Improving Asthma Control Test completion rates across a multi-site pediatric pulmonary clinic network: a quality improvement initiative.

OBJECTIVE: Assessing asthma control is an essential part of the outpatient management of children with asthma and can be performed through validated questionnaires such as the Asthma Control Test (ACT). Systematic approaches to incorporating the ACT in outpatient visits are often lacking, contributing to inconsistent completion rates. We conducted a quality improvement initiative to increase the proportion of visits where the ACT is completed for children with asthma in our multi-site pediatric pulmonary clinic network. METHODS: We developed an intervention of sending the ACT questionnaire to patients and caregivers through the electronic patient portal to complete prior to their visits. This strategy was first piloted at one clinic beginning in July 2020 and then expanded to 5 other clinics in the network in October 2020. Our outcome measure was average monthly proportion of visits with a completed ACT, tracked using statistical process control charts. The process measure was method of ACT completion tracked using run charts. RESULTS: At the pilot clinic, average monthly completion rate rose within 3 months of the intervention from 27% to 72% and was sustained more than 22 months. Completion across all clinics increased from 57% pre-intervention to 76% post-intervention. Importantly, the intervention did not rely on clinic staff to administer the questionnaire and did not interfere with existing clinic flow. CONCLUSION: An intervention of delivering the ACT electronically to patients and caregivers for completion prior to visits led to a rapid and sustained improvement in ACT completion rates across a large, pediatric pulmonary clinic network.

Urine scRNAseq reveals new insights into the bladder tumor immune microenvironment.

Due to bladder tumors' contact with urine, urine-derived cells (UDCs) may serve as a surrogate for monitoring the tumor microenvironment (TME) in bladder cancer (BC). However, the composition of UDCs and the extent to which they mirror the tumor remain poorly characterized. We generated the first single-cell RNA-sequencing of BC patient UDCs with matched tumor and peripheral blood mononuclear cells (PBMC). BC urine was more cellular than healthy donor (HD) urine, containing multiple immune populations including myeloid cells, CD4+ and CD8+ T cells, natural killer (NK) cells, B cells, and dendritic cells (DCs) in addition to tumor and stromal cells. Immune UDCs were transcriptionally more similar to tumor than blood. UDCs encompassed cytotoxic and activated CD4+ T cells, exhausted and tissue-resident memory CD8+ T cells, macrophages, germinal-center-like B cells, tissue-resident and adaptive NK cells, and regulatory DCs found in tumor but lacking or absent in blood. Our findings suggest BC UDCs may be surrogates for the TME and serve as therapeutic biomarkers.

16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.

The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. Conclusions and consensus from discussions of these topics are included in this article.

Multi-cancer early detection (MCED) tests: prioritizing equity from bench to bedside.

Multi-cancer early detection (MCED) tests are blood-based tests designed to screen for signals of multiple cancers. There is growing interest and investment in examining the potential benefits and applications of MCED tests. If MCED tests are shown to have clinical utility, it is important to ensure that all people-regardless of their demographic or socioeconomic background-equitably benefit from these tests. Unfortunately, with health care innovation, such considerations are often ignored until after inequities emerge. We urge for-profit companies, scientists, clinicians, payers, and government agencies to prioritize equity now-when MCEDs are still being developed and researched. In an effort to avoid creating and exacerbating cancer inequities, we propose 9 equity considerations for MCEDs.

Navigating privacy and security in telemedicine for primary care.

OBJECTIVE: To examine patient and provider perspectives on privacy and security considerations in telemedicine during the COVID-19 pandemic. STUDY DESIGN: Qualitative study with patients and providers from primary care practices in 3 National Patient-Centered Clinical Research Network sites in New York, New York; North Carolina; and Florida. METHODS: Semistructured interviews were conducted, audio recorded, transcribed verbatim, and coded using an inductive process. Data related to privacy and information security were analyzed. RESULTS: Sixty-five patients and 21 providers participated. Patients and providers faced technology-related security concerns as well as difficulties ensuring privacy in the transformed shared space of telemedicine. Patients expressed increased comfort doing telemedicine from home but often did not like their providers to offer virtual visits from outside an office setting. Providers initially struggled to find secure and Health Insurance Portability and Accountability Act-compliant platforms and devices to host the software. Whereas some patients preferred familiar platforms such as FaceTime, others recognized potential security concerns. Audio-only encounters sometimes raised patient concerns that they would not be able to confirm the identity of the provider. CONCLUSIONS: Telemedicine led to novel concerns about privacy because patients and providers were often at home or in public spaces, and they shared concerns about software and hardware security. In addition to technological safeguards, our study emphasizes the critical role of physical infrastructure in ensuring privacy and security. As telemedicine continues to evolve, it is important to address and mitigate concerns around privacy and security to ensure high-quality and safe delivery of care to patients in remote settings.

Examining the Trajectory of Health-Related Quality of Life among Coronavirus Disease Patients.

BACKGROUND: Recent studies have reported a reduction in health-related quality of life (HR-QoL) among post-coronavirus disease 2019 (COVID-19) patients. However, there remains a gap in research examining the heterogeneity and determinants of HR-QoL trajectory in these patients. OBJECTIVE: To describe and identify factors explaining the variability in HR-QoL trajectories among a cohort of patients with history of COVID-19. DESIGN: A prospective study using data from a cohort of COVID-19 patients enrolled into a registry established at a health system in New York City. PARTICIPANTS: Participants were enrolled from July 2020 to June 2022, and completed a baseline evaluation and two follow-up visits at 6 and 12 months. METHODS: We assessed HR-QoL with the 29-item Patient Reported Outcomes Measurement Information System instrument, which was summarized into mental and physical health domains. We performed latent class growth and multinomial logistic regression to examine trajectories of HR-QoL and identify factors associated with specific trajectories. RESULTS: The study included 588 individuals with a median age of 52 years, 65% female, 54% White, 18% Black, and 18% Hispanic. We identified five physical health trajectories and four mental health trajectories. Female gender, having pre-existing hypertension, cardiovascular disease, asthma, and hospitalization for acute COVID-19 were independently associated with lower physical health. In addition, patients with increasing body mass index were more likely to experience lower physical health over time. Female gender, younger age, pre-existing asthma, arthritis and cardiovascular disease were associated with poor mental health. CONCLUSIONS: We found significant heterogeneity of HR-QoL after COVID-19, with women and patients with specific comorbidities at increased risk of lower HR-QoL. Implementation of targeted psychological and physical interventions is crucial for enhancing the quality of life of this patient population.

Racial and ethnic differences in post-traumatic stress trajectories in breast cancer survivors.

PURPOSE: To describe differences in post-traumatic stress (PTS) symptoms over time among racial and ethnic minoritized breast cancer survivors (BCS) with comorbid diabetes. DESIGN: In a multisite longitudinal study, post-traumatic stress was evaluated at baseline, 6 and 12 months through self-reported questionnaires (Impact of Events Scale-Revised [IES-R]). PARTICIPANTS: One hundred and seventy-eight post-treatment BCS with diabetes were recruited from three tertiary medical centers. FINDINGS: Relative to non-Hispanic White women, minoritized women reported higher total IES-R scores at all time points. In the adjusted model, Latina women reported persistently higher IES-R total scores and Latina, and 'Other' women reported higher avoidance scores. CONCLUSIONS: Minoritized BCS with comorbid diabetes report higher rates of cancer related PTS that persist over 12 months. IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS: Post diagnosis PTS evaluation and support is important in survivorship and primary care practices. Linkage to socially and culturally sensitive community support may be warranted.

World Trade Center workers with asthma and post-traumatic stress disorder perceive airflow limitation more accurately.

BACKGROUND: Post-traumatic stress disorder (PTSD) is a major risk factor for increased asthma morbidity among World Trade Center (WTC) workers. OBJECTIVE: To investigate whether differences in perception of airflow limitation mediate the association of PTSD with worse asthma control in WTC workers. METHODS: We collected data from WTC workers on asthma control (Asthma Control Questionnaire and Asthma Quality of Life Questionnaire) and daily peak expiratory flow (PEF) measures over 6 weeks. Perception of airway limitation was assessed by comparing guessed vs actual PEF values. Post-traumatic stress disorder was diagnosed using the Structured Clinical Interview. We used unadjusted and adjusted models to compare PEF and perception measures in WTC workers with PTSD with those of workers without PTSD. RESULTS: Overall, 25% of 224 participants had PTSD. Post-traumatic stress disorder was associated with worse Asthma Control Questionnaire (2.2±0.8 vs 1.1±0.9, P < .001) and Asthma Quality of Life Questionnaire (3.9±1.1 vs 5.4±1.1, P < .001) scores. Adjusted analyses showed no significant differences in PEF between WTC workers with (351.9±143.3 L/min) and those without PTSD (364.6±131.6 L/min, P = .55). World Trade Center workers with PTSD vs those without PTSD had increased proportion of accurate perception (67.0±37.2% vs 53.5±38.1%, P = .01) and decreased underperception (23.3.0±32.1% vs 38.9±37.5%, P = .004) of airflow limitation during periods of limitation. Similar results were obtained in adjusted analyses. CONCLUSION: This study indicates that differences in perception of airflow limitation may mediate the relationship of PTSD and increased asthma symptoms, given WTC workers with PTSD have worse self-reported asthma control, an increased proportion of accurate perception, and decreased underperception, despite no differences in daily PEF measures.

Assessing the interrelationship between asthma and obesity self-management behaviors.

Asthma and obesity are common coexisting conditions with increasing prevalence and substantial morbidity. This study examines the inter-relationship between illness and treatment beliefs in asthma and obesity and how they influence self-management behaviors. Overweight and obese adults ≥ 18 years with asthma were recruited from primary care and pulmonary practices in New York, NY and Denver, CO (n = 219). Path analysis was used to examine the relationship between asthma, weight and exercise-related illness and medication beliefs and SMB. Necessity beliefs about asthma medications and diet were associated with better medication adherence and healthier dietary behaviors (ß = 0.276, p = < 0.001, ß = 0.148, p = 0.018 respectively) whereas concerns about these self-care activities were associated with poorer adherence and worse dietary behaviors (ß = - 0.282, p < 0.001, ß = - 0.188, p = 0.003 respectively). We found no statistically significant association of exercise behaviors with any other weight or asthma illness or treatment beliefs. Our study demonstrates that necessity and concerns about treatment are associated with adherence in asthma and obesity. The lack of association of exercise behaviors with any asthma or weight related beliefs may reflect limited awareness of the impact of weight on asthma and warrants additional research.

The parabrachial to central amygdala pathway is critical to injury-induced pain sensitization in mice.

The spino-ponto-amygdaloid pathway is a major ascending circuit relaying nociceptive information from the spinal cord to the brain. Potentiation of excitatory synaptic transmission in the parabrachial nucleus (PBN) to central amygdala (CeA) pathway has been reported in rodent models of persistent pain. However, the functional significance of this pathway in the modulation of the somatosensory component of pain was recently challenged by studies showing that spinal nociceptive neurons do not target CeA-projecting PBN cells and that manipulations of this pathway have no effect on reflexive-defensive somatosensory responses to peripheral noxious stimulation. Here, we showed that activation of CeA-projecting PBN neurons is critical to increase both stimulus-evoked and spontaneous nociceptive responses following an injury in male and female mice. Using optogenetic-assisted circuit mapping, we confirmed a functional excitatory projection from PBN→CeA that is independent of the genetic or firing identity of CeA cells. We then showed that peripheral noxious stimulation increased the expression of the neuronal activity marker Fos in CeA-projecting PBN neurons and that chemogenetic inactivation of these cells decreased behavioral hypersensitivity in models of neuropathic and inflammatory pain without affecting baseline nociception. Lastly, we showed that chemogenetic activation of CeA-projecting PBN neurons is sufficient to induced bilateral hypersensitivity without injury. Together, our results indicate that the PBN→CeA pathway is a key modulator of pain-related behaviors that can increase reflexive-defensive and affective-motivational responses to somatosensory stimulation in injured states without affecting nociception under normal physiological conditions.

Development of a novel instrument to characterize telemedicine programs in primary care.

BACKGROUND: Given the rapid deployment of telemedicine at the onset of the COVID - 19 pandemic, updated assessment methods are needed to study and characterize telemedicine programs. We developed a novel semi - structured survey instrument to systematically describe the characteristics and implementation processes of telemedicine programs in primary care. METHODS: In the context of a larger study aiming to describe telemedicine programs in primary care, a survey was developed in 3 iterative steps: 1) literature review to obtain a list of telemedicine features, facilitators, and barriers; 2) application of three evaluation frameworks; and 3) stakeholder engagement through a 2-stage feedback process. During survey refinement, items were tested against the evaluation frameworks while ensuring it could be completed within 20-25 min. Data reduction techniques were applied to explore opportunity for condensed variables/items. RESULTS: Sixty initially identified telemedicine features were reduced to 32 items / questions after stakeholder feedback. Per the life cycle framework, respondents are asked to report a month in which their telemedicine program reached a steady state, i.e., "maturation". Subsequent questions on telemedicine features are then stratified by telemedicine services offered at the pandemic onset and the reported point of maturation. Several open - ended questions allow for additional telemedicine experiences to be captured. Data reduction techniques revealed no indication for data reduction. CONCLUSION: This 32-item semi-structured survey standardizes the description of primary care telemedicine programs in terms of features as well as maturation process. This tool will facilitate evaluation of and comparisons between telemedicine programs across the United States, particularly those that were deployed at the pandemic onset.

Greater executive dysfunction in patients post-COVID-19 compared to those not infected.

BACKGROUND: A number of patients post-coronavirus disease-19 (COVID-19) report cognitive impairment (CI), even months after acute infection. We aimed to assess if COVID-19 is associated with increased incidence of CI in comparison to controls. METHODS: We analyzed data from the Mount Sinai Health System Post-COVID-19 Registry in New York City, a prospective cohort of patients post-COVID-19 ≥18 years of age and non-infected controls. CI was defined by scores ≥ 1.0 standard deviation below population norms, and was assessed using well-validated measures of attention, working memory, processing speed, executive functioning/cognitive flexibility, language, learning, and memory. Logistic regression models assessed odds for CI in each domain in patients post-COVID-19 vs. controls after adjusting for potential confounders. In exploratory analyses, we assessed odds for CI by site of acute COVID-19 care as a proxy for disease severity. FINDINGS: 417 patients post-COVID-19 and 151 controls (mean age 49 years, 63% female, 21% Black, 17% Latinx) were included. In adjusted analyses, patients were significantly more likely than controls to have CI in executive functioning (odds ratio [OR]: 2.19; 95% confidence interval [CI]: 1.03 to 4.67), particularly those treated in outpatient (OR: 2.22; 95% CI: 1.02 to 4.82) and inpatient hospital (OR: 3.59; 95% CI: 1.27 to 10.16) settings. There were no significant associations between CI in other domains and history of COVID-19 or site of acute care. INTERPRETATION: Patients post-COVID-19 have greater odds of executive dysfunction, suggesting that focused cognitive screening may be prudent, even in those with mild to moderate disease. Studies should explore the pathophysiology and potential treatments for CI in this population. FUNDING: This work was funded by the Icahn School of Medicine at Mount Sinai.

Impact of diabetes on stage I lung cancer treatment patterns and prognosis in older adults: A population-based cohort study.

Background: Diabetes is a common comorbidity in patients with early-stage non-small cell lung cancer (NSCLC), a growing population due to increased LC screening. However, it is unknown if diabetes is associated with less aggressive NSCLC treatment and worse NSCLC outcomes. This study aimed to investigate treatment patterns and outcomes of older patients with Stage I NSCLC and diabetes. Methods: Using national cancer registry data linked to Medicare, we identified patients ≥65 years old with Stage I NSCLC. Patients were categorized as having no diabetes, diabetes without severe complications (DM-c), or diabetes with ≥1 severe complication (DM + c). We used multinomial logistic regression to assess the association of diabetes and NSCLC treatment. The association of diabetes category with NSCLC and non-NSCLC survival was analyzed with Fine-Grey competing-risks regression. Results: In 25,358 patients (75% no diabetes, 12% DM-c and 13% had DM + c), adjusted analyses showed that DM-c and DM + c were associated with increased odds of receiving limited resection rather than lobectomy (odds ratio [OR]: 1.22, 95% confidence interval [CI]: 1.07-1.37 and OR 1.42, 95% CI 1.26-1.59, respectively). Competing risk regression showed diabetes was associated with increased risk of non-NSCLC death (DM-c hazard ratio [HR] 1.16, 95% CI: 1.08-1.25, DM + c HR 1.49, 95% CI: 1.40-1.59), but not NSCLC-specific death. Conclusion: This study uncovers critical information on how diabetes is associated with less aggressive early-stage NSCLC care in older patients. This study also confirms that diabetes increases death from non-lung cancer causes and managing comorbidities is crucial to improving outcomes in older early-stage NSCLC survivors.

A Qualitative Study on Using Telemedicine for Precepting and Teaching in the Academic Setting.

PURPOSE: To examine the impact of telemedicine use on precepting and teaching among preceptors and patients during the COVID-19 pandemic. METHOD: The authors conducted a secondary analysis of a qualitative study focusing on providers' and patients' experiences with and attitudes toward telemedicine at 4 academic health centers. Teaching and precepting were emergent codes from the data and organized into themes. Themes were mapped to domains from the 2009 Consolidated Framework for Implementation Research (CFIR), a framework that assists with effective implementation and consists of 5 domains: intervention characteristics, outer settings, inner settings, characteristics of individuals, and process. RESULTS: In total, 86 interviews were conducted with 65 patients and 21 providers. Nine providers and 3 patients recounted descriptions related to teaching and precepting with telemedicine. Eight themes were identified, mapping across all 5 CFIR domains, with the majority of themes (n = 6) within the domains of characteristics of individuals, processes, and intervention characteristics. Providers and patients described how a lack of prepandemic telemedicine experience and inadequate processes in place to precept and teach with telemedicine affected the learning environment and perceived quality of care. They also discussed how telemedicine exacerbated existing difficulties in maintaining resident continuity. Providers described ways communication changed with telemedicine use during the pandemic, including having to wear masks while in the same room as the trainee and sitting closely to remain within range of the camera, as well as the benefit of observing trainees with the attending's camera off. Providers expressed a lack of protected structure and time for teaching and supervising with telemedicine, and a general view that telemedicine is here to stay. CONCLUSIONS: Efforts should focus on increasing knowledge of telemedicine skills and improving processes to implement telemedicine in the teaching setting in order to best integrate it into undergraduate and graduate medical education.

Substance Use Disorders in the Geriatric Population: a Review and Synthesis of the Literature of a Growing Problem in a Growing Population.

Purpose of review: Substance use disorders are becoming increasingly prevalent in the geriatric population, necessitating an updated understanding of the existing literature. This review aims to describe the epidemiology, special considerations, and management of substance use disorders in older adults. Recent findings: PubMed, Ovid MEDLINE, and PsychINFO databases were searched from their inception through June 2022 using the following keywords: "substance use disorder," "substance abuse," "abuse," "illicit substances," "illicit drugs," "addiction," "geriatric," "elderly," "older adults," "alcohol," "marijuana," "cannabis," "cocaine," "heroin," "opioid," and "benzodiazepine." Our findings suggest an increasing trend in substance use in older adults despite medical and psychiatric consequences when using such substances. The majority of older patients admitted to substance abuse treatment programs were not referred by healthcare providers, suggesting room for improvement in the screening and discussion of substance use disorders. Our review also suggests that there should be careful consideration of COVID-19 and racial disparities when screening, diagnosing, and treating substance use disorders in the older population. Summary: This review provides updated information on epidemiology, special considerations, and management of substance use disorders in older adults. As substance use disorders become more prevalent in older adults, primary care physicians must be prepared to recognize and diagnose substance use disorders as well as collaborate with and refer patients to geriatric medicine, geriatric psychiatry, and addiction medicine.

Community Navigation and Supportive Care Experiences of Low-Income Black and Latina Cancer Survivors: Patient and Navigator Perspectives.

Background: Little is known about the role of community-based navigation in supportive care delivery for historically marginalized cancer survivors. The purposes of this study were to evaluate supportive care experiences of low-income, Black and Latina cancer survivors and examine the care role of their community navigator. Methods: Qualitative evaluation of semi-structured interviews with Black and Latina cancer survivors (n=10) and navigators (n=4) from a community-based organization for low-income women were conducted and analyzed using content analysis. Results: Content analysis yielded six themes that described the supportive care experience over time and before and after navigator support. Navigating supportive care alone: a) internal and external influencers; b) alone and just surviving; c) feeling overwhelmed and distressed. Community Navigator delivered supportive care: a) establishing trust and safety; b) accepting multi-dimensional, navigator assisted supportive care management; c) distress alleviation. Conclusions: Low-income Black and Latina women with cancer reported internal strength yet endured cancer care alone leading to a feeling of distress. Subsequently, community navigators provided patient-centric, supportive care and alleviate physical and emotional distress. These findings highlight the importance of increasing awareness of and linkage to community navigators who may be able to meet the supportive care needs of diverse patient populations.

What Affects Treatment Underuse in Multiple Myeloma in the United States: A Qualitative Study.

BACKGROUND: Multiple myeloma (MM) is the second most common hematologic malignancy. African Americans are more likely than Whites to be diagnosed with and die of MM, but they experience the same survival times in clinical trials, suggesting that differences in survival may be attributed to differences in receipt of treatment or differences in access to new treatments. We undertook this study to identify the reasons and needs underlying disparities in treatment among patients diagnosed with MM. METHODS: We conducted in-depth interviews in 2019-2020 with patients diagnosed with MM between 2010 and 2014 who were identified as eligible for transplant and maintenance therapy and having experienced delays in or underuse of treatment for MM. Underuse was defined as the lack of a particular treatment that the patient was eligible to receive, not being transplanted if eligible, and/or not receiving maintenance therapy. Underuse included patients' decision to delay harvest or autologous stem cell transplant (ASCT) for the time being and return to the decision in the future. All interviews were audio-recorded and transcribed verbatim. Four investigators independently coded transcripts through inductive analysis to assess reasons for treatment decisions. RESULTS: Of the 29 patients interviewed, 68% experienced treatment underuse: 21% self-identified as African American, 5% as Hispanic, 10% as mixed race, 57% as White, and 16% as Asian. There were no racial differences in reasons for underuse or delay. Themes relating to treatment underuse included: perceived pros and cons of treatment, including potential harm or lack thereof in delaying treatment; physician recommendations; and personal agency. CONCLUSION: Patients' decision making, delays, and underuse of MM treatment are influenced by social, personal, medical, and contextual factors. Patients consider their relationship with their physician to be one of the most significant driving forces in their decisions and treatment plans.

The Telemedicine Experience in Primary Care Practices in the United States: Insights From Practice Leaders.

PURPOSE: The need to rapidly implement telemedicine in primary care during the coronavirus disease 2019 (COVID-19) pandemic was addressed differently by various practices. Using qualitative data from semistructured interviews with primary care practice leaders, we aimed to report commonly shared experiences and unique perspectives regarding telemedicine implementation and evolution/maturation since March 2020. METHODS: We administered a semistructured, 25-minute, virtual interview with 25 primary care practice leaders from 2 health systems in 2 states (New York and Florida) included in PCORnet, the Patient-Centered Outcomes Research Institute clinical research network. Questions were guided by 3 frameworks (health information technology evaluation, access to care, and health information technology life cycle) and involved practice leaders' perspectives on the process of telemedicine implementation in their practice, with a specific focus on the process of maturation and facilitators/barriers. Two researchers conducted inductive coding of qualitative data open-ended questions to identify common themes. Transcripts were electronically generated by virtual platform software. RESULTS: Twenty-five interviews were administered for practice leaders representing 87 primary care practices in 2 states. We identified the following 4 major themes: (1) the ease of telemedicine adoption depended on both patients' and clinicians' prior experience using virtual health platforms, (2) regulation of telemedicine varied across states and differentially affected the rollout processes, (3) visit triage rules were unclear, and (4) there were positive and negative effects of telemedicine on clinicians and patients. CONCLUSIONS: Practice leaders identified several challenges to telemedicine implementation and highlighted 2 areas, including telemedicine visit triage guidelines and telemedicine-specific staffing and scheduling protocols, for improvement.