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Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice

OBJECTIVES: This article provides an overview of the Upper Limb International Spasticity (ULIS) programme, which aims to develop a common core dataset for evaluation of real-life practice and outcomes in the treatment of upper-limb spasticity with botulinum toxin A (BoNT-A). Here we present the stud...

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Autores principales: Turner-Stokes, Lynne, Fheodoroff, Klemens, Jacinto, Jorge, Maisonobe, Pascal, Zakine, Benjamin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612778/
https://www.ncbi.nlm.nih.gov/pubmed/23512837
http://dx.doi.org/10.1136/bmjopen-2012-002230
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author Turner-Stokes, Lynne
Fheodoroff, Klemens
Jacinto, Jorge
Maisonobe, Pascal
Zakine, Benjamin
author_facet Turner-Stokes, Lynne
Fheodoroff, Klemens
Jacinto, Jorge
Maisonobe, Pascal
Zakine, Benjamin
author_sort Turner-Stokes, Lynne
collection PubMed
description OBJECTIVES: This article provides an overview of the Upper Limb International Spasticity (ULIS) programme, which aims to develop a common core dataset for evaluation of real-life practice and outcomes in the treatment of upper-limb spasticity with botulinum toxin A (BoNT-A). Here we present the study protocol for ULIS-II, a large, international cohort study, to describe the rationale and steps to ensure the validity of goal attainment scaling (GAS) as the primary outcome measure. METHODS AND ANALYSIS DESIGN: An international, multicentre, observational, prospective, before-and-after study, conducted at 84 centres in 22 countries across three continents. PARTICIPANTS: 468 adults presenting with poststroke upper limb spasticity in whom a decision had already been made to inject BoNT-A (5–12 consecutive participants recruited per centre). INTERVENTIONS: Physicians were free to choose targeted muscles, BoNT-A preparation, injected doses/technique and timing of follow-up in accordance with their usual practice and the goals for treatment. Primary outcome measure: GAS. Secondary outcomes: Measurements of spasticity, standardised outcome measures and global benefits. Steps to ensure validity included: (1) targeted training of all investigators in the use of GAS; (2) within-study validation of goal statements and (3) establishment of an electronic case report form with an in-built tracking facility for separation of baseline/follow-up data. ANALYSIS: Efficacy population: all participants who had (1) BoNT-A injection and (2) subsequent assessment of GAS. Primary efficacy variable: percentage (95% CI) achievement of the primary goal from GAS following one BoNT-A injection cycle. ETHICS AND DISSEMINATION: This non-interventional study is conducted in compliance with guidelines for good pharmacoepidemiology practices. Appropriate ethical approvals were obtained according to local regulations. ULIS-II will provide important information regarding treatment and outcomes from BoNT-A in real-life upper limb spasticity management. The results will be published separately. REGISTRATION: ClinicalTrials.gov identifier: NCT01020500.
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spelling pubmed-36127782013-07-08 Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice Turner-Stokes, Lynne Fheodoroff, Klemens Jacinto, Jorge Maisonobe, Pascal Zakine, Benjamin BMJ Open Rehabilitation Medicine OBJECTIVES: This article provides an overview of the Upper Limb International Spasticity (ULIS) programme, which aims to develop a common core dataset for evaluation of real-life practice and outcomes in the treatment of upper-limb spasticity with botulinum toxin A (BoNT-A). Here we present the study protocol for ULIS-II, a large, international cohort study, to describe the rationale and steps to ensure the validity of goal attainment scaling (GAS) as the primary outcome measure. METHODS AND ANALYSIS DESIGN: An international, multicentre, observational, prospective, before-and-after study, conducted at 84 centres in 22 countries across three continents. PARTICIPANTS: 468 adults presenting with poststroke upper limb spasticity in whom a decision had already been made to inject BoNT-A (5–12 consecutive participants recruited per centre). INTERVENTIONS: Physicians were free to choose targeted muscles, BoNT-A preparation, injected doses/technique and timing of follow-up in accordance with their usual practice and the goals for treatment. Primary outcome measure: GAS. Secondary outcomes: Measurements of spasticity, standardised outcome measures and global benefits. Steps to ensure validity included: (1) targeted training of all investigators in the use of GAS; (2) within-study validation of goal statements and (3) establishment of an electronic case report form with an in-built tracking facility for separation of baseline/follow-up data. ANALYSIS: Efficacy population: all participants who had (1) BoNT-A injection and (2) subsequent assessment of GAS. Primary efficacy variable: percentage (95% CI) achievement of the primary goal from GAS following one BoNT-A injection cycle. ETHICS AND DISSEMINATION: This non-interventional study is conducted in compliance with guidelines for good pharmacoepidemiology practices. Appropriate ethical approvals were obtained according to local regulations. ULIS-II will provide important information regarding treatment and outcomes from BoNT-A in real-life upper limb spasticity management. The results will be published separately. REGISTRATION: ClinicalTrials.gov identifier: NCT01020500. BMJ Publishing Group 2013-03-18 /pmc/articles/PMC3612778/ /pubmed/23512837 http://dx.doi.org/10.1136/bmjopen-2012-002230 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions this is an open-access article distributed under the terms of the creative commons attribution non-commercial license, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. see: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
spellingShingle Rehabilitation Medicine
Turner-Stokes, Lynne
Fheodoroff, Klemens
Jacinto, Jorge
Maisonobe, Pascal
Zakine, Benjamin
Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice
title Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice
title_full Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice
title_fullStr Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice
title_full_unstemmed Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice
title_short Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice
title_sort upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin a in real-life clinical practice
topic Rehabilitation Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612778/
https://www.ncbi.nlm.nih.gov/pubmed/23512837
http://dx.doi.org/10.1136/bmjopen-2012-002230
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