Background/Aims All agree that informed consent is a process, but past research has focused content analyses post-consent or in one conversation in the consent series. Our aim was to identify and describe the content of different types of consent conversations. Methods We conducted a secondary analysis of 38 adult oncology phase 1 consent conversations, which were audio-recorded, transcribed, coded, and qualitatively analyzed for type and content. Results Four types of consent conversations were identified: 1) priming; 2) patient-centered options; 3) trial-centered; and 4) decision made. The analysis provided a robust description of the content discussed in each type of conversation. Two themes, supportive care and prognosis, were rarely mentioned. Four themes clustered in the patient-centered (type 2) conversations: affirmation of honesty, comfort, progression and offer of supportive care. Conclusion We identified and described four types of consent conversations. Our novel findings include 1) four different types of conversations with one – priming – not mentioned before; 2) a change of focus from describing the content of one consent conversation to describing the content of different types. These in-depth descriptions provide the foundation for future research to determine if the four types of conversations occur in sequence, thus describing the structure of the consent process and providing the basis for coaching interventions to alert physicians to the appropriate content for each type of conversation. A switch from a focus on one conversation to the types of conversations in the process may better align the consent conversations with the iterative process of shared-decision making.
BackgroundCardiovascular clinical trials depend on patient enrollment. Enrollment rates appear inadequate, but little is known about how frequently patients accept or decline offers of enrollment. The objective of this study was to assess trends and predictors of patient acceptance of offers to enroll in clinical trials for cardiovascular disease.Methods and ResultsWe utilized an established database containing all randomized, controlled trials (n=1224) in cardiovascular disease published between 2001 and 2012 in the 8 highest‐impact general medical and cardiology journals. Studies were eligible if the number of patients approached and number of patients declining enrollment could be ascertained from published materials. All studies were screened for eligibility. Each eligible study was reviewed by 3 co‐authors. All discrepancies were resolved by the group. The main outcome was acceptance rate, defined as the number of patients enrolled divided by the number patients who were eligible and approached. Only 21.7% (n=266) of studies provided information sufficient to assess patient enrollment and refusals. The median acceptance rate across trials was 83.2%. Significant predictors of higher enrollment included: enrollment in the acute setting (P=0.031); geographical region (P<0.001 for group); and trial sponsorship (P=0.006 for group).ConclusionsRates of reporting data sufficient to calculate acceptance rates are low. This compromises the ability to identify drivers of low enrollment and assess trial generalizability. However, the high rates of acceptance observed suggest that factors other than patients’ decisions may be the primary drivers of declining rates of trial enrollment.
text pagesThere was no specific funding for this editorial and the authors have no conflicts to report.Precis: Koyfman et al report an innovative research strategy analyzing the simplicity of both the consent document and conversation. We offer modifications to their two recommendations.
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