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Article ; Online: Estimating the cost of Rh testing and prophylaxis in early pregnancy: A time-driven activity-based costing study.

Gilmore, Emma V / Russell, Louise B / Harvie, Heidi S / Schreiber, Courtney A

2024 , Page(s) 110468

Abstract: Objective: To estimate the cost of Rh testing and prophylaxis for first-trimester vaginal bleeding in the ambulatory setting.: Study design: We used time-driven, activity-based costing to analyze tasks associated with Rh testing and prophylaxis of ... ...

Abstract	Objective: To estimate the cost of Rh testing and prophylaxis for first-trimester vaginal bleeding in the ambulatory setting. Study design: We used time-driven, activity-based costing to analyze tasks associated with Rh testing and prophylaxis of first-trimester vaginal bleeding at one hospital-based outpatient and two independent reproductive health clinics. At each site, we observed 10 patients undergoing Rh-typing and two patients undergoing Rh prophylaxis. We computed the costs of blood Rh-typing by both fingerstick and phlebotomy, cost of locating previous blood type in the electronic health record (available for 69.8% of hospital-based patients), and costs associated with Rh immune globulin prophylaxis. All costs are reported in 2021 US dollars. Results: The hospital-based clinic reviewed the electronic health record to confirm Rh-status (cost, $26.18 per patient) and performed a phlebotomy, at $47.11 per patient, if none was recorded. The independent clinics typed blood by fingerstick, at a per-patient cost of $4.07. Rh-immune globulin administration costs, including the medication, were similar across facilities, at a mean of $145.66 per patient. Projected yearly costs for testing and prophylaxis were $55,831 for the hospital-based clinic, which was the lowest-volume site, $47,941 for Clinic A, which saw 150 patients/month, and $185,654 for Clinic B, which saw 600 patients/month. Conclusions: Rh testing and prophylaxis for first-trimester vaginal bleeding generates considerable costs for outpatient facilities, even for Rh-positive patients with a prior blood type on record. Implications: Rh testing and prophylaxis for first-trimester bleeding generate considerable costs even for Rh-positive patients and those with a previously known blood type. These findings highlight the need to reconsider this practice, which is no longer supported by evidence and already safely waived in multiple medical settings in the United States and around the world.
Language	English
Publishing date	2024-04-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	80106-9
ISSN	1879-0518 ; 0010-7824
ISSN (online)	1879-0518
ISSN	0010-7824
DOI	10.1016/j.contraception.2024.110468
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Article ; Online: Medical management of early pregnancy loss is cost-effective compared with office uterine aspiration.

Nagendra, Divyah / Gutman, Sarah M / Koelper, Nathanael C / Loza-Avalos, Sandra E / Sonalkar, Sarita / Schreiber, Courtney A / Harvie, Heidi S

American journal of obstetrics and gynecology

2022 Volume 227, Issue 5, Page(s) 737.e1–737.e11

Abstract: Background: Early pregnancy loss, also referred to as miscarriage, is common, affecting approximately 1 million people in the United States annually. Early pregnancy loss can be treated with expectant management, medications, or surgical procedures- ... ...

Abstract	Background: Early pregnancy loss, also referred to as miscarriage, is common, affecting approximately 1 million people in the United States annually. Early pregnancy loss can be treated with expectant management, medications, or surgical procedures-strategies that differ in patient experience, effectiveness, and cost. One of the medications used for early pregnancy loss treatment, mifepristone, is uniquely regulated by the Food and Drug Administration. Objective: This study aimed to compare the cost-effectiveness from the healthcare sector perspective of medical management of early pregnancy loss, using the standard of care medication regimen of mifepristone and misoprostol, with that of office uterine aspiration. Study design: We developed a decision analytical model to compare the cost-effectiveness of early pregnancy loss treatment with medical management with that of office uterine aspiration. Data on medical management came from the Pregnancy Failure Regimens randomized clinical trial, and data on uterine aspiration came from the published literature. The analysis was from the healthcare sector perspective with a 30-day time horizon. Costs were in 2018 US dollars. Effectiveness was measured in quality-adjust life-years gained and the rate of complete gestational sac expulsion with no additional interventions. Our primary outcome was the incremental cost per quality-adjust life-year gained. Sensitivity analysis was performed to identify the key uncertainties. Results: Mean per-person costs were higher for uterine aspiration than for medical management ($828 [95% confidence interval, $789-$868] vs $661 [95% confidence interval, $556-$766]; P=.004). Uterine aspiration more frequently led to complete gestational sac expulsion than medical management (97.3% vs 83.8%; P=.0001); however, estimated quality-adjust life-years were higher for medical management than for uterine aspiration (0.082 [95% confidence interval, 0.8148-0.08248] vs 0.079 [95% confidence interval, 0.0789-0.0791]; P<.0001). Medical management dominated uterine aspiration, with lower costs and higher confidence interval. The probability that medical management is cost-effective relative to uterine aspiration is 97.5% for all willingness-to-pay values of ≥$5600/quality-adjust life-year. Sensitivity analysis did not identify any thresholds that would substantially change outcomes. Conclusion: Although office-based uterine aspiration more often results in treatment completion without further intervention, medical management with mifepristone pretreatment costs less and yields similar quality-adjust life-years, making it an attractive alternative. Our findings provided evidence that increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care.
MeSH term(s)	Pregnancy ; Female ; Humans ; Abortion, Spontaneous/drug therapy ; Mifepristone/therapeutic use ; Cost-Benefit Analysis ; Misoprostol/therapeutic use ; Drug Therapy, Combination
Chemical Substances	Mifepristone (320T6RNW1F) ; Misoprostol (0E43V0BB57)
Language	English
Publishing date	2022-06-30
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80016-8
ISSN	1097-6868 ; 0002-9378
ISSN (online)	1097-6868
ISSN	0002-9378
DOI	10.1016/j.ajog.2022.06.054
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Article ; Online: Practical Use of Self-Adjusted Nitrous Oxide During Transrectal Prostate Biopsy: A Double-Blind Randomized Controlled Trial.

Escobar, Abigail J / Krishna, Suprita / Flowers, K Mikayla / Abello, Alejandro / Gershman, Boris / Wagner, Andrew A / Chang, Peter / Korets, Ruslan / Mistretta, Christopher J / Schreiber, Kristen L / Olumi, Aria F / Rayala, Heidi J

The Journal of urology

2023 Volume 211, Issue 2, Page(s) 214–222

Abstract: Purpose: Transrectal prostate biopsy is a common ambulatory procedure that can result in pain and anxiety for some men. Low-dose, adjustable nitrous oxide is increasingly being used to improve experience of care for patients undergoing painful ... ...

Abstract	Purpose: Transrectal prostate biopsy is a common ambulatory procedure that can result in pain and anxiety for some men. Low-dose, adjustable nitrous oxide is increasingly being used to improve experience of care for patients undergoing painful procedures. This study seeks to evaluate the efficacy and safety of low-dose (<45%) nitrous oxide, which has not been previously established for transrectal prostate biopsies. Materials and methods: A single-institution, prospective, double-blind, randomized, controlled trial was conducted on patients undergoing transrectal prostate biopsies. Patients were randomized to receive either self-adjusted nitrous oxide or oxygen, in addition to routine periprostatic bupivacaine block. Nitrous oxide at levels between 20% and 45% were adjusted to patients' desired effect. Patients completed a visual analog scale for anxiety, State Trait Anxiety Inventory, and a visual analog scale for pain immediately before and after biopsy. The blinded operating urologist evaluated ease of procedure. Periprocedural vitals and complications were assessed. Patients were allowed to drive home independently. Results: A total of 133 patients received either nitrous oxide (66) or oxygen (67). There was no statistically significant difference in the primary anxiety end point of State Trait Anxiety Inventory or the visual analog scale for anxiety scores between the nitrous oxide and oxygen groups. However, patients in the nitrous oxide group reported significantly lower visual analog scale for pain scores compared to the oxygen group ( Conclusions: Patient-adjusted nitrous oxide at levels of 20% to 45% is a safe adjunct during transrectal prostate biopsy. Although there was not an observed difference in the primary end point of anxiety, nitrous oxide was associated with lower patient-reported pain scores.
MeSH term(s)	Male ; Humans ; Prostate/pathology ; Nitrous Oxide/pharmacology ; Lidocaine ; Prospective Studies ; Prostatic Neoplasms/pathology ; Biopsy/adverse effects ; Pain/etiology ; Oxygen/pharmacology ; Double-Blind Method ; Anesthetics, Local
Chemical Substances	Nitrous Oxide (K50XQU1029) ; Lidocaine (98PI200987) ; Oxygen (S88TT14065) ; Anesthetics, Local
Language	English
Publishing date	2023-11-20
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	3176-8
ISSN	1527-3792 ; 0022-5347
ISSN (online)	1527-3792
ISSN	0022-5347
DOI	10.1097/JU.0000000000003789
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Article ; Online: Aberrant DNA Methylation, Expression, and Occurrence of Transcript Variants of the ABC Transporter

Zappe, Katja / Kopic, Antonio / Scheichel, Alexandra / Schier, Ann-Katrin / Schmidt, Lukas Emanuel / Borutzki, Yasmin / Miedl, Heidi / Schreiber, Martin / Mendrina, Theresa / Pirker, Christine / Pfeiler, Georg / Hacker, Stefan / Haslik, Werner / Pils, Dietmar / Bileck, Andrea / Gerner, Christopher / Meier-Menches, Samuel / Heffeter, Petra / Cichna-Markl, Margit

Cells

2023 Volume 12, Issue 11

Abstract: The ABC transporter ABCA7 has been found to be aberrantly expressed in a variety of cancer types, including breast cancer. We searched for specific epigenetic and genetic alterations and alternative splicing variants of ABCA7 in breast cancer and ... ...

Abstract	The ABC transporter ABCA7 has been found to be aberrantly expressed in a variety of cancer types, including breast cancer. We searched for specific epigenetic and genetic alterations and alternative splicing variants of ABCA7 in breast cancer and investigated whether these alterations are associated with ABCA7 expression. By analyzing tumor tissues from breast cancer patients, we found CpGs at the exon 5-intron 5 boundary aberrantly methylated in a molecular subtype-specific manner. The detection of altered DNA methylation in tumor-adjacent tissues suggests epigenetic field cancerization. In breast cancer cell lines, DNA methylation levels of CpGs in promoter-exon 1, intron 1, and at the exon 5-intron 5 boundary were not correlated with
MeSH term(s)	Humans ; Female ; Breast Neoplasms/pathology ; DNA Methylation/genetics ; ATP-Binding Cassette Transporters/genetics ; ATP-Binding Cassette Transporters/metabolism ; Alternative Splicing/genetics ; RNA, Messenger/genetics ; RNA, Messenger/metabolism
Chemical Substances	ATP-Binding Cassette Transporters ; RNA, Messenger ; ABCA7 protein, human
Language	English
Publishing date	2023-05-24
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2661518-6
ISSN	2073-4409 ; 2073-4409
ISSN (online)	2073-4409
ISSN	2073-4409
DOI	10.3390/cells12111462
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Article: Monocyte-derived inflammatory dendritic cells in the granuloma during mycobacterial infection.

Schreiber, Heidi A / Sandor, Matyas

Advances in experimental medicine and biology

2012 Volume 946, Page(s) 277–293

Abstract: The monocyte-derived, inflammatory dendritic cell subset plays an important role during immune responses against infections. This review will focus on the complex, changing role of this subset during mycobacterial infection. Studies demonstrate that in ... ...

Abstract	The monocyte-derived, inflammatory dendritic cell subset plays an important role during immune responses against infections. This review will focus on the complex, changing role of this subset during mycobacterial infection. Studies demonstrate that in addition to sustaining a systemic anti-mycobacterial response, the inflammatory dendritic cell subset present in Mycobacterium-induced granulomas also influences local immune regulation within the granuloma over the course of infection. This review will also survey the literature on how similar and different inflammatory dendritic cell subsets during other infections.
MeSH term(s)	Animals ; Dendritic Cells/immunology ; Granuloma/immunology ; Humans ; Inflammation/immunology ; Monocytes/immunology ; Mycobacterium/immunology ; Mycobacterium Infections/immunology
Language	English
Publishing date	2012
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2214-8019 ; 0065-2598
ISSN (online)	2214-8019
ISSN	0065-2598
DOI	10.1007/978-1-4614-0106-3_16
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Article ; Online: Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial.

Nagendra, Divyah / Koelper, Nathanael / Loza-Avalos, Sandra E / Sonalkar, Sarita / Chen, Melissa / Atrio, Jessica / Schreiber, Courtney A / Harvie, Heidi S

JAMA network open

2020 Volume 3, Issue 3, Page(s) e201594

Abstract: Importance: Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of ...

Abstract	Importance: Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of care, misoprostol alone. The cost of mifepristone may be a barrier to implementation of the regimen. Objective: To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States. Design, setting, and participants: This preplanned. prospective economic evaluation was performed concurrently with a randomized clinical trial in 3 US sites from May 1, 2014, through April 30, 2017. Participants included 300 women with anembryonic gestation or embryonic or fetal demise. Cost-effectiveness was computed from the health care sector and societal perspectives, with a 30-day time horizon. Data were analyzed from July 1, 2018, to July 3, 2019. Interventions: Mifepristone pretreatment plus misoprostol administration vs misoprostol alone. Main outcomes and measures: Costs in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy. Incremental cost-effectiveness ratios (ICERs) of mifepristone and misoprostol vs misoprostol alone were calculated, and cost-effectiveness acceptability curves were generated. Results: Among the 300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years), mean costs were similar for groups receiving mifepristone pretreatment and misoprostol alone from the health care sector perspective ($696.75 [95% CI, $591.88-$801.62] vs $690.88 [95% CI, $562.38-$819.38]; P = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41]; P = .32). The mifepristone pretreatment group had higher QALYs (0.0820 [95% CI, 0.0815-0.0825] vs 0.0806 [95% CI, 0.0800-0.0812]; P = .001) and a higher completion rate after first treatment (83.8% vs 67.1%; P < .001) than the group receiving misoprostol alone. From the health care sector perspective, mifepristone pretreatment was cost-effective relative to misoprostol alone with an ICER of $4225.43 (95% CI, -$195 053.30 to $367 625.10) per QALY gained. From the societal perspective, mifepristone pretreatment dominated misoprostol alone (95% CI, -$5 111 629 to $1 801 384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingness-to-pay of $150 000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively. Conclusions and relevance: This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone. Trial registration: ClinicalTrials.gov Identifier: NCT02012491.
MeSH term(s)	Abortifacient Agents, Steroidal/economics ; Abortifacient Agents, Steroidal/therapeutic use ; Abortion, Induced/economics ; Abortion, Induced/methods ; Abortion, Induced/statistics & numerical data ; Adult ; Cost-Benefit Analysis ; Embryo Loss/therapy ; Female ; Humans ; Mifepristone/economics ; Mifepristone/therapeutic use ; Misoprostol/economics ; Misoprostol/therapeutic use ; Pregnancy ; Prospective Studies
Chemical Substances	Abortifacient Agents, Steroidal ; Misoprostol (0E43V0BB57) ; Mifepristone (320T6RNW1F)
Language	English
Publishing date	2020-03-02
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2020.1594
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Article ; Online: Elevated Aromatase (CYP19A1) Expression Is Associated with a Poor Survival of Patients with Estrogen Receptor Positive Breast Cancer.

Friesenhengst, Andrea / Pribitzer-Winner, Tamara / Miedl, Heidi / Pröstling, Katharina / Schreiber, Martin

Hormones & cancer

2018 Volume 9, Issue 2, Page(s) 128–138

Abstract: Genetic variants in CYP19A1, the gene encoding aromatase, have been reported to be associated with circulating estrogen concentrations, a key risk factor for breast cancer. The mechanism underlying this association is still unclear; it has been suggested ...

Abstract	Genetic variants in CYP19A1, the gene encoding aromatase, have been reported to be associated with circulating estrogen concentrations, a key risk factor for breast cancer. The mechanism underlying this association is still unclear; it has been suggested that some of these variants may alter the expression and/or activity of aromatase. Here we analyzed the expression of intra-tumoral CYP19A1 messenger RNA (mRNA) and the genotypes of rs10046, a well-characterized single nucleotide polymorphism in CYP19A1, in 138 breast cancer patients and 15 breast cancer cell lines. The genotype TT was detected in 36 patients and six cell lines, genotype CT in 55 patients and five cell lines, and genotype CC in 28 patients and four cell lines. We found no evidence for a significant association of CYP19A1 levels with rs10046 genotypes, although expression tended to be higher in tumors and cell lines with the homozygous risk genotype TT. We also found no evidence for a significant association of rs10046 genotypes with breast cancer prognosis. In contrast, high CYP19A1 expression was highly significantly associated with a poor overall, disease-free, and metastasis-free survival in estrogen receptor-positive but not negative breast cancer patients. Moreover, CYP19A1 mRNA was significantly elevated in postmenopausal patients and in patients older than 50 years, and a trend towards a positive correlation with ER status and ESR1 mRNA expression was observed. These findings highlight the key role of aromatase in estrogen receptor-positive breast cancer biology.
MeSH term(s)	Age Factors ; Aromatase/genetics ; Aromatase/metabolism ; Austria/epidemiology ; Breast Neoplasms/epidemiology ; Breast Neoplasms/genetics ; Breast Neoplasms/mortality ; Cell Line, Tumor ; Estrogens/blood ; Female ; Genotype ; Humans ; Polymorphism, Single Nucleotide ; Postmenopause ; RNA, Messenger/analysis ; Receptors, Estrogen/metabolism ; Risk ; Survival Analysis
Chemical Substances	Estrogens ; RNA, Messenger ; Receptors, Estrogen ; Aromatase (EC 1.14.14.1) ; CYP19A1 protein, human (EC 1.14.14.1)
Language	English
Publishing date	2018-01-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2543318-0
ISSN	1868-8500 ; 1868-8497
ISSN (online)	1868-8500
ISSN	1868-8497
DOI	10.1007/s12672-017-0317-2
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Article: A novel chemical biology and computational approach to expedite the discovery of new-generation polymyxins against life-threatening

Jiang, Xukai / Patil, Nitin A / Azad, Mohammad A K / Wickremasinghe, Hasini / Yu, Heidi / Zhao, Jinxin / Zhang, Xinru / Li, Mengyao / Gong, Bin / Wan, Lin / Ma, Wendong / Thompson, Philip E / Yang, Kai / Yuan, Bing / Schreiber, Falk / Wang, Lushan / Velkov, Tony / Roberts, Kade D / Li, Jian

Chemical science

2021 Volume 12, Issue 36, Page(s) 12211–12220

Abstract: Multidrug-resistant Gram-negative bacteria represent a major medical challenge worldwide. New antibiotics are desperately required with 'old' polymyxins often being the only available therapeutic option. Here, we systematically investigated the structure- ...

Abstract	Multidrug-resistant Gram-negative bacteria represent a major medical challenge worldwide. New antibiotics are desperately required with 'old' polymyxins often being the only available therapeutic option. Here, we systematically investigated the structure-activity relationship (SAR) of polymyxins using a quantitative lipidomics-informed outer membrane (OM) model of
Language	English
Publishing date	2021-08-19
Publishing country	England
Document type	Journal Article
ZDB-ID	2559110-1
ISSN	2041-6539 ; 2041-6520
ISSN (online)	2041-6539
ISSN	2041-6520
DOI	10.1039/d1sc03460j
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Article ; Online: The role of dendritic cells in mycobacterium-induced granulomas.

Schreiber, Heidi A / Sandor, Matyas

Immunology letters

2010 Volume 130, Issue 1-2, Page(s) 26–31

Abstract: The presence of dendritic cells (DCs) in mycobacterium-containing granulomas, as well as in other granuloma-inducing diseases, is beginning to be appreciated. This review will summarize what is known about DCs with regards to the granuloma and discuss ... ...

Abstract	The presence of dendritic cells (DCs) in mycobacterium-containing granulomas, as well as in other granuloma-inducing diseases, is beginning to be appreciated. This review will summarize what is known about DCs with regards to the granuloma and discuss the potential roles DCs may be playing during mycobacterial infection. Potential functions may include mycobacterial dissemination from lesions or sampling of granuloma-containing mycobacterial antigens and migration to the draining lymph nodes to maintain continuous T cell priming. Additionally, the review will discuss the potential outcomes of DC-T cell cross-talk within the granuloma and whether it results in boosting the effector functions of newly arrived T cells or anergizing systemic T cells locally. Understanding the DCs complex and changing role during this critical stage may help explain how latency is achieved and maintained. Such knowledge might also lead to improved vaccination strategies.
MeSH term(s)	Animals ; Dendritic Cells/immunology ; Granuloma/etiology ; Granuloma/microbiology ; Granuloma/physiopathology ; Humans ; Mycobacterium ; Receptor Cross-Talk/immunology
Language	English
Publishing date	2010-01-04
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	445150-8
ISSN	1879-0542 ; 0165-2478
ISSN (online)	1879-0542
ISSN	0165-2478
DOI	10.1016/j.imlet.2009.12.009
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Article: Optimization of PDE3A Modulators for SLFN12-Dependent Cancer Cell Killing.

Lewis, Timothy A / de Waal, Luc / Wu, Xiaoyun / Youngsaye, Willmen / Wengner, Antje / Kopitz, Charlotte / Lange, Martin / Gradl, Stefan / Ellermann, Manuel / Lienau, Philip / Schreiber, Stuart L / Greulich, Heidi / Meyerson, Matthew

ACS medicinal chemistry letters

2019 Volume 10, Issue 11, Page(s) 1537–1542

Abstract: 6-(4-(Diethylamino)-3-nitrophenyl)-5-methyl-4,5-dihydropyridazin-3( ... ...

Abstract	6-(4-(Diethylamino)-3-nitrophenyl)-5-methyl-4,5-dihydropyridazin-3(2
Language	English
Publishing date	2019-10-18
Publishing country	United States
Document type	Journal Article
ISSN	1948-5875
ISSN	1948-5875
DOI	10.1021/acsmedchemlett.9b00360
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