Perspectives from patients with chronic lung disease on a telehealth-facilitated integrated palliative care model: a qualitative content analysis study.

BACKGROUND: Chronic lung disease affects nearly 37 million Americans and often results in significant quality of life impairment and healthcare burden. Despite guidelines calling for palliative care (PC) integration into pulmonary care as a vital part of chronic lung disease management, existing PC models have limited access and lack scalability. Use of telehealth to provide PC offers a potential solution to these barriers. This study explored perceptions of patients with chronic lung disease regarding a telehealth integrated palliative care (TIPC) model, with plans to use findings to inform development of an intervention protocol for future testing. METHODS: For this qualitative study, we conducted semi-structured interviews between June 2021- December 2021 with patients with advanced chronic lung disease. Interviews explored experiences with chronic lung disease, understanding of PC, and perceived acceptability of the proposed model along with anticipated facilitators and barriers of the TIPC model. We analyzed findings with a content analysis approach. RESULTS: We completed 20 interviews, with two that included both a patient and caregiver together due to patient preference. Perceptions were primarily related to three categories: burden of chronic lung disease, pre-conceived understanding of PC, and perspective on the proposed TIPC model. Analysis revealed a high level of disease burden related to chronic lung disease and its impact on day-to-day functioning. Although PC was not well understood, the TIPC model using a shared care planning approach via telehealth was seen by most as an acceptable addition to their chronic lung disease care. CONCLUSIONS: These findings emphasize the need for a patient-centered, shared care planning approach in chronic lung disease. The TIPC model may be one option that may be acceptable to individuals with chronic lung disease. Future work includes using findings to refine our TIPC model and conducting pilot testing to assess acceptability and utility of the model.

"Once I take that one bite": the consideration of harm reduction as a strategy to support dietary change for patients with diabetes.

BACKGROUND: Despite well-established guidelines to treat diabetes, many people with diabetes struggle to manage their disease. For many, this struggle is related to challenges achieving nutrition-related lifestyle changes. We examined how people with diabetes describe barriers to maintaining a healthy diet and considered the benefits of using a harm reduction approach to assist patients to achieve nutrition-related goals. METHODS: This is a secondary analysis of 89 interviews conducted with adults who had type 1 or type 2 diabetes. Interviews were analyzed using a content analysis approach. Themes regarding food or diet were initially captured in a "food" node. Data in the food node were then sub-coded for this analysis, again using a content analysis approach. RESULTS: Participants frequently used addiction language to talk about their relationship with food, at times referring to themselves as "an addict" and describing food as "their drug." Participants perceived their unhealthy food choices either as a sign of weakness or as "cheating." They also identified food's ability to comfort them and an unwillingness to change as particular challenges to sustaining a healthier diet. CONCLUSION: Participants often described their relationship with food through an addiction lens. A harm reduction approach has been associated with positive outcomes among those with substance abuse disorder. Patient-centered communication incorporating the harm reduction model may improve the patient-clinician relationship and thus improve patient outcomes and quality-of-life while reducing health-related stigma in diabetes care. Future work should explore the effectiveness of this approach in patients with diabetes. TRIAL REGISTRATION: Registered on ClinicalTrials.gov, NCT02792777. Registration information submitted 02/06/2016, with the registration first posted on the ClinicalTrials.gov website 08/06/2016. Data collection began on 29/04/2016.

Perspectives of COVID-19 vaccine-hesitant emergency department patients to inform messaging platforms to promote vaccine uptake.

OBJECTIVES: Efforts to promote COVID-19 vaccine acceptance must consider the critical role of the emergency department (ED) in providing health care to underserved patients. Focusing on patients who lacked primary care, we sought to elicit the perspectives of unvaccinated ED patients regarding COVID-19 vaccination concerns and potential approaches that might increase their vaccine acceptance. METHODS: We conducted this qualitative interview study from August to November 2021 at four urban EDs in San Francisco, California; Seattle, Washington; Durham, North Carolina; and Philadelphia, Pennsylvania. We included ED patients who were ≥18 years old, fluent in English or Spanish, had not received a COVID-19 vaccine, and did not have primary care physicians or clinics. We excluded patients who were unable to complete an interview, in police custody, under suspicion of active COVID-19 illness, or presented with a psychiatric chief complaint. We enrolled until we reached thematic saturation in relevant domains. We analyzed interview transcripts with a content analysis approach focused on identifying concerns about COVID-19 vaccines and ideas regarding the promotion of vaccine acceptance and potential trusted messengers. RESULTS: Of 65 patients enrolled, 28 (43%) identified as female, their median age was 36 years (interquartile range 29-49), and 12 (18%) interviews were conducted in Spanish. Primary concerns about COVID-19 vaccines included risk of complications, known and unknown side effects, and fear of contracting COVID-19 from vaccines. Trust played a major role for patients in deciding which sources to use for vaccine information and in engendering vaccine acceptance. Health care providers and family or friends were commonly cited as trusted messengers of information. CONCLUSIONS: We characterized concerns about COVID-19 vaccines, uncovered themes that may promote vaccine acceptance, and identified trusted messengers-primarily health care professionals. These data may inform the development of nuanced COVID-19 vaccine messaging platforms to address COVID-19 vaccine hesitancy among underserved ED populations.

PROmotion of COvid-19 VA(X)ccination in the Emergency Department-PROCOVAXED: study protocol for a cluster randomized controlled trial.

BACKGROUND: We conducted in-depth interviews to characterize reasons for COVID-19 vaccine hesitancy in emergency department (ED) patients and developed messaging platforms that may address their concerns. In this trial, we seek to determine whether provision of these COVID-19 vaccine messaging platforms in EDs will be associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients. METHODS: This is a cluster-randomized controlled trial (RCT) evaluating our COVID-19 vaccine messaging platforms in seven hospital EDs (mix of academic, community, and safety-net EDs) in four US cities. Within each study site, we randomized 30 1-week periods to the intervention and 30 1-week periods to the control. Adult patients who have not received a COVID-19 vaccine are eligible with these exclusions: (1) major trauma, intoxication, altered mental status, or critical illness; (2) incarceration; (3) psychiatric chief complaint; and (4) suspicion of acute COVID-19 illness. Participants receive an orally administered Intake survey. During intervention weeks, participants then receive three COVID-19 vaccine messaging platforms (4-min video, one-page informational flyer and a brief, scripted face-to-face message delivered by an ED physician or nurse); patients enrolled during non-intervention weeks do not receive these platforms. Approximately, an hour after intake surveys, participants receive a Vaccine Acceptance survey during which the primary outcome of acceptance of the COVID-19 vaccine in the ED is ascertained. The other primary outcome of receipt of a COVID-19 vaccine within 32 days is ascertained by electronic health record review and phone follow-up. To determine whether provision of vaccine messaging platforms is associated with a 7% increase in vaccine acceptance and uptake, we will need to enroll 1290 patients. DISCUSSION: Highlighting the difficulties of trial implementation during the COVID-19 pandemic in acute care settings, our novel trial will lay the groundwork for delivery of public health interventions to vulnerable populations whose only health care access occurs in EDs. CONCLUSIONS: Toward addressing vaccine hesitancy in vulnerable populations who seek care in EDs, our cluster-RCT will determine whether implementation of vaccine messaging platforms is associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients. TRIAL STATUS: We began enrollment in December 2021 and expect to continue through 2022. TRIAL REGISTRATION: ClinicalTrials.gov NCT05142332 . Registered 02 December 2021.

"Unfortunately, I don't have an answer for you": How resident physicians communicate diagnostic uncertainty to patients during emergency department discharge.

OBJECTIVE: To describe how emergency medicine resident physicians discuss diagnostic uncertainty during a simulated ED discharge discussion. METHODS: A secondary content analysis of simulated clinical encounter audiotapes completed by emergency medicine residents across two sites. RESULTS: When discussing lack of diagnosis, residents explained the evaluation revealed no cause for symptoms, noted concerning diagnoses that were excluded, and acknowledged both symptoms and patients' feelings. Residents used explicit and implicit language to discuss diagnostic uncertainty with similar frequency. Almost half of the residents discussed the ED role as focused on emergent illness to give patients context for their uncertain diagnoses. However, 28% of residents in this study did not discuss diagnostic uncertainty in any form. All residents provided reassurance. CONCLUSION: Residents use a range of approaches to discuss diagnostic uncertainty with patients at the time of a simulated ED discharge, with some residents omitting discussion of uncertainty entirely. PRACTICE IMPLICATIONS: These findings represent the current state of communication, which needs improvement. These findings do not immediately transfer to clinical practice recommendations, but rather support a need for both further study and development of formal communication training on this topic.

Development of the Oncology Opportunity Cost Assessment Tool: Item Generation and Content Validity Testing.

PURPOSE: The purpose of this study was to develop the Oncology Opportunity Cost Assessment Tool (OOCAT), a survey instrument to evaluate the opportunity costs patients experience when seeking medical oncology care. METHODS: Development of the OOCAT involved extensive patient engagement through both focus groups and interviews. First, the study team developed a list of opportunity cost concepts, which included patients' logistical and financial considerations related to seeking care. We conducted focus groups with patients to expand upon this list of concepts, and then developed a set of questions that incorporated all the concepts generated during the focus groups. To refine these questions, we next performed cognitive interviews with another set of patients to ensure content validity and clarity of instrument items, refining the OOCAT iteratively on the basis of feedback. RESULTS: We engaged 23 participants (17 patients and six caregivers) across four focus groups and 17 participants in cognitive interviews. Focus group participants generated 112 concepts, which resulted in an initial OOCAT with 16 questions. Cognitive interviews resulted in modification of 12 questions and addition of two questions (related to coordination of transportation and impact on home responsibilities). The final OOCAT consisted of 18 items examining time requirements for appointments, financial implications of traveling to appointments for the patient and the caregiver, and logistical and quality-of-life challenges associated with traveling for appointments. CONCLUSION: We developed the OOCAT, an instrument designed to evaluate patient-level opportunity costs of seeking medical oncology care. Further studies to validate the OOCAT are underway.

COVID-19 Pandemic Influence on Medical Oncology Provider Perceptions of Telehealth Video Visits.

PURPOSE: The COVID-19 pandemic necessitated a rapid expansion of telehealth use in oncology, a specialty in which prior utilization was low in part because of barriers perceived by providers. Understanding the changing perceptions of medical oncology providers during the pandemic is critical for continued expansion and improvement of telehealth in cancer care. This study was designed to identify medical oncology providers' perceptions of telehealth video visits as influenced by the COVID-19 pandemic. METHODS: We conducted semi-structured interviews with medical oncology providers from November 20, 2020, to January 27, 2021, at the Sidney Kimmel Cancer Center at Thomas Jefferson University, a National Cancer Institute-designated cancer center in an urban, academic health system in Philadelphia, PA. We assessed provider perceptions of the impact of the COVID-19 pandemic on (1) provider-level comfort and willingness for telehealth, (2) provider-perceived patient comfort and willingness to engage in telehealth, and (3) continued barriers to successful telehealth use. RESULTS: Volunteer and convenience sampling resulted in the participation of 25 medical oncology providers, including 18 physicians and seven advanced practice providers, in semi-structured interviews. Of the 25 participants, 13 (52%) were female and 19 (76%) were White, with an average age of 48.5 years (standard deviation = 12.6). Respondents largely stated an increased comfort level and willingness for use of video visits. In addition, respondents perceived a positive change in patient comfort and willingness, mostly driven by convenience, accessibility, and reduced risk of COVID-19 exposure. However, several reported technologic issues and limited physical examination capability as remaining barriers to telehealth adoption. CONCLUSION: The rapid adoption of telehealth necessitated by the COVID-19 pandemic has increased provider-level and provider-perceived patient comfort and willingness to engage in video visits for cancer care. As both providers and patients increasingly accept telehealth across many use cases, future work should focus on further addressing technology and physical examination barriers and ensuring continued reimbursement for telehealth as a routine part of covered care.

Patient Markers of Successful Diabetes Management.

PURPOSE: For individuals with diabetes, diabetes health status may not align with A1C targets. Patients may use nonclinical targets when assessing their diabetes management success. Identifying these targets is important in developing patient-centered management plans. The purpose of this study was to identify patient markers of successful diabetes management among patients in an urban academic health system. METHODS: A secondary analysis of semistructured interviews was completed with 89 adults with type 1 or type 2 diabetes. Participants had a recent diabetes-related emergency department (ED) visits or hospitalization or were primary care patients with an A1C >7.5%. Interviews were conducted to saturation. Demographic data were collected via self-report and electronic medical records. Interviews were analyzed using conventional content analysis. This analysis focused on patient perceptions of successful management coded to "measuring management success." RESULTS: Although most participants cited A1C or blood glucose as a marker of successful diabetes management, they had varied understanding of these metrics. Most used a combination of targets from the following categories: 1) A1C, blood glucose, and numbers; 2) engagement in medical care; 3) taking medication and medication types; 4) symptoms; 5) diet, exercise, and weight; and 6) stress management and social support. CONCLUSION: Individuals not meeting glycemic goals and/or with recent diabetes-related ED visits or hospitalizations had varied understanding of A1C and blood glucose targets. They use multiple additional markers of successful management and had a desire for management discussions that incorporate these markers. These measures should be incorporated into their care plans along with clinical targets.

Medical Oncology Patient Perceptions of Telehealth Video Visits.

PURPOSE: Telehealth in medical oncology has expanded secondary to the COVID-19 pandemic. However, quantitative research on medical oncology telehealth use shows conflicting results on patient satisfaction, whereas qualitative data are sparse. Our qualitative study aimed to identify the factors influencing patient acceptability of video visits for medical oncology care before and at the onset of the expansion of telehealth because of the COVID-19 pandemic. METHODS: Semi-structured interviews were conducted between November 2019 and April 2020 with 20 patients who participated in a telehealth visit with a medical oncology provider at Thomas Jefferson University. RESULTS: Of the 20 participants, 13 (65%) were female and 15 (75%) were White, with a mean (standard deviation) age of 60.5 years (11.8). Patients identified convenience, anxiety, COVID-19, and provider preference as positively influencing the acceptability of video visits; however, some patients noted limitations in provider connection, physical examinations, and visit length as disadvantages. Regarding receipt of serious or bad news, some preferred video visits for privacy, immediacy of results, news processing, and family comfort. Others preferred in-person encounters for provider support and the ability to receive written information and in-person referrals. CONCLUSION: Patient-perceived factors influencing general acceptability, appropriateness of serious and bad news delivery, and future uses of telehealth were unique to each individual, but shared common themes. Understanding each patient's perspective of telehealth acceptability and tailoring use to their preferences is critical for continued utilization. Further research is needed to understand and address reasons for lack of telehealth uptake among certain patients.

Patient-important outcomes to inform shared decision making and goal setting for diabetes treatment.

OBJECTIVE: Despite well-established treatment guidelines, diabetes is difficult to manage for many individuals. The importance of using shared decision making to optimize diabetes treatment is recognized, yet what matters most to individuals with diabetes is not well established. Our goal was to identify patients' goals and priorities for diabetes management. METHODS: We engaged 141 participants through interviews and group concept mapping to identify patient-important outcomes (PIOs) for diabetes care. We generated a master list of PIOs by aggregating interview data coded to "goals" and ideas brainstormed during concept mapping, and then a patient advisory board sorted the PIOs into higher-level domains. RESULTS: We identified 41 PIOs sorted into 7 broad domains: optimize daily self-care, optimize long term health, learn about diabetes, achieve measurable goals, manage medications, manage diet and best utilize medical / professional services. CONCLUSIONS: Most (4/7) of PIO domains focused on personal and life goals, not medically-oriented goals. Use of these PIOs and domains may facilitate more effective SDM discussions for patients with diabetes. PRACTICE IMPLICATIONS: Use of PIOs from this work can enable the empowerment of patients to voice their priorities during SDM conversations, thus facilitating development of truly individualized diabetes treatment plans.

Medical Oncology Professionals' Perceptions of Telehealth Video Visits.

Importance: Telehealth has emerged as a means of improving access and reducing cost for medical oncology care; however, use by specialists prior to the coronavirus disease 2019 (COVID-19) pandemic still remained low. Medical oncology professionals' perceptions of telehealth for cancer care are largely unknown, but are critical to telehealth utilization and expansion efforts. Objective: To identify medical oncology health professionals' perceptions of the barriers to and benefits of telehealth video visits. Design, Setting, and Participants: This qualitative study used interviews conducted from October 30, 2019, to March 5, 2020, of medical oncology health professionals at the Thomas Jefferson University Hospital, an urban academic health system in the US with a cancer center. All medical oncology physicians, physicians assistants, and nurse practitioners at the hospital were eligible to participate. A combination of volunteer and convenience sampling was used, resulting in the participation of 29 medical oncology health professionals, including 20 physicians and 9 advanced practice professionals, in semistructured interviews. Main Outcomes and Measures: Medical oncology health professionals' perceptions of barriers to and benefits of telehealth video visits as experienced by patients receiving cancer treatment. Results: Of the 29 participants, 15 (52%) were women and 22 (76%) were White, with a mean (SD) age of 48.5 (12.0) years. Respondents' perceptions were organized using the 4 domains of the National Quality Forum framework: clinical effectiveness, patient experience, access to care, and financial impact. Respondents disagreed on the clinical effectiveness and potential limitations of the virtual physical examination, as well as on the financial impact on patients. Respondents also largely recognized the convenience and improved access to care enabled by telehealth for patients. However, many reported concern regarding the health professional-patient relationship and their limited ability to comfort patients in a virtual setting. Conclusions and Relevance: Medical oncology health professionals shared conflicting opinions regarding the barriers to and benefits of telehealth in regard to clinical effectiveness, patient experience, access to care, and financial impact. Understanding oncologists' perceptions of telehealth elucidates potential barriers that need to be further investigated or improved for telehealth expansion and continued utilization; further research is ongoing to assess current perceptions of health professionals and patients given the rapid expansion of telehealth during the COVID-19 pandemic.

"I had no other choice but to catch it too": the roles of family history and experiences with diabetes in illness representations.

BACKGROUND: A family history of diabetes and family members' experiences with diabetes may influence individuals' beliefs and expectations about their own diabetes. No qualitative studies have explored the relationship between family history and experiences and individuals' diabetes illness representations. METHODS: Secondary data analysis of 89 exploratory, semi-structured interviews with adults with type 1 or type 2 diabetes seeking care in an urban health system. Participants had a recent diabetes-related ED visit/hospitalization or hemoglobin A1c > 7.5%. Interviews were conducted until thematic saturation was achieved. Demographic data were collected via self-report and electronic medical record review. Interviews were audio-recorded, transcribed, and coded using a conventional content analysis approach. References to family history and family members' experiences with diabetes were analyzed using selected domains of Leventhal's Common Sense Model of Self-Regulation. RESULTS: Participants cited both genetic and behavioral family history as a major cause of their diabetes. Stories of relatives' diabetes complications and death figured prominently in their discussion of consequences; however, participants felt controllability over diabetes through diet, physical activity, and other self-care behaviors. CONCLUSIONS: Findings supported an important role of family diabetes history and experience in development of diabetes illness representations. Further research is needed to expand our understanding of the relationships between these perceptions, self-management behaviors, and outcomes. Family practice providers, diabetes educators and other team members should consider expanding assessment of current family structure and support to also include an exploration of family history with diabetes, including which family members had diabetes, their self-care behaviors, and their outcomes, and how this history fits into the patient's illness representations.

Patient experience and challenges in group concept mapping for clinical research.

BACKGROUND AND OBJECTIVE: Group concept mapping (GCM) is a research method that engages stakeholders in generating, structuring and representing ideas around a specific topic or question. GCM has been used with patients to answer questions related to health and disease but little is known about the patient experience as a participant in the process. This paper explores the patient experience participating in GCM as assessed with direct observation and surveys of participants. METHODS: This is a secondary analysis performed within a larger study in which 3 GCM iterations were performed to engage patients in identifying patient-important outcomes for diabetes care. Researchers tracked the frequency and type of assistance required by each participant to complete the sorting and rating steps of GCM. In addition, a 17-question patient experience survey was administered over the telephone to the participants after they had completed the GCM process. Survey questions asked about the personal impact of participating in GCM and the ease of various steps of the GCM process. RESULTS: Researchers helped patients 92 times during the 3 GCM iterations, most commonly to address software and computer literacy issues, but also with the sorting phase itself. Of the 52 GCM participants, 40 completed the post-GCM survey. Respondents averaged 56 years of age, were 50% female and had an average hemoglobin A1c of 9.1%. Ninety-two percent (n = 37) of respondents felt that they had contributed something important to this research project and 90% (n = 36) agreed or strongly agreed that their efforts would help others with diabetes. Respondents reported that the brainstorming session was less difficult when compared with sorting and rating of statements. DISCUSSION: Our results suggest that patients find value in participating in GCM. Patients reported less comfort with the sorting step of GCM when compared with brainstorming, an observation that correlates with our observations from the GCM sessions. Researchers should consider using paper sorting methods and objective measures of sorting quality when using GCM in patient-engaged research to improve the patient experience and concept map quality.

The power of the group: comparison of interviews and group concept mapping for identifying patient-important outcomes of care.

BACKGROUND: Data are limited regarding how to effectively and efficiently identify patient priorities for research or clinical care. Our goal was to compare the comprehensiveness and efficiency of group concept mapping (GCM), a group participatory method, to interviews for identifying patient goals when seeking care. METHODS: We engaged patients with moderately- to poorly-controlled diabetes mellitus in either GCM or an individual interview. The primary outcome was the comprehensiveness of GCM brainstorming (the first stage of GCM) as compared to interviews for eliciting patient-important outcomes (PIOs) related to seeking care. Secondary outcomes included 1) comprehensiveness of GCM brainstorming and interviews compared to a master list of PIOs and 2) efficiency of GCM brainstorming, the entire GCM process and interviews. RESULTS: We engaged 89 interview participants and 52 GCM participants (across 3 iterations of GCM) to identify outcomes most important to patients when making decisions related to diabetes management. We identified 26 PIOs in interviews, 33 PIOs in the first GCM brainstorming session, and 38 PIOs across all three GCM brainstorming sessions. The initial GCM brainstorming session identified 77% (20/26) of interview PIOs, and all 3 GCM brainstorming sessions combined identified 88% (23/26). When comparing GCM brainstorming and interviews to the master list of PIOs, the initial GCM brainstorming sessions identified 80% (33/41), all 3 GCM brainstorming sessions identified 93% (38/41) and interviews identified 63% (26/41) of all PIOs. Compared to interviews, GCM brainstorming required less research team time, more patient time, and had a lowest cost. The entire GCM process still required less research team time than interviews, though required more patient time and had a higher cost than interviews. CONCLUSIONS: GCM brainstorming is a powerful tool for effectively and efficiently identifying PIOs in certain scenarios, though it does not provide the breadth and depth of individual interviews or the higher level conceptual organization of the complete process of GCM. Selection of the optimal method for patient engagement should include consideration of multiple factors including depth of patient input desired, research team expertise, resources, and the population to be engaged. TRIAL REGISTRATION: Registered on ClinicalTrials.gov , NCT02792777. Registration information submitted 6/2/2016, with the registration first posted on the ClinicalTrials.gov website 6/8/2016. Data collection began on 4/29/2016.

Patient Uncertainty as a Predictor of 30-day Return Emergency Department Visits: An Observational Study.

OBJECTIVE: The objective was to examine the relationship between patient uncertainty at the time of emergency department (ED) discharge as measured by the "Uncertainty Scale" (U-Scale) and 30-day return ED visits. We hypothesized that a higher score on the U-Scale predicts a higher likelihood of a 30-day return ED visit. METHODS: This was a cross-sectional single-site pilot study performed with adult patients discharged from an urban academic ED to assess the relationship of U-Scale total and subscale scores with 30-day return ED visits. We collected demographic and U-Scale scores at the time of ED discharge and subsequent 30-day ED utilization data by follow-up telephone call. RESULTS: No association was found between the total U-Scale score and subsequent ED utilization. Patients with higher uncertainty on the Treatment Quality subscale of the U-Scale had higher odds of a 30-day return ED visit (adjusted odds ratio [AOR] = 1.16), while patients with lower uncertainty on the Decision to Seek Care subscale had higher odds of a 30-day return ED visit (AOR = 0.68). CONCLUSION: Patient uncertainty as measured by the U-Scale total score was not predictive of subsequent ED utilization. However, uncertainty related to treatment quality and the decision to seek care as measured by the U-Scale subscales may be important in predicting repeat ED utilization. Unlike individual patient factors such as age and race that have been associated with frequent ED visits in prior studies, these domains of uncertainty are potentially modifiable. Providers and health systems may successfully prevent recurrent acute care encounters through implementation of interventions designed to address patient uncertainty. Further work is needed to refine the U-Scale and test its predictive utility among a larger patient cohort.