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Sarah E Lamb - One of the best experts on this subject based on the ideXlab platform.

  • mechanical supports for acute severe ankle sprain a pragmatic multicentre randomised controlled trial
    The Lancet, 2009
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Matthew Cooke
    Abstract:

    Summary Background Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (AirCast brace, Bledsoe boot, or 10-day Below-Knee Cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. Methods We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Results Patients who received the Below-Knee Cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the Cast compared with tubular compression bandage (mean difference 9%; 95% CI 2·4–15·0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between AirCast brace and tubular compression bandage was 8%; 95% CI 1·8–14·2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases). Interpretation A short period of immobilisation in a Below-Knee Cast or AirCast results in faster recovery than if the patient is only given tubular compression bandage. We recommend Below-Knee Casts because they show the widest range of benefit. Funding National Co-ordinating Centre for Health Technology Assessment.

  • treatment of severe ankle sprain a pragmatic randomised controlled trial comparing the clinical effectiveness and cost effectiveness of three types of mechanical ankle support with tubular bandage the Cast trial
    Health Technology Assessment, 2009
    Co-Authors: Matthew Cooke, Jennifer Marsh, Jane L Hutton, Rachel A Nakash, R M Jarvis, Michael Clark, Susan R. Wilson, Ala Szczepura, Sarah E Lamb
    Abstract:

    OBJECTIVE To estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage. DESIGN A randomised controlled trial, designed to reflect practice in UK hospital emergency departments. SETTING Eight emergency departments in England. PARTICIPANTS Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture. INTERVENTIONS 584 participants were randomised to one of four treatment arms: tubular bandage, below knee Cast, AirCast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve. MAIN OUTCOME MEASURES Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D). RESULTS When adjusted for age, sex and baseline scores, the below knee Cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the AirCast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee Cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the AirCast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the AirCast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee Cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution. CONCLUSIONS The below knee Cast and the AirCast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.

  • clinical and cost effectiveness of mechanical support for severe ankle sprains design of a randomised controlled trial in the emergency department isrctn 37807450
    BMC Musculoskeletal Disorders, 2005
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Michael Clark, Ala Szczepura, S Wilson, Emma J Withers, Jeremy Dale
    Abstract:

    The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee Cast, AirCast® brace and Bledsoe® boot) in comparison to Tubigrip®, and (2) to compare the cost of each strategy, including subsequent health care costs. Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Jane L Hutton - One of the best experts on this subject based on the ideXlab platform.

  • Modelling the rate of change in a longitudinal study with missing data, adjusting for contact attempts
    Statistics in Medicine, 2011
    Co-Authors: Mouna Akacha, Jane L Hutton
    Abstract:

    The Collaborative Ankle Support Trial (Cast) is a longitudinal trial of treatments for severe ankle sprains in which interest lies in the rate of improvement, the effectiveness of reminders and potentially informative missingness. A model is proposed for continuous longitudinal data with non-ignorable or informative missingness, taking into account the nature of attempts made to contact initial non-responders. The model combines a non-linear mixed model for the outcome model with logistic regression models for the reminder processes. A sensitivity analysis is used to contrast this model with the traditional selection model, where we adjust for missingness by modelling the missingness process. The conclusions that recovery is slower, and less satisfactory with age and more rapid with below knee Cast than with a tubular bandage do not alter materially across all models investigated. The results also suggest that phone calls are most effective in retrieving questionnaires. Copyright (C) 2011 John Wiley & Sons, Ltd.

  • mechanical supports for acute severe ankle sprain a pragmatic multicentre randomised controlled trial
    The Lancet, 2009
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Matthew Cooke
    Abstract:

    Summary Background Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (AirCast brace, Bledsoe boot, or 10-day Below-Knee Cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. Methods We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Results Patients who received the Below-Knee Cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the Cast compared with tubular compression bandage (mean difference 9%; 95% CI 2·4–15·0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between AirCast brace and tubular compression bandage was 8%; 95% CI 1·8–14·2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases). Interpretation A short period of immobilisation in a Below-Knee Cast or AirCast results in faster recovery than if the patient is only given tubular compression bandage. We recommend Below-Knee Casts because they show the widest range of benefit. Funding National Co-ordinating Centre for Health Technology Assessment.

  • treatment of severe ankle sprain a pragmatic randomised controlled trial comparing the clinical effectiveness and cost effectiveness of three types of mechanical ankle support with tubular bandage the Cast trial
    Health Technology Assessment, 2009
    Co-Authors: Matthew Cooke, Jennifer Marsh, Jane L Hutton, Rachel A Nakash, R M Jarvis, Michael Clark, Susan R. Wilson, Ala Szczepura, Sarah E Lamb
    Abstract:

    OBJECTIVE To estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage. DESIGN A randomised controlled trial, designed to reflect practice in UK hospital emergency departments. SETTING Eight emergency departments in England. PARTICIPANTS Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture. INTERVENTIONS 584 participants were randomised to one of four treatment arms: tubular bandage, below knee Cast, AirCast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve. MAIN OUTCOME MEASURES Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D). RESULTS When adjusted for age, sex and baseline scores, the below knee Cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the AirCast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee Cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the AirCast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the AirCast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee Cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution. CONCLUSIONS The below knee Cast and the AirCast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.

  • clinical and cost effectiveness of mechanical support for severe ankle sprains design of a randomised controlled trial in the emergency department isrctn 37807450
    BMC Musculoskeletal Disorders, 2005
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Michael Clark, Ala Szczepura, S Wilson, Emma J Withers, Jeremy Dale
    Abstract:

    The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee Cast, AirCast® brace and Bledsoe® boot) in comparison to Tubigrip®, and (2) to compare the cost of each strategy, including subsequent health care costs. Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Matthew Cooke - One of the best experts on this subject based on the ideXlab platform.

  • mechanical supports for acute severe ankle sprain a pragmatic multicentre randomised controlled trial
    The Lancet, 2009
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Matthew Cooke
    Abstract:

    Summary Background Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (AirCast brace, Bledsoe boot, or 10-day Below-Knee Cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. Methods We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Results Patients who received the Below-Knee Cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the Cast compared with tubular compression bandage (mean difference 9%; 95% CI 2·4–15·0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between AirCast brace and tubular compression bandage was 8%; 95% CI 1·8–14·2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases). Interpretation A short period of immobilisation in a Below-Knee Cast or AirCast results in faster recovery than if the patient is only given tubular compression bandage. We recommend Below-Knee Casts because they show the widest range of benefit. Funding National Co-ordinating Centre for Health Technology Assessment.

  • treatment of severe ankle sprain a pragmatic randomised controlled trial comparing the clinical effectiveness and cost effectiveness of three types of mechanical ankle support with tubular bandage the Cast trial
    Health Technology Assessment, 2009
    Co-Authors: Matthew Cooke, Jennifer Marsh, Jane L Hutton, Rachel A Nakash, R M Jarvis, Michael Clark, Susan R. Wilson, Ala Szczepura, Sarah E Lamb
    Abstract:

    OBJECTIVE To estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage. DESIGN A randomised controlled trial, designed to reflect practice in UK hospital emergency departments. SETTING Eight emergency departments in England. PARTICIPANTS Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture. INTERVENTIONS 584 participants were randomised to one of four treatment arms: tubular bandage, below knee Cast, AirCast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve. MAIN OUTCOME MEASURES Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D). RESULTS When adjusted for age, sex and baseline scores, the below knee Cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the AirCast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee Cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the AirCast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the AirCast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee Cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution. CONCLUSIONS The below knee Cast and the AirCast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.

Rachel A Nakash - One of the best experts on this subject based on the ideXlab platform.

  • mechanical supports for acute severe ankle sprain a pragmatic multicentre randomised controlled trial
    The Lancet, 2009
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Matthew Cooke
    Abstract:

    Summary Background Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (AirCast brace, Bledsoe boot, or 10-day Below-Knee Cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. Methods We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Results Patients who received the Below-Knee Cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the Cast compared with tubular compression bandage (mean difference 9%; 95% CI 2·4–15·0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between AirCast brace and tubular compression bandage was 8%; 95% CI 1·8–14·2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases). Interpretation A short period of immobilisation in a Below-Knee Cast or AirCast results in faster recovery than if the patient is only given tubular compression bandage. We recommend Below-Knee Casts because they show the widest range of benefit. Funding National Co-ordinating Centre for Health Technology Assessment.

  • treatment of severe ankle sprain a pragmatic randomised controlled trial comparing the clinical effectiveness and cost effectiveness of three types of mechanical ankle support with tubular bandage the Cast trial
    Health Technology Assessment, 2009
    Co-Authors: Matthew Cooke, Jennifer Marsh, Jane L Hutton, Rachel A Nakash, R M Jarvis, Michael Clark, Susan R. Wilson, Ala Szczepura, Sarah E Lamb
    Abstract:

    OBJECTIVE To estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage. DESIGN A randomised controlled trial, designed to reflect practice in UK hospital emergency departments. SETTING Eight emergency departments in England. PARTICIPANTS Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture. INTERVENTIONS 584 participants were randomised to one of four treatment arms: tubular bandage, below knee Cast, AirCast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve. MAIN OUTCOME MEASURES Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D). RESULTS When adjusted for age, sex and baseline scores, the below knee Cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the AirCast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee Cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the AirCast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the AirCast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee Cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution. CONCLUSIONS The below knee Cast and the AirCast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.

  • Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450]
    BMC Musculoskeletal Disorders, 2005
    Co-Authors: Se Lamb, Rachel A Nakash, Michael Clark, Ala Szczepura, Jl Marsh, Jl Hutton, Ej Withers, S Wilson, Jr Dale, Mw Cooke
    Abstract:

    Background The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee Cast, AirCast^® brace and Bledsoe^® boot) in comparison to Tubigrip^®, and (2) to compare the cost of each strategy, including subsequent health care costs. Methods/design Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. Discussion This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

  • clinical and cost effectiveness of mechanical support for severe ankle sprains design of a randomised controlled trial in the emergency department isrctn 37807450
    BMC Musculoskeletal Disorders, 2005
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Michael Clark, Ala Szczepura, S Wilson, Emma J Withers, Jeremy Dale
    Abstract:

    The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee Cast, AirCast® brace and Bledsoe® boot) in comparison to Tubigrip®, and (2) to compare the cost of each strategy, including subsequent health care costs. Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Jennifer Marsh - One of the best experts on this subject based on the ideXlab platform.

  • mechanical supports for acute severe ankle sprain a pragmatic multicentre randomised controlled trial
    The Lancet, 2009
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Matthew Cooke
    Abstract:

    Summary Background Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (AirCast brace, Bledsoe boot, or 10-day Below-Knee Cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. Methods We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Results Patients who received the Below-Knee Cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the Cast compared with tubular compression bandage (mean difference 9%; 95% CI 2·4–15·0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between AirCast brace and tubular compression bandage was 8%; 95% CI 1·8–14·2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases). Interpretation A short period of immobilisation in a Below-Knee Cast or AirCast results in faster recovery than if the patient is only given tubular compression bandage. We recommend Below-Knee Casts because they show the widest range of benefit. Funding National Co-ordinating Centre for Health Technology Assessment.

  • treatment of severe ankle sprain a pragmatic randomised controlled trial comparing the clinical effectiveness and cost effectiveness of three types of mechanical ankle support with tubular bandage the Cast trial
    Health Technology Assessment, 2009
    Co-Authors: Matthew Cooke, Jennifer Marsh, Jane L Hutton, Rachel A Nakash, R M Jarvis, Michael Clark, Susan R. Wilson, Ala Szczepura, Sarah E Lamb
    Abstract:

    OBJECTIVE To estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage. DESIGN A randomised controlled trial, designed to reflect practice in UK hospital emergency departments. SETTING Eight emergency departments in England. PARTICIPANTS Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture. INTERVENTIONS 584 participants were randomised to one of four treatment arms: tubular bandage, below knee Cast, AirCast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve. MAIN OUTCOME MEASURES Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D). RESULTS When adjusted for age, sex and baseline scores, the below knee Cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the AirCast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee Cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the AirCast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the AirCast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee Cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution. CONCLUSIONS The below knee Cast and the AirCast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.

  • clinical and cost effectiveness of mechanical support for severe ankle sprains design of a randomised controlled trial in the emergency department isrctn 37807450
    BMC Musculoskeletal Disorders, 2005
    Co-Authors: Jennifer Marsh, Jane L Hutton, Rachel A Nakash, Sarah E Lamb, Michael Clark, Ala Szczepura, S Wilson, Emma J Withers, Jeremy Dale
    Abstract:

    The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee Cast, AirCast® brace and Bledsoe® boot) in comparison to Tubigrip®, and (2) to compare the cost of each strategy, including subsequent health care costs. Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.