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The consent form as a possible cause of side effects.

Author: CairnsJ A, MyersM G, SingerJ

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

Mentioning gastrointestinal side effects in the consent form of a study on aspirin or sulfinpyrazone for unstable angina led to a six-fold increase in withdrawals due to mild gastrointestinal symptoms. Major gastrointestinal complications were similar across all centers, and no patients withdrew due to other side effects. This suggests that consent forms may influence patient reporting of side effects.
Paper Details　
Original Abstract of the Article :
In a multicenter trial of aspirin or sulfinpyrazone in the treatment of unstable angina, we examined the possible importance to the outcome of mentioning potential side effects in the consent form. Inclusion, in two of the three centers, of a statement outlining possible gastrointestinal side effect...See full text at original site
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引用元：
https://doi.org/10.1038/clpt.1987.142

データ提供：米国国立医学図書館（NLM）

Informed Consent: Navigating the Desert of Side Effects

The desert of clinical trials often presents the challenge of managing side effects, particularly when informed consent forms are used. This research investigates the potential influence of consent forms on the reporting of side effects, revealing a fascinating aspect of patient behavior. The study, a multicenter trial of aspirin or sulfinpyrazone for unstable angina, examined the impact of mentioning potential gastrointestinal side effects in the consent form. The findings demonstrate a significant increase in withdrawals from the study due to subjective, minor gastrointestinal symptoms in centers that included a statement outlining these potential side effects. However, major gastrointestinal complications were similar across all centers.

The Shifting Sands of Patient Behavior: Informed Consent and Side Effects

The study's findings offer a unique glimpse into the psychological aspects of clinical trials, suggesting that simply mentioning potential side effects in consent forms can influence patient perception and reporting. This research highlights the importance of carefully considering the language used in consent forms and the potential impact on patient behavior.

Navigating the Desert: Understanding Informed Consent

This research emphasizes the importance of clear and transparent communication in clinical trials. The study underscores the potential influence of consent forms on patient reporting, highlighting the need for a nuanced approach that balances informed consent with minimizing undue anxiety and potential bias. The findings encourage researchers and clinicians to carefully consider the language and content of informed consent documents, seeking to optimize patient understanding and minimize unnecessary withdrawals.

Dr. Camel's Conclusion

The desert of clinical trials often presents challenges, including the management of side effects. This research sheds light on the fascinating interplay between informed consent and patient behavior, revealing the potential influence of consent forms on side effect reporting. The study underscores the importance of clear and transparent communication, emphasizing the need for carefully crafted consent documents that balance informed consent with minimizing anxiety and promoting accurate reporting.

Date :
  1. Date Completed 1987-10-22
  2. Date Revised 2022-03-30
Further Info :

Pubmed ID

3621780

DOI: Digital Object Identifier

10.1038/clpt.1987.142

Related Literature

Article Analysis
・Side Effects of sulfinpyrazone
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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