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A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening older women for the prevention of fractures: rationale, design and methods for the SCOOP study

A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening older women for the prevention of fractures: rationale, design and methods for the SCOOP study
A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening older women for the prevention of fractures: rationale, design and methods for the SCOOP study
SCOOP is a UK seven-centre, pragmatic, randomised controlled trial with 5-year follow-up, including 11,580 women aged 70 to 85 years, to assess the effectiveness and cost-effectiveness of a community-based screening programme to reduce fractures. It utilises the FRAX algorithm and DXA to assess the 10-year probability of fracture. Introduction Osteoporotic, or low-trauma, fractures present a considerable burden to the National Health Service and have major adverse effects on quality of life, disability and mortality for the individual. Methods Given the availability of efficacious treatments and a risk assessment tool based upon clinical risk factors and bone mineral density, a case exists to undertake a community-based controlled evaluation of screening for subjects at high risk of fracture, under the hypothesis that such a screening programme would reduce fractures in this population. Results This study is a UK seven-centre, unblinded, pragmatic, randomised controlled trial with a 5-year follow-up period. A total of 11,580 women, aged 70 to 85 years and not on prescribed bone protective therapy will be consented to the trial by post via primary care providing 90% power to detect an 18% decrease in fractures. Conclusions Participants will be randomised to either a screening arm or control. Those undergoing screening will have a 10-year fracture probability computed from baseline risk factors together with bone mineral density measured by DXA in selected subjects. Individuals above an age-dependent threshold of fracture probability will be recommended for treatment for the duration of the trial. Subjects in the control arm will receive 'usual care'. Participants will be followed up 6 months after randomisation and annually by postal questionnaires with independent checking of hospital and primary care records. The primary outcome will be the proportion of individuals sustaining fractures in each group. An economic analysis will be carried out to assess cost-effectiveness of screening. A qualitative evaluation will be conducted to examine the acceptability of the process to participants.

0937-941X
2507-2515
Shepstone, L.
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Fordham, R.
948599ae-13f7-4e69-a8ee-a59c367c6e76
Lenaghan, E.
a861d3dd-4cc6-4634-922f-3d3f02b81e27
Harvey, I.
a8dffa7c-7412-4861-a03d-11e41d8632d7
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Gittoes, N.
fcf8e08c-9c98-422c-9b50-5d19090598a5
Heawood, A.
cf79bfe7-76a9-4804-ae7b-141bd44f3a7a
Peters, T.
9aca9392-f159-4016-bf12-19a7b4b50c47
O'Neill, T.
5d05841d-fc0c-4af6-a772-3ff389d87461
Torgerson, D.
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Holland, R.
ff5a81aa-9b8a-47f8-8ce6-c80db32f62a6
Howe, A.
c166c6c8-2850-419b-9f97-75d17bf0886a
Marshall, T.
724ec6bf-cb74-4b6b-af08-15ac11568ad5
Kanis, J.
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McCloskey, E.
5211de37-303a-42f8-b24b-00c475264f78
Shepstone, L.
6ede9fae-ee4e-4825-8729-0e98cb86b711
Fordham, R.
948599ae-13f7-4e69-a8ee-a59c367c6e76
Lenaghan, E.
a861d3dd-4cc6-4634-922f-3d3f02b81e27
Harvey, I.
a8dffa7c-7412-4861-a03d-11e41d8632d7
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Gittoes, N.
fcf8e08c-9c98-422c-9b50-5d19090598a5
Heawood, A.
cf79bfe7-76a9-4804-ae7b-141bd44f3a7a
Peters, T.
9aca9392-f159-4016-bf12-19a7b4b50c47
O'Neill, T.
5d05841d-fc0c-4af6-a772-3ff389d87461
Torgerson, D.
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Holland, R.
ff5a81aa-9b8a-47f8-8ce6-c80db32f62a6
Howe, A.
c166c6c8-2850-419b-9f97-75d17bf0886a
Marshall, T.
724ec6bf-cb74-4b6b-af08-15ac11568ad5
Kanis, J.
d8c75fae-089a-46ed-8c71-8690dd1a967b
McCloskey, E.
5211de37-303a-42f8-b24b-00c475264f78

Shepstone, L., Fordham, R., Lenaghan, E., Harvey, I., Cooper, C., Gittoes, N., Heawood, A., Peters, T., O'Neill, T., Torgerson, D., Holland, R., Howe, A., Marshall, T., Kanis, J. and McCloskey, E. (2012) A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening older women for the prevention of fractures: rationale, design and methods for the SCOOP study. Osteoporosis International, 23 (10), 2507-2515. (doi:10.1007/s00198-011-1876-7). (PMID:22314936)

Record type: Article

Abstract

SCOOP is a UK seven-centre, pragmatic, randomised controlled trial with 5-year follow-up, including 11,580 women aged 70 to 85 years, to assess the effectiveness and cost-effectiveness of a community-based screening programme to reduce fractures. It utilises the FRAX algorithm and DXA to assess the 10-year probability of fracture. Introduction Osteoporotic, or low-trauma, fractures present a considerable burden to the National Health Service and have major adverse effects on quality of life, disability and mortality for the individual. Methods Given the availability of efficacious treatments and a risk assessment tool based upon clinical risk factors and bone mineral density, a case exists to undertake a community-based controlled evaluation of screening for subjects at high risk of fracture, under the hypothesis that such a screening programme would reduce fractures in this population. Results This study is a UK seven-centre, unblinded, pragmatic, randomised controlled trial with a 5-year follow-up period. A total of 11,580 women, aged 70 to 85 years and not on prescribed bone protective therapy will be consented to the trial by post via primary care providing 90% power to detect an 18% decrease in fractures. Conclusions Participants will be randomised to either a screening arm or control. Those undergoing screening will have a 10-year fracture probability computed from baseline risk factors together with bone mineral density measured by DXA in selected subjects. Individuals above an age-dependent threshold of fracture probability will be recommended for treatment for the duration of the trial. Subjects in the control arm will receive 'usual care'. Participants will be followed up 6 months after randomisation and annually by postal questionnaires with independent checking of hospital and primary care records. The primary outcome will be the proportion of individuals sustaining fractures in each group. An economic analysis will be carried out to assess cost-effectiveness of screening. A qualitative evaluation will be conducted to examine the acceptability of the process to participants.

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Published date: October 2012
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 348296
URI: http://eprints.soton.ac.uk/id/eprint/348296
ISSN: 0937-941X
PURE UUID: e3962246-2b4f-45d2-ac7f-63310c8c5532
ORCID for C. Cooper: ORCID iD orcid.org/0000-0003-3510-0709

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Date deposited: 12 Feb 2013 09:51
Last modified: 03 Dec 2019 01:58

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Contributors

Author: L. Shepstone
Author: R. Fordham
Author: E. Lenaghan
Author: I. Harvey
Author: C. Cooper ORCID iD
Author: N. Gittoes
Author: A. Heawood
Author: T. Peters
Author: T. O'Neill
Author: D. Torgerson
Author: R. Holland
Author: A. Howe
Author: T. Marshall
Author: J. Kanis
Author: E. McCloskey

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