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Documentation NIHR HTA Programme 23 August 2012 The NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), based at the University of Southampton, manages evaluation research programmes and activities for the NIHR Health Technology Assessment Programme tel: +44(0)23 8059 5586 email: [email protected] National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre University of Southampton, Alpha House fax: +44(0)23 8059 5639 web: www.hta.ac.uk Enterprise Road, Southampton, SO16 7NS PROTOCOL ACtive Treatment for Idiopathic AdolescenT Scoliosis (ACTIvATeS): a pilot randomised controlled trial Draft version 1.0 (02/7/2012) ISRCTN90480705 Funding body: NIHR HTA 10/38/03 Ethics committee approval date: Protocol Amendments: Amendment No. Date of Amendment Date of Approval Names and contact numbers of ACTIvATeS study team: Study Lead Sponsor Dr Mark Williams Dr Peter Hedges Research Fellow Director of Research Support Services Clinical Trials Unit The University of Warwick Warwick Medical School Kirby Corner Road The University of Warwick Coventry CV4 8UW Gibbet Hill Road Tel: 024 7652 3859 Coventry CV4 7AL Email: [email protected] 02476574648 Email: [email protected] ChiefInvestigator Fundingforthisstudy Professor Sallie Lamb National Institute of Health Research Director Health Technology Assessment Agency Clinical Trials Unit Warwick Medical School http://www.hta.ac.uk/ The University of Warwick Gibbet Hill Road Coventry CV4 7AL Tel: 024 7657 4658 Email: [email protected] Co-applicants Dr Karen Barker Professor Jeremy Fairbank Director of Therapy Research Consultant Spinal, Orthopaedic and Trauma Nuffield Department of Orthopaedics Surgeon Rheumatology and Musculoskeletal Nuffield Department of Orthopaedics Nuffield Orthopaedic Centre NHS Trust Rheumatology and Musculoskeletal Windmill Road Nuffield Orthopaedic Centre NHS Trust Oxford OX3 7LD Windmill Road Tel: 01865 738080 Oxford OX3 7LD Email: [email protected] Tel: 01865227374 Email: [email protected] Mr Ian Harding Dr Anne-Marie Slowther Consultant Orthopaedic Surgeon Associate Professor Clinical Ethics Frenchay Hospital Warwick Medical School North Bristol NHS Trust The University of Warwick Frenchay Park Road Gibbet Hill Road, Bristol BS16 1LE Coventry CV4 7AL Telephone: 0117 340 3744 Tel: 02476 574513 Email: [email protected] Email: [email protected] 2 Dr Mark Williams Mr Peter Heine Research Fellow Research Fellow Clinical Trials Unit Clinical Trials Unit Warwick Medical School Warwick Medical School The University of Warwick The University of Warwick Gibbet Hill Road Gibbet Hill Road, Coventry CV4 7AL Coventry CV4 7AL 02476574648 Tel: 02476150989 Email: [email protected] Email: [email protected] Dr Francine Toye Dr Esther Williamson Research Physiotherapist Research Fellow Physiotherapy Research Unit Clinical Trials Unit Nuffield Orthopaedic Centre NHS Trust Warwick Medical School Windmill Road The University of Warwick Oxford OX3 7LD Gibbet Hill Road Tel: 01865738080 Coventry CV4 7AL Email: [email protected] Tel: 02476151665 Email: [email protected] Dr Ranjit Lall Prof Stavros Petrou Trial statistician Health Economist Clinical Trials Unit Clinical Trials Unit Warwick Medical School Warwick Medical School The University of Warwick The University of Warwick Gibbet Hill Road Gibbet Hill Road Coventry CV4 7AL Coventry CV4 7AL Tel: 02476 574649 Tel: 02476 151124 Email: [email protected] Email: [email protected] Dr Neil Coulson Associate Professor in Health Psychology Faculty of Medicine and Health Sciences Level B, International House Jubilee Campus Nottingham NG8 1B Tel: 0115 846 6642 Email: [email protected] Specialist collaborators Steve Bunce Anne Richards Clinical Specialist Physiotherapist Clinical Specialist Physiotherapist Frenchay Hospital Nuffield Orthopaedic Centre NHS Trust North Bristol NHS Trust Windmill Road Frenchay Park Road Oxford OX3 7LD Bristol BS16 1LE Mr Adrian Gardner Orthopaedic surgeon Royal Orthopaedic Hospital Bristol Road South Birmingham B31 2AP 3 Independent monitoring committee Chair: Sally Kerry Mr Jayesh Trivedi Research Design Service London - Research Consultant Orthopaedic Surgeon Adviser Head of the Department of Spinal Studies Reader in Medical Statistics Robert Jones and Agnes Hunt Orthopaedic Centre for Primary Care and Public Health Hospital NHS Foundation Trust Blizard Institute Oswestry SY10 7AG Barts and The London School of Medicine Tel:01691404088 and Dentistry Email: [email protected] (secretary) Yvonne Carter Building 58 Turner Street London E1 2AB Tel : 020 7882 7208 Email: [email protected] Dr Stephanie Clark (Chair of SAUK) Dr Alison Rushton supported by Sarah Wiles (Communications Senior Lecturer in Physiotherapy Manager) and Laura Counsell (General School of Health and Population Sciences Manager) College of Medical and Dental Sciences The Scoliosis Association (UK) 52 Pritchatts Road Unit 4 Ivebury Court University of Birmingham 325 Latimer Road Edgbaston London W10 6RA Birmingham B15 2TT Tel: 0208 964 5343 Tel: 0121 415 8597 Email: [email protected] Email: [email protected] [email protected] Randomisation Tel: 024 765 150402 (Mon-Fri, 9am to 5pm) Fax: 024 765 150549 4 Contents List of Abbreviations ...................................................................................................7 1 Background .........................................................................................................8 1.1 Epidemiology and burden of condition ..............................................................8 1.2 Existing knowledge ........................................................................................9 1.3 The need for a pilot study ............................................................................. 10 1.4 Good Clinical Practice ................................................................................... 11 1.5 CONSORT ................................................................................................... 11 2 Trial Design .......................................................................................................11 2.1 Summary of the pilot study ........................................................................... 11 2.2 Flow Diagram .............................................................................................. 12 2.3 Aims and Objectives..................................................................................... 13 2.3.1 Aims ....................................................................................................13 2.3.2 Objectives.............................................................................................13 2.4 Eligibility for pilot RCT .................................................................................. 13 2.4.1 Inclusion criteria ....................................................................................13 2.4.2 Exclusion criteria: ..................................................................................13 2.5 Informed Consent ........................................................................................ 14 2.6 Planned investigations .................................................................................. 15 2.6.1 Evaluation of an exercise intervention compared to usual care.....................17 2.6.2 Qualitative study ...................................................................................19 2.7 Outcome Measures....................................................................................... 20 2.7.1 Criteria for progression to a randomised controlled trial ..............................20 2.7.2 Outcome measures ................................................................................21 2.8 Sample size ................................................................................................ 22 2.9 Recruitment and randomisation ..................................................................... 22 2.9.1 Identifying potential participants..............................................................22 2.9.2 Method of randomisation ........................................................................23 2.10 Post-randomisation withdrawals and exclusions ............................................... 23 2.11 Blinding of treatment allocation ..................................................................... 23 2.12 Compliance/contamination ............................................................................ 23 3 Methods and Assessments ...................................................................................25 3.1 Schedule of delivery of intervention and data collection .................................... 25 Table 1 Pilot RCT events......................................................................................... 25 5 4 Adverse Event Management .................................................................................26 4.1 Definitions .................................................................................................. 26 4.1.1 Adverse Events (AE) ..............................................................................26 4.1.2 Serious Adverse Events (SAEs)................................................................26 4.2 Reporting SAEs during the pilot RCT............................................................... 26 4.3 End of the pilot RCT ....................................................................................
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