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Navigating the U.S. regulatory landscape for neurologic digital health technologies

Busis, Neil A; Marolia, Dilshad; Montgomery, Robert; Balcer, Laura J; Galetta, Steven L; Grossman, Scott N
Digital health technologies (DHTs) can transform neurological assessments, improving quality and continuity of care. In the United States, the Food & Drug Administration (FDA) oversees the safety and efficacy of these technologies, employing a detailed regulatory process that classifies devices based on risk and requires rigorous review and post-market surveillance. Following FDA approval, DHTs enter the Current Procedural Terminology, Relative Value Scale Update Committee, and Centers for Medicare & Medicaid Services coding and valuation processes leading to coverage and payment decisions. DHT adoption is challenged by rapid technologic advancements, an inconsistent evidence base, marketing discrepancies, ambiguous coding guidance, and variable health insurance coverage. Regulators, policymakers, and payers will need to develop better methods to evaluate these promising technologies and guide their deployment. This includes striking a balance between patient safety and clinical effectiveness versus promotion of innovation, especially as DHTs increasingly incorporate artificial intelligence. Data validity, cybersecurity, risk management, societal, and ethical responsibilities should be addressed. Regulatory advances can support adoption of these promising tools by ensuring DHTs are safe, effective, accessible, and equitable.
PMCID:11014948
PMID: 38609447
ISSN: 2398-6352
CID: 5646182

Exemplar Hospital initiation trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098B a randomized implementation study to support hospitals in caring for patients with opioid use disorder

Bart, Gavin; Korthuis, P Todd; Donohue, Julie M; Hagedorn, Hildi J; Gustafson, Dave H; Bazzi, Angela R; Enns, Eva; McNeely, Jennifer; Ghitza, Udi E; Magane, Kara M; Baukol, Paulette; Vena, Ashley; Harris, Jacklyn; Voronca, Delia; Saitz, Richard
BACKGROUND:Hospitalizations involving opioid use disorder (OUD) are increasing. Medications for opioid use disorder (MOUD) reduce mortality and acute care utilization. Hospitalization is a reachable moment for initiating MOUD and arranging for ongoing MOUD engagement following hospital discharge. Despite existing quality metrics for MOUD initiation and engagement, few hospitals provide hospital based opioid treatment (HBOT). This protocol describes a cluster-randomized hybrid type-2 implementation study comparing low-intensity and high-intensity implementation support strategies to help community hospitals implement HBOT. METHODS:Four state implementation hubs with expertise in initiating HBOT programs will provide implementation support to 24 community hospitals (6 hospitals/hub) interested in starting HBOT. Community hospitals will be randomized to 24-months of either a low-intensity intervention (distribution of an HBOT best-practice manual, a lecture series based on the manual, referral to publicly available resources, and on-demand technical assistance) or a high-intensity intervention (the low-intensity intervention plus funding for a hospital HBOT champion and regular practice facilitation sessions with an expert hub). The primary efficacy outcome, adapted from the National Committee on Quality Assurance, is the proportion of patients engaged in MOUD 34-days following hospital discharge. Secondary and exploratory outcomes include acute care utilization, non-fatal overdose, death, MOUD engagement at various time points, hospital length of stay, and discharges against medical advice. Primary, secondary, and exploratory outcomes will be derived from state Medicaid data. Implementation outcomes, barriers, and facilitators are assessed via longitudinal surveys, qualitative interviews, practice facilitation contact logs, and HBOT sustainability metrics. We hypothesize that the proportion of patients receiving care at hospitals randomized to the high-intensity arm will have greater MOUD engagement following hospital discharge. DISCUSSION:Initiation of MOUD during hospitalization improves MOUD engagement post hospitalization. Few studies, however, have tested different implementation strategies on HBOT uptake, outcome, and sustainability and only one to date has tested implementation of a specific type of HBOT (addiction consultation services). This cluster-randomized study comparing different intensities of HBOT implementation support will inform hospitals and policymakers in identifying effective strategies for promoting HBOT dissemination and adoption in community hospitals. TRIAL REGISTRATION:NCT04921787.
PMCID:11007900
PMID: 38600571
ISSN: 1940-0640
CID: 5672882

Beyond traffic jam alleviation: evaluating the health and health equity impacts of New York City's congestion pricing plan

Ghassabian, Akhgar; Titus, Andrea R; Conderino, Sarah; Azan, Alexander; Weinberger, Rachel; Thorpe, Lorna E
New York City (NYC) is slated to be the first jurisdiction in the USA to implement a cordon-based congestion tax, which will be levied on vehicles entering its Central Business District. Several cities around the world, for example, London and Stockholm, have had similar cordon-based pricing programmes, defined as road pricing that charges drivers a fee for entering a specified area (typically a congested urban centre). In addition to reducing congestion and creating revenue, projections suggest the NYC congestion pricing plan may yield meaningful traffic-related air quality improvements that could result in health benefits. NYC is a large city with high air pollution and substantial racial/ethnic and socioeconomic health inequities. The distinct geography and meteorological conditions of the city also suggest that the policy's impact on air quality may extend beyond the NYC metropolitan area. As such, the potential breadth, directionality and magnitude of health impacts on communities who might be heavily affected by the nation's first congestion pricing plan should be empirically investigated. We briefly review evaluation studies of other cordon-based congestion pricing policies and argue that implementation of this policy provides an excellent opportunity to employ a quasi-experimental study design to evaluate the policy's impacts on air quality and health outcomes across population subgroups using a health equity lens. We discuss why real-time evaluations of the NYC congestion pricing plan can potentially help optimise benefits for communities historically negatively affected by traffic-related air pollution. Assessing intended and unintended impacts on health equity is key to achieving these goals.
PMID: 38195634
ISSN: 1470-2738
CID: 5624072

Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies

Skolarus, Ted A; Hawley, Sarah T; Forman, Jane; Sales, Anne E; Sparks, Jordan B; Metreger, Tabitha; Burns, Jennifer; Caram, Megan V; Radhakrishnan, Archana; Dossett, Lesly A; Makarov, Danil V; Leppert, John T; Shelton, Jeremy B; Stensland, Kristian D; Dunsmore, Jennifer; Maclennan, Steven; Saini, Sameer; Hollenbeck, Brent K; Shahinian, Vahakn; Wittmann, Daniela A; Deolankar, Varad; Sriram, S
BACKGROUND:Many men with prostate cancer will be exposed to androgen deprivation therapy (ADT). While evidence-based ADT use is common, ADT is also used in cases with no or limited evidence resulting in more harm than benefit, i.e., overuse. Since there are risks of ADT (e.g., diabetes, osteoporosis), it is important to understand the behaviors facilitating overuse to inform de-implementation strategies. For these reasons, we conducted a theory-informed survey study, including a discrete choice experiment (DCE), to better understand ADT overuse and provider preferences for mitigating overuse. METHODS:Our survey used the Action, Actor, Context, Target, Time (AACTT) framework, the Theoretical Domains Framework (TDF), the Capability, Opportunity, Motivation-Behavior (COM-B) Model, and a DCE to elicit provider de-implementation strategy preferences. We surveyed the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on the likelihood of stopping overuse as ADT monotherapy for localized prostate cancer ("yes"/"probably yes," "probably no"/"no"), and characterized corresponding Likert scale responses to seven COM-B statements. We used multivariable regression to identify associations between stopping ADT overuse and COM-B responses. RESULTS:Our survey was completed by 84 respondents (13% response rate), with 27% indicating "probably no"/"no" to stopping ADT overuse. We found differences across respondents who said they would and would not stop ADT overuse in demographics and COM-B statements. Our model identified 2 COM-B domains (Opportunity-Social, Motivation-Reflective) significantly associated with a lower likelihood of stopping ADT overuse. Our DCE demonstrated in-person communication, multidisciplinary review, and medical record documentation may be effective in reducing ADT overuse. CONCLUSIONS:Our study used a behavioral theory-informed survey, including a DCE, to identify behaviors and context underpinning ADT overuse. Specifying behaviors supporting and gathering provider preferences in addressing ADT overuse requires a stepwise, stakeholder-engaged approach to support evidence-based cancer care. From this work, we are pursuing targeted improvement strategies. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, NCT03579680.
PMCID:11005280
PMID: 38594740
ISSN: 2662-2211
CID: 5725762

Response to Letter to the Editor From Landrigan et al: "Chemicals Used in Plastic Materials: An Estimate of the Attributable Disease Burden and Costs in the United States"

Trasande, Leonardo; Park, Kevin; Obsekov, Vladislav; Belliveau, Michael
PMID: 38752204
ISSN: 2472-1972
CID: 5733632

Climate change perception and its association with cancer screening intent

Qian, Zhiyu; Beatrici, Edoardo; Trinh, Quoc-Dien; Kibel, Adam S; Loeb, Stacy; Iyer, Hari S; Cole, Alexander P
As the climate crisis deepens, its adverse effects on human health are becoming evident, including impacts on cancer pathogenesis and treatment. This study explored the link between individuals' awareness of the health impacts of climate change and interest in cancer screening. Using the 2021 Health Information National Trends Survey, our study demonstrated a statistically significant association between recognition of climate change as a personal health threat and interest in cancer screening. Although the study's retrospective nature and self-reported data pose some limitations, these findings signal a promising avenue for future research on the intersection of climate and cancer risk. This research supports the development of public health interventions that incorporate components of environmental health literacy alongside cancer screening efforts.
PMID: 38086539
ISSN: 1460-2105
CID: 5589222

Refer rather than treat: coping with uncertainty in municipal primary care clinics in India

Gore, Radhika
Purpose: The institutional conditions of primary care provision remain understudied in low- and middle-income countries. This study analyzes how primary care doctors cope with medical uncertainty in municipal clinics in urban India. As street-level bureaucrats, the municipal doctors occupy two roles simultaneously: medical professional and state agent. They operate under conditions that characterize health systems in low-resource contexts globally: inadequate state investment, weak regulation and low societal trust. The study investigates how, in these conditions, the doctors respond to clinical risk, specifically related to noncommunicable diseases (NCDs). Design/methodology/approach: The analysis draws on year-long ethnographic fieldwork in Pune (2013"“14), a city of three million, including 30 semi-structured interviews with municipal doctors. Findings: Interpreting their municipal mandate to exclude NCDs and reasoning their medical expertise as insufficient to treat NCDs, the doctors routinely referred NCD cases. They expressed concerns about violence from patients, negative media attention and unsupportive municipal authorities should anything go wrong clinically. Originality/value: The study contextualizes street-level service-delivery in weak institutional conditions. Whereas street-level workers may commonly standardize practices to reduce workload, here the doctors routinized NCD care to avoid the sociopolitical consequences of clinical uncertainty. Modalities of the welfare state and medical care in India "“ manifest in weak municipal capacity and healthcare regulation "“ appear to compel restraint in service-delivery. The analysis highlights how norms and social relations may shape primary care provision and quality.
SCOPUS:85184403682
ISSN: 0144-333x
CID: 5700712

Disparities in Visual Field Testing Frequency Among Subjects With Glaucoma

Madu, Chisom T; Lee, Ting-Fang; Sohn, Ashley; Hu, Jiyuan; Matayev, Rachel; Paranjpe, Vikram; Fam, Jonathan; Wronka, Andrew; Kim, Eleanore T; Zambrano, Ronald; Wollstein, Gadi; Schuman, Joel S
PURPOSE/UNASSIGNED:Prior evidence suggests racial disparities in the utilization of visual field testing (VFT) for the diagnosis and monitoring of glaucoma. In this study, we considered the effect of baseline glaucoma severity and socioeconomic disadvantage along with other potential confounders such as test reliability, ancillary tests, and glaucoma surgeries on racial disparity in the frequency of VFT. METHODS/UNASSIGNED:The records of all subjects with a diagnosis of glaucoma who received VFT at an academic, tertiary care facility from January 2018 to December 2021 were accessed. Analysis was performed to compare VFT frequency, the total number of office visits (DoS), and the ratio of VFT frequency to DoS (VFT/DoS) across self-reported races while controlling for sex, age, socioeconomic disadvantage (Area Deprivation Index), VF reliability indicators and baseline mean deviation, optical coherence tomography frequency, and glaucoma surgeries. RESULTS/UNASSIGNED:Among the 2654 subjects (1515 White, 782 Black, and 357 Asian) included in this study, Black subjects had the worst socioeconomic status and disease severity at baseline. They also experienced a 3% lower VFT/DoS ratio compared to White subjects (P = 0.031). Asian subjects had a 5% lower VFT/DoS ratio compared to White subjects (P = 0.015). DISCUSSION/UNASSIGNED:We identified racial disparity in performing VFT in subjects with glaucoma even when multiple confounders were considered. Further investigation is necessary to identify other race-associated factors to work toward reducing racial disparities in VFT. TRANSLATIONAL RELEVANCE/UNASSIGNED:Black and Asian subjects with glaucoma receive fewer VFT per visit compared to White subjects even when considering socioeconomic disadvantage and disease severity.
PMCID:10996970
PMID: 38564202
ISSN: 2164-2591
CID: 5670052

The Real Impact of the Alabama Supreme Court Decision in LePage v Center for Reproductive Medicine

Bayefsky, Michelle J; Caplan, Arthur L; Quinn, Gwendolyn P
PMID: 38436997
ISSN: 1538-3598
CID: 5691912

Trajectories of maternal depressive symptoms from infancy through early childhood: The roles of perceived financial strain, social support, and intimate partner violence

Ku, Seulki; Werchan, Denise M; Feng, Xin; Blair, Clancy
Although new mothers are at risk of heightened vulnerability for depressive symptoms, there is limited understanding regarding changes in maternal depressive symptoms over the course of the postpartum and early childhood of their child's life among rural, low-income mothers from diverse racial backgrounds. This study examined distinct trajectories of depressive symptoms among rural low-income mothers during the first five years of their child's life, at 6, 15, 24, and 58 months, using data from the Family Life Project (N = 1,292). Latent class growth analysis identified four distinct trajectories of maternal depressive symptoms, including Low-decreasing (50%; n = 622), Low-increasing (26%; n = 324), Moderate-decreasing (13%; n = 156), and Moderate-increasing (11%; n = 131) trajectories. Multinomial logistic regression demonstrated that higher perceived financial strain and intimate partner violence, and lower social support predicted higher-risk trajectories (Low-increasing, Moderate-decreasing, and Moderate-increasing) relative to the Low-decreasing trajectory. Compared to the Low-decreasing trajectory, lower neighborhood safety/quietness predicted to the Low-increasing trajectory. Moreover, lower social support predicted the Moderate-increasing trajectory, the highest-risk trajectory, compared to those in Moderate-decreasing. The current analyses underscore the heterogeneity on patterns of depressive symptoms among rural, low-income mothers, and that the role of both proximal and broader contexts contributing to distinct trajectories of maternal depressive symptoms over early childhood.
PMID: 38561991
ISSN: 1469-2198
CID: 5729032