Patient Safety Commons^™

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

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. …

Development And Evaluation Of An Implementation Strategy To Increase Hpv Vaccination Among Underserved Youth Across Texas: A Protocol Paper, Paula M Cuccaro, Jihye Choi, Lara S Savas, Efrat K Gabay, Mayra Aguilar Mcbride, Amy Montelongo Eldridge, Timothy J Walker

Faculty, Staff and Student Publications

BACKGROUND: All for Them is a theory-based and evidence-informed multilevel, multicomponent program delivered through schools to increase HPV vaccination among medically underserved youth across Texas. Given the potential logistical challenges of program implementation, understanding how to best support the implementation and sustainment of the program is critical. The overall goals of this study are twofold: 1) develop a multifaceted implementation strategy, Implementing All for Them (IM-AFT); and 2) evaluate the impact of IM-AFT on implementation outcomes for schools and healthcare providers to successfully implement All for Them in their respective settings.

METHODS: This study is underpinned by a comprehensive and …

Neurohospitalist Core Competencies, Jana J Wold, Jetter Robertson, Jerome A Jeevarajan, Molly G Knox, Prateek Thatikunta, Guillermo E Solorzano, Kristin Galetta, Shefali Dujari, Tarini Goyal, Matthew E Ehrlich, Jonathan P Donnelly, Elizabeth Marriott, Vishal A Mandge, Roshni S Dhoot, Matthew W Luedke, Matthew B Maas, Margaret Y Yu, Michel Toledano, Rafid Mustafa, Jamie L Palaganas, Kathryn Kvam, Rachelle Dugue, Ethan Meltzer, Lahoud Touma, Maulik P Shah, Vanja C Douglas, Karen Orjuela, Brian J Scott, Joshua P Klein, David J Likosky, Jennifer R Simpson, Megan B Richie, Carolin Dohle, Jane G Morris, Carl A Gold

Faculty, Staff and Student Publications

The Neurohospitalist Core Competencies comprise a set of competency-based learning objectives that encapsulate the knowledge, skills, and attitudes of neurohospitalitists who specialize in the care of hospitalized patients with neurologic conditions. These competencies serve to characterize the rapidly expanding field of neurohospitalist medicine. The 27 chapters are divided into 3 sections entitled: neurological conditions, clinical interventions and interpretation of ancillary studies, and neurohospitalist role in the healthcare system. Each individual learning objective in the chapters describes a specific concept with an action verb to illustrate the behavior that the neurohospitalist exhibits. The individual neurohospitalist may not exhibit mastery in each …

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

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 …

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 …

Practical Considerations For Navigating Withdrawal From The Federal Select Agent Program, Scott J Patlovich, Kristin G King, Robert J Emery, Zackary B Becker, Rebecca B Kairis

Faculty, Staff and Student Publications

INTRODUCTION: Clear guidance is provided by the Federal Select Agent Program (FSAP) to assist registered entities in nearly all facets of compliance with the Federal select agent regulations (7 CFR Part 331; 9 CFR Part 121; 42 CFR Part 73). If a registered entity chooses to discontinue its registration, detailed instructions for registration withdrawal are deeply embedded within a document entitled "eFSAP Form 1 Amendment Instructions," which is found on the FSAP website within the electronic Federal Select Agent Program (eFSAP) Resource Center.

METHODS: Using the information found within the eFSAP Form 1 Amendment Instructions, as well as extensive written …

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 …

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 …

A Review Of Magnetic Resonance (Mr) Safety: The Essentials To Patient Safety, Aren Shah, Shima Aran

Faculty, Staff and Student Publications

Nearly 40 million magnetic resonance imaging (MRI) scans are performed each year in the United States. MRI has become a relatively safe non-invasive diagnostic tool. To maintain a safe magnetic resonance (MR) environment, specific policies and safety procedures are required. The four zones of an MR site allow MR personnel to closely monitor and restrict the area. Screening patients with a questionnaire asking about implants, allergies to contrast agents, and other relevant medical information is important to safely perform an MRI scan. Providers may need to consider anesthesia for patients with claustrophobia who are unable to remain motionless. Radiologists and …

Perioperative Team-Based Morbidity And Mortality Conferences: A Systematic Review Of The Literature, Aubrey Samost-Williams, Roni Rosen, Alexander Hannenberg, Melis Lydston, Garrett M Nash, Mary Brindle

Faculty, Staff and Student Publications

OBJECTIVE: This systematic review aimed to identify key elements of perioperative team-based morbidity and mortality conferences (TBMMs) and their impact on patient safety, education, and quality improvement outcomes.

BACKGROUND: Patient safety in the perioperative period is influenced by system, team, and individual behaviors. However, despite this recognition, single-discipline morbidity and mortality conferences remain a mainstay of educational and quality improvement efforts.

METHODS: A structured search was conducted in MEDLINE Complete, Embase, Web of Science, ClinicalTrials.gov, Cochrane CENTRAL, and ProQuest Dissertations and Theses Global in July 2022. Search results were screened, and the articles meeting inclusion criteria were abstracted.

RESULTS: Seven …

Add-On Soft Electronic Interfaces For Continuous Cuffless Blood Pressure Monitoring, Myeong Namkoong, Balaji Baskar, Lakhvir Singh, Heng Guo, Justin Mcmurray, Kimberly Branan, Md Saifur Rahman, Chin-To Hsiao, Josh Kuriakose, Joanna Hernandez, Arda A Arikan, Luis E Garza-Rivera, Gerard L Coté, Limei Tian

Faculty, Staff and Student Publications

Continuous monitoring of arterial blood pressure is clinically important for the diagnosis and management of cardiovascular diseases. Soft electronic devices with skin-like properties show promise in a wide range of applications, including the human-machine interface, the Internet of things, and health monitoring. Here, we report the use of add-on soft electronic interfaces to address the connection challenges between soft electrodes and rigid data acquisition circuitry for bioimpedance monitoring of cardiac signals, including heart rate and cuffless blood pressure. Nanocomposite films in add-on electrodes provide robust electrical and mechanical contact with the skin and the rigid circuitry. We demonstrate bioimpedance sensors …

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 …

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 …

Evaluating The Usability Of An Emergency Department After Visit Summary: Staged Heuristic Evaluation, Hanna J Barton, Megan E Salwei, Rachel A Rutkowski, Kathryn Wust, Sheryl Krause, Peter Lt Hoonakker, Paula Vw Dail, Denise M Buckley, Alexis Eastman, Brad Ehlenfeldt, Brian W Patterson, Manish N Shah, Barbara J King, Nicole E Werner, Pascale Carayon

Faculty, Staff and Student Publications

BACKGROUND: Heuristic evaluations, while commonly used, may inadequately capture the severity of identified usability issues. In the domain of health care, usability issues can pose different levels of risk to patients. Incorporating diverse expertise (eg, clinical and patient) in the heuristic evaluation process can help assess and address potential negative impacts on patient safety that may otherwise go unnoticed. One document that should be highly usable for patients-with the potential to prevent adverse outcomes-is the after visit summary (AVS). The AVS is the document given to a patient upon discharge from the emergency department (ED), which contains instructions on how …

Independent Associations Of Neighborhood Deprivation And Patient-Level Social Determinants Of Health With Textbook Outcomes After Inpatient Surgery, Susanne Schmidt, Jeongsoo Kim, Michael A Jacobs, Daniel E Hall, Karyn B Stitzenberg, Lillian S Kao, Bradley B Brimhall, Chen-Pin Wang, Laura S Manuel, Hoah-Der Su, Jonathan C Silverstein, Paula K Shireman

Faculty, Staff and Student Publications

OBJECTIVE: Assess associations of Social Determinants of Health (SDoH) using Area Deprivation Index (ADI), race/ethnicity and insurance type with Textbook Outcomes (TO).

SUMMARY BACKGROUND DATA: Individual- and contextual-level SDoH affect health outcomes, but only one SDoH level is usually included.

METHODS: Three healthcare system cohort study using National Surgical Quality Improvement Program (2013-2019) linked with ADI risk-adjusted for frailty, case status and operative stress examining TO/TO components (unplanned reoperations, complications, mortality, Emergency Department/Observation Stays and readmissions).

RESULTS: Cohort (34,251 cases) mean age 58.3 [SD=16.0], 54.8% females, 14.1% Hispanics, 11.6% Non-Hispanic Blacks, 21.6% with ADI>85, and 81.8% TO. Racial and …

Sustainability Considerations For Consumables Used In Microbiological And Biomedical Laboratories, Autumn Cerda, Robert Emery, Scott Patlovich

Faculty, Staff and Student Publications

Introduction: The 6th edition of the Biosafety in Microbiological and Biomedical Laboratories includes Appendix L on sustainability that describes a series of considerations for biocontainment facilities. But many biosafety practitioners may not be familiar with sustainability options that are available, feasible, and safe for laboratory settings as training in this realm is not common.

Methods: With a particular focus on consumable products used in containment laboratory operations, a comparative assessment was made regarding sustainability activities employed in the healthcare setting, where significant advances have been achieved.

Results: Table 1 has been created that describes various consumables that result in waste …

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

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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

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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 …

Analysis Of Nurse And Patient Preferences For Pre-Filled Pen Devices For Self-Injection Of Highly Purified Human Menopausal Gonadotropin (Hp-Hmg, Menopurr, Guy De Mesmaeker, Brigitte Calles, Judith A Smith

Faculty, Staff and Student Publications

PURPOSE: This study aimed to identify the most important attributes for a gonadotropin pen as perceived by assisted reproductive technology (ART) patients and fertility nurses, and to examine how well a prototype HP-hMG (MENOPUR

PATIENTS AND METHODS: This market research study incorporated a two-part survey with respondents (N=221) from Poland, Spain and the UK. Respondents included patients (n=141) who consulted a fertility specialist in the previous 2 years, and fertility nurses (n=80) who assisted in at least 75 ART cycles/year. Patients were divided into two subgroups depending on their experience with ART (experienced and naïve). Key attributes for an injection …

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

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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.

Experiential Learning In Patient Safety: A Multi-Center Study Examining Emergency Medicine Residents' Situational Awareness Of Hazards Via Simulation, Kamna S Balhara, Nathan Olson, Jessica L Wilson, Rosemarie G Ramos, Harlan J Goode, Andrew E Muck, Adriana S Olson

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Introduction The 2016 Clinical Learning Environment Review established that experiential patient safety curricula for residents are uncommon. Moreover, these curricula do not incorporate non-technical skills linked to safety, such as situational awareness (SA). We developed an in-situ patient safety simulation exercise incorporating core SA concepts and subsequently assessed exercise feasibility and acceptability, and measured residents' safety SA. Methods A simulation scenario and mock chart were designed, incorporating 16 patient safety hazards. Residents at two institutions reviewed the chart and had 10 minutes in an emergency department room with the simulated scenario to document identified hazards, followed by a facilitated debriefing. …

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

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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

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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, …

An Observational Retrospective Study Of Adverse Events And Behavioral Outcomes During Pediatric Dental Sedation, Kawtar Zouaidi, Gregory Olson, Helen H Lee, Elsbeth Kalenderian, Muhammad F Walji

Faculty, Staff and Student Publications

Purpose: The purpose of this study was to examine a university-based dental electronic health records (EHR) database to identify sedation-related adverse events (AEs) and assess patients' behavioral outcomes during routine pediatric dental sedations (PDSs) in a dental school clinic.

Methods: A database was screened for patients younger than 18 years old who had received dental sedation in 2019. The qualifying EHRs were then accessed and sedations were reviewed for AEs, which were categorized using a 12-point classification system and the Tracking and Reporting Outcomes of Procedural Sedation Tool. Patient behaviors were assessed using provider progress notes and categorized as presence/ …

Long-Term Impacts Faced By Patients And Families After Harmful Healthcare Events, Madelene J Ottosen, Emily W Sedlock, Aitebureme O Aigbe, Sigall K Bell, Thomas H Gallagher, Eric J Thomas

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BACKGROUND: Patients and families report experiencing a multitude of harms from medical errors resulting in physical, emotional, and financial hardships. Little is known about the duration and nature of these harms and the type of support needed to promote patient and family healing after such events. We sought to describe the long-term impacts (LTIs) reported by patients and family members who experienced harmful medical events 5 or more years ago.

METHODS: We performed a content analysis on 32 interviews originally conducted with 72 patients or family members about their views of the factors contributing to their self-reported harmful event. Interviews …

The Cortico-Limbo-Thalamo-Cortical Circuits: An Update To The Original Papez Circuit Of The Human Limbic System, Jochen Profit, Paul J Sharek, Xin Cui, Courtney C Nisbet, Eric J Thomas, Daniel S Tawfik, Henry C Lee, David Draper, J Bryan Sexton

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OBJECTIVES: Key validated clinical metrics are being used individually and in aggregate (Baby-MONITOR) to monitor the performance of neonatal intensive care units (NICUs). The degree to which perceptions of key components of safety culture, safety climate, and teamwork are related to aspects of NICU quality of care is poorly understood. The objective of this study was to test whether NICU performance on key clinical metrics correlates with caregiver perceptions of safety culture.

STUDY DESIGN: Cross-sectional study of 6253 very low-birth-weight infants in 44 NICUs. We measured clinical quality via the Baby-MONITOR and its nine risk-adjusted and standardized subcomponents (antenatal corticosteroids, …

Preoccupation With Failure And Adherence To Shared Baselines: Measuring High-Reliability Organizational Culture, Jason M Etchegaray, Eric J Thomas, Jochen Profit

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OBJECTIVE: To create, administer, and psychometrically examine a survey to measure two new organizational culture factors - preoccupation with failure and adherence to shared baselines - in healthcare settings.

METHOD: Direct care providers (n = 4484) from a large healthcare system in the Southern United States completed a survey as part of their annual safety culture assessment.

RESULTS: We provide evidence about the internal consistency (Cronbach's alpha ranged from .80 to .89) factor structure, concurrent validity (correlation with overall patient safety grade ranged from .60 to .67, p

CONCLUSIONS: We established evidence for internal consistency and validity of two new …