Silver Spring Research Articles

Effective Communication of System-Level Events for Hospital System Health and Nurse Well-Being: A Qualitative Study

Many injuries and deaths occur yearly in the United States due to preventable errors; however, documented harm is lower in hospitals with Magnet® designation from the American Nurses Credentialing Center (Silver Spring, MD, USA). This manuscript illustrates insights from Magnet® and non-Magnet® nurses and nursing leaders regarding what impacts hospital system health, how those factors are communicated, and how hospital system health impacts patient safety. A qualitative descriptive approach was used with semi-structured interview questions. Within-methods data triangulation was applied to transcribed interviews using thematic analysis, application of the Goodwin statistic, and natural language processing (NLP). Thematic analysis revealed the four main themes of Healthy Systems, Unhealthy Systems, Patient Safety, and Nurse Well-Being. NLP revealed non-Magnet® leaders and nurses scored highest for anxiety, anger, and sadness, in contrast to Magnet® participants who had the highest levels of positive emotion. Key findings from the Magnet® participants revealed that poaching employees and placing people in the wrong positions harm hospital system health and patient safety. The use of within-methods data triangulation illuminated the contextual depth of the participants’ speech, revealing the alarming emotional state that non-Magnet® nurses and leaders are facing. Healthcare staff’s wellness must be prioritized to cultivate environments that provide safe care.

Safety and immunogenicity of a next-generation live-attenuated yellow fever vaccine produced in a Vero cell line in the USA: a phase 1 randomised, observer-blind, active-controlled, dose-ranging clinical trial

Recent outbreaks between 2015-17 and production delays have led to a yellow fever vaccine shortage. Therefore, there is an urgent need for new yellow fever vaccines with improved production scalability. A next-generation live-attenuated yellow fever vaccine candidate (vYF), produced in a Vero cell line has shown similar immunogenicity to licensed yellow fever vaccines in preclinical studies. In this study, we aimed to report the safety and immunogenicity of vYF in human clinical trial participants. In this first in-human, phase 1 randomised, observer-blind, active-controlled, dose-ranging clinical trial conducted at a single centre in the USA (Walter Reed Army Institute of Research, Silver Spring, MD, USA), 72 healthy adults (aged 18-60 years), without a known history of flavivirus infection or vaccination were randomly assigned (1:1:1:1) using interactive response technology to receive one dose of either vYF at 4, 5 or 6 Log CCID50 or the licensed YF-VAX (18 individuals per group). The primary outcomes were safety, neutralising antibody (NAb) titres through D180 post-vaccination in the per-protocol analysis set (comprised of yellow fever-naive participants who received their intended vaccine and provided a valid post-vaccination blood sample), and occurrence, and level of yellow fever viraemia in each vaccine group through D14 post-vaccination. All vYF doses had a safety and tolerability profile similar to YF-VAX. The most frequently reported solicited injection site reactions (vYF groups vs YF-VAX group) were pain (22% [12 of 54 participants, 95% CI 12-36] vs 28% [five of 18 participants, 10-54]), and erythema (13% [seven of 54 participants, 5-25] vs 39% [seven of 18 participants, 17-64]), with headache (32% [17 of 54 participants, 20-46] vs 44% [eight of 18 participants, 22-69]) and malaise (26% [14 of 54 participants, 15-40] vs 33% [six of 18 participants, 13-59]) as the most frequently reported solicited systemic reactions. One grade 3 solicited reaction (erythema) reported in the YF-VAX group resolved spontaneously. No serious unsolicited adverse events or deaths were reported. Viraemia was transiently detected in 50 participants between D4 and D10 in all groups and was observed in more participants or for a longer time in the vYF 6 Log CCID50 and YF-VAX groups. All yellow fever-naive vaccine recipients across the study groups seroconverted yielding four-fold increase from baseline in yellow fever NAb titres measured by yellow fever microneutralisation assay by D28 and were seroprotected with yellow fever NAb titres of at least 10 [1/dil]). Overall, 100% (18 of 18 participants, 95% CI 82-100), 89% (16 participants, 65-99), 100% (18 participants, 82-100), and 94% (17 participants, 73-100) of participants in the vYF 4 Log, vYF 5 Log, vYF 6 Log CCID50 groups, and YF-VAX group, respectively, remained seroprotected through D180. vYF has a similar safety and immunogenicity profile to YF-VAX. In general, the vYF 5 Log CCID50 dose appeared to show optimal viraemia, safety, and immunogenicity, and was chosen for subsequent development. Sanofi.

Evaluating physical controls on conduit flow contribution to spring discharge

The physical controls on the contribution of conduit to spring discharge, quantified as the ratio of conduit flow to spring discharge (Qc/Q), are evaluated through numerical simulations using MODFLOW-Conduit Flow Process. The controlling factors include the ratio of conduit surface roughness to conduit diameter (ε/D), the hydraulic conductivity ratio between the conduit wall and the porous matrix (Kc/K), the ratio of groundwater recharge to the hydraulic conductivity of the porous matrix, and conduit density (Cd) defined as the ratio of total conduit length to springshed area. For a single conduit, Qc/Q increases with Kc/K when flow in the conduit is laminar. When flow is turbulent, Qc/Q is stable and then decreases with ε/D, increases with Kc/K, and decreases with R/K due to the limited exchange capacity between matrix and conduit (i.e., small Kc/K). The results of hypothetical conduit networks show that Qc/Q increases with Cd but is not sensitive to the two sets of network structure evaluated. The sensitivity analysis for the Silver Springs in Florida shows that the spatial heterogeneity of conduit diameter causes higher Qc/Q, and Qc/Q is most sensitive to the conduit density, followed by R/K, and then Kc/K.

Refinement bounds for the expected number of renewal epochs over a finite interval

ABSTRACT Primary quantities of interest in renewal theory are the expected number of renewals in ( 0 , t ] , known as renewal function (denoted by U ( t ) ), and the expected number of renewals in ( t , t + h ] , given by the difference U ( t + h ) − U ( t ) .One of the most known bounds for the expected number of renewals over a finite interval is the one delivered by Barlow and Proschan [Statistical theory of reliability and life testing. MD: Silver Spring; 1981. Reprint Edition. To begin with]. The essential quantity of this bound is the difference U ( t + h ) − U ( t ) − U ( h ) . In this paper, initially, we offer bounds for the conditional tails of the backward and forward recurrence times, and we give a renewal-type equation for the difference U ( t + h ) − U ( t ) − U ( h ) . Employing those results, we refine the provided bound by Barlow and Proschan [Statistical theory of reliability and life testing. MD: Silver Spring; 1981. Reprint Edition. To begin with]. The results are illustrated with numerical examples.

Addressing the Knowledge Gaps for Providing Optimal Drug Pharmacotherapy for the Obese.

The Journal of Clinical PharmacologyAccepted Articles Supplement Article Addressing the Knowledge Gaps for Providing Optimal Drug Pharmacotherapy for the Obese Gilbert J. Burckart Pharm.D., FCP, Corresponding Author Gilbert J. Burckart Pharm.D., FCP [email protected] orcid.org/0000-0003-2005-9301 Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA Corresponding Author: Dr. Gilbert J. Burckart, Rm 3184, Bldg 51, 10903 New Hampshire Ave, Silver Spring, MD, USA. Email: [email protected]Search for more papers by this authorDavid J. Greenblatt M.D., FCP, David J. Greenblatt M.D., FCP Program in Pharmacology and Drug Development, Tufts University School of Medicine and Tufts Medical Center, Boston, MA, USASearch for more papers by this author Gilbert J. Burckart Pharm.D., FCP, Corresponding Author Gilbert J. Burckart Pharm.D., FCP [email protected] orcid.org/0000-0003-2005-9301 Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA Corresponding Author: Dr. Gilbert J. Burckart, Rm 3184, Bldg 51, 10903 New Hampshire Ave, Silver Spring, MD, USA. Email: [email protected]Search for more papers by this authorDavid J. Greenblatt M.D., FCP, David J. Greenblatt M.D., FCP Program in Pharmacology and Drug Development, Tufts University School of Medicine and Tufts Medical Center, Boston, MA, USASearch for more papers by this author First published: 02 May 2023 https://doi.org/10.1002/jcph.2264 This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as https://doi.org/10.1002/jcph.2264 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article. Accepted ArticlesAccepted, unedited articles published online and citable. The final edited and typeset version of record will appear in the future. RelatedInformation

FRI073 Use Of Obesogenic Medications Among Patients With Type 2 Diabetes In The Dominican Republic

Abstract Disclosure: S.P. Agramonte Villar: None. C.R. Gil Vega: None. J.M. Reynoso Ortiz: None. L.R. Sosa Pinedo: None. R.A. Vasquez Morel: None. C.M. Polanco Santos: None. V.T. San Martin: None. Background: Obesity is a major risk factor for the development and progression of type 2 diabetes mellitus (T2DM). Among the modifiable factors that can promote weight gain is the use of obesogenic medications (OM). The prevalence of the use of OM in patients with T2DM in the Dominican Republic (DR) is unknown. Objective: This study aimed to evaluate the use of OM among patients with T2DM in the DR. Methods: Cross-sectional study based on patient surveys and anthropometric measurements obtained in an outpatient primary care clinic in Santo Domingo, DR between October 2022 and November 2022. Patients aged ≥18 years with a known diagnosis of T2DM were included. Weight status was categorized according to body mass index (BMI). OM were defined according to the study by Hales et al1. Results: A total of 220 patients were surveyed and analyzed. Overall, 57.7% (127/220) of the patients reported a current use of one or more OM; 50.0% (110/220) were using one OM, 6.4% (14/220) were using two OM, and 1.3% (3/220) were using three OM. Among the patients using at least one OM, 45.7% (58/127) had overweight (BMI 25.0-29.9 kg/m2) and 40.9% (52/127) had obesity (BMI >30 kg/m2). The most frequently used antidiabetes OM was insulin [any type] (n=83), followed by glyburide (n=17) and glimepiride (n=13). The most commonly used non-antidiabetes OM was metoprolol (n=8), followed by atenolol (n=6) and pregabalin (n=6). Conclusion: More than half of the patients with T2DM were using at least one OM. The use of OM can contribute to weight gain and may hinder weight loss efforts in these patients, thus potentially negatively impacting the management of their underlying chronic disease. Reference: 1. Hales CM et al. Use of prescription medications associated with weight gain among US adults, 1999-2018: A nationally representative survey. Obesity (Silver Spring). 2022;30:229-239. Presentation: Friday, June 16, 2023

Invited Commentary: Patterns of Lung Injury and the Challenging Role of the Radiologist

HomeRadioGraphicsVol. 43, No. 7 PreviousNext Chest ImagingInvited Commentary: Patterns of Lung Injury and the Challenging Role of the RadiologistSeth Kligerman , Teri Franks, Jeff GalvinSeth Kligerman , Teri Franks, Jeff GalvinAuthor AffiliationsFrom the Department of Radiology, National Jewish Health, 1400 S Jackson St, Denver, CO 80209 (S.K.); Division of Pulmonary and Mediastinal Pathology, The Joint Pathology Center, Joint Task Force, Defense Health Agency, Silver Spring, Md (T.F.); and Departments of Diagnostic Radiology and Nuclear Medicine and Internal Medicine (Pulmonary/Critical Care), University of Maryland School of Medicine, Baltimore, Md (J.G.).Address correspondence to S.K. (email: [email protected]).Seth Kligerman Teri FranksJeff GalvinPublished Online:Jun 8 2023https://doi.org/10.1148/rg.230013MoreSectionsFull textPDF ToolsImage ViewerAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinked In

Nitrate attenuation potential in karst conduits and aquifer matrix

A critical determinant of the effective denitrification potential in karst aquifers is the relative contribution of matrix and non-matrix (e.g., conduits) to the total groundwater flow. This work tests the hypothesis that observed karst aquifer-scale denitrification rates represent the superposition of the effects from matrix zones, which have low denitrification rates and long residence times, and non-matrix zones, which have higher denitrification rates and short residence times. To better evaluate karst whole-aquifer denitrification capacity, this study examined groundwater chemical data from 69 individual wells across the springshed of Silver Springs, FL, and conducted five push–pull tracer tests (PPTTs) in matrix and non-matrix aquifer sections. Mean residence times and mean zero-order denitrification rates (K0) were determined using reduced-complexity analytical models for matrix and non-matrix zones. Significant nitrate degradation at the local scale was observed in wells that sampled matrix portions of the aquifer (K0 ≈ 5 to 7 × 103 μmol N/L/d), indicating denitrification hotspots comparable to previous results employing the same PPTT method. However, PPTTs in matrix portions of the aquifer found no evidence of aquifer denitrification, likely due to the short residence times experienced during PPTTs. The analytical models coupled with the measured nitrate concentrations and excess N2 data in groundwater discharged at the spring vents showed whole-aquifer estimates of residence times tavg = 4.2 years and aquifer denitrification rate K0,avg = 0.01 ± 0.01 μmol N/L/d that were consistent with previous studies. However, the average denitrification rate for non-matrix zones K0,nm = 1.29 ± 0.92 μmol N/L/d was two orders of magnitude higher than that for matrix zones K0,m = 0.002 ± 0.001 μmol N/L/d. Whole-aquifer denitrification measures thus reflect the weighted contributions of low denitrification in non-matrix zones, which constitute the majority of the groundwater flow, and high-denitrification but low-flow matrix zones. The modeling approach with non-matrix networks from this study can provide insight into the catchment-scale N budget and transport in karst aquifers.

Safety and immunogenicity of a purified inactivated Zika virus vaccine candidate in adults primed with a Japanese encephalitis virus or yellow fever virus vaccine in the USA: a phase 1, randomised, double-blind, placebo-controlled clinical trial

Zika virus infection is a threat to at-risk populations, causing major birth defects and serious neurological complications. Development of a safe and efficacious Zika virus vaccine is, therefore, a global health priority. Assessment of heterologous flavivirus vaccination is important given co-circulation of Japanese encephalitis virus and yellow fever virus with Zika virus. We investigated the effect of priming flavivirus naive participants with a licensed flavivirus vaccine on the safety and immunogenicity of a purified inactivated Zika vaccine (ZPIV). This phase 1, placebo-controlled, double-blind trial was done at the Walter Reed Army Institute of Research Clinical Trials Center in Silver Spring, MD, USA. Eligible participants were healthy adults aged 18-49 years, with no detectable evidence of previous flavivirus exposure (by infection or vaccination), as measured by a microneutralisation assay. Individuals with serological evidence of HIV, hepatitis B, or hepatitis C infection were excluded, as were pregnant or breastfeeding women. Participants were recruited sequentially into one of three groups (1:1:1) to receive no primer, two doses of intramuscular Japanese encephalitis virus vaccine (IXIARO), or a single dose of subcutaneous yellow fever virus vaccine (YF-VAX). Within each group, participants were randomly assigned (4:1) to receive intramuscular ZPIV or placebo. Priming vaccinations were given 72-96 days before ZPIV. ZPIV was administered either two or three times, at days 0, 28, and 196-234. The primary outcome was occurrence of solicited systemic and local adverse events along with serious adverse events and adverse events of special interest. These data were analysed in all participants receiving at least one dose of ZPIV or placebo. Secondary outcomes included measurement of neutralizing antibody responses following ZPIV vaccination in all volunteers with available post-vaccination data. This trial is registered at ClinicalTrials.gov, NCT02963909. Between Nov 7, 2016, and Oct 30, 2018, 134 participants were assessed for eligibility. 21 did not meet inclusion criteria, 29 met exclusion criteria, and ten declined to participate. 75 participants were recruited and randomly assigned. 35 (47%) of 75 participants were male and 40 (53%) were female. 25 (33%) of 75 participants identified as Black or African American and 42 (56%) identified as White. These proportions and other baseline characteristics were similar between groups. There were no statistically significant differences in age, gender, race, or BMI between those who did and did not opt into the third dose. All participants received the planned priming IXIARO and YF-VAX vaccinations, but one participant who received YF-VAX dropped out before receipt of the first dose of ZPIV. 50 participants received a third dose of ZPIV or placebo, including 14 flavivirus-naive people, 17 people primed with Japanese encephalitis virus vaccine, and 19 participants primed with yellow fever vaccine. Vaccinations were well tolerated across groups. Pain at the injection site was the only adverse event reported more frequently in participants who received ZPIV than in those who received placebo (39 [65%] of 60 participants, 95% CI 51·6-76·9 who received ZPIV vs three [21·4%] of 14 who received placebo; 4·7-50·8; p=0·006). No patients had an adverse event of special interest or serious adverse event related to study treatment. At day 57, the flavivirus-naive volunteers had an 88% (63·6-98·5, 15 of 17) seroconversion rate (neutralising antibody titre ≥1:10) and geometric mean neutralising antibody titre (GMT) against Zika virus of 100·8 (39·7-255·7). In the Japanese encephalitis vaccine-primed group, the day 57 seroconversion rate was 31·6% (95% CI 12·6-56·6, six of 19) and GMT was 11·8 (6·1-22·8). Participants primed with YF-VAX had a seroconversion rate of 25% (95% CI 8·7-49·1, five of 20) and GMT of 6·6 (5·2-8·4). Humoral immune responses rose substantially following a third dose of ZPIV, with seroconversion rates of 100% (69·2-100; ten of ten), 92·9% (66·1-99·8; 13 of 14), and 60% (32·2-83·7, nine of 15) and GMTs of 511·5 (177·6-1473·6), 174·2 (51·6-587·6), and 79 (19·0-326·8) in the flavivirus naive, Japanese encephalitis vaccine-primed, and yellow fever vaccine-primed groups, respectively. We found ZPIV to be well tolerated in flavivirus naive and primed adults but that immunogenicity varied significantly according to antecedent flavivirus vaccination status. Immune bias towards the flavivirus antigen of initial exposure and the timing of vaccination may have impacted responses. A third ZPIV dose overcame much, but not all, of the discrepancy in immunogenicity. The results of this phase 1 clinical trial have implications for further evaluation of ZPIV's immunisation schedule and use of concomitant vaccinations. Department of Defense, Defense Health Agency; National Institute of Allergy and Infectious Diseases; and Division of Microbiology and Infectious Disease.

School Readiness Among Children With Congenital Heart Disease.

School Readiness Among Children With Congenital Heart Disease.

“We Aim at Nothing Less Than the Whole World”: The Seventh-day Adventist Church's Missionary Enterprise and the General Conference Secretariat, 1863–2019. By A. L. Chism, D. J. B. Trim and M. F. Younker. General Conference Archives Monographs, Vol. 1. Silver Spring, MD: Office of Archives, Statistics, and Research, Seventh-day Adventist Church World Headquarters, 2021. xxvi + 285 pp. $9.99 paper.

“We Aim at Nothing Less Than the Whole World”: The Seventh-day Adventist Church's Missionary Enterprise and the General Conference Secretariat, 1863–2019. By A. L. Chism, D. J. B. Trim and M. F. Younker. General Conference Archives Monographs, Vol. 1. Silver Spring, MD: Office of Archives, Statistics, and Research, Seventh-day Adventist Church World Headquarters, 2021. xxvi + 285 pp. $9.99 paper.

Noise suppression plan for demolishing a parking garage

The headquarters of a pharmaceutical corporation planned to replace a parking garage with additional office buildings at the site in Silver Spring, Maryland. Neighbors adjacent to the location included private offices, public buildings, and residences. In order for approval to pursue construction projects in Montgomery County, Maryland, a Noise Suppression Plan must be submitted to the Montgomery County Department of Environmental Protection. The contractor responsible for demolishing the parking garage hired Scantek, Inc. to build and compose the Noise Suppression Plan. The Noise Suppression Plan offered a three-prong approach to insure a maximum sound level of 75 dBA at a 500-feet radius around the construction site during normal business-time period. The noise sources (construction equipment) were addressed by optimizing operations such as separating the noise sources (activity zones) within the site and limiting engine throttles (rpm) powering the hydraulic pumps. Additionally, acoustic barriers were installed for the entire perimeter of the construction site. Finally, acoustic absorption bulk-material was piled at strategically locations to reduce sound reflections and acoustic reaction energy. The construction company sent a notice to all neighbors adjacent to the parking garage ahead of the demolition to inform of schedules, expectations, and contact information. The demolition moved ahead without notable complaints from the neighbors.

In Memoriam: Varsha Bhatt-Mehta, PharmD, MS, FCCP.

The Journal of Clinical PharmacologyAccepted Articles In Memoriam In Memoriam: Varsha Bhatt-Mehta, PharmD, MS, FCCP Gelareh Abulwerdi Ph.D. M.S, Corresponding Author Gelareh Abulwerdi Ph.D. M.S [email protected] Office of Clinical Pharmacology, U.S. FDA, Silver Spring, Maryland, USA Correspondence Gelareh Abulwerdi, Ph.D., M.S., Office of Clinical Pharmacology, U.S. FDA. Email: [email protected]Search for more papers by this authorGilbert J. Burckart Pharm.D, Gilbert J. Burckart Pharm.D orcid.org/0000-0003-2005-9301 Office of Clinical Pharmacology, U.S. FDA, Silver Spring, Maryland, USASearch for more papers by this authorMilap C. Nahata Pharm.D. M.S. FCCP FASHP FAPhA FPPA, Milap C. Nahata Pharm.D. M.S. FCCP FASHP FAPhA FPPA Colleges of Pharmacy and Medicine, Ohio State University, Columbus, Ohio, USASearch for more papers by this authorHanna Phan Pharm.D. FCCP FPPA, Hanna Phan Pharm.D. FCCP FPPA College of Pharmacy, University of Michigan, Ann Arbor, Maryland, USASearch for more papers by this author Gelareh Abulwerdi Ph.D. M.S, Corresponding Author Gelareh Abulwerdi Ph.D. M.S [email protected] Office of Clinical Pharmacology, U.S. FDA, Silver Spring, Maryland, USA Correspondence Gelareh Abulwerdi, Ph.D., M.S., Office of Clinical Pharmacology, U.S. FDA. Email: [email protected]Search for more papers by this authorGilbert J. Burckart Pharm.D, Gilbert J. Burckart Pharm.D orcid.org/0000-0003-2005-9301 Office of Clinical Pharmacology, U.S. FDA, Silver Spring, Maryland, USASearch for more papers by this authorMilap C. Nahata Pharm.D. M.S. FCCP FASHP FAPhA FPPA, Milap C. Nahata Pharm.D. M.S. FCCP FASHP FAPhA FPPA Colleges of Pharmacy and Medicine, Ohio State University, Columbus, Ohio, USASearch for more papers by this authorHanna Phan Pharm.D. FCCP FPPA, Hanna Phan Pharm.D. FCCP FPPA College of Pharmacy, University of Michigan, Ann Arbor, Maryland, USASearch for more papers by this author First published: 24 April 2023 https://doi.org/10.1002/jcph.2250 This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as https://doi.org/10.1002/jcph.2250 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Accepted ArticlesAccepted, unedited articles published online and citable. The final edited and typeset version of record will appear in the future. RelatedInformation

Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods.

Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods.

ArtiFacts: Austin Moore's Hip.

1Collections Manager, Historical Collections, National Museum of Health and Medicine, Defense Health Agency, Silver Spring, MD, USA Alan J. Hawk ✉, National Museum of Health and Medicine Defense Health Agency, 2460 Linden Lane, Silver Spring, MD 20910, USA, Email: [email protected] A note from the Editor-in-Chief: We are pleased to present the next installment of “ArtiFacts.” In each column, the Collections Manager of the Historical Collections Division of the National Museum of Health and Medicine (NMHM) will present a photograph of a visually or historically interesting artifact from the museum’s collection and provide the story behind the picture. The NMHM, whose collection was recognized as a National Historic Landmark, was originally developed from the Army Medical Museum established during the Civil War to collect “specimens of morbid anatomy together with projectiles and foreign bodies removed.” Its mission today is to inspire interest in, and promote the understanding of, medicine to the public. The author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request. The opinions expressed are those of the writers, and do not reflect the opinion or policy of CORR® or The Association of Bone and Joint Surgeons®. The opinions or assertions herein are those of the author and do not represent the views of the Defense Health Agency or of the Department of Defense.

Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials

Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials

Lancet Diabetes & Endocrinology Commission on the Definition and Diagnosis of Clinical Obesity

Obesity was first recognised as a disease by WHO in 1948, then between 2013 and 2022 by several medical societies and countries. 1 WHO ConsultationAppropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004; 363: 157-163 Summary Full Text Full Text PDF PubMed Scopus (8005) Google Scholar , 2 Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000; 894: 1-253 Google Scholar , 3 Carruba MO Busetto L Bryant S et al. The European Association for the Study of Obesity (EASO) endorses the milan charter on urban obesity. Obes Facts. 2021; 14: 163-168 Crossref PubMed Scopus (3) Google Scholar , 4 American Society for Metabolic and Bariatric SurgeryConsensus statement on obesity as a disease. https://asmbs.org/resources/consensus-statement-on-obesity-as-a-diseaseDate: 2022 Date accessed: February 20, 2023 Google Scholar , 5 Bray GA Kim KK Wilding JPH World Obesity FObesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017; 18: 715-723 Crossref PubMed Scopus (577) Google Scholar , 6 Jastreboff AM Kotz CM Kahan S Kelly AS Heymsfield SB Obesity as a disease: the Obesity Society 2018 position statement. Obesity (Silver Spring). 2019; 27: 7-9 Crossref PubMed Scopus (152) Google Scholar , 7 Pollack A NY TimesA.M.A. recognizes obesity as a disease. https://www.nytimes.com/2013/06/19/business/ama-recognizes-obesity-as-a-disease.htmlDate: 2013 Date accessed: February 26, 2023 Google Scholar , 8 Mechanick JI Garber AJ Handelsman Y et al. American Association of Clinical Endocrinologists' position statement on obesity and obesity medicine. Endocr Pract. 2012; 18: 642-648 Summary Full Text Full Text PDF PubMed Scopus (92) Google Scholar However, the notion that obesity is a disease and not merely a risk factor for other illnesses remains highly controversial, both within and beyond medical circles. This debate constitutes far more than arcane semantics, and seriously affects the provision of therapeutic strategies to improve health among people living with obesity.

In Memoriam: William T. Hogarth

In Memoriam: William T. Hogarth

Anesthesia, Coming of Age in the World of Modern In Silico Drug Design.

Anesthesia, Coming of Age in the World of Modern In Silico Drug Design.

A Review of the Use of Decellularized, Porcine, Small-Intestinal, Submucosal, Extracellular-Matrix Patch Material in Congenital Heart Surgery

Patch material is frequently used by pediatric cardiac surgeons during repair of congenital heart disease. The ideal patch material would be pliable, durable, promote native tissue ingrowth, and allow for somatic growth. Intraoperatively, other desirable characteristics would include the material be hemostatic (i.e. lack of bleeding at needle holes) and isotropic (i.e. stretching in all directions, allowing for complex 3-dimensional patches). Decellularized, porcine, small-intestinal, submucosal, extracellular matrix material has shown promise as a potentially ideal patch material. Proxicor (4-ply) and Tyke (2-ply) (Aziyo Biologics, Silver Spring, MD) are commercially available, extracellular matrix material products that are approved by the United States Food and Drug Administration for use in pediatric cardiac surgery. While initial studies were encouraging regarding the extracellular matrix material potential for native tissue ingrowth, subsequent studies have not reproduced the early findings. In most histological analyses, explanted extracellular matrix material has demonstrated chronic inflammatory cell migration and scarring. Despite the lack of transformation, extracellular matrix material does have the advantages of remaining pliable and resisting calcification, which are desirable in the reconstruction of congenital heart defects.