Dataset Information

Decision aids for randomised controlled trials: a qualitative exploration of stakeholders' views.

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.

SUBMITTER: Gillies K

PROVIDER: S-EPMC4139633 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Publications

Decision aids for randomised controlled trials: a qualitative exploration of stakeholders' views.

Gillies Katie K Skea Zoë C ZC Campbell Marion K MK

BMJ open 20140819 8

<h4>Objectives</h4>To explore stakeholders' perceptions of decision aids designed to support the informed consent decision-making process for randomised controlled trials.<h4>Design</h4>Qualitative semistructured interviews. Participants were provided with prototype trial decision aids in advance to stimulate discussion. Interviews were analysed using an established interpretive approach.<h4>Participants</h4>23 stakeholders: Trial Managers (n=5); Research Nurses (n=5); Ethics Committee Chairs (n ...[more]

PMID: 25138811

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Dataset Information

Decision aids for randomised controlled trials: a qualitative exploration of stakeholders' views.

Objectives

Design

Participants

Setting

Results

Conclusions

Publications

Decision aids for randomised controlled trials: a qualitative exploration of stakeholders' views.

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