Final Publication Research Articles

A Protocol for a Bibliometric Analysis of Traditional, Complementary, and Integrative Medicine Research Preprints

Background: Traditional, complementary, and integrative medicine (TCIM) has witnessed significant growth in interest globally. Despite its popularity, TCIM research encounters numerous challenges including funding, methodological issues, and risk of bias. Preprints (scientific manuscripts openly accessible before formal peer review) present a potential solution, and understanding the characteristics and impact of TCIM preprints could offer valuable insights.Methods: A bibliometric analysis will be conducted on all TCIM-related preprints, since inception, and posted on preprint servers with TCIM subject filters. Preprints will be sourced from servers listed in the Accelerating Science and Publication in Biology directory which allow filtering by TCIM-related categories. The preprint server and URLs, preprint server’s disciplinary scope, ownership type, screening processes, external content indexing, permanence of content, preservation of content, and comments will be extracted. The number of TCIM-related preprints yielded, and which TCIM-related term each preprint server uses will be noted. Data will be extracted from each eligible preprint: preprint server, title, DOI, preprint posted date, status of preprint, journal of final publication, final publication date, type of preprint, abstract of preprint, authors, author affiliation(s), country of corresponding author, funders, number of views, number of downloads, number of comments, number of citations, number of versions, and keywords. Descriptive statistics will be used to summarize the bibliometric characteristics, and trend analysis will identify publication patterns over time.Conclusion: This protocol was developed for a study to identify trends in TCIM research dissemination, and contribute to a better understanding of how preprints are being used to advance the field

Illuminating Entomological Dark Matter with DNA Barcodes in an Era of Insect Decline, Deep Learning, and Genomics.

Most insects encountered in the field are initially entomological dark matter in that they cannot be identified to species while alive. This explains the enduring quest for efficient ways to identify collected specimens. Morphological tools came first but are now routinely replaced or complemented with DNA barcodes. Initially too expensive for widespread use, these barcodes have since evolved into powerful tools for specimen identification and sorting, given that the evolution of sequencing approaches has dramatically reduced the cost of barcodes, thus enabling decentralized deployment across the planet. In this article, we review how DNA barcodes have become a key tool for accelerating biodiversity discovery and analyzing insect communities through both megabarcoding and metabarcoding in an era of insect decline. We predict that DNA barcodes will be particularly important for assembling image training sets for deep learning algorithms, global biodiversity genomics, and functional analysis of insect communities.Review in Advance first posted online on October 1, 2024. Updated on November 5, 2024. Changes may still occur before final publication.

Presentation of studies at conferences and their final full publication in the field of neonatology in Spain

Presentation of studies at conferences and their final full publication in the field of neonatology in Spain

Bibliometric Analysis of Sharenting: Current Status and Inducing Marketing Strategies

In the current digital world, parents are more towards sharing pictures, videos and much more about their children on social media and various parenting sites, called as sharenting. Sharenting is a new and fast-emerging phenomenon, but only a few studies are available. The current study is a comprehensive analysis of the literature on sharenting, as no bibliometric analysis has yet been done on this topic. Therefore, the current study aims to conduct bibliometric analysis with the use of the Scopus database, which results in a total of 417 papers. After limiting it to the final publication, journal and only English language, we were left with 340 papers. These 340 papers are used for the analysis, with the help of the Biblioshiny package of R and VOSviewer software. This study contributed to the literature by (a) classifying the existing literature into four clusters, namely ‘Information Assessment Method’, ‘ParentWork’, ‘Online Resources and Forums’, ‘Parenting for Child Health’; (b) proposing research model for the marketing field based on cluster analysis; and (c) highlighting the future research directions in the sharenting domain. To establish its implications, this review study has integrated scattered knowledge into one body by providing theoretical and managerial implications of sharenting.

Utilization of the Transparent Peer Review Policy to Train Graduate Pharmacy Students on Scientific Critique

ObjectiveRecognizing the importance of training graduate students in scientific critique and peer review, we introduced an innovative instructional strategy using the transparent peer review policy (TPRP). This study aimed to explore students’ feedback and reflection on how published peer review reports influenced their scientific critique skills and thought process. MethodsWe used TPRP-adopting journals’ publicly available peer review reports for Master of Science in Pharmacy students, who analyzed real cases, including author submissions, reviewer comments, author rebuttals, editorial decisions, and final publications. A reflection assignment required students to share their insights on the TPRP-adopting journals’ review processes and how these influenced their scientific reviewing skills. Qualitative content analysis of the submitted reflections was conducted by two instructors not involved in developing or delivering this aspect of the course. ResultsEleven students submitted reflections on their learning experiences through this public-facing peer review process. The analysis revealed that TPRP increased the students’ awareness of the peer review process and fundamental principles of scientific critique. Five key themes emerged: understanding research content, inspiring ideas, fostering objectivity, enriching peer review comprehension, and evaluating transparent peer review pros and cons. Students showed a positive attitude toward this pedagogical approach for acquiring the targeted skills. ConclusionWe utilized peer review reports from TPRP-supporting journals as an educational tool, providing training on the fundamentals of peer review and scientific critique. This study suggests recommending TPRP-supported journal reports as a valuable educational tool for teaching scientific critique and peer review skills among graduate students.

A scoping review of out-of-hospital research in Ireland from 2000 to 2022

A key component to the continued development of any profession is a strong research culture. For paramedicine, a research culture that acknowledges the uniqueness of the out-of-hospital setting allows clinical practice to develop. Recent international publications investigating paramedicine research outputs demonstrated that Ireland was not strongly represented in the production of paramedicine-based research. The aim of this scoping review was to identify and evaluate the quantity and quality of the research published to date in the Irish out-of-hospital literature, and to identify research gaps that may need to be addressed. A scoping review was conducted using the Joanna Briggs Institute guidance. All studies that reported on out-of-hospital care in the Republic of Ireland were included. MEDLINE, CINAHL, EMBASE, Cochrane Library, and grey literature sources were searched from 2000 until 2022 for relevant articles in March 2023. Key authors were contacted to identify missing articles and data were extracted to present the final publication yield. Scientific quality was assessed using Clarivate Average Journal Impact Factor Percentiles. Over 3200 research outputs were identified from the databases with a final yield of 294 research outputs included in this review. Research outputs were identified for most years included in the review period, with outputs published in a large range of journals. Research heavily focused on areas linked to the Clinical Practice Guidelines, and predominantly used quantitative data collection methods. Most authors identified in this review were named on only one output. However, diversification in research topics and methodologies, a concerted effort to ensure practitioners are leading research and support to ensure that conference presentations are continued to peer-reviewed publication would strengthen this resolve.

Stereotactic Body Radiation Therapy Versus Conventional Radiation Therapy for Painful Spinal Metastases: A Comparative Analysis of Randomized Trials and Practical Considerations

IntroductionRecent randomized trials have compared the efficacy and safety of stereotactic body radiation therapy (SBRT) with standard conventional external beam radiotherapy (cEBRT) for the treatment of painful spinal metastases. We conducted a composite analysis of these trials in order to inform current practice using pooled outcomes. MethodsData from each randomized trial were abstracted from the final publications with biologically effective doses (BEDs) recalculated for SBRT and cEBRT. Primary outcome measures were overall (OR) and complete pain response (CR) rates at 1, 3, and 6-months, and rates of vertebral compression fracture (VCF). Random effects models were used to estimate primary outcome measures and meta-regression assessed the effect of BED. ResultsFour prospective randomized clinical trials published between 2018 and 2024 were included, with a total of 686 patients (383 and 303 in the SBRT and cEBRT groups, respectively). Dose and fraction (fx) number for the SBRT group ranged from 24 Gy/ 1 fx to 48.5 Gy/ 10 fx (median BED10 50 Gy), and for the cEBRT group from 8 Gy/ 1 fx to 30 Gy/ 10 fx (median BED10 28 Gy). The 1, 3, and 6-month OR rates for SBRT and cEBRT were similar: 53.6%, 52.4%, 58.8% vs. 48.4%, 47.9%, 43.8%, respectively (p>0.05). The 3-month CR rate was significantly higher for SBRT compared to cEBRT (31.9% vs. 14.8%, RR 2.26; 95% CI, 1.48-3.45, p<0.001), but not the 6-month rate (34.4% vs. 16.3% RR 1.83; 95% CI, 0.74-4.53, p=0.194). VCF rates were similar at 17.3% and 18.4% for SBRT and cEBRT, respectively. No significant dose-dependent effect was observed with increasing BED for any efficacy or safety outcomes. ConclusionsOR pain response rates are similar, but CR pain response rates appear higher with SBRT compared to cEBRT, yet no dose-dependent effects were identified despite approximately 1.8x BED dose with SBRT.

The implementation of the elective subject "Public Health" in the final year for medical students at Göttingen University Medical Center: results of the UNITE project

International and national frameworks and initiatives call for strengthening the training of health professionals in the public health service (PHS) through cooperation with universities. The German Medical Licensing Regulations of 21st Sep 2021 provides for an integration of PHS into undergraduate medical training in the final year since 1st May 2022. The present study presents the procedure and results of the final year elective Public Health (PH) implementation for medical students at the University Medical Center Göttingen (UMG) in cooperation with the local PHS. In the twelve-month project UNITE (07/21-06/22), the final year elective PH was implemented in seven steps: analysis of the framework conditions, conception of the elective, preparation of a logbook, pilot phase with five students in one-week rotations, public relations for students, introduction of a medical didactic training for staff of the health department and implementation of the elective PHS with students. A cooperation agreement between UMG and the Health Department regulates the training of medical students. Students complete four-week rotations in the areas of public health service and funeral services, paediatric and adolescent medical service, infection control and social psychiatric service. The logbook for students contains learning objectives for individuals specialised in services for self-assessment of the acquired competences. The didactics training was implemented with high learning success of the participating staff. So far three final year students have successfully completed the elective. The implementation of final year elective PHS strengthens the anchoring of public health topics in the education of medical students in Göttingen and makes PHS more visible as a professional perspective. Essential for the successful implementation were the establishment of a continuous cooperation between the university and the health department, student-oriented teaching-learning concept with a logbook suitable for the location, a trained multiprofessional team in the health department, and the evaluation of the elective for quality assurance and further development of the training. The concept presented here can help other locations in establishing the final year elective in PH and can be adapted to specific local conditions.

A revised radiocarbon calibration curve 350-250 BCE impacts high-precision dating of the Kyrenia Ship.

The Kyrenia Ship, found off the north coast of Cyprus, is a key vessel in the history of scientific underwater excavations and in the history of Greek shipbuilding. The first volume of the site's final publication appeared in 2023 and provides detailed archaeological information tightly constraining the dating of the ship. A very specific date range is proposed: ca. 294-290 BCE, but is based on a less than certain reading of one coin recovered from the ship. While there is clear benefit to finding high-precision dates for the Kyrenia Ship and its rich assemblage using independent scientific dating (combined with Bayesian chronological modeling), efforts to do so proved more challenging and complex than initially anticipated. Strikingly, extensive radiocarbon dating on both wooden materials from the ship and on short-lived contents from the final use of the ship fail to offer dates using the IntCal20 calibration curve-the current Northern Hemisphere radiocarbon calibration curve at the time of writing-that correspond with the archaeological constraints. The issue rests with a segment of IntCal20 ca. 350-250 BCE reliant on legacy pre-AMS radiocarbon data. We therefore measured new known-age tree-ring samples 350-250 BCE, and, integrating another series of new known-age tree-ring data, we obtained a redefined and more accurate calibration record for the period 433-250 BCE. These new data permit a satisfactory dating solution for the ship and may even indicate a date that is a (very) few years more recent than current estimations. These new data in addition confirm and only very slightly modify the dating recently published for the Mazotos ship, another Greek merchant ship from the southern coast of Cyprus. Our work further investigated whether ship wood samples impregnated with a common preservative, polyethylene glycol (PEG), can be cleaned successfully, including a known-age test.

Path Forward: Materials Data Modernization for ASME Codes and Standards in the Artificial Intelligence Era

Abstract Development of the ASME Materials Properties Database was initiated in the early 2010s to support the ASME Codes and Standards. As information technologies advance at an accelerated pace with the artificial intelligence era on the horizon, the ASME Materials Properties Database must be further modernized from a database to a knowledgebase to ride the wave of digital information revolution and effectively support the ASME Codes and Standards in the new era. This paper is intended to provide an overview of the ASME Materials Properties Database and discuss a roadmap for its future development to facilitate understanding of and participation from different sectors of the Codes and Standards community. It first reviews the basic concepts of data, information, knowledge, database, and database system as well as the pros and cons in different types of data management and then discusses the path forward for a desired evolution of the database into a self-explanatory and machine-readable knowledgebase that is consistent with human cognitive processes for the Codes and Standards development and, furthermore, provides resources for data processing and analysis to reach an eventual goal of streamlining the Codes and Standards development from the initial inquiry, throughout data submission, analysis, …, to Codes and Standards rule establishment for final publication.

Evidence for and against manganese deficiency as causal for congenital joint deficiency disease or death in fetal and neonatal cattle.

Measures of manganese (Mn) status in cattle vary among studies, and no single criterion accurately predicts or diagnoses Mn deficiency and pathologic outcomes. Mn deficiency causes congenital joint laxity and dwarfism (CJLD) when total dietary intake is <20 ppm Mn dry matter (DM) for most of the pregnancy. However, the recommended dietary intake of 40 ppm DM can also result in clinical Mn deficiency. Some studies have found that CJLD occurs in calves from cows fed red clover or silage but not in calves from cows fed hay. The concentration of Mn in the liver is the best indicator of Mn status in neonates and adults but cannot be interpreted in fetuses. Serum, plasma, and whole blood concentrations of Mn are unreliable indicators of bovine Mn status. The primary objective of our report is to present evidence linking CJLD to a primary or secondary Mn deficiency. To predict and diagnose Mn deficiency in cattle, we propose using a combination of clinical signs, dietary Mn, liver Mn at birth and beyond, positive response to Mn supplementation or the replacement of silage with other forages, and ruling out other causes of malformations. By following these recommendations, we expect that CJLD and gestational death will decrease as hepatic Mn concentrations increase at birth. Many publications we reviewed are not statistically sound, and future research should include a statistician from the initial discussions of the study through the final publication.

A phase 3 global study of telisotuzumab vedotin versus docetaxel in previously treated patients with c-Met 0verexpressing, EGFR wildtype, locally advanced/metastatic nonsquamous NSCLC (TeliMET NSCLC-01).

TPS8656 Background: Non-small cell lung cancer (NSCLC) encompasses over two-thirds of lung cancer diagnoses, most presenting as advanced disease. c-Met (MET protein) is overexpressed in NSCLC. In this study, we investigate telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate composed of a c-Met–targeting antibody (telisotuzumab) and a microtubule polymerization inhibitor (cytotoxin monomethyl auristatin E). Interim efficacy analysis of the Phase 2 LUMINOSITY study (NCT03539536) of Teliso-V monotherapy showed an objective response rate (ORR) of 37% (95% CI: 24–51) in previously treated patients (pts) with c-Met overexpressing epidermal growth factor receptor (EGFR) wildtype (WT) nonsquamous NSCLC and 52% (95% CI: 31–73) in the high c-Met overexpressing group (Camidge DR et al. J Clin Oncol. 2022;40(16_suppl):9016). Methods: This randomized, open-label, global Phase 3 study (NCT04928846) evaluates the efficacy, safety, pharmacokinetics, and pharmacodynamics of Teliso-V monotherapy compared with docetaxel in pts with locally advanced/metastatic c-Met overexpressing EGFR WT nonsquamous NSCLC who have progressed on prior therapy. Enrollment began in May 2022. To be eligible across global sites, pts must be ≥18 years old with c-Met overexpressing (ie, ≥25% tumor cells at 3+ intensity by IHC assay [anti-MET clone SP44; Roche Tissue Diagnostics]) locally advanced/metastatic EGFR WT NSCLC, with ECOG score ≤1. Pts must have progressed on at least one prior line of therapy, which can include no more than one line of prior chemotherapy, and must be naïve to c-Met–targeted antibodies and docetaxel. Target enrollment is 698 pts. Pts will be randomized 1:1 to Teliso-V (1.9 mg/kg every 2 weeks) and docetaxel (control, 75 mg/m2 every 3 weeks). Treatment continues until disease progression or discontinuation criteria are met. Co-primary endpoints are progression-free survival by independent central review and overall survival. Secondary endpoints include ORR, duration of response, and patient-reported outcomes. Safety, adverse events (AEs), drug discontinuation or dosing modification due to AEs, and tolerability will be assessed. Previously presented at the 2023 ESMO Congress, Final Publication Number: 1501TiP, Antonio Lugini et al. - Reused with permission. Clinical trial information: NCT04928846 .

First-in-human, phase 1/2 study of GSK4524101, an oral DNApolymerase theta inhibitor (POLQi), alone or combined with the poly(ADP-ribose) polymerase (PARP) inhibitor (PARPi) niraparib in adults with solid tumors.

TPS3174 Background: Double-stranded DNA breaks (DSBs) in human cells are typically repaired via nonhomologous end joining (NHEJ) or homologous recombination (HR). Deficiency of HR-mediated DNA repair plays a role in the initiation and progression of many tumor types. In tumors with HR deficiency, PARP inhibition leads to generation of DSBs that cannot be effectively repaired because of the HR defect, resulting in synthetic lethality. This finding has led to the clinical development and approval of several PARPi for the treatment of various tumors including certain ovarian, breast, prostate, and pancreatic cancers that are prone to display HR deficiency (HRd). DNA polymerase theta (encoded by POLQ) mediates an alternative DNA repair mechanism, microhomology-mediated end joining (MMEJ). DNA polymerase theta is generally not detectable in normal tissues but is upregulated in many tumor types. In preclinical studies, POLQi plus PARPi treatment demonstrated superior efficacy to PARPi alone in preventing the growth of HRd tumors. To evaluate the clinical potential of combining POLQi and PARPi, this first-in-human study investigates treatment with GSK4524101, an investigational POLQi, with or without the PARPi niraparib, in patients with solid tumors. Methods: This open-label, multicenter, phase 1/2 study (NCT06077877) opened in October 2023 and comprises dose-finding (part 1, including a food-effect cohort) and dose-expansion (part 2) parts. This trial aims to assess the maximum-tolerated dose, pharmacokinetics, safety, and preliminary antitumor activity of oral GSK4524101 with or without niraparib. The primary endpoints are safety (part 1) and confirmed objective response rate (part 2). Secondary endpoints include pharmacokinetics, safety, progression-free survival (part 2), and response duration (part 2). Up to 135 patients may be enrolled. To be eligible, patients must be aged ≥18 years; have an advanced or metastatic solid tumor, an Eastern Cooperative Oncology Group performance status score of 0–2, and a life expectancy of ≥3 months; and have exhausted all standard treatment options. Individuals are ineligible if they have not recovered from chemotherapy-associated adverse events or have symptomatic uncontrolled brain or leptomeningeal metastases, a history of myelodysplastic syndrome or acute myeloid leukemia, uncontrolled hypertension, or a second malignancy that has progressed or required active treatment in the previous 2 years. The study is actively recruiting in the US and Canada; as of January 1, 2024, 1 patient has been dosed. Patients enrolled in part 1 will receive GSK4524101 alone or GSK4524101 plus niraparib; patients enrolled in part 2 will be randomized to either GSK4524101 plus niraparib or niraparib alone. Part 1 of this study is expected to complete in 2025. Data presented on behalf of the original authors with their permission. Presented at the American Association for Cancer Research (AACR) Annual Meeting 2024; April 5-10, 2024; San Diego, CA. Final publication number: 9686. Reused with permission. Clinical trial information: NCT06077877 .

Advances in the Application of AI Robots in Critical Care: Scoping Review.

In recent epochs, the field of critical medicine has experienced significant advancements due to the integration of artificial intelligence (AI). Specifically, AI robots have evolved from theoretical concepts to being actively implemented in clinical trials and applications. The intensive care unit (ICU), known for its reliance on a vast amount of medical information, presents a promising avenue for the deployment of robotic AI, anticipated to bring substantial improvements to patient care. This review aims to comprehensively summarize the current state of AI robots in the field of critical care by searching for previous studies, developments, and applications of AI robots related to ICU wards. In addition, it seeks to address the ethical challenges arising from their use, including concerns related to safety, patient privacy, responsibility delineation, and cost-benefit analysis. Following the scoping review framework proposed by Arksey and O'Malley and the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we conducted a scoping review to delineate the breadth of research in this field of AI robots in ICU and reported the findings. The literature search was carried out on May 1, 2023, across 3 databases: PubMed, Embase, and the IEEE Xplore Digital Library. Eligible publications were initially screened based on their titles and abstracts. Publications that passed the preliminary screening underwent a comprehensive review. Various research characteristics were extracted, summarized, and analyzed from the final publications. Of the 5908 publications screened, 77 (1.3%) underwent a full review. These studies collectively spanned 21 ICU robotics projects, encompassing their system development and testing, clinical trials, and approval processes. Upon an expert-reviewed classification framework, these were categorized into 5 main types: therapeutic assistance robots, nursing assistance robots, rehabilitation assistance robots, telepresence robots, and logistics and disinfection robots. Most of these are already widely deployed and commercialized in ICUs, although a select few remain under testing. All robotic systems and tools are engineered to deliver more personalized, convenient, and intelligent medical services to patients in the ICU, concurrently aiming to reduce the substantial workload on ICU medical staff and promote therapeutic and care procedures. This review further explored the prevailing challenges, particularly focusing on ethical and safety concerns, proposing viable solutions or methodologies, and illustrating the prospective capabilities and potential of AI-driven robotic technologies in the ICU environment. Ultimately, we foresee a pivotal role for robots in a future scenario of a fully automated continuum from admission to discharge within the ICU. This review highlights the potential of AI robots to transform ICU care by improving patient treatment, support, and rehabilitation processes. However, it also recognizes the ethical complexities and operational challenges that come with their implementation, offering possible solutions for future development and optimization.

One must reconstitute the functions of interest from purified proteins.

I am often asked by students and younger colleagues and now by the editors of this issue to tell the history of the development of the in vitro motility assay and the dual-beam single-molecule laser trap assay for myosin-driven actin filament movement, used widely as key assays for understanding how both muscle and nonmuscle myosin molecular motors work. As for all discoveries, the history of the development of the myosin assays involves many people who are not authors of the final publications, but without whom the assays would not have been developed as they are. Also, early experiences shape how one develops ideas and experiments, and influence future discoveries in major ways. I am pleased here to trace my own path and acknowledge the many individuals involved and my early science experiences that led to the work I and my students, postdoctoral fellows, and sabbatical visitors did to develop these assays. Mentors are too often overlooked in historical descriptions of discoveries, and my story starts with those who mentored me.

Development and implementation of personal learning environment-based writing for publication scaffolding platform for Ph.D. Students

This research tackles the challenges Ph.D. students face in academic publishing, which are not fully addressed by existing support systems. It introduces the personal learning environment-based writing for publication (PLE-WfP) platform, created to offer extensive support in academic writing and publication. Developed and tested over ten months with thirteen Year 1 Ph.D. Chinese students at a Thai university, the platform uses a mixed-methods approach encompassing development, intervention, and feedback analysis through reflective diaries. The PLE-WfP platform, structured in individual, group, and submission stages, guides students from beginning writing to collaborative research and final publication, addressing common publishing challenges. Participants expressed a strong preference for the platform’s personalized assistance over conventional methods, highlighting its relevance, adaptability, promptness, and thoroughness. The importance of the academic community in enhancing collaborative writing, confidence, emotional regulation, and resource sharing was also emphasized. This study highlights the need for emotional and financial support in addition to cognitive and technical assistance in academic writing. By providing a novel scaffolding approach, this research contributes valuable insights and solutions to the academic community, demonstrating significant theoretical and practical benefits for global academic discourse.

Abstract PO1-19-11: Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for HER2+ Metastatic Breast Cancer (HER2CLIMB-05, Trial in Progress)

Abstract Background The current first-line (1L) standard of care (SOC) for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) is trastuzumab (T) plus pertuzumab (P) and a taxane. Despite advances in 1L SOC, most patients progress during maintenance therapy with T+P. Tucatinib is a tyrosine kinase inhibitor (TKI) approved in combination with T and capecitabine for adults with HER2+ MBC, with and without brain metastases (BM). In HER2CLIMB, addition of tucatinib significantly prolonged progression-free survival (PFS) and overall survival (OS) in patients with HER2+ MBC and was well tolerated. Adding tucatinib also reduced the risk of disease progression or death in patients with untreated and/or active BM (Murthy et al. NEJM 2020, Curigliano et al. Ann Oncol 2022). HER2CLIMB-05 investigates whether adding tucatinib to 1L SOC as maintenance therapy will extend PFS while maintaining quality of life (QOL). Methods HER2CLIMB-05 (NCT05132582) is a phase 3, randomized, double-blind study evaluating tucatinib plus T+P as maintenance therapy for HER2+ MBC. Approximately 650 patients will be enrolled. Eligible patients will have advanced HER2+ disease, no progression on 4–8 cycles of prior 1L SOC, Eastern Cooperative Oncology Group Performance Status of 0 or 1, and no or asymptomatic BM. Exclusion criteria include prior treatment with anti-HER2 and/or anti-epidermal growth factor receptor TKI (prior SOC for early BC is permitted) or inability to undergo contrast magnetic resonance imaging of the brain. Patients will be randomized 1:1 to receive either tucatinib or placebo twice daily, with T+P once every 21 days. Patients with hormone receptor-positive disease may receive endocrine therapy. The primary endpoint is investigator-assessed PFS. Secondary endpoints include OS, time to deterioration of health-related QOL, central nervous system PFS, safety, and pharmacokinetic (PK) parameters. PFS and OS will be compared using a two-sided stratified log-rank test between treatment groups. Time-to-event endpoints will be summarized using the Kaplan–Meier method. PK and safety data will be summarized using descriptive statistics. Enrollment is ongoing in Austria, Chile, Greece, Italy, Japan, Poland, Portugal, Spain, the US, and several other European, APAC, and LATAM countries. This abstract was previously presented at ESMO-BC 2022, FPN (Final Publication Number): 415, by Veronique Dieras (reused with permission). Citation Format: Erika Hamilton, Junji Tsurutani, Giuseppe Curigliano, Miguel Martín, Ciara O'Sullivan, Joo Hyuk Sohn, Konstantinos Tryfonidis, Libero Santarpia, Shan Yang, Véronique Diéras. Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for HER2+ Metastatic Breast Cancer (HER2CLIMB-05, Trial in Progress) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-19-11.

Writing and publishing papers in academic radiology: Why it needs to be more than a box checked for promotion

An ongoing challenge in academic radiology is balancing the need to read the scans and generate relative value units (RVUs) with the need to ensure academic leadership and the consistent production of impactful publications. Indeed, the tripartite mission of academic radiology (i.e. clinical care, research, and teaching) does not lend itself to obvious answers in an era when institutions and departments are increasingly focused on RVU generation. Even the minority of radiologists who are interested in pursuing the academic mission and accept academic jobs are likely to find their time increasingly squeezed by massive volumes of scans to read and the priority placed on RVU generation. There are often no incentives for impactful academic work, leading to a decreasing relative number of manuscript submissions from U.S.-based researchers. With the lack of external incentivization for publication, writing and publishing papers must instead be driven by intrinsic enjoyment and a sense of accomplishment. The ability to think of an idea, to get a group of co-authors together, to acquire the data and/or put together the idea into a form that is ready for final publication, and to see that process through to the end is rewarded only by personal satisfaction. Perhaps, in the era of RVU generation, publishing papers in a form of defiance of a system that is hampering the academic mission.

A transdiagnostic group exercise intervention for mental health outpatients in Germany (ImPuls): results of a pragmatic, multisite, block-randomised, phase 3 controlled trial

Globally, mental health conditions pose a substantial burden of disease. Despite the availability of evidence-based pharmacological and psychological treatments, the symptoms of a substantial subgroup of patients do not respond to these interventions, and only a minority of patients have access to them. This study aimed to assess the efficacy of ImPuls, a 6-month transdiagnostic group exercise intervention, plus treatment-as-usual, compared with treatment-as-usual alone in outpatients with various mental disorders. In this pragmatic, two-arm, multisite, randomised controlled trial in Germany, ten outpatient rehabilitative and medical care facilities were involved as study sites. Participants were outpatients diagnosed according to ICD-10 with one or more of the following disorders based on structured clinical interviews: moderate or severe depression, primary insomnia, post-traumatic stress disorder (PTSD), panic disorder, or agoraphobia. Participants were required to be aged between 18 years and 65 years, insured by the health insurers Allgemeine Ortskrankenkasse Baden-Württemberg or Techniker Krankenkasse, fluent in German, and without medical contraindications for exercise. Blocks of six participants were randomly allocated to ImPuls plus treatment-as-usual or treatment-as-usual alone (allocation ratio: 1:1), stratified by study site. The randomisation sequence was generated by an external data manager. The team responsible for data collection and management was masked to the randomisation sequence. The ImPuls intervention comprised evidence-based outdoor exercises lasting 30 min, and aimed at achieving at least moderate intensity. It also incorporated behavioural change techniques targeting motivational and volitional determinants of exercise behaviour. Treatment-as-usual was representative of typical outpatient health care in Germany, allowing patients access to any standard treatments. The primary outcome was global symptom severity at 6 months after randomisation, measured using self-report on the Brief Symptom Inventory (BSI-18) and analysed in the intention-to-treat sample. No individuals with lived experience of mental illness were involved in conducting the study or writing the final publication. Safety was assessed in all participants. The trial was registered with the German Clinical Trials Register (DRKS00024152) with a completion date of June 30, 2024. 600 patients provided informed consent, were recruited to the study, and underwent a diagnostic interview between Jan 1, 2021, and May 31, 2022. Following this, 199 were excluded on the basis of inclusion and exclusion criteria and one withdrew consent during the baseline assessment. Of the 400 eligible participants, 284 (71%) self-identified as female, 106 (27%) self-identified as male, and nine (2%) self-identified as other. The mean age was 42·20 years (SD 13·23; range 19-65). Ethnicity data were not assessed. 287 (72%) participants met the criteria for moderate or severe depression, 81 (20%) for primary insomnia, 37 (9%) for agoraphobia, 46 (12%) for panic disorder, and 72 (18%) for PTSD. 199 participants were allocated to the intervention group of ImPuls plus treatment-as-usual and 201 to the control group of treatment-as-usual alone. 38 (19%) participants did not receive the minimum ImPuls intervention dose. ImPuls plus treatment-as-usual demonstrated superior efficacy to treatment-as-usual alone in reducing global symptom severity, with an adjusted difference on BSI-18 of 4·11 (95% CI 1·74-6·48; d=0·35 [95% CI 0·14-0·56]; p=0·0007) at 6 months. There were no significant differences in the total number of adverse events or serious adverse events between the two groups. There was one serious adverse event (male, torn ligament) related to the intervention. ImPuls is an efficacious transdiagnostic adjunctive treatment in outpatient mental health care. Our findings suggest that exercise therapy should be implemented in outpatient mental health care as an adjunctive transdiagnostic treatment for mental disorders such as depression, insomnia, panic disorder, agoraphobia, and PTSD. Transdiagnostic group exercise interventions might ameliorate the existing disparity in care provision between the many individuals in need of evidence-based treatment and the few who are receiving it. The German Innovation Fund of the Federal Joint Committee of Germany.

Why state-of-the-art analytical models for eddy current losses in PM of PMSM are insufficient for variable speed motors

This is the third paper in a series on novel methods for calculating eddy current losses in permanent magnets (PM) and the shortcomings of previously conducted analyses. In the first paper, Ruoho’s work on homogeneous materials was discussed. The distribution of fields has been expanded to include the reaction field of the eddy currents within the permanent magnets. This approach was based on the methods of the harmonic complex AC calculation. In the second paper, the models were expanded to enable a harmonic calculation of eddy current losses in permanent magnets for homogeneous fields including the effects of eddy current losses in an adjacent ferromagnetic material, leakage flux factors, and source behavior. In this third and final publication, a look at state-of-the-art analytical models will be taken. With regard to the results of the second publication of this series, it can be shown that established analytical models are insufficient when calculating inverter-related eddy current losses in permanent magnets of permanent magnet synchronous machines (PMSM). Furthermore, a short introduction to eddy current loss mechanics in permanent magnets of PMSM will be given.