Scientific Publications
Healthcare Resource Utilization of Patients with Short Bowel Syndrome Dependent on Parenteral Support: A Retrospective Claims Analysis
AUTHOR(S): Ali A1, Micic D2, Gallivan M1, Kulkarni A3, Henderson J4, Mitchell G4 1Trinity Life Sciences, Waltham, MA, USA, 2University of Chicago Medical Center, Gastroenterology, Hepatology, and Nutrition, Chicago, IL, USA, 3Trinity Life Sciences, Malden, MA, USA, 4VectivBio AG, Basel, Basel, Switzerland
OBJECTIVES: Short bowel syndrome with intestinal failure (SBS-IF) is a rare, chronic, debilitating malabsorptive condition often caused by massive resection of the…
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Scientific Publications
Implications of the Implementation of the Joint Committee Assessment on Launch Planning for Medical Technologies in Europe
Acosta Luis S1, O’Hara M2, Yeh M2
1Trinity Partners, LLC, London, UK, 2Trinity Life Sciences, Waltham, MA, USA
The EU-wide Joint Clinical Assessment (JCA) is set to be operational from January 2025. The Trinity team reviewed the available literature and summarized the JCA implications for medical device launch planning and evidence-generation requirements, including the central role that HEOR expertise across different geographies will…
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Scientific Publications
Health Equity Frameworks – Healthcare System Actions and Priorities
Gulaid A1, Goldman E2, Skaar J1, Dehipawala S3
1Trinity Life Sciences, New York, NY, USA, 2Trinity Life Sciences, Waltham, MA, USA, 3Trinity Life Sciences, Bellerose, NY, USA
Health equity has been defined as attainment of the highest level of health for all people, regardless of race, ethnicity, disability, and/or other factors affecting access to care and health outcomes in healthcare delivery. Health equity is becoming a priority for payers and hospitals…
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Scientific Publications
Autoimmune screening panel (ASP) is routinely ordered as a part of diagnostic work-up in people with suspected multiple sclerosis (MS). However, data on prevalence and significance of ASP seropositivity in MS is scarce.
Authors
D. Bandari, M. Adamson, M. Bowman, A. Gutierrez, A. Athavale, B. Oak, N. Hadker, F. Branco, C. Geremakis, J. B. Lewin, S. L. Shankar
Journal
ECTRIMS 2022
View publication…
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Scientific Publications
Cremophor EL (CrEL) is a solubilizer used in paclitaxel and is associated with side effects (i.e., hypersensitivity reactions, peripheral neuropathy). Current CrEL-containing therapies require long infusion times (2-4 hours) and pre-medication with steroids to manage these side-effects. However, the holistic burden of CrEL on patients is not well studied. This study aimed to characterize the burden associated with CrEL-paclitaxel treatment on patients with ovarian cancer, including clinical, safety, and quality of life (QoL) implications.
Authors
Diana Brixner, Anke-Peggy Holtorf, Ayesha…
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Scientific Publications
OBJECTIVES: Point of care rapid diagnostic tests (RDTs) have demonstrated accurate and timely diagnosis across decentralized settings, broadening patient access in remote locations and improving pathways to diagnosis. This study aimed to synthesize published and other literature on the clinical, societal, and economic value of RDTs for infectious disease across Asia, Africa, and Latin America.
METHODS: A systematic literature review (SLR) was conducted using PubMed and Embase for publications dated 2017 to 2021 in accordance with PRISMA guidelines using RDT and infectious…
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Scientific Publications
OBJECTIVES: The European Medicines Agency’s in-vitro diagnostics (IVD) regulation (IVD-R) will roll out over the next 5 years; under IVD-R, Notified Bodies (NBs) will be required to review a larger proportion of IVDs (estimated increase from 8% to 80%). Under IVD-R manufacturers will not only have to demonstrate safety and equivalence of their IVD, but also scientific validity and analytical/clinical performance. Thought papers have hypothesized IVD-R’s impact on development timelines and evidence requirements. Key concerns include delays in approval timelines due…
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Scientific Publications
OBJECTIVES: As COVID-19 severely restricted patients’ ability to visit care settings in-person, the use of telehealth was impacted; the immediate and enduring impact on telehealth utilization is an unanswered question. This study aimed to identify medical conditions typically treated using telehealth and quantify trends in telehealth utilization through the COVID-19 pandemic.
METHODS: A retrospective analysis was performed using a 10 million-record random sample of patients with telehealth visits (with telehealth defined by CPT codes with telehealth modifiers or place-of-service codes).…
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Scientific Publications
OBJECTIVES: Cell and gene therapies (CGT) have prompted innovation in the life sciences landscape and captured national attention. However, the real-world use across this therapeutic class is not well quantified. This study aims to evaluate CGT uptake and quantify utilization patterns in the US, from 2015-2021.
METHODS: This study analyzed patient-level US claims data in the Komodo Healthcare Map™, a dataset including longitudinal medical and prescription claims encompassing adjudicated claims of >150 million unique enrollees from the US commercial, Medicare,…
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Scientific Publications
OBJECTIVES: Endogenous Cushing’s syndrome (CS) is a rare endocrine disorder characterized by chronic cortisol overproduction. Our objective was to summarize the economic and health-related (HR) quality of life (QoL) burden of CS and evaluate post-treatment burden.
METHODS: A systematic literature review (SLR) using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was conducted to identify peer-reviewed manuscripts and conference abstracts published in English from 2015 to December 4th, 2020, in PubMed, MEDLINE, and Embase.
RESULTS: Forty-five publications were included. Data…
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