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Article ; Online: Assessing the Impact of Indiana Public Law 194 on Curbing the Concurrent Opioid Prescribing for Indiana Medicaid Enrollees

Carolina Vivas-Valencia / Nicole Adams / Paul Griffin / Nan Kong

Substance Abuse: Research and Treatment, Vol

2023 Volume 17

Abstract: Background: Several US states have introduced legislation to support the legitimate medical use of opioids while limiting misuse and diversion. One concern which has been addressed through legislation is preventing individuals from seeking opioid ... ...

Abstract	Background: Several US states have introduced legislation to support the legitimate medical use of opioids while limiting misuse and diversion. One concern which has been addressed through legislation is preventing individuals from seeking opioid prescriptions concurrently from multiple providers. However, the impact of this legislation on the incidence of patients receiving concurrent prescriptions remains relatively unexplored. This study examines this phenomenon based on claims data from Medicaid enrollees and the enactment of legislation in Indiana. Methods: Indiana Medicaid claims data over the period of January 2014 to December 2019 were used to determine the changes in the percentage of individuals receiving opioid prescriptions from multiple providers within a 30-day period, that is, concurrent opioid prescription (COP) individuals. Indiana Medicaid enrollees with a diagnosis of opioid use disorder (OUD) receiving opioid prescriptions, that is, the OUD-group, were identified and separated from the enrollees without a diagnosis but receiving opioid prescriptions, that is, the non-OUD group. The mean percentages of COP individuals (with or without an OUD diagnosis) within the subset of individuals that received opioid prescriptions were compared before and after the passage of Indiana Public Law 194. Results: There were 5336 who met the criteria of COP individuals, and 2050 of those were in the OUD-group. In either group, there was a significant difference in the change in percentages (slope) before and after Indiana Public Law 194 passed. In addition, there was a significant decrease in the mean percentage of COP individuals in the non-OUD group, while the difference was not significant in the OUD group. Conclusion: Our study suggests that Indiana Public Law 194 had a positive impact on curbing COP. This study is limited by the level of details available from claims data and suggests additional studies to evaluate prescription use and prescribing practices are warranted.
Keywords	Public aspects of medicine ; RA1-1270
Subject code	306
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	SAGE Publishing
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A multilevel logistic regression model for identifying the relevance of environmental risk factors on Gestational Diabetes Mellitus

Carolina Gonzalez-Canas / Toyya A. Pujol / Paul Griffin / Zachary Hass

Healthcare Analytics, Vol 3, Iss , Pp 100152- (2023)

2023

Abstract: The overarching goal of this research is to determine whether a woman’s risk of developing Gestational Diabetes Mellitus (GDM) is affected by environmental factors. The importance of environmental factors is an important question for public health policy ...

Abstract	The overarching goal of this research is to determine whether a woman’s risk of developing Gestational Diabetes Mellitus (GDM) is affected by environmental factors. The importance of environmental factors is an important question for public health policy across many diseases. Moreover, this paper focuses on highlighting several methodological challenges specific to the types of data commonly available to address this and related research questions.Medicaid health insurance claims information for Indiana was used to identify pregnant women from the study period, an outcome variable of GDM and demographic control variables. The Medicaid location data was available at the region level (three digit ZIP code) and corresponding regional environmental factors were rolled up to the ZIP-3 level from public county data. We fit a multilevel logistic regression model (MLM) to account for the correlation caused by the clustering of women within the same regions. Model results generally align with known risk factors and additionally a region’s racial makeup, number of birthing hospitals, food environment index, and amount of air pollution were found to be risk factors of GDM.This is, to the best of our knowledge, the first research that tests the association of multiple environmental factors with GDM. Despite the appropriateness of the model to the structure of the data, we see several challenges that must be overcome to realize the full utility of MLM using currently available data. (1) Some form of data triangulation is necessary to overcome false negatives in the outcome variable due to the use of health insurance claims. (2) A more favorable data use agreement is necessary to allow for more granular identification of patient location to avoid obscuring relationships between region level variables and GDM risk. (3) The impact of sample balancing on the inference of multilevel logistic model coefficients remains an open question.
Keywords	Multilevel logistic regression ; Under sampling ; Gestational Diabetes Mellitus ; Environmental factors ; Risk factor ; Medicaid claims ; Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	310
Language	English
Publishing date	2023-11-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A digital alkali spin maser

Stuart Ingleby / Paul Griffin / Terry Dyer / Marcin Mrozowski / Erling Riis

Scientific Reports, Vol 12, Iss 1, Pp 1-

2022 Volume 7

Abstract: Abstract Self-oscillating atomic magnetometers, in which the precession of atomic spins in a magnetic field is driven by resonant modulation, offer high sensitivity and dynamic range. Phase-coherent feedback from the detected signal to the applied ... ...

Abstract	Abstract Self-oscillating atomic magnetometers, in which the precession of atomic spins in a magnetic field is driven by resonant modulation, offer high sensitivity and dynamic range. Phase-coherent feedback from the detected signal to the applied modulation creates a resonant spin maser system, highly responsive to changes in the background magnetic field. Here we show a system in which the phase condition for resonant precession is met by digital signal processing integrated into the maser feedback loop. This system uses a modest chip-scale laser and mass-produced dual-pass caesium vapour cell and operates in a 50 $$\mu $$ μ T field, making it a suitable technology for portable measurements of the geophysical magnetic field. We demonstrate a Cramér-Rao lower bound-limited resolution of 50 fT at 1 s sampling cadence, and a sensor bandwidth of 10 kHz. This device also represents an important class of atomic system in which low-latency digital processing forms an integral part of a coherently-driven quantum system.
Keywords	Medicine ; R ; Science ; Q
Subject code	535
Language	English
Publishing date	2022-07-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Identifying and analyzing sepsis states

Chih-Hao Fang / Vikram Ravindra / Salma Akhter / Mohammad Adibuzzaman / Paul Griffin / Shankar Subramaniam / Ananth Grama

PLOS Digital Health, Vol 1, Iss 11, p e

A retrospective study on patients with sepsis in ICUs.

2022 Volume 0000130

Abstract: Sepsis accounts for more than 50% of hospital deaths, and the associated cost ranks the highest among hospital admissions in the US. Improved understanding of disease states, progression, severity, and clinical markers has the potential to significantly ... ...

Abstract	Sepsis accounts for more than 50% of hospital deaths, and the associated cost ranks the highest among hospital admissions in the US. Improved understanding of disease states, progression, severity, and clinical markers has the potential to significantly improve patient outcomes and reduce cost. We develop a computational framework that identifies disease states in sepsis and models disease progression using clinical variables and samples in the MIMIC-III database. We identify six distinct patient states in sepsis, each associated with different manifestations of organ dysfunction. We find that patients in different sepsis states are statistically significantly composed of distinct populations with disparate demographic and comorbidity profiles. Our progression model accurately characterizes the severity level of each pathological trajectory and identifies significant changes in clinical variables and treatment actions during sepsis state transitions. Collectively, our framework provides a holistic view of sepsis, and our findings provide the basis for future development of clinical trials, prevention, and therapeutic strategies for sepsis.
Keywords	Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	610
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Ultrastructural insight into SARS-CoV-2 entry and budding in human airway epithelium

Andreia L. Pinto / Ranjit K. Rai / Jonathan C. Brown / Paul Griffin / James R. Edgar / Anand Shah / Aran Singanayagam / Claire Hogg / Wendy S. Barclay / Clare E. Futter / Thomas Burgoyne

Nature Communications, Vol 13, Iss 1, Pp 1-

2022 Volume 14

Abstract: Human airway epithelium infected with SARS-CoV-2 shows viral entry occurring at the apical plasma membrane, excluding cilia. Here, the visualization of viral fusion at the cell surface and budding profiles within infected cells through high-resolution ... ...

Abstract	Human airway epithelium infected with SARS-CoV-2 shows viral entry occurring at the apical plasma membrane, excluding cilia. Here, the visualization of viral fusion at the cell surface and budding profiles within infected cells through high-resolution electron microscopy and tomography provide new insight into the infection process.
Keywords	Science ; Q
Language	English
Publishing date	2022-03-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients

Miko Yamada / Dennis M. Miller / Melinda Lowe / Casey Rowe / Dominic Wood / H. Peter Soyer / Kelly Byrnes-Blake / Julia Parrish-Novak / Laura Ishak / James M. Olson / Gordon Brandt / Paul Griffin / Lynda Spelman / Tarl W. Prow

Contemporary Clinical Trials Communications, Vol 23, Iss , Pp 100830- (2021)

2021

Abstract: BLZ-100 (tozuleristide) is an intraoperative fluorescent imaging agent that selectively detects malignant tissue and can be used in real time to guide tumor resection. The purpose of this study was to assess the safety, tolerability, and pharmacokinetics ...

Abstract	BLZ-100 (tozuleristide) is an intraoperative fluorescent imaging agent that selectively detects malignant tissue and can be used in real time to guide tumor resection. The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of BLZ-100 and to explore the pharmacodynamics of fluorescence imaging of skin tumors. In this first-in-human study, BLZ-100 was administered intravenously to 21 adult patients 2 days before excising known or suspected skin cancers. Doses were 1, 3, 6, 12, and 18 mg, with 3–6 patients/cohort. Fluorescence imaging was conducted before and up to 48 h after dosing. BLZ-100 was well tolerated. There were no serious adverse events, deaths, or discontinuations due to adverse events, and no maximum tolerated dose (MTD) was identified. Headache (n = 2) and nausea (n = 2) were the only BLZ-100 treatment-related adverse events reported for >1 patient. Median time to maximal serum concentration was <0.5 h. Exposure based on maximal serum concentrations increased in a greater than dose-proportional manner. For intermediate dose-levels (3–12 mg), 4 of 5 basal cell carcinomas and 4 of 4 melanomas were considered positive for BLZ-100 fluorescence. BLZ-100 was well tolerated at all dose levels tested and these results support further clinical testing of this imaging agent in surgical oncology settings. Clinicaltrials.gov: NCT02097875.
Keywords	Skin neoplasms ; Fluorescent dyes ; Cystine-knot miniproteins ; Medicine (General) ; R5-920
Subject code	616 ; 610
Language	English
Publishing date	2021-09-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Immune responses to a HSV-2 polynucleotide immunotherapy COR-1 in HSV-2 positive subjects

Janin Chandra / Wai-Ping Woo / Julie L Dutton / Yan Xu / Bo Li / Sally Kinrade / Julian Druce / Neil Finlayson / Paul Griffin / Kerry J Laing / David M Koelle / Ian H Frazer

PLoS ONE, Vol 14, Iss 12, p e

A randomized double blinded phase I/IIa trial.

2019 Volume 0226320

Abstract: Background Genital herpes simplex infection affects more than 500 million people worldwide. We have previously shown that COR-1, a therapeutic HSV-2 polynucleotide vaccine candidate, is safe and well tolerated in healthy subjects. Objective Here, we ... ...

Abstract	Background Genital herpes simplex infection affects more than 500 million people worldwide. We have previously shown that COR-1, a therapeutic HSV-2 polynucleotide vaccine candidate, is safe and well tolerated in healthy subjects. Objective Here, we present a single center double-blind placebo-controlled, randomized phase I/IIa trial of COR-1 in HSV-2 positive subjects in which we assessed safety and tolerability as primary endpoints, and immunogenicity and therapeutic efficacy as exploratory endpoints. Methods Forty-four HSV-2+ subjects confirmed by positive serology or pathology, and positive qPCR during baseline shedding, with a recurrent genital HSV-2 history of at least 12 months including three to nine reported lesions in 12 months prior to screening, aged 18 to 50 years females and males with given written informed consent, were randomized into two groups. Three immunizations at 4-week intervals and one booster immunization at 6 months, each of 1 mg COR-1 DNA or placebo, were administered intradermally as two injections of 500 μg each to either one forearm or both forearms. Results No serious adverse events, life-threatening events or deaths occurred throughout the study. As expected, HSV-2 infected subjects displayed gD2-specific antibody titers prior to immunization. COR-1 was associated with a reduction in viral shedding after booster administration compared with baseline. Conclusions This study confirms the previously demonstrated safety of COR-1 in humans and indicates a potential for use of COR-1 as a therapy to reduce viral shedding in HSV-2 infected subjects.
Keywords	Medicine ; R ; Science ; Q
Subject code	150
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A Revised Protocol for Culture of Airway Epithelial Cells as a Diagnostic Tool for Primary Ciliary Dyskinesia

Janice L. Coles / James Thompson / Katie L. Horton / Robert A. Hirst / Paul Griffin / Gwyneth M. Williams / Patricia Goggin / Regan Doherty / Peter M. Lackie / Amanda Harris / Woolf T. Walker / Christopher O’Callaghan / Claire Hogg / Jane S. Lucas / Cornelia Blume / Claire L. Jackson

Journal of Clinical Medicine, Vol 9, Iss 3753, p

2020 Volume 3753

Abstract: Air–liquid interface (ALI) culture of nasal epithelial cells is a valuable tool in the diagnosis and research of primary ciliary dyskinesia (PCD). Ex vivo samples often display secondary dyskinesia from cell damage during sampling, infection or ... ...

Abstract	Air–liquid interface (ALI) culture of nasal epithelial cells is a valuable tool in the diagnosis and research of primary ciliary dyskinesia (PCD). Ex vivo samples often display secondary dyskinesia from cell damage during sampling, infection or inflammation confounding PCD diagnostic results. ALI culture enables regeneration of healthy cilia facilitating differentiation of primary from secondary ciliary dyskinesia. We describe a revised ALI culture method adopted from April 2018 across three collaborating PCD diagnostic sites, including current University Hospital Southampton COVID-19 risk mitigation measures, and present results. Two hundred and forty nasal epithelial cell samples were seeded for ALI culture and 199 (82.9%) were ciliated. Fifty-four of 83 (63.9%) ex vivo samples which were originally equivocal or insufficient provided diagnostic information following in vitro culture. Surplus basal epithelial cells from 181 nasal brushing samples were frozen in liquid nitrogen; 39 samples were ALI-cultured after cryostorage and all ciliated. The ciliary beat patterns of ex vivo samples (by high-speed video microscopy) were recapitulated, scanning electron microscopy demonstrated excellent ciliation, and cilia could be immuno-fluorescently labelled (anti-alpha-tubulin and anti-RSPH4a) in representative cases that were ALI-cultured after cryostorage. In summary, our ALI culture protocol provides high ciliation rates across three centres, minimising patient recall for repeat brushing biopsies and improving diagnostic certainty. Cryostorage of surplus diagnostic samples was successful, facilitating PCD research.
Keywords	PCD ; ALI culture ; bio-resource ; primary nasal epithelium ; diagnostics ; Medicine ; R
Subject code	610
Language	English
Publishing date	2020-11-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Evaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial.

Silvana Sekuloski / Michael R Batzloff / Paul Griffin / William Parsonage / Suzanne Elliott / Jon Hartas / Peter O'Rourke / Louise Marquart / Manisha Pandey / Fran A Rubin / Jonathan Carapetis / James McCarthy / Michael F Good

PLoS ONE, Vol 13, Iss 7, p e

2018 Volume 0198658

Abstract: BACKGROUND:Group A streptococcus (GAS) is a serious human pathogen that affects people of different ages and socio-economic levels. Although vaccination is potentially one of the most effective methods to control GAS infection and its sequelae, few ... ...

Abstract	BACKGROUND:Group A streptococcus (GAS) is a serious human pathogen that affects people of different ages and socio-economic levels. Although vaccination is potentially one of the most effective methods to control GAS infection and its sequelae, few prototype vaccines have been investigated in humans. In this study, we report the safety and immunogenicity of a novel acetylated peptide-protein conjugate vaccine candidate MJ8VAX (J8-DT), when delivered intramuscularly to healthy adults. METHODS:A randomized, double-blinded, controlled Phase I clinical trial was conducted in 10 healthy adult participants. Participants were randomized 4:1 to receive the vaccine candidate (N = 8) or placebo (N = 2). A single dose of the vaccine candidate (MJ8VAX), contained 50 μg of peptide conjugate (J8-DT) adsorbed onto aluminium hydroxide and re-suspended in PBS in a total volume of 0.5 mL. Safety of the vaccine candidate was assessed by monitoring local and systemic adverse reactions following intramuscular administration. The immunogenicity of the vaccine was assessed by measuring the levels of peptide (anti-J8) and toxoid carrier (anti-DT)-specific antibodies in serum samples. RESULTS:No serious adverse events were reported over 12 months of study. A total of 13 adverse events (AEs) were recorded, two of which were assessed to be associated with the vaccine. Both were mild in severity. No local reactogenicity was recorded in any of the participants. MJ8VAX was shown to be immunogenic, with increase in vaccine-specific antibodies in the participants who received the vaccine. The maximum level of vaccine-specific antibodies was detected at 28 days post immunization. The level of these antibodies decreased with time during follow-up. Participants who received the vaccine also had a corresponding increase in anti-DT serum antibodies. CONCLUSIONS:Intramuscular administration of MJ8VAX was demonstrated to be safe and immunogenic. The presence of DT in the vaccine formulation resulted in a boost in the level of anti-DT antibodies. ...
Keywords	Medicine ; R ; Science ; Q
Subject code	630
Language	English
Publishing date	2018-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine

Rebecca Webster / Silvana Sekuloski / Anand Odedra / Stephen Woolley / Helen Jennings / Fiona Amante / Katharine R. Trenholme / Julie Healer / Alan F. Cowman / Emily M. Eriksson / Priyanka Sathe / Jocelyn Penington / Adam J. Blanch / Matthew W. A. Dixon / Leann Tilley / Michael F. Duffy / Alister Craig / Janet Storm / Jo-Anne Chan /

Krystal Evans / Anthony T. Papenfuss / Louis Schofield / Paul Griffin / Bridget E. Barber / Dean Andrew / Michelle J. Boyle / Fabian de Labastida Rivera / Christian Engwerda / James S. McCarthy

BMC Medicine, Vol 19, Iss 1, Pp 1-

2021 Volume 13

Abstract: Abstract Background There is a clear need for novel approaches to malaria vaccine development. We aimed to develop a genetically attenuated blood-stage vaccine and test its safety, infectivity, and immunogenicity in healthy volunteers. Our approach was ... ...

Abstract	Abstract Background There is a clear need for novel approaches to malaria vaccine development. We aimed to develop a genetically attenuated blood-stage vaccine and test its safety, infectivity, and immunogenicity in healthy volunteers. Our approach was to target the gene encoding the knob-associated histidine-rich protein (KAHRP), which is responsible for the assembly of knob structures at the infected erythrocyte surface. Knobs are required for correct display of the polymorphic adhesion ligand P. falciparum erythrocyte membrane protein 1 (PfEMP1), a key virulence determinant encoded by a repertoire of var genes. Methods The gene encoding KAHRP was deleted from P. falciparum 3D7 and a master cell bank was produced in accordance with Good Manufacturing Practice. Eight malaria naïve males were intravenously inoculated (day 0) with 1800 (2 subjects), 1.8 × 105 (2 subjects), or 3 × 106 viable parasites (4 subjects). Parasitemia was measured using qPCR; immunogenicity was determined using standard assays. Parasites were rescued into culture for in vitro analyses (genome sequencing, cytoadhesion assays, scanning electron microscopy, var gene expression). Results None of the subjects who were administered with 1800 or 1.8 × 105 parasites developed parasitemia; 3/4 subjects administered 3× 106 parasites developed significant parasitemia, first detected on days 13, 18, and 22. One of these three subjects developed symptoms of malaria simultaneously with influenza B (day 17; 14,022 parasites/mL); one subject developed mild symptoms on day 28 (19,956 parasites/mL); and one subject remained asymptomatic up to day 35 (5046 parasites/mL). Parasitemia rapidly cleared with artemether/lumefantrine. Parasitemia induced a parasite-specific antibody and cell-mediated immune response. Parasites cultured ex vivo exhibited genotypic and phenotypic properties similar to inoculated parasites, although the var gene expression profile changed during growth in vivo. Conclusions This study represents the first clinical investigation of a ...
Keywords	Malaria ; Vaccine ; Plasmodium falciparum ; Genetically attenuated ; KAHRP ; PfEMP1 ; Medicine ; R
Subject code	572
Language	English
Publishing date	2021-11-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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