bluuebunny/crossref_metadata_2025_split huggingface dataset:
Volume-outcome relationship in balloon aortic valvuloplasty: results of a consecutive, patient-level data analysis from a Japanese nationwide multicentre registry (J-SHD)
Authors: Iwasaki Masamichi , Konishi Akihide , Takahara Mitsuyoshi , Kohsaka Shun , Okuda Masanori , Hayashi Takatoshi , Takamisawa Itaru , Ishii Hideki , Amano Tetsuya , Shinke Toshiro , Ikari Yuji 
Published: October 2023

ObjectiveTranscatheter balloon aortic valvuloplasty (BAV) remains an important alternative treatment for severe, symptomatic aortic stenosis. With increasing numbers of BAVs being performed, the need for large-scale volume-outcome relationship assessments has become evident. Here, we aimed to explain such relationships by analysing consecutive, patient-level BAV data recorded in a prospective Japanese nationwide multicentre registry.DesignProspective study.SettingData of 1920 BAVs performed in 200 Japanese hospitals from January 2015 to December 2019.ParticipantsThe mean patient age was 85 years, and 36.9% of procedures involved male patients.MethodsThe efficacy of BAV was assessed by reducing the mean transaortic valve gradient after the procedure. We also assessed in-hospital complication rates, including in-hospital death, bleeding, urgent surgery, distal embolism, vessel rupture and contrast-induced nephropathy. Based on the distribution of case volume (median 20, IQR 10–46), we divided the patients into high-volume (≥20) and low-volume (<20) groups. In-hospital complication risk was assessed with adjustment by logistic regression modelling.ResultsIndications for BAV included palliative/destination (44.2%), bridge to transcatheter aortic valve replacement (34.5%), bridge to surgical aortic valve replacement (7.4%) and salvage (9.7%). Reduction of the mean transaortic valve gradient was similar between the high-volume and low-volume groups (20 mm Hg vs 20 mm Hg, p=0.12). The proportion of in-hospital complications during BAV was 4.2%, and the incidence of complications showed no difference between the high-volume and low-volume groups (4.2% vs 4.1%, p=1.00). Rather than hospital volume, salvage procedure was an independent predictor of in-hospital complications (OR, 4.04; 95% CI, 2.03 to 8.06; p<0.001).ConclusionThe current study demonstrated that procedural outcomes of BAV were largely independent of its institutional volume.
Evaluation of US oncology electronic health record real-world data to reduce uncertainty in health technology appraisals: a retrospective cohort study
Authors: Mpofu Philani , Kent Seamus , Jónsson Páll , Pittell Harlan , Groves Brad , Altomare Ivy , Copeland Amanda , Baxi Shrujal , Bargo Danielle , Sujenthiran Arun , Adamson Blythe 
Published: October 2023

ObjectivesExamine whether data from early access to medicines in the USA can be used to inform National Institute for Health and Care Excellence (NICE) health technology assessments (HTA) in oncology.DesignRetrospective cohort study.SettingOncology-based community and academic treatment centres in the USA.ParticipantsPatients present in a nationwide electronic health record (EHR)-derived deidentified database.InterventionsCancer drugs that underwent NICE technology appraisal (TA) between 2014 and 2019.Primary and secondary outcome measuresThe count and follow-up time of US patients, available in the EHR, who were exposed to cancer drugs of interest in the period between Food and Drug Administration (FDA) approval and dates relevant to the NICE appraisal process.ResultsIn 59 of 60 TAs analysed, the cancer therapy was approved in the USA before the final appraisal by NICE. The median time from FDA approval to the publication of NICE recommendations was 18.5 months, at which time the US EHR-derived database had, on average, 269 patients (SD=356) exposed to the new therapy, with a median of 75.3 person-years (IQR: 13.1–173) in time-at-risk. A case study generated evidence on real-world overall survival and treatment duration.ConclusionsAcross different cancer therapies, there was substantial variability in US real-world data accumulated between FDA approval and NICE decision milestones. The applicability of these data to generate evidence for HTA decision-making should be assessed on a case-by-case basis depending on the intended HTA use case.
Health locus of control and self-management behaviours among individuals with ischaemic heart disease: protocol for a scoping review
Authors: Wang Run , Zhou Chunlan , Parry Monica 
Published: October 2023

IntroductionIschaemic heart disease is a significant cause of morbidity and mortality worldwide. Self-management is a way to reduce the risk associated with ischaemic heart disease; however, some individuals may not have the ability or willingness to engage in self-management behaviours. One approach to identify an individual’s readiness and capacity to engage in self-management behaviours is to assess their health locus of control. Based on the Individual and Family Self-Management Theory, this review’s objectives are to describe: (1) how health locus of control affects the process of engaging in self-management behaviours, (2) impacts of health locus of control on outcomes associated with self-management behaviours and (3) potential contextual variations in the relationship between health locus of control and self-management behaviours.Methods and analysisThe scoping review will be guided by the Joanna Briggs Institute methodological framework. A comprehensive search will encompass seven electronic databases (Ovid Medline, CINAHL, EMBASE, APA PsycINFO, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Scopus) and grey literature sources (ProQuest Dissertations, ClinicalTrials.gov). Collaborative efforts with library experts will inform our search strategies, building on insights from previous reviews centred on self-management and ischaemic heart disease. Two review authors will independently conduct the screening and data extraction processes; discrepancies will be resolved through consensus or discussion with a third review author. The review will include English studies from database inception, focusing on the health locus of control among adults with ischaemic heart disease. Findings will be presented graphically and tabularly, together with a narrative description.Ethics and disseminationWe will collect data from published and grey literature, meaning ethical approval is not necessary. Findings will be published in peer-reviewed journals and presented at academic conferences.Registration detailsOpen Science Framework (https://doi.org/10.17605/OSF.IO/B4A6F).
Comparisons of procedural characteristics and clinical outcomes between SMARTTOUCH SURROUNDFLOW catheter and other catheters for atrial fibrillation radiofrequency catheter ablation: a systematic literature review
Authors: Li Jianyong , Zhou Guifang , Li Xinzhong , Huang Senlin , Lin Hairuo , Lin Shaopeng , Tan Liang , Chen Wendong , Huang Xiaobo , Wang Yuegang 
Published: October 2023

BackgroundSMARTTOUCH SURROUNDFLOW (STSF) catheter is the new generation of SMARTTOUCH (ST) catheter with an upgraded irrigation system for radiofrequency catheter ablation (RFCA) in patients with atrial fibrillation (AF).MethodsThis systematic literature review searched the major English and Chinese bibliographic databases from 2016 to 2022 for any original clinical studies assessing the STSF catheter for RFCA in AF patients. Meta-analysis with a random effects model was used for evidence synthesis.ResultsPooled outcomes from 19 included studies indicated that STSF catheter was associated with a significantly shorter procedure time (weighted mean difference (WMD): −17.4 min, p<0.001), shorter ablation time (WMD: −6.6 min, p<0.001) and lower catheter irrigation fluid volume (WMD: −492.7 mL, p<0.001) than ST catheter. Pooled outcomes from four included studies with paroxysmal AF patients reported that using the STSF catheter for RFCA was associated with a significantly shorter ablation time (WMD: −5.7 min, p<0.001) and a lower risk of 1-year postablation arrhythmia recurrence (rate ratio: 0.504, p<0.001) than the SURROUNDFLOW (SF) catheter. Significant reductions in procedure time and ablation time associated with the STSF catheter were also reported in the other four studies using non-ST/SF catheters as the control. Overall complications of STSF catheter and control catheters were comparable.ConclusionsUsing the STSF catheter was superior to using the ST catheter to conduct RFCA for AF by significantly reducing procedure time, ablation time, fluoroscopy time and irrigation fluid volume. The superiority of the STSF catheter over the SF catheter and other non-ST/SF catheters for RFCA needs further confirmation.
Childbirth self-efficacy and fear of childbirth and their predictors in adolescent and adult pregnant women referring to health centres of Urmia-Iran: a cross-sectional study
Authors: Effati Daryani Fatemeh , Mohammadi Azam , Mirghafourvand Mojgan 
Published: October 2023

ObjectiveAdolescent pregnancy as a growing phenomenon in the world has been investigated from different aspects. However, the examination of childbirth fear and self-efficacy has received less attention. Therefore, this study was conducted to compare the self-efficacy and fear of childbirth and to determine their predictors in adolescent and adult pregnant women.DesignIn this comparative cross-sectional study, participants were selected through two-stage cluster sampling method. Data were collected using the Childbirth Self-Efficacy Inventory and Wijma Delivery Expectancy/Experience Questionnaire. The Pearson correlation test, independent t-test, and general linear model were used for data analysis.SettingUrmia health centres, Iran in 2020.ParticipantsThree hundred and sixty adults and adolescent pregnant women.ResultsThe mean (SD) of fear of childbirth was 114.7 (14.1) and 108.1 (23.1) in adolescent and adult pregnant women, respectively. The mean (SD) of childbirth self-efficacy in the active phase and the second stage of labour respectively were also obtained 208.8 (28.6) and 203.5 (32.1) for adolescent pregnant women and 213.8 (25.7) and 212.0 (26.5) for adult ones. There was a significant difference between adolescent and adult pregnant women in fear of childbirth (p=0.001), self-efficacy expectancy (p=0.003) and total childbirth self-efficacy (p=0.008) in the second stage of labour. After adjusting the sociodemographic characteristics, the mean score of fear of childbirth was significantly higher in adolescent pregnant women than in adult ones whereas the mean total self-efficacy score in the second stage of labour was significantly lower in adolescent pregnant women than in adult ones.ConclusionThis study showed that adolescent pregnant women had more fear of childbirth and low self-efficacy than adult mothers, and there was also a relationship between fear of childbirth and self-efficacy. Paying more attention to fear and self-efficacy in childbirth and their predictors by health providers can improve pregnancy and childbirth outcomes.
Factors affecting point-of-care ultrasound implementation in general practice: a survey in Danish primary care clinics
Authors: Andersen Camilla Aakjær , Brodersen John Brandt , Graumann Ole , Davidsen Annette Sofie , Jensen Martin Bach 
Published: October 2023

ObjectiveThe implementation of point-of-care ultrasound (POCUS) in general practice varies, but it is unknown what determines this variation. The purpose of this study was to explore (1) the overall proportion of POCUS-users among general practitioners (GPs), (2) the current use of POCUS by GPs, (3) factors related to the implementation of POCUS in general practice and (4) GPs’ concerns related to POCUS use in general practice.DesignAn online survey was distributed in June 2019.SettingGeneral practice.ParticipantsGPs working in office-based primary care clinics in Denmark.Main outcome measuresThe questionnaire was developed using mixed methods and included questions about participants’ characteristics, past POCUS training and experience, capability, opportunity and motivation for using POCUS in the primary care setting. Results were summarised using descriptive statistics. Association between GPs’ background characteristics and POCUS use was tested using logistics regression.ResultsResponses were analysed from 1216 questionnaires corresponding to 36.4% of all GPs in Denmark. The majority (72.3%) of participants had previous POCUS experience, 14.7% had access to a POCUS device and 11.5% used POCUS. Several factors motivated participants to use POCUS. However, barriers existed such as lack of remuneration and high workload. Additionally, many GPs questioned their ability to scan with sufficient diagnostic accuracy and the impact of POCUS on the consultation. Of non-users, 28.7% believed they would be using POCUS in the future.ConclusionAlthough, the majority of GPs had past experience with POCUS and felt motivated to use it, few had implemented POCUS. Several factors influenced the GPs’ capability, opportunity and motivation for using POCUS and several concerns were registered by non-users.
A Parent–child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol
Authors: Simard Marie-Noëlle , Lepage Charles , Gaudet Isabelle , Paquette Natacha , Doussau Amélie , Poirier Nancy C , Beauchamp Miriam H , Côté Sylvana M , Pinchefsky Elana , Brossard-Racine Marie , Mâsse Benoît , Gallagher Anne 
Published: October 2023

IntroductionPreschoolers and school-aged children with congenital heart disease (CHD) are at higher risk of attention deficit hyperactivity disorder (ADHD) compared with the general population. To this day, no randomised controlled trial (RCT) aiming to improve attention has been conducted in young children with CHD. There is emerging evidence indicating that parent–child yoga interventions improve attention and reduce ADHD symptoms in both typically developing and clinical populations.Methods and analysisThis is a single-blind, two-centre, two-arm trial during which 24 children with CHD and their parents will be randomly assigned to (1) a parent–child yoga intervention in addition to standard clinical care or (2) standard clinical care alone. All participants will undergo standardised assessments: (1) at baseline, (2) immediately post-treatment and (3) 6 months post-treatment. Descriptive statistics will be used to estimate the feasibility and neurodevelopmental outcomes. This feasibility study will evaluate: (1) recruitment capacity; (2) retention, drop-out and withdrawal rates during the yoga programme and at the 6-month follow-up; (3) adherence to the intervention; (4) acceptability of the randomisation process by families; (5) heterogeneity in the delivery of the intervention between instructors and use of home-based exercises between participants; (6) proportion of missing data in the neurodevelopmental assessments and (7) SD of primary outcomes of the full RCT in order to determine the future appropriate sample size.Ethics and disseminationEthical approval has been obtained by the Research Ethics Board of the Sainte-Justine University Hospital. The findings will be disseminated in peer-reviewed journals and conferences and presented to the Canadian paediatric grand round meetings.Trial registration numberNCT05997680.
Long-term neurodevelopmental outcome in children born after vacuum-assisted delivery compared with second-stage caesarean delivery and spontaneous vaginal delivery: a cohort study
Authors: Romero Stefhanie , Lindström Katarina , Listermar Johanna , Westgren Magnus , Ajne Gunilla 
Published: October 2023

ObjectiveTo evaluate long-term neurodevelopment in children born after low-or mid-station vacuum-assisted delivery (VAD) compared with children delivered by second-stage caesarean delivery (SSCD) or spontaneous vaginal delivery (SVD).DesignCross-sectional cohort study.SettingTwo delivery wards, Karolinska University Hospital, Sweden.Patients253 children born by low-station or mid-station VAD, 247 children born after an SVD, and 86 children born via an SSCD accepted to participate.InterventionsThe Five-to-Fifteen questionnaire was used as a validated screening method for neurodevelopmental difficulties, assessed by parents.Main outcomes measuresResults in the Five-to-Fifteen questionnaire. In addition, registered neurodevelopmental ICD-10 diagnoses were collected. Regression analyses estimated associations between delivery modes.ResultsChildren born after VAD exhibited an increased rate of long-term neurodevelopmental difficulties in motor skills (OR 2.2, 95% CI 1.3 to 3.8) and perception (OR 1.7, 95% CI 1.002 to 2.9) compared with SVD. Similar findings were seen in the group delivered with an SSCD compared with SVD (motor skills: OR 3.3, 95% CI 1.8 to 6.4 and perception: OR 2.3, 95% CI 1.2 to 4.4). The increased odds for motor skills difficulties after VAD and SSCD remained after adjusting for proposed confounding variables. There were significantly more children in the VAD group with registered neurodevelopmental ICD-10 diagnoses such as attention deficit/hyperactivity disorders.ConclusionsThe differences in long-term neurodevelopmental difficulties in children delivered with a VAD or SSCD compared with SVD in this study indicate the need for increased knowledge in the field to optimise the management of second stage of labour.
Development of the Life Gatekeeper suicide prevention training programme in China: a Delphi study
Authors: Cai Chengxi , Yin Chen , Tong Yongsheng , Qu Diyang , Ding Yunzhi , Ren Daixi , Chen Peiyu , Yin Yi , An Jing , Chen Runsen 
Published: October 2023

BackgroundYouth suicide has been a pressing public mental health concern in China, yet there is a lack of gatekeeper intervention programmes developed locally to prevent suicide among Chinese adolescents.AimsThe current Delphi study was the first step in the systematic development of the Life Gatekeeper programme, the first gatekeeper programme to be developed locally in China that aims to equip teachers and parents with the knowledge, skills and ability to identify and intervene with students at high risk of suicide.MethodsThe Delphi method was used to elicit a consensus of experts who were invited to evaluate the importance of training content, the feasibility of the training delivery method, the possibility of achieving the training goals and, finally, the appropriateness of the training materials. Two Delphi rounds were conducted among local experts with diversified professional backgrounds in suicide research and practice. Statements were accepted for inclusion in the adjusted training programme if they were endorsed by at least 80% of the panel.ResultsConsensus was achieved on 201 out of 207 statements for inclusion into the adapted guidelines for the gatekeeper programme, with 151 from the original questionnaire and 50 generated from comments of the panel members. These endorsed statements were synthesised to develop the content of the Life Gatekeeper training programme.ConclusionsThis Delphi study provided an evidence base for developing the first gatekeeper training programme systematically and locally in China. We hope that the current study can pave the way for more evidence-based suicide prevention programmes in China. Further study is warranted to evaluate the effectiveness of the Life Gatekeeper training programme.
Asymmetric anti-CLL-1×CD3 bispecific antibody, ABL602 2+1, with attenuated CD3 affinity endows potent antitumor activity but limited cytokine release
Authors: Lee Eunhee , Lee Shinai , Park Sumyeong , Son Yong-Gyu , Yoo Jiseon , Koh Youngil , Shin Dong-Yeop , Lim Yangmi , Won Jonghwa 
Published: October 2023

BackgroundAcute myeloid leukemia (AML) is a type of leukemia in adults with a high mortality rate and poor prognosis. Although targeted therapeutics, chemotherapy, and hematopoietic stem cell transplantation can improve the prognosis, the recurrence rate is still high, with a 5-year survival rate of approximately 40%. This study aimed to develop an IgG-based asymmetric bispecific antibody that targets CLL-1 and CD3 for treating AML.MethodsABL602 candidates were compared in terms of binding activity, T-cell activation, and tumor-killing activities. ABL602-mediated T-cell activation and tumor-killing activities were determined by measuring the expression of activation markers, cytokines, cytolytic proteins, and the proportion of dead cells. We evaluated in vivo tumor growth inhibitory activity in two mouse models bearing subcutaneously and orthotopically engrafted human AML. Direct tumor-killing activity and T-cell activation in patient-derived AML blasts were also evaluated.ResultsABL602 2+1 showed a limited CD3 binding in the absence of CLL-1, suggesting that steric hindrance on the CD3 binding arm could reduce CLL-1 expression-independent CD3 binding. Although the CD3 binding activity was attenuated compared with that of 1+1, ABL602 2+1 exhibited much stronger T-cell activation and potent tumor-killing activities in AML cell lines. ABL602 2+1 efficiently inhibited tumor progression in subcutaneously and orthotopically engrafted AML mouse models. In the orthotopic mouse model, tumor growth inhibition was observed by gross measurement of luciferase activity, as well as a reduced proportion of AML blasts in the bone marrow, as determined by flow cytometry and immunohistochemistry (IHC) staining. ABL602 2+1 efficiently activated T cells and induced the lysis of AML blasts, even at very low effector:target (E:T) ratios (eg, 1:50). Compared with the reference 1+1 antibody, ABL602 did not induce the release of cytokines including interleukin-6 and tumor necrosis factor-α in the healthy donor-derived peripheral blood mononuclear cell.ConclusionsWith its potent tumor-killing activity and reduced cytokine release, ABL602 2+1 is a promising candidate for treating patients with AML and warrants further study.
Efficacy of adhesive strapping on umbilical hernia in children: a systematic review and meta-analysis of cohort studies
Authors: Sugimoto Takuya , Tahara Kazunori , Uchida Koshi , Yoshimoto Kazuhiko 
Published: October 2023

BackgroundAlthough adhesive strapping (AS) for pediatric umbilical hernia (UH), which was once obsolete, has been reconsidered as a common practice in Japan, its efficacy is still unclear. This study aimed to evaluate its efficacy by reviewing related articles.MethodsA comprehensive literature search of PubMed, Cochrane, Google Scholar, and Igaku Chuo Zasshi via Ichushi-Web was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Cohort studies reporting on the UH closure rate after AS compared with observation-only management were included.ResultsA total of 10 cohort studies were included, and the overall UH closure rate was not statistically significant (p=0.31, risk ratio (RR)=0.76, 95% confidence interval (CI) 0.45 to 1.28). However, there were significant differences in the UH closure rate at the age of 6 months (p<0.01, RR=0.55, 95% CI 0.41 to 0.75) and the efficacy of preventing protruding umbilici with redundant skin (p=0.049, RR=0.16, 95% CI 0.03 to 0.99).ConclusionsAlthough the efficacy of AS on UH compared with observation-only management did not differ in terms of the UH closure rate, the application of AS may be effective for faster UH closure and the prevention of protruding umbilici. However, due to the high heterogeneity of the study, further large-scale studies, particularly randomized controlled trials, are warranted to reach a conclusion.PROSPERO registration numberCRD42022314417.