Publications by authors named "Mitchell Goldstein"

31 Publications

Guidance for palivizumab prophylaxis and implications for compliance.

Pediatr Pulmonol 2021 Sep 21. Epub 2021 Sep 21.

Division of Neonatology, Loma Linda University Children's Hospital, Loma Linda, California, USA.

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http://dx.doi.org/10.1002/ppul.25634DOI Listing
September 2021

Using a learning community model for virtual medical student support during the COVID19 pandemic.

Int J Med Educ 2021 07 27;12:136-139. Epub 2021 Jul 27.

Department of Pediatrics Division of Pediatric Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore MD, USA.

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http://dx.doi.org/10.5116/ijme.60e2.c777DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411346PMC
July 2021

Using a learning community model for virtual medical student support during the COVID19 pandemic.

Int J Med Educ 2021 07 27;12:136-139. Epub 2021 Jul 27.

Department of Pediatrics Division of Pediatric Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore MD, USA.

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http://dx.doi.org/10.5116/ijme.60e2.c777DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411346PMC
July 2021

The Future of Respiratory Syncytial Virus Disease Prevention and Treatment.

Infect Dis Ther 2021 Mar 3;10(Suppl 1):47-60. Epub 2021 Mar 3.

Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, CA, USA.

Respiratory syncytial virus (RSV) is a major cause of respiratory tract infections in infants, young children, and older or immunocompromised adults. Although aerosolized ribavirin was licensed for RSV treatment on the basis of data demonstrating a reduced need for supplemental oxygen, ribavirin use is limited because of issues with efficacy, safety, and cost. Currently, the treatment of RSV is primarily supportive. New antiviral treatments for RSV are in the early stages of development, but it will be years until any of these may be licensed by the US Food and Drug Administration (FDA). Palivizumab, an RSV monoclonal antibody [immunoprophylaxis (IP)], has demonstrated effectiveness in disease prevention and is the only licensed IP for RSV disease in specific high-risk pediatric populations. Although its efficacy is well established, some challenges that may interfere with its clinical use include cost, need for monthly injections, and changing policy for use by the American Academy of Pediatrics (AAP). Preventing RSV disease would be possible through RSV vaccine development (e.g., live-attenuated, vector-based subunit, or particle-based). Alternatively, new long-acting monoclonal antibodies have demonstrated promising results in early clinical trials. Despite scientific advances, until new agents become available, palivizumab should continue to be used to reduce RSV disease burden in high-risk patients for whom it is indicated.
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http://dx.doi.org/10.1007/s40121-020-00383-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7926075PMC
March 2021

Severity and Cost of RSV Hospitalization Among US Preterm Infants Following the 2014 American Academy of Pediatrics Policy Change.

Infect Dis Ther 2021 Mar 3;10(Suppl 1):27-34. Epub 2021 Mar 3.

Department of Pediatrics, Norton Children's Hospital and University of Louisville Hospital, Louisville, KY, USA.

The American Academy of Pediatrics (AAP) Committee on Infectious Diseases (COID) periodically publishes recommendations for respiratory syncytial virus (RSV) immunoprophylaxis (IP) use in pediatric patients considered to be at highest risk for severe RSV infection. In 2014, for the first time, the AAP COID stopped recommending the use of RSV IP for otherwise healthy infants born at 29 weeks' gestational age (wGA) or later, stating that RSV hospitalization (RSVH) rates in this population are similar to those of term infants. Subsequently, epidemiological studies in the US at national and regional levels provided evidence of the impact of the policy change in 29-34 wGA infants. The results of these studies demonstrated a significant decrease in IP use after 2014 that was associated with an increased rate of RSVH in 29-34 wGA infants and an increase in morbidities. RSVH-related morbidities included pediatric intensive care unit (ICU) admissions, an increased need for mechanical ventilation, and an increase in the length of stay. After the change in recommendations, the costs of RSVH also rose among 29-34 wGA infants. The severity of the illness and expenses associated with RSVH were generally higher among 29-34 wGA infants of younger chronologic age compared with older preterm infants. Overall, these studies underscore that 29-34 wGA infants continue to be a high-risk pediatric population that could benefit from the protection provided by RSV IP. On the basis of these data, in 2018, the National Perinatal Association developed guidelines that recommended RSV IP for all ≤ 32 wGA infants and 32-35 wGA infants with additional risk factors. Re-evaluation of the AAP COID policy is warranted in light of these observations.
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http://dx.doi.org/10.1007/s40121-020-00389-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017024PMC
March 2021

Impact of the 2014 American Academy of Pediatrics Policy on RSV Hospitalization in Preterm Infants in the United States.

Infect Dis Ther 2021 Mar 3;10(Suppl 1):17-26. Epub 2021 Mar 3.

Department of Pediatrics, NYU Langone Hospital-Long Island and the NYU Long Island School of Medicine, Mineola, NY, USA.

Despite being a leading cause of hospitalization due to lower respiratory tract infections, the treatment of respiratory syncytial virus (RSV) infection is primarily supportive. Palivizumab is the only licensed immunoprophylaxis (IP) available for preventing severe RSV infection in high-risk populations including ≤ 35 weeks' gestational age (wGA) infants and children with chronic lung disease of prematurity or congenital heart disease. The American Academy of Pediatrics (AAP) has published its IP recommendations since the approval of palivizumab. In 2014, the AAP stopped recommending RSV IP in 29-34 wGA infants without comorbidities and stated that RSV hospitalization (RSVH) risk in otherwise healthy ≥ 29 wGA infants and term infants was similar. Since then, experts in the field have debated the appropriateness of the 2014 policy change, and several real-world evidence studies at the national and regional levels in the US have examined the impact of the AAP policy on 29-34 wGA infants. Overall, these studies showed a significant decline in RSV IP use and a concurrent increase in RSVH risk among 29-34 wGA infants relative to term infants in the seasons after the 2014 policy change. A similar decrease in IP use and increase in RSVH risk was also observed among < 29 wGA infants relative to term infants after the 2014 policy change. This decrease could be an unintended consequence as < 29 wGA infants are an in-policy population recommended to receive RSV IP. According to the National Perinatal Association, strong evidence exists to support the use of RSV IP in all ≤ 32 wGA and 32-35 wGA infants with risk factors such as attending day care, having ≥ 1 school-aged siblings, twin or greater multiple gestation, younger age, and exposure to parental smoking. Until new preventive and treatment options become available, palivizumab can help prevent and mitigate RSV disease burden among high-risk preterm infants.
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http://dx.doi.org/10.1007/s40121-020-00388-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017053PMC
March 2021

Update on respiratory syncytial virus hospitalizations among U.S. preterm and term infants before and after the 2014 American Academy of Pediatrics policy on immunoprophylaxis: 2011-2017.

Hum Vaccin Immunother 2021 05 22;17(5):1536-1545. Epub 2020 Oct 22.

US Medical Affairs, AstraZeneca, Gaithersburg, MD, USA.

Palivizumab is the only licensed respiratory syncytial virus (RSV) immunoprophylaxis (IP) available to prevent severe RSV disease in high-risk pediatric populations, including infants born at 29-34 weeks' gestational age (wGA). In 2014, the American Academy of Pediatrics (AAP) stopped recommending RSV IP use for otherwise healthy 29-34 wGA infants and stated that 29-34 wGA infants and term infants have similar RSV hospitalization (RSVH) rates. This study aimed to compare RSV IP use and RSVH rates in 29-34 wGA infants and term infants during the 3 RSV seasons before and after the 2014 AAP policy change. RSV IP use in otherwise healthy infants 29-30, 31-32, and 33-34 wGA was estimated from pharmacy or outpatient medical claims for palivizumab. RSVH rates in the first 6 months of life were calculated per 100 infant-seasons. RSVH rate ratios were used to compare preterm infants and term infants before and after the policy change. Across infant cohorts (29-34 wGA) and chronologic age groups (<3 months and 3-<6 months), absolute decreases in RSV IP use between the combined 2011-2014 seasons and 2014-2017 seasons ranged from 7% to 38% and from 68% to 97%, respectively. Compared with 2011-2014, the RSVH risk increased 2.09-fold (< .001) and 1.76-fold (< .001) in 2014-2017 for infants born at 29-34 wGA and aged <6 months with commercial and Medicaid insurance, respectively. Overall, RSV IP use declined in the RSV seasons following the 2014 RSV IP policy change, and RSVH increased among 29-34 wGA infants aged <6 months.
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http://dx.doi.org/10.1080/21645515.2020.1822134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078654PMC
May 2021

Increased proportion of physical child abuse injuries at a level I pediatric trauma center during the Covid-19 pandemic.

Child Abuse Negl 2021 06 25;116(Pt 2):104756. Epub 2020 Sep 25.

Division of Pediatric Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States.

Background And Objectives: The Covid-19 pandemic has forced mass closures of childcare facilities and schools. While these measures are necessary to slow virus transmission, little is known regarding the secondary health consequences of social distancing. The purpose of this study is to assess the proportion of injuries secondary to physical child abuse (PCA) at a level I pediatric trauma center during the Covid-19 pandemic.

Methods: A retrospective review of patients at our center was conducted to identify injuries caused by PCA in the month following the statewide closure of childcare facilities in Maryland. The proportion of PCA patients treated during the Covid-19 era were compared to the corresponding period in the preceding two years by Fisher's exact test. Demographics, injury profiles, and outcomes were described for each period.

Results: Eight patients with PCA injuries were treated during the Covid-19 period (13 % of total trauma patients), compared to four in 2019 (4 %, p < 0.05) and three in 2018 (3 %, p < 0.05). The median age of patients in the Covid-19 period was 11.5 months (IQR 6.8-24.5). Most patients were black (75 %) with public health insurance (75 %). All injuries were caused by blunt trauma, resulting in scalp/face contusions (63 %), skull fractures (50 %), intracranial hemorrhage (38 %), and long bone fractures (25 %).

Conclusions: There was an increase in the proportion of traumatic injuries caused by physical child abuse at our center during the Covid-19 pandemic. Strategies to mitigate this secondary effect of social distancing should be thoughtfully implemented.
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http://dx.doi.org/10.1016/j.chiabu.2020.104756DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7518108PMC
June 2021

Nonaccidental trauma in pediatric patients: evidence-based screening criteria for ophthalmologic examination.

J AAPOS 2020 08 19;24(4):226.e1-226.e5. Epub 2020 Aug 19.

Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore, Maryland. Electronic address:

Background: Ophthalmologic examination is included in the work-up for pediatric nonaccidental trauma (NAT) when there is concern for retinal hemorrhage. However, dilated fundus examination entails patient discomfort and prohibition of assessment of pupillary response. Previous studies have suggested that patients without neuroimaging abnormalities are unlikely to have retinal hemorrhage. The purpose of the current study was to analyze the findings in patients who received NAT evaluation with eye examination at our institution, and to propose screening criteria for inclusion of ophthalmologic examination in NAT evaluation.

Methods: The medical records of patients who received NAT evaluation with ophthalmologic examination at The Johns Hopkins Children's Center Pediatric Emergency Department from August 2014 to July 2018 were reviewed retrospectively. Data collected included demographics, presenting symptoms, imaging findings, and ophthalmologic examination findings. The main outcome measure was presence of retinal hemorrhage.

Results: A total of 192 evaluations with ophthalmologic examination were included, representing 190 unique individuals of mean age 8.4 ± 9.5 months at presentation. In approximately half (54%) of the evaluations, there were abnormal findings on neuroimaging. Fifteen children (8%) had retinal hemorrhage, all of whom also had abnormal neuroimaging. Abnormal neuroimaging was associated with presence of retinal hemorrhage, with an odds ratio of 21.0 (95% CI, 3.47-∞; P < 0.001). Of the 15 children with retinal hemorrhage, 14 had subdural hemorrhage.

Conclusions: When neuroimaging abnormalities are present, ophthalmologic examination should be performed as part of the pediatric NAT evaluation. When there is no evidence of head injury on neuroimaging, ophthalmologic examination should not be routine.
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http://dx.doi.org/10.1016/j.jaapos.2020.03.012DOI Listing
August 2020

Unintended Consequences Following the 2014 American Academy of Pediatrics Policy Change for Palivizumab Prophylaxis among Infants Born at Less than 29 Weeks' Gestation.

Am J Perinatol 2021 08 16;38(S 01):e201-e206. Epub 2020 Apr 16.

Biopharmaceutical Medical Department, AstraZeneca, Gaithersburg, Maryland.

Objective: The aim of this study is to compare outpatient respiratory syncytial virus (RSV) immunoprophylaxis (IP) use and relative RSV hospitalization (RSVH) rates for infants <29 weeks' gestational age (wGA) versus term infants before and after the 2014 American Academy of Pediatrics (AAP) policy change.

Study Design: Infants were identified in the MarketScan Commercial and Multi-State Medicaid databases. Outpatient RSV IP receipt and relative <29 wGA/term hospitalization risks in 2012 to 2014 and 2014 to 2016 were assessed using rate ratios and a difference-in-difference model.

Results: Outpatient RSV IP receipt by infants <29 wGA and aged <3 months in the Commercial and Medicaid populations and those aged 3 to <6 months in the Medicaid population declined after 2014. Relative RSVH risks for infants <29 wGA were numerically greater after 2014, with infants aged <3 months and Medicaid infants experiencing the greatest increases. Difference-in-difference results indicated a significantly increased relative risk of RSVH for infants <29 wGA versus term (both cohorts aged 0 to <6 months) in the Medicaid-insured population (1.68,  = 0.0054). A nonsignificant increase of similar magnitude occurred in the commercially insured population (1.57,  = 0.2867).

Conclusion: The 2014 policy change was associated with a decrease in RSV IP use and an increase in RSVH risk among otherwise healthy infants <29 wGA.
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http://dx.doi.org/10.1055/s-0040-1709127DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8397527PMC
August 2021

Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial.

J Perinatol 2020 06 26;40(6):888-895. Epub 2020 Feb 26.

Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.

Objective: To examine the effects of 30% oral dextrose on biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress in preterm neonates experiencing a clinically required heel lance.

Study Design: Utilizing a prospective study design, preterm neonates that met study criteria (n = 169) were randomized to receive either (1) 30% oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2 min before heel lance. Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance. Pain was measured using the premature infant pain profile-revised (PIPP-R).

Results: Oral dextrose, administered alone or with facilitated tucking, did not alter plasma markers of ATP utilization and oxidative stress.

Conclusion: A single dose of 30% oral dextrose, given before a clinically required heel lance, decreased signs of pain without increasing ATP utilization and oxidative stress in premature neonates.
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http://dx.doi.org/10.1038/s41372-020-0634-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7253349PMC
June 2020

Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial.

J Perinatol 2020 06 26;40(6):888-895. Epub 2020 Feb 26.

Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.

Objective: To examine the effects of 30% oral dextrose on biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress in preterm neonates experiencing a clinically required heel lance.

Study Design: Utilizing a prospective study design, preterm neonates that met study criteria (n = 169) were randomized to receive either (1) 30% oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2 min before heel lance. Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance. Pain was measured using the premature infant pain profile-revised (PIPP-R).

Results: Oral dextrose, administered alone or with facilitated tucking, did not alter plasma markers of ATP utilization and oxidative stress.

Conclusion: A single dose of 30% oral dextrose, given before a clinically required heel lance, decreased signs of pain without increasing ATP utilization and oxidative stress in premature neonates.
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http://dx.doi.org/10.1038/s41372-020-0634-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7253349PMC
June 2020

Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial.

J Perinatol 2020 06 26;40(6):888-895. Epub 2020 Feb 26.

Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.

Objective: To examine the effects of 30% oral dextrose on biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress in preterm neonates experiencing a clinically required heel lance.

Study Design: Utilizing a prospective study design, preterm neonates that met study criteria (n = 169) were randomized to receive either (1) 30% oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2 min before heel lance. Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance. Pain was measured using the premature infant pain profile-revised (PIPP-R).

Results: Oral dextrose, administered alone or with facilitated tucking, did not alter plasma markers of ATP utilization and oxidative stress.

Conclusion: A single dose of 30% oral dextrose, given before a clinically required heel lance, decreased signs of pain without increasing ATP utilization and oxidative stress in premature neonates.
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http://dx.doi.org/10.1038/s41372-020-0634-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7253349PMC
June 2020

Impact of the 2014 American Academy of Pediatrics Immunoprophylaxis Policy on the Rate, Severity, and Cost of Respiratory Syncytial Virus Hospitalizations among Preterm Infants.

Am J Perinatol 2020 01 20;37(2):174-183. Epub 2019 Aug 20.

AstraZeneca, Gaithersburg, Maryland.

Objective: This study examined the rate, severity, and cost of respiratory syncytial virus (RSV) hospitalizations among preterm infants 29 to 34 weeks gestational age (wGA) versus term infants before and after a 2014 change in the American Academy of Pediatrics policy for RSV immunoprophylaxis.

Study Design: Preterm (29-34 wGA) and term infants born from July 2011 to March 2017 and aged < 6 months were identified in a U.S. commercial administrative claims database. RSV hospitalization (RSVH) rate ratios, severity, and costs were evaluated for the 2011 to 2014 and 2014 to 2017 RSV seasons. Postpolicy changes in RSVH risks for preterm versus term infants were assessed with difference-in-difference (DID) modeling to control for patient characteristics and temporal trends.

Results: In the DID analysis, prematurity-associated RSVH risk was 55% greater in 2014 to 2017 versus 2011 to 2014 (relative risk = 1.55, 95% confidence interval: 1.10-2.17,  = 0.011). RSVH severity increased among preterm infants after 2014 and was highest among those aged < 3 months. Differences in mean RSVH costs for preterm infants in 2014 to 2017 versus 2011 to 2014 were not statistically significant.

Conclusion: RSVH risk for preterm versus term infants increased after the policy change, confirming previous national analyses. RSVHs after the policy change were more severe, particularly among younger preterm infants.
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http://dx.doi.org/10.1055/s-0039-1694008DOI Listing
January 2020

Relationship-Centered Advising in a Medical School Learning Community.

J Med Educ Curric Dev 2019 Jan-Dec;6:2382120519827895. Epub 2019 Mar 25.

Division of Pediatric Emergency Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Background: Medical schools are required to have formal advising structures; however, there are limited data on how to optimally meet that mandate. Learning communities (LC), with their emphasis on longitudinal relationships, offer a unique scaffold for advising.

Program Description: The Johns Hopkins School of Medicine (JHSOM) LC focuses on curricular and extracurricular longitudinal connections between students and advisors. A core component of the LC is a relationship-centered advising (RCA) model drawing from best practices in physician-patient relationships, life coaching, and social contract theories. The key elements of the model include dyadic and small group advising, while the LC structure allows for faculty development in these domains. Relationship-centered advising approaches the collaborative advising work between students and advisors through explicit valuing of personal experiences, mutual respect, and earned trust. Framing the advising relationship in this way allows it to grow with the student along their medical school journey.

Program Evaluation & Results: Student and faculty satisfaction with this model is high. Data from annual, anonymous student evaluations consistently indicate high degree of trust in and satisfaction from these relationships.

Discussion: Relationship-centered advising aims to create a relationally anchored platform on which students can develop their personal and professional identities. This LC-based advising model is adaptable across schools regardless of structure and resources.
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http://dx.doi.org/10.1177/2382120519827895DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434435PMC
March 2019

Respiratory Syncytial Virus Hospitalizations among U.S. Preterm Infants Compared with Term Infants Before and After the 2014 American Academy of Pediatrics Guidance on Immunoprophylaxis: 2012-2016.

Am J Perinatol 2018 12 19;35(14):1433-1442. Epub 2018 Jun 19.

Truven Health Analytics, an IBM Company, Cambridge, Massachusetts.

Objective: The objective of this study was to compare risk for respiratory syncytial virus (RSV) hospitalizations (RSVH) for preterm infants 29 to 34 weeks gestational age (wGA) versus term infants before and after 2014 guidance changes for immunoprophylaxis (IP), using data from the 2012 to 2016 RSV seasons.

Study Design: Using commercial and Medicaid claims databases, infants born between July 1, 2011 and June 30, 2016 were categorized as preterm or term. RSVH during the RSV season (November-March) were identified for infants aged <6 months and rate ratios (RRs) for hospitalization comparing preterm and term infants were calculated. Difference-in-difference models were fit to evaluate the changes in hospitalization risks in preterm versus term infants from 2012 to 2014 seasons to 2014 to 2016 seasons.

Results: In all seasons, preterm infants had higher RSVH rates than term infants. Seasonal RRs prior to the guidance change for preterm wGA categories versus term infants ranged from 1.6 to 3.4. After the guidance change, the seasonal RRs ranged from 2.6 to 5.6. In 2014 to 2016, the risk associated with prematurity of 29 to 34 wGA versus term was significantly higher than in 2012 to 2014 (<0.0001 for commercial and Medicaid samples).

Conclusion: In infants aged <6 months, the risk for RSVH for infants 29 to 34 wGA compared with term infants increased significantly after the RSV IP recommendations became more restrictive.
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http://dx.doi.org/10.1055/s-0038-1660466DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6260117PMC
December 2018

Palivizumab Prophylaxis for Respiratory Syncytial Virus: Examining the Evidence Around Value.

Open Forum Infect Dis 2018 Mar 7;5(3):ofy031. Epub 2018 Feb 7.

University of Washington School of Pharmacy, Seattle, Washington.

Respiratory syncytial virus (RSV) infection is the most common cause of lower respiratory tract infection and the leading cause of hospitalization among young children, incurring high annual costs among US children under the age of 5 years. Palivizumab has been found to be effective in reducing hospitalization and preventing serious lower respiratory tract infections in high-risk infants. This paper presents a systematic review of the cost-effectiveness studies of palivizumab and describes the main highlights of a round table discussion with clinical, payer, economic, research method, and other experts. The objectives of the discussion were to (1) review the current state of clinical, epidemiology, and economic data related to severe RSV disease; (2) review new cost-effectiveness estimates of RSV immunoprophylaxis in US preterm infants, including a review of the field's areas of agreement and disagreement; and (3) identify needs for further research.
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http://dx.doi.org/10.1093/ofid/ofy031DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5833316PMC
March 2018

The 2014-2015 National Impact of the 2014 American Academy of Pediatrics Guidance for Respiratory Syncytial Virus Immunoprophylaxis on Preterm Infants Born in the United States.

Am J Perinatol 2018 01 7;35(2):192-200. Epub 2017 Sep 7.

Health Economics and Outcomes Research, AstraZeneca, Gaithersburg, Maryland.

Objective: This article aims to compare respiratory syncytial virus (RSV) immunoprophylaxis (IP) use and RSV hospitalization rates (RSVH) in preterm and full-term infants without chronic lung disease of prematurity or congenital heart disease before and after the recommendation against RSV IP use in preterm infants born at 29 to 34 weeks' gestational age (wGA).

Study Design: Infants in commercial and Medicaid claims databases were followed from birth through first year to assess RSV IP and RSVH, as a function of infant's age and wGA. RSV IP was based on pharmacy or outpatient medical claims for palivizumab. RSVH was based on inpatient medical claims with a diagnosis of RSV.

Results: Commercial and Medicaid infants 29 to 34 wGA represented 2.9 to 3.5% of all births. RSV IP use in infants 29 to 34 wGA decreased 62 to 95% (< 0.01) in the 2014-2015 season relative to the 2013-2014 season. Compared with the 2013-2014 season, RSVH increased by 2.7-fold (= 0.02) and 1.4-fold (= 0.03) for infants aged <3 months and 29 to 34 wGA in the 2014-2015 season with commercial and Medicaid insurance, respectively. In the 2014-2015 season, RSVH for infants 29 to 34 wGA were two to seven times higher than full-term infants without high-risk conditions.

Conclusion: Following the 2014 RSV IP guidance change, RSV IP use declined and RSVH increased among infants born at 29 to 34 wGA and aged <3 months.
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http://dx.doi.org/10.1055/s-0037-1606352DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6193366PMC
January 2018

Development and Implementation of a School-Wide Institute for Excellence in Education to Enable Educational Scholarship by Medical School Faculty.

Teach Learn Med 2018 Jan-Mar;30(1):103-111. Epub 2017 Jul 28.

b Johns Hopkins University School of Medicine Institute for Excellence in Education, Johns Hopkins University School of Medicine , Baltimore , Maryland , USA.

Problem: Educational scholarship is an important component for faculty at Academic Medical Centers, especially those with single-track promotion systems. Yet, faculty may lack the skills and mentorship needed to successfully complete projects. In addition, many educators feel undervalued.

Intervention: To reinvigorate our school's educational mission, the Institute for Excellence in Education (IEE) was created. Here we focus on one of the IEE's strategic goals, that of inspiring and supporting educational research, scholarship, and innovation.

Context: Using the 6-step curriculum development process as a framework, we describe the development and outcomes of IEE programs aimed at enabling educational scholarship at the Johns Hopkins University School of Medicine.

Outcome: Four significant programs that focused on educational scholarship were developed and implemented: (a) an annual conference, (b) a Faculty Education Scholars' Program, (c) "Shark Tank" small-grant program, and (d) Residency Redesign Challenge grants. A diverse group of primarily junior faculty engaged in these programs with strong mentorship, successfully completing and disseminating projects. Faculty members have been able to clarify their personal goals and develop a greater sense of self-efficacy for their desired paths in teaching and educational research.

Lessons Learned: Faculty require programs and resources for educational scholarship and career development, focused on skills building in methodology, assessment, and statistical analysis. Mentoring and the time to work on projects are critical. Key to the IEE's success in maintaining and building programs has been ongoing needs assessment of faculty and learners and a strong partnership with our school's fund-raising staff. The IEE will next try to expand opportunities by adding additional mentoring capacity and further devilment of our small-grants programs.
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http://dx.doi.org/10.1080/10401334.2017.1325741DOI Listing
August 2018

Using Patient-Centered Care After a Prenatal Diagnosis of Trisomy 18 or Trisomy 13: A Review.

JAMA Pediatr 2017 04;171(4):382-387

Division of Neonatology, Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, California.

Importance: Patient-centered care (PCC) has been advocated by the Institute of Medicine to improve health care in the United States. Four concepts of PCC align with clinical ethics principles and are associated with enhanced patient/parent satisfaction. These concepts are dignity and respect, information sharing, participation, and collaboration. The objective of this article is to use the PCC approach as a framework for an extensive literature review evaluating the current status of counseling regarding prenatal diagnosis of trisomy 18 (T18) or trisomy 13 (T13) and to advocate PCC in the care of these infants.

Observations: Extensive availability of prenatal screening and diagnostic testing has led to increased detection of chromosomal anomalies early in pregnancy. After diagnosis of T18 or T13, counseling and care have traditionally been based on assumptions that these aneuploidies are lethal or associated with poor quality of life, a view that is now being challenged. Recent evidence suggests that there is variability in outcomes that may be improved by postnatal interventions, and that quality-of-life assumptions are subjective. Parental advocacy for their infant's best interest mimics this variability as requests for resuscitation, neonatal intensive care, and surgical intervention are becoming more frequent.

Conclusions And Relevance: With new knowledge and increased parental advocacy, physicians face ethical decisions in formulating recommendations including interruption vs continuation of pregnancy, interventions to prolong life, and choices to offer medical or surgical procedures. We advocate a PCC approach, which has the potential to reduce harm when inadequate care and counseling strategies create conflicting values and uncertain outcomes between parents and caregivers in the treatment of infants with T18 and T13.
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http://dx.doi.org/10.1001/jamapediatrics.2016.4798DOI Listing
April 2017

Using Patient-Centered Care After a Prenatal Diagnosis of Trisomy 18 or Trisomy 13: A Review.

JAMA Pediatr 2017 04;171(4):382-387

Division of Neonatology, Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, California.

Importance: Patient-centered care (PCC) has been advocated by the Institute of Medicine to improve health care in the United States. Four concepts of PCC align with clinical ethics principles and are associated with enhanced patient/parent satisfaction. These concepts are dignity and respect, information sharing, participation, and collaboration. The objective of this article is to use the PCC approach as a framework for an extensive literature review evaluating the current status of counseling regarding prenatal diagnosis of trisomy 18 (T18) or trisomy 13 (T13) and to advocate PCC in the care of these infants.

Observations: Extensive availability of prenatal screening and diagnostic testing has led to increased detection of chromosomal anomalies early in pregnancy. After diagnosis of T18 or T13, counseling and care have traditionally been based on assumptions that these aneuploidies are lethal or associated with poor quality of life, a view that is now being challenged. Recent evidence suggests that there is variability in outcomes that may be improved by postnatal interventions, and that quality-of-life assumptions are subjective. Parental advocacy for their infant's best interest mimics this variability as requests for resuscitation, neonatal intensive care, and surgical intervention are becoming more frequent.

Conclusions And Relevance: With new knowledge and increased parental advocacy, physicians face ethical decisions in formulating recommendations including interruption vs continuation of pregnancy, interventions to prolong life, and choices to offer medical or surgical procedures. We advocate a PCC approach, which has the potential to reduce harm when inadequate care and counseling strategies create conflicting values and uncertain outcomes between parents and caregivers in the treatment of infants with T18 and T13.
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http://dx.doi.org/10.1001/jamapediatrics.2016.4798DOI Listing
April 2017

Epidemiology of Injury-Related Emergency Department Visits in the US Among Youth with Autism Spectrum Disorder.

J Autism Dev Disord 2016 Aug;46(8):2756-2763

Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Several reports suggest children with autism spectrum disorder (ASD) are more likely to be seen for injury-related ED visits; however, no nationally representative study has examined this question. Using data from the 2008 Nationwide Emergency Department Sample, over a quarter of all visits among those with ASD were related to injury. In the multivariate analyses, the odds of an injury-related visit was 54 % greater among those with ASD compared to youth with intellectual disability (ID), but 48 % less compared to youth without ID or ASD. Compared to all other pediatric injury-visits in the US, visits among children with ASD were more likely to be due to self-inflicted injury and poisoning and were more likely to result in hospitalization (all p < 0.001).
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http://dx.doi.org/10.1007/s10803-016-2820-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4939109PMC
August 2016

Self-harm, Assault, and Undetermined Intent Injuries Among Pediatric Emergency Department Visits.

Pediatr Emerg Care 2015 Dec;31(12):813-8

From the *Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine; †Department of Mental Health, Johns Hopkins Bloomberg School of Public Health; ‡Center for Autism and Related Disorders, Kennedy Krieger Institute; §Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD.

Objectives: Although injuries are a known cause of morbidity and mortality among children and adolescents, little is known about the epidemiology of injury-related emergency department (ED) visits in the United States by injury intent. The objective of this analysis was to examine ED outcomes, defined as death in the ED, inpatient admission, and visit cost, among ED visits stratified by injury intent (i.e., self-harm, assault, and injury with undetermined intent, as compared with unintentional injuries).

Methods: All injury-related ED visits in the United States for children and adolescents, ages 8 to 17 years, were identified using the 2008 Nationwide Emergency Department Sample. Multivariate survey weighted logistic and linear regression analyses were then used to estimate the likelihood of death on ED visit, inpatient admission, and cost across the 4 injury types.

Results: In 2008, with the use of weighted estimates, there were 66,895 self-harm, 176,125 assault, 24,144 undetermined injury, and 4,244,589 unintentional injury ED visits among children 8 to 17 years. Visits due to self-harm, assault and undetermined injuries were more likely to result in death during the ED visit compared with visits due to unintentional injuries. Self-harm and undetermined intent were also associated with greater odds of inpatient admission as well as 90% and 60% higher ED visit costs, respectively.

Conclusions: Data from this nationwide sample of pediatric ED visits highlight the resource burden of self-harm, undetermined intent, and assault injury visits. Pediatric EDs may provide a window of opportunity for better case identification and intervention with children experiencing violence and injury.
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http://dx.doi.org/10.1097/PEC.0000000000000627DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4706151PMC
December 2015

Self-harm, Assault, and Undetermined Intent Injuries Among Pediatric Emergency Department Visits.

Pediatr Emerg Care 2015 Dec;31(12):813-8

From the *Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine; †Department of Mental Health, Johns Hopkins Bloomberg School of Public Health; ‡Center for Autism and Related Disorders, Kennedy Krieger Institute; §Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD.

Objectives: Although injuries are a known cause of morbidity and mortality among children and adolescents, little is known about the epidemiology of injury-related emergency department (ED) visits in the United States by injury intent. The objective of this analysis was to examine ED outcomes, defined as death in the ED, inpatient admission, and visit cost, among ED visits stratified by injury intent (i.e., self-harm, assault, and injury with undetermined intent, as compared with unintentional injuries).

Methods: All injury-related ED visits in the United States for children and adolescents, ages 8 to 17 years, were identified using the 2008 Nationwide Emergency Department Sample. Multivariate survey weighted logistic and linear regression analyses were then used to estimate the likelihood of death on ED visit, inpatient admission, and cost across the 4 injury types.

Results: In 2008, with the use of weighted estimates, there were 66,895 self-harm, 176,125 assault, 24,144 undetermined injury, and 4,244,589 unintentional injury ED visits among children 8 to 17 years. Visits due to self-harm, assault and undetermined injuries were more likely to result in death during the ED visit compared with visits due to unintentional injuries. Self-harm and undetermined intent were also associated with greater odds of inpatient admission as well as 90% and 60% higher ED visit costs, respectively.

Conclusions: Data from this nationwide sample of pediatric ED visits highlight the resource burden of self-harm, undetermined intent, and assault injury visits. Pediatric EDs may provide a window of opportunity for better case identification and intervention with children experiencing violence and injury.
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http://dx.doi.org/10.1097/PEC.0000000000000627DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4706151PMC
December 2015

Medical student and faculty perceptions of volunteer outpatients versus simulated patients in communication skills training.

Acad Med 2011 Nov;86(11):1437-42

Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA.

Purpose: To determine whether medical students and faculty perceive differences in the effectiveness of interactions with real patients versus simulated patients (SPs) in communication skills training.

Method: In 2008, the authors recruited volunteer outpatients (VOs) from the Johns Hopkins University School of Medicine internal medicine practice to participate in communication skills training for all first-year medical students. VOs and SPs were assigned to clinic rooms in the simulation center. Each group of five students and its preceptor rotated through randomly assigned rooms on two of four session days; on both days, each student interviewed one patient for 15 minutes, focusing on past medical and family history or social history. Patients used their own histories, not scripts; students were not blinded to patient type. Students and faculty then rated aspects of the interview experience. Generalized linear latent and mixed-models analysis was used to compare ratings of communication skills training with VOs versus SPs.

Results: All 121 first-year students participated in 242 interviews, resulting in 237 usable questionnaires (98%). They rated their experiences with VOs significantly higher than those with SPs on comfort, friendliness, amount of learning, opportunity to build relationships, and overall meeting of communication skills training needs. The 24 faculty preceptors' ratings of the 242 interactions did not differ significantly between VOs and SPs.

Conclusions: Use of VOs was well received by students and faculty for teaching communication skills. Expanding and further studying VOs' participation will allow greater understanding of their potential role in communication skills training of preclinical medical students.
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http://dx.doi.org/10.1097/ACM.0b013e3182305bc0DOI Listing
November 2011

Randomized controlled trial of cephalexin versus clindamycin for uncomplicated pediatric skin infections.

Pediatrics 2011 Mar 21;127(3):e573-80. Epub 2011 Feb 21.

Johns Hopkins University, Department of Pediatrics, Division of Pediatric Emergency Medicine, CMSC 144, 600 N Wolfe St, Baltimore, MD 21287, USA.

Objective: To compare clindamycin and cephalexin for treatment of uncomplicated skin and soft tissue infections (SSTIs) caused predominantly by community-associated (CA) methicillin-resistant Staphylococcus aureus (MRSA). We hypothesized that clindamycin would be superior to cephalexin (an antibiotic without MRSA activity) for treatment of these infections.

Patients And Methods: Patients aged 6 months to 18 years with uncomplicated SSTIs not requiring hospitalization were enrolled September 2006 through May 2009. Eligible patients were randomly assigned to 7 days of cephalexin or clindamycin; primary and secondary outcomes were clinical improvement at 48 to 72 hours and resolution at 7 days. Cultures were obtained and tested for antimicrobial susceptibilities, pulsed-field gel electrophoresis type, and Panton-Valentine leukocidin status.

Results: Of 200 enrolled patients, 69% had MRSA cultured from wounds. Most MRSA were USA300 or subtypes, positive for Panton-Valentine leukocidin, and clindamycin susceptible, consistent with CA-MRSA. Spontaneous drainage occurred or a drainage procedure was performed in 97% of subjects. By 48 to 72 hours, 94% of subjects in the cephalexin arm and 97% in the clindamycin arm were improved (P = .50). By 7 days, all subjects were improved, with complete resolution in 97% in the cephalexin arm and 94% in the clindamycin arm (P = .33). Fevers and age less than 1 year, but not initial erythema > 5 cm, were associated with early treatment failures, regardless of antibiotic used.

Conclusions: There is no significant difference between cephalexin and clindamycin for treatment of uncomplicated pediatric SSTIs caused predominantly by CA-MRSA. Close follow-up and fastidious wound care of appropriately drained, uncomplicated SSTIs are likely more important than initial antibiotic choice.
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http://dx.doi.org/10.1542/peds.2010-2053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3387913PMC
March 2011

A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis.

N Engl J Med 2007 Jul;357(4):331-9

University of Utah, Salt Lake City, USA.

Background: Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited.

Methods: We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events.

Results: Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes.

Conclusions: In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].).
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http://dx.doi.org/10.1056/NEJMoa071255DOI Listing
July 2007

Evolving epidemiology of pediatric Staphylococcus aureus cutaneous infections in a Baltimore hospital.

Pediatr Emerg Care 2006 Oct;22(10):717-23

Department of Pediatrics, The Johns Hopkins University, Baltimore, MD, USA.

Objectives: To examine the epidemiology, antibiotic susceptibility profiles, and outcomes in pediatric Staphylococcus aureus (SA) cutaneous infections at a time when community-associated (CA) methicillin-resistant SA (CA-MRSA) infections seemed to be increasing in our community.

Methods: The hospital microbiology database was searched for unique skin and wound SA isolates among pediatric patients between November 2002 and October 2003. Demographic and clinical data were abstracted from medical records. Cases were classified as either health care-associated (HA) or CA.

Results: Among 181 pediatric SA cutaneous infections, 81 (45%) were caused by MRSA. Most (84%) of these MRSA were CA. Between the first 6 months and second 6 months of the study period, CA-MRSA increased from 15% to 45% (P < 0.001) of all SA cutaneous infections. Ninety-eight percent and 94% of CA-MRSA were susceptible to trimethoprim/sulfamethoxazole and clindamycin (confirmed by D test), respectively. Hospitalization occurred for 25% of CA-MRSA and 75% of HA-MRSA (P = 0.004). Drainage procedures were performed for 70% of CA-MRSA. No cases of CA-MRSA skin infections were accompanied by bacteremia.

Conclusions: The CA-MRSA cutaneous infections increased in children in our urban Baltimore hospital in 2003. These CA-MRSA were erythromycin resistant, clindamycin susceptible, and trimethoprim/sulfamethoxazole susceptible. The CA-MRSA cutaneous infections frequently required drainage and were not associated with bacteremia. Children with cutaneous MRSA infections were less likely to have traditional health care risk factors than children with cutaneous methicillin-sensitive SA infections--an inversion of past patterns of MRSA infections--but were equally likely to be hospitalized when other factors were considered. These CA-MRSA cutaneous infections can be managed with abscess drainage and culture, careful follow-up, and empirical clindamycin therapy when clinically indicated.
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http://dx.doi.org/10.1097/01.pec.0000236832.23947.a0DOI Listing
October 2006

Early dynamic changes in pulse oximetry signals in preterm newborns with histologic chorioamnionitis.

Pediatr Crit Care Med 2006 Mar;7(2):138-42

Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte, Siena, Italy.

Objective: No reliable clinical markers of histologic chorioamnionitis (HCA), a major and often subclinical cause of prematurity leading to high neonatal morbidity and mortality, are available to date. Increasing evidence indicates myocardial dysfunctions in affected fetuses and newborns. We sought to assess the value of nonlinear dynamics from pulse oximetry signals in identifying affected newborns.

Design: Prospective case-control study.

Setting: Tertiary level neonatal intensive care unit, Brindisi Hospital.

Patients And Intervention: Pulse oximetry-derived signals (pulse rate, oxygen saturation, and perfusion index), recorded within the first 1.5 hrs of life, were analyzed for 110 very low-birth-weight infants, of whom 54 had histopathological evidence of HCA.

Measurements And Main Results: Four different time series parameters were determined for nonlinear dynamical (NLD) analysis. Significantly decreased Lempel-Ziv, Lyapunov largest exponent, and correlation dimension, with significantly increased Hurst values for heart rate and perfusion index (p < .00001), were observed in newborns with HCA. Heart rate Lempel-Ziv
Conclusions: Our findings indicate that early autonomic tone balance abnormalities are present in newborns with HCA and suggest that early dynamic analysis of pulse oximetry signals could be useful in identifying affected infants.
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http://dx.doi.org/10.1097/01.PCC.0000201002.50708.62DOI Listing
March 2006

Carcinoembryonic antigen in the staging and follow-up of patients with colorectal cancer.

Cancer Invest 2005 ;23(4):338-51

Division of Neoplastic Diseases, Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA.

CEA is a complex glycoprotein produced by 90% of colorectal cancers and contributes to the malignant characteristics of a tumor. It can be measured in serum quantitatively, and its level in plasma can be useful as a marker of disease. Because of its lack of sensitivity in the early stages of colorectal cancer, CEA measurement is an unsuitable modality for population screening. An elevated preoperative CEA is a poor prognostic sign and correlates with reduced overall survival after surgical resection of colorectal carcinoma. A failure of the CEA to return to normal levels after surgical resection is indicative of inadequate resection of occult systemic disease. Frequent monitoring of CEA postoperatively may allow identification of patients with metastatic disease for whom surgical resection or other localized therapy might be potentially beneficial. To identify this group, serial CEA measurement appears to be more effective than clinical evaluation or any other diagnostic modality, although its sensitivity for detecting recurrent disease is not as high for locoregional or pulmonary metastases as it is for liver metastases. Several studies have shown that a small percentage of patients followed postoperatively with CEA monitoring and who undergo CEA-directed salvage surgery for metastatic disease will be alive and disease-free 5 years after surgery. Furthermore, CEA levels after salvage surgery do appear to predict survival in patients undergoing resection of liver or pulmonary metastases. However, several authors argue that CEA surveillance is not cost-effective in terms of lives saved. In support of this argument, there is no clear difference in survival after resection of metastatic disease with curative intent between patients in whom the second-look surgery was performed on the basis of elevated CEA levels and those with other laboratory or imaging abnormalities. There is also no clear consensus on the frequency or duration of CEA monitoring, although the ASCO guidelines currently recommend every 2-3 months for at least 2 years after diagnosis. In the follow-up of patients undergoing palliative therapy, the CEA level correlates well with response, and CEA is indicative of not only response but may also identify patients with stable disease for whom there is also a demonstrated benefit in survival and symptom relief with combination chemotherapy. More recently, scintigraphic imaging after administration of radiolabeled antibodies afforded an important radionuclide technique that adds clinically significant information in assessing the extent and location of disease in patients with colorectal cancer above and beyond or complementary to conventional imaging modalities. Immunotherapy based on CEA is a rapidly advancing area of clinical research demonstrating antibody and T-cell responses.
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http://dx.doi.org/10.1081/cnv-58878DOI Listing
September 2005
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