Patient Safety Commons^™

Efficacy And Safety Of Elamipretide In Individuals With Primary Mitochondrial Myopathy: The Mmpower-3 Randomized Clinical Trial, Amel Karaa, Enrico Bertini, Valerio Carelli, Bruce H Cohen, Gregory M Enns, Marni J Falk, Amy Goldstein, Gráinne Siobhan Gorman, Richard Haas, Michio Hirano, Thomas Klopstock, Mary Kay Koenig, Cornelia Kornblum, Costanza Lamperti, Anna Lehman, Nicola Longo, Maria Judit Molnar, Sumit Parikh, Han Phan, Robert D S Pitceathly, Russell Saneto, Fernando Scaglia, Serenella Servidei, Mark Tarnopolsky, Antonio Toscano, Johan L K Van Hove, John Vissing, Jerry Vockley, Jeffrey S Finman, David A Brown, James A Shiffer, Michelango Mancuso, Mmpower-3 Trial Investigators

Faculty, Staff and Student Publications

BACKGROUND AND OBJECTIVES: Primary mitochondrial myopathies (PMMs) encompass a group of genetic disorders that impair mitochondrial oxidative phosphorylation, adversely affecting physical function, exercise capacity, and quality of life (QoL). Current PMM standards of care address symptoms, with limited clinical impact, constituting a significant therapeutic unmet need. We present data from MMPOWER-3, a pivotal, phase-3, randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of elamipretide in participants with genetically confirmed PMM.

METHODS: After screening, eligible participants were randomized 1:1 to receive either 24 weeks of elamipretide at a dose of 40 mg/d or placebo subcutaneously. Primary efficacy endpoints …

Phase Ii Trial Of Medi0457 And Durvalumab For Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers, Van K Morris, Amir Jazaeri, Shannon N Westin, Curtis Pettaway, Solly George, Ryan W Huey, Michaela Grinsfelder, Aaron Shafer, Benny Johnson, David Vining, Ming Guo, Bryan Fellman, Michael Frumovitz

Faculty, Staff and Student Publications

BACKGROUND: Human papillomavirus (HPV) types 16/18 drive oncogenesis for most patients with cervical, anal, and penile cancers. MEDI0457, a therapeutic DNA vaccine containing plasmids for E6 and E7 HPV-16/18 viral oncogenes and IL-12 adjuvant, is safe and provokes an immune response against E6/E7. We tested MEDI0457 with the anti-PD-L1 antibody durvalumab for patients with HPV-associated cancers.

METHODS: Patients with recurrent/metastatic, treatment-refractory HPV-16/18 cervical cancer, or rare HPV-associated (anal and penile) cancers were eligible. Prior immune checkpoint inhibition was not permitted. Patients received MEDI0457 7 mg intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg …

Ethical Considerations Surrounding Vaccine Development During A Public Health Crisis, Syed Arsalan Akhter Zaidi, Kainat Saleem, Rahul Bollam, Bushra Zaidi

Journal of Health Ethics

Epidemics and Pandemics have been plaguing mankind since many centuries, and are a cause of major healthcare expense in modern times. The novel coronavirus pandemic of 2019-2020 spread worldwide faster than many previous pandemics, including EBOLA in 2017. Although personal protective equipment, and social distancing slowed the outbreak, a vaccine is needed to ensure global immunization and to stop this deadly outbreak. Developing a vaccine in times of a public health crisis comes with a lot of ethical considerations, including overlooking proper informed consent, the issue of using placebo in control arm of trials, extended timelines of development of vaccines, …

Fostering Patient Safety: Importance Of Nursing Documentation, Shamsa Samani, Salma Amin Rattani

School of Nursing & Midwifery

Background: Nurses are professionally accountable for assessing and documenting patients’ vital signs. Nurses failing to fulfill this responsibility position their patients at risk. This paper presents two real-life cases pertaining to patients’ safety resulting in fatal outcomes, leading to the professional, legal, and ethical liability of nurses as the providers of patient care.
Objective: This paper focuses on the role of organizational culture in fostering patient safety specifically in monitoring and documentation of patients’ vital signs and early recognition of warning signs.
Methodology: A comprehensive literature search was conducted using various databases, examining the significance of vital signs monitoring and …

Oxygen Therapy Education To Improve Oxygen Safety In The Emergency Department: A Quality Improvement Project, Latania Wolfe

DNP Projects

Background and Significance: Oxygen is often administered in emergency departments (ED) in US without the nurses and other healthcare staff inputting orders for this medication. This gap in placing orders poses a risk to patient safety and poses a regulation issue.

Purpose: The goal of this quality improvement project is to increase the rate of orders placed for patients using oxygen in ED staff by 12% from March 1, 2023 to May 31, 2023.

Methods: The Model for Improvement guided this quality improvement project. Two PDSA cycles were completed.

Results: PDSA #1 Completed SWOT analysis and used information to …

Establishing A Routine Process Of Medication Reconciliation In A Rural Primary Care Clinic To Address Unnecessary Polypharmacy In Patients 65 And Older, Jessica Kirkwood-Harp

Doctor of Nursing Practice Projects

Background: Medication safety by reducing the proportion of older adults who use inappropriate medications is a Healthy People 2030 goal (Office of Disease Prevention and Health Promotion, n.d.(a)). The research for this proposal supported an established medication reconciliation (MR) to reduce errors and adverse drug events (ADEs). Consistent MR is essential for patient safety and positive patient outcomes in rural outpatient primary care clinics, as these patients possess multiple comorbidities.

Purpose: This Doctor of Nursing Practice (DNP) quality improvement project (QIP) established a routine MR process within a rural primary care clinic with reduced unnecessary polypharmacy and decreased risk of …

The Effectiveness Of Disinfection Protocols In Medical School Osteopathic Manipulative Medicine Labs., Harrison A. Patrizio, Riley Phyu, Thomas Boyle, Todd Schachter

Rowan-Virtua School of Osteopathic Medicine Departmental Research

CONTEXT: In light of the COVID-19 pandemic, healthcare-associated infections have taken center stage. Healthcare has adjusted workflows to accommodate for more robust disinfecting regiments to help protect the community. This has resulted in the need for medical institutions to reevaluate the current disinfection protocols down to the student level. The osteopathic manipulative medicine (OMM) laboratory provides an optimal avenue for assessing the effectiveness of medical students' ability to clean examination tables. With OMM laboratories having a high level of interaction, adequate disinfection is important for the health and safety of students and teaching faculties.

OBJECTIVES: This study will evaluate the …

Pediatric Ercp In The Setting Of Acute Pancreatitis: A Secondary Analysis Of An International Multicenter Cohort Study, Carolena Trocchia, Racha Khalaf, Ernest Amankwah, Wenly Ruan, Douglas S Fishman, Bradley A Barth, Quin Y Liu, Matthew Giefer, Kyung Mo Kim, Mercedes Martinez, Luigi Dall'oglio, Filippo Torroni, Paola De Angelis, Simona Faraci, Sam Bitton, Steven L Werlin, Kulwinder Dua, Roberto Gugig, Clifton Huang, Petar Mamula, J Antonio Quiros, Yuhua Zheng, Travis Piester, Amit Grover, Victor L Fox, Michael Wilsey, David M Troendle

Faculty, Staff and Students Publications

Previous studies have demonstrated the safety of performing endoscopic retrograde cholangiopancreatography (ERCP) in the pediatric population; however, few have addressed the outcomes of children undergoing ERCP during acute pancreatitis (AP). We hypothesize that ERCP performed in the setting of AP can be executed with similar technical success and adverse event profiles to those in pediatric patients without pancreatitis. Using the Pediatric ERCP Database Initiative, a multi-national and multi-institutional prospectively collected dataset, we analyzed 1124 ERCPs. One hundred and ninety-four (17%) of these procedures were performed in the setting of AP. There were no difference in the procedure success rate, procedure …

Preemption In State Tobacco Minimum Legal Sales Age Laws In The Us, 2022: A Policy Analysis Of State Statutes And Case Laws, Page D. Dobbs, Ginny Chadwich, Eric Crosbie, Jessica Breslin, Lisa Henriksen

Health, Human Performance and Recreation Faculty Publications and Presentations

Preemptive statutory language within tobacco minimum legal sales age (MLSA) laws has prohibited localities from enacting stricter laws than state statutes. With the recent uptake of state Tobacco 21 laws in the US, the current landscape of preempted MLSA laws is unknown. This study sought to update the status of preemption in MLSA laws enacted in US states between 2015–2022. A public health attorney reviewed state tobacco MLSA laws (n = 50) and state tobacco control codes, searching for language regarding preemption. When statutes were unclear, case law was reviewed by examining local ordinances that were invalidated by state court …

Birthing Reimagined: Perceptions Of Safety And Autonomy In Birth Experiences Among Postpartum Individuals During Covid-19, Beldina Orinda

Senior Honors Papers / Undergraduate Theses

Background: Safety during childbirth is a priority for care providers, but patients' perceptions of safety may differ from those of providers, especially in biomedical settings.1–4 This can influence health outcomes and satisfaction with the birth experience.5–7 We hypothesize that autonomy, defined as the ability to make decisions about care during childbirth, may enhance feelings of safety and positive mental health outcomes.9,15

Methods: Surveys via REDCap v11.1.29 captured the experiences and Edinburgh Postnatal Depression Scale (EPDS) scores of pregnant and postpartum women. Participants (n=49) included 15 pregnant and 34 postpartum individuals, aged 18 and older, who had given …

Ethical Considerations Of Clinical Research In Emergency Care Settings: A Review, Adith Velavan

Honors Scholar Theses

Emergency and acute care settings are some of the most volatile and high intensity areas of any healthcare operation. Better understanding of systems and treatments in these spaces are critical to improving outcomes for the high risk patients that are treated there. Clinical research serves as a cornerstone of modern medical research, and is critical to the further improvement of clinical care in these settings. This thesis serves to explore the ethicality of such research given the constraints of emergency medicine settings. Not only does this thesis provide a strong foundation regarding the history and current practices of clinical research, …

Calculating Risk: A Scoping Review Of Ncaa D1 Football Players’ Motivations To Play And The Correlation To Demographic Characteristics And Injury Experiences, Kathleen D. Walsh

Honors Theses

The purpose of this research was to investigate the motivations of National Collegiate Athletic Association (NCAA) Division 1 (D1) football players for playing the game and how these motivations are associated with their socioeconomic status (SES). Further, the research aimed to investigate how the uncovered motivations were linked to injury experiences. The original project was designed as a survey-based mixed methods study on a national scale. However, issues with participant recruitment led to sidelining of that primary research. The research presented is a scoping review of the available literature pertaining to the research question: What is known from existing literature …

Isolated Temazepam Overdose: A Unique Case Of An Unresponsive Female, Eric Doane

Rowan-Virtua Research Day

Cases of acute overdose presenting to the emergency department pose a great challenge given that history can sometimes be limited or at times be inaccurate. While naloxone is routinely given in the field to help reduce opiate’s sedating effects, the routine use of flumazenil has not been routinely adopted in cases of benzodiazepine overdose. This is because, unlike naloxone, there are many medications that act on the GABA receptor, and flumazenil is only specific for binding to the benzodiazepine/GABA receptor. This can lead to an unmasking of other medications that may be co-ingested that also effect the GABA receptor leading …

Case Report: Epinephrine-Containing Topical Anesthetic Gel Inducing Systemic Epinephrine Toxicity, Md Fateha, Philip Willsie

Rowan-Virtua Research Day

Systemic epinephrine toxicity is a rare complication following inadvertent or excessively large or rapid subcutaneous, intramuscular or intravenous administration. Signs and symptoms of epinephrine toxicity include rapid onset of transient agitation, hypertension, tachycardia, lactic acidosis, and dysrhythmias with potentially fatal consequences. In this case report, we present a 33-year-old female who experienced epinephrine toxicity following the use of a topical anesthetic cream containing lidocaine and epinephrine. The patient had multiple applications to her chest before and during tattoo placement which led to tachycardia, elevated blood pressure, headache, chest pain, nausea, vomiting, and anxiety. The patient was brought into the ED …

Chemical Restraints In The Emergency Department, Nicholas Noffsinger

Rowan-Virtua Research Day

Chemical restraint is a critical intervention used in emergency departments to manage acutely agitated or violent patients. It involves the administration of medication to induce sedation and control behavior, with the goal of ensuring patient and staff safety while allowing necessary medical interventions to be performed. However, the use of chemical restraints necessitates close observation of vital signs and any potential side effects, as well as careful consideration of patient-specific considerations.

Release The Kratom: Post-Acute Withdrawal Syndrome In A 70 Year Old Male, Nardin El-Shammaa, Kyle Street, Narsimha Pinninti

Rowan-Virtua Research Day

Centuries in Eastern medicine.. Kratom has been commonly used for chronic pain and opiate withdrawal symptoms with first reported cases in the United States in the early 2000s. It is a plant that consists of psychoactive alkaloids that target opioid receptors with different affinity. Effects from Kratom are dose-dependent, at lower doses, it acts as a stimulant, while at higher doses produces analgesia and euphoria. Although Kratom is legal and easily accessible over the counter, there have been increasing reports of potential for addiction and toxicity. Cessation of Kratom can result in withdrawal symptoms similar to opiate withdrawal. Here we …

Addressing The Health Needs Of The (D/D)Eaf And Hard Of Hearing Community, Zainab Krayem, Rachel Jeff-Macauley, Nicolette Falco, Vanesa Pizutelli

Rowan-Virtua Research Day

The term deaf refers to individuals with total or partial hearing loss. However, it encompasses much more, representing a culture—Deaf culture. The distinction in spelling is important: "Deaf," with an uppercase "D," refers to individuals born Deaf who have been raised within Deaf culture, while "deaf," with a lowercase "d," typically refers to those who lost their hearing later in life and may not have grown up in Deaf culture. People who identify as deaf, Deaf, or hard of hearing (d/D/hoh) are often mistakenly assumed to have cognitive impairments or are broadly categorized as disabled. However, many in the community …

The Effectiveness Of Cleaning Protocols In Medical School Omm Labs By Medical Students, Harrison Patrizio, Riley Phyu, Thomas Boyle, Todd Schachter

Rowan-Virtua Research Day

In light of the COVID-19 pandemic, disinfection in healthcare has taken center stage. Healthcare has adjusted workflows to accommodate for more robust cleaning regimens to help protect the community. This has resulted in the need for medical institutions to reevaluate the current cleaning protocols down to the student level. Osteopathic Manipulative Medicine (OMM) lab provides an optimal avenue for assessing medical student’s examination table cleaning effectiveness. With OMM labs being an activity with a high level of interaction, the quality of examination table cleaning is important for the health and safety of students and teaching faculties. Our study highlights that …

Perinatal Experiences Of People With Autism Spectrum Disorders: A Preliminary Scoping Review, Tanvi Shah, Andrea Iannuzzelli, Venkateswar Venkataman

Rowan-Virtua Research Day

Autism Spectrum Disorder (ASD) is a developmental disorder that is diagnosed in early childhood, typically in people who are assigned male at birth. However, this diagnosis and the sensory and behavioral divergence that comes with ASD stay with people throughout their lives. Based on the DSM-V diagnostic criteria and the history of how Autism and Autism Spectrum Disorders were first identified, many people who do not identify as male and/or present atypically do not receive a formal diagnosis until later in life or self-diagnose. This in turn has led to a lack of research in both populations that do not …

Effects Of Attention-Deficit/Hyperactivity Disorder On Patients Undergoing Percutaneous Coronary Intervention Procedure: Insights From The National Inpatient Sample, Rafail Beshai, Keri Anacker, Keith Anacker, Tony Elias, Veyola Rezkalla, Maziyar Daneshvar, Howard Weinberg

Rowan-Virtua Research Day

Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder that can affect children and adults and is characterized by deficits in attention, self-regulation, and executive functioning. Symptoms can seriously affect daily functioning and may present as hyperactivity, inattentive behaviors, or a combination of both. There are data to suggest patients with ADHD suffer from increased rates of cardiovascular disease, however not much is known specifically regarding the relationship between ADHD and undergoing Percutaneous Coronary Intervention. We sought to examine this relationship in greater detail by perusing the national inpatient sample database to describe in-hospital trends and outcomes among these …