 It's not just what you say, it's also how you say it: Opening the 'black box' of informed consent appointments in randomised controlled trialsJulia Wade, Jenny L. Donovan, J. Athene Lane, David E. Neal and Freddie C. Hamdy Social Science & Medicine, 2009, vol. 68, issue 11, 2018-2028 Abstract: Randomised controlled trials (RCTs) represent the gold standard methodology for determining effectiveness of healthcare interventions. Poor recruitment to RCTs can threaten external validity and waste resources. An inherent tension exists between safeguarding informed decision-making by participants and maximising numbers enrolled. This study investigated what occurs during informed consent appointments in an ongoing multi-centre RCT in the UK. Objectives were to investigate: 1] how study staff presented study information to participants; 2] what evidence emerged as to how well-informed participants were when proceeding to randomisation or treatment selection; and 3] what aspects of the communication process may facilitate improvements in providing evidence of informed consent. Qualitative analysis of a purposive sample of 23 recruitment appointments from three study centres and involving several recruitment staff applied techniques of thematic, content and conversation analysis (CA). Thematic analysis and CA revealed variation in appointment content and structure. Appointments were mostly recruiter-led or participant-led, and this structure was associated with what evidence emerged as to how participants understood information provided and whether they were in equipoise. Participant-led appointments provided this evidence more consistently. Detailed CA identified communication techniques which, when employed by recruiters, provided evidence as to how participants understood the choices before them. Strategic use of open questions, pauses and ceding the floor in the interaction facilitated detailed and systematic exploration of each participant's concerns and position regarding equipoise. We conclude that the current focus on content to be provided to achieve informed consent should be broadened to encompass consideration of how information is best conveyed to potential participants. A model of tailored information provision using the communication techniques identified and centred on eliciting and addressing participants' concerns is proposed. Use of these techniques is necessary to make potential participants' understanding of key issues and their position regarding equipoise explicit in order to facilitate truly informed consent. Keywords: UK; Informed; consent; Recruitment; Randomised; controlled; trial; (RCT); Conversation; analysis; Shared; decision-making; Prostate; cancer (search for similar items in EconPapers) Downloads: (external link) Related works: Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text Persistent link: https://EconPapers.repec.org/RePEc:eee:socmed:v:68:y:2009:i:11:p:2018-2028 Ordering information: This journal article can be ordered from Access Statistics for this article Social Science & Medicine is currently edited by Ichiro (I.) Kawachi and S.V. (S.V.) Subramanian More articles in Social Science & Medicine from Elsevier |
Is your work missing from RePEc? Here is how to contribute.
Questions or problems? Check the EconPapers FAQ or send mail to .
EconPapers is hosted by the
School of Business at Örebro University.