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Are large clinical trials in orthopaedic trauma justified?

BACKGROUND: The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. METHODS: The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment...

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Autores principales: Sprague, Sheila, Tornetta, Paul, Slobogean, Gerard P., O’Hara, Nathan N., McKay, Paula, Petrisor, Brad, Jeray, Kyle J., Schemitsch, Emil H., Sanders, David, Bhandari, Mohit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5909275/
https://www.ncbi.nlm.nih.gov/pubmed/29678204
http://dx.doi.org/10.1186/s12891-018-2029-3
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author Sprague, Sheila
Tornetta, Paul
Slobogean, Gerard P.
O’Hara, Nathan N.
McKay, Paula
Petrisor, Brad
Jeray, Kyle J.
Schemitsch, Emil H.
Sanders, David
Bhandari, Mohit
author_facet Sprague, Sheila
Tornetta, Paul
Slobogean, Gerard P.
O’Hara, Nathan N.
McKay, Paula
Petrisor, Brad
Jeray, Kyle J.
Schemitsch, Emil H.
Sanders, David
Bhandari, Mohit
author_sort Sprague, Sheila
collection PubMed
description BACKGROUND: The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. METHODS: The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. RESULTS: The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75–3.04; RR: 1.39, 95% CI: 0.60–3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81–1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50–1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04–1.57). CONCLUSIONS: Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. TRIAL REGISTRATION: NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.
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spelling pubmed-59092752018-04-30 Are large clinical trials in orthopaedic trauma justified? Sprague, Sheila Tornetta, Paul Slobogean, Gerard P. O’Hara, Nathan N. McKay, Paula Petrisor, Brad Jeray, Kyle J. Schemitsch, Emil H. Sanders, David Bhandari, Mohit BMC Musculoskelet Disord Research Article BACKGROUND: The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. METHODS: The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. RESULTS: The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75–3.04; RR: 1.39, 95% CI: 0.60–3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81–1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50–1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04–1.57). CONCLUSIONS: Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. TRIAL REGISTRATION: NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008. BioMed Central 2018-04-20 /pmc/articles/PMC5909275/ /pubmed/29678204 http://dx.doi.org/10.1186/s12891-018-2029-3 Text en © The Author(s). 2018 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
Sprague, Sheila
Tornetta, Paul
Slobogean, Gerard P.
O’Hara, Nathan N.
McKay, Paula
Petrisor, Brad
Jeray, Kyle J.
Schemitsch, Emil H.
Sanders, David
Bhandari, Mohit
Are large clinical trials in orthopaedic trauma justified?
title Are large clinical trials in orthopaedic trauma justified?
title_full Are large clinical trials in orthopaedic trauma justified?
title_fullStr Are large clinical trials in orthopaedic trauma justified?
title_full_unstemmed Are large clinical trials in orthopaedic trauma justified?
title_short Are large clinical trials in orthopaedic trauma justified?
title_sort are large clinical trials in orthopaedic trauma justified?
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5909275/
https://www.ncbi.nlm.nih.gov/pubmed/29678204
http://dx.doi.org/10.1186/s12891-018-2029-3
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