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1.
Ann Emerg Med ; 2024 Jul 03.
Article in English | MEDLINE | ID: mdl-38970569
2.
Res Sq ; 2024 Jun 18.
Article in English | MEDLINE | ID: mdl-38947088

ABSTRACT

Background: Vancomycin, an antibiotic with activity against Methicillin-resistant Staphylococcus aureus (MRSA), is frequently included in empiric treatment for community-acquired pneumonia (CAP) despite the fact that MRSA is rarely implicated in CAP. Conducting polymerase chain reaction (PCR) testing on nasal swabs to identify the presence of MRSA colonization has been proposed as an antimicrobial stewardship intervention to reduce the use of vancomycin. Observational studies have shown reductions in vancomycin use after implementation of MRSA colonization testing, and this approach has been adopted by CAP guidelines. However, the ability of this intervention to safely reduce vancomycin use has yet to be tested in a randomized controlled trial. Methods: STOP-Vanc is a pragmatic, prospective, single center, non-blinded randomized trial. Adult patients with suspicion for CAP who are receiving vancomycin and admitted to the Medical Intensive Care Unit at Vanderbilt University Medical Center will be screened for eligibility. Eligible patients will be enrolled and randomized in a 1:1 ratio to either receive MRSA nasal swab PCR testing in addition to usual care (intervention group), or usual care alone (control group). PCR testing results will be transmitted through the electronic health record to the treating clinicians. Primary providers of intervention group patients with negative swab results will also receive a page providing clinical guidance recommending discontinuation of vancomycin. The primary outcome will be vancomycin-free hours alive, defined as the number of hours alive and free of the use of vancomycin within the first seven days following trial enrollment estimated using a proportional odds ratio model. Secondary outcomes include 30-day all-cause mortality and time alive off vancomycin. Discussion: STOP-Vanc will provide the first randomized controlled trial data regarding the use of MRSA nasal swab PCR testing to guide antibiotic de-escalation. This study will provide important information regarding the effect of MRSA PCR testing and antimicrobial stewardship guidance on clinical outcomes in an intensive care unit setting. Trial registration: This trial was registered on ClinicalTrials.gov on February 22, 2024. (ClinicalTrials.gov identifier: NCT06272994).

3.
Healthcare (Basel) ; 12(13)2024 Jul 07.
Article in English | MEDLINE | ID: mdl-38998888

ABSTRACT

Adam, a justice-involved young man, was brought into the emergency department at the county hospital in cardiogenic shock due to a recurring episode of injection-drug-use-related infective endocarditis (IDU-IE). Adam had initiated injection opioid use in prison. He was surgically treated for the previous episodes of IDU-IE but was unable to fully recover due to limitations in care within penal medicine. This case report explores the prison as a determinant of health, interactions between clinical, welfare, and penal medicine, to produce and maintain health inequities, and structural drivers of physician moral injury through an interview with Adam and reflexive writings from emergency medicine physicians. This case demonstrates the need for three types of structural health interventions: (1) restorative justice, community-based reentry programs, and housing as welfare medicine, (2) increased harm reduction services across healthcare, especially penal medicine, and (3) equitable institutional protocols (contrary to ambiguous guidelines) to treat clinical conditions like IDU-IE that disproportionately impact structurally vulnerable patients.

4.
Nutr Clin Pract ; 2024 Jul 12.
Article in English | MEDLINE | ID: mdl-38994914

ABSTRACT

Parenteral nutrition (PN) is a complex preparation that contains multiple component products with the associated risk for incompatibilities and diminished stabilities when combined together as an admixture. Significant patient harm can result from prescribing, preparing, and administering PN without confirming compatibility and stability. Incompatibility or instability is rarely obvious to the unaided eye, so safe PN admixture relies on incorporating physicochemical properties of the included components into compatibility and stability decisions. Practices include applying active ingredient concentration limits to reduce risk for incompatibilities and instabilities. The purpose of the current article is to distill the wide-ranging information on PN compatibility and stability into a feasible blueprint that individual healthcare organizations can then use to design and implement practical initiatives. Compatibility and stability considerations can be incorporated into the routine tasks of PN prescribing, order reviewing, preparing, and administering. The focus of this review is on identifying potential physicochemical interactions that can be addressed at each step in the PN use process. Organizations should incorporate compatibility and stability considerations into the routine procedures and practices of all clinicians involved with PN therapy. Those clinicians in healthcare organizations and caregivers in the home should then be in a position to safely provide the appropriate PN admixtures in terms of compatibility and stability.

5.
J Surg Oncol ; 2024 Jul 17.
Article in English | MEDLINE | ID: mdl-39016067

ABSTRACT

BACKGROUND & OBJECTIVES: Screening for pancreatic cancer is recommended for individuals with a strong family history, certain genetic syndromes, or a neoplastic cyst of the pancreas. However, limited data supports a survival benefit attributable to screening these higher-risk individuals. METHODS: All patients enrolled in screening at a High-Risk Pancreatic Cancer Clinic (HRC) from July 2013 to June 2020 were identified from a prospectively maintained institutional database and compared to patients evaluated at a Surgical Oncology Clinic (SOC) at the same institution during the same period. Clinical outcomes of patients selected for surgical resection, particularly clinicopathologic stage and overall survival, were compared. RESULTS: Among 826 HRC patients followed for a median (IQR) of 2.3 (0.8-4.2) years, 128 were selected for surgical resection and compared to 402 SOC patients selected for resection. Overall survival was significantly longer among HRC patients (median survival: not reached vs. 2.6 years, p < 0.001). Among 31 HRC and 217 SOC patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC), the majority of HRC patients were diagnosed with stage 0 disease (carcinoma in situ), while the majority of SOC patients were diagnosed with stage II disease (p < 0.001). Overall survival after resection of invasive PDAC was also significantly longer among HRC patients compared to SOC patients (median survival 5.5 vs. 1.6 years, p = 0.002). CONCLUSION: Patients at increased risk for PDAC and followed with guideline-based screening exhibited downstaging of disease and improved survival from PDAC in comparison to patients who were not screened.

6.
Article in English | MEDLINE | ID: mdl-38929040

ABSTRACT

Despite the lack of evidence, opioids are still routinely used as a solution to long-term management for chronic noncancer pain (CNCP). Given the significant risks associated with long-term opioid use, including the increased number of unregulated opioid pills at large in the opioid ecosystem, opioid cessation or reduction may be the desired goal of the patient and clinician. Viable nonpharmacological interventions (NPIs) to complement and/or replace opioids for CNCP are needed. Comprehensive reviews that address the impact of NPIs to help adults with CNCP reduce opioid use safely are lacking. We conducted a literature search in PubMed, CINAHL, Embase, PsycINFO, and Scopus for studies published in English. The initial search was conducted in April 2021, and updated in January 2024. The literature search yielded 19,190 relevant articles. Thirty-nine studies met the eligibility criteria and underwent data extraction. Of these, nineteen (49%) were randomized controlled trials, eighteen (46%) were observational studies, and two (5%) were secondary analyses. Among adults with CNCP who use opioids for pain management, studies on mindfulness, yoga, educational programs, certain devices or digital technology, chiropractic, and combination NPIs suggest that they might be an effective approach for reducing both pain intensity and opioid use, but other NPIs did not show a significant effect (e.g., hypnosis, virtual reality). This review revealed there is a small to moderate body of literature demonstrating that some NPIs might be an effective and safe approach for reducing pain and opioid use, concurrently.


Subject(s)
Analgesics, Opioid , Chronic Pain , Humans , Chronic Pain/drug therapy , Chronic Pain/therapy , Analgesics, Opioid/therapeutic use , Opioid-Related Disorders , Pain Management/methods
7.
medRxiv ; 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38883802

ABSTRACT

Background: Assessing COVID-19 vaccine effectiveness (VE) and severity of SARS-CoV-2 variants can inform public health risk assessments and decisions about vaccine composition. BA.2.86 and its descendants, including JN.1 (referred to collectively as "JN lineages"), emerged in late 2023 and exhibited substantial genomic divergence from co-circulating XBB lineages. Methods: We analyzed patients hospitalized with COVID-19-like illness at 26 hospitals in 20 U.S. states admitted October 18, 2023-March 9, 2024. Using a test-negative, case-control design, we estimated the effectiveness of an updated 2023-2024 (Monovalent XBB.1.5) COVID-19 vaccine dose against sequence-confirmed XBB and JN lineage hospitalization using logistic regression. Odds of severe outcomes, including intensive care unit (ICU) admission and invasive mechanical ventilation (IMV) or death, were compared for JN versus XBB lineage hospitalizations using logistic regression. Results: 585 case-patients with XBB lineages, 397 case-patients with JN lineages, and 4,580 control-patients were included. VE in the first 7-89 days after receipt of an updated dose was 54.2% (95% CI = 36.1%-67.1%) against XBB lineage hospitalization and 32.7% (95% CI = 1.9%-53.8%) against JN lineage hospitalization. Odds of ICU admission (adjusted odds ratio [aOR] 0.80; 95% CI = 0.46-1.38) and IMV or death (aOR 0.69; 95% CI = 0.34-1.40) were not significantly different among JN compared to XBB lineage hospitalizations. Conclusions: Updated 2023-2024 COVID-19 vaccination provided protection against both XBB and JN lineage hospitalization, but protection against the latter may be attenuated by immune escape. Clinical severity of JN lineage hospitalizations was not higher relative to XBB lineage hospitalizations.

8.
J Am Coll Radiol ; 21(7): 1108-1118, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38944444

ABSTRACT

Advanced imaging, including ultrasonography, computed tomography, and magnetic resonance imaging (MRI), is an integral component to the evaluation and management of ill and injured children in the emergency department. As with any test or intervention, the benefits and potential impacts on management must be weighed against the risks to ensure that high-value care is being delivered. There are important considerations specific to the pediatric patient related to the ordering and interpretation of advanced imaging. This policy statement provides guidelines for institutions and those who care for children to optimize the use of advanced imaging in the emergency department setting and was coauthored by experts in pediatric and general emergency medicine, pediatric radiology, and pediatric surgery. The intent is to guide decision-making where children may access care.


Subject(s)
Diagnostic Imaging , Emergency Service, Hospital , Humans , Diagnostic Imaging/standards , Child , United States , Pediatrics/standards
9.
J Am Coll Radiol ; 21(7): e37-e69, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38944445

ABSTRACT

Advanced diagnostic imaging modalities, including ultrasonography, computed tomography, and magnetic resonance imaging (MRI), are key components in the evaluation and management of pediatric patients presenting to the emergency department. Advances in imaging technology have led to the availability of faster and more accurate tools to improve patient care. Notwithstanding these advances, it is important for physicians, physician assistants, and nurse practitioners to understand the risks and limitations associated with advanced imaging in children and to limit imaging studies that are considered low value, when possible. This technical report provides a summary of imaging strategies for specific conditions where advanced imaging is commonly considered in the emergency department. As an accompaniment to the policy statement, this document provides resources and strategies to optimize advanced imaging, including clinical decision support mechanisms, teleradiology, shared decision-making, and rationale for deferred imaging for patients who will be transferred for definitive care.


Subject(s)
Emergency Service, Hospital , Humans , Child , Diagnostic Imaging/methods , Decision Support Systems, Clinical
10.
Ethics Hum Res ; 46(4): 27-37, 2024.
Article in English | MEDLINE | ID: mdl-38944884

ABSTRACT

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.


Subject(s)
Ethics Committees, Research , Patient Reported Outcome Measures , Quality Improvement , Humans , Ethics Committees, Research/standards , Quality Improvement/standards , Surveys and Questionnaires/standards
11.
Pediatrics ; 154(1)2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38932710

ABSTRACT

Advanced imaging, including ultrasonography, computed tomography, and magnetic resonance imaging, is an integral component to the evaluation and management of ill and injured children in the emergency department. As with any test or intervention, the benefits and potential impacts on management must be weighed against the risks to ensure that high-value care is being delivered. There are important considerations specific to the pediatric patient related to the ordering and interpretation of advanced imaging. This policy statement provides guidelines for institutions and those who care for children to optimize the use of advanced imaging in the emergency department setting and was coauthored by experts in pediatric and general emergency medicine, pediatric radiology, and pediatric surgery. The intent is to guide decision-making where children may access care.


Subject(s)
Emergency Service, Hospital , Humans , Emergency Service, Hospital/standards , Child , Magnetic Resonance Imaging/standards , Diagnostic Imaging/standards , Diagnostic Imaging/methods , Tomography, X-Ray Computed/standards , Ultrasonography/methods
12.
Pediatrics ; 154(1)2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38932719

ABSTRACT

Advanced diagnostic imaging modalities, including ultrasonography, computed tomography, and magnetic resonance imaging, are key components in the evaluation and management of pediatric patients presenting to the emergency department. Advances in imaging technology have led to the availability of faster and more accurate tools to improve patient care. Notwithstanding these advances, it is important for physicians, physician assistants, and nurse practitioners to understand the risks and limitations associated with advanced imaging in children and to limit imaging studies that are considered low value, when possible. This technical report provides a summary of imaging strategies for specific conditions where advanced imaging is commonly considered in the emergency department. As an accompaniment to the policy statement, this document provides resources and strategies to optimize advanced imaging, including clinical decision support mechanisms, teleradiology, shared decision-making, and rationale for deferred imaging for patients who will be transferred for definitive care.


Subject(s)
Emergency Service, Hospital , Humans , Child , Magnetic Resonance Imaging/methods , Tomography, X-Ray Computed/methods , Diagnostic Imaging/methods , Decision Support Systems, Clinical , Teleradiology , Decision Making, Shared , Ultrasonography/methods
13.
J Med Chem ; 67(12): 10248-10262, 2024 Jun 27.
Article in English | MEDLINE | ID: mdl-38848667

ABSTRACT

Herein, we describe the design and synthesis of γ-secretase modulator (GSM) clinical candidate PF-06648671 (22) for the treatment of Alzheimer's disease. A key component of the design involved a 2,5-cis-tetrahydrofuran (THF) linker to impart conformational rigidity and lock the compound into a putative bioactive conformation. This effort was guided using a pharmacophore model since crystallographic information was not available for the membrane-bound γ-secretase protein complex at the time of this work. PF-06648671 achieved excellent alignment of whole cell in vitro potency (Aß42 IC50 = 9.8 nM) and absorption, distribution, metabolism, and excretion (ADME) parameters. This resulted in favorable in vivo pharmacokinetic (PK) profile in preclinical species, and PF-06648671 achieved a human PK profile suitable for once-a-day dosing. Furthermore, PF-06648671 was found to have favorable brain availability in rodent, which translated into excellent central exposure in human and robust reduction of amyloid ß (Aß) 42 in cerebrospinal fluid (CSF).


Subject(s)
Alzheimer Disease , Amyloid Precursor Protein Secretases , Amyloid beta-Peptides , Amyloid Precursor Protein Secretases/antagonists & inhibitors , Amyloid Precursor Protein Secretases/metabolism , Alzheimer Disease/drug therapy , Humans , Animals , Amyloid beta-Peptides/metabolism , Rats , Structure-Activity Relationship , Mice , Male , Drug Discovery , Furans/pharmacology , Furans/pharmacokinetics , Furans/chemical synthesis , Furans/chemistry , Furans/therapeutic use , Rats, Sprague-Dawley , Brain/metabolism
14.
N Engl J Med ; 390(23): 2165-2177, 2024 Jun 20.
Article in English | MEDLINE | ID: mdl-38869091

ABSTRACT

BACKGROUND: Among critically ill adults undergoing tracheal intubation, hypoxemia increases the risk of cardiac arrest and death. The effect of preoxygenation with noninvasive ventilation, as compared with preoxygenation with an oxygen mask, on the incidence of hypoxemia during tracheal intubation is uncertain. METHODS: In a multicenter, randomized trial conducted at 24 emergency departments and intensive care units in the United States, we randomly assigned critically ill adults (age, ≥18 years) undergoing tracheal intubation to receive preoxygenation with either noninvasive ventilation or an oxygen mask. The primary outcome was hypoxemia during intubation, defined by an oxygen saturation of less than 85% during the interval between induction of anesthesia and 2 minutes after tracheal intubation. RESULTS: Among the 1301 patients enrolled, hypoxemia occurred in 57 of 624 patients (9.1%) in the noninvasive-ventilation group and in 118 of 637 patients (18.5%) in the oxygen-mask group (difference, -9.4 percentage points; 95% confidence interval [CI], -13.2 to -5.6; P<0.001). Cardiac arrest occurred in 1 patient (0.2%) in the noninvasive-ventilation group and in 7 patients (1.1%) in the oxygen-mask group (difference, -0.9 percentage points; 95% CI, -1.8 to -0.1). Aspiration occurred in 6 patients (0.9%) in the noninvasive-ventilation group and in 9 patients (1.4%) in the oxygen-mask group (difference, -0.4 percentage points; 95% CI, -1.6 to 0.7). CONCLUSIONS: Among critically ill adults undergoing tracheal intubation, preoxygenation with noninvasive ventilation resulted in a lower incidence of hypoxemia during intubation than preoxygenation with an oxygen mask. (Funded by the U.S. Department of Defense; PREOXI ClinicalTrials.gov number, NCT05267652.).


Subject(s)
Hypoxia , Intubation, Intratracheal , Noninvasive Ventilation , Oxygen Inhalation Therapy , Adult , Aged , Female , Humans , Male , Middle Aged , Critical Illness/therapy , Heart Arrest/therapy , Hypoxia/etiology , Hypoxia/prevention & control , Intubation, Intratracheal/adverse effects , Intubation, Intratracheal/methods , Masks , Noninvasive Ventilation/methods , Oxygen/administration & dosage , Oxygen/blood , Oxygen Inhalation Therapy/methods , Oxygen Saturation
15.
J Surg Res ; 300: 336-344, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38843720

ABSTRACT

INTRODUCTION: Pediatric scald burns account for 12% of all U.S. burn center admissions and are the most common type of burn in children. We hypothesized that geospatial analysis of burn registry data could identify specific geographic areas and risk factors to focus injury prevention efforts. METHODS: The burn registry of a U.S. regional burn center was used to retrospectively identify pediatric scald burn patients ages 0-17, from January 2018 to June 2023. Geocoding of patient home addresses with census tract data was performed. Area Deprivation Index (ADI) was assigned to patients at the census block group level. Burn incident hot spot analysis to identify statistically significant burn incident clusters was done using the Getis Ord Gi∗ statistic. RESULTS: There were 950 pediatric scald burn patients meeting study criteria. The cohort was 52% male and 36% White, with median age of 3 y and median total body surface area of 1.5%; 23.8% required hospital admission. On multivariable logistic regression, increased child poverty levels (P = 0.004) and children living in single-parent households (P = 0.009) were associated with increased scald burn incidence. Geospatial analysis identified burn hot spots, which were associated with higher ADI (P < 0.001). Black patients were more likely to undergo admission compared to White patients. CONCLUSIONS: Geospatial analysis of burn registry data identified geographic areas at high risk of pediatric scald burn. ADI, poverty, and children in single-parent households were the greatest predictors of injury. Addressing these inequalities requires targeted injury prevention education, enhanced outpatient support systems and more robust community resources.


Subject(s)
Burns , Registries , Humans , Burns/epidemiology , Male , Child, Preschool , Female , Child , Infant , Retrospective Studies , Adolescent , Registries/statistics & numerical data , Risk Factors , Infant, Newborn , Spatial Analysis , Burn Units/statistics & numerical data , United States/epidemiology , Incidence
16.
J Surg Oncol ; 2024 Jun 18.
Article in English | MEDLINE | ID: mdl-38894619

ABSTRACT

OBJECTIVES: The objective of the current study was to characterize prognostic factors related to long-term recurrence-free survival after curative-intent resection of intrahepatic cholangiocarcinoma (ICC). METHODS: Data on patients who underwent curative-intent resection for ICC between 2000 and 2020 were collected from an international multi-institutional database. Prognostic factors were investigated among patients who recurred within 5 years versus long-term survivors who survived more than 5 years with no recurrence. RESULTS: Among 635 patients who underwent curative-intent resection for ICC, 104 (16.4%) patients were long-term survivors with no recurrence beyond 5 years after surgery. Patients who survived for more than 5 years with no recurrence were more likely to have less aggressive tumor features, as well as have undergone an R0 resection versus patients who recurred within 5 years after resection. On multivariable analysis, tumor size (>5 cm) (HR: 1.535, 95% CI: 1.254-1.879), satellite lesions (HR: 1.253, 95% CI: 1.003-1.564), and lymph node metastasis (HR: 1.733, 95% CI: 1.349-2.227) were independently associated with recurrence within 5 years. Patients who recurred beyond 5 years (n = 23), 2-5 years (n = 60), and within 2 years (n = 471) had an incrementally worse post-recurrence survival (PRS, 28.0 vs. 20.0 vs. 12.0 months, p = 0.032). Among patients with N0 status, tumor size (>5 cm) (HR: 1.612, 95% CI: 1.087-2.390) and perineural invasion (PNI) (HR: 1.562,95% CI: 1.081-2.255) were risk factors associated with recurrence. Among patients with N1 disease, only a minority (5/128, 3.9%) of patients survived with no recurrence to 5 years. CONCLUSION: Roughly 1 in 6 patients survived for more than 5 years with no recurrence following curative-intent resection of ICC. Among N0 patients, tumor recurrence was associated with tumor size and PNI. Only a small subset of N1 patients experienced long-term survival.

17.
Article in English | MEDLINE | ID: mdl-38898569

ABSTRACT

Backgrounds/Aims: The guidelines regarding the management of intraductal papillary mucinous neoplasms (IPMNs) all have slightly different surgical indications for high-risk lesions. We aim to retrospectively compare the accuracy of four guidelines in recommending surgery for high-risk IPMNs, and assess the accuracy of elevated CA-19-9 levels and imaging characteristics of IPMNs considered high-risk in predicting malignancy or high-grade dysplasia (HGD). Methods: The final histopathological diagnosis of surgically resected high-risk IPMNs during 2013-2020 were compared to preoperative surgical indications, as enumerated in four guidelines: the 2015 American Gastroenterological Association (AGA), 2017 International Consensus, 2018 European Study Group, and 2018 American College of Gastroenterology (ACG). Surgery was considered "justified" if histopathology of the surgical specimen showed HGD/malignancy, or there was postoperative symptomatic improvement. Results: Surgery was postoperatively justified in 26/65 (40.0%) cases. All IPMNs with HGD/malignancy were detected by the 2018 ACG and the combined (absolute and relative criteria) 2018 European guidelines. The combined ("high-risk stigmata" and "worrisome features") 2017 International guideline missed 1/19 (5.3%) IPMNs with HGD/malignancy. The 2015 AGA guideline missed the most cases (11/19, 57.9%) of IPMNs with HGD/malignancy. We found the features most-associated with HGD/malignancy were pancreatic ductal dilation, and elevated CA-19-9 levels. Conclusions: Following the 2015 AGA guideline results in the highest rate of missed HGD/malignancy, but the lowest rate of operating on IPMNs without these features; meanwhile, the 2018 ACG and the combined (absolute and relative criteria) 2018 European guidelines result in more operations for IPMNs without HGD/malignancy, but the lowest rates of missed HGD/malignancy in IPMNs.

18.
CHEST Crit Care ; 2(1)2024 Mar.
Article in English | MEDLINE | ID: mdl-38742219

ABSTRACT

BACKGROUND: For every critically ill adult receiving invasive mechanical ventilation, clinicians must select a mode of ventilation. The mode of ventilation determines whether the ventilator directly controls the tidal volume or the inspiratory pressure. Newer hybrid modes allow clinicians to set a target tidal volume; the ventilator controls and adjusts the inspiratory pressure. A strategy of low tidal volumes and low plateau pressure improves outcomes, but the optimal mode to achieve these targets is not known. RESEARCH QUESTION: Can a cluster-randomized trial design be used to assess whether the mode of mandatory ventilation affects the number of days alive and free of invasive mechanical ventilation among critically ill adults? STUDY DESIGN AND METHODS: The Mode of Ventilation During Critical Illness (MODE) trial is a cluster-randomized, multiple-crossover pilot trial being conducted in the medical ICU at an academic center. The MODE trial compares the use of volume control, pressure control, and adaptive pressure control. The study ICU is assigned to a single-ventilator mode (volume control vs pressure control vs adaptive pressure control) for continuous mandatory ventilation during each 1-month study block. The assigned mode switches every month in a randomly generated sequence. The primary outcome is ventilator-free days to study day 28, defined as the number of days alive and free of invasive mechanical ventilation from the final receipt of mechanical ventilation to 28 days after enrollment. Enrollment began November 1, 2022, and will end on July 31, 2023. RESULTS: This manuscript describes the protocol and statistical analysis plan for the MODE trial of ventilator modes comparing volume control, pressure control, and adaptive pressure control. INTERPRETATION: Prespecifying the full statistical analysis plan prior to completion of enrollment increases rigor, reproducibility, and transparency of the trial results. CLINICAL TRIAL REGISTRATION: The trial was registered with clinicaltrials.gov on October 3, 2022, before initiation of patient enrollment on November 1, 2022 (ClinicalTrials.gov identifier: NCT05563779).

19.
Pediatrics ; 153(6)2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38813646

ABSTRACT

OBJECTIVES: We compared the emergency department (ED) evaluation and outcomes of young head-injured infants to older children. METHODS: Using the Pediatric Health Information Systems database, we performed a retrospective, cross-sectional analysis of children <2 years old with isolated head injuries (International Classification of Diseases, 10th Revision, diagnoses) at one of 47 EDs from 2015 to 2019. Our primary outcome was utilization of diagnostic cranial imaging. Secondary outcomes were diagnosis of traumatic brain injury (TBI), clinically important TBI, and mortality. We compared outcomes between the youngest infants (<3 months old) and children 3 to 24 months old. RESULTS: We identified 112 885 ED visits for children <2 years old with isolated head injuries. A total of 62 129 (55%) were by males, and 10 325 (9.1%) were by infants <3 months of age. Compared with older children (12-23 months old), the youngest infants were more likely to: Undergo any diagnostic cranial imaging (50.3% vs 18.3%; difference 31.9%, 95% confidence interval [CI] 35.0-28.9%), be diagnosed with a TBI (17.5% vs 2.7%; difference 14.8%, 95% CI 16.4%-13.2%) or clinically important TBI (4.6% vs 0.5%; difference 4.1%, 95% CI 3.8%-4.5%), and to die (0.3% vs 0.1%; difference 0.2%, 95% CI 0.3%-0.1%). Among those undergoing computed tomography or MRI, TBIs were significantly more common in the youngest infants (26.4% vs 8.8%, difference 17.6%, 95% CI 16.3%-19.0%). CONCLUSIONS: The youngest infants with head injuries are significantly more likely to undergo cranial imaging, be diagnosed with brain injuries, and die, highlighting the need for a specialized approach for this vulnerable population.


Subject(s)
Craniocerebral Trauma , Emergency Service, Hospital , Humans , Infant , Emergency Service, Hospital/statistics & numerical data , Male , Female , Retrospective Studies , Cross-Sectional Studies , Craniocerebral Trauma/epidemiology , Craniocerebral Trauma/diagnostic imaging , Craniocerebral Trauma/diagnosis , Brain Injuries, Traumatic/diagnostic imaging , Brain Injuries, Traumatic/epidemiology , Brain Injuries, Traumatic/diagnosis , Infant, Newborn , Age Factors , Tomography, X-Ray Computed
20.
Ecol Appl ; 34(4): e2979, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38710618

ABSTRACT

Knowledge of interspecific and spatiotemporal variation in demography-environment relationships is key for understanding the population dynamics of sympatric species and developing multispecies conservation strategies. We used hierarchical random-effects models to examine interspecific and spatial variation in annual productivity in six migratory ducks (i.e., American wigeon [Mareca americana], blue-winged teal [Spatula discors], gadwall [Mareca strepera], green-winged teal [Anas crecca], mallard [Anas platyrhynchos] and northern pintail [Anas acuta]) across six distinct ecostrata in the Prairie Pothole Region of North America. We tested whether breeding habitat conditions (seasonal pond counts, agricultural intensification, and grassland acreage) or cross-seasonal effects (indexed by flooded rice acreage in primary wintering areas) better explained variation in the proportion of juveniles captured during late summer banding. The proportion of juveniles (i.e., productivity) was highly variable within species and ecostrata throughout 1961-2019 and generally declined through time in blue-winged teal, gadwall, mallard, pintail, and wigeon, but there was no support for a trend in green-winged teal. Productivity in Canadian ecostrata declined with increasing agricultural intensification and increased with increasing pond counts. We also found a strong cross-seasonal effect, whereby more flooded rice hectares during winter resulted in higher subsequent productivity. Our results suggest highly consistent environmental and anthropogenic effects on waterfowl productivity across species and space. Our study advances our understanding of current year and cross-seasonal effects on duck productivity across a suite of species and at finer spatial scales, which could help managers better target working-lands conservation programs on both breeding and wintering areas. We encourage other researchers to evaluate environmental drivers of population dynamics among species in a single modeling framework for a deeper understanding of whether conservation plans should be generalized or customized given limited financial resources.


Subject(s)
Ducks , Animals , Ducks/physiology , Ecosystem , Seasons , Anthropogenic Effects , Population Dynamics , Species Specificity
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