Trials Journal
Category: Publications
Author: Elizabeth N Allen, Karen I Barnes, Adiel Mushi, Isolide Massawe, Sarah G Staedke, Ushma Mehta, Lasse S Vestergaard, Martha M Lemnge, Clare I Chandler
Published Date: 13 December 2011
There is no consensus on the ideal methodology for eliciting participant-reported harms, but question methods influence the extent and nature of data detected. This gives potential for measurement error and undermines meta-analyses of adverse effects. We undertook to identify barriers to accurate and complete reporting of harms data, by qualitatively exploring participants’ experiences of illness and treatment, and reporting behaviours; and compared the number and nature of data detected by three enquiry methods.