Abstract
OBJECTIVES: To explore stakeholders' perceptions of decision aids designed to support the informed consent decision-making process for randomised controlled trials.
DESIGN: Qualitative semistructured interviews. Participants were provided with prototype trial decision aids in advance to stimulate discussion. Interviews were analysed using an established interpretive approach.
PARTICIPANTS: 23 stakeholders: Trial Managers (n=5); Research Nurses (n=5); Ethics Committee Chairs (n=5); patients (n=4) and Clinical Principal Investigators (n=4).
SETTING: Embedded within two ongoing randomised controlled trials. All interviews conducted with UK-based participants.
RESULTS: Certain key aspects (eg, values clarification exercises, presentation of probabilities, experiences of others and balance of options) in the prototype decision aids were perceived by all stakeholders as having a significant advantage (over existing patient information leaflets) in terms of supporting well informed appropriate decisions. However, there were some important differences between the stakeholder groups on specific content (eg, language used in the section on positive and negative features of taking part in a trial and the overall length of the trial decision aids). Generally the stakeholders believed trial decision aids have the potential to better engage potential participants in the decision-making process and allow them to make more personally relevant decisions about their participation.
CONCLUSIONS: Compared to existing patient information leaflets, stakeholders perceived decision aids for trial participation to have the potential to promote a more 'informed' decision-making process. Further efforts to develop, refine and formally evaluate trial decision aids should be explored.
Original language | English |
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Article number | e005734 |
Journal | BMJ Open |
Volume | 4 |
Issue number | 8 |
DOIs | |
Publication status | Published - 19 Aug 2014 |
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Profiles
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Kate Gillies
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Senior Research Fellow
- Public Health, Health Services and Primary Care
- Institute of Applied Health Sciences
Person: Academic Related - Research
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Zoe Skea
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Lecturer (Scholarship), Research Fellow
- Public Health, Health Services and Primary Care
Person: Academic Related - Scholarship, Academic Related - Research