Hip protectors: recommendations for conducting clinical trials--an international consensus statement (part II).
Hip protectors: recommendations for conducting clinical trials--an international consensus statement (part II).
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DOI：
10.1007/s00198-009-1055-2
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发表时间：
2010-01
期刊：
影响因子：
--
通讯作者：
Kiel DP
中科院分区：
文献类型：
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作者：
Cameron ID;Robinovitch S;Birge S;Kannus P;Khan K;Lauritzen J;Howland J;Evans S;Minns J;Laing A;Cripton P;Derler S;Plant D;Kiel DP
虽然髋关节保护器在一些临床试验中是有效的，但许多，包括所有在社区环境中，一直无法证明有效性。这部分是由于设计和分析上的差异。本报告的目的是为后续的临床研究提出建议。2007年11月，国际髋关节保护器研究小组召开会议，讨论髋关节保护器临床有效性的障碍。本文代表了该小组关于进行髋关节保护器未来临床试验的推荐方法的共识声明。共识建议包括：使用经过充分生物力学测试的髋关节保护器，使用假髋关节保护器，在髋关节骨折年发生率至少为3%的人群中进行临床试验，证明充分依从性的导入期，监测福尔斯和依从性，以及纳入经济学分析。需要更大规模和更昂贵的临床试验来明确研究髋关节保护器的有效性。
While hip protectors are effective in some clinical trials, many, including all in community settings, have been unable to demonstrate effectiveness. This is due partly to differences in the design and analysis. The aim of this report is to develop recommendations for subsequent clinical research. In November of 2007, the International Hip Protector Research Group met to address barriers to the clinical effectiveness of hip protectors. This paper represents a consensus statement from the group on recommended methods for conducting future clinical trials of hip protectors. Consensus recommendations include the following: the use of a hip protector that has undergone adequate biomechanical testing, the use of sham hip protectors, the conduct of clinical trials in populations with annual hip fracture incidence of at least 3%, a run-in period with demonstration of adequate adherence, surveillance of falls and adherence, and the inclusion of economic analyses. Larger and more costly clinical trials are required to definitively investigate effectiveness of hip protectors.