bluuebunny/crossref_metadata_2025_split huggingface dataset:
Kotter’s 8 stages of change: implementation of clinical screening protocols for assessing patients for COVID-19 – a review of an academic medical centre’s preparedness
Authors: Ravi Shashank , Patel Sunny R , Laurence Sheneé K , Sebok-Syer Stefanie S , Gharahbaghian Laleh 
Published: May 2022

BackgroundCOVID-19 screening protocols rapidly evolved as a result of changing Centers for Disease Control and Prevention (CDC) and California Department of Public Health (CDPH) recommendations. These protocols led to operational improvements at one large academic medical centre using change management methods explained in Kotter’s 8-stage change model.MethodsWe reviewed all iterations of clinical process maps for identifying, isolating and assessing COVID-19 infections in paediatric and adult populations within one emergency department (ED) from 28 February 2020 to 5 April 2020. We incorporated CDC and CDPH criteria for the various roles of healthcare workers in ED patient assessment.ResultsUsing Kotter’s 8-stage change model, we outlined the chronological evolution of basic screening criteria, as well as how these were reviewed, modified and implemented during the onset and through the time of greatest uncertainty of COVID-19 in the USA. Our results demonstrate a successful creation, and subsequent execution, of rapidly changing protocols across a large workforce.ConclusionWe effectively applied a business change management framework to the hospital management response during a pandemic; we share these experiences and challenges to inform and guide future operational decision making during times of rapid change.
Clinical and histological findings at second but not at first kidney biopsy predict end-stage kidney disease in a large multicentric cohort of patients with active lupus nephritis
Authors: Gatto Mariele , Radice Francesca , Saccon Francesca , Calatroni Marta , Frontini Giulia , Trezzi Barbara , Zen Margherita , Ghirardello Anna , Tamborini Francesco , Binda Valentina , L'Imperio Vincenzo , Doria Andrea , Vaglio Augusto , Sinico Renato Alberto , Moroni Gabriella , Iaccarino Luca 
Published: May 2022

ObjectiveTo investigate second kidney biopsy as predictor of end-stage kidney disease (ESKD) in active lupus nephritis (LN).MethodsPatients with biopsy-proven LN (International Society of Nephrology/Renal Pathology Society 2003) who had undergone a second kidney biopsy between January 1990 and December 2018 were included. Clinical and histological findings at first and at second biopsy were analysed with Cox proportional hazard models to predict ESKD, defined as start of kidney replacement therapy. Survival curves were calculated with Kaplan-Meier method.ResultsNinety-two patients with LN were included, 87% females, mean follow-up 17.9±10.1 years. Reasons for second kidney biopsy encompassed nephritic flares (n=28, 30.4%), proteinuric flares (n=46, 50%) or lack of renal response (n=18, 19.5%). Class switch from first biopsy occurred in 50.5% of cases, mainly from non-proliferative towards proliferative classes. Class IV remained stable in over 50% of cases. Twenty-five patients (27.2%) developed ESKD, mostly belonging to the nephritic flare group (17/28, 60.7%). Independent predictors of ESKD at second biopsy were activity index (AI; (HR 95% CI) 1.20 (1.03 to 1.41), p=0.022), chronicity index (CI; 1.41 (1.09 to 1.82), p=0.008) and 24h-proteinuria (1.22 (1.04 to 1.42), p=0.013). AI≥2 (log-rank p=0.031), CI >4 (log-rank p=0.001) or proteinuria ≥3.5 g/day (log-rank=0.009) identified thresholds for higher ESKD risk. In a subgroup analysis, glomerular activity and tubular chronicity mostly accounted for AI and CI association with ESKD. No histological or laboratory predictors emerged at first biopsy (95% CI): AI: 0.88 to 1.19; CI: 0.66 to 1.20; proteinuria 0.85 to 1.08.ConclusionsFindings at second but not at first kidney biopsy in patients with persistently active or relapsing LN inform about ESKD development in a long-term follow-up.
Early-onset cardiac dysfunction following allogeneic haematopoietic stem cell transplantation
Authors: Moriyama Shohei , Fukata Mitsuhiro , Hieda Michinari , Yokoyama Taku , Yoshimoto Goichi , Kusaba Hitoshi , Nakashima Yasuhiro , Miyamoto Toshihiro , Maruyama Toru , Akashi Koichi 
Published: May 2022

ObjectiveHeart failure following allogeneic haematopoietic stem cell transplantation (allo-HSCT) is a serious complication that requires early detection; however, the clinical implications of early-onset cancer therapy-related cardiac dysfunction (CTRCD) following allo-HSCT remain unclear. We investigated the determinants and prognostic impact of early-onset CTRCD in allo-HSCT recipients.MethodsThe records of 136 patients with haematological malignancies who underwent allo-HSCT at our institute were retrospectively reviewed. Early-onset CTRCD was defined as a decrease in left ventricular ejection fraction (LVEF) of ≥10% and an LVEF of ≤53% within 100 days after HSCT.ResultsEarly-onset CTRCD was diagnosed in 23 out of 136 included patients (17%), and the median duration from HSCT to CTRCD diagnosis was 24 (9–35) days. Patients were followed up for 347 (132–1268) days. In multivariate logistic regression analysis, cumulative doxorubicin dosage (each 10 mg/m2) and severity of acute graft-versus-host disease (GVHD/grade) were independent indicators of early-onset CTRCD (OR (95% CI) 1.04 (1.00 to 1.07); p=0.032; OR (95% CI) 1.87 (1.19 to 2.95), p=0.004, respectively). The overall and primary disease death rates were significantly higher in allo-HSCT recipients with early-onset CTRCD than in those without early-onset CTRCD (HR (95% CI) 1.98 (1.11 to 3.52), p=0.016; HR (95% CI) 2.96 (1.40 to 6.29), p=0.005, respectively), independent of primary disease type, remission status and transplantation type.ConclusionsSevere acute GVHD and higher cumulative anthracycline are two significant determinants of early-onset CTRCD. Early-onset CTRCD following allo-HSCT regulates survival in patients with haematological malignancies.
Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies
Authors: Dikranian Ara H , Gonzalez-Gay Miguel A , Wellborne Frank , Álvaro-Gracia José María , Takiya Liza , Stockert Lori , Paulissen Jerome , Shi Harry , Tatulych Svitlana , Curtis Jeffrey R 
Published: May 2022

ObjectiveTofacitinib is an oral Janus kinase for the treatment of rheumatoid arthritis (RA). This post hoc analysis assessed whether baseline body mass index (BMI) impacts tofacitinib efficacy in patients with RA.MethodsPooled data from six phase 3 studies in patients receiving tofacitinib 5 mg (N=1589) or 10 mg (N=1611) twice daily or placebo (advancing to active treatment at months 3 or 6; N=680), ±conventional synthetic disease-modifying antirheumatic drugs, were stratified by baseline BMI (<25, 25 to <30, ≥30 kg/m2). Endpoints (through to month 6) were assessed descriptively: American College of Rheumatology 20/50/70 response rates; changes from baseline (∆) in Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4(ESR)), DAS28-4(C-reactive protein), Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) and pain; and proportions of patients achieving DAS28-4(ESR) ≥1.2 and HAQ-DI ≥0.22 decreases from baseline, low disease activity (DAS28-4(ESR) ≤3.2 or CDAI ≤10) and radiographic non-progression (Δmodified Total Sharp Score ≤0.5; months 12 and 24). Estimates were adjusted using multivariable models for selected outcomes. Univariate/multivariable regression analyses determined predictors of month 6 outcomes.ResultsOf 3880 patients included, 1690 (43.6%), 1173 (30.2%) and 1017 (26.2%) had baseline BMI <25, 25 to <30 and ≥30 kg/m2, respectively. Tofacitinib showed greater efficacy improvements versus placebo in each BMI category. Differences in efficacy outcomes (adjusted and unadjusted) were generally not clinically meaningful across BMI categories within treatment groups. In regression analyses, BMI was not consistently associated with selected outcomes.ConclusionsBaseline BMI did not consistently affect tofacitinib response suggesting that tofacitinib is an effective oral treatment option for adults with moderate to severe RA regardless of baseline BMI, including patients with BMI ≥30 kg/m2.Trial registration numbersNCT00814307, NCT01039688; NCT00960440; NCT00847613; NCT00856544; NCT00853385.
Non-B subtypes account for a large proportion of clustered primary HIV-1 infections in Italy
Authors: Bozzi Giorgio , Fabeni Lavinia , Abbate Isabella , Berno Giulia , Muscatello Antonio , Taramasso Lucia , Fabbiani Massimiliano , Nozza Silvia , Tambussi Giuseppe , Rusconi Stefano , Giacomelli Andrea , Focà Emanuele , Pinnetti Carmela , d'Ettorre Gabriella , Mussini Cristina , Borghi Vanni , Celesia Benedetto Maurizio , Madeddu Giordano , Di Biagio Antonio , Ripamonti Diego , Squillace Nicola , Antinori Andrea , Gori Andrea , Capobianchi Maria Rosaria , Bandera Alessandra 
Published: May 2022

Objectives and designUsingpolsequences obtained for routine resistance testing, we characterised the molecular patterns of HIV-1 transmission and factors associated with being part of a transmission cluster among individuals who in 2008–2014 presented with primary HIV-1 infection (PHI) at 11 urban centres across Italy.MethodsPolsequences were obtained by Sanger sequencing. Transmission clusters were identified by phylogenetic analysis (maximum likelihood method, confirmed by Bayesian analysis). Multivariable logistic regression explored factors associated with a participant being part of a transmission cluster.ResultsThe PHI cohort comprised 186 participants (159/186, 85.5% males) with median age 44 years, median CD4 count 464 cells/mm3and median plasma HIV-1 RNA 5.6 log10copies/mL. Drug resistance associated mutations were found in 16/186 (8.6%). A diversity of non-B subtypes accounted for 60/186 (32.3%) of all infections. A total of 17 transmission clusters were identified, including 44/186 (23.7%) participants. Each cluster comprised 2–6 sequences. Non-B subtypes accounted for seven clusters and 22/44 (50%) of clustered sequences. In multivariable logistic regression analysis, factors associated with being part of a transmission cluster comprised harbouring a non-B subtype (adjusted OR (adjOR) 2.28; 95% CI 1.03 to 5.05; p=0.04) and showing a lower plasma HIV-1 RNA (adjOR 0.80, 95% CI 0.64 to 0.99; p=0.04).ConclusionsThere was a large contribution of diverse non-B subtypes to transmission clusters among people presenting with acute or recent HIV-1 infection in this cohort, illustrating the evolving dynamics of the HIV-1 epidemic in Italy, where subtype B previously dominated.
Detecting anal human papillomavirus infection in men who have sex with men living with HIV: implications of assay variability
Authors: Torres Montserrat , Silva-Klug Ana , Ferrer Elena , Saumoy Maria , Trenti Loris , Tous Sara , Esteban Ana , Baixeras Nuria , Catala Isabel , Vidal August , G Bravo Ignacio , Podzamczer Daniel , de Sanjose Silvia 
Published: May 2022

BackgroundIncidence of anal cancer (AC) caused by persistent human papillomavirus (HPV) infection has risen in the last years in men who have sex with men (MSM) living with HIV. There is consensus that this population should be screened for anal precancerous lesions, but the role of HPV DNA testing in AC screening programmes is still under debate.ObjectivesThis study employed two molecular test to detect anal HPV DNA and compared assay performance and prognostic value for the diagnosis of histology proven high-grade intraepithelial anal lesions.MethodsMSM living with HIV attended their regular check-up visits consisting of detection of anal HPV infection, anal cytology, digital anorectal examination and high resolution anoscopy. HPV DNA was detected using Hybrid Capture 2 High-Risk test (HC2, total assay) and LINEAR ARRAY HPV Genotyping Test (LA, type-specific assay)ResultsAmong 274 participant, prevalence of HPV DNA was 48.5% by HC2 and 89.4% by LA. HPV16 (30.6%) and HPV6 (19.6%) were the most common genotypes identified. Prevalence of multiple HPV infections was 56.2%. Agreement between HPV DNA assays was 75.2% (κ=0.51; 95% CI 0.42 to 0.60). Total HPV detection demonstrated high sensitivity (90%; 95% CI 68.3 to 98.8) and moderate specificity (58.4%; 95% CI 50.2 to 66.3), while type-specific HPV16/18 genotyping provided an increase in specificity and showed the highest area under the curve (0.81; 95% CI 0.74 to 0.89) and Youden’s index (0.63).ConclusionsBoth methodologies identified a high prevalence of anal HPV infection and multiple HPV infections in MSM living with HIV, showing a moderate overall agreement between them. Either total HPV detection or type-specific HPV16/18 detection together with a threshold ≥atypical squamous cells of undetermined significance for abnormal cytology showed an acceptable diagnostic accuracy.
Long-term modification of gut microbiota by broad-spectrum antibiotics improves stroke outcome in rats
Authors: Liu Chang , Cheng Xi , Zhong Shanshan , Liu Zhouyang , Liu Fangxi , Lin Xinyu , Zhao Yinan , Guan Meiting , Xiao Ting , Jolkkonen Jukka , Wang Ying , Zhao Chuansheng 
Published: May 2022

BackgroundThe brain-gut axis is a major regulator of the central nervous system. We investigated the effects of treatment with broad-spectrum antibiotics on gut and brain inflammation, infarct size and long-term behavioral outcome after cerebral ischemia in rats.MethodsRats were treated with broad-spectrum antibiotics (ampicillin, vancomycin, ciprofloxacin, meropenem and metronidazole) for 4 weeks before the endothelin-1 induced ischemia. Treatment continued for 2 weeks until the end of behavioral testing, which included tapered ledged beam-walking, adhesive label test and cylinder test. Gut microbiome, short-chain fatty acids and cytokine levels were measured together with an assessment of infarct size, neuroinflammation and neurogenesis.ResultsThe results revealed that the antibiotics exerted a clear impact on the gut microbiota. This was associated with a decrease in systemic and brain cytokine levels, infarct size and apoptosis in the perilesional cortex and improved behavioral outcome.ConclusionOur results highlighted the significant relationship between intestinal microbiota and beneficial neuro-recovery after ischemic stroke.
High-flow nasal oxygen versus conventional oxygen therapy in patients with COVID-19 pneumonia and mild hypoxaemia: a randomised controlled trial
Authors: Crimi Claudia , Noto Alberto , Madotto Fabiana , Ippolito Mariachiara , Nolasco Santi , Campisi Raffaele , De Vuono Stefano , Fiorentino Giuseppe , Pantazopoulos Ioannis , Chalkias Athanasios , Libra Alessandro , Mattei Alessio , Scala Raffaele , Clini Enrico M , Ergan Begum , Lujan Manel , Winck Joao Carlos , Giarratano Antonino , Carlucci Annalisa , Gregoretti Cesare , Groff Paolo , Cortegiani Andrea 
Published: May 2022

RationaleIn patients with COVID-19 pneumonia and mild hypoxaemia, the clinical benefit of high-flow nasal oxygen (HFNO) remains unclear. We aimed to examine whether HFNO compared with conventional oxygen therapy (COT) could prevent escalation of respiratory support in this patient population.MethodsIn this multicentre, randomised, parallel-group, open-label trial, patients with COVID-19 pneumonia and peripheral oxygen saturation (SpO2) ≤92% who required oxygen therapy were randomised to HFNO or COT. The primary outcome was the rate of escalation of respiratory support (ie, continuous positive airway pressure, non-invasive ventilation or invasive mechanical ventilation) within 28 days. Among secondary outcomes, clinical recovery was defined as the improvement in oxygenation (SpO2≥96% with fractional inspired oxygen (FiO2) ≤30% or partial pressure of arterial carbon dioxide/FiO2ratio >300 mm Hg).ResultsAmong 364 randomised patients, 55 (30.3%) of 181 patients assigned to HFNO and 70 (38.6%) of 181 patients assigned to COT underwent escalation of respiratory support, with no significant difference between groups (absolute risk difference −8.2% (95% CI −18% to +1.4%); RR 0.79 (95% CI 0.59 to 1.05); p=0.09). There was no significant difference in clinical recovery (69.1% vs 60.8%; absolute risk difference 8.2% (95% CI −1.5% to +18.0%), RR 1.14 (95% CI 0.98 to 1.32)), intensive care unit admission (7.7% vs 11.0%, absolute risk difference −3.3% (95% CI −9.3% to +2.6%)), and in hospital length of stay (11 (IQR 8–17) vs 11 (IQR 7–20) days, absolute risk difference −1.0% (95% CI −3.1% to +1.1%)).ConclusionsAmong patients with COVID-19 pneumonia and mild hypoxaemia, the use of HFNO did not significantly reduce the likelihood of escalation of respiratory support.Trial registration numberNCT04655638.
Perceived effectiveness of objective elements of vaping prevention messages among adolescents
Authors: Boynton Marcella H , Sanzo Nora , Brothers Whitney , Kresovich Alex , Sutfin Erin L , Sheeran Paschal , Noar Seth M 
Published: May 2022

IntroductionIn recent years, vaping prevention campaigns have proliferated in response to a surge of e-cigarette use among adolescents in the USA. To date, the research literature has provided minimal guidance as to what vaping prevention message elements have the greatest potential for discouraging vaping, are ineffective or have unintended negative effects. The purpose of the current study was to identify and test a large set of vaping prevention ads used by federal, state, local and non-governmental agencies, examining how objectively coded message elements of vaping prevention messages might affect youth.MethodsA convenience sample of adolescents (N=1501) completed an online survey with each participant rating seven randomly selected vaping prevention ads from a pool of 220 ads on perceived message effectiveness (PME) and vaping appeal. Ads were coded on 37 objective elements in three message categories: themes, imagery and other features. Analyses examined how objective elements predicted PME.ResultsAddiction, chemicals, negative health symptoms and effects, and cigarette comparison themes were associated with higher PME, as were graphic images and warning symbols. Industry targeting, environmental impact, flavour themes, images of food and people’s faces were associated with lower PME, as were hashtags, statistics and first-person language or the word ‘teen’. Most elements were not associated with appeal, but ads with a flavour theme were associated with increased vaping appeal.ConclusionPromising vaping prevention messages focus on the adverse consequences of vaping, use negative imagery and avoid speaking for teens using their vernacular or perspective.
A comparison of anesthetic efficacy between dorsal penile nerve block (DPNB) with lidocaine and eutectic mixture of local anesthetics (EMLA) cream during neonatal circumcision
Authors: Emordi Victor Chekwube , Osifo David Osarumwense , Evbuomwan Iyekeoretin 
Published: May 2022

ObjectiveCircumcision is often performed in neonates and is associated with significant pain. This study was conducted to compare the anesthetic efficacy of two methods of local anaesthesia for neonatal circumcision: topical eutectic mixture of local anesthetics (EMLA) cream and dorsal penile nerve block (DPNB) with lidocaine.MethodsMale neonates who presented for circumcision and met the eligibility criteria were recruited for the study and were randomly assigned to one of the two methods of anesthesia before the procedure. Anesthetic efficacy was compared by pain assessment during four standardized steps of the procedure (clamping, crushing, tying, and cutting of the foreskin, respectively) using the modified Neonatal Infant Pain Scale (NIPS), changes in transcutaneous oxygen saturation (SpO2), heart rate (HR), and preoperative and postoperative salivary cortisol levels. Patients also were evaluated after 24 hours to assess for complications.ResultsTotally, 138 babies were recruited. Significantly higher NIPS scores were observed among babies who had EMLA cream during tying (p=0.019) and cutting (p=0.043). The rise in mean HR from baseline was statistically significant throughout the procedure in the EMLA group. In the DPNB group, there was no significant rise in mean HR during crushing (p=0.919) and cutting (p=0.197). There was a significant decrease in mean SpO2from baseline in both groups. Salivary cortisol showed significant increase in mean levels in both groups. No significant untoward effects were observed.ConclusionDPNB with lidocaine has a better pain control compared with EMLA cream during neonatal circumcision. Both methods are safe in neonates.
Postoperative apnea after pyloromyotomy for infantile hypertrophic pyloric stenosis
Authors: Camporesi Anna , Diotto Veronica , Zoia Elena , Rotta Simone , Tarantino Federica , Eccher Laura Maria Giuditta , Calcaterra Valeria , Pelizzo Gloria , Gemma Marco 
Published: May 2022

ObjectiveInfantile hypertrophic pyloric stenosis (IHPS), which causes gastric outlet obstruction and hypochloremic hypokalemic metabolic alkalosis, could pose a risk of postoperative apnea in patients. The aim of this study is to evaluate the incidence of postoperative apnea in babies admitted to a tertiary-level pediatric surgical center in Milano, Italy with diagnosis of IHPS in 2010–2019. The secondary objective is to evaluate the risk factors for postoperative apnea.MethodsThis is a single-center, retrospective, observational cohort study. All patients admitted to our institution with diagnosis of IHPS during the study period were enrolled. Demographic and surgical variables, along with blood gas parameters, were obtained from the population. Postoperative apnea was defined as a respiratory pause longer than 15 s or a respiratory pause lasting less than 15 s, but associated with either bradycardia (heart rate <120 per minute), desaturation (SatO2<90%), cyanosis, or hypotonia. Occurrence was obtained from nursing charts and was recorded as a no/yes dichotomous variable.ResultsOf 122 patients, 12 (9.84%) experienced apnea and 110 (90.16%) did not. Using univariate analysis, we found that only postoperative hemoglobin was significantly different between the groups (p=0.03). No significant multivariable model was better than this univariate model for prediction of apnea.ConclusionsPostoperative anemia, possibly due to hemodilution, increased the risk of postoperative apnea. It could be hypothesized that anemia can be added as another apnea-contributing factor in a population at risk due to metabolic changes.