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dc.contributor.authorPolit, Deniseen_US
dc.contributor.authorGillespie, Brigiden_US
dc.date.accessioned2017-05-03T14:33:13Z
dc.date.available2017-05-03T14:33:13Z
dc.date.issued2009en_US
dc.date.modified2010-07-12T06:40:20Z
dc.identifier.issn00296562en_US
dc.identifier.doi10.1097/NNR.0b013e3181bf1505en_AU
dc.identifier.urihttp://hdl.handle.net/10072/31115
dc.description.abstractBackground: In randomized controlled trials (RCTs), the intention-to-treat (ITT) principle, which involves maintaining study participants in the treatment groups to which they were randomized regardless of postrandomization withdrawal, is the recommended analytic approach for preserving the integrity of randomization, yet little is known about the use of ITT in nursing RCTs. Objectives: The purpose of this study was to describe the extent to which nurse researchers who conduct RCTs state that they have used ITT, the extent to which they adhere to ITT principles, and the methods they use to handle missing data. Methods: Data regarding ITT analysis, participant flow, rates of attrition, and methods of handling missing data were extracted and coded from a consecutive sample of 124 RCTs published in 16 nursing journals in 2007 and 2008. Results: ITT was declared in only 15.3% of the nursing RCTs, and a definition of ITT was offered in fewer than half of these studies. On the basis of the authors' descriptions of analytic procedures, it was concluded that 10.5% of those claiming ITT use had used a per-protocol analysis rather than an ITT analysis. Overall, 46.8% of the RCTs were classified as having either a classic or a modified ITT analysis, indicating that many nurse researchers are not stating their actual adherence to ITT, despite advice to do so in the Consolidated Standards of Reporting Trials guidelines. Conclusions: Nurse researchers conducting RCTs should be more diligent in following the Consolidated Standards of Reporting Trials guidelines about ITT, documenting ITT use in their reports, clarifying their definition of ITT, and presenting flowcharts that describe subject flow. Readers of nursing reports, in evaluating evidence from RCTs, should not rely on stated use of ITT but should examine how analyses were conducted.en_US
dc.description.peerreviewedYesen_US
dc.description.publicationstatusYesen_AU
dc.format.extent123717 bytes
dc.format.mimetypeapplication/pdf
dc.languageEnglishen_US
dc.language.isoen_AU
dc.publisherLippincott Williams & Wilkinsen_US
dc.publisher.placeUSAen_US
dc.relation.ispartofstudentpublicationNen_AU
dc.relation.ispartofpagefrom391en_US
dc.relation.ispartofpageto399en_US
dc.relation.ispartofissue6en_US
dc.relation.ispartofjournalNursing Researchen_US
dc.relation.ispartofvolume58en_US
dc.rights.retentionYen_AU
dc.subject.fieldofresearchNursing not elsewhere classifieden_US
dc.subject.fieldofresearchcode321103en_US
dc.subject.fieldofresearchcode111099en_US
dc.titleThe Use of the Intention-to-Treat Principle in Nursing Clinical Trialsen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Peer Reviewed (HERDC)en_US
dc.type.codeC - Journal Articlesen_US
gro.facultyGriffith Health, School of Nursing and Midwiferyen_US
gro.rights.copyrightCopyright 2009 LWW. This is a non-final version of an article published in final form in Journal of Nursing Research [Volume, Issue, Page numbers]. Reproduced in accordance with the copyright policy of the publisher. Please refer to the journal link for access to the definitive, published version.en_AU
gro.date.issued2009
gro.hasfulltextFull Text


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