bluuebunny/crossref_metadata_2025_split huggingface dataset:
Psychological problems and the associated factors related to the COVID-19 pandemic lockdown among college students in Amhara Region, Ethiopia: a cross-sectional study
Authors: Woday Tadesse Abay , Mihret Setegn Tarekegn , Biset Gebeyaw , Kassa Ayesheshim Muluneh 
Published: February 2022

ObjectiveThe central aim of this study was to assess the level of psychological problems among college students during school closure due to the emerging COVID-19 pandemic.DesignInstitution-based, cross-sectional study.SettingColleges in the Amhara regional state of Ethiopia.ParticipantsParticipants were college students (N=422, >18 years) who were actively enrolled in the selected colleges preceding the survey.MethodsData entry was done using Epi Info V.7.02 and data analysis was done using SPSS V.24.0. Variables with a p value less than 0.25 in the bivariate analysis were entered into the multivariable logistic regression model. Model fitness was checked using the Hosmer-Lemeshow model fitness test. Statistically significant level was declared at p<0.05.OutcomeLevel of psychological problem.ResultsThis study involved 408 students, with a response rate of 96.6%. In this study, 77.2%, 71.8% and 48.5% of students experienced depression, anxiety and stress-related psychological problems during the lockdown, respectively. The multivariable logistic regression model showed that being female (adjusted OR (AOR)=1.68, 95% CI 1.09 to 2.91), inadequate practice of prevention measures (AOR=1.74, 95% CI 1.01 to 3.02) and living in an urban residency (AOR=0.76, 95% CI 0.48 to 0.94) were independent predictors of psychological problems among students.ConclusionsThe study revealed that the level of anxiety, stress and depression disorders is optimally high among college students. Therefore, local governments should develop effective psychological interventions for students. Moreover, it is important to consider the educational enrolment type and the academic year of students.
Hypertensive disorders in pregnancy and risk of asthma in offspring: a systematic review and meta-analysis
Authors: Li Ping , Xiong Tao , Hu Yong 
Published: February 2022

ObjectivesThe association between hypertensive disorders in pregnancy (HDP) and an increased risk of asthma in offspring remains controversial. No systematic review of this topic has been performed. The aim of this systematic review was to summarise the available evidence regarding the association between HDP and the risk of asthma in offspring.DesignSystematic review and meta-analysis.MethodsOn the basis of a prepared protocol, a systematic search of PubMed, EMBASE, the Cochrane Library and Web of Science was performed using a detailed search strategy from the database inception to 17 January 2020. Cohort, case–control and cross-sectional studies published in English reporting the diagnoses of maternal HDP and asthma in offspring were included. The Meta-analysis of Observational Studies in Epidemiology guidelines were followed throughout the study. The estimated pooled ORs of HDP and asthma in offspring were calculated from the studies, and the meta-analysis was performed using random-effects models.ResultsTen cohort studies involving a total of 6 270 430 participants were included. According to the Newcastle-Ottawa Scale, the overall methodological quality was good since 8 studies were of high quality and 2 studies were of moderate quality. After controlling for potential confounders, HDP was associated with a possible increased risk of asthma in offspring, with a pooled adjusted OR (aOR) of 1.19 (95% CI 1.12 to 1.26). The subgroup analyses according to HDP subgroups, sibling design, study quality, study location, offspring ages, singleton status, exposure assessment, outcome assessment and adjusted factors showed similar results.ConclusionsExposure to HDP may be associated with an increased risk of asthma in offspring. Further research is needed to verify the results and determine whether the observed relationship is causal.PROSPERO registration numberCRD42020148250.
Expectation-induced enhancement of pain, itch and quality of life in psoriasis patients: study protocol of a randomised controlled trial
Authors: Hölsken Stefanie , Krefting Frederik , Schedlowski Manfred , Sondermann Wiebke 
Published: February 2022

IntroductionExperimental and clinical data demonstrate that skin diseases like psoriasis are affected by psychological factors and can be modulated by interventions other than conventional drug therapy. The expectation of patients towards the benefit of a forthcoming treatment as well as treatment pre-experiences have been demonstrated as crucial factors mediating placebo responses in inflammatory skin diseases. However, it is unknown whether and to what extent treatment outcomes of psoriasis patients under therapy with monoclonal antibodies like secukinumab can be experimentally modulated at subjective and physiological levels by modifying the expectation of patients via verbal instruction or prior experience.Methods and analysisTreatment expectations will be modulated in patients with moderate-to-severe psoriasis undergoing treatment with the anti-interleukin-17A monoclonal antibody secukinumab. Patients with a Psoriasis Area and Severity Index (PASI) >12 will be randomly allocated to one of three groups (N=40 each). As a standard schedule, patients in the pharmacological control group (group 1) will be treated weekly with 300 mg secukinumab, while patients in groups 2 and 3 will receive only 75 mg secukinumab (75% dose reduction) during all treatment weeks. In addition to the injections, patients in group 3 will ingest a novel tasting drink, with a cover story explaining that previous studies showed additional beneficial effects of this combination (drug and drink). Patients will be assessed and treated at nine visits over a 16-week period, during which the severity of pain and itch symptoms, skin lesions and quality of life will be analysed with standardised questionnaires and the PASI.Ethics and disseminationThis study was approved by the Ethics committee of the Medical Faculty of the University Duisburg-Essen. Study outcomes will be published in peer-reviewed scientific journals.
Prediction of exacerbation frequency of AECOPD based on next-generation sequencing and its relationship with imbalance of lung and gut microbiota: a protocol of a prospective cohort study
Authors: Deng Li , Yan Jiali , Xu Huachong , Huang Chunzhen , Lv Yiwen , Wu Qianxin , Xu Yinji , Chen Xiaoyin 
Published: February 2022

IntroductionPatients with frequent acute exacerbation phenotype chronic obstructive pulmonary disease (AECOPD) have a higher hospitalisation rate than infrequent exacerbation, the disease progresses quickly and treatment is more difficult. At present, it is impossible to predict patients with COPD with frequent acute exacerbation phenotypes. The composition of the lower respiratory tract flora and the intestinal flora is closely related to AECOPD, but the specific association mechanism between them is not very clear. This study used metagenomic next-generation sequencing (mNGS) technology to explore the microbial characteristics of the intestinal tract and airways of patients with COPD, and analyse the correlation between the sequencing results and inflammatory factors, immune factors and nutritional factors.Methods and analysisThis will be a prospective cohort study. We intend to recruit 152 patients with stable COPD. In the baseline, we will detect the participants’ induced sputum and faecal flora through mNGS, and changes in blood immune levels, and the patient’s condition is evaluated. Every 2 months, we will check the number of acute exacerbation through the phone range. After 12 months, we will check again the changes in the blood immune level, evaluate the patient’s condition and count the number of episodes.Ethics and disseminationThis study has been approved by the ethics committee of Guangdong Provincial Hospital of Traditional Chinese Medicine (approval number ZF2019-219-03). The results of the study will be published in peer-reviewed journals.Trial registration numberClinicalTrials.gov Registry (ChiCTR2000032870).
Health profiles and racial disparities among individuals on probation in Hennepin County, Minnesota, 2016: a cross-sectional study
Authors: Olson Marin , Shlafer Rebecca J , Bodurtha Peter , Watkins Jonathan , Hougham Courtney , Winkelman Tyler N A 
Published: February 2022

ObjectivesTo estimate the health characteristics and racial/ethnic health disparities among a probation cohort in Hennepin County. We hypothesised the probation population would have higher health needs compared with the general population as well as significant racial/ethnic health disparities.DesignCross-sectional study using linked administrative records.ParticipantsOf 7992 eligible individuals, 5873 met inclusion criteria of 6 or more months of eligibility for a full-benefit Minnesota healthcare plan.SettingProbation system in Hennepin County in 2016.OutcomesWe compared health condition prevalence among our probation cohort with survey data from the general population and analysed by race/ethnicity. We also measured sociodemographic characteristics, including the use of safety-net services.ResultsIndividuals were predominantly male (80.5%), young (mean age: 35.5 years), and disproportionately black or African American (52.9%). A majority of individuals enrolled in Medicaid were eligible via Medicaid expansion (65.9%). Compared with the general population, individuals on probation had higher rates of substance use disorders (66.5% vs 8.1%), mental illness (55.3% vs 14.4%) and many physical conditions (eg, asthma: 17.0% vs 12.5%, chronic kidney disease: 5.8% vs 0.2%). White individuals on probation were significantly more likely than black or African American individuals to have a diagnosed substance use disorder (71.6% vs 62.0%) or mental health disorder (64.9% vs 48.5%), but fewer chronic physical health conditions (average: 0.52 vs 0.73 chronic physical conditions).ConclusionsIndividuals on probation have high health needs, which vary substantially by race/ethnicity. Without attention to this variation, interventions to address health conditions in this population could worsen racial/ethnic disparities.
Prognostic value of derived neutrophil-to-lymphocyte ratio (dNLR) in patients with non-small cell lung cancer receiving immune checkpoint inhibitors: a meta-analysis
Authors: Yang Tao , Hao Lizheng , Yang Xinyu , Luo Changyong , Wang Guomi , Lin Cai Caroline , Qi Shuo , Li Zhong 
Published: February 2022

ObjectivesDerived neutrophil-to-lymphocytes ratio (dNLR) has recently been reported as a novel potential biomarker associated with prognosis of non-small cell lung cancer (NSCLC). However, evidence for the prognostic utility of dNLR in patients with NSCLC treated with immune checkpoint inhibitors (ICIs) remains inconsistent. The objective of this work was to evaluate the association between pretreatment dNLR and prognosis of patients with NSCLC treated with ICIs.DesignThis study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Data sourcesPubMed, EMBASE, Web of Science and the Cochrane Library were searched for eligible studies up to 16 October 2020.Eligibility criteria(1) Human subjects receiving ICIs therapy and who had been diagnosed with NSCLC; (2) the baseline values of dNLR were obtained; (3) the objective of the study was to investigate the relationships between dNLR and overall survival (OS) or progression-free survival (PFS) in NSCLC and (4) HR and 95% CI were displayed in the original article or could be extracted from Kaplan-Meier curves.Data extraction and synthesisTwo investigators extracted data independently. Data synthesis was performed via systematic review and meta-analysis of eligible cohort studies. Meta-analysis was performed with Cochran’s Q test and I2 statistics. Publication bias of studies was assessed by Begg’s test and Egger’s test. We used V.12.0 of the Stata statistical software.ResultsThis analysis included eight studies (2456 cases) on the prognostic utility of dNLR in ICI therapy for NSCLC. The results indicate that higher dNLR significantly predicted poor OS (HR=1.65, 95% CI 1.46 to 1.88; p<0.001) and PFS (HR=1.38, 95% CI 1.23 to 1.55; p<0.001). Subgroup analyses of OS-related studies indicated that there were similar results in stratifications by ethnicity, sample size, type of HR and dNLR cut-off value. As for PFS-related studies, subgroup analyses showed no significant difference in Asian populations. Publication biases were not detected using Begg’s test and Egger’s linear regression test.ConclusionsThis meta-analysis indicated that elevated pretreatment dNLR may be a negative prognostic predictor for patients with NSCLC treated with ICIs. More large-sample and higher-quality studies are warranted to support our findings.PROSPERO registration numberCRD42021214034.
Protocol for a prospective observational study: the Australia and New
Zealand Diabetic and Ischaemic Foot Outcomes Study (ANZ-DIFOS)
Authors: Hart Odette , Jansen Shirley , Fitridge Robert , Khashram Manar 
Published: February 2022

Introduction
Diabetic foot disease is a common condition globally and is
over-represented in indigenous populations. The propensity for patients
with diabetic foot disease to undergo minor or major limb amputation is
a concern. Diabetic foot disease and lower limb amputation are
debilitating for patients and have a substantial financial impact on
health services. The purpose of this multicentre study is to
prospectively report the presentation, management and outcomes of
diabetic foot disease, to validate existing scoring systems and assess
long term outcomes for these patients particularly in relation to major
limb amputation.

Methods and analysis
This is a multisite, international, prospective observational study,
being undertaken at Waikato Hospital, New Zealand (NZ); Sir Charles
Gairdner Hospital, the Royal Adelaide Hospital and the Queen Elizabeth
Hospital, Australia. Consecutive participants with diabetic foot disease
that meet inclusion criteria and agree to participate will be recruited
from multidisciplinary team diabetic foot clinic, vascular clinic,
dialysis and admission to hospital. Follow-up of participants will occur
at 1, 3, 6 and 12 months. At recruitment and follow-up reviews,
information about service details, demographic and clinical history,
wound data and discharge information will be recorded. The primary
outcomes are the time to wound healing, major amputation, overall
mortality and amputation-free survival at 12 months. This study started
in NZ in August 2020 and will commence in Australian sites in early
2021.

Ethics and dissemination
New Zealand Central Health and Disability Ethics Committee
(20/CEN/122), Waikato DHB Research Department (RDO020044), Quality
Improvement HoD Sir Charles Gairdner Hospital (39715) and the Central
Adelaide Local Health Network (CALHN) Human Research Ethics Committee
(13928). Results will be presented at international conferences and
published in peer-reviewed journals.

Trial registration number
Australian New Zealand Clinical Trials Registry
(ACTRN12621000337875).
Impact of Bariatric surgery on EmbrYONic, fetal and placental Development (BEYOND): protocol for a prospective cohort study embedded in the Rotterdam periconceptional cohort
Authors: Snoek Katinka M , Steegers-Theunissen Régine P M , Klaassen René A , Laven Joop S E , Schoenmakers Sam 
Published: February 2022

IntroductionThe worldwide obesity epidemic has resulted in a rise of bariatric surgery in women of reproductive age, which can lead to ‘iatrogenic undernutrition’. Long-lasting undernutrition can affect maternal health, pregnancy outcomes and offspring. We hypothesise that embryonic and placental growth are impaired in pregnancies after bariatric surgery due to the changed nutritional and microbiome dynamics. Therefore, our aim is to conduct the Bariatrics and EmbrYONic Development (BEYOND) study to investigate parameters of maternal nutritional and health status after bariatric surgery, both periconceptionally and during pregnancy, particularly concentrating on embryonic and fetal growth trajectories as well as placental development.Methods and analysisWe designed a single-centre prospective, observational cohort, which investigates the iatrogenic nutritional and health status of women after bariatric surgery, periconceptionally and during pregnancy. The BEYOND study is embedded in the Rotterdam Periconceptional Cohort, a tertiary hospital-based birth cohort study. Eligible participants are women planning pregnancy or <12+0 weeks pregnant, ≥18 and ≤45 years of age, who have undergone bariatric surgery (cases) or without prior bariatric surgery (controls) and their male partners. Medical charts will be reviewed and questionnaires regarding general health, lifestyle and food intake will be collected. Moreover, we will perform serial three-dimensional ultrasounds to assess embryonic growth and placental development and two-dimensional ultrasounds for fetal growth assessment. The microbiome, including the virome, and blood samples will be sampled during the preconception period and in each trimester. Multivariable linear mixed model analyses will be used to assess the associations between bariatric surgery and pregnancy outcomes.Ethics and disseminationThis proposal was approved by the Medical Ethics Committee from the Erasmus MC, Rotterdam, The Netherlands. Study results will be submitted for publication in high-impact journals, presented at scientific conferences, implemented into guidelines and communicated through the Erasmus MC and collaborating partners.Trial registration numberNL8217 (www.trialregister.nl).
Endobronchial ultrasound in diagnosing and staging of lung cancer by Acquire 22G TBNB versus regular 22G TBNA needles: study protocol of a randomised clinical trial
Authors: Kuijvenhoven Jolanda C , Kramer Tess , Korevaar Daniël A , Ninaber Maarten K , Trisolini Rocco , Szlubowski Artur , Gnass Maciej , von der Thüsen Jan , Cohen Danielle , Bonta Peter I , Annema Jouke T 
Published: February 2022

IntroductionAccurate diagnosis and staging of lung cancer is crucial because it directs treatment and prognosis. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound with bronchoscope fine-needle aspiration (EUS-B-FNA) are important in this process by sampling hilar/mediastinal lymph nodes and centrally located lung tumours. With the upcoming of immunotherapy and targeted therapies, assessment of programmed death ligand 1 (PD-L1) expression and molecular profiling has become important but is often impossible in cytological samples obtained through standard 22G TBNA needles. Recently, a three-pronged cutting edge 22G needle was developed that allows for transbronchial needle biopsy (TBNB). Our objective is to determine if EBUS/EUS-B-guided nodal/lung tumour sampling with Acquire 22G TBNB needles results in an improved suitability rate for the assessment of PD-L1 expression in comparison to standard 22G TBNA needles in patients with a final diagnosis of lung cancer.Methods and analysisThis is an investigator-initiated, parallel group randomised clinical trial. Patients are recruited at respiratory medicine outpatient clinics of participating university and general hospitals in the Netherlands, Poland and Italy. In total 158 adult patients with (suspected) lung cancer are included if they have an indication for mediastinal/hilar lymph node or lung tumour sampling by EBUS-TBNA and/or EUS-B-FNA based on current clinical guidelines. Web-based randomisation between the two needles will be performed. Samples obtained from mediastinal/hilar lymph nodes and/or primary tumour will be processed for cytology smears and cell block analysis and reviewed by blinded reference pathologists. An intention-to-treat analysis will be applied. Patients with missing data will be excluded from analysis for that specific variable but included in the analysis of other variables. This study is financially supported by Boston Scientific.Ethics and disseminationThe study was approved by the local Ethics Committee (Medisch Ethische Toetsingscommissie Amsterdam Medical Center (AMC)). Dissemination will involve publication in a peer-reviewed biomedical journal.Trial registration numberNL7701; Pre-results.
Cohort profile: the Acquired Brain Injury Community REhabilitation and Support Services OuTcomes CohoRT (ABI-RESTaRT), Western Australia, 1991–2020
Authors: Mann Georgina , Troeung Lakkhina , Wagland Janet , Martini Angelita 
Published: February 2022

PurposeTransition back into the community following acute management of acquired brain injury (ABI) is a critical part of recovery. Post-acute rehabilitation and transitional care can significantly improve outcomes. The Acquired Brain Injury Community REhabilitation and Support Services OuTcomes CohoRT (ABI-RESTaRT) is a novel whole-population cohort formed to better understand the needs of individuals with ABI receiving post-acute rehabilitation and disability services in Western Australia (WA), and to improve their outcomes. To do this a unique combination of (1) internal clinical/rehabilitation data, and (2) externally linked health data from the WA Data Linkage System was used, including hospitalisations, emergency department presentations, mental health service use and death records, to measure longitudinal needs and outcomes of individuals with ABI over 29 years, making this the largest, most diverse post-acute ABI cohort in Australia to date.ParticipantsWhole-population cohort of individuals (n=1011) with an ABI who received post-acute community-based neurorehabilitation or disability support services through Brightwater Care Group from 1991 to 2020.Findings to dateComprehensive baseline demographic, clinical and rehabilitation data, outcome measures and linked health data have been collected and analysed. Non-traumatic brain injury (eg, stroke, hypoxia) was the main diagnostic group (54.9%, n=555), followed by traumatic brain injury (34.9%, n=353) and eligible neurological conditions (10.2%, n=103). Mean age at admission was 45.4 years, and 67.5% were men (n=682). The cohort demonstrated significant heterogeneity, socially and clinically, with differences between ABI groups across a number of domains.Future plansABI-RESTaRT is a dynamic whole-population cohort that will be updated over time as individuals enrol in the service. Future analyses will assess longitudinal brain injury outcomes, the changing health and social needs of individuals with ABI and evaluate and inform post-acute services to best support these individuals.RegistrationThis cohort is not linked to a clinical trial, and is not registered.