bluuebunny/crossref_metadata_2025 huggingface dataset:
Population diversity of cardiovascular outcome trials and real-world patients with diabetes in a Chinese tertiary hospital
Authors: Zhou Yi-Ling , Zhang Yong-Gang , Zhang Rui , Zhou You-Lian , Li Nan , Wang Mi-Ye , Tian Hao-Ming , Li She-Yu
Published: March 2021

Background:

Recent cardiovascular outcome trials (CVOTs) changed the therapeutic strategy of guidelines for type 2 diabetes. We compared the characteristics of patients from real-world hospital settings with those of participants in recent pragmatic randomized trials.

Methods:

This electronic medical record (EMR)-based retrospective observational study investigated the data of patients with diabetes from inpatient and outpatient settings in West China Hospital of Sichuan University from January 1, 2011, to June 30, 2019. We identified patients meeting the inclusion criteria of a pragmatic randomized trial (EMPA-REG OUTCOME) based on EMRs and compared their baseline characteristics with those of the trial participants. The cutoff for the clinical significance of each characteristic was set as its minimal clinically important difference based on expert consultation.

Results:

We included 48,257 inpatients and 36,857 outpatients with diabetes and found that 8389 (17.4%) inpatients and 2646 (7.2%) outpatients met the inclusion criteria for the EMPA-REG OUTCOME trial. Compared with the trial population, the real-world inpatients meeting the eligibility criteria of the EMPA-REG OUTCOME had similar age, blood pressure, and lipid profiles but comprised of fewer males, metformin users, anti-hypertensive drug users, and aspirin users, and had a lower body mass index. The group of outpatients meeting the eligibility criteria had fewer males, similar age, fewer metformin users, fewer insulin users, fewer anti-hypertensive drug users, and fewer aspirin users compared with the trial population.

Conclusions:

The trial population in EMPA-REG OUTCOME represents only a small portion of patients with diabetes from the inpatient and outpatient departments of a Chinese tertiary medical center. Evidence localization in different clinical settings and validation are essential to enabling extrapolation of the results from CVOTs in patients with diabetes to Chinese clinical practice.
A Study of Botulinum Toxin A for Ultraviolet-Induced Hyperpigmentation: A Randomized Controlled Trial
Authors: Vachiramon Vasanop , Kositkuljorn Chaninan , Leerunyakul Kanchana , Rattananukrom Teeraphong , Jurairattanaporn Natthachat
Published: March 2021

BACKGROUND

Ultraviolet (UV) exposure contributes to skin hyperpigmentation. Recently, botulinum neurotoxin type A (BoNT-A) showed a promising protective effect on UVB-induced hyperpigmentation in both in vitro and animal models.

OBJECTIVE

The study aimed to investigate the preventive effect of BoNT-A against UVB-induced hyperpigmentation in human subjects.

MATERIALS AND METHODS

A prospective, double-blinded, randomized controlled trial was performed in 15 healthy participants. Four separate square areas on the abdomen were randomly injected intradermally with different dilutions of BoNT-A (1:2.5, 1:5, 1:7.5) and normal saline (control). Two weeks after injection, hyperpigmented spots were induced by UVB irradiation at the experimental sites. The lightness index and hyperpigmentation scores from blinded physician and participants were evaluated.

RESULTS

Fifteen participants completed the study. One week after UVB irradiation, all BoNT-A-treated sites had a significantly lower degree of hyperpigmentation than the control site in lightness index and hyperpigmentation scores from blinded physician and participants (p < .05). However, no statistically significant difference was observed between different concentrations of BoNT-A. No side effects were observed throughout the study period.

CONCLUSION

Intradermal BoNT-A injection provided a protective effect from UVB-induced hyperpigmentation. It may be used for other hyperpigmentation disorders that are aggravated by UVB.
Addressing New Possibilities and New Challenges: Automated Nondestructive Hematocrit Normalization for Dried Blood Spots
Authors: Luginbühl Marc , Gaugler Stefan
Published: March 2021

The patient's hematocrit (HCT) level can adversely affect the analysis results when dried blood spots (DBS) are used for sampling. Volumetric DBS sampling has been proposed to nullify the impact of HCT area bias (spreading area) on DBS by normalizing to a known sample volume. However, this strategy ignores DBS-related parameters such as analyte properties (red blood cell–to-plasma ratio) and HCT recovery bias. With the recent release of fully automated HCT measurement systems for DBS analysis, a broad range of end users are now able to measure and correct a sample's HCT level in a nondestructive manner. These systems permit correction for all known HCT-related impacts on DBS, such as analyte properties, HCT recovery bias, HCT area bias, and venous blood–to-DBS ratio, supporting and accelerating future quantitative DBS applications. However, with these novel tools, new questions arise concerning the normalization of analytical results, the choice of technique (single-wavelength reflectance vs near-infrared spectroscopy), and the DBS card-handling process post sampling. Herein, the necessary considerations for end users are addressed and examples are provided.
Unexpected Vancomycin Pharmacokinetic Profile Secondary to Macromolecular Complexing: A Case Series
Authors: Rice Mikhaila L. , Go John Raymond , Rivera Christina G. , Zeuli John D. , Saleh Omar Abu , Baumann Nikola A. , Stevens Ryan W.
Published: March 2021

Background:

The optimal dosing and monitoring of vancomycin has been largely debated for decades, with key guideline changes for recommended monitoring in 2009 and 2020. Current and past practices for pharmacokinetic dose optimization use serum drug assays to guide dose adjustment to effectively balance efficacy and the risks of toxicity. These assays detect both bound and unbound serum concentrations. Vancomycin is believed to be 50%–55% protein bound in most cases; however, some variability in this parameter has been previously published. The authors report 2 cases of abnormal vancomycin pharmacokinetics discovered based on unexpected serum levels during routine clinical care.

Methods:

Unexpected vancomycin levels, observed during clinical care for 2 separate patients, were further evaluated to determine the source of the abnormal pharmacokinetics. In case 1, serial dilution was performed to assure that assay interference was not associated with the significant elevation (>100 mg/L). In both cases, samples were filtered using a Millipore Centrifree 30 KDa centrifugal filter to separate bound vancomycin, with a Protein G spin kit used to bind IgG and remove IgG complexes from the patient sample. In case 2, a polyethylene glycol precipitation was also performed to precipitate large-molecular-weight complexes.

Results:

In both cases, laboratory analysis revealed abnormal vancomycin protein-binding profiles with macromolecular complex formation. Immunoglobulin G played a role in the macrocomplex in both patients.

Conclusions:

In cases of unusual or unexpected vancomycin pharmacokinetics in the absence of renal dysfunction, an abnormal protein-binding profile should be considered. Bound vancomycin may yield elevated serum levels, leading to poorly informed dose adjustments and risk for treatment failure. Given implications for therapeutic drug monitoring and unknown impacts on efficacy and toxicity, further investigations into population incidence and risk factors for abnormal protein binding of vancomycin are warranted.
Evaluating Functional Outcomes in Reanimation Surgery for Chronic Facial Paralysis: A Systematic Review
Authors: Rodriguez Colon Ricardo , Park Jenn J. , Boczar Daniel , Diep Gustave K. , Berman Zoe P. , Trilles Jorge , Chaya Bachar F. , Rodriguez Eduardo D.
Published: March 2021

Background:

Chronic facial paralysis can lead to significant functional and psychosocial impairment. Treatment often involves free muscle flap-based facial reanimation surgery. Although surgical techniques have advanced considerably over the years, consensus has yet to be reached for postoperative outcome evaluation. To facilitate outcome comparison between the various techniques for free muscle-flap-based reanimation, a standardized, widely accepted functional outcomes assessment tool must be adopted.

Methods:

In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we performed a systematic review of the PubMed, Cochrane, and Embase databases to identify the reported functional outcome measurement tools used in the free muscle flap-based reanimation literature.

Results:

The search yielded 219 articles, 43 of which met our inclusion and exclusion criteria. We noted an increase in publications reporting the utilization of objective measures over time, particularly software-based tools, as well as increased utilization of patient reported outcomes measures.

Conclusions:

Based on the trends identified in the literature, we suggest standardization of outcome measures following facial reanimation surgery with free muscle-flap using a combination of the Facial Assessment by Computer Evaluation (FACEgram) software and the Facial Clinimetric Evaluation (FaCE) Scale.
A Novel mRNA Modification Mutation in a Patient With Ligneous Conjunctivitis Coexisting With Heterozygous Familial Mediterranean Fever Mutation
Authors: Koseoglu Neslihan D. , Ceylaner Serdar , Yildirim Nilgun
Published: March 2021

Purpose:

To describe a novel mRNA mutation associated with ligneous conjunctivitis (LC) in a patient with heterozygous familial Mediterranean fever (FMF) mutation.

Methods:

Case presentation of a patient with LC and heterozygous FMF mutation. The patient was evaluated for various genetically predisposed inflammatory diseases through whole exome sequencing.

Results:

LC is a rare inflammatory ocular pathology presenting with recurrent conjunctivitis episodes with eosinophilic fibrin-rich pseudomembranes. FMF is an autoinflammatory disease presenting with recurrent episodes of fever, arthritis, and other inflammatory conditions. Various plasminogen (PLG) gene mutations have been identified in LC, whereas a variety of mutations in the Mediterranean fever (MEFV) gene have been identified in FMF patients. Based on the inflammatory nature of both pathologies, we aimed to evaluate and identify any potential common genetic pathway. We were not able to identify any mutation in PLG gene through whole gene sequencing; however, the patient was positive for heterozygous M680I FMF mutation, and we observed 22% of NM_000301.3:c.2130T>G (p.T710=) variant in mRNA isolated from affected tissue, which was not present in DNA sequence.

Conclusions:

To the best of our knowledge, this is the first case of LC caused by an mRNA mutation coexisting with another genetically predisposed autoinflammatory disease mutation.
Toric intraocular lens power calculation in cataract patients with keratoconus
Authors: Ton Yokrat , Barrett Graham D. , Kleinmann Guy , Levy Adi , Assia Ehud I.
Published: March 2021

Purpose:

Intraocular lens (IOL) power calculation in eyes with keratoconus typically results in hyperopic postoperative refractive error. The purpose of this study was to investigate the visual and refractive outcomes in patients with keratoconus having cataract surgery with a toric IOL and compare IOL power calculation accuracy of conventional formulas and keratoconus-specific formulas.

Setting:

Ein-Tal Eye Center, Tel-Aviv, Israel.

Design:

Retrospective case-series study.

Methods:

Postoperative visual acuity and manifest refraction were examined. The error in predicted refraction and IOL power calculation accuracy within a range of 0.50 to 2.00 diopters (D) were compared between different IOL calculating formulas.

Results:

32 eyes with keratoconus were included. Visual acuity improved in all cases, and subjective astigmatism decreased from −2.95 ± 2.10 D to −0.95 ± 0.80 D (P < .001). The mean absolute errors were as follows: Barrett True-K formula for keratoconus with measured or predicted posterior corneal power, 0.34 D; Barrett Universal II formula, 0.64 D; Kane formula, 0.69 D; Kane formula for keratoconus, 0.49 D; SRK/T formula, 0.56 D; Haigis formula, 0.72 D; Holladay 1 formula, 0.71 D, and Hoffer Q formula, 0.87 D. Barrett True-K formula with measured posterior corneal power, SRK/T formula, and Kane formula for keratoconus resulted in a prediction error within ±0.50 D of 87.5%, 59.4%, and 53.1%, respectively.

Conclusions:

Cataract removal with a toric IOL significantly improves visual acuity and decreases astigmatism in keratoconic eyes with a topographic central relatively regular astigmatic component. Keratoconus-specific formulas resulted in lower mean error in predicted refraction compared with conventional calculating formulas. Using the posterior corneal power within the Barrett True-K formula for keratoconus improved IOL power prediction accuracy.
Pharmacokinetic Profile of the Asenapine Transdermal System (HP-3070)
Authors: Suzuki Katsumi , Castelli Mariacristina , Komaroff Marina , Starling Brittney , Terahara Takaaki , Citrome Leslie
Published: March 2021

Purpose/Background

The asenapine transdermal system (HP-3070) is the first antipsychotic patch approved in the United States for treatment of adults with schizophrenia.

Methods/Procedures

Three phase 1, open-label, randomized studies characterized the pharmacokinetic (PK) profile of HP-3070 by assessing its relative bioavailability compared with sublingual asenapine, its single-/multiple-dose PK and dose proportionality, and the effects of application site, ethnicity, and external heat on bioavailability. Two studies were conducted in healthy subjects, and 1 was conducted in adults with schizophrenia.

Findings/Results

During single HP-3070 administration, asenapine concentrations increased gradually over approximately 12 hours and remained steady until the patch was removed 24 hours after application. Asenapine area under the curve values at HP-3070 3.8 and 7.6 mg/24 hours doses were similar to those for sublingual asenapine 5 and 10 mg twice-daily doses, respectively, whereas peak exposure (maximum observed plasma concentration) was significantly lower. During daily application of HP-3070, steady-state PK was reached within approximately 72 hours after initiating daily dosing and was characterized by peak-to-trough asenapine plasma concentration ratio of approximately 1.5. HP-3070 PK was dose proportional in the dose range studied, not affected by administration site, and similar across the studied ethnic groups. Application of external heat increased the rate of asenapine absorption (time to reach maximum observed plasma concentration) but did not significantly affect peak and total exposure.

Implications/Conclusions

HP-3070 exhibited a dose-dependent PK profile unaffected by site of administration or ethnicity. HP-3070 showed a predictable absorption profile with limited variability, with an area under the curve similar to that of sublingual asenapine. Based on these PK metrics, HP-3070 steadily delivers asenapine with lower peaks and troughs than sublingual administration of asenapine.
Aortic arch calcification: a novel parameter for prediction of masked hypertension
Authors: Akbay Ertan , Çoner Ali , Akinci Sinan , Adar Adem , Çakan Fahri , Müderrisoğlu Haldun
Published: March 2021

Background

Masked hypertension is directly related to increased cardiovascular morbidity and mortality but remains underdiagnosed in clinical practice. The aim of the study was to search the role of aortic arch calcification (AAC) in the diagnosis of masked hypertension.

Methods and results

Among the patients who underwent ambulatory blood pressure monitoring (ABPM) in our clinic, those with office blood pressure (OBP) <140/90 mmHg were included in the study population. According to OBP, they were divided into two groups as normal (<130/85 mmHg) and high normal (130–139/85–89 mmHg) OBP groups. Subjects were also investigated for the presence of masked hypertension with ABPM and searched in masked hypertension and control groups. Masked hypertension was defined as in the latest 2017 ACC/AHA Hypertension guideline and was diagnosed as the daytime BP ≥ 135/85 mmHg and nighttime BP ≥ 120/70 mmHg. AAC was evaluated on direct X-ray telecardiography. Diagnosis of masked hypertension was searched depending on the presence of AAC and OBP measurements as well. A total of 216 volunteers were involved in the study [mean age 45.2 ± 12.2 years; female gender 120 (55.5%)]. One hundred ten volunteers (50.9%) had masked hypertension according to the ABPM. AAC was significantly more common in the masked hypertension group (44.5% vs. 26.4%) (P = 0.005). AAC had a positive predictive value of 79% in those with high normal OBP in the diagnosis of masked hypertension, and also AAC had a negative predictive value of 74% in those with normal OBP.

Conclusion

AAC can be used as a reliable diagnostic tool to exclude and predict masked hypertension during office examination.
Comparison of Biliary Drainage Techniques for Malignant Biliary Obstruction
Authors: Xie Jesse , Garg Shashank , Perisetti Abhilash , Tharian Benjamin , Murad Mohammad Hassan , Inamdar Sumant
Published: March 2021

Background and Aims:

Endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic biliary drainage, and endoscopic ultrasound (EUS)-guided biliary drainage are all established techniques for drainage of malignant biliary obstruction. This network meta-analysis (NMA) was aimed at comparing all 3 modalities to each other.

Materials and Methods:

Multiple databases were searched from inception to October 2019 to identify relevant studies. All the patients were eligible to receive any one of the 3 interventions. Data extraction and risk of bias assessment was performed using standardized tools. Outcomes of interest were technical success, clinical success, adverse events, and reintervention. Direct meta-analyses were performed using the random-effects model. NMA was conducted using a multivariate, consistency model with random-effects meta-regression. The GRADE approach was followed to rate the certainty of evidence.

Results:

The final analysis included 17 studies with 1566 patients. Direct meta-analysis suggested that EUS-guided biliary drainage had a lower reintervention rate than ERCP. NMA did not show statistically significant differences to favor any one intervention with certainty across all the outcomes. The overall certainty of evidence was found to be low to very low for all the outcomes.

Conclusions:

The available evidence did not favor any intervention for drainage of malignant biliary obstruction across all the outcomes assessed. ERCP with or without EUS should be considered first to allow simultaneous tissue acquisition and biliary drainage.
Low Rates of Hepatitis B Virus Treatment Among Treatment-Eligible Patients in Safety-Net Health Systems
Authors: Wong Robert J. , Jain Mamta K. , Therapondos George , Niu Bolin , Kshirsagar Onkar , Thamer Mae
Published: March 2021

Background:

Timely initiation of antiviral therapy in chronic hepatitis B virus (CHB) reduces risk of disease progression. We evaluate overall treatment rates and predictors of treatment among treatment-eligible safety-net CHB patients.

Methods:

We retrospectively evaluated adults with CHB from 2010 to 2018 across 4 large safety-net health systems in the United States. CHB was identified with ICD-9/10 diagnosis coding and confirmed with laboratory data. Treatment eligibility was determined using American Association for the Study of Liver Diseases (AASLD) guidelines. Comparison of CHB treatment rates among treatment-eligible patients were performed using χ2 testing, Kaplan Meier methods and log-rank testing. Adjusted multivariate Cox proportional hazards models evaluated independent predictors of receiving treatment among eligible patients.

Results:

Among 5157 CHB patients (54.7% male, 34.6% African American, 22.3% Asian), 46.8% were treatment-eligible during the study period. CHB treatment rates were 48.4% overall and 37.3% among CHB patients without human immunodeficiency virus. Significantly lower odds of treatment were observed in females versus males (odds ratio: 0.40, 95% confidence interval: 0.33-0.49, P<0.001) and patients age 65 years or above versus age below 45 years (odds ratio: 0.68, 95% confidence interval: 0.51-0.92, P=0.012). Conversely, significantly greater odds of treatment were observed in African American and Asians versus non-Hispanic whites, CHB patients with indigent care versus commercially insured patients, and non-English speaking versus English speaking patients.

Conclusion:

Among a large multicentered, safety-net cohort of CHB patients, 46.8% of treatment-eligible CHB patients overall and 37.3% of treatment-eligible CHB patients without human immunodeficiency virus received antiviral therapy. Improving CHB treatment rates among treatment-eligible patients represents “low hanging fruit,” given the clear benefits of antiviral therapy in mitigating disease progression.
Proactive therapeutic drug monitoring is more effective than conventional management in inducing fecal calprotectin remission in inflammatory bowel disease
Authors: Fernandes Samuel Raimundo , Serrazina Juliana , Rodrigues Inês Coelho , Bernardo Sónia , Rita Gonçalves Ana , Valente Ana , Baldaia Cilénia , Santos Paula Moura , Correia Luís Araújo , Tato Marinho Rui
Published: March 2021

Background

Proactive therapeutic drug monitoring (pTDM) may improve treatment outcomes in inflammatory bowel disease.

Aims and methods

We compared 135 patients following a prospective pTDM protocol aiming at an infliximab trough level (IFXTL) between 5 and 10 μg/ml with sequential measurements of Fc, with 108 patients from a retrospective group under conventional management. We evaluated the rates of Fc remission (<250 μg/g) and other clinical outcomes at 2-year of follow-up.

Results

pTDM associated with higher rates of Fc remission (69.6% vs. 50.0%; P = 0.002), and steroid-free clinical remission (78.4% vs. 55.2%, P = 0.028) with a trend for clinical remission (79.3% vs. 68.5%, P = 0.075). There was no difference in treatment discontinuation (P = 0.195), hospitalization (P = 0.156), and surgery (P = 0.110). Higher IFXTL associated with Fc remission at week 14 (6.59 vs. 2.96 μg/ml, P < 0.001), and at the end of follow-up (8.10 vs. 5.03 μg/ml, P = 0.001). In patients reaching Fc remission after week 14, IFXTL increased from week 14 to the end of follow-up (2.71 vs. 8.54 μg/ml, P < 0.001). Fc remission associated with higher rates of clinical (85.8% vs. 56.8% P < 0.001) and steroid-free clinical remission (86.9% vs. 50.0% P < 0.001), lower IFX discontinuation (8.8% vs. 36.8%, P < 0.001), and hospitalization (13.5% vs. 33.7%, P < 0.001), without significance for surgery (6.1% vs. 12.6%, P = 0.101).

Conclusion

pTDM was more effective than conventional management in inducing Fc remission which was associated with improved outcomes.
Natural history and predictors associated with the evolution of portal venous system thrombosis in liver cirrhosis
Authors: Xu Shixue , Guo Xiaozhong , Xu Xiangbo , Wang Le , Tacke Frank , Primignani Massimo , He Yanglan , Yin Yue , Yi Fangfang , Qi Xingshun
Published: March 2021

Background

Portal venous system thrombosis (PVST) will progress in some cases, indicating worse outcome and the necessity of antithrombotic treatment, but will spontaneously improve in others. It is crucial to understand the natural history of PVST in liver cirrhosis. However, the knowledge regarding how to predict the evolution of PVST in cirrhotic patients is very scant.

Methods

Sixty-nine cirrhotic patients without malignancy, who had undergone repeated contrast-enhanced computed tomography or MRI to evaluate the severity of PVST at the first and last admissions, were included. Logistic regression analysis was performed to identify the risk factors for the evolution of PVST in liver cirrhosis. Odds ratios (ORs) were calculated.

Results

Among 42 patients without PVST at the first admission, 10 (23.8%) developed PVST at the last admission. Serum albumin level (OR = 0.873), prothrombin time (OR = 1.619), activated partial thromboplastin time (OR = 1.169), Child-Pugh score (OR = 1.560) and model for end-stage liver disease (MELD) score (OR = 1.292) at the last admission were significant risk factors associated with the development of PVST. Among 27 patients with PVST at the first admission, 11 (40.7%), 4 (14.8%) and 12 (44.4%) had improvement, stabilization and progression of PVST at the last admission, respectively. ΔMELD score (OR = 0.714) was the only significant risk factor associated with the improvement of PVST; additionally, serum albumin level at the first admission (OR = 1.236) was the only significant risk factor associated with the progression of PVST.

Conclusion

Aggravation and amelioration of liver dysfunction may predict the development and improvement of PVST in liver cirrhosis, respectively.
Standardized Discharge Planning Tool Leads to Earlier Discharges and Fewer Readmissions
Authors: Kucharczuk Colleen , Lightheart Erin , Kodan Allison , Haynes Cassandra , Rabatin Susan , Burke Joy , Senger Jamie , Lee Lindsay , Brinley Sarah , Decena Mary Angela , Cruz Juanita M. , Hirsh Rebecca , McCauley Kathy
Published: March 2021

Background:

In an inpatient setting, aspects of discharge planning are often left to the provider's memory, leading to errors, inefficiencies, and avoidable costs.

Methods:

A multidisciplinary team of oncology practitioners used process improvement methodologies to redesign the discharge planning process.

Interventions:

The primary intervention was an evidence-based discharge planning tool, called the discharge navigator, used from admission through discharge.

Results:

Thirty-day unplanned readmission rates decreased by 29.0% from preimplementation (March 2017 through August 2017) to postimplementation (September 2017 through March 2020). The percentage of patients discharged before noon increased 76.2%. A comparable service not utilizing the intervention saw lesser or no improvement in these measures.

Conclusion:

The tool provided a systematic approach to discharge planning. Key design elements included a centralized location within the electronic health record and an electronic shortcut to populate the tool. Although developed for a specialized population, most elements are applicable to any hospitalized patient.
Quantitative Image Analysis for Tissue Biomarker Use: A White Paper From the Digital Pathology Association
Authors: Lara Haydee , Li Zaibo , Abels Esther , Aeffner Famke , Bui Marilyn M. , ElGabry Ehab A. , Kozlowski Cleopatra , Montalto Michael C. , Parwani Anil V. , Zarella Mark D. , Bowman Douglas , Rimm David , Pantanowitz Liron
Published: March 2021

Tissue biomarkers have been of increasing utility for scientific research, diagnosing disease, and treatment response prediction. There has been a steady shift away from qualitative assessment toward providing more quantitative scores for these biomarkers. The application of quantitative image analysis has thus become an indispensable tool for in-depth tissue biomarker interrogation in these contexts. This white paper reviews current technologies being employed for quantitative image analysis, their application and pitfalls, regulatory framework demands, and guidelines established for promoting their safe adoption in clinical practice.
Transmitting Device Identifiers of Implants From the Point of Care to Insurers: A Demonstration Project
Authors: Krupka Dan C. , Graham Jove , Wilson Natalia A. , Li Angela , Landman Adam B. , Bhatt Deepak L. , Nguyen Louis L. , Reich Amanda J. , Gupta Avni , Zerhouni Yasmin A. , Capatch Kevin J. , Concheri Kevin P. , Weissman Joel S.
Published: March 2021

Background

For implanted devices, an effective postmarket surveillance system does not exist. For medications, the Food and Drug Administration’s Sentinel Initiative plays that role, relying mainly on drug codes in insurance claims. Unique device identifiers (UDIs) could play an analogous role for implants, but there is no mandate for providers to include UDIs in claims or for payers to record them. Objections have been raised to incorporating UDIs into claims based on a potential burden on providers.

Methods

To assess this purported barrier, we modified information systems at 2 provider-payer dyads to allow for the transmission of UDI data from provider to payer. In addition, to illustrate the potential benefit of including device data in claims, we used our data to compare rates of 90-day adverse events after implantation using the electronic health record (EHR) alone with the EHR plus claims.

Results

The software system modifications were modest and performed as designed. Moreover, the level of difficulty of their development and implementation was comparable to that associated with a typical new release of an existing system. In addition, our data demonstrated the ability of claims-based data plus EHR data to reveal a larger percentage of postprocedure adverse events than data from EHRs alone.

Conclusions

Modifying information systems to allow for the transmission of UDI data from providers to payers should not impose a substantial burden on either. Implementation of a postmarket surveillance system based on such data in claims will require, however, the development of a system analogous to Sentinel.
Cerebrovascular Disease Correlates With Longitudinal Brain Atrophy in Virally Suppressed Older People Living With HIV
Authors: Samboju Vishal , Cobigo Yann , Paul Robert , Naasan Georges , Hillis Madeline , Tsuei Torie , Javandel Shireen , Valcour Victor , Milanini Benedetta
Published: March 2021

Background:

Mild cognitive difficulties and progressive brain atrophy are observed in older people living with HIV (PLWH) despite persistent viral suppression. Whether cerebrovascular disease (CVD) risk factors and white matter hyperintensity (WMH) volume correspond to the observed progressive brain atrophy is not well understood.

Methods:

Longitudinal structural brain atrophy rates and WMH volume were examined among 57 HIV-infected participants and 40 demographically similar HIV-uninfected controls over an average (SD) of 3.4 (1.7) years. We investigated associations between CVD burden (presence of diabetes, hypertension, hyperlipidemia, obesity, smoking history, and atrial fibrillation) and WMH with atrophy over time.

Results:

The mean (SD) age was 64.8 (4.3) years for PLWH and 66.4 (3.2) years for controls. Participants and controls were similar in age and sex (P > 0.05). PLWH were persistently suppressed (VL <375 copies/mL with 93% <75 copies/mL). The total number of CVD risk factors did not associate with atrophy rates in any regions of interests examined; however, body mass index independently associated with progressive atrophy in the right precentral gyrus (β = −0.30; P = 0.023), parietal lobe (β = −0.28; P = 0.030), and frontal lobe atrophy (β = −0.27; P = 0.026) of the HIV-infected group. No associations were found in the HIV-uninfected group. In both groups, baseline WMH was associated with progressive atrophy rates bilaterally in the parietal gray in the HIV-infected group (β = −0.30; P = 0.034) and the HIV-uninfected participants (β = −0.37; P = 0.033).

Conclusions:

Body mass index and WMH are associated with atrophy in selective brain regions. However, CVD burden seems to partially contribute to progressive brain atrophy in older individuals regardless of HIV status, with similar effect sizes. Thus, CVD alone is unlikely to explain accelerated atrophy rates observed in virally suppressed PLWH. In older individuals, addressing modifiable CVD risk factors remains important to optimize brain health.
A Pretreatment Prognostic Score to Stratify Survival in Pancreatic Cancer
Authors: Hank Thomas , Hinz Ulf , Reiner Thomas , Malleo Giuseppe , König Anna-Katharina , Maggino Laura , Marchegiani Giovanni , Kaiser Jörg , Paiella Salvatore , Binco Alessandra , Salvia Roberto , Hackert Thilo , Bassi Claudio , Büchler Markus W. , Strobel Oliver
Published: March 2021

Objective:

The aim of this study was to develop and validate a pretreatment prognostic score in pancreatic cancer (PDAC).

Background:

Pretreatment prognostication in PDAC is important for treatment decisions but remains challenging. Available prognostic tools are derived from selected cohorts of patients who underwent resection, excluding up to 20% of patients with exploration only, and do not adequately reflect the pretreatment scenario.

Methods:

Patients undergoing surgery for PDAC in Heidelberg from July 2006 to June 2014 were identified from a prospective database. Pretreatment parameters were extracted from the database and the laboratory information system. Parameters independently associated with overall survival by uni- and multivariable analyses were used to build a prognostic score. A contemporary cohort from Verona was used for external validation.

Results:

In 1197 patients, multiple pretreatment parameters were associated with overall survival by univariable analyses. American Society of Anesthesiology classification, carbohydrate antigen 19-9 (CA19-9), carcinoembryonic antigen, C-reactive protein, albumin, and platelet count were independently associated with survival and were used to create the Heidelberg Prognostic Pancreatic Cancer (HELPP)-score. The HELPP-score was closely associated with overall survival (median survival between 31.3 and 4.8 months; 5-year survival rates between 35% and 0%) and was able to stratify survival in subgroups with or without resection as well as in CA19-9 nonsecretors. In the resected subgroup the HELPP-score stratified survival independently of pathological prognostic factors. The HELPP-score was externally validated and was superior to CA19-9 in both the development and validation cohorts.

Conclusion:

The HELPP-score is a readily available prognostic tool based on pretreatment routine parameters to stratify survival in PDAC independently of resection status and pathological tumor stage.
Donor CMV Reactivation as a Novel Risk Factor for CMV Replication in Seropositive Liver Transplant Recipients
Authors: Limaye Ajit P. , Rahnemai-Azar Amir A. , Nazarian Susanna M. , Perkins James D. , Reyes Jorge D.
Published: March 2021

Background.

Risk factors for cytomegalovirus (CMV) viremia in CMV seropositive liver transplant recipients are incompletely defined and have focused primarily on recipient factors. We hypothesized that active CMV replication (CMV viremia) in seropositive donors might increase the risk for CMV viremia in recipients, as reported for other viruses in organ transplantation.

Methods.

From January 3, 2009, to July 27, 2015, stored plasma from consecutive CMV seropositive liver donors was retrospectively tested for CMV viremia by PCR. From April 20, 2012, to July 27, 2015, CMV seropositive recipients of a liver transplant from the donors during this time period received preemptive therapy for CMV prevention (valganciclovir therapy for CMV viremia ≥250 IU/mL). The association of recipient factors and donor CMV viremia with viremia in recipients was assessed.

Results.

Among 317 CMV-seropositive donors, CMV viremia was detected in 11 (3.5%) and was associated with longer time to collection after admission and bacteremia. Among 115 CMV-seropositive liver recipients, 5 (4.3%) received an organ from a donor with CMV viremia. Donor CMV viremia was independently associated with higher incidence of CMV viremia ≥250 IU/mL and shorter time to onset of CMV viremia ≥250 IU/mL in recipients: 4 (80%) versus 26 (23.6%), P = 0.02, and hazard ratio 8.55 (2.60–28.10), P = 0.003, respectively.

Conclusion.

Donor CMV reactivation is associated with CMV viremia in seropositive orthotopic liver transplant recipients receiving preemptive therapy, identifying a novel potential risk factor for CMV infection in seropositive liver transplant recipients. Future studies should independently validate and assess these findings in other organ transplant settings.
Biliary Strictures Are Associated With Both Early and Late Hepatic Artery Stenosis
Authors: Hann Angus , Seth Rashmi , Mergental Hynek , Hartog Hermien , Alzoubi Mohammad , Stangou Arie , El-Sherif Omar , Ferguson James , Roberts Keith , Muiesan Paolo , Oo Ye , Issac John R. , Mirza Darius , Perera M. Thamara P.R.
Published: March 2021

Background.

Hepatic artery stenosis (HAS) following liver transplantation results in hypoperfusion and ischemic damage to the biliary tree. This study aimed to investigate how vascular intervention, liver function test derangement, and time point of HAS onset influence biliary complications.

Methods.

A single-center retrospective study of adult patients that underwent primary liver transplantation. Patients were grouped according to the presence or absence of HAS and then into early (≤90 d) or late (>90 d) subgroups. Biliary complications comprised anastomotic (AS) or non ASs (NASs).

Results.

Computed tomography angiography confirmed HAS was present in 39 of 1232 patients (3.2%). This occurred at ≤90 and >90 days in 20 (1.6%) and 19 (1.5%), respectively. The incidence of biliary strictures (BSs) in the group with HAS was higher than the group without (13/39; 33% versus 85/1193; 7.1%, P = 0.01). BS occurred in 8/20 (40.0%) and 5/19 (26.3%) of the early and late groups, respectively. The need for biliary intervention increased if any liver function test result was ≥3× upper limit of normal (P = 0.019).

Conclusions.

BS occurs at a significantly higher rate in the presence of HAS. Onset of HAS at ≤90 or ≥90 days can both be associated with morbidity. Significant liver function test derangement at HAS diagnosis indicates a higher likelihood of biliary intervention for strictures.
A Novel Surgical Technique to Assure Donor and Recipient Safety: Pyloric to Segment 4 Arterial Reconstruction
Authors: Fraile Andres , Mercado Luis M. , Paladini Hugo , Ramisch Diego A. , Descalzi Valeria , Yantorno Silvina , Farinelli Pablo A. , Schelotto Pablo Barros , Gondolesi Gabriel E.
Published: March 2021

Background.

Strategies to extend the pool of organs include and promote the use of segmental liver grafts. While performing a living donor left lateral segment (LLS) liver transplant and in split procedures, the hepatic artery´s division becomes critical when a dominant segment 4 artery (S4A) emerges from the left hepatic artery (LHA). We aim to describe a novel technique that consists of performing microsurgical reconstruction from the pyloric artery (PA) to S4A.

Case Reports.

A 45-y-old living donor was evaluated to use his LLS as a graft for a pediatric recipient. During the procedure, a dominant S4A born from the LHA was dissected. To obtain an appropriate LHA length and diameter for the recipient, it was necessary to transect it. An extended right lobe split graft was used in a 61-y-old patient. The S4A born from LHA had to be sectioned during the split procedure. In both cases, segment 4 remained incompletely perfused. The PA was dissected with enough length to be rotated, to perform a microsurgical anastomosis to the S4A, recovering parenchyma’s color and Doppler signal while vascular permeability was demonstrated using CT scan. There was no biliary or cut surface complication.

Conclusions.

PA to S4A reconstruction is a simple and novel technique that can be used for LLS and extended right lobe split graft and might contribute to increase donor selection and reduce living donor and recipient S4A-related complications.
Semaphorin 3C attracts MGE-derived cortical interneurons in the deep migratory stream guiding them into the developing neocortex
Authors: Aiello Kiara , Bolz Jürgen
Published: March 2021

While it is known that Semaphorin 3C acts as a guidance cue for axons during brain development, their potential role during interneuron migration is largely unknown. One striking observation is that Sema3C demarcates the pallial/subpallial border and the intracortical pathway of cortical interneurons in the dorsal telencephalon. Moreover, migrating cortical interneurons express Neuropilin1 and Neuropilin2, described receptors for Semaphorin 3A, 3F and 3C. All these reasons prompt us to examine possible roles for Sema3C on cortical interneuron migration.

Using severalin vitroapproaches, we showed that Nrp1-expressing MGE-derived interneurons from the deep migratory stream migrate towards the increasing Sema3C gradients. In contrast, inhibitory neurons from the superficial migratory stream that express Nrp2, do not respond to this guidance cue. In the present study, we proposed that diffusible Sema3C expressed in the Pallium provides a permissive corridor that attracts the Nrp1-expressing interneurons from the DMS into the dorsal telencephalon.
Societal factors affecting on innovative sustainable development of nanotechnology: a morphological approach
Authors: Kousari Sahar , Ghazinoory Sepehr , Saghafi Fatemeh
Published: March 2021

Purpose

This study aims to investigate the probable future scenarios of nanotechnology development and their implications in Iran considering anticipatory knowledge, suitable methodology and integral perspective.

Design/methodology/approach

The study used framework morphology, a method for creating scenarios and their implications developed by the Delphi method that covers the consistent morphological space and make contact with previous scenario work, as well as the current and projected research and policy situation in Iran.

Findings

The study identified five scenarios, namely, “no nano” scenario headlines picturing a future society that there is no impact of nanotechnology in it. The “nano flow” scenario and indicates prospering nanotechnology in the full sides of the market. The “no nano contact” scenario suspecting that apart from the already banned nanotechnological applications in food, cosmetics, clothes and agricultural applications might bear equally unacceptable risks. The “hidden nano” scenario by pointing out the effects of accidents and crimes traced back to intended or unintended misuse of nanotechnological applications. Then finally, the “red nano” scenario illustration headlines the prospects of medical, energy system efficiency and nanotechnological applications in information and communication technologies.

Practical implications

The policymakers could use the scenarios and their implications as part of its considerations in strategic planning.

Originality/value

This paper represents the first time that a framework for societal implications has been applied to nanotechnology development topic in Iran.
Grey variable dual precision rough set model and its application
Authors: Du Junliang , Liu Sifeng , Liu Yong
Published: March 2021

Purpose

The purpose of this paper is to advance a novel grey variable dual precision rough set model for grey concept.

Design/methodology/approach

To obtain the approximation of a grey object, the authors first define the concepts of grey rough membership degree and grey degree of approximation on the basic thinking logic of variable precision rough set. Based on grey rough membership degree and grey degree of approximation, the authors proposed a grey variable dual precision rough set model. It uses a clear knowledge concept to approximate a grey concept, and the output result is also a clear concept.

Findings

The result demonstrates that the proposed model may be closer to the actual decision-making situation, can effectively improve the rationality and scientificity of the approximation and reduce the risk of decision-making. It can effectively achieve the whitenization of grey objects. The model can be degenerated to traditional variable precision rough fuzzy set model, variable precision rough set model and classic Pawlak rough set, when some specific conditions are met.

Practical implications

The method exposed in the paper can be used to solve multi-criteria decision problems with grey decision objects and provide a decision rule. It can also help us better realize knowledge discovery and attribute reduction. It can effectively achieve the whitenization of grey object.

Originality/value

This method proposed in this paper implements a rough approximation of grey decision object and obtains low-risk probabilistic decision rule. It can effectively achieve a certain degree of whitenization of some grey objects.
Assessing electricity and CO2 emission savings through energy efficiency measures in shopping malls in India: a feasibility study of appliance retrofit
Authors: Maheshwari Jyoti , Paliwal Pramod , Garg Amit
Published: March 2021

Purpose

Energy-efficient retrofitting of existing buildings is an inexpensive way of reducing energy consumption and mitigating climate change impacts. The purpose of this study is to examine electricity savings and carbon dioxide (CO2) emission reduction potentials of energy-efficient retrofit measures for surveyed two large shopping malls in India.

Design/methodology/approach

A techno-economic model was developed to estimate the electricity savings achieved due to energy-efficient retrofit measures in shopping malls that were surveyed in 2017. Alternative scenarios were constructed based on capital cost and cost of conserved energy (CCE) value for retrofit measures: cheapest replacement, best available technology and best value for money. The life-cycle electricity and CO2 emission savings and payback period for end-use retrofit measures were evaluated.

Findings

The estimated average electricity savings were around 39–56% for various retrofit measures across all three scenarios while the average CO2 emission reductions were around 50–125 kt-CO2. Retrofits to light-emitting diode lights and air conditioners with inverter technology offered more life-cycle electricity savings. Paybacks for most lighting end-use measures were estimated to be within 1.5 years while for most space conditioning end-use measures were between 1 and 4 years.

Originality/value

The primary survey-based comprehensive research makes an exclusive contribution by estimating life-cycle electricity savings and CO2 emission reductions for energy-efficient retrofit measures of lighting and space cooling end-use appliances for existing shopping malls. The present research methodology can also be deployed in other types of commercial buildings and in residential buildings to estimate electricity savings from energy-efficient retrofit measures.
Arresting fake news sharing on social media: a theory of planned behavior approach
Authors: Pundir Vartika , Devi Elangbam Binodini , Nath Vishnu
Published: March 2021

Purpose

This study aims to examine the collective impact of awareness and knowledge about fake news, attitudes toward news verification, perceived behavioral control, subjective norms, fear of missing out (FoMO) and sadism on social media users’ intention to verify news before sharing on social media.

Design/methodology/approach

The current study’s conceptual framework is developed by a comprehensive literature review on social networking and the theory of planned behavior. The data for samples were collected from 400 respondents in India to test the conceptual framework using the partial least square–structural equation modeling technique.

Findings

The results show that awareness and knowledge, perceived behavioral control, attitudes toward news verification and FoMO are significant predictors of intention to verify news before sharing.

Research limitations/implications

The present study concludes implications for managers of social media companies and policy actors that want to take steps toward arresting the spread of fake news via social media.

Originality/value

Academic investigation on fake news sharing on social media has recently gained traction. The current work is unique because it uses the theory of planned behavior as a basis for predicting social media user’s intention to verify news before sharing on social media.