bluuebunny/crossref_metadata_2025_split huggingface dataset:
How low can you go? Examining the effects of brief online training and post-training consultation dose on implementation mechanisms and outcomes for measurement-based care
Authors: Lyon Aaron R. , Liu Freda F. , Connors Elizabeth H. , King Kevin M. , Coifman Jessica I. , Cook Heather , McRee Erin , Ludwig Kristy , Law Amy , Dorsey Shannon , McCauley Elizabeth 
Published: July 2022

Abstract
Background
Initial training and ongoing post-training consultation (i.e., ongoing support following training, provided by an expert) are among the most common implementation strategies used to change clinician practice. However, extant research has not experimentally investigated the optimal dosages of consultation necessary to produce desired outcomes. Moreover, the degree to which training and consultation engage theoretical implementation mechanisms—such as provider knowledge, skills, and attitudes—is not well understood. This study examined the effects of a brief online training and varying dosages of post-training consultation (BOLT+PTC) on implementation mechanisms and outcomes for measurement-based care (MBC) practices delivered in the context of education sector mental health services.

Methods
A national sample of 75 clinicians who provide mental health interventions to children and adolescents in schools were randomly assigned to BOLT+PTC or control (services as usual). Those in BOLT+PTC were further randomized to 2-, 4-, or 8-week consultation conditions. Self-reported MBC knowledge, skills, attitudes, and use (including standardized assessment, individualized assessment, and assessment-informed treatment modification) were collected for 32 weeks. Multilevel models were used to examine main effects of BOLT+PTC versus control on MBC use at the end of consultation and over time, as well as comparisons among PTC dosage conditions and theorized mechanisms (skills, attitudes, knowledge).

Results
There was a significant linear effect of BOLT+PTC over time on standardized assessment use (b = .02, p < .01), and a significant quadratic effect of BOLT+PTC over time on individualized assessment use (b = .04, p < .001), but no significant effect on treatment modification. BOLT + any level of PTC resulted in higher MBC knowledge and larger growth in MBC skill over the intervention period as compared to control. PTC dosage levels were inconsistently predictive of outcomes, providing no clear evidence for added benefit of higher PTC dosage.

Conclusions
Online training and consultation in MBC had effects on standardized and individualized assessment use among clinicians as compared to services as usual with no consistent benefit detected for increased consultation dosage. Continued research investigating optimal dosages and mechanisms of these established implementation strategies is needed to ensure training and consultation resources are deployed efficiently to impact clinician practices.

Trial registration
ClinicalTrials.gov NCT05041517. Retrospectively registered on 10 September 2021.
Attiny85 controlled watch winder for self-winding mechanical watches
Authors: Thothadri Madhavan 
Published: July 2022

AbstractIn mechanical self-winding movement, the center-anchored Rotating Weight rotates about its axis with physical motions of the hand. It thereby winds the mainspring only when worn and stops during lay-offs. A watch winder re-creates the physical motions to maintain the beat in the caliber, when not worn. The paper proposes a residential tourbillon watch winder for self-winding mechanical calibers. The main objectives of this paper are to minimize the working time of the winder and consequently optimize its power consumption. A significant trade-off between the winding and unwinding ratios of the mainspring is ensured, maintaining a higher former ratio using a single-phase 9 RPM Permanent Magnet Synchronous Motor. The proposed model states the sufficiency of the winder to work only for 60% of the time. The model uses Watchdog timer to rekindle Attiny85 Microcontroller from sleep mode for scheduling the working time of the winder. The disclosed model is deployed to a Seiko (7S26A) caliber and a Citizen (8200A) Caliber for a period of 26 days to validate the working. The results show that the proposed model with the Seiko caliber requires 41.1 h for winding while the commercial models require 70.99 h. Similarly with the Citizen Caliber, the proposed watch winder requires only 28.8 h which is 21.11 h less than the time required by commercial models.
Exploring patients' experience of peer-supported open dialogue and standard care following a mental health crisis: qualitative 3-month follow-up study
Authors: Sunthararajah Sailaa , Clarke Katherine , Razzaque Russell , Chmielowska Marta , Brandrett Benjamin , Pilling Stephen 
Published: July 2022

Background
Experience of crisis care may vary across different care models.

Aims
To explore the experience of care in standard care and ‘open dialogue’ (a peer-supported community service focused on open dialogue and involving social networks for adults with a recent mental health crisis) 3 months after a crisis.

Method
We conducted semi-structured interviews with 11 participants (6 received open dialogue; 5 received treatment as usual (TAU)) in a feasibility study of open dialogue and analysed the data using a three-step inductive thematic analysis to identify themes that (a) were frequently endorsed and (b) represented the experiences of all participants.

Results
Four themes emerged: (a) feeling able to rely on and access mental health services; (b) supportive and understanding family and friends; (c) having a choice and a voice; and (d) confusion and making sense of experiences. Generally, there was a divergence in experience across the two care models. Open dialogue participants often felt able to rely on and access services and involve their family and friends in their care. TAU participants described a need to rely on services and difficulty when it was not met, needing family and friends for support and wanting them to be more involved in their care. Some participants across both care models experienced confusion after a crisis and described benefits of sense-making.

Conclusions
Understanding crisis care experiences across different care models can inform service development in crisis and continuing mental healthcare services.
Phase II LEAP-004 Study of Lenvatinib Plus Pembrolizumab for Melanoma With Confirmed Progression on a Programmed Cell Death Protein-1 or Programmed Death Ligand 1 Inhibitor Given as Monotherapy or in Combination
Authors: Arance Ana , de la Cruz-Merino Luis , Petrella Teresa M. , Jamal Rahima , Ny Lars , Carneiro Ana , Berrocal Alfonso , Márquez-Rodas Ivan , Spreafico Anna , Atkinson Victoria , Costa Svedman Fernanda , Mant Andrew , Khattak Muhammad A. , Mihalcioiu Catalin , Jang Sekwon , Cowey C. Lance , Smith Alan D. , Hawk Natalyn , Chen Ke , Diede Scott J. , Krepler Clemens , Long Georgina V. 
Published: July 2022

PURPOSE Effective treatments are needed for melanoma that progresses on inhibitors of programmed cell death protein-1 (PD-1) or its ligand (PD-L1). We conducted the phase II LEAP-004 study to evaluate the combination of the multikinase inhibitor lenvatinib and the PD-1 inhibitor pembrolizumab in this population (ClinicalTrials.gov identifier: NCT03776136 ). METHODS Eligible patients with unresectable stage III-IV melanoma with confirmed progressive disease (PD) within 12 weeks of the last dose of a PD-1/L1 inhibitor given alone or with other therapies, including cytotoxic T-cell lymphocyte–associated antigen 4 (CTLA-4) inhibitors, received lenvatinib 20 mg orally once daily plus ≤ 35 doses of pembrolizumab 200 mg intravenously once every 3 weeks until PD or unacceptable toxicity. The primary end point was objective response rate (ORR) per RECIST, version 1.1, by independent central review. RESULTS A total of 103 patients were enrolled and treated. The median study follow-up was 15.3 months. ORR in the total population was 21.4% (95% CI, 13.9 to 30.5), with three (2.9%) complete responses and 19 (18.4%) partial responses. The median duration of response was 8.3 months (range, 3.2-15.9+). ORR was 33.3% in the 30 patients with PD on prior anti–PD-1 plus anti–CTLA-4 therapy. The median progression-free survival and overall survival in the total population were 4.2 months (95% CI, 3.8 to 7.1) and 14.0 months (95% CI, 10.8 to not reached), respectively. Grade 3-5 treatment-related adverse events occurred in 47 (45.6%) patients, most commonly hypertension (21.4%); one patient died from a treatment-related event (decreased platelet count). CONCLUSION Lenvatinib plus pembrolizumab provides clinically meaningful, durable responses in patients with advanced melanoma with confirmed PD on prior PD-1/L1 inhibitor-based therapy, including those with PD on anti–PD-1 plus anti–CTLA-4 therapy. The safety profile was as expected. These data support lenvatinib plus pembrolizumab as a potential regimen for this population of high unmet need.
CA-125 KELIM as a Potential Complementary Tool for Predicting Veliparib Benefit: An Exploratory Analysis From the VELIA/GOG-3005 Study
Authors: You Benoit , Sehgal Vasudha , Hosmane Balakrishna , Huang Xin , Ansell Peter J. , Dinh Minh H. , Bell-McGuinn Katherine , Luo Xizhi , Fleming Gini F. , Friedlander Michael , Bookman Michael A. , Moore Kathleen N. , Steffensen Karina D. , Coleman Robert L. , Swisher Elizabeth M. 
Published: July 2022

PURPOSE In VELIA trial, veliparib combined with carboplatin-paclitaxel, followed by maintenance (veliparib-throughout) was associated with improved progression-free survival (PFS) compared with carboplatin-paclitaxel alone in patients with high-grade ovarian carcinomas. We explored the prognostic value of the modeled cancer antigen (CA)-125 elimination rate constant K (KELIM), which is known to be an indicator of the intrinsic tumor chemosensitivity (the faster the rate of CA-125 decline, the higher the KELIM and the higher the chemosensitivity), and its association with benefit from veliparib. PATIENTS AND METHODS Individual KELIM values were estimated from longitudinal CA-125 kinetics. Patients were categorized as having favorable (≥ median) or unfavorable (< median) KELIM. The prognostic value of KELIM for veliparib-related PFS benefit was explored in cohorts treated with primary or interval debulking surgery, according to the surgery completeness, the disease progression risk group, and the homologous recombination (HR) status ( BRCA mutation, HR deficiency [HRD], or HR proficiency [HRP]). RESULTS The data from 854 of 1,140 enrolled patients were analyzed (primary debulking surgery, n = 700; interval debulking surgery, n = 154). Increasing KELIM values were associated with higher benefit from veliparib in HRD cancer, as were decreasing KELIM values in HRP cancer. The highest PFS benefit from veliparib was observed in patients with both favorable KELIM and BRCA mutation (hazard ratio, 0.28; 95% CI, 0.13 to 0.61) or BRCA wild-type HRD cancer (hazard ratio, 0.43; 95% CI, 0.26 to 0.70), consistent with the association between poly (adenosine diphosphate-ribose) polymerase inhibitor efficacy and platinum sensitivity. In contrast, seventy-four percent of patients with a BRCA mutation and unfavorable KELIM progressed within 18 months while on veliparib. The patients with HRP cancer and unfavorable KELIM might have benefited from the veliparib chemosensitizing effect. CONCLUSION In addition to HRD/ BRCA status, the tumor primary chemosensitivity observed during the first-line chemotherapy might be another complementary determinant of poly (adenosine diphosphate-ribose) polymerase inhibitor efficacy.
Universal quantum effect of two-body correlation in a weakly interacting Bose gas
Authors: Song Pham The 
Published: July 2022

Abstract
Based on the Cornwall-Jackiw-Tomboulis (CJT) effective action approach and the requirement to preserve the Goldstone theorem within two-loop approximation, we study the universal quantum effect, which is related to the two-body correlation, in a homogeneous weakly interacting Bose gas at zero temperature. We find the state equations that provide the condensate fraction, energy density, chemical potential, and sound speed. They are the series expansions of the gas parameter.
Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits
Authors: Sachs Rachel E. , Jazowski Shelley A. , Gavulic Kyle A. , Donohue Julie M. , Dusetzina Stacie B. 
Published: July 2022

Abstract
Many state Medicaid officials are concerned about rising prescription drug spending, particularly drugs approved through the Food and Drug Administration's (FDA) accelerated approval pathway. The authors examined how much of Medicaid programs' accelerated approval spending is attributable to products that have demonstrated clinical benefits versus those that have not. Their findings provide support for states' concerns that pharmaceutical companies often fail to complete their required postapproval confirmatory studies within the FDA's requested timeline. But the findings also highlight one issue that policy stakeholders have not yet devoted substantial attention to: the use of surrogate endpoints involved in the postapproval confirmatory studies for most of the products in this study's sample. The granularity of the study's results enabled an analysis of the impact of different policy recommendations on both the accelerated approval pathway and Medicaid programs. These findings inform the current policy debate, suggesting that policy stakeholders might focus attention on products converting their approval on the basis of surrogate outcomes rather than on clinical outcomes.
Improving Access to High-Value, High-Cost Medicines: The Use of Subscription Models to Treat Hepatitis C Using Direct-Acting Antivirals in the United States
Authors: Auty Samantha G. , Griffith Kevin N. , Shafer Paul R. , Gee Rebekah E. , Conti Rena M. 
Published: July 2022

Abstract
State payers may face financial incentives to restrict use of high-cost medications. Yet, restrictions on access to high-value medications may have deleterious effects on population health. Direct-acting antivirals (DAAs), available since 2013, can cure chronic infection with hepatitis C virus (HCV). With prices upward of $90,000 for a treatment course, states have struggled to ensure access to DAAs for Medicaid beneficiaries and the incarcerated, populations with a disproportionate share of HCV. Advance purchase commitments (APCs), wherein a payer commits to purchase a certain quantity of medications at lower prices, offer payers incentives to increase access to high-value medications while also offering companies guaranteed revenue. This article discusses the use of subscription models, a type of APC, to support increased access to high-value DAAs for treating HCV. First, the authors provide background information about HCV, its treatment, and state financing of prescription medications. They then review the implementation of HCV subscription models in two states, Louisiana and Washington, and the early evidence of their impact. The article discusses challenges to evaluating state-sponsored subscription models, and it concludes by discussing implications of subscription models that target DAAs and other high-value, high-cost medicines.
Pursuing Pharmacoequity: Determinants, Drivers, and Pathways to Progress
Authors: Chalasani Rohan , Krishnamurthy Sudarshan , Suda Katie J. , Newman Terri V. , Delaney Scott W. , Essien Utibe R. 
Published: July 2022

Abstract
The United States pays more for medical care than any other nation in the world, including for prescription drugs. These costs are inequitably distributed, as individuals from underrepresented racial and ethnic groups in the United States experience the highest costs of care and unequal access to high-quality, evidence-based medication therapy. Pharmacoequity refers to equity in access to pharmacotherapies or ensuring that all patients, regardless of race and ethnicity, socioeconomic status, or availability of resources, have access to the highest quality of pharmacotherapy required to manage their health conditions. Herein the authors describe the urgent need to prioritize pharmacoequity. This goal will require a bold and innovative examination of social policy, research infrastructure, patient and prescriber characteristics, as well as health policy determinants of inequitable medication access. In this article, the authors describe these determinants, identify drivers of ongoing inequities in prescription drug access, and provide a framework for the path toward achieving pharmacoequity.
Assessing US Pharmaceutical Policy and Pricing Reform Legislation in Light of European Price and Cost Control Strategies
Authors: Rodwin Marc A. 
Published: July 2022

AbstractThis article compares the pharmaceutical pricing policies employed by public and private insurers in the United States with seven price and spending control strategies employed in the United Kingdom, France, and Germany. Differences between American and European policies explain why American pharmaceutical prices and per capita spending are higher than in European nations. The article then analyzes two recent bills as examples of significant American reform ideas—H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (introduced in 2019) and the Build Back Better Act (BBBA, introduced in 2021)—and compares them with European cost control strategies. Key drug price provisions of the BBBA were incorporated into the recently enacted Inflation Reduction Act (IRA). H.R. 3 would have used an international (mostly European) price index to cap U.S. prices; the BBBA would cap Medicare prices at a discount from average U.S. market prices. Neither bill would employ the key cost control strategies that European nations do. Both bills would have significantly less impact on prices than legislation that employs European-style cost controls. This article proposes steps that Congress could take in line with European strategies to lower purchase prices and costs for patients. These measures would have to overcome political obstacles that currently stymie reform.
Reforming the Medicare Part D Benefit Design: Financial Implications for Beneficiaries, Private Plans, Drug Manufacturers, and the Federal Government
Authors: Trish Erin , Kaiser Katrina M. , Celestin Jeanai , Joyce Geoffrey 
Published: July 2022

Abstract
Context: Reforming the Medicare Part D program—which provides prescription drug coverage to 49 million beneficiaries—has emerged as a key policy priority.
Methods: The authors evaluate prescription drug claims from a 100% sample of Medicare Part D beneficiaries to evaluate the current spending distribution across different payers for different types of beneficiaries across different benefit phases. They then model how these estimates would change under a proposal to redesign the Medicare Part D standard benefit.
Findings: Spending patterns differ for beneficiaries who do and do not qualify for low-income subsidies. Part D plans face limited liability for total spending under the current standard benefit design, amounting to 36% of total spending for beneficiaries who do not receive low-income subsidies and 28% of total spending for those who do. Proposed reforms would increase plan liability and significantly change the distribution of liability across plans, drug manufacturers, and the federal government.
Conclusions: Though the original goal of the Part D program was to create a market of competing private plans that provide prescription drug coverage to Medicare beneficiaries, the standard benefit design that was included in the original legislation reflected significant political compromises. Reforming the standard benefit design to give plans more skin in the game could significantly affect competition in the market, with differential impact across drug classes and types of beneficiaries.
A 4-Yr Mixed Longitudinal Study of Health Behaviors and Fat Mass Accrual during Adolescence and Early Adulthood
Authors: MCCONNELL-NZUNGA JENNIFER , GABEL LEIGH , MACDONALD HEATHER M. , RHODES RYAN E. , HOFER SCOTT M. , NAYLOR PATTI-JEAN , MCKAY HEATHER A. 
Published: July 2022

ABSTRACT

Purpose
Physical activity (PA), sedentary time (SED), and energy intake (EI) are associated with fat mass accrual in children and youth. Previous studies relied primarily on cross-sectional designs and proxy measures of body composition such as body mass index. We aimed to prospectively investigate associations between PA, SED, EI, and total body fat mass accrual using dual-energy x-ray absorptiometry.

Methods
This analysis of the mixed longitudinal Healthy Bones III Study included data from 312 participants (138 boys age 9 to 21 yr at baseline). For each participant, we acquired a maximum of four annual total body dual-energy x-ray absorptiometry scans from which we determined fat mass (in kilograms; n = 748 observations). We assessed total PA, moderate-to-vigorous PA (MVPA) and SED with accelerometers (ActiGraph GT1M) and measured EI via 24-h dietary recall. We fit sex-specific multilevel models adjusting for maturity (years from age at peak height velocity (APHV)), weight status, ethnicity, total PA, MVPA, SED, and EI.

Results
Boys and girls demonstrated divergent trajectories of fat mass accrual; rate of fat mass accrual in girls was four times greater than boys at APHV and increased across adolescence, whereas boys’ fat mass plateaued after APHV. In boys, within-person change in MVPA negatively predicted fat mass independent of SED; each annual increase in MVPA of 6 min·d−1 was associated with a 0.21-kg lower fat mass. In girls, between-person average MVPA negatively predicted fat mass accrual independent of SED; greater MVPA of 4 min·d−1 across adolescence was associated with a 0.31-kg lower fat mass.

Conclusions
MVPA demonstrates an independent and negative effect on fat mass in boys and girls. Given different trajectories of fat mass accrual and movement behaviors between boys and girls, PA interventions aimed at preventing obesity in youth may benefit from a sex and gendered approach.