occupational per-patient radiation dose from a conservative protocol for veterinary (18) F-fluorodeoxyglucose positron emission tomography

The occupational external radiation dose to human medical personnel from positron emission tomography (PET) radiopharmaceuticals has been documented, but to date no corresponding veterinary staff dose data are available. Electronic personal dosimeters (EPDs) were used in this study to measure the per-patient external radiation doses to veterinary staff using a PET/CT (PET combined with computed tomography) protocol in which the patient radiopharmaceutical dose was injected after anesthetic induction. Radiation doses were recorded for the nuclear medicine technologists, the on-duty anesthesiology technologist, and an occasional observer from 19 veterinary (18) F-fluorodeoxyglucose PET/CT studies. Patient mass range was 2.8 to 61.0 kg (22.3 kg mean) and injected activity averaged 6 MBq kg(-1) . The dose range received by nuclear medicine technologists per procedure was 0-30 μSv (9.1 μSv mean), by anesthetists 1-22 μSv (8.2 μSv mean), and by the observer 0-2 μSv (0.5 μSv mean). In both feline and canine studies, placement of the EPD on staff was a significant predictor of radiation dose. Additional significant predictors of staff radiation dose from canine studies included job position and injected activity. The per-patient occupational radiation doses to veterinary PET/CT technologists were slightly greater than those reported for human nuclear medicine PET/CT technologists, but were comparable to estimated radiation doses for nurses caring for nonambulatory human PET/CT patients. Efforts toward maintaining staff radiation doses as low as reasonably achievable (ALARA) will be important as veterinary PET/CT caseload increases.     

A retrospective analysis of radiation oncology related scientific articles in the journal Veterinary Radiology and Ultrasound: Trends over 40 years (1976‐2015)

The journal Veterinary Radiology & Ultrasound is a veterinary specialty journal devoted to the fields of veterinary diagnostic imaging and radiation oncology. The purpose of this retrospective, observational study is to evaluate progressive trends in radiation oncology articles published in Veterinary Radiology & Ultrasound during the 40‐year period (1976‐2015) and describe a shift of trends through several viewpoints. This 40‐year period was divided into four subperiods: Period 1 (1976‐1985), Period 2 (1986‐1995), Period 3 (1996‐2005), and Period 4 (2006‐2015). These articles were divided into six categories based on the nature of the study: 1) studies related to teletherapy with endpoints being patient outcome, 2) radiation therapy dosimetry/planning, 3) patient setup, 4) reviews, 5) case reports, and 6) others. The number of radiation oncology articles in Veterinary Radiology & Ultrasound has increased over the 40‐year period. The number of authors per article has increased between Periods 1 and 3. The number of articles related to linear accelerator has increased between Periods 3 and 4. The median number of treated patients per clinical article related to teletherapy ranged from 15 to 21, which has not changed significantly over the 40‐year period. The most commonly used radiation therapy protocols during Periods 2 and 3 were fine‐fractionated protocols (defined as 10 or more fractions), whereas coarse‐fractionated protocols were more common during Periods 1 and 4. Findings from this study highlight the notable changes of trends in veterinary radiation oncology articles published in Veterinary Radiology & Ultrasound, which clearly reflect changes in the field of veterinary radiation oncology during the past 40 years.     

Randomization,blinding, data handling and sample size estimation in papers published in Veterinary Anaesthesia and Analgesia in 2009 and 2019

ObjectiveTo evaluate reporting of items indicative of bias and weak study design.Study designLiterature survey.PopulationPapers published in Veterinary Anaesthesia and Analgesia.MethodsReporting of randomization, blinding, sample size estimation and data exclusion were compared for papers published separated by a 10 year interval. A reporting rate of more than 95% was considered ideal. The availability of data supporting results in a publicly accessible repository was also assessed. Selected papers were randomized and identifiers removed for review, with data from 59 (57 in 2009, two in 2008) and 56 (52 in 2019, four in 2018) papers analyzed. Items were categorized for completeness of reporting using a previously published operationalized checklist. Two reviewers reviewed all papers independently.ResultsFull reporting of randomization increased over time from 13.6% to 85.7% [95% confidence interval (CI), 57.8–86.6%; p < 0.0001], as did sample size estimation (from 0% to 20%; 95% CI, 7.6–32.4%; p = 0.002). Reporting of blinding (49.2% and 50.0%; 95% CI, –18.3% to 20.0%; p = 1.0) and exclusions of samples/animals (39.0% and 50.0%; 95% CI, –8.8% to 30.8%; p = 0.3) did not change significantly. Data availability was low (2008/2009, zero papers; 2018/2019, two papers). None of the items studied exceeded the predetermined ideal reporting rate.Conclusions and clinical relevanceThese results indicate that reporting quality remains low, with a risk of bias.