Decision Aids in Randomised Trials: The DART Study

Summary 

The use of decision-support interventions in the context of decisions about trial participation is an emergent field.  There is a lack of evidence about what information is deemed important to support informed decisions about trial participation, whether different stakeholder groups agree on the relevance and importance of different types of information for inclusion and whether such tools are useful and acceptable for use in this context.

Informed by the wider trials and decision aid literature, a list of possible items which could be included in a trial participation aid was developed. There was consensus in the Delphi study across all stakeholder groups that the majority (60/66) of suggested items should be included in a trial participation decision aid.  These included: information about trial participation and standard care; information on the likelihood of receiving different treatments; information to help patients’ determine what matters most to them; ensuring the information is balanced; guidance on how to make a decision; disclosure of any conflicts of interest; using plain language in the tool and guidance on the decision support development process. However, some areas of divergence of opinion between stakeholder groups emerged (particularly around whether patient narratives should be included).  The prototype decision aids were found to be generally well received by stakeholders, with most agreeing these were an improvement on existing patient information leaflets for trials and recognising their potential to improve decision making in this context.

This study has shown that there remains a paucity of research around the role of trial participation decision aids.  We successfully identified a range of information features that multiple stakeholders agree should be central to any decision aid.  However, the place of patient narratives is controversial and requires further research.   This study has also shown that decision aids for trial participation are feasible to develop and broadly acceptable and useful to a wide range of stakeholders.

Contact

Katie Gillies; k.gillies@abdn.ac.uk                        

Status

Completed

Publications

Gillies K, Skea ZC, Maclennan SJ, Ramsay CR, Campbell MK.  Determining information for inclusion in a decision-support intervention for clinical trial participation: A modified Delphi approach.  Clin Trials. 2013;10(6):967-76. doi: 10.1177/1740774513508339. Epub 2013 Nov 4.

Gillies, K., Huang, W., Skea, Z., Brehaut, J. & Cotton, S. (2014). 'Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation'. Trials, vol 15, 62. 
[Online] DOI: 10.1186/1745-6215-15-62
[Online] AURA: Gillies_2014.pdf

Gillies, K., Elwyn, G. & Cook, J. (2014). 'Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials'. Trials, vol 15, 307. 
[Online] DOI: 10.1186/1745-6215-15-307
[Online] AURA: Gillies_2014.pdf

Gillies, K., Skea, ZC. & Campbell, MK. (2014). 'Decision aids for randomised controlled trials: a qualitative exploration of stakeholders' views'. BMJ Open, vol 4, no. 8, e005734. 
[Online] DOI: 10.1136/bmjopen-2014-005734
[Online] AURA: Gillies_2014.pdf

Gillies, K. & Entwistle, VA. (2012). 'Supporting positive experiences and sustained articipation in clinical trials: Looking beyond information provision'. Journal of Medical Ethics, ol 38, no. 12, pp. 751-756. 
[Online] DOI: 10.1136/medethics-2011-100059
[Online] AURA: Gillies_2012.pdf
[Link] http://www.scopus.com/inward/record.url?scp=84872316213&partnerID=8YFLogxK