RT Journal A1 Zlowodzki, Michael A1 Bhandari, Mohit T1 Outcome Measures and Implications for Sample-Size Calculations JF The Journal of Bone & Joint Surgery JO The Journal of Bone & Joint Surgery YR 2009 FD May 1 VO 91 IS Supplement_3 SP 35 OP 40 DO 10.2106/JBJS.H.01602 UL http://dx.doi.org/10.2106/JBJS.H.01602 AB This article focuses on items to consider when selecting outcome measures for a clinical study. The choice of outcome measures depends largely on the research question and the study design. Sample-size requirements can vary greatly, depending on the type and the number of outcome measures selected. In this paper, we review the differences between categorical and continuous outcomes as well as the differences between primary and secondary outcomes and we discuss the concept of minimally important differences and the problems associated with composite outcomes. We also provide instruction on how to conduct and present a sample-size calculation.