TY - JOUR
T1 - Do randomised controlled trials evaluating functional outcomes following botulinum neurotoxin-A align with focal spasticity guidelines?
T2 - A systematic review
AU - Sutherland, Edwina
AU - Hill, Bridget
AU - Singer, Barby J
AU - Ashford, Stephen
AU - Hoare, Brian
AU - Hastings-Ison, Tandy
AU - Fheodoroff, Klemens
AU - Berwick, Steffen
AU - Dobson, Fiona
AU - Williams, Gavin
N1 - Funding Information:
Thirteen studies reported receiving some funding support from a pharmaceutical company. Ten of these studies declared total funding support from a pharmaceutical company, while a further three declared partial funding support (the other funding component was often through a local hospital grant). In addition to this, during the completion of these studies, twelve authors also received pharmaceutical company grants. Of these, there was overlap observed in five studies where both the author and the project had received funding from a pharmaceutical company.
Publisher Copyright:
© 2022 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2022/1/4
Y1 - 2022/1/4
N2 - PURPOSE: The impact of botulinum neurotoxin-A (BoNT-A) on functional outcomes when managing focal muscle spasticity remains unclear. It is possible that randomised controlled trial (RCT) design and/or reporting may be a contributing factor. The objective of this review was to determine the extent to which RCTs evaluating functional outcomes following BoNT-A align with focal spasticity guidelines.MATERIALS AND METHODS: RCTs published from 2010 were included if they targeted focal spasticity, included BoNT-A, randomised a physical intervention to the upper/lower limb, or the primary outcome(s) related to the activity/participation domains of the International Classification of Functioning, Disability, and Health. Data extraction and quality appraisal using the Modified PEDro and Modified McMasters Tool were performed independently by two reviewers. General research practices were also extracted such as compliance with therapy reporting guidelines.RESULTS: Fifty-two RCTs were eligible. Individualised goal setting was uncommon (25%). Six studies (11.5%) included multi-disciplinary management, and five (9.6%) included patient/caregiver education. Four studies (7.7%) measured outcomes beyond 6 months. The Median Modified PEDro score was 11/15.CONCLUSIONS: Alignment with focal spasticity guidelines in RCTs was generally low. Our understanding of the impact of focal spasticity management on functional outcomes may be improved if RCT design aligned more closely with guideline recommendations.IMPLICATIONS FOR REHABILITATIONThe influence of BoNT-A on improved functional outcomes is yet to be determined.Individualised goal setting with a multi-disciplinary team is uncommon in an RCT design, despite it being a key guideline recommendation.Given the long-term nature of spasticity management, guidelines recommend short as well as long-term reviews following intervention however RCTs rarely assess beyond 6 months.
AB - PURPOSE: The impact of botulinum neurotoxin-A (BoNT-A) on functional outcomes when managing focal muscle spasticity remains unclear. It is possible that randomised controlled trial (RCT) design and/or reporting may be a contributing factor. The objective of this review was to determine the extent to which RCTs evaluating functional outcomes following BoNT-A align with focal spasticity guidelines.MATERIALS AND METHODS: RCTs published from 2010 were included if they targeted focal spasticity, included BoNT-A, randomised a physical intervention to the upper/lower limb, or the primary outcome(s) related to the activity/participation domains of the International Classification of Functioning, Disability, and Health. Data extraction and quality appraisal using the Modified PEDro and Modified McMasters Tool were performed independently by two reviewers. General research practices were also extracted such as compliance with therapy reporting guidelines.RESULTS: Fifty-two RCTs were eligible. Individualised goal setting was uncommon (25%). Six studies (11.5%) included multi-disciplinary management, and five (9.6%) included patient/caregiver education. Four studies (7.7%) measured outcomes beyond 6 months. The Median Modified PEDro score was 11/15.CONCLUSIONS: Alignment with focal spasticity guidelines in RCTs was generally low. Our understanding of the impact of focal spasticity management on functional outcomes may be improved if RCT design aligned more closely with guideline recommendations.IMPLICATIONS FOR REHABILITATIONThe influence of BoNT-A on improved functional outcomes is yet to be determined.Individualised goal setting with a multi-disciplinary team is uncommon in an RCT design, despite it being a key guideline recommendation.Given the long-term nature of spasticity management, guidelines recommend short as well as long-term reviews following intervention however RCTs rarely assess beyond 6 months.
UR - http://www.scopus.com/inward/record.url?scp=85122255554&partnerID=8YFLogxK
U2 - 10.1080/09638288.2021.2011437
DO - 10.1080/09638288.2021.2011437
M3 - Article
C2 - 34982603
SN - 0963-8288
SP - 1
EP - 9
JO - Disability and Rehabilitation
JF - Disability and Rehabilitation
ER -