PURPOSE:As metastatic breast cancer (mBC) treatment evolves, there is a need to understand how clinical meaningfulness, or a meaningful change in a patient's daily life, and clinically meaningful outcomes inform patient-centered care. Partnering with key stakeholders ensures patient-centered research incorporates the knowledge and expertise of advisors with lived experience. We describe a multistakeholder engagement approach to examine how people living with mBC (PLWmBC), caregivers, and health care providers interpret clinical meaningfulness and clinically meaningful outcomes and their influence on mBC treatment decision making and care. METHODS:Qualitative focus groups with PLWmBC, caregivers, and health care providers were conducted and analyzed along three overarching themes: interpretations of clinical meaningfulness and clinically meaningful outcomes; treatment recommendations, preferences, and decisions; and implications for clinical practice. Patient-led and professional organizations served as research partners in study design, implementation, and interpretation of findings. RESULTS:Partnerships were established with four patient-led and three professional organizations representing diverse constituencies throughout the United States. Twenty-two focus groups were conducted with 50 PLWmBC, 24 caregivers, and 41 health care providers (oncologists, n = 11; advanced practice providers, n = 13; oncology nurses, n = 17) between March and June 2023. PLWmBC and caregivers were unfamiliar with the concepts of clinical meaningfulness and clinically meaningful outcomes. Although health care providers were familiar, they did not use the terms when discussing treatment with PLWmBC. Across groups, participants emphasized the importance of meaningful outcomes beyond overall survival, including quality of life and improvement in symptoms and functioning. Participants noted that outcomes considered meaningful are individualized and dynamic. CONCLUSION:This study offers insight into how partnering with patient advocacy and professional organizations can enhance research quality and aid translation of findings to clinical practice, thereby supporting patient-centered care.

Introduction‘Shocks’ or external stressors to vaccination programmes can lead to decreased vaccination coverage rates. The capacity of vaccination ecosystems to effectively respond and adapt to shocks demonstrates programme resilience. This study sought to describe components that contribute to resilience in national immunisation programmes.MethodsMixed-methods study comprising in-depth interviews and surveys with n=30 vaccination programme experts in eight countries (Brazil, Costa Rica, Greece, Japan, Nigeria, Philippines, Spain and the USA). We elicited data on country-specific shocks, associated effects and factors that facilitated or impeded programme resilience. Interviews and open-ended survey responses were analysed qualitatively, with closed-ended survey questions analysed using descriptive statistics.ResultsExperts described immediate effects of shocks including decreased vaccine uptake and negative perceptions of vaccination from the public and media. Late emerging impacts included increased vaccine hesitancy and vaccine-preventable disease (VPD) rates. Stakeholder education, immunisation information systems (IIS) and programme financing were key factors to strengthening programme resilience. Appropriately trained frontline healthcare personnel can counter vaccine misinformation that otherwise erodes trust and contributes to hesitancy. The COVID-19 pandemic also exposed structural weaknesses in programme resilience, with experts highlighting the need for robust IIS and workforce support to mitigate burnout and strengthen resilience when a shock occurs.ConclusionsOur findings provide preliminary insights into factors that experts believe to be associated with vaccination programme resilience. Anticipating, adapting and responding to shocks is central to strengthening systems, ensuring ecosystem resilience and protecting against current and future VPD threats.

Background. Over the last 25 years, clinical practice guidelines have emerged as a means to standardize and improve care. As pharmaceutical innovations develop, guidelines are updated to incorporate new interventions. However, the extent to which pharmacotherapies are represented as treatment options in guideline recommendations has not been well elucidated. This study aimed to quantify the role pharmacotherapy has played in clinical practice guidelines across a range of chronic diseases over the past 20 years. Methods. Clinical practice guidelines published from 2000 to 2021 were identified for five chronic diseases: ischemic heart disease (IHD), non-small cell lung cancer (NSCLC), chronic obstructive pulmonary disease (COPD), Alzheimer’s disease (AD), and type 2 diabetes (T2D). Guidelines were reviewed and data on treatment recommendations were collected, including the type of intervention, line of therapy, and, for pharmacotherapies, year of regulatory approval and year of inclusion in guidelines. Results. In total, 92 clinical practice guidelines were reviewed. Among the 184 discrete recommended interventions across the five disease areas, 146 (79.3%) were pharmacotherapies, 21 (11.4%) were behavioral modifications, 6 (3.3%) were surgical interventions, and 11 (6%) were other interventions. Across guidelines, when a line of therapy was specified, behavioral modifications and pharmacotherapies were most frequently recommended as first-line interventions, whereas surgical interventions were more often recommended for subsequent lines of treatment. The time from regulatory approval of novel pharmacotherapies to inclusion in guideline recommendations varied considerably by disease area and geography. Conclusions. Across the reviewed disease areas, behavioral interventions and pharmacotherapies are shown to be critical components of clinical practice. Over the last 20 years, novel pharmaceutical innovations have been incorporated into clinical practice guideline recommendations; however, with varying speeds of adoption. Given the increasing pace of pharmacologic innovation, timely updates of clinical practice guidelines are critical to evolving the standard of care and practicing evidence-based medicine.

Background Teclistamab was recently approved as the first-in-class B-cell maturation antigen (BCMA) x CD3 bispecific therapy with personalized weight-based dosing for relapsed or refractory multiple myeloma (MM). Given its novelty, there are immediate needs for data based on real-world (RW) practices to optimize operational processes and improve experiences while ensuring patient safety in the RW. The aims of this study were to describe how US clinicians with early RW experience with teclistamab (1) manage the step-up dosing (SUD) and transition of care (ToC) to and from referring sites; (2) monitor, manage, and prevent adverse events (AEs), i.e., cytokine release syndrome (CRS), infections, and immune effector cell-associated neurotoxicity syndrome (ICANS); and (3) perceive desired future care models for optimal patient care. Methods Between April and July 2023, 60-minute, 1-on-1 in-depth structured interviews were conducted virtually with hematologists and oncologists who had treated patients with teclistamab in a RW setting. Interviews elicited clinicians' current SUD and ToC processes in their practices, AE management, and perspectives on SUD model evolution. A subsequent 90-minute roundtable discussion was held in June 2023 to discuss interview findings. Results A total of 20 clinicians representing 19 practices across 14 states completed interviews: 84% (16/19 practices) treated >50 patients with MM monthly, 69% had treated >10 patients with teclistamab, and 90% were academic medical centers. Of these interviewees, 10 participated in the roundtable discussion, joined by 3 community clinicians without teclistamab experience. Among the 19 interviewed practices, 14 (74%) were administering SUD exclusively in inpatient settings. This was being done predominantly (86%; 12/14) in 1 continuous admission with a planned length of stay of 7 days, and with 71% (10/14) following a day 1-3-5 dosing schedule. Five practices reported using outpatient models (Figure 1). The sophistication of outpatient models varied and depended on multiple factors at the practice level, including prior outpatient cellular therapy experience, staffing/facility structure, patient volume, and outpatient monitoring capability. Most (95%) of the interviewed practices initiated teclistamab for patients referred from community practices; 53% transferred at least 1 patient back to a referring practice to continue teclistamab. The time to transfer ranged from 2 weeks to 2 months to (1) ensure that patients were responding to and tolerating treatment prior to transfer and (2) recover any financial loss from inpatient SUD. Community clinicians preferred to resume care of their patients once patients were deemed clinically stable. More than half (68%) of practices reported leveraging existing CAR-T protocols for AE monitoring and management. Patients were typically monitored for CRS every 4 hours for vital signs and daily for complete blood count, comprehensive metabolic panel, C-reactive protein, and ferritin. CRS prophylaxis with tocilizumab was reported by 11% of practices. 74% (14/19) of practices used tocilizumab for treatment of grade 2 or higher CRS. 94% (17/18) of reporting practices utilized intravenous immunoglobulin for primary infection prophylaxis, typically at a dose of 0.4 g/kg every 4-8 weeks to maintain an IgG level above 400 mg/dL. ICANS risk was considered low, and corticosteroids were the preferred treatment for ICANS. Payer reimbursement, treatment availability and lack of approved indications were noted as barriers for certain prophylactic treatments. Clinicians indicated a desire to administer SUD in an outpatient setting for patient convenience and to reduce healthcare resource use. Comorbidities, tumor burden, and caregiver support were key patient-level factors to be considered for outpatient SUD. Remote patient monitoring was a potential solution to enhance the outpatient SUD administration. Conclusions The results indicated diverse RW administration and patient management strategies in practices with early familiarity with teclistamab, and consolidated practice-based experiences to help inform clinicians employing this innovative therapy. As patient care models evolve, outpatient or community-based SUD may become more common in the future. Ongoing evidence generation on RW treatment outcomes of various SUD models and AE management strategies is warranted.

Abstract Background: While many clinical and non-clinical factors inform metastatic breast cancer (mBC) treatment recommendations; patient preferences, values, and care goals also influence how treatment options are weighed, deliberated, and decided upon. Additionally, in the mBC care setting, clinical meaningfulness and clinically meaningful outcomes (e.g., survival, quality-of-life) are important factors to consider along the care continuum. However, the extent to which patients and their oncology care team align on the interpretation and use of these concepts during treatment decision-making has not been well elucidated. This study examined perspectives on the concepts of (i) clinical meaningfulness and (ii) clinically meaningful outcomes associated with mBC treatment among five key stakeholder groups: patients, caregivers, oncologists, advanced practice providers (APPs), and oncology nurses. Methods: Qualitative semi-structured in-person and web-based focus groups were conducted between March and June 2023 among: (i) people living with mBC; (ii) unpaid or informal caregivers to people with mBC; and providers involved in the care of patients with mBC, including (iii) oncologists, (iv) APPs (i.e., physician assistants and nurse practitioners), and (v) oncology nurses. Discussion guides were developed to elicit stakeholder perspectives on clinical meaningfulness and clinically meaningful outcomes to help identify areas of convergence and divergence between and within stakeholder groups. All discussions were audio recorded and transcribed. The constant comparative approach was used to identify key themes. Results: Twenty-two focus groups were conducted with 50 patients, 24 caregivers, 8 oncologists, 13 APPs, and 17 oncology nurses. Overall, patients and caregivers were unfamiliar with the concepts of clinical meaningfulness and clinically meaningful outcomes, underscoring the critical need for using accessible and patient-friendly terminology in treatment decision-making discussions. While some providers were familiar with these concepts, they reported not using these terms when discussing treatment recommendations with patients. Although some provider participants thought clinical meaningfulness described quantitative endpoints (e.g., additional months of survival), participants across all stakeholder groups described patients’ abilities to achieve life goals (e.g., participation in milestone events and social activities, ability to travel) as paramount. Recommendations for improving treatment decision-making discussions included taking a patient-centered approach, with inclusive, dynamic patient-provider discussions and continuous evaluation of patient priorities across the care continuum, not just at diagnosis. Meaningful outcomes beyond overall survival need to be considered, including quality of life, progression-free survival, minimal or manageable side effects, and improvement in symptom burden and functioning. Across all stakeholders, participants stressed that outcomes considered meaningful are highly individualized and dynamic, evolving over time as patients move through the treatment journey and life stages. Conclusions: Clinical meaningfulness is poorly understood and not often considered in the clinical setting when making mBC treatment decisions, highlighting a need for accessible and patient-friendly terminology in mBC treatment decision-making conversations. While participants valued overall survival, the importance of meaningful outcomes that support patients’ quality of life was emphasized. Study findings can be used to inform both practice and clinical research to better capture meaningful outcomes for patients. Citation Format: Stephanie Graff, Emily Freeman, Meaghan Roach, Rozanne Wilson, Ricki Fairley, Mary Gullatte, Jeanne Stemland, Becky Chan, Paulina Wochal, Julie Katz, Suepattra May-Slater. Understanding clinical meaningfulness in metastatic breast cancer treatment decision-making: experiences and perspectives of patients, caregivers, and clinicians [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-10-06.

33 Background: The COVID-19 pandemic generated unprecedented interruptions and impacts on healthcare services across the US, including cancer care delivery. Patient perspectives on navigating colorectal cancer (CRC) care throughout the pandemic have not been well documented. This study explored patient experiences and perspectives around CRC care delivery throughout the pandemic by examining the impacts of COVID-19 on planned treatment, healthcare access, and quality of care. Methods: Patients diagnosed with CRC prior to January 2020 and who received treatment for CRC during 2019 participated in this qualitative study. Semi-structured interviews explored treatment experiences before and during the pandemic and were conducted between December 2021 and March 2022. Thematic analysis was used to identify key themes. Results: Twenty-four patients with CRC (mean age 45.4 years [SD=9.7]; 75% female; 62.5% current stage IV) completed an interview. Participants reported diminished mental health as the most salient impact of the pandemic related to their CRC care. Participants expressed how difficult, isolating, and lonely they felt navigating cancer treatment, particularly as a result of visitor restriction policies that did not allow their support person (e.g., spouse) to be present during visits or stays. Increased anxiety, fear, and worry over how the pandemic may affect their planned cancer care, including fear of contracting the virus themselves, were major concerns. Other impacts experienced included barriers to physically accessing care facilities (e.g., reduced appointment availability, staffing shortages), delays to patients’ planned treatment (e.g., canceled surgery), and increased access to and use of telehealth, which was perceived as being more convenient and safer than in-person visits. Participant perspectives on the quality of care they received throughout the pandemic were based on frequency and personalization of patient-provider communication, ability to access their usual care and support services (e.g., care navigators, support groups), and provider attention to their mental health. To improve the quality of cancer care in a pandemic setting, participants recommended personalized and frequent communications from the oncology care team, holistic care that includes mental health support, and streamlined insurance preauthorization processes. Conclusions: While the long-term impacts of COVID-19 on CRC care delivery have yet to be fully understood, this study highlights the key challenges patients experienced while receiving CRC care during the pandemic. Recognizing the strain of the pandemic on patients’ mental health and well-being will help to ensure patient-provider communication and support services consider the short and long-term effects of the pandemic for cancer patients as well as help contribute to improved treatment-related outcomes.

338 Background: In metastatic breast cancer (mBC), treatment decision-making is informed by many factors including patient values, preferences, and care goals. Important to treatment decision-making is clinical meaningfulness, or the degree to which a treatment for mBC results in a meaningful change in the patient’s daily life, and clinically meaningful outcomes that are relevant to patients (e.g., survival, quality of life). However, patient and clinician perspectives and alignment on these concepts have not been well elucidated. Engaging patients and other key stakeholders as research collaborators is vital to guiding the delivery of high-quality cancer care focused on outcomes that patients considered meaningful. The aim of this work is to describe the implementation of an innovative multi-collaborator engagement with patient advocates and professional oncology societies to support a study examining perspectives on clinical meaningfulness in mBC treatment among clinicians, patients, and caregivers in the United States. Methods: This mixed-methods study utilizes qualitative semi-structured in-person and virtual focus groups to inform the development of collaborator-specific surveys on clinical meaningfulness in mBC. A multi-collaborator engagement approach was selected to support the conception, implementation, and completion of this study. Specifically, we have convened a collaboration with patient advocacy groups and professional membership organizations to engage researchers, patients, caregivers, and clinicians. The collaboration is designed to: i) facilitate the development of study protocols and key data collection documents; ii) review and reflect on findings and salience for relevant populations; and iii) participate in dissemination activities whereby collaborators co-create, co-present and discuss findings and their impact on clinical practice. Results: To date, we have partnered with four breast cancer patient advocacy groups representing sociodemographic diverse constituencies throughout the US and three oncology professional membership organizations. By describing how to implement these partnerships, we seek to present a collaboration roadmap that can be replicated and adapted to similar studies in oncology care delivery. Such a comprehensive and rigorous approach aims to enhance the quality of data collection and interpretation, generating evidence that will optimally improve patient-centered mBC care delivery and meaningful patient outcomes. Conclusions: Engaging patients and other key collaborators in research is important to generate clinically meaningful evidence to those involved in mBC treatment decision-making. This study offers a robust methodological approach for gaining insights into the delivery of patient-centered cancer care.

INTRODUCTION:The treatment landscape in locally advanced/unresectable or metastatic urothelial carcinoma (aUC) has evolved with the use of immune checkpoint inhibitors (ICIs) in the first line (1L) and platinum-refractory settings and with the recent approval of avelumab as 1L maintenance therapy for patients achieving disease control with platinum-containing regimens. Oncology provider perspectives and decision-making processes regarding aUC management, especially with the integration of recently approved strategies, such as maintenance therapy, have not been well-described.PATIENTS AND METHODS:Qualitative interview study with US oncologists and oncology nurses in academic and community settings in August 2020. Interviews explored decision-making around aUC 1L treatment eligibility determinants and selection, programmed cell death 1 ligand 1 (PD-L1) testing practices, and use of maintenance therapy. Thematic analysis was used to identify drivers of 1L treatment decisions.RESULTS:Eighteen oncologists (women, 11%; >15 years in practice, 55%; academic, 39%) and 18 oncology nurses (women, 94%; >15 years in practice, 34%; academic, 50%) participated. Providers preferred platinum-based regimens in 1L setting and reserved 1L ICI monotherapy for frail patients. Providers preferred chemotherapy followed by switch maintenance ICI, as opposed to concurrent combination chemotherapy and ICI, followed by ICI as continuation maintenance. Decision-making was driven by need to adhere to treatment decision-making guidelines, characteristics of the patient, treatment efficacy and patient preference.CONCLUSION:Providers adhered to guidelines and level I evidence in decision-making in the aUC 1L setting. Future studies should further evaluate barriers to the adoption of standard-of-care strategies and factors impacting decision-making in the real-world setting.

Introduction: Treatment advances for metastatic breast cancer (mBC) have improved overall survival (OS) in some mBC subtypes; however, there remains no cure for mBC. Considering the use of progression-free survival (PFS) and other surrogate endpoints in clinical trials, we must understand patient perspectives on measures used to assess treatment efficacy. Objective: To explore global patient perceptions of the concept of PFS and its potential relation to quality of life (QoL). Materials and methods: Virtual roundtables in Europe and the United States and interviews in Japan with breast cancer patients, patient advocates, and thought leaders. Discussions were recorded, transcribed, and analyzed thematically. Results: Lengthened OS combined with no worsening or improvement in QoL remain the most important end-points for mBC patients. Time when the disease is not progressing is meaningful to patients when coupled with improvements in QoL and no added treatment toxicity. Clinical terminology such as "PFS" is not well understood, and participants underscored the need for patient-friendly terminology to better illustrate the concept. Facets of care that patients with mBC value and that may be related to PFS include relief from cancer-related symptoms and treatment-related toxicities as well as the ability to pursue personal goals. Improved communication between patients and providers on managing treatment-related toxicities and addressing psychosocial challenges to maintain desired QoL is needed. Conclusion: While OS and QoL are considered the most relevant endpoints, patients also value periods of time without disease progression. Incorporation of these considerations into the design and conduct of future clinical trials in mBC, as well as HTA and reimbursement decision-making, is needed to better capture the potential value of a therapeutic innovation.

BACKGROUND: Despite therapeutic advances for patients with schizophrenia, improving patient outcomes and reducing the cost of care continue to challenge formulary decision makers. OBJECTIVES: To (1) understand the perspectives of formulary decision makers on challenges to optimal schizophrenia population management and (2) identify best practices and recommendations for mitigating these challenges. METHODS: This mixed-methods study, conducted in a double-blind manner, comprised in-depth telephone interviews with formulary decision makers from February through May 2020, and a web-based follow-on survey that was sent to all participants in October 2020. US-based formulary decision makers were recruited if they were directly involved in schizophrenia drug formulary or coverage decision making for national or regional payers, health systems, or behavioral health centers. Formulary decision makers' perceptions of challenges, policies, and programs related to schizophrenia population health management were assessed generally and in the context of the COVID-19 pandemic. RESULTS: 19 formulary decision makers participated in the interviews and 18 (95%) completed the survey. Participants reported a spectrum of patient- and payer-driven challenges in schizophrenia population health management, including medication nonadherence, high pharmacy and medical costs, and frequent hospitalizations and emergency department visits. Participants noted that COVID-19 had worsened all identified challenges, although patient unemployment (mean score of 2.00 on a scale of 1 [made much worse] to 5 [made much better]) and reduced access to psychiatric care (mean score, 2.12) were most negatively affected. The most common strategies implemented in order to improve schizophrenia population health management included case management (89%), telemedicine (83%), care coordination programs (72%), strategies to mitigate barriers to accessing medication (61%), and providing nonmedical services to address social determinants of health (56%). Participants noted that, ideally, all treatments for schizophrenia would be available on their formularies without utilization management policies in place in order to increase accessibility to medication, but cost to the health plans made that difficult. Whereas 61% of respondents believed that long-acting injectable antipsychotics (LAIs) were currently underused in their organizations, only 28% represented organizations with open access policies for LAIs. Participants believed that among patients with schizophrenia, LAIs were most beneficial for those with a history of poor or uncertain adherence to oral medications (mean score of 4.50 on a scale of 1 [not at all beneficial] to 5 [extremely beneficial]) and those with recurring emergency department visits and inpatient stays (mean score, 3.94). Study participants reported slightly increased use of LAIs (mean score of 3.17 on a scale of 1 [negatively impacted] to 5 [positively impacted]) among their patients with schizophrenia in response to the COVID-19 pandemic; 29% of participants reported easing access restrictions for LAIs. CONCLUSIONS: Participants described persisting challenges and various approaches intended to improve schizophrenia population health management. They also recommended strategies to optimize future health management for this population, including expanding programs to address social determinants of health and mitigating barriers to accessing treatment. DISCLOSURES: This study was funded by Janssen Scientific Affairs, LLC. Roach, Graf, Pednekar, and Chou are employees of PRECISIONheor, which received financial support from Janssen Scientific Affairs, LLC, to conduct this study. Chou owns equity in Precision Medicine Group, the parent company of PRECISIONheor. Lin and Benson are employees of Janssen Scientific Affairs, LLC. Doshi has served as a consultant, advisory board member, or both, for Acadia, Allergan, Boehringer Ingelheim, Janssen, Merck, Otsuka, and Sage Therapeutics and has received research funding from AbbVie, Biogen, Humana, Janssen, Novartis, Merck, Pfizer, PhRMA, Regeneron, Sanofi, and Valeant.

"BPI21-004: A Qualitative Study Describing Oncology Practitioners’ Approaches to First-Line (1L) Treatment of Metastatic Urothelial Cancer (mUC) in the United States" published on 17 Mar 2021 by National Comprehensive Cancer Network.

407 Background: Avelumab first-line (1L) maintenance therapy for patients (pts) with advanced/mUC that has not progressed with platinum-containing chemotherapy was recently approved in the US based on improved overall survival seen in the JAVELIN Bladder 100 trial. However, provider perspectives regarding 1L maintenance therapy in mUC have not been reported. Methods: We performed a qualitative interview study with US oncologists and oncology nurses treating pts with mUC in academic and community practices. Telephone interviews were conducted in August 2020 using a semi-structured discussion guide to explore decision-making processes about treatment for pts with mUC and perspectives about ICI maintenance therapy in the 1L setting. The latter was defined as either 1) ICI for pts who achieve disease control with platinum-containing chemotherapy (Regimen A) or 2) ICI + chemotherapy followed by ICI (Regimen B). Thematic analysis identified key determinants and clinical considerations associated with ICI maintenance therapy in mUC. Results: Results for 18 oncologists (mean age 51.3 yrs [SD 9]; 11% female; 55% with >15 yrs in practice; 39% academic) and 18 oncology nurses (mean age 43.8 yrs [SD 11.1]; 94% female; 34% with >15 yrs in practice; 50% academic) are reported. Cisplatin- and carboplatin-based chemotherapy regimens were the most commonly administered 1L treatments, with ICI monotherapy reserved only for frail (i.e., comorbid and/or elderly) pts. All oncologists recommended 4-6 cycles of 1L chemotherapy. Providers reported different perspectives about the maintenance approaches. Those who expressed a preference for Regimen A (oncologists, 66.6%; nurses, 71.4%) cited potentially less toxicity as a key factor driving their choice. Providers who preferred Regimen B cited the perceived potential for deeper and more durable responses based on previous experience with this maintenance approach in other tumors as a driver of their choice. For Regimen A, providers universally did not recommend a treatment break between chemotherapy and ICI maintenance because of concerns about progression. Frequency of administration was not cited as a driver of treatment decisions for either maintenance approach; instead, providers prioritized survival and tolerability. Responses were generally consistent between oncologists and nurses. Conclusions: Overall, providers adhered to new guidelines for 1L treatment of mUC (NCCN and ESMO) and expressed receptivity toward Regimen A. Although few providers had experience with this new regimen, most preferred it vs ICI + chemotherapy followed by ICI in 1L mUC. Our findings highlight the need to increase provider awareness of Regimen A, i.e., avelumab maintenance in pts with response or stable disease with 1L chemotherapy as a standard of care in advanced/mUC, which has Level I evidence.

BackgroundEvaluation of patients with serious mental illness (SMI) relies largely on patient or caregiver self-reported symptoms. New digital technologies are being developed to better quantify the longitudinal symptomology of patients with SMI and facilitate disease management. However, as these new technologies become more widely available, psychiatrists may be uncertain about how to integrate them into daily practice. To better understand how digital tools might be integrated into the treatment of patients with SMI, this study examines a case study of a successful technology adoption by physicians: endocrinologists’ adoption of digital glucometers. ObjectiveThis study aims to understand the key facilitators of and barriers to clinician and patient adoption of digital glucose monitoring technologies to identify lessons that may be applicable across other chronic diseases, including SMIs. MethodsWe conducted focus groups with practicing endocrinologists from 2 large metropolitan areas using a semistructured discussion guide designed to elicit perspectives of and experiences with technology adoption. The thematic analysis identified barriers to and facilitators of integrating digital glucometers into clinical practice. Participants also provided recommendations for integrating digital health technologies into clinical practice more broadly. ResultsA total of 10 endocrinologists were enrolled: 60% (6/10) male; a mean of 18.4 years in practice (SD 5.6); and 80% (8/10) working in a group practice setting. Participants stated that digital glucometers represented a significant change in the treatment paradigm for diabetes care and facilitated more effective care delivery and patient engagement. Barriers to the adoption of digital glucometers included lack of coverage, provider reimbursement, and data management support, as well as patient heterogeneity. Participant recommendations to increase the use of digital health technologies included expanding reimbursement for clinician time, streamlining data management processes, and customizing the technologies to patient needs. ConclusionsDigital glucose monitoring technologies have facilitated more effective, individualized care delivery and have improved patient engagement and health outcomes. However, key challenges faced by the endocrinologists included lack of reimbursement for clinician time and nonstandardized data management across devices. Key recommendations that may be relevant for other diseases include improved data analytics to quickly and accurately synthesize data for patient care management, streamlined software, and standardized metrics.

: Neurodegenerative diseases are a leading cause of disability and death in the United States, and the burden of rare neurodegenerative conditions such as atypical Parkinsonian syndromes is expected to grow in the coming years as the size of the older population increases at an unprecedented rate. Atypical Parkinsonian syndromes encompass a collective of rare neurodegenerative diseases that are often misdiagnosed as Parkinson ’ s disease due to similar signs and symptoms. These syndromes include progressive supranuclear palsy (PSP), multiple system atrophy (MSA), and corticobasal degeneration (CBD), and are characterized by rapid disease progression and decreased life expectancy. In this paper, we describe the substantial burden atypical Parkinsonian syndromes pose to the healthcare system and patients attributable to challenges in diagnosis, ineffective treatment options, and rapid functional decline. Despite increased understanding and recognition of these disorders, there remains signi fi cant unmet need for patients with atypical Parkinsonian syndromes. We provide recommendations to policymakers to support access to effective disease management of atypical Parkinsonian syndromes through legislative efforts that i) prioritize development of disease-modifying treatments, ii) focus on objectively assessing disease progression in addition to symptom management, and iii) bring forth economic frameworks that capture the full value of treatments.

OBJECTIVE This study compared health care use and costs among patients with treatment-resistant versus treatment-responsive depression across Medicaid, Medicare, and commercial payers. METHODS A retrospective cohort study was conducted by using Truven Health Analytics' commercial (2006-2017; N=111,544), Medicaid (2007-2017; N=24,036), and Medicare supplemental (2006-2017; N=8,889) claims databases. Participants were adults with major depressive disorder who had received one or more antidepressant treatments. Treatment resistance was defined as failure of two or more antidepressant treatments of adequate dose and duration. Annual use (hospitalizations and outpatient and emergency department [ED] visits) and costs were compared across patients by treatment-resistant status in each payer population. Incremental burden of treatment-resistant depression was estimated with regression analyses. Monthly changes in costs during 1-year follow-up were assessed to understand differential cost trends by treatment-resistant status. RESULTS In the three payer populations, patients with treatment-resistant depression incurred higher health care utilization than those with treatment-responsive depression (hospitalization, odds ratios [ORs]=1.32-1.76; ED visits, ORs=1.38-1.45; outpatient visits, incident rate ratio=1.29-1.54; p<0.001 for all). Compared with those with treatment-responsive depression, those with treatment resistance incurred higher annual costs (from $4,093 to $8,054 higher; p<0.001). Patients with treatment-resistant depression had higher costs at baseline compared with patients with treatment-responsive depression and incurred higher costs each month throughout follow-up. CONCLUSIONS Treatment-resistant depression imposes a significant health care burden on insurers. Treatment-resistant depression may exist and affect health care burden before a patient is identified as having treatment-resistant depression. Findings underscore the need for effective and timely treatment of treatment-resistant depression.