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HEALTH TECHNOLOGY ASSESSMENT VOLUME 20 ISSUE 55 JULY 2016 ISSN 1366-5278 Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, survey and costing analysis Joanne O’Connor, Dorothy McCaughan, Catriona McDaid, Alison Booth, Debra Fayter, Roccio Rodriguez-Lopez, Roy Bowers, Lisa Dyson, Cynthia P Iglesias, Simon Lalor, Rory J O’Connor, Margaret Phillips and Gita Ramdharry DOI 10.3310/hta20550 Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, survey and costing analysis ’ Joanne O Connor,1 Dorothy McCaughan,2 Catriona McDaid,2* Alison Booth,3 Debra Fayter,3 Roccio Rodriguez-Lopez,3 Roy Bowers,4 Lisa Dyson,2 ’ Cynthia P Iglesias,2 Simon Lalor,5 Rory J O Connor,6 Margaret Phillips7 and Gita Ramdharry8 1Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK 2Department of Health Sciences, University of York, York, UK 3Centre for Reviews and Dissemination, University of York, York, UK 4Biomedical Engineering, University of Strathclyde, Glasgow, UK 5Queen Mary’s Hospital, St George’s University Hospitals NHS Foundation Trust, London, UK 6Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK 7Royal Derby Hospital, Derby, UK 8Kingston University and St George’s University of London, London, UK *Corresponding author Declared competing interests of authors: During this study SimonLalor was anemployee of Opcare, acompany that provides orthotic and prosthetic services to the UK NHS. This company doesnot manufacture orthotic devices, although asister company ORTHO CFAB does. Cynthia Iglesias is amember of the National Institute for Health andCare Excellence Medical Technologies Assessment Committee and member of the European Clinical Research Infrastructure Network. Published July 2016 DOI: 10.3310/hta20550 This reportshould be referenced as follows: O’Connor J, McCaughan D, McDaid C, Booth A, Fayter D, Rodriguez-Lopez R,et al.Orthotic management of instability of theknee related to neuromuscular andcentral nervous system disorders: systematic review, qualitative study, survey and costinganalysis. Health Technol Assess 2016;20(55). HealthTechnology Assessment isindexed and abstracted in IndexMedicus/MEDLINE, Excerpta Medica/EMBASE, ScienceCitation Index Expanded (SciSearch®) andCurrent Contents®/ Clinical Medicine. Health Technology Assessment HTA/HTATAR ISSN1366-5278(Print) ISSN2046-4924(Online) Impactfactor:4.058 HealthTechnologyAssessmentisindexedinMEDLINE,CINAHL,EMBASE,TheCochraneLibraryandtheISIScienceCitationIndex. ThisjournalisamemberofandsubscribestotheprinciplesoftheCommitteeonPublicationEthics(COPE)(www.publicationethics.org/). Editorialcontact:[email protected] ThefullHTAarchiveisfreelyavailabletoviewonlineatwww.journalslibrary.nihr.ac.uk/hta.Print-on-demandcopiescanbepurchasedfromthe reportpagesoftheNIHRJournalsLibrarywebsite:www.journalslibrary.nihr.ac.uk CriteriaforinclusionintheHealthTechnologyAssessmentjournal ReportsarepublishedinHealthTechnologyAssessment(HTA)if(1)theyhaveresultedfromworkfortheHTAprogramme,and(2)they areofasufficientlyhighscientificqualityasassessedbythereviewersandeditors. ReviewsinHealthTechnologyAssessmentaretermed‘systematic’whentheaccountofthesearchappraisalandsynthesismethods(to minimisebiasesandrandomerrors)would,intheory,permitthereplicationofthereviewbyothers. HTAprogramme TheHTAprogramme,partoftheNationalInstituteforHealthResearch(NIHR),wassetupin1993.Itproduceshigh-qualityresearch informationontheeffectiveness,costsandbroaderimpactofhealthtechnologiesforthosewhouse,manageandprovidecareintheNHS. ‘Healthtechnologies’arebroadlydefinedasallinterventionsusedtopromotehealth,preventandtreatdisease,andimproverehabilitation andlong-termcare. ThejournalisindexedinNHSEvidenceviaitsabstractsincludedinMEDLINEanditsTechnologyAssessmentReportsinformNationalInstitute forHealthandCareExcellence(NICE)guidance.HTAresearchisalsoanimportantsourceofevidenceforNationalScreeningCommittee(NSC) policydecisions. FormoreinformationabouttheHTAprogrammepleasevisitthewebsite:http://www.nets.nihr.ac.uk/programmes/hta Thisreport TheresearchreportedinthisissueofthejournalwasfundedbytheHTAprogrammeasprojectnumber13/30/02.Thecontractualstartdate wasinApril2014.ThedraftreportbeganeditorialreviewinJuly2015andwasacceptedforpublicationinNovember2015.Theauthorshave beenwhollyresponsibleforalldatacollection,analysisandinterpretation,andforwritinguptheirwork.TheHTAeditorsandpublisherhave triedtoensuretheaccuracyoftheauthors’reportandwouldliketothankthereviewersfortheirconstructivecommentsonthedraft document.However,theydonotacceptliabilityfordamagesorlossesarisingfrommaterialpublishedinthisreport. ThisreportpresentsindependentresearchfundedbytheNationalInstituteforHealthResearch(NIHR).Theviewsandopinionsexpressedby authorsinthispublicationarethoseoftheauthorsanddonotnecessarilyreflectthoseoftheNHS,theNIHR,NETSCC,theHTAprogramme ortheDepartmentofHealth.Ifthereareverbatimquotationsincludedinthispublicationtheviewsandopinionsexpressedbythe intervieweesarethoseoftheintervieweesanddonotnecessarilyreflectthoseoftheauthors,thoseoftheNHS,theNIHR,NETSCC,theHTA programmeortheDepartmentofHealth. ©Queen’sPrinterandControllerofHMSO2016.ThisworkwasproducedbyO’Connoretal.underthetermsofacommissioning contractissuedbytheSecretaryofStateforHealth.Thisissuemaybefreelyreproducedforthepurposesofprivateresearchand studyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournalsprovidedthatsuitableacknowledgement ismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbe addressedto:NIHRJournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre, AlphaHouse,UniversityofSouthamptonSciencePark,SouthamptonSO167NS,UK. PublishedbytheNIHRJournalsLibrary(www.journalslibrary.nihr.ac.uk),producedbyPrepressProjectsLtd,Perth,Scotland (www.prepress-projects.co.uk). Health Technology Assessment Editor-in-Chief Professor Hywel Williams Director, HTA Programme, UK and Foundation Professor and Co-Director of the Centre of Evidence-Based Dermatology, University of Nottingham, UK NIHR Journals Library Editor-in-Chief Professor Tom Walley Director, NIHR Evaluation, Trials and Studies and Director of the EME Programme, UK NIHR Journals Library Editors Professor Ken Stein Chair of HTA Editorial Board and Professor of Public Health, University of Exeter Medical School, UK Professor Andree Le May Chair of NIHR Journals Library Editorial Group (EME, HS&DR, PGfAR, PHR journals) Dr Martin Ashton-Key Consultant in Public Health Medicine/Consultant Advisor, NETSCC, UK Professor Matthias Beck Chair in Public Sector Management and Subject Leader (Management Group), Queen’s University Management School, Queen’s University Belfast, UK Professor Aileen Clarke Professor of Public Health and Health Services Research, Warwick Medical School, University of Warwick, UK Dr Tessa Crilly Director, Crystal Blue Consulting Ltd, UK Dr Eugenia Cronin Senior Scientific Advisor, Wessex Institute, UK Ms Tara Lamont Scientific Advisor, NETSCC, UK Professor Elaine McColl Director, Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, UK Professor William McGuire Professor of Child Health, Hull York Medical School, University of York, UK Professor Geoffrey Meads Professor of Health Sciences Research, Health and Wellbeing Research and Development Group, University of Winchester, UK Professor John Norrie Health Services Research Unit, University of Aberdeen, UK Professor John Powell Consultant Clinical Adviser, National Institute for Health and Care Excellence (NICE), UK Professor James Raftery Professor of Health Technology Assessment, Wessex Institute, Faculty of Medicine, University of Southampton, UK Dr Rob Riemsma Reviews Manager, Kleijnen Systematic Reviews Ltd, UK Professor Helen Roberts Professor of Child Health Research, UCL Institute of Child Health, UK Professor Jonathan Ross Professor of Sexual Health and HIV, University Hospital Birmingham, UK Professor Helen Snooks Professor of Health Services Research, Institute of Life Science, College of Medicine, Swansea University, UK Professor Jim Thornton Professor of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, University of Nottingham, UK Professor Martin Underwood Director, Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, UK Please visit the website for a list of members of the NIHR Journals Library Board: www.journalslibrary.nihr.ac.uk/about/editors Editorial contact: [email protected] NIHRJournalsLibrary www.journalslibrary.nihr.ac.uk DOI:10.3310/hta20550 HEALTHTECHNOLOGYASSESSMENT2016 VOL.20 NO.55 Abstract Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, survey and costing analysis Joanne O’Connor,1 Dorothy McCaughan,2 Catriona McDaid,2* Alison Booth,3 Debra Fayter,3 Roccio Rodriguez-Lopez,3 Roy Bowers,4 Lisa Dyson,2 Cynthia P Iglesias,2 Simon Lalor,5 Rory J O’Connor,6 Margaret Phillips7 and Gita Ramdharry8 1Institute of Healthand Society, Newcastle University, Newcastle upon Tyne, UK 2Department of Health Sciences, University of York, York, UK 3Centre forReviews andDissemination, University of York, York, UK 4Biomedical Engineering, University ofStrathclyde, Glasgow, UK 5Queen Mary’s Hospital, St George’s University Hospitals NHSFoundation Trust, London,UK 6Leeds Institute ofRheumatic andMusculoskeletal Medicine, University of Leeds, Leeds, UK 7Royal DerbyHospital, Derby, UK 8Kingston University and St George’s University ofLondon, London, UK *Corresponding author [email protected] Background: Patients whohave knee instability that isassociated with neuromuscular disease(NMD) and central nervous system (CNS) conditions can betreated using orthoses, suchas knee–ankle–foot orthoses (KAFOs). Objectives: To assess existing evidence on the effectiveness of orthoses; patient perspectives; types of orthotic devicesprescribed in the UK NHS; and associated costs. Methods: Qualitative study of views of orthoses users –aqualitative in-depth interview study was undertaken. Data were analysed for thematic content. A coding scheme was developed andan inductive approach was used to identify themes. Systematic review – 18databases were searched up to November 2014: MEDLINE, MEDLINE In-Process &Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health, EMBASE, PASCAL, Scopus, Science Citation Index, BIOSIS Previews, Physiotherapy Evidence Database, RecalLegacy, Cochrane Database of Systematic Reviews, Databaseof Abstracts of Reviews of Effects, Health Technology Assessment database, Cochrane Central Register of Controlled Trials, Conference Proceedings Citation Index: Science, Health Management Consortium, ClinicalTrials.gov, International Clinical Trials Registry Platform and NationalTechnical Information Service. Studies of adults using anorthosis for instability of theknee related to NMD or aCNS disorder were included. Data were extracted and quality was assessed by two researchers. Narrative synthesis was undertaken. Survey and costing analysis –aweb surveyof orthotists, physiotherapists and rehabilitation medicine physicians was undertaken. Telephone interviews with orthotists informed acosting analysis. ©Queen’sPrinterandControllerofHMSO2016.ThisworkwasproducedbyO’Connoretal.underthetermsofacommissioningcontractissuedbytheSecretaryofStatefor Health.Thisissuemaybefreelyreproducedforthepurposesofprivateresearchandstudyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournals vii providedthatsuitableacknowledgementismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbe addressedto:NIHRJournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre,AlphaHouse,UniversityofSouthamptonScience Park,SouthamptonSO167NS,UK. ABSTRACT Results: Qualitative study –atotal of 24 people participated. Potential for engagement indaily activities was of vital importance to patients; theextent to which their deviceenabled thiswas the yardstick by which itwas measured. Patients’prime desiredoutcome was areduction in pain, falls or trips, with improved balance and stability. Effectiveness, reliability, comfort and durability were themost valued features of orthoses. Many expressed frustration with perceived deficiencies in service provision relating to appointment and administrative systems andreferral pathways. Systematic review –atotal of 21 studies (478 participants) were included of people who had post-poliosyndrome, inclusion bodymyositis, were post strokeor had spinal cordinjury. The studies evaluated KAFOs (mainly carbon fibre), stance control KAFO and hipKAFOs. All of the studies were at risk of bias and, in general, were poorlyreported. Survey and costing analysis –in total, 238 health-care professionals responded. Arange of orthoses isprescribed for knee instability that is related to NMD or CNS conditions, approximately half being custom-made. At least 50% of respondents thought that comfort and confidence inmobility were extremely important treatment outcomes. The cost of individual KAFOs was highly variable, ranging from £73 to £3553. Conclusions: Various types of orthoses are used inthe NHS to manage patients with NMD/CNS conditions and knee instability, both custom-made and prefabricated, of variable cost. Evidence onthe effectiveness of theorthoses is limited, especially in relation to theoutcomes that are important to orthoses users. Limitations: The population includedwas broad, limiting anyin-depth consideration of specific conditions. The response rate to thesurvey was low, and thecosting analysis was based on someassumptions that may notreflect the true costs of providing KAFOs. Future work: Future work should include high-quality research on the effectiveness and cost-effectiveness of orthoses;development of acoreset of outcome measures; further exploration of theviews and experiences of patients; and thebest models of service delivery. Study registration: This study isregistered as PROSPERO CRD42014010180. The qualitative study is registered as Current Controlled Trials ISRCTN65240228. Funding: TheNational Institute for Health Research HealthTechnology Assessment programme. viii NIHRJournalsLibrary www.journalslibrary.nihr.ac.uk

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Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, . Allied Health, EMBASE, PASCAL, Scopus, Science Citation Index, BIOSIS Previews, Physiotherapy Evidence .. There were no language restrictions.
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