bluuebunny/crossref_metadata_2025_split huggingface dataset:
Codesigning a systemic discharge intervention for inpatient mental health settings (MINDS): a protocol for integrating realist evaluation and an engineering-based systems approach
Authors: Hackmann Corinna , Komashie Alexander , Handley Melanie , Murdoch Jamie , Wagner Adam P , Grünwald Lisa Marie , Waller Sam , Kaminskiy Emma , Zeilig Hannah , Jones Julia , Bray Joy , Bagge Sophie , Simpson Alan , Dalkin Sonia Michelle , Clarkson John , Borghini Giovanni , Kipouros Timoleon , Rohricht Frank , Taousi Zohra , Haighton Catherine , Rae Sarah , Wilson Jon 
Published: September 2023

IntroductionTransition following discharge from mental health hospital is high risk in terms of relapse, readmission and suicide. Discharge planning supports transition and reduces risk. It is a complex activity involving interacting systemic elements. The codesigning a systemic discharge intervention for inpatient mental health settings (MINDS) study aims to improve the process for people being discharged, their carers/supporters and staff who work in mental health services, by understanding, co-designing and evaluating implementation of a systemic approach to discharge planning.Methods and analysisThe MINDS study integrates realist research and an engineering-informed systems approach across three stages. Stage 1 applies realist review and evaluation using a systems approach to develop programme theories of discharge planning. Stage 2 uses an Engineering Better Care framework to codesign a novel systemic discharge intervention, which will be subjected to process and economic evaluation in stage 3. The programme theories and resulting care planning approach will be refined throughout the study ready for a future clinical trial. MINDS is co-led by an expert by experience, with researchers with lived experience co-leading each stage.Ethics and disseminationMINDS stage 1 has received ethical approval from Yorkshire & The Humber—Bradford Leeds (Research Ethics Committee (22/YH/0122). Findings from MINDS will be disseminated via high-impact journal publications and conference presentations, including those with service user and mental health professional audiences. We will establish routes to engage with public and service user communities and National Health Service professionals including blogs, podcasts and short videos.Trial registration numberMINDS is funded by the National Institute of Health Research (NIHR 133013)https://fundingawards.nihr.ac.uk/award/NIHR133013. The realist review protocol is registered on PROSPERO.PROSPERO registration numberCRD42021293255.
Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy
Authors: Kuniyoshi Ouki , Sano Motohiko , Nakano Yasuhiro , Kawaguchi Takashi , Hatakeyama Tomoki , Tsuchiya Yusuke , Inada Yusuke , Harada Tomohiko , Kurosaki Miyuki , Mashiko Tomoe , Miyaji Tempei , Yamaguchi Takuhiro 
Published: September 2023

IntroductionSymptom-related adverse events associated with perioperative chemotherapy in patients with breast cancer include short-term adverse events such as nausea and vomiting. However, changes in the severity and duration of prolonged symptom-related adverse events have not been fully investigated. We present a protocol of a study that aims to clarify the prevalence of symptom-related adverse events in patients with breast cancer 1 year after neoadjuvant or adjuvant chemotherapy using an electronic patient-reported outcomes (ePRO) system.Methods and analysisThis multicentre prospective observational cohort study will include patients with breast cancer who have received preoperative or postoperative adjuvant chemotherapy. The final injection date of the cytotoxic agent will be the study initiation date. Patients will report every 2 weeks from the initiation date to 12 weeks and every 4 weeks from 12 weeks to 1 year, and they can enter this information into the ePRO system from anywhere. The primary outcome will be the prevalence of symptom-related adverse events according to the ePRO system 1 year after the date of the last injection of the cytotoxic drug used in neoadjuvant or adjuvant chemotherapy for breast cancer. To increase multi-institutional enrolment, two cohorts will be included. Cohort 1 will comprise patients with acquisition of baseline patient information regarding preoperative chemotherapy and presurgery characteristics. Cohort 2 will comprise patients without acquisition of baseline patient information. The target sample size is ≥250 per year.Ethics and disseminationThe study protocol has been approved by the ethics committee at each participating institution. The results will be presented at major national and international conferences and submitted to peer-reviewed journals.Trial statusRegistration was started in October 2021. By August 2022, a total of 132 participants were enrolled. Follow-up will be continued through December 2024.Trial registration numberUMIN000045422.
Estimating the cost impact of atrial fibrillation using a prospective cohort study and population-based controls
Authors: Aebersold Helena , Foster-Witassek Fabienne , Serra-Burriel Miquel , Brüngger Beat , Aeschbacher Stefanie , Beer Jürg-Hans , Blozik Eva , Blum Manuel , Bonati Leo , Conen David , Conte Giulio , Felder Stefan , Huber Carola , Kuehne Michael , Moschovitis Giorgio , Mueller Andreas , Paladini Rebecca E , Reichlin Tobias , Rodondi Nicolas , Springer Anne , Stauber Annina , Sticherling Christian , Szucs Thomas , Osswald Stefan , Schwenkglenks Matthias 
Published: September 2023

AimsAtrial fibrillation (AF) costs are expected to be substantial, but cost comparisons with the general population are scarce. Using data from the prospective Swiss-AF cohort study and population-based controls, we estimated the impact of AF on direct healthcare costs from the Swiss statutory health insurance perspective.MethodsSwiss-AF patients, enrolled from 2014 to 2017, had documented, prevalent AF. We analysed 5 years of follow-up, where clinical data, and health insurance claims in 42% of the patients were collected on a yearly basis. Controls from a health insurance claims database were matched for demographics and region. The cost impact of AF was estimated using five different methods: (1) ordinary least square regression (OLS), (2) OLS-based two-part modelling, (3) generalised linear model-based two-part modelling, (4) 1:1 nearest neighbour propensity score matching and (5) a cost adjudication algorithm using Swiss-AF data non-comparatively and considering clinical data. Cost of illness at the Swiss national level was modelled using obtained cost estimates, prevalence from the Global Burden of Disease Project, and Swiss population data.ResultsThe 1024 Swiss-AF patients with available claims data were compared with 16 556 controls without known AF. AF patients accrued CHF5600 (EUR5091) of AF-related direct healthcare costs per year, in addition to non-AF-related healthcare costs of CHF11100 (EUR10 091) per year accrued by AF patients and controls. All five methods yielded comparable results. AF-related costs at the national level were estimated to amount to 1% of Swiss healthcare expenditure.ConclusionsWe robustly found direct medical costs of AF patients were 50% higher than those of population-based controls. Such information on the incremental cost burden of AF may support healthcare capacity planning.
Cognitive control subprocess deficits and compensatory modulation mechanisms in patients with frontal lobe injury revealed by EEG markers: a basic study to guide brain stimulation
Authors: Liu Sinan , Shi Chaoqun , Meng Huanhuan , Meng Yu , Gong Xin , Chen Xiping , Tao Luyang 
Published: September 2023

BackgroundFrontal lobe injury (FLI) is related to cognitive control impairments, but the influences of FLI on the internal subprocesses of cognitive control remain unclear.AimsWe sought to identify specific biomarkers for long-term dysfunction or compensatory modulation in different cognitive control subprocesses.MethodsA retrospective case-control study was conducted. Event-related potentials (ERP), oscillations and functional connectivity were used to analyse electroencephalography (EEG) data from 12 patients with unilateral frontal lobe injury (UFLI), 12 patients with bilateral frontal lobe injury (BFLI) and 26 healthy controls (HCs) during a Go/NoGo task, which included several subprocesses: perceptual processing, anticipatory preparation, conflict monitoring and response decision.ResultsCompared with the HC group, N2 (the second negative peak in the averaged ERP waveform) latency, and frontal and parietal oscillations were decreased only in the BFLI group, whereas P3 (the third positive peak in the averaged ERP waveform) amplitudes and sensorimotor oscillations were decreased in both patient groups. The functional connectivity of the four subprocesses was as follows: alpha connections of posterior networks in the BFLI group were lower than in the HC and UFLI groups, and these alpha connections were negatively correlated with neuropsychological tests. Theta connections of the dorsal frontoparietal network in the bilateral hemispheres of the BFLI group were lower than in the HC and UFLI groups, and these connections in the uninjured hemisphere of the UFLI group were higher than in the HC group, which were negatively correlated with behavioural performances. Delta and theta connections of the midfrontal-related networks in the BFLI group were lower than in the HC group. Theta across-network connections in the HC group were higher than in the BFLI group but lower than in the UFLI group.ConclusionsThe enhancement of low-frequency connections reflects compensatory mechanisms. In contrast, alpha connections are the opposite, therefore revealing more abnormal neural activity and less compensatory connectivity as the severity of injury increases. The nodes of the above networks may serve as stimulating targets for early treatment to restore corresponding functions. EEG biomarkers can measure neuromodulation effects in heterogeneous patients.
War and disaster are forcing a major rethink around mass casualty management
Authors: Horne Simon , Hunt P , Hall B , Jefferys S , Vassallo J , Gurney I 
Published: September 2023

Mass casualty events (MASCAL) do not follow the same rules as typical major incidents. In the West at least, the latter often occur in stable, networked trauma systems, whereas MASCAL are characterised by overwhelming numbers of patients, compounded by protracted scene and transport times, decompensated response systems and significant disruption to infrastructure, command and control.This paper describes the 8Ds approach being taken by the UK Defence Medical Services and the North Atlantic Treaty Organization Emergency Medicine Panel framework to approach MASCAL. The eight domains were derived from literature about management of casualties in the World Wars, and also from approaches taken by civilian health systems as they struggle to manage increasing demand. They are:distribute;decompress;delay;delegate;deliver faster and deliver better;dynamic levels of care; andde-escalate. These domains will allow a structured approach to research and innovate around MASCAL, informing better guidelines for their management.
Early-Stage Breast Cancer Detection in Breast Milk
Authors: Saura Cristina , Ortiz Carolina , Matito Judit , Arenas Enrique J. , Suñol Anna , Martín Ágatha , Córdoba Octavi , Martínez-Sabadell Alex , García-Ruiz Itziar , Miranda Ignacio , Morales-Comas Clara , Carrasco Estela , Viaplana Cristina , Peg Vicente , Nuciforo Paolo , Bayó-Puxan Neus , Gonzalez-Medina Alberto , Miquel Josep M. , Gómez-Rey Marina , Villacampa Guillermo , Arévalo Silvia , Espinosa-Bravo Martín , Balmaña Judith , Dienstmann Rodrigo , Arribas Joaquin , Tabernero Josep , Vivancos Ana , Sansó Miriam 
Published: September 2023

Abstract

Breast cancer occurring during pregnancy (PrBC) and postpartum (PPBC) is usually diagnosed at more advanced stages compared with other breast cancer, worsening its prognosis. PPBC is particularly aggressive, with increased metastatic risk and mortality. Thus, effective screening methods to detect early PrBC and PPBC are needed. We report for the first time that cell-free tumor DNA (ctDNA) is present in breast milk (BM) collected from patients with breast cancer. Analysis of ctDNA from BM detects tumor variants in 87% of the cases by droplet digital PCR, while variants remain undetected in 92% of matched plasma samples. Retrospective next-generation sequencing analysis in BM ctDNA recapitulates tumor variants, with an overall clinical sensitivity of 71.4% and specificity of 100%. In two cases, ctDNA was detectable in BM collected 18 and 6 months prior to standard diagnosis. Our results open up the potential use of BM as a new source for liquid biopsy for PPBC detection.

Significance:
For the first time, we show that BM obtained from patients with breast cancer carries ctDNA, surpassing plasma-based liquid biopsy for detection and molecular profiling of early-stage breast cancer, even prior to diagnosis by image.
See related commentary by Cunningham and Turner, p. 2125.
This article is featured in Selected Articles from This Issue, p. 2109
Neoadjuvant Durvalumab Alone or Combined with Novel Immuno-Oncology Agents in Resectable Lung Cancer: The Phase II NeoCOAST Platform Trial
Authors: Cascone Tina , Kar Gozde , Spicer Jonathan D. , García-Campelo Rosario , Weder Walter , Daniel Davey B. , Spigel David R. , Hussein Maen , Mazieres Julien , Oliveira Julio , Yau Edwin H. , Spira Alexander I. , Anagnostou Valsamo , Mager Raymond , Hamid Oday , Cheng Lin-Yang , Zheng Ying , Blando Jorge , Tan Tze Heng , Surace Michael , Rodriguez-Canales Jaime , Gopalakrishnan Vancheswaran , Sellman Bret R. , Grenga Italia , Soo-Hoo Yee , Kumar Rakesh , McGrath Lara , Forde Patrick M. 
Published: September 2023

Abstract

Neoadjuvant chemoimmunotherapy improves pathologic complete response rate and event-free survival in patients with resectable non–small cell lung cancer (NSCLC) versus chemotherapy alone. NeoCOAST was the first randomized, multidrug platform trial to examine novel neoadjuvant immuno-oncology combinations for patients with resectable NSCLC, using major pathologic response (MPR) rate as the primary endpoint. Eighty-three patients received a single cycle of treatment: 26 received durvalumab (anti–PD-L1) monotherapy, 21 received durvalumab plus oleclumab (anti-CD73), 20 received durvalumab plus monalizumab (anti-NKG2A), and 16 received durvalumab plus danvatirsen (anti-STAT3 antisense oligonucleotide). MPR rates were higher for patients in the combination arms versus durvalumab alone. Safety profiles for the combinations were similar to those of durvalumab alone. Multiplatform immune profiling suggested that improved MPR rates in the durvalumab plus oleclumab and durvalumab plus monalizumab arms were associated with enhanced effector immune infiltration of tumors, interferon responses and markers of tertiary lymphoid structure formation, and systemic functional immune cell activation.

Significance:
A neoadjuvant platform trial can rapidly generate clinical and translational data using candidate surrogate endpoints like MPR. In NeoCOAST, patients with resectable NSCLC had improved MPR rates after durvalumab plus oleclumab or monalizumab versus durvalumab alone and tumoral transcriptomic signatures indicative of augmented immune cell activation and function.
See related commentary by Cooper and Yu, p. 2306.
This article is featured in Selected Articles from This Issue, p. 2293
Association of Neighborhood Recreation Centers and Poststroke Outcomes in a Population-Based Cohort
Authors: Delhey Leanna M. , Shi Xu , Morgenstern Lewis B. , Brown Devin L. , Smith Melinda A. , Case Erin C. , Springer Mellanie V. , Lisabeth Lynda D. 
Published: September 2023

BACKGROUND:
Higher neighborhood socioeconomic status has been favorably associated with stroke outcomes. This may be due to these areas having more beneficial resources such as recreational centers. We aimed to determine if neighborhood density of recreation centers is favorably associated with stroke outcomes.

METHODS:
We conducted analyses of data from the Brain Attack Surveillance in Corpus Christi project, a cohort of stroke survivors ≥45 years of age residing in Nueces County, TX (2009–2020). We included non-Hispanic White and Mexican American incident stroke survivors, who were not institutionalized prestroke and completed baseline and follow-up assessments (N=1392). We calculated the density of fitness and recreational sports centers within their residential census tract during the year of their stroke. Outcomes included function (self-ratings on activities of daily living and instrumental activities of daily living), cognition (modified mini-mental state exam), depression (Patient Health Questionnaire-8), and quality of life (abbreviated Stroke-Specific Quality of Life Scale). We fit confounder-adjusted gamma-distributed mixed generalized linear models with a log link for each outcome and considered interaction with stroke severity.

RESULTS:
On average, participants were 65 years old, 53% male, and 63% Mexican American. Median recreational centers were 1.60 per square mile (interquartile range, 0.41–3.06). Among moderate-severe stroke survivors, greater density of recreation centers (75th versus 25th percentile) was associated with more favorable function and possibly quality of life (activities of daily living/instrumental activities of daily living, 4.8% change [95% CI, −0.11% to −9.27%]; Stroke-Specific Quality of Life Scale, 3.7% change [95% CI, −0.7% to 8.2%]). Minimal nonsignificant differences were observed among the overall stroke population and those with mild stroke.

CONCLUSIONS:
The availability of recreation centers may be beneficial for poststroke function and quality of life among those with moderate-severe stroke. If further research confirms recreation centers to be beneficial, this could inform rehabilitation following stroke.
Climate Change Policies and Control of Corruption: A Cross-National Analysis of CO2 Emissions
Authors: Alasaly Shahd , Basso Larissa , Hargrove Andrew , Sommer Jamie M. 
Published: September 2023

Abstract
Given current climate change issues, scholars have recently focused on how different adaptation and mitigation policies may be effective at improving the environment. On the one hand, researchers argue that climate change policies will help reduce environmental problems like CO2 emissions due to their focus on green energy and markets. On the other hand, many argue that these policies are too small in scope, reformist, and do not address the underlying issues driving climate change. However, little is known about how climate change policies as a whole are impacting CO2 emissions cross-nationally. To address this research gap, the authors use two-way fixed effects regression analysis to test how climate change policies impact CO2 emissions per capita across 159 nations from 1996 to 2018. Most importantly, this analysis considers how factors like governance, specifically a nation’s control of corruption, moderates the impact of climate change policies on CO2 emissions.
Why We Don’t Mind the Gap
Authors: Kitsnik Joanna 
Published: September 2023

Abstract
Rising socio-economic inequality has been paired with tolerance of inequality. When explaining individual tolerance of unequal income distribution, contextual factors capturing socio-economic conditions and objective inequality are less important than individual-level values and beliefs about the origins of and reasonings behind the unequal circumstances. These inequality-legitimizing narratives constitute a range of ideas from equal opportunities and individual liberties to egalitarian values and beliefs about the function of meritocracy. Findings from the linear mixed effects models on the cross-sectional data from the Integrated Values Study (2017–2020) on 34 OECD countries support the argument that individuals’ agreement with inequality legitimizing narratives predicts higher tolerance of unequal income distribution. However, country-level objective inequality and economic prosperity both fail to directly predict tolerance of unequal incomes. When compared to contextual factors, the acceptance of inequality legitimizing narratives is a significantly better predictor of inequality tolerance.
The Love for International Organizations
Authors: d’Aspremont Jean 
Published: September 2023

Abstract
Albeit the object of compelling criticisms in recent decades, international organizations continue to occupy a very central place in the practical, conceptual, cognitive, imaginary, and emotional universe of international lawyers. This article argues that the resilient centrality of international organizations in international legal thought and practice is the manifestation of international lawyers’ love for such institutions. This article’s main aim is to provide an account of the drivers that inform international lawyers’ love for international organizations with a view to elucidating what lies behind the centrality of international organizations in international legal thought and practice. Among the drivers of international lawyers’ love for international organizations, attention is paid to the representations of international organizations as taking care of people, as showing where to look for power, as knowing so much, as romanticising history, as providing a shared standard of experience, as textualising the universe, as providing and organizing space for discontent, as expanding international lawyers’ field of study, and as holding many secrets.
East African Community (eac) – Inspiring Constitutional Change by Promoting Constitutionalism?
Authors: Milej Tomasz 
Published: September 2023

Abstract
The East African Community (eac) is considered to be one of the most successful international organizations in Africa. Due to the founding Treaty’s commitment to democracy, human rights, rule of law and to achieving of a political federation, one may think that the eac has a potential to promote the ideas of transformative African constitutionalism in the participating states. However, the history of regional integration in East Africa, the eac’s current institutional set-up and its substantive law tell a different story. The organization’s elitist legacy and an integration model depending on the goodwill of the heads of state do not fully deliver on the principles which the Treaty pronounces. It is the pro-active stance taken by the East African Court of Justice (eacj) and to some extent also by the East African Legislative Assembly (eala) that keeps the constitutionalism and the hopes of East Africans alive.