Show simple item record

dc.contributor.authorPolit, Denise F
dc.contributor.authorGillespie, Brigid M
dc.date.accessioned2017-05-03T14:33:13Z
dc.date.available2017-05-03T14:33:13Z
dc.date.issued2009
dc.date.modified2010-07-12T06:40:20Z
dc.identifier.issn0029-6562
dc.identifier.doi10.1097/NNR.0b013e3181bf1505
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.
dc.description.peerreviewedYes
dc.description.publicationstatusYes
dc.format.extent123717 bytes
dc.format.mimetypeapplication/pdf
dc.languageEnglish
dc.language.isoeng
dc.publisherLippincott Williams & Wilkins
dc.publisher.placeUSA
dc.relation.ispartofstudentpublicationN
dc.relation.ispartofpagefrom391
dc.relation.ispartofpageto399
dc.relation.ispartofissue6
dc.relation.ispartofjournalNursing Research
dc.relation.ispartofvolume58
dc.rights.retentionY
dc.subject.fieldofresearchNursing
dc.subject.fieldofresearchNursing not elsewhere classified
dc.subject.fieldofresearchcode4205
dc.subject.fieldofresearchcode420599
dc.titleThe Use of the Intention-to-Treat Principle in Nursing Clinical Trials
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
gro.facultyGriffith Health, School of Nursing and Midwifery
gro.rights.copyright© 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.
gro.date.issued2009
gro.hasfulltextFull Text
gro.griffith.authorGillespie, Brigid M.


Files in this item

This item appears in the following Collection(s)

  • Journal articles
    Contains articles published by Griffith authors in scholarly journals.

Show simple item record