Publications by authors named "Maureen J Miller"

13 Publications

  • Page 1 of 1

How do I… facilitate a rapid response to a public health emergency requiring plasma collection with a public-private partnership?

Transfusion 2021 Sep 12. Epub 2021 Sep 12.

Bloodworks Northwest, Seattle, Washington, USA.

In March 2020, there were no treatment options for COVID-19. Passive immune therapy including anti-SARS-CoV-2 hyperimmune globulin (hIVIG) was a logical candidate for COVID-19 therapeutic trials, given past success treating emerging pathogens with endogenous neutralizing antibodies. We established a plasma collection protocol for persons recovered from COVID-19. To speed recruitment in the first U.S. hotspot, Seattle, Washington, federal and state public health agencies collaborated with Bloodworks Northwest to collect convalescent plasma (CP) for manufacturing hIVIG. During March-December 2020, we identified and recruited prospective CP donors via letters to persons recovered from COVID-19 with laboratory-confirmed SARS-CoV-2 infection. Prospective donors were pre-screened and administered a medical history survey. Anti-SARS-CoV-2 neutralizing antibody (NAb) titers were classified as qualifying (≥1:80) or non-qualifying (<1:80) for enrollment based on a live virus neutralization assay. Generalized estimating equations were used to identify characteristics of donors associated with qualifying versus nonqualifying NAb titers. Overall, 21,359 letters resulted in 3207 inquiries, 2159 prescreenings with laboratory-confirmed SARS-CoV-2 infection, and 573 donors (27% of all pre-screenings with confirmed infection) who provided a screening plasma donation. Of 573 donors screened, 254 (44%) provided plasma with qualifying NAb titers, resulting in 1284 units for hIVIG manufacture. In a multivariable model, after adjusting for other factors, time (60 days) from COVID-19 symptom onset to screening was associated with lower odds of qualifying NAb (adjusted odds ratio = 0.67, 95% CI: 0.48-0.94). The collaboration facilitated a rapid response to develop and provide hIVIG for clinical trials and CP for transfusion. Only 1 in 12 donor inquiries resulted in a qualifying plasma donation. Challenges included recruitment and the relatively low percentage of persons with high NAb titers and limited screening capacity. This resource-intensive collaboration may not be scalable but informs preparedness and response strategies for plasma collection in future epidemics. Operational readiness plans with templates for screening, consent, and data collection forms are recommended.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/trf.16630DOI Listing
September 2021

Estimated US Infection- and Vaccine-Induced SARS-CoV-2 Seroprevalence Based on Blood Donations, July 2020-May 2021.

JAMA 2021 Sep 2. Epub 2021 Sep 2.

COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia.

Importance: People who have been infected with or vaccinated against SARS-CoV-2 have reduced risk of subsequent infection, but the proportion of people in the US with SARS-CoV-2 antibodies from infection or vaccination is uncertain.

Objective: To estimate trends in SARS-CoV-2 seroprevalence related to infection and vaccination in the US population.

Design, Setting, And Participants: In a repeated cross-sectional study conducted each month during July 2020 through May 2021, 17 blood collection organizations with blood donations from all 50 US states; Washington, DC; and Puerto Rico were organized into 66 study-specific regions, representing a catchment of 74% of the US population. For each study region, specimens from a median of approximately 2000 blood donors were selected and tested each month; a total of 1 594 363 specimens were initially selected and tested. The final date of blood donation collection was May 31, 2021.

Exposure: Calendar time.

Main Outcomes And Measures: Proportion of persons with detectable SARS-CoV-2 spike and nucleocapsid antibodies. Seroprevalence was weighted for demographic differences between the blood donor sample and general population. Infection-induced seroprevalence was defined as the prevalence of the population with both spike and nucleocapsid antibodies. Combined infection- and vaccination-induced seroprevalence was defined as the prevalence of the population with spike antibodies. The seroprevalence estimates were compared with cumulative COVID-19 case report incidence rates.

Results: Among 1 443 519 specimens included, 733 052 (50.8%) were from women, 174 842 (12.1%) were from persons aged 16 to 29 years, 292 258 (20.2%) were from persons aged 65 years and older, 36 654 (2.5%) were from non-Hispanic Black persons, and 88 773 (6.1%) were from Hispanic persons. The overall infection-induced SARS-CoV-2 seroprevalence estimate increased from 3.5% (95% CI, 3.2%-3.8%) in July 2020 to 20.2% (95% CI, 19.9%-20.6%) in May 2021; the combined infection- and vaccination-induced seroprevalence estimate in May 2021 was 83.3% (95% CI, 82.9%-83.7%). By May 2021, 2.1 SARS-CoV-2 infections (95% CI, 2.0-2.1) per reported COVID-19 case were estimated to have occurred.

Conclusions And Relevance: Based on a sample of blood donations in the US from July 2020 through May 2021, vaccine- and infection-induced SARS-CoV-2 seroprevalence increased over time and varied by age, race and ethnicity, and geographic region. Despite weighting to adjust for demographic differences, these findings from a national sample of blood donors may not be representative of the entire US population.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jama.2021.15161DOI Listing
September 2021

Assessment of Coagulation and Hemostasis Biomarkers in a Subset of Patients With Chronic Cardiovascular Disease.

Clin Appl Thromb Hemost 2021 Jan-Dec;27:10760296211032292

Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA.

Measurement of a single marker of coagulation may not provide a complete picture of hemostasis activation and fibrinolysis in patients with chronic cardiovascular diseases. We assessed retrospective orders of a panel which included prothrombin fragment 1.2 (PF1.2), thrombin: antithrombin complexes, fibrin monomers, and D-dimers in patients with heart assist devices, cardiomyopathies, atrial fibrillation and intracardiac thrombosis (based on ordering ICD-10 codes). During 1 year there were 117 panels from 81 patients. Fifty-six (69%) patients had heart assist devices, cardiomyopathy was present in 17 patients (21%) and 29 patients (36%) had more than 1 condition. PF1.2 was most frequently elevated in patients with cardiomyopathy (61.1%) compared to those with cardiac assist devices (15.7%; = 0.0002). D-dimer elevation was more frequent in patients with cardiac assist devices (98.8%) compared to those patients with cardiomyopathy (83.3%; = 0.014). Patients with cardiomyopathy show increases of PF1.2 suggesting thrombin generation. In contrast, elevations of D-dimers without increase in other coagulation markers in patients with cardiac assist devices likely reflect the presence of the intravascular device and not necessarily evidence of hemostatic activation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/10760296211032292DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8274080PMC
July 2021

Severe Acute Respiratory Syndrome Coronavirus 2 Testing Trends Among Persons Aged <18 Years in an Outpatient Pediatric Practice - Metropolitan Atlanta, Georgia, May-December 2020.

J Adolesc Health 2021 07;69(1):144-148

CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia.

Purpose: The purpose of this study was to analyze trends in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing and test positivity among persons aged <18 years in a three-site outpatient pediatric practice in Atlanta, Georgia, serving approximately 35,000 pediatric patients.

Methods: Using electronic medical records, weekly trends in SARS-CoV-2 tests performed and the 14-day moving average of test positivity were examined, overall and by age group, during May 24-December 5, 2020.

Results: Among 4,995 patients who received at least 1 SARS-CoV-2 test, 6,813 total tests were completed. Overall test positivity was 5.4% and was higher among older pediatric patients (<5 years: 3.3%; 5-11 years: 4.1%; 12-17 years: 8.6%). The number of tests and test positivity increased after holidays and school breaks.

Conclusions: Families might benefit from communication focused on reducing SARS-CoV-2 transmission during holidays. In addition, given higher test positivity in children aged 12-17 years, tailoring public health messaging to older adolescents could help limit SARS-CoV-2 transmission risk in this population.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jadohealth.2021.04.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219291PMC
July 2021

Impact of COVID-19 on Cervical Cancer Screening Rates Among Women Aged 21-65 Years in a Large Integrated Health Care System - Southern California, January 1-September 30, 2019, and January 1-September 30, 2020.

MMWR Morb Mortal Wkly Rep 2021 Jan 29;70(4):109-113. Epub 2021 Jan 29.

On March 19, 2020, the governor of California issued a statewide stay-at-home order to contain the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19).* The order reduced accessibility to and patient attendance at outpatient medical visits, including preventive services such as cervical cancer screening. In-person clinic visits increased when California reopened essential businesses on June 12, 2020. Electronic medical records of approximately 1.5 million women served by Kaiser Permanente Southern California (KPSC), a large integrated health care system, were examined to assess cervical cancer screening rates before, during, and after the stay-at-home order. KPSC policy is to screen women aged 21-29 years every 3 years with cervical cytology alone (Papanicolaou [Pap] test); those aged 30-65 years were screened every 5 years with human papillomavirus (HPV) testing and cytology (cotesting) through July 15, 2020, and after July 15, 2020, with HPV testing alone, consistent with the latest recommendations from U.S. Preventive Services Task Force. Compared with the 2019 baseline, cervical cancer screening rates decreased substantially during the stay-at-home order. Among women aged 21-29 years, cervical cytology screening rates per 100 person-months declined 78%. Among women aged 30-65 years, HPV test screening rates per 100 person-months decreased 82%. After the stay-at-home order was lifted, screening rates returned to near baseline, which might have been aided by aspects of KPSC's integrated, organized screening program (e.g., reminder systems and tracking persons lost to follow-up). As the pandemic continues, groups at higher risk for developing cervical cancers and precancers should be evaluated first. Ensuring that women receive preventive services, including cancer screening and appropriate follow-up in a safe and timely manner, remains important.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.15585/mmwr.mm7004a1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7842810PMC
January 2021

Refractory thrombotic thrombocytopenic purpura related to checkpoint inhibitor immunotherapy.

Transfusion 2021 01 29;61(1):322-328. Epub 2020 Oct 29.

Center for Transfusion and Cellular Therapy, Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.

Background: Checkpoint inhibitors enhance T-lymphocyte-mediated antitumor responses, resulting in increased survival for patients with neoplastic disease. However, a subset of patients receiving checkpoint inhibitor therapy may experience adverse complications that include the development of autoimmune conditions, such as thrombotic thrombocytopenic purpura (TTP). Given the potential etiologic differences of checkpoint inhibitor-related autoimmunity, TTP that develops in the presence of checkpoint inhibitors may be refractory to current treatment methods and therefore may require additional treatment and prognostic consideration.

Case Report: Herein, we describe the unique clinical course of a patient who was treated with the combined checkpoint inhibitors nivolumab and ipilimumab for Stage IV malignant melanoma, who subsequently developed TTP. Unlike many patients with TTP, this patient failed to develop a sustained response to therapeutic plasma exchange. Additional use of steroids, anti-CD20, and plasma cell-targeting therapy (bortezomib) also failed to substantially reverse thrombocytopenia in a sustainable fashion. During this time, her melanoma progressed, and she ultimately succumbed.

Conclusion: This case illustrates not only that TTP may be a potential complication of checkpoint inhibitor therapy, but also that TTP developing in this setting may result in an unpredictable response to commonly employed TTP treatment modalities. Ultimately, checkpoint inhibitor-related TTP may require distinct management approaches and prognostic considerations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/trf.16117DOI Listing
January 2021

Educational Case: Babesiosis and Transfusion-Transmitted Infections.

Acad Pathol 2020 Jan-Dec;7:2374289520935591. Epub 2020 Jul 17.

Department of Pathology, NYU Winthrop Hospital, Mineola, NY, USA.

http://journals.sagepub.com/doi/10.1177/2374289517715040..
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/2374289520935591DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7370331PMC
July 2020

Validation of PLASMIC score: an academic medical center case series (2012-present).

Transfusion 2020 07 26;60(7):1536-1543. Epub 2020 Jun 26.

Department of Pathology and Laboratory Medicine, Center for Transfusion and Cellular Therapies, Emory University School of Medicine, Atlanta, Georgia, USA.

Background: The PLASMIC score is a rapid and inexpensive tool for predicting severe ADAMTS13 deficiency (activity <10%) in patients with suspected thrombotic thrombocytopenic purpura (TTP) by analyzing seven parameters (platelet count; combined hemolysis variable; absence of active neoplasia; absence of an organ or stem-cell transplant; mean corpuscular value; international normalized ratio; and serum creatinine). The purpose of this study was to validate the PLASMIC score at a large multi-institutional academic medical center.

Methods: An internal database of consultations to the transfusion medicine service, which oversees therapeutic apheresis at our institution, was reviewed to identify patients who were evaluated for and/or received plasma exchange for suspected TTP. These consultations covered the time period of January 2012 to February 2019. PLASMIC scoring criteria and ADAMTS13 assay results were abstracted from the electronic medical record, the PLASMIC score was calculated, and cases stratified into risk categories (low, intermediate, high risk) based on the score value.

Results: Of 58 patients identified, 46 met inclusion criteria, and 27 demonstrated ADAMTS13 activity <10%. Correlation of severe ADAMTS13 deficiency with risk-stratified groups resulted in 78% sensitivity, 63% specificity, 75% positive predictive value (PPV), and 67% negative predictive value (NPV).

Discussion: These findings paralleled those from validation studies performed at other institutions. They provided insufficient evidence to recommend routine use of the PLASMIC score to rule out TTP among patients at our hospitals. Nonetheless, these results reinforce the importance of early ADAMTS13 testing as a diagnostic triage tool for patients with suspected TTP.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/trf.15916DOI Listing
July 2020

Memoir of an Undeadhead-A Blood Transfusion Pathologist's Vampire Weekend Romance.

Authors:
Maureen J Miller

JAMA 2019 Nov;322(19):1846-1847

Center for Transfusion and Cellular Therapies, Department of Pathology & Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jama.2019.15183DOI Listing
November 2019

The making of a grans fan.

Transfusion 2019 10;59(10):3288-3289

Department of Pathology and Laboratory Medicine, Center for Transfusion and Cellular Therapies, Emory University School of Medicine, Atlanta, GA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/trf.15458DOI Listing
October 2019

A double spike causes double trouble.

Transfusion 2019 07;59(7):2191-2192

Department of Pathology and Laboratory Medicine, Center for Transfusion and Cellular Therapies, Emory University School of Medicine, Atlanta, Georgia.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/trf.15297DOI Listing
July 2019

Parathyromatosis with a papillary architecture.

Histopathology 2019 10 1;75(4):598-602. Epub 2019 Sep 1.

Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, NYU Langone Health, New York, NY, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/his.13928DOI Listing
October 2019

Challenges in preventing and treating hemolytic complications associated with red blood cell transfusion.

Transfus Clin Biol 2019 May 25;26(2):130-134. Epub 2019 Mar 25.

Center for Transfusion Medicine and Cellular Therapies, Department of Laboratory Medicine and Pathology, Emory University School of Medicine, 101, Woodruff Circle, 30322 Atlanta, GA, USA. Electronic address:

Red blood cell (RBC) transfusion support represents a critical component of sickle cell disease (SCD) management. However, as with any therapeutic intervention, RBC transfusion is not without risk. Repeat exposure to allogeneic RBCs can result in the development of RBC alloantibodies that can make it difficult to find compatible RBCs for future transfusions and can directly increase the risk of developing acute or delayed hemolytic transfusion reactions, which can be further complicated by hyperhemolysis. Several prophylactic and treatment strategies have been employed in an effort to reduce or prevent hemolytic transfusion reactions. However, conflicting data exist regarding the efficacy of many of these approaches. We will explore the challenges associated with predicting, preventing and treating different types of hemolytic transfusion reactions in patients with SCD in addition to describing future strategies that may aid in the management of the complex transfusion requirements of SCD patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.tracli.2019.03.002DOI Listing
May 2019
-->