bluuebunny/crossref_metadata_2025 huggingface dataset:
A Unique Case of Metastatic Oral Kaposi Sarcoma in an HIV-Negative Patient
Authors: Short Spencer H. , McGlone Michael , Nayak Chetan S.
Published: January 2025

Kaposi’s sarcoma (KS) is a tumor involving blood vessels and lymphatic tissue. It is caused by human herpes virus-8, typically in HIV infection in individuals with AIDS. There are 4 major types of KS including classic, endemic, immunosuppression, and AIDS-related. Endemic KS is unique among the different types as it is associated with patients with HIV-seronegative and can present either as an indolent tumor or as a fast-growing mass. The authors discuss a unique presentation of metastatic, endemic KS in a patient with HIV-negative, non-immunosuppression, which has yet to be described in the United States. A 38-year-old male with a history of same-sex partners, presented with a new oral lesion that had appeared 6 weeks ago. He was negative for human papillomavirus or HIV infection. A computed tomography (CT) scan demonstrated destructive lesions of the hard palate. The specimens obtained from biopsy were consistent with endemic KS. A Positron Emission Tomography – computed tomography (PET-CT) scan showed widely-metastatic disease. Case reports have described a rare subtype of HIV-seronegative KS in men who have sex with men. However, these are typically-indolent tumors with exclusively-cutaneous manifestation. This is a unique case of aggressive, widely-metastatic endemic KS metastatic in a patient with HIV-negative.
Cavernous Hemangioma of the External Auditory Canal Involving the Tympanic Membrane: Case Report and Literature Review
Authors: Huang Qingli , Qin Haiping , Li Lianqing , Gong Lili , Lv Yanhui
Published: January 2025

Cavernous hemangiomas of the external auditory canal simultaneously affecting the tympanic membrane are extremely rare. Endoscopic otosurgery has been successfully used for resecting various ear lesions because of its wider surgical field of view and minimal trauma. We report the case of a 50-year-old male patient who presented with a 6-month history of left ear congestion. Otoendoscopic examination of the left ear revealed a dark red neoplasm blocking the bony external auditory canal. After admission, surgical contraindications were eliminated, and the patient underwent otoendoscopic resection of the canal tumor. Postoperatively, the patient’s symptoms were relieved, and there was no reoccurrence during the 1-month follow-up. The tumor was successfully removed using otoendoscopy, followed by tympanoplasty.
Longitudinal associations of self-control with subjective well-being and psychological well-being: The mediating roles of basic psychological need satisfaction and self-authenticity
Authors: Li Qingqing , Liu Mingjia , Zhou Zongkui , Hong Wei
Published: January 2025

Although cumulative evidence has shown that self-control promotes well-being, the underlying psychological mechanisms remain unclear. Studies indicate that basic psychological need satisfaction and self-authenticity may contribute to this relationship. This longitudinal study investigated the associations between self-control and subjective and psychological well-being while examining the mediating role of basic psychological need satisfaction and self-authenticity in a large sample of 2,539 Chinese adolescents ( Mage = 17.27, SD = 0.86). Results showed that participants with higher self-control were more likely to report greater subjective and psychological well-being. Basic psychological need satisfaction and self-authenticity were highly and positively correlated with self-control and both types of well-being. Structural equation models indicated that self-control directly and indirectly predicts the two types of well-being through basic psychological need satisfaction and self-authenticity. Specifically, the associations between self-control and well-being outcomes were partially accounted for by the serial mediating effects of basic psychological need satisfaction and self-authenticity. The findings indicate that elevated levels of self-control may facilitate the attainment of greater satisfaction of basic psychological needs, and subsequently foster self-authenticity. This is likely to have a positive impact on both subjective well-being and psychological well-being. Overall, this study advances our understanding of the underlying mechanisms through which self-regulation predicts adolescent well-being.
Exploring the Phenomenon of Victim Blaming Toward Women With an Intimate Partner Violence Experience and the Role of Empathy
Authors: Taccini Federica , Mannarini Stefania
Published: January 2025

Women who have experienced intimate partner violence (IPV) often encounter victim blaming from the general population, where individuals attribute responsibility to the victim’s behavior for the violent episode. This phenomenon is influenced by levels of empathy, with lower empathy correlating with a higher likelihood of blaming women exposed to partner violence. Two studies were conducted. The aim of the first study was to explore the general population’s perceptions of IPV severity, inclination to excuse the perpetrator, and tendency to blame women. The second objective was to investigate the predictive role of empathy in victim blaming. Study One ( N = 5,834) was conducted using a vignette methodology to assess victim blaming, minimization of depicted violence, excusing the perpetrator, and perceptions of violence severity. Specifically, five vignettes were used: one was the “Control Vignette,” depicting a police officer responding to a neighbor’s call about a physical altercation between two partners, resulting in visible injuries to the woman. This vignette was then manipulated by adding different pieces of information in four other vignettes: a “Cheating Episode Vignette”; a “Reaction Vignette”; a “Financial Stressor Vignette”; and an “Alcohol Abuse Vignette.” Study Two ( N = 7,236) was conducted using a mediational analysis. Results revealed increased tendencies to blame women for violence, particularly in scenarios involving infidelity and reaction from the woman. The second study confirmed empathy’s predictive role in victim blaming, highlighting the intricate interplay of empathy, perception of violence, and blame assignment. These findings underscore the importance of promoting empathy for a compassionate and responsible society, suggesting that fostering empathy could contribute to reducing victim-blaming tendencies.
Influence of heat treatment on the microstructure and thermal conductivity of duplex stainless steel manufactured via wire arc additive manufacturing
Authors: Sanjeeviprakash Karunanithi , Sankarapandian Sankarasabapathi , Rajesh Kannan Arasappan , Shanmugam Nallathambi Siva
Published: January 2025

Duplex stainless steels (DSSs) are widely used in various applications, such as pressure vessels and desalination plants under varying environmental conditions. This study explores the microstructural features and thermal characteristics of the as-built and heat-treated duplex stainless steels (ER2209 DSS) fabricated via wire arc additive manufacturing (WAAM). Electron Backscatter Diffraction (EBSD) is used to examine the microstructural features, and a laser flash analyzer is utilized to determine the thermal conductivity of the as-built and heat-treated WAAM samples. As-built structures mainly have low ferrite (18.3%), and the varying heat treatment conditions (annealing at 1250 °C/1263 °C/1275 °C for 1hour and water quenching) followed in this research study significantly improved the ferrite content (51.8% to 57.2%) and grain size. Laser flash analysis results show a positive correlation between temperature and thermal properties, aligning closely with those of DSS 2205. The results indicate that above Debye temperature (within 300–400 °C), the specific heat capacity values of all samples increase minimally. Thermal conductivity increases with temperature, primarily driven by free electron movement. As-built WAAM samples, with a finer grain size, exhibit lower thermal conductivity due to phonon scattering at grain boundaries, and a high austenite phase compared to heat-treated samples. These findings emphasize the influence of phase fraction and grain size on the thermal behavior of WAAM-produced DSSs for high-temperature applications.
Historical archives from the Roman Monarchic and Republican periods show human perceptions of environment and climate change in Italy, 753–29 BCE
Authors: Paparella Claudia , Bernard Seth , Bini Monica , Columbu Andrea , Isola Ilaria , Harper Kyle , Post Ruben , Zonneveld Karin , Zanchetta Giovanni
Published: January 2025

Historical archives for the Roman Monarchic and Republican periods (753–29 BCE) offer a highly resolved series of observations of environmental and climatic phenomena in Central Italy. This paper presents a new collection of these historical archives, gathering 319 observations across the period. We introduce the historical character of these archives and point out aspects affecting their analysis and interpretation for reconstruction of past environmental and climatic conditions in Italy in the latter half of the first millenium BCE. Archival information is seen to be generally reliable from the fifth century BCE onward, providing a valuable source about regional past climate. The historical archives’ anecdotal nature along with complexities of their formation and transmission encourage cautious and closely contextualized interpretation, and we advocate the use of this information most of all to understand Romans’ changing experience of environment and climate. We offer comparison of this data to current understanding of regional climate conditions based on scientific proxies, especially speleothems and marine cores. These records show some convergence with the historical archives, and we discuss the possibility that this may reflect a relatively warm, wet climate period (Roman Warm Period) in Italy coterminous with Rome’s initial phase of imperial expansion.
A Dynamic Theoretical Model Based on Compensatory Ethics: How Religious Belief Shapes Tourists’ Pro-Environmental Behavior
Authors: Liu Chao , Hou Yuansi , Gu Ruitong , Cai Yingying
Published: January 2025

The neoclassical economic view, which posits that individuals’ behavioral motivations stem from utility maximization, overlooks the crucial role of ethical dimension. This oversight limits its ability to adequately explain tourist behavior, particularly in religious tourism and pro-environmental contexts where morality is a crucial determinant of tourist actions. Therefore, this paper aims to employ the compensatory ethics model as the intrinsic mechanism to elucidate how religious belief shapes tourists’ pro-environmental behavior. By using data derived from the WVS database and field survey, this interdisciplinary study develops a dynamic theoretical model based on compensatory ethics theory by integrating theories from religious tourism, behavioral economics, and religious studies. The results demonstrate that religious beliefs can attenuate tourists’ time preference and positively impact their pro-environmental behavior. Tourists exhibit different willingness for pro-environmental behavior during the moral licensing and moral cleansing phases. Furthermore, it provides beneficial practical insights for the religious tourism domain.
Presence of Heavy Metals in Vegetables Irrigated with Wastewater-Impacted Rivers and Its Health Risks in Ethiopia: Systematic Review
Authors: Negassa Belay , Dadi Dessalegn , Soboksa Negasa Eshete , Fekadu Samuel
Published: January 2025

Background:

Vegetables play critical role in human nutrition and overall health. However, consumption of vegetables cultivated through wastewater-impacted river can be source of potentially toxic heavy metals, which can cause detrimental health effects when their concentration exceeds the recommended maximum levels. Despite growing body of evidence highlighting the dangers associated with heavy metal accumulation in vegetables, there remains critical gap in systematic assessments within Ethiopian context. Therefore, objective of this review is to reveal heavy metals concentrations in vegetables grown with wastewater-impacted river and assess associated public health risks.

Methodology:

Research articles published in English were identified through systematic searching using electronic databases including PubMed, Google Scholar, WHO/FAO library, and searching from Google manually. The outcomes of interest were mean concentration of heavy metals in vegetables and associated health risks. Cross-sectional studies that met inclusion criteria were considered. Data were extracted by independent reviewers. Methodological quality of included studies was assessed using critical appraisal tools. Moreover, health risks of consumers were assessed through evaluating estimated daily intakes (EDI), Health Risk Index (HRI), and Hazard Index (HI).

Results:

Nineteen articles were included in this systematic review. The findings revealed that the mean concentration of Pb, Cr, Cd, As, Hg, Cu, Ni, Zn, Mn, and Fe in tested vegetables ranged from: 0.28-7.68, 0.75-33.01, 0.14-3.93, 0.05-3.13, ND-4.25, 0.92-15.33, 2.13-13.1, 18.27-62.83, 8.83-331.8, and 177.8-1034.3 mg/kg (dry weight), respectively. The EDI of Pb, Cr, Cd, As, Hg, Cu, Ni, Zn, Mn, and Fe in vegetables was range from: 0.00104-0.0286, 0.00279-0.123, 0.00052-0.0146, 0.0000372-0.0116, 0.0124-0.0158, 0.00342-0.0439, 0.0079-0.0487, 0.068-0.23, 0.03-1.23, and 0.53-3.84 mg/kg/day, respectively. The HRI of toxic heavy metals for all vegetable types ranged as; Pb (0.26-7.15), Cr (0.00186-0.0820), Cd (0.52-14.6), As (0.12-38.7), and Hg (1.24-1.58). The HRI due to consumption of all vegetables was 35, 0.168, 46.6, 70, and 2.82 for Pb, Cr, Cd, As, and Hg, respectively indicating severe health impact except for Cr.

Conclusion:

This review underscores health implications linked to consumption of vegetables cultivated using wastewater in Ethiopia. It revealed that the concentration of toxic heavy metals in vegetables grown with wastewater-affected water was higher than the maximum allowable safe limit set for edible vegetables by WHO that would be a public health risk.
Healthcare Professionals’ Ratings and Views of Person-Centred Care in the Context of Allogeneic Hematopoietic Stem Cell Transplantation
Authors: O’Sullivan Anna , Winterling Jeanette , Malmborg Kisch Annika , Bergkvist Karin , Edvardsson David , Wengström Yvonne , Lundh Hagelin Carina
Published: January 2025

Introduction:

Allogeneic stem cell transplantation (allo-HCT) involves a long trajectory with high risk of complications. In person-centred care (PCC), patients’ needs, resources and the care relationship are central to the care process. Healthcare professionals’ (HCPs) ratings of PCC have not previously been investigated in this context.

Objectives:

The aim of this study was to investigate healthcare professionals’ ratings and views of person-centred care in allo-HCT care, and associations with individual characteristics and targeted PCC education.

Design:

Cross-sectional study, employing quantitative and qualitative methods.

Methods:

85 HCPs at two Swedish allo-HCT centres participated (80% women; mean age: 44 years, range: 23-72 years). A survey was conducted using the PCC Assessment Tool (P-CAT), containing 13 items, a total scale (min 13-max 65) and two subscales (I: min 8-max 40; II: min 5-max 25). Additionally, HCPs’ written responses to four study-specific questions about PCC were collected.

Results:

The mean for P-CAT total scale was 45.31, (subscale I: 28.41; subscale II: 16.90). Higher ratings of PCC were reported for assessment of patients’ needs, discussion about how to provide PCC and patients’ care, while time to provide PCC, the care environment and how the organization prevents providing PCC were rated lower. Higher age and targeted PCC education were associated with higher PCC ratings. HCPs described PCC as the patient being seen as a capable individual with their own resources, with PCC increasing patient and family involvement—giving higher satisfaction and tailored care for patients. However, HCPs reported time as a barrier for PCC.

Conclusion:

HCPs’ ratings of PCC in this context are high regarding discussing and assessing patients’ needs, but there is room for improvement regarding organizational and environmental aspects. Targeted PCC education increases the level of PCC. HCPs’ views of PCC partly reflect the foundations of PCC—patient’s narrative, capability and involvement.
Does language experience and bilingualism shape empathy and emotional intelligence?
Authors: Ward Rebecca , Ragosko Malgozata
Published: January 2025

Aims and objectives:

Previous research has reported that varied language experiences and language use can play a role in the development of empathy and emotional intelligence (EI). The present study aimed to investigate the association between language experience, bilingualism and personality.

Methodology:

One hundred and forty-two participants completed a language background questionnaire along with a series of measures to assess empathy and both trait and ability EI.

Data and analysis:

Measures included the Trait Emotional Intelligence Questionnaire short form (TEIQue), the Toronto Empathy Questionnaire (TEQ), and the Situational Test of Emotional Understanding Brief (STEU-B). Hierarchical regression models, analyses of variance (ANOVAs), and Structural Equation Modelling were used to examine the relationships between language experience, bilingualism, and measures of empathy and EI.

Findings:

Findings reveal that bilingualism and language experiences did not contribute to empathy and EI. These results question the role that linguistic experience has in shaping empathy and EI. However, a significant difference in empathy and EI scores emerged when comparing participants who processed information in their first (or native) language to those who did not, suggesting that empathy and EI are stronger when processed in the first language.

Originality:

This study provides a new understanding of the influence of language background on empathy and EI as well as the impact of processing information in a first language.

Significance:

This study highlights the importance of considering the role that language has in future cross-cultural and cross-linguistic studies. Implications for the use of culturally appropriate measures and future research are discussed.
The impact of mechanical vibrations on pressure pulsation, considering the nonlinearity of the hydraulic valve
Authors: Stosiak Michał , Karpenko Mykola , Ivannikova Viktoriia , Maskeliūnaitė Lijana
Published: January 2025

The article identifies some of the forces acting on hydraulic valves used in the civil and military vehicles. Particular attention was paid to the single-stage electrically controlled “on/off” hydraulic directional control valve. Special attention was focused on vibrations of hydraulic directional valve four ways, three positions (4/3) controlled by typical solenoids. Military vehicles can be a source of vibrations in low and high range of frequency. The spectrum of vibrations frequency is wide in this case. The value of the natural frequency of vibrations of the hydraulic directional control valve spool, whose body was affected by mechanical vibrations, was estimated. The paper shows that the natural vibrations of the directional control valve spool can coincide with the frequency of external vibrations acting on the valve from the ground. The mathematical description takes into account that when the spool is overdriven, the oscillating movement of the directional control valve spool is described by a model that takes into account the nonlinearity resulting from the fact that the spool is in the extreme position—it is a poor nonlinear mechanical system. The results of theoretical considerations were confronted with the results of experimental research. In addition, the presented modified model was used to assess the impact of the capacitance change on the value of the amplitude of pressure pulsations caused by the vibrations of the directional control valve spool.
The expression of values on social media: An analytical framework
Authors: Shifman Limor , Trillò Tommaso , Hallinan Blake , Mizoroki Saki , Green Avishai , Scharlach Rebecca , Frosh Paul
Published: January 2025

Social media is a central arena for the articulation of values, shaping what people around the world deem important and desirable. However, traditional value typologies struggle to capture the dynamic nature of value expression in digital spheres and overlook new communication-related values prevalent in these environments. Addressing these gaps, we developed an analytical framework for investigating value expression on social media, comprising three general value orientations ( Do well, Do good, and Feel good) and four communicative value orientations ( Inform, Influence, Bond, and Express). We drew on extensive cross-national research to construct the framework and examined its utility through a study of TikTok videos related to the FIFA World Cup in Qatar. Our analysis shows how value orientations enable the identification of patterns that underpin complex discourses. Ultimately, our framework offers a pathway to understand what people present as valuable on social media, as well as the broader value ecosystem platforms cultivate.
An incremental intelligent fault diagnosis method based on dual-teacher knowledge distillation and dynamic residual fusion
Authors: Shang Zhiwu , Wang Xunbo , Pan Cailu , Liu Fei , Cheng Hongchuan
Published: January 2025

The intelligent fault diagnosis (IFD) method based on incremental learning (IL) can expand new fault categories without retraining the model, making it a research hotspot in the field of fault diagnosis. Currently, the combination of knowledge distillation (KD) and replay techniques has been widely used to alleviate catastrophic forgetting in IL. However, this method still has some limitations: first, the difference in data distribution of different incremental tasks may cause concept drift, hindering the model’s adaptation to new tasks; second, replay techniques may lead to an imbalance in the number of samples between new and old classes due to the limited storage of exemplar library, resulting in classifier learning bias. To address these limitations, this article proposes an incremental IFD method (IIFD-DDRF) based on dual-teacher knowledge distillation (DTKD) and dynamic residual fusion (DRF) (IIFD-DDRF). First, a DTKD strategy is proposed, which transmits new and old knowledge through two teacher models, helping the student model better adapt to new tasks while retaining old knowledge. Second, a DRF method is proposed to handle dynamic data imbalance. This method incorporates lightweight branch layers specific to the task, encoding old task knowledge and performing residual fusion to optimize classifier output. Additionally, a dynamic branch layer merging mechanism is adopted to effectively prevent excessive growth of the model. Finally, the effectiveness and advancement of this method are validated on three datasets: bearings and gearboxes.
A little less conversation, a little more action: Schools and the prevention of violent extremism through reasoned engagement
Authors: Stevens David
Published: January 2025

Many liberal democratic countries have enacted policy programmes aimed at preventing support for violent extremism. In countries such as the United Kingdom, part of this responsibility falls upon state-maintained schools. Teachers are charged with – among other things – challenging the claims, arguments and ideological narratives supportive of terrorism as well as promoting liberal democratic values as a counterweight. Insofar as the aim is to rationally dissuade those in danger of being ‘radicalised’ in this way, this article argues that this approach is unlikely to succeed in all but a narrow range of cases. It argues that the claims that radicalisation occurs through lack of knowledge or poor critical reasoning skills, and that improving these things is the antidote, is at odds with the consensus of social scientific research on partisanship and knowledge, and the phenomenon of motivated reasoning. Challenging beliefs and ideological narratives – whether directly or through more indirect mechanisms – will likely serve to entrench and harden those beliefs in those being drawn towards them. Contrary to this, the article argues that adoption of beliefs supervenes on membership in groups or affiliation to social movements and causes. Individuals receive the benefits of belonging, self-esteem and friendship from such affiliations. It is the receipt of these goods that drives commitment to cherished, identity-forming beliefs. Reasoned engagement therefore misses its target because those beliefs are not held on an epistemic basis. This has important consequences for education. Reasoned engagement is only likely to work where the person seeking to persuade, and the target of that persuasion, have fundamental beliefs and commitments in common. Educational resources are better focused on providing the contexts for students to receive and enjoy the feelings of belonging, self-esteem and friendship, rather than focusing those resources on defeating arguments.
Yes, It Matters: Assessing Service-Related Cultural Competency of New York State Department of Health-Funded Providers From Multiple Angles
Authors: Levandowski Brooke A. , naimool kk , Rietberg-Miller Susan B. , Aldrich Petra L.
Published: January 2025

Background:

While cultural competency has been recognized as an important feature in health care delivery, evaluating intervention effectiveness is often overlooked.

Methods:

This project used an explanatory sequential mixed methods study design within a community-based participatory research structure. A 29-item Organization cultural competency Checklist was created and distributed to a purposive sample of staff at 55 New York State (NYS) Department of Health AIDS Institute-funded health and human service providers. Organizations recruited clients to complete a 27-item Client Checklist. Basic univariate analyses were conducted on quantitative items (Stata v.18). For questions asked to both groups, we conducted chi-square tests to determine statistically significant differences (p-value < 0.10). Qualitative stories about the impact of culturally competent care provision were analyzed using the Most Significant Change process by a Community Advisory Board (CAB) of LGBTQ+ NYS residents.

Results:

The Organization Checklist had 92 responses from 37 organizations. The Client Checklist yielded 32 responses from five organizations. While high agreement between client and staff was reached on the majority of items, opportunities for improvement included updated intake forms and strengthening relationships with other local LGBTQ+ organizations. Using 62 raw stories, the CAB identified two main themes of affirming and un-affirming care, further organized into personal, perception, provider, and systemic categories.

Discussion:

Clients reported higher engagement in health-seeking behavior with culturally competent providers and care-avoidance with culturally incompetent care. Clients decided the safety of expending emotional labor to educate providers. Improving organizational cultural competency is an ongoing process requiring consistent and prompt attention.
Some Lessons From Participatory Evaluation of the COVID-19 Response in the African Region
Authors: Phori Peter , Fawcett Stephen , Nikiema Nidjergou Noemie , Mpeke-Ntollo Lurole , Kirigia Doris , Kakule Siku Deogratias , Mwakisha Jemimah , Amalet Armel Brice , Ndzondo Franck , Diouf Aloyse Waly
Published: January 2025

This summary report describes partners’ experiences and reflections on responding to the COVID-19 pandemic in selected countries in the African Region. Using a common protocol for participatory evaluation and sensemaking, it communicates country partners’ experiences with the COVID-19 response in Gabon, Kenya, and Senegal as well as a regional perspective from partners in the World Health Organization Regional Office for Africa (WHO AFRO). This report describes factors identified as associated with decreases (bending the curve) of new cases of COVID-19 over time, as well those associated with increases (worsening) of new cases, seen during the study period (2020–2021). We also report on partners’ identification of factors that enabled (made easier or possible) implementation of the COVID-19 response; and those that impeded (made more difficult) the response in participating countries, and in the broader WHO African Region. This report concludes with lessons learned and recommendations for practice in responding to public health emergencies based on experiences in the African Region.
Lessons Learned From the Use of Human-Centered Design Approaches to Improve Nutrition in Nigeria
Authors: Brandt Amelia J. , Van Lith Lynn M. , Chipanta Nokafu K. Sandra , Sherburne Lisa , Oladeinde Kizzy Ufumwen , Samba Angela , Haygood TiaSamone , Onyechi Chizoba , Idiong Eno’bong , Olaniru Sammy , Bala Amina , Adoyi Gloria , DeNormandie Justin , Storey J. Douglas , Abdu-Aguye Shittu
Published: January 2025

Background. Improving children’s diets from 6 to 24 months can support children’s survival, growth, and development, but progress toward this goal has stalled globally. Human-centered design offers a new approach to resolving program challenges, especially when integrated with social and behavior change (SBC) theory and rigorous evaluation. Method. Two human-centered design processes were conducted. In Ebonyi state, Federal Capital Territory, and Sokoto state a combined high-fidelity prototype, drawn from three low-fidelity prototypes, focusing on improving dietary diversity was developed and tested. In Kebbi state eight low-fidelity prototypes focused on developing tools to improve community health worker (CHW) nutrition counseling were developed and tested. High-fidelity prototype testing combined design and behavior change indicators and qualitative and quantitative methods. Prototype Testing Results. Seven of the eight prototypes in Kebbi state tested well. Prototypes that integrated SBC theory and encouraged two-way conversations between CHWs and caregivers were most successful. The high-fidelity prototype tested in Sokoto demonstrated improved knowledge and efficacy regarding dietary diversity and increased self-reported dietary diversity. Three low-fidelity prototypes in Kebbi will be combined into a counseling package for CHWs. The implementation of the high-fidelity nutrition prototype will be expanded. Discussion. Human-centered design is a promising approach to address complex global health challenges and can be strengthened through the integration of SBC theory and traditional monitoring and evaluation approaches, but this is challenging. Implications for Practice. It is essential to establish a foundation of human-centered design and SBC knowledge among all implementers, incorporate both knowledge bases throughout the process, and center in-country expertise.
Evaluation of Clinical Effect of Acupuncture on Chronic Prostatitis: Meta Analysis
Authors: Fang Wen , Wang Shi , Dong Jin-Kai , Zhang Jing-Yun , Li Xue-Chao , Fu Cheng-Wei , Liu Qing-Guo
Published: January 2025

This study aims to evaluate the clinical efficacy of acupuncture and moxibustion in CP treatment and assess the quality of clinical literature. Controlled clinical trials (CCT) and randomized controlled trials (RCTs) from PubMed, Web of Science, NLM, CNKI, and Wanfang (January 2003 to January 2023) were analyzed. Relevant data were extracted and statistically analyzed using RevMan 5.1 software. Twenty high-quality papers (JADAD≥3) involving 1,661 patients were included. Meta-analysis showed a significant difference in the overall response rate between the test and control groups in CP treatment (odds ratio [OR] = 4.08 [95% CI = 3.13, 5.33], p < .001). The National Institutes of Health–Chronic Prostatitis Symptom Index (NIH-CPSI) posttreatment comparison showed significantly better symptom improvement in the acupuncture and moxibustion group (mean difference [MD] = –4.87 [95% CI = −6.145, −3.59]). Acupuncture and moxibustion significantly improve response rates and symptom scores in CP treatment compared with control treatments (drugs, sham acupuncture). This suggests that acupuncture and moxibustion are effective for CP and worth promoting, though further exploration of their mechanisms is needed.
Exclusion of people from oncology clinical trials based on functional status
Authors: Agaronnik Nicole D , Peters Mary Linton B , Iezzoni Lisa I
Published: January 2025

Background/Aims:

People with disability have higher rates of cancer, excluding skin cancer, compared with people without disability. Food and Drug Administration draft guidelines from 2024 address use of performance status criteria to determine eligibility for clinical trials, advocating for less restrictive thresholds. We examined the exclusion of people with disability from clinical trials based on performance status and other criteria.

Methods:

We reviewed eligibility criteria in approved interventional Phase III and Phase IV oncology clinical trials listed on ClinicalTrails.gov between 1 January 2019 and 31 December 2023. Functional status thresholds were assessed using the Eastern Cooperative Oncology Group Performance Status Scale and Karnofsky Performance Scale in clinical trial eligibility criteria. Qualitative analysis was used to review eligibility criteria relating to functional impairments or disability.

Results:

Among 96 oncology clinical trials, approximately 40% had restrictive Eastern Cooperative Oncology Group and Karnofsky Performance Scale thresholds, explicitly including only patients with Eastern Cooperative Oncology Group 0 or 1, or equivalent Karnofsky Performance Scale 70 or greater. Only 20% of studies included patients with Eastern Cooperative Oncology Group 2 and Karnofsky Performance Scale 60. Multiple studies contained miscellaneous eligibility criteria that could potentially exclude people with disability. No studies described making accommodations for people with disability to participate in the clinical trial.

Conclusion:

Draft Food and Drug Administration guidelines recommend including patients with Eastern Cooperative Oncology Group scores of 2 and Karnofsky Performance Scale scores of 60 in oncology clinical trials. We found that oncology clinical trials often exclude people with more restrictive performance status scores than the draft Food and Drug Administration guidelines, as well as other criteria that relate to disability. These estimates provide baseline information for assessing how the 2024 Food and Drug Administration guidance, if finalized, might affect the inclusion of people with disability in future trials.
A framework for sequential monitoring of individual N-of-1 trials and combining results across a series of sequentially monitored N-of-1 trials
Authors: Selukar Subodh , Prince David K , May Susanne
Published: January 2025

Background:

N-of-1 trials compare two or more treatment options for a single participant. These trials have been used to study options for chronic conditions such as arthritis and attention deficit hyperactivity disorder. In addition, they have been suggested as a means to study interventions in rare populations that may not be tractable to include in standard clinical trials, such as treatment options for HIV-positive patients in need of organ transplant. Sequential monitoring of accruing data has been well-studied in traditional clinical trials, but these methods have not yet been implemented in N-of-1 trials. However, the option to validly stop an N-of-1 trial early could deliver faster decisions that could directly improve the patient’s health.

Methods:

In this work, we propose and evaluate a framework to (1) facilitate sequential monitoring in individual N-of-1 trials with a continuous outcome and (2) combine results across a series of already-completed sequentially monitored N-of-1 trials. By employing the block structure common to N-of-1 trials, we suggest that existing approaches to sequential monitoring may be employed when data from one N-of-1 trial are analyzed with a linear mixed-effects model. To combine results across a series of already-completed sequentially monitored N-of-1 trials, we propose combining the naive estimates from constituent trials in a random-effects model with inverse-variance weighting. We evaluate these proposals via simulation.

Results:

We find that type 1 error can be substantially inflated for N-of-1 trials with a small number of planned blocks but can reach the nominal rate for trials with more planned blocks or those with larger numbers of periods per block or by using a [Formula: see text]-value correction. For those settings with acceptable type 1 error, sequential monitoring results in similar power and on average earlier stopping compared with trials with no sequential monitoring. And, as expected, we find that including a larger number of constituent trials in a series reduces the mean-squared error of the combined point estimator.

Conclusion:

Under suitable design considerations, our proposed framework for sequential monitoring can support clinicians in providing important decisions earlier, on average, for patients engaged in N-of-1 trials.
Unlocking breast cancer in Brazilian public health system: Using tissue microarray for accurate immunohistochemical evaluation with limitations in subtyping
Authors: Ruppenthal Rubia Denise , Pilar Emily Ferreira Salles , Santos Jordan Boeira dos , Coelho Rafael Correa , Henriques Carina Machado Costamilan , Uchôa Diego de Mendonça , Graudenz Marcia Silveira
Published: January 2025

Background:

Breast cancer (BC) is a significant burden on healthcare systems, especially in low- and middle-income countries where access to diagnosis and treatment is challenging.

Objectives:

The purpose of this study was to assess the diagnostic accuracy and cost using tissue microarray (TMA) instead of traditional immunohistochemical (IHC) evaluation for estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER2), and the proliferation marker Ki-67 and BC subtyping within the Brazilian public health system.

Design:

This is a retrospective cohort study comparing TMA slides with traditional whole-slide evaluation for IHC markers in 242 BC cases.

Methods:

We used formalin-fixed tissue blocks for TMA assembly. Clinical data and IHC scores for ER, PR, HER2, and Ki-67 were obtained from pathology reports. Cohen’s kappa ( k) was used to assess TMA performance.

Results:

BC samples were distributed in 10 TMAs and 968 cores were scored (242 BC cases × 4 markers). In 97% of these, TMA reached high quality to adequate IHC scoring with minimal technical issues. Inter-examiner agreement was almost perfect for all markers (ranging from 0.85 for HER2 to 0.91 for ER, p < 0.001). The intratumoral heterogeneity ranged from almost perfect agreement for ER and HER2 to moderate to substantial for PR and Ki-67. TMA offers substantial time and cost savings, with an approximately 11-fold reduction compared to traditional methods. The concordance between TMA and original reports was almost perfect, with 93% overall agreement ( k = 0.81, p < 0.001). However, TMA performance varied between markers, with intratumoral heterogeneity significantly impacting discordant results, particularly for Ki-67 and HER2. This ultimately affected the accuracy of BC subtyping. TMA performed well in identifying luminal A and triple-negative cases, but misclassification was common for luminal B and HER2-positive cases.

Conclusion:

TMA offers accurate and lower-cost results in the individualized IHC assessment of BC markers. However, we do not recommend the use of TMA in the subtyping of BC, where analysis of the whole section remains necessary for more accurate results. We advocate more studies using the TMA approach in the Brazilian public health system to advance women’s health care.
Outcomes among patients with coronary artery bypass grafts presenting with acute coronary syndrome: impact of revascularization
Authors: Bews Hilary J. , Hiebert Brett , Liu Shuangbo , Ducas John , Ravandi Amir , Minhas Kunal , Kass Malek , Love Michael P. , Wijeysundera Harindra C. , Shah Ashish H.
Published: January 2025

Background:

Patients post-coronary artery bypass graft (CABG) can re-present with acute coronary syndrome (ACS); however, culprit lesion identification, as well as revascularization, is often challenging. Furthermore, the impact of revascularization in this patient group is relatively unknown.

Objectives:

The purpose of our study was to evaluate the efficacy of percutaneous coronary intervention (PCI) in patients with previous CABG surgery presenting with ACS.

Methods:

Using data from the Manitoba Center for Health Policy, we identified patients treated with CABG between April 1979 and March 2018, who subsequently presented with the primary diagnosis of ACS. Patients were divided into four groups: (1) managed medically and not investigated by cardiac catheterization and (2) investigated by cardiac catheterization and treated (2a) medically, (2b) with PCI, and (2c) with redo-CABG. Inverse probability treatment-weighted survival analyses were performed. Ethical approval was obtained from the local research board.

Results:

Nearly 20% of patients treated with CABG presented with ACS at a median of 7.2 years (age at the time of CABG: 66 years (interquartile range: 58–73 years); 75.6% male). Patients treated with PCI ( N = 929) demonstrated improved survival compared to the patients investigated by catheterization but treated medically ( N = 952; hazard ratio 0.87, 95% confidence interval 0.77–0.97, p = 0.02). Patients who underwent redo CABG ( N = 171) experienced 13% mortality within the first year, but subsequently, demonstrated a trend toward improved survival.

Conclusion:

ACS is not uncommon following CABG. Revascularization is associated with prognostic improvement; however, such could be accounted for by inherent group differences, including comorbidities and coronary anatomy These findings should be validated in a prospective randomized study.
Advancements in dual biologic therapy for inflammatory bowel diseases: efficacy, safety, and future directions
Authors: Fabisiak Adam , Caban Miłosz , Dudek Patrycja , Strigáč Aleksandra , Małecka-Wojciesko Ewa , Talar-Wojnarowska Renata
Published: January 2025

Inflammatory bowel diseases (IBDs), primarily encompassing ulcerative colitis and Crohn’s disease, represent a challenging spectrum of disorders with a multifaceted pathogenesis. Despite the array of available treatments, a demand for novel therapeutic options persists to achieve remission in a broader patient population. Research findings indicate that relying solely on a single biologic drug may limit future treatment choices, prompting consideration for a more suitable shift from step-up to top-down strategies in certain cases. In the backdrop of advancing drug development, reimagining the application of existing therapies presents a promising avenue. Among these innovative approaches is combination therapy. This review explores the outcomes of recent randomized clinical trials, systematic reviews, and case studies, focusing on dual biologic therapy. It underscores the effectiveness, safety, and tolerability of combining two biologic drugs in IBD, providing insights into a potentially impactful treatment strategy.
Selpercatinib in Chinese patients with RET-fusion-positive non-small-cell lung cancer: updated efficacy and safety analysis from the randomized LIBRETTO-321 phase II trial
Authors: Lu Shun , Cheng Ying , Huang Dingzhi , Sun Yuping , Wu Lin , Zhou Chengzhi , Zhou Jianying , Guo Ye , Shao Jingxin , Zhang Wanli
Published: January 2025

Background:

Selpercatinib is approved for the treatment of RET-fusion-positive non-small-cell lung cancer (NSCLC).

Objective:

We present a final update on LIBRETTO-321 to enhance the understanding of long-term efficacy and safety in Chinese patients.

Design:

This open-label, multicenter, phase II study included patients with advanced RET-altered solid tumors.

Methods:

The primary endpoint was objective response rate (ORR), and Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was assessed by the independent review committee. Secondary endpoints were duration of response (DOR), progression-free survival (PFS), overall survival (OS), central nervous system (CNS) response, and safety.

Results:

A total of 47 patients (treatment-naïve ( n = 11); pre-treated ( n = 36)) with NSCLC were enrolled. The ORR in overall NSCLC was 72.3% (95% CI: 57.4, 84.4), treatment-naïve was 100.0% (95% CI: 71.5, 100.0); and pre-treated was 63.9% (95% CI: 46.2, 79.2). Median DOR was not reached for overall NSCLC, with 53% of responses ongoing at the data cutoff (median follow-up: 34.2 months). With a median follow-up of 35.9 months, the median PFS for overall NSCLC was 27.6 months (95% CI: 22.3, not evaluable (NE)), treatment-naïve was 27.6 months (95% CI: 16.4, NE), and pre-treated was 27.8 months (95% CI: 19.29, NE). The 3-year OS rate for overall NSCLC was 62.0% (95% CI: 45.9, 74.6) with a median follow-up of 38.1 months. Among five patients with measurable CNS metastases, four achieved intracranial responses. The safety profile was consistent with previous reports.

Conclusion:

With additional follow-up, selpercatinib showed durable responses, prolonged survival, and a consistent safety profile in Chinese patients with RET-fusion-positive NSCLC.

Trial registration:

Clinical Trials.gov identifier (NCT04280081).
Efficacy and safety of camrelizumab plus famitinib in patients with previously treated non-small-cell lung cancer: a single-arm, phase II trial
Authors: Gao Ming , Zhang Xia , Yan Huan , Zhao Yan , Yuan Fang , Sun Decong , Yang Xuejiao , Ju Yanfang , Wang Lijie , Tao Haitao , Tian Luyuan , Zhao Changhong , Ma Junxun , Hu Yi , Liu Zhefeng
Published: January 2025

Background:

For non-small-cell lung cancer (NSCLC) patients who progressed after first-line chemotherapy, immunotherapy targeting programmed cell death (ligand) 1 has shown promising activity. However, the activity is relatively limited in patients harboring epidermal growth factor receptor (EGFR) mutations.

Objectives:

This study aimed to evaluate the efficacy and safety of camrelizumab plus famitinib in previously treated patients with locally advanced and metastatic NSCLC.

Design:

A single-center, single-arm, phase II study.

Methods:

Previously treated patients with locally advanced and metastatic NSCLC were enrolled to receive camrelizumab (200 mg, administered intravenously every 3 weeks) and famitinib (20 mg, administered orally once daily). Patients harboring EGFR mutation genes had received at least one EGFR tyrosine kinase inhibitor and no more than two lines of chemotherapy regimen before the enrollment. The other patients had progressed on first-line chemotherapy with or without immunotherapy before the enrollment. The primary endpoint was the objective response rate (ORR) per RECIST v1.1 by the investigator.

Results:

Our study encompassed 23 NSCLC patients between October 2019 and October 2022. For all patients, the confirmed ORR was 30.4%, and the disease control rate was 95.7%. The median progression-free survival (PFS) was 6.9 months (95% CI: 4.9 months–not reached). The median overall survival (OS) was not reached. 1- and 2-year OS rates were 85.6% (95% CI: 71.8%–100.0%) and 56.8% (95% CI: 37.7%–85.7%). Especially, for the 6 patients with EGFR genetic aberrations, the confirmed ORR was 33.3%, the median PFS was 10.3 months (95% CI: 1.8–18.8 months), and the median OS was 20.3 months (95% CI: 0.8–39.8 months). The most common grade 3 and above treatment-related adverse events were platelet count decreased, white blood cell count decreased, and hypertension. No unexpected adverse events were reported.

Conclusion:

Camrelizumab plus famitinib demonstrated encouraging clinical activity with a manageable safety profile in previously treated patients with locally advanced and metastatic NSCLC. The results warranted further validation.

Trial registration:

Chinese Clinical Trial Registry identifier: ChiCTR1900026641.