The use of the intention-to-treat principle in nursing clinical trials

Nursing Research
Denise F Polit, Brigid M Gillespie

Abstract

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. 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. 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. 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 res...Continue Reading

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Citations

May 10, 2013·Journal of Continuing Education in Nursing·Marilyn H Oermann, Julia Shaw-Kokot
Dec 4, 2010·Nursing Research·Denise F PolitRuth Griffin
Mar 29, 2014·Scandinavian Journal of Occupational Therapy·Inger JanssonAnita Björklund
Dec 17, 2014·BMC Women's Health·Claire CurmiYenna Salamonson
Oct 6, 2012·Nursing Outlook·Joan M Riley, Judy A Beal
Mar 4, 2011·International Journal of Nursing Studies·Denise F Polit
Jan 25, 2011·Nursing Outlook·Denise F Polit, Sally Northam
Mar 20, 2013·Journal of Continuing Education in Nursing·M Cecilia WendlerGeri Kirkbride
Aug 13, 2015·Journal of Clinical Nursing·Claire CurmiYenna Salamonson
Oct 24, 2012·Scandinavian Journal of Caring Sciences·Ingrid FromInger Johansson
Mar 31, 2012·Journal of Nursing Scholarship : an Official Publication of Sigma Theta Tau International Honor Society of Nursing·Eun-Ok Im, Sun Ju Chang
Aug 27, 2010·Journal of Nursing Scholarship : an Official Publication of Sigma Theta Tau International Honor Society of Nursing·Fernanda Machado da SilvaLucila Castanheira Nascimento
Jul 21, 2010·Research in Nursing & Health·Denise F Polit, Brigid M Gillespie
Mar 21, 2013·Worldviews on Evidence-based Nursing·Jui-Ying FengYing-Ju Chang
Nov 19, 2011·Research in Nursing & Health·Denise F Polit, Wendy Chaboyer
Mar 24, 2016·Journal of Nursing Management·Angela ChristiansenAndrew Kirkcaldy
Jun 15, 2016·International Journal of Nursing Studies·Lynne WilliamsChristopher R Burton
Mar 16, 2011·Palliative Medicine·Barbara A JackA Merriman
Jul 21, 2017·International Journal of Nursing Practice·Feray Gökdoğan, Duygu Kes
Aug 2, 2013·British Journal of Nursing : BJN·Gary Mitchell, Hugh O'Donnell
Apr 17, 2013·British Journal of Nursing : BJN·Karen Waldie
Dec 5, 2009·Journal of the American Academy of Nurse Practitioners·Valerie T CotterMelissa A Taylor
Aug 30, 2019·Journal of Family Medicine and Primary Care·Mohsen Adib-HajbagheryParisa Nasirpour

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