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The consent form as a possible cause of side effects
Abstract
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 effects resulted in a sixfold increase (P less than 0.001) in the number of subjects in these centers withdrawing from the study because of subjective, minor gastrointestinal symptoms. Major gastrointestinal complications such as peptic ulcer or bleeding as diagnosed by study physicians were similar in the three centers. Furthermore, no patient discontinued therapy because of subjective, nongastrointestinal side effects. Post hoc analysis suggests that the inclusion of gastrointestinal side effects in the consent form may have increased the likelihood of patients attributing gastrointestinal symptoms to drug therapy, leading to subsequent withdrawal from the study.
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Cited by
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251
Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement
Ioannidis, J. P. A., Evans, S. J. W., Gøtzsche, P. C., O'Neill, R. T., Altman, D. G., Schulz, K., Moher, D., & for the CONSORT Group* (2004) · Annals of Internal Medicine · doi:10.7326/0003-4819-141-10-200411160-00009 · Cited by 1,593
Barriers to Participation in Randomised Controlled Trials
Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., & Prescott, R. (1999) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(99)00141-9 · Cited by 907
Nonspecific medication side effects and the nocebo phenomenon
Barsky, A. J. (2002) · JAMA · doi:10.1001/jama.287.5.622 · Cited by 784
The double-blind, randomized, placebo-controlled trial
Kaptchuk, T. J. (2001) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(00)00347-4 · Cited by 595
Metadata
- Authors
- Myers, M. G., Cairns, J. A., & Singer, J.
- Venue
- Clinical Pharmacology and Therapeutics
- Publisher
- Wiley
- Published
- 1987-09
- Volume
- 42
- Issue
- 3
- Pages
- 250-253
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W1966754527
- Cited by
- 219
- References
- 0
- FWCI
- 3.08
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: The consent form as a possible cause of side effects. https://app.cochat.ai/papers/10.1038/clpt.1987.142
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- Myers, M. G., Cairns, J. A., & Singer, J. (1987). The consent form as a possible cause of side effects. Clinical Pharmacology and Therapeutics. https://doi.org/10.1038/clpt.1987.142
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
