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A Randomised Controlled Trial of the Use of Aciclovir And/Or Prednisolone for the Early Treatment of Bell’S Palsy: the BELLS Study

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A Randomised Controlled Trial of the Use of Aciclovir And/Or Prednisolone for the Early Treatment of Bell’S Palsy: the BELLS Study Health Technology Assessment 2009; Vol. 13: No. 47 A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell’s palsy: the BELLS study FM Sullivan, IRC Swan, PT Donnan, JM Morrison, BH Smith, B McKinstry, RJ Davenport, LD Vale, JE Clarkson, R Hernández, K Stewart, V Hammersley, S Hayavi, A McAteer, D Gray and F Daly October 2009 DOI: 10.3310/hta13470 Health Technology Assessment NIHR HTA programme www.hta.ac.uk HTA How to obtain copies of this and other HTA programme reports An electronic version of this publication, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable CD-ROM is also available (see below). 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AbstractOutcomeAppendix .............................................................dependent 12 .on.the.time.delay.to.. iii commencementRecruiters’ notes.of. treatment......................................... ................. 43 . 97 ContentsOutcome .............................................................dependent.on.severity.at.onset. .... v44 Assessors’Appendix. concordance13 . ............................... 44 A randomised controlled trial of the List of abbreviationsWeekly recruitment .......................................... update (example). vii..... 99 Chapter 7 use of aciclovir and/or prednisolone for ExecutiveDiscussionAppendix summary 14................................................... ........................................... .ix47 StrengthsBriefing.and .noteslimitations for researchers.of.the.study .................... ........ 47 .103 the early treatment of Bell’s palsy: the ChapterImplications 1 .for.practice. ............................. 48 BackgroundAppendix 15................................................ 1 BELLS study ChapterDisease Form8. condition C ......................................................... ........................................ 1 .107 ProvenanceConclusion.of ...................................................the.Scottish.Bell’s.Palsy.Study . 49 1 GovernanceAppendix .16................................................. 1 ChapterApprovals Form9 . .................................................... B ......................................................... 1 .109 1* 2 3 StudyOpportunities.calendar. ............................................for further research ............. 251 FM Sullivan, IRC Swan, PT Donnan, PrimaryAppendix.research 17 . ......................................... 51 JM Morrison,4 BH Smith,5 B McKinstry,6 ChapterEvidence 2House–Brackmann .synthesis. ...................................... Assessors ..................... 51 .111 7 8,9 10 Methods ...................................................... 3 RJ Davenport, LD Vale, JE Clarkson, AcknowledgementsReferrersAppendix. ..................................................... 18 ........................................... 353 9 11 6 RecruitersHealth. .................................................... Utilities Index Mark 3 ..................... 5 .113 R Hernández, K Stewart, V Hammersley, ReferencesPatients. .................................................................................................................. 655 4 5 5 3 InterventionsAppendix 19. .............................................. 6 S Hayavi, A McAteer, D Gray and F Daly AppendixIdentificationBrief 1 Pain.of .Inventorycoded.treatments .................................... ............. 7 .119 1 ResearchersBELLS protocol. ................................................. ............................................ 757 Scottish School of Primary Care, University of Dundee, UK AssessorsAppendix. ..................................................... 20 . 9 2Department of Otolaryngology, University of Glasgow, UK AppendixObjectivesDerriford 2 . .................................................... Appearance Scale (DAS59). .......9 .123 3Community Health Sciences, University of Dundee, UK PrimaryTrial Steering.outcomes Committee. ....................................... ........................... 967 4Division of Community Based Sciences, University of Glasgow, UK SecondaryAppendix.outcomes 21 . ................................... 10 5Centre of Academic Primary Care, University of Aberdeen, UK AppendixPatient 3 deaths on the BELLS study Methods.used.to.enhance.the.quality.of.measurements........... .127 6Community Health Sciences, University of Edinburgh, UK Data.............................................................. Monitoring and Ethics Committee11 (DMEC) 7 69Appendix 22 Department of Clinical Neurosciences, University of Edinburgh, UK ChapterDATA 3CONSORT .MONITORING Checklist.AND of .itemsETHICS to .includeCOMMITTEE when 8Health Services Research Unit, University of Aberdeen, UK Study.............................................................. reportingdesign ............................................... a randomised trial ......................71. 13 .129 9Health Economics Research Unit, University of Aberdeen, UK SampleREPORT.size.TEMPLATE. ..................................................1. .............................. .1371 10Dental Health Services Research Unit, University of Dundee, UK ExplanationDATAHealth.MONITORING Technology.of.any.interim Assessment.AND.analyses.ETHICS reports.and.COMMITTEE.stopping published.rules to 11St John’s Hospital, Livingston, UK ............................................................................................................................date .............................................................1372 .131 RandomisationREPORT.TEMPLATE. .............................................2. .............................. .1372 *Corresponding author SubgroupHealth Technology.analyses. ...................................... Assessment . 14 Appendixprogramme 4 ................................................. .151 ChapterBELLS 4 Study Management Committee ..... 75 Declared competing interests of authors: none Results ........................................................ 15 AppendixParticipant 5 .flow. ........................................... 15 ProtocolTimetable.deviations of approvals.from. study................................as.planned,.together. 77 .with. Published October 2009 reasons. .................................................... 15 DOI: 10.3310/hta13470 AppendixRecruitment 6 . ................................................ 15 BaselineHow cruel.data to. ............................................... call it Bell’s palsy . 18 Outcomesby Graeme.and.estimation Garden. ........................... ............... 1881 This report should be referenced as follows: Ancillary.analyses. ........................................ 25 AppendixAdverse 7.events .and.side.effects. .................. 26 Sullivan FM, Swan IRC, Donnan PT, Morrison JM, Smith BH, McKinstry B, et al. A Local Principal Investigators ...................... 83 randomised controlled trial of the use of aciclovir and/or prednisolone for the early Chapter 5 treatment of Bell’s palsy: the BELLS study. Health Technol Assess 2009;13(47). AppendixEconomic 8 evaluation of treatments ........... 27 IntroductionScottish Bell’s. ................................................ Palsy Study: ‘BELLS’ ............. .2785 Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Aim. ............................................................
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