Can patient decision aids help people make good decisions about participating in clinical trials?
Author Information
Author(s): Brehaut Jamie C, Lott Alison, Fergusson Dean A, Shojania Kaveh G, Kimmelman Jonathan, Saginur Raphael
Primary Institution: Ottawa Health Research Institute
Hypothesis
Incorporating decision aids into the informed consent process will improve the extent to which participants make decisions that are informed and consistent with their preferences.
Conclusion
The study aims to provide initial evidence about whether patient decision aids can improve the informed consent process in clinical trials.
Supporting Evidence
- Patient decision aids have been shown to improve decision quality in other contexts.
- Existing consent processes often lead to poor participant understanding.
- Decision aids can enhance knowledge of key aspects of decisions and reduce uncertainty.
Takeaway
This study is trying to find out if special tools can help people understand and decide better about joining clinical trials.
Methodology
The study will involve assessing consent documents, interviewing trial participants, developing decision aids, and conducting a pilot observational study comparing the new tools to standard consent forms.
Potential Biases
Potential bias may arise from the involvement of authors in local research ethics boards.
Limitations
The study does not address all ethical concerns related to informed consent and focuses only on investigator-initiated trials.
Participant Demographics
Participants will include adults from various clinical areas, specifically targeting those involved in ongoing clinical trials.
Digital Object Identifier (DOI)
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