Aurora Health Care

Background In 2008, bevacizumab received accelerated Food and Drug Administration (FDA) approval for use in human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Based on the preclinical and preliminary clinical activity of the trastuzumab and bevacizumab combination, ECOG-ACRIN E1105 trial was developed to determine if the addition of bevacizumab to a chemotherapy and trastuzumab combination for first-line therapy would improve progression-free survival (PFS) in patients with HER2-positive MBC. Findings 96 patients were randomized to receive standard first-line chemotherapy and trastuzumab with or without bevacizumab between November 2007 and October 2009, and 93 began protocol therapy. Induction therapy was given for 24 weeks, followed by maintenance trastuzumab with or without bevacizumab. 60% (56/93) began carboplatin and 74% (69/93) completed 6 cycles of induction therapy. Primary endpoint was PFS. Median PFS was 11.1 and 13.8 months for placebo and bevacizumab arms, respectively (hazard ratio [HR] 95%, Confidence Interval [Cl] for bevacizumab vs. placebo: 0.73 [0.43–1.23], p = 0.24), and at a median follow-up of 70.7 months, median survival was 49.1 and 63 months (HR [95% Cl] for OS: 1.09 [0.61–1.97], p = 0.75). The most common toxicities across both arms were neutropenia and hypertension, with left ventricular systolic dysfunction, fatigue, and sensory neuropathy reported more frequently with bevacizumab. Conclusions In this trial, the addition of bevacizumab did not improve outcomes in patients with metastatic HER2-positive breast cancer. Although the trial was underpowered due to smaller than anticipated sample size, these findings corroborated other clinical trials during this time.

Jordan performed the Middle East’s first living-donor kidney transplant in 1972. In 1977, the country became one of the first Arab countries to regulate organ donation and transplantation. Despite these early advances in living donor transplantation, Jordan’s organ donation after brain death program remains inactive, making it challenging to meet organ demand and placing many patients on long transplant waiting lists. As of 2020, only 14.2% of the patients with end-stage kidney disease have access to a living donor. The scarcity of compatible living donors exacerbates Jordan’s organ shortage, leaving patients with extended waits and uncertain transplant prospects. Due to the lack of living donors and the inactive brain death donation program, additional options are needed to meet organ demand. Kidney paired exchange (KPE), emerges as a potential solution to the problem of donor shortage and donor-recipient incompatibility. By allowing living donors to direct their donated organs to different compatible recipients, KPE offers the promise of expanding transplant opportunities for patients without suitable living donors. However, the current Jordanian law restricting living kidney donation to fifth-degree relatives further limits the pool of potential donors, aggravating the organ shortage situation. This article explores the feasibility of implementing KPE in Jordan and proposes an approach to implementing KPE in Jordan, considering ethical and legal aspects to substantially increase kidney transplants.

Background High quality supportive care is fundamental to achieve optimal health outcomes for people affected by cancer. Use of quality indicators provides comparative information for monitoring, management, and improvement of care within and across healthcare systems. The aim of this Australian study was to develop and test a minimum viable set of cancer supportive care quality indicators that would be feasible to implement and generate usable data for policy and practice. Methods A two-round, modified reactive Delphi process was employed firstto develop the proposed indicators. Participants with expertise in cancer control in Australia, the United Kingdom, and Canada rated their level of agreement on a 7-point Likert scale against criteria assessing the importance, feasibility, and usability of proposed indicators. Relative response frequencies were assessed against pre-specified consensus criteria and a ranking exercise, which delivered the list of proposed indicators. Draft indicators were then presented to a purposive sample of clinicial and health management staff via qualitative interviews at two acute care settings in Melbourne, Australia for feedback regarding feasibility. Desktop audits of online published health service policy and practice descriptions were also conducted at participating acute care settings to confirm health service data availability and feasibility of collection to report against proposed indicators. Results Sixteen quality indicators associated with the delivery of quality cancer supportive care in Australian acute healthcare settings met pre-specified criteria for inclusion. Indicators deemed ‘necessary’ were mapped and ranked across five key categories: Screening, Referrals, Data Management, Communication and Training, and Culturally Safe and Accessible Care. Testing confirmed indicators were viewed as feasible by clinical and health management staff, and desktop audits could provide a fast and reasonably effective method to assess general adherence and performance. Conclusions The development of quality indicators specific to cancer supportive care provides a strong framework for measurement and monitoring, service improvement, and practice change with the potential to improve health outcomes for people affected by cancer. Evaluation of implementation feasibility of these expert consensus generated quality indicators is recommended.

PURPOSE Cyclin-dependent kinase (CDK) 4/6 inhibitors (CDK4/6is) are an important component of treatment for hormone receptor–positive/human epidermal growth factor receptor 2–negative (HER2–) metastatic breast cancer (MBC), but it is not known if patients might derive benefit from continuation of CDK4/6i with endocrine therapy beyond initial tumor progression or if the addition of checkpoint inhibitor therapy has value in this setting. METHODS The randomized multicenter phase II PACE trial enrolled patients with hormone receptor–positive/HER2– MBC whose disease had progressed on previous CDK4/6i and aromatase inhibitor (AI) therapy. Patients were randomly assigned 1:2:1 to receive fulvestrant (F), fulvestrant plus palbociclib (F + P), or fulvestrant plus palbociclib and avelumab (F + P + A). The primary end point was investigator-assessed progression-free survival (PFS) in patients treated with F versus F + P. RESULTS Overall, 220 patients were randomly assigned between September 2017 and February 2022. The median age was 57 years (range, 25-83 years). Most patients were postmenopausal (80.9%), and 40% were originally diagnosed with de novo MBC. Palbociclib was the most common previous CDK4/6i (90.9%). The median PFS was 4.8 months on F and 4.6 months on F + P (hazard ratio [HR], 1.11 [90% CI, 0.79 to 1.55]; P = .62). The median PFS on F + P + A was 8.1 months (HR v F, 0.75 [90% CI, 0.50 to 1.12]; P = .23). The difference in PFS with F + P and F + P + A versus F was greater among patients with baseline ESR1 and PIK3CA alterations. CONCLUSION The addition of palbociclib to fulvestrant did not improve PFS versus fulvestrant alone among patients with hormone receptor–positive/HER2– MBC whose disease had progressed on a previous CDK4/6i plus AI. The increased PFS seen with the addition of avelumab warrants further investigation in this patient population.

Background The challenge of surgical treatment of hindfoot collapse can be exacerbated by host conditions that may limit healing potential and increase the risk of infection. Many patients with neuropathy, Charcot joint, or end-stage arthritis that undergo tibiotalocalcaneal (TTC) fusion with bulk allograft progress to nonunion and often require amputation. 3D-printed titanium implants provide benefits that may improve outcomes of limb salvage within this population, but long-term outcomes of these implants have not yet been reported, given their relatively recent development. This study reports mid-term outcomes of patients with Charcot arthropathy or end-stage arthritis who received 3D-printed titanium cage and dynamic hindfoot fusion nail combination fixation for limb salvage. Methods This study was a retrospective review of consecutive patients who underwent hindfoot arthrodesis with a combination of patient-specific 3D-printed titanium cage and dynamic hindfoot fusion nail by a single surgeon at a single institution. The primary outcome was to establish the safety of the 3D-printed cage in a medically complicated population. Medical records were reviewed for adverse events, including subsequent surgical intervention and implant survivorship. The secondary outcome was to evaluate the efficacy of the 3D-printed cage, as evaluated by patient-reported pre- and post-operative 11-point Numeric Rating Scale (NRS) pain score, ambulation status, and satisfaction. Deformity correction was evaluated by radiograph. Descriptive statistics were calculated, and a Kaplan-Meier curve of all-cause reoperation was produced. Results This study evaluated 13 cases with at least one year follow-up. Mean follow-up was 3.72 years (range 2.67–4.60 years). As of the most recent follow-up, 11 of 13 cages remain implanted, with two cages having been explanted in the setting of amputations indicated by conditions unrelated to the cage itself. Patients reported a mean pre-operative NRS pain of 6.6 ± 2.9 points. At the last follow-up, mean NRS pain was 2.0 ± 1.7 points. Pre-operatively, six of 13 patients reported the ability to ambulate independently without an assistive device. Post-operatively, 11 of 13 patients were able to ambulate independently. Conclusion This study reports mid-term outcomes of TTC arthrodesis with a patient-specific 3D-printed titanium cage and dynamic intramedullary nail in patients with Charcot arthropathy or non-traumatic arthritis. The results demonstrate no implant-related complications and promising outcomes in terms of fusion, deformity correction, and patient satisfaction, which are especially remarkable in the setting of Charcot arthropathy. While this data is promising as a technique for limb salvage in this patient population, further experimental studies are required to demonstrate superiority. Level of Evidence: Level IV

Aim: Understanding factors that shape leading health systems' (LHS) perspectives around heart failure (HF) treatment. Patients & methods: First of its kind study using a cross-sectional, descriptive, mixed-method design (from executives and frontline healthcare providers) with quantitative survey (n = 35) and qualitative interview (n = 12) data from 47 participants (41 different LHS). Results: 97% of LHS had dedicated HF programs, but variations in maturity highlights opportunities for care standardization. Treatment innovations continue, though practitioners may struggle to keep pace amid provider/patient barriers. HF programs strive to co-locate supportive care services to optimize treatment, but access can prove challenging. Conclusion: Opportunities exist, with external partner support, for LHS to become more comprehensive HF care providers, increasing standardization of care across LHS and improved HF treatment.

Pembrolizumab leads to a durable response in ultra-hypermutated, high-grade, glioma.

In the United States, primary care clinicians (PCPs) typically diagnose and treat most patients who have or who may be developing neurocognitive disorders (NCDs). However, as many as two‐thirds of patients remain underdiagnosed, misdiagnosed or experience a delay in the diagnosis. Many barriers to care have been cited for these failures in diagnosis, including PCP limitations in time and expertise, as well as inadequate technical, financial, and staffing resources. Diagnostic delays may particularly impact minority populations, exacerbating the disparate burden these communities bear from dementing disorders. In contrast, an early diagnosis is an impetus to advanced care planning, to strategizing for patient safety, and to initiating interventions that may preserve cognitive function and enhance quality of life. The main objective for this proposal is to increase the rate of cognitive screening in patients 65 years and older. PCP practices that serve diverse communities are early implementation sites. This proposal focuses on addressing barriers to testing by providing PCPs with educational resources to enhance the efficiency and quality of care for patients with neurocognitive disorders. The goal is to educate PCPs on the importance of early cognitive screening and to provide tools to help manage their patients with cognitive disorders and dementia more efficiently. Primary care providers are offered multiple educational and practice supports for managing patients who have an abnormal cognitive screen. The BrainCheck digital cognitive testing tool allows clinical support staff to rapidly test patients for cognitive impairment. Educational tools include succinct didactic lectures; a SharePoint site that serves as a resource hub for and weekly Project ECHO® based Memory Care Case Conferences (CME provided). EHR tools include simple order sets and templates. The practice support tool is an implementation of eConsults to quickly link PCPs to dementia experts in order to answer questions about patient care. The outcomes of this project measured in terms of PCP feedback, cognitive testing gains, educational participation, and tool usage will allow us to design more effective strategies for increasing cognitive testing and improving the management of patients with dementia at the health system level.

Background: Cardiac rehabilitation (CR) is underutilized despite demonstrated improvement to quality of life and mortality for patients with cardiovascular disease (CVD) patients. As a part of an ongoing study among an underserved urban population to improve participation in CR alongside a mobile application (app) to encourage healthful habits, we assessed CR and app perceptions among participants. Methods: We conducted in-depth open-ended interviews with a sample of patients with low socioeconomic status at Denver Health, an urban safety-net hospital with generally racially and ethnically diverse patients. We transcribed interviews and performed content analysis to identify themes. Study staff trained in qualitative methods interviewed patients on thevia phone with the goal of understanding their perceptions of CR and app use. We transcribed interviews and performed content analysis to identify themes. Results: Among 19 interviews (6 female), all patients enjoyed CR, especially the interaction with CR staff. Four patients self-identified as non-app users (1 female) vs. 15 users (5 female). Users were aged 55 years old (SD 10.4) on average, versus 66.5 years old (SD 3.4 years) among non-users. Overall 18/19 interviewees were below the poverty line in Denver for a single income household (Table). Non-users expressed reluctance around technology, and one could not recall training on app use by research study staff though they had generally higher educational status. Users identified communication with CR staff via the app as the most useful feature. Conclusion: Overall, patients liked CR, and most identified themselves as app users. Users appreciated education about healthy diet, and the ability to interact with CR staff. App users were surprisingly of lower educational status, but similar income backgrounds. This may suggest that older users among a vulnerable population require more support in accessing mobile interventions despite educational status.

Introduction: Left bundle branch area pacing (LBBAP) is a type of conduction system pacing that has been considered as an alternative to biventricular pacing (BVP) in patients requiring cardiac resynchronization therapy (CRT). Hypothesis: We performed a meta-analysis comparing the clinical and echocardiographic outcomes between LBBAP and BVP in patients requiring CRT. Methods: We performed a systematic literature review in Embase, PubMed, and SCOPUS for all the related articles until November 2022. The literature search yielded 44 publications, of which 6 studies fulfilled the inclusion criteria. The Inverse Variance random effects model was used for continuous variables to calculate Mean Difference (MD) and 95% confidence intervals (CI) and Mantel- Haenszel random effects model was used for dichotomous variables to calculate odds ratio (OR) and 95% confidence intervals (CI). Outcomes analyzed were changed in left ventricle ejection fraction (LVEF), left ventricle end-diastolic dimension (LVEDD), NYHA class, and QRS duration and patients with the echocardiographic response (as defined as LVEF improvement >5%) and heart failure hospitalizations. Results: Over a mean follow up of 8+/-2 months, LBBAP when compared to BVP resulted in significant difference in LVEF improvement (MD = 5.78 % (95% CI [4.75%, 6.80%], P<0.00001), QRS duration reduction (MD = -24.77 ms) (95% CI [-32.78, -16.77], P<0.00001), NYHA class reduction (MD = -0.43, 95% CI [-0.78, -0.08], P=0.02) and number of patients with echocardiographic response (OR = 2.94, 95% CI [1.40-6.14], P=0.004) at follow up. There was no significant difference in LVEDD reduction (MD = -0.5 mm, 95% CI [-3.36, 2.37], P=0.73) and HF hospitalization rates (OR = 0.42, 95% CI [0.11-1.61], P=0.21) between the 2 groups. Conclusions: LBBAP is an effective alternative to BVP in patients with an indication for CRT.

Introduction: Nudges are simple messages designed to elicit behavior change. In a multi-center pragmatic clinical trial, we embedded nudge messages into short message service texts (SMS) to encourage patients to refill medications to improve medication adherence. In this study, we assessed patient perceptions of the nudge messages. Methods: We conducted in-depth, open-ended interviews with a sample of English and Spanish speaking patients with cardiovascular disease and documented medication refill gaps enrolled in the clinical trial from a tertiary care academic center, UCHealth, and an urban safety-net hospital, Denver Health. We transcribed interviews and performed content analysis to identify themes. Patients were interviewed about their experiences over the phone using interview guides and perceptions of the nudge messages. Content analysis was done by a trained reviewer to identify themes. Results: Among 12 interviews (4 in Spanish), all appreciated the nudge messages, even though some had successful systems to remind them of medications already. All patients interviewed had no concerns about the messages because they were discreet and respected patient privacy. Some patients felt the health system was caring for them by sending messages. Suggestions for improvement included: 1) medications instructions, such as whether to take them with food; 2) dietary education; and 3) reminders for taking medication in the middle of the day, the doses that were more likely to be missed. Despite liking the messages, most self-reported no change in their medication taking behavior due to reminders they had set up themselves. They did, however, appreciate the nudge messages, and a few patients stated that the messages helped them ‘stay on track’ with refills. Conclusions: Patients appreciated the nudge messages that encouraged them to pick up medication, and generally felt supported by the healthcare system in receiving them. Most patients had no suggestions for improving the nudges. Self-reported behavior change in taking medications was low, though patients’ statements suggested the messages were still helpful with refills. True behavior change will be revealed in the final quantitative analysis of the trial.

374 Background: Timely initiation of subsequent oral chemotherapy cycles for hematologic malignancies is essential as delays can lead to suboptimal treatment and provider and patient confusion. Between July 1, 2022, and January 31, 2023, we identified a mean 59% of patients with hematologic malignancies who were prescribed oral chemotherapy at our practice began cycle 2 or cycle 3 on time. Methods: A multidisciplinary team applied quality improvement methodologies and tools, taught by ASCO Quality Training Program, to improve the processes associated with providing timely cycles of oral chemotherapy. By using the Model for Improvement, process map development, brainstorming, affinity sorting, fishbone diagram, pareto charts, and prioritization matrices, an aim was established, and improvement focus was narrowed. We aimed to increase timely initiation of cycle 2 or cycle 3 oral chemotherapy prescribed in our practice to an average > 90%. The following outcome measure was developed based on an internal benchmark to define improvement: on-time cycle 2 or cycle 3 oral chemotherapy documented initiation defined as being within 3 days before or after the anticipated cycle start date for patients within our practice site. We designed multiple small-scale tests of change to minimize issues including creation of a pharmacist-generated communication process for admitted patients on oral chemotherapy followed by our practice and enhancement of process education resources. Using the Plan Do Study Act (PDSA) Cycle, process measures were developed to identify whether interventions were performed as planned and measure how the system reacted to change over time. Change management is equally important to testing or implementing change. To protect psychological safety and minimize distractions, we encouraged in-person meetings with established ground rules. Agenda goal, problem, and aim statements were displayed as visual reminders. Results: Between February 1, 2023, and May 31, 2023, resulting from PDSA Cycle #1, implementation of a pharmacist-generated communication process, mean on-time cycle 2 or cycle 3 oral chemotherapy starts increased to 87%. After optimizing staff education resources, PDSA Cycle #2 exceeded the AIM for the month of May at 92%. The average documentation of patients crossing transitions of care in response to a new pharmacist communication workflow increased to 98% from pre-intervention 19%. Documentation following process education resource optimization increased to 90% from pre-intervention 80%. Conclusions: By implementing a new pharmacist communication workflow and optimizing process education resources, we improved our mean on-time cycle 2 or cycle 3 oral chemotherapy starts to 89%. Sustainability plans include monthly outcome and process measure evaluation, presentation to system senior leadership, and transitioning review to our system quality improvement coordinator.

372 Background: Melphalan hydrochloride is a primary agent used in the conditioning regimen for autologous stem cell transplant indications including multiple myeloma and lymphoma. Brand Alkeran labelling indicates the drug concentration must not exceed 0.45 mg/mL and should be given over a minimum 15 minutes but infused in its entirety within 60 minutes from preparation. Caution is provided as data has shown a loss of potency by 1% every 10 minutes after melphalan dilution. Time and concentration constraints often require the dose being divided into two infusion bags with the option to Y-site. These limitations necessitated an optimized process to ensure melphalan completion within the 60-minute timeframe. Methods: Our institution began to formally audit melphalan administration data in November 2018 as part of a new program quality metric. A retrospective evaluation was performed which assessed the total time from melphalan dilution in a normal saline (NS) bag to melphalan infusion completion. The aim was to increase compliance within 60 minutes from 86.2% to 100%. We utilized the Plan-Do-Study-Act (PDSA) cycle method to address opportunities for improvement. PDSA 1 included staff education on the importance of timely administration; same-day audit forms were created to dissect any potential fallouts promptly. This form included documentation of the time from vial reconstitution to delivery to the pharmacist within the patient care unit. Secondary to re-evaluation of package insert verbiage and discussion with the manufacturer, we redefined the audit start time to be melphalan vial reconstitution instead of dilution in the infusion bag. PDSA 2 incorporated specific checkpoints for vial reconstitution (12 minutes) and bag delivery (20 minutes) and changed from concurrent to sequential bag administration. Results: A total 285 melphalan infusions were eligible for analysis (mean 1.91 bags per patient). Baseline data showed 86.2% of infusions completed within the 60-minute timeframe. Average time-to-completion was 50.2 minutes (N=73). PDSA 1 revealed 100% compliance of chemotherapy verification documentation and 97.9% infusion completion with an average time of 42.8 minutes (N=97). PDSA 2 resulted 99.1% compliance (one infusion fallout) and an average completion time of 41.2 minutes (N=115). Overall survival (OS) at 1-year for baseline, PDSA 1, and PDSA 2 groups was 94.7%, 95.9%, and 98.3% respectively ( p=0.66). Conclusions: The outcome measure average and mean time-to-completion improved from 86.2% to 99.1% and 50.2 to 41.2 minutes, respectively, secondary to process measure implementation despite the more stringent redefined vial dilution start time. A lone fallout of 62 minutes in PDSA 2 was triaged and determined to be due to unpredictable line complications. No significant differences in OS were observed. Ultimately, our process was optimized in terms of both compliance and efficiency.

Surveillance methods that permit rapid detection of circulating pathogens in low-resource settings are desperately needed. In this study, we evaluated a mosquito bloodmeal-based surveillance method (“xenosurveillance”) in rural Guatemala. Twenty households from two villages (Los Encuentros and Chiquirines) in rural southwest Guatemala were enrolled and underwent weekly prospective surveillance from August 2019 to December 2019 (16 weeks). When febrile illness was reported in a household, recently blood-fed mosquitoes were collected from within dwellings and blood samples taken from each member of the household. Mosquitoes were identified to species and blood sources identified by sequencing. Shotgun metagenomic sequencing was used to identify circulating viruses. Culex pipiens (60.9%) and Aedes aegypti (18.6%) were the most abundant mosquitoes collected. Bloodmeal sources were most commonly human (32.6%) and chicken (31.6%), with various other mammal and avian hosts detected. Several mosquito-specific viruses were detected, including Culex orthophasma virus. Human pathogens were not detected. Therefore, xenosurveillance may require more intensive sampling to detect human pathogens in Guatemala and ecologically similar localities in Central America.

The objective of the study was to evaluate the long‐term strength and gait outcomes after intramedullary nailing of isolated tibial diaphyseal fractures. This retrospective cohort study was conducted at an academic Level I trauma center. Fifteen participants with isolated tibial diaphyseal fractures (OTA/AO 42) at least 2 years postoperative from intramedullary nailing (IMN) provided informed consent. The average age was 40 ± 14 (range, 24‐69); there were nine men and six women. Knee flexion‐extension strength data were collected. Temporal spatial, kinematic and kinetic gait parameters were measured and compared to historic control data. Participants completed the SF‐36 and sMFA questionnaires. The mean length of follow‐up between surgery and gait analysis was 6 ± 2 years. The fractured limb demonstrated deficits in quadriceps strength between 9.8‐23.4% compared to the unaffected limb. Temporal spatial parameters revealed slower walking speed, shorter stride length, decreased cadence, and shorter single limb support time in the fractured limb. Altered kinematic and kinetic findings included a knee extension shift during stance, with an increased knee flexor moment demand and decreased total knee power during loading and midstance. These findings represent deficits in concentric and eccentric knee extensor activity. Additionally, the fractured limb demonstrated decreased ankle dorsiflexion during stance and diminished ankle push‐off power. Long‐term outcomes after IMN of tibial diaphyseal fractures demonstrate decreased quadriceps strength and altered gait parameters that may have implications to the high incidence of knee and ankle pain in the fractured limb. This article is protected by copyright. All rights reserved.

People experiencing homelessness (PEH) are at disproportionate risk of becoming infected and having severe illness from coronavirus disease 2019 (COVID-19), especially when residing in congregate settings like homeless shelters. Behavioral health problems related to substance use disorder (SUD) and severe mental illness (SMI) may have created additional challenges for PEH to practice prevention measures like mask wearing, physical distancing, handwashing, and quarantine and isolation. The study objective was to understand the perceived barriers PEH face regarding COVID-19 non-pharmaceutical prevention strategies and identify recommendations for overcoming barriers. From August-October 2020, qualitative phone interviews with 50 purposively selected behavioral health professionals across the United States serving PEH with SUD or SMI were conducted. Professionals described that PEH faced barriers to prevention that were structural (e.g., access to necessary resources), behavioral (related to SUD or SMI), or related to the priority of other needs. Recommendations to overcome these barriers included providing free prevention resources (e.g., masks and hand sanitizer), providing education about importance of prevention strategies, and prioritizing access to stable housing. Interviews took place before COVID-19 vaccines were available, so barriers to vaccination are not included in this paper. Findings can help support tailored approaches during COVID-19 and future public health threats.

Background: The identification of metabolites related to BP may afford opportunities to reveal novel biomarkers, elucidate pathogenesis, and provide potential intervention targets for prevention of hypertension. Methods: We conducted 2 cross-sectional analyses using data from the Early Teen ( n = 560, median age: 12.9y; IQR: 12.5-13.3y) and Mid-Teen ( n = 503, median age: 17.4y; IQR: 17.2-17.8y) visits of Project Viva. At each visit, we assayed plasma metabolites via untargeted metabolomics profiling (1135 at Early Teen; 1278 at Mid-Teen) and measured systolic BP (SBP) and diastolic BP (DBP). Using weighted-correlation network analysis, we identified metabolite modules and examined associations with BP using Spearman's partial correlations, adjusting for age, sex, and height. We used false discovery rate (FDR) to account for testing across multiple modules. Results: At the Early Teen visit, we identified a module of 59 metabolites ( Figure ; Network 7) comprised primarily of steroids (e.g., 24 androgenic steroids, 19 corticosteroids) that was correlated with higher SBP and DBP (ρ adjusted = 0.13-0.16; FDR ≤ 0.03). Associations were similar between males vs. females. Within this network, androgenic steroids (e.g., androstenediol (3beta,17beta) disulfate and monosulfate) seemed to drive the overall associations. At the Mid-Teen visit, the module primarily consisting of androgenic steroids was also correlated with higher SBP in the unadjusted models (ρ crude = 0.23; FDR < 0.01), but the association was attenuated in the adjusted model. Conclusions: A distinct module of metabolites, largely driven by androgenic steroids, was associated with higher BP in adolescents.

Purpose: To determine whether a community health worker (CHW)-led intervention could improve health-related quality of life (HRQoL; primary outcome) more than usual care among low-income and racial and ethnic minoritized populations newly diagnosed with cancer. Methods: This randomized clinical trial was conducted from November 1, 2018, until August 31, 2021, in outpatient cancer clinics in Atlantic City, NJ, and Chicago, IL. Hourly low-wage worker members of an employer union health fund age 18 years or older with newly diagnosed solid tumor and hematologic malignancies were randomly assigned 1:1 to usual care (control group) or usual care augmented with a trained CHW for 12 months (intervention group). The CHW assisted participants with advance care planning (ACP), proactively screened symptoms, and referred participants to community-based resources for identified health-related social needs. Usual care comprised nurse case management and benefits redesign (waived copayments and free transportation for any cancer care received at preferred oncology clinics in each city). The primary outcome was HRQoL. Secondary outcomes included patient activation, satisfaction with decision, ACP documentation, health care use, total health care costs, and overall survival. Results: A total of 160 participants were enrolled. Intervention group participants had a greater increase in mean HRQoL scores at 4-month and 12-month follow-up as compared with baseline than control group participants (expected mean difference, 11.25 [95% CI, 7.28 to 15.22]; 11.29 [95% CI, 6.96 to 15.62], respectively). Conclusion: In this randomized trial, a CHW-led intervention significantly improved HRQoL for low-income and racial and ethnic minoritized patients with cancer more than usual care alone.