Decades-old, common ICU practices including deep sedation, immobilization, and limited family access are being challenged. We endeavoured to evaluate the relationship between ABCDEF bundle ...performance and patient-centered outcomes in critical care.
Prospective, multicenter, cohort study from a national quality improvement collaborative.
68 academic, community, and federal ICUs collected data during a 20-month period.
15,226 adults with at least one ICU day.
We defined ABCDEF bundle performance (our main exposure) in two ways: 1) complete performance (patient received every eligible bundle element on any given day) and 2) proportional performance (percentage of eligible bundle elements performed on any given day). We explored the association between complete and proportional ABCDEF bundle performance and three sets of outcomes: patient-related (mortality, ICU and hospital discharge), symptom-related (mechanical ventilation, coma, delirium, pain, restraint use), and system-related (ICU readmission, discharge destination). All models were adjusted for a minimum of 18 a priori determined potential confounders.
Complete ABCDEF bundle performance was associated with lower likelihood of seven outcomes: hospital death within 7 days (adjusted hazard ratio, 0.32; CI, 0.17-0.62), next-day mechanical ventilation (adjusted odds ratio AOR, 0.28; CI, 0.22-0.36), coma (AOR, 0.35; CI, 0.22-0.56), delirium (AOR, 0.60; CI, 0.49-0.72), physical restraint use (AOR, 0.37; CI, 0.30-0.46), ICU readmission (AOR, 0.54; CI, 0.37-0.79), and discharge to a facility other than home (AOR, 0.64; CI, 0.51-0.80). There was a consistent dose-response relationship between higher proportional bundle performance and improvements in each of the above-mentioned clinical outcomes (all p < 0.002). Significant pain was more frequently reported as bundle performance proportionally increased (p = 0.0001).
ABCDEF bundle performance showed significant and clinically meaningful improvements in outcomes including survival, mechanical ventilation use, coma, delirium, restraint-free care, ICU readmissions, and post-ICU discharge disposition.
Although growing evidence supports the safety and effectiveness of the ABCDEF bundle (A, assess, prevent, and manage pain; B, both spontaneous awakening and spontaneous breathing trials; C, choice of ...analgesic and sedation; D, delirium: assess, prevent, and manage; E, early mobility and exercise; and F, family engagement and empowerment), intensive care unit providers often struggle with how to reliably and consistently incorporate this interprofessional, evidence-based intervention into everyday clinical practice. Recently, the Society of Critical Care Medicine completed the ICU Liberation ABCDEF Bundle Improvement Collaborative, a 20-month, nationwide, multicenter quality improvement initiative that formalized dissemination and implementation strategies and tracked key performance metrics to overcome barriers to ABCDEF bundle adoption. The purpose of this article is to discuss some of the most challenging implementation issues that Collaborative teams experienced, and to provide some practical advice from leading experts on ways to overcome these barriers.
The ABCDEF bundle (A, assess, prevent, and manage pain; B, both spontaneous awakening and spontaneous breathing trials; C, choice of analgesic and sedation; D, delirium: assess, prevent, and manage; ...E, early mobility and exercise; and F, family engagement and empowerment) improves intensive care unit patient-centered outcomes and promotes interprofessional teamwork and collaboration. The Society of Critical Care Medicine recently completed the ICU Liberation ABCDEF Bundle Improvement Collaborative, a 20-month, multicenter, national quality improvement initiative that formalized dissemination and implementation strategies to promote effective adoption of the ABCDEF bundle. The purpose of this article is to describe 8 of the most frequently asked questions during the Collaborative and to provide practical advice from leading experts to other institutions implementing the ABCDEF bundle.
Foliar fungicide applications to corn (Zea mays L.) occur at one or more application timings ranging from early vegetative growth stages to mid-reproductive stages. Previous studies indicated that ...fungicide applications are profitable under high disease pressure when applied during the tasseling to silking growth stages. Few comprehensive studies in corn have examined the impact of fungicide applications at an early vegetative growth stage (V6) compared to late application timings (VT) for yield response and return on fungicide investment (ROI) across multiple locations.
Compare yield response of fungicide application timing across multiple fungicide classes and calculate the probability of positive ROI.
Data were collected specifically for this analysis using a uniform protocol conducted in 13 states in the United States and one province in Canada from 2014-2015. Data were subjected to a primary mixed-model analysis of variance. Subsequent univariate meta-analyses, with and without moderator variables, were performed using standard meta-analytic procedures. Follow-up power and prediction analyses were performed to aid interpretation and development of management recommendations.
Fungicide application resulted in a range of yield responses from -2,683.0 to 3,230.9 kg/ha relative to the non-treated control, with 68.2% of these responses being positive. Evidence suggests that all three moderator variables tested (application timing, fungicide class, and disease base level), had some effect (α = 0.05) on the absolute difference in yield between fungicide treated and non-treated plots (Formula: see text). Application timing influenced Formula: see text, with V6 + VT and the VT application timings resulting in greater yield responses than the V6 application timing alone. Fungicide formulations that combined demethylation inhibitor and quinone outside inhibitor fungicides significantly increased yield response.
Foliar fungicide applications can increase corn grain yield. To ensure the likelihood of a positive ROI, farmers should focus on applications at VT and use fungicides that include a mix of demethylation inhibitor and quinone outside inhibitor active ingredients.
To report the design and implementation of the Right Drug, Right Dose, Right Time-Using Genomic Data to Individualize Treatment protocol that was developed to test the concept that prescribers can ...deliver genome-guided therapy at the point of care by using preemptive pharmacogenomics (PGx) data and clinical decision support (CDS) integrated into the electronic medical record (EMR).
We used a multivariate prediction model to identify patients with a high risk of initiating statin therapy within 3 years. The model was used to target a study cohort most likely to benefit from preemptive PGx testing among the Mayo Clinic Biobank participants, with a recruitment goal of 1000 patients. We used a Cox proportional hazards model with variables selected through the Lasso shrinkage method. An operational CDS model was adapted to implement PGx rules within the EMR.
The prediction model included age, sex, race, and 6 chronic diseases categorized by the Clinical Classifications Software for International Classification of Diseases, Ninth Revision codes (dyslipidemia, diabetes, peripheral atherosclerosis, disease of the blood-forming organs, coronary atherosclerosis and other heart diseases, and hypertension). Of the 2000 Biobank participants invited, 1013 (51%) provided blood samples, 256 (13%) declined participation, 555 (28%) did not respond, and 176 (9%) consented but did not provide a blood sample within the recruitment window (October 4, 2012, through March 20, 2013). Preemptive PGx testing included CYP2D6 genotyping and targeted sequencing of 84 PGx genes. Synchronous real-time CDS was integrated into the EMR and flagged potential patient-specific drug-gene interactions and provided therapeutic guidance.
This translational project provides an opportunity to begin to evaluate the impact of preemptive sequencing and EMR-driven genome-guided therapy. These interventions will improve understanding and implementation of genomic data in clinical practice.
Direct-acting antiviral agents (DAAs) are used increasingly to treat hepatitis C virus (HCV) infection. Reports were published recently on hepatitis B virus (HBV) reactivation (HBV-R) in patients ...with HBV-HCV co-infection. Hepatitis B virus reactivation, defined as an abrupt increase in HBV replication in patients with inactive or resolved HBV infection, may result in clinically significant hepatitis.
To assess whether HBV-R is a safety concern in patients receiving HCV DAAs.
Descriptive case series.
U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
29 patients with HBV-R receiving HCV DAAs.
Clinical and laboratory data.
The FDA identified 29 unique reports of HBV-R in patients receiving DAAs from 22 November 2013 to 15 October 2016. Two cases resulted in death and 1 case in liver transplantation. Patients in whom HBV-R developed were heterogeneous regarding HCV genotype, DAAs received, and baseline HBV characteristics. At baseline, 9 patients had a detectable HBV viral load, 7 had positive results on hepatitis B surface antigen (HBsAg) testing and had an undetectable HBV viral load, and 3 had negative results on HBsAg testing and had an undetectable HBV viral load. For the remaining 10 patients, data points were not reported or the data were uninterpretable. Despite provider knowledge of baseline HBV, HBV-R diagnosis and treatment were delayed in 7 cases and possibly 7 others.
The quality of information varied among reports. Because reporting is voluntary, HBV-R associated with DAAs likely is underreported.
Hepatitis B virus reactivation is a newly identified safety concern in patients with HBV-HCV co-infection treated with DAAs. Patients with a history of HBV require clinical monitoring while receiving DAA therapy. Studies would help determine the risk factors for HBV-R, define monitoring frequency, and identify patients who may benefit from HBV prophylaxis and treatment. DAAs remain a safe and highly effective treatment for the management of HCV infection.
None.
Introduction: Social determinants of health (SDOH) impact well-being. We tested the association between incident diabetes risk and SDOH using 2 measures, the Area Deprivation Index (ADI) and Social ...Vulnerability Index (SVI) .
Methods: We examined 2015-2021 medical and claims data from the UC Data Warehouse for overweight/obese adults (age>18 yrs; BMI>25 kg/m2; >23 if Asian) . We ran 4 cox proportional hazards regression models with an outcome variable of incident diabetes; 1) base model with age, sex, race, ethnicity, income, BMI, prediabetes and comorbidities, 2) base model + ADI, 3) base model + SVI, and 4) base model + ADI and + SVI. Since SDOH indices were missing for ∼17%, we added them using an interaction term with an indicator variable.
Results: Among 36,946 adults, 33,587 (91%) had >1 follow-up assessment. Among these, mean age was 43 yrs, BMI 28 kg/m2, ADI 3.9 (SD 2.4) , SVI 0.34 (SD 0.24) ; 14% had prediabetes. Over 4.6 (SD 3.3) mean follow-up yrs, 715 (2%) developed diabetes. In the base model, incident diabetes risk significantly increased with each additional yr of age (HR 1.03) , unit BMI (HR 1.09) , prediabetes (HR 2.2) , and in Asian (HR 1.5) or other/multi-racial groups (HR 1.6) compared to Whites; risk decreased with hyperlipidemia (HR 0.72) . These associations were significant in all SDOH models (base +ADI, +SVI or +both) . In our SDOH models, incident diabetes risk was not associated with the degree of area deprivation or social vulnerability. However, diabetes risk decreased if ADI estimates (HR 0.54 95%CI 0.38, 0.77) or SVI estimates (HR 0.48 95%CI 0.36, 0.63) were present (vs. undetermined/unknown) . In the SDOH model with both ADI/SVI, diabetes risk decreased if SVI was present (HR 0.49 95%CI 0.34, 0.70) .
Conclusion: In our real-world cohort of overweight/obese adults, the degree of area deprivation or social vulnerability was not associated with risk of incident diabetes when traditional risk factors were available. More studies of SDOH measures are needed to inform national diabetes prevention efforts.
Disclosure
K.Ramm: None. C.Mangione: n/a. T.Moin: None. N.Jackson: None. U.Chung: None. O.Duru: None. K.Shedd: None. S.Soetenga: None. T.B.Loeb: None. D.Elashoff: None. A.B.Hamilton: None.
Funding
NIH/NIDDK 1R01DK124503
Leiomyosarcoma (LMS) is a rare, aggressive soft-tissue sarcoma that seldom spreads to the bone. The spine can be either the site of LMS osseous metastases or the primary tumor site. The optimal ...treatment option for spinal LMS is still unclear. The authors present a cohort of patients with spinal LMS treated with either upfront surgery or upfront CyberKnife stereotactic radiosurgery (SRS).
The authors retrospectively studied the clinical and radiological outcomes of 17 patients with spinal LMS treated at their institution between 2004 and 2020. Either surgery or SRS was used as the upfront treatment. The clinical and radiological outcomes were assessed. A systematic review of the literature was also conducted.
Of the 17 patients (20 spinal lesions), 12 (70.6%) were female. The median patient age was 61 years (range 41-80 years). Ten patients had upfront surgery for their spinal lesions, and 7 had upfront CyberKnife radiosurgery. The median follow-up was 11 months (range 0.3-130 months). The median overall survival (OS) for the entire cohort was 13 months (range 0.3-97 months). In subgroup analysis, the median OS was lower for the surgical group (13 months, range 0.3-50 months), while the median OS for the SRS group was 15 months (range 5-97 months) (p = 0.5). Forty percent (n = 4) of those treated with surgery presented with local recurrence at a median of 6.7 months (range 0.3-36 months), while only 14% (n = 1) of those treated with CyberKnife radiosurgery had local recurrence after 5 months. Local tumor control (LTC) rates at the 6-, 12-, and 18-month follow-ups were 72%, 58%, and 43%, respectively, for the SRS group and 40%, 30%, and 20%, respectively, for the surgery group (p < 0.05). The literature review included 35 papers with 70 patients harboring spinal LMS; only 2 patients were treated with SRS. The literature review confirms the clinical and radiological outcomes of the surgical group, while data on SRS are anecdotal.
The authors present the largest series in the literature of spinal LMS and the first on SRS for spinal LMS. This study shows that LTC is statistically significantly better in patients receiving upfront SRS instead of surgery. The OS does not appear different between the two groups.