(Sample) size matters! An examination of sample size from the SPRINT trial study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures.
(Sample) size matters! An examination of sample size from the SPRINT trial study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures.
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DOI：
10.1097/bot.0b013e3182647e0e
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发表时间：
2013-04
影响因子：
2.3
通讯作者：
Walter S
中科院分区：
文献类型：
--
作者：
SPRINT Investigators;Bhandari M;Tornetta P 3rd;Rampersad SA;Sprague S;Heels-Ansdell D;Sanders DW;Schemitsch EH;Swiontkowski M;Walter S
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. 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. 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. N/A
