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Patient Expectations of Benefit from Phase I Clinical Trials: Linguistic Considerations in Diagnosing a Therapeutic Misconception
Abstract
The ethical treatment of cancer patients participating in clinical trials requires that patients are well-informed about the potential benefits and risks associated with participation. When patients enrolled in phase I clinical trials report that their chance of benefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type (e.g., "On average, 5 out of every 100 patients will benefit") can be confused with expressions of uncertainty of the belief type (e.g., "The chance that I will benefit is about 80%"). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subserve multiple speech acts, some of which may be indirect. For example, a patient reporting a high expected benefit may be reporting a belief about the future, reassuring family members, and/or attempting to improve his or her outcome by a public assertion of optimism. These sources of linguistic confusion should be considered in judging whether the patient's reported expectation is grounds for a bioethical concern that there has been a failure in the informed consent process.
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Surrogates' own prognostic estimates may have served as illocutionary acts-expressions intended to express positive attitude, optimism, or faith; highlight patients' unrecognized qualities of resilience; or counter clinicians' pessimism.
“their own prognostic estimates may also have served as “illocutionary acts”—that is, expressions distinct from comprehension with which they intended to express positive attitude, optimism, or faith; to highlight patients’ unrecognized qualities of resilience; or to counter clinicians’ pessimism (15, 34–36).”
From Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation (2019) · cites this paper as [34]
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Self-citation
Metadata
- Authors
- Weinfurt, K. P., Sulmasy, D. P., Schulman, K. A., & Meropol, N. J.
- Affiliations
- Duke University (US)
- New York Medical College (US)
- Duke Medical Center (US)
- Fox Chase Cancer Center (US)
- Corresponding author
- Weinfurt, K.P.
- Venue
- Theoretical Medicine and Bioethics
- Published
- 2003-07
- Volume
- 24
- Issue
- 4
- Pages
- 329-344
- ISSN
- 0166-2031 (ISSN-L)
- 1386-7415
- 1573-1200
- OpenAlex
- W1516915792
- Cited by
- 74
- References
- 22
- Citations by year
- 2026: 1 · 2024: 1 · 2023: 2 · 2021: 4 · 2020: 2 · 2019: 5 · 2018: 2 · 2016: 7 · 2015: 5 · 2014: 1 · 2013: 4 · 2012: 5
- FWCI
- 4.70
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Metamedicine (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- National Cancer Institute (R01CA082085)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
- Keywords
- therapeutic misconception, informed consent, cancer patients, philosophy of language, multivocality, speech acts, clinical trial ethics
- MeSH terms
- Colonic Neoplasms, Female, Humans, Informed Consent, Linguistics, Liver Neoplasms, Lung Neoplasms, Middle Aged, Patients, Physician-Patient Relations, Treatment Outcome, Clinical Trials, Phase I as Topic, Risk Assessment, Comprehension, Uncertainty
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