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Full-Text Articles in Patient Safety

Career Impact Of The National Interprofessional Fellowship In Patient Safety: An Alumni Evaluation, Bradley V Watts, Kathleen Carluzzo, Blake F Webb, Kelley Arredondo Jun 2025

Career Impact Of The National Interprofessional Fellowship In Patient Safety: An Alumni Evaluation, Bradley V Watts, Kathleen Carluzzo, Blake F Webb, Kelley Arredondo

Faculty, Staff and Students Publications

Background: There has been a proliferation of health professions training programmes focused on quality and patient safety, but little information regarding the outcomes of these programmes. The purpose of this study was to examine the impact of an interprofessional quality and patient safety curriculum on career outcomes of interprofessional healthcare learners for the Veterans Affairs Patient Safety Fellowship.

Method: We conducted a survey-based assessment of 117 alumni of the Interprofessional Fellowship in Patient Safety assessing their satisfaction with the training program and career impacts.

Results: 84 of 117 alumni were located and participated in the assessment. Fellows entered the training …


Revisions To The Safety Assurance Factors For Electronic Health Record Resilience (Safer) Guides To Update National Recommendations For Safe Use Of Electronic Health Records, Dean F Sittig, Trisha Flanagan, Patricia Sengstack, Rosann T Cholankeril, Sara Ehsan, Amanda Heidemann, Daniel R Murphy, Hojjat Salmasian, Jason S Adelman, Hardeep Singh Apr 2025

Revisions To The Safety Assurance Factors For Electronic Health Record Resilience (Safer) Guides To Update National Recommendations For Safe Use Of Electronic Health Records, Dean F Sittig, Trisha Flanagan, Patricia Sengstack, Rosann T Cholankeril, Sara Ehsan, Amanda Heidemann, Daniel R Murphy, Hojjat Salmasian, Jason S Adelman, Hardeep Singh

Faculty, Staff and Student Publications

The Safety Assurance Factors for Electronic Health Record (EHR) Resilience (SAFER) Guides provide recommendations to healthcare organizations for conducting proactive self-assessments of the safety and effectiveness of their EHR implementation and use. Originally released in 2014, they were last updated in 2016. In 2022, the Centers for Medicare and Medicaid Services required their annual attestation by US hospitals.

Objectives: This case study describes how SAFER Guide recommendations were updated to align with current evidence and clinical practice.

Materials and methods: Over nine months, a multidisciplinary team updated SAFER Guides through literature reviews, iterative feedback, and online meetings.

Results: We reduced …


A Qualitative Assessment Of Changes In Occupational Exposures Among Healthcare Facility Workers, David Gimeno Ruiz De Porras, Jenil Patel, Sadie Conway, Lisa Pompeii, Laura E Mitchell, Arch Carson, Lawrence W Whitehead, Inkyu Han, Jan-Paul Zock, Paul K Henneberger, Riddhi Patel, Joy De Los Reyes, George L Delclos Feb 2025

A Qualitative Assessment Of Changes In Occupational Exposures Among Healthcare Facility Workers, David Gimeno Ruiz De Porras, Jenil Patel, Sadie Conway, Lisa Pompeii, Laura E Mitchell, Arch Carson, Lawrence W Whitehead, Inkyu Han, Jan-Paul Zock, Paul K Henneberger, Riddhi Patel, Joy De Los Reyes, George L Delclos

Faculty, Staff and Student Publications

Adult-onset asthma, notably prevalent among healthcare professionals, especially nurses, is often attributed to occupational factors such as exposure to cleaning agents. Studies consistently underscore the substantial role of such exposure in work-related asthma among hospital staff. We aimed to (a) identify and characterize current practices in cleaning and aerosolized medication administration; (b) assess changes in practices since a similar 2003 study of Texas healthcare workers; and (c) identify factors contributing to diverse exposures within healthcare job categories. We conducted focus groups with 38 participants in 6 healthcare settings, analyzing current practices, changes since 2003, and factors contributing to exposure diversity. …


Analyzing And Mitigating The Risks Of Patient Harm During Operating Room To Intensive Care Unit Patient Handoffs., Nara Regina Spall Martins, Edson Zangiacomi Martinez, Cláudia Marquez Simões, Paul Barach, Maria José Carvalho Carmona Jan 2025

Analyzing And Mitigating The Risks Of Patient Harm During Operating Room To Intensive Care Unit Patient Handoffs., Nara Regina Spall Martins, Edson Zangiacomi Martinez, Cláudia Marquez Simões, Paul Barach, Maria José Carvalho Carmona

SKMC Student Presentations and Publications

Patients continue to suffer from preventable harm and uneven quality outcomes. Reliable clinical outcomes depend on the quality of robust administrative systems and reliable support processes. Critically ill patient handoffs from the operating room (OR) to the intensive care unit (ICU) are known to be high-risk events. We describe a novel perspective on how risk factors associated with the process of patient handoff communication between the OR and the ICU can lead to flawed communication, degraded team awareness, medical errors, and increased patient harm. Data were collected from two semi-structured focus groups using a five-step risk management approach at a …


A Comprehensive Analysis Of In-Hospital Adverse Events After Scopolamine Administration: Insights From A Retrospective Cohort Study Using A Large Nationwide Inpatient Database, George Sun, Marc Torjman, Kevin Min Nov 2024

A Comprehensive Analysis Of In-Hospital Adverse Events After Scopolamine Administration: Insights From A Retrospective Cohort Study Using A Large Nationwide Inpatient Database, George Sun, Marc Torjman, Kevin Min

Department of Anesthesiology Faculty Papers

BACKGROUND: Scopolamine is a widely used antiemetic in anesthetic practice, particularly for postoperative and post-discharge nausea and vomiting. Despite its frequent usage and recognized efficacy, concerns have emerged regarding the potential for increased side effects, particularly in elderly patients. Further research is needed to assess safety and determine age thresholds for adverse events. This study hypothesizes associations between perioperative scopolamine use, worse clinical outcomes, increased pneumonia, delirium, urinary retention, and readmissions.

METHODS: A large, retrospective cohort study was performed using the TriNetX Analytics Network database on patients undergoing major surgical procedures between Jan 1, 2009, and March 21, 2018, to …


Understanding The Impact Of Covid-19 On Yoga Instruction: Examining Teaching Methodology, Class Components, And Injury Patterns In The Northeastern Us, Sojung Kim, June Solow, Donald H Lein, Harshvardhan Singh Nov 2024

Understanding The Impact Of Covid-19 On Yoga Instruction: Examining Teaching Methodology, Class Components, And Injury Patterns In The Northeastern Us, Sojung Kim, June Solow, Donald H Lein, Harshvardhan Singh

Rowan-Virtua School of Osteopathic Medicine Departmental Research

OBJECTIVES: This study aimed to examine the impact of COVID-19 on the perspectives of yoga instructors (YIs) regarding teaching methodology, class components, and yoga-related injuries among their clients DESIGN: A cross-sectional design in this study.

SETTING: A total of 407 YIs from Northeastern United States completed a customized, web-based survey.

MAIN OUTCOME MEASURES: Chi-square tests were carried out to determine changes in yoga teaching format before and during the pandemic, as well as the counts of yoga related injuries between face-to-face (FtoF) and online teaching format. Independent t tests were used to compare the characteristics of yoga teaching elements.

RESULTS: …


Frontline Nursing Staff’S Perceptions Of Intravenous Medication Administration: The First Step Toward Safer Infusion Processes-A Qualitative Study, Masashi Uramatsu, Naoko Kimura, Takako Kojima, Yoshikazu Fujisawa, Tomoko Oto, Paul Barach Jun 2024

Frontline Nursing Staff’S Perceptions Of Intravenous Medication Administration: The First Step Toward Safer Infusion Processes-A Qualitative Study, Masashi Uramatsu, Naoko Kimura, Takako Kojima, Yoshikazu Fujisawa, Tomoko Oto, Paul Barach

College of Population Health Faculty Papers

OBJECTIVES: Intravenous medication errors continue to significantly impact patient safety and outcomes. This study sought to clarify the complexity and risks of the intravenous administration process.

DESIGN: A qualitative focus group interview study.

SETTING: Focused interviews were conducted using process mapping with frontline nurses responsible for medication administration in September 2020.

PARTICIPANTS: Front line experiened nurses from a Japanese tertiary teaching hospital.

PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was to identify the mental models frontline nurses used during intravenous medication administration, which influence their interactions with patients, and secondarily, to examine the medication process gaps between the …


Implementation Of A Health Information Technology Safety Classification System In The Veterans Health Administration’S Informatics Patient Safety Office, Danielle Kato, Joe Lucas, Dean F Sittig Jun 2024

Implementation Of A Health Information Technology Safety Classification System In The Veterans Health Administration’S Informatics Patient Safety Office, Danielle Kato, Joe Lucas, Dean F Sittig

Faculty, Staff and Student Publications

Objective: Implement the 5-type health information technology (HIT) patient safety concern classification system for HIT patient safety issues reported to the Veterans Health Administration's Informatics Patient Safety Office.

Materials and methods: A team of informatics safety analysts retrospectively classified 1 year of HIT patient safety issues by type of HIT patient safety concern using consensus discussions. The processes established during retrospective classification were then applied to incoming HIT safety issues moving forward.

Results: Of 140 issues retrospectively reviewed, 124 met the classification criteria. The majority were HIT failures (eg, software defects) (33.1%) or configuration and implementation problems (29.8%). Unmet user …


Patient Characteristics Of, And Remedial Interventions For, Complaints And Medico-Legal Claims Against Doctors: A Rapid Review Of The Literature, Timothy J Schultz, Michael Zhou, Jodi Gray, Jackie Roseleur, Richard Clark, Dylan A Mordaunt, Peter D Hibbert, Georgie Haysom, Michael Wright Apr 2024

Patient Characteristics Of, And Remedial Interventions For, Complaints And Medico-Legal Claims Against Doctors: A Rapid Review Of The Literature, Timothy J Schultz, Michael Zhou, Jodi Gray, Jackie Roseleur, Richard Clark, Dylan A Mordaunt, Peter D Hibbert, Georgie Haysom, Michael Wright

Faculty, Staff and Student Publications

BACKGROUND: It is uncertain if patient's characteristics are associated with complaints and claims against doctors. Additionally, evidence for the effectiveness of remedial interventions on rates of complaints and claims against doctors has not been synthesised.

METHODS: We conducted a rapid review of recent literature to answer: Question 1 "What are the common characteristics and circumstances of patients who are most likely to complain or bring a claim about the care they have received from a doctor?" and Question 2 "What initiatives or interventions have been shown to be effective at reducing complaints and claims about the care patients have received …


Close Contacts Of Xenograft Recipients: Ethical Considerations Due To Risk Of Xenozoonosis, Daniel J Hurst, Luz Padilla, Daniel Rodger, Tamar Schiff, David K C Cooper Mar 2024

Close Contacts Of Xenograft Recipients: Ethical Considerations Due To Risk Of Xenozoonosis, Daniel J Hurst, Luz Padilla, Daniel Rodger, Tamar Schiff, David K C Cooper

Rowan-Virtua School of Osteopathic Medicine Departmental Research

With decades of pre-clinical studies culminating in the recent clinical application of xenotransplantation, it would appear timely to provide recommendations for operationalizing oversight of xenotransplantation clinical trials. Ethical issues with clinical xenotransplantation have been described for decades, largely centering on animal welfare, the risks posed to the recipient, and public health risks posed by potential spread of xenozoonosis. Much less attention has been given to considerations relating to potentially elevated risks faced by those who may care for or otherwise have close contact with xenograft recipients. This paper examines the ethical and logistical issues raised by the potential exposure to …


The Acceptance And Use Of Digital Technologies For Self-Reporting Medication Safety Events After Care Transitions To Home In Patients With Cancer: Survey Study, Yun Jiang, Misun Hwang, Youmin Cho, Christopher R Friese, Sarah T Hawley, Milisa Manojlovich, John C Krauss, Yang Gong Mar 2024

The Acceptance And Use Of Digital Technologies For Self-Reporting Medication Safety Events After Care Transitions To Home In Patients With Cancer: Survey Study, Yun Jiang, Misun Hwang, Youmin Cho, Christopher R Friese, Sarah T Hawley, Milisa Manojlovich, John C Krauss, Yang Gong

Faculty, Staff and Student Publications

BACKGROUND: Actively engaging patients with cancer and their families in monitoring and reporting medication safety events during care transitions is indispensable for achieving optimal patient safety outcomes. However, existing patient self-reporting systems often cannot address patients' various experiences and concerns regarding medication safety over time. In addition, these systems are usually not designed for patients' just-in-time reporting. There is a significant knowledge gap in understanding the nature, scope, and causes of medication safety events after patients' transition back home because of a lack of patient engagement in self-monitoring and reporting of safety events. The challenges for patients with cancer in …


The Mrna-Lnp Vaccines - The Good, The Bad And The Ugly?, Botond Z. Igyártó, Zhen Qin Feb 2024

The Mrna-Lnp Vaccines - The Good, The Bad And The Ugly?, Botond Z. Igyártó, Zhen Qin

Department of Microbiology and Immunology Faculty Papers

The mRNA-LNP vaccine has received much attention during the COVID-19 pandemic since it served as the basis of the most widely used SARS-CoV-2 vaccines in Western countries. Based on early clinical trial data, these vaccines were deemed safe and effective for all demographics. However, the latest data raise serious concerns about the safety and effectiveness of these vaccines. Here, we review some of the safety and efficacy concerns identified to date. We also discuss the potential mechanism of observed adverse events related to the use of these vaccines and whether they can be mitigated by alterations of this vaccine mechanism …


Effect Of Russian Current Expert Modes On Quadriceps Muscle Torque In Healthy Adults: A Single-Blinded Randomized Controlled Trial, Ansam Hasan, Ibrahim Moustafa, Tamer Shousha Jan 2024

Effect Of Russian Current Expert Modes On Quadriceps Muscle Torque In Healthy Adults: A Single-Blinded Randomized Controlled Trial, Ansam Hasan, Ibrahim Moustafa, Tamer Shousha

Faculty, Staff and Student Publications

BACKGROUND: Russian current (RC), a well-known neuromuscular electrical stimulation operating at 2500 Hz, has demonstrated significant strength improvement over traditional exercises due to its high tolerance and low pain provocation. Despite extensive NMES parameter research, the specific effects of expert modes, particularly ON2 and Rest, remain unexplored. This study investigates the direct effect of these expert modes on quadriceps muscle strength in healthy adults.

METHODS: This is a single-blind, randomization-controlled trial. Forty-eight healthy university students (31 females, 17 males) were assigned in two randomized experimental groups either the ON2 or Rest mode for a 15-minute electrical stimulation session. Quadriceps maximum …


Early Immersion In Team-Based Event Review: Experiential Patient Safety Education For Pgy 1 Internal Medicine Residents, Michelle Perkons, Alexis Wickersham, Sonia Bharel, Timothy Kuchera, Rebecca Jaffe Jan 2024

Early Immersion In Team-Based Event Review: Experiential Patient Safety Education For Pgy 1 Internal Medicine Residents, Michelle Perkons, Alexis Wickersham, Sonia Bharel, Timothy Kuchera, Rebecca Jaffe

Department of Medicine Faculty Papers

INTRODUCTION: In recent years, there has been a national push to incorporate high-fidelity quality improvement and patient safety (QIPS) education into physician training programs. In fact, integration of robust patient safety education became an Accreditation Council for Graduate Medical Education (ACGME) Common Program Requirement for residency programs in 2017. We developed a curriculum to not only fulfill the ACGME's requirement but also provide PGY 1 internal medicine residents with the skills needed to become active participants in ongoing patient safety work throughout their training and careers.

METHODS: Our patient safety curriculum was woven into residents' existing protected educational time and …


An Interactive, Case-Based Workshop On The Patient Experience For Internal Medicine Residents, Julian Swanson, Doris Lin, Kristen A Staggers, Priti Dangayach Jan 2024

An Interactive, Case-Based Workshop On The Patient Experience For Internal Medicine Residents, Julian Swanson, Doris Lin, Kristen A Staggers, Priti Dangayach

Faculty, Staff and Students Publications

INTRODUCTION: The technological revolution has narrowed the information gap between physician and patient. This has led to an evolution in medicine from paternalistic to patient-centric, with health care systems now prioritizing patient experience to achieve higher satisfaction scores. Therefore, it is imperative to start early in educating trainees on how to best address the holistic needs of the patient while also delivering high-quality care.

METHODS: We implemented a 1-hour workshop that was repeated weekly over 8 weeks to capture all internal medicine residents in our program. During the workshop, we reviewed the historical evolution of patient care from paternalistic to …


Empagliflozin In Patients Admitted To Hospital With Covid-19 (Recovery): A Randomised, Controlled, Open-Label, Platform Trial, Recovery Collaborative Group Dec 2023

Empagliflozin In Patients Admitted To Hospital With Covid-19 (Recovery): A Randomised, Controlled, Open-Label, Platform Trial, Recovery Collaborative Group

Faculty, Staff and Student Publications

BACKGROUND: Empagliflozin has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory, metabolic, and haemodynamic effects. The RECOVERY trial aimed to assess its safety and efficacy in patients admitted to hospital with COVID-19.

METHODS: In the randomised, controlled, open-label RECOVERY trial, several possible treatments are compared with usual care in patients hospitalised with COVID-19. In this analysis, we assess eligible and consenting adults who were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus oral empagliflozin 10 mg once daily for 28 days or until discharge …


The Effectiveness Of Disinfection Protocols In Osteopathic Family Medicine Offices, Riley Phyu, Harrison A Patrizio, Thomas Boyle, Todd Schachter Sep 2023

The Effectiveness Of Disinfection Protocols In Osteopathic Family Medicine Offices, Riley Phyu, Harrison A Patrizio, Thomas Boyle, Todd Schachter

Rowan-Virtua School of Osteopathic Medicine Departmental Research

CONTEXT: Healthcare-associated infections (HAIs) pose a substantial public health threat. Despite significant strides to curb HAIs in hospital environments, outpatient settings have not received the same degree of attention. Given their emphasis on holistic, patient-centered care, osteopathic family medicine offices are pivotal in both disease prevention and comprehensive patient treatment. The importance of simple yet effective disinfection protocols, such as thorough cleaning between patient appointments, cannot be overstated in these settings because they are integral to minimizing disease transmission.

OBJECTIVES: This study aims to assess the effectiveness of the current disinfection protocols in osteopathic family medicine offices.

METHODS: A cross-sectional …


Identifying Contributing Factors Associated With Dental Adverse Events Through A Pragmatic Electronic Health Record-Based Root Cause Analysis, Elsbeth Kalenderian, Suhasini Bangar, Alfa Yansane, Duong Tran, Emily Sedlock, Yan Xiao, Janelle Urata, Greg Olson, Amy Franklin, Krishna Kookal, Ana Ibarra-Noriega, Sayali Tungare, Oluwabunmi Tokede, Heiko Spallek, Joel M White, Muhammad F Walji Aug 2023

Identifying Contributing Factors Associated With Dental Adverse Events Through A Pragmatic Electronic Health Record-Based Root Cause Analysis, Elsbeth Kalenderian, Suhasini Bangar, Alfa Yansane, Duong Tran, Emily Sedlock, Yan Xiao, Janelle Urata, Greg Olson, Amy Franklin, Krishna Kookal, Ana Ibarra-Noriega, Sayali Tungare, Oluwabunmi Tokede, Heiko Spallek, Joel M White, Muhammad F Walji

Faculty, Staff and Student Publications

OBJECTIVE: This study assessed contributing factors associated with dental adverse events (AEs).

METHODS: Seven electronic health record-based triggers were deployed identifying potential AEs at 2 dental institutions. From 4106 flagged charts, 2 reviewers examined 439 charts selected randomly to identify and classify AEs using our dental AE type and severity classification systems. Based on information captured in the electronic health record, we analyzed harmful AEs to assess potential contributing factors; harmful AEs were defined as those that resulted in temporary moderate to severe harm, required hospitalization, or resulted in permanent moderate to severe harm. We classified potential contributing factors according …


Communication Of Patients’ And Family Members’ Ethical Concerns To Their Healthcare Providers, Mariam Noorulhuda, Christine Grady, Paul Wakim, Talia Bernhard, Hae Lin Cho, Marion Danis Jul 2023

Communication Of Patients’ And Family Members’ Ethical Concerns To Their Healthcare Providers, Mariam Noorulhuda, Christine Grady, Paul Wakim, Talia Bernhard, Hae Lin Cho, Marion Danis

Student Papers, Posters & Projects

BACKGROUND: Little is known about communication between patients, families, and healthcare providers regarding ethical concerns that patients and families experience in the course of illness and medical care. To address this gap in the literature, we surveyed patients and family members to learn about their ethical concerns and the extent to which they discussed them with their healthcare providers.

METHODS: We surveyed adult, English-speaking patients and family members receiving inpatient care in five hospitals in the Washington DC-Baltimore metropolitan area from July 2017 to March 2020. Descriptive statistics were used to determine the frequency, comfortableness, and helpfulness of discussions regarding …


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 Jul 2023

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 Jul 2023

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 …


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 Jun 2023

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 …


Electronic Health Records' Support For Primary Care Physicians' Situation Awareness: A Metanarrative Review, April Savoy, Himalaya Patel, Daniel R Murphy, Ashley N D Meyer, Jennifer Herout, Hardeep Singh Mar 2023

Electronic Health Records' Support For Primary Care Physicians' Situation Awareness: A Metanarrative Review, April Savoy, Himalaya Patel, Daniel R Murphy, Ashley N D Meyer, Jennifer Herout, Hardeep Singh

Faculty, Staff and Students Publications

OBJECTIVE: Situation awareness (SA) refers to people's perception and understanding of their dynamic environment. In primary care, reduced SA among physicians increases errors in clinical decision-making and, correspondingly, patients' risk of experiencing adverse outcomes. Our objective was to understand the extent to which electronic health records (EHRs) support primary care physicians (PCPs)' SA during clinical decision-making.

METHOD: We conducted a metanarrative review of papers in selected academic databases, including CINAHL and MEDLINE. Eligible studies included original peer-reviewed research published between January 2012 and August 2020 on PCP-EHR interactions. We iteratively queried, screened, and summarized literature focused on EHRs supporting PCPs' …


Association Of Endovascular Thrombectomy Vs Medical Management With Functional And Safety Outcomes In Patients Treated Beyond 24 Hours Of Last Known Well, Amrou Sarraj, Timothy J Kleinig, Ameer E Hassan, Pere Cardona Portela, Santiago Ortega-Gutierrez, Michael G Abraham, Nathan W Manning, James E Siegler, Nitin Goyal, Laith Maali, Spiros Blackburn, Teddy Y Wu, Jordi Blasco, Arturu Renú, Navdeep S Sangha, Juan F Arenillas, Margy E Mccullough-Hicks, Adam Wallace, Daniel Gibson, Deep K Pujara, Faris Shaker, Mercedes De Lera Alfonso, Marta Olivé-Gadea, Mudassir Farooqui, Juan S Vivanco Suarez, Zachary Iezzi, Jane Khalife, Colleen G Lechtenberg, Syed K Qadri, Rami B Moussa, Mohammad A Abdulrazzak, Tareq S Almaghrabi, Osman Mir, James Beharry, Balaji Krishnaiah, Megan Miller, Najwa Khalil, Gagan J Sharma, Aristeidis H Katsanos, Ali Fadhil, Kelsey R Duncan, Yin Hu, Sheryl B Martin-Schild, Georgios K Tsivgoulis, Dennis Cordato, Anthony Furlan, Leonid Churilov, Peter J Mitchell, Adam S Arthur, Mark W Parsons, James C Grotta, Clark W Sitton, Marc Ribo, Gregory W Albers, Bruce C V Campbell Feb 2023

Association Of Endovascular Thrombectomy Vs Medical Management With Functional And Safety Outcomes In Patients Treated Beyond 24 Hours Of Last Known Well, Amrou Sarraj, Timothy J Kleinig, Ameer E Hassan, Pere Cardona Portela, Santiago Ortega-Gutierrez, Michael G Abraham, Nathan W Manning, James E Siegler, Nitin Goyal, Laith Maali, Spiros Blackburn, Teddy Y Wu, Jordi Blasco, Arturu Renú, Navdeep S Sangha, Juan F Arenillas, Margy E Mccullough-Hicks, Adam Wallace, Daniel Gibson, Deep K Pujara, Faris Shaker, Mercedes De Lera Alfonso, Marta Olivé-Gadea, Mudassir Farooqui, Juan S Vivanco Suarez, Zachary Iezzi, Jane Khalife, Colleen G Lechtenberg, Syed K Qadri, Rami B Moussa, Mohammad A Abdulrazzak, Tareq S Almaghrabi, Osman Mir, James Beharry, Balaji Krishnaiah, Megan Miller, Najwa Khalil, Gagan J Sharma, Aristeidis H Katsanos, Ali Fadhil, Kelsey R Duncan, Yin Hu, Sheryl B Martin-Schild, Georgios K Tsivgoulis, Dennis Cordato, Anthony Furlan, Leonid Churilov, Peter J Mitchell, Adam S Arthur, Mark W Parsons, James C Grotta, Clark W Sitton, Marc Ribo, Gregory W Albers, Bruce C V Campbell

Faculty, Staff and Student Publications

IMPORTANCE: The role of endovascular thrombectomy is uncertain for patients presenting beyond 24 hours of the time they were last known well.

OBJECTIVE: To evaluate functional and safety outcomes for endovascular thrombectomy (EVT) vs medical management in patients with large-vessel occlusion beyond 24 hours of last known well.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective observational cohort study enrolled patients between July 2012 and December 2021 at 17 centers across the United States, Spain, Australia, and New Zealand. Eligible patients had occlusions in the internal carotid artery or middle cerebral artery (M1 or M2 segment) and were treated with EVT or …


Thrombectomy Outcomes With General Vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From The Extend-Ia Trials And Select Study, Amrou Sarraj, Gregory W Albers, Peter J Mitchell, Ameer E Hassan, Michael G Abraham, Spiros Blackburn, Gagan Sharma, Nawaf Yassi, Timothy J Kleinig, Darshan G Shah, Teddy Y Wu, Muhammad Shazam Hussain, Wondwoseen G Tekle, Santiago Ortega Gutierrez, Amin Nima Aghaebrahim, Diogo C Haussen, Gabor Toth, Deep Pujara, Ronald F Budzik, William Hicks, Nirav Vora, Randall C Edgell, Sabreena Slavin, Colleen G Lechtenberg, Laith Maali, Abid Qureshi, Lee Rosterman, Mohammad Ammar Abdulrazzak, Tareq Almaghrabi, Faris Shaker, Osman Mir, Ashish Arora, Sheryl Martin-Schild, Clark W Sitton, Leonid Churilov, Rishi Gupta, Maarten G Lansberg, Raul G Nogueira, James C Grotta, Geoffrey Alan Donnan, Stephen M Davis, Bruce C V Campbell Jan 2023

Thrombectomy Outcomes With General Vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From The Extend-Ia Trials And Select Study, Amrou Sarraj, Gregory W Albers, Peter J Mitchell, Ameer E Hassan, Michael G Abraham, Spiros Blackburn, Gagan Sharma, Nawaf Yassi, Timothy J Kleinig, Darshan G Shah, Teddy Y Wu, Muhammad Shazam Hussain, Wondwoseen G Tekle, Santiago Ortega Gutierrez, Amin Nima Aghaebrahim, Diogo C Haussen, Gabor Toth, Deep Pujara, Ronald F Budzik, William Hicks, Nirav Vora, Randall C Edgell, Sabreena Slavin, Colleen G Lechtenberg, Laith Maali, Abid Qureshi, Lee Rosterman, Mohammad Ammar Abdulrazzak, Tareq Almaghrabi, Faris Shaker, Osman Mir, Ashish Arora, Sheryl Martin-Schild, Clark W Sitton, Leonid Churilov, Rishi Gupta, Maarten G Lansberg, Raul G Nogueira, James C Grotta, Geoffrey Alan Donnan, Stephen M Davis, Bruce C V Campbell

Faculty, Staff and Student Publications

BACKGROUND AND OBJECTIVES: The effect of anesthesia choice on endovascular thrombectomy (EVT) outcomes is unclear. Collateral status on perfusion imaging may help identify the optimal anesthesia choice.

METHODS: In a pooled patient-level analysis of EXTEND-IA, EXTEND-IA TNK, EXTEND-IA TNK part II, and SELECT, EVT functional outcomes (modified Rankin Scale score distribution) were compared between general anesthesia (GA) vs non-GA in a propensity-matched sample. Furthermore, we evaluated the association of collateral flow on perfusion imaging, assessed by hypoperfusion intensity ratio (HIR) - Tmax > 10 seconds/Tmax > 6 seconds (good collaterals - HIR < 0.4, poor collaterals - HIR ≥ 0.4) on the association between anesthesia type and EVT outcomes.

RESULTS: Of 725 treated with EVT, 299 (41%) received GA …


Patient And Clinician Perceptions Of Precision Cardiology Care: Findings From The Heartcare Study, Hadley Stevens Smith, Clarissa E Sanchez, Ronald Maag, Alexandria Buentello, David R Murdock, Ginger A Metcalf, Trevor D Hadley, Daniel L Riconda, Eric Boerwinkle, Xander H T Wehrens, Christie M Ballantyne, Richard A Gibbs, Amy L Mcguire, Stacey Pereira Dec 2022

Patient And Clinician Perceptions Of Precision Cardiology Care: Findings From The Heartcare Study, Hadley Stevens Smith, Clarissa E Sanchez, Ronald Maag, Alexandria Buentello, David R Murdock, Ginger A Metcalf, Trevor D Hadley, Daniel L Riconda, Eric Boerwinkle, Xander H T Wehrens, Christie M Ballantyne, Richard A Gibbs, Amy L Mcguire, Stacey Pereira

Faculty, Staff and Students Publications

BACKGROUND: Routine genome-wide screening for cardiovascular disease risk may inform clinical decision-making. However, little is known about whether clinicians and patients would find such testing useful or acceptable within the context of a genomics-enabled learning health system.

METHODS: We conducted surveys with patients and their clinicians who were participating in the HeartCare Study, a precision cardiology care project that returned results from a next-generation sequencing panel of 158 genes associated with cardiovascular disease risk. Six weeks after return of results, we assessed patients' and clinicians' perceived utility and disutility of HeartCare, the effect of the test on clinical recommendations, and …


Standards In Semen Examination: Publishing Reproducible And Reliable Data Based On High-Quality Methodology, Lars Björndahl, Christopher L R Barratt, David Mortimer, Ashok Agarwal, Robert J Aitken, Juan G Alvarez, Natalie Aneck-Hahn, Stefan Arver, Elisabetta Baldi, Lluís Bassas, Florence Boitrelle, Riana Bornman, Douglas T Carrell, José A Castilla, Gerardo Cerezo Parra, Jerome H Check, Patricia S Cuasnicu, Sally Perreault Darney, Christiaan De Jager, Christopher J De Jonge, Joël R Drevet, Erma Z Drobnis, Stefan S Du Plessis, Michael L Eisenberg, Sandro C Esteves, Evangelini A Evgeni, Alberto Ferlin, Nicolas Garrido, Aleksander Giwercman, Ilse G F Goovaerts, Trine B Haugen, Ralf Henkel, Lars Henningsohn, Marie-Claude Hofmann, James M Hotaling, Piotr Jedrzejczak, Pierre Jouannet, Niels Jørgensen, Jackson C Kirkman Brown, Csilla Krausz, Maciej Kurpisz, Ulrik Kvist, Dolores J Lamb, Hagai Levine, Kate L Loveland, Robert I Mclachlan, Ali Mahran, Liana Maree, Sarah Martins Da Silva, Michael T Mbizvo, Andreas Meinhardt, Roelof Menkveld, Sharon T Mortimer, Sergey Moskovtsev, Charles H Muller, Maria José Munuce, Monica Muratori, Craig Niederberger, Cristian O'Flaherty, Rafael Oliva, Willem Ombelet, Allan A Pacey, Michael A Palladino, Ranjith Ramasamy, Liliana Ramos, Nathalie Rives, Eduardo Rs Roldan, Susan Rothmann, Denny Sakkas, Andrea Salonia, Maria Cristina Sánchez-Pozo, Rosanna Sapiro, Stefan Schlatt, Peter N Schlegel, Hans-Christian Schuppe, Rupin Shah, Niels E Skakkebæk, Katja Teerds, Igor Toskin, Herman Tournaye, Paul J Turek, Gerhard Van Der Horst, Monica Vazquez-Levin, Christina Wang, Alex Wetzels, Theodosia Zeginiadou, Armand Zini Oct 2022

Standards In Semen Examination: Publishing Reproducible And Reliable Data Based On High-Quality Methodology, Lars Björndahl, Christopher L R Barratt, David Mortimer, Ashok Agarwal, Robert J Aitken, Juan G Alvarez, Natalie Aneck-Hahn, Stefan Arver, Elisabetta Baldi, Lluís Bassas, Florence Boitrelle, Riana Bornman, Douglas T Carrell, José A Castilla, Gerardo Cerezo Parra, Jerome H Check, Patricia S Cuasnicu, Sally Perreault Darney, Christiaan De Jager, Christopher J De Jonge, Joël R Drevet, Erma Z Drobnis, Stefan S Du Plessis, Michael L Eisenberg, Sandro C Esteves, Evangelini A Evgeni, Alberto Ferlin, Nicolas Garrido, Aleksander Giwercman, Ilse G F Goovaerts, Trine B Haugen, Ralf Henkel, Lars Henningsohn, Marie-Claude Hofmann, James M Hotaling, Piotr Jedrzejczak, Pierre Jouannet, Niels Jørgensen, Jackson C Kirkman Brown, Csilla Krausz, Maciej Kurpisz, Ulrik Kvist, Dolores J Lamb, Hagai Levine, Kate L Loveland, Robert I Mclachlan, Ali Mahran, Liana Maree, Sarah Martins Da Silva, Michael T Mbizvo, Andreas Meinhardt, Roelof Menkveld, Sharon T Mortimer, Sergey Moskovtsev, Charles H Muller, Maria José Munuce, Monica Muratori, Craig Niederberger, Cristian O'Flaherty, Rafael Oliva, Willem Ombelet, Allan A Pacey, Michael A Palladino, Ranjith Ramasamy, Liliana Ramos, Nathalie Rives, Eduardo Rs Roldan, Susan Rothmann, Denny Sakkas, Andrea Salonia, Maria Cristina Sánchez-Pozo, Rosanna Sapiro, Stefan Schlatt, Peter N Schlegel, Hans-Christian Schuppe, Rupin Shah, Niels E Skakkebæk, Katja Teerds, Igor Toskin, Herman Tournaye, Paul J Turek, Gerhard Van Der Horst, Monica Vazquez-Levin, Christina Wang, Alex Wetzels, Theodosia Zeginiadou, Armand Zini

Faculty, Staff and Student Publications

Biomedical science is rapidly developing in terms of more transparency, openness and reproducibility of scientific publications. This is even more important for all studies that are based on results from basic semen examination. Recently two concordant documents have been published: the 6th edition of the WHO Laboratory Manual for the Examination and Processing of Human Semen, and the International Standard ISO 23162:2021. With these tools, we propose that authors should be instructed to follow these laboratory methods in order to publish studies in peer-reviewed journals, preferable by using a checklist as suggested in an Appendix to this article.


Building Consensus For A Shared Definition Of Adverse Events: A Case Study In The Profession Of Dentistry, Amy Franklin, Elsbeth Kalenderian, Nutan Hebballi, Veronique Delattre, Jini Etoule, Joel White, Ram Vaderhobli, Denice Stewart, Karla Kent, Alfa Yansane, Muhammad Walji Aug 2022

Building Consensus For A Shared Definition Of Adverse Events: A Case Study In The Profession Of Dentistry, Amy Franklin, Elsbeth Kalenderian, Nutan Hebballi, Veronique Delattre, Jini Etoule, Joel White, Ram Vaderhobli, Denice Stewart, Karla Kent, Alfa Yansane, Muhammad Walji

Faculty, Staff and Student Publications

BACKGROUND: To achieve high-quality health care, adverse events (AEs) must be proactively recognized and mitigated. However, there is often ambiguity in applying guidelines and definitions. We describe the iterative calibration process needed to achieve a shared definition of AEs in dentistry. Our alignment process includes both independent and consensus building approaches.

OBJECTIVE: We explore the process of defining dental AEs and the steps necessary to achieve alignment across different care providers.

METHODS: Teams from 4 dental institutions across the United States iteratively reviewed patient records after identification of charts using an automated trigger tool. Calibration across teams was supported through …


Development Of A Quality Improvement Dental Chart Review Training Program, Elsbeth Kalenderian, Nutan B Hebballi, Amy Franklin, Alfa Yansane, Ana M Ibarra Noriega, Joel White, Muhammad F Walji Aug 2022

Development Of A Quality Improvement Dental Chart Review Training Program, Elsbeth Kalenderian, Nutan B Hebballi, Amy Franklin, Alfa Yansane, Ana M Ibarra Noriega, Joel White, Muhammad F Walji

Faculty, Staff and Student Publications

INTRODUCTION: Chart review is central to understanding adverse events (AEs) in medicine. In this article, we describe the process and results of educating chart reviewers assigned to evaluate dental AEs.

METHODS: We developed a Web-based training program, "Dental Patient Safety Training," which uses both independent and consensus-based curricula, for identifying AEs recorded in electronic health records in the dental setting. Training included (1) didactic education, (2) skills training using videos and guided walkthroughs, (3) quizzes with feedback, and (4) hands-on learning exercises. In addition, novice reviewers were coached weekly during consensus review discussions. TeamExpert was composed of 2 experienced reviewers, …


Translating Electronic Health Record-Based Patient Safety Algorithms From Research To Clinical Practice At Multiple Sites, Andrew J Zimolzak, Hardeep Singh, Daniel R Murphy, Li Wei, Sahar A Memon, Divvy K Upadhyay, Saritha Korukonda, Lisa Zubkoff, Dean F Sittig Jul 2022

Translating Electronic Health Record-Based Patient Safety Algorithms From Research To Clinical Practice At Multiple Sites, Andrew J Zimolzak, Hardeep Singh, Daniel R Murphy, Li Wei, Sahar A Memon, Divvy K Upadhyay, Saritha Korukonda, Lisa Zubkoff, Dean F Sittig

Faculty, Staff and Students Publications

INTRODUCTION: Researchers are increasingly developing algorithms that impact patient care, but algorithms must also be implemented in practice to improve quality and safety.

OBJECTIVE: We worked with clinical operations personnel at two US health systems to implement algorithms to proactively identify patients without timely follow-up of abnormal test results that warrant diagnostic evaluation for colorectal or lung cancer. We summarise the steps involved and lessons learned.

METHODS: Twelve sites were involved across two health systems. Implementation involved extensive software documentation, frequent communication with sites and local validation of results. Additionally, we used automated edits of existing code to adapt it …