bluuebunny/crossref_metadata_2025_split huggingface dataset:
Proportionate translation of study materials and measures in a multinational global health trial: methodology development and implementation
Authors: Charles Ashleigh , Korde Palak , Newby Chris , Grayzman Alina , Hiltensperger Ramona , Mahlke Candelaria , Moran Galia , Nakku Juliet , Niwemuhwezi Jackie , Nixdorf Rebecca , Paul Eva , Puschner Bernd , Ramesh Mary , Ryan Grace Kathryn , Shamba Donat , Kalha Jasmine , Slade Mike 
Published: January 2022

ObjectivesCurrent translation guidelines do not include sufficiently flexible translation approaches for different study materials. We aimed to develop a proportionate methodology to inform translation of all types of study materials in global health trials.DesignThe design included three stages: (1) categorisation of study materials, (2) integration of existing translation frameworks and (3) methodology implementation (Germany, India, Israel, Tanzania and Uganda) and refinement.ParticipantsThe study population comprised 27 mental health service users and 27 mental health workers who were fluent in the local language in stage 7 (pretesting), and 54 bilingual mental health service users, aged 18 years or over, and able to give consent as judged by a clinician for step 9 (psychometric evaluation).SettingThe study took place in preparation for the Using Peer Support in Developing Empowering Mental Health Services (UPSIDES) randomised controlled trial (ISRCTN26008944).Primary outcome measureThe primary outcome measure was the Social Inclusion Scale (SIS).ResultsThe typology identifies four categories of study materials: local text, study-generated text, secondary measures and primary measure. The UPSIDES Proportionate Translation Methodology comprises ten steps: preparation, forward translation, reconciliation, back translation, review, harmonisation, pretesting, finalisation, psychometric evaluation and dissemination. The translated primary outcome measure for the UPSIDES Trial (SIS) demonstrated adequate content validity (49.3 vs 48.5, p=0.08), convergent validity and internal consistency (0.73), with minimal floor/ceiling effects.ConclusionThis methodology can be recommended for translating, cross-culturally adapting and validating all study materials, including standardised measures, in future multisite global trials. The methodology is particularly applicable to multi-national studies involving sites with differing resource levels. The robustness of the psychometric findings is limited by the sample sizes for each site. However, making this limitation explicit is preferable to the typical practice of not reporting adequate details about measure translation and validation.Trail registration numberISRCTN26008944
Active-fluidics versus gravity-fluidics system in phacoemulsification for age-related cataract (AGSPC): study protocol for a prospective, randomised, double-blind, controlled clinical trial
Authors: Luo Yu , Li Hongyu , Chen Wenqian , Gao Yi , Ma Tianju , Ye Zi , Li Zhaohui 
Published: January 2022

IntroductionThe active-fluidics system is a new irrigation system of phacoemulsification that automatically detects and maintains stable intraocular pressure at the set value. This trial is designed to compare the efficacy, visual outcomes, safety and patients’ subjective perceptions of cataract surgery with the active-fluidics system and gravity-fluidics system.Methods and analysisThis trial will recruit 110 patients with age-related cataract at the Chinese People’s Liberation Army (PLA) General Hospital (Beijing, China) and they will be randomly assigned to the active-fluidics group and gravity-fluidics group in a ratio of 1:1 to have phacoemulsification. Patients will be followed up at 1 day, 1 week, 1 month and 3 months postoperatively. The primary outcomes are the cumulative dissipated energy and best corrected visual acuity. Secondary outcomes include: estimated fluid usage, U/S time, total aspiration time, intraocular pressure, corneal endothelium parameters, retinal thickness, macular superficial vessel density, pain scores, scores of the Cataract surgery Patient-Reported Outcome Measures Questionnaire and the complication rates. The data will be independently analysed by the statistical team, who will be masked for the allocation information as participants are.Ethics and disseminationThis study was approved by the Ethics Committee of Chinese PLA General Hospital (approval no. S2021-068-01). Informed consent will be obtained from each participant. All the results will be published in peer-reviewed journals and used for scholarly communication or technical guidance. Protocol version 1.0.Trial registration numberChinese Clinical Trial Registry (ChiCTR2100044409).
Implications of resource constraints and high workload on speaking up about threats to patient safety: a qualitative study of surgical teams in Ghana
Authors: Mawuena Emmanuel Kwasi , Mannion Russell 
Published: January 2022

BackgroundAlthough under-resourcing of healthcare facilities and high workload is known to undermine patient safety, there is a dearth of evidence about how these factors affect employee voice and silence about unsafe care. We address this gap in the literature by exploring how resource constraints and high workload influence the willingness of staff to speak up about threats to patient safety in surgical departments in Ghana.MethodSemistructured interviews with a purposeful sample of 91 multidisciplinary professionals drawn from a range of specialities, ranks and surgical teams in two teaching hospitals in Ghana. Conservation of Resources theory was used as a theoretical frame for the study. Data were processed and analysed thematically with the aid of NVivo 12.ResultsEndemic resource constraints and excessive workload generate stress that undermines employee willingness to speak up about unsafe care. The preoccupation with managing scarce resources predisposes managers in surgical units to ignore or downplay concerns raised and not to instigate appropriate remedial actions. Resource constraints lead to rationing and improvising in order to work around problems with inadequate infrastructure and malfunctioning equipment, which in turn creates unsupportive environments for staff to air legitimate concerns. Faced with high workloads, silence was used as a coping strategy by staff to preserve energy and avoid having to take on the burden of additional work.ConclusionUnder-resourcing and high workload contribute significantly towards undermining employee voice about unsafe care. We highlight the central role that adequate funding and resourcing play in creating safe environments and that supporting ‘hearer’ courage may be as important as supporting speaking up in the first place.
Emitted radiation in superconformal field theories
Authors: Galvagno Francesco 
Published: January 2022

AbstractThe computation of the emitted radiation by an accelerated external particle can be addressed in a gauge theory with the insertion of a Wilson loop. With the addition of conformal symmetry, this problem is consistently formalized in terms of correlation functions in the presence of the Wilson loop, which are constrained by defect CFT techniques. In theories with extended supersymmetry, we can also resort to supersymmetric localization on a four-sphere. By using this set of tools, we review the close relation between the Bremsstrahlung function and the stress energy tensor one-point coefficient in abelian theories and in superconformal field theories. After presenting the state of the art for generic CFTs, we mainly focus on the supersymmetric cases. We discuss the differences between the maximally supersymmetric $${\mathcal {N}}=4$$

N
=
4

case and $${\mathcal {N}}=2$$

N
=
2

SCFTs, and finally, we review the general and exact result for the emitted radiation in terms of a first-order derivative of the Wilson loop expectation value on a squashed sphere.
Mass movements
Authors: Brain Matthew J. , Rosser Nick J. 
Published: January 2022

Abstract

In this chapter, we consider key advances in the understanding of mass movements between
c.
1965 and
c.
2000. This period saw a burgeoning need for a greater level of understanding of mass-movement processes in response to a series of high-impact mass-movement events, and because of the need to develop infrastructure safely. A series of step changes were enabled through hillslope geomorphology (broadly defined) being open to overarching and consolidating concepts, methods and models from cognate disciplines, whilst seizing opportunities to gain insight from rapidly advancing methods increasingly focused at a scale of investigation relevant to landsliding. By
c.
2000, geomorphologists had made significant contributions to our understanding of mass-movement processes and ultimately led many key conceptual advances, notably relating to: bridging across scales of hillslope investigation; linking and developing understanding of process, form and mechanisms of slope stability; and articulating the temporal characteristics of slope stability and mass movement.
Correlation and Relative Prognostic Value of Fractional Flow Reserve and Pd/Pa of Nonculprit Lesions in ST-Segment–Elevation Myocardial Infarction
Authors: Piróth Zsolt , Fülöp Gábor , Boxma-de Klerk Bianca M. , Abdelghani Mohammad , Omerovic Elmir , Andréka Péter , Fontos Géza , Neumann Franz-Josef , Richardt Gert , Smits Pieter C. 
Published: January 2022

Background:
The applicability of resting indices to guide noninfarct-related artery revascularization in ST-elevation myocardial infarction is unknown.

Methods:
We analyzed the correlation and prognostic value of fractional flow reserve (FFR) and resting distal coronary to aortic pressure ratio (Pd/Pa) in all patients of the Compare-Acute trial in whom, after successful primary percutaneous coronary intervention, the noninfarct-related artery was interrogated by both and treated medically. The treating cardiologist was blinded to these values. The primary end point was the composite of target vessel (interrogated noninfarct-related artery) related nonfatal target vessel myocardial infarction and target vessel repeat revascularization at 36 months.

Results:

Five hundred seventeen patients (665 vessels) were included. On receiver-operating characteristic analysis, the optimal Pd/Pa cut off for FFR≤0.80 was 0.905 (
C
statistic: 0.894). The diagnostic accuracy of Pd/Pa was 80.15% (95% CI, 76.91%–83.12%) with respect to FFR. During the 36-month follow-up, 130 target vessel revascularization and 14 target vessel myocardial infarction occurred. FFR and Pd/Pa had a diagnostic accuracy to predict these events of 62.86% (95% CI, 59.06%–66.54%) and 56.84% (95% CI, 52.98%–60.64%), respectively (
P
=0.20). When they were discrepant, FFR was significantly better than Pd/Pa in identifying which vessels could be safely deferred (
P
=0.048).

Conclusions:
Immediately after successful primary percutaneous coronary intervention, resting Pd/Pa has a diagnostic accuracy of 80% with respect to FFR measured in the noninfarct-related artery. FFR is not significantly superior in predicting target vessel myocardial infarction and target vessel revascularization during 36 months of follow-up but, in case FFR and Pd/Pa are discrepant, FFR is superior in identifying which nonculprit vessels can be safely deferred.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT01399736.
COVID-19 anxiety and quality of life among Iranian nurses
Authors: Mohamadzadeh Tabrizi Zohreh , Mohammadzadeh Fatemeh , Davarinia Motlagh Quchan Arezoo , Bahri Narjes 
Published: January 2022

Abstract
Background
The Coronavirus Disease 2019 (COVID-19) pandemic has exposed nurses, who are a very important group involved in the care of these patients, to many stresses that may affect their quality of life. This study aimed to determine the relationship between COVID-19 anxiety and the quality of life among Iranian nurses.

Method
This online cross-sectional study enrolled 1,131 of Iranian nurses working at the time of the COVID-19 outbreak in treatment centers in different parts of Iran from April to May 2020. The convenience sampling strategy was used. Data were collected using a demographic questionnaire, the 36-Item Short-Form Health Survey (SF-36), and Corona Disease Anxiety Scale (CDAS). The stepwise multiple linear regression models were used to examine the relationships among self-reported anxiety concerning COVID-19 and SF-36 quality of life, its components, and subscales. Partial r was used as an estimate of effect size.

Result
The mean SF-36 score was 65.2 (SD=17.6). The mean score of the mental component summary (MCS) (M=56.8, SD=22.3) was lower than the mean score of the physical component summary (PCS) (M=71.6, SD=17.5). The mean score of COVID-19 anxiety was 17.8 (SD=10.5). Of the participants, 378 (33.4%; 95% CI [30.7%, 36.3%]), and 152 (13.4%; 95% CI [11.5%, 15.6%]) reported moderate and severe anxiety, respectively. According to the results of stepwise multiple linear regression model, after adjusting for possible confounding variables, the SF-36 quality of life was still significantly negatively associated with COVID-19 anxiety, with a large effect size (The partial r = -0.515, p < 0.001). The relationship between the SF-36 components and COVID-19 anxiety were also significant, and moderate to large effect sizes were observed (The partial r for (PCS; COVID-19 anxiety) = -0.404; p < 0.001, and for (MCS; COVID-19 anxiety) = -0.521; p < 0.001). In addition, significant correlation coefficients for every subscale of the SF-36 were found for COVID-19 anxiety and its two components, with small to large effect sizes (The partial correlations= -0.211 to -0.524, all ps< 0.001).

Conclusions
The results showed that higher COVID-19 anxiety in nurses decreases their quality of life. In order to increase nurses’ quality of life during the COVID-19 pandemic, it is recommended to design and implement programs to reduce their COVID-19 anxiety.
STAT3 exerts pro-tumor and anti-autophagy roles in cervical cancer
Authors: Wu Lin , Shen Bowen , Li Junpeng , Zhang Huirong , Zhang Ke , Yang Yao , Zu Zhenyu , Shen Dongxiang , Luo Min 
Published: January 2022

Abstract
Background
STAT3 plays an important role in cervical cancer. LC3B, the most potential molecular biomarker of autophagy that may promote or inhibit cancer progression, can be downregulated by STAT3. However the role of STAT3 in the autophagy of cervical cancer remains unclear.

Purpose
This study aimed to evaluate the relationship between STAT3 and LC3B in protein level, and verify whether STAT3 promotes proliferation, migration and plate colony formation by inhibiting autophagy of cervical cancer cells through bcl2-beclin1 axis.

Results
STAT3 was overexpressed in cervical cancer tissues, and negatively correlated with the expression level of LC3B. STAT3 knockout or knockdown significantly increased the autophagy level and decreased proliferation, migration, plate colony formation and subcutaneous tumorigenesis of cervical cancer cells in vitro and in vivo. STAT3 is known to mediate autophagy through Bcl2-Beclin1 complex. Bcl2 was positively whereas Beclin1 negatively correlated with STAT3 expression, indicating that Bcl2-Beclin1 complex involved in this transition.

Conclusion
STAT3 may upregulate the autophagy level of cervical cancer cells through the Bcl2-Beclin1 axis. This indicates that STAT3 may be an important prognostic and therapeutic target for cervical cancer.
Safety of accelerated hypofractionated whole pelvis radiation therapy prior to high dose rate brachytherapy or stereotactic body radiation therapy prostate boost
Authors: Phuong Christina , Chan Jason W. , Ni Lisa , Wall Phillip , Mohamad Osama , Wong Anthony C. , Hsu I.-Chow , Chang Albert J. 
Published: January 2022

Abstract
Background
To evaluate acute and late genitourinary and gastrointestinal toxicities and patient reported urinary and sexual function following accelerated, hypofractionated external beam radiotherapy to the prostate, seminal vesicles and pelvic lymph nodes and high dose rate (HDR) brachytherapy or stereotactic body radiation therapy (SBRT) prostate boost.

Methods
Patients at a single institution with NCCN intermediate- and high-risk localized prostate cancer with logistical barriers to completing five weeks of whole pelvic radiotherapy (WPRT) were retrospectively reviewed for toxicity following accelerated, hypofractionated WPRT (41.25 Gy in 15 fractions of 2.75 Gy). Patients also received prostate boost radiotherapy with either HDR brachytherapy (1 fraction of 15 Gy) or SBRT (19 Gy in 2 fractions of 9.5 Gy). The duration of androgen deprivation therapy was at the discretion of the treating radiation oncologist. Toxicity was evaluated by NCI CTCAE v 5.0.

Results
Between 2015 and 2017, 22 patients with a median age of 71 years completed accelerated, hypofractionated WPRT. Median follow-up from the end of radiotherapy was 32 months (range 2–57). 5%, 73%, and 23% of patients had clinical T1, T2, and T3 disease, respectively. 86% of tumors were Gleason grade 7 and 14% were Gleason grade 9. 68% and 32% of patients had NCCN intermediate- and high-risk disease, respectively. 91% and 9% of patients received HDR brachytherapy and SBRT prostate boost following WPRT, respectively. Crude rates of grade 2 or higher GI and GU toxicities were 23% and 23%, respectively. 3 patients (14%) had late or persistent grade 2 toxicities of urinary frequency and 1 patient (5%) had late or persistent GI toxicity of diarrhea. No patient experienced grade 3 or higher toxicity at any time. No difference in patient-reported urinary or sexual function was noted at 12 months.

Conclusions
Accelerated, hypofractionated whole pelvis radiotherapy was associated with acceptable GU and GI toxicities and should be further validated for those at risk for harboring occult nodal disease.
Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial
Authors: Arnedt J. Todd , Cardoni M. Elizabeth , Conroy Deirdre A. , Graham Mandilyn , Amin Sajni , Bohnert Kipling M. , Krystal Andrew D. , Ilgen Mark A. 
Published: January 2022

AbstractBackgroundAlcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available treatments. Insomnia is a robust predictor of relapse and pilot studies have shown that CBT for insomnia improves insomnia and daytime functioning in adults with AUD and insomnia. The impact of CBT for insomnia on relapse, however, is unclear. This trial will compare telemedicine-delivered CBT for insomnia (CBT-TM) with sleep hygiene education (SHE-TM) on improving insomnia/sleep, daytime symptom, and drinking outcomes in treatment-seeking AUD adults with insomnia. The study will also determine the effects of treatment on sleep mechanisms and their association with clinical outcomes.MethodsThis is a single-site randomized controlled trial with planned enrollment of 150 adults meeting criteria for both AUD and chronic insomnia. Eligible participants will be randomized 1:1 to 6 sessions of telemedicine-delivered Cognitive Behavioral Therapy for Insomnia (CBT-TM) or Sleep Hygiene Education (SHE-TM) with clinical assessments conducted at pre-treatment, post- treatment, and at 3, 6, and 12 months post-treatment. Overnight polysomnography will be conducted before and after treatment. Primary clinical outcomes will include post-treatment scores on the Insomnia Severity Index and the General Fatigue subscale of the Multidisciplinary Fatigue Inventory, and the percent of days abstinent (PDA) on the interview-administered Time Line Follow Back. EEG delta activity, derived from overnight polysomnography, will be the primary endpoint to assess the sleep homeostasis mechanism.DiscussionThis adequately powered randomized controlled trial will provide clinically relevant information about whether targeting insomnia is effective for improving treatment outcomes among treatment-seeking adults with AUD. Additionally, the study will offer new scientific insights on the impact of an evidence-based non-medication treatment for insomnia on a candidate mechanism of sleep dysfunction in this population - sleep homeostasis.Trial registrationCClinicalTrials.govNCT # 04457674. Registered on 07 July 2020.
Individualized positive end-expiratory pressure guided by end-expiratory lung volume in early acute respiratory distress syndrome: study protocol for the multicenter, randomized IPERPEEP trial
Authors: Grieco Domenico Luca , Maggiore Salvatore Maurizio , Bellani Giacomo , Spadaro Savino , Spinelli Elena , Tonetti Tommaso , Menga Luca S. , Pozzi Marco , Battaglini Denise , Di Mussi Rosa , Bruni Andrea , De Gaetano Andrea , Iovino Carmine Giovanni , Brioni Matteo , Mojoli Francesco , Foti Giuseppe , Volta Carlo Aberto , Pelosi Paolo , Navalesi Paolo , Grasso Salvatore , Ranieri V. Marco , Antonelli Massimo ,   the IPERPEEP study group
Published: January 2022

Abstract
Background
In acute respiratory distress syndrome (ARDS), response to positive end-expiratory pressure (PEEP) is variable according to different degrees of lung recruitability. The search for a tool to individualize PEEP based on patients’ individual response is warranted.
End-expiratory lung volume (EELV) assessment by nitrogen washin-washout aids bedside estimation of PEEP-induced alveolar recruitment and may therefore help titrate PEEP on patient’s individual recruitability.
We designed a randomized trial to test whether an individualized PEEP setting protocol driven by EELV measurement may improve a composite clinical outcome in patients with moderate-to-severe ARDS (IPERPEEP trial).

Methods
IPERPEEP is an open-label, multicenter, randomized trial that will be conducted in 10 intensive care units in Italy and will enroll 132 ARDS patients showing PaO2/FiO2 ratio ≤ 150 mmHg within 24 h from endotracheal intubation while on mechanical ventilation with PEEP 5 cmH2O.
To standardize lung volumes at study initiation, all patients will undergo mechanical ventilation with tidal volume of 6 ml/kg of predicted body weight and PEEP set to obtain a plateau pressure within 28 and 30 cmH2O for 30 min (EXPRESS PEEP).
Afterwards, a 5-step decremental PEEP trial will be conducted (EXPRESS PEEP to PEEP 5 cmH2O), and EELV will be measured at each step. Recruitment-to-inflation ratio will be calculated for each PEEP range from EELV difference. Patients will be then randomized to receive mechanical ventilation with PEEP set according to the optimal recruitment observed in the PEEP trial (IPERPEEP arm) trial or to achieve a plateau pressure of 28–30 cmH2O (control arm, EXPRESS strategy). In both groups, tidal volume size, use of prone positioning and neuromuscular blocking agents, and weaning from PEEP and from mechanical ventilation will be standardized.
The primary endpoint of the study is a composite clinical outcome incorporating in-ICU mortality, 60-day ventilator-free days, and serum interleukin-6 concentration over the course of the initial 72 h of treatment.

Discussion
The IPERPEEP study is a randomized trial powered to elucidate whether an individualized PEEP setting protocol based on bedside assessment of lung recruitability can improve a composite clinical outcome during moderate-to-severe ARDS.

Trial registration
ClinicalTrials.govNCT04012073. Registered 9 July 2019.