Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study
Abstract Background Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical ind...
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| Format: | Article |
| Language: | English |
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BMC
2017-10-01
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| Series: | BMC Veterinary Research |
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| Online Access: | http://link.springer.com/article/10.1186/s12917-017-1207-0 |
| _version_ | 1819205665258733568 |
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| author | K. J. Wareham R. M. Hyde D. Grindlay M. L. Brennan R. S. Dean |
| author_facet | K. J. Wareham R. M. Hyde D. Grindlay M. L. Brennan R. S. Dean |
| author_sort | K. J. Wareham |
| collection | DOAJ |
| description | Abstract Background Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. Methods A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Results Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Conclusions Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions. |
| first_indexed | 2024-12-23T04:55:19Z |
| format | Article |
| id | doaj.art-2ef98d69891e40c2895bf5cfa6ed8a71 |
| institution | Directory Open Access Journal |
| issn | 1746-6148 |
| language | English |
| last_indexed | 2024-12-23T04:55:19Z |
| publishDate | 2017-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Veterinary Research |
| spelling | doaj.art-2ef98d69891e40c2895bf5cfa6ed8a712022-12-21T17:59:22ZengBMCBMC Veterinary Research1746-61482017-10-011311910.1186/s12917-017-1207-0Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional studyK. J. Wareham0R. M. Hyde1D. Grindlay2M. L. Brennan3R. S. Dean4Centre for Evidence-based Veterinary Medicine, School of Veterinary Medicine and Science, The University of NottinghamCentre for Evidence-based Veterinary Medicine, School of Veterinary Medicine and Science, The University of NottinghamCentre of Evidence Based Dermatology, The University of NottinghamCentre for Evidence-based Veterinary Medicine, School of Veterinary Medicine and Science, The University of NottinghamCentre for Evidence-based Veterinary Medicine, School of Veterinary Medicine and Science, The University of NottinghamAbstract Background Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. Methods A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Results Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Conclusions Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions.http://link.springer.com/article/10.1186/s12917-017-1207-0QualityPrimary outcomeStudy design and data analysisClinical trialsEvidence based medicine |
| spellingShingle | K. J. Wareham R. M. Hyde D. Grindlay M. L. Brennan R. S. Dean Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study BMC Veterinary Research Quality Primary outcome Study design and data analysis Clinical trials Evidence based medicine |
| title | Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study |
| title_full | Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study |
| title_fullStr | Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study |
| title_full_unstemmed | Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study |
| title_short | Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study |
| title_sort | sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources a cross sectional study |
| topic | Quality Primary outcome Study design and data analysis Clinical trials Evidence based medicine |
| url | http://link.springer.com/article/10.1186/s12917-017-1207-0 |
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