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Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

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Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people : a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial). / Cockayne, Sarah; Rodgers, Sara; Green, Lorraine; Fairhurst, Caroline; Adamson, Joy; Scantlebury, Arabella; Corbacho Martín, Belén; Hewitt, Catherine E; Hicks, Kate; Hull, Robin; Keenan, Anne-Maree; Lamb, Sarah E; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony; Richardson, Zoe; Vernon, Wesley; Watson, Judith; Torgerson, David J.

In: Health technology assessment, Vol. 21, No. 24, 03.05.2017, p. 1-198.

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Harvard

Cockayne, S, Rodgers, S, Green, L, Fairhurst, C, Adamson, J, Scantlebury, A, Corbacho Martín, B, Hewitt, CE, Hicks, K, Hull, R, Keenan, A-M, Lamb, SE, McIntosh, C, Menz, HB, Redmond, A, Richardson, Z, Vernon, W, Watson, J & Torgerson, DJ 2017, 'Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)', Health technology assessment, vol. 21, no. 24, pp. 1-198. https://doi.org/10.3310/hta21240

APA

Cockayne, S., Rodgers, S., Green, L., Fairhurst, C., Adamson, J., Scantlebury, A., ... Torgerson, D. J. (2017). Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial). Health technology assessment, 21(24), 1-198. https://doi.org/10.3310/hta21240

Vancouver

Cockayne S, Rodgers S, Green L, Fairhurst C, Adamson J, Scantlebury A et al. Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial). Health technology assessment. 2017 May 3;21(24):1-198. https://doi.org/10.3310/hta21240

Author

Cockayne, Sarah ; Rodgers, Sara ; Green, Lorraine ; Fairhurst, Caroline ; Adamson, Joy ; Scantlebury, Arabella ; Corbacho Martín, Belén ; Hewitt, Catherine E ; Hicks, Kate ; Hull, Robin ; Keenan, Anne-Maree ; Lamb, Sarah E ; McIntosh, Caroline ; Menz, Hylton B ; Redmond, Anthony ; Richardson, Zoe ; Vernon, Wesley ; Watson, Judith ; Torgerson, David J. / Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people : a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial). In: Health technology assessment. 2017 ; Vol. 21, No. 24. pp. 1-198.

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@article{48826c3dee73483bb6c9ca6c1a1b9715,
title = "Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)",
abstract = "BACKGROUND: Falls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DESIGN: A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SETTING: Nine NHS trusts in the UK and one site in Ireland.PARTICIPANTS: In total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493; usual care, n = 517) via a secure, remote service. Blinding was not possible.INTERVENTIONS: All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.MAIN OUTCOME MEASURES: The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.RESULTS: The primary analysis consisted of 484 (98.2{\%}) intervention and 507 (98.1{\%}) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95{\%} confidence interval (CI) 0.73 to 1.05; p = 0.16]. The proportion of participants experiencing a fall was lower (50{\%} vs. 55{\%}, adjusted odds ratio 0.78, 95{\%} CI 0.60 to 1.00; p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95{\%} CI -£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95{\%} CI -0.0050 to 0.0314 QALYs] and had a 65{\%} probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LIMITATIONS: Owing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.CONCLUSIONS: The intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.FUTURE WORK: Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.TRIAL REGISTRATION: Current Controlled Trials ISRCTN68240461.FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.",
author = "Sarah Cockayne and Sara Rodgers and Lorraine Green and Caroline Fairhurst and Joy Adamson and Arabella Scantlebury and {Corbacho Mart{\'i}n}, Bel{\'e}n and Hewitt, {Catherine E} and Kate Hicks and Robin Hull and Anne-Maree Keenan and Lamb, {Sarah E} and Caroline McIntosh and Menz, {Hylton B} and Anthony Redmond and Zoe Richardson and Wesley Vernon and Judith Watson and Torgerson, {David J}",
note = "This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details",
year = "2017",
month = "5",
day = "3",
doi = "10.3310/hta21240",
language = "English",
volume = "21",
pages = "1--198",
journal = "Health technology assessment",
issn = "1366-5278",
publisher = "NHS National Institute for Health Research",
number = "24",

}

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TY - JOUR

T1 - Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people

T2 - Health technology assessment

AU - Cockayne, Sarah

AU - Rodgers, Sara

AU - Green, Lorraine

AU - Fairhurst, Caroline

AU - Adamson, Joy

AU - Scantlebury, Arabella

AU - Corbacho Martín, Belén

AU - Hewitt, Catherine E

AU - Hicks, Kate

AU - Hull, Robin

AU - Keenan, Anne-Maree

AU - Lamb, Sarah E

AU - McIntosh, Caroline

AU - Menz, Hylton B

AU - Redmond, Anthony

AU - Richardson, Zoe

AU - Vernon, Wesley

AU - Watson, Judith

AU - Torgerson, David J

N1 - This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details

PY - 2017/5/3

Y1 - 2017/5/3

N2 - BACKGROUND: Falls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DESIGN: A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SETTING: Nine NHS trusts in the UK and one site in Ireland.PARTICIPANTS: In total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493; usual care, n = 517) via a secure, remote service. Blinding was not possible.INTERVENTIONS: All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.MAIN OUTCOME MEASURES: The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.RESULTS: The primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05; p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00; p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI -£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LIMITATIONS: Owing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.CONCLUSIONS: The intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.FUTURE WORK: Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.TRIAL REGISTRATION: Current Controlled Trials ISRCTN68240461.FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

AB - BACKGROUND: Falls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DESIGN: A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SETTING: Nine NHS trusts in the UK and one site in Ireland.PARTICIPANTS: In total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493; usual care, n = 517) via a secure, remote service. Blinding was not possible.INTERVENTIONS: All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.MAIN OUTCOME MEASURES: The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.RESULTS: The primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05; p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00; p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI -£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LIMITATIONS: Owing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.CONCLUSIONS: The intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.FUTURE WORK: Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.TRIAL REGISTRATION: Current Controlled Trials ISRCTN68240461.FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

UR - http://www.scopus.com/inward/record.url?scp=85021261136&partnerID=8YFLogxK

U2 - 10.3310/hta21240

DO - 10.3310/hta21240

M3 - Article

VL - 21

SP - 1

EP - 198

JO - Health technology assessment

JF - Health technology assessment

SN - 1366-5278

IS - 24

ER -