bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Effect of Growth Hormone Treatment on Physical Performance Indices in Children With Idiopathic Short Stature
Authors: Weinberg Adi , Dror Nitzan , Motin Katya , Pantanowitz Michal , Nemet Dan , Eliakim Alon 
Published: April 2021

Purpose: To examine the effect of growth hormone (GH) treatment on physical performance in children with idiopathic short stature and normal GH secretion. Materials and Methods: A total of 24 children participated in the study (13 GH-treated, 11 non-treated, aged 8–13 y, 11 males and 13 females, Tanner stage 1–2). Participants performed a battery of motor skill performance tests (Eurofit), as well as the Wingate anaerobic test. Results: No statistically significant differences in any of the Eurofit physical fitness test results (eg, 20-m shuttle run 33.0 [15.1] vs 25.1 [21.0] laps in treated and nontreated participants, respectively, P = .25) or the Wingate anaerobic test were found between the groups (eg, peak power 5.0 [2.9] vs 3.9 [2.6] watts/kg in treated and nontreated participants, respectively, P = .2). Conclusions: Therapeutic usage of exogenous GH for pre and early pubertal children with idiopathic short stature and normal GH secretion was not associated with beneficial effects on physical performance indices. This suggests that the use of GH as a potential performance enhancing agent, in this age group, at least at commonly used doses, is not advantageous.
Detection of SARS-CoV-2 genomic and subgenomic RNA in retina and optic nerve of patients with COVID-19
Authors: Casagrande Maria , Fitzek Antonia , Spitzer Martin , Püschel Klaus , Glatzel Markus , Krasemann Susanne , Aepfelbacher Martin , Nörz Dominik , Lütgehetmann Marc , Pfefferle Susanne , Schultheiss Maximilian 
Published: April 2021

PurposePresence of SARS-CoV-2 RNA in human retinal biopsies (RBs) was previously reported by us. In this consecutive study, we analysed RB and optic nerve biopsies (ONBs) in deceased patients with confirmed COVID-19 assessing viral RNA load, possible virus replication and infectivity.Patients and methodsIn this case series, 14 eyes of 14 deceased patients with COVID-19 were enucleated during autopsy. RB and ONB were subjected to molecular detection of viral RNA, virus cultivation and immunohistochemistry. SARS-CoV-2 RNA loads were compared with RNA loads in the respective throat swabs, vitreous humour and blood samples.ResultsSARS-CoV-2 RNA was detected in 7/14 RBs and in 10/13 ONBs. While virus isolation failed and immunohistochemistry of SARS-CoV-2 spike protein was negative, subgenomic RNA (sgRNA) was detectable (40% RB; 60% ONB).ConclusionSARS-CoV-2 RNA is detectable in RB and ONB of patients with COVID-19. Presence of sgRNA could point to a SARS-CoV-2 infection of neuronal tissue, but as virus isolation failed and immunohistochemistry of SARS-CoV-2 spike protein was negative, an active infection seems unlikely.
Characterisation of macular neovascularisation in geographic atrophy
Authors: Sacconi Riccardo , Brambati Maria , Miere Alexandra , Costanzo Eliana , Capuano Vittorio , Borrelli Enrico , Battista Marco , Parravano Mariacristina , Souied Eric H , Bandello Francesco , Querques Giuseppe 
Published: April 2021

AimTo characterise macular neovascularisation (MNV) developing in eyes affected by geographic atrophy (GA).MethodsIn this multicentric longitudinal study involving three retina referral centres, patients previously affected by GA who developed an active MNV were included. Patients were investigated using structural optical coherence tomography (OCT), fundus autofluorescence, OCT-angiography and dye angiographies. Patients were treated with ProReNata antivascular endothelial growth factor (VEGF) injections and were revaluated after treatment.ResultsAmong 512 patients previously diagnosed with GA, 40 eyes of 40 patients (mean age 80.8±7.9 years, mean GA area 8.73±7.39 mm2) presented with treatment-naïve exudative MNV (accounting for an estimated prevalence of 7.81%; 5.49 to 10.13, 95% CIs) and thus were included in the analysis. 67.5% of MNVs were classified as type 2 MNV, 25% as type 1, 2.5% as type 3 and 5% as mixed phenotype. In 92.5% of cases, active MNV in GA showed subretinal hyperreflective material with or without evidence of subretinal/intraretinal hyporeflective exudation. During a mean follow-up of 28±25 months, patients were treated with 6.6±6.3 anti-VEGF injections, with 2.9±1.4 injections in the first year of treatment. No patient developed GA enlargement in the area of MNV.ConclusionsMNVs in GA showed different features and therapeutic response in comparison to previously reported features of MNV in age-related macular degeneration (AMD) without GA. For these reasons, the combined phenotype (ie, GA with neovascular AMD) should be considered as a distinct entity in the research and clinical setting.
Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants
Authors: Elliott Catherine , Alexander Caroline , Salt Alison , Spittle Alicia J , Boyd Roslyn N , Badawi Nadia , Morgan Catherine , Silva Desiree , Geelhoed Elizabeth , Ware Robert S , Ali Alishum , McKenzie Anne , Bloom David , Sharp Mary , Ward Roslyn , Bora Samudragupta , Prescott Susan , Woolfenden Susan , Le Vuong , Davidson Sue-Anne , Thornton Ashleigh , Finlay-Jones Amy , Jensen Lynn , Amery Natasha ,   Early Moves Clinical Working Group, Valentine Jane 
Published: April 2021

IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.
Study protocol for You.Mind!: boosting first-line mental health care for YOUngsters suffering from chronic conditions with mindfulness: a randomised staggered within-subjects design
Authors: Kock Merle , Van Hoecke Eline , Raes Filip , Van der Gucht Katleen 
Published: April 2021

IntroductionAdolescents with chronic conditions often experience high levels of stress, anxiety and depression, and reduced quality of life. Mindfulness-based interventions (MBIs) have been found to improve emotional distress in clinical and non-clinical populations and are a promising technique to support adolescents with chronic conditions in managing their symptoms and ultimately enhance their quality of life.Methods and analysisTo test the effects of an MBI on emotional distress and quality of life and delineate the underlying mechanisms, the You.Mind! study uses a randomised staggered within-subjects design. Thirty adolescents with a chronic condition will be randomised to a baseline phase of 14–28 days followed by an MBI, consisting of four online group sessions and online support spread over 8 weeks. Outcomes will be assessed by short, repeated measurements throughout the baseline, intervention and follow-up phases and by standardised questionnaires and experience sampling measures before randomisation, at postintervention and at 3-months follow-up. Analysis will be based on general linear modelling and multilevel mixed-effects modelling.Ethics and disseminationEthical approval was obtained from the Ethics Committee Research UZ/KU Leuven and the Ethics Committee of Ghent University Hospital and Ghent University (S63485). Results will be disseminated through presentations at public lectures, scientific institutions and meetings, and through publication in peer-reviewed journals.Trial registration numberNCT04359563.
Addressing HIV care, mental health and substance use among youth and young adults in the Bay Area: description of an intervention to improve information, motivation and behavioural skills
Authors: McCuistian Caravella , Wootton Angie R , Legnitto-Packard Dominique , Gruber Valerie A. , Dawson-Rose Carol , Johnson Mallory O. , Saberi Parya 
Published: April 2021

ObjectiveYouth represent a population disparately impacted by the HIV epidemic. With most new HIV diagnoses occurring among adolescents and young adults, novel approaches to address this disparity are necessary. The objective of the current study was to describe the Youth to Telehealth and Text to Improve Engagement in Care (Y2TEC) intervention, which aims to fill this gap. The Y2TEC intervention (trial registration NCT03681145) offers an innovative approach to improve HIV treatment engagement among youth living with HIV by focusing on treatment barriers related to mental health and substance use. This allows for a holistic approach to providing culturally informed intervention strategies for this population.Participants and settingThe Y2TEC intervention was developed for youth with HIV in the large metropolitan area of the San Francisco Bay Area. The Y2TEC intervention was developed based on formative interdisciplinary research and is grounded in the information–motivation–behavioural skills model.ResultsThe intervention includes 12 sessions each lasting 20–30 minutes, which are delivered through videoconferencing and accompanying bidirectional text messaging. The intervention sessions are individualised, with session dosage in each major content area determined by participant’s level of acuity.ConclusionsThe Y2TEC intervention is well positioned to help decrease HIV-related disparities in youth living with HIV through its innovative use of video-counselling technologies and an integrated focus on HIV, mental health and substance use.
Contexts and mechanisms that promote access to healthcare for populations experiencing homelessness: a realist review
Authors: Siersbaek Rikke , Ford John Alexander , Burke Sara , Ní Cheallaigh Clíona , Thomas Steve 
Published: April 2021

ObjectiveThe objective of this study was to identify and understand the health system contexts and mechanisms that allow for homeless populations to access appropriate healthcare when needed.DesignA realist review.Data sourcesOvid MEDLINE, embase.com, CINAHL, ASSIA and grey literature until April 2019.Eligibility criteria for selecting studiesThe purpose of the review was to identify health system patterns which enable access to healthcare for people who experience homelessness. Peer-reviewed articles were identified through a systematic search, grey literature search, citation tracking and expert recommendations. Studies meeting the inclusion criteria were assessed for rigour and relevance and coded to identify data relating to contexts, mechanisms and/or outcomes.AnalysisInductive and deductive coding was used to generate context–mechanism–outcome configurations, which were refined and then used to build several iterations of the overarching programme theory.ResultsSystematic searching identified 330 review articles, of which 24 were included. An additional 11 grey literature and primary sources were identified through citation tracking and expert recommendation. Additional purposive searching of grey literature yielded 50 records, of which 12 were included, for a total of 47 included sources. The analysis found that healthcare access for populations experiencing homelessness is improved when services are coordinated and delivered in a way that is organised around the person with a high degree of flexibility and a culture that rejects stigma, generating trusting relationships between patients and staff/practitioners. Health systems should provide long-term, dependable funding for services to ensure sustainability and staff retention.ConclusionsWith homelessness on the rise internationally, healthcare systems should focus on high-level factors such as funding stability, building inclusive cultures and setting goals which encourage and support staff to provide flexible, timely and connected services to improve access.
Exploring the Epidemiology of Cancer after Solid Organ Transplantation (EpCOT): an observational cohort study
Authors: Sharif Adnan , Peracha Javeria , Winter David , Reulen Raoul , Hawkins Mike 
Published: April 2021

IntroductionSolid organ transplant patients are counselled regarding increased risk of cancer (principally due to their need for lifelong immunosuppression) and it ranks as one of their biggest self-reported worries. Post-transplantation cancer is common, associated with increased healthcare costs and emerging as a leading cause of post-transplant mortality. However, epidemiology of cancer post-transplantation remains poorly understood, with limitations including translating data from different countries and national data being siloed across different registries and/or data warehouses.Methods and analysisStudy methodology for Epidemiology of Cancer after Solid Organ Transplantation involves record linkage between the UK Transplant Registry (from NHS Blood and Transplant), Hospital Episode Statistics (for secondary care episodes from NHS Digital), National Cancer Registry (from cancer registration data hosted by Public Health England) and the National Death Registry (from NHS Digital). Deterministic record linkage will be conducted by NHS Digital, with a fully anonymised linked dataset available for analysis by the research team. The study cohort will consist of up to 85 410 solid organ transplant recipients,who underwent a solid organ transplant in England between 1 January 1985 and 31 December 2015, with up-to-date outcome data.Ethics and disseminationThis study has been approved by the Confidentiality Advisory Group (reference: 16/CAG/0121), Research Ethics Committee (reference: 15/YH/0320) and Institutional Review Board (reference: RRK5471). The results of this study will be presented at national and international conferences, and manuscripts with results will be submitted for publication in high-impact peer-reviewed journals. The information produced will also be used to develop national evidence-based clinical guidelines to inform risk stratification to enable risk-based clinical follow-up.Trial registration numberNCT02991105.
Are medical record front page data suitable for risk adjustment in hospital performance measurement? Development and validation of a risk model of in-hospital mortality after acute myocardial infarction
Authors: Wu Chaoqun , Zhang Danwei , Bai Xueke , Zhou Tiannan , Wang Yongfei , Lin Zhenqiu , He Guangda , Li Xi 
Published: April 2021

ObjectivesTo develop a model of in-hospital mortality using medical record front page (MRFP) data and assess its validity in case-mix standardisation by comparison with a model developed using the complete medical record data.DesignA nationally representative retrospective study.SettingRepresentative hospitals in China, covering 161 hospitals in modelling cohort and 156 hospitals in validation cohort.ParticipantsRepresentative patients admitted for acute myocardial infarction. 8370 patients in modelling cohort and 9704 patients in validation cohort.Primary outcome measuresIn-hospital mortality, which was defined explicitly as death that occurred during hospitalisation, and the hospital-level risk standardised mortality rate (RSMR).ResultsA total of 14 variables were included in the model predicting in-hospital mortality based on MRFP data, with the area under receiver operating characteristic curve of 0.78 among modelling cohort and 0.79 among validation cohort. The median of absolute difference between the hospital RSMR predicted by hierarchical generalised linear models established based on MRFP data and complete medical record data, which was built as ‘reference model’, was 0.08% (10th and 90th percentiles: −1.8% and 1.6%). In the regression model comparing the RSMR between two models, the slope and intercept of the regression equation is 0.90 and 0.007 in modelling cohort, while 0.85 and 0.010 in validation cohort, which indicated that the evaluation capability from two models were very similar.ConclusionsThe models based on MRFP data showed good discrimination and calibration capability, as well as similar risk prediction effect in comparison with the model based on complete medical record data, which proved that MRFP data could be suitable for risk adjustment in hospital performance measurement.
Chinesisation, adaptation and validation of the Chelsea Critical Care Physical Assessment Tool in critically ill patients: a cross-sectional observational study
Authors: Zhang Zhigang , Wang Guoqiang , Wu Yuchen , Guo Jin , Ding Nannan , Jiang Biantong , Wei Huaping , Li Bin , Yue Weigang , Tian Jinhui 
Published: April 2021

PurposeTo translate and adapt the Chelsea Critical Care Physical Assessment Tool (CPAx) into Chinese version (‘CPAx-Chi’), test the reliability and validity of CPAx-Chi, and verify the cut-off point for the diagnosis of intensive care unit-acquired weakness (ICU-AW).Study designCross-sectional observational study.MethodsForward and back translation, cross-cultural adaptation and pretesting of CPAx into CPAx-Chi were based on the Brislin model. Participants were recruited from the general ICU of five third-grade class-A hospitals in western China. Two hundred critically ill adult patients (median age: 53 years; 64% men) with duration of ICU stay ≥48 hours and Glasgow Coma Scale ≥11 were included in this study. Two researchers simultaneously and independently assessed eligible patients using the Medical Research Council Muscle Score (MRC-Score) and CPAx-Chi.ResultsThe content validity index of items was 0.889. The content validity index of scale was 0.955. Taking the MRC-Score scale as standard, the criterion validity of CPAx-Chi was r=0.758 (p<0.001) for researcher A, and r=0.65 (p<0.001) for researcher B. Cronbach’s α was 0.939. The inter-rater reliability was 0.902 (p<0.001). The area under the receiver operating characteristic curves of CPAx-Chi for diagnosing ICU-AW based on MRC-Score ≤48 were 0.899 (95% CI 0.862 to 1.025) and 0.874 (95% CI 0.824 to 0.925) for researcher B. The best cut-off point for CPAx-Chi for the diagnosis of ICU-AW was 31.5. The sensitivity was 87% and specificity was 77% for researcher A, whereas it was 0.621, 31.5, 75% and 87% for researcher B, respectively. The consistency was high when taking CPAx-Chi ≤31 and MRC-Score ≤48 as the cut-off points for the diagnosis of ICU-AW. Cohen’s kappa=0.845 (p=0.02) in researcher A and 0.839 (p=0.04) for researcher B.ConclusionsCPAx-Chi demonstrated content validity, criterion-related validity and reliability. CPAx-Chi showed the best accuracy in assessment of patients at risk of ICU-AW with good sensitivity and specificity at a recommended cut-off of 31.
'It’s not something you can take in your hands'. Swiss experts’ perspectives on health data ownership: an interview-based study
Authors: Martani Andrea , Geneviève Lester Darryl , Elger Bernice , Wangmo Tenzin 
Published: April 2021

ObjectivesThe evolution of healthcare and biomedical research into data-rich fields has raised several questions concerning data ownership. In this paper, we aimed to analyse the perspectives of Swiss experts on the topic of health data ownership and control.DesignIn our qualitative study, we selected participants through purposive and snowball sampling. Interviews were recorded, transcribed verbatim and then analysed thematically.SettingSemi-structured interviews were conducted in person, via phone or online.ParticipantsWe interviewed 48 experts (researchers, policy makers and other stakeholders) of the Swiss health-data framework.ResultsWe identified different themes linked to data ownership. These include: (1) the data owner: data-subjects versus data-processors; (2) uncertainty about data ownership; (3) labour as a justification for data ownership and (4) the market value of data. Our results suggest that experts from Switzerland are still divided about who should be the data owner and also about what ownership would exactly mean. There is ambivalence between the willingness to acknowledge patients as the data owners and the fact that the effort made by data-processors (eg, researchers) to collect and manage the data entitles them to assert ownership claims towards the data themselves. Altogether, a tendency to speak about data in market terms also emerged.ConclusionsThe development of a satisfactory account of data ownership as a concept to organise the relationship between data-subjects, data-processors and data themselves is an important endeavour for Switzerland and other countries who are developing data governance in the healthcare and research domains. Setting clearer rules on who owns data and on what ownership exactly entails would be important. If this proves unfeasible, the idea that health data cannot trulybelong toanyone could be promoted. However, this will not be easy, as data are seen as an asset to control and profit from.