Top

Published in:

01-01-2010 | Consensus Statement

Hip protectors: recommendations for conducting clinical trials—an international consensus statement (part II)

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

Published in: Osteoporosis International | Issue 1/2010

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.

Gullberg B, Johnell O, Kanis JA (1997) Worldwide projections for hip fracture. Osteoporosis Int 7:407–413CrossRef

Parker MJ, Gillespie WJ, Gillespie LD (2005) Hip protectors for preventing hip fractures in older people. Cochrane Database of Systematic Reviews 2005, Issue 3. Art. No.: CD001255. doi:10.1002/14651858.CD001255.pub3

Sawka AM, Boulos P, Beattie K et al (2005) Do hip protectors decrease the risk of hip fracture in institutional-and community-dwelling elderly? A systematic review and meta-analysis of randomized controlled trials. Osteoporos Int 16:1461–1474CrossRefPubMed

Segui-Gomez M, Keuffel E, Frick KD (2002) Cost and effectiveness of hip protectors among the elderly. Int J Technol Assess Health Care 18:55–66PubMed

Colon-Emeric CS, Datta CK, Matchar DB (2003) An economic analysis of external hip protector use in ambulatory nursing facility residents. Age Ageing 32:47–52CrossRefPubMed

Singh S, Sun H, Anis AH (2004) Cost–effectiveness of hip protectors in the prevention of osteoporosis related hip fractures in the elderly nursing home residents. J Rheumatol 31:1607–1613PubMed

Kiel DP, Magaziner J, Zimmerman S et al (2007) Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA 298:413–422CrossRefPubMed

Birks YF, Porthouse J, Addie C et al (2004) Randomized controlled trial of hip protectors among women living in the community. Osteoporos Int 15:701–706CrossRefPubMed

Cameron ID, Cumming RG, Kurrle SE et al (2003) A randomised trial of hip protector use by frail elderly older women living in their own homes. Inj Prev 9:138–141CrossRefPubMed

10.

Robinovich S, Evans S, Minns J et al (2009) Hip protectors: recommendations for biomechanical testing—an international consensus statement. Osteoporos Int. doi:10.1007/s00198-009-1045-4

11.

Howland J, Peterson E, Kivell E (2006) Hip protector efficacy and barriers to adoption to prevent fall-related injuries in older adults: findings and recommendations from an international workgroup. J Safety Res 37:421–424CrossRefPubMed

12.

Moher D, Schulz KF, Altman DG (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet 357:1191–1194CrossRefPubMed

13.

Campbell MK, Elbourne DR, Altman DG et al (2004) CONSORT statement: extension to cluster randomised trials. BMJ 328:702–708CrossRefPubMed

14.

Järvinen TN, Sievänen H, Khan KM et al (2008) Shifting the focus in fracture prevention from osteoporosis to falls. BMJ 336:124–126CrossRefPubMed

15.

Siris ES, Miller PD, Barrett-Connor E et al (2001) Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA 286:2815–2822CrossRefPubMed

16.

Black DM, Steinbuch M, Palermo L et al (2001) An assessment tool for predicting fracture risk in postmenopausal women. Osteoporos Int 12:519–528CrossRefPubMed

17.

WHO (2008) Frax: WHO fracture risk assessment tool. http://www.shef.ac.uk/FRAX/index.htm. Accessed 31 Jan 2009

18.

Chen JS, Simpson JM, March LM et al (2008) Risk factors for fracture following a fall among older people in residential care facilities in Australia. J Am Geriatr Soc 56:2020–2026CrossRefPubMed

19.

Wagner H, Melhus H, Gedeborg R et al (2009) Simply ask them about their balance—future fracture risk in a nationwide cohort study of twins. Am J Epidemiol 169:143–149CrossRefPubMed

20.

Delbaere K, Close JCT, Menz HB et al (2008) Development and validation of falls risk screening tools for use in residential aged care facilities. Med J Aust 189:193–196PubMed

21.

Lord SR, March LM, Cameron ID et al (2003) Differing risk factors for falls in nursing home and intermediate-care residents who can and cannot stand. J Am Geriatr Soc 51:1645–1650CrossRefPubMed

22.

Rapp K, Becker C, Lamb SE et al (2008) Hip fractures in institutionalized elderly people: incidence rates and excess mortality. J Bone Miner Res 23:1825–1831CrossRefPubMed

23.

Cali C, Kiel DP (1995) An epidemiologic study of fall-related fractures among institutionalized older people. J Am Geriatr Soc 43:1336–1440PubMed

24.

The Finnish National Hospital Discharge Register (2007) The National Institute for Health and Welfare, Helsinki, Finland

25.

Bentzen H, Forsen L, Becker C et al (2008) Uptake and adherence with soft- and hard-shelled hip protectors in Norwegian Nursing Homes: a cluster randomized trial. Osteoporos Int 19:101–111CrossRefPubMed

26.

Cameron ID, Venman J, Kurrle SE et al (2001) Hip protectors in aged-care facilities: a randomized trial of use by individual higher-risk residents. Age Ageing 30:477–481CrossRefPubMed

27.

Chan DK, Hillier G, Coore M et al (2000) Effectiveness and acceptability of a newly designed hip protector: a pilot study. Arch Gerontol Geriatr 30:25–34CrossRefPubMed

28.

Hubacher M, Wettstein A (2001) Acceptance of hip protectors for hip fracture prevention in nursing homes. Osteoporos Int 12:794–799CrossRefPubMed

29.

Jantti P, Aho H, Maki-Jokela L (1996) Protector trousers in prevention of hip fractures [Turvahousut lonkanseudun murtumien ehkäisyssä]. Suomen Lõõkõrilehti 51:3387–3389

30.

Van Schoor NM, Smit JH, Twisk JWR et al (2003) Prevention of hip fractures by external hip protectors: a randomized controlled trial. JAMA 289:1957–1962CrossRefPubMed

31.

Villar MT, Hill P, Inskip H et al (1998) Will elderly rest home residents wear hip protectors? Age Ageing 27:195–198CrossRefPubMed

32.

Ekman A, Mallmin H, Michaelsson N et al (1997) External hip protectors to prevent osteoporotic hip fractures. Lancet 350:563–564CrossRefPubMed

33.

Harada A, Mizuno M, Takemura M et al (2001) Hip fracture prevention trial using hip protectors in Japanese nursing homes. Osteoporos Int 12:215–221CrossRefPubMed

34.

Kannus P, Parkkari J, Niemi S et al (2000) Prevention of hip fracture in elderly people with use of a hip protector. N Engl J Med 343:1506–1513CrossRefPubMed

35.

Koike T, Orito Y, Toyoda H et al (2009) External hip protectors are effective for the elderly with higher-than-average risk factors for hip fractures. Osteoporos Int 20:1613–1620. doi:10.1007/s00198-008-0824-7 CrossRefPubMed

36.

Lauritzen JB, Petersen MM, Lund B (1993) Effect of external hip protectors on hip fractures. Lancet 341:11–13CrossRefPubMed

37.

Meyer G, Warnke A, Bender R et al (2003) Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial. BMJ 326:76–78CrossRefPubMed

38.

O'Halloran PD, Cran GW, Beringer TR et al (2004) A cluster randomised controlled trial to evaluate a policy of making hip protectors available to residents of nursing homes. Age Ageing 33:582–588CrossRefPubMed

39.

Kurrle SE, Cameron ID, Quine S et al (2004) Adherence with hip protectors: a proposal for standardised definitions. Osteoporos Int 15:1–4CrossRefPubMed

40.

Norton N, Campbell AJ, Lee-Joe T et al (1997) Circumstances of falls resulting in hip fractures among older people. J Am Geriatr Soc 45:1108–1112PubMed

41.

Parkkari J, Kannus P, Palvanen M et al (1999) Majority of hip fractures occur as a result of a fall and impact on the greater trochanter of the femur: a prospective controlled hip fracture study with 206 consecutive patients. Calcif Tissue Int 65:183–187CrossRefPubMed

42.

Lamb S, Jørstad-Stein EC, Hauer K et al (2005) Development of a common outcome data set for fall injury prevention trials: the Prevention of Falls Network Europe consensus. J Am Geriatr Soc 53:1618–1622CrossRefPubMed

43.

Marra CA, Woolcott JC, Kopec JA et al (2005) 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 60:1571–1582CrossRefPubMed

44.

Coucill W, Bryan S, Bentham P et al (2001) EQ-5D in patients with dementia: an investigation of inter-rater agreement. Med Care 39:760–771CrossRefPubMed

45.

Barton BA, Birge SJ, Magaziner J et al (2008) The hip impact protection project: design and methods. Clin Trials 5:347–355CrossRefPubMed

46.

Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group (2008) Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 148:295–309PubMed

47.

van Schoor NM, van der Veen AJ, Schaap LA et al (2006) Biomechanical comparison of hard and soft hip protectors, and the influence of soft tissue. Bone 39:401–407CrossRefPubMed

Title: Hip protectors: recommendations for conducting clinical trials—an international consensus statement (part II)
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
Publication date: 01-01-2010
Publisher: Springer-Verlag
Published in: Osteoporosis International / Issue 1/2010
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-009-1055-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Hip protectors: recommendations for conducting clinical trials—an international consensus statement (part II)

Abstract

Introduction

Methods

Results and conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results and conclusions

Please log in to get access to this content

Other articles of this Issue 1/2010

The effect of telomere length, a marker of biological aging, on bone mineral density in elderly population

Wnt pathway genes in osteoporosis and osteoarthritis: differential expression and genetic association study

Application of the National Osteoporosis Foundation Guidelines to postmenopausal women and men: the Framingham Osteoporosis Study

Baseline serum estradiol and fracture reduction during treatment with hormone therapy: The Women's Health Initiative randomized trial

The potential impact of new National Osteoporosis Foundation guidance on treatment patterns

Tracking of size-adjusted bone mineral content and bone area in boys and girls from 10 to 17 years of age