Factors Associated With Decision to Use and Dosing of Sugammadex in Children: A Retrospective Cross-Sectional Observational Study.

BACKGROUND: Sugammadex was initially approved for reversal of neuromuscular blockade in adults in the United States in 2015. Limited data suggest sugammadex is widely used in pediatric anesthesia practice however the factors influencing use are not known. We explore patient, surgical, and institutional factors associated with the decision to use sugammadex versus neostigmine or no reversal, and the decision to use 2 mg/kg vs 4 mg/kg dosing. METHODS: Using data from the Multicenter Perioperative Outcomes Group (MPOG) database, an EHR-derived registry, we conducted a retrospective cross-sectional study. Eligible cases were performed between January 1, 2016 and December 31, 2020, for children 0 to 17 years at US hospitals. Cases involved general anesthesia with endotracheal intubation and administration of rocuronium or vecuronium. Using generalized linear mixed models with institution and anesthesiologist-specific random intercepts, we measured the importance of a variety of patient, clinician, institution, anesthetic, and surgical risk factors in the decision to use sugammadex versus neostigmine, and the decision to use a 2 mg/kg vs 4 mg/kg dose. We then used intraclass correlation statistics to evaluate the proportion of variance contributed by institution and anesthesiologist specifically. RESULTS: There were 97,654 eligible anesthetics across 30 institutions. Of these 47.1% received sugammadex, 43.1% received neostigmine, and 9.8% received no reversal agent. Variability in the choice to use sugammadex was attributable primarily to institution (40.4%) and attending anesthesiologist (27.1%). Factors associated with sugammadex use (compared to neostigmine) include time from first institutional use of sugammadex (odds ratio [OR], 1.08, 95% confidence interval [CI], 1.08-1.09, per month, P < .001), younger patient age groups (0-27 days OR, 2.59 [2.00-3.34], P < .001; 28 days-1 year OR, 2.72 [2.16-3.43], P < .001 vs 12-17 years), increased American Society of Anesthesiologists [ASA] physical status (ASA III: OR, 1.32 [1.23-1.42], P < .001 ASA IV OR, 1.71 [1.46-2.00], P < .001 vs ASA I), neuromuscular disease (OR, 1.14 (1.04-1.26], P = .006), cardiac surgery (OR, 1.76 [1.40-2.22], P < .001), dose of neuromuscular blockade within the hour before reversal (>2 ED95s/kg OR, 4.58 (4.14-5.07], P < .001 vs none), and shorter case duration (case duration <60 minutes OR, 2.06 [1.75-2.43], P < .001 vs >300 minutes). CONCLUSIONS: Variation in sugammadex use was primarily explained by institution and attending anesthesiologist. Patient factors associated with the decision to use sugammadex included younger age, higher doses of neuromuscular blocking agents, and increased medical complexity.

Variation in Intraoperative Opioid Administration by Patient, Clinician, and Hospital Contribution.

Importance: The opioid crisis has led to scrutiny of opioid exposures before and after surgical procedures. However, the extent of intraoperative opioid variation and the sources and contributing factors associated with it are unclear. Objective: To analyze attributable variance of intraoperative opioid administration for patient-, clinician-, and hospital-level factors across surgical and analgesic categories. Design, Setting, and Participants: This cohort study was conducted using electronic health record data collected from a national quality collaborative database. The cohort consisted of 1 011 268 surgical procedures at 46 hospitals across the US involving 2911 anesthesiologists, 2291 surgeons, and 8 surgical and 4 analgesic categories. Patients without ambulatory opioid prescriptions or use history undergoing an elective surgical procedure between January 1, 2014, and September 11, 2020, were included. Data were analyzed from January 2022 to July 2023. Main Outcomes and Measures: The rate of intraoperative opioid administration as a continuous measure of oral morphine equivalents (OMEs) normalized to patient weight and case duration was assessed. Attributable variance was estimated in a hierarchical structure using patient, clinician, and hospital levels and adjusted intraclass correlations (ICCs). Results: Among 1 011 268 surgical procedures (mean [SD] age of patients, 55.9 [16.2] years; 604 057 surgical procedures among females [59.7%]), the mean (SD) rate of intraoperative opioid administration was 0.3 [0.2] OME/kg/h. Together, clinician and hospital levels contributed to 20% or more of variability in intraoperative opioid administration across all analgesic and surgical categories (adjusting for surgical or analgesic category, ICCs ranged from 0.57-0.79 for the patient, 0.04-0.22 for the anesthesiologist, and 0.09-0.26 for the hospital, with the lowest ICC combination 0.21 for anesthesiologist and hosptial [0.12 for the anesthesiologist and 0.09 for the hospital for opioid only]). Comparing the 95th and fifth percentiles of opioid administration, variation was 3.3-fold among anesthesiologists (surgical category range, 2.7-fold to 7.7-fold), 4.3-fold among surgeons (surgical category range, 3.4-fold to 8.0-fold), and 2.2-fold among hospitals (surgical category range, 2.2-fold to 4.3-fold). When adjusted for patient and surgical characteristics, mean (square error mean) administration was highest for cardiac surgical procedures (0.54 [0.56-0.52 OME/kg/h]) and lowest for orthopedic knee surgical procedures (0.19 [0.17-0.21 OME/kg/h]). Peripheral and neuraxial analgesic techniques were associated with reduced administration in orthopedic hip (51.6% [95% CI, 51.4%-51.8%] and 60.7% [95% CI, 60.5%-60.9%] reductions, respectively) and knee (48.3% [95% CI, 48.0%-48.5%] and 60.9% [95% CI, 60.7%-61.1%] reductions, respectively) surgical procedures, but reduction was less substantial in other surgical categories (mean [SD] reduction, 13.3% [8.8%] for peripheral and 17.6% [9.9%] for neuraxial techniques). Conclusions and Relevance: In this cohort study, clinician-, hospital-, and patient-level factors had important contributions to substantial variation of opioid administrations during surgical procedures. These findings suggest the need for a broadened focus across multiple factors when developing and implementing opioid-reducing strategies in collaborative quality-improvement programs.

Description of the Content and Quality of Publicly Available Information on the Internet About Inhaled Volatile Anesthesia and Total Intravenous Anesthesia: Descriptive Study.

BACKGROUND: More than 300 million patients undergo surgical procedures requiring anesthesia worldwide annually. There are 2 standard-of-care general anesthesia administration options: inhaled volatile anesthesia (INVA) and total intravenous anesthesia (TIVA). There is limited evidence comparing these methods and their impact on patient experiences and outcomes. Patients often seek this information from sources such as the internet. However, the majority of websites on anesthesia-related topics are not comprehensive, updated, and fully accurate. The quality and availability of web-based patient information about INVA and TIVA have not been sufficiently examined. OBJECTIVE: This study aimed to (1) assess information on the internet about INVA and TIVA for availability, readability, accuracy, and quality and (2) identify high-quality websites that can be recommended to patients to assist in their anesthesia information-seeking and decision-making. METHODS: Web-based searches were conducted using Google from April 2022 to November 2022. Websites were coded using a coding instrument developed based on the International Patient Decision Aids Standards criteria and adapted to be appropriate for assessing websites describing INVA and TIVA. Readability was calculated with the Flesch-Kincaid (F-K) grade level and the simple measure of Gobbledygook (SMOG) readability formula. RESULTS: A total of 67 websites containing 201 individual web pages were included for coding and analysis. Most of the websites provided a basic definition of general anesthesia (unconsciousness, n=57, 85%; analgesia, n=47, 70%). Around half of the websites described common side effects of general anesthesia, while fewer described the rare but serious adverse events, such as intraoperative awareness (n=31, 46%), allergic reactions or anaphylaxis (n=29, 43%), and malignant hyperthermia (n=18, 27%). Of the 67 websites, the median F-K grade level was 11.3 (IQR 9.5-12.8) and the median SMOG score was 13.5 (IQR 12.2-14.4), both far above the American Medical Association (AMA) recommended reading level of sixth grade. A total of 51 (76%) websites distinguished INVA versus TIVA as general anesthesia options. A total of 12 of the 51 (24%) websites explicitly stated that there is a decision to be considered about receiving INVA versus TIVA for general anesthesia. Only 10 (20%) websites made any direct comparisons between INVA and TIVA, discussing their positive and negative features. A total of 12 (24%) websites addressed the concept of shared decision-making in planning anesthesia care, but none specifically asked patients to think about which features of INVA and TIVA matter the most to them. CONCLUSIONS: While the majority of websites described INVA and TIVA, few provided comparisons. There is a need for high-quality patient education and decision support about the choice of INVA versus TIVA to provide accurate and more comprehensive information in a format conducive to patient understanding.

A randomized trial of a mobile health intervention to augment cardiac rehabilitation.

Mobile health (mHealth) interventions may enhance positive health behaviors, but randomized trials evaluating their efficacy are uncommon. Our goal was to determine if a mHealth intervention augmented and extended benefits of center-based cardiac rehabilitation (CR) for physical activity levels at 6-months. We delivered a randomized clinical trial to low and moderate risk patients with a compatible smartphone enrolled in CR at two health systems. All participants received a compatible smartwatch and usual CR care. Intervention participants received a mHealth intervention that included a just-in-time-adaptive intervention (JITAI) as text messages. The primary outcome was change in remote 6-minute walk distance at 6-months stratified by device type. Here we report the results for 220 participants enrolled in the study (mean [SD]: age 59.6 [10.6] years; 67 [30.5%] women). For our primary outcome at 6 months, there is no significant difference in the change in 6 min walk distance across smartwatch types (Intervention versus control: +31.1 meters Apple Watch, -7.4 meters Fitbit; p = 0.28). Secondary outcomes show no difference in mean step counts between the first and final weeks of the study, but a change in 6 min walk distance at 3 months for Fitbit users. Amongst patients enrolled in center-based CR, a mHealth intervention did not improve 6-month outcomes but suggested differences at 3 months in some users.

Does Anesthesia Quality Improvement Participation Lead to Incremental Savings in a Surgical Quality Collaborative Population? A Retrospective Observational Study.

BACKGROUND: The Anesthesiology Performance Improvement and Reporting Exchange (ASPIRE) Collaborative Quality Initiative (CQI) was launched as a partnership among hospitals to measure quality, review evidence-based practices, and improve anesthesia-related outcomes. Cost savings and improved patient outcomes have been associated with surgical CQI participation, but the impact of an anesthesia CQI on health care cost has not been thoroughly assessed. In this study, we evaluated whether participation in an anesthesia CQI led to health care savings. We hypothesized that ASPIRE participation is associated with reduced total episode payments for payers and major, high-volume procedures included in the Michigan Value Collaborative (MVC) registry. METHODS: In this retrospective observational study, we compared MVC episode payment data from Group 1 ASPIRE hospitals, the first cluster of 8 Michigan hospitals to join ASPIRE in January 2015, to non-ASPIRE matched control hospitals. MVC computes price-standardized, risk-adjusted payments for patients insured by Blue Cross Blue Shield of Michigan Preferred Provider Organization, Blue Care Network Health Maintenance Organization, and Medicare Fee-for-Service plans. Episodes from 2014 comprised the pre-ASPIRE time period, and episodes from June 2016 to July 2017 constituted the post-ASPIRE time period. We performed a difference-in-differences analysis to evaluate whether ASPIRE implementation was associated with greater reduction in total episode payments compared to the change in the control hospitals during the same time periods. RESULTS: We found a statistically significant reduction in total episode (-$719; 95% CI [-$1340 to -$97]; P = .023) payments at the 8 ASPIRE hospitals (N = 17,852 cases) compared to the change observed in 8 matched non-ASPIRE hospitals (N = 12,987 cases) for major, high-volume surgeries, including colectomy, colorectal cancer resection, gastrectomy, esophagectomy, pancreatectomy, hysterectomy, joint replacement (knee and hip), and hip fracture repair. In secondary analyses, 30-day postdischarge (-$354; 95% CI [-$582 to -$126]; P = .002) payments were also significantly reduced in ASPIRE hospitals compared to non-ASPIRE controls. Subgroup analyses revealed a significant reduction in total episode payments for joint replacements (-$860; 95% CI [-$1222 to -$499]; P < .001) at ASPIRE-participating hospitals. Sensitivity analyses including patient-level covariates also showed consistent results. CONCLUSIONS: Participation in an anesthesiology CQI, ASPIRE, is associated with lower total episode payments for selected major, high-volume procedures. This analysis supports that participation in an anesthesia CQI can lead to reduced health care payments.

Epidemiologic Questionnaire (EPI-Q) - a scalable, app-based health survey linked to electronic health record and genotype data.

The Epidemiologic Questionnaire (EPI-Q) was established to collect broad, uniform, self-reported health data to supplement electronic health record (EHR) and genotype information from participants in the University of Michigan (UM) Precision Health cohorts. Recruitment of EPI-Q participants, who were already enrolled in 1 of 3 ongoing UM Precision Health cohorts-the Michigan Genomics Initiative, Mental Health Biobank, and Metabolism, Endocrinology, and Diabetes cohorts-began in March 2020. Of 54,043 retrospective invitations, 5,577 individuals enrolled, representing a 10.3% response rate. Of these, 3,502 (63.7%) were female, and the average age was 56.1 years (standard deviation, 15.4). The baseline survey comprises 11 modules on topics including personal and family health history, lifestyle, and cancer screening and history. Additionally, 11 optional modules cover topics including financial toxicity, occupational exposure, and life meaning. The questions are based on standardized and validated instruments used in other cohorts, and we share resources to expedite development of similar surveys. Data are collected via the MyDataHelps platform, which enables current and future participants to share non-Michigan Medicine EHR data. Recruitment is ongoing. Cohort data are available to those with institutional review board approval; for details, contact the Data Office for Clinical and Translational Research (DataOffice@umich.edu).

A survey of surgical patients' perspectives and preferences towards general anesthesia techniques and shared-decision making.

BACKGROUND: The decision about which type of general anesthetic to administer is typically made by the clinical team without patient engagement. This study examined patients' preferences, experiences, attitudes, beliefs, perceptions, and perceived social norms about anesthesia and about engaging in the decision regarding general anesthetic choice with their clinician. METHODS: We conducted a survey in the United States, sent to a panel of surgical patients through Qualtrics (Qualtrics, Provo, UT) from March 2022 through May 2022. Questions were developed based on the Theory of Planned Behavior and validated measures were used when available. A patient partner who had experienced both intravenous and inhaled anesthesia contributed to the development and refinement of the questions. RESULTS: A total of 806 patients who received general anesthesia for an elective procedure in the last five years completed the survey. 43% of respondents preferred a patient-led decision making role and 28% preferred to share decision making with their clinical team, yet only 7.8% reported being engaged in full shared decision making about the anesthesia they received. Intraoperative awareness, pain, nausea, vomiting and quickly returning to work and usual household activities were important to respondents. Waking up in the middle of surgery was the most commonly reported concern, despite this experience being reported only 8% of the time. Most patients (65%) who searched for information about general anesthesia noted that it took a lot of effort to find the information, and 53% agreed to feeling frustrated during the search. CONCLUSIONS: Most patients prefer a patient-led or shared decision making process when it comes to their anesthetic care and want to be engaged in the decision. However, only a small percentage of patients reported being fully engaged in the decision. Further studies should inform future shared decision-making tools, informed consent materials, educational materials and framing of anesthetic choices for patients so that they are able to make a choice regarding the anesthetic they receive.

Cardiometabolic disease and obesity patterns differentially predict acute kidney injury after total joint replacement: a retrospective analysis.

BACKGROUND: Acute kidney injury (AKI) is a frequent yet understudied postoperative total joint arthroplasty complication. This study aimed to describe cardiometabolic disease co-occurrence using latent class analysis, and associated postoperative AKI risk. METHODS: This retrospective analysis examined patients ≥18 years old undergoing primary total knee or hip arthroplasties within the US Multicenter Perioperative Outcomes Group of hospitals from 2008 to 2019. AKI was defined using modified Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Latent classes were constructed from eight cardiometabolic diseases including hypertension, diabetes, and coronary artery disease, excluding obesity. A mixed-effects logistic regression model was constructed for the outcome of any AKI and the exposure of interaction between latent class and obesity status adjusting for preoperative and intraoperative covariates. RESULTS: Of 81 639 cases, 4007 (4.9%) developed AKI. Patients with AKI were more commonly older and non-Hispanic Black, with more significant comorbidity. A latent class model selected three groups of cardiometabolic patterning, labelled 'hypertension only' (n=37 223), 'metabolic syndrome (MetS)' (n=36 503), and 'MetS+cardiovascular disease (CVD)' (n=7913). After adjustment, latent class/obesity interaction groups had differential risk of AKI compared with those in 'hypertension only'/non-obese. Those 'hypertension only'/obese had 1.7-fold increased odds of AKI (95% confidence interval [CI]: 1.5-2.0). Compared with 'hypertension only'/non-obese, those 'MetS+CVD'/obese had the highest odds of AKI (odds ratio 3.1, 95% CI: 2.6-3.7), whereas 'MetS+CVD'/non-obese had 2.2 times the odds of AKI (95% CI: 1.8-2.7; model area under the curve 0.76). CONCLUSIONS: The risk of postoperative AKI varies widely between patients. The current study suggests that the co-occurrence of metabolic conditions (diabetes mellitus, hypertension), with or without obesity, is a more important risk factor for acute kidney injury than individual comorbid diseases.

Genetic predisposition may not improve prediction of cardiac surgery-associated acute kidney injury.

Background: The recent integration of genomic data with electronic health records has enabled large scale genomic studies on a variety of perioperative complications, yet genome-wide association studies on acute kidney injury have been limited in size or confounded by composite outcomes. Genome-wide association studies can be leveraged to create a polygenic risk score which can then be integrated with traditional clinical risk factors to better predict postoperative complications, like acute kidney injury. Methods: Using integrated genetic data from two academic biorepositories, we conduct a genome-wide association study on cardiac surgery-associated acute kidney injury. Next, we develop a polygenic risk score and test the predictive utility within regressions controlling for age, gender, principal components, preoperative serum creatinine, and a range of patient, clinical, and procedural risk factors. Finally, we estimate additive variant heritability using genetic mixed models. Results: Among 1,014 qualifying procedures at Vanderbilt University Medical Center and 478 at Michigan Medicine, 348 (34.3%) and 121 (25.3%) developed AKI, respectively. No variants exceeded genome-wide significance (p < 5 × 10-8) threshold, however, six previously unreported variants exceeded the suggestive threshold (p < 1 × 10-6). Notable variants detected include: 1) rs74637005, located in the exonic region of NFU1 and 2) rs17438465, located between EVX1 and HIBADH. We failed to replicate variants from prior unbiased studies of post-surgical acute kidney injury. Polygenic risk was not significantly associated with post-surgical acute kidney injury in any of the models, however, case duration (aOR = 1.002, 95% CI 1.000-1.003, p = 0.013), diabetes mellitus (aOR = 2.025, 95% CI 1.320-3.103, p = 0.001), and valvular disease (aOR = 0.558, 95% CI 0.372-0.835, p = 0.005) were significant in the full model. Conclusion: Polygenic risk score was not significantly associated with cardiac surgery-associated acute kidney injury and acute kidney injury may have a low heritability in this population. These results suggest that susceptibility is only minimally influenced by baseline genetic predisposition and that clinical risk factors, some of which are modifiable, may play a more influential role in predicting this complication. The overall impact of genetics in overall risk for cardiac surgery-associated acute kidney injury may be small compared to clinical risk factors.

Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial.

INTRODUCTION: Millions of patients receive general anaesthesia for surgery annually. Crucial gaps in evidence exist regarding which technique, propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA), yields superior patient experience, safety and outcomes. The aim of this pilot study is to assess the feasibility of conducting a large comparative effectiveness trial assessing patient experiences and outcomes after receiving propofol TIVA or INVA. METHODS AND ANALYSIS: This protocol was cocreated by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 300-patient, two-centre, randomised, feasibility pilot trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to propofol TIVA or INVA, stratified by centre and procedural complexity. The feasibility endpoints include: (1) proportion of patients approached who agree to participate; (2) proportion of patients who receive their assigned randomised treatment; (3) completeness of outcomes data collection and (4) feasibility of data management procedures. Proportions and 95% CIs will be calculated to assess whether prespecified thresholds are met for the feasibility parameters. If the lower bounds of the 95% CI are above the thresholds of 10% for the proportion of patients agreeing to participate among those approached and 80% for compliance with treatment allocation for each randomised treatment group, this will suggest that our planned pragmatic 12 500-patient comparative effectiveness trial can likely be conducted successfully. Other feasibility outcomes and adverse events will be described. ETHICS AND DISSEMINATION: This study is approved by the ethics board at Washington University (IRB# 202205053), serving as the single Institutional Review Board for both participating sites. Recruitment began in September 2022. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media. TRIAL REGISTRATION NUMBER: NCT05346588.

Patient-, Clinician-, and Institution-level Variation in Inotrope Use for Cardiac Surgery: A Multicenter Observational Analysis.

BACKGROUND: Conflicting evidence exists regarding the risks and benefits of inotropic therapies during cardiac surgery, and the extent of variation in clinical practice remains understudied. Therefore, the authors sought to quantify patient-, anesthesiologist-, and hospital-related contributions to variation in inotrope use. METHODS: In this observational study, nonemergent adult cardiac surgeries using cardiopulmonary bypass were reviewed across a multicenter cohort of academic and community hospitals from 2014 to 2019. Patients who were moribund, receiving mechanical circulatory support, or receiving preoperative or home inotropes were excluded. The primary outcome was an inotrope infusion (epinephrine, dobutamine, milrinone, dopamine) administered for greater than 60 consecutive min intraoperatively or ongoing upon transport from the operating room. Institution-, clinician-, and patient-level variance components were studied. RESULTS: Among 51,085 cases across 611 attending anesthesiologists and 29 hospitals, 27,033 (52.9%) cases received at least one intraoperative inotrope, including 21,796 (42.7%) epinephrine, 6,360 (12.4%) milrinone, 2,000 (3.9%) dobutamine, and 602 (1.2%) dopamine (non-mutually exclusive). Variation in inotrope use was 22.6% attributable to the institution, 6.8% attributable to the primary attending anesthesiologist, and 70.6% attributable to the patient. The adjusted median odds ratio for the same patient receiving inotropes was 1.73 between 2 randomly selected clinicians and 3.55 between 2 randomly selected institutions. Factors most strongly associated with increased likelihood of inotrope use were institutional medical school affiliation (adjusted odds ratio, 6.2; 95% CI, 1.39 to 27.8), heart failure (adjusted odds ratio, 2.60; 95% CI, 2.46 to 2.76), pulmonary circulation disorder (adjusted odds ratio, 1.72; 95% CI, 1.58 to 1.87), loop diuretic home medication (adjusted odds ratio, 1.55; 95% CI, 1.42 to 1.69), Black race (adjusted odds ratio, 1.49; 95% CI, 1.32 to 1.68), and digoxin home medication (adjusted odds ratio, 1.48; 95% CI, 1.18 to 1.86). CONCLUSIONS: Variation in inotrope use during cardiac surgery is attributable to the institution and to the clinician, in addition to the patient. Variation across institutions and clinicians suggests a need for future quantitative and qualitative research to understand variation in inotrope use affecting outcomes and develop evidence-based, patient-centered inotrope therapies.

Tracheostomy, Feeding-Tube, and In-Hospital Postoperative Mortality in Children: A Retrospective Cohort Study.

BACKGROUND: Neuromuscular/neurologic disease confers increased risk of perioperative mortality in children. Some patients require tracheostomy and/or feeding tubes to ameliorate upper airway obstruction or respiratory failure and reduce aspiration risk. Empiric differences between patients with and without these devices and their association with postoperative mortality have not been previously assessed. METHODS: This retrospective cohort study using the Pediatric Health Information System measured 3- and 30-day in-hospital postsurgical mortality among children 1 month to 18 years of age with neuromuscular/neurologic disease at 44 US children's hospitals, from April 2016 to October 2018. We summarized differences between patients presenting for surgery with and without these devices using standardized differences. Then, we calculated 3- and 30-day mortality among patients with tracheostomy, feeding tube, both, and neither device, overall and stratified by important exposures, using Fisher exact test to test whether differences were significant. RESULTS: There were 43,193 eligible patients. Unadjusted 3-day mortality was 1.3% (549/43,193); 30-day mortality was 2.7% (1168/43,193). Most (79.1%) used neither a feeding tube or tracheostomy, 1.2% had tracheostomy only, 15.5% had feeding tube only, and 4.2% used both devices. Compared to children with neither device, children using either or both devices were more likely to have multiple CCCs, dysphagia, chronic pulmonary disease, cerebral palsy, obstructive sleep apnea, or malnutrition, and a prolonged intensive care unit (ICU) stay within the previous year. They were less likely to present for high-risk surgeries (33% vs 57%). Having a feeding tube was associated with decreased 3-day mortality overall compared to having neither device (0.9% vs 1.3%, P = .003), and among children having low-risk surgery, and surgery during urgent or emergent hospitalizations. Having both devices was associated with decreased 3-day mortality among children having low-risk surgery (0.8% vs 1.9%; P = .013), and during urgent or emergent hospitalizations (1.6% vs 2.9%; P = .023). For 30-day mortality, having a feeding tube or both devices was associated with lower mortality when the data were stratified by the number of CCCs. CONCLUSIONS: Patients requiring tracheostomy, feeding tube, or both are generally sicker than patients without these devices. Despite this, having a feeding tube was associated with lower 3-day mortality overall and lower 30-day mortality when the data were stratified by the number of CCCs. Having both devices was associated with lower 3-day mortality in patients presenting for low-risk surgery, and surgery during urgent or emergent hospitalizations.

The Michigan Genomics Initiative: A biobank linking genotypes and electronic clinical records in Michigan Medicine patients.

Biobanks of linked clinical patient histories and biological samples are an efficient strategy to generate large cohorts for modern genetics research. Biobank recruitment varies by factors such as geographic catchment and sampling strategy, which affect biobank demographics and research utility. Here, we describe the Michigan Genomics Initiative (MGI), a single-health-system biobank currently consisting of >91,000 participants recruited primarily during surgical encounters at Michigan Medicine. The surgical enrollment results in a biobank enriched for many diseases and ideally suited for a disease genetics cohort. Compared with the much larger population-based UK Biobank, MGI has higher prevalence for nearly all diagnosis-code-based phenotypes and larger absolute case counts for many phenotypes. Genome-wide association study (GWAS) results replicate known findings, thereby validating the genetic and clinical data. Our results illustrate that opportunistic biobank sampling within single health systems provides a unique and complementary resource for exploring the genetics of complex diseases.

Association between choice of reversal agent for neuromuscular block and postoperative pulmonary complications in patients at increased risk undergoing non-emergency surgery: STIL-STRONGER, a multicentre matched cohort study.

BACKGROUND: Postoperative pulmonary complications are a source of morbidity after major surgery. In patients at increased risk of postoperative pulmonary complications we sought to assess the association between neuromuscular blocking agent reversal agent and development of postoperative pulmonary complications. METHODS: We conducted a retrospective matched cohort study, a secondary analysis of data collected in the prior STRONGER study. Data were obtained from the Multicenter Perioperative Outcomes Group. Included patients were aged 18 yr and older undergoing non-emergency surgery under general anaesthesia with tracheal intubation with neuromuscular block and reversal, who were predicted to be at elevated risk of postoperative pulmonary complications. This risk was defined as American Society of Anesthesiologists Physical Status 3 or 4 in patients undergoing either intrathoracic or intra-abdominal surgery who were either aged >80 yr or underwent a procedure lasting >2 h. Cohorts were defined by reversal with neostigmine or sugammadex. The primary composite outcome was the occurrence of pneumonia or respiratory failure. RESULTS: After matching by institution, sex, age (within 5 yr), body mass index, anatomic region of surgery, comorbidities, and neuromuscular blocking agent, 3817 matched pairs remained. The primary postoperative pulmonary complications outcome occurred in 224 neostigmine cases vs 100 sugammadex cases (5.9% vs 2.6%, odds ratio 0.41, P<0.01). After adjustment for unbalanced covariates, the adjusted odds ratio for the association between sugammadex use and the primary outcome was 0.39 (P<0.0001). CONCLUSIONS: In a cohort of patients at increased risk for pulmonary complications compared with neostigmine, use of sugammadex was independently associated with reduced risk of subsequent development of pneumonia or respiratory failure.

Overcoming barriers in the design and implementation of clinical trials for acute kidney injury: a report from the 2020 Kidney Disease Clinical Trialists meeting.

Acute kidney injury (AKI) is a growing epidemic and is independently associated with increased risk of death, chronic kidney disease (CKD) and cardiovascular events. Randomized-controlled trials (RCTs) in this domain are notoriously challenging and many clinical studies in AKI have yielded inconclusive findings. Underlying this conundrum is the inherent heterogeneity of AKI in its etiology, presentation and course. AKI is best understood as a syndrome and identification of AKI subphenotypes is needed to elucidate the disease's myriad etiologies and to tailor effective prevention and treatment strategies. Conventional RCTs are logistically cumbersome and often feature highly selected patient populations that limit external generalizability and thus alternative trial designs should be considered when appropriate. In this narrative review of recent developments in AKI trials based on the Kidney Disease Clinical Trialists (KDCT) 2020 meeting, we discuss barriers to and strategies for improved design and implementation of clinical trials for AKI patients, including predictive and prognostic enrichment techniques, the use of pragmatic trials and adaptive trials.