Outcome assessment in clinical trials of fracture-healing

被引:129
作者
Morshed, Saam [1 ]
Corrales, Luis [1 ]
Genant, Harry [1 ]
Miclau, Theodore, III [1 ]
机构
[1] Univ Calif San Francisco, San Francisco Gen Hosp, Dept Orthopaed Surg, San Francisco, CA 94110 USA
关键词
D O I
10.2106/JBJS.G.01556
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
Although there are numerous methods for defining fracture-healing in clinical studies, no consensus exists regarding the most valid and reliable manner for assessing union or for determining which outcomes are most important. This article summarizes and describes methods for the clinical assessment of fracture-healing and reports results from a systematic review of prevalent definitions currently used in published clinical studies. Conventional radiography and ad hoc clinical definitions continue to be the most commonly used means of assessing fracture-healing in clinical studies. Investigators must improve upon and apply more rigorous outcome assessment in clinical trials, emphasize patient-important outcomes, and report factors that may bias estimated effects.
引用
收藏
页码:62 / 67
页数:6
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