Publications by authors named "David S Cooper"

206 Publications

Methimazole Drug Allergy: A Possible Solution Using a "Methimazole Solution".

Endocr Pract 2020 Dec 19. Epub 2020 Dec 19.

Division of Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, Maryland.

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http://dx.doi.org/10.1016/j.eprac.2020.12.007DOI Listing
December 2020

Acute Kidney Injury, Fluid Overload, and Renal Replacement Therapy Differ by Underlying Diagnosis in Neonatal Extracorporeal Support and Impact Mortality Disparately.

Blood Purif 2021 Jan 18:1-10. Epub 2021 Jan 18.

Pediatrics, University of Alabama Birmingham, Birmingham, Alabama, USA.

Introduction: We aimed to characterize acute kidney injury (AKI), fluid overload (FO), and renal replacement therapy (RRT) utilization by diagnostic categories and examine associations between these complications and mortality by category.

Methods: To test our hypotheses, we conducted a retrospective multicenter, cohort study including 446 neonates (categories: 209 with cardiac disease, 114 with congenital diaphragmatic hernia [CDH], 123 with respiratory disease) requiring extracorporeal membrane oxygenation (ECMO) between January 1, 2007, and December 31, 2011.

Results: AKI, FO, and RRT each varied by diagnostic category. AKI and RRT receipt were most common in those neonates with cardiac disease. Subjects with CDH had highest peak %FO (51% vs. 28% cardiac vs. 32% respiratory; p < 0.01). Hospital survival was 55% and varied by diagnostic category (45% cardiac vs. 48% CDH vs. 79% respiratory; p < 0.001). A significant interaction suggested risk of mortality differed by diagnostic category in the presence or absence of AKI. In its absence, diagnosis of CDH (vs. respiratory disease) (OR 3.04, 95% CL 1.14-8.11) independently predicted mortality. In all categories, peak %FO (OR 1.20, 95% CL 1.11-1.30) and RRT receipt (OR 2.12, 95% CL 1.20-3.73) were independently associated with mortality.

Discussion/conclusions: Physiologically distinct ECMO diagnoses warrant individualized treatment strategies given variable incidence and effects of AKI, FO, and RRT by category on mortality.
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http://dx.doi.org/10.1159/000512538DOI Listing
January 2021

Outcomes of Multiple Runs of Extracorporeal Membrane Oxygenation: An analysis of the Extracorporeal Life Support Registry.

J Intensive Care Med 2020 Dec 22:885066620981903. Epub 2020 Dec 22.

Divisions of Cardiology and Critical Care Medicine, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.

Objective: When patients deteriorate after decannulation from extracorporeal membrane oxygenation (ECMO), a second run of extracorporeal support may be considered. However, repeat cannulation can be difficult and poor outcomes associated with multiple ECMO runs are a concern. The aim of this study was to evaluate outcomes and identify factors associated with survival and mortality in cases of multiple runs of extracorporeal membrane oxygenation.

Design: Retrospective cohort analysis of the Extracorporeal Life Support Organization Registry.

Setting: The Extracorporeal Life Support Organization's registry was queried for neonates, children, and adults receiving 2 or more runs of ECMO during the same hospitalization, for any indication, from 1998 to 2015.

Patients: 1,818 patients from the Extracorporeal Life Support Organization Registry.

Results: Of the 1,818 patients, 1,648 underwent 2 runs and 170 underwent 3 or more runs of ECMO. The survival to discharge rate was 36.7% for 2 runs and 29.4% for 3 or more runs. No significant differences in survival were detected in analysis by decade of ECMO run (p = 0.21). Pediatric patients had less mortality than adults (OR: 0.45, 95%CI: 0.24-0.82). Cardiac support on the first run portrayed worse mortality than pulmonary support regardless of final run indication (OR:1.38, 95%CI: 1.09-1.75). Across all age groups, patients receiving pulmonary support on the last run tended to have higher survival rates regardless of support type on the first run. The only first run complication independently predictive of mortality on the final run was renal complications (OR: 1.60, 95%CI: 1.28-1.99).

Conclusions: Though the use of multiple runs of ECMO is growing, outcomes remain poor for most cohorts. Survival decreases with each additional run. Patients requiring additional runs for a pulmonary indication should be considered prime candidates. Renal complications on the first run significantly increases the risk of mortality on subsequent runs, and as such, careful consideration should be applied in these cases.
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http://dx.doi.org/10.1177/0885066620981903DOI Listing
December 2020

Pattern of head circumference growth following bidirectional Glenn in infants with single ventricle heart disease.

Cardiol Young 2020 Dec 11:1-8. Epub 2020 Dec 11.

Department of Pediatrics, University of Cincinnati College of Medicine, Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.

Background: Infants with single ventricle congenital heart disease demonstrate increasing head growth after bidirectional Glenn; however, the expected growth trajectory has not been well described.

Aims: 1) We will describe the pattern of head circumference growth in the first year after bidirectional Glenn. 2) We will determine if head growth correlates with motor developmental outcomes approximately 12 months after bidirectional Glenn.

Methods: Sixty-nine single ventricle patients underwent bidirectional Glenn between 2010 and 2016. Patients with structural brain abnormalities, grade III-IV intra-ventricular haemorrhage, significant stroke, or obstructive hydrocephalus were excluded. Head circumference and body weight measurements from clinical encounters were evaluated. Motor development was measured with Psychomotor Developmental Index of the Bayley Scales of Infant Development, Third Edition. Generalised estimating equations assessed change in head circumference z-scores from baseline (time of bidirectional Glenn) to 12 months post-surgery.

Results: Mean age at bidirectional Glenn was 4.7 (2.3) months and mean head circumference z-score based on population-normed data was -1.13 (95% CI -1.63, -0.63). Head circumference z-score increased to 0.35 (95% CI -0.20, 0.90) (p < 0.0001) 12 months post-surgery. Accelerated head growth, defined as an increase in z-score of >1 from baseline to 12 months post-surgery, was present in 46/69 (66.7%) patients. There was no difference in motor Psychomotor Developmental Index scores between patients with and without accelerated head growth.

Conclusion: Single ventricle patients demonstrated a significant increase in head circumference after bidirectional Glenn until 10-12 months post-surgery, at which time growth stabilised. Accelerated head growth did not predict sub-sequent motor developmental outcomes.
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http://dx.doi.org/10.1017/S1047951120004394DOI Listing
December 2020

Glucocorticoid Receptor Polymorphisms in Children Undergoing Congenital Heart Surgery with Cardiopulmonary Bypass.

J Pediatr Intensive Care 2020 Dec 29;9(4):241-247. Epub 2020 Apr 29.

Department of Pediatrics, The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.

We conducted a candidate gene association study to test the hypothesis that different gene polymorphisms will be associated with corticosteroid responsiveness and study outcomes among children undergoing congenital heart surgery. This is a prospective observational cohort study at a large, tertiary pediatric cardiac center on children undergoing corrective or palliative congenital heart surgery. A total of 83 children were enrolled. DNA was isolated for three polymorphisms of interest namely N363 (rs56149945) and 9β (rs6198) associated with increased sensitivity to corticosteroids and I (rs41423247) associated with decreased sensitivity to corticosteroids. Duration of inotropic use, low cardiac output scores (LCOS), and vasoactive inotrope scores were examined in relation to these three polymorphisms. Using Kaplan-Meier analysis, heterozygous individuals showed longer transcriptional intermediary factor (TIF) compared with wild type for N363 polymorphism (  = 0.05). In multivariable Cox regression, heterozygous alleles for 9β polymorphism showed significantly shorter TIF compared with wild type (hazard ratio = 2.04 [1.08-3.87],  = 0.03). The relationship between lower LCOS scores and alleles groups was significant for 9β heterozygous polymorphism only (1.5 [1-2.2],  = 0.01) in comparison to wild type and homozygous. The presence of heterozygote alleles for the increased corticosteroid sensitivity is associated with longer TIF compared with wild type. Conversely, the presence of heterozygous alleles for the decreased sensitivity to corticosteroids is associated with shorter TIF compared with wild type.
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http://dx.doi.org/10.1055/s-0040-1709658DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7588289PMC
December 2020

Misdiagnosis of Paraganglioma by I-mIBG Without Stable Iodine Blockade of Thyroidal Radioiodine Uptake.

J Endocr Soc 2020 Sep 17;4(9):bvaa099. Epub 2020 Jul 17.

Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland.

Iodine-123/iodine-131 (I/I)-metaiodobenzylguanidine (mIBG) scan is an established tool for the localization and treatment of neuroendocrine tumors such as paragangliomas (PGL). To minimize thyroid irradiation by the radioactive iodine in the mIBG preparation, blockade of thyroidal iodine uptake with high doses of stable iodine used to be given routinely as part of all mIBG protocols. As I is now more frequently utilized than I, concern about thyroid radiation has lessened and thyroid blockade is often considered unnecessary. However, in certain situations, the lack of thyroid blockade can significantly impact treatment decisions. This report describes 2 patients who had mediastinal masses incidentally discovered on CT scans, and on further evaluation were found to have symptoms suggesting catecholamine excess with mildly elevated plasma normetanephrine levels. I-mIBG scans were performed without thyroid blockade, which demonstrated accumulation of tracer in the masses that were therefore deemed positive for PGL. Both patients underwent surgical resection of the masses with their surgical pathology revealing ectopic thyroid tissue (ETT). These cases illustrate that if appropriate thyroid blockade is not performed, ETT concentrating radioiodine from mIBG can lead to falsely positive mIBG scans and unnecessary surgical procedures. We conclude that in the setting of a mass suspicious for PGL in a location potentially representing ETT, such as the mediastinum, thyroid blockade should be employed for mIBG protocols to avoid false positive scans caused by ETT.
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http://dx.doi.org/10.1210/jendso/bvaa099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7414919PMC
September 2020

Eliminating Catheter-Associated Urinary Tract Infections in a Pediatric Cardiac ICU.

Pediatr Crit Care Med 2020 09;21(9):e819-e826

Cardiac Intensive Care Unit, The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Objectives: To eliminate catheter-associated urinary tract infections in a pediatric cardiac ICU.

Design: Quality improvement methodology.

Setting: Twenty-five bed cardiac ICU in a quaternary freestanding children's hospital.

Patients: All patients with an indwelling urinary catheter admitted to the cardiac ICU.

Interventions: Catheter-associated urinary tract infection was defined according to National Healthcare Safety Network criteria. Failure modes and effects analysis and Pareto charts were used to determine etiology of process failures. We implemented a team-based multi-interventional approach in 2012 using the Model for Improvement, which included as follows: 1) establish indications for inserting and/or maintaining bladder catheterization, 2) standardization of maintenance care for the indwelling urinary catheters, 3) protocol for management of the leaking urinary catheters, 4) incorporation of urinary catheter days and prompts for removal in daily rounds, and 5) review of all cases of prolonged indwelling urinary catheter use (> 3 d). Process control charts were used to evaluate change.

Measurements And Main Results: From 2011 to 2018, we showed an early and sustained improvement in catheter-associated urinary tract infection prevention standards compliance from 44% to 96% (52% improvement). These interventions showed a reduction and then elimination of catheter-associated urinary tract infections from January 2012 to the present day, despite fluctuations in total indwelling urinary catheter days.

Conclusions: Utilization of quality improvement methodology allowed us to identify components of care that contributed to catheter-associated urinary tract infections. After addressing these issues, we noted a substantial reduction and then elimination of catheter-associated urinary tract infections in our pediatric cardiac ICU. Widely disseminating these interventions across multiple pediatric hospitals to determine the ability to achieve similar results are important next steps.
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http://dx.doi.org/10.1097/PCC.0000000000002469DOI Listing
September 2020

Vascular Access in Children With Congenital Heart Defects.

Pediatrics 2020 06;145(Suppl 3):S294-S295

Southern Thoracic Surgical Association, Chicago, Illinois.

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http://dx.doi.org/10.1542/peds.2019-3474NDOI Listing
June 2020

The Michigan Appropriateness Guide for Intravenous Catheters in Pediatrics: miniMAGIC.

Pediatrics 2020 06;145(Suppl 3):S269-S284

Patient Safety Enhancement Program and Center for Clinical Management Research, US Department of Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.

Objectives: Vascular access device decision-making for pediatric patients remains a complex, highly variable process. To date, evidence-based criteria to inform these choices do not exist. The objective of the Michigan Appropriateness Guide for Intravenous Catheters in pediatrics (miniMAGIC) was to provide guidance on device selection, device characteristics, and insertion technique for clinicians, balancing and contextualizing evidence with current practice through a multidisciplinary panel of experts.

Methods: The RAND Corporation and University of California, Los Angeles Appropriateness Method was used to develop miniMAGIC, which included the following sequential phases: definition of scope and key terms, information synthesis and literature review, expert multidisciplinary panel selection and engagement, case scenario development, and appropriateness ratings by an expert panel via 2 rounds.

Results: The appropriateness of the selection, characteristics, and insertion technique of intravenous catheters commonly used in pediatric health care across age populations (neonates, infants, children, and adolescents), settings, diagnoses, clinical indications, insertion locations, and vessel visualization devices and techniques was defined. Core concepts including vessel preservation, insertion and postinsertion harm minimization (eg, infection, thrombosis), undisrupted treatment provision, and inclusion of patient preferences were emphasized.

Conclusions: In this study, we provide evidence-based criteria for intravenous catheter selection (from umbilical catheters to totally implanted venous devices) in pediatric patients across a range of clinical indications. miniMAGIC also highlights core vascular access practices in need of collaborative research and innovation.
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http://dx.doi.org/10.1542/peds.2019-3474IDOI Listing
June 2020

Central Venous Catheter Utilization and Complications in the Pediatric Cardiac ICU: A Report From the Pediatric Cardiac Critical Care Consortium (PC4).

Pediatr Crit Care Med 2020 08;21(8):729-737

Department of Pediatrics, The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Objectives: Current central venous catheter utilization in patients within pediatric cardiac ICUs is not well elucidated. We aim to describe current use of central venous catheters in a multi-institutional cohort and to explore the prevalence and risk factors for central line-associated thrombosis and central line-associated bloodstream infections.

Design: Observational analysis.

Setting: Pediatric Cardiac Critical Care Consortium hospitals.

Patients: Hospitalizations with at least one cardiac ICU admission from October 2013 to July 2016.

Interventions: None.

Measurements And Main Results: There were 17,846 hospitalizations and 69% included greater than or equal to one central venous catheter. Central venous catheter use was higher in younger patients (86% neonates). Surgical hospitalizations included at least one central venous catheter 88% of the time compared with 35% of medical hospitalizations. The most common location for central venous catheters was internal jugular (46%). Central venous catheters were in situ a median of 4 days (interquartile range, 2-10). There were 248 hospitalizations (2% overall, 1.8% medical, and 2.1% surgical) with at least one central line-associated thrombosis (271 total thromboses). Thrombosis was diagnosed at a median of 7 days (interquartile range, 4-14) after catheter insertion. There were 127 hospitalizations (1% overall, 1.4% medical, and 1% surgical) with at least one central line-associated bloodstream infection (136 total infections) with no association with catheter type or location. Central line-associated bloodstream infection was diagnosed at a median of 19 days (interquartile range, 8-36) after catheter insertion. Significant risk factors for central line-associated thrombosis and central line-associated bloodstream infection were younger age, greater surgical complexity, and total catheter days.

Conclusions: Utilization of central venous catheters in pediatric cardiac ICUs differs according to indication for hospitalization. Although thrombosis and central line-associated bloodstream infection are infrequent complications of central venous catheter use in cardiac ICU patients, these events can have important short- and long-term consequences for patients. Total central venous catheter line days were the only modifiable risk factor identified. Future study must focus on understanding central venous catheter practices in high-risk patient subgroups that reduce the prevalence of thrombosis and central line-associated bloodstream infection.
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http://dx.doi.org/10.1097/PCC.0000000000002306DOI Listing
August 2020

Outcomes of Pediatric Patients Treated With Extracorporeal Membrane Oxygenation for Intractable Supraventricular Arrhythmias.

Pediatr Crit Care Med 2020 08;21(8):e547-e556

Department of Pediatrics, Division of Pediatric Cardiology, The Heart Institute at Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Objectives: Extracorporeal membrane oxygenation is used to support refractory cardiorespiratory failure. Outcomes and complications when extracorporeal membrane oxygenation is used to support cardiorespiratory failure secondary to arrhythmia in pediatric patients remain poorly defined. Our purpose is to describe pediatric patients requiring extracorporeal membrane oxygenation support for supraventricular arrhythmias in the context of normal cardiac anatomy and congenital heart disease and identify patient/peri-extracorporeal membrane oxygenation variables associated with extracorporeal membrane oxygenation-related complications and survival.

Design: Retrospective multicenter review from 1993 to 2016.

Setting: Extracorporeal Life Support Organization registry.

Subjects: Patients younger than 21 years old requiring extracorporeal membrane oxygenation support for supraventricular arrhythmias.

Interventions: None.

Measurements And Main Results: A total of 342 patients were identified (weight, 3.8 kg [3.2-7.5 kg]; age at extracorporeal membrane oxygenation initiation, 24 d [6-222]; 61% male). Sixty-five percentage survived to hospital discharge. Complications were frequent (85%) and most commonly cardiac related (31%). In multivariable modeling, mortality was associated with congenital heart disease, time from intubation to extracorporeal membrane oxygenation initiation, use of bicarbonate prior to extracorporeal membrane oxygenation, extracorporeal membrane oxygenation duration, and the presence of a complication. The presence of any complication was associated with a three-fold increase in the odds of death. In subgroup analysis of isolated supraventricular arrhythmias patients, similar patient and extracorporeal membrane oxygenation characteristics were associated with outcome. A lower pre-extracorporeal membrane oxygenation pH and PCO2 and site of venous cannulation were associated with complications (p < 0.02).

Conclusions: Extracorporeal membrane oxygenation use for medically refractory supraventricular arrhythmias was associated with a 65% survival to hospital discharge. However, there was a high rate of complications, the presence of which was associated with decreased survival. Complications appeared to be related to pre-extracorporeal membrane oxygenation clinical status and whether earlier extracorporeal membrane oxygenation cannulation prior to patient deterioration would improve outcomes needs additional evaluation.
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http://dx.doi.org/10.1097/PCC.0000000000002315DOI Listing
August 2020

Pre-operative neutrophil-lymphocyte ratio predicts low cardiac output in children after cardiac surgery.

Cardiol Young 2020 Apr 5;30(4):521-525. Epub 2020 Mar 5.

Department of Pediatrics, Section of Critical Care Medicine, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.

Neutrophil-lymphocyte ratio has been associated with clinical outcomes in several groups of cardiac patients, including patients with coronary artery disease, cardiac failure, and cardiac transplant recipients. We hypothesised that pre- and/or post-operative haematological cell counts are associated with clinical outcomes in children undergoing cardiac surgery for CHD. We performed a post hoc analysis of data collected as part of a prospective observational cohort study (n = 83, data available n = 47) of children evaluated for glucocorticoid receptor levels after cardiac surgery (July 2015-January 2016). The association of neutrophil-lymphocyte ratio with low cardiac output syndrome, time to inotrope free, and vasoactive-inotropic score was examined using proportional odds analysis, cox regression, and linear regression models, respectively. A majority (80%) of patients were infants (median/interquartile range 4.1/0.2-7.6 months) with conotruncal (36%) and left-sided obstructed lesions (28%). Two patients required mechanical circulatory support and three died. Higher pre-operative neutrophil-lymphocyte ratio was associated with higher cumulative odds of severe/moderate versus mild low cardiac output on post-operative day 1 (odds ratio 2.86; 95% confidence interval 1.18-6.93; p = 0.02). Pre-operative neutrophil-lymphocyte ratio was not significantly associated with time to inotrope free or vasoactive-inotrope score. Post-operative neutrophil-lymphocyte ratio was also not associated with outcomes. In children after congenital heart surgery, higher pre-operative neutrophil-lymphocyte ratio was associated with a higher chance of low cardiac output in the early post-operative period. Pre-operative neutrophil-lymphocyte ratio maybe a useful prognostic marker in children undergoing congenital heart surgery.
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http://dx.doi.org/10.1017/S1047951120000487DOI Listing
April 2020

Hyperthyroidism and Dementia.

Thyroid 2020 05 26;30(5):648-650. Epub 2020 Mar 26.

Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland, Oregon, USA.

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http://dx.doi.org/10.1089/thy.2020.0136DOI Listing
May 2020

Fluid overload and fluid removal in pediatric patients on extracorporeal membrane oxygenation requiring continuous renal replacement therapy: a multicenter retrospective cohort study.

Pediatr Nephrol 2020 05 17;35(5):871-882. Epub 2020 Jan 17.

Department of Pediatric, Medical University of South Carolina, Charleston, SC, USA.

Objective: The aim of this study was to characterize continuous renal replacement therapy (CRRT) utilization on extracorporeal membrane oxygenation (ECMO) and to determine the association of both fluid overload (FO) at CRRT initiation and fluid removal during CRRT with mortality in a large multicenter cohort.

Methods: Retrospective chart review of all children < 18 years of age concurrently treated with ECMO and CRRT from January 1, 2007, to December 31, 2011, at six tertiary care children's hospital. Children treated with hemodialysis or peritoneal dialysis were excluded from the FO analysis.

Measurements And Main Results: A total of 756 of the 1009 children supported with ECMO during the study period had complete FO data. Of these, 357 (47.2%) received either CRRT or were treated with an in-line filter and thus entered into the final analysis. Survival to ECMO decannulation was 66.4% and survival to hospital discharge was 44.3%. CRRT initiation occurred at median of 1 day (IQR 0, 2) after ECMO initiation. Median FO at CRRT initiation was 20.1% (IQR 5, 40) and was significantly lower in ECMO survivors vs. non-survivors (15.3% vs. 30.5% p = 0.005) and in hospital survivors vs. non-survivors (13.5% vs. 25.9%, p = 0.004). Median FO at CRRT discontinuation was significantly lower in ECMO survivors (23% vs. 37.6% p = 0.002) and hospital survivors vs. non-survivors (22.6% vs. 36.1%, p = 0.002). In ECMO survivors, after adjusting for pH at CRRT initiation, non-renal complications, ECMO mode, support type, center, patient age and AKI, FO at CRRT initiation (p = 0.01), and FO at CRRT discontinuation (p = 0.0002) were independently associated with duration of ECMO. In a similar multivariable analysis, FO at CRRT initiation (adjusted adds ratio [aOR] 1.09, 95% CI 1.00-1.18, p = 0.045) and at CRRT discontinuation (aOR 1.11, 95% CI 1.03-1.19, p = 0.01) were independently associated with hospital mortality.

Conclusions: In a multicenter pediatric ECMO cohort, this study demonstrates that severe FO was very common at CRRT initiation. We found an independent association between the degree of FO at CRRT initiation with adverse outcomes including mortality and increased duration of ECMO support. The results suggest that intervening prior to the development of significant FO may be a clinical therapeutic target and warrants further evaluation.
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http://dx.doi.org/10.1007/s00467-019-04468-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7517652PMC
May 2020

Clinically Asymptomatic Sleep-Disordered Breathing in Infants with Single-Ventricle Physiology.

J Pediatr 2020 03 14;218:92-97. Epub 2020 Jan 14.

Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.

Objectives: To assess clinically asymptomatic infants with single-ventricle physiology (SVP) for sleep-disordered breathing (SDB) in the supine and car seat positions using polysomnography. Polysomnography results also were compared with results of a standard Car Seat Challenge to measure the dependability of the standard Car Seat Challenge.

Study Design: This was an observational study of 15 infants with SVP. Polysomnography data included Obstructive Index, Central Index, Arousal Index, Apnea Hypopnea Index, and sleep efficiency. Polysomnography heart rate and oxygen saturation data were used to compare polysomnography with the standard Car Seat Challenge.

Results: Polysomnography demonstrated that all 15 infants had SDB and 14 had obstructive sleep apnea (Obstructive Index ≥1/hour) in both the supine and car seat positions. Infants with SVP had a statistically significant greater median Obstructive Index in the car seat compared with supine position (6.3 vs 4.2; P = .03), and median spontaneous Arousal Index was greater in the supine position compared with the car seat (20.4 vs 15.2; P = .01). Comparison of polysomnography to standard Car Seat Challenge results demonstrated 5 of 15 (33%) of infants with SVP with abnormal Obstructive Index by polysomnography would have passed a standard Car Seat Challenge.

Conclusions: Infants with SVP without clinical symptoms of SDB may be at high risk for SDB that appears worse in the car seat position. The standard Car Seat Challenge is not dependable in the identification of infants with SVP and SDB. Further studies are warranted to further delineate its potential impact of SDB on the clinical outcomes of infants with SVP.
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http://dx.doi.org/10.1016/j.jpeds.2019.11.005DOI Listing
March 2020

Improvement in Pediatric Cardiac Surgical Outcomes Through Interhospital Collaboration.

J Am Coll Cardiol 2019 12;74(22):2786-2795

Department of Pediatrics, University of Michigan Medical School, Ann Arbor, Michigan.

Background: Patients undergoing complex pediatric cardiac surgery remain at considerable risk of mortality and morbidity, and variation in outcomes exists across hospitals. The Pediatric Cardiac Critical Care Consortium (PC4) was formed to improve the quality of care for these patients through transparent data sharing and collaborative learning between participants.

Objectives: The purpose of this study was to determine whether outcomes improved over time within PC4.

Methods: The study analyzed 19,600 hospitalizations (18 hospitals) in the PC4 clinical registry that included cardiovascular surgery from August 2014 to June 2018. The primary exposure was 2 years of PC4 participation; this provided adequate time for hospitals to accrue data and engage in collaborative learning. Aggregate case mix-adjusted outcomes were compared between the first 2 years of participation (baseline) and all months post-exposure. We also evaluated outcomes from the same era in a cohort of similar, non-PC4 hospitals.

Results: During the baseline period, there was no evidence of improvement. We observed significant improvement in the post-exposure period versus baseline for post-operative intensive care unit mortality (2.1% vs. 2.7%; 22% relative reduction [RR]; p = 0.001), in-hospital mortality (2.5% vs. 3.3%; 24% RR; p = 0.001), major complications (10.1% vs. 11.5%; 12% RR; p < 0.001), intensive care unit length of stay (7.3 days vs. 7.7 days; 5% RR; p < 0.001), and duration of ventilation (61.3 h vs. 70.6 h; 13% RR; p = 0.01). Non-PC4 hospitals showed no significant improvement in mortality, complications, or hospital length of stay.

Conclusions: This analysis demonstrates improving cardiac surgical outcomes at children's hospitals participating in PC4. This change appears unrelated to secular improvement trends, and likely reflects PC4's commitment to transparency and collaboration.
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http://dx.doi.org/10.1016/j.jacc.2019.09.046DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6981276PMC
December 2019

Correction to: Thyroid hormone therapy: past, present, and future.

Endocrine 2019 Dec;66(3):701

Evgenideion Hospital, Unit of Endocrinology, Diabetes and Metabolism, National and Kapodistrian University of Athens, 20 Papadiamantopoulou Str., 11528, Athens, Greece.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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http://dx.doi.org/10.1007/s12020-019-02126-1DOI Listing
December 2019

Thyroid hormone therapy: past, present, and future.

Endocrine 2019 Oct 15;66(1):1-2. Epub 2019 Oct 15.

Evgenideion Hospital, Unit of Endocrinology, Diabetes and Metabolism, National and Kapodistrian University of Athens, 20 Papadiamantopoulou Str., 11528, Athens, Greece.

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http://dx.doi.org/10.1007/s12020-019-02090-wDOI Listing
October 2019

Screening for differentiated thyroid cancer in selected populations.

Lancet Diabetes Endocrinol 2020 01 4;8(1):81-88. Epub 2019 Oct 4.

Division of Endocrinology, Diabetes, and Metabolism, The Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address:

The main purpose of cancer screening programmes should not be to detect all cancers, but to discover potentially fatal or clinically relevant cancers. The US Preventive Services Task Force recommends against screening for thyroid cancer in the general, asymptomatic adult population, as such screening would result in harms that outweigh any potential benefits. This recommendation does not apply to patients with symptoms or to individuals at increased risk of thyroid cancer because of a history of exposure to ionising radiation (in childhood, as radioactive fallout, or in medical treatment as low-dose radiotherapy for benign conditions or high-dose radiation for malignancy), inherited genetic syndromes associated with thyroid cancer (eg, familial adenomatous polyposis), or one or more first-degree relatives with a history of thyroid cancer. We discuss the evidence for and against screening individuals who are at high risk, and consider the different screening tools available.
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http://dx.doi.org/10.1016/S2213-8587(19)30324-9DOI Listing
January 2020

Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants.

J Clin Pharmacol 2020 01 25;60(1):16-27. Epub 2019 Aug 25.

Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.

Intravenous administration of acetaminophen is an alternative to the oral and rectal routes, which may be contraindicated in particular clinical settings. This randomized, placebo-controlled study of intravenous acetaminophen (Ofirmev, Mallinckrodt Pharmaceuticals, Bedminster, New Jersey) in neonate and infant patients with acute postoperative pain assessed pharmacokinetics (PK) and safety, in addition to efficacy and pharmacodynamics of repeated doses administered over 24 hours. Neonate and infant patients (<2 years of age) who were undergoing surgery or had experienced a traumatic injury and were expected to need pain management for at least 24 hours were enrolled. Subjects were randomly assigned to receive intravenous acetaminophen low dose, intravenous acetaminophen high dose, or placebo. A population PK model of intravenous acetaminophen was updated by combining 581 samples from the current study of 158 neonate and infant subjects with results from a previously developed model. The individual predicted-versus-observed concentrations plots showed that the structural PK model fit the blood and plasma acetaminophen concentration-versus-time profiles in the active and placebo groups. Terminal elimination half-life was prolonged in neonates and younger infants and in intermediate and older infants similar to values in adults. When compared with placebo, total rescue opioid consumption was similar and significantly fewer intravenous acetaminophen patients prematurely discontinued because of treatment-emergent adverse events (P < .01). For intravenous acetaminophen, neonates receiving 12.5 mg/kg every 6 hours had PK profiles similar to younger, intermediate, and older infants, adolescents, and adults weighing <50 kg receiving 15 mg/kg every 6 hours and adults ≥ 50 kg receiving 1000 mg every 6 hours.
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http://dx.doi.org/10.1002/jcph.1508DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6973014PMC
January 2020

Higher Flow on Cardiopulmonary Bypass in Pediatrics Is Associated With a Lower Incidence of Acute Kidney Injury.

Semin Thorac Cardiovasc Surg 2020 Winter;32(4):1015-1020. Epub 2019 Aug 16.

Cardiac Intensive Care Unit, Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.

Adequate perfusion is of paramount concern during cardiopulmonary bypass (CPB) and different methodologies are employed to optimize oxygen delivery. Temperature, hematocrit, and cardiac index (CI) are all modulated during CPB to ensure appropriate support. This study examines 2 different perfusion strategies and their impact on various outcome measures including acute kidney injury (AKI), urine output on CPB, ICU length of stay, time to extubation, and mortality. Predicated upon surgeon preference, the study institution employs 2 different perfusion strategies (PS) during congenital cardiac surgery requiring CPB. One method utilizes a targeted 2.4 L/min/m CI and nadir hematocrit of 28% (PS1), the other a 3.0 L/min/m CI with a nadir hematocrit of 25% (PS2). This study retrospectively examines CPB cases during which the 2 perfusion strategies were applied to determine potential differences in packed red blood cell administration, urine output during CPB, AKI post-CPB as defined by the KDIGO criteria, and operative survival as defined by the Society of Thoracic Surgeons. Significant differences were found in urine output while on CPB (P < 0.01) and all combined stages of postoperative AKI (P = 0.01) with the PS2 group faring better in both measures. No significant difference was found between the 2 groups for packed red blood cell administration, mortality, time to extubation, or ICU length of stay. Avoiding a nadir hematocrit less than 25% has been well established but maintaining anything greater than that may not be necessary to achieve adequate oxygen delivery on CPB. Our results indicate that higher CI and oxygen delivery on CPB are associated with a lower rate of AKI and this may be achieved with increased flow rather than increasing the hematocrit thus avoiding unnecessary transfusion.
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http://dx.doi.org/10.1053/j.semtcvs.2019.08.007DOI Listing
August 2019

Commentary: Thyroid Hormone (T3) Replacement After Congenital Heart Surgery: "I'll Be Back"… But Still Not Work.

Semin Thorac Cardiovasc Surg 2020 7;32(1):96-97. Epub 2019 Aug 7.

The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.

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http://dx.doi.org/10.1053/j.semtcvs.2019.08.002DOI Listing
April 2020

Thyroid hormone therapy for hypothyroidism.

Endocrine 2019 Oct 1;66(1):18-26. Epub 2019 Aug 1.

Division of Endocrinology, Diabetes, and Metabolism, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.

The purpose of this article will be to review the basics of thyroid hormone therapy, including various thyroid hormone formulations, the institution and monitoring of thyroid hormone therapy, adverse effects of overtreatment, the management of patients with persistent symptoms despite normal thyroid function tests, and potential new innovations in thyroid hormone therapy. The conclusions support the necessity to personalize thyroid hormone replacement therapy in hypothyroid patients.
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http://dx.doi.org/10.1007/s12020-019-02023-7DOI Listing
October 2019

Contemporary Debates in Adult Papillary Thyroid Cancer Management.

Endocr Rev 2019 12;40(6):1481-1499

Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University School of Medicine, Baltimore, Maryland.

An ever-increasing population of patients with papillary thyroid cancer is engaging with health care systems around the world. Numerous questions about optimal management have arisen that challenge conventional paradigms. This is particularly the case for patients with low-risk disease, who comprise most new patients. At the same time, new therapies for patients with advanced disease are also being introduced, which may have the potential to prolong life. This review discusses selected controversial issues in adult papillary thyroid cancer management at both ends of the disease spectrum. These topics include: (i) the role of active surveillance for small papillary cancers; (ii) the extent of surgery in low-risk disease (lobectomy vs total thyroidectomy); (iii) the role of postoperative remnant ablation with radioiodine; (iv) optimal follow-up strategies in patients, especially those who have only undergone lobectomy; and (v) new therapies for advanced disease. Although our current management is hampered by the lack of large randomized controlled trials, we are fortunate that data from ongoing trials will be available within the next few years. This information should provide additional evidence that will decrease morbidity in low-risk patients and improve outcomes in those with distant metastatic disease.
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http://dx.doi.org/10.1210/er.2019-00085DOI Listing
December 2019

Subclinical Hypothyroidism: A Review.

JAMA 2019 Jul;322(2):153-160

Division of Endocrinology, Diabetes, and Metabolism, The Johns Hopkins University School of Medicine, Baltimore, Maryland.

Importance: Subclinical hypothyroidism, defined as an elevated serum thyrotropin (often referred to as thyroid-stimulating hormone, or TSH) level with normal levels of free thyroxine (FT4) affects up to 10% of the adult population.

Observations: Subclinical hypothyroidism is most often caused by autoimmune (Hashimoto) thyroiditis. However, serum thyrotropin levels rise as people without thyroid disease age; serum thyrotropin concentrations may surpass the upper limit of the traditional reference range of 4 to 5 mU/L among elderly patients. This phenomenon has likely led to an overestimation of the true prevalence of subclinical hypothyroidism in persons older than 70 years. In patients who have circulating thyroid peroxidase antibodies, there is a greater risk of progression from subclinical to overt hypothyroidism. Subclinical hypothyroidism may be associated with an increased risk of heart failure, coronary artery disease events, and mortality from coronary heart disease. In addition, middle-aged patients with subclinical hypothyroidism may have cognitive impairment, nonspecific symptoms such as fatigue, and altered mood. In the absence of large randomized trials showing benefit from levothyroxine therapy, the rationale for treatment is based on the potential for decreasing the risk of adverse cardiovascular events and the possibility of preventing progression to overt hypothyroidism. However, levothyroxine therapy may be associated with iatrogenic thyrotoxicosis, especially in elderly patients, and there is no evidence that it is beneficial in persons aged 65 years or older.

Conclusions And Relevance: Subclinical hypothyroidism is common and most individuals can be observed without treatment. Treatment might be indicated for patients with subclinical hypothyroidism and serum thyrotropin levels of 10 mU/L or higher or for young and middle-aged individuals with subclinical hypothyroidism and symptoms consistent with mild hypothyroidism.
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http://dx.doi.org/10.1001/jama.2019.9052DOI Listing
July 2019

Evaluation of Pediatric Cardiac ICU Advanced Practice Provider Education and Practice Variation.

Pediatr Crit Care Med 2019 12;20(12):1164-1169

The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Objectives: The education, training, and scope of practice of cardiac ICU advanced practice providers is highly variable. A survey was administered to cardiac ICU advanced practice providers to examine specific variations in orientation format, competency assessment during and at the end of orientation, and scope of clinical practice to determine gaps in resources and need for standardization.

Design: This study was a cross-sectional descriptive study utilizing survey responses.

Setting: Pediatric cardiac ICUs in the United States.

Subjects: The survey was delivered to a convenience sample of advanced practice providers currently practicing in pediatric cardiac ICUs.

Interventions: A list of pediatric cardiothoracic surgery programs was generated from the Society of Thoracic Surgery database. A self-administered, electronic survey was delivered via email to advanced practice providers at those institutions. Descriptive data were compared using a chi-square test or Fisher exact test depending on the normalcy of data. Continuous data were compared using a Student t test or Mann-Whitney U test.

Measurements And Main Results: Eighty-three of 157 advanced practice providers responded (53% response rate, representing 36 institutions [35% of institutions]). Sixty-five percent of respondents started as new graduates. Ninety-three to one-hundred percent obtain a history and physical, order/interpret laboratory, develop management plans, order/titrate medications, and respiratory support. Ability to perform invasive procedures was highly variable but more likely for those in a dedicated cardiac ICU. Seventy-seven percent were oriented by another advanced practice provider, with a duration of orientation less than 4 months (66%). Fifty percent of advanced practice providers had no guidelines in place to guide learning/competency during orientation. Sixty-seven percent were not evaluated in any way on their knowledge or skills during or at the end of orientation. Orientation was rated as poor/fair by the majority of respondents for electrophysiology (58%) and echocardiography (69%). Seventy-one percent rated orientation as moderately effective or less. Respondents stated they would benefit from more structured didactic education with clear objectives, standardized management guidelines, and more simulation/procedural practice. Eighty-five percent were very/extremely supportive of a standardized cardiac ICU advanced practice provider curriculum.

Conclusions: Orientation for cardiac ICU advanced practice providers is highly variable, content depends on the institution/preceptor, and competency is not objectively defined or measured. A cardiac ICU advanced practice provider curriculum is needed to standardize education and promote the highest level of advanced practice provider practice.
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http://dx.doi.org/10.1097/PCC.0000000000002069DOI Listing
December 2019

Commentary: I am not throwing away my shot…to predict when your patient will decompensate.

J Thorac Cardiovasc Surg 2019 07 24;158(1):246-247. Epub 2019 Apr 24.

Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; The Heart Institute, Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2019.03.111DOI Listing
July 2019

Cardiac Surgery in Patients With Trisomy 13 and 18: An Analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

J Am Heart Assoc 2019 07 25;8(13):e012349. Epub 2019 Jun 25.

1 Heart Institute Cincinnati Children's Hospital Medical Center Cincinnati OH.

Background Congenital heart disease is common in patients with Trisomy 13 (T13) and Trisomy 18 (T18), but offering cardiac surgery to these patients has been controversial. We describe the landscape of surgical management across the United States, perioperative risk factors, and surgical outcomes in patients with T13 and T18. Methods and Results Patients in the Society of Thoracic Surgeons Congenital Heart Surgery Database with T13 and T18 who underwent cardiac surgery (2010-2017) were included. There were 343 operations (T13: n=73 and T18: n=270) performed on 304 patients. Among 125 hospitals, 87 (70%) performed at least 1 operation and 26 centers (30%) performed ≥5 T13/T18 operations. Operations spanned the full spectrum of complexity with 29% (98/343) being in the highest categories of estimated risk. The operative mortality rate was 15%, with a 56% complication rate. Preoperative mechanical ventilation was associated with an odds ratio of mortality >8 for both patients with T13 and T18 (both P<0.012) while presence of a gastrostomy tube (odds ratio, 0.3; P=0.03) or prior cardiac surgery (odds ratio, 0.2; P=0.02) was associated with better survival in patients with T18 but not patients with T13. Conclusions Data from this nationally representative sample indicate that most centers offer surgical intervention for both patients with T13 and T18, even in highly complex patients. However, the overall mortality rate was high in this select patient cohort. The association of preoperative mechanical ventilation with mortality suggests that this subset of patients with T13 and T18 should perhaps not be considered surgical candidates. This information is valuable to clinicians and families for counseling and deciding what interventions to offer.
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http://dx.doi.org/10.1161/JAHA.119.012349DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6662341PMC
July 2019

Psychometric testing of the developmental care scale for neonates with congenital heart disease.

Cardiol Young 2019 Jun 10;29(6):749-755. Epub 2019 Jun 10.

Heart Institute, Cincinnati Children's Hospital Medical Center,Cincinnati, OH,USA.

Purpose: Developmental care of neonates with CHD is essential for proper neurodevelopment. Measurement of developmental care specific to these neonates is needed to ensure consistent implementation within and across cardiac ICUs. The purpose of this study was to psychometrically test the Developmental Care Scale for Neonates with Congenital Heart Disease, which measures the quality of developmental care provided by bedside nurses to neonates in the cardiac ICU.

Methods: Psychometric testing was conducted with 119 cardiac ICU nurses to provide evidence of internal consistency reliability and construct validity. Participants were predominantly young (median = 32 years), white (90%) females (93%) with bachelor's degrees (78%) and a median experience in the cardiac ICU of 7 years.

Results: Evidence of internal consistency reliability (α =.89) was provided with corrected item-total correlations ranging from .31 to .77. Exploratory factor analysis provided evidence of construct validity as a unidimensional scale, as well as a multidimensional scale consisting of four subscales: creating the external environment, assessment of family well-being, caregiver activities toward the neonate, and basic human needs.

Conclusions: Evidence of reliability and validity of the 31-item Developmental Care Scale for Neonates with Congenital Heart Disease was established with nurses caring for neonates in the cardiac ICU. This instrument will serve as a valuable outcome measure tasked with improving developmental care performance and makes it possible to identify relationships between developmental care performance and neonatal neurodevelopmental outcomes in future research.
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http://dx.doi.org/10.1017/S1047951119000337DOI Listing
June 2019

Development of a System to Measure and Improve Outcomes in Congenital Heart Disease: Heart Institute Safety, Quality, and Value Program.

Jt Comm J Qual Patient Saf 2019 07 31;45(7):495-501. Epub 2019 May 31.

Achieving excellent outcomes for patients with congenital heart disease requires coordinated effort and resources, and a need has developed for a structure that facilitates improvement and measures cardiac centers' progress toward optimal patient care.

Methods: The Heart Institute (HI) at Cincinnati Children's Hospital developed a Safety, Quality and Value (SQV) program to formalize the use of quality improvement (QI) methods with the goal of optimizing patient outcomes, experience, and value. The SQV program adopted a conceptual framework that considers aspects of structure, process, outcome, and value in defining quality metrics, and the program used the Model for Improvement to guide design and implementation of QI interventions.

Results: In the first four years since its inception, the SQV program facilitated important improvements in clinical outcomes, cost reductions, and safety. In addition to achieving measurable improvements, the creation of a formal SQV program fostered a culture of transparency and accountability, providing a new structure for how the HI shares clinical data among clinicians, hospital leadership, and the public.

Conclusion: The creation of an infrastructure to strategically design, implement, and support QI efforts in a clinically busy pediatric acquired and congenital heart institute was successful in meeting its initial aims and is a promising approach and model for other programs.
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http://dx.doi.org/10.1016/j.jcjq.2019.04.003DOI Listing
July 2019