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Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial)
BACKGROUND: Patients with traumatic knee complaints regularly consult their general practitioner (GP). MRI might be a valuable diagnostic tool to assist GPs in making appropriate treatment decisions and reducing costs. Therefore, this study will assess the cost-effectiveness of referral to MRI by GP...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3973891/ https://www.ncbi.nlm.nih.gov/pubmed/24588860 http://dx.doi.org/10.1186/1471-2474-15-63 |
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author | Swart, Nynke M van Oudenaarde, Kim Algra, Paul R Bindels, Partick JE van den Hout, Wilbert B Koes, Bart W Nelissen, Rob GHH Verhaar, Jan AN Bloem, Hans JL Bierma-Zeinstra, Sita MA Reijnierse, Monique Luijsterburg, Pim AJ |
author_facet | Swart, Nynke M van Oudenaarde, Kim Algra, Paul R Bindels, Partick JE van den Hout, Wilbert B Koes, Bart W Nelissen, Rob GHH Verhaar, Jan AN Bloem, Hans JL Bierma-Zeinstra, Sita MA Reijnierse, Monique Luijsterburg, Pim AJ |
author_sort | Swart, Nynke M |
collection | PubMed |
description | BACKGROUND: Patients with traumatic knee complaints regularly consult their general practitioner (GP). MRI might be a valuable diagnostic tool to assist GPs in making appropriate treatment decisions and reducing costs. Therefore, this study will assess the cost-effectiveness of referral to MRI by GPs compared with usual care, in patients with persistent traumatic knee complaints. DESIGN AND METHODS: This is a multi-centre, open-labelled randomised controlled non-inferiority trial in combination with a concurrent observational cohort study. Eligible patients (aged 18–45 years) have knee complaints due to trauma (or sudden onset) occurring in the preceding 6 months and consulting their GP. Participants are randomised to: 1) an MRI group, i.e. GP referral to MRI, or 2) a usual care group, i.e. no MRI. Primary outcomes are knee-related daily function, medical costs (healthcare use and productivity loss), and quality of life. Secondary outcomes are disability due to knee complaints, severity of knee pain, and patients’ perceived recovery and satisfaction. Outcomes are measured at baseline and at 1.5, 3, 6, 9 and 12 months follow-up. Also collected are data on patient demographics, GPs’ initial working diagnosis, GPs’ preferred management at baseline, and MRI findings. DISCUSSION: In the Netherlands, the additional diagnostic value and cost-effectiveness of direct access to knee MRI for patients presenting with traumatic knee complaints in general practice is unknown. Although GPs increasingly refer patients to MRI, the Dutch clinical guideline ‘Traumatic knee complaints’ for GPs does not recommend referral to MRI, mainly because the cost-effectiveness is still unknown. TRIAL REGISTRATION: Dutch Trial Registration: NTR3689. |
format | Online Article Text |
id | pubmed-3973891 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-39738912014-04-04 Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial) Swart, Nynke M van Oudenaarde, Kim Algra, Paul R Bindels, Partick JE van den Hout, Wilbert B Koes, Bart W Nelissen, Rob GHH Verhaar, Jan AN Bloem, Hans JL Bierma-Zeinstra, Sita MA Reijnierse, Monique Luijsterburg, Pim AJ BMC Musculoskelet Disord Study Protocol BACKGROUND: Patients with traumatic knee complaints regularly consult their general practitioner (GP). MRI might be a valuable diagnostic tool to assist GPs in making appropriate treatment decisions and reducing costs. Therefore, this study will assess the cost-effectiveness of referral to MRI by GPs compared with usual care, in patients with persistent traumatic knee complaints. DESIGN AND METHODS: This is a multi-centre, open-labelled randomised controlled non-inferiority trial in combination with a concurrent observational cohort study. Eligible patients (aged 18–45 years) have knee complaints due to trauma (or sudden onset) occurring in the preceding 6 months and consulting their GP. Participants are randomised to: 1) an MRI group, i.e. GP referral to MRI, or 2) a usual care group, i.e. no MRI. Primary outcomes are knee-related daily function, medical costs (healthcare use and productivity loss), and quality of life. Secondary outcomes are disability due to knee complaints, severity of knee pain, and patients’ perceived recovery and satisfaction. Outcomes are measured at baseline and at 1.5, 3, 6, 9 and 12 months follow-up. Also collected are data on patient demographics, GPs’ initial working diagnosis, GPs’ preferred management at baseline, and MRI findings. DISCUSSION: In the Netherlands, the additional diagnostic value and cost-effectiveness of direct access to knee MRI for patients presenting with traumatic knee complaints in general practice is unknown. Although GPs increasingly refer patients to MRI, the Dutch clinical guideline ‘Traumatic knee complaints’ for GPs does not recommend referral to MRI, mainly because the cost-effectiveness is still unknown. TRIAL REGISTRATION: Dutch Trial Registration: NTR3689. BioMed Central 2014-03-03 /pmc/articles/PMC3973891/ /pubmed/24588860 http://dx.doi.org/10.1186/1471-2474-15-63 Text en Copyright © 2014 Swart et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Swart, Nynke M van Oudenaarde, Kim Algra, Paul R Bindels, Partick JE van den Hout, Wilbert B Koes, Bart W Nelissen, Rob GHH Verhaar, Jan AN Bloem, Hans JL Bierma-Zeinstra, Sita MA Reijnierse, Monique Luijsterburg, Pim AJ Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial) |
title | Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial) |
title_full | Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial) |
title_fullStr | Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial) |
title_full_unstemmed | Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial) |
title_short | Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial) |
title_sort | efficacy of mri in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (tackle trial) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3973891/ https://www.ncbi.nlm.nih.gov/pubmed/24588860 http://dx.doi.org/10.1186/1471-2474-15-63 |
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