Background The aim of this study was to examine adolescent patients’ perspectives on their understanding and decision making about a pediatric Phase I cancer study. Procedure Participants included adolescents ages 14-21 years with cancer (N = 20), all of whom attended a Phase I study consent conference. Participants responded to closed- and open-ended questions on a verbally administered structured interview, which assessed aspects of understanding and decision making about the Phase I study. Results All participants decided to enroll in the Phase I study. The majority of participants understood that participation was voluntary, entailed risks, and that they could withdraw. Most also believed that participation in the Phase I study would increase the length of their lives. The most frequent reasons for enrolling were positive clinical benefit, needing an option, impact on quality of life, and few side effects or fewer than those of current or past treatments. Eighty-five percent of participants reported that they themselves made the final decision about enrollment in the Phase I study. Conclusions Most participants hoped or expected that the Phase I study would provide a direct benefit (increased survival time or cure) and reported that they themselves were the final decision-maker about enrollment. Clinicians may underestimate the role of adolescents, especially if they believe that parents typically make such decisions. Future research should assess the actual participation of children and adolescents during the informed consent process and explore the role of hope in their decision making about Phase I studies.

Background Informed consent for clinical research includes two components: informed consent documents (ICD) and informed consent conversations (ICC). Readability software has been used to help simplify the language of the ICD, but rarely employed to assess the language during the ICC, which may influence the quality of informed consent. This analysis was completed to determine if length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected use of simpler language and comprehensiveness. Methods Prospective study where ICCs were audio-recorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL) and Flesch Reading Ease Score (FRES) of ICCs were compared to corresponding ICDs, including the frequency that investigators addressed 8 pre-specified critical consent elements during the ICC. Results Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4,677 vs. 6,364; p=0.0016), had lower FKGL (6 vs. 9.7; p=<0.0001) and higher FRES (77.8 vs. 56.7; p<0.0001) than their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity. Conclusions Clinicians use more understandable language during ICCs than the corresponding ICD, but less reliably cover elements critical to fully informed consent. Focused efforts at providing communication training for clinician-investigators should be done to optimize the synergy between the ICD and conversation.

BACKGROUND. This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials. METHODS. A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate. RESULTS. Pediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no-attempt-to-influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies.Responses to an open-ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician-family communication. CONCLUSIONS. Pediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted. Cancer 2010;116:3244

Background Patient satisfaction with in-person medical visits includes patient-clinician engagement. However, communication, empathy, and other relationship-centered care measures in virtual visits have not been adequately investigated. Objective This study aims to comprehensively consider patient experience, including relationship-centered care measures, to assess patient satisfaction during virtual visits. Methods We conducted a large survey study with open-ended questions to comprehensively assess patients’ experiences with virtual visits in a diverse patient population. Adults with a virtual visit between June 21, 2017, and July 12, 2017, were invited to complete a survey of 21 Likert-scale items and textboxes for comments following their visit. Factor analysis of the survey items revealed three factors: experience with technology, patient-clinician engagement, and overall satisfaction. Multivariable logistic regression was used to test the associations among the three factors and patient demographics, clinician type, and prior relationship with the clinician. Using qualitative framework analysis, we identified recurrent themes in survey comments, quantitatively coded comments, and computed descriptive statistics of the coded comments. Results A total of 65.7% (426/648) of the patients completed the survey; 64.1% (273/426) of the respondents were women, and the average age was 46 (range 18-86) years. The sample was geographically diverse: 70.2% (299/426) from Ohio, 6.8% (29/426) from Florida, 4.2% (18/426) from Pennsylvania, and 18.7% (80/426) from other states. With regard to insurance coverage, 57.5% (245/426) were undetermined, 23.7% (101/426) had the hospital’s employee health insurance, and 18.7% (80/426) had other private insurance. Types of virtual visits and clinicians varied. Overall, 58.4% (249/426) of patients had an on-demand visit, whereas 41.5% (177/426) had a scheduled visit. A total of 41.8% (178/426) of patients had a virtual visit with a family physician, 20.9% (89/426) with an advanced practice provider, and the rest had a visit with a specialist. Most patients (393/423, 92.9%) agreed that their virtual visit clinician was interested in them as a person, and their virtual visit made it easy to get the care they needed (383/421, 90.9%). A total of 81.9% (344/420) of respondents agreed or strongly agreed that their virtual visit was as good as an in-person visit by a clinician. Having a prior relationship with their virtual visit clinician was associated with less comfort and ease with virtual technology among patients (odds ratio 0.58, 95% CI 0.35-0.98). In terms of technology, patients found the interface easy to use (392/423, 92.7%) and felt comfortable using it (401/423, 94.8%). Technical difficulties were associated with lower odds of overall satisfaction (odds ratio 0.46, 95% CI 0.28-0.76). Conclusions Patient-clinician engagement in virtual visits was comparable with in-person visits. This study supports the value and acceptance of virtual visits. Evaluations of virtual visits should include assessments of technology and patient-clinician engagement, as both are likely to influence patient satisfaction.

During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.