{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T11:51:20Z","timestamp":1765885880898,"version":"build-2065373602"},"reference-count":40,"publisher":"BMJ","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2013,2,11]]},"published-print":{"date-parts":[[2013]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis design<\/jats:title>\n                  <jats:p>An international, multicentre, observational, prospective, before-and-after study, conducted at 84 centres in 22 countries across three continents.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Participants<\/jats:title>\n                  <jats:p>468 adults presenting with poststroke upper limb spasticity in whom a decision had already been made to inject BoNT-A (5\u201312 consecutive participants recruited per centre).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Interventions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Analysis<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Registration<\/jats:title>\n                  <jats:p>ClinicalTrials.gov identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01020500\">NCT01020500<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2012-002230","type":"journal-article","created":{"date-parts":[[2013,3,19]],"date-time":"2013-03-19T20:29:03Z","timestamp":1363724943000},"page":"e002230","source":"Crossref","is-referenced-by-count":29,"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"],"prefix":"10.1136","volume":"3","clinical-trial-number":[{"clinical-trial-number":"nct01020500","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Lynne","family":"Turner-Stokes","sequence":"first","affiliation":[{"name":"Department of Palliative Care, Policy and Rehabilitation, Cicely Saunders Institute, School of Medicine, King's College London, London, UK"}]},{"given":"Klemens","family":"Fheodoroff","sequence":"additional","affiliation":[{"name":"Department of Neurorehabilitation, Gailtal-Klinik, Hermagor, Austria"}]},{"given":"Jorge","family":"Jacinto","sequence":"additional","affiliation":[{"name":"Servi\u00e7o de Reabilita\u00e7\u00e3o de adultos 3, Centro de Medicina de Reabilita\u00e7\u00e3ode Alcoit\u00e3o, Estoril, Portugal"}]},{"given":"Pascal","family":"Maisonobe","sequence":"additional","affiliation":[{"name":"Departments of Biostatistics & Data Management, Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France"}]},{"given":"Benjamin","family":"Zakine","sequence":"additional","affiliation":[{"name":"Departments of Biostatistics & Data Management, Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France"}]}],"member":"239","published-online":{"date-parts":[[2013,3,18]]},"reference":[{"key":"2025101810170445000_3.3.e002230.1","doi-asserted-by":"publisher","DOI":"10.1191\/0269215504cr727oa"},{"key":"2025101810170445000_3.3.e002230.2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2008.02114.x"},{"key":"2025101810170445000_3.3.e002230.3","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.0000105386.05173.5E"},{"key":"2025101810170445000_3.3.e002230.4","doi-asserted-by":"publisher","DOI":"10.1191\/0269215502cr512oa"},{"key":"2025101810170445000_3.3.e002230.5","doi-asserted-by":"publisher","DOI":"10.1159\/000091222"},{"key":"2025101810170445000_3.3.e002230.6","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2009.02915.x"},{"key":"2025101810170445000_3.3.e002230.7","unstructured":"Spasticity in adults: Management using Botulinum Toxin. National guidelines. London: Royal College of Physicians, 2009."},{"key":"2025101810170445000_3.3.e002230.8","doi-asserted-by":"crossref","unstructured":"Sheean G Lannin NA Turner-Stokes L . Botulinum toxin assessment, intervention and after-care for upper limb hypertonicity in adults: international consensus statement. Eur J Neurol 2010;(Suppl 2):74\u201393.","DOI":"10.1111\/j.1468-1331.2010.03129.x"},{"key":"2025101810170445000_3.3.e002230.9","doi-asserted-by":"publisher","DOI":"10.1007\/s00702-007-0833-2"},{"key":"2025101810170445000_3.3.e002230.10","doi-asserted-by":"publisher","DOI":"10.1080\/09638280110112891"},{"key":"2025101810170445000_3.3.e002230.11","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.69.2.217"},{"key":"2025101810170445000_3.3.e002230.12","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.61.1.30"},{"key":"2025101810170445000_3.3.e002230.13","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa011892"},{"key":"2025101810170445000_3.3.e002230.14","doi-asserted-by":"publisher","DOI":"10.1016\/0304-3940(94)12124-9"},{"key":"2025101810170445000_3.3.e002230.15","doi-asserted-by":"publisher","DOI":"10.1177\/026921559701100404"},{"key":"2025101810170445000_3.3.e002230.16","doi-asserted-by":"publisher","DOI":"10.1097\/00002060-200001000-00010"},{"key":"2025101810170445000_3.3.e002230.17","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.46.5.1306"},{"key":"2025101810170445000_3.3.e002230.18","doi-asserted-by":"publisher","DOI":"10.1191\/026921500666642221"},{"key":"2025101810170445000_3.3.e002230.19","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1016\/j.apmr.2005.09.003","article-title":"Opening the black box of post-stroke rehabilitation: stroke rehabilitation patients, processes, and outcomes","volume":"86","author":"DeJong","year":"2005","journal-title":"Arch Phys Med Rehabil"},{"key":"2025101810170445000_3.3.e002230.20","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.2003.025551"},{"key":"2025101810170445000_3.3.e002230.21","first-page":"S13","article-title":"Physical therapy and botulinum toxin-A (BoNT-A)\u2014the temporal relationship between spasticity reduction and functional gain (AAPMR Annual Assembly Poster 14)","volume":"2","author":"Turner-Stokes","year":"2010","journal-title":"Phys Med Rehabil"},{"key":"2025101810170445000_3.3.e002230.22","doi-asserted-by":"publisher","DOI":"10.1007\/BF01530764"},{"key":"2025101810170445000_3.3.e002230.23","doi-asserted-by":"publisher","DOI":"10.1002\/pri.36"},{"key":"2025101810170445000_3.3.e002230.24","doi-asserted-by":"crossref","first-page":"81","DOI":"10.2340\/16501977-0474","article-title":"Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double blind placebo controlled randomised clinical trial","volume":"42","author":"Turner-Stokes","year":"2010","journal-title":"J Rehabil Med"},{"key":"2025101810170445000_3.3.e002230.25","doi-asserted-by":"publisher","DOI":"10.2340\/16501977-0366"},{"key":"2025101810170445000_3.3.e002230.26","doi-asserted-by":"crossref","first-page":"15","DOI":"10.2340\/16501977-0663","article-title":"Rationale and design of a multicentre, double-blind, prospective, randomized, European and Canadian study: evaluating patient outcomes and costs of managing adults with post-stroke focal spasticity","volume":"43","author":"Borg","year":"2011","journal-title":"J Rehabil Med"},{"key":"2025101810170445000_3.3.e002230.27","doi-asserted-by":"publisher","DOI":"10.1177\/0269215510389198"},{"key":"2025101810170445000_3.3.e002230.28","doi-asserted-by":"publisher","DOI":"10.1177\/0269215508101742"},{"key":"2025101810170445000_3.3.e002230.29","doi-asserted-by":"crossref","first-page":"1583","DOI":"10.1080\/09638280701618828","article-title":"Goal attainment scaling: current methodological challenges","volume":"29","author":"Tennant","year":"2007","journal-title":"Disabil Rehabil"},{"key":"2025101810170445000_3.3.e002230.30","doi-asserted-by":"publisher","DOI":"10.1093\/geront\/38.6.735"},{"key":"2025101810170445000_3.3.e002230.31","unstructured":"International classification of functioning, disability and health. Geneva: World Health Organisation, 2002: http:\/\/www.who.int\/classifications\/icf\/en\/ (accessed Jan 2013)"},{"key":"2025101810170445000_3.3.e002230.32","doi-asserted-by":"crossref","first-page":"1032","DOI":"10.2340\/16501977-0885","article-title":"Investigating muscle selection for botulinum toxin-A injections in adults with post-stroke upper limb spasticity","volume":"43","author":"Baguley","year":"2011","journal-title":"J Rehabil Med"},{"key":"2025101810170445000_3.3.e002230.33","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e318070c07b"},{"key":"2025101810170445000_3.3.e002230.34","doi-asserted-by":"publisher","DOI":"10.1097\/MRR.0b013e328332f5e0"},{"key":"2025101810170445000_3.3.e002230.35","first-page":"S189","article-title":"The neurological impairment scale: a predictor of functional outcome in patients with severe complex disability (AAPMR Annual Assembly Poster 38)","volume":"3","author":"Turner-Stokes","year":"2011","journal-title":"Phys Med Rehabil"},{"key":"2025101810170445000_3.3.e002230.36","doi-asserted-by":"crossref","unstructured":"Ashford S Slade M Turner-Stokes L . Conceptualisation and development of the arm activity measure (ArmA) for assessment of activity in the hemiparetic arm. Disabil Rehabil 2013. In press. Published Online January 2013.","DOI":"10.1037\/t70989-000"},{"key":"2025101810170445000_3.3.e002230.37","doi-asserted-by":"crossref","unstructured":"Ashford S Turner-Stokes L Siegert RJ . Initial psychometric evaluation of the Arm Activity measure (ArmA)\u2014a measure of active and passive function in the hemiparetic arm. Clin Rehabil. Published online before print 20 February 2013 doi: 10.1177\/0269215512474942.","DOI":"10.1177\/0269215512474942"},{"key":"2025101810170445000_3.3.e002230.38","doi-asserted-by":"publisher","DOI":"10.1191\/0269215502cr546oa"},{"key":"2025101810170445000_3.3.e002230.39","doi-asserted-by":"publisher","DOI":"10.1177\/0269215509343846"},{"key":"2025101810170445000_3.3.e002230.40","first-page":"s338","article-title":"Validation of individual person-centered goal statements for goal attainment scaling in a large international cohort study of botulinum toxin type A for upper limb spasticity after stroke","volume":"3","author":"Turner-Stokes","year":"2011","journal-title":"Phys Med Rehabil"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2012-002230","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T17:17:15Z","timestamp":1760807835000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2012-002230"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013]]},"references-count":40,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2013,3,18]]},"published-print":{"date-parts":[[2013]]}},"alternative-id":["10.1136\/bmjopen-2012-002230"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2012-002230","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2013]]}}}