Nevin Manimala

Anesthesiology. 2025 Aug 4. doi: 10.1097/ALN.0000000000005694. Online ahead of print.

ABSTRACT

BACKGROUND: Chronic pain is a leading cause of disability globally, with limited treatment options and frequent adverse effects. The IMI-PainCare-BioPain project aimed to enhance analgesic drug development by standardizing biomarkers. This study, IMI2-PainCare-BioPain-RCT1, evaluated the effects of lacosamide, pregabalin, and tapentadol on peripheral nerve excitability in healthy subjects through a randomized, double-blind, placebo-controlled crossover trial.

METHODS: The study included 43 healthy participants aged 18-45 years. Participants underwent four treatment periods where they received single doses of lacosamide (200 mg), pregabalin (150 mg), tapentadol (100 mg), or placebo. High-frequency stimulation was applied to induce hyperalgesia. The two primary endpoints were changes in Strength Duration Time Constant (SDTC) in large sensory and motor fibers between lacosamide and placebo periods at the first post-dose timepoint compared to baseline (60 min). Other predefined endpoints included recovery cycle, threshold electrotonus (TEd), and S2 accommodation as well as effects of pregabalin and tapentadol.

RESULTS: Lacosamide statistically significantly reduced SDTC in large sensory fibers (mean reduction 0.04 (95% CI 0.01-0.08), p = 0.012) and in motor fibers (mean reduction 0.04 (95% CI 0.00-0.07), p = 0.039) but had no effect on small sensory fibers at the first timepoint compared to placebo. There were no effects of pregabalin and tapentadol on SDTC. Of other predefined endpoints, lacosamide produced statistically significant changes in subexcitability, S2 accommodation TEd(peak), and TEd40(Accom) in large sensory fibers. No statistically significant changes were observed in refractoriness, relative refractory period, or accommodation half-time at the first timepoint compared to placebo.

CONCLUSIONS: This study demonstrates that nerve excitability testing can detect pharmacodynamic effects on large myelinated fibers in healthy subjects. Lacosamide statistically significantly reduced peripheral nerve excitability, particularly in large sensory fibers.

PMID:40758952 | DOI:10.1097/ALN.0000000000005694

Blood Adv. 2025 Aug 4:bloodadvances.2024015787. doi: 10.1182/bloodadvances.2024015787. Online ahead of print.

ABSTRACT

We aim to evaluate the efficacy of brentuximab vedotin (BV) combined with gemcitabine followed by BV maintenance in relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL). Patients (pts) with at least 5% CD30-positive cells by immunohistochemistry received 4 GBV induction (28d) cycles of gemcitabine 1000 mg/m2 (d1;d15) plus BV 1.8 mg/kg (d8) followed in responding pts by up to 12 BV maintenance (21d) cycles. Primary end point was overall response rate (ORR) after 4 induction cycles by CT-scan-based Lugano criteria. Of the 71 enrolled pts (median age of 66 years), 80.3% had received 1 prior line, 60.6% were refractory. The diagnoses per pathology central review were TFHL (47.9%), ALCL, [ALK- (19.7%) and ALK+ (7%)], PTCL-NOS (12.7%) and other entities (12.7%). In the intention-to-treat analysis, ORR was 46.5% with 19.7% complete response. Twenty-eight pts received maintenance. Grade 3-4 adverse events reported in ≥10% of pts during induction comprised: of neutropenia (55%), thrombocytopenia (14%), anemia (21%), infection (14%); during maintenance comprised of neutropenia (39%), thrombocytopenia (21%) and peripheral neuropathy (14%). With a median follow-up of 32.6 months, the median duration of response (DOR), progression-free (PFS) and overall survival were 15.8, 4.5 and 12.9 months, respectively. Efficacy, higher in ALCL, was present in the TFHL and PTCL-NOS group with and ORR, CR, PFS and DOR of 37.2%, 18.6%, 4 and 12.5 months, respectively. A negative association of high baseline soluble CD30 on both response and survival was found, which in ad hoc analysis appeared highly relevant in TFHL and PTCL-NOS patients. EudraCT 2017-000409-1 and NCT03496779.

PMID:40758949 | DOI:10.1182/bloodadvances.2024015787

Health Aff (Millwood). 2025 Aug;44(8):970-976. doi: 10.1377/hlthaff.2024.01661.

ABSTRACT

Black and Latino patients are disproportionately affected by end-stage renal disease and face significant disparities in treatment, with underuse of peritoneal dialysis and higher conversion rates from home peritoneal dialysis to in-center hemodialysis. With concerted efforts from policy makers to increase the uptake of home dialysis modalities such as peritoneal dialysis, policies to better support Black and Latino patients who receive peritoneal dialysis are greatly needed. Through in-depth, semistructured interviews conducted during the period July 2022-June 2023 in Seattle, Washington, this qualitative study explored the experiences of twelve Black and eight Latino/a participants from a local community-based dialysis organization who were either receiving home peritoneal dialysis or had transferred from home peritoneal dialysis to in-center hemodialysis. Factors that influenced participants’ experiences with peritoneal dialysis included poor mental health, the medicalization of the home, and language and cultural barriers. Our findings suggest that policies to improve access to mental health services, promote the use of community spaces for storage of dialysis supplies, and address language and cultural barriers in health care could improve the experiences of Black and Latino patients receiving peritoneal dialysis.

PMID:40758932 | DOI:10.1377/hlthaff.2024.01661

Health Aff (Millwood). 2025 Aug;44(8):933-942. doi: 10.1377/hlthaff.2024.01495.

ABSTRACT

Persistent shortages of workers providing long-term services and supports (LTSS) for more than a dozen years have led to increased reliance on foreign-born workers to meet the growing demand. However, there is a dearth of empirical data on long-term changes in the composition of the direct care workforce by nativity status and care setting. Using data from the American Community Survey (2012-22), we examined the extent to which foreign-born workers contributed to LTSS workforce growth and how their participation was distributed across care settings. We found that foreign-born direct care workers have increasingly filled workforce gaps, particularly in the home and community-based services (HCBS) sector. The HCBS workforce grew by more than 24 percent during the period 2012-22, while the institutional workforce declined by 23 percent; this decline was primarily due to the exodus of native-born workers. Foreign-born workers accounted for approximately half of the increase in the direct care workforce in HCBS settings during this period. To address continued workforce shortages in LTSS and meet the demand for HCBS, policy makers should consider immigration reforms to support a sustainable supply of foreign-born workers, investments in training and career pathways, and improvements in job quality through higher wages and opportunities for career advancement.

PMID:40758931 | DOI:10.1377/hlthaff.2024.01495

Health Aff (Millwood). 2025 Aug;44(8):953-962. doi: 10.1377/hlthaff.2024.01494.

ABSTRACT

Nonprofit hospital workers represent a significant portion of the US health care workforce. Previous research indicates that wage inequalities exist within nonprofit hospitals, varying by hospital characteristics. To explore whether these inequalities have grown over time, particularly during the COVID-19 pandemic, we used Internal Revenue Service Form 990 and Medicare cost reports from the period 2009-23 to examine trends in wages and wage inequalities within nonprofit hospitals and assess differences by hospital characteristics. Persistent and widening wage inequalities in most years were observed, except during some years of the pandemic. Because hospitals are often large employers, wage inequality within them may reflect and reinforce broader patterns of local economic inequality, making this a relevant metric for evaluating the social benefit of nonprofit hospitals.

PMID:40758930 | DOI:10.1377/hlthaff.2024.01494

Health Aff (Millwood). 2025 Aug;44(8):1005-1010. doi: 10.1377/hlthaff.2024.01394.

ABSTRACT

Between 2018 and 2022, remote physiologic monitoring (RPM) claims increased, especially for Black (25,253 percent) and Hispanic (5,051 percent) Medicare patients. After adjustment for age, sex, and clinical factors, in 2022, Black and Hispanic Medicare patients had 88 percent and 84 percent higher RPM use rates, respectively, compared with White patients.

PMID:40758929 | DOI:10.1377/hlthaff.2024.01394

Health Aff (Millwood). 2025 Aug;44(8):925-932. doi: 10.1377/hlthaff.2025.00144.

ABSTRACT

The mental health of US children and adolescents has reached a crisis point. As of 2023, 18 percent of adolescents had experienced a major depressive episode in the past year-more than double the percentage in 2010-and one-fifth of teens had seriously considered suicide. This article describes the alarming growth in the teen prevalence of mood disorders, suicidal ideation and death, and fatal drug overdoses and in the volume of pediatric patients visiting emergency departments and hospitals for mental health diagnoses. The crisis varies by sex and disproportionately affects LGBTQ+, rural, and racially and economically marginalized youth. For example, among LGBTQ+ high school students, nearly two in three report persistent sadness or hopelessness, and one-fifth have attempted suicide. Increased access to social media and lethal agents (for example, firearms and fentanyl) and deficiencies in behavioral health care are likely contributors. Although further research is needed to fully understand the etiologies of the youth mental health crisis and the effectiveness of individual interventions, the lack of political will-not evidence-poses the greatest barrier to meaningful action.

PMID:40758927 | DOI:10.1377/hlthaff.2025.00144

Health Aff (Millwood). 2025 Aug;44(8):996-1004. doi: 10.1377/hlthaff.2024.01659.

ABSTRACT

The COVID-19 public health emergency disrupted access to in-person behavioral health treatment beginning in the spring of 2020. This prompted federal telehealth flexibilities that have permitted the initiation of controlled medications, including prescription stimulants for attention-deficit/hyperactivity disorder, via telehealth and without an in-person medical evaluation. In a national sample of child and adult Medicaid and Children’s Health Insurance Program (CHIP) enrollees, we found that the start of the public health emergency was associated with an immediate level increase of 24.7 telehealth-only stimulant initiations per 100,000 enrollees per month and an immediate level reduction of 53.5 in-person initiations per 100,000 enrollees per month. Key subgroups, including young adult and female enrollees, used telehealth for stimulant initiations at least as much as the overall Medicaid/CHIP sample. Still, total initiation rates during the public health emergency remained below pre-public health emergency levels through December 2022. These findings may inform considerations about extending telehealth flexibilities, showing that among Medicaid/CHIP enrollees, telehealth compensated for much of the pre-public health emergency levels of in-person stimulant initiations, but it did not appear to contribute to stimulant overprescribing that could elevate risks for misuse and diversion.

PMID:40758925 | DOI:10.1377/hlthaff.2024.01659

Health Aff (Millwood). 2025 Aug;44(8):943-952. doi: 10.1377/hlthaff.2025.00266.

ABSTRACT

Obstetricians and gynecologists (OB-GYNs) provide essential health care to women across their lifespan. Yet nearly half of US counties have no OB-GYNs, with nonmetropolitan communities disproportionately affected. Targeted Regulation of Abortion Providers (TRAP) laws, spurred by the 1992 US Supreme Court decision in Planned Parenthood v. Casey, impose regulatory burdens on abortion providers and may have influenced whether and where OB-GYNs choose to practice, which has not yet been comprehensively studied. Using a staggered difference-in-differences design and county-level data, we found that TRAP laws were associated with an average reduction of 4.67 percent in the density of OB-GYNs per 100,000 women ages 15-44 during the period 1993-2021, between Casey and the Dobbs v. Jackson Women’s Health Organization decision in 2022. TRAP laws affected both general and fellowship-trained OB-GYNs, as well as counties without abortion facilities. Concerningly, TRAP laws led to lower physician density in nonmetropolitan counties-a difference that persisted for a decade. As OB-GYN shortages are projected to worsen and TRAP laws are still in effect in twenty-four states, policy makers should consider the long-run effects of TRAP laws on women’s access to health care and their potential to exacerbate geographic disparities in access to care.

PMID:40758924 | DOI:10.1377/hlthaff.2025.00266

Health Aff (Millwood). 2025 Aug;44(8):977-985. doi: 10.1377/hlthaff.2025.00037.

ABSTRACT

Despite coverage regulations requiring most insurers to cover pre-exposure prophylaxis (PrEP) without cost sharing, insurance coverage issues and cost-sharing practices persist. In this study, we assessed the prevalence of denials and cost sharing associated with PrEP among sexual and gender minority people in the US. Between August 2022 and July 2023, we recruited, via geosocial networking applications, sexual and gender minority people, who completed a screening survey for an HIV prevention study. Of 11,410 participants reporting current or former PrEP use, 23.7 percent had ever experienced a denial for their PrEP, ranging from 8.5 percent for generic tenofovir disoproxil fumarate and emtricitabine to 48.2 percent for Descovy. In addition, 34.6 percent reported cost sharing within the prior two years. The majority (58.3 percent) of cost-sharing instances were for laboratory bloodwork, and most (61.5 percent) were among privately insured people. Continued insurance denials and cost sharing associated with PrEP necessitate further policy intervention to address gaps in coverage, billing errors, and challenges resulting from formulary tiering.

PMID:40758923 | DOI:10.1377/hlthaff.2025.00037