bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient accrual and understanding of informed consent in a two-stage consent design
Authors: Vickers Andrew J , Vertosick Emily A , Carlsson Sigrid V , Ehdaie Behfar , Kim Scott Y H 
Published: February 2021

Background: We previously introduced the concept of “two-stage” (or “just-in-time”) informed consent for randomized trials with usual care control. We argued that conducting consent in two stages—splitting information about research procedures from information about the experimental intervention—would reduce the decisional anxiety, confusion, and information overload commonly associated with informed consent. We implemented two-stage consent in a low-stakes randomized trial of a mindfulness meditation intervention for procedural distress in patients undergoing prostate biopsy. Here, we report accrual rates and patient understanding of the consent process. Methods: Patients approached for consent for the biopsy trial were asked to complete the standard “Quality of Informed Consent” questionnaire to assess their knowledge and understanding of the trial. Results: Accrual was excellent with 108 of 110 (98%) patients approached for consent signing first-stage consent. All 51 patients randomized to the experimental arm and who later presented for biopsy signed second-stage consent and received the mindfulness intervention. Quality of Informed Consent data were available for 48 patients assigned to the mindfulness treatment arm and 44 controls. The mean Quality of Informed Consent score was similar in the meditation and control arms with and overall mean of 75 (95% confidence interval = 74–76) for the knowledge section and 86 (95% confidence interval = 81–90) for understanding, comparable to the normative scores of 80 and 88. On further analysis and patient interview, two of the Quality of Informed Consent questions were found to be misleading in the context of a two-stage consent study for a mindfulness intervention. Excluding these questions increased knowledge scores to 88 (95% confidence interval = 87–90). Conclusion: We found promising data that two-stage consent facilitated accrual without compromising patient understanding of randomized trials or compliance with allocated treatment. Further research is needed incorporating randomized comparison of two-stage consent to standard consent approaches, measuring patient anxiety and distress as an outcome, using suitable modifications to the Quality of Informed Consent questionnaire and trials with higher stakes.
Soft tissue abnormalities in Wassel Type VI radial polydactyly: a detailed anatomical study
Authors: Saito Susumu , Tsuge Itaru , Yamanaka Hiroki , Morimoto Naoki 
Published: February 2021

Wassel VI radial polydactyly is associated with metacarpal adduction and radial deviation of the metacarpophalangeal joint of the ulnar duplicate. The soft tissue abnormalities responsible for these deformities were characterized using preoperative multi-planar three-dimensional ultrasound and intraoperative observation in four patients. In all patients, the abductor pollicis brevis and superficial head of the flexor pollicis brevis inserted into the radial first metacarpal, whereas the adductor pollicis and deep head of the flexor pollicis brevis inserted into the ulnar thumb. Aberrant location of the flexor pollicis longus and absence of the A1 pulley system was associated with severe radial deviation. An additional superficial thenar muscle along the ulnar metacarpal was associated with minimal metacarpal adduction. Uneven forces on the ulnar duplicate could be associated with these characteristic deformities and joint instability. Knowledge of these abnormalities allows better planning of surgery and further insight into this rare radial polydactyly configuration. Level of evidence: II
Description of an integrated e-health monitoring system in a Portuguese higher education institution: the e.cuidHaMUstm program
Authors: Brandão Maria Piedade , Sa-Couto Pedro , Gomes Gonçalo , Beça Pedro 
Published: February 2021

Background: The World Health Organization and the International Labour Organization recognize that workplace health is not only affected by occupational hazards, but is mainly affected by social determinants and individual factors. An accelerated rise in noncommunicable diseases has fostered the importance of creating supportive environments and encouraging healthy behaviours. Therefore, an operational approach to making workplaces healthy and sustainable is needed. This paper describes the development of an e-Health monitoring program entitled ‘Integrated eHealth Monitoring System for Health Management in Universities’ (e.cuidHaMUsTM) as a possible solution to that operational approach. Methods: We developed the program e.cuidHaMUsTM that proposes to detect risk behaviours related to noncommunicable diseases and to implement problem-solving measures by establishing a health-promoting workspace in a Portuguese higher education institution. Based on the ‘I-Change’ conceptual model, our program provides personalized feedback; improves health-related knowledge, attitude and good practices; and encourages actions to promote healthy lifestyles through individual health capacitation. Focusing on evaluation as an activity that generates knowledge, the e.cuidHaMUsTM program aggregates all the relevant health information, shares the results with decision-makers and evaluates health-related policy changes in the workplace. Discussion: This paper presents the design of the e.cuidHaMUsTM program, the development of an eHealth web platform to share information between the different stakeholders, and a questionnaire to evaluate the health status of higher education institution workers (e.cuidHaMUs.QueST®). Also, the procedures for data collection and analysis are outlined. The e.cuidHaMUsTM program can enhance health surveillance through cross-sectional and longitudinal studies and provide scientific evidence to support the envisioned interventions and promotions of healthy lifestyles. This program is an effort to incorporate a holistic culture of health-promoting workspace in higher education institution policies.
Risk Factors for Plantar Fasciitis in Physically Active Individuals: A Systematic Review and Meta-analysis
Authors: Hamstra-Wright Karrie L. , Huxel Bliven Kellie C. , Bay R. Curtis , Aydemir Burcu 
Published: February 2021

Context: Plantar fasciitis (PF) is a common condition in active individuals. The lack of agreement on PF etiology makes treatment challenging and highlights the importance of understanding risk factors for preventive efforts. Objective: The purpose of this systematic review and meta-analysis was to determine what factors may put physically active individuals at risk of developing PF. Data Sources: CENTRAL, CINAHL, EMBASE, Gray Lit, LILACS, MEDLINE (PubMed), ProQuest, Scopus, SPORTDiscus, and Web of Science were searched through April 2018 and updated in April 2020. Study Selection: Studies were included if they were original research investigating PF risk factors, compared physically active individuals with and without PF, were written in English, and were accessible as full-length, peer-reviewed articles. Study Design: Systematic review and meta-analysis. Level of Evidence: Level 3, because of inconsistent definitions and blinding used in the included observational studies. Data Extraction: Data on sample characteristics, study design and duration, groups, PF diagnosis, and risk factors were extracted. The methodological quality of the studies was assessed using the Strengthening the Reporting of Observational Studies in Epidemiology statement. When means and standard deviations of a particular risk factor were presented 2 or more times, that risk factor was included in the meta-analysis. Results: Sixteen studies were included in the systematic review and 11 risk factors in the meta-analysis. Increased plantarflexion range of motion (weighted mean difference [MD] = 7.04°; 95% CI, 5.88-8.19; P < 0.001), body mass index (MD = 2.13 kg/m2; 95% CI, 1.40-2.86; P < 0.001; I2 = 0.00%), and body mass (MD = 4.52 kg; 95% CI, 0.55-8.49; P = 0.026) were risk factors for PF. Conclusion: Interventions focused on addressing a greater degree of plantarflexion range of motion, body mass index, and body mass and their load on the force-absorbing plantar surface structures may be a good starting point in the prevention and treatment of active individuals with PF.
Patterns of Admission and Clinical Outcomes Among Patients Admitted to Medical Intensive Care Unit of a Teaching and Referral Hospital, Northwest Ethiopia
Authors: Tesema Hailemariam Getachew , Lema Girmay Fitiwi , Mesfin Nebiyu , Fentie Demeke Yilkal , Arefayne Nurhusen Riskey 
Published: February 2021

Background The intensive care unit (ICU) is a health care delivery service for patients who are in critical condition with potentially recoverable diseases. Patients can benefit from more detailed observation, monitoring and advanced treatment than other wards or department. The care is advancing but in resource-limited settings, it is lagging far behind and mortality is still higher due to various reasons. Therefore, we aimed to determine the admission patterns, clinical outcomes and associated factors among patients admitted medical intensive care unit (MICU). Methods A retrospective cross-sectional study was conducted based on a record review of logbook and charts of patients admitted from September, 2015 to April, 2019. Data were entered and analysed using SPSS version 20. Both bivariate and multivariate logistic regression analyses were used and a P-value < 0.05 was considered statistically significant. Results A total of 738 patients were admitted to medical intensive care unit (MICU) during September, 2015 - April, 2019. Five hundred and four patients (68%) of all intensive care unit (ICU) admissions had complete data. Out of the 504 patients, 268 (53.2%) patients were females. Cardiovascular disease 182(36.1%) was the commonest categorical admission diagnosis. The overall mortality rate was 38.7%. In the multivariate analysis, mortality was associated with need for mechanical ventilation (AOR = 5.87, 95% CI: 3.24 - 10.65) and abnormal mental status at admission (AOR = 2.8, 95% CI: 1.83-4.29). Patients who had stay less than four days in MICU were 5 times more likely to die than those who has stay longer time (AOR= 5.58, 95% CI: 3.58- 8.69). Conclusions The overall mortality was considerably high and cardiovascular diseases were the most common cause of admission in MICU. Need for mechanical ventilator, length of intensive care unit stay and mental status at admission were strongly associated with clinical outcome of patients admitted to medical intensive care unit.
Trans-Tubular Translaminar Microscopic-Assisted Nucleotomy for Lumbar Disc Herniations in the Hidden Zone
Authors: Abdelrahman Hamdan , Seyed-Emadaldin Sadat , Krajnovic Branko , Ezzati Ali , Abdelgawaad Ahmed Shawky 
Published: February 2021

Study Design: A prospective cohort study in a high-flow spine center in Germany. Objectives: This study aimed to evaluate clinical outcomes and complications of the trans-tubular translaminar microscopic-assisted percutaneous nucleotomy in cases of cranially migrated lumbar disc herniations (LDH). Methods: Between January 2013 and January 2018, 66 consecutive patients with cranio-laterally migrated LDH were operated upon. The following outcome measures were evaluated: (1) Visual Analog Scale (VAS) for leg and back pain; (2) Oswestry Disability Index (ODI) and Macnab´s criteria. All patients were operated upon with trans-tubular Translaminar Microscopic-assisted Percutaneous Nucleotomy (TL-MAPN). Perioperative radiographic and clinical evaluations were reported. The mean follow-up period was 32 months. Results: The mean age was 59 years. L4/L5 was the commonest affected level (27 patients). The mean preoperative VAS for leg pain was 6.44 (±2.06), improved to 0,35 (±0.59) postoperatively. Dural injury occurred in 1 patient, treated with dural patch. Improved neurological function was reported in 41/44 Patients (neurological improvement rate of 93%) at the final follow up. There was a significant improvement in the mean ODI values, from 50.19 ± 4.92 preoperatively to 10.14 ± 2.22 postoperatively (P < 0.001). Sixty four out of 66 patients (96%) showed an excellent or good functional outcome according to Macnab´s criteria. No recurrent herniations were observed. Conclusion: The translaminar approach is a viable minimal invasive technique for cranially migrated LDH. The preservation of the flavum ligament is one of the main advantages of this technique. It is an effective, safe and reproducible minimally invasive surgical alternative in treatment of cranially migrated LDHs.
Does Instrumentation of the Fractured Level in Thoracolumbar Fixation Affect the Functional and Radiological Outcome?
Authors: Mohammed Riaz , Carrasco Roberto , Verma Rajat , Siddique Irfan , Mohammad Saeed , Elmalky Mahmoud 
Published: February 2021

Study Design: Retrospective comparative study. Objectives: To compare radiological and functional outcomes of patients with fixation constructs utilizing pedicle screw stabilization at the fracture level (FL group) versus patients with non-fracture level (NFL group) fixation in single level fractures of the thoracolumbar junction (T11-L1). Methods: 53 patients of whom fracture level screw was used in 34 (FL group) were compared to 19 patients in NFL group. Radiological parameters analyzed were sagittal index, bi-segmental kyphosis (Cobb) angle and degree of vertebral height restoration. Prospectively collected patient reported functional outcomes and post-operative complications were also studied. Stepwise regression analysis adjusted by age, gender and functional scores was performed to account for the small numbers and unequal sizes of the groups. Results: Back pain score was significantly lower in the FL group ( P < 0.025). Core Outcome Measures Index scores and leg pain scores, though low in the FL group, were not statistically significant. The regression analysis showed that the inclusion of the fracture-level screw was independently associated with a greater change in sagittal index and vertebral height restoration post-operatively. Sagittal index was maintained through to final follow up as well. The bi-segmental Cobb’s angle correction was not associated with fracture-level screw construct. There was no significant difference between the groups for revision surgery, deep infection, implant failure or length of hospital stay. Conclusion: The inclusion of the fracture-level pedicle screws in the fixation construct significantly improves the immediate and final measured radiological parameters, with improved functional scores in single level unstable vertebral fractures of the thoracolumbar junction.
Toxicity assessment of gold ions and gold nanoparticles to golden perch larvae (Macquaria ambigua)
Authors: Shuster Jeremiah , Rea Maria A.D. , Nidumolu Bhanu , Kumar Anupama 
Published: February 2021

AbstractGolden perch (Macquaria ambigua) is a freshwater game-fish native to central and southeast Australia. Larvae of this fish species were used in two different types of experiments to evaluate the effects of short-term exposures (up to 6 days) to aqueous gold, 5 nm gold nanoparticles (AuNPs), or 50 nm AuNPs. Relative to the control, increased gold concentrations corresponded with yolk-sac edema (swelling). Larvae exposed to 50 μM of 5 nm AuNPs had yolk-sacs that were ~1.5 times larger resulting in the appearance of bent notochords. After two days of exposure, 100% mortality was observed. Total mortalities were <25% in the other larvae–gold systems, suggesting that these larvae can quickly adapt to the presence of gold. In terms of an oxidative stress response, the larvae from all systems did not express high enzymatic activity. The state of the gold determined how much could be taken up (or immobilised) by a larva. Aqueous gold and 5 nm AuNPs easily pass through cells; therefore, larvae exposed to these forms of gold contained the highest concentrations. Scanning electron microscopy confirmed that cells comprising the epithelium and fins contained AuNPs. Aqueous gold was reduced to nanometre-scale particles within cells. Comparatively, 5 nm AuNPs appeared to be aggregated within cells forming clusters hundreds of nanometres in size. On the contrary, 50 nm AuNPs were not observed within cells but were detected within larvae by (single particle) inductively coupled plasma mass spectroscopy, suggesting that these AuNPs were probably taken up through the mouth or gills. The results of the present study demonstrate that exposure to AuNPs had adverse effects on developing golden perch larvae. Additionally, these effects were dependent on the size of the AuNPs.
Thrombotic Complications in COVID-19 Patients: Low Incidence of Thrombotic Complications Among Critically Ill COVID-19 Patients in Singapore
Authors: Lim Cheryl XQ , Tan Chuen Wen , Fan Bingwen Eugene , Teo Winnie , Tung Moon Ley , Shafi Humaira , Christopher Dheepa , Zheng Shuwei , Peh Wee Ming , Chan Stephrene , Chong Vanessa CL , Gallardo Christian Aledia , Chang Cheng Chieh Ray , Ling Li Min , Tan Jing Yuan , Lee Ken Cheah Hooi , Phua Ghee Chee , Cherng Benjamin , Low Jenny Guek-Hong , Ho Vui Kian , Prasad Vishnu , Wong Lester Jung Long , Chee Yen-Lin , Ong Kiat Hoe , Lee Lai Heng , Ng Heng Joo , Yap Eng Soo 
Published: February 2021

Objective
Arterial and venous thrombosis are reported to be common in critically ill COVID-19 patients.
This study aims to describe the thrombotic and bleeding rates in COVID-19 patients admitted to intensive care units (ICU) in Singapore.
Design
Retrospective observational study involving all consecutive adult COVID-19 patients who required ICU admission between 23 January 2020 and 30 April 2020.
Setting
National multicenter study involving all eight public hospitals in Singapore.
Patients
111 consecutive COVID-19 patients who required ICU admission were included.
Measurements and Main Results
Primary outcome was any venous or arterial thrombotic events occurred in ICU. Other measures included (1) the overall, venous and arterial thrombotic events throughout the hospitalisation, (2) major and minor bleeding events. The overall thrombotic rate in ICU was 11.7% (n=13), with 1.8% (n=2) venous and 9.9% (n=11) arterial events. The overall thrombotic rates throughout hospitalisation, censored at 30 April 2020, increased to 18.0% (n=20) with 6.3% (n=7) venous and 11.7% (n=13) arterial events. Major and minor bleeding rates were 14.8% (n=16) and 3.7% (n=4), respectively. Two-third of the patients received pharmacological thromboprophylaxis in ICU.
Conclusions
Critically ill COVID-19 patients in Singapore have lower VTE but higher arterial thrombosis rates with higher bleeding manifestations than other reported cohorts. Standard thromboprophylaxis may be sufficient to prevent thrombotic complications in patients with similar demographics.

Disclosures
No relevant conflicts of interest to declare.
Clonal Architecture Analysis of TET2 Identified Distinct Origins in Myelodysplastic Syndromes
Authors: Shi Zhongxun , Li Bing , Qin Tiejun , Xu Zefeng , Pan Lijuan , Qu Shiqiang , Huang Gang , Xiao Zhijian 
Published: February 2021

Next-generation sequencing (NGS) has deepened our understanding of myelodysplastic syndromes (MDS). Genetic mutations of TET2 were common in MDS and were also detected in asymptomatic elder persons, which were defined as aged related clonal haematopoiesis (ARCH) and considered as a myelodysplastic syndrome precursor state. In this study, we analyzed the mutation profiles of TET2 in 770 newly-diagnosed MDS subjects. 73 mutations were found in 67 of 770(8.7%) subjects. 14.9% were frame shifts, 29.9% were nonsense, 44.8% were missense and 10.7% harbored 2 TET2 mutations. TET2MT subjects were older than TET2WT subjects (P=0.024) and the variant allele frequency (VAF) of TET2 was positively correlated with age (r=0.318, P=0.009). Clonal architecture was determined using a copy number-adjusted VAF difference between 2 mutation events in 49 TET2MT subjects with 2 or more mutations. 19 (38.3%) were TET2ancestral and 30(61.2%) were TET2subclonal. TET2ancestral subjects were significantly older than TET2WT subjects (P=0.013) while no difference was found between TET2subclonal subjects and TET2WT subjects (P=0.509). The frequency of cytosine-to-thymine (C→T) transition was significantly higher in TET2ancestralsubjects compared with TET2subclonal subjects (P=0.029), which was considered to be a somatic mutational signature of aging, indicating that MDS driven by TET2ancestral was likely derived from TET2MT ARCH. The most common upstream mutations in TET2subclonal subjects were U2AF1 (16.7%) and ASXL1 (13.3%), and the most common downstream mutations in TET2ancestral subjects were ASXL1 (21.1%) and RUNX1 (15.8%). TET2 mutations rarely existed alone in TET2ancestral subjects (14.3%) and were always accompanied by another mutations like U2AF1, SF3B1 and ASXL1, suggesting that the acquisition of another mutation led to the progress of ARCH to MDS in TET2ancestral subjects. TET2MT had no impact on survivals in overall cohort (P=0.218) while predicted poorer survivals in IPSS-R lower risk group (P=0.004). Additional ASXL1, U2AF1 and RUNX1 mutations in TET2MT subjects indicated poorer prognosis compared with TET2WT subjects (P=0.005; P=0.04; P&lt;0.001) .There was no significant difference in OS of TET2MT subjects with different clonal architecture (P=0.76). Subjects with TET2 VAF≥30% had poorer survivals compared with TET2WT subjects (P=0.057). In conclusion, TET2MT MDS subjects with different clonal architectures may have different origins. TET2ancestral subjects may be derived from ARCH and progressed to MDS after secondary hits. The effects of TET2 mutation on the prognosis depended on the accompanying mutations and clonal burdens.

Disclosures
No relevant conflicts of interest to declare.
An Immune Score Model of the Bone Marrow Micro-Environment Predicts Survival in Chronic Lymphocytic Leukaemia
Authors: Liang Yang , Huang Han-ying , Wang Yun , Wang Weida , Lin Huan-xin 
Published: February 2021

Background: Most prognostic and predictive models for survival of persons with chronic lymphocytic leukaemia (CLL) are based on clinical and laboratory co-variates and have AUCs of 0.65 to 0.74 indicating considerable inaccuracy. No current prognostic model uses data on immune state of the bone marrow micro-environment to predict survival.
Methods: We downloaded relevant data from International Cancer Genome Consortium (CLL-ES; N = 485) and Gene Expression Omnibus (GSE22762; N = 195) with survival data. We used a LASSO Cox regression model to build a survival prediction model based on the expression of immune-related genes in the bone marrow micro-environment. Immune cells corresponding to these immune genes were deduced Using CIBERSORT and compared in cohorts with different survival probabilities.
Results: An immune signature based on 9 immune-related genes were constructed in the training cohort (CLL-ES) and tested in a validation cohort (GSE22762). The AUCs of 1, 3 and 5 -year survivals were 0.83 [95% Confidence Interval, 0.63, 0.97], 0.79 [0.67, 0.89] and 0.82 [0.73, 0.90] in training and 0.66 [0.55, 0.79], 0.60 [0.50, 0.69] and 0.66 [0.58, 0.76]in the validation cohort. Subjects in the high-risk cohort identified by immune signature had significantly worse 5-year survival compared with those in low-risk cohort group (training cohort: 91% [87, 95%] vs. 99% [98, 100%], P &lt;0.001; validation cohort: 61% [50, 71%] vs 81% [80, 82%], P = 0.003). Subjects with a low-risk immune signature had a higher proportion of CD4-postive T-cells, activated NK-cells compared with those in the high-risk cohort (p &lt; 0.05).
Conclusion: The immune score model of the bone marrow micro-environment we developed accurately predicts survival of persons with CLL. These data suggest a role for immune cells in the bone marrow micro-environment on survival. The immune score we describe can be combined with other prediction models to improve accuracy.
Keywords
ICGC, GEO, chronic lymphocytic leukemia, immunity, prognostic model

Disclosures
No relevant conflicts of interest to declare.