Publications by authors named "Paul Levy"

47 Publications

Consensus recommendations for the classification and long-term follow up of infants who screen positive for Krabbe Disease.

Mol Genet Metab 2021 Apr 3. Epub 2021 Apr 3.

Marcus Center for Cellular Cures, Duke University School of Medicine, 2400 Pratt Street, Room 9026, Durham, NC 27705, USA.

Objective: To provide updated evidence and consensus-based recommendations for the classification of individuals who screen positive for Krabbe Disease (KD) and recommendations for long-term follow-up for those who are at risk for late onset Krabbe Disease (LOKD).

Methods: KD experts (KD NBS Council) met between July 2017 and June 2020 to develop consensus-based classification and follow-up recommendations. The resulting newly proposed recommendations were assessed in a historical cohort of 47 newborns from New York State who were originally classified at moderate or high risk for LOKD.

Results: Infants identified by newborn screening with possible KD should enter one of three clinical follow-up pathways (Early infantile KD, at-risk for LOKD, or unaffected), based on galactocerebrosidase (GALC) activity, psychosine concentration, and GALC genotype. Patients considered at-risk for LOKD based on low GALC activity and an intermediate psychosine concentration are further split into a high-risk or low-risk follow-up pathway based on genotype. Review of the historical New York State cohort found that the updated follow-up recommendations would reduce follow up testing by 88%.

Conclusion: The KD NBS Council has presented updated consensus recommendations for efficient and effective classification and follow-up of NBS positive patients with a focus on long-term follow-up of those at-risk for LOKD.
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http://dx.doi.org/10.1016/j.ymgme.2021.03.016DOI Listing
April 2021

Outcomes After Use of a Lymph Node Collection Kit for Lung Cancer Surgery: A Pragmatic, Population-Based, Multi-Institutional, Staggered Implementation Study.

J Thorac Oncol 2021 Apr 16;16(4):630-642. Epub 2021 Feb 16.

Department of Surgery, Washington University, St. Louis, Missouri.

Introduction: Suboptimal pathologic nodal staging prevails after curative-intent resection of lung cancer. We evaluated the impact of a lymph node specimen collection kit on lung cancer surgery outcomes in a prospective, population-based, staggered implementation study.

Methods: From January 1, 2014, to August 28, 2018, we implemented the kit in three homogeneous institutional cohorts involving 11 eligible hospitals from four contiguous hospital referral regions. Our primary outcome was pathologic nodal staging quality, defined by the following evidence-based measures: the number of lymph nodes or stations examined, proportions with poor-quality markers such as nonexamination of lymph nodes, and aggregate quality benchmarks including the National Comprehensive Cancer Network criteria. Additional outcomes included perioperative complications, health care utilization, and overall survival.

Results: Of 1492 participants, 56% had resection with the kit and 44% without. Pathologic nodal staging quality was significantly higher in the kit cases: 0.2% of kit cases versus 9.8% of nonkit cases had no lymph nodes examined; 3.2% versus 25.3% had no mediastinal lymph nodes; 75% versus 26% attained the National Comprehensive Cancer Network criteria (p < 0.0001 for all comparisons). Kit cases revealed no difference in perioperative complications or health care utilization except for significantly shorter duration of surgery, lower proportions with atelectasis, and slightly higher use of blood transfusion. Resection with the kit was associated with a lower hazard of death (crude, 0.78 [95% confidence interval: 0.61-0.99]; adjusted 0.85 [0.71-1.02]).

Conclusions: Lung cancer surgery with a lymph node collection kit significantly improved pathologic nodal staging quality, with a trend toward survival improvement, without excessive perioperative morbidity or mortality.
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http://dx.doi.org/10.1016/j.jtho.2020.12.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012255PMC
April 2021

Cardiac evaluation of the kidney or liver transplant candidate.

Curr Opin Organ Transplant 2021 Feb;26(1):77-84

Department of Medicine-Division of Gastroenterology and Hepatology.

Purpose Of Review: As the field of transplant has advanced, cardiac events have become the leading cause of morbidity and mortality after liver and kidney transplantation ahead of graft failure and infection. This trend has been bolstered by the transplantation of older and sicker patients who have a higher burden of cardiovascular risk factors, accentuating the need to determine which patients should undergo more extensive cardiac evaluation prior to transplantation.

Recent Findings: Computed tomography coronary angiography with or without coronary artery calcium scoring is now preferred over stress imaging in most transplant candidates for assessment of coronary artery disease. Assessment of cardiac structure and function using transthoracic echocardiography with tissue doppler imaging and strain imaging is recommended, particularly in liver transplant candidates who are at high risk of cirrhotic cardiomyopathy, for which new diagnostic criteria were recently published in 2019.

Summary: Cardiac evaluation of liver and kidney transplant candidates requires a global assessment for both short and long-term risk for cardiac events. Imaging of cardiac structure and function using transthoracic echocardiography with tissue doppler imaging and strain imaging is recommended. Risk stratification should consider both the anatomic and functional consequences of coronary artery disease in transplant candidates.

Video Abstract: http://links.lww.com/MOT/A27.
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http://dx.doi.org/10.1097/MOT.0000000000000838DOI Listing
February 2021

Supracondylar humerus fractures in low- and lower middle-income countries: a scoping review of the current epidemiology, treatment modalities, and outcomes.

Int Orthop 2020 11 21;44(11):2443-2448. Epub 2020 Jul 21.

UCSF Department of Orthopedic Surgery, Institute for Global Orthopaedics and Traumatology, San Francisco, CA, USA.

Background: The purpose of this scoping review was to examine the nature and quality of research regarding paediatric supracondylar humerus (SCH) fractures in low and lower middle-income countries (LICs).

Methods: We searched PubMed, Embase, Web of Science, and African Journals Online on January 9, 2018, for studies of SCH fractures in LICs. Studies were categorized by geographic region, Gartland classification of included patients, and study design. We evaluated each study's methodology and conclusions.

Results: Out of 1805 results, we analyzed 105 studies, most of which included type 3 fractures only (66%). Many were conducted in South Asia (58%) and assessed treatment outcomes (78%). Most of the studies had level IV evidence (67%). Common limitations of research were small sample size (12%) and inadequate follow-up (6%). Epidemiological studies concluded that SCH fractures are more common among male children, are usually secondary to falls, and rarely present with nerve injuries. Most therapeutic studies reported outcomes of surgery (91%). Thirteen studies concluded that all-lateral versus cross-pinning techniques have similar outcomes. Seven studies reported preference for closed reduction over open reduction, when intra-operative fluoroscopy was available. Most common outcome measures were Flynn criteria (77%) and range of motion (53%). None of the papers looked at treatment costs.

Conclusions: Our data show a predominance of small level IV studies from LICs, with few studies of higher level of evidence. Many studies examined controversies with surgical technique, similar to studies performed in high-income countries. Few studies examined non-operative treatment, which is commonly the predominant treatment available for patients in LICs. Further investigation of common treatment modalities and outcomes for SCH fractures in LICs is needed.
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http://dx.doi.org/10.1007/s00264-020-04694-8DOI Listing
November 2020

Incorporating Medical Student Documentation Into the Billable Encounter: A Pragmatic Approach to Implementation of the 2018 Centers for Medicare & Medicaid Services Rule Revision.

Chest 2020 Aug 19;158(2):698-704. Epub 2020 Feb 19.

Department of Internal Medicine, University of Rochester Medical Center, Rochester, NY.

In early 2018, the Centers for Medicare & Medicaid Services released the Medical Review of Evaluation and Management (E/M) Documentation, which allows supervising teaching physicians to rely on a medical student's documentation to support billing for E/M services. This change has potential to enhance education, clinical documentation quality, and the satisfaction of students, postgraduate trainees, and teaching physicians. However, its practical adoption presents many challenges that must be navigated successfully to realize these important goals in compliance with federal and local requirements, while avoiding unintended downstream problems. Implementation requires careful planning, policy creation, education, and monitoring, all with collaboration between institutional leaders, compliance and information technology professionals, educators, and learners. In this paper, we review the 2018 Centers for Medicare & Medicaid Services rule change, address common questions and potential impacts, outline practical workflows to meet the supervision requirement, and discuss steps for successful implementation.
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http://dx.doi.org/10.1016/j.chest.2020.02.010DOI Listing
August 2020

Survival Before and After Direct Surgical Quality Feedback in a Population-Based Lung Cancer Cohort.

Ann Thorac Surg 2019 05 27;107(5):1487-1493. Epub 2018 Dec 27.

Multidisciplinary Thoracic Oncology Program, Baptist Cancer Center, Memphis, Tennessee. Electronic address:

Background: Surgical resection is the main curative modality for non-small cell lung cancer (NSCLC), but variation in the quality of care contributes to suboptimal survival rates. Improving surgical outcomes by eliminating quality deficits is a key strategy for improving population-level lung cancer survival. We evaluated the long-term survival effect of providing direct feedback on institutional performance in a population-based cohort.

Methods: The Mid-South Quality of Surgical Resection cohort includes all NSCLC resections at 11 hospitals in four contiguous Dartmouth Hospital Referral Regions in Arkansas, Mississippi, and Tennessee. We evaluated resections from 2004 to 2013, before and after onset of a benchmarked performance feedback campaign to surgery and pathology teams in 2009.

Results: We evaluated 2,206 patients: 56% preintervention (pre-era) and 44% postintervention (post-era). Preoperative positron emission tomography/computed tomography (46% vs 82%, p < 0.0001), brain scans (6% vs 21%, p < 0.0001), and bronchoscopy (8% vs 27%, p < 0.0001) were more frequently used in the post-era. Patients had 5-year survival of 47% (44% to 50%) in the pre-era compared with 53% (50% to 56%) in the post-era (p = 0.0028). The post-era had an adjusted hazard ratio of 0.85 (95% confidence interval [CI], 0.75 to 0.97; p = 0.0158) compared with the pre-era. This differed by extent of resection (p = 0.0113): compared with the pre-era, the post-era adjusted hazard ratio was 0.49 (95% CI, 0.33 to 0.72) in pneumonectomy, 0.91 (95% CI, 0.79 to 1.05) in lobectomy/bilobectomy, and 0.85 (95% CI, 0.63 to 1.15) in segmentectomy/wedge resections.

Conclusions: Overall survival after surgical resection improved significantly in a high lung cancer mortality region of the United States. Reasons may include better selection of patients for pneumonectomy and more thorough staging.
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http://dx.doi.org/10.1016/j.athoracsur.2018.11.058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478525PMC
May 2019

Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement.

J Am Coll Cardiol 2018 06;71(24):2717-2726

Multicare Tacoma General, Tacoma, Washington.

Background: The burden oral anticoagulation is a limitation of mechanical valve prostheses.

Objectives: The aim of this study was to test whether patients could be safely managed with dual-antiplatelet therapy (DAPT) (aspirin 325 mg and clopidogrel 75 mg) or lower warfarin after On-X mechanical aortic valve replacement (mAVR).

Methods: PROACT (Prospective Randomized On-X Anticoagulation Trial) (n = 576) is a multicenter (41 sites) noninferiority trial. From June 2006 through February 2014, 201 patients ≥18 years of age without thromboembolic risk factors undergoing mAVR were randomized to receive DAPT (n = 99) or standard warfarin plus aspirin (n = 102) 3 months after mAVR (low-risk arm). From June 2006 through October 2009, 375 patients with 1 or more thromboembolic risk factors were also randomized to lower intensity warfarin plus aspirin (international normalized ratio 1.5 to 2.0; n = 185) or standard warfarin plus aspirin (international normalized ratio 2.0 to 3.0; n = 190) 3 months after mAVR (high-risk arm).

Results: The low-risk arm was terminated for excess cerebral thromboembolic events (3.12% per patient-year vs. 0.29% per patient-year, p = 0.02) in the DAPT group at up to 8.8-year follow-up (631.6 patient-years), with no differences in bleeding or all-cause mortality. High-risk arm patients experienced significantly lower major (1.59% per patient-year vs. 3.94% per patient-year, p = 0.002) and minor (1.27% per patient-year vs. 3.49% per patient-year, p = 0.002) bleeding up to 8.7-year follow-up (2,035.2 patient-years), with no differences in thromboembolism (0.42% per patient-year vs. 0.09% per patient-year, p = 0.20) and all-cause mortality.

Conclusions: DAPT was associated with higher rates of thromboembolism and valve thrombosis compared with control in the low-risk arm. International normalized ratios were safely maintained at 1.5 to 2.0 in high-risk patients, without differences in mortality or thromboembolic complications. (Randomized On-X Anticoagulation Trial [PROACT]; NCT00291525).
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http://dx.doi.org/10.1016/j.jacc.2018.03.535DOI Listing
June 2018

Effectiveness of Implemented Interventions on Pathologic Nodal Staging of Non-Small Cell Lung Cancer.

Ann Thorac Surg 2018 07 11;106(1):228-234. Epub 2018 Mar 11.

Multidisciplinary Thoracic Oncology Program, Baptist Cancer Center, Memphis, Tennessee. Electronic address:

Background: Accurate pathologic nodal staging improves early stage non-small cell lung cancer survival. In an ongoing implementation study, we measured the impact of a surgical lymph node specimen collection kit and a more thorough pathologic gross dissection method on attainment of guideline-recommended pathologic nodal staging quality.

Methods: We prospectively collected data on curative intent non-small cell lung cancer resections from 2009 to 2016 from 11 hospitals in four contiguous Dartmouth Hospital referral regions. We categorized patients into four groups based on exposure to the two interventions in our staggered implementation study design. We used χ tests to examine the differences in demographic and disease characteristics and surgical quality criteria across implementation groups.

Results: Of 2,469 patients, 1,615 (65%) received neither intervention; 167 (7%) received only the pathology intervention; 264 (11%) received only the surgery intervention; and 423 (17%) had both. Rates of nonexamination of lymph nodes reduced sequentially in the order of no intervention, novel dissection, kit, and combined interventions, including nonexamination of any lymph nodes and hilar/intrapulmonary and mediastinal nodes (p < 0.001 for all comparisons). The rates of attainment of National Comprehensive Cancer Network, Commission on Cancer, American Joint Committee on Cancer, and American College of Surgeons Oncology Group guidelines increased significantly in the same sequential order (p < 0.001 for all comparisons).

Conclusions: The combined effect of two interventions to improve pathologic lymph node examination has a greater effect on attainment of a range of surgical quality criteria than either intervention alone.
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http://dx.doi.org/10.1016/j.athoracsur.2018.02.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019187PMC
July 2018

Trisomies.

Pediatr Rev 2018 Feb;39(2):104-106

Children's Hospital at Montefiore, Bronx, NY.

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http://dx.doi.org/10.1542/pir.2016-0198DOI Listing
February 2018

Evolution in the Surgical Care of Patients With Non-Small Cell Lung Cancer in the Mid-South Quality of Surgical Resection Cohort.

Semin Thorac Cardiovasc Surg 2017 Spring;29(1):91-101. Epub 2016 Oct 14.

Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, Tennessee; Division of General Thoracic Surgery, Multidisciplinary Thoracic Oncology Program, Baptist Cancer Center, Memphis, Tennessee. Electronic address:

Surgery is the most important curative treatment modality for patients with early-stage non-small cell lung cancer (NSCLC). We examined the pattern of surgical resection for NSCLC in a high incidence and mortality region of the United States over a 10-year period (2004-2013) in the context of a regional surgical quality improvement initiative. We abstracted patient-level data on all resections at 11 hospitals in 4 contiguous Dartmouth Hospital Referral Regions in North Mississippi, East Arkansas, and West Tennessee. Surgical quality measures focused on intraoperative practice, with emphasis on pathologic nodal staging. We used descriptive statistics and trend analyses to assess changes in practice over time. To measure the effect of an ongoing regional quality improvement intervention with a lymph node specimen collection kit, we used period effect analysis to compare trends between the preintervention and postintervention periods. Of 2566 patients, 18% had no preoperative biopsy, only 15% had a preoperative invasive staging test, and 11% underwent mediastinoscopy. The rate of resections with no mediastinal lymph nodes examined decreased from 48%-32% (P < 0.0001), whereas the rate of resections examining 3 or more mediastinal stations increased from 5%-49% (P < 0.0001). There was a significant period effect in the increase in the number of N1, mediastinal, and total lymph nodes examined (all P < 0.0001). A quality improvement intervention including a lymph node specimen collection kit shows early signs of having a significant positive effect on pathologic nodal examination in this population-based cohort. However, gaps in surgical quality remain.
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http://dx.doi.org/10.1053/j.semtcvs.2016.10.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5502738PMC
September 2017

Laboratory Formulary: A Model for High-Value Evidence-Based Medicine.

Clin Chem 2017 07 17;63(7):1299-1300. Epub 2017 May 17.

Department of Medicine University of Rochester Medical Center Rochester, NY.

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http://dx.doi.org/10.1373/clinchem.2016.270819DOI Listing
July 2017

Prognostic Value of National Comprehensive Cancer Network Lung Cancer Resection Quality Criteria.

Ann Thorac Surg 2017 May 31;103(5):1557-1565. Epub 2017 Mar 31.

Multidisciplinary Thoracic Oncology Program, Baptist Cancer Center, Memphis, Tennessee.

Background: The National Comprehensive Cancer Network (NCCN) surgical resection guidelines for non-small cell lung cancer recommend anatomic resection, negative margins, examination of hilar/intrapulmonary lymph nodes, and examination of three or more mediastinal nodal stations. We examined the survival impact of these criteria.

Methods: A population-based observational study was done using patient-level data from all curative-intent, non-small cell lung cancer resections from 2004 to 2013 at 11 institutions in four contiguous Dartmouth Hospital referral regions in three US states. We used an adjusted Cox proportional hazards model to assess the overall survival impact of attaining NCCN guidelines.

Results: Of 2,429 eligible resections, 91% were anatomic, 94% had negative margins, 51% sampled hilar nodes, and 26% examined three or more mediastinal nodal stations. Only 17% of resections met all four criteria; however, there was a significant increasing trend from 2% in 2004 to 39% in 2013 (p < 0.001). Compared with patients whose surgery missed one or more criteria, the hazard ratio for patients whose surgery met all four criteria was 0.71 (95% confidence interval: 0.59 to 0.86, p < 0.001). Margin status and the nodal staging criteria were most strongly linked with survival.

Conclusions: Attainment of NCCN surgical quality guidelines was low, but improving, over the past decade in this cohort from a high lung cancer mortality region of the United States. The NCCN quality criteria, especially the nodal examination criteria, were strongly associated with survival. The quality of nodal examination should be a focus of quality improvement in non-small cell lung cancer care.
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http://dx.doi.org/10.1016/j.athoracsur.2017.01.098DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5401641PMC
May 2017

Clinical outcomes of children with abnormal newborn screening results for Krabbe disease in New York State.

Genet Med 2016 12 12;18(12):1235-1243. Epub 2016 May 12.

Division of Genetics, Wadsworth Center, New York State Department of Health, Albany, New York, USA.

Background: Early infantile Krabbe disease is rapidly fatal, but hematopoietic stem cell transplantation (HSCT) may improve outcomes if performed soon after birth. New York State began screening all newborns for Krabbe disease in 2006.

Methods: Infants with abnormal newborn screen results for Krabbe disease were referred to specialty-care centers. Newborns found to be at high risk for Krabbe disease underwent a neurodiagnostic battery to determine the need for emergent HSCT.

Results: Almost 2 million infants were screened. Five infants were diagnosed with early infantile Krabbe disease. Three died, two from HSCT-related complications and one from untreated disease. Two children who received HSCT have moderate to severe developmental delays. Forty-six currently asymptomatic children are considered to be at moderate or high risk for development of later-onset Krabbe disease.

Conclusions: These results show significant HSCT-associated morbidity and mortality in early infantile Krabbe disease and raise questions about its efficacy when performed in newborns diagnosed through newborn screening. The unanticipated identification of "at risk" children introduces unique ethical and medicolegal issues. New York's experience raises questions about the risks, benefits, and practicality of screening newborns for Krabbe disease. It is imperative that objective assessments be made on an ongoing basis as additional states begin screening for this disorder.Genet Med 18 12, 1235-1243.
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http://dx.doi.org/10.1038/gim.2016.35DOI Listing
December 2016

Newborn screening for Krabbe disease in New York State: the first eight years' experience.

Genet Med 2016 Mar 21;18(3):239-48. Epub 2016 Jan 21.

Laboratory of Human Genetics, Wadsworth Center, New York State Department of Health, Albany, New York, USA.

Purpose: Krabbe disease (KD) results from galactocerebrosidase (GALC) deficiency. Infantile KD symptoms include irritability, progressive stiffness, developmental delay, and death. The only potential treatment is hematopoietic stem cell transplantation. New York State (NYS) implemented newborn screening for KD in 2006.

Methods: Dried blood spots from newborns were assayed for GALC enzyme activity using mass spectrometry, followed by molecular analysis for those with low activity (≤12% of the daily mean). Infants with low enzyme activity and one or more mutations were referred for follow-up diagnostic testing and neurological examination.

Results: Of >1.9 million screened, 620 infants were subjected to molecular analysis and 348 were referred for diagnostic testing. Five had enzyme activities and mutations consistent with infantile KD and manifested clinical/neurodiagnostic abnormalities. Four underwent transplantation, two are surviving with moderate to severe handicaps, and two died from transplant-related complications. The significance of many sequence variants identified is unknown. Forty-six asymptomatic infants were found to be at moderate to high risk for disease.

Conclusions: The positive predictive value of KD screening in NYS is 1.4% (5/346) considering confirmed infantile cases. The incidence of infantile KD in NYS is approximately 1 in 394,000, but it may be higher for later-onset forms.
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http://dx.doi.org/10.1038/gim.2015.211DOI Listing
March 2016

Interview with Paul Levy.

Healthc (Amst) 2015 Dec 14;3(4):286-8. Epub 2015 Nov 14.

Harvard Medical School, US.

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http://dx.doi.org/10.1016/j.hjdsi.2015.10.003DOI Listing
December 2015

A Stochastic Burst Follows the Periodic Morning Peak in Individual Drosophila Locomotion.

PLoS One 2015 3;10(11):e0140481. Epub 2015 Nov 3.

Department of Physics, University of Miami, Coral Gables, Florida, United States of America.

Coupling between cyclically varying external light and an endogenous biochemical oscillator known as the circadian clock, modulates a rhythmic pattern with two prominent peaks in the locomotion of Drosophila melanogaster. A morning peak appears around the time lights turn on and an evening peak appears just before lights turn off. The close association between the peaks and the external 12:12 hour light/dark photoperiod means that respective morning and evening peaks of individual flies are well-synchronized in time and, consequently, feature prominently in population-averaged data. Here, we report on a brief but strong stochastic burst in fly activity that, in contrast to morning and evening peaks, is detectable only in single fly recordings. This burst was observed across 3 wild-type strains of Drosophila melanogaster. In a single fly recording, the burst is likely to appear once randomly within 0.5-5 hours after lights turn on, last for only 2-3 minutes and yet show 5 times greater activity compared to the maximum of morning peak with data binned in 3 minutes. Owing to its variable timing and short duration, the burst is virtually undetectable in population-averaged data. We use a locally-built illumination system to study the burst and find that its incidence in a population correlates with light intensity, with ~85% of control flies showing the behavior at 8000 lux (1942 μW/cm2). Consistent with that finding, several mutant flies with impaired vision show substantially reduced frequency of the burst. Additionally, we find that genetic ablation of the clock has insignificant effect on burst frequency. Together, these data suggest that the pronounced burst is likely generated by a light-activated circuit that is independent of the circadian clock.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0140481PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631454PMC
June 2016

Predictors of substance use among vulnerable adolescents in five cities: findings from the well-being of adolescents in vulnerable environments study.

J Adolesc Health 2014 Dec 19;55(6 Suppl):S39-47. Epub 2014 Nov 19.

Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Purpose: Adolescent substance use has numerous consequences. Our goals in this article are to compare the prevalence and correlates of substance use among ethnically diverse adolescents.

Methods: Data were from 2,332 adolescents aged 15-19 years recruited via respondent-driven sampling from disadvantaged settings in five cities. Multivariate logistic regression was used to identify correlates of current substance use.

Results: About half of the respondents were male. Most adolescents (73.4%) were currently enrolled in school and identified a father (86.2%) and mother (98.6%) figure and strong peer support. Sixty-two percent reported lifetime use of at least one substance. Overall, the most common substances ever used were alcohol (44.6%), cigarettes (26.2%), and marijuana (17.9%). Mean age at first use of alcohol was 14.2 ± 3.1 years. Current alcohol use was highest in Johannesburg (47.4%) and lowest in Delhi (2.1%). The mean age at first use of cigarettes was 14.4 ± 2.8 years. Current cigarette smoking was highest in Johannesburg (32.5%) and lowest in Delhi (3.7%). Male gender predicted current alcohol use in all sites, older age (17-19 years) was also a predictor in Baltimore. Male gender (Johannesburg and Shanghai), older age (Baltimore and Shanghai), and being out of school (Baltimore, Johannesburg, and Shanghai) predicted current cigarette smoking. Absence of a caring father figure was predictive for current alcohol use in Baltimore and Shanghai. Stronger peer support predicted alcohol (Johannesburg and Shanghai) and cigarette use (Johannesburg).

Conclusions: Substance use is still a major issue among adolescents around the world, underscoring the need for continued research and interventions.
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http://dx.doi.org/10.1016/j.jadohealth.2014.08.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4493747PMC
December 2014

Copy, paste, and cloned notes in electronic health records: prevalence, benefits, risks, and best practice recommendations.

Chest 2014 Mar;145(3):632-8

The modern medical record is not only used by providers to record nuances of patient care, but also is a document that must withstand the scrutiny of insurance payers and legal review. Medical documentation has evolved with the rapid growth in the use of electronic health records (EHRs). The medical software industry has created new tools and more efficient ways to document patient care encounters and record results of diagnostic testing. While these techniques have resulted in efficiencies and improvements in patient care and provider documentation, they have also created a host of new problems, including authorship attribution, data integrity, and regulatory concerns over the accuracy and medical necessity of billed services. Policies to guide provider documentation in EHRs have been developed by institutions and payers with the goal of reducing patient care risks as well as preventing fraud and abuse. In this article, we describe the major content-importing technologies that are commonly used in EHR documentation as well as the benefits and risks associated with their use. We have also reviewed a number of institutional policies and offer some best practice recommendations.
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http://dx.doi.org/10.1378/chest.13-0886DOI Listing
March 2014

Copy, Paste, and Cloned Notes in Electronic Health Records.

Chest 2014 03;145(3):632-638

University of Rochester Medical Center, Rochester, NY.

The modern medical record is not only used by providers to record nuances of patient care, but also is a document that must withstand the scrutiny of insurance payers and legal review. Medical documentation has evolved with the rapid growth in the use of electronic health records (EHRs). The medical software industry has created new tools and more efficient ways to document patient care encounters and record results of diagnostic testing. While these techniques have resulted in efficiencies and improvements in patient care and provider documentation, they have also created a host of new problems, including authorship attribution, data integrity, and regulatory concerns over the accuracy and medical necessity of billed services. Policies to guide provider documentation in EHRs have been developed by institutions and payers with the goal of reducing patient care risks as well as preventing fraud and abuse. In this article, we describe the major content-importing technologies that are commonly used in EHR documentation as well as the benefits and risks associated with their use. We have also reviewed a number of institutional policies and offer some best practice recommendations.
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http://dx.doi.org/10.1378/chest.13-0886DOI Listing
March 2014

Outcome of infants diagnosed with 3-methyl-crotonyl-CoA-carboxylase deficiency by newborn screening.

Mol Genet Metab 2012 Aug 20;106(4):439-41. Epub 2012 Apr 20.

Department of Pediatrics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.

Introduction: 3-Methyl CoA carboxylase (3-MCC) deficiency is an inborn error of metabolism in the catabolism of the amino acid leucine. Original reports suggested this disorder was associated with significant neurological and biochemical effects. However newborn screening has identified a higher than expected incidence of this disorder with apparent normal outcome in most cases.

Method: A retrospective analysis of thirty-five cases of 3-MCC deficiency identified by newborn screening and diagnosed by enzyme or molecular analysis.

Results: There was a strong inverse correlation between initial C5OH level and residual enzyme activity. A few reports of hypoglycemia, ketosis, poor feeding/failure to thrive or fasting intolerance were reported, but there was no clear relationship between symptoms and residual enzyme activity. Developmental outcome included several children with mental retardation (including one with Down syndrome and one with schizencephaly) and two with Autism Spectrum disorders but there was no apparent relationship to residual enzyme activity. Free carnitine deficiency was relatively common.

Discussion: Although residual enzyme activity was clearly related to metabolite elevation, there was no apparent relationship with other measures of outcome. The number of reports of neurologic abnormalities or metabolic symptoms (poor feeding, hypoglycemia, fasting intolerance, etc.) is concerning, but the significance is unclear in this retrospective sample.
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http://dx.doi.org/10.1016/j.ymgme.2012.04.006DOI Listing
August 2012

Never events? Well, hardly ever.

Authors:
Paul F Levy

Virtual Mentor 2011 Sep 1;13(9):659-62. Epub 2011 Sep 1.

President and chief executive officer of Beth Israel Deaconess Medical Center in Boston.

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http://dx.doi.org/10.1001/virtualmentor.2011.13.9.oped1-1109DOI Listing
September 2011

An overview of newborn screening.

Authors:
Paul A Levy

J Dev Behav Pediatr 2010 Sep;31(7):622-31

Department of Pediatrics, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Bronx, NY, USA.

This review of newborn screening examines the beginning of screening with the story of phenylketonuria and explores the principles of screening and the criteria with which disorders were added to newborn screening panels. The explosion of tests that are screened for followed the adoption of tandem mass spectrometry (MS-MS) technology. The inequity of state newborn screening panels was brought to the forefront with an American Academy of Pediatrics task force report in 2000 that called for a national panel. The American College of Medical Genetics convened an expert panel to produce such a panel. In 2006, they published their panel of disorders, recommending a panel of 29 core disorders and 25 additional secondary targets. Ethical arguments about newborn screening have resurfaced with the recent expansion of testing that include arguments about consent, mandatory participation, benefits to those screened, and cost-both to the individual and society. Finally, the future direction of screening is discussed. Newborn screening is undergoing rapid expansion. The addition of tests involves ethical, financial, and social pressures.
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http://dx.doi.org/10.1097/DBP.0b013e3181eedf01DOI Listing
September 2010

Other voices. Hospital CEO, blog star. Interview by Bill Santamour.

Authors:
Paul Levy

Hosp Health Netw 2009 Nov;83(11):12-3

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November 2009

Lack of genotype-phenotype correlations and outcome in MCAD deficiency diagnosed by newborn screening in New York State.

Mol Genet Metab 2010 Mar 1;99(3):263-8. Epub 2009 Nov 1.

Department of Pediatrics, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Box 777, Rochester, NY 14642, USA.

Introduction: Medium chain acyl-CoA dehydrogenase (MCAD) deficiency is one of the most common inborn errors of metabolism. Affected patients have impaired ability to break down medium chain fatty acids during fasting, and typically present in the early years of life with hypoketotic hypoglycemia, Reye syndrome-like symptoms, brain damage or death. The development of newborn screening (NBS) for MCAD deficiency has greatly improved outcome, but some patients still appear at risk for severe complications. We reviewed the outcome of patients identified with MCAD deficiency by the New York State NBS process to identify biochemical or genotypic markers which might predict outcome.

Method: All eight NBS follow-up centers in New York State contributed the cases of MCAD deficiency diagnosed by newborn screen, who received diagnostic and follow-up care in their clinic. Data reviewed included gender, age, birthweight, initial NBS octanoylcarnitine level (C8) and C8/C2 ratio, follow-up C8 and hexanoylglycine, race/ethnicity, and presence of neonatal or later symptoms.

Results: We identified 53 cases of MCAD deficiency. More than one quarter of patients had a post-neonatal symptomatic admission (predominantly lethargy associated with an intercurrent illness). No genotype or C8 level was protective for neonatal or later symptoms. There was a relationship between initial C8 level or C8/C2 ratio and occurrence of later symptoms (7.3 micromol/L in the asymptomatic vs. 19.1 micromol/L in the symptomatic, p<0.0002 for C8, and 0.26 vs. 0.6, respectively, for C8/C2 ratio, p<0.012). Four infants had initial C8 level >30 micromol/L; these infants had a high rate of symptomatic or multiple symptomatic episodes or a history of sibling death from "SIDS", and typically had deletion, nonsense or splice sites mutations. Infants having a history of a symptomatic episode were more likely to have higher initial C8 on NBS and a genotype predicted to strongly affect protein function. In our ethnically diverse group of patients, the c.985A>G mutation was rarely found in non-Caucasians.

Discussion: No genotype or metabolite profile is protective from symptoms. The strong relationship between initial C8 level and outcome suggests that in at least some cases neonates having high initial C8 levels may be demonstrating an increased susceptibility to catabolic stress, and may merit additional precautions. Our data also suggest that these infants are more likely to carry severe mutations including homozygosity for the common mutation, deletions, nonsense or splice site mutations. The reports of significant lethargy or hypoglycemia during intercurrent illness in over one quarter of cases even when early medical intervention is recommended (and even when initial C8 is not profoundly elevated) underscores the importance of continued vigilance to prevent stressful fasting in this disorder.
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http://dx.doi.org/10.1016/j.ymgme.2009.10.188DOI Listing
March 2010

Creating a nationally representative sample of patients from trauma centers.

J Trauma 2009 Sep;67(3):637-42; discussion 642-4

American College of Surgeons, Committee on Trauma, Chicago, Illinois, USA.

Background: The National Trauma Data Bank (NTDB) was developed as a convenience sample of registry data from contributing trauma centers (TCs), thus, inferences about trauma patients may not be valid at the national level. The NTDB National Sample was created to obtain nationally representative estimates of trauma patients treated in the US level I and II TCs.

Methods: Level I and II TCs in the Trauma Information Exchange Program were identified and a random stratified sample of 100 TCs was selected. The probability-proportional-to-size method was used to select TCs and sample weights were calculated. National Sample Program estimates from 2003 to 2006 were compared with raw NTDB data, and to a subset of TCs in the Healthcare Cost and Utilization Project Nationwide Inpatient Sample, a population-based dataset drawn from community hospitals.

Results: Weighted estimates from the NTDB National Sample range from 484,000 (2004) to 608,000 (2006) trauma incidents. Crude NTDB data over-represented the proportion of younger patients (0 years-14 years) compared with the NTDB National Sample, which does not include children's hospitals. Few TCs in Trauma Information Exchange Program are included in Healthcare Cost and Utilization Project Nationwide Inpatient Sample, but estimates based on this subset indicate a higher percentage of older patients (age 65 year or older, 23.98% versus 17.85%), lower percentage male patients, and a lower percentage of motor vehicle accidents compared with NTDB National Sample.

Conclusion: Although nationally representative data regarding trauma patients are available in other population-based samples, they do not represent TCs patients and lack the specificity of National Sample Program data, which contains detailed information on injury mechanisms, diagnoses, and hospital treatment.
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http://dx.doi.org/10.1097/TA.0b013e3181b84294DOI Listing
September 2009

Regression modeling of combined data from multiple sample surveys.

Authors:
Lei Li Paul S Levy

Stat Med 2009 Jul;28(16):2160-9

Statistics and Epidemiology Research Unit, RTI International, Triangle Park, NC 27709-2194, USA.

Combined data from multiple sample surveys are often used in population-based epidemiologic studies. Combining data can be beneficial in that sampling errors are reduced and coverage biases are corrected. Also, it is often necessary in order to use information lacking in one survey but available in another. We propose an estimation equations method for generalized linear models from the combined data. The estimation procedures for logistic regression models and Poisson regression models are developed. An example of estimating the relative risk of death by smoking status is used as an illustration and a simulation study is performed to examine the performance of the method.
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http://dx.doi.org/10.1002/sim.3610DOI Listing
July 2009

Inborn errors of metabolism: part 1: overview.

Authors:
Paul A Levy

Pediatr Rev 2009 Apr;30(4):131-7; quiz 137-8

Children's Hospital at Montefiore, Bronx, NY, USA.

After completing this article, readers should be able to: 1. Recognize the signs and symptoms that are suggestive of an inborn error of metabolism. 2. Describe the characteristics of different classes of metabolic syndromes. 3. Formulate a logical diagnostic approach to determining which specific condition is present when an inborn error of metabolism is suspected. 4. Delineate the value and scope of newborn screening programs. 5. Be aware of treatment modalities for inborn errors of metabolism.
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http://dx.doi.org/10.1542/pir.30-4-131DOI Listing
April 2009

Inborn errors of metabolism: part 2: specific disorders.

Authors:
Paul A Levy

Pediatr Rev 2009 Apr;30(4):e22-8

Children's Hospital at Montefiore, Bronx, NY.

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http://dx.doi.org/10.1542/pir.30-4-e22DOI Listing
April 2009

Exposure to beryllium and occurrence of lung cancer: findings from a cox proportional hazards analysis of data from a retrospective cohort mortality study.

J Occup Environ Med 2009 Apr;51(4):480-6

RTI International, Research Triangle Park, NC, USA.

Objective: The objective was to assess highly confounded patterns in a standardized mortality ratio (SMR) analysis of lung cancer in beryllium worker cohorts.

Methods: We used Cox proportional hazards single- and multi-variate models to assess confounding and the SMR patterns.

Results: We confirmed the lack of association of lung cancer with time worked. We could not confirm the original study's finding of lung cancer highly associated with earlier plants and or with workers hired in the 1940s compared to the 1950s. The pattern of higher rates of lung cancer with increasing latency was attenuated when covariates were added to the model. We could not exclude that the lower SMR and hazard ratios for workers hired in the 1960s might be related to assumed lower beryllium exposures.

Conclusion: The patterns observed provide little support for an association of lung cancer with beryllium work factors. This result is likely due to the absence in the original study of a significant overall excess of lung cancer after smoking adjustment.
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http://dx.doi.org/10.1097/JOM.0b013e31819968f3DOI Listing
April 2009

Newborn screening for Krabbe disease: the New York State model.

Pediatr Neurol 2009 Apr;40(4):245-52; discussion 253-5

Hunter James Kelly Research Institute, Department of Neurology, University at Buffalo, State University of New York, Buffalo, New York, USA.

Krabbe disease is a rare inherited neurologic disorder affecting the central and peripheral nervous systems. The disease has four phenotypes: early infantile, later onset, adolescent, and adult. The only known treatment is hematopoietic stem cell transplantation, which is, in the early infantile form of the disease, most beneficial if performed before onset of clinical symptoms. In August 2006, New York State began screening all newborns for Krabbe disease. A rapid and accurate technique for assessing galactocerebrosidase activity and performing DNA mutation analysis had been developed. Interpreting these results was limited, however, because neither enzyme activity nor genetic mutation reliably predicts phenotype. A series of initiatives were therefore developed by a multidisciplinary group of neurologists, geneticists, metabolic pediatricians, neurodevelopmental pediatricians, and transplant physicians (the Krabbe Consortium of New York State) to enhance the effectiveness of the newborn screening program. A standardized clinical evaluation protocol was designed based on the available literature, criteria for transplantation for the early infantile phenotype were formulated, a clinical database and registry was developed, and a study of developmental and functional outcomes was instituted. This multidisciplinary standardized approach to evaluating infants who have positive results on newborn screening may serve as a model for other states as they begin the process of screening for Krabbe disease and other lysosomal storage disorders.
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http://dx.doi.org/10.1016/j.pediatrneurol.2008.11.010DOI Listing
April 2009