McMaster University

McMaster University

(Sample) Size Matters! An Examination of Sample Size from the SPRINT Trial.

We would like to share with you the most recent publication from the MacOrtho team on the topic of sample size and power in randomized trials.

Bhandari M, Tornetta P 3rd, Rampersad SA, Sprague S, Heels-Ansdell D, Sanders DW, Schemitsch EH, Swiontkowski M, Walter S. (Sample) Size Matters! An Examination of Sample Size from the SPRINT Trial. Journal of Orthopaedic Trauma. 2012 Jun 22. [Epub ahead of print]

Introduction: Inadequate sample size and power in randomized trials can result in misleading findings. This study demonstrates the effect of sample size in a large, clinical trial by evaluating the results of the SPRINT (Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial fractures) trial as it progressed.

: The SPRINT trial evaluated reamed versus unreamed nailing of the tibia in 1226 patients, as well as in open and closed fracture subgroups (N=400 and N=826, respectively). We analyzed the re-operation rates and relative risk comparing treatment groups at 50, 100 and then increments of 100 patients up to the final sample size. Results at various enrollments were compared to the final SPRINT findings.

Results: In the final analysis, there was a statistically significant decreased risk of re-operation with reamed nails for closed fractures (relative risk reduction 35%). Results for the first 35 patients enrolled suggested reamed nails increased the risk of reoperation in closed fractures by 165%. Only after 543 patients with closed fractures were enrolled did the results reflect the final advantage for reamed nails in this subgroup. Similarly, the trend towards an increased risk of re-operation for open fractures (23%) was not seen until 62 patients with open fractures were enrolled.

Conclusions: Our findings highlight the risk of conducting a trial with insufficient sample size and power. Such studies are not only at risk of missing true effects, but also of giving misleading results.

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