bluuebunny/crossref_metadata_2025_split huggingface dataset:
Primary outcome reporting in adolescent depression clinical trials needs standardization
Authors: Monsour Andrea , Mew Emma J. , Patel Sagar , Chee-a-tow Alyssandra , Saeed Leena , Santos Lucia , Courtney Darren , Watson Priya N. , Monga Suneeta , Szatmari Peter , Offringa Martin , Butcher Nancy J. 
Published: May 2020

Abstract
Background: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. Methods: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as “fully reported”, “partially reported”, or “not reported” for each checklist item, as applicable. Results: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6-17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. Conclusions: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed. Trial registration: Not applicable
A cross-sectional study on caregivers’ perspective of the quality of life and adherence of paediatric HIV patients to Highly Active Antiretroviral Therapy
Authors: Lahai Michael , James Peter Bai. , Wannang Noel N. , Wurie Haja R. , Conteh Sorie , Bah Abdulai Jawo , Samai Mohamed H 
Published: May 2020

Abstract
Background: Poor compliance to highly active antiretroviral therapy (HAART) can result in the poor quality of life in children living with HIV/AIDS because of low plasma drug concentration and the possibility of drug resistance. This study evaluates the response of caregivers for determination of adherence and the four quality of life domains in children (aged 14 years and under) on HAART.Methods: We conducted a cross-sectional study of 188 children, each accompanied by their caregivers at Ola During Children's Hospital and Makeni Government Hospital between September and November 2016. Adherence to HAART and Quality of life was assessed using the WHO Quality of life summary questionnaire (WHOQOL-BREF). We obtained ethical approval from the Sierra Leone Ethics and Scientific Review Committee. Results: The study revealed 5.9% adherence amongst paediatric patients, and a strong association of adherent patients(p=0.019*) to the physical health domain (mean=64.61 SD=8.1).Caregiver HIV status showed a strong association with the physical (mean=58.3, SD=11.7 and p=0.024*), and psychological health domains (mean=68.2, SD=14.7 and p=0.001). Caregiver type (mother/father/sibling) accompanying child to hospital also showed strong associated with the physical (mean=58.0, SD=10.6, p <0.001), psychological (mean 68.2 SD=14.81 p <0.001) and environmental health domains (mean=59.7, SD=13.47, p <0.001). Further regression analysis showed a strong association with physical health domain for HIV positive caregivers (p=0.014) and adherent paediatric patients (p=0.005). Nuclear family also showed a strong association with psychological (p<0.001) and environmental (p=0.001) health domains. Conclusion: This study showed a strong association between the quality of life domains and the involvement of nuclear family caregiver, HIV-positive caregiver and adherence to HAART. Our study suggests that the involvement of any member of the nuclear family, HIV positive parents and patient adherence to therapy can improve the quality of life of paediatric HIV/AIDS patients on highly active antiretroviral therapy in the two hospitals.
A Cost-of-Illness analysis of β-Thalassaemia major in children in Sri Lanka – Experience from a tertiary level teaching hospital
Authors: Reed-Embleton Hamish , Arambepola Savinda , Dixon Simon , Maldonado Behrouz Nezafat , Premawardhena Anuja , Arambepola Mahinda , Khan Jahangir A. M. , Allen Stephen 
Published: May 2020

Abstract
Background: Sri Lanka has a high prevalence of b-thalassaemia major. Clinical management is complex and long-term and includes regular blood transfusion and iron chelation therapy. The economic burden of β-thalassaemia for the Sri Lankan healthcare system and households is currently unknown.Methods: A prevalence-based, cost-of-illness study was conducted on the Thalassaemia Unit, Department of Paediatrics, Kandy Teaching Hospital, Sri Lanka. Data were collected from clinical records, consultations with the head of the blood bank and a consultant paediatrician directly involved with the care of patients, alongside structured interviews with families to gather data on the personal costs incurred such as those for travel. Results: Thirty-four children aged 2-17 years with transfusion dependent thalassaemia major and their parent/guardian were included in the study. The total average cost per patient year to the hospital was $US 2601 of which $US 2092 were direct costs and $US 509 were overhead costs. Mean household expenditure was $US 206 per year with food and transport per transfusion ($US 7.57 and $US 4.26 respectively) being the highest cost items. Nine (26.5%) families experienced catastrophic levels of healthcare expenditure (>10% of income) in the care of their affected child. The poorest households were the most likely to experience such levels of expenditure. Conclusions: β-thalassaemia major poses a significant economic burden on health services and the families of affected children in Sri Lanka. Greater support is needed for the high proportion of families that suffer catastrophic out-of-pocket costs.
Long-term survival of elderly patients after intensive care unit admission for acute respiratory infection: a population-based, propensity-score matched cohort study.
Authors: Guillon Antoine , Hermetet C. , Barker K. A. , Jouan Y. , Gaborit C. , Ehrmann S. , Manach Y. Le , Dequin P F , Grammatico-Guillon L. 
Published: May 2020

Abstract
Background: Intensive care unit (ICU) hospitalisations of elderly patients with acute respiratory infection (ARI) have increased, yet the long-term effect of ICU admission among elderly individuals remain unknown. We examined differences over the two years after discharge in mortality, healthcare utilization and frailty score between elderly survivors of ARI in the ICU and an elderly control population.Methods: We used 2009-2017 data from 39 hospital discharge databases. Patients ≥80 years old discharged alive from ICU-hospitalisation for acute respiratory infection were propensity-score matched with controls (cataract surgery) discharged from the hospital at the same time and adjusted for age, sex and comorbidities present before hospitalisation. We reported 2-year mortality and compared healthcare utilization and frailty scores in the 2-year periods before and after ICU-hospitalisation.Results: 1,220 elderly survivors of acute respiratory infection in the ICU were discharged, and 988 were successfully matched with controls. After discharge, patients had a 10.1-fold [95%CI, 6.1-17.3] higher risk of death at 6 months and 3.6-fold [95%CI, 2.9-4.6] higher risk of death at 2 years compared with controls. They also had a 2-fold increase in both healthcare utilization and frailty score in the 2 years after hospital discharge, whereas healthcare utilization and frailty scores among controls were stable before and after hospitalisation.Conclusions: We observed a substantially increased rate of death in the years after ICU-hospitalisation for elderly patients along with elevated healthcare resource use and accelerated age-associated decline as assessed by frailty score. These findings provide data for better informed goals-of-care discussions and may help target post-ICU discharge services.Funding: None
Rare partial trisomy and tetrasomy of 15q11-q13 associated with developmental delay and autism spectrum disorder
Authors: Lu Yinghong , Liang Yi , Ning Sisi , Deng Guosheng , Xie Yulin , Song Jujie , Zuo Na , Feng Chunfeng , Qin Yunrong 
Published: May 2020

Abstract
Background: Small supernumerary marker chromosomes (sSMCs), are additional abnormal chromosomes, which can’t be detected accurately by banding cytogenetic analysis. Abnormal phenotypes were observed in about 30% of SMC carriers. Duplication of chromosome 15 and related disorders, characterized by hypotonia motor delays, autism spectrum disorder (ASD), intellectual disability, and epilepsy including infantile spasms, might be account for 50% of the total sSMCs. Case presentation: An 11-month-old infant with an sSMC fond by banding cytogenetics was referred to our clinic because of developmental retardation and autism spectrum disorder. After several months of rehabilitation treatment, the progress of motor development was obvious, but the consciousness was still far from satisfied. High-resolution karyotype analysis, multiplex ligation-dependent probe amplification and copy number variation sequencing (CNV-Seq) were conducted to confirm the identity of the sSMC. A bisatellited dicentric sSMC was observed clearly in high-resolution karyotype analysis and a 10.16-Mb duplication of 15q11.1q13.2 (3.96 copies) together with a 1.84-Mb duplication of 15q13.2q13.3 (3 copies) was showed by CNV-Seq in the proband. It suggested that the molecular cytogenetic karyotype was 47,XY,+dic(15;15)(q13.2;q13.3). Furthermore, the clinical symptoms of the proband mostly fit 15q duplication related disorders which are characterized by hypotonia motor delays, autism spectrum disorder (ASD), and intellectual disability. Conclusion: We reported for the first time using CNV-Seq to detect sSMCs and find a partial trisomy and tetrasomy of 15q11-q13 associated with developmental delay and autism spectrum disorder. Our report indicates that CNV-seq is a useful and economical way for diagnosis of dup15q and related disorders.
Correlates of Physical Activity Behavior in Adults: A Data Mining Approach
Authors: Farrahi Vahid , Niemelä Maisa , Kärmeniemi Mikko , Puhakka Soile , Kangas Maarit , Korpelainen Raija , Jämsä Timo 
Published: May 2020

Abstract
Purpose: A data mining approach was applied to establish a multilevel hierarchy predicting physical activity (PA) behavior, and to methodologically identify the correlates of PA behavior. Methods: Cross-sectional data from the population-based Northern Finland Birth Cohort 1966 study, collected in the most recent follow-up at age 46, were used to create a hierarchy using the chi-square automatic interaction detection (CHAID) decision tree technique for predicting PA behavior. PA behavior is defined as active or inactive depending on participants’ activity profiles, which were previously created through a multidimensional (clustering) approach on continuous accelerometer-measured activity intensities in one week. The input variables (predictors) used for decision tree fitting consisted of individual, demographical, psychological, behavioral, environmental, and physical factors. Using generalized linear mixed models, we also analyzed how factors emerging from the model were associated with three PA metrics, including daily time (minutes per day) in sedentary (SED), light PA (LPA), and moderate-to-vigorous PA (MVPA), to assure the relative importance of methodologically identified factors. Results: Of the 4,582 participants with valid accelerometer data at the latest follow-up, 2,701 and 1,881 had active and inactive profiles, respectively. We used a total of 168 factors as input variables to classify these two PA behaviors. Out of these 168 factors, the decision tree selected 36 factors of different domains from which 54 subgroups of participants were formed. The emerging factors from the model explained minutes per day in SED, LPA, and/or MVPA, including body fat percentage (SED: B=26.5, LPA: B=-16.1, and MVPA: B=-11.7), normalized heart rate recovery 60 seconds after exercise (SED: B=-16.1, LPA: B=9.9, and MVPA: B=9.6), average weekday total sitting time (SED: B=34.1, LPA: B=-25.3, and MVPA: B=-5.8), and extravagance score (SED: B=6.3 and LPA: B=-3.7). Conclusions: Using data mining, we established a data-driven model composed of 36 different factors of relative importance from empirical data. This model may be used to identify subgroups for multilevel intervention allocation and design. Additionally, this study methodologically discovered an extensive set of factors that can be a basis for additional hypothesis testing in PA correlates research.
Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up
Authors: Zhang Peng , Lv Hong , Qi Xia , Xiao Wenjing , Xue Qinghua , Zhang Lei , Li Lihuan , Shi Jia 
Published: May 2020

Abstract
Background: Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population. Methods: In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n=142), tranexamic acid (group T, n=143) or normal saline (group C, n=141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety.Results: Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 hours (688.39±393.55ml vs 854.33±434.03ml MD -165.95ml, 95%CI -262.88ml to -69.01ml, p<0.001) and the volume of allogeneic erythrocyte transfusion (2.57±3.15 unit vs 3.73±4.21 unit, MD-1.16 unit, 95%CI -2.06 units to -0.26 units, p=0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups. Conclusions: Ulinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up. Trial registration: The trial was retrospectively registered on February 2, 2010. Trial registration number: https://www.clinicaltrials.gov. Identifier: NCT01060189.
Incidence of acute kidney injury and use of renal replacement therapy in intensive care unit patients in Indonesia
Authors: Jonny Jonny , Hasyim Moch , Angelia Vedora , Jahya Ayu Nursantisuryani , Hilman Lydia Permata , Kusumaningrum Venna Febrian , Srisa Nattachai 
Published: May 2020

Abstract
Background : Currently, there is limited epidemiology data on acute kidney injury (AKI) in Indonesia.Therefore, we assessed the incidence of AKI and the utilization of renal replacement therapy (RRT) in Indonesia. Methods : Demographic and clinical data were collected from 952 ICU participants. The participants were categorized into AKI and non-AKI groups. The participants were further classified according to the 3 different stages of AKI as per the Kidney Disease Improving Global Outcome (KDIGO) criteria. Results : Overall incidenceof AKI was 43%. The participants were divided into three groups based on the AKI stages: 18.5% had stage 1, 33% had stage 2, and 48.5% had stage 3. Primary diagnosis of renal disease and high APACHE II score were the risk factors associated with AKI (OR = 4.53, 95% CI: 1.67-12.33, p=0.003 and OR = 1.14 per 1 unit increase, 95% CI: 1.09-1.20, p<0.001, respectively).Chronic kidney disease was the risk factor for severe AKI. Sepsis was the leading cause of AKI.Among the AKI participants, 24.6% required RRT. The most common RRT modalities were intermittent hemodialysis (71.7%), followed by slow low-efficiency dialysis (22.8%), continuous renal replacement therapy (4.3%), and peritoneal dialysis (1.1%). Conclusions : This study showed that AKI was a common problem in the Indonesian ICU. We strongly believe that identification of the risk factors associated with AKI will help us develop a predictive score for AKI so we can prevent and improve AKI outcome in the future.
Impact of coronary collateralization on long-term clinical outcomes in type 2 diabetic patients after successful recanalization of chronic total occlusion
Authors: Yang Zhen Kun , Shen Ying , Dai Yang , Wang Xiao Qun , Hu Jian , Ding Feng Hua , Zhang Rui Yan , Lu Lin , Shen Wei Feng 
Published: May 2020

Abstract
Background: To assess the prognostic role of coronary collaterals in patients with type 2 diabetes mellitus (T2DM) after successful percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).Methods: Coronary collateralization was graded according to Rentrop scoring system in 198 type 2 diabetic patients and 335 non-diabetics with stable angina undergoing PCI for at least one CTO lesion. Left ventricular ejection fraction (LVEF) was determined and major adverse cardio-cerebral events (MACCE) were recorded during follow-up.Results: Poor collateralization was more common in patients with T2DM than in non-diabetics (40% vs 29%, p=0.008). At 13.5±4.1 months, the rate of composite MACCE (17.3% vs 27.6%, p=0.034) and repeat revascularization (15.2% vs 25.5%, p=0.026) was lower and the increase in LVEF (3.10 % vs 1.80%, p=0.024) was greater in patients with good collaterals than in those with poor collaterals for non-diabetic group. The associations were in the same direction for T2DM group (35% vs 44%; 30% vs 36%; 2.14% vs 1.65%, respectively) with a higher all-cause mortality in diabetic patients with poor collaterals (p=0.034). Multivariable Cox proportional hazards analysis showed that coronary collateralization was an independent factor for time to MACCE (HR 2.155，95%CI 1.290-3.599, P=0.003) and repeat revascularization (HR 2.326, 95%CI 1.357-3.986, p=0.002) in non-diabetic patients, but did not enter the model in those with T2DM.Conclusions: T2DM is associated with reduced coronary collateralization. The effects of the status of coronary collateralization on long-term clinical outcomes and left ventricular function appear to be similar in size in type 2 diabetic patients and non-diabetics after successful recanalization of CTO.
Muramyl dipeptide mediated immunomodulation on monocyte subsets exerts therapeutic effects in a mouse model of Alzheimer’s disease
Authors: Malekia Adham Fani , Cisbania Giulia , Plante Marie-Michèle , Préfontaine Paul , Laflamme Nataly , Gosselin Jean , Rivest Serge 
Published: May 2020

Abstract
Background: Muramyl dipeptide (MDP) is a component derived from minimal peptidoglycan motif from bacteria, and it is a ligand for the NOD2 receptor. Peripheral administration of MDP converts Ly6Chigh into Ly6Clow monocytes. Previously we have shown that Ly6Clow monocytes play crucial roles in the pathology of a mouse model of Alzheimer’s disease (AD). However, medications with mild immunomodulatory effects that solely target specific monocyte subsets, without triggering microglial activation are rare. Methods: 3-months old APPswe/PS1 transgenic male mice and age-matched C57BL/6J mice were used for high frequency (2-times/week) over 6-months and low frequency (once a week) over 3 months of intraperitoneally MDP (10 mg/kg) administrations. Flow cytometry analysis of monocyte subsets in blood, behavioral and postmortem analyses were performed. Results: Memory tests showed mild to a strong improvement in memory function, increased expression levels of postsynaptic density protein 95 (PSD95), and low-density lipoprotein receptor-related protein 1 (LRP1), which are involved in synaptic plasticity and amyloid-beta (Aβ) elimination, respectively. In addition, we found monocyte chemoattractant protein-1(MCP-1) levels significantly increased, whereas intercellular adhesion molecule-1(ICAM-1) significantly decreased and microglial marker (Iba1) did not change in the treatment group compared to the control. In parallel, we discovered elevated cyclooxygenase-2 (COX2) expression levels in the treated group, which might be a positive factor for synaptic activity. Conclusions: Our results demonstrate that MDP is beneficial in both the early phase and, to some extent, later phases of the pathology in the mouse model of AD. These data open the way for potential MDP-based medications for AD.
Urinary tract infection is associated with hypokalemia: a case control study
Authors: Shen Ai-Ling , Lin Hsiu-Li , Lin Hsiu-Chen , Tseng Yuan-Fu , Hsu Chien-Yeh , Chou Che-Yi 
Published: May 2020

Abstract
Background Hypokalemia is a common clinical problem. The association between urinary tract infection (UTI) and hypokalemia is not clear. Hypokalemia is common in patients with UTI in clinical observation. The aim of the study is to determine if UTI is associated with hypokalemia.Methods Patients hospitalized with UTI and the control group were retrieved from the Longitudinal Health Insurance Database 2005. The control group was patients hospitalized with other reasons and were matched for the confoundings of UTI and hypokalemia. We analyze the risk of hypokalemia using logistic regression and calculate the odds ratio (OR) and 95% confidence interval (CI) of OR.Results We analyzed 43719 UTI patients and control patients. Hypokalemia was found in 4540 (10.4%) patients with UTI and 1842 (4.2%) control patients. The percentage of patients with hypokalemia was higher in UTI patients (chi-square, p < 0.001). UTI was associated with hypokalemia and the odds ratio (OR) was 2.27 [95% confidence interval (CI): 2.17 - 2.41]. Cerebrovascular accident, chronic obstructive pulmonary disease, hypertension, congestive heart failure, diarrhea, medications including thiazides, sulfonamides, xanthines, and laxatives were independently associated with hypokalemia. Recurrent UTI was associated with hypokalemia in UTI patients (OR: 1.13, 95% CI: 1.05 – 1.23, p < 0.001).Conclusions Urinary tract infection is associated with hypokalemia among inpatients. The association is independent of patients’ comorbidities and medications. Recurrent UTI is associated with increased hypokalemia in UTI patients.