TY  - JOUR
T1  - Revisiting Sample Size: Are Big Trials the Answer?
AU  - Lurati Buse, Giovanna A.L.
AU  - Botto, Fernando
AU  - Devereaux, P.J.
Y1  - 2012/07/18
N1  - 10.2106/JBJS.K.01270
JO  - The Journal of Bone & Joint Surgery
SP  - 75
EP  - 79
VL  - 94
IS  - Suppl 1(E)
N2  - Abstract: 
  The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence.
SN  - 0021-9355
M3  - doi: 10.2106/JBJS.K.01270
UR  - http://dx.doi.org/10.2106/JBJS.K.01270
ER  -