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.

Digging Deeper: Understanding Trajectories and Experiences of Shared Decision-Making for Primary Prevention ICD Implantation.

BACKGROUND: Shared decision-making using a decision aid is required for patients undergoing implantation of primary prevention implantable cardioverter-defibrillators (ICD). It is unknown how much this process has impacted patients' experiences or choices. Effective shared decision-making requires an understanding of how patients make ICD decisions. A qualitative key informant study was chosen to capture the breadth of patients' experiences making ICD decisions in the context of required shared decision-making. METHODS AND RESULTS: We conducted in-depth interviews with 20 patients referred to electrophysiology clinics for the consideration of primary prevention ICD implantation. Purposeful sampling from a prior survey study evaluating mandated shared decision-making was based on patient characteristics and responses to the initial survey questions. Qualitative descriptive analysis of the interviews was performed using a multilevel coding strategy. Patients' paths to an ICD decision often involved multiple visits with multiple clinicians. However, the decision aid was almost exclusively provided to the patient during electrophysiology clinic visits. Some patients used the numeric data in the decision aid to make an ICD decision based on the risk-benefit profile; others made decisions based on other data or based on trust in clinicians' recommendations. Patients highlighted information related to living with the device as particularly important in helping them to make their ICD decisions. Some patients struggled with the emotional aspects of making an ICD decision. CONCLUSIONS: Patients' ICD decision-making paths poses a challenge to episodic shared decision-making and may make tools such as decision aids perfunctory if used solely during the electrophysiology visit. Understanding patients' ICD decision-making paths, especially in the context of encounters with primary cardiologists, can inform the implementation strategies of shared decision-making help to enhance its impact. Components of decision aids focusing on the experience of living with an ICD rather than probabilistic data may also be more impactful, although the nature of their impact will differ.

Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding?

In phase I trials, some biospecimens are used both for research and patient care and some for research only. Some research participants have therapeutic misconception, assuming all biospecimens are for patient care. This study's aim was to test if a simple information chart would improve understanding of nontherapeutic research procedures. A two-arm study was conducted. Participants in the control group (C) were asked whether biospecimens were for their care, for research only, or for both. The experimental group (E) was asked the same questions but provided with a study-specific information chart labeling the purpose of each biospecimen. One hundred one patients were interviewed. In both arms, understanding that pretreatment blood draws were for patient care and research was moderate (49% for C and 62% for E). Understanding that posttreatment blood draws were for research only was significantly higher in the experimental arm (16% for C and 44% for E; p = 0.002). Providing a simple information chart may help alleviate this aspect of therapeutic misconception.

The impact of government-mandated shared decision-making for implantable defibrillators: A natural experiment.

BACKGROUND: In 2018, the Centers for Medicare and Medicaid Services (CMS) mandated that patients considering implantation of an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death undergo shared decision-making (SDM) using a decision-aid. OBJECTIVE: To observe the impact of the CMS's mandate on core measures of SDM using a natural experiment. RESEARCH DESIGN, SUBJECTS, AND MEASURES: Patients who underwent implantation of a primary prevention ICD within the Emory Healthcare system between 2017-2019 (pre and post SDM mandate) were surveyed. Survey domains included knowledge about the ICD, decisional conflict, values-choice concordance, and engagement in decision-making. Patients who had an ICD implant after the mandate were also asked about their views of the decision aid (DA). Responses of patients who had ICD implanted prior to the mandate were compared to those after the mandate using either Student t test or Chi-Squared tests. RESULTS: Of 101 patients who completed the survey, 45 had an ICD placed before the mandate and 56 had an ICD placed after. There were no major differences between knowledge, decisional conflict, values choice concordance, or patient engagement. Compared to patients with ICDs placed before the mandate, patients with ICDs after the mandate were more likely to subjectively feel more informed about the benefits of the procedure but were less likely to be able to correctly identify the frequency of complications. CONCLUSIONS: Policy effects to promote SDM that solely focus on a decision-aid may not substantively impact patient centered care.

Videos improve patient understanding of chemotherapy terminology in a rural setting.

BACKGROUND: It is critical patients understand the terms used to describe oncology treatments; however, even basic chemotherapy terminology can be misunderstood. Rural communities tend to have especially low levels of health literacy compared with nonrural communities. To address low health literacy in rural communities, this study tested rural participants' understanding of previously developed educational chemotherapy videos that were designed for an underserved urban population. Participants were also asked for feedback to determine if the videos could be improved. METHODS: Fifty English-speaking patients who reside in counties classified as rural according to the Rural-Urban Continuum Code designations (RUCC 4-9) participated in the study. Participants were asked to define 6 chemotherapy terms before and after viewing a short, animated video explaining the term in English. Rates of correct and incorrect definitions provided by participants were also compared with previously published results from an urban cohort. RESULTS: All participants had statistically significantly higher rates of correct definitions for all 6 terms following the video intervention. Palliative chemotherapy understanding improved the most (10% correct prevideo and 76% postvideo intervention). For each video, the majority of participants (77%-92%) suggested no changes to the videos. CONCLUSION: Given the prevalence of low health literacy in rural communities, it is important to have effective educational interventions to improve the understanding of basic oncology-treatment terminology. This study found that short, educational videos, originally designed for an underserved urban population, can significantly improve understanding of commonly misunderstood chemotherapy terminology in a rural setting as well. LAY SUMMARY: Chemotherapy terminology can be confusing to patients. Understanding can be especially difficult in areas with low health literacy, such as underserved urban and rural communities. To address this concern, previously developed short, animated videos describing basic chemotherapy terminology were found to improve patient understanding in an underserved urban setting. In this study, the videos were tested in a rural population and their effectiveness was established. Participants in the rural setting were significantly more likely to correctly define all 6 tested terms after watching the videos. Educational tools for high-need populations are essential to ensure patients can understand the treatment they receive.

Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting.

BACKGROUND: Therapeutic misconception (TM) refers to research subjects' failure to distinguish the goals of clinical research from standard personal care. TM has traditionally been determined by questioning the patient about the research study's purpose. Recent research, however, has questioned whether TM is as prevalent as reported due to discrepancies between patient/researcher interpretations of TM questions. The authors have created an interview tool receptive to these advancements to more accurately determine the prevalence of TM. METHODS: Patients were questioned about the trial's purpose as follows: 1) "Is the trial mostly intending to help research and gain knowledge?," 2) "Is it mostly intending to help you as a person?," or 3) "Don't know." Participants were then asked what they thought this question was asking: A) "What my own intentions are for participating," B) "What the official purpose of the research study is," or C) "Not sure." A patient exhibited TM by answering that the official trial purpose was to help him or her. RESULTS: Patients (n = 98) had a mean age of 60 years, were mostly White (64%), had a combined family annual income ≥$60,000 (61%), and 49% had a college degree. Twelve of 98 patients (12%) definitely exhibited TM. This was much lower than the author's original finding of 68% in a similar cohort. Twenty-four of 98 patients (24.5%) were unclear about what one or both questions were asking and could not be categorized. CONCLUSIONS: Previously, a patient was thought to have TM if they answered that the purpose of the trial was to benefit to him or her. An additional query about how patients interpreted that question revealed only 12% definitely had TM. LAY SUMMARY: Therapeutic misconception (TM) refers to research subjects' failure to distinguish the goals of clinical research from standard personal care. TM signals a basic misunderstanding of the purpose of clinical research, threatening valid informed consent to participate in clinical trials. TM has traditionally been determined by questioning patients about their research study's purpose. Recent research, however, has questioned whether TM is as prevalent due to discrepancies between patient/researcher interpretations of TM questions. By developing an interview-tool receptive to these advancements, we report a lower TM estimate in the phase 1 setting (12%) than we found previously in a similar cohort (68%).

Allocating Scarce Health Care Resources During Pandemics: Making the Case for Patients with Advanced and Metastatic Cancer.

The oncology community is concerned that patients with cancer will be unfairly classified in pandemic allocation guidance. Past guidance either excluded patients with metastatic cancer from consideration or categorized them as having a survival of less than 1 year. Given recent improvements in treatments, we recommend that the prognosis of an individual patient with cancer be determined with input from a cancer specialist or, if this is impractical, that the presence of active metastatic solid cancer or relapsed hematologic malignancy is graded as a major comorbidity, with a likelihood that survival will be less than 5 years; severe limitation in physical functioning (3 or 4 on the Eastern Cooperative Oncology Group performance status) would define a patient with advanced cancer as having a severe comorbidity, with a likelihood of less than 1 year of survival. Cancer may be the "Emperor of all Maladies," but it is no longer a certain death sentence.

Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions.

PURPOSE: Debate continues over whether explicit recommendations for a clinical trial should be included as an element of shared decision making within oncology. We aimed to determine if and how providers make explicit recommendations in the setting of phase I cancer clinical trials. METHODS: Twenty-three patient/provider conversations about phase I trials were analyzed to determine how recommendations are made and how the conversations align with a shared decision-making framework. In addition, 19 providers (9 of whose patient encounters were observed) were interviewed about the factors they consider when deciding whether to recommend a phase I trial. RESULTS: We found that providers are comprehensive in the factors they consider when recommending clinical trials. The two most frequently stated factors were performance status (89%) and patient preferences (84%). Providers made explicit recommendations in 19 conversations (83%), with 12 of those being for a phase I trial (12 [63%] of 19). They made these recommendations in a manner consistent with a shared decision-making model; 18 (95%) of the 19 conversations during which a recommendation was made included all steps, or all but 1 step, of shared decision making, as did 11 of the 12 conversations during which a phase I trial was recommended. In 7 (58%) of these later conversations, providers also emphasized the importance of the patient's opinion. CONCLUSION: We suggest that providers not hesitate to make explicit recommendations for phase I clinical trials, because they are able to do so in a manner consistent with shared decision making. With further research, these results can be applied to other clinical trial settings.