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Article ; Online: Respiratory support in the emergency department a systematic review and meta-analysis.

O'Donnell, Jane / Pirret, Alison / Hoare, Karen / Fenn, Rebecca / McDonald, Elissa

2024

Abstract: Background: An estimated 20% of emergency department (ED) patients require respiratory support (RS). Evidence suggests that nasal high flow (NHF) reduces RS need.: Aims: This review compared NHF to conventional oxygen therapy (COT) or noninvasive ... ...

Abstract	Background: An estimated 20% of emergency department (ED) patients require respiratory support (RS). Evidence suggests that nasal high flow (NHF) reduces RS need. Aims: This review compared NHF to conventional oxygen therapy (COT) or noninvasive ventilation (NIV) in adult ED patients. Method: The systematic review (SR) and meta-analysis (MA) methods reflect the Cochrane Collaboration methodology. Six databases were searched for randomized controlled trials (RCTs) comparing NHF to COT or NIV use in the ED. Three summary estimates were reported: (1) need to escalate care, (2) mortality, and (3) adverse events (AEs). Results: This SR and MA included 18 RCTs (n = 1874 participants). Two of the five MA conclusions were statistically significant. Compared with COT, NHF reduced the risk of escalation by 45% (RR 0.55; 95% CI [0.33, 0.92], p = .02, NNT = 32); however, no statistically significant differences in risk of mortality (RR 1.02; 95% CI [0.68, 1.54]; p = .91) and AE (RR 0.98; 95% CI [0.61, 1.59]; p = .94) outcomes were found. Compared with NIV, NHF increased the risk of escalation by 60% (RR 1.60; 95% CI [1.10, 2.33]; p = .01); mortality risk was not statistically significant (RR 1.23, 95% CI [0.78, 1.95]; p = .37). Linking evidence to action: Evidence-based decision-making regarding RS in the ED is challenging. ED clinicians have at times had to rely on non-ED evidence to support their practice. Compared with COT, NHF was seen to be superior and reduced the risk of escalation. Conversely, for this same outcome, NIV was superior to NHF. However, substantial clinical heterogeneity was seen in the NIV delivered. Research considering NHF versus NIV is needed. COVID-19 has exposed the research gaps and slowed the progress of ED research.
Language	English
Publishing date	2024-03-22
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2401967-7
ISSN	1741-6787 ; 1545-102X
ISSN (online)	1741-6787
ISSN	1545-102X
DOI	10.1111/wvn.12718
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Article ; Online: "It's Time to Do It, to Make It a Major Part of Medicine": Faculty Experience With a Shift Toward an Antioppressive Medical School Curriculum.

McDonald, Jordan A / Rincón, Alejandra / Daniel, Rosny / O'Sullivan, Patricia S / Hauer, Karen E

Academic medicine : journal of the Association of American Medical Colleges

2023 Volume 99, Issue 5, Page(s) 558–566

Abstract: Purpose: Health inequities compel medical educators to transform curricula to prepare physicians to improve the health of diverse populations. This mandate requires curricular focus on antioppression, which is a change for faculty who learned and taught ...

Abstract	Purpose: Health inequities compel medical educators to transform curricula to prepare physicians to improve the health of diverse populations. This mandate requires curricular focus on antioppression, which is a change for faculty who learned and taught under a different paradigm. This study used the Concerns-Based Adoption Model (CBAM) to explore faculty perceptions of and experiences with a shift to a curriculum that prioritizes antioppressive content and process. Method: In this qualitative study, authors interviewed faculty course directors and teachers at the University of California, San Francisco School of Medicine from March 2021 to January 2022. Questions addressed faculty experience and understanding regarding the curriculum shift toward antioppression, perceptions of facilitators and barriers to change, and their interactions with colleagues and learners about this change. Using the CBAM components as sensitizing concepts, the authors conducted thematic analysis. Results: Sixteen faculty participated. Their perceptions of their experience with the first year of an antioppression curriculum initiative were characterized by 3 broad themes: (1) impetus for change, (2) personal experience with antioppressive curricular topics, and (3) strategies necessary to accomplish the change. Faculty described 3 driving forces for the shift toward antioppressive curricula: moral imperative, response to national and local events, and evolving culture of medicine. Despite broad alignment with the change, faculty expressed uncertainties on 3 subthemes: uncertainty about what is an antioppressive curriculum, the scientific perspective, and fear. Faculty also reflected on primary facilitators and barriers to accomplishing the change. Conclusions: The shift to an antioppressive curriculum compels faculty to increase their knowledge and skills and adopt a critical, self-reflective lens on the interplay of medicine and oppression. This study's findings can inform faculty development efforts and highlight curricular leadership and resources needed to support faculty through this type of curricular change.
MeSH term(s)	Curriculum ; Humans ; Faculty, Medical/psychology ; Schools, Medical/organization & administration ; Qualitative Research ; San Francisco ; Male ; Female
Language	English
Publishing date	2023-12-28
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	96192-9
ISSN	1938-808X ; 1040-2446
ISSN (online)	1938-808X
ISSN	1040-2446
DOI	10.1097/ACM.0000000000005616
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Article ; Online: Technoeconomic Modeling and Simulation for Plant-Based Manufacturing of Recombinant Proteins.

McNulty, Matthew J / Nandi, Somen / McDonald, Karen A

Methods in molecular biology (Clifton, N.J.)

2022 Volume 2480, Page(s) 159–189

Abstract: Technoeconomic modeling and simulation is a critical step in defining a manufacturing process for evaluation of commercial viability and to focus experimental process research and development efforts. Technoeconomic analysis (TEA) is increasingly ... ...

Abstract	Technoeconomic modeling and simulation is a critical step in defining a manufacturing process for evaluation of commercial viability and to focus experimental process research and development efforts. Technoeconomic analysis (TEA) is increasingly demanded alongside scientific innovation by both public and private funding agencies to maximize efficiency of resource allocation. It is particularly important for plant-based manufacturing, and other nontraditional recombinant protein production platforms, to explicitly demonstrate the manufacturing potential and to identify critical technical and economic challenges through robust technoeconomic analysis. In addition, in silico process modeling and TEA of scaled biomanufacturing facilities allows rapid evaluation of the impacts of process and economic changes on capital expenditures (CAPEX, also sometimes referred to as total capital investment), operational expenditures (OPEX, also known as total manufacturing costs or total production costs), cost of goods sold (COGS, also known as unit production costs), and profitability metrics such as net present value (NPV) and discounted cash flow rate of return (DCROR, also known as internal rate of return or IRR). These models can also be used to assess environmental, health, and safety impact of a designed biomanufacturing facility to evaluate its sustainability and environmental-friendliness. Here we describe a general method for performing technoeconomic modeling and simulation for and environmental assessment of plant-based manufacturing of recombinant proteins.
MeSH term(s)	Computer Simulation ; Plants ; Recombinant Proteins/genetics
Chemical Substances	Recombinant Proteins
Language	English
Publishing date	2022-05-26
Publishing country	United States
Document type	Journal Article
ISSN	1940-6029
ISSN (online)	1940-6029
DOI	10.1007/978-1-0716-2241-4_11
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Article ; Online: Respiratory support of adults in the emergency department: A protocol for a prospective, observational, multicenter point prevalence study.

O'Donnell, Jane / Pirret, Alison / Hoare, Karen / McDonald, Elissa

Health science reports

2022 Volume 6, Issue 1, Page(s) e966

Abstract: Background and aims: Providing respiratory support (RS) to patients may improve their oxygenation and ventilation, reducing the work of breathing. Emergency department (ED) patients often need RS; COVID-19 has heightened this need. Patients receiving RS ...

Abstract	Background and aims: Providing respiratory support (RS) to patients may improve their oxygenation and ventilation, reducing the work of breathing. Emergency department (ED) patients often need RS; COVID-19 has heightened this need. Patients receiving RS may need escalation of their treatment; hence, studies considering the prevalence of escalation are warranted. Method: This is a protocol for a prospective, observational, multicenter point prevalence study (PPS). Researchers will collect data over 2 days. All participants are adult ED patients needing RS. The setting is four EDs in New Zealand. The primary research question asks, "Which patients receiving RS require escalation of therapy in the ED?" For example, transitioning from conventional oxygen therapy (COT) to intubation is deemed an escalation of therapy. A sample size of 80 participants is required to resolve the primary research question. Secondary research questions: (1) Which patients receive nasal high flow (NHF) in the ED? (2) How is NHF therapy delivered in the ED? (3) What are the effects of NHF therapy on physiological and patient-centered outcomes? Research Electronic Data Capture (REDCap) will be used for data organization. Data will be imported for analysis from REDCap to IBM SPSS software (Statistics for Windows, Version 27.0). Data reporting on the primary outcome shall be considered by analysis of variance, regression modeling, and determination of two treatment effects: Odds Ratio and Number Needed to Treat. Statistical significance for inferential statistics shall use a two-sided Conclusion: This novel PPS may reduce the evidence and clinical practice gap on RS delivery and ED patient outcomes, as evidenced by the emergence of COVID-19.
Language	English
Publishing date	2022-11-30
Publishing country	United States
Document type	Journal Article
ISSN	2398-8835
ISSN (online)	2398-8835
DOI	10.1002/hsr2.966
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Article: A method to simplify bioreactor processing for recombinant protein production in rice cell suspension cultures.

Macharoen, Kantharakorn / McDonald, Karen A / Nandi, Somen

MethodsX

2020 Volume 7, Page(s) 101139

Abstract: Transgenic plant cell suspension culture is a promising platform for recombinant protein production. Rice cell suspension culture is one of the systems that has been developed due to its unique metabolically-regulated promoter, rice alpha-amylase 3D ( ...

Abstract	Transgenic plant cell suspension culture is a promising platform for recombinant protein production. Rice cell suspension culture is one of the systems that has been developed due to its unique metabolically-regulated promoter, rice alpha-amylase 3D (
Language	English
Publishing date	2020-11-12
Publishing country	Netherlands
Document type	Journal Article
ISSN	2215-0161
ISSN	2215-0161
DOI	10.1016/j.mex.2020.101139
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Article: From Farm to Finger Prick-A Perspective on How Plants Can Help in the Fight Against COVID-19.

McDonald, Karen A / Holtz, R Barry

Frontiers in bioengineering and biotechnology

2020 Volume 8, Page(s) 782

Abstract: As a consequence of the COVID-19 pandemic crisis, farmers across the country are plowing under their fields and laying off workers. Plant biomass has been shown by the DARPA "Blue Angel" project in 2010 to be an efficient way to rapidly make vaccines and ...

Abstract	As a consequence of the COVID-19 pandemic crisis, farmers across the country are plowing under their fields and laying off workers. Plant biomass has been shown by the DARPA "Blue Angel" project in 2010 to be an efficient way to rapidly make vaccines and diagnostics. This technology could pivot some areas of agriculture toward biomedical products to aid in the COVID-19 pandemic response.
Keywords	covid19
Language	English
Publishing date	2020-07-03
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2719493-0
ISSN	2296-4185
ISSN	2296-4185
DOI	10.3389/fbioe.2020.00782
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Article ; Online: Factors Affecting Referral and Patient Access to Heart Function Clinics in Ontario: A Qualitative Study of Stakeholders.

Mamataz, Taslima / Fowokan, Adeleke / Hajaj, Ahmad Mohammad / Asghar, Areeba / Abrahamyan, Lusine / McDonald, Michael / Harkness, Karen / Grace, Sherry L

CJC open

2023 Volume 5, Issue 6, Page(s) 421–428

Abstract: Background: Though heart failure patients benefit from multidisciplinary care in heart function clinics (HFCs), utilization is suboptimal and inequitable. This study investigated factors influencing referral and patient access to HFCs from multiple ... ...

Abstract	Background: Though heart failure patients benefit from multidisciplinary care in heart function clinics (HFCs), utilization is suboptimal and inequitable. This study investigated factors influencing referral and patient access to HFCs from multiple stakeholders' perspectives, namely policy-makers (PM), providers at HFCs and patients. Methods: In this qualitative study, semi-structured interviews with a purposive sample of Ontario stakeholders were conducted between February-June 2020 and July-December 2022 (paused due to pandemic) via Teams. Interview transcripts were concurrently analyzed using systematic text condensation with Nvivo. Two authors coded individually, with disagreements discussed with senior author. Results: Interviews with 7 HFCs (6 physicians, 1 nurse), 6 PM and 4 patients were completed before saturation; 5 themes emerged. First, with regard to health system organization, stakeholders reported gaps related to continuity of care, limited capacity and insufficient funding. Second, with regard to referral appropriateness and timeliness, sub-themes related to unclear referral criteria, varying clinic scope, and delays in triage, testing and time-to-visit. The third theme related to clinic characteristics, raised issues of varying clinic services and composition of healthcare professions/expertise. The fourth theme regarding patient factors related to comorbidity/frailty, socioeconomic status, barriers due to location (parking, traffic) and affinity to specific providers. The final theme related to the COVID-19 pandemic concerned increased referral volumes, loss to follow-up care, transition to online delivery modalities and patient refusal of in-person visits. Many facilitators to improve HFC referral and access were raised. Conclusions: Resources must be provided, and stakeholders brought together to standardize and integrate the HF care continuum.
Language	English
Publishing date	2023-03-09
Publishing country	United States
Document type	Journal Article
ISSN	2589-790X
ISSN (online)	2589-790X
DOI	10.1016/j.cjco.2023.03.002
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Article ; Online: Applications of Plant-Made Fibroblast Growth Factor for Human Pluripotent Stem Cells.

Jia, Junjing / Wilson, Whitney / Karmaker, Anindya / Nishimura, Asuka / Otsuka, Hayuma / Ohara, Kazuaki / Okawa, Hiroshi / McDonald, Karen / Nandi, Somen / Albeck, John G / Rodriguez, Raymond / Zhou, Ping / Nolta, Jan A

Stem cells and development

2024 Volume 33, Issue 3-4, Page(s) 57–66

Abstract: Human embryonic stem cells (hESCs) and induced pluripotent stem cells (hiPSCs) hold great potential in regenerative medicine. These cells can be expanded indefinitely in theory and are able to differentiate into different types of cells for cell ... ...

Abstract	Human embryonic stem cells (hESCs) and induced pluripotent stem cells (hiPSCs) hold great potential in regenerative medicine. These cells can be expanded indefinitely in theory and are able to differentiate into different types of cells for cell therapies, drug screening, and basic biology studies. The reliable and effective propagation of hESCs and hiPSCs is important for their downstream applications. Basic fibroblast growth factor (bFGF) is critical to hESCs and hiPSCs for maintaining their pluripotency. Plant-produced growth factors are safe to use without potential contamination of infectious viruses and are less expensive to produce. In this study, we used rice cell-made basic fibroblast growth factor (RbFGF) to propagate hESCs and hiPSCs for at least eight passages. Both hESCs and hiPSCs cultured with RbFGF not only maintained the morphology but also the specific expression (OCT4, SSEA4, SOX2, and TRA-1-60) of PSCs, similar to those cultured with the commercial
MeSH term(s)	Humans ; Fibroblast Growth Factor 2/pharmacology ; Pluripotent Stem Cells ; Fibroblasts ; Cell Culture Techniques ; Induced Pluripotent Stem Cells ; Cell Differentiation
Chemical Substances	Fibroblast Growth Factor 2 (103107-01-3)
Language	English
Publishing date	2024-01-24
Publishing country	United States
Document type	Journal Article
ZDB-ID	2142214-X
ISSN	1557-8534 ; 1547-3287
ISSN (online)	1557-8534
ISSN	1547-3287
DOI	10.1089/scd.2023.0135
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Article: Plant-based production and characterization of a promising Fc-fusion protein against microgravity-induced bone density loss.

Xiong, Yongao / Hirano, Hiroto / Lane, Nancy E / Nandi, Somen / McDonald, Karen A

Frontiers in bioengineering and biotechnology

2022 Volume 10, Page(s) 962292

Abstract: Microgravity-induced bone loss is a main obstacle for long term space missions as it is difficult to maintain bone mass when loading stimuli is reduced. With a typical bone mineral density loss of 1.5% per month of microgravity exposure, the chances for ... ...

Abstract	Microgravity-induced bone loss is a main obstacle for long term space missions as it is difficult to maintain bone mass when loading stimuli is reduced. With a typical bone mineral density loss of 1.5% per month of microgravity exposure, the chances for osteoporosis and fractures may endanger astronauts' health. Parathyroid Hormone or PTH (1-34) is an FDA approved treatment for osteoporosis, and may reverse microgravity-induced bone loss. However, PTH proteins requires refrigeration, daily subcutaneous injection, and have a short shelf-life, limiting its use in a resource-limited environment, like space. In this study, PTH was produced in an Fc-fusion form via transient expression in plants, to improve the circulatory half-life which reduces dosing frequency and to simplify purification if needed. Plant-based expression is well-suited for space medicine application given its low resource consumption and short expression timeline. The PTH-Fc accumulation profile in plant was established with a peak expression on day 5 post infiltration of 373 ± 59 mg/kg leaf fresh weight. Once the PTH-Fc was purified, the amino acid sequence and the binding affinity to its target, PTH 1 receptor (PTH1R), was determined utilizing biolayer interferometry (BLI). The binding affinity between PTH-Fc and PTH1R was 2.30 × 10
Language	English
Publishing date	2022-09-12
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2719493-0
ISSN	2296-4185
ISSN	2296-4185
DOI	10.3389/fbioe.2022.962292
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Article ; Online: Analysis of Variability of Functionals of Recombinant Protein Production Trajectories Based on Limited Data.

Liao, Shuting / Macharoen, Kantharakorn / McDonald, Karen A / Nandi, Somen / Paul, Debashis

International journal of molecular sciences

2022 Volume 23, Issue 14

Abstract: Making statistical inference on quantities defining various characteristics of a temporally measured biochemical process and analyzing its variability across different experimental conditions is a core challenge in various branches of science. This ... ...

Abstract	Making statistical inference on quantities defining various characteristics of a temporally measured biochemical process and analyzing its variability across different experimental conditions is a core challenge in various branches of science. This problem is particularly difficult when the amount of data that can be collected is limited in terms of both the number of replicates and the number of time points per process trajectory. We propose a method for analyzing the variability of smooth functionals of the growth or production trajectories associated with such processes across different experimental conditions. Our modeling approach is based on a spline representation of the mean trajectories. We also develop a bootstrap-based inference procedure for the parameters while accounting for possible multiple comparisons. This methodology is applied to study two types of quantities-the "time to harvest" and "maximal productivity"-in the context of an experiment on the production of recombinant proteins. We complement the findings with extensive numerical experiments comparing the effectiveness of different types of bootstrap procedures for various tests of hypotheses. These numerical experiments convincingly demonstrate that the proposed method yields reliable inference on complex characteristics of the processes even in a data-limited environment where more traditional methods for statistical inference are typically not reliable.
MeSH term(s)	Recombinant Proteins/genetics ; Research Design
Chemical Substances	Recombinant Proteins
Language	English
Publishing date	2022-07-10
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms23147628
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