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dc.contributor.authorCastillo, Maria Isabel
dc.contributor.authorLarsen, Emily
dc.contributor.authorCooke, Marie
dc.contributor.authorMarsh, Nicole M
dc.contributor.authorWallis, Marianne C
dc.contributor.authorFinucane, Julie
dc.contributor.authorBrown, Peter
dc.contributor.authorMihala, Gabor
dc.contributor.authorCarr, Peter J
dc.contributor.authorByrnes, Joshua
dc.contributor.authorWalker, Rachel
dc.contributor.authorCable, Prudence
dc.contributor.authorZhang, Li
dc.contributor.authorSear, Candi
dc.contributor.authorJackson, Gavin
dc.contributor.authorRowsome, Anna
dc.contributor.authorRyan, Alison
dc.contributor.authorHumphries, Julie C
dc.contributor.authorSivyer, Susan
dc.contributor.authorFlanigan, Kathy
dc.contributor.authorRickard, Claire M
dc.date.accessioned2019-06-19T13:02:30Z
dc.date.available2019-06-19T13:02:30Z
dc.date.issued2018
dc.identifier.issn2044-6055
dc.identifier.doi10.1136/bmjopen-2017-019916
dc.identifier.urihttp://hdl.handle.net/10072/382061
dc.description.abstractIntroduction Peripheral intravenous catheters (PIVCs) are frequently used in hospitals. However, PIVC complications are common, with failures leading to treatment delays, additional procedures, patient pain and discomfort, increased clinician workload and substantially increased healthcare costs. Recent evidence suggests integrated PIVC systems may be more effective than traditional non-integrated PIVC systems in reducing phlebitis, infiltration and costs and increasing functional dwell time. The study aim is to determine the efficacy, cost–utility and acceptability to patients and professionals of an integrated PIVC system compared with a non-integrated PIVC system. Methods and analysis Two-arm, multicentre, randomised controlled superiority trial of integrated versus non-integrated PIVC systems to compare effectiveness on clinical and economic outcomes. Recruitment of 1560 patients over 2 years, with randomisation by a centralised service ensuring allocation concealment. Primary outcomes: catheter failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, localised or catheter-associated bloodstream infections. Secondary outcomes: first time insertion success, types of PIVC failure, device colonisation, insertion pain, functional dwell time, adverse events, mortality, cost–utility and consumer acceptability. One PIVC per patient will be included, with intention-to-treat analysis. Baseline group comparisons will be made for potentially clinically important confounders. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure. An as-treated analysis will assess the effect of protocol violations. Kaplan-Meier survival curves with log-rank tests will compare failure by group over time. Secondary endpoints will be compared between groups using parametric/non-parametric techniques.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherBMJ Publishing Group
dc.publisher.placeUnited Kingdom
dc.relation.ispartofpagefrom1
dc.relation.ispartofpageto7
dc.relation.ispartofissue5
dc.relation.ispartofjournalBMJ Open
dc.relation.ispartofvolume8
dc.subject.fieldofresearchHealth economics
dc.subject.fieldofresearchMedical devices
dc.subject.fieldofresearchNursing
dc.subject.fieldofresearchBiomedical and clinical sciences
dc.subject.fieldofresearchHealth sciences
dc.subject.fieldofresearchPsychology
dc.subject.fieldofresearchcode380108
dc.subject.fieldofresearchcode400308
dc.subject.fieldofresearchcode4205
dc.subject.fieldofresearchcode32
dc.subject.fieldofresearchcode42
dc.subject.fieldofresearchcode52
dc.titleIntegrated versus nOn-integrated Peripheral inTravenous catheter. Which Is the most effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM study): A randomised controlled trial protocol
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
dc.description.versionVersion of Record (VoR)
gro.facultyGriffith Health, School of Nursing and Midwifery
gro.rights.copyright© The Author(s) 2018. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.
gro.hasfulltextFull Text
gro.griffith.authorWalker, Rachel M.
gro.griffith.authorCooke, Marie L.
gro.griffith.authorByrnes, Joshua M.
gro.griffith.authorLarsen, Emily N.


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