bluuebunny/crossref_metadata_2025_split huggingface dataset:
Twelve-month efficacy of CGRP monoclonal antibodies and predictive value of short-term response: results of an Australian multicentre study
Authors: Ray Jason Charles , Dalic Linda , Baker Josephine , Cheng Shuli , Hutton Elspeth Jane , Matharu Manjit 
Published: January 2024

IntroductionClinical trials show that calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are effective preventative treatments for chronic migraine. Their efficacy over longer time periods and in cohorts originally excluded from trials remains uncertain. This study aims to explore the impact of CGRP mAbs in an Australian real-life setting.MethodsA multicentre cohort study was performed in the tertiary headache clinics of the Alfred and Austin Hospitals, Melbourne, Australia. Patients were commenced on a CGRP mAb for chronic migraine and asked to keep a headache diary, recorded at 3 monthly appointments for 12 months. Primary outcome was a ≥50% reduction in monthly headache days (MHD).ResultsFrom a population of 105 patients, 90 patients commenced galcanezumab and 15 commenced fremanezumab. The ≥50% responder rate of the cohort was 52.4% after 3 months. Over 12 months follow-up, 25.7% of the cohort ceased due to a lack of efficacy and 16.2% ceased due to an adverse event. There was no difference in response or cessation between medications. There was poor agreement in 3-month and 12-month response rates (Cohen’s κ=0.130; p=0.171). On subgroup analysis, continuous headache at baseline and number of trialled preventative treatments were the only factors associated with efficacy.ConclusionCGRP mAbs were associated with sustained reductions in MHD over 12-month follow-up in patients with resistant migraine in Australia. Further studies are required to determine treatment options for patients with continuous headache. Poor agreement between outcomes at 3 and 12 months highlights the need to assess some patients at later timepoints.
Detecting signatures of consciousness in acute brain injury after stimulation with apomorphine and methylphenidate: protocol for a placebo-controlled, randomized, cross-over study
Authors: Othman Marwan H , Møller Kirsten , Kjaergaard Jesper , Kondziella Daniel 
Published: January 2024

IntroductionAcute brain injury can lead to states of decreased consciousness, that is, disorder of consciousness (DoC). Detecting signs of consciousness early is vital for DoC management in the intensive care unit (ICU), neurorehabilitation and long-term prognosis. Our primary objective is to investigate the potential of pharmacological stimulant therapies in eliciting signs of consciousness among unresponsive or low-responsive acute DoC patients.MethodsIn a placebo-controlled, randomised, cross-over setting, we evaluate the effect of methylphenidate and apomorphine in 50 DoC patients with acute traumatic or non-traumatic brain injury admitted to the ICU. Patients are examined before and after administration of the trial drugs using (1) neurobehavioural scales to determine the clinical level of consciousness, (2) automated pupillometry to record pupillary responses as a signature for awareness and (3) near-infrared spectroscopy combined with electroencephalography to record neurovascular coupling as a measure for cortical activity. Primary outcomes include pupillary dilations and increase in cortical activity during passive and active paradigms.EthicsThe study has been approved by the ethics committee (Journal-nr: H-21022096) and follows the principles of the Declaration of Helsinki. It is deemed to pose minimal risks and to hold a significant potential to improve treatment options for DoC patients. If the stimulants are shown to enhance cortical modulation of pupillary function and neurovascular coupling, this would warrant a large multicentre trial to evaluate their clinical impact.DisseminationResults will be available on EudraCT, clinicaltrialsregister.eu and published in an international peer-reviewed journal.Trial registration numberEudraCT Number: 2021-001453-31.
Are children with disabilities more likely to be malnourished than children without disabilities? Evidence from the Multiple Indicator Cluster Surveys in 30 countries
Authors: Rotenberg Sara , Chen Shanquan , Hunt Xanthe , Smythe Tracey , Kuper Hannah 
Published: January 2024

IntroductionA key Sustainable Development Goal target is to eliminate all forms of malnutrition. Existing evidence suggests children with disabilities are at greater risks of malnutrition, exclusion from nutrition programmes and mortality from severe acute malnutrition than children without disabilities. However, there is limited evidence on the nutritional outcomes of children with disabilities in large-scale global health surveys.MethodsWe analysed Multiple Indicator Cluster Survey data from 30 low and middle-income countries to compare nutritional outcomes for children aged 2–4 years with and without disabilities. We estimated the adjusted prevalence ratios for stunting, wasting and underweight comparing children with and without disabilities by country and sex, using quasi-Poisson models with robust SEs. We accounted for the complex survey design, wealth quintile, location and age in the analyses. We meta-analysed these results to create an overall estimate for each of these outcomes.ResultsOur analyses included 229 621 children aged 2–4 across 30 countries, including 15 071 children with disabilities (6.6%). Overall, children with disabilities were more likely to be stunted (adjusted risk ratio (aRR) 1.16, 95% CI 1.11 to 1.20), wasted (aRR 1.28, 95% CI 1.18 to 1.39) and underweight (aRR 1.33, 95% CI 1.17, 1.51) than children without disabilities. These patterns were observed in both girls and boys with disabilities, compared with those without.ConclusionChildren with disabilities are significantly more likely to experience all forms of malnutrition, making it critical to accelerate efforts to improve disability inclusion within nutrition programmes. Ending all forms of malnutrition will not be achievable without a focus on disability.
Impact of a peer-support programme to improve loneliness and social isolation due to COVID-19: does adding a secure, user friendly video-conference solution work better than telephone support alone? Protocol for a three-arm randomised clinical trial
Authors: Lee Jacques Simon , Rose Louise , Borgundvaag Bjug , McLeod Shelley L , Melady Donald , Mohindra Rohit , Sinha Samir K , Wesson Virginia , Wiesenfeld Lesley , Kolker Sabrina , Kiss Alex , Lowthian Judy 
Published: January 2024

IntroductionThe COVID-19 pandemic has forced the implementation of physical distancing and self-isolation strategies worldwide. However, these measures have significant potential to increase social isolation and loneliness. Among older people, loneliness has increased from 40% to 70% during COVID-19. Previous research indicates loneliness is strongly associated with increased mortality. Thus, strategies to mitigate the unintended consequences of social isolation and loneliness are urgently needed. Following the Obesity-Related Behavioural Intervention Trials model for complex behavioural interventions, we describe a protocol for a three-arm randomised clinical trial to reduce social isolation and loneliness.Methods and analysisA multicentre, outcome assessor blinded, three-arm randomised controlled trial comparing 12 weeks of: (1) the HOspitals WoRking in Unity (‘HOW R U?’) weekly volunteer-peer support telephone intervention; (2) ‘HOW R U?’ deliver using a video-conferencing solution and (3) a standard care group. The study will follow Consolidated Standard of Reporting Trials guidelines.We will recruit 24–26 volunteers who will receive a previously tested half day lay-training session that emphasises a strength-based approach and safety procedures. We will recruit 141 participants ≥70 years of age discharged from two participating emergency departments or referred from hospital family medicine, geriatric or geriatric psychiatry clinics. Eligible participants will have probable baseline loneliness (score ≥2 on the de Jong six-item loneliness scale). We will measure change in loneliness, social isolation (Lubben social network scale), mood (Geriatric Depression Score) and quality of life (EQ-5D-5L) at 12–14 weeks postintervention initiation and again at 24–26 weeks.Ethics and disseminationApproval has been granted by the participating research ethics boards. Participants randomised to standard care will be offered their choice of telephone or video-conferencing interventions after 12 weeks. Results will be disseminated through journal publications, conference presentations, social media and through the International Federation of Emergency Medicine.Trial registration numberNCT05228782.
Validation of oxygen saturations measured in the community by emergency medical services as a marker of clinical deterioration in patients with confirmed COVID-19: a retrospective cohort study
Authors: Inada-Kim Matthew , Chmiel Francis P , Boniface Michael , Burns Daniel , Pocock Helen , Black John , Deakin Charles 
Published: January 2024

ObjectivesTo evaluate oxygen saturation and vital signs measured in the community by emergency medical services (EMS) as clinical markers of COVID-19-positive patient deterioration.DesignA retrospective data analysis.SettingPatients were conveyed by EMS to two hospitals in Hampshire, UK, between 1 March 2020 and 31 July 2020.ParticipantsA total of 1080 patients aged ≥18 years with a COVID-19 diagnosis were conveyed by EMS to the hospital.Primary and secondary outcome measuresThe primary study outcome was admission to the intensive care unit (ICU) within 30 days of conveyance, with a secondary outcome representing mortality within 30 days of conveyance. Receiver operating characteristic (ROC) analysis was performed to evaluate, in a retrospective fashion, the efficacy of different variables in predicting patient outcomes.ResultsVital signs measured by EMS staff at the first point of contact in the community correlated with patient 30-day ICU admission and mortality. Oxygen saturation was comparably predictive of 30-day ICU admission (area under ROC (AUROC) 0.753; 95% CI 0.668 to 0.826) to the National Early Warning Score 2 (AUROC 0.731; 95% CI 0.655 to 0.800), followed by temperature (AUROC 0.720; 95% CI 0.640 to 0.793) and respiration rate (AUROC 0.672; 95% CI 0.586 to 0.756).ConclusionsInitial oxygen saturation measurements (on air) for confirmed COVID-19 patients conveyed by EMS correlated with short-term patient outcomes, demonstrating an AUROC of 0.753 (95% CI 0.668 to 0.826) in predicting 30-day ICU admission. We found that the threshold of 93% oxygen saturation is prognostic of adverse events and of value for clinician decision-making with sensitivity (74.2% CI 0.642 to 0.840) and specificity (70.6% CI 0.678 to 0.734).
Do school-based smoking preventive interventions have unintended effects? Post hoc analysis of the Focus cluster randomised controlled trial
Authors: Kjeld Simone G , Thygesen Lau C , Danielsen Dina , Jensen Marie P , Krølner Rikke F , Pisinger Charlotta , Andersen Susan 
Published: January 2024

ObjectivesPublic health interventions are designed to improve specific health-related outcomes; however, they may also produce negative side effects, such as substitution use, psychological or social harms. Knowledge about the unintended effects of school-based smoking preventive interventions is sparse. Hence, this study examined these potential unintended effects of the smoking-reducing intervention, Focus, among students in the vocational education and training setting.DesignCluster randomised controlled trial stratified by school type with 5 months follow-up.Setting and participantsAcross Denmark, eight schools were randomised to the intervention group (n=844 students, response proportion 76%) and six schools to the control group (n=815 students, response proportion 75%). This study focused solely on students who smoked at baseline (N=491).InterventionsThe intervention was developed systematically based on theory and a thoroughly mixed-methods needs assessment. Intervention components included a comprehensive school tobacco policy (smoke-free school hours) supported by a 3-day course for school staff and launched by an edutainment session for students; class-based lessons and a quit-and-win competition; and individual telephone smoking cessation support.OutcomesAlternative tobacco and nicotine products (regular use of smokeless tobacco, hookah and e-cigarettes), regular cannabis use, boredom and loneliness at school, stress and perceived stigmatisation among smokers.ResultsWe found no statistically significant unintended effects of the intervention. Nonetheless, insignificant findings indicated that students in the intervention group were less likely to be bored during school hours (OR 0.59, 95% CI 0.32 to 1.10) and experience stress (OR 0.62, 95% CI 0.35 to 1.10), but more likely to report feeling stigmatised compared with the control group (OR 1.55, 95% CI 0.71 to 3.40).ConclusionsOverall, findings suggested no unintended effects of the Focus trial with respect to substitution use, psychological, nor group or social harms. Future research is encouraged to report potential harmful outcomes of smoking preventive interventions, and interventions should be aware of the possible stigmatisation of smokers.Trial registration numberISRCTN16455577.
Seroprevalence of anti-SARS-CoV-2 antibodies and risk of viral exposure among healthcare workers in the South Kivu province, eastern Democratic Republic of the Congo: a cross-sectional study
Authors: Chasinga Tshass B , Cikwanine Jean-Paul Buhendwa , Kribi Sarah , Yoyu Jonathan Tunangoya , Hofmann Natalie , Grossegesse Marica , Nitsche Andreas , Tomczyk Sara , Vietor Ann C , Leendertz Fabian H , Eckmanns Tim , Kusinza Aline B , Munguakonkwa Eric , Kalk Andreas , Raha Maroyi , Kambale Nelson S , Ayagirwe Rodrigue B , Schubert Grit , Mukwege Denis 
Published: January 2024

ObjectivesHealthcare workers (HCWs) are on the frontline of combating COVID-19, hence are at elevated risk of contracting an infection with SARS-CoV-2. The present study aims to measure the impact of SARS-CoV-2 on HCWs in central sub-Saharan Africa.SettingA cross-sectional serological study was conducted at six urban and five rural hospitals during the first pandemic wave in the South Kivu province, Democratic Republic of the Congo (DRC).ParticipantsSerum specimens from 1029 HCWs employed during the first pandemic wave were collected between August and October 2020, and data on demographics and work-related factors were recorded during structured interviews.Primary and secondary outcome measuresThe presence of IgG antibodies against SARS-CoV-2 was examined by ELISA. Positive specimens were further tested using a micro-neutralisation assay. Factors driving SARS-CoV-2 seropositivity were assessed by multivariable analysis.ResultsOverall SARS-CoV-2 seroprevalence was high among HCWs (33.1%), and significantly higher in urban (41.5%) compared with rural (19.8%) hospitals. Having had presented with COVID-19-like symptoms before was a strong predictor of seropositivity (31.5%). Personal protective equipment (PPE, 88.1% and 11.9%) and alcohol-based hand sanitizer (71.1% and 28.9%) were more often available, and hand hygiene was more often reported after patient contact (63.0% and 37.0%) in urban compared with rural hospitals, respectively. This may suggest that higher exposure during non-work times in high incidence urban areas counteracts higher work protection levels of HCWs.ConclusionsHigh SARS-CoV-2 seropositivity indicates widespread transmission of the virus in this region of DRC. Given the absence of publicly reported cases during the same time period at the rural sites, serological studies are very relevant in revealing infection dynamics especially in regions with low diagnostic capacities. This, and discrepancies in the application of PPE between urban and rural sites, should be considered in future pandemic response programmes.
Language Access Systems Improvement initiative: impact on professional interpreter utilisation, a natural experiment
Authors: Karliner Leah S , Gregorich Steven E , Mutha Sunita , Kaplan Celia , Livaudais-Toman Jennifer , Pathak Sarita , Garcia Maria E , Diamond Lisa 
Published: January 2024

ObjectivesThis study aims to evaluate the Language Access Systems Improvement (LASI) initiative’s impact on professional interpreter utilisation in primary care and to explore patient and clinician perspectives on professional interpreter use.DesignMulti methods: Quantitative natural experiment pre-LASI and post-LASI, qualitative semistructured interviews with clinicians and focus groups with patients post-LASI.SettingLarge, academic primary care practice.ParticipantsCantonese, Mandarin, Spanish, English-speaking adult patients and their clinicians.InterventionLASI initiative: Implementation of a clinician language proficiency test and simultaneous provision of on-demand access to professional interpreters via video medical interpretation.Main outcome measuresQuantitative: Proportion of language discordant primary care visits which were professionally interpreted. Qualitative: Salient themes related to professional interpreter use and non-use.ResultsThe researchers categorised language concordance for 1475 visits with 152 unique clinicians; 698 were not fully language concordant (202 pre-LASI and 496 post-LASI). Professional interpreter utilisation increased (pre-LASI 57% vs post-LASI 66%; p=0.01); the visits with the lowest percentage of profssional interpreter use post-LASI were those in which clinicians and patients had partial language concordance. In inverse probability weighted analysis, restricting to 499 visits with strict estimated propensity score overlap (100% common support), post-LASI visits had higher odds of using a professional interpreter compared with pre-LASI visits (OR 2.39; 95% CI 1.04 to 5.48). Qualitative results demonstrate video interpretation was convenient and well liked by both clinicians and patients. Some partially bilingual clinicians reported frustration with patient refusal of interpreter services; others reported using the video interpreters as a backup during visits. Views of the care-partner role differed for clinicians and patients. Clinicians reported sometimes having family interpret out of convenience or habit, whereas patients reported wanting family members present for support and advocacy, not interpretation.ConclusionsLASI increased utilisation of professional interpreters; however, this was least prominent for partially language concordant visits. Health systems wishing to implement LASI or similar interventions will need to support clinicians and patients with partial bilingual skills in their efforts to use professional interpreters.Trial registration numberHSRP20153367.
Perceptions of senior nursing students on how the COVID-19 pandemic influenced their clinical practice in the Northwest Province, South Africa: a qualitative study
Authors: Apolinario Sofia Fatima Filomena , Bam Edith Nokwanda , Moagi Miriam 
Published: January 2024

ObjectiveTo explore and describe senior nursing students’ perspectives on clinical practice during COVID-19 and provide the most up-to-date information on the quality of clinical experience for nursing students in relation to nursing practice, nursing education, and nursing research.DesignThe research design that was employed is a qualitative, explorative, descriptive in order to explore and describe nursing students’ perceptions of clinical, training during the COVID-19 pandemic.SettingThe study took place in a local university located in the Northwest province, South Africa.ParticipantsThe population consisted of 16 senior nursing students who had been exposed to clinical practice during the COVID-19 pandemic. There were 14 women and 2 men. Study included full-time, registered undergraduate nursing students who enrolled in 2019. All nursing students who did not engage in clinical practice before or during COVID-19 were exempt.InterventionsThere were no direct interventions in this study; however, few recommendations were made for each of the themes that emerged in this study.Primary and secondary outcome measuresThe researchers’ aim with the study was to find out the nursing students’ perspective on clinical training during a global pandemic, through interviews and focus group discussions. The researcher did in fact receive such feedback from the participants.ResultsFour major themes emerged: (1) the lack of preceptors to facilitate clinical teaching; (2) not allowed to work in COVID-19 wards; (3) difficulties with online classes and tests and (4) poor communication.ConclusionThe COVID-19 pandemic influenced how students viewed and experienced clinical training, which in turn had an impact on their learning experiences. These effects also had some impact on their experiences and decisions to continue working as professional nurses.
Risk factors for cognitive impairment in middle-aged type 2 diabetic patients: a cross-sectional study
Authors: Li Yao-Shuang , Li Jing-Bo , Wang Jun-Jia , Wang Xiao-He , Jiang Wei-Ran , Qiu Hui-Na , Xia Long-Fei , Wu Fan , Lin Chen-Ying , Liu Yan-Lan , Lin Jing-Na 
Published: January 2024

ObjectiveThe aim of this study was to investigate risk factors for cognitive impairment (CI) and explore the relationship between obesity and cognition in hospitalised middle-aged patients with type 2 diabetes (T2DM).MethodsSubjects were divided into normal cognitive function (NCF) (n=320) and CI (n=204) groups based on the results of the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). The risk factors for CI were determined by logistic regression analysis and generalised linear modelling. The associations between obesity parameters (body mass index (BMI) and waist circumference (WC)) and cognitive ability were studied with the use of linear regression analysis, piecewise regression modelling and interaction analysis. The receiver operating characteristic curve analysis was used to examine the diagnostic value of influencing factors for ccResultsThe prevalence of CI was 38.9% in hospitalised middle-aged T2DM patients (median age, 58 years). Age, WC, hypoglycaemic episode within past 3 months and cerebrovascular disease (CVD) were identified as independent risk factors for CI, while the independent protective factors were education, diabetic dietary pattern, overweight and obesity. BMI was a protective factor for the MoCA score within a certain range, whereas WC was a risk factor for the MMSE and MoCA scores. The area under the curve for the combination of BMI and WC was 0.754 (p<0.001).ConclusionAge, education, diabetic dietary pattern, WC, overweight, obesity, hypoglycaemic episode in 3 months and CVD may be potential influencing factors for the occurrence of CI in hospitalised middle-aged population with T2DM. The combination of BMI and WC may represent a good predictor for early screening of CI in this population. Nevertheless, more relevant prospective studies are still needed.