bluuebunny/crossref_metadata_2025_split huggingface dataset:
Method to determine the statistical technical variability of SUV metrics
Authors: De Luca Giulia M. R. , Habraken Jan B. A. 
Published: June 2022

Abstract
Background
The Standardized Uptake Value (SUV) Max, SUVMean, and SUVPeak are metrics used to quantify positron emission tomography (PET) images. In order to assess the significance of a change in these metrics for diagnostic purposes, it is relevant to know their variation. The sources of variation can be biological or technical. In this study, we present a method to determine the statistical technical variation of SUV in PET images.

Results
This method was tested on a NEMA quality phantom with spheres of various diameters with a full-length acquisition time of 150 s per bed position and foreground-to-background activity ratio of F18-2-fluoro-2-deoxy-d-glucose (FDG) of 10:1. Our method divides the 150 s acquisition into subsets with statistically independent frames of shorter reconstruction length. SUVMax, Mean and Peak were calculated for each reconstructed image in a subset. The coefficient of variation of SUV within each subset has been used to estimate the expected coefficient of variation at 150 s reconstruction length. We report the largest coefficient of variation of the SUV metrics for the smallest sphere and the smallest variation for the largest sphere. The expected variation at 150 s reconstruction length does not exceed 6% for the smallest sphere and 2% for the largest sphere.

Conclusions
With the presented method, we aim to determine the statistical technical variation of SUV. The method enables the evaluation of the effect of SUV metric choice (Max, Mean, Peak) and lesion size on the technical variation and, therefore, to evaluate its relevance on the total variation of the SUV value between clinical studies.
The design and evaluation of a health education control for comparison with cognitive behavioural therapy for individuals with acquired brain injury
Authors: Ymer Lucy , McKay Adam , Wong Dana , Ponsford Jennie 
Published: June 2022

Abstract
Background
In psychological research, control conditions in the form of “treatment as usual” provide support for intervention efficacy, but do not allow the attribution of positive outcomes to the unique components of the treatment itself. Attentionally and structurally equivalent active control conditions, such as health education (HE), have been implemented in recent trials of cognitive behavioural therapy (CBT). However, descriptions and evaluations of these control conditions are limited. The aims of this paper were to (i) provide a detailed description and rationale for a novel HE active control condition and (ii) to evaluate the face validity, treatment integrity and feasibility of HE.

Method
We developed a HE active control similar in structure and duration to a CBT intervention for reducing sleep disturbance and fatigue (CBT-SF) in a pilot randomised controlled trial (n = 51). Face validity was measured using post-treatment participant satisfaction and helpfulness ratings for fatigue and sleep symptoms, treatment fidelity was measured with integrity monitoring ratings from an independent expert and feasibility was measured with completion and attrition rates. HE and CBT-SF groups were compared using Wilcoxon rank-sum tests and chi-square tests of independence.

Results
There were no significant differences in participant ratings of overall satisfaction between HE (n = 17) and CBT (n = 34) or in how helpful each intervention was for fatigue symptoms. Participants rated helpfulness for sleep symptoms higher in the CBT-SF group compared to HE. Integrity monitoring ratings were not significantly different for overall treatment delivery and therapist competency, but HE had greater module adherence than CBT-SF. There were no significant differences in completion or attrition rates between groups.

Conclusion
Our findings suggest that the HE control had adequate face validity, was delivered with fidelity and was feasible and suitable for use as a comparator for CBT-SF. In providing a real-world example of practical and theoretical issues we considered when designing this control condition, we aim to provide a framework and guidance for future investigators.

Trial registration
ACTRN12617000879369 (registered 15/06/2017) and ACTRN12617000878370 (registered 15/06/2017).
Recognizing patient partner contributions to health research: a mixed methods research protocol
Authors: Fox Grace , Fergusson Dean A. , Nicholls Stuart G. , Smith Maureen , Stacey Dawn , Lalu Manoj M. 
Published: June 2022

Abstract
Background
The overall aim of this program of research is to assess when/how patient partners are compensated financially for their contributions to health research. The research program consists of three studies to address the following questions: (1) What is the prevalence of reporting patient partner financial compensation? (2) What are researcher and institutional attitudes around patient partner financial compensation? (3) What are the current practices of patient partner financial compensation and what guidance exists to inform these practices?

Methods
In our first project, we will conduct a systematic review to assess the prevalence of reporting patient partner financial compensation and identify current financial compensation practices on an international scale. We will identify a cohort of published studies that have engaged patients as partners through a forward citation search of the Guidance for Reporting the Involvement of Patients and the Public (GRIPP I and II) checklists. We will extract details of financial compensation (type of financial compensation, amount, payment frequency etc.) and reported benefits, challenges, barriers and enablers to financially compensating patient partners. Quantitative data will be analyzed descriptively, and qualitative data will undergo thematic analysis. In our second project, we will conduct a cross-sectional survey of researchers who have engaged patient partners. We will also survey members of their affiliated institutions to gain further understanding of stakeholder experiences and attitudes with patient partner financial compensation. Survey responses will be analyzed by calculating prevalence. In our third project, we will conduct a scoping review to identify all published guidance and policy documents that guide patient partner financial compensation. Overton, the largest available online database of international policy documents, and the grey literature will be systematically searched. Data items will be extracted and presented descriptively. A comprehensive overview of guidance documents will be presented, which will represent a repository of resources that stakeholders can refer to when developing a financial compensation strategy.

Discussion
Our three studies will not only inform and assist patient partners and researchers by informing compensation strategies, but also support the inclusion of diverse perspectives. We will disseminate findings through traditional mediums (publications, conferences) as well as social media, non-technical summaries, and visual abstracts.
The effects of climate change on the livelihood of rural women: a case study of Ilorin South, Nigeria
Authors: Duru Jemima , Aro Joseph , Oladipo Rachael Ebunoluwa 
Published: June 2022

Abstract
Background
Globally, the increasing impacts of climate change continue to be seen in rising sea temperature, flooding, and fluctuation in weather patterns. Recently, the phenomenon has become a reality for poor communities whose livelihoods are being washed away by floods and children whose education is being truncated by the economic impacts of climate change. Therefore, this research aims to determine the effects of climate change on the livelihood of rural women who are said to be more vulnerable to the culminating effects of anthropogenically induced climate change disasters. To achieve the aim and objectives of this study, the research was conducted phenomenologically using questionnaires, interviews, and focus group discussions to access the assets required for improving the livelihood of rural women affected by climate change.

Results
The interpreted results of the data gathered using questionnaires showed that rural women in Ilorin South Local Government Area (LGA) of Kwara State, Nigeria, are impacted by the perils of anthropogenically induced climate change disasters that have impacts on their livelihood. These implications can be seen in the resilience of the methods used by these rural women to combat the continuing impact of climate change on their livelihood. The findings of the research also indicate that there are other factors making them vulnerable to the impacts of climate change such as lack of basic infrastructures, low capital base, and the use of crude farming methods.

Conclusion
From the suggestions in this study, we can conclude that climate change is already affecting the livelihood of rural women. However, a collective effort is required to implement the proactive measures required to improve rural women’s resilience to the impact of climate change on their livelihood.
Prevalence of severe acute respiratory syndrome coronavirus 2 spike antibodies in some healthcare settings in Egypt
Authors: El-Ghitany Engy Mohamed , Farghaly Azza Galal , Farag Shehata , Hashish Mona H. , Charl Fahmy , Omran Eman A. 
Published: June 2022

Abstract
Background
Healthcare workers (HCWs) are at the front line in battling infection transmission, such as that in coronavirus disease 19 (COVID-19). Additionally, they may act as potential carriers passing the virus on to others. Anti-spike (anti-S) antibodies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are formed either as a result of infection or vaccination with both indicating immunity against future COVID-19 infection.

Aim
This study aimed to identify the prevalence of COVID-19 seropositivity among HCWs.

Methods
This cross-sectional study included 559 HCWs from 39 hospitals with variable degrees of COVID-19 exposure risk (depending on the occupation, department, and hospital type). Demographic data were recorded as well as history of COVID-19 infection and vaccination. Serum samples were collected and tested for SARS-CoV-2 spike antibodies.

Results
Anti-S positivity was found in 59.0% of the participating 559 HCWs, indicating a high level of seroprotection. Of the 559 HCWs, 34.1% had reported previous infection with COVID-19. Following infection, only 46 (24.0%) of those affected received vaccination. Anti-S seropositivity was found in 39.1% of participants who were unvaccinated and had no history of infection. Physicians had the highest median anti-S titers (58.0 relative units (RU)/mL), whereas pharmacists and office staff had the lowest (25.7 and 38.2 RU/mL, respectively).

Conclusions
Overall, 59.0% of the 559 HCWs were anti-S positive, indicating a relatively high seroprotective status. Among those who were unvaccinated and had no history of infection, 39.1% were seropositive for anti-S, denoting a high rate of silent/asymptomatic infections. Screening of HCWs for SARS-CoV-2 anti-S is recommended, along with the vaccination of seronegative individuals.
Effect of antimicrobial administration on fecal microbiota of critically ill dogs: dynamics of antimicrobial resistance over time
Authors: Menard Julie , Goggs Robert , Mitchell Patrick , Yang Yufan , Robbins Sarah , Franklin-Guild Rebecca J. , Thachil Anil J. , Altier Craig , Anderson Renee , Putzel Gregory G. , McQueary Holly , Goodman Laura B. 
Published: June 2022

Abstract
Background
Multidrug resistance in companion animals poses significant risks to animal and human health. Prolonged antimicrobial drug (AMD) treatment in animals is a potential source of selection pressure for antimicrobial resistance (AMR) including in the gastrointestinal microbiota. We performed a prospective study of dogs treated for septic peritonitis, pyometra, or bacterial pneumonia and collected repeated fecal samples over 60 days. Bacterial cultures and direct molecular analyses of fecal samples were performed including targeted resistance gene profiling.

Results
Resistant Escherichia coli increased after 1 week of treatment (D1:21.4% vs. D7:67.9% P < 0.001) and returned to baseline proportions by D60 (D7:67.9% vs D60:42.9%, P = 0.04). Dogs with septic peritonitis were hospitalized significantly longer than those with pneumonia or pyometra. Based on genetic analysis, Simpson’s diversity index significantly decreased after 1 week of treatment (D1 to D7, P = 0.008), followed by a gradual increase to day 60 (D1 and D60, P = 0.4). Detection of CTX-M was associated with phenotypic resistance to third-generation cephalosporins in E. coli (OR 12.1, 3.3–68.0, P < 0.001). Lincosamide and macrolide-resistance genes were more frequently recovered on days 14 and 28 compared to day 1 (P = 0.002 and P = 0.004 respectively).

Conclusion
AMR was associated with prescribed drugs but also developed against AMDs not administered during the study. Companion animals may be reservoirs of zoonotic multidrug resistant pathogens, suggesting that veterinary AMD stewardship and surveillance efforts should be prioritized.

Graphical abstract
Meta-analysis and systematic literature review of COVID-19 associated bradycardia as a predictor of mortality
Authors: Umeh Chukwuemeka A. , Kumar Sabina , Wassel Elias , Barve Pranav 
Published: June 2022

Abstract
Background
Cardiac arrhythmias have been identified as independent predictors of mortality in Coronavirus disease 2019 (COVID-19) patients. While some studies have reported poor prognosis with bradycardia in COVID-19 patients, others have not found any association between bradycardia and mortality in COVID-19 patients. This study aims to assess the relationship between bradycardia and mortality in COVID-19 patients by reviewing existing literature.

Main body
Articles were obtained by systematically searching the PubMed and Google scholar databases. Qualitative and quantitative analyses of the studies on bradycardia and mortality in COVID-19 were done. A pooled estimate, with a sample size of 1320 patients, comparing the effect of patients that were bradycardic during their admission with those that were not on mortality showed that bradycardia did not lead to increased mortality in COVID-19 patients (OR 1.25, 95% CI 0.41–3.84, p = 0.7).

Conclusions
This meta-analysis showed that bradycardia was not significantly associated with mortality in COVID-19 patients. However, this study is limited by the few studies on bradycardia and mortality in COVID-19 patients. Therefore, future studies should investigate this relationship so that clinicians can prognostically triage and treat COVID-19 patients appropriately.
Mid-term follow-up and outcomes of patients with prosthetic heart valves: a single-centre experience
Authors: Bennett Sadie , Demetriades Polyvios , Banks Keely , Tafuro Jacopo , Oatham Rosie , Griffiths Timothy , Oxley Cheryl , Clews Sally , Heatlie Grant , Kwok Chun Shing , Duckett Simon 
Published: June 2022

Abstract
Background
Patients with prosthetic heart valves (PHV) require long-term follow-up, usually within a physiologist led heart valve surveillance clinic. These clinics are well established providing safe and effective patient care. The disruption of the COVID-19 pandemic on services has increased wait times thus we undertook a service evaluation to better understand the patients currently within the service and PHV related complications.

Methods
A clinical service evaluation of the heart valve surveillance clinic was undertaken to assess patient demographics, rates of complications and patient outcomes in patients who had undergone a PHV intervention at our institute between 2010 and 2020.

Results
A total of 294 patients (mean age at time of PHV intervention: 71 ± 12 years, 68.7% male) were included in this service evaluation. Follow-up was 5.9 ± 2.7 years (range: 10 years). 37.1% underwent baseline transthoracic echo (TTE) assessment and 83% underwent annual TTE follow-up. Significant valve related complications were reported in 20 (6.8%) patients. Complications included a change in patient functional status secondary to significant PHV regurgitation (0.3%) or stenosis (0.3%), PHV thrombosis (0.3%) or infective endocarditis (3.7%). Significant valve related complications resulted in ten hospital admission (3.4%), two re-do interventions (0.6%), and four deaths (1.3%).

Conclusions
This service evaluation highlights the large number of patients requiring ongoing surveillance. Only a small proportion of patients develop significant PHV related complications resulting in a low incidence of re-do interventions and deaths.
Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC).
Authors: Krop Ian E. , Masuda Norikazu , Mukohara Toru , Takahashi Shunji , Nakayama Takahiro , Inoue Kenichi , Iwata Hiroji , Toyama Tatsuya , Yamamoto Yutaka , Hansra Damien Mikael , Takahashi Masato , Osaki Akihiko , Koyama Kumiko , Inoue Tatsuya , Yonekura Takatoshi , Mostillo Joseph , Ohwada Shoichi , Tanaka Yoshimi , Sternberg David W. , Yonemori Kan 
Published: June 2022

1002 Background: Patritumab deruxtecan (HER3-DXd) is a novel, investigational ADC composed of a human anti-HER3 monoclonal antibody covalently bound to a topoisomerase I inhibitor payload via a stable tetrapeptide-based cleavable linker. Here we report updated safety and efficacy data from this ongoing study (U31402-A-J101; NCT02980341; JapicCTI-163401) of HER3-DXd in pts with previously treated MBC. Methods: U31402-A-J101 is a phase 1/2, multicenter, open-label, first-in-human study of HER3-DXd in pts with HER3-expressing MBC (N = 182). The study enrolled pts in dose-escalation (3.2-8.0 mg/kg IV Q3W) and dose-finding portions across molecular subtypes (n = 66; including HER2+ MBC, n = 14) followed by dose expansion in the following subtypes: HER3 high (4.8 mg/kg [n = 33] or 6.4 mg/kg [n = 31]), HER3 low (6.4 mg/kg [n = 21]) HR+/HER2− MBC or HER3-high TNBC (6.4 mg/kg [n = 31]). HER3-high and -low were defined as ≥75% and 25% ‒ < 75% membrane positivity. The primary objective was to assess safety and efficacy; secondary objectives included determining the relationship between efficacy and HER3 expression. Results: At data cutoff (16 Aug 2021), median study duration was 31.9 mo (range, 15-56). Median age was 57 y (range, 30-83); 132 (72.5%) and 50 (27.5%) pts had an ECOG PS of 0 or 1. Pts had a median of 5 (range, 1-13) prior lines of therapy for locally advanced/metastatic disease. Median treatment duration with HER3-DXd was 5.9 mo (range, 0.7-30.6). In a pooled evaluation of dose escalation/finding and expansion, efficacy is shown in pts with HR+/HER2− MBC, TNBC, and HER2+ MBC in the Table. Overall, 130 pts (71.4%) had grade ≥3 TEAEs; the most common (≥15%) were decreased neutrophil count (39.6%), decreased platelet count (30.8%), anemia (18.7%), and decreased white blood cell count (18.1%). 12 pts (6.6%) experienced treatment-related interstitial lung disease according to central adjudication, including 1 grade 5 event. Conclusions: A pooled analysis in this heavily pretreated population showed promising efficacy in pts with HR+/HER2− and HER2+ MBC as well as TNBC. The safety profile with longer follow-up is consistent with previous reports and showed adequate safety and tolerability. Studies are ongoing in MBC tumor types, with a focus on biomarkers associated with efficacy. Clinical trial information: NCT02980341. [Table: see text]
Update on phase 1 study of tazemetostat, an enhancer of zeste homolog 2 inhibitor, in pediatric patients with relapsed or refractory integrase interactor 1–negative tumors.
Authors: Chi Susan N. , Bourdeaut Franck , Casanova Michela , Kilburn Lindsay Baker , Hargrave Darren R. , McCowage Geoffrey Brian , Pinto Navin R. , Yang Jay , Chadha Raminder , Kahali Bhaskar , Tapia Coya , Nysom Karsten 
Published: June 2022

10040 Background: A defining feature of malignant rhabdoid tumors (MRTs), epithelioid sarcoma (ES), and poorly differentiated chordomas (PDC) is loss of integrase interactor 1 (INI1) expression, which induces dependence on enhancer of zeste homolog 2 (EZH2). Tazemetostat (TAZ) is a selective EZH2 inhibitor approved by the US Food and Drug Administration for patients (pts) aged ≥16 y with metastatic or locally advanced ES ineligible for complete resection. Pediatric dose escalation and interim efficacy and safety data for the dose expansion were previously reported. Updated efficacy, safety, subgroup analyses, and translational results are reported here. Methods: NCT02601937 is a phase 1 multicenter study evaluating TAZ monotherapy ≤2400 mg/m2 daily in pediatric pts with relapsed or refractory INI1− tumors (MRT, atypical teratoid rhabdoid tumor [ATRT], select tumors with rhabdoid features, other INI1− tumors, and SS18-SSX synovial sarcoma). Primary endpoint for dose expansion was objective response rate (ORR). Secondary endpoints included safety/tolerability, duration of response (DOR), progression-free survival (PFS), and overall survival. Selected exploratory flow data using 250,000 cells from peripheral blood were available for up to 25 pts. Results: Phase 1 enrolled 109 pts (escalation, n=46; expansion, n=63; Table) with mean ages of 5.4 y in the dose escalation and 7.4 y in the dose expansion. ORRs were 7% (3/46) in the dose escalation and 14% (9/63) in the dose expansion. Per tumor category in the dose expansion, ORRs were 24% (5/21) ATRT, 33% (2/6) PDC, 22% (2/9) ES, and 0% in non–CNS RTs (n=21) and other tumors (n=6). ORR for pts with prior radiotherapy was 14% (11/80) vs 3% (1/29) with prior radiotherapy ( P>0.05). In the dose expansion, median PFS was 8 wk (95% CI: 8–13), OS was 21 wk (95% CI: 13–38), and DOR was 35 wk (95% CI: 24–121). Grade 3–4 treatment-related treatment-emergent adverse event rates were 15% (7/46) in the dose escalation and 22% (14/63) in dose expansion. Differences between responders (R) and nonresponders (NR) at C1D1 for neutrophil counts were significant ( P<0.05). All R (6/6) had <125,000 total neutrophils at C1D1 vs 42% (8/19) of NR; 50% (3/6) of R had >50,000 total CD3 T cells vs 0% (0/19) of NR. Conclusions: TAZ showed promising antitumor activity in ATRT, ES, and PDC. Potential synergism between prior radiotherapy and TAZ requires further investigation. TAZ was generally well tolerated. The biological/clinical significance of differences in peripheral blood cell counts between R and NR at C1D1 needs further investigation. Clinical trial information: NCT02601937. [Table: see text]