Hip Protectors: Recommendations for Conducting Clinical Trials--an International Consensus Statement (part II)

Overview

Journal Osteoporos Int

Specialties Endocrinology
Orthopedics

Date 2009 Oct 7

PMID 19806284

Citations 16

Authors

I D Cameron

S Robinovitch

S Birge

P Kannus

K Khan

J Lauritzen

J Howland

S Evans

J Minns

A Laing

P Cripton

S Derler

D Plant

D P Kiel

Affiliations

Soon will be listed here.

Abstract

Introduction: 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.

Methods: 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.

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Hip protectors are cost-effective in the prevention of hip fractures in patients with high fracture risk.

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References

van Schoor N, van der Veen A, Schaap L, Smit T, Lips P . Biomechanical comparison of hard and soft hip protectors, and the influence of soft tissue. Bone. 2006; 39(2):401-7. DOI: 10.1016/j.bone.2006.01.156. View

Barton B, Birge S, Magaziner J, Zimmerman S, Ball L, Brown K . The Hip Impact Protection Project: design and methods. Clin Trials. 2008; 5(4):347-55. PMC: 3725461. DOI: 10.1177/1740774508095120. View

Moher D, Schulz K, Altman D . The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001; 357(9263):1191-4. View

Lauritzen J, Petersen M, Lund B . Effect of external hip protectors on hip fractures. Lancet. 1993; 341(8836):11-3. DOI: 10.1016/0140-6736(93)92480-h. View

Koike T, Orito Y, Toyoda H, Tada M, Sugama R, Hoshino M . External hip protectors are effective for the elderly with higher-than-average risk factors for hip fractures. Osteoporos Int. 2009; 20(9):1613-20. DOI: 10.1007/s00198-008-0824-7. View

Jarvinen T, Sievanen H, Khan K, Heinonen A, Kannus P . Shifting the focus in fracture prevention from osteoporosis to falls. BMJ. 2008; 336(7636):124-6. PMC: 2206310. DOI: 10.1136/bmj.39428.470752.AD. View

Norton R, Campbell A, Robinson E, Butler M . Circumstances of falls resulting in hip fractures among older people. J Am Geriatr Soc. 1997; 45(9):1108-12. DOI: 10.1111/j.1532-5415.1997.tb05975.x. View

Delbaere K, Close J, Menz H, Cumming R, Cameron I, Sambrook P . Development and validation of fall risk screening tools for use in residential aged care facilities. Med J Aust. 2008; 189(4):193-6. DOI: 10.5694/j.1326-5377.2008.tb01980.x. View

Marra C, Woolcott J, Kopec J, Shojania K, Offer R, Brazier J . A comparison of generic, indirect utility measures (the HUI2, HUI3, SF-6D, and the EQ-5D) and disease-specific instruments (the RAQoL and the HAQ) in rheumatoid arthritis. Soc Sci Med. 2005; 60(7):1571-82. DOI: 10.1016/j.socscimed.2004.08.034. View

10.

Chen J, Simpson J, March L, Cameron I, Cumming R, Lord S . Risk factors for fracture following a fall among older people in residential care facilities in Australia. J Am Geriatr Soc. 2008; 56(11):2020-6. DOI: 10.1111/j.1532-5415.2008.01954.x. View

11.

Meyer G, Warnke A, Bender R, Muhlhauser I . Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial. BMJ. 2003; 326(7380):76. PMC: 139934. DOI: 10.1136/bmj.326.7380.76. View

12.

OHalloran P, Cran G, Beringer T, Kernohan G, ONeill C, Orr J . A cluster randomised controlled trial to evaluate a policy of making hip protectors available to residents of nursing homes. Age Ageing. 2004; 33(6):582-8. DOI: 10.1093/ageing/afh200. View

13.

Lord S, March L, Cameron I, Cumming R, Schwarz J, Zochling J . Differing risk factors for falls in nursing home and intermediate-care residents who can and cannot stand unaided. J Am Geriatr Soc. 2003; 51(11):1645-50. DOI: 10.1046/j.1532-5415.2003.51518.x. View

14.

Campbell M, Elbourne D, Altman D . CONSORT statement: extension to cluster randomised trials. BMJ. 2004; 328(7441):702-8. PMC: 381234. DOI: 10.1136/bmj.328.7441.702. View

15.

Singh S, Sun H, Anis A . Cost-effectiveness of hip protectors in the prevention of osteoporosis related hip fractures in elderly nursing home residents. J Rheumatol. 2004; 31(8):1607-13. View

16.

Kiel D, Magaziner J, Zimmerman S, Ball L, Barton B, Brown K . Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007; 298(4):413-22. DOI: 10.1001/jama.298.4.413. View

17.

van Schoor N, Smit J, Twisk J, Bouter L, Lips P . Prevention of hip fractures by external hip protectors: a randomized controlled trial. JAMA. 2003; 289(15):1957-62. DOI: 10.1001/jama.289.15.1957. View

18.

Birks Y, Porthouse J, Addie C, Loughney K, Saxon L, Baverstock M . Randomized controlled trial of hip protectors among women living in the community. Osteoporos Int. 2004; 15(9):701-6. DOI: 10.1007/s00198-004-1599-0. View

19.

Siris E, Miller P, Barrett-Connor E, Faulkner K, Wehren L, Abbott T . Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA. 2001; 286(22):2815-22. DOI: 10.1001/jama.286.22.2815. View

20.

Boutron I, Moher D, Altman D, Schulz K, Ravaud P . Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008; 148(4):295-309. DOI: 10.7326/0003-4819-148-4-200802190-00008. View