Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study

Wareham, Kathryn; Hyde, Robert; Grindlay, D. J. C.; Dean, Rachel

doi:10.1186/s12917-017-1207-0

Cited by 7 publications

(6 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A documentation of a sample size calculation was presented in only few articles. This is in accordance with the findings of Wareham et al, 26 where only 14.3% reported a sample size calculation and Giuffrida 16 with 22.0%. In addition, in most studies the number of animals was low.…”

Section: Discussionsupporting

confidence: 93%

“…The low prevalence of rare diseases might also play a role. The median sample size seems to have improved as it is 31 according to this study and 30 animals within the trial of Wareham et al 26 A limitation of this study is that we did not recalculate the power of the studies. A recalculation, however, would not have been reasonable for most studies because main target parameters were not specified for most studies.…”

Section: Discussionmentioning

confidence: 77%

See 1 more Smart Citation

Study design quality of research on dogs published in peer‐reviewed journals

Schulte

Arlt

2022

Veterinary Record

View full text Add to dashboard Cite

Background: In the past it has been criticised that only a low proportion of well-designed and well-reported studies in some medical specialities is available. The objective of this study was to systematically evaluate the quality of literature about canine medicine published in peer-reviewed journals in relation to six specific veterinary medicine specialities. Methods: A literature search was conducted and 25 studies per speciality were selected. The quality of the articles (n = 150) published between 2007 and 2019 was evaluated with a validated checklist. Results: In articles related to all specialities, deficits were found, such as not adequate number of animals in 60.0% of the studies. In 88.0%, information about housing and feeding of the dogs were not specified. In 69.4% of the prospective clinical studies, an ethical approval was reported, and written informed consent of the owners was obtained in 46.2%. Conclusions:The findings revealed extensive deficits in the design and reporting of studies in canine medicine. The demand for improvement is obvious and should be addressed by authors, reviewers and journal editors in the future. Our results underline that practitioners should critically appraise the quality of literature before implementing information into practice.

show abstract

Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 77%

Study design quality of research on dogs published in peer‐reviewed journals

Schulte

Arlt

2022

Veterinary Record

View full text Add to dashboard Cite

show abstract

“…The minimum sample size was exceeded and a post-hoc power calculation confirmed the study was adequately powered to detect a difference between the groups. Sample size and power calculation is actually considered a crucial factor in the reliability of RCT results although it has been shown to be still vastly underreported in the veterinary trials literature [43][44][45].…”

Section: Discussionmentioning

confidence: 99%

Management of otitis externa with an led-illuminated gel: a randomized controlled clinical trial in dogs

et al. 2020

View full text Add to dashboard Cite

Background: Canine otitis externa is a painful condition which can be challenging to treat due to difficulties in the administration of otic medication. This can be due to lack of owner compliance in the application of ear drops or due to the resentment that some dogs demonstrate when attempts are made to administer topical medication into a sensitive ear canal. The aim of the study was to assess the efficacy of a topical LED-illuminated gel (LIG) in canine otitis externa in comparison to standard of care therapy. Dogs with spontaneous otitis externa were randomly allocated in three groups: groups QW received LIG once weekly; BW received LIG twice weekly; group C received enrofloxacin and silver sulfadiazine twice daily. LIG consists of a topical application of a gel containing chromophores that, when illuminated by a LED lamp, re-emit fluorescent light which can stimulate physiological responses, promoting healing and controlling bacteria. The evaluation protocol (T 0 to T 5) considered clinical assessment (OTIS-3-index-scoring-system; pruritus-severity-scale; pain-severity-score; aural temperature), cytological scoring system, quali-quantitative bacteriologic assessment. Results: All groups (QW, n = 21; BW, n = 23; C, n = 20) showed improvement during the study (QW: P < 0.02 for cytological and pain scores, P < 0.003 for bacteriologic assessment, P < 10 − 4 for pruritus, total OTIS-3 and temperature assessments; BW: P < 10 − 4 for all clinical, cytological and bacteriologic assessments; C: P < 0.02 for all clinical and cytological assessments, P < 10 − 4 for bacteriologic assessment). The highest clinical score reduction occurred in Group BW (P < 0.014 in T 3 ; P < 0.001 in T 4 and P < 10 − 4 in T 5). BW reached the clinically relevant effect level at T 3 (− 3.26 ± 1.21 levels), QW reached it at T 4 (− 3.24 ± 0.99), C did not reach it. No differences between groups were seen in the reduction of CFU/mL (T 0-T 5). Conclusions: All treatment groups showed a positive clinical effect. LIG administered twice-a-week was the most favourable protocol of the study. LIG may be considered beneficial in the management of canine otitis externa; it seems to be effective in controlling the clinical condition, including the signs of inflammation and local pain, the bacterial growth, and it may help increasing treatment compliance.

show abstract

“…Multiple outcomes were included in almost all (91/100) clinical trials related to health and production in livestock (Sargeant et al, 2009), with a mean of 9.5 (range 1 to 41) outcomes per trial. Wareham et al, (2017) reported that the median number of outcomes in trials in cattle (dairy or beef) was 5.5, with a range of 1 to 36. Although it may increase the efficiency of data collection, having multiple outcomes has important implications for study design and analysis.…”

Section: Determining the Number Of Outcomes To Include In A Trialmentioning

confidence: 99%

Invited review: Maximizing value and minimizing waste in clinical trial research in dairy cattle: Selecting interventions and outcomes to build an evidence base

Sargeant

O’Connor

LeBlanc

et al. 2022

Journal of Dairy Science

View full text Add to dashboard Cite

Clinical trials are a valuable study design for evaluating interventions when it is ethical and feasible for investigators to randomly allocate study animals to intervention groups. Researchers may choose to evaluate the comparative efficacy of intervention groups for their effect on outcomes that are relevant to the specific objectives of their trial. However, the results across multiple trials on the same intervention and with the same outcome should be considered when making decisions on whether to use an intervention, because the results of a single trial are subject to sampling error and do not reflect all biological variability. The objective of this review was to provide an overview of important concepts when selecting intervention groups and outcomes within a randomized controlled trial, and when building a body of evidence for intervention efficacy across multiple trials. Empirical evidence is presented to highlight that integrating and interpreting the efficacy of an intervention across trials is hindered by a lack of replication of interventions across trials. Inconsistency in the outcomes and their measurement among trials also limits the ability to build a body of evidence for the efficacy of interventions. The development of core outcome sets for specific topic areas in dairy science, updated as necessary, may improve consistency across trials and aid in the development of a body of evidence for evidence-based decision-making.

show abstract

Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study

Cited by 7 publications

References 21 publications

Study design quality of research on dogs published in peer‐reviewed journals

Study design quality of research on dogs published in peer‐reviewed journals

Management of otitis externa with an led-illuminated gel: a randomized controlled clinical trial in dogs

Invited review: Maximizing value and minimizing waste in clinical trial research in dairy cattle: Selecting interventions and outcomes to build an evidence base

Contact Info

Product

Resources

About