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Are large clinical trials in orthopaedic trauma justified?
Authors
Douglas Altman
Jeff Anglen
+31 more
Drew Bednar
Mohit Bhandari
Markus Bischoff
Michael Bosse
Lisa Buckingham
Gregory J. Della Rocca
Matthew Denkers
Aravin Duraikannan
Rajiv Gandhi
Gordon H. Guyatt
Diane Heels-Ansdell
Kyle J. Jeray
Desmond Kwok
Susan Liew
Paula McKay
Nathan N. O\u27Hara
Brad Petrisor
Krishan Rajaratnam
Bill Ristevski
John Sadler
Parag Sancheti
David Sanders
Emil H. Schemitsch
Gerard P. Slobogean
Rebecca G. Snider
Sheila Sprague
Kerry Tai
Stephanie L. Tanner
Paul Tornetta
Stephen Walter
Dale Williams
Publication date
20 April 2018
Publisher
Scholarship@Western
Abstract
© 2018 The Author(s). 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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Last time updated on 23/11/2020