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  1. Article ; Online: OpNotes and Clinical Exercises: Activities to Enhance the Clinical Context of the Preclerkship Anatomy Dissection Laboratory.

    Meredith, M Alex / Harrell, Kelly M / Foster, Kenneth W / Edwards, Cherie / Puche, Adam C

    Academic medicine : journal of the Association of American Medical Colleges

    2023  Volume 98, Issue 8, Page(s) 912–916

    Abstract: Problem: Despite numerous pedagogical approaches and technologies now available for medical gross anatomy, students can find it difficult to translate what occurs in a dissection laboratory into the context of clinical practice.: Approach: Using ... ...

    Abstract Problem: Despite numerous pedagogical approaches and technologies now available for medical gross anatomy, students can find it difficult to translate what occurs in a dissection laboratory into the context of clinical practice.
    Approach: Using complementary and collaborative approaches at 2 different medical schools, Virginia Commonwealth University (VCU) and University of Maryland (UM), we designed and implemented a series of clinical activities in the preclerkship medical gross anatomy laboratory that directly link dissected structures to clinical procedures. These activities specifically direct students to perform simulated clinically related procedures on anatomic donors during laboratory dissection sessions. The activities are called OpNotes at VCU and Clinical Exercises at UM. Each activity in the VCU OpNotes requires about 15 minutes of group activity at the end of a scheduled laboratory and involves faculty to grade the student responses submitted via a web-based-assessment form. Each exercise in UM Clinical Exercises also requires about 15 minutes of group activity during the schedule laboratory but does not involve faculty to complete grading.
    Outcomes: Cumulatively, the activities in OpNotes and Clinical Exercises both brought clinical context directly to anatomical dissections. These activities began in 2012 at UM and 2020 at VCU, allowing a multiyear and multi-institute development and testing of this innovative approach. Student participation was high, and perception of its effectiveness was almost uniformly positive.
    Next steps: Future iterations of the program will work to assess the efficacy of the program as well as to streamline the scoring and delivery of the formative components. Collectively, we propose that the concept of executing clinic-like procedures on donors in anatomy courses is an effective means of enhancing learning in the anatomy laboratory while concurrently underscoring the relevance of basic anatomy to future clinical practice.
    MeSH term(s) Humans ; Curriculum ; Dissection/education ; Learning ; Educational Measurement ; Faculty ; Anatomy/education ; Education, Medical, Undergraduate/methods ; Students, Medical ; Cadaver
    Language English
    Publishing date 2023-03-22
    Publishing country United States
    Document type Journal Article
    ZDB-ID 96192-9
    ISSN 1938-808X ; 1040-2446
    ISSN (online) 1938-808X
    ISSN 1040-2446
    DOI 10.1097/ACM.0000000000005216
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  2. Article ; Online: Plasma glucosylsphingosine correlations with baseline disease burden and response to eliglustat in two clinical trials of previously untreated adults with Gaucher disease type 1.

    Peterschmitt, M Judith / Foster, Meredith C / Ji, Allena J / Zajdel, Marianne B / Cox, Gerald F

    Molecular genetics and metabolism

    2023  Volume 138, Issue 3, Page(s) 107527

    Abstract: In Gaucher disease type 1 (GD1), accumulation of the lipid substrates glucosylceramide and glucosylsphingosine (lyso-GL-1 or lyso-Gb1), primarily in the spleen, liver, and bone marrow, leads to progressive hepatosplenomegaly, anemia, thrombocytopenia, ... ...

    Abstract In Gaucher disease type 1 (GD1), accumulation of the lipid substrates glucosylceramide and glucosylsphingosine (lyso-GL-1 or lyso-Gb1), primarily in the spleen, liver, and bone marrow, leads to progressive hepatosplenomegaly, anemia, thrombocytopenia, and skeletal disease. Plasma glucosylceramide elevations are modest, variable, and normalize within weeks of starting treatment before clinical changes are evident, and therefore, have limited value for monitoring treatment responses. Serum chitotriosidase activity, a widely used GD biomarker, is also elevated in many other conditions but is not measurable in 5-10% of individuals due to a common CHIT1 null variant. Plasma glucosylsphingosine is increasingly recognized as a useful biomarker for GD1: elevations are highly specific to the disease and show no overlap with normal controls, it is in the causal pathway of disease, and levels are reliably measured by liquid chromatography-tandem mass spectrometry. We report correlations of plasma glucosylsphingosine with baseline disease burden and eliglustat treatment response in previously untreated adults with GD1 in the Phase 2 (NCT00358150), open-label, single-arm trial of 26 patients with up to 8 years of follow-up and the placebo-controlled Phase 3 ENGAGE trial (NCT00891202) of 40 patients with up to 4.5 years of follow-up. At baseline, untreated patients showed moderate to strong correlations between plasma glucosylsphingosine and spleen volume, liver volume, and hemoglobin level. Organ volumes and hematologic parameters improved in parallel with reductions in plasma glucosylsphingosine during eliglustat treatment in both trials. Moderate correlations were seen between plasma glucosylsphingosine reduction and spleen and liver volume reductions during eliglustat treatment. These clinical trial data add to the growing body of evidence supporting plasma glucosylsphingosine as both a diagnostic and pharmacodynamic/response biomarker for GD1.
    MeSH term(s) Humans ; Adult ; Gaucher Disease/diagnosis ; Glucosylceramides/metabolism ; Biomarkers
    Chemical Substances sphingosyl beta-glucoside (52050-17-6) ; eliglustat (DR40J4WA67) ; Glucosylceramides ; Biomarkers
    Language English
    Publishing date 2023-01-25
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1418518-0
    ISSN 1096-7206 ; 1096-7192
    ISSN (online) 1096-7206
    ISSN 1096-7192
    DOI 10.1016/j.ymgme.2023.107527
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  3. Article ; Online: Chicken Soup for the Unstable Shoulder: Stabilization Reduces Depressive Symptoms: Commentary on an article by Danielle G. Weekes, MD, et al.: "Prevalence of Clinical Depression Among Patients After Shoulder Stabilization. A Prospective Study".

    Henn, R Frank / Meredith, Sean J / Foster, Michael / Gallagher, Marjorie C

    The Journal of bone and joint surgery. American volume

    2019  Volume 101, Issue 18, Page(s) e97

    MeSH term(s) Depression ; Humans ; Prevalence ; Prospective Studies ; Shoulder ; Shoulder Injuries/psychology
    Language English
    Publishing date 2019-11-06
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 220625-0
    ISSN 1535-1386 ; 0021-9355
    ISSN (online) 1535-1386
    ISSN 0021-9355
    DOI 10.2106/JBJS.19.00760
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  4. Article ; Online: Long-term effects of eliglustat on skeletal manifestations in clinical trials of patients with Gaucher disease type 1.

    Cox, Timothy M / Charrow, Joel / Lukina, Elena / Mistry, Pramod K / Foster, Meredith C / Peterschmitt, M Judith

    Genetics in medicine : official journal of the American College of Medical Genetics

    2022  Volume 25, Issue 2, Page(s) 100329

    Abstract: Purpose: Most patients with Gaucher disease have progressive and often disabling skeletal manifestations. We examined the long-term effect of eliglustat treatment on bone outcomes in clinical trials in adults with Gaucher disease type 1.: Methods: ... ...

    Abstract Purpose: Most patients with Gaucher disease have progressive and often disabling skeletal manifestations. We examined the long-term effect of eliglustat treatment on bone outcomes in clinical trials in adults with Gaucher disease type 1.
    Methods: Data from 4 completed phase 2 and 3 trials were evaluated in treatment-naïve patients or patients switching to eliglustat from enzyme replacement therapy (ERT).
    Results: Overall, 319 of 393 (81%) eliglustat-treated patients remained in their trials until completion or commercial eliglustat became available. Mean eliglustat treatment duration ranged from 3.3 to 6.5 years. In treatment-naïve patients and ERT-switch patients, frequency and severity of bone pain decreased during eliglustat treatment. Mean lumbar spine T-scores shifted from abnormal to normal in treatment-naïve patients and remained in the healthy reference range or improved modestly in ERT-switch patients. Mean total bone marrow burden score shifted from marked-to-severe to moderate in treatment-naïve patients and remained moderate in ERT-switch patients. MIP-1β (marker of active bone disease) was elevated at baseline and decreased to the healthy reference range in treatment-naïve patients and remained in the healthy reference range among ERT-switch patients.
    Conclusion: These findings confirm the long-term efficacy of eliglustat on skeletal complications of Gaucher disease in treatment-naïve and ERT-switch patients.
    MeSH term(s) Adult ; Humans ; Gaucher Disease/drug therapy ; Enzyme Inhibitors/therapeutic use ; Pyrrolidines/therapeutic use ; Pyrrolidines/adverse effects ; Enzyme Replacement Therapy ; Glucosylceramidase/therapeutic use
    Chemical Substances eliglustat (DR40J4WA67) ; Enzyme Inhibitors ; Pyrrolidines ; Glucosylceramidase (EC 3.2.1.45)
    Language English
    Publishing date 2022-12-05
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1455352-1
    ISSN 1530-0366 ; 1098-3600
    ISSN (online) 1530-0366
    ISSN 1098-3600
    DOI 10.1016/j.gim.2022.10.011
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  5. Article ; Online: Kidney Transplants from HLA-Incompatible Live Donors and Survival.

    Dad, Taimur / Foster, Meredith C / Weiner, Daniel E

    The New England journal of medicine

    2016  Volume 375, Issue 3, Page(s) 288

    MeSH term(s) Histocompatibility ; Humans ; Kidney Transplantation ; Living Donors
    Language English
    Publishing date 2016-07-21
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc1604523#SA3
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  6. Article ; Online: Post hoc longitudinal assessment of the efficacy and safety of recombinant factor IX Fc fusion protein in hemophilia B.

    Shapiro, Amy D / Kulkarni, Roshni / Ragni, Margaret V / Chambost, Hervé / Mahlangu, Johnny / Oldenburg, Johannes / Nolan, Beatrice / Ozelo, Margareth C / Foster, Meredith C / Willemze, Annemieke / Barnowski, Christopher / Jain, Nisha / Winding, Bent / Dumont, Jennifer / Lethagen, Stefan / Barnes, Chris / Pasi, K John

    Blood advances

    2023  Volume 7, Issue 13, Page(s) 3049–3057

    Abstract: Long-term efficacy and safety of the extended half-life recombinant factor IX Fc fusion protein (rFIXFc) has been established among previously treated patients with severe hemophilia B in 2 phase 3 trials (B-LONG [#NCT01027364] and Kids B-LONG [# ... ...

    Abstract Long-term efficacy and safety of the extended half-life recombinant factor IX Fc fusion protein (rFIXFc) has been established among previously treated patients with severe hemophilia B in 2 phase 3 trials (B-LONG [#NCT01027364] and Kids B-LONG [#NCT01440946]) and a long-term extension study (B-YOND [#NCT01425723]). In this study, we report post hoc analyses of pooled longitudinal data for up to 6.5 years for rFIXFc prophylaxis. In the B-LONG study, subjects ≥12 years received weekly dose-adjusted prophylaxis (WP; starting dose, 50 IU/kg), individualized interval-adjusted prophylaxis (IP; initially, 100 IU/kg every 10 days), or on-demand dosing. In the Kids B-LONG study, subjects <12 years received 50 to 60 IU/kg every 7 days, adjusted as needed. In the B-YOND study, subjects received WP (20-100 IU/kg every 7 days), IP (100 IU/kg every 8-16 days), modified prophylaxis, or on-demand dosing; switching between treatment groups was permitted. A total of 123 subjects from B-LONG and 30 from Kids B-LONG study were included, of whom 93 and 27, respectively, enrolled in the B-YOND study. The median cumulative duration of treatment was 3.63 years (range, 0.003-6.48 years) in B-LONG/B-YOND and 2.88 years (range, 0.30-4.80 years) in Kids B-LONG/B-YOND group. Annualized bleed rates (ABRs) remained low, annualized factor consumption remained stable, and adherence remained high throughout treatment. Low ABRs were also maintained in subjects with dosing intervals ≥14 days or with target joints at baseline. Complete resolution of evaluable target joints and no recurrence in 90.2% of baseline target joints during follow-up were observed. rFIXFc prophylaxis was associated with sustained clinical benefits, including long-term bleed prevention and target joint resolution, for severe hemophilia B.
    MeSH term(s) Humans ; Factor IX/adverse effects ; Factor IX/therapeutic use ; Hemophilia A/drug therapy ; Hemophilia B/drug therapy ; Hemophilia B/complications ; Hemorrhage/chemically induced ; Immunoglobulin Fc Fragments/adverse effects ; Immunoglobulin Fc Fragments/therapeutic use ; Recombinant Fusion Proteins/adverse effects ; Recombinant Fusion Proteins/therapeutic use
    Chemical Substances Factor IX (9001-28-9) ; factor IX Fc fusion protein ; Immunoglobulin Fc Fragments ; Recombinant Fusion Proteins
    Language English
    Publishing date 2023-02-28
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2915908-8
    ISSN 2473-9537 ; 2473-9529
    ISSN (online) 2473-9537
    ISSN 2473-9529
    DOI 10.1182/bloodadvances.2022009230
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  7. Article ; Online: Estimation of Life-Years Saved by Solid-Organ Transplant.

    Foster, Meredith C / Varothai, Narittaya / Weiner, Daniel E

    JAMA surgery

    2015  Volume 150, Issue 10, Page(s) 1015

    MeSH term(s) Humans ; Organ Transplantation/mortality ; Registries ; Tissue and Organ Procurement/statistics & numerical data
    Language English
    Publishing date 2015-10
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 2701841-6
    ISSN 2168-6262 ; 2168-6254
    ISSN (online) 2168-6262
    ISSN 2168-6254
    DOI 10.1001/jamasurg.2015.1936
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  8. Article ; Online: Comparison of techniques for culture of dialysis water and fluid.

    Maltais, Jo-Ann B / Meyer, Klemens B / Foster, Meredith C

    Hemodialysis international. International Symposium on Home Hemodialysis

    2017  Volume 21, Issue 2, Page(s) 197–205

    Abstract: Introduction: Microbiological culture of dialysis water and fluid is a routine safety measure. In the United States (U.S.), laboratories perform these cultures on trypticase soy agar at 35-37°C for 48 h (TSA-48h), not on the tryptone glucose extract ... ...

    Abstract Introduction: Microbiological culture of dialysis water and fluid is a routine safety measure. In the United States (U.S.), laboratories perform these cultures on trypticase soy agar at 35-37°C for 48 h (TSA-48h), not on the tryptone glucose extract agar or Reasoner's 2A agar at 17-23°C for 7 days (TGEA-7d and R2A-7d, respectively) recommended by international standards. We compared culture methods to identify samples exceeding the accepted action level of 50 CFU/mL.
    Methods: Dialysis water and fluid samples collected from 41 U.S. dialysis programs between 2011 and 2014 were cultured at two U.S. laboratories. Each sample was cultured using (1) either TGEA-7d or R2A-7d and (2) TSA-48h. We compared proportions exceeding the action level by different methods and test characteristics of TSA-48h to those of TGEA-7d and R2A-7d.
    Findings: The proportion of water samples yielding colony counts ≥50 CFU/mL by TGEA-7d was significantly different from the proportion by TSA-48h (P = 0.001; difference in proportion 4.3% [95%CI 1.3-7.3%]). The proportions of dialysis fluid samples ≥50 CFU/mL by TGEA-7d and TSA-48h were not significantly different; there were no significant differences for comparisons of R2A-7d to TSA-48h.
    Discussion: In dialysis fluid, TSA-48h was comparable to TGEA-7d and R2A-7d in identifying samples as having bacterial counts ≥50 CFU/mL. In dialysis water, TSA-48h was comparable to R2A-7d in identifying samples ≥50 CFU/mL, but TGEA-7d did yield significantly more results above 50 CFU/mL. Nonetheless, the negative predictive value of a TSA-48h result of <50 CFU/mL in dialysis water exceeded 95%.
    MeSH term(s) Culture Media/chemistry ; Dialysis Solutions/chemistry ; Fluid Therapy/methods ; Humans ; Renal Dialysis/methods ; Water Microbiology
    Chemical Substances Culture Media ; Dialysis Solutions
    Language English
    Publishing date 2017-04
    Publishing country Canada
    Document type Journal Article
    ZDB-ID 2192458-2
    ISSN 1542-4758 ; 1492-7535
    ISSN (online) 1542-4758
    ISSN 1492-7535
    DOI 10.1111/hdi.12477
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  9. Article ; Online: Isatuximab plus pomalidomide and dexamethasone in frail patients with relapsed/refractory multiple myeloma: ICARIA-MM subgroup analysis.

    Schjesvold, Fredrik / Bringhen, Sara / G Richardson, Paul / Perrot, Aurore / Leleu, Xavier / Moreau, Philippe / A Dimopoulos, Meletios / Hulin, Cyrille / Tekle, Christina / Foster, Meredith C / Poole, Elizabeth M / van de Velde, Helgi / Facon, Thierry

    American journal of hematology

    2021  Volume 96, Issue 11, Page(s) E423–E427

    MeSH term(s) Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Agents, Immunological/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Frail Elderly ; Humans ; Multiple Myeloma/drug therapy ; Neoplasm Recurrence, Local/drug therapy ; Thalidomide/analogs & derivatives ; Thalidomide/therapeutic use ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal, Humanized ; Antineoplastic Agents, Immunological ; Thalidomide (4Z8R6ORS6L) ; pomalidomide (D2UX06XLB5) ; isatuximab (R30772KCU0)
    Language English
    Publishing date 2021-09-23
    Publishing country United States
    Document type Clinical Trial, Phase III ; Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 196767-8
    ISSN 1096-8652 ; 0361-8609
    ISSN (online) 1096-8652
    ISSN 0361-8609
    DOI 10.1002/ajh.26319
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  10. Article ; Online: A post hoc analysis of previously untreated patients with severe hemophilia A who developed inhibitors in the PUPs A-LONG trial.

    Carcao, Manuel / Schiavulli, Michele / Kulkarni, Roshni / Rendo, Pablo / Foster, Meredith / Santagostino, Elena / Casiano, Sandra / Königs, Christoph

    Blood advances

    2024  Volume 8, Issue 6, Page(s) 1494–1503

    Abstract: Abstract: Inhibitor development is a major therapeutic complication for people with hemophilia. The phase 3 PUPs A-LONG study evaluated the safety and efficacy of efmoroctocog alfa (a recombinant factor VIII Fc fusion protein, herein referred to as ... ...

    Abstract Abstract: Inhibitor development is a major therapeutic complication for people with hemophilia. The phase 3 PUPs A-LONG study evaluated the safety and efficacy of efmoroctocog alfa (a recombinant factor VIII Fc fusion protein, herein referred to as rFVIIIFc) in previously untreated patients (PUPs) with severe hemophilia A. Male PUPs <6 years old were enrolled and received rFVIIIFc; inhibitor development was the primary end point. Post hoc analyses, including patient treatment regimen patterns and timing of inhibitor development, descriptive and Kaplan-Meier analyses of time to first inhibitor-positive test by treatment regimen and by titer, and consumption, were performed to describe patients who developed inhibitors during PUPs A-LONG. We investigated patient characteristics (eg, demographics and genotype) and nongenetic risk factors (eg, intense factor exposure and central venous access device [CVAD] placement) that may predict inhibitor development and characteristics of inhibitor development (low-titer vs high-titer inhibitor). Baseline characteristics were similarly distributed for age, race, and ethnicity across both patients who were inhibitor-positive and those who were inhibitor-negative (all P > .05). High-risk F8 variants were associated with development of high-titer inhibitors (P = .028). High-titer inhibitor development was often preceded by the presence of a low-titer inhibitor. Patients whose low-titer inhibitor progressed to a high-titer inhibitor received a higher mean dose per infusion (98.4 IU/kg, n = 5) compared with those whose low-titer inhibitor resolved spontaneously (59.2 IU/kg, n = 7; P = .033) or persisted (45.0 IU/kg, n = 5; P = .047). There was no association between CVAD placement surgery and inhibitor development. Post hoc analyses suggest that F8 genotype and dose of factor are as important as inhibitor risk factors and require further investigation. This study was registered at ClinicalTrials.gov as #NCT02234323.
    MeSH term(s) Humans ; Male ; Ethnicity ; Hemophilia A/therapy ; Kaplan-Meier Estimate ; Recombinant Proteins/adverse effects ; Risk Factors ; Child, Preschool
    Chemical Substances Recombinant Proteins
    Language English
    Publishing date 2024-01-23
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article
    ZDB-ID 2915908-8
    ISSN 2473-9537 ; 2473-9529
    ISSN (online) 2473-9537
    ISSN 2473-9529
    DOI 10.1182/bloodadvances.2023011475
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