bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results
Authors: Gold Ralf , Arnold Douglas L , Bar-Or Amit , Fox Robert J , Kappos Ludwig , Mokliatchouk Oksana , Jiang Xiaotong , Lyons Jennifer , Kapadia Shivani , Miller Catherine 
Published: September 2021

Background: Dimethyl fumarate (DMF) demonstrated favorable benefit–risk in relapsing-remitting multiple sclerosis (RRMS) patients in phase-III DEFINE and CONFIRM trials, and ENDORSE extension. Objective: The main aim of this study is assessing DMF safety/efficacy up to 13 years in ENDORSE. Methods: Randomized patients received DMF 240 mg twice daily or placebo (PBO; Years 0–2), then DMF (Years 3–10; continuous DMF/DMF or PBO/DMF); maximum follow-up (combined studies), 13 years. Results: By January 2020, 1736 patients enrolled/dosed in ENDORSE (median follow-up 8.76 years (ENDORSE range: 0.04–10.98) in DEFINE/CONFIRM and ENDORSE); 52% treated in ENDORSE for ⩾6 years. Overall, 551 (32%) patients experienced serious adverse events (mostly multiple sclerosis (MS) relapse or fall; one progressive multifocal leukoencephalopathy); 243 (14%) discontinued treatment due to adverse events (4% gastrointestinal (GI) disorders). Rare opportunistic infections, malignancies, and serious herpes zoster occurred, irrespective of lymphocyte count. For DMF/DMF ( n = 501), overall annualized relapse rate (ARR) remained low (0.143 (95% confidence interval (CI), 0.120–0.169)), while for PBO/DMF ( n = 249), ARR decreased after initiating DMF and remained low throughout (ARR 0–2 years, 0.330 (95% CI, 0.266–0.408); overall ARR (ENDORSE, 0.151 (95% CI, 0.118–0.194)). Over 10 years, 72% DMF/DMF and 73% PBO/DMF had no 24-week confirmed disability worsening. Conclusion: Sustained DMF safety/efficacy was observed in patients followed up to 13 years, supporting DMF’s positive benefit/risk profile for long-term RRMS treatment.
Real-world executive functioning for autistic children in school and home settings
Authors: Tschida Jessica E , Yerys Benjamin E 
Published: September 2021

Executive function challenges are commonly reported in the home setting for children with an autism spectrum disorder diagnosis (hereafter, autism), but little is known about these challenges in the school setting. A total of 337 youth (autism, N = 241 and typically developing, N = 96) were assessed using Behavior Rating Inventory of Executive Function ratings from home and school settings. Within each setting, we examined differences in specific executive function skills between diagnostic groups. Then, we examined if the autism group showed similar peak executive function impairments, associations with age, and relationships with adaptive behavior across settings. Finally, we examined inter-rater reliability. Autism and typically developing groups differed on all Behavior Rating Inventory of Executive Function scales in both settings. The Shift scale was the peak impairment in the autism group in both settings. There was also an effect of age on executive function impairment in both settings, and executive function ratings in both settings significantly predicted individual adaptive behavior domains. Inter-rater correlations for autistic participants were similar to inter-rater reliability correlations from the Behavior Rating Inventory of Executive Function standardization sample. This study shows that autistic children experience similar but not identical real-world executive function challenges across school and home settings and that supports may vary by setting. Lay abstract Executive functioning skills are important for children to be able to control thoughts, emotions, and actions, and for their ability to adapt to different settings. Previous studies have found that autistic children have difficulty with executive functioning, but most of these studies took place in the home setting. Executive functioning skills in autistic children have not yet been fully examined in the school setting. This is a knowledge gap that needs to be addressed because the school setting is potentially one of the most demanding in terms of executive functioning and is a setting where executive function interventions are already being used for autistic children. In order to learn more about executive functioning for autistic children in the school setting, this study compared ratings of executive function from autistic children’s caregivers and school professionals. The study found that autistic children experience similar but not identical executive function challenges across school and home settings and that supports may differ in each setting. Having information about differences in executive functioning challenges and supports for autistic children across settings can help lead to development of supports that are tailored to each setting.
Severe equestrian injuries: A seven-year review of admissions to a UK major trauma centre
Authors: Gharooni Aref-Ali , Anwar Fahim , Ramdeep Romann , Mee Harry 
Published: September 2021

Background Equestrian sports are regaining popularity in the United Kingdom. Due to horses’ considerable weight and speed, serious injuries can occur. Riding style and equipment differ between North America and the United Kingdom with previous studies focusing on the former. Objective This study aims to assess the pattern of horse-related injury admissions to a major trauma centre in the United Kingdom. Methods A retrospective study of our hospital’s trauma registry between years 2012 and 2020 was performed. Cases included those admitted for severe horse-related injuries (irrespective of age/sex) with Injury Severity Score (ISS) of ≥ 4. Demographics, injury characteristics (ISS, Glasgow Coma Scale (GCS), injury region and operations), hospital stay and Glasgow Outcome Scale (GOS) on discharge were extracted. Four groups were formed based on mechanism of injury: fall from horse, fall and horse landing on top (FL group), kicked, and fall and kicked (FK group). Comparisons in injury and outcomes were analysed between these groups. Results 301 (2.8%) eligible cases were identified from 10,911 cases. 70.8% were female with mean (± SD) age of 42.7 (± 16.5) years. Most common mechanism of injury was fall (72.8%) then kicked (14.6%) with groups FL and FK forming < 10% each. No significant difference was found between the groups initial GCS, ISS, total or ICU length of stay and GOS ( p > 0.05). Most common regions of injury were orthopaedic (41.9%), spinal (26.2%), thoracic (20.1%) and head injuries (19.3%). 75% had good recovery on GOS though there were 3 fatalities relating to severe traumatic brain injury. Conclusion Orthopaedic limb injuries form the majority of horse-related injuries which contrasts the 1970s where head injury prevailed which is likely due to the widespread use of better head protection. Consideration should be given to enhanced limb safety equipment to prevent injury.
Accuracy of injury coding in a trauma registry
Authors: Isles Siobhan , McBride Paul , Sawyer Matt , Campbell Alaina , Speed Gordon , O’Leary Katrina , Evans Melisa , Rider Sonya , Gabbe Belinda 
Published: September 2021

Introduction Abbreviated Injury Scale has significant advantages over administrative coding systems for trauma analytics as it was developed specifically for injury, provides greater depth of characterisation of injury and has an integrated severity measure. It is used by trauma registries globally as it allows benchmarking between registries and is used to drive quality improvement. However, the consistency of scoring between individuals is not well understood. An audit was undertaken in six tertiary trauma centres in New Zealand to determine variation between AIS coders. Methods Each of six sites was audited by two experienced auditors. A random selection of case was identified in ISS categories 13–24, 25–44 and 45+. The case notes were pulled, and the auditors independently audited the notes,and then compared their results for a consensus result. The consensus result was then compared with the original coders. Results 111 cases were audited. Coding concordance was found in 31% of cases. Of the 69% of cases where discordant coding was observed, the discordance was attributed to incorrect coding (49%), missed injuries (43%) and other reasons (7%). Head and chest body regions were associated with the greatest number, and largest differences in coding scores. The overall mean difference across all cases was an ISS score of 1. Conclusions The overall accuracy of data held in the New Zealand Trauma Registry (NZTR) is suitable for quality improvement and benchmarking purposes, but more work is needed to improve the accuracy of individual cases, particularly those with head/neck and chest injury. Standardised tools to ensure the accuracy of data in a trauma registry is a gap which needs to be addressed to maintain confidence in a contemporary trauma system.
Usefulness and acceptability of an animation to raise awareness to grief experienced by carers of individuals with dementia
Authors: Scher Clara , Crawley Sophie , Cooper Claudia , Sampson Elizabeth L , Moore Kirsten J 
Published: September 2021

Aim Many carers of individuals with dementia experience high levels of grief before and after the death of the person with dementia. This study aimed to determine the usefulness, acceptability, and relevance of an animation developed to raise awareness to grief experienced by carers of people with dementia. Methods This research had a cross-sectional survey design. We contacted carers of people with dementia over the phone or email. Participants evaluated the animation through an online or paper-based survey. We used descriptive statistics and analysed qualitative data using thematic analysis. We required a sample of 40 carers to adequately power the study with a target of 75% of carers finding the animation useful, acceptable, and relevant. Results 31/78 carers approached evaluated the animation. Ninety-four percent of participants found the animation relevant to their situation, meeting our target. However, we fell short of this target for usefulness (68%) and acceptability (73%). The qualitative responses suggested that participants felt the animation could help improve the understanding of grief among carers, family, friends, and healthcare professionals. Carers also shared that the animation would be most useful for carers of newly diagnosed people with dementia. Conclusion Most carers of people with dementia in this study reported that the animation was useful, acceptable, and relevant. Dissemination of the resource may be useful for the majority of carers, with the caveat that a few carers may find it distressing and need to be referred for further support.
Total Knee Arthroplasty in Patients With Prior Ipsilateral Hip Fusion: A Surgical Technique
Authors: Encinas-Ullán Carlos A. , Gómez-Cardero Primitivo , Rodríguez-Merchán E. Carlos 
Published: September 2021

Background: In patients with severe osteoarthritis of the knee with prior ipsilateral hip fusion who require total knee arthroplasty (TKA), a controversial issue is whether to first convert the hip fusion to a total hip arthroplasty (THA) or to perform TKA without reconstruction of the hip. Also, immobility of the ipsilateral, fused hip adds significant technical challenge because the usual positioning of the leg requires modification in order to gain access needed for the TKA. Technique: In such cases, we position the patient with the knee suspended, similar to how we perform knee arthroscopy. In our experience, the ipsilateral knee has significant deformity and is best addressed with a constrained, hinged TKA. Results: In 3 patients with severe knee osteoarthritis with prior ipsilateral hip fusion—a 72-year-old man and a 79-year-old woman with hip arthrodesis due to posttraumatic arthritis and an 81-year-old woman with hip arthrodesis due to congenital dislocation of the hip—rotating-hinge knee prostheses were implanted due to severe knee instability. All 3 patients had satisfactory results, without complications, after follow-up of 1 to 5 years. Conclusions: We obtained satisfactory results in the short and medium term without previously converting the hip arthrodesis to THA by positioning patients with the knee suspended, in a way similar to when knee arthroscopy is performed, and implanting rotating hinge TKAs due to severe preoperative knee instability.
Programmed death-ligand 1 single nucleotide polymorphism affects breast cancer chemosensitivity and adverse events in the neoadjuvant setting
Authors: Lu* Jinglu , Wu* Ziping , Peng Jing , Xu Shuguang , Zhou Liheng , Lin Yanping , Wang Yan , Yin Wenjin , Lu Jinsong 
Published: September 2021

Objective We aimed to determine whether single nucleotide polymorphisms in the PD-L1 gene are related to the response and adverse events of patients receiving neoadjuvant therapy and to explore the mechanism. Methods Nine single nucleotide polymorphisms of PD-L1 were selected and tested among patients before neoadjuvant therapy. Four models were used in single nucleotide polymorphism genotype analysis: the addictive model compared TT vs TA vs AA; the dominant model compared TT vs TA+AA; the recessive model compared TT+TA vs AA; and the over-dominant model compared TT+AA vs TA (A as the minor allele). We analyzed the associations between single nucleotide polymorphism genotypes and pathological complete response, disease-free survival, and adverse events. Overexpression of the targeted microRNA was carried out using microRNA mimics. Logistic regression was used to analyze the associations between different single nucleotide polymorphism genotypes and pathological complete response outcome. Kaplan–Meier plots and log-rank tests were used to compare disease-free survival between groups with different single nucleotide polymorphism genotypes. The Cox proportional hazards model was used to calculate the adjusted hazard ratio. The Spearman's correlation test was used to determine the correlations between different genotypes and adverse events. Results rs4143815C>G was associated with better pathological complete response in the addictive and over-dominant models and with poorer disease-free survival in the recessive model. Patients with different genotypes had different adverse events. Overexpression of miR34c resulted in the downregulation of PD-L1 mRNA expression. Conclusion The PD-L1 single nucleotide polymorphism rs4143815 was associated with the pathological complete response rate, disease-free survival, and adverse events in breast cancer patients receiving neoadjuvant therapy. The interaction between miR34c and PD-L1 might be affected by rs4143815.
Postpartum stress and protective factors in women who gave birth in the United States during the COVID-19 pandemic
Authors: Mollard Elizabeth , Kupzyk Kevin , Moore Tiffany 
Published: September 2021

Objectives: The COVID-19 pandemic has caused considerable stress throughout the world. Little is known about how postpartum women who gave birth during the early months of the pandemic were impacted. The purpose of this study was to explore and describe the associations between potential risk, protective factors, and psychological distress among postpartum women who gave birth during the early months of the COVID-19 pandemic. Methods: Postpartum women over the age of 18 years who gave birth in the US hospitals between March and July of 2020 and spoke English completed a survey about their experiences. Demographic and health variables were measured via self-report. Stress was measured using the Perceived Stress Scale-10. Mastery was measured with the Pearlin Mastery Scale. Resilience was measured with the Connor–Davidson Resilience Scale-2. Results: This study included 885 women. Participants had higher stress and lower resilience relative to pre-pandemic norms. Participants had high levels of depression, anxiety, and stress. Women who had an infant admitted to the neonatal intensive care unit had more stress. Income, full-time employment, and partnered relationships were associated with lower stress. Resilience and mastery were related to lower stress, depression, and anxiety. Black, Indigenous, or People of Color women showed higher stress and lower resiliency. Single women were likely to report lower levels of mastery than partnered women. Conclusion: Stress, depression, and anxiety were high in postpartum women in this study. Income, partnered relationships, and employment security, along with protective traits such as mastery and resilience, may reduce the impact of stress on postpartum women in a pandemic. Care models should be modified to support women during a pandemic. Health disparities exist in postpartum stress. Future interventions should focus on building resiliency and mastery and ensuring appropriate resources are available to postpartum women in a pandemic.
Boothless Aided Audiometry: A Pilot Study
Authors: Chua Kenneth Wei De , Yuen Heng Wai , Kamath Savitha 
Published: September 2021

Background Although free-field aided audiometry is not the gold standard of hearing aid verification because of its many limitations, it is still circumstantially needed. The conventional method of sound-field aided audiometry requires a sound-proof booth. However, as clinicians face a high-volume of audiometric tests ordered daily at the otolaryngology clinic, a sound-proof booth may not be always available when needed. This study aims to explore if out-of-booth free-field aided audiometry can be just as reliable as the conventional method. Methods A pilot exploration of 10 patients (20 ears), with at least a moderate degree of bilateral symmetrical sensorineural hearing loss was conducted. Patients were recruited during their follow-up hearing aid appointments with their audiologist. All patients had been fitted with hearing aids for at least 6 months in duration, and their hearing aids were optimized. Results Out-of-booth aided audiometry for the main frequencies of interest was reliable with good correlation between the two methods at primary frequencies (500 Hz–4 KHz). However, results in the high frequencies were less reliable and needs to be interpreted cautiously. Conclusion Out-of-booth sound-field audiometry may be a quick and reliable method that can be used to fulfil its intended purpose with the added advantage of not needing an arguably expensive audiometric booth. However, not all frequencies of interest can be assessed with reliable measurements. Further larger studies are needed to validate the reliability of boothless sound-field audiometry to meet evolving healthcare needs.
Impact of Vitamin D Therapy on the Progress COVID-19: Six Weeks Follow-Up Study of Vitamin D Deficient Elderly Diabetes Patients
Authors: Soliman Amin R. , Abdelaziz Tarek Samy , Fathy Ahmed 
Published: September 2021

Background Coronavirus disease-19 (COVID-19) is an ongoing pandemic causing considerable fatalities worldwide. Vitamin D modulates the immune response through effects on various cells, such as: macrophages, B and T lymphocytes, neutrophils, and dendritic cells. Aim To explore whether supplementation of vitamin D, in the form of a single intramuscular cholecalciferol injection, to patients with diabetes, COVID-19, and low vitamin D levels could improve the prognosis of those patients. Methods This was a placebo-controlled randomized prospective study. The study has two arms as follows: the intervention arm (40 vitamin D deficient diabetes elderly patients that acquired SARS-CoV-2), compared to the control arm (16 elderly diabetes patients, with deficient vitamin D with SARS-CoV-2). Patients in the intervention arm were given vitamin D as a single intramuscular injection (200,000 IU); patients in the control arm were given placebo. The primary outcome was mortality within 6 weeks of the diagnosis of COVID-19. Clinical, laboratory, treatment, and outcome data were recorded after 6 weeks of follow-up. Results No significant difference in 6 weeks mortality was observed between patients who received vitamin D and patients who received placebo (17.5% vs 18.8%, p = 0.838). Age, presence of hypertension, and chronic obstructive pulmonary disease were independent predictors of mortality at 6 weeks. Conclusion Vitamin D supplementation did not reduce the severity or mortality of COVID-19 at 6 weeks. Further large scale studies are required to explore the effect of vitamin D therapy on survival in patients with diabetes mellitus who acquire COVID-19.
A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis
Authors: Christou Andri , Papastavrou Evridiki , Merkouris Anastasios , Charalambous Andreas 
Published: September 2021

Objectives: The clinical assessment of radioiodine-induced sialadenitis is relied on the observer-defined toxicity grading model. However, this model has significant limitations, the major one being the lack of systematic assessment based on objective criteria. The main aim of this study was the development and testing of an assessment tool which could examine the severity of post-irradiation sialadenitis. Methods: The development of the Sialadenitis Assessment Tool proceeded through three phases. The first and second phases included a literature review and the development of the tool which derived from the review, respectively. The third phase involved a pilot testing of the Assessment Tool to a sample of 34 patients undergoing I131 therapy. The assessment was carried out by two independent healthcare professionals, pre- and post-radioiodine therapy. The results of the assessment tool were compared with other scales, including the DIRIX and EORTC H&N35. Results: According to the Cohen’s kappa test, the Sialadenitis Assessment Tool is a reliable tool for the assessment of sialadenitis (Cohen’s κ = 1). The concurrent and internal validity tests showed a tendency of association with most variables (p < 0.001) in the DIRIX and EORTC QLQ-HN35 scales. Conclusion: Preliminary evidence show that Sialadenitis Assessment Tool is a valid and reliable tool to assess radioiodine-induced sialadenitis in patients undergoing I131 therapy post-thyroidectomy.