bluuebunny/crossref_metadata_2025 huggingface dataset:
A Mock Circulation Loop for In Vitro Hemodynamic Evaluation of Aorta: Application in Aortic Dissection
Authors: Chen Duanduan , Liang Shichao , Li Zhenfeng , Mei Yuqian , Dong Huiwu , Ma Yihao , Zhao Jing , Xu Shangdong , Zheng Jun , Xiong Jiang
Published: August 2021

Purpose

Aortic dissection (AD) is a catastrophic disease with complex hemodynamic conditions, however, understandings regarding its perfusion characteristics were not sufficient. In this study, a mock circulation loop (MCL) that integrated the Windkessel element and patient-specific silicone aortic phantoms was proposed to reproduce the aortic flow environment in vitro.

Materials and Methods

Patient-specific normal and dissected aortic phantoms with 12 branching vessels were established and embedded into this MCL. Velocities for aortic branches based on 20 healthy volunteers were regarded as the standardized data for flow division. By altering boundary conditions, the proposed MCL could mimic normal resting and left-sided heart failure (LHF) conditions. Flow rates and pressure status of the aortic branches could be quantified by separate sensors.

Results

In normal resting condition, the simulated heart rate and systemic flow rate were 60 bpm and 4.85 L/minute, respectively. For the LHF condition, the systolic and diastolic blood pressures were 75.94±0.77 mmHg and 57.65±0.35 mmHg, respectively. By tuning the vascular compliance and peripheral resistance, the flow distribution ratio (FDR) of each aortic branch was validated by the standardized data in the normal aortic phantom (mean difference 2.4%±1.70%). By comparing between the normal and dissected aortic models under resting condition, our results indicated that the AD model presented higher systolic (117.82±0.60 vs 108.75±2.26 mmHg) and diastolic (72.38±0.58 vs 70.46±2.33 mmHg) pressures, the time-average velocity in the true lumen (TL; 36.95 cm/s) was higher than that in the false lumen (FL; 22.95 cm/s), and the blood transport direction between the TL and FL varied in different re-entries.

Conclusions

The proposed MCL could be applied as a research tool for in vitro hemodynamic analysis of the aorta diseases under various physical conditions.
Research on Individuals Aged One Hundred and Over: Protocol from the Sevilla and Castilla y León Centenarian Studies
Authors: García-González Juan Manuel , del Rey Alberto
Published: August 2021

Spain’s population of people aged 100 years and over has increased tenfold since the last quarter of the 20th century, exceeding 16,000 individuals by 2019. Despite this cohort’s growth, which has made centenarians a significant segment of Spain’s population in their own right, centenarians have remained little studied from the perspective of social sciences. A key challenge for research concerning centenarians is understanding their personal experiences of reaching this landmark age; such information could help to identify the sociodemographic and psychosocial factors that enable people to live such extraordinarily long lives. Given this context, the present article describes the research protocol followed in the projects SeviCent – Sevilla Centenarian Study and C&LCent – Castilla y León Centenarian Study, which are mainstream qualitative studies of people aged 100 years and over who reside in the regions with the lowest and highest life expectancy in Spain, respectively. The general aim of these studies was to analyze, through semi-structured interviews conducted between 2018 and 2019 that were based on a biographical and life-cycle approach, the physical, social, and emotional wellbeing of a cohort of centenarians who had no cognitive impairments. Specifically, based on the experiences of applying this protocol, the present study describes the methodological considerations—research design, sampling, interview script, indicators, fieldwork, and analysis plan—that should be included in future qualitative, social sciences–focused studies concerning very old people for whom the population segment is scarce, scattered, and fragile.
Effect of off-sized balls on contact stiffness and stress and analysis of the wear prediction model of linear rolling guideways
Authors: Wang Jiali , Zhang Guangpeng , Fan Hetao , Fan Zehui , Huang Yumei
Published: August 2021

The characteristics between the rolling balls and raceways are the key to study a linear rolling guideway (LRG). In this paper, the contact stresses of an LRG with off-sized balls incorporating the variation of the contact angle are given by the established LRG joint model. Moreover, the effect of the location, number, and the deviation degree of the off-sized balls on the stress distribution are studied. In addition, the contact stress distribution between the balls and raceway for different arrangement cases of the off-sized balls are analyzed. The random arrangement case can improve the stiffness and service life of the LRG. Based on the Archard wear theory, the wear prediction model of the LRG is established and the displacements and angular displacements of the slider caused by wear in reciprocating motion are obtained. The effectiveness of the contact stiffness and wear prediction model of the LRG is verified by simulations and analysis.
Long non-coding RNA ZFAS1 alleviates sepsis-induced myocardial injury via target miR-34b-5p/SIRT1
Authors: Chen Dan-Dan , Wang Hong-Wu , Cai Xing-Jun
Published: August 2021

Long non-coding RNA ZFAS1 is down-regulated in sepsis. However, whether ZFAS1 participates in sepsis-induced cardiomyopathy (SIC) remains largely unknown. LPS injection to rats was used to establish an in vivo sepsis model, while LPS stimulation with H9C2 cell was used to mimic an in vitro sepsis-induced myocardial injury model. Western blots and quantitative RT-PCR were performed to evaluate protein and mRNA levels, respectively. ELISA was conducted to determine cytokine levels in supernatant. Flow cytometry was used to test apoptosis. Dual-luciferase assay was performed to validate binding between ZFAS1 and miR-34b-5p, miR-34b-5p and SIRT1. Our data revealed that ZFAS1 and SIRT1 were down-regulated, while miR-34b-5p was up-regulated in LPS-induced H9C2 cells. Inhibition of miR-34b-5p or overexpression of ZFAS1 alleviated inflammatory response and cell apoptosis in LPS-stimulated H9C2 cells. A mechanism study revealed that ZFAS1 sponged miR-34b-5p and thus elevated expression of SIRT1, which was prohibited by miR-34b-5p. ZFAS1 alleviated inflammatory response and cell apoptosis in LPS-stimulated H9C2 cells via the miR-34b-5p/SIRT1 axis, providing novel potential therapeutic targets for SIC.
Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020
Authors: Shah Viraj N. , Pasick Luke J. , Benito Daniel A. , Ghiam Michael K. , D’Aguillo Christine
Published: August 2021

Background

Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents.

Objective

To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents.

Methods

The US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents.

Results

After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%).

Conclusions

PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage.
The role of user preferences in engagement with online learning
Authors: Ilin Vladislav
Published: August 2021

Digital technology in education has become a staple of many contemporary classrooms. Educational technology offers many benefits, including access to knowledge, mobility, multiple means of engagement, accessibility, distance learning, as well as the ability to connect in unprecedented ways. There is a growing body of research that examines digital learning tools, online classroom environments, learning management systems and other technologies that are integrated into the learning process. Such research extends to analysing the positive impacts of online and blended learning; however, few studies explore the user preferences of the learners. Without assessment of the user preference, the benefits of learning through technology are often lessened. This research explores and analyses how user media preferences influence engagement and motivation in online learning. One hundred twenty-two KS3 (13-year-olds) secondary school were provided voluntary access to a purpose-built online learning resource that augmented their in-class Holocaust history curriculum with learning materials in audio, video and e-text. Data were collected through web analytics and user feedback forms. The analytical tools provided detailed quantitative data on user activity on the site, while the feedback forms yielded qualitative data on usefulness and enjoyment. Results provided insights on the usage trends and user preferences that influence engagement. These behavioural patterns reflect user motivation and learning preferences and can be utilised to personalise digital content delivery to increase engagement with online learning materials.
Patient Satisfaction With Oral vs Intravenous Sedation for Vitrectomy Surgery: A Randomized, Noninferiority Clinical Trial
Authors: Siegel Nicole H. , Fiorello Marissa G. , Ness Steven , Kim Jiwoo , Vig Viha , Peeler Crandall E. , Chen Xuejing , Subramanian Manju L.
Published: August 2021

Purpose:

This work aims to determine whether patient satisfaction with oral sedation is noninferior to intravenous (IV) sedation in vitrectomy surgery.

Methods:

This prospective, randomized, double-masked, noninferiority clinical trial measured patient satisfaction in 84 participants receiving oral or IV sedation during vitrectomy surgery under monitored anesthesia care. Patients were excluded if they were unable to receive benzodiazepines.

Results:

The primary outcome was patient satisfaction. Secondary outcomes included surgeon and anesthesia provider satisfaction, need for supplemental anesthesia, and surgical complications. Among the 84 patients (46 [54.8%] men; mean [SD] age, 57.0 [12.7 years]), mean patient satisfaction scores were 5.22 ± 0.81 (range, 3.08-6; scale 1-6) with oral and 5.25 ± 0.63 (range, 3.83-6; scale 1-6) with IV sedation. With an a priori noninferiority margin of 0.5 and a difference in mean scores between the groups of 0.03 (1-tailed 95% CI, infinity to 0.29), our results demonstrated the noninferiority of oral sedation ( P = .002). There were no significant differences in surgeon or anesthesia satisfaction or major intraoperative complications. Five patients receiving oral (11.9%) and 3 receiving IV (7.1%) sedation required supplemental IV sedation (difference, 4.8%; P = .46).

Conclusions:

Patient satisfaction for oral sedation was noninferior to IV sedation for vitrectomy surgery.
An interrater reliability study of gait analysis systems with the dual task paradigm in healthy young and older adults
Authors: Klotzbier Thomas Jürgen , Wollesen Bettina , Vogel Oliver , Rudisch Julian , Cordes Thomas , Jöllenbeck Thomas , Vogt Lutz
Published: August 2021

Background and aims

One reason for the controversial discussion of whether the dual task (DT) walking paradigm has an added value for diagnosis in clinical conditions might be the use of different gait measurement systems. Therefore, the purpose was 1) to detect DT effects of central gait parameters obtained from five different gait analysis devices in young and old adults, 2) to assess the consistency of the measurement systems, and 3) to determine if the absolut and proportional DT costs (DTC) are greater than the system-measurement error under ST.

Methods

Twelve old (72.2 ± 7.9y) and 14 young adults (28.3 ± 6.2y) walked a 14.7-m distance under ST and DT at a self-selected gait velocity. Interrater reliability, precision of the measurement and sensitivity to change were calculated under ST and DT.

Results

An age effect was observed in almost all gait parameters for the ST condition. For DT only differences for stride length (p < .029, ɳ2p = .239) as well as single and double limb support (p = .036, ɳ2p = .227; p = .034, ɳ2p = .218) remained. The measurement systems showed a lower absolute agreement compared to consistency across all systems.

Conclusions

When reporting DT effects, the real changes in performance and random measurement errors should always be accounted for. These findings have strong implications for interpreting DT effects.
Modified completely intrafascial radical cysprostatectomy for bladder cancer: a single-center, blinded, controlled study
Authors: Wang Xiao , Guo Jia , Wang Lei , Wang Min , Weng Xiaodong , Chen Hui , Liu Xiuheng
Published: August 2021

Background

We have proposed a modified, completely intrafascial radical cysprostatectomy (RC) to treat bladder cancer patients with the aim of preserving the patients’ post-surgical urinary control and erectile function. This study aimed to evaluate the oncological and functional outcomes of this innovation relatively to that with the conventional technique.

Methods

A retrospective, single-center, blinded, and controlled study was conducted using the medical data of patients since the past 5 years from the hospital database. A total of 44 patients were included, including 20 who received complete intrafascial cysprostatectomy and 24 who received conventional interfascial surgeries. The patients’ continent and sexual information of 1-year follow-up after the surgery were extracted. The oncological and functional outcomes of the 2 groups were compared and analyzed.

Results

The demographics parameters of the 2 groups showed no significant difference. The results of follow-up of the oncological outcomes did not reveal any significant difference between the completely intrafascial group and the conventional interfascial group in terms of the positive surgical margins, local recurrences, and distant metastasis. Patients following neobladder diversion in the intrafascial group showed a faster recovery of the urinary control, with a 76.9% (10/13) daytime continent rate at 3-month, as well as 46.2% (6/13) and 58.3% (7/12) nighttime continent rates at 3-month and 6-month, respectively. Regarding the sexual functions, our results revealed significant advantages in favor of completely intrafascial technique on the post-surgical International Index of Erectile Function (IIEF)-5 score at 3-, 9-, and 12-month follow-up relative to that with the conventional interfascial process. Thus, the IIEF score of patients in the intrafascial group was 11.4 ± 3.5 at 3-month, 14.1 ± 3.6 at 9-month, and 15.2 ± 3.8 at 12-month follow-up after the cystectomy, which was significantly greater than that of the patients in the control group.

Conclusions

Our novel data illustrated that the modified completely intrafascial technique could result in a better sexual function and faster continence recovery for patients following RC, without any compromise in the cancer control. Thus, this technique could be considered as an alternative extirpative technique for bladder cancer treatment in a clinical setting.
The frequency of medical reversals in a cross-sectional analysis of high-impact oncology journals, 2009–2018
Authors: Haslam Alyson , Gill Jennifer , Crain Tyler , Herrera-Perez Diana , Chen Emerson Y. , Hilal Talal , Kim Myung S. , Prasad Vinay
Published: August 2021

Background

Identifying ineffective practices that have been used in oncology is important in reducing wasted resources and harm. We sought to examine the prevalence of practices that are being used but have been shown in RCTs to be ineffective (medical reversals) in published oncology studies.

Methods

We cross-sectionally analyzed studies published in three high-impact oncology medical journals (2009–2018). We abstracted data relating to the frequency and characterization of medical reversals.

Results

Of the 64 oncology reversals, medications (44%) represented the most common intervention type (39% were targeted). Fourteen (22%) were funded by pharmaceutical/industry only and 56% were funded by an organization other than pharmaceutical/industry. The median number of years that the practice had been in use prior to the reversal study was 9 years (range 1–50 years).

Conclusion

Here we show that oncology reversals most often involve the administration of medications, have been practiced for years, and are often identified through studies funded by non-industry organizations.
Conspicuousness and recurrence related factors of ultrasound-guided microwave ablation in the treatment of benign thyroid nodules
Authors: Xia Baoying , Yu Boyang , Wang Xiaofei , Ma Yu , Liu Feng , Gong Yanping , Zou Xiuhe , Lei Jianyong , Su Anping , Wei Tao , Zhu Jingqiang , Lu Qiang , Li Zhihui
Published: August 2021

Objective

Microwave ablation (MWA) is a minimally invasive technique for the treatment of benign thyroid nodules. The purpose of this study was to evaluate efficacy and safety of ultrasound-guided MWA in the treatment of benign thyroid nodules, and to find out the recurrence related factors, so as to provide reference for future clinical work.

Methods

This study retrospectively analyzed the patients who received ultrasound-guided MWA for benign thyroid nodules in our hospital from October 2018 to March 2020. A total of 214 patients were included in the study. We assessed thyroid volume changes (represented by volume reduction ratio VRR), the energy per 1 mL reduction in nodular volume (represented by energy volume ratio ΔE), the serum levels of free triiodide thyroid hormone (FT3), free thyroxine (FT4), thyrotropin (TSH) and complications after MWA treatment.

Results

There were a total of 306 nodules in 214 patients, including 183 (85.51%) females and 31 (14.49%) males. The median diameter and volume of the nodule were 33 mm and 8.01 mL. The VRR at 1 month, 3 months, 6 months and 12 months were 40.79%, 60.37%, 74.59% and 85.60%, respectively. In addition, MWA had a better ablation effect for small nodules (initial volume ≤ 10 mL). In recurrent studies, we found that ΔE was an independent risk factor for benign thyroid nodules (P < 0.05).

Conclusions

Ultrasound-guided MWA is effective and safe in the treatment of benign thyroid nodules. In addition, it has little damage to surrounding tissues and no effect on thyroid function. Especially, the nodules with smaller initial volume, the treatment is better. On the other hand, the energy per 1 mL reduction ΔE in nodular volume may be associated with nodular recurrence, which requires further follow-up for longer periods. At this stage, we consider that ultrasound-guided MWA can be used as one of the main clinical treatment methods for benign thyroid nodules.
The Association of Broadband Internet Access and Telemedicine Utilization in rural Western Tennessee: an observational study
Authors: Quinton Jacob K. , Ong Michael K. , Vangala Sitaram , Tetleton-Burns Anna , Webb Ashley , Sarkisian Catherine , Casillas Alejandra , Kakani Preeti , Han Maria , Pirtle Claude J.
Published: August 2021

Background

Broadband access has been highlighted as a national policy priority to improve access to care in rural communities.

Objective

To determine whether broadband internet availability was associated with telemedicine adoption among a rural patient population in western Tennessee.

Methods

Observational study using electronic medical record data from March 13th, 2019 to March 13th, 2021. Multivariable logistic regression incorporating individual-level characteristics with broadband availability, income, educational attainment, and primary care physician supply at the zip code level, and rural status as determined at the county level.

Setting

Single health system in western Tennessee.

Participants

Adult patients with one or more in-person or remote encounter in a health system in western Tennessee and residing in western Tennessee between March 13th, 2019 and March 13th, 2021 (N = 54,688).

Outcome measures

Completion of one or more video encounters in the year following March 13th, 2020 (N = 3199; 7%). Our primary characteristic of interest was the proportion of residents in each zip code with access to the internet meeting the Federal Communications Commission definition of broadband access, adjusting for age, gender, race, income, educational attainment, insurance type, rural status, and primary care provider supply.

Results

Patients in a rural western Tennessee health system were predominantly white (79%), residing in rural zip codes (73%) with median household incomes ($52,085) less than state and national averages. Patients residing in a zip code where there is 80 to 100% broadband access compared to 0 to 20% were more likely in the year following March 13th, 2020 to have completed both telemedicine and in-person visits ([OR; 95% CI] 1.57; 1.29, 1.94), completed only telemedicine visits (2.26; 1.71, 2.97), less likely to have only completed in-person visits (0.81; 0.74, 0.89), but no more or less likely to have accessed no care (1.07; 0.97, 1.18).

Discussion

The availability of broadband internet was shown to be one of many factors associated with the utilization of telemedicine for a rural, working-class community after March 13th, 2020.

Conclusions

Access to broadband internet is a determinant of access to telemedicine for patients in rural communities and should be a priority for policymakers interested in improving health and access to care for rural patients.
Oral vitamin D supplementation induces transcriptomic changes in rectal mucosa that are linked to anti-tumour effects
Authors: Vaughan-Shaw P. G. , Grimes G. , Blackmur J. P. , Timofeeva M. , Walker M. , Ooi L. Y. , Svinti Victoria , Donnelly Kevin , Din F. V. N. , Farrington S. M. , Dunlop M. G.
Published: August 2021

Background

The risk for several common cancers is influenced by the transcriptomic landscape of the respective tissue-of-origin. Vitamin D influences in vitro gene expression and cancer cell growth. We sought to determine whether oral vitamin D induces beneficial gene expression effects in human rectal epithelium and identify biomarkers of response.

Methods

Blood and rectal mucosa was sampled from 191 human subjects and mucosa gene expression (HT12) correlated with plasma vitamin D (25-OHD) to identify differentially expressed genes. Fifty subjects were then administered 3200IU/day oral vitamin D3 and matched blood/mucosa resampled after 12 weeks. Transcriptomic changes (HT12/RNAseq) after supplementation were tested against the prioritised genes for gene-set and GO-process enrichment. To identify blood biomarkers of mucosal response, we derived receiver-operator curves and C-statistic (AUC) and tested biomarker reproducibility in an independent Supplementation Trial (BEST-D).

Results

Six hundred twenty-nine genes were associated with 25-OHD level (P < 0.01), highlighting 453 GO-term processes (FDR<0.05). In the whole intervention cohort, vitamin D supplementation enriched the prioritised mucosal gene-set (upregulated gene-set P < 1.0E−07; downregulated gene-set P < 2.6E−05) and corresponding GO terms (P = 2.90E−02), highlighting gene expression patterns consistent with anti-tumour effects. However, only 9 individual participants (18%) showed a significant response (NM gene-set enrichment P < 0.001) to supplementation. Expression changes in HIPK2 and PPP1CC expression served as blood biomarkers of mucosal transcriptomic response (AUC=0.84 [95%CI 0.66–1.00]) and replicated in BEST-D trial subjects (HIPK2 AUC=0.83 [95%CI 0.77–0.89]; PPP1CC AUC=0.91 [95%CI 0.86–0.95]).

Conclusions

Higher plasma 25-OHD correlates with rectal mucosa gene expression patterns consistent with anti-tumour effects, and this beneficial signature is induced by short-term vitamin D supplementation. Heterogenous gene expression responses to vitamin D may limit the ability of randomised trials to identify beneficial effects of supplementation on CRC risk. However, in the current study blood expression changes in HIPK2 and PPP1CC identify those participants with significant anti-tumour transcriptomic responses to supplementation in the rectum. These data provide compelling rationale for a trial of vitamin D and CRC prevention using easily assayed blood gene expression signatures as intermediate biomarkers of response.
Role of family functioning and health-related quality of life in pre-school children with dental caries: a cross-sectional study
Authors: Bilal Sobia , Abdulla Anshad Mohamed , Andiesta Niekla Survia , Babar Muneer Gohar , Pau Allan
Published: August 2021

Background

The aim of this cross-sectional study was to evaluate the effect of family functioning on oral health related quality of life (OHRQoL) and dental caries status among 4- to 6-year-old Chinese pre-school children in Malaysia.

Methodology

This study was approved by the institutional Joint Research and Ethics Committee, International Medical University, Malaysia (number 373/2016); consisted of 180 eligible pre-school children from a private school. Study tools included demographic, clinical oral health data form, the Early Childhood Oral Health Impact Scale (ECOHIS) and family functioning—12-item general functioning subscale. Written consent was sought prior to data collection. Data were analysed by SPSS v.22.0; descriptive statistics for socio-demographic details, clinical information, HRQoL and FAD scores. The parametric tests included independent sample t test and ANOVA to evaluate the associations between the dependent variable. Binary logistic regression models were applied to assess the impacts on OHRQoL (Pvalue < 0.05).

Results

A response rate of 80.5% was achieved. Sample means for FAD-GF12 scores ranged < 2, indicating normal family functioning. The ECOHIS scores mean was 0.52 (SD = 0.68). In the children impact section the highest score of impacts 20 was noted followed by family impact section with the score of 12. It was observed that children with dental caries had a significant (P = 0.014) negative impact on OHRQoL (mean 0.72, SD = 0.50) as compared to children with no caries (mean 0.34 SD = 0.39). The bivariate regression analysis after getting adjusted indicated three predictors associated to poor HRQoL: having two or more siblings (OR = 4.73,P = 0.013), relationship (mother) of the respondent to the child (OR = 2.86,P = 0.013) and having dental caries (OR = 8.12,P ≤ 0.001).

Conclusion

Findings of this study indicates that number of siblings, relationship of the respondent to the child and dental caries status are independently associated with health-related quality of life. However, family functioning does not mediate poor HRQoL in association to dental caries.
Prognostic value of Onodera’s nutritional index for intermediate- and high-risk gastrointestinal stromal tumors treated with or without tyrosine kinase inhibitors
Authors: Wang Feng , Tao Tingting , Yu Heng , Xu Yingying , Yang Zhi , Xia Xuefeng , Wang Meng , Zong Liang , Guan Wenxian
Published: August 2021

Background

Immunoinflammatory and nutritional markers, such as the peripheral blood neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and Onodera’s prognostic nutritional index (OPNI), have gained considerable attention and have been preliminarily revealed as prognostic markers of gastrointestinal stromal tumors (GISTs).

Methods

In this study, we first investigated the prognostic value of OPNI in GISTs treated with or without TKIs based on the propensity score matching (PSM) method. All of the patients had received surgical resection for primary GIST, and data from 2010 to 2018 were initially and retrospectively identified from our gastrointestinal center. Recurrence-free survival (RFS) was calculated by the Kaplan–Meier method and compared by the log-rank test.

Results

The patients were divided into groups treated and not treated with TKIs, and we used the propensity score matching method to homogenize their baseline data. Multivariate Cox proportional hazard regression models were applied to identify associations with outcome variables. A total of 563 GISTs were initially chosen, and 280 of them were included for analysis under the inclusion criteria. After PSM, there were 200 patients included. Multivariate analyses identified OPNI as an independent prognostic marker that was associated with primary site, tumor size, mitotic index, tumor rupture, necrosis, and modified NIH risk classification. Low OPNI (< 42.6; HR 0.409; P < 0.001) was associated with worse RFS.

Conclusions

Preoperative OPNI is a novel and useful prognostic marker for GISTs both treated and not treated with TKIs. Higher NLR and PLR have negative effects on RFS.
Factors associated with bleeding events during catheter ablation with uninterrupted periprocedural edoxaban for atrial fibrillation: a subanalysis of the KYU-RABLE study
Authors: Abe Ichitaro , Takahashi Naohiko , Mukai Yasushi , Kimura Tetsuya , Yamaguchi Keita , Takita Atsushi , Origasa Hideki , Okumura Ken ,   on behalf of the KYU-RABLE Investigators
Published: August 2021

Background

Data are limited on patient background characteristics associated with catheter ablation (CA)-related bleeding events in Japanese patients with non-valvular atrial fibrillation receiving uninterrupted periprocedural edoxaban. This subanalysis of the KYU-RABLE study focused on univariate and multivariate analyses to identify correlations between bleeding events and baseline patient demographics and CA-related characteristics.

Methods

Patients with non-valvular atrial fibrillation (NVAF) enrolled from the KYU-RABLE study were included in the study. We performed univariate and multivariate analyses to investigate the correlation of major, minor, and clinically relevant non-major bleeding events with the patient baseline data at enrollment, and with CA procedures.

Results

A total of 513 NVAF patients were included in the full analysis set. Univariate analysis showed that the incidence of the bleeding events was higher in patients with HAS-BLED score ≥ 3 compared with those with a score < 3 (odds ratio [OR]: 9.48, 95% CI: 2.36–38.01; p = 0.002), in those with creatinine clearance (CrCL) ≤50 mL/min compared with those with CrCL > 50 mL/min (OR: 10.59, 95% CI: 3.65–30.79; p < 0.0001), and in those receiving edoxaban 30 mg compared with those receiving edoxaban 60 mg (OR: 3.49, 95% CI: 1.18–10.38; p = 0.025). Multivariate analysis showed that HAS-BLED score ≥ 3 (OR: 7.93, 95% CI: 1.66–37.88; p = 0.0094) and CrCl ≤ 50 mL/min (OR: 7.78, 95% CI: 2.17–27.90; p = 0.0016) were significant predictors of bleeding events among KYU-RABLE patients.

Conclusions

These predictors of CA-related bleeding events may allow informed decision-making and better AF patient selection for CA with uninterrupted periprocedural edoxaban.

Trial registration

KYU-RABLE, UMIN000029693. Registered 1 December 2017.
Personalising treatment plan quality review with knowledge-based planning in the TROG 15.03 trial for stereotactic ablative body radiotherapy in primary kidney cancer
Authors: Hardcastle Nicholas , Cook Olivia , Ray Xenia , Moore Alisha , Moore Kevin L. , Pryor David , Rossi Alana , Foroudi Farshad , Kron Tomas , Siva Shankar
Published: August 2021

Introduction

Quality assurance (QA) of treatment plans in clinical trials improves protocol compliance and patient outcomes. Retrospective use of knowledge-based-planning (KBP) in clinical trials has demonstrated improved treatment plan quality and consistency. We report the results of prospective use of KBP for real-time QA of treatment plan quality in the TROG 15.03 FASTRACK II trial, which evaluates efficacy of stereotactic ablative body radiotherapy (SABR) for kidney cancer.

Methods

A KBP model was generated based on single institution data. For each patient in the KBP phase (open to the last 31 patients in the trial), the treating centre submitted treatment plans 7 days prior to treatment. A treatment plan was created by using the KBP model, which was compared with the submitted plan for each organ-at-risk (OAR) dose constraint. A report comparing each plan for each OAR constraint was provided to the submitting centre within 24 h of receiving the plan. The centre could then modify the plan based on the KBP report, or continue with the existing plan.

Results

Real-time feedback using KBP was provided in 24/31 cases. Consistent plan quality was in general achieved between KBP and the submitted plan. KBP review resulted in replan and improvement of OAR dosimetry in two patients. All centres indicated that the feedback was a useful QA check of their treatment plan.

Conclusion

KBP for real-time treatment plan review was feasible for 24/31 cases, and demonstrated ability to improve treatment plan quality in two cases. Challenges include integration of KBP feedback into clinical timelines, interpretation of KBP results with respect to clinical trade-offs, and determination of appropriate plan quality improvement criteria.
Enhanced interfragmentary stability and improved clinical prognosis with use of the off-axis screw technique to treat vertical femoral neck fractures in nongeriatric patients
Authors: Jiang Dajun , Zhan Shi , Cai Qianying , Hu Hai , Jia Weitao
Published: July 2021

Background

The optimal internal fixation strategy for vertical femoral neck fractures (VFNFs) in nongeriatric patients remains uncertain. Therefore, the purpose of this study was to compare the clinical prognoses and underlying mechanical characteristics of a novel off-axis screw technique with dynamic hip screws (DHSs) and three traditional parallel screws.

Methods

This study included a clinical investigation and a patient-specific finite element analysis (FEA). In the clinical investigation, VFNF patients were grouped by fixation type: (1) use of three parallel screws (G-TRI); (2) augmentation with an off-axis screw (G-ALP); and (3) DHS with an anti-rotational screw (G-DHS). Fixation failures (nonunion, femoral neck shortening (FNS), varus deformation, screw cut-out) and avascular necrosis (AVN) consequent to the three types of fixations were compared. In the FEA, twenty-four fixation models with the three fixation types were created based on the data of eight healthy volunteers. Models were assessed under walking conditions. Stiffness, interfragmentary motion (IFM), and implant stress were evaluated.

Results

In the clinical investigation, the fixation failure rate was significantly (p < 0.05) lower in G-ALP (18.5%) than in G-DHS (37.5%) and G-TRI (39.3%). No significant difference in AVN was observed among the three fixation groups. In the FEA, stiffness and implant stress in the G-DHS models were significantly (p < 0.05) higher, and the IFM of G-ALP was significantly (p < 0.05) lower among the groups.

Conclusions

Among fixation types for VFNFs, the off-axis screw technique exhibited better interfragmentary stability (lowest IFM) and a lower fixation failure rate (especially FNS). Analyzing interfragmentary stability in biomechanical experiments is more consistent with clinical prognosis than construct stability for VFNFs, suggesting that internal fixations should aim for this outcome.
Surgical outcomes in cardiogenic shock patients with preoperative extracorporeal membrane oxygenation (ECMO)
Authors: Abuharb Mahmoud Yousef Ibrahim , Ran Dong , Jubing Zheng , Taoshuai Liu , Haiming Dong , Xiaotong Hou , Yue Song , Yang Zhao , Yang Li
Published: August 2021

Objectives

To summarise the surgical outcomes in patients with cardiogenic shock supported by preoperative extracorporeal membrane oxygenation (ECMO).

Methods

Between May 2012 and August 2017, eight patients with cardiogenic shock, who were supported by ECMO, underwent emergency surgery; four of them had isolated coronary artery bypass grafting, three had coronary artery bypass grafting with mitral replacement, and one had mitral valve replacement with left ventricular posterior wall repair.

Results

All eight patients were successfully weaned off from ECMO after their surgeries. Postoperative ECMO time ranged from 6.8 to 228.0 h, with a median of 68.4 h. Two patients died postoperatively while another six survived. The follow up time for the six patients ranged from three to 66 months, whereby one of them died in the third month due to septicaemia. The remaining five patients survived with good cardiac function based on the NYHA classification.

Conclusion

ECMO is a vital bridge in the preparation of critically-ill patients for cardiac surgery. It is associated with acceptable outcomes among most of the patients.
Social and medical needs of rare metabolic patients: results from a MetabERN survey
Authors: Sestini Sylvia , Paneghetti Laura , Lampe Christina , Betti Gianni , Bond Simon , Bellettato Cinzia Maria , Maurizio Scarpa
Published: August 2021

Background

Many surveys have been performed over the years to assess the medical and social requirements of patients with a rare disease, but no studies have focused specifically on patients in Europe or with an inherited metabolic disease (IMD). To obtain a comprehensive overview of the social and psychological status and needs of IMD patients, especially in Europe, the European Reference Network for Hereditary Metabolic Disorders (MetabERN) has performed a dedicated survey among its metabolic patients.

Results

A total of 924 patients and caregivers responded to the questionnaire. Most participants were from 25 European countries, with Spain, Italy, and Germany being the most represented; only eight participants were extra-European. The survey showed that most social assistance services, from free educational/development services for those with intellectual disability to transition from childhood to adult care and job placement support, are available for a limited number of patients or are unknown to the majority of patients or their parents/caregivers. Similarly, psychological assistance for the patient or the parent/caregiver is available for a small fraction of respondents, despite the fact that the majority considers this type of support necessary for both the patient and the caregiver. In addition, for most IMD patients local specialised or emergency medical assistance is lacking, although national clinical pathways are defined, and medical professionals of reference are readily available when needed. Lastly, while most national health services in Europe cover all or part of the expenses for medications, medical devices, food supplements, dietary integrators, physiotherapy, and speech therapy, significant gaps in the economic support for healthcare and other expenses still exist.

Conclusions

Overall, our survey reveals a widespread lack of social, psychological, and economic support for IMD patients in Europe. More needs to be done to provide daily assistance to IMD patients in order to alleviate the burden on caregivers and to allow patients to become independent and productive adults. Where support is actually available locally or nationally, most IMD patients are not aware of it, so an active dissemination of this information among the metabolic community is essential.
Growth hormone treatment for adults with Prader-Willi syndrome: another point of view
Authors: Hirsch Harry J. , Gross-Tsur Varda
Published: August 2021

Growth hormone treatment for children with Prader Willi syndrome (PWS) has shown proven benefits not only in increasing final height but also with positive effects on body composition and motor development. In a recent letter to the editor, Hoybye and colleagues recommend growth hormone treatment for adults with PWS based exclusively on the genetic diagnosis and without regard for growth hormone secretory status. We question whether the benefits of growth hormone treatment in PWS adults, mainly improvement in body composition, are significant enough to justify the as yet unkown consequences of long-term treatment in an adult population. Morbidity and mortality in PWS are mainly due to complications of obesity, and growth hormone treatment does not result in a decrease in BMI or waist circumference. Increases in insulin-like factor-1 as a result of growth hormone treatment over the course of several decades in PWS adults raises concern over possible increase risk of cancer. Compliance with daily injections is likely to be poor. We suggest that efforts to provide appropriate dietary and exercise regimens may be more beneficial and cost-effective than advocating for growth hormone treatment for adults with PWS.
Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial
Authors: Norton Christine , Syred Jonathan , Kerry Sally , Artom Micol , Sweeney Louise , Hart Ailsa , Czuber-Dochan Wladyslawa , Taylor Stephanie J. C. , Mihaylova Borislava , Roukas Chris , Aziz Qasim , Miller Laura , Pollok Richard , Saxena Sonia , Stagg Imogen , Terry Helen , Zenasni Zohra , Dibley Lesley , Moss-Morris Rona
Published: August 2021

Background

Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support.

Primary research question

In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0–10 scale) compared with care as usual?

Methods

A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation.

We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups.

Discussion

The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients’ quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals.

Trial registration

ISRCTN71618461. Registered on 9 September 2019.
Do biologic therapies reduce aortic inflammation in rheumatoid arthritis patients?
Authors: Trang D. A. M. Thuy , Okamura Koichi , Suto Takahito , Sakane Hideo , Yonemoto Yukio , Nakajima Takahito , Tsushima Yoshito , Chikuda Hirotaka
Published: August 2021

Objectives

Rheumatoid arthritis (RA) patients have an increased risk of cardiovascular disease (CVD). In the present study, we evaluated the inflammatory activity of the ascending aorta in RA patients who received biological treatment.

Methods

We assessed the aortic wall inflammation of RA patients using 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography before and after 6 months of biologic therapies. We also compared the inflammatory activity at the aortic wall in RA patients with remission or low disease activity (RLDA) and those with moderate or high disease activity (MHDA). The aortic uptake was measured by the standardized uptake value (SUV) and the target-to-background ratio (TBR).

Results

A total of 64 patients were included in the analysis (mean age, 58.4 ± 13.8 years old; female, 77%). The Disease Activity Score for 28 joints (DAS28) erythrocyte sedimentation rate (ESR) had significantly decreased after 6 months: from 5.0 ± 1.2 to 3.3 ± 1.2 (p < 0.001). The FDG uptake in the ascending aorta changed from baseline to 6 months, showing a maximum SUV (SUVmax) of 1.83 ± 0.34 to 1.90 ± 0.34 (p = 0.059) and TBR of 1.71 ± 0.23 to 1.75 ± 0.24 (p = 0.222). The SUVmax and TBR after 6 months were significantly higher in the RLDA group than in the MHDA group (2.05 ± 0.32 vs. 1.79 ± 0.33 (p = 0.002) and 1.89 ± 0.33 vs. 1.65 ± 0.20 (p = 0.001), respectively). The percentage of monocytes also significantly increased from baseline to 6 months: from 5.9 ± 1.6 to 6.9 ± 2.6 (p = 0.032).

Conclusion

The inflammation activity at the ascending aorta in RA patients did not change significantly after 6 months of biological treatment. RA patients with a low disease activity or in clinical remission after 6 months of biological treatment still had an increased inflammatory activity at the aortic wall.
Development of the external and internal shame scale: Japanese version
Authors: Hiramatsu Yoichi , Asano Kenichi , Kotera Yasuhiro , Endo Ayumu , Shimizu Eiji , Matos Marcela
Published: August 2021

Objective

Shame contains external and internal aspects. However, a Japanese language scale for simultaneously assessing both aspects of shame has not been developed to date. This study aimed to standardize the Japanese version of the External and Internal Shame Scale (EISS-J). An online survey was conducted among university students (N = 203) at six universities in Japan (Study 1). A retest questionnaire was sent to the participants by email three weeks after the first survey (Study 2). Study 1 examined the internal consistency, factor structure, and criterion-related validity of the EISS-J, while Study 2 examined its test-retest reliability. Moreover, an additional study was conducted to examine the criterion-related validity of the scale.

Results

Study 1 demonstrated the high internal consistency of the EISS-J. Moreover, confirmatory factor analysis indicated a two-factor model: external and internal shame. However, exploratory factor analysis indicated a three-factor structure. Study 2 confirmed the test-retest reliability of the scale. Furthermore, both studies indicated correlations between the EISS-J and fear of compassion, anger, humiliation, depression, anxiety, and stress. In addition, the study established the criterion-related validity of the scale. These results confirmed adequate reliability and validity of the EISS-J.