Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Wareham, K. J., Hyde, R. M., Grindlay, D., Brennan, M. L., Dean, R. S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5628436/
https://www.ncbi.nlm.nih.gov/pubmed/28978314
http://dx.doi.org/10.1186/s12917-017-1207-0
_version_ 1783268882931253248
author Wareham, K. J.
Hyde, R. M.
Grindlay, D.
Brennan, M. L.
Dean, R. S.
author_facet Wareham, K. J.
Hyde, R. M.
Grindlay, D.
Brennan, M. L.
Dean, R. S.
author_sort Wareham, K. J.
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12917-017-1207-0) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-5628436
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-56284362017-10-13 Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study Wareham, K. J. Hyde, R. M. Grindlay, D. Brennan, M. L. Dean, R. S. BMC Vet Res Research Article 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12917-017-1207-0) contains supplementary material, which is available to authorized users. BioMed Central 2017-10-04 /pmc/articles/PMC5628436/ /pubmed/28978314 http://dx.doi.org/10.1186/s12917-017-1207-0 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Wareham, K. J.
Hyde, R. M.
Grindlay, D.
Brennan, M. L.
Dean, R. S.
Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study
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 Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5628436/
https://www.ncbi.nlm.nih.gov/pubmed/28978314
http://dx.doi.org/10.1186/s12917-017-1207-0
work_keys_str_mv AT warehamkj samplesizeandnumberofoutcomemeasuresofveterinaryrandomisedcontrolledtrialsofpharmaceuticalinterventionsfundedbydifferentsourcesacrosssectionalstudy
AT hyderm samplesizeandnumberofoutcomemeasuresofveterinaryrandomisedcontrolledtrialsofpharmaceuticalinterventionsfundedbydifferentsourcesacrosssectionalstudy
AT grindlayd samplesizeandnumberofoutcomemeasuresofveterinaryrandomisedcontrolledtrialsofpharmaceuticalinterventionsfundedbydifferentsourcesacrosssectionalstudy
AT brennanml samplesizeandnumberofoutcomemeasuresofveterinaryrandomisedcontrolledtrialsofpharmaceuticalinterventionsfundedbydifferentsourcesacrosssectionalstudy
AT deanrs samplesizeandnumberofoutcomemeasuresofveterinaryrandomisedcontrolledtrialsofpharmaceuticalinterventionsfundedbydifferentsourcesacrosssectionalstudy