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Informed Consent In Surgical Practice With Patients’ Experiences: A Cross-Sectional Study, Seda Kumru, Pakize Yiğit, Meryem Demirtaş, Hüseyin Fındık

Patient Experience Journal

This study aims to evaluate patients' experiences and perspectives regarding informed consent in surgical practice. Data for this cross-sectional study were collected from 276 patients using a questionnaire developed by Falagas et al. Descriptive statistics were employed for all questions. Statistical tests such as the Mann-Whitney U test, Kruskal-Wallis test, and Spearman's rank correlation analysis were performed, and Cohen's effect sizes were reported. IBM SPSS 23.0 was used for all analyses, and p<0.05 was considered statistically significant. A high score on both The Delivered Information Index and The Patient-Physician Index represents a positive informed consent process. Among the participants, 65.2% indicated that they understood all parts of the consent form. Of all patients, 92.8% reported that information about the specific surgical procedure was provided by physicians. However, 47.5% of the patients reported that they did not feel comfortable with their surgeons. The mean score of the Delivered Information Index was 5.63 (2.38). The mean patient-physician relationship score was 14.38 (3.31). There was a moderate positive correlation between the delivered information index and the patient-physician relationship (r=0.50; p<0.001). In addition, there was a moderate positive correlation between the delivered information index and the time spent on the informed consent process, as well as between the patient-physician relationship and the time spent on the informed consent process (r=0.52; r=0.40, respectively). The study emphasized the lack of communication between patients and physicians, the limitation of information on treatment risks, adverse effects, and alternative treatment options.

Experience Framework

This article is associated with the Policy & Measurement lens of The Beryl Institute Experience Framework (https://theberylinstitute.org/experience-framework/).

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Patient Perspectives Of Health-Related Social Needs Screening In An Urban Academic Adult Primary Care Practice, Antony Nguyen, Joselvin Galeas, Jane Jih

Patient Experience Journal

Health-related social needs (HRSNs) affect health outcomes and healthcare utilization. Patients’ perspectives on the incorporation of HRSN screening in primary care settings is limited. We sought to explore adult primary care patient perspectives of HRSN screening from optional patient-provided free-text comments as part of a pilot self-administered HRSN screening survey on seven domains of HRSNs from the Accountable Health Communities HRSNs Screening Tool. The survey was available in English, Chinese or Spanish with a section titled “Comments” that invited patient respondents to provide anonymous free-text responses. We performed a thematic analysis of the written patient comments. Of the 679 participants …

The Silence Of Mitotic Figures, Hope K. Haefner Md

Patient Experience Journal

A career in medicine is guided by the patients you treat and those who have taught you to treat these individuals. Communication is of utmost importance in all aspects of healthcare. However, there are times when communication can be difficult. This story takes you through a physician’s experience that led to a career in women’s healthcare, reflecting on the silence that prevailed as her journey began.

Experience Framework

This article is associated with the Staff & Provider Engagement lens of The Beryl Institute Experience Framework (https://theberylinstitute.org/experience-framework/).

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Renal Disease Rehabilitation And Delaying Dialysis, Spencer Brown, Natalie Sterner

Clinical Research in Practice: The Journal of Team Hippocrates

A clinical decision report using:

Greenwood SA, Koufaki P, Mercer TH, et al. Effect of exercise training on estimated GFR, vascular health, and cardiorespiratory fitness in patients with CKD: a pilot randomized controlled trial. Am J Kidney Dis. 2015;65(3):425-434. https://doi.org/10.1053/j.ajkd.2014.07.015

for a patient with non-dialysis CKD interested in slowing the progression toward necessary dialysis.

Slow Surgical Correction Affects More Than Just The Bowels, Emilia M. Clementi

Clinical Research in Practice: The Journal of Team Hippocrates

Reflection on how delayed colostomy reversal affects a patient's mental and physical well-being.

A Phase Ii Study Of Bevacizumab And Temsirolimus In Advanced Extra-Pancreatic Neuroendocrine Tumors., Sonia M Abuzakhm, Vineeth Sukrithan, Briant Fruth, Rui Qin, Jonathan Strosberg, Timothy J Hobday, Thomas Semrad, Diane Reidy-Lagunes, Hedy Lee Kindler, George P Kim, Jennifer J Knox, Andreas Kaubisch, Miguel Villalona-Calero, Helen Chen, Charles Erlichman, Manisha H Shah

Oncology Articles

We assessed the efficacy and safety of combining bevacizumab with temsirolimus in patients with advanced extra-pancreatic neuroendocrine tumors. This NCI-sponsored multicenter, open-label, phase II study (NCT01010126) enrolled patients with advanced, recurrent, or metastatic extra-pancreatic neuroendocrine tumors. All patients were treated with temsirolimus and bevacizumab until disease progression or unacceptable toxicity. Temsirolimus 25 mg was administered i.v. on days 1, 8, 15, and 22 and bevacizumab 10 mg/kg i.v. on days 1 and 15 of a 4-week cycle. Discontinuation of temsirolimus or bevacizumab did not require discontinuation of the other agent. The primary endpoints were objective response rate and 6-month progression-free …

Incidental Recognition Of Umbilical-Portal-Systemic Venous Shunt Diagnosed During Bpp For Decreased Fetal Movement, Kathleen Lundeberg, Adam Hiett

Obstetrics and Gynecology Faculty Publications

Background: The prevalence of prenatally diagnosed umbilical-portal systemic venous shunts (UPSVS) is reportedly rare, ranging from 0.003-0.209% [1]. Disruption in the normal development of the fetal venous system can be caused by primary failure of a system or by secondary occlusion of an already transformed system [2]. While UPSVS’s are rare, the downstream effects are potentially fatal, including intrauterine growth restriction, high output cardiac failure, associated neonatal morbidity and mortality, and thus necessitate early detection with appropriate monitoring.

Introduction: The patient was a 21-year-old G2P1001 who presented to the Maternal Fetal Medicine Ultrasound Genetics (MFMUG) clinic at 36w2d for a …

Enhancing Diabetes Care In Lmics: Insights From A Multinational Consensus, Jose Carlos Miranda, S Abbas Raza, Babatope Kolawole, Jahanzeb Kamal Khan, Atiba Alvi, Fariha Sadiq Ali, Ejim Emmanuel Chukwudi, Nanik Ram, Amira Oluwatoyin

Section of Diabetes, Endocrinology and Metabolism

The International Cardio-Metabolic Forum held a plenary session to establish a multinational consensus on the challenges faced in diabetes management within lower-middle-income countries (LMICs) and their potential solutions. Stakeholders, including patients, family/caretakers, healthcare professionals, and healthcare policymakers & organizations, participated in discussions. The audience of 280 doctors from 15 different countries (Pakistan, Qatar, Sri Lanka, Kenya, Myanmar, Georgia, Nigeria, Philippines, Uzbekistan, Iraq, Tanzania, Cambodia, Kazakhstan, South Sudan and Libya) was divided into 4 groups led by Group Leaders to represent each stakeholder group. Questionnaires addressing key challenges and solutions specific to each group were used to facilitate consensus development. Participants …

Benchmark Dataset For Training Machine Learning Models To Predict The Pathway Involvement Of Metabolites, Erik D. Huckvale, Christian D. Powell, Huan Jin, Hunter N. B. Moseley

Markey Cancer Center Faculty Publications

Metabolic pathways are a human-defined grouping of life sustaining biochemical reactions, metabolites being both the reactants and products of these reactions. But many public datasets include identified metabolites whose pathway involvement is unknown, hindering metabolic interpretation. To address these shortcomings, various machine learning models, including those trained on data from the Kyoto Encyclopedia of Genes and Genomes (KEGG), have been developed to predict the pathway involvement of metabolites based on their chemical descriptions; however, these prior models are based on old metabolite KEGG-based datasets, including one benchmark dataset that is invalid due to the presence of over 1500 duplicate entries. …

Ada Deficiency: Improvement In Immune Function After Enzyme Replacement Therapy, Esosa Adah, Nikita Raje

Posters

Introduction: Adenosine deaminase (ADA)-deficient severe combined immunodeficiency (SCID) is characterized by severe lymphocytopenia affecting T-, and B-,lymphocytes, with non-immunological manifestations including neurodevelopmental deficits, sensorineural deafness, and skeletal abnormalities. Treatment modalities include enzyme replacement therapy(ERT) and/or autologous gene therapy or hematopoietic stem cell treatment. We report a 9-month-old female with ADA deficient T-B-NK+ SCID treated with ERT while awaiting stem cell treatment. Case Description: A 9-month-old female with a history of failure to thrive, hypotonia and loss of developmental milestones had genetic testing done that showed variants ADA c.911 T>G, c.302G>A. She was admitted for further work up. Lymphocyte …

Psychological Safety And Conflict Management Among Nurse Practitioners In Interprofessional Teams, Scott Tyler Faust

Electronic Theses and Dissertations

This quantitative correlational study explored the relationships between perceived psychological safety, conflict management styles, and perceived conflict management success among nurse practitioners (NPs) operating in interprofessional acute or critical care teams in the United States. Despite existing literature on conflict management and psychological safety, there is a noticeable gap concerning the interplay of these factors, specifically among NPs. A multi-item survey was developed from validated measures to assess psychological safety, conflict management success, and conflict management style. The final sample included 944 NPs. The findings revealed a statistically significant difference in the scores of perceived psychological safety, depending on the …

Tunnel-Free Acromioclavicular Joint Reconstruction Is Associated With Improved Initial Reduction And Higher Patient Satisfaction, Brittany A Olsen, Joshua W Rollins, Daniel H Ngo, James M Gregory

Faculty, Staff and Student Publications

BACKGROUND: Many surgical techniques have been described for acromioclavicular (AC) joint reconstruction. Creation of bone tunnels through the clavicle or coracoid has been shown to be a risk factor for fracture. Use of an AC reconstruction technique that does not create bone tunnels may obviate this risk. This study aims to evaluate clinical outcomes of AC joint reconstruction using a tunnel-free technique compared to reconstruction using a cortical button and clavicular drill holes.

METHODS: Consecutive patients who underwent AC joint reconstruction by a single surgeon in a subspecialty referral practice were included. One group of patients received cortical button fixation …

Bowel Cleanout Prior To Intrathecal Baclofen Pump Implantation: Effects On Acute Post- Operative Gastrointestinal Complications, Amanda Lindenberg, Brittni Walton, Sathya Vadivelu, Matthew J. Mclaughlin

Posters

Background: Intrathecal baclofen (ITB) pumps have been used for management of spasticity and dystonia There is limited data on immediate post-operative complications such as GI adverse events after surgery for ITB pump related procedures. This study aimed to compare patients who underwent a pre-operative bowel cleanout to those who did not and the relationship with post-operative nausea, vomiting and constipation requiring an escalation of their bowel regimen. Design: Retrospective cohort study. Setting: Pediatric acute care hospital. Participants: All patients who underwent new ITB pump and/or catheter placement from January 2015-December 2022. Interventions: Preoperative bowel clean out. Main Outcome Measure: Quantity …

Increasing Annual Eye Exam Completion For Children With Cystic Fibrosis Receiving Cftr Modulators, Paula Capel, Claire Elson, Stephanie Duehlmeyer, Jessica Haynes, Amanda Conway, Christopher M. Oermann

Posters

Background: CFTR modulators are life-changing therapy for people with CF. During preclinical studies of ivacaftor, cataracts were identified in juvenile rat pups. Subsequently, noncongenital cataracts have been reported in children receiving CFTR modulator therapy [1], so baseline and annual slit lamp eye examinations for cataract development are recommended for children with CF (aged <18). At Children’s Mercy Kansas City (CMKC), our standard practice is to conduct baseline and annual ophthalmologic examinations to assess for cataracts in children with CF prescribed CFTR modulator therapy, but there was no formal process for tracking adherence to this standard and ensuring that examinations were completed. A quality improvement project was undertaken in May 2022 to determine the rate of completion of annual eye exams and increase adherence to our annual monitoring standard.

Methods: To improve adherence to annual monitoring standards, a quality improvement taskforce including CF care team nurses and pharmacists was developed. A database was used to document baseline and follow-up eye examinations. A standardized communication process was developed and deployed that included an eye exam brochure (Figure …

Maternal And Perinatal Outcomes Of Women With Vaginal Birth After Cesarean Section Compared To Repeat Cesarean Birth In Select South Asian And Latin American Settings Of The Global Network For Women's And Children's Health Research, Lester Figueroa, Margo Harrison, Manolo Mazariegos, Shivaprasad Gouda, Avinash Kavi, Richard Derman, Archana Patel, Prabir Das, Sarah Saleem, Farnaz Naqvi

Community Health Sciences

Objective: Our objective was to analyze a prospective population-based registry including five sites in four low- and middle-income countries to observe characteristics associated with vaginal birth after cesarean versus repeat cesarean birth, as well as maternal and newborn outcomes associated with the mode of birth among women with a history of prior cesarean.
Hypothesis: Maternal and perinatal outcomes among vaginal birth after cesarean section will be similar to those among recurrent cesarean birth.
Methods: A prospective population-based study, including home and facility births among women enrolled from 2017 to 2020, was performed in communities in Guatemala, India (Belagavi and Nagpur), …

Population-Specific Mutation Patterns In Breast Tumors From African American, European American, And Kenyan Patients, Wei Tang, Jung S. Byun, Tiffany H. Dorsey, Harris G. Yfantis, Anuoluwapo Ajao, Huaitian Liu, Margaret S. Pichardo, Catherine M. Pichardo, Alexandra R. Harris, Shahin Sayed

Pathology, East Africa

Women of African descent have the highest breast cancer mortality in the United States and are more likely than women from other population groups to develop an aggressive disease. It remains uncertain to what extent breast cancer in Africa is reminiscent of breast cancer in African American or European American patients. Here, we performed whole-exome sequencing of genomic DNA from 191 breast tumor and non-cancerous adjacent tissue pairs obtained from 97 African American, 69 European American, 2 Asian American, and 23 Kenyan patients. Our analysis of the sequencing data revealed an elevated tumor mutational burden in both Kenyan and African …

Anticoagulation Therapies And Vte Risk Assessment, Children's Mercy Kansas City

Clinical Pathways

No abstract provided.

Hyperleukocytosis/Leukapheresis, Children's Mercy Kansas City

Clinical Pathways

Hyperleukocytosis is a life-threatening oncology emergency, defined as a white blood cell (WBC) count ≥ 100,000/µL and can occur in up to 20% of patients with acute myeloid or lymphoid leukemias (Abla et al., 2016). Hyperleukocytosis may lead to leukostasis and subsequent end organ damage, commonly affecting the central nervous system, respiratory and renal systems, and can also cause tumor lysis syndrome (TLS), another oncology emergency, and lead to metabolic derangements and further renal dysfunction (Porcu et al., 2000). Treatment of hyperleukocytosis includes supportive care, early initiation of chemotherapy and/or leukapheresis (Zhang et al., 2021). There are no definitive guidelines …

Birth Brachial Plexus Injury (Bbpi): Management Of Shoulder Subluxation/Dislocation, Children's Mercy Kansas City

Clinical Pathways

BBPI most often, but not always, occurs during the delivery process as the infant descends through the birth canal and the shoulder becomes lodged on the mother’s pelvic bone. As contraction begins, the infant’s neck and shoulder are stretched which can cause tears or ruptures of the nerves within the brachial plexus thus impacting the sensation and movement of the affected upper extremity. Incidence of brachial plexus injuries in the United States is 0.4 to 4 in 1,000 live births (Abzug, et al., 2018; Foad et al., 2008; Hoeksma et al., 2004; Waters, 1997). Although many of these infants will …

Limited Clinical Utility Of Routine Mycobacterial Cultures For The Management Of Diabetic Foot Infections, Laila M. Castellino, Clare Mccormick-Baw, Tyler Coye, Peter A. Crisologo, John J. Hanna, Francesca Lee, Andrew Clark, Michael Fanning, Amanda L. Killeen

School of Podiatric Medicine Publications

Mycobacterial infections of the foot and ankle are uncommon. In a cohort of 2340 patients with diabetic foot infection (DFI) in a region with increased prevalence of mycobacterial disease, we identified no clinically significant positive cultures over a 3-year period. Routine mycobacterial culture of DFIs is of limited clinical utility.

Access To Pediatric Neurology Training And Services Worldwide:A Survey By The International Child Neurology Association, Jo M Wilmshurst, Coriene Catsman- Berrevoets, Donald L. Gilbert, Lakshmi Nagarajan, Pauline Samia, Esra Serdaroglu Serdaroglu, Chahnez Triki, Jorge Vidaurre, Biju Hameed

Paediatrics and Child Health, East Africa

Pediatric neurology is the medical subspecialty responsible for diagnosing and managing diseases and disorders of the nervous system in childhood and adolescence. In many, but not all, regions of the world, the discipline of pediatric neurology is recognized as a specialty or subspecialty of either neurology or pediatrics. Significant knowledge and competencies in this area are necessary to be effective in clinical practice. The need for this is driven by the high burden of disease from neurologic conditions in children and the effect on their families. As the first part of a multistaged project under the auspices of the International …

World Allergy Organization (Wao) Diagnosis And Rationale For Action Against Cow's Milk Allergy (Dracma) Guidelines Update – X – Breastfeeding A Baby With Cow's Milk Allergy, Vicki Mcwilliam, Merryn Netting, Evelyn Volders, Debra Palmer, Ignacio Ansotegui, Stefania Arasi, Amal H. Assa'ad, Sami L. Bahna, Antonio Bognanni, Rose Kamenwa

Paediatrics and Child Health, East Africa

Cow’s milk allergy is rare in exclusively breastfed infants. To support the continuation of breastfeeding an infant after diagnosis with a cow’s milk allergy, it is critical to examine the evidence for and against any form of cow’s milk elimination diet for lactating mothers. In this narrative review, we highlight the lack of high-quality evidence, hence subsequent controversy, regarding whether the minuscule quantities of cow’s milk proteins detectable in human milk cause infant cow’s milk allergy symptoms. Current clinical practice recommendations advise a 2–4 week trial of maternal cow’s milk dietary elimination for: a) IgE-mediated cow’s milk allergy only if …

Multimodal Analysis Of Secondary Cerebellar Alterations After Pediatric Traumatic Brain Injury, Finian Keleher, Hannah M Lindsey, Rebecca Kerestes, Houshang Amiri, Robert F Asarnow, Talin Babikian, Brenda Bartnik-Olson, Erin D Bigler, Karen Caeyenberghs, Carrie Esopenko, Linda Ewing-Cobbs, Christopher C Giza, Naomi J Goodrich-Hunsaker, Cooper B Hodges, Kristen R Hoskinson, Andrei Irimia, Marsh Königs, Jeffrey E Max, Mary R Newsome, Alexander Olsen, Nicholas P Ryan, Adam T Schmidt, Dan J Stein, Stacy J Suskauer, Ashley L Ware, Anne L Wheeler, Brandon A Zielinski, Paul M Thompson, Ian H Harding, David F Tate, Elisabeth A Wilde, Emily L Dennis

Faculty, Staff and Student Publications

Importance: Traumatic brain injury (TBI) is known to cause widespread neural disruption in the cerebrum. However, less is known about the association of TBI with cerebellar structure and how such changes may alter executive functioning.

Objective: To investigate alterations in subregional cerebellum volume and cerebral white matter microstructure after pediatric TBI and examine subsequent changes in executive function.

Design, setting, and participants: This retrospective cohort study combined 12 data sets (collected between 2006 and 2020) from 9 sites in the Enhancing Neuroimaging Genetics Through Meta-Analysis Consortium Pediatric TBI working group in a mega-analysis of cerebellar structure. Participants with TBI or …

Physical Examination Versus Ultrasonography For Detection Of Ulnar Nerve Subluxation In Professional Baseball Pitchers, Austin Looney, Hannah Day, Manoj Reddy, Ryan Paul, Levon Nazarian, Steven Cohen

Rothman Institute Papers

Background: Despite the importance of accurately detecting ulnar nerve subluxation in vulnerable athletes, few studies have compared the performance of physical examination and ultrasound in this population. Purpose/Hypothesis: The purpose of this study was to compare the diagnostic validity of physical examination versus ultrasound in detecting ulnar nerve subluxation at the cubital tunnel of the elbow in professional baseball pitchers. It was hypothesized that ultrasound would more sensitively detect ulnar nerve subluxation. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Physical and sonographic examinations for ulnar nerve subluxation were performed on 186 elbows of 95 consecutive male professional …

Blood Culture Versus Antibiotic Use For Neonatal Inpatients In 61 Hospitals Implementing With The Nest360 Alliance In Kenya, Malawi, Nigeria, And Tanzania: A Cross-Sectional Study, Sarah Murless-Collins, Kondwani Kawaza, Nahya Salim, Elizabeth Molyneux, Msandeni Chiume, Jalemba Aluvaala Aluvaala, William Macharia, Veronica Chinyere Ezeaka, Opeyemi Odedere, Donat Shamba

Paediatrics and Child Health, East Africa

Background: Thirty million small and sick newborns worldwide require inpatient care each year. Many receive antibiotics for clinically diagnosed infections without blood cultures, the current ‘gold standard’ for neonatal infection detection. Low neonatal blood culture use hampers appropriate antibiotic use, fuelling antimicrobial resistance (AMR) which threatens newborn survival. This study analysed the gap between blood culture use and antibiotic prescribing in hospitals implementing with Newborn Essential Solutions and Technologies (NEST360) in Kenya, Malawi, Nigeria, and Tanzania.

Methods: Inpatient data from every newborn admission record (July 2019–August 2022) were included to describe hospital-level blood culture use and antibiotic prescription. Health Facility …

Assessing The Neuropsychiatric Sequelae Of Ketamine After Use For Acute Agitation, Steven Sun Md, Henry Slone, Katherine B. Martin Md, Edward R. Norris Md, Fapa, Fapm

Department of Psychiatry

No abstract provided.

Survival Of Cervical Cancer Patients At Moi Teaching And Referral Hospital, Eldoret In Western Kenya, E Mwaliko, P. Itsura, A. Keter, N. Buziba, H. Bastiaens, A. Jackie, A. Obala, V. Naanyu, P. Gichangi, Marleen Temmerman

Obstetrics and Gynaecology, East Africa

Background Cervical cancer is a major health burden and the second most common cancer after breast cancer among women in Kenya. Worldwide cervical cancer constitutes 3.1% of all cancer cases. Mortality rates are greatest among the low-income countries because of lack of awareness, screening and early-detection programs and adequate treatment facilities.

The main aim was to estimate survival and determine survival predictors of women with cervical cancer and limited resources in western Kenya.

Methods Retrospective charts review of women diagnosed with cervical cancer and follow-up for two years from the date of the histologic diagnosis. The outcome of interest was …

Inflammation And Fibrosis In Orbital Inflammatory Disease: A Histopathologic Analysis., Rohan Verma, Allison J Chen, Dongseok Choi, David J Wilson, Hans E Grossniklaus, Roger A Dailey, John D Ng, Eric A Steele, Stephen R Planck, Craig N Czyz, Bobby S Korn, Don O Kikkawa, Jill A Foster, Michael Kazim, Gerald J Harris, Deepak P Edward, Azza Al Maktabi, James T Rosenbaum

Surgery Articles

PURPOSE: The purpose of this study was to compare the histopathologic inflammation and fibrosis of orbital adipose tissue in orbital inflammatory disease (OID) specimens.

METHODS: In this retrospective cohort study, inflammation, and fibrosis in orbital adipose tissue from patients with thyroid-associated orbitopathy (TAO), granulomatosis with polyangiitis (GPA), sarcoidosis, nonspecific orbital inflammation (NSOI), and healthy controls were scored by 2 masked ocular pathologists. Both categories were scored on a scale of 0 to 3 with scoring criteria based on the percentage of specimens containing inflammation or fibrosis, respectively. Tissue specimens were collected from oculoplastic surgeons at 8 international centers representing 4 …

Investigating The Association Between Mast Cell Activation Syndrome And Irritable Bowel Syndrome, Ishaan Jakhar, Maggie Urschler, Medha Singh, Suman Sahil, Hassan Ahmad

Posters

Investigating the Association between Mast Cell Activation Syndrome and Irritable Bowel Syndrome Introduction Mast Cell Activation Syndrome (MCAS) involves the inappropriate release of chemical mediators resulting in varied episodic symptoms. Irritable Bowel Syndrome (IBS) is a common functional abdominal disorder where mucosal immune alterations play a key role. Since mast cells function as gatekeepers for the intestinal interface, we examined what proportion of patients diagnosed with MCAS also had IBS along with comorbid risk factors. Methods All patients in our study were 18 years of age or older. We used Cerner Healthfacts to gather our cohorts of patients with MCAS, …

Real-World Utilization Of An Intrauterine, Vacuum-Induced, Hemorrhage-Control Device., Dena Goffman, Kara M Rood, Angela Bianco, Joseph R Biggio, Paul Dietz, Kelly Drake, Erica Heilman, Maeve Hopkins, Monique De Four Jones, Tyler Katz, Courtney Martin, Mona Prasad, Marcela C Smid, Kathryn D Wine, Robert Ryan, Candice Yong, Patricia I Carney, Hyagriv N Simhan

Women’s Health Articles

OBJECTIVE: To assess the real-world effectiveness and safety of a U.S. Food and Drug Administration (FDA)-cleared intrauterine vacuum-induced-hemorrhage control device for postpartum hemorrhage (PPH) management.

METHODS: Sixteen centers in the United States participated in this observational, postmarket registry medical record review (October 2020 through March 2022). The primary effectiveness outcome was treatment success , defined as bleeding control after insertion with no treatment escalation or bleeding recurrence. Additional outcomes included blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. Treatment success and severe maternal morbidity measures (transfusion of 4 or more units of red …