bluuebunny/crossref_metadata_2025_split huggingface dataset:
Informing National Health Service patients about participation in clinical research: A comparison of opt-in and opt-out approaches across the United Kingdom
Authors: Henshall Catherine , Potts Jennifer , Walker Sophie , Hancock Mark , Underwood Mark , Broughton Nick , Ede Roger , Kernot Catherine , O’Neill Lorcan , Geddes John R , Cipriani Andrea 
Published: November 2020

Objective: Recruitment to clinical research in the National Health Service remains challenging. One barrier is accessing patients to discuss research participation. Two general approaches are used in the United Kingdom to facilitate this: an ‘opt-in’ approach (when clinicians communicate research opportunities to patients) and an ‘opt-out’ approach (all patients have the right to be informed of relevant research opportunities). No evidence-based data are available, however, to inform the decision about which approach is preferable. This study aimed to collect information from ‘opt-in’ and ‘opt-out’ Trusts and identify which of the two approaches is optimal for ensuring National Health Service patients are given opportunities to discuss research participation. Method: This sequential mixed methods study comprised three phases: (1) an Appreciative Inquiry across UK Trusts, (2) online surveys and (3) focus groups with National Health Service staff and patients at a representative mental health Trust. Results: The study was conducted between June and October 2019. Out of seven National Health Service Mental Health Trusts contacted (three ‘opt-out’ and four ‘opt-in’), only four took part in phase 1 of the study and three of them were ‘opt-out’ Trusts. Benefits of an ‘opt-out’ approach included greater inclusivity of patients and the removal of research gatekeepers, while the involvement of research-active clinicians and established patient–clinician relationships were cited as important to ‘opt-in’ success. Phases 2 and 3 were conducted at a different Trust (Oxford Health NHS Foundation Trust) which was using an ‘opt-in’ approach. Of 333 staff and member survey responders, 267 (80.2%) favoured moving to an ‘opt-out’ approach (phase 2). Nineteen staff and 16 patients and carers participated in focus groups (phase 3). Concern was raised by staff regarding the lack of time for clinical research, with clinical work taking precedence over research; patients were concerned about a lack of research activity; all considered research to be beneficial and were supportive of a move to ‘opt-out’. Conclusion: Findings suggest that ‘opt-out’ is more beneficial than ‘opt-in’, with the potential to vastly increase patient access to research opportunities and to enable greater equality of information provision for currently marginalised groups. This should ensure that healthcare research is more representative of the entire population, including those with a mental health diagnosis.
The effect of custom carbon ankle-foot orthosis alignment on roll-over shape and center of pressure velocity
Authors: Russell Esposito Elizabeth , Ruble Mitchell D , Ikeda Andrea J , Wilken Jason M 
Published: November 2020

Background:
Maintaining an optimal rolling of the foot over the ground is thought to increase the stability and efficiency of pathologic gait. Ankle-foot orthoses are often prescribed to improve gait mechanics in individuals with lower extremity injuries; however, their design may compromise how the foot rolls over the ground.

Objectives:
The aim of this study was to investigate the effects of the sagittal plane ankle-foot orthosis alignment on roll-over shape and center of pressure velocity in individuals with lower limb reconstructions.

Study design:
Randomized cross-over study with a control group comparison.

Methods:
In total, 12 individuals with lower limb reconstruction who used a custom carbon ankle-foot orthosis and 12 uninjured controls underwent gait analysis. Ankle-foot orthosis users were tested in their clinically-provided ankle-foot orthosis alignment, with an alignment that was 3° more plantarflexed, and with an alignment that was 3° more dorsiflexed. Components of roll-over shape and center of pressure velocity were calculated from heel strike on the ankle-foot orthosis limb to contralateral heel strike.

Results:
Roll-over shape radius was not affected by 3° changes to alignment and was not significantly different from controls. Aligning the ankle-foot orthosis in more dorsiflexion than clinically provided resulted in a smaller peak center of pressure velocity that occurred later in stance.

Conclusion:
Individuals using custom carbon ankle-foot orthoses can accommodate 3° alterations in the dorsiflexion or plantarflexion alignment.
Hindfoot Alignment Change After Total Ankle Arthroplasty for Varus Osteoarthritis
Authors: Son Hyuck Sung , Choi Jung Gyu , Ahn Jungtae , Jeong Bi O 
Published: November 2020

Background: In patients with end-stage varus ankle osteoarthritis (OA), hindfoot varus malalignment resulting from the varus deformity of the ankle joint is common. Although total ankle arthroplasty (TAA) performed to correct varus deformity of the ankle joint has the effect of correcting hindfoot alignment, no reports to date have described how much hindfoot alignment correction can be achieved. The purpose of this study was to identify correlation between ankle deformity correction and hindfoot alignment change after performing TAA in patients with end-stage varus ankle OA. Methods: A total of 61 cases that underwent TAA for end-stage varus ankle OA and followed up for at least 1 year were enrolled for this study. Correlation between changes of tibial-ankle surface angle (TAS), talar tilt (TT), and tibiotalar surface angle (TTS) and changes of hindfoot alignment angle (HA), hindfoot alignment ratio (HR), and hindfoot alignment distance (HD) measured preoperatively and at postoperative year 1 was analyzed. Results: TAS, TT, and TTS changed from 83.9 ± 4.1 degrees, 5.8 ± 5.0 degrees, and 78.1 ± 5.9 degrees, respectively, before operation to 89.2 ± 2.1 degrees, 0.4 ± 0.5 degrees, and 88.7 ± 2.3 degrees, respectively, after operation. HA, HR, and HD also changed from −9.2 ± 4.6 degrees, 0.66 ± 0.18, and −11.2 ± 6.9 mm to −3.7 ± 4.1 degrees, 0.48 ± 0.14, and −5.0 ± 5.3 mm. All the changes were statistically significant ( P < .001, respectively). The regression slope of correlation was 0.390 ( R2 = 0.654) between TTS and HA; 0.017 ( R2 = 0.617) between TTS and HR; and 0.560 ( R2 = 0.703) between TTS and HD. Conclusion: In patients with end-stage varus ankle OA, changes of hindfoot alignment could be predicted based on degree of ankle deformity corrected with TAA. Level of Evidence: Level IV, case series.
Bilateral choroidal detachment and myopic shift after acetazolamide intake for laser capsulotomy
Authors: Musetti Donatella , Nicolò Massimo , Bagnis Alessandro , Cutolo Carlo Alberto , Traverso Carlo Enrico 
Published: November 2020

Introduction: To report a case of bilateral choroidal effusion after laser capsulotomy. Case description: A healthy 85 years old white woman was referred to our hospital with a diagnosis of posterior capsule opacification in the left eye. The patient was treated with laser capsulotomy and oral acetazolamide was administered after the procedure. The day after, the patient visited the emergency room complaining bilateral blurred vision. A myopic shift and peripheral choroidal detachment was noted in both eyes. Discontinuation of acetazolamide and treatment with topical steroid and cyclopentolate resulted in a significant improvement in visual acuity and the complete resolution of the choroidal detachment in 1 week. Conclusion: To the best of our knowledge, this is the first reported case of choroidal detachment and acute transient myopia following the administration of oral acetazolamide after laser capsulotomy.
Fovea-sparing coats disease: A rare clinical entity
Authors: Girolamo Matteo Maria , De Francesco Sonia , Salvoldi Federica , Barchitta Matteo , Menicacci Cristina , Hadjistilianou Theodora 
Published: November 2020

Purpose: To evaluate the rarity, clinical features and management of Coats disease characterized by fovea-sparing enhancing the importance of pediatric retinal screening and early management to maintain a good visual acuity. Methods: Retrospective analysis of approximately 40 patients affected by Coats disease between 2000 and 2020 at the Retinoblastoma Referral Center and Ophthalmology unit of the University of Siena in Italy. Results: Two patients with fovea sparing Coats disease were included. Both presented an extrafoveal Coats disease (stage 2A by Shields classification) when they were 5 and 6 years old respectively. They had no anterior findings and a presenting visual acuity of 20/20 reflecting the early stage and a milder phenotype of the disease which are indeed more likely to be found in patients older than 3 years at presentation. Both presented telangiectasia and retinal exudation in the affected eye. Standard Argon laser photocoagulation and subsequently Cryotherapy were performed in the telangiectatic retinal periphery of both patients obtaining an excellent control and regression of the disease. Conclusions: Careful pediatric retinal screening and early management are crucial to ensure a good visual prognosis in such an early feature of Coats disease as fovea sparing since this condition unfortunately tends to recall the physician’s attention in more advanced stages. Due to the extremely poor number of articles regarding such a rare feature of Coats disease like fovea sparing, we report our experience.
Late-stage sequela of an isolated optic neuropathy after acute magnesium valproate overdose: A case report
Authors: Chen Xuhao , Di Haohao , Hong Ying , Zhang Chun 
Published: November 2020

Background: Magnesium valproate is a valproic acid (VPA) derivative that is widely used for the treatment of epilepsy and bipolar disorders. Acute overdose of VPA may cause complicated systemic syndromes; however, the reports of ocular sequelae caused by toxic optic neuropathy (TON) are rare. Case presentation: We present a case of a 19-year-old female with bilateral damage to visual function after acute VPA overdose. She was comatose and received systemic treatments for 1 month, during which she suffered a substantial loss of visual function without any evident neurological sequelae. The first recorded visual acuity was no light perception in the right eye (OD) and hand motion in the left eye (OS). Her best-corrected visual acuity improved to 20/100 OS after 4 months of hyperbaric oxygen therapy and neurotrophic treatments. Her visual field was limited to an inferior nasal area OS. Therefore, a diagnosis of TON was made. Her visual function remained stable in the left eye, but did not recover in the right eye during the 5-month follow-up. We found damage to the optic nerve pathway during ophthalmic examinations. Conclusion: We report a rare case of TON caused by acute VPA overdose. Hyperbaric oxygen therapy, and neuroprotective and neurotrophic treatments might be effective at the early stage but cannot fully reverse the damage to the optic nerve. The present case indicates the potential neurotoxicity of VPA. It is crucial to determine the severity of an isolated optic nerve sequela caused by VPA overdose, though it might be rare as observed in previous reports. Further confirmation of the likelihood of its causation and its pathophysiology is needed in the future.
Low levels of circulating anti-ageing hormone Klotho predict the onset and progression of diabetic retinopathy
Authors: Corcillo Antonella , Fountoulakis Nikolaos , Sohal Angela , Farrow Frederick , Ayis Salma , Karalliedde Janaka 
Published: November 2020

Background: Klotho is a circulating anti-ageing hormone that predicts progression of cardiovascular and renal disease. The role of Klotho in diabetic retinopathy is unknown. Methods: We performed a single-centre observational study of 81 people (males 62%) with type 2 diabetes followed for a median of 44 months. Circulating levels of Klotho and other markers, were measured from stored samples. The primary outcome was progression of retinopathy defined as new onset retinopathy or step change in retinopathy grading. Results: During follow-up, 46 (57%) people reached the primary outcome. People with progression of retinopathy had lower levels of serum Klotho as compared to those without (median (interquartile range) 226.9 (171.1–394.0) vs 484.5 (221.8–709.9) pg/ml, p = 0.001). In multivariable logistic regression analyses, baseline Klotho level was the only variable independently associated with reduced risk of progression of retinopathy. Our results suggest that a halving of circulating Klotho levels increases the risk of retinopathy progression by 44%. Conclusion: In people with type 2 diabetes, lower circulating levels of the vascular protective hormone Klotho are associated with increased risk of progression of diabetic retinopathy. Klotho may be a novel biomarker and potential treatment target for diabetic eye disease.
The Changing Learning Technological Landscape for Trainers in the Wake of COVID-19
Authors: Hughes Claretha 
Published: November 2020

The Problem Due to the unexpected and rapid spread of COVID-19 throughout the world, training professionals are faced with three distinct problems: (1) lack of technological infrastructure; (2) the conflict between essential and non-essential workers; and (3) the ability to rapidly train workers to use new technology while working from home. Trainers are seeking to help workers and organizations use learning technologies to navigate the continuously changing workplace landscape in the midst of and after the COVID-19 pandemic. The Recommendation Forced expansion of learning technologies by trainers during COVID-19 provides an opportunity to expand worker development. Not only will trainers expand their knowledge of the use of technology, they will also become better proficient at selecting appropriate technology for employee development. Trainers should become better advocates for the use of technology by demonstrating their own expertise in using learning technologies; use their communication skills to teach workers about context and how to transition current skills into new jobs; and help workplace leaders better understand how technology and people can co-exist in the workplace. Stakeholders The stakeholders who can benefit from this article are trainers, workplace leaders, workers who are forced to work from home, essential workers who must go to work each day, displaced workers, furloughed workers, and laid off workers.
Not All Those Who Wander Are Lost: Critically Reflective Research for a New HRD Landscape
Authors: Crocco Oliver S. , Grenier Robin S. 
Published: November 2020

The Problem The pandemic and subsequent changes to norms and practices in the workplace mean that for many, existing meaning-making structures are challenged and the limits of existing ways of knowing are revealed. The problem for HRD scholars and practitioners is that dominant approaches to research are largely insufficient for understanding individuals’ meaning making in response to the pandemic. The Recommendation Two critically reflexive method/ologies are presented and overlaid with Constructive-Developmental Theory (CDT) to offer not only a means of capturing data about individuals’ experiences during/post-pandemic but for interpreting the data with an understanding of the mental complexities associated with capturing an emic perspective. The Stakeholders Stakeholders include HRD scholars and practitioners who conduct research in organizations.
Accuracy of the Upper Limb Prediction Algorithm PREP2 Applied 2 Weeks Poststroke: A Prospective Longitudinal Study
Authors: Lundquist Camilla Biering , Nielsen Jørgen Feldbæk , Arguissain Federico Gabriel , Brunner Iris Charlotte 
Published: November 2020

Background The Predict Recovery Potential algorithm (PREP2) was developed to predict upper limb (UL) function early after stroke. However, assessment in the acute phase is not always possible. Objective To assess the prognostic accuracy of the PREP2 when applied in a subacute neurorehabilitation setting. Methods This prospective longitudinal study included patients ≥18 years old with UL impairment following stroke. Patients were assessed in accordance with the PREP2 approach. However, 2 main components, the shoulder abduction finger extension (SAFE) score and motor-evoked potentials (MEPs) were obtained 2 weeks poststroke. UL function at 3 months was predicted in 1 of 4 categories and compared with the actual outcome at 3 months as assessed by the Action Research Arm Test. The prediction accuracy of the PREP2 was quantified using the correct classification rate (CCR). Results Ninety-one patients were included. Overall CCR of the PREP2 was 60% (95% CI 50%-71%). Within the 4 categories, CCR ranged from the lowest value at 33% (95% CI 4%-85%) for the category Limited to the highest value at 78% (95% CI 43%-95%) for the category Poor. In the present study, the overall CCR was significantly lower ( P < .001) than the 75% reported by the PREP2 developers. Conclusions The low overall CCR makes PREP2 obtained 2 weeks poststroke unsuited for clinical implementation. However, PREP2 may be used to predict either excellent UL function in already well-recovered patients or poor UL function in patients with persistent severe UL paresis.
Disregarded Measurement Uncertainty Contributions and Their Magnitude in Measuring Plasma Glucose
Authors: Petersmann Astrid , Macdonald Rainer , Nauck Matthias 
Published: November 2020

Background: Each measurement is subject to measurement uncertainty (MU). Consequently, each measurement of plasma glucose concentration used for diagnosis and monitoring of diabetes mellitus (DM) is affected. Although concepts and methods of MU are well established in many fields of science and technology, they are presently only incompletely implemented by medical laboratories, neglecting MU of target values of internal quality control (IQC) materials. Methods: An empirical and practical approach for the estimation of MU based on the analysis of routine IQC using control samples with assigned target values is presented. Its feasibility is demonstrated exemplarily by analyzing IQC data from one year obtained for glucose employing the hexokinase method with IQC of two different concentrations. Results: Combined relative extended ( k = 2) MU comprising bias, coefficient of variation (CV), and MU of the target values assigned to control materials were about 9% with a lower (~ 56 mg/dL; ~3.1 mmol/L) and 8% with a higher (~ 346 mg/dL; ~19.2 mmol/L) concentration sample, analyzing IQC of one year from three different devices. Conclusions: Estimation of MU in this study is quite reliable due to the large number of IQC data from one year. The MU of the target values of the commercial control material in this study was considerably larger than other MU contributions, ie, standard deviation and bias. In the future, the contribution of MU of commercial IQC should be addressed more carefully and technologies to measure glucose should be geared toward smaller MU possible, as needed, especially for glucose concentration measurements in diagnosis and management of DM.
Replay Simulations with Personalized Metabolic Model for Treatment Design and Evaluation in Type 1 Diabetes
Authors: Hughes Jonathan , Gautier Thibault , Colmegna Patricio , Fabris Chiara , Breton Marc D 
Published: November 2020

Background: The capacity to replay data collected in real life by people with type 1 diabetes mellitus (T1DM) would lead to individualized (vs population) assessment of treatment strategies to control blood glucose and possibly true personalization. Patek et al introduced such a technique, relying on regularized deconvolution of a population glucose homeostasis model to estimate a residual additive signal and reproduce the experimental data; therefore, allowing the subject-specific replay of what-if scenarios by altering the model inputs (eg, insulin). This early method was shown to have a limited domain of validity. We propose and test in silico a similar approach and extend the method applicability. Methods: A subject-specific model personalization of insulin sensitivity and meal-absorption parameters is performed. The University of Virginia (UVa)/Padova T1DM simulator is used to generate experimental scenarios and test the ability of the methodology to accurately reproduce changes in glucose concentration to alteration in meal and insulin inputs. Method performance is assessed by comparing true (UVa/Padova simulator) and replayed glucose traces, using the mean absolute relative difference (MARD) and the Clarke error grid analysis (CEGA). Results: Model personalization led to a 9.08 and 6.07 decrease in MARD over a prior published method of replaying altered insulin scenarios for basal and bolus changes, respectively. Replay simulations achieved high accuracy, with MARD <10% and more than 95% of readings falling in the CEGA A-B zones for a wide range of interventions. Conclusions: In silico studies demonstrate that the proposed method for replay simulation is numerically and clinically valid over broad changes in scenario inputs, indicating possible use in treatment optimization.
Cardiac complications in patients hospitalised with COVID-19
Authors: Linschoten Marijke , Peters Sanne , van Smeden Maarten , Jewbali Lucia S , Schaap Jeroen , Siebelink Hans-Marc , Smits Peter C , Tieleman Robert G , van der Harst Pim , van Gilst Wiek H , Asselbergs Folkert W ,   for the CAPACITY-COVID collaborative consortium
Published: November 2020

Aims:To determine the frequency and pattern of cardiac complications in patients hospitalised with coronavirus disease (COVID-19).Methods and results:CAPACITY-COVID is an international patient registry established to determine the role of cardiovascular disease in the COVID-19 pandemic. In this registry, data generated during routine clinical practice are collected in a standardised manner for patients with a (highly suspected) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection requiring hospitalisation. For the current analysis, consecutive patients with laboratory confirmed COVID-19 registered between 28 March and 3 July 2020 were included. Patients were followed for the occurrence of cardiac complications and pulmonary embolism from admission to discharge. In total, 3011 patients were included, of which 1890 (62.8%) were men. The median age was 67 years (interquartile range 56–76); 937 (31.0%) patients had a history of cardiac disease, with pre-existent coronary artery disease being most common (n=463, 15.4%). During hospitalisation, 595 (19.8%) patients died, including 16 patients (2.7%) with cardiac causes. Cardiac complications were diagnosed in 349 (11.6%) patients, with atrial fibrillation (n=142, 4.7%) being most common. The incidence of other cardiac complications was 1.8% for heart failure (n=55), 0.5% for acute coronary syndrome (n=15), 0.5% for ventricular arrhythmia (n=14), 0.1% for bacterial endocarditis (n=4) and myocarditis (n=3), respectively, and 0.03% for pericarditis (n=1). Pulmonary embolism was diagnosed in 198 (6.6%) patients.Conclusion:This large study among 3011 hospitalised patients with COVID-19 shows that the incidence of cardiac complications during hospital admission is low, despite a frequent history of cardiovascular disease. Long-term cardiac outcomes and the role of pre-existing cardiovascular disease in COVID-19 outcome warrants further investigation.