Most patients had spiritual needs. A slight majority thought it appropriate to be asked about these needs, although fewer thought this compared with reports in other settings. Few had their spiritual needs addressed by the staff. Patients whose spiritual needs were not met reported lower ratings of quality and satisfaction with care.
Purpose
Patients’ estimates of their chances of therapeutic benefit from participation in early-phase trials greatly exceed historical data. Ethicists worry that this “therapeutic misestimation” undermines the validity of informed consent.
Patients and Methods
We interviewed 45 patients enrolled in phase I or II oncology trials about their expectations of therapeutic benefit and their reasons for those expectations. We employed a phenomenological, qualitative approach with one primary coder to identify emergent themes, verified by 2 independent coders.
Results
Median expectations of therapeutic benefit varied from 50% to 80%, depending on how the question was asked. Justifications universally invoked hope and optimism, and 27/45 participants used one of these words. Three major themes emerged: (1) optimism as performative, that is, the notion that positive thoughts and expressions improve chances of benefit; (2) fighting cancer as a battle; and (3) faith in God, science, or both. Many participants described a culture in which optimism was encouraged and expected, such that trial enrollment became a way of reflecting this expectation. Many reported they had been told few patients would benefit and appeared to understand the uncertainties of clinical research, yet expressed high expected personal therapeutic benefit. More distressed participants were less likely to invoke performative justifications for their expectations (50% vs 84%; P = .04).
Conclusion
Expressions of high expected therapeutic benefit had little to do with reporting knowledge and more to do with expressing optimism. These results have implications for understanding how to obtain valid consent from participants in early-phase clinical trials.
Staff nurses were more likely than their physician colleagues to believe they should be allowed to initiate DNR discussions, were more confident in their ability to discuss DNR than house officers, and had more positive attitudes. These results suggest further exploration of the role nurses should play in the DNR process.
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