Barriers and Facilitators to End-of-Life Care Delivery in ICUs: A Qualitative Study.

OBJECTIVES: To understand frontline ICU clinician's perceptions of end-of-life care delivery in the ICU. DESIGN: Qualitative observational cross-sectional study. SETTING: Seven ICUs across three hospitals in an integrated academic health system. SUBJECTS: ICU clinicians (physicians [critical care, palliative care], advanced practice providers, nurses, social workers, chaplains). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: In total, 27 semi-structured interviews were conducted, recorded, and transcribed. The research team reviewed all transcripts inductively to develop a codebook. Thematic analysis was conducted through coding, category formulation, and sorting for data reduction to identify central themes. Deductive reasoning facilitated data category formulation and thematic structuring anchored on the Systems Engineering Initiative for Patient Safety model identified that work systems (people, environment, tools, tasks) lead to processes and outcomes. Four themes were barriers or facilitators to end-of-life care. First, work system barriers delayed end-of-life care communication among clinicians as well as between clinicians and families. For example, over-reliance on palliative care people in handling end-of-life discussions prevented timely end-of-life care discussions with families. Second, clinician-level variability existed in end-of-life communication tasks. For example, end-of-life care discussions varied greatly in process and outcomes depending on the clinician leading the conversation. Third, clinician-family-patient priorities or treatment goals were misaligned. Conversely, regular discussion and joint decisions facilitated higher familial confidence in end-of-life care delivery process. These detailed discussions between care teams aligned priorities and led to fewer situations where patients/families received conflicting information. Fourth, clinician moral distress occurred from providing nonbeneficial care. Interviewees reported standardized end-of-life care discussion process incorporated by the people in the work system including patient, family, and clinicians were foundational to delivering end-of-life care that reduced both patient and family suffering, as well as clinician moral distress. CONCLUSIONS: Standardized work system communication tasks may improve end-of life discussion processes between clinicians and families.

Perception of shared learning environment differs between vascular surgery and general surgery residents.

BACKGROUND: An enriching learning environment is integral to resident wellness and education. Integrated vascular (VS) and general surgery (GS) residents share 18 months of core GS rotations during the postgraduate years 1-3 (PGY1-3); differences in their experiences may help identify practical levers for change. METHODS: We used a convergent mixed-methods design. Cross-sectional surveys were administered after the 2020 American Board of Surgery In-Training Examination and Vascular Surgery In-Training Examination, assessing eight domains of the learning environment and resident wellness. Multivariable logistic regression models identified factors associated with thoughts of attrition between categorical PGY1-3 residents at 57 institutions with both GS and VS programs. Resident focus groups were conducted during the 2022 Vascular Annual Meeting to elicit more granular details about the experience of the learning environment. Transcripts were analyzed using inductive and deductive logics until thematic saturation was achieved. RESULTS: Surveys were completed by 205 VS and 1198 GS PGY1-3 residents (response rates 76.8% for VS and 82.5% for GS). After adjusting for resident demographics, PGY level, and program type, GS residents were more likely than their VS peers to consider leaving their programs (odds ratio [OR]: 2.61, 95% confidence interval [CI]: 1.37-4.99). This finding did not persist after adjusting for differences in perceptions of the learning environment, specifically: GS residents had higher odds of mistreatment (OR: 1.99, 95% CI: 1.36-2.90), poorer work-life integration (OR: 2.88, 95% CI: 1.41-5.87), less resident camaraderie (OR: 3.51, 95% CI: 2.26-5.45), and decreased meaning in work (OR: 2.94, 95% CI: 1.80-4.83). Qualitative data provided insight into how the shared learning environment was perceived differently: (1) vascular trainees expressed that early specialization and a smaller, more invested faculty allow for an apprenticeship model with early operative exposure, hands-on guidance, frequent feedback, and thus early skill acquisition (meaning in work); (2) a smaller program is conducive to closer relationships with co-residents and faculty, increasing familiarity (camaraderie and work-life integration); and (3) due to increased familiarity with program leadership, vascular trainees feel more comfortable reporting mistreatment, allowing for prompt responses (mistreatment). CONCLUSIONS: Despite sharing a learning environment, VS and GS residents experience training differently, contributing to differential thoughts of attrition. These differences may be attributable to intrinsic features of the integrated training paradigm that are not easily replicated by GS programs, such as smaller program size and higher faculty investment due to early specialization. Alternative strategies to compensate for these inherent differences should be considered (eg, structured operative entrustment programs and faculty incentivization).

Surgeon Understanding and Perceptions of Social Determinants of Health.

INTRODUCTION: Social determinants of health impact surgical outcomes. Characterization of surgeon understanding of social determinants of health is necessary prior to implementation of interventions to address patient needs. The study objective was to explore understanding, perceived importance, and practices regarding social determinants of health among surgeons. METHODS: Surgical residents and attending surgeons at a single academic medical center completed surveys regarding social determinants of health. We conducted semi-structured interviews to further explore understanding and perceived importance. A conceptual framework from the World Health Organization (WHO) Commission on Social Determinants of Health informed the thematic analysis. RESULTS: Survey response rate was 47.9% (n = 69, 44 residents [63.8%], 25 attendings [36.2%]). Respondents primarily reported good (n = 29, 42.0%) understanding of social determinants of health and perceived this understanding to be very important (n = 42, 60.9%). Documentation occurred seldom (n = 35, 50.7%), and referrals occurred seldom (n = 26, 37.7%) or never (n = 20, 29.0%). Residents reported a higher rate of prior training than attendings (95.5% versus 56.0%, P < 0.001). Ten interviews were conducted (six residents, four attendings). Residents demonstrated greater understanding of socioeconomic positions and hierarchies shaped by structural mechanisms than attendings. Both residents and attendings demonstrated understanding of intermediary determinants of health status and linked social determinants to impacting patients' health and well-being. Specific knowledge gaps were identified regarding underlying structural mechanisms including the social, economic, and political context that influence an individual's socioeconomic position. CONCLUSIONS: Self-reported understanding and importance of social determinants of health among surgeons were high. Interviews revealed gaps in understanding that may contribute to limited practices.

Investigating the 2016 surge in firearm violence in Illinois, USA, through community-based organisations: a qualitative study.

BACKGROUND: Illinois experienced a historic firearm violence surge in 2016 with a decline to baseline rates in 2018. This study aimed to understand this 2016 surge through the direct accounts of violence prevention community-based organisations (CBOs) in Illinois. METHODS: We conducted semistructured interviews with 20 representatives from 13 CBOs from the south and west sides of greater Chicago metropolitan area. Interviews were audio recorded, coded and analysed thematically. RESULTS: We identified lack of government-derived infrastructure and systemic poverty as the central themes of Illinois's 2016 firearm violence surge. Participants highlighted the Illinois Budget Impasse halted funding for violence prevention efforts, leading to 2016's violence. This occurred in the context of a strained relationship with the criminal justice system, where disengagement from police and mistrust in the justice system led victims and families to seek justice outside of the judicial system. Participants emphasised that systemic poverty and the obliteration of community support structures led to overwhelming desperation, which, in turn, increased risky behaviours perceived as necessary for survival. Participants disproportionately identified that this impacted the young people in their communities. CONCLUSIONS: Lack of government-derived infrastructure and systemic poverty were the central themes of the 2016 firearm violence surge. The insights gained from the 2016 surge are applicable to understanding both current and future surges. CBOs focused on violence prevention offer insights into the context and conditions fuelling surges in the epidemic of violence.

Effect of Complementary Interventions to Redesign Care on Teamwork and Quality for Hospitalized Medical Patients : A Pragmatic Controlled Trial.

BACKGROUND: Multiple challenges impede interprofessional teamwork and the provision of high-quality care to hospitalized patients. OBJECTIVE: To evaluate the effect of interventions to redesign hospital care delivery on teamwork and patient outcomes. DESIGN: Pragmatic controlled trial. Hospitals selected 1 unit for implementation of interventions and a second to serve as a control. (ClinicalTrials.gov: NCT03745677). SETTING: Medical units at 4 U.S. hospitals. PARTICIPANTS: Health care professionals and hospitalized medical patients. INTERVENTION: Mentored implementation of unit-based physician teams, unit nurse-physician coleadership, enhanced interprofessional rounds, unit-level performance reports, and patient engagement activities. MEASUREMENTS: Primary outcomes were teamwork climate among health care professionals and adverse events experienced by patients. Secondary outcomes were length of stay (LOS), 30-day readmissions, and patient experience. Difference-in-differences (DID) analyses of patient outcomes compared intervention versus control units before and after implementation of interventions. RESULTS: Among 155 professionals who completed pre- and postintervention surveys, the median teamwork climate score was higher after than before the intervention only for nurses (n = 77) (median score, 88.0 [IQR, 77.0 to 91.0] vs. 80.0 [IQR, 70.0 to 89.0]; P = 0.022). Among 3773 patients, a greater percentage had at least 1 adverse event after compared with before the intervention on control units (change, 1.61 percentage points [95% CI, 0.01 to 3.22 percentage points]). A similar percentage of patients had at least 1 adverse event after compared with before the intervention on intervention units (change, 0.43 percentage point [CI, -1.25 to 2.12 percentage points]). A DID analysis of adverse events did not show a significant difference in change (adjusted DID, -0.92 percentage point [CI, -2.49 to 0.64 percentage point]; P = 0.25). Similarly, there were no differences in LOS, readmissions, or patient experience. LIMITATION: Adverse events occurred less frequently than anticipated, limiting statistical power. CONCLUSION: Despite improved teamwork climate among nurses, interventions to redesign care for hospitalized patients were not associated with improved patient outcomes. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Simultaneous Cannabis and Alcohol Use among Medical Cannabis Patients.

Background: During the past two decades of cannabis legalization, the prevalence of medical cannabis (MC) use has increased and there has also been an upward trend in alcohol consumption. As less restricted cannabis laws generate more adult cannabis users, there is concern that more individuals may be simultaneously using medical cannabis with alcohol. A few studies have examined simultaneous use of medical cannabis with alcohol, but none of those studies also assessed patients' current or previous non-medical cannabis use. This paper explores simultaneous alcohol and medical cannabis use among medical cannabis patients with a specific focus on previous history of cannabis use and current non-medical cannabis use. Methods: A retrospective cohort study of MC patients (N = 319) from four dispensaries located in New York. Bivariate chi-square tests and multivariable logistic regression are used to estimate the extent to which sociodemographic and other factors were associated with simultaneous use. Results: Approximately 29% of the sample engaged in simultaneous use and a large share of these users report previous (44%) or current (66%) use of cannabis for non-medical purposes. MC patients who either previously or currently use cannabis non-medicinally, men, and patients using MC to treat a pain-related condition, were significantly more likely to report simultaneous alcohol/MC use. Conclusions: Findings indicate that there may be differential risks related to alcohol/MC use, which should be considered by cannabis regulatory policies and prevention/treatment programs. If patients are using cannabis and/or alcohol to manage pain, clinicians should screen for both alcohol and cannabis use risk factors.

Mixed Methods Assessment of Incivility During Surgical Mortality and Morbidity Conference.

OBJECTIVE: This study assessed incivility during Mortality and Morbidity (M&M) Conference. BACKGROUND: A psychologically safe environment at M&M Conference enables generative discussions to improve care. Incivility and exclusion demonstrated by "shame and blame" undermine generative discussion. METHODS: We used a convergent mixed-methods design to collect qualitative data through non-participant observations of M&M conference and quantitative data through standardized survey instruments of M&M participants. The M&M conference was attended by attending surgeons (all academic ranks), fellows, residents, medical students on surgery rotation, advanced practice providers, and administrators from the department of surgery. A standardized observation guide was developed, piloted and adapted based on expert non-participant feedback. The Positive and Negative Affect Schedule Short-Form (PANAS) and the Uncivil Behavior in Clinical Nursing Education (UBCNE) survey instruments were distributed to the Department of Surgery clinical faculty and categorical general surgery residents in an academic medical center. RESULTS: We observed 11 M&M discussions of 30 cases, over six months with four different moderators. Case presentations (virtual format) included clinical scenario, decision-making, operative management, complications, and management of the complications. Discussion was free form, without a standard structure. The central theme that limited discussion participation from attending surgeon of record, as well as absence of a systems-approach discussion led to blame and blame then set the stage for incivility. Among 147 eligible to participate in the survey, 54 (36.7%) responded. Assistant professors had a 2.60 higher Negative Affect score (p-value=0.02), a 4.13 higher Exclusion Behavior score (p-value=0.03), and a 7.6 higher UBCNE score (p-value=0.04) compared to associate and full professors. Females had a 2.7 higher Negative Affect Score compared to males (p-value=0.04). CONCLUSION: Free-form M&M discussions led to incivility. Structuring discussion to focus upon improving care may create inclusion and more generative discussions to improve care.

See One, Do One, Improve One's Wellness: Resident Autonomy in US General Surgery Programs, A Mixed-methods Study.

OBJECTIVE: We sought to examine the factors associated with resident perceptions of autonomy and to characterize the relationship between resident autonomy and wellness. BACKGROUND: Concerns exist that resident autonomy is decreasing, impacting competence. METHODS: Quantitative data were collected through a cross-sectional survey administered after the 2020 ABSITE. Qualitative data were collected through interviews and focus groups with residents and faculty at 15 programs. RESULTS: Seven thousand two hundred thirty-three residents (85.5% response rate) from 324 programs completed the survey. Of 5139 residents with complete data, 4424 (82.2%) reported appropriate autonomy, and these residents were less likely to experience burnout [odds ratio (OR) 0.69; 95% CI 0.58-0.83], suicidality (OR 0.69; 95% CI 0.54-0.89), and thoughts of leaving their programs (OR 0.45; 95% CI 0.37-0.54). Women were less likely to report appropriate autonomy (OR 0.81; 95% CI 0.68-0.97). Residents were more likely to report appropriate autonomy if they also reported satisfaction with their workload (OR 1.65; 95% CI 1.28-2.11), work-life balance (OR 2.01; 95% CI 1.57-2.58), faculty engagement (OR 3.55; 95% CI 2.86-4.35), resident camaraderie (OR 2.23; 95% CI, 1.78-2.79), and efficiency and resources (OR 2.37; 95% CI 1.95-2.88). Qualitative data revealed that (1) autonomy gives meaning to the clinical experience of residency, (2) multiple factors create barriers to autonomy, and (3) autonomy is not inherent to the training paradigm, requiring residents to learn behaviors to "earn" it. CONCLUSION: Autonomy is not considered an inherent part of the training paradigm such that residents can assume that they will achieve it. Resources to function autonomously should be allocated equitably to support all residents' educational growth and wellness.

Is the Implementation of an Interprofessional Communication Smart Phone Application Associated With Improved Survival Among Critically Ill Surgical Patients?

INTRODUCTION: Patients admitted to intensive care units (ICUs) have high rates of mortality and morbidity. Improved communication between providers within ICUs may reduce morbidity. The goal of this study is to leverage a natural experiment of the temporally staggered implementation of a smart phone application for interprofessional communication to quantify the association with postoperative mortality and morbidity among critically ill surgical patients. METHODS: We conducted an observational case-control study and utilized a difference-in-difference model to determine the impact of temporally staggered implementation of an interprofessional communication smart phone application on mortality, postoperative hyperglycemia, malnutrition, venous thromboembolism (VTE), and surgical site infections. Our study included patients who underwent surgical procedures and were admitted to the ICU at one of three hospitals (one academic medical center, hospital A, and two community hospitals, hospitals B and C) in a single health system between March 2018 and April 2021. RESULTS: Our cohort consisted of 1457 patients, of which 1174 were hospitalized at hospital A and 283 at hospitals B and C. In the full cohort, 80 (5.6%) patients died during ICU admission. Difference-in-difference analysis demonstrated a relative difference in mortality of 4.8% [1.1%-8.5%] (P = 0.04) at hospitals B and C compared to hospital A after the implementation of the application. Our model demonstrated a 2.5% difference in VTEs [1.1%-3.8%], P = 0.03. There were no significant reductions in hyperglycemia, malnutrition, or surgical site infection. CONCLUSIONS: The implementation of an interprofessional communication smart phone application is associated with reduced mortality and VTE incidence among critically ill surgical patients across three diverse hospitals.

Pediatric Patient and Caregiver Agreement on Perioperative Expectations and Self-Reported Outcomes.

INTRODUCTION: Alignment between pediatric patients and caregiver perspectives on patient-reported outcome (PRO) data is contingent upon context. We aimed to assess agreement between patient and caregiver responses to a series of perioperative domains. METHODS: Agreement between pediatric patients and caregiver responses to preoperative and postoperative surveys about surgery preparedness, perioperative expectations, PRO Measurement Information System (PROMIS) measures for overall health and pain, and reaching milestones gathered as part of an ongoing clinical trial for children undergoing gastrointestinal surgery, was evaluated. Gwet's AC and Spearman's correlation coefficients were calculated, as appropriate, to assess agreement. RESULTS: Of 209 enrolled patients, 65 (31.1%) dyads completed all three surveys and were included. For the domains of education, expectations, and comprehension, patients and caregivers had good agreement with Gwet AC1 with values of 0.80, 0.61, and 0.64, respectively. For milestones, patients and caregivers had very good agreement (Gwet AC1 of 0.95). Milestones measured whether patients achieved certain goals within a prespecified time, including enteral intake (Gwet AC1 0.91 and 0.92 respectively), transition to oral pain medication (Gwet AC1 0.94), ambulation (Gwet AC1 1.00), and return of bowel function (Gwet AC1 0.97). There was moderate to strong agreement between patients and caregivers on PROMIS pain questions (Spearman's correlation: 0.71 preoperatively and 0.51 postoperatively). On PROMIS global health questions, there was strong agreement (0.69 preoperatively and 0.65 postoperatively). CONCLUSIONS: Pediatric patient and caregiver agreement on perioperative survey items ranged from moderate to strong. Caregivers' responses may be acceptable when some patient-level responses are not available.

Barriers and Facilitators to Implementing Patient-Reported Outcome Monitoring in Gastrointestinal Surgery.

INTRODUCTION: More than 30% of patients experience complications after major gastrointestinal (GI) surgery, many of which occur after discharge when patients and families must assume responsibility for monitoring. Patient-reported outcomes (PROs) have been proposed as a tool for remote monitoring to identify deviations in recovery, and recognize and manage complications earlier. This study's objective was to characterize barriers and facilitators to the use of PROs as a patient monitoring tool following GI surgery. METHODS: We conducted semistructured interviews with GI surgery patients and clinicians (surgeons, nurses, and advanced practitioners). Patients and clinicians were asked to describe their experience using a PRO monitoring system in three surgical oncology clinics. Using a phenomenological approach, research team dyads independently coded the transcripts using an inductively developed codebook and the constant comparative approach with differences reconciled by consensus. RESULTS: Ten patients and five clinicians participated in the interviews. We identified four overarching themes related to functionality, workflow, meaningfulness, and actionability. Functionality refers to barriers faced by clinicians and patients in using the PRO technology. Workflow represents problematic integration of PROs into the clinical workflow and need for setting expectations with patients. Meaningfulness refers to lack of patient and clinician understanding of the impact of PROs on patient care. Finally, actionability reflects barriers to follow-up and practical use of PRO data. CONCLUSIONS: While use of PRO systems for postoperative patient monitoring have expanded, significant barriers persist for both patients and clinicians. Implementation enhancements are needed to optimize functionality, workflow, meaningfulness, and actionability.

Evaluation of emergency department treat-and-release encounters after major gastrointestinal surgery.

BACKGROUND AND OBJECTIVES: Emergency department (ED) utilization after gastrointestinal cancer operations is poorly characterized. Our study objectives were to determine the incidence of, reasons for, and predictors of ED treat-and-release encounters after gastrointestinal cancer operations. METHODS: Patients who underwent elective esophageal, hepatobiliary, gastric, pancreatic, small intestinal, or colorectal operations for cancer were identified in the 2015-2017 Healthcare Cost and Utilization Project State Inpatient and State Emergency Department Databases for New York, Maryland, and Florida. The primary outcomes were the incidence of ED treat-and-release encounters and readmissions within 30 days of discharge. RESULTS: Among 51 527 patients at 406 hospitals, 4047 (7.9%) had an ED treat-and-release encounter, and 5573 (10.8%) had an ED encounter with readmission. In total, 40.7% of ED encounters were treat-and-release encounters. ED treat-and-release encounters were most frequently for pain (12.0%), device/ostomy complaints (11.7%), or wound complaints (11.4%). ED treat-and-release encounters predictors included non-Hispanic Black race/ethnicity (odds ratio [OR] 1.24, 95% confidence interval [CI] 1.12-1.37) and Medicare (OR 1.27, 95% CI 1.16-1.40) or Medicaid (OR 1.82, 95% CI 1.62-2.40) coverage. CONCLUSIONS: ED treat-and-release encounters are common after major gastrointestinal operations, making up nearly half of postdischarge ED encounters. The reasons for ED treat-and-release encounters differ from those for ED encounters with readmissions.

Age- and Sex-Specific Needs for Children Undergoing Inflammatory Bowel Disease Surgery: A Qualitative Study.

INTRODUCTION: The use of enhanced recovery protocols (ERP) is extending to pediatric surgical populations, such as patients with inflammatory bowel diseases (IBDs). Given the variation in age- and sex-specific characteristics of pediatric IBD patients, it is important to understand the unique needs of subgroups, such as male versus female or preadolescent versus older patients, when implementing ERPs. We gathered clinician, patient, and caregiver perspectives on age- and sex-specific needs for children undergoing IBD surgery. METHODS: We used semistructured interviews and focus groups to assess ERP needs and perceived differences in needs between preadolescent (10-13 y), older (14-19 y), male, and female IBD patients. Participants included clinicians, patients who had recent IBD surgery, and patients' caregivers. RESULTS: Forty-eight clinicians, six patients, and eight caregivers participated. Three broad categories of themes emerged: concerns, needs, and experiences related to the (1) surgical care process; (2) continuum of IBD care; and (3) suggestions to make surgical care more patient centered. With regard to surgical care processes, stakeholders reported different communication needs for preadolescent and older children. Key themes about the continuum of IBD care were the need (1) for support from child life specialists and (b) to address young women's health issues. Suggestions to make surgical care more patient centered included providing older children with patient experiences that reflect their perspective as young adults. CONCLUSIONS: The findings highlight the need to adopt a patient-centered approach for ERP use that actively addresses age- and sex-specific factors while engaging patients and caregivers as partners with clinicians to improve surgical care for children with IBD.

Effect of COVID-19 on the implementation of a multifaceted intervention to improve teamwork and quality for hospitalized patients: a qualitative interview study.

BACKGROUND: Healthcare organizations made major adjustments to deliver care during the COVID pandemic, yet little is known about how these adjustments shaped ongoing quality and safety improvement efforts. We aimed to understand how COVID affected four U.S. hospitals' prospective implementation efforts in an ongoing quality improvement initiative, the REdesigning SystEms to Improve Teamwork and Quality for Hospitalized Patients (RESET) project, which implemented complementary interventions to redesign systems of care for medical patients. METHODS: We conducted individual semi-structured interviews with 40 healthcare professionals to determine how COVID influenced RESET implementation. We used conventional qualitative content analysis to inductively code transcripts and identify themes in MAXQDA 2020. RESULTS: We identified three overarching themes and nine sub-themes. The three themes were (1) COVID exacerbated existing problems and created new ones. (2) RESET and other quality improvement efforts were not the priority during the pandemic. (3) Fidelity of RESET implementation regressed. CONCLUSION: COVID had a profound impact on the implementation of a multifaceted intervention to improve quality and teamwork in four hospitals. Notably, COVID led to a diversion of attention and effort away from quality improvement efforts, like RESET, and sites varied in their ability to renew efforts over time. Our findings help explain how COVID adversely affected hospitals' quality improvement efforts throughout the pandemic and support the need for research to identify elements important for fostering hospital resilience.

Health Care Providers' and Professionals' Experiences With Telehealth Oncology Implementation During the COVID-19 Pandemic: A Qualitative Study.

BACKGROUND: Rapid implementation of telehealth for cancer care during COVID-19 required innovative and adaptive solutions among oncology health care providers and professionals (HPPs). OBJECTIVE: The aim of this qualitative study was to explore oncology HPPs' experiences with telehealth implementation during the COVID-19 pandemic. METHODS: This study was conducted at Moffitt Cancer Center (Moffitt), an NCI (National Cancer Institute)-Designated Comprehensive Cancer Center. Prior to COVID-19, Moffitt piloted telehealth visits on a limited basis. After COVID-19, Moffitt rapidly expanded telehealth visits. Telehealth visits included real-time videoconferencing between HPPs and patients and virtual check-ins (ie, brief communication with an HPP by telephone only). We conducted semistructured interviews with 40 oncology HPPs who implemented telehealth during COVID-19. The interviews were recorded, transcribed verbatim, and analyzed for themes using Dedoose software (version 4.12). RESULTS: Approximately half of the 40 participants were physicians (n=22, 55%), and one-quarter of the participants were advanced practice providers (n=10, 25%). Other participants included social workers (n=3, 8%), psychologists (n=2, 5%), dieticians (n=2, 5%), and a pharmacist (n=1, 3%). Five key themes were identified: (1) establishing and maintaining patient-HPP relationships, (2) coordinating care with other HPPs and informal caregivers, (3) adapting in-person assessments for telehealth, (4) developing workflows and allocating resources, and (5) future recommendations. Participants described innovative strategies for implementing telehealth, such as coordinating interdisciplinary visits with multiple HPPs and inviting informal caregivers (eg, spouse) to participate in telehealth visits. Health care workers discussed key challenges, such as workflow integration, lack of physical exam and biometric data, and overcoming the digital divide (eg, telehealth accessibility among patients with communication-related disabilities). Participants recommended policy advocacy to support telehealth (eg, medical licensure policies) and monitoring how telehealth affects patient outcomes and health care delivery. CONCLUSIONS: To support telehealth growth, implementation strategies are needed to ensure that HPPs and patients have the tools necessary to effectively engage in telehealth. At the same time, cancer care organizations will need to engage in advocacy to ensure that policies are supportive of oncology telehealth and develop systems to monitor the impact of telehealth on patient outcomes, health care quality, costs, and equity.

Genetically determined NLRP3 inflammasome activation associates with systemic inflammation and cardiovascular mortality.

AIMS: Inflammation plays an important role in cardiovascular disease (CVD) development. The NOD-like receptor protein-3 (NLRP3) inflammasome contributes to the development of atherosclerosis in animal models. Components of the NLRP3 inflammasome pathway such as interleukin-1ß can therapeutically be targeted. Associations of genetically determined inflammasome-mediated systemic inflammation with CVD and mortality in humans are unknown. METHODS AND RESULTS: We explored the association of genetic NLRP3 variants with prevalent CVD and cardiovascular mortality in 538 167 subjects on the individual participant level in an explorative gene-centric approach without performing multiple testing. Functional relevance of single-nucleotide polymorphisms on NLRP3 inflammasome activation has been evaluated in monocyte-enriched peripheral blood mononuclear cells (PBMCs). Genetic analyses identified the highly prevalent (minor allele frequency 39.9%) intronic NLRP3 variant rs10754555 to affect NLRP3 gene expression. rs10754555 carriers showed significantly higher C-reactive protein and serum amyloid A plasma levels. Carriers of the G allele showed higher NLRP3 inflammasome activation in isolated human PBMCs. In carriers of the rs10754555 variant, the prevalence of coronary artery disease was significantly higher as compared to non-carriers with a significant interaction between rs10754555 and age. Importantly, rs10754555 carriers had significantly higher risk for cardiovascular mortality during follow-up. Inflammasome inducers (e.g. urate, triglycerides, apolipoprotein C3) modulated the association between rs10754555 and mortality. CONCLUSION: The NLRP3 intronic variant rs10754555 is associated with increased systemic inflammation, inflammasome activation, prevalent coronary artery disease, and mortality. This study provides evidence for a substantial role of genetically driven systemic inflammation in CVD and highlights the NLRP3 inflammasome as a therapeutic target.

Racial disparities in survival outcomes among breast cancer patients by molecular subtypes.

PURPOSE: Differences in tumor biology, genomic architecture, and health care delivery patterns contribute to the breast cancer mortality gap between White and Black patients in the US. Although this gap has been well documented in previous literature, it remains uncertain how large the actual effect size of race is for different survival outcomes and the four breast cancer subtypes. METHODS: We established a breast cancer patient cohort at the University of Chicago Comprehensive Cancer Center. We chose five major survival outcomes to study: overall survival, recurrence-free survival, breast-cancer-specific survival, time-to-recurrence and post-recurrence survival. Cox proportional hazards models were used to estimate the hazard ratios between Black and White patients, adjusting for selected patient, tumor, and treatment characteristics, and also stratified by the four breast cancer subtypes. RESULTS: The study included 2795 stage I-III breast cancer patients (54% White and 38% Black). After adjusting for selected patient, tumor and treatment characteristics, Black patients still did worse than White patients in all five survival outcomes. The racial difference was highest within the HR-/HER2+ subgroup, in both overall survival (hazard ratio = 4.00, 95% CI 1.47-10.86) and recurrence-free survival (hazard ratio = 3.00, 95% CI 1.36-6.60), adjusting for age at diagnosis, cancer stage, and comorbidities. There was also a significant racial disparity within the HR+/HER2- group in both overall survival and recurrence-free survival. CONCLUSIONS: Our study confirmed that racial disparity existed between White and Black breast cancer patients in terms of both survival and recurrence, and found that this disparity was largest among HR-/HER2+ and HR+/HER2- patients.

Determining the potential clinical value of panel-based pharmacogenetic testing in patients with chronic pain or gastroesophageal reflux disease.

We aimed to determine the potential value of panel-based pharmacogenetic (PGx) testing in patients with chronic pain or gastroesophageal reflux disease (GERD) who underwent single-gene PGx testing to guide opioid or proton pump inhibitor (PPI) therapy, respectively. Of 448 patients included (chronic pain, n = 337; GERD, n = 111), mean age was 57 years, 68% were female, and 73% were white. Excluding opiates for the pain cohort and PPIs for the GERD cohort, 76.6% of patients with pain and 71.2% with GERD were prescribed at least one additional medication with a high level of PGx evidence, most commonly ondansetron or selective serotonin reuptake inhibitors. The most common genes that could inform PGx drug prescribing were CYP2C19, CYP2D6, CYP2C9, and SLCO1B1. Our findings suggest that patients with chronic pain or GERD are commonly prescribed drugs with a high level of evidence for a PGx-guided approach, supporting panel-based testing in these populations.

A hybrid implementation-effectiveness randomized trial of CYP2D6-guided postoperative pain management.

PURPOSE: Cytochrome P450 2D6 (CYP2D6) genotype-guided opioid prescribing is limited. The purpose of this type 2 hybrid implementation-effectiveness trial was to evaluate the feasibility of clinically implementing CYP2D6-guided postsurgical pain management and determine that such an approach did not worsen pain control. METHODS: Adults undergoing total joint arthroplasty were randomized 2:1 to genotype-guided or usual pain management. For participants in the genotype-guided arm with a CYP2D6 poor (PM), intermediate (IM), or ultrarapid (UM) metabolizer phenotype, recommendations were to avoid hydrocodone, tramadol, codeine, and oxycodone. The primary endpoints were feasibility metrics and opioid use; pain intensity was a secondary endpoint. Effectiveness outcomes were collected 2 weeks postsurgery. RESULTS: Of 282 patients approached, 260 (92%) agreed to participate. In the genotype-guided arm, 20% had a high-risk (IM/PM/UM) phenotype, of whom 72% received an alternative opioid versus 0% of usual care participants (p < 0.001). In an exploratory analysis, there was less opioid consumption (200 [104-280] vs. 230 [133-350] morphine milligram equivalents; p = 0.047) and similar pain intensity (2.6 ± 0.8 vs. 2.5 ± 0.7; p = 0.638) in the genotype-guided vs. usual care arm, respectively. CONCLUSION: Implementing CYP2D6 to guide postoperative pain management is feasible and may lead to lower opioid use without compromising pain control.

Multisite investigation of strategies for the clinical implementation of pre-emptive pharmacogenetic testing.

PURPOSE: The increased availability of clinical pharmacogenetic (PGx) guidelines and decreasing costs for genetic testing have slowly led to increased utilization of PGx testing in clinical practice. Pre-emptive PGx testing, where testing is performed in advance of drug prescribing, is one means to ensure results are available at the time of prescribing decisions. However, the most efficient and effective methods to clinically implement this strategy remain unclear. METHODS: In this report, we compare and contrast implementation strategies for pre-emptive PGx testing by 15 early-adopter institutions. We surveyed these groups, collecting data on testing approaches, team composition, and workflow dynamics, in addition to estimated third-party reimbursement rates. RESULTS: We found that while pre-emptive PGx testing models varied across sites, institutions shared several commonalities, including methods to identify patients eligible for testing, involvement of a precision medicine clinical team in program leadership, and the implementation of pharmacogenes with Clinical Pharmacogenetics Implementation Consortium guidelines available. Finally, while reimbursement rate data were difficult to obtain, the data available suggested that reimbursement rates for pre-emptive PGx testing remain low. CONCLUSION: These findings should inform the establishment of future implementation efforts at institutions considering a pre-emptive PGx testing program.