Evert: Cryotherapy Versus Salicylic Acid for the Treatment of Verrucae
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EVerT: Cryotherapy versus salicylic acid for the treatment of verrucae - a randomised controlled trial Cockayne, S, Curran, M, Denby, G, Hashmi, F, Hewitt, C, Hicks, K, Jayakody, S, Kang'ombe, A, McIntosh, C and Watt, I http://dx.doi.org/10.3310/hta15320 Title EVerT: Cryotherapy versus salicylic acid for the treatment of verrucae - a randomised controlled trial Authors Cockayne, S, Curran, M, Denby, G, Hashmi, F, Hewitt, C, Hicks, K, Jayakody, S, Kang'ombe, A, McIntosh, C and Watt, I Type Article URL This version is available at: http://usir.salford.ac.uk/id/eprint/28468/ Published Date 2011 USIR is a digital collection of the research output of the University of Salford. Where copyright permits, full text material held in the repository is made freely available online and can be read, downloaded and copied for non-commercial private study or research purposes. Please check the manuscript for any further copyright restrictions. 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Health Technology Assessment 2011; Vol. 15: No.321 Primary outcome: complete clearance of verrucae at 12 weeks Health Technology Assessment 2011; Vol. 15: No. 32 ISSNSecondary 1366-5278 outcomes ISSN 1366-5278 Additional data collected AbstractSix-month patient questionnaire ChapterChange 5 of circumstances form ListEconomic ofNon-serious abbreviations analysis adverse event form SummaryReview ofof non-seriousthe resource adverse usage event form ExecutiveMissingSerious datasummary adverse on resource event form use and outcome DataObjectiveReview analysis of serious adverse events SummaryMethods of findings ResultsAppendix 5 ChapterConclusionsAdvertising 6 material 115 DiscussionTrialPoster registration – version 1 EVerT: cryotherapy versus salicylic KeyFundingPoster findings – version 2 ComparisonPress releases with other studies/reviews acid for the treatment of verrucae – a ChapterTreatmentLetters 1 to regimen pharmacists/GPs/parents of school students PatientBackgroundLetter satisfaction to GPs (version with treatment1 21 November 2006) randomised controlled trial StrengthsWhatLetter are to and verrucae?parent limitations of school of thechildren study GeneralisabilityWhat treatments of theare resultsavailable? ImplicationsWhatAppendix evidence 6for health is there care for the most commonly used treatments? ImplicationsWhyFlow did chart we for fordo research EVerTthe trial? trial 135 S Cockayne, M Curran, G Denby, F Hashmi, Specific objectives of the trial AcknowledgementsAppendix 7 C Hewitt, K Hicks, S Jayakody, A Kang’ombe, ChapterCollaborationsTrial 2protocol and contributions of the authors 137 StatementMethods of independence of researchers C McIntosh, N McLarnon, E Stamuli, Health Technology Assessment programme TrialTrial Steering design Committee members K Thomas, G Turner, D Torgerson and I Watt on DataApprovals Monitoring obtained and Ethics Committee members PublicationsTrial sites behalf of the EVerT team Participant eligibility ReferencesRecruitment into the trial Baseline assessment AppendixIneligible 1patients RegulatoryRandomisation approvals 51 Sample size AppendixTrial interventions 2 DetailsParticipant of the follow-up study sites 53 Trial completion Appendix 3 Measurement of primary outcome Patient information sheets and consent form 55 Measurement of secondary outcomes Patient information sheets Additional data collected Patient information sheet for children Statistical analysis Consent form Economic analysis Cryotherapy patient’s advice sheet ChapterAcid therapy 3 patient’s advice sheet Protocol changes Appendix 4 Inclusion and exclusion criteria Data collection forms 69 Treatment regimens Baseline patient questionnaire Clarification of secondary outcomes and analysis Randomisation form Questionnaire response rates Patient ineligible form September 2011 Recruitment Podiatrist’s treatment assessment form 10.3310/hta15320 ChapterPatient 4 pain questionnaire Week-1Clinical patient results questionnaire section Week-3Trial recruitment patient questionnaire Week-12Baseline patientparticipant questionnaire characteristics Health Technology Assessment Verruca(e) has gone form NIHR HTA programme Podiatrist outcome assessment form www.hta.ac.uk HTA How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). 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EVerT: cryotherapy versus salicylic acid for the treatment of verrucae – a randomised controlled trial S Cockayne,1* M Curran,2 G Denby,2 F Hashmi,3 C Hewitt,1 K Hicks,1 S Jayakody,1 A Kang’ombe,1 C McIntosh,4 N McLarnon,5 E Stamuli,1 K Thomas,6 G Turner,1 D Torgerson1 and I Watt1,7 on behalf of the EVerT team 1Department of Health Sciences, York Trials Unit, University of York, York, UK 2School of Health, University of Northampton, Northampton, UK 3University of Brighton, School of Health Professions, Division of Podiatry, Eastbourne, UK 4The National University of Ireland Galway, School of Podiatry, Galway, Ireland 5Glasgow Caledonian University, School of Health and Social Care, Glasgow, UK 6Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK 7Hull York Medical School, University of York, York, UK *Corresponding author Declared competing interests of authors: The 50% salicylic acid (Verrugon) plasters and felt pads were provided to the University of York, free of charge, by the manufacturer William Ransom & Son Plc. BOC Cryospeed provided liquid nitrogen storage equipment at reduced cost. Neither company has had any input into the design, analysis and reporting of the study. Published September 2011 DOI: 10.3310/hta15320 This report should be referenced as follows: Cockayne S, Curran M, Denby G, Hashmi F, Hewitt C, Hicks K, et al. EVerT: cryotherapy versus salicylic acid for the treatment of verrucae – a randomised controlled trial. Health Technol Assess 2011;15(32). Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta Medica/EMBASE, Science Citation Index Expanded (SciSearch) and Current Contents/ Clinical Medicine. ii NIHR Health Technology Assessment programme The Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. ‘Health technologies’ are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the ‘National Knowledge Service’. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. First is the commissioned route. Suggestions for research are actively sought from people working in the NHS, from the public and consumer groups and from professional bodies such as royal colleges and NHS trusts. These suggestions are carefully prioritised by panels of independent experts (including NHS service users). The HTA programme then commissions the research by competitive tender. Second, the HTA programme provides grants for clinical trials for researchers who identify research questions. These