bluuebunny/crossref_metadata_2025_split huggingface dataset:
A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
Authors: Suman Arnela , van Es Jasmijn , Gardarsdottir Helga , Grobbee Diederick E. , Hawkins Kimberly , Heath Megan A. , Mackenzie Isla S. , van Thiel Ghislaine , Zuidgeest Mira G. P. ,   on behalf of the Trials@Home Consortium
Published: October 2022

Abstract
Background
The COVID-19 pandemic significantly impacted the conduct of clinical trials through delay, interruption or cancellation. Decentralised methods in clinical trials could help to continue trials during a pandemic. This paper presents the results of an exploratory study conducted early in the pandemic to gain insight into and describe the experiences of organisations involved in clinical trials, with regard to the impact of COVID-19 on the conduct of trials, and the adoption of decentralised methods prior to, and as mitigation for the impact, of COVID-19.

Methods
A survey with 11 open-ended and four multiple choice questions was conducted in June 2020 among member organisations of the public-private “Trials@Home” consortium. The survey investigated (1) the impact and challenges of COVID-19 on the continuation of ongoing clinical trials, (2) the adoption of decentralised methods in clinical trials prior to and as a mitigation strategy for COVID-19, (3) the challenges of conducting clinical trials during COVID-19, (4) the expected permanency of COVID-19-driven changes to the adoption of decentralised methods in clinical trials, and (5) lessons learned from conducting clinical trials during the COVID-19 pandemic. A thematic, inductive analysis of open survey questions was performed, complemented with descriptive statistics (frequencies and distributions).

Results
The survey had a response rate of 81%. All organisations included in the analysis (n = 18) implemented (some) decentralised methods in their clinical trials prior to COVID-19, and 15 (83%) implemented decentralised methods as mitigation for COVID-19. Decentralised methods for IMP supply, patient-health care provider interaction and communication, clinic visits and source document verification were used more often as mitigation strategies than they were used prior to COVID-19. Many respondents expect to maintain those decentralised methods they implemented during COVID-19 in ongoing trials, as well as implement them in future trials.

Conclusions
Decentralised methods are a widely implemented mitigation strategy for trial conduct in the face of the COVID-19 pandemic. The results of this survey show that there is an interest to continue the use of decentralised methods in future trials, but important points of attention have been identified that need solutions to help guide the transition from the traditional trial model to a more decentralised trial model.
Examining evidence of time-dependent treatment effects: an illustration using regression methods
Authors: Jachno Kim M. , Heritier Stephane , Woods Robyn L. , Mahady Suzanne , Chan Andrew , Tonkin Andrew , Murray Anne , McNeil John J. , Wolfe Rory 
Published: October 2022

AbstractBackgroundFor the design and analysis of clinical trials with time-to-event outcomes, the Cox proportional hazards model and the logrank test have been the cornerstone methods for many decades. Increasingly, the key assumption of proportionality—or time-fixed effects—that underpins these methods has been called into question. The availability of novel therapies with new mechanisms of action and clinical trials of longer duration mean that non-proportional hazards are now more frequently encountered.MethodsWe compared several regression-based methods to model time-dependent treatment effects. For illustration purposes, we used selected endpoints from a large, community-based clinical trial of low dose daily aspirin in older persons. Relative and absolute estimands were defined, and analyses were conducted in all participants. Additional exploratory analyses were undertaken by selected subgroups of interest using interaction terms in the regression models.DiscussionIn the trial with median 4.7 years follow-up, we found evidence for non-proportionality and a time-dependent treatment effect of aspirin on cancer mortality not previously reported in trial findings. We also found some evidence of time-dependence to an aspirin by age interaction for major adverse cardiovascular events. For other endpoints, time-fixed treatment effect estimates were confirmed as appropriate.ConclusionsThe consideration of treatment effects using both absolute and relative estimands enhanced clinical insights into potential dynamic treatment effects. We recommend these analytical approaches as an adjunct to primary analyses to fully explore findings from clinical trials.
Functional characterization of a farnesyl diphosphate synthase from Dendrobium nobile Lindl
Authors: Gong Daoyong , Wu Bin , Qin Hongting , Fu Dezhao , Guo Shunxing , Wang Bochu , Li Biao 
Published: October 2022

AbstractDendrobium nobile Lindl. has been used as a traditional Chinese medicine for a long time, in which the most important compound is dendrobine functioning in a variety of pharmacological activities. Farnesyl diphosphate synthase (FPPS) is one of the key enzymes in the biosynthetic pathway of dendrobine. In this work, we found the expression profiles of DnFPPS were correlated with the contents of dendrobine under the methyl jasmonate (MeJA) treatments at different time. Then, the cloning and functional identification of a novel FPPS from D. nobile. The full length of DnFPPS is 1231 bp with an open reading frame of 1047 bp encoding 348 amino acids. The sequence similarity analysis demonstrated that DnFPPS was in the high homology with Dendrobium huoshanense and Dendrobium catenatum and contained four conserved domains. Phylogenetic analysis showed that DnFPPS was the close to the DhFPPS. Then, DnFPPS was induced to express in Escherichia coli, purified, and identified by SDS-PAGE electrophoresis. Gas chromatography-mass spectrometry analysis indicated that DnFPPS could catalyze dimethylallyl pyrophosphate and isopentenyl pyrophosphate to produce farnesyl diphosphate. Taken together, a novel DnFPPS was cloned and functionally identified, which supplied a candidate gene for the biosynthetic pathway of dendrobine.
Early postoperative serum aspartate aminotransferase for prediction of post-hepatectomy liver failure
Authors: Vassanasiri Watoo , Rungsakulkij Narongsak , Suragul Wikran , Tangtawee Pongsatorn , Muangkaew Paramin , Mingphruedhi Somkit , Aeesoa Suraida 
Published: October 2022

Abstract
Background
Post-hepatectomy liver failure (PHLF) is a serious complication of hepatectomy. The current criteria for PHLF diagnosis (ISGLS consensus) require laboratory data on or after postoperative day (POD) 5, which may delay treatment for patients at risk. The present study aimed to determine the associations between early postoperative (POD1) serum aminotransferase levels and PHLF.

Methods
The medical records of patients who underwent hepatectomy at Ramathibodi Hospital from January 2008 to December 2019 were retrospectively examined. Patients were classified into PHLF and non-PHLF groups. Preoperative characteristics, intraoperative findings, and early postoperative laboratory data (serum AST, ALT, bilirubin, and international normalized ratio (INR) on POD0 to POD5) were analyzed.

Results
A total of 890 patients were included, of whom 31 (3.4%) had PHLF. Cut-off points for AST of 260 U/L and ALT of 270 U/L on POD1 were predictive of PHLF. In multivariate analysis, AST > 260 U/L on POD1, ICG-R15, major hepatectomy, blood loss, and INR were independently associated with PHLF.

Conclusions
Early warning from elevated serum AST on POD1, before a definitive diagnosis of PHLF is made on POD5, can help alert physicians that a patient is at risk, meaning that active management and vigilant monitoring can be initiated as soon as possible.
Heat storage efficiency, ground surface uplift and thermo-hydro-mechanical phenomena for high-temperature aquifer thermal energy storage
Authors: Vidal Rubén , Olivella Sebastià , Saaltink Maarten W. , Diaz-Maurin François 
Published: October 2022

AbstractHigh-temperature aquifer thermal energy storage (HT-ATES) systems can help in balancing energy demand and supply for better use of infrastructures and resources. The aim of these systems is to store high amounts of heat to be reused later. HT-ATES requires addressing problems such as variations of the properties of the aquifer, thermal losses and the uplift of the surface. Coupled thermo-hydro-mechanical (THM) modelling is a good tool to analyse the viability and cost effectiveness of HT-ATES systems and to understand the interaction of processes, such as heat flux, groundwater flow and ground deformation. The main problem of this modelling is its high computational cost. We propose a dimensional and numerical analysis of the thermo-hydro-mechanical behaviour of a pilot HT-ATES. The results of this study have provided information about the dominant thermo-hydraulic fluxes, evolution of the energy efficiency of the system and the role of the hydraulic and thermal loads generated by the injection and extraction of hot water.
Characterization and prediction of the clinical result with a specific model of mini-scleral contact lens in corneas with keratoconus
Authors: Sidi Mohamed Hamida Abdelkader , Marta García-Barchín , Pedro Ruiz-Fortes , Piñero David P. 
Published: October 2022

Abstract
Background
To investigate which factors are correlated with the visual improvement achieved with a specific model of scleral contact lens (SCL) in keratoconus (KC) eyes and to define a model to predict such improvement according to the pre-fitting data. In addition, the changes occurred with the fitting of a specific model of SCL during a period of 3 months in corneas with KC have been investigated.

Methods
Longitudinal retrospective study including 30 eyes of 18 patients (age, 14–65 years) with KC fitted with the SCL ICD16.50 (Paragon Vision Sciences). Visual, refractive, corneal tomographic and ocular aberrometric changes were evaluated during a 3-month follow-up. Likewise, the characterization of the post-lens meniscus was performed by optical coherence tomography (OCT) with the measurement of central, nasal and temporal vaults.

Results
The visual acuity increased significantly from a mean pre-fitting value with spectacles of 0.23 ± 0.07 logarithm of minimal angle of resolution (logMAR) to a mean value of 0.10 ± 0.04 logMAR after 1 month of SCL wear (P < 0.001). An improvement of 1 or more lines of visual acuity with the SCL occurred in 62.1% of the eyes. A significant decrease in central, nasal, and temporal vault was observed after 1 month of SCL wear (P ≤ 0.046). Likewise, there was a significant difference between nasal and temporal vaults during the first month of SCL use (P = 0.008). Furthermore, a significant reduction of ocular high order (P = 0.028) and primary coma root mean square (P = 0.018) was found with the SCL. A predicting linear equation of the change in visual acuity achievable with the SCL was obtained (P < 0.001, R2 = 0.878) considering the pre-fitting spectacle corrected distance visual acuity, and the power and sagittal lens of SCL.

Conclusions
The scleral contact lens evaluated provides an efficacious visual rehabilitation in KC due to the improvement of visual acuity and the correction of low and high-order ocular aberrations. This visual acuity improvement can be predicted from some pre-fitting variables.
Barriers to the implementation, uptake and scaling up of the healthy plate model among regular street food consumers: a qualitative inquiry in Dar-es-Salaam city, Tanzania
Authors: Kagaruki Gibson B. , Mahande Michael J. , Kreppel Katharina S. , Mbata Doris , Kilale Andrew M. , Shayo Elizabeth H. , Mfinanga Sayoki G. , Bonfoh Bassirou 
Published: October 2022

Abstract
Introduction
The healthy plate model is considered one of the practical approaches to reduce the average portion of staple food in main meals, consequently reducing the risks associated with diabetes and other Non-communicable Diseases (NCDs). Despite its potential benefits, studies on the implementation of the healthy plate model are limited in Africa. An inquiry explored barriers to implementation, uptake, and scaling up of the healthy plate model among street food vendors and consumers in three districts of Dar-es-Salaam city in Tanzania.

Methods
A qualitative research design was adopted. Qualitative data collection techniques were employed including; Key Informant Interviews (KIIs) with purposefully selected food and nutrition stakeholders at the National, Regional, District and Ward levels. Focus Group Discussions (FGDs) were conducted with purposefully selected street food consumers and vendors. A total of (13) KIIs were conducted as well as (6) FGDs with street food vendors (2 FGDs) and consumers (4 FGDs). Interview data was managed using Nvivo 12 Software and analyzed thematically.

Results
Three key themes emerged from participants’ accounts: (i) strategic policy barriers, (ii) food production and preparation environment barriers (producers and vendors), and (iii) individual barriers (consumers and vendors). The strategic policy barriers included absence of guidelines and regulations that focus on NCDs linked to nutrition and lack of education guidance for vendors and consumers. The food production and preparation environment barriers included safety and risks concerns regarding the quality of water used for irrigation and washing fruits and vegetables and the areas where vegetables and fruits are grown and prepared. Individual barriers included low consumer income, knowledge on nutrition, unhealthy eating practices and; low vendors’ knowledge as well as low investment capital.

Conclusion
Implementation, uptake and scaling up of the healthy plate model for street food consumers in Dar es Salaam City continues to be constrained by barriers in policy, food production and preparation environment, and individual obstacles. Strengthening of food and nutrition policies, ensuring safety of the food production and preparation environment and, consumer and vendor awareness creation and income generation efforts, provide useful entry points for the successful scaling up of a healthy plate model. This could consequently contribute towards prevention of diet related NCDs, including diabetes.
Feasibility of a telephone-delivered educational intervention for knowledge transfer of COVID-19-related information to older adults in Hong Kong: a pre–post-pilot study
Authors: Fung Mong Yung , Lee Yu Hong , Lee Yan Tung Astor , Wong Mei Ling , Li Joyce Tik Sze , Nok Ng Enoch E. , Lee Vivian Wing Yan 
Published: October 2022

AbstractBackgroundDuring the COVID-19 pandemic, educational interventions have become necessary to prevent the spread of health-related misinformation among Hong Kong older adults. The primary objective of this study was to assess the feasibility of a student-led, telephone-delivered intervention to improve COVID-19-related health knowledge among Hong Kong older adults. The secondary objective was to evaluate the impact of the intervention on the student volunteers.MethodsTwenty-five participants aged 65 or above who were able to communicate in Cantonese and had no hearing or cognitive impairments were recruited for this longitudinal pre–post-study from a community center in Hong Kong. The pilot telephone-delivered intervention consisted of five telephone call sessions conducted by 25 student volunteers. Each participant was paired with the same volunteer throughout the intervention. The first four sessions included pre-tests that assessed the participants’ understanding of three COVID-19-related themes: medication safety, healthcare voucher scheme, and COVID-19 myth-busting. Standardized explanations of the pre-test questions were offered to participants during the phone calls. In the last session, a post-test on all the themes was conducted. The intervention’s feasibility was assessed based on (a) percentage changes in the participants’ test scores, (b) attrition rate, and (c) the acceptability of the intervention by the participants. The impact of the intervention on the student volunteers was evaluated based on a student feedback survey. There was no control group.ResultsSignificant improvements in the participants’ test scores (out of 100%) for all themes were observed after the intervention: from 76 to 95.2% for medication safety, from 64.0 to 88.8% for the healthcare voucher scheme, and from 78.0 to 93.2% for COVID-19 myth-busting. The average improvement in test scores of the three themes was 18.4% (95% CI 12.2 to 24.6%). Most participants were satisfied with the program. The student feedback survey suggested that the intervention enhanced students’ communication skills and understanding of Hong Kong older adults.ConclusionThis pilot study offers initial evidence of the potential and feasibility of student-led, telephone-delivered educational interventions for the transfer of COVID-19-related knowledge to older adults and their benefits for the student volunteers. Future studies should include larger samples and a control group.
Foreword: translanguaging LPP
Authors: Wei Li 
Published: October 2022

AbstractFor me, language policy and planning (LPP) is both a field of practical enquiry and a field of theoretical enquiry. As a practical field, LPP is about actions; actions that are taken by various agents and agencies on the structure, use and acquisition of language. As a theoretical field, LPP critically assesses these actions and further our understanding of why individuals and society decide to take certain actions at certain times in certain ways with regard to language structure, language use and language acquisition. Ultimately, this will help to further our understanding of society. Crucially, LPP as a theoretical field of enquiry needs to raise critical questions about the actions, rather than simply describing and documenting what the actions are. In doing so, LPP studies need to adopt specific theoretical stances. In the present case, the theoretical perspective that the contributors to this special issue have adopted is that of Translanguaging. I am grateful to the editors of the special issue for their invitation to write this short foreword to introduce and contextualise the special issue. I want to do so by highlighting what I think the potential contributions of Translanguaging as an analytical concept are to the studies of LPP, with reference to the Greater Bay Are of China that I would describe as an emerging and evolving Translanguaging Space.
Clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter EAGLE study
Authors: Hayakawa Naoki , Takahara Mitsuyoshi , Nakama Tatsuya , Horie Kazunori , Takanashi Keisuke , Kanagami Teruaki , Ichihara Shinya , Arakawa Masataka , Tobita Kazuki , Mori Shinsuke , Iwata Yo , Suzuki Kenji , Kanda Junji 
Published: October 2022

Abstract
Background
Several studies have reported the efficacy of drug-coated balloons (DCB) for simple femoropopliteal (FP) lesions. However, the effectiveness of DCB for FP chronic total occlusive lesions (CTO) is controversial. The present study investigated the clinical outcomes of DCB for FP-CTO.

Materials and methods
We retrospectively analyzed 359 limbs of 318 patients who underwent endovascular therapy with DCB for FP-CTO between July 2017 and February 2021 at seven cardiovascular centers. The primary endpoint was 12-month primary patency. The secondary endpoints were the 12-month rates of freedom from: (1) clinically-driven target lesion revascularization (CD-TLR), and (2) re-occlusion. The association of baseline characteristics with the 12-month restenosis risk was investigated using the Cox proportional hazards regression model.

Results
The 12-month rate of primary patency was 79.8% (95% confidence interval [95%CI], 75.1% to 84.8%), whereas the corresponding rates of freedom from CD-TLR and re-occlusion were 86.4% (95%CI: 82.6% to 90.4%) and 88.5% (95%CI: 84.7% to 92.4%), respectively. The bailout stent rate was 8.9%. Independent risk factors for restenosis were hemodialysis (adjusted hazard ratio, 2.18 [1.39 to 3.45]; P = 0.001), chronic limb-threatening ischemia (CLTI) (2.02 [1.33 to 3.07]; P = 0.001), and restenosis lesion (2.02 [1.32 to 3.08]; P = 0.001). Use of dual antiplatelet therapy (DAPT) was identified as a protective factor for restenosis (0.54 [0.35 to 0.82]; P = 0.003).

Conclusions
Despite the low rate of bailout stent, DCB treatment for FP-CTO was effective in real-world clinical practice. Hemodialysis, CLTI, and restenosis lesion were independent risk factors for 12-month restenosis, and the use of DAPT significantly attenuated the risk of 12-month restenosis.
Patients’ and staff members’ experiences of restrictive practices in acute mental health in-patient settings: systematic review and thematic synthesis
Authors: Butterworth Hannah , Wood Lisa , Rowe Sarah 
Published: October 2022

Background
Recent guidance has called for the reduction of restrictive practice use owing to growing concerns over the harmful physical and psychological effects for both patients and staff. Despite concerns and efforts, these measures continue to be used regularly to manage challenging behaviour in psychiatric in-patient settings.

Aims
To undertake a systematic review of patients’ and staff members’ experiences of restrictive practices in acute psychiatric in-patient settings.

Method
A systematic review and thematic synthesis was conducted using data from 21 qualitative papers identified from a systematic search across three electronic databases (PsycInfo, Embase and MEDLINE) and citation searching. The protocol for the review was pre-registered on PROSPERO (CRD42020176859). The quality of included papers was examined using the Critical Appraisal Skills Programme (CASP).

Results
Four overarching themes emerged from the experiences of patients: the psychological effects, staff communication, loss of human rights and making changes. Likewise, the analysis of staff data produced four themes: the need for restrictive practices, the psychological impact, decision-making and making changes. Patient and staff experiences of restrictive practices were overwhelmingly negative, and their use carried harmful physical and psychological consequences. Lack of support following restraint events was a problem for both groups.

Conclusions
Future programmes seeking to improve or reduce restrictive practices should consider the provision of staff training covering behaviour management and de-escalation techniques, offering psychological support to both patients and staff, the importance of effective staff–patient communication and the availability of alternatives.