Hiller, Louise, Dunn, Janet A., Higgins, Helen B., Ogburn-Storey, Emma, Loi, Shrushma, Vallier, Anne-Laure and Earl, Helena M.. (2011) Optimising patient recall of adverse events over prolonged time periods. Trials, Vol.12 (Suppl.1). A74. ISSN 1745-6215

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Abstract

Large, simple, pragmatic, low-risk, maintenance treatment trials may seem straightforward to design, run and analyse. However, if trial case record forms (CRFs) are completed infrequently, the reliability of patient recall over these long time-periods is questionable, especially when recording individual incidences and severity of toxicities of specific interest to the trial. It is essential to know these detailed toxicities as it forms an indication of the reduced level of exposure when comparing treatment duration in a non-inferiority trial. Optimal methods of achieving accurate data are required.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Clinical trials -- Methodology, Drugs -- Side effects -- Reporting, Patient self-monitoring
Journal or Publication Title:	Trials
Publisher:	Bio Med Central
ISSN:	1745-6215
Date:	13 December 2011
Volume:	Vol.12
Number:	Suppl.1
Page Range:	A74
Identification Number:	10.1186/1745-6215-12-S1-A74
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Description:	Poster presentation at Clinical Trials Methodology Conference 2011, Bristol, UK. 4-5 October 2011
URI:	http://wrap.warwick.ac.uk/id/eprint/42349

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