Description of the types and content of phase 1 clinical trial consent conversations in practice

Abstract

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.

Discussing molecular testing in oncology care: Comparing patient and physician information preferences

“…However, there are neither established communication guidelines for the information physicians should include during these discussions 14,17,50 nor patient-physician consensus on the most important information to discuss. [18][19][20][21][22][23][42][43][44][45][46] Therefore, it is vital to include current patients' voices and preferences in creating molecular testing guidelines. This study successfully identified patients' and physicians' preferences for molecular testing communication, patients' preferences for the method of receiving information, and physicians' preferences for communication aids.…”

“…In clinical observations, discrepancies have been identified between physician practice and patient preference for information. For example, although a majority of cancer patients report prognostic information as important and necessary, physicians frequently omit this information …”

“…In clinical observations, discrepancies have been identified between physician practice and patient preference for information. For example, although a majority of cancer patients report prognostic information as important and necessary, [18][19][20][21] physicians frequently omit this information. 18,22,23 Existing patient and physician barriers to adequate communication exacerbate molecular testing communication gaps.…”

“…[35][36][37][38][39] Recognizing patient preferences is particularly difficult, because physicians expect patients to express their preferences 40 ; however, patients often do not speak up, and physicians do not readily recognize indirect expressions of concern. 41 The difficulty physicians have in knowing the amount and type of information to discuss 4,17 and the well documented discordance between physician and patient information preferences in other areas, [18][19][20][21][22][23][42][43][44][45][46] combined with a lack of research on molecular testing communication, make it vital to include patients' voices in guideline development. Therefore, we conducted a study to identify patients' and physicians' top preferences for molecular testing information, and who and how this information is communicated, to inform future guidelines for tumor molecular testing discussions.…”

What advanced cancer patients with limited treatment options know about clinical research: a qualitative study

“…The American Society of Clinical Oncology (ASCO) has recognized the challenges of communicating effectively about such complex topics [1–3], and has called on clinicians to uncover and address communication problems that hinder ACP understanding [1]. Communication skills training programs that serve these aims are widely available to oncologists [4–6] and embedded in graduate medical education [7].…”