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dc.contributor.authorMeyer, Matthew Jen_US
dc.contributor.authorStanislaus, Anne Ben_US
dc.contributor.authorLee, Jaroneen_US
dc.contributor.authorWaak, Karenen_US
dc.contributor.authorRyan, Cherylen_US
dc.contributor.authorSaxena, Richaen_US
dc.contributor.authorBall, Stephanieen_US
dc.contributor.authorSchmidt, Ulrichen_US
dc.contributor.authorPoon, Trudyen_US
dc.contributor.authorPiva, Simoneen_US
dc.contributor.authorWalz, Matthiasen_US
dc.contributor.authorTalmor, Daniel Sen_US
dc.contributor.authorBlobner, Manfreden_US
dc.contributor.authorLatronico, Nicolaen_US
dc.contributor.authorEikermann, Matthiasen_US
dc.date.accessioned2014-03-01T02:25:16Z
dc.date.issued2013en_US
dc.identifier.citationMeyer, M. J., A. B. Stanislaus, J. Lee, K. Waak, C. Ryan, R. Saxena, S. Ball, et al. 2013. “Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients.” BMJ Open 3 (8): e003262. doi:10.1136/bmjopen-2013-003262. http://dx.doi.org/10.1136/bmjopen-2013-003262.en
dc.identifier.issn2044-6055en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:11855877
dc.description.abstractIntroduction: Immobilisation in the intensive care unit (ICU) leads to muscle weakness and is associated with increased costs and long-term functional disability. Previous studies showed early mobilisation of medical ICU patients improves clinical outcomes. The Surgical ICU Optimal Mobilisation Score (SOMS) trial aims to test whether a budget-neutral intervention to facilitate goal-directed early mobilisation in the surgical ICU improves participant mobilisation and associated clinical outcomes. Methods and analysis The SOMS trial is an international, multicentre, randomised clinical study being conducted in the USA and Europe. We are targeting 200 patients. The primary outcome is average daily SOMS level and key secondary outcomes are ICU length of stay until discharge readiness and ‘mini’ modified Functional Independence Measure (mmFIM) at hospital discharge. Additional secondary outcomes include quality of life assessed at 3 months after hospital discharge and global muscle strength at ICU discharge. Exploratory outcomes will include: ventilator-free days, ICU and hospital length of stay and 3-month mortality. We will explore genetic influences on the effectiveness of early mobilisation and centre-specific effects of early mobilisation on outcomes. Ethics and dissemination Following Institutional Review Board (IRB) approval in three institutions, we started study recruitment and plan to expand to additional centres in Germany and Italy. Safety monitoring will be the domain of the Data and Safety Monitoring Board (DSMB). The SOMS trial will also explore the feasibility of a transcontinental study on early mobilisation in the surgical ICU. Results: The results of this study, along with those of ancillary studies, will be made available in the form of manuscripts and presentations at national and international meetings. Registration This study has been registered at clinicaltrials.gov (NCT01363102).en
dc.language.isoen_USen
dc.publisherBMJ Publishing Groupen
dc.relation.isversionofdoi:10.1136/bmjopen-2013-003262en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3753523/pdf/en
dash.licenseLAAen_US
dc.subjectProtocolen
dc.subjectREHABILITATION MEDICINEen
dc.subjectRESPIRATORY MEDICINE (see Thoracic Medicine)en
dc.titleSurgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patientsen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalBMJ Openen
dash.depositing.authorMeyer, Matthew Jen_US
dc.date.available2014-03-01T02:25:16Z
dc.identifier.doi10.1136/bmjopen-2013-003262*
dash.authorsorderedfalse
dash.contributor.affiliatedLee, Jarone
dash.contributor.affiliatedSchmidt, Ulrich
dash.contributor.affiliatedMeyer, Matthew
dash.contributor.affiliatedEikermann, Matthias
dash.contributor.affiliatedTalmor, Daniel
dash.contributor.affiliatedSaxena, Richa


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