Understanding Associations Between Patient-Level Factors and Participation in a Breast Cancer Clinical Trial.

Background: Although breast cancer (BC) clinical trials offer novel treatments, participating patients often do not represent populations seen in clinics. This study assessed how patient sociodemographics, attitudes, and knowledge about clinical trials may be associated with participation.

Methods: This cross sectional analysis used survey data collected August-September 2021 by Translational Breast Cancer Research Consortium (TBCRC) and December 2022 by Patient Advocate Foundation (PAF) among women with a BC diagnosis.

Risk of early functional decline and its association with overall survival among older adults with newly diagnosed gastrointestinal malignancies undergoing systemic therapy.

Introduction: Older adults with cancer undergoing systemic therapy are at the greatest risk of experiencing adverse effects including functional decline. We aimed to understand the risk of functional decline at three months after starting systemic therapy among older adults with gastrointestinal (GI) cancer undergoing systemic therapy.

Materials And Methods: Using data from a prospective cohort study, we identified older adults ≥60y with newly diagnosed GI cancer initiating systemic therapy at our institution, who underwent functional status evaluation at baseline and at three months follow up.

Exploring Differences in Blood Product Administration by Patient Age and Injury Severity.

Introduction: Trauma-related hemorrhage is the leading cause of preventable death in the United States. Current resuscitation guidelines are based largely on data from younger and middle-aged adults, while influencing practice for adults of all ages. We examined age-related differences in blood product administration among individuals predicted to receive massive transfusions for the treatment of trauma-related hemorrhage.

A Matched Case-Control Study Examining the Association Between Exposure to Depot Medroxyprogesterone Acetate and Cerebral Meningioma Using an Active Comparator.

The recent literature has reported an increased association between the use of depot medroxyprogesterone acetate (dMPA) and cerebral meningioma (CM). Prior studies have been limited in generalizability and did not use an active comparator as a control. The current matched case-control study utilized a bootstrapped sampling design, matching 241 CM cases with controls (i.

Reducing NICU ventilator days by preventing fluid overload with the CAN-U-P-LOTS standardized bundle.

Background: Fluid overload in critically ill neonates and infants is associated with higher ventilation days, prolonged length of stay, and mortality.

Methods: This quality improvement study enrolled infants admitted to Children's of Alabama NICU (excluding those with tracheostomies, severe congenital kidney or heart disease, DNR status, or severe genetic conditions). We compared 7 months of pre-intervention data (211 neonates) with 7 months of post-implementation data (218 neonates).

Is Mechanism a Biological Variable?: A Secondary Analysis of the PROPPR Trial.

Objective: The purpose of this study was to evaluate for differences in the baseline mortality rates of patients injured by different mechanisms, in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial, and compare their responses to 2 resuscitation paradigms. Our hypothesis was there are differences between the blunt and penetrating trauma patients, with regard to baseline and effect size.

Background: Previous research including clinical trials and basic science research suggests differences in mortality among patients injured by blunt or penetrating mechanisms, although differences between these 2 mechanisms-both baseline and effect size-are rarely considered explicitly.

Effect of pretreatment lab abnormalities on the time-to-treatment discontinuation and overall survival of metastatic breast cancer patients receiving CDK 4/6i, PI3Ki, and/or mTORi.

Purpose: Metastatic breast cancer (MBC) randomized controlled trials (RCTs) enroll healthier patients than the general population; however, many women have a lab abnormality at the time of their diagnosis, RCTs inadequately represent this patient population. To better understand this population, this study estimated time-to-treatment discontinuation (TTD) and overall survival (OS) for patients with and without lab abnormalities receiving a targeted therapy for MBC.

Methods: This retrospective study used the nationwide, de-identified electronic health record-derived Flatiron Health database to include women with hormone receptor-positive, Human epidermal growth factor receptor 2- negative MBC with receipt of a targeted therapy between 2011 and 2020.

Growth after pediatric and neonatal acute kidney injury: a meta-analysis.

Background: Acute kidney injury (AKI) occurs commonly in critically ill children. The impact of AKI on pediatric growth outcomes has been sparsely described.

Objective: To compare growth in children with a history of AKI compared to those without AKI.

Evaluating reimbursement for prehospital blood transfusions: A nationwide survey.

Background: Prehospital blood transfusion improves survival among patients in hemorrhagic shock but remains underutilized, in part due to financial barriers. However, little is known about how prehospital blood transfusion programs are reimbursed. The objective of this study is to determine the percentage of prehospital blood transfusion programs that receive reimbursement, the percentage of patients receiving blood who were public health insurance-eligible (pediatric and geriatric patients), and the most common reason for blood transfusions in these populations.

Noninvasive Monitoring of Traumatic Intracranial Hematoma Progression Using the Infrascanner: Preliminary Experience.

Objectives: Early detection of intracranial hematoma (ICH) expansion is critical to improving outcomes in patients with traumatic brain injuries (TBIs). The Infrascanner 2000 (InfraScan Inc) is a US Food and Drug Administration-cleared device capable of detecting ICHs. We report our preliminary experience of conducting a prospective evaluation of serial infrascans to evaluate the diagnostic performance of the device for monitoring changes in ICH size.

Association of patent ductus arteriosus treatment in extremely low gestational age neonates with two year kidney outcomes: a secondary analysis of the preterm erythropoietin neuroprotection trial (PENUT).

Background: Management of patent ductus arteriosus (PDA) is variable and includes expectant, medical, and procedural options. Both the hemodynamic effects of a PDA and its treatment put neonates at risk for acute kidney injury (AKI). Little is known about how different management approaches to a PDA, either conservative management or active management and either medical or surgical treatment, in preterm neonates impact kidney function over the longer term.

System-Level Transformations to Increase Patient Participation in Clinical Trials.

Purpose: Over the course of the COVID-19 pandemic, the Food and Drug Administration allowed cancer clinical trials to make modifications. As policymakers consider sustaining these modifications, understanding patient perspectives on impact is critical.

Methods: This cross-sectional study used survey data collected between August 2021 and September 2021 by the Translational Breast Cancer Research Consortium and December 2022 by Patient Advocate Foundation among female breast cancer survivors.

Use of standardized nasal and skin decolonization to reduce rates of bacteremia in patients undergoing extracorporeal membrane oxygenation.

Objective: We aimed to determine if implementation of universal nasal decolonization with daily chlorhexidine bathing will decrease blood stream infections (BSI) in patients undergoing extracorporeal membrane oxygenation (ECMO).

Design: Retrospective cohort study.

Setting: Tertiary care facility.

Evaluation of the Management Strategies for Adhesive Small-Bowel Obstruction.

Introduction: The management of adhesive small-bowel obstruction (aSBO) continues to have wide variation, with no one management strategy accepted as the optimal. The first objective was to evaluate the methods of management and the variations in the management of aSBO at our institution and evaluate the outcomes of those management strategies. The second objective was to compare our outcomes to those of a published study by which patients were managed using an institutional protocol for aSBO.

Association Between Blood Type and Mortality Among Severely Injured Patients Enrolled in the Pragmatic Randomized Optimal Platelet and Plasma Ratios Trial.

Introduction: Previous studies suggested that type O blood may be associated with increased mortality and/or thrombotic complications among trauma patients. The purpose of this analysis was to evaluate the relationship between endogenous blood type, mortality, and complications among patients receiving massive transfusions, using data from the Pragmatic Randomized Optimal Platelet and Plasma Ratios trial.

Materials And Methods: This was a secondary analysis of the Pragmatic Randomized Optimal Platelet and Plasma Ratios trial that included patients with the reported blood type (A, AB, B, or O) data.

Analysis of time to regulatory approval in an exception from informed consent trial in trauma patients.

Background: The interactive media-based approach to community consultation and public disclosure (CC/PD), a key step when conducting exception from informed consent (EFIC) clinical trials, is intended to be completed in 4 months. This analysis characterizes the process, from initiation of CC/PD activities to institutional review board approval, to better understand the barriers and how these can be mitigated.

Methods: This is a retrospective post hoc analysis of data collected as part of the CC/PD campaigns conducted for a large trial involving up to 90 trauma centers in the United States.

The Association between Medroxyprogesterone Acetate Exposure and Meningioma.

Background/objectives: Medroxyprogesterone acetate (MPA) is a synthetic progesterone that is most commonly used as a contraceptive. MPA acts by binding to the progesterone receptor of the hypothalamus, and this receptor has been found to be important in the pathophysiology of meningiomas. Recent research has reported an increased association between the use of MPA and intracranial meningioma, though the literature is mostly limited by low numbers of meningioma cases and low exposure to MPA.

Association of delayed cord clamping with acute kidney injury and two-year kidney outcomes in extremely premature neonates: a secondary analysis of the Preterm Erythropoietin Neuroprotection Trial (PENUT).

Background: Delayed cord clamping (DCC) occurs in most preterm births.

Objective: Evaluate the association of DCC with acute kidney injury (AKI) and two-year kidney outcomes.

Methods: Secondary analysis of the Preterm Erythropoietin Neuroprotection Trial of neonates born 24 to 27 weeks' gestation.

Interactive Media-Based Approach for an Exception From Informed Consent Trial Involving Patients With Trauma.

Importance: Exception From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive.

Objective: To describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests.

Diagnostic performance of the ABC score in the PROPPR trial.

Introduction: The Assessment of Blood Consumption (ABC) score is used to predict massive transfusions (MT). However, its diagnostic performance has not been widely examined, especially when used as an objective tool to enroll patients in multi-center clinical trials. The purpose of this study was to evaluate the performance of the ABC score in enrolling patients in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial.

Iron Deficiency Among Hospitalized Patients With Congestive Heart Failure.

Introduction: Studies have demonstrated the efficacy of intravenous (IV) iron when administered to patients with congestive heart failure (CHF) and iron deficiency (ID). We aimed to better understand the adherence of treatment for ID among a population with CHF, with particular interest in high-risk groups not often studied due to inadequate recruitment.

Methods: A retrospective chart review at our institution was conducted from January 1, 2012, to July 7, 2021.