Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback.

BACKGROUND: Although patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation of important information in consent forms for these trials. METHODS: The study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial's consent form. The location of information in the consent forms was compared to the participants' suggestions for placement. RESULTS: 34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the "Risks" section.  3/5(60%) consents did this. CONCLUSIONS: Designing consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding.

Quality of life and decisional regret after total glossectomy with laryngectomy: A single-institution case series.

OBJECTIVES: Total glossectomy with total laryngectomy is a life-altering procedure reserved for extensive or recurrent head and neck cancer. There is minimal literature describing quality of life in these patients, partly due to high mortality rates. METHODS: Patients who had undergone a total glossectomy with laryngectomy between 2014 and 2021 at our institution, identified by chart review, were eligible. Four validated scales were used to assess quality of life and satisfaction with decision. RESULTS: Four of five survivors agreed to participate. The average scores for the Satisfaction with Decision scale and the University of Washington Quality of Life scale were 4.4/5 and 70/100, respectively, showing that patients were satisfied with their decision and quality of life. However, the average function score for the UW-QoL scale, 36.4/100, highlights negative effects of the procedure on mood, oral function, and activity. CONCLUSIONS: This case description provides a picture of patients' quality of life after total glossectomy with laryngectomy, which may be useful for counseling future patients.

Evaluation of Standard-of-Care Practices Among Physicians Who Treat Other Physicians: A Qualitative Study.

Importance: Ethical discussions have suggested that physicians who treat other physicians may put their physician-patients at risk of receiving non-standard-of-care treatment, which may result in worse outcomes. This phenomenon occurs when a physician treats a fellow physician as a VIP (very important person), and is therefore known as VIP syndrome. It is important to assess physicians' perceptions when treating physician-patients. Objective: To determine whether the physicians treating other physicians have attitudes toward or act in ways that could place physician-patients at risk for VIP syndrome. Design, Setting, and Participants: This 2-part qualitative study was conducted from December 1, 2021, to February 28, 2022. Physicians who worked at a single comprehensive cancer center with experience treating other physicians were eligible to participate. Convenience sampling was used. Emails and flyers were sent out with study information, and if interested, physicians were able to schedule an interview. Of 24 physicians responding, 3 did not have experience treating other physicians, yielding a sample of 21 (88%), which was sufficient to reach a saturation of themes. After the initial structured interview of physicians, follow-up key informant interviews were performed. Exposures: The structured interview was developed on the basis of a literature review and focused on factors that may contribute to VIP syndrome. Main Outcomes and Measures: Participant responses to open-ended questions were qualitatively coded using standard multilevel semantic analysis to assess physician perceptions of treating fellow physicians. A series of Likert-scaled questions were used to identify potential contributing factors to VIP syndrome. Results: Twenty-one physicians (11 men [52%], 11 White [52%], and 15 [71%] younger than 49 years) participated. Although no physician interviewed stated that they altered their usual treatment plans, 11 (52%) agreed that their physician-patients tried to dictate their own care, and 17 (81%) believed that their physician-patients obtained privileges, such as use of medical knowledge to participate in in-depth discussions of care, ability to obtain and use the treating physicians personal contact information, and receiving faster access to care. Eleven respondents (52%) reported increased stress, and 12 (57%) experienced more pressure not to disappoint their physician-patients. Conclusions and Relevance: The findings of this qualitative study suggest that when physicians treat other physicians, the physician-patients may obtain privileges unavailable to patients who are not physicians. Therefore, guidelines to help physicians navigate the complex relationships between themselves and their physician-patients are needed to ensure equitable outcomes between physician and nonphysician patients.

Comparative Analysis of Au and Au@SiO2 Nanoparticle-Protein Interactions for Evaluation as Platforms in Theranostic Applications.

Gold nanoparticles are utilized in a variety of sensing and detection technologies because of their unique physiochemical properties. Their tunable size, shape, and surface charge enable them to be used in an array of platforms. The purpose of this study is to conduct a thorough spectroscopic characterization of Au and functionalized hybrid Au@SiO2 nanoparticles under physiological conditions and in the presence of two proteins known to be abundant in serum, bovine serum albumin and human ubiquitin. The information obtained from this study will enable us to develop design principles to synthesize an array of surface-enhanced Raman spectroscopy-based nanoparticles as platforms for theranostic applications. We are particularly interested in tailoring the surface chemistry of the Au@SiO2 nanoparticles for applications in theranostic technologies. We employ common spectroscopic techniques, with particular emphasis on circular dichroism and heteronuclear single quantum correlation nuclear magnetic resonance (HSQC NMR) spectroscopy, as combinatorial tools to understand protein conformational dynamics, binding site interactions, and protein corona for the design of nanoparticles capable of reaching their intended target in vivo. Our results conclude that protein adsorption onto the nanoparticle surface prevents nanoparticle aggregation. We observed that varying the ionic strength and type of ion influences the aggregation and aggregation rate of each respective nanoparticle. The conformation of proteins and the absorption of proteins on the surface of Au nanoparticles are also influenced by ionic strength. Using two-dimensional [15N-1H]-HSQC NMR experiments to compare the interactions of Au and Au@SiO2 nanoparticles with 15N-ubiquitin, we observed small chemical shift perturbations in some amino acid peaks and differences in binding site interactions with ubiquitin and respective nanoparticles.