Journal
CLINICAL TRIALS
Volume -, Issue -, Pages -Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/17407745231185058
Keywords
Informed consent; randomized controlled trials; clinical protocols; research design; surveys and questionnaires; anxiety
Categories
Ask authors/readers for more resources
This study compared the effects of one-stage and two-stage informed consent on patient understanding, anxiety, and decisional quality. The results showed that two-stage consent slightly outperformed one-stage consent in terms of patient understanding, while the differences in anxiety and decisional outcomes were small.
Background/Aims It has been proposed that informed consent for randomized trials should be split into two stages, with the purported advantage of decreased information overload and patient anxiety. We compared patient understanding, anxiety and decisional quality between two-stage and traditional one-stage consent. Methods We approached patients at an academic cancer center for a low-stakes trial of a mind-body intervention for procedural distress during prostate biopsy. Patients were randomized to hear about the trial by either one- or two-stage consent (n = 66 vs n = 59). Patient-reported outcomes included Quality of Informed Consent (0-100); general and consent-specific anxiety and decisional conflict, burden, and regret. Results Quality of Informed Consent scores were non-significantly superior for two-stage consent, by 0.9 points (95% confidence interval = -2.3, 4.2, p = 0.6) for objective and 1.1 points (95% CI = -4.8, 7.0, p = 0.7) for subjective understanding. Differences between groups for anxiety and decisional outcomes were similarly small. In a post hoc analysis, consent-related anxiety was lower among two-stage control patients, likely because scores were measured close to the time of biopsy in the two-stage patients receiving the experimental intervention. Conclusion Two-stage consent maintains patient understanding of randomized trials, with some evidence of lowered patient anxiety. Further research is warranted on two-stage consent in higher-stakes settings.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available