bluuebunny/crossref_metadata_2025_split huggingface dataset:
Restoration of elective spine surgery during the first wave of COVID-19
Authors: Mohammed Riaz , Shah Pranav , Durst Alexander , Mathai Naveen J. , Budu Alexandru , Woodfield Julie , Marjoram Tom , Sewell Matthew ,   The BASS Collaborative Study Group
Published: December 2021

Aims With resumption of elective spine surgery services in the UK following the first wave of the COVID-19 pandemic, we conducted a multicentre British Association of Spine Surgeons (BASS) collaborative study to examine the complications and deaths due to COVID-19 at the recovery phase of the pandemic. The aim was to analyze the safety of elective spinal surgery during the pandemic. Methods A prospective observational study was conducted from eight spinal centres for the first month of operating following restoration of elective spine surgery in each individual unit. Primary outcome measure was the 30-day postoperative COVID-19 infection rate. Secondary outcomes analyzed were the 30-day mortality rate, surgical adverse events, medical complications, and length of inpatient stay. Results In all, 257 patients (128 males) with a median age of 54 years (2 to 88) formed the study cohort. The mean number of procedures performed from each unit was 32 (16 to 101), with 118 procedures (46%) done as category three prioritization level. The majority of patients (87%) were low-medium “risk stratification” category and the mean length of hospital stay was 5.2 days. None of the patients were diagnosed with COVID-19 infection, nor was there any mortality related to COVID-19 during the 30-day follow-up period, with 25 patients (10%) having been tested for symptoms. Overall, 32 patients (12%) developed a total of 34 complications, with the majority (19/34) being grade 1 to 2 Clavien-Dindo classification of surgical complications. No patient required postoperative care in an intensive care setting for any unexpected complication. Conclusion This study shows that safe and effective planned spinal surgical services can be restored avoiding viral transmission, with diligent adherence to national guidelines and COVID-19-secure pathways tailored according to the resources of the individual spinal units. Cite this article: Bone Jt Open 2021;2(12):1096–1101.
Prevalence and predictive factors for bilateral carpal tunnel syndrome by electrodiagnosis: A retrospective study
Authors: Singjam Apiradee , Charoentanyarak Kanchana , Saengsuwan Jittima 
Published: December 2021

Introduction
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy. Patients who have unilateral symptoms are frequently found to have bilateral CTS by electrodiagnostic (EDx) study. We aimed to (a) study the prevalence and identify the predictive factors for bilateral CTS diagnosed by EDx; and (b) develop a model to predict bilateral CTS.

Methods
The retrospective clinical and EDx data of patients with CTS were collected and analyzed using the Chi-squared test and multiple logistic regression analysis. A model was fitted, and the best cutoff point determined. Calibration and discrimination performance of the model were performed.

Results
A total of 327 patients with a mean age of 50.0 years were enrolled. Most were women (82.6%), and the most common presenting symptom was hand numbness (93.6%). The median duration of symptoms was 60 days. The prevalence of bilateral CTS was 80.7%. In the multivariate analysis, the predictive factors for bilateral CTS were the presence of bilateral symptoms (AOR 6.7 [95%CI 3.1–14.3]), thenar muscle weakness (AOR 3.9 [95%CI 1.3–11.6]), and age ≥ 45 years (AOR 2.5 [95%CI 1.3–4.6]). The logistic regression model was fitted, and the best cutoff point determined. The area under the receiver operating curve (AUC) was 0.76. The respective optimism-corrected C index and Somers’ D was 0.762 and 0.524.

Conclusion
The prevalence of bilateral CTS was 80.7%. Our findings suggest bilateral CTS was predicted with adequate diagnostic accuracy by bilateral symptoms, age ≥ 45 years, and thenar muscle weakness.
The risks and benefits of providing HIV services during the COVID-19 pandemic
Authors: Stover John , Kelly Sherrie L. , Mudimu Edinah , Green Dylan , Smith Tyler , Taramusi Isaac , Bansi-Matharu Loveleen , Martin-Hughes Rowan , Phillips Andrew N. , Bershteyn Anna 
Published: December 2021

Introduction
The COVID-19 pandemic has caused widespread disruptions including to health services. In the early response to the pandemic many countries restricted population movements and some health services were suspended or limited. In late 2020 and early 2021 some countries re-imposed restrictions. Health authorities need to balance the potential harms of additional SARS-CoV-2 transmission due to contacts associated with health services against the benefits of those services, including fewer new HIV infections and deaths. This paper examines these trade-offs for select HIV services.

Methods
We used four HIV simulation models (Goals, HIV Synthesis, Optima HIV and EMOD) to estimate the benefits of continuing HIV services in terms of fewer new HIV infections and deaths. We used three COVID-19 transmission models (Covasim, Cooper/Smith and a simple contact model) to estimate the additional deaths due to SARS-CoV-2 transmission among health workers and clients. We examined four HIV services: voluntary medical male circumcision, HIV diagnostic testing, viral load testing and programs to prevent mother-to-child transmission. We compared COVID-19 deaths in 2020 and 2021 with HIV deaths occurring now and over the next 50 years discounted to present value. The models were applied to countries with a range of HIV and COVID-19 epidemics.

Results
Maintaining these HIV services could lead to additional COVID-19 deaths of 0.002 to 0.15 per 10,000 clients. HIV-related deaths averted are estimated to be much larger, 19–146 discounted deaths per 10,000 clients.

Discussion
While there is some additional short-term risk of SARS-CoV-2 transmission associated with providing HIV services, the risk of additional COVID-19 deaths is at least 100 times less than the HIV deaths averted by those services. Ministries of Health need to take into account many factors in deciding when and how to offer essential health services during the COVID-19 pandemic. This work shows that the benefits of continuing key HIV services are far larger than the risks of additional SARS-CoV-2 transmission.
A non-randomized clinical trial to examine patients’ experiences and communication during telemonitoring of pacemakers after five years follow-up
Authors: Catalan-Matamoros Daniel , Lopez-Villegas Antonio , Leal Costa Cesar , Bautista-Mesa Rafael , Robles-Musso Emilio , Rocamora Perez Patricia , Lopez-Liria Remedios 
Published: December 2021

Patients with pacemakers need regular follow-ups which are demanding. Telemonitoring for pacemaker can provide a new opportunity to avoid follow-up visits. On the other hand, in-person visits could help patients with pacemakers to cope better with the anxiety linked to their condition and maintain better communication with their doctors than simple remote control of their device status. Therefore, our objective was to analyze the experiences and communication comparing telemonitoring (TM) versus conventional monitoring (CM) of patients with pacemakers. A single-center, controlled, non-randomized, non-blinded clinical trial was designed. Data were collected five years after implantation in a cohort of 89 consecutive patients assigned to two different groups: TM and CM. The ‘Generic Short Patient Experiences Questionnaire’ (GS-PEQ) was used to assess patients’ experiences, and the Healthcare Communication Questionnaire (HCCQ) was used to measure the communication of patients with healthcare professionals. Additionally, an ad-hoc survey including items from the ‘Telehealth Patient Satisfaction Survey’ and a ‘costs survey’ was used. After five years, 55 patients completed the study (TM = 21; CM = 34). Participants’ mean (±SD) age was 81 (±6.47), and 31% were females. No differences in baseline characteristics between groups were found. The comparative analyses TM versus CM showed some significant differences. According to GS-PEQ, TM users received adequate information about their diagnosis or afflictions (p = .035) and the treatment was better adapted to their situation (p = .009). Both groups reported negative experiences regarding their involvement in their treatment decisions, the waiting time before admission, and perceived a low-benefit. According to HCCQ, the TM group experienced poorer consultation management by the healthcare provider (p = .041). Participants reported positive overall communication experiences. The study provides insights into the experiences and communication in PM monitoring services as well as specific areas where users reported negative experiences such as the consultation management by clinicians.
Trial registration: ClinicalTrials.gov NCT02234245.
Comparison of biosimilar Tigerase and Pulmozyme in long-term symptomatic therapy of patients with cystic fibrosis and severe pulmonary impairment (subgroup analysis of a Phase III randomized open-label clinical trial (NCT04468100))
Authors: Amelina Elena L. , Krasovsky Stanislav A. , Akhtyamova-Givirovskaya Nina E. , Kashirskaya Nataliya Yu. , Abdulganieva Diana I. , Asherova Irina K. , Zilber Ilya E. , Kozyreva Liliya S. , Kudelya Lubov M. , Ponomareva Natalya D. , Revel-Muroz Nataliya P. , Reutskaya Elena M. , Stepanenko Tatiana A. , Seitova Gulnara N. , Ukhanova Olga P. , Magnitskaya Olga V. , Kudlay Dmitry A. , Markova Oksana A. , Gapchenko Elena V. 
Published: December 2021

Background
Patients with cystic fibrosis (CF) need costly medical care and adequate therapy with expensive medicinal products. Tigerase® is the first biosimilar of dornase alfa, developed by the lead Russian biotechnology company GENERIUM. The aim of the manuscript to present post hoc sub-analysis of patients’ data with cystic fibrosis and severe pulmonary impairment of a larger comparative study (phase III open label, prospective, multi-centre, randomized study (NCT04468100)) of a generic version of recombinant human DNase Tigerase® to the only comparable drug, Pulmozyme®

Methods
In the analyses included subgroup of 46 severe pulmonary impairment patients with baseline FEV1 level 40–60% of predicted (23 patients in each treatment group) out of 100 patients registered in the study phase III open label, prospective, multi-center, randomized study (NCT04468100), and compared efficacy endpoints (FEV1, FVC, number and time of exacerbations, body weight, St.George’s Respiratory Questionnaire) as well as safety parameters (AEs, SAEs, anti-drug antibody) within 24 treatment weeks.

Results
All outcomes were comparable among the studied groups. In the efficacy dataset, the similar mean FEV1 and mean FVC changes for 24 weeks of both treatment groups were observed. The groups were also comparable in safety, all the secondary efficacy parameters and immunogenicity.

Conclusions
The findings from this study support the clinical Tigerase® biosimilarity to Pulmozyme® administered in CF patients with severe impairment of pulmonary function.
Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial
Authors: Stockbridge Melissa D. , Fridriksson Julius , Sen Souvik , Bonilha Leonardo , Hillis Argye E. 
Published: December 2021

In this forthcoming multicenter, prospective, randomized, double-blind placebo-controlled trial, we will investigate the augmentative effects of a selective serotonin reuptake inhibitor, escitalopram, on language therapy in individuals with post-stroke aphasia. We hypothesize that, when combined with language therapy, daily escitalopram will result in greater improvement than placebo in an untrained picture naming task (Philadelphia Naming Test short form) administered one week after the end of language therapy. We also will examine whether escitalopram’s effect on language is independent of its effect on depression, varies with lesion location, or is associated with increased functional connectivity within the left hemisphere. Finally, we will examine whether individuals with BDNF met alleles show reduced response to treatment and reduced changes in connectivity. We expect to enroll 88 participants over four years. Participants are given escitalopram or placebo within one week of their stroke for 90 days and receive fifteen 45-minute computer-delivered sessions of language treatment beginning 60 days from the start of drug therapy. Patients then complete a comprehensive assessment of language at one, five, and twenty weeks after the last language therapy session. ELISA is the first randomized, controlled trial evaluating the effect of a selective serotonin reuptake inhibitor on the improvement of language in people with aphasia undergoing language treatment during the acute to subacute post-stroke period.
Trial registration: The trial is registered with ClinicalTrials.gov NCT03843463.
Quantification of stroke volume in a simulated healthy volunteer model of traumatic haemorrhage; a comparison of two non-invasive monitoring devices using error grid analysis alongside traditional measures of agreement
Authors: Hutchings Sam D. , Watchorn Jim , McDonald Rory , Jeffreys Su , Bates Mark , Watts Sarah , Kirkman Emrys 
Published: December 2021

Introduction
Haemorrhage is a leading cause of death following traumatic injury and the early detection of hypovolaemia is critical to effective management. However, accurate assessment of circulating blood volume is challenging when using traditional vital signs such as blood pressure. We conducted a study to compare the stroke volume (SV) recorded using two devices, trans-thoracic electrical bioimpedance (TEB) and supra-sternal Doppler (SSD), against a reference standard using trans- thoracic echocardiography (TTE).

Methods
A lower body negative pressure (LBNP) model was used to simulate hypovolaemia and in half of the study sessions lower limb tourniquets were applied as these are common in military practice and can potentially affect some haemodynamic monitoring systems. In order to provide a clinically relevant comparison we constructed an error grid alongside more traditional measures of agreement.

Results
21 healthy volunteers aged 18–40 were enrolled and underwent 2 sessions of LBNP, with and without lower limb tourniquets. With respect to absolute SV values Bland Altman analysis showed significant bias in both non-tourniquet and tourniquet strands for TEB (-42.5 / -49.6 ml), rendering further analysis impossible. For SSD bias was minimal but percentage error was unacceptably high (35% / 48%). Degree of agreement for dynamic change in SV, assessed using 4 quadrant plots showed a seemingly acceptable concordance rate for both TEB (86% / 93%) and SSD (90% / 91%). However, when results were plotted on an error grid, constructed based on expert clinical opinion, a significant minority of measurement errors were identified that had potential to lead to moderate or severe patient harm.

Conclusion
Thoracic bioimpedance and suprasternal Doppler both demonstrated measurement errors that had the potential to lead to clinical harm and caution should be applied in interpreting the results in the detection of early hypovolaemia following traumatic injury.
The diagnostic accuracy and prognostic value of OCT for the evaluation of the visual function in children with a brain tumour: A systematic review
Authors: Nuijts Myrthe A. , Imhof Saskia M. , Veldhuis Nienke , Dekkers Coco C. , Schouten – van Meeteren Antoinette Y. N. , Stegeman Inge 
Published: December 2021

Purpose
To systematically review the evidence on the diagnostic accuracy and prognostic value of retinal optical coherence tomography (OCT) to detect visual acuity (VA) or visual field (VF) loss in children with a brain tumour.

Methods
PubMed, Embase and Cochrane Library databases were searched from inception to February 2021. We included studies evaluating retinal OCT and standard visual function parameters (VA and or VF) in children with a brain tumour. Two authors independently extracted data from each included study. They also assessed the methodological quality of the studies using the QUADAS-2 or QUIPS tool. The diagnostic accuracy of OCT was evaluated with receiver operating characteristic analysis, sensitivity, specificity, positive predictive value and negative predictive value. The prognostic value of OCT was evaluated with predictive measures (odds ratio).

Results
We included five diagnostic studies, with a total of 186 patients, all diagnosed with optic pathway glioma. No prognostic studies were eligible for inclusion. Included studies evaluated either retinal nerve fiber layer (RNFL) thickness or ganglion cell layer—inner plexiform layer (GCL-IPL) thickness. There was considerable heterogeneity between OCT devices, OCT protocols, visual function parameters and threshold values. Sensitivity and specificity for RNFL thickness measurement ranged from 60.0% to 100.0% and 76.6% to 100%, respectively. For GCL-IPL thickness measurement, area under the curve ranged from 0.91 to 0.98 for different diameters.

Conclusion
The literature regarding the diagnostic accuracy and prognostic value of OCT parameters in children with a brain tumour is scarce. Due to heterogeneity and a considerable risk of bias of included studies, we cannot draw solid conclusions regarding the accuracy of retinal OCT. Future research should investigate the potential of OCT as diagnostic and prognostic tool for the evaluation of the visual function and detection of visual impairment in children with any type of brain tumour.
Association between serum 25-hydroxyvitamin D and physical performance measures in middle-aged and old Japanese men and women: The Unzen study
Authors: Uchiyama Michiko , Mizukami Satoshi , Arima Kazuhiko , Nishimura Takayuki , Tomita Yoshihito , Abe Yasuyo , Tanaka Natsumi , Honda Yuzo , Goto Hisashi , Hasegawa Maiko , Sou Youko , Tsujimoto Ritsu , Kanagae Mitsuo , Osaki Makoto , Aoyagi Kiyoshi 
Published: December 2021

PurposeRegarding epidemiological studies, the role of vitamin D in musculoskeletal functionality (muscle weakness and physical performance) among elderly people is still controversial. The purpose of the present study was to investigate the associations between 25-hydroxyvitamin D [25(OH)D] and physical performance among community-dwelling middle-aged and old Japanese men and women.MethodsThe subjects were community-dwelling 297 men and 415 women aged 50 years and over. Data on height (m) and weight (kg) were collected. Serum 25(OH)D, parathyroid hormone, calcium, and albumin levels were measured. Serum 25(OH)D was classified into deficiency group: < 20 ng/mL, insufficiency group: 20–30 ng/mL, and sufficiency group: ≧ 30 ng/mL. Physical performance was assessed by grip strength, chair stand time, and functional reach. Information on current smoking, alcohol drinking, regular exercise, any comorbidities (hypertension, heart disease, diabetes mellitus, lung disease, and stroke), and pain (lumbar and knee) was collected.ResultsVitamin D deficiency and insufficiency based on serum 25(OH)D levels were observed in 15.2% and 56.9% of men and 52.0% and 43.6% of women, respectively. In men, higher serum 25(OH)D levels were associated with better grip strength (p for trend = 0.003), chair stand time (p for trend = 0.042), and functional reach (p for trend <0.001). On the other hand, these parameters were not associated with serum 25(OH)D levels in women.ConclusionA higher level of serum 25(OH)D was associated with better physical performance in men but not in women.
Examination of validity, reliability, and interpretability of a self-reported questionnaire on Occupational Balance in Informal Caregivers (OBI-Care) – A Rasch analysis
Authors: Röschel Anna , Wagner Christina , Dür Mona 
Published: December 2021

Objectives
Informal caregivers often experience a restriction in occupational balance. The self-reported questionnaire on Occupational Balance in Informal Caregivers (OBI-Care) is a measurement instrument to assess occupational balance in informal caregivers. Measurement properties of the German version of the OBI-Care had previously been assessed in parents of preterm infants exclusively. Thus, the aim of this study was to examine the measurement properties of the questionnaire in a mixed population of informal caregivers.

Methods
A psychometric study was conducted, applying a multicenter cross-sectional design. Measurement properties (construct validity, internal consistency, and interpretability) of each subscale of the German version of the OBI-Care were examined. Construct validity was explored by assessing dimensionality, item fit and overall fit to the Rasch model, and threshold ordering. Internal consistency was examined with inter-item correlations, item-total correlations, Cronbach’s alpha, and person separation index. Interpretability was assessed by inspecting floor and ceiling effects.

Results
A total of 196 informal caregivers, 171 (87.2%) female and 25 (12.8%) male participated in this study. Mean age of participants was 52.27 (±12.6) years. Subscale 1 was multidimensional, subscale 2 and subscale 3 were unidimensional. All items demonstrated item fit and overall fit to the Rasch model and displayed ordered thresholds. Cronbach’s Alpha and person separation index values were excellent for each subscale. There was no evidence of ceiling or floor effects.

Conclusions
We identified satisfying construct validity, internal consistency, and interpretability. Thus, the findings of this study support the application of the German version of the OBI-Care to assess occupational balance in informal caregivers.
Possible relationship between esophageal dilatation and severity of M. abscessus pulmonary disease
Authors: Hara Hiromichi , Okuda Keitaro , Araya Jun , Utsumi Hirofumi , Takekoshi Daisuke , Ito Saburo , Wakui Hiroshi , Minagawa Shunsuke , Numata Takanori , Kuwano Kazuyoshi 
Published: December 2021

ObjectivesRecently, incidence ofMycobacterium abscessus (Mab)pulmonary disease (Mab-PD) is increasing worldwide. We aimed to identify factors associated with severity ofMycobacterium abscessus (Mab)pulmonary disease (Mab-PD).MethodsAll patients diagnosed as Mab-PD based on the official ATS/IDSA statement between 2017 January 1 and 2021 July 31 were included (n = 13). We reviewed medical records, bacteriological and laboratory data of the patients. Severity of lung lesions and esophageal diameters in chest CT were quantitatively evaluated. Gaffky score in the sputum was used as airway mycobacterial burden. We explored the factors associated with high CT score and high Gaffky score.ResultsMaximum diameter of esophagus (MDE) in severe disease (CT score≧10) was greater than that in milder disease (CT score<10) (18.0±7.9mm, 9.3±3.1mm, respectively, p = 0.01), and MDE was well correlated with CT score (R = 0.69, p = 0.007). MDE in high mycobacterial burden group (Gaffky score ≧5) tended to be greater than that in low mycobacterial burden group (Gaffky score <5) (16.1±6.8mm, 10.1±5.5mm, respectively, p = 0.12), and MDE was well correlated with Gaffky score (R = 0.68, p = 0.009). Lung lesions were bilateral and predominant in middle or lower lobes.ConclusionsEsophageal dilatation was correlated with severity ofMab-PD and airway mycobacterial burden. Gastroesophageal reflux might be associated withMabdisease progression.