Immunogenicity of a 2-Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.

We compared the serologic responses of 1 dose versus 2 doses of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults. A 2-dose boosting regimen with a variant vaccine did not increase the magnitude or the durability of the serological responses compared to a single variant vaccine boost.

Immunogenicity of the BA.1 and BA.4/BA.5 Severe Acute Respiratory Syndrome Coronavirus 2 Bivalent Boosts: Preliminary Results From the COVAIL Randomized Clinical Trial.

In a randomized clinical trial, we compare early neutralizing antibody responses after boosting with bivalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines based on either BA.1 or BA.4/BA.5 Omicron spike protein combined with wild-type spike. Responses against SARS-CoV-2 variants exhibited the greatest reduction in titers against currently circulating Omicron subvariants for both bivalent vaccines.

Assessment of the occlusal outcomes in patients treated with orthognathic surgery and clear aligners.

OBJECTIVE: This retrospective two-centre study aimed to evaluate the occlusal outcomes in patients undergoing orthognathic surgery with clear aligners. METHODS: A retrospective chart review and occlusal outcomes for 15 patients (10 females and five males) with different types of dentofacial deformities in the anteroposterior, vertical and transverse dimensions, who underwent orthognathic surgery in conjunction with clear aligners were evaluated. Weighed Peer Assessment Rating (PAR) index scores of the pre-treatment and post-treatment digital models were used to assess initial complexity, final occlusal outcomes and degree of improvement with surgery and clear aligners. RESULTS: The mean post-treatment PAR score was 3.5 ± 2.54, which was a statistically significant improvement from the pre-treatment PAR score of 27.63 ± 12.09, an 87% improvement was achieved. All subcategories of the PAR index showed statistically significant improvement except for midline assessment component. CONCLUSIONS: Occlusal outcomes with aligners showed great improvement as indicated with the PAR index scores. Orthognathic surgical cases can be treated efficiently with aligners and future studies should compare occlusal outcomes between orthognathic surgical patients treated with clear aligners and those treated with fixed appliances.

Psychometric properties of the evidence-based practice mentorship scale.

BACKGROUND: Evidence-based practice (EBP) improves the quality of care, decreases healthcare costs, and improves job satisfaction. However, nurses and other clinicians, as well as their institutions, struggle to consistently implement EBP. The Advancing Research and Clinical practice through close Collaboration (ARCC©) Model established that a cadre of EBP mentors is key to improving EBP knowledge, beliefs, competency, and implementation in clinicians. Yet, there has not been a valid and reliable measure of EBP mentorship. AIMS: The aim of this study was to determine the psychometric properties of the new 8-item EBP Mentorship Scale. This scale measures the degree to which clinicians perceive that EBP mentorship is available to them. METHODS: The EBP Mentorship Scale data were obtained from a previous national cross-sectional descriptive study with 2344 nurses from 19 hospitals and healthcare systems. Descriptive statistics summarized the sample and distributions of the scale items. Cronbach's alpha, exploratory factor analysis (EFA), and confirmatory factor analysis (CFA) were conducted. RESULTS: Cronbach's alpha of the scale was 0.99. A one-factor model was supported by EFA and retained for CFA. Model fit indices for CFA indicated a good fit. LINKING EVIDENCE TO ACTION: The new EBP Mentorship Scale is valid and reliable and can be used to assess the level of EBP mentorship support available in hospitals and healthcare systems. EBP mentors are key in sustaining an EBP organizational culture and enhancing clinician EBP knowledge, beliefs, competency, and implementation.

Psychometric properties of the Organizational Culture and Readiness Scale for System-Wide Integration of Evidence-Based Practice.

BACKGROUND: Patient safety metrics declined due to COVID-19-related strains placed on hospitals and hospital systems. Because evidence-based practice (EBP) can improve patient outcomes and quality of care and empower clinicians, a renewed focus on organizational EBP culture is needed. The Advancing Research and Clinical practice through close Collaboration (ARCC©) Model describes how to use a system-wide approach to advance and sustain EBP in hospital systems to improve outcomes. EBP culture is a key variable that directly impacts EBP knowledge, beliefs, competency, and implementation. The ARCC© Model uses the Organizational Culture and Readiness Scale for System-Wide Integration of Evidence-Based Practice (OCRSIEP) to identify organizational characteristics that influence clinician and patient outcomes. Although the scale has been reported to have excellent reliability, a comprehensive psychometric analysis has yet to be performed that confirms its construct validity. AIMS: The aim of this study was to describe the OCRSIEP's construct validity and reliability via an in-depth psychometric analysis. METHODS: OCRSIEP assessment data were obtained from a prior national study with 2344 nurses from 19 hospitals and healthcare systems. Descriptive statistics summarized the sample and distributions of the 25 scale items. Construct validity was assessed via exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Cronbach's alpha assessed reliability. RESULTS: A one-factor model was supported by EFA with item Q17b excluded (i.e., to what extent are decisions generated from upper administration). Model fit indices for CFA indicated a good fit (CFI = 0.978, TLI = 0.973, RMSEA = 0.077, SRMR = 0.027). Cronbach's alpha was 0.96 for all items and 0.97 with item Q17b excluded, both indicating outstanding internal consistency. LINKING EVIDENCE TO ACTION: The OCRSIEP is valid and reliable and can be used to assess EBP culture and readiness in hospitals and healthcare systems at the organizational level.

EBP education and skills building for leaders: An RCT to promote EBP infrastructure, process and implementation in a comprehensive cancer center.

BACKGROUND: Implementation of evidence-based practice (EBP) in healthcare remains challenging. The influence of leadership has been recognized. However, few randomized trials have tested effects of an educational and skills building intervention for leaders in clinical settings. AIMS: Test effects of an EBP leadership immersion intervention on EBP attributes over time among two cohorts of leaders at a national comprehensive cancer center. METHODS: A stratified, randomized, wait-list group, controlled design was conducted. Participants received the evidence-based intervention one year apart (2020, n = 36; 2021, n = 30) with EBP knowledge, beliefs, competencies, implementation self-efficacy, implementation behaviors, and organizational readiness measured at pre- and post-intervention, and one- and two-year follow-ups. Participants applied learnings to a specific clinical or organization priority topic. RESULTS: Baseline outcomes variables and demographics did not differ between cohorts except for age and years of experience. Both cohorts demonstrated significant changes in EBP attributes (except organizational readiness) post-intervention. Mixed linear modeling revealed group by time effects at 3-months for all EBP attributes except implementation behaviors and organizational readiness after the first intervention, favoring cohort 2020, with retained effects for EBP beliefs and competencies at one year. Following Cohort 2021 intervention, at 12-weeks post-intervention, implementation behaviors were significantly higher for cohort 2021. LINKING EVIDENCE TO ACTION: An intensive EBP intervention can increase healthcare leaders' EBP knowledge and competencies. Aligning EBP projects with organizational priorities is strategic. Follow-up with participants to retain motivation, knowledge and competencies is essential. Future research must demonstrate effects on clinical outcomes.

Fatty acid metabolism and colon cancer protection by dietary methyl donor restriction.

INTRODUCTION: A methyl donor depleted (MDD) diet dramatically suppresses intestinal tumor development in Apc-mutant mice, but the mechanism of this prevention is not entirely clear. OBJECTIVES: We sought to gain insight into the mechanisms of cancer suppression by the MDD diet and to identify biomarkers of cancer risk reduction. METHODS: A plasma metabolomic analysis was performed on ApcΔ14/+ mice maintained on either a methyl donor sufficient (MDS) diet or the protective MDD diet. A group of MDS animals was also pair-fed with the MDD mice to normalize caloric intake, and another group was shifted from an MDD to MDS diet to determine the durability of the metabolic changes. RESULTS: In addition to the anticipated changes in folate one-carbon metabolites, plasma metabolites related to fatty acid metabolism were generally decreased by the MDD diet, including carnitine, acylcarnitines, and fatty acids. Some fatty acid selectivity was observed; the levels of cancer-promoting arachidonic acid and 2-hydroxyglutarate were decreased by the MDD diet, whereas eicosapentaenoic acid (EPA) levels were increased. Machine-learning elastic net analysis revealed a positive association between the fatty acid-related compounds azelate and 7-hydroxycholesterol and tumor development, and a negative correlation with succinate and ß-sitosterol. CONCLUSION: Methyl donor restriction causes dramatic changes in systemic fatty acid metabolism. Regulating fatty acid metabolism through methyl donor restriction favorably effects fatty acid profiles to achieve cancer protection.

Membrane-based therapeutic plasma exchange: Hemodynamics and operational characteristics leading to procedure failure.

BACKGROUND AND OBJECTIVES: Therapeutic plasma exchange (TPE) is a blood purification treatment capable of removing large molecular weight substances from plasma. It is commonly used for the removal of circulating pathogenic immunoglobulins presumed to be the cause of many autoimmune diseases. TPE can be performed with a membrane-based system (mTPE) or a centrifugal-based system (cTPE). When plasma separation is performed with a membrane, filter clotting can lead to longer treatment time, higher cost and can negatively impact patient satisfaction. In this study, we examine the operational characteristics that might influence filter life. DESIGN, SETTING, PARTICIPANTS, & MEASURES: We report on 24 patients, with a total of 135 mTPE treatments in a single tertiary care academic center using the NxStage machine. The study focuses on treatment specific parameters that may lead to procedure failure. The main parameters of interest were transmembrane pressure (TMP) and the filtration fraction as displayed on the machine (FFd) compared to the calculated filtration fraction (FFc). Primary outcome was to measure whether TMP, FFc, and FFd influenced filter survival. Secondary outcomes included factors that might have indirectly resulted in filter failure, including hematocrit (Hct), platelet count, heparin use, and intra-treatment calcium administration. RESULTS: In this study, we demonstrated that machine displayed filtration fractions (FFd) were lower than FFc and this difference was significantly larger in TPE sessions that experienced a clotting event (7.58 vs 6.22, P = .031). TPE sessions that clotted had a higher mean TMP (57.48 mmHg vs 44.43 mmHg, P = .001) and clotting events tended to have a lower mean blood flow rate (175.83 mL/min vs 189.55 mL/min, P = .002). In TPE sessions that received prefilter calcium administration, a higher mean dose of calcium gluconate was found in the sessions that experienced clotting (3.27 g vs 2.70 g, P = .013). Patients who experienced at least one clotting event were noted to be heavier than those patients without any clotting events (91.52 kg vs 72.15 kg, P = .040). Prefilter heparin administration was not associated with a lower incidence of filter clotting. We did not find a statistically significant difference in clotting events based upon type of intravenous access, pretreatment hematocrit, or pretreatment platelet counts. CONCLUSION: Among patients undergoing mTPE, machine FFd on the NxStage system are consistently lower than FFc. Treatments where there was a greater difference between displayed and FFc had a greater likelihood of filter clotting. Treatments with higher TMP were associated with failed treatments. Prefilter calcium administration during treatment was associated with increased filter clotting. Lower blood flow rates and higher patient weight were also associated with increased filter clotting. Prefilter heparin administration did not reduce the incidence of filter clotting.

Bayesian variable selection for the Cox regression model with spatially varying coefficients with applications to Louisiana respiratory cancer data.

The Cox regression model is a commonly used model in survival analysis. In public health studies, clinical data are often collected from medical service providers of different locations. There are large geographical variations in the covariate effects on survival rates from particular diseases. In this paper, we focus on the variable selection issue for the Cox regression model with spatially varying coefficients. We propose a Bayesian hierarchical model which incorporates a horseshoe prior for sparsity and a point mass mixture prior to determine whether a regression coefficient is spatially varying. An efficient two-stage computational method is used for posterior inference and variable selection. It essentially applies the existing method for maximizing the partial likelihood for the Cox model by site independently first and then applying an Markov chain Monte Carlo algorithm for variable selection based on results of the first stage. Extensive simulation studies are carried out to examine the empirical performance of the proposed method. Finally, we apply the proposed methodology to analyzing a real dataset on respiratory cancer in Louisiana from the Surveillance, Epidemiology, and End Results (SEER) program.

Biomarkers of orthodontic tooth movement with fixed appliances and vibration appliance therapy: a pilot study.

INTRODUCTION: The aim of this study was to investigate the effect of supplemental vibratory force on biomarkers of bone remodelling during orthodontic tooth movement, the rate of mandibular anterior alignment (RMAA), and compliance with a vibration device. DESIGN, SETTINGS, AND PARTICIPANTS: Forty patients between the ages 15-35 undergoing fixed appliance treatment that presented to a university orthodontic clinic were randomly allocated to supplemental use of an intraoral vibrational device (n = 20, AcceleDent®) or fixed appliance only (n = 20). Salivary multiplex assay was completed to analyse the concentration of selected biomarkers of bone remodelling before treatment (T0) and at three following time points (T1, T2, T3), 4-6 weeks apart. Irregularity of the mandibular anterior teeth and compliance was assessed at the same trial time points. Data were analysed blindly on an intention-to-treat basis with descriptive statistics, Mann-Whitney U-test, Wilcoxon signed-rank test, and linear mixed effects regression modelling. RESULTS: No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed. No correlation was found between changes in irregularity and biomarker level from baseline to another time point. Lastly, there was no association between RMAA and compliance with the AcceleDent® device. CONCLUSIONS: Supplemental vibratory force during orthodontic treatment with fixed appliances does not affect biomarkers of bone remodelling or the RMAA. LIMITATIONS: The main limitation of the study was the small sample size and the large variability in the salivary biomarkers. HARMS: No harms were observed during the duration of the trial. PROTOCOL: The protocol was not published prior to trial commencement. REGISTRATION: The study was registered in Clinical Trials.gov (NCT02119455) first posted on April 2014.

Hair cortisol, perceived stress, and social support in mother-child dyads living in an urban neighborhood.

Women and children belonging to a racial/ethnic minority bear a disproportionate burden of psychosocial stress that increases their vulnerability to adverse health outcomes. Hair cortisol has been rapidly advanced as a biomarker of the intensity and course of the stress response over time and may provide an opportunity to increase our understanding of the role of psychological stress in health. However, research on the link between hair cortisol levels and subjective measures of maternal and child stress among low-income and minority individuals is limited. The goal of this study was to examine the association between stress and hair cortisol in low income, minority women and children who experience disproportionate exposure to chronic stress. A convenience sample of 54 minority mother/child dyads from a busy primary care clinic in the second poorest medium-sized city in the US participated in the study. Mothers self-reported perceived stress, social support, household characteristics and other demographic factors, and their children (ages 7-14 years) reported on the perceived level of safety in their neighborhood and exposure to violence as markers of child stress. Three-centimeter hair samples were collected from both mothers and children during the clinic visit, and hair cortisol levels were assessed via enzyme-linked immunosorbent assays. Linear regression models examined associations between maternal and child hair cortisol, and between hair cortisol and perceived stress level in women, and moderation by social support. Maternal hair cortisol was not significantly associated with mother's perceived stress. Maternal and child hair cortisol levels were positively associated (p = .007) but this association was not moderated by maternal perceived social support. These findings suggest that hair cortisol is strongly associated among this sample of minority mother-child dyads and is not moderated by social support.

Fecal Microbiota Transplantation for Clostridium difficile Infection: A One-Center Experience.

BACKGROUND: Clostridium difficile is a gram-positive, anaerobic, and spore-forming bacillus, which is responsible for the majority of antibiotic-associated diarrhea and colitis. OBJECTIVE: Determine if fecal microbiota transplantation (FMT) is effective in a population sample from Connecticut. METHODS: We report the clinical experience of 92 consecutive patients from one gastroenterology practice in central Connecticut treated by colonoscopy with FMT for infection with Clostridium difficile from 2012 to 2017. The analyses are based on clinical follow-up up to 3 months after the FMT procedure and on medical chart review. RESULTS: Overall, complete recovery occurred in 86% of patients. As previously reported in a limited number of previous studies, community-acquired cases were more common than hospital-acquired cases, and community-acquired cases were more likely to be female. CONCLUSIONS: Consistent with some previous reports, we found the following: the source of the donor for FMT did not make a difference in recovery: material from nonrelatives was as effective as from close relatives; and the presence of multiple comorbidities did not make a difference in recovery: patients with 2 or more comorbidities did as well as those with one or none.

One Health research ethics review processes in African countries: Challenges and opportunities.

One Health research has gained attention over the past few decades due to its potential to improve health challenges across the globe. However, obtaining ethics approvals for timely implementation of One Health research is a challenge in some contexts. Our study was undertaken to describe various challenges faced by researchers, research ethics committees (RECs) and members of regulatory bodies in Africa. An online survey was conducted between March and June 2021. The effect of predictors, including respondents' role (e.g., REC member, regulator and/or One Health researcher), sex, education, age, and country, on the perception of challenges and opportunities when conducting and reviewing One Health research, was investigated using multivariable linear regression models. Participants with different roles did not perceive any of the examined challenges differently during review of One Health-related research; but female participants (p = 0.026) and those with ten or more years of experience (p = 0.0325) perceived insufficient One Health knowledge as less of a challenge. Professional role was an important predictor (p = 0.025) for the perception of the establishment of a mandatory One Health review system. Respondents with multiple roles perceived the creation of ad hoc committees for review of One Health research under emergency situations to be less important (p = 0.02); and REC members perceived the creation of such committees to be less feasible (p = 0.0697). Our study showed that perceptions of the importance and feasibility of opportunities for improvement of One Health research ethics review under emergency and non-emergency situations varied across professional roles. This emphasizes the need to consider such improvement strategies; and the need for continuous and timely evaluation for improvement of ethics review of One Health and emergency research in Africa.

Associations among infection prevention professionals' mental/physical health, lifestyle behaviors, shift length, race, and workplace wellness support during COVID-19.

BACKGROUND: COVID-19 added stress to infection prevention professionals' (IPs) work-life that may have impacted their well-being. This study aimed to describe IPs' mental and physical health and lifestyle behaviors during the pandemic and their associations with IP role, perceived worksite wellness support, shift length, and race and/or ethnicity. METHODS: A random sample of Association for Professionals in Infection Control and Epidemiology members (6,000) were emailed a survey assessing mental and physical well-being, lifestyle behaviors, and perceived worksite wellness support. RESULTS: A total of 926 IPs responded (15% response rate). Few met guidelines for sleep (34.1%), physical activity (18.8%), and fruit and vegetable consumption (7.3%). Rates of depression, anxiety, and burnout were 21.5%, 29.8%, and 65%. Front line and practicing IPs and IP administrators and directors had more negative mental health impacts than IPs in other roles. IPs with organizational wellness support were less likely to report negative COVID-19 impacts. IPs working 9-11+ hours/day were more likely to report worsening physical and mental health due to COVID-19. There were no significant differences in odds of negative COVID-19 impacts on lifestyle behaviors between white and racial and ethnically diverse IPs. CONCLUSIONS: IPs who worked shorter shifts and had more organizational wellness support had better well-being outcomes. Organizations must fix system issues that result in poor health and invest in workforce wellness.

Clinicians' perceptions on implementation strategies used to facilitate ABCDEF bundle adoption: A multicenter survey.

BACKGROUND: Intensive care unit (ICU) clinicians struggle to routinely implement the ICU Liberation bundle (ABCDEF bundle). As a result, critically ill patients experience increased risk of morbidity and mortality. Despite extensive research related to the barriers and facilitators of bundle use, little is known regarding which implementation strategies are used to facilitate its adoption and sustainability. OBJECTIVES: To identify implementation strategies used to increase adoption of the ABCDEF bundle and how those strategies are perceived by end-users (i.e., ICU clinicians) related to their helpfulness, acceptability, feasibility, and cost. METHODS: We conducted a national, cross-sectional survey of ICU clinicians from the 68 ICU sites that previously participated in the Society of Critical Care Medicine's ICU Liberation Collaborative. The survey was structured using the 73 Expert Recommendations for Implementing Change (ERIC) implementation strategies. Surveys were delivered electronically to site contacts. RESULTS: Nineteen ICUs (28%) returned completed surveys. Sites used 63 of the 73 ERIC implementation strategies, with frequent use of strategies that may be readily available to clinicians (e.g., providing educational meetings or ongoing training), but less use of strategies that require changes to well-established organizational systems (e.g., alter incentive allowance structure). Overall, sites described the ERIC strategies used in their implementation process to be moderately helpful (mean score >3<4 on a 5-point Likert scale), somewhat acceptable and feasible (mean score >2<3), and either not-at-all or somewhat costly (mean scores >1<3). CONCLUSIONS: Our results show a potential over-reliance on accessible strategies and the possible benefit of unused ERIC strategies related to changing infrastructure and utilizing financial strategies.

Rhinologist Use of Antibiotics With Nasal Packing for Epistaxis.

BACKGROUND: There is limited evidence supporting the usage of prophylactic antibiotics in the setting of nasal packing for epistaxis. It is unclear what current antiobiotic usage patterns are by otolaryngologists. OBJECTIVES: Characterize the antibiotic prescribing practices employed by otolaryngologists in the management of epistaxis patients treated with packing as well as the underlying rationale. Explore the impact of experience, geography, and academic affiliation on treatment decisions. METHODS: An anonymous survey of antibiotic prescribing patterns for patients with epistaxis requiring nasal packing was distributed to all physician members of the American Rhinologic Society. Responses to each question were descriptively summarized including 95% confidence intervals and were linked to demographics using Fisher's exact tests. RESULTS: One thousand one hundred and thirteen surveys were distributed with 307 responses (27.6%). Antibiotic prescription rates varied based on packing type, with 20.0% prescribing antibiotics for dissolvable packing compared to 84.2% to 84.6% for nondissolvable packing. The absorbance of nondissolvable packing does not impact the decision to prescribe antibiotics (P > .999). Precisely 69.7% (95% CI: 64.0%-74.8%) stop antibiotics immediately following packing removal. Precisely 85.6% (95% CI: 81.6%-89.9%) cite the risk of toxic shock syndrome (TSS) when prescribing antibiotics. Notable regional differences include greater utilization of amoxicillin-clavulanate in the Midwest (67.6%) and Northeast (61.4%) as compared with the South (42.1%) and West (45.1%) (P = .013). Further, years in practice were positively associated with several patterns including prescribing antibiotics for patients with dissolvable packing (P = .008), citing prevention of sinusitis as a rationale for antibiotic use (P < .001), and a higher likelihood of having treated a patient with TSS (P = .002). CONCLUSIONS: Antibiotic use in patients with epistaxis controlled with nondissolvable packing is common. Treatment patterns are influenced by geography, years in practice, and practice type. LEVEL OF EVIDENCE: 4.

Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.

In this brief report, we compare the magnitude and durability of the serologic response of one versus two doses (separated by 56 days) of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults.

Immunogenicity of the BA.1 and BA.4/BA.5 SARS-CoV-2 Bivalent Boosts: Preliminary Results from the COVAIL Randomized Clinical Trial.

In a randomized clinical trial, we compare early neutralizing antibody responses after boosting with bivalent SARS-CoV-2 mRNA vaccines based on either BA.1 or BA.4/BA.5 Omicron spike protein combined with wildtype spike. Responses against SARS-CoV-2 variants exhibited the greatest reduction in titers against currently circulating Omicron subvariants for both bivalent vaccines.

Psychometric Properties of the New Working Parent Burnout Scale.

INTRODUCTION: Parental burnout is an underrecognized condition with adverse consequences for parents and children. The objective of this study was to determine the psychometric properties of a new scale, the Working Parent Burnout Scale, and a concurrent one-item assessment. METHOD: A cross-sectional survey was conducted. The sample included parents (N = 1,285) living with children < 18 years. Content, face, construct, and predictive validity and reliability were established. RESULTS: Cronbach α was 0.90 with the elimination of item four on the scale. All factor loadings were > 0.40. The one-factor model was supported by confirmatory factor analysis. The Pearson r correlation was 0.59 for the total score on the original 10-item burnout scale (item 4 excluded) and the one-item assessment. DISCUSSION: These are the first known scales to measure working parent burnout. By better identifying parental burnout, preventive and interventional approaches can be initiated to enhance parent and child outcomes.

Factors Associated With Spontaneous Awakening Trial and Spontaneous Breathing Trial Performance in Adults With Critical Illness: Analysis of a Multicenter, Nationwide, Cohort Study.

BACKGROUND: Broad-scale adoption of spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs) into everyday practice has been slow, and uncertainty exists regarding what factors facilitate or impede their routine delivery. RESEARCH QUESTION: What patient, practice, and pharmacologic factors are associated with SAT and SBT performance and to what extent do they predict overall SAT/SBT performance? STUDY DESIGN AND METHODS: This secondary analysis used data collected from a national quality improvement collaborative composed of 68 diverse ICUs. Adults with critical illness adults who received mechanical ventilation and/or continuously infused sedative medications were included. We performed mixed-effects logistic regression modeling, created receiver operating characteristic curves, and calculated the area under the curve (AUC). RESULTS: Included in the SAT and SBT analysis were 4,847 and 4,938 patients, respectively. In multivariable models controlling for admitting patient characteristics, factors independently associated with higher odds of a next-day SAT and SBT included physical restraint use (adjusted odds ratio [AOR], 1.63; 95% CI, 1.42-1.87; AOR, 1.83; 95% CI, 1.60-2.09), documented target sedation level (AOR, 1.68; 95% CI, 1.41-2.01; AOR, 1.46; 95% CI, 1.24-1.72), more frequent level of arousal assessments (AOR, 1.22; 95% CI, 1.03-1.43; AOR, 1.32; 95% CI, 1.13-1.54), and dexmedetomidine administration (AOR, 1.23; 95% CI, 1.05-1.45; AOR, 1.52; 95% CI, 1.27-1.80). Factors independently associated with lower odds of a next-day SAT and SBT included deep sedation/coma (AOR, 0.69; 95% CI, 0.60-0.80; AOR, 0.33; 95% CI, 0.28-0.37) and benzodiazepine (AOR, 0.83; 95% CI, 0.72-0.95; AOR, 0.67; 95% CI, 0.59-0.77) or ketamine (AOR, 0.34; 95% CI, 0.16-0.71; AOR, 0.40; 95% CI, 0.18-0.88) administration. Models incorporating admitting, daily, and unit variations displayed moderate discriminant accuracy in predicting next-day SAT (AUC, 0.73) and SBT (AUC, 0.72) performance. INTERPRETATION: There are a number of modifiable factors associated with SAT/SBT performance that are amenable to the development and testing of implementation interventions.