Hip protectors: recommendations for conducting clinical trials—an international consensus statement (part II)
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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.
Results and conclusions
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.
KeywordsAged Clinical trial Hip fractures Nursing home Materials testing
This research was supported in part by the Canadian Institutes for Health Research (CIHR) through a Planning/Development Grant from the International Opportunities Program (P.I.: Robinovitch). Dr. Kiel and Birge were supported by a grant from the National Institute on Aging R01 AG18461. Dr. Kannus was supported by Competitive Research Funding of the Pirkanmaa Hospital District, Tampere, Finland.
The authors acknowledge the assistance of Dr Bruce Barton and Dr Jennifer Davis in revising this paper.
Conflicts of interest
S.N. Robinovitch is a paid consultant to Tytex A/S, manufacturer of the Safehip line of wearable hip protectors.
S.J. Birge has served on speakers' bureaus for Merck, Novartis, Wyeth and as a consultant to Glaxo-Smith Kline and Pfizer.
P. Kannus has received grant funding, lecturing fees, or consulting fees from Aventis, MSD, Novartis, Pfizer, Respecta, and Roche.
J.B. Lauritzen has been a paid consultant to Tytex A/S until 2006.
S.L. Evans is was a consultant to the Ascent Group on hip protector design and testing and is currently a consultant to Dow Corning on impact protection materials and testing.
R.J. Minns received financial assistance from WinHealth (the European distributors of HipSaver hip protectors) for the construction of the test rig in his laboratory.
A.C. Laing has received funding for conference travel from Tytex A/S.
D.P. Kiel has received grants, served on advisory boards, or served on speakers’ bureaus for Eli Lilly, Novartis, Merck, Procter and Gamble, Amgen, GSK, Pfizer, Lifeline, and Hologic.
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