Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...

The aim of the study was to compare trends and differences in preoperative and prolonged postoperative opioid use following spinal cord stimulator (SCS) implantation and to determine factors associated with prolonged postoperative opioid use. Methods: A database of private-payer insurance records was queried to identify patients who underwent a primary paddle lead SCS placement via a laminectomy (CPT-C3655) from 2008-2015. Our resulting cohort was stratified into those with prolonged postoperative opioid use, opioid use between 3-and 6-month postoperation, and those without. Multivariate logistic regression was used to determine the effect preoperative opioid use and other factors of interest had on prolonged postoperative opioid use. Subgroup analysis was performed on preoperative opioid users to further quantify the effect of differing magnitudes of preoperative opioid use. Results: A total of 2,374 patients who underwent SCS placement were identified. Of all patients, 1,890 patients (79.6%) were identified as having prolonged narcotic use. Annual rates of preoperative (p = 0.023) and prolonged postoperative narcotic use (p < 0.001) decreased over the study period. Significant independent predictors of prolonged postoperative opioid use were age < 65 years (odds ratio [OR], 1.52; p = 0.004), male sex (OR, 1.33; p = 0.037), preoperative anxiolytic (OR, 1.55; p = 0.004) and muscle relaxant (OR, 1.42; p = 0.033), and narcotic use (OR, 15.04; p < 0.001). Increased number of preoperative narcotic prescriptions correlated with increased odds of prolonged postoperative use. Conclusion: Patients with greater number of preoperative opioid prescriptions may not attain the same benefit from SCSs as patients with less opioid use. The most significant predictor of prolonged narcotic use was preoperative opioid use.

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Incidental durotomy (ID) can occur in up to 14% of all lumbar spine surgeries. The risk of this complication is markedly higher among elderly patients with advanced spinal pathology. In addition, revision cases and other more invasive procedures increase the risk of ID. When unrepaired, IDs can increase the risk of developing meningitis and can lead to the formation of cerebrospinal fluid fistulas and pseudomeningoceles. Intraoperative recognition and repair are essential to ID management, although repair techniques vary considerably. Although primary suture repair is considered the “benchmark,” indirect repair alone has shown comparable outcomes. Given the concern for infection after ID, many have indicated for prolonged prophylactic antibiotic regimens. However, there is little clinical evidence that this is necessary after adequate repair. The addition of subfascial drains have been shown to promote wound healing and early ambulation, whereas no consensus on duration of indwelling drains exists and such management is largely case dependent. Early ambulation after surgery has not shown to be associated with increased risk of further ID complications and decreases rehabilitation time, length of stay, and risk of venous thromboembolism. However, there remains a role for conservation mobilization protocols in more severe cases where notable symptoms are observed.

Objective: The aim were to (1) evaluate differences in postoperative outcomes and cost associated with outpatient anterior lumbar interbody fusion (ALIF) compared with inpatient ALIF, and to (2) identify independent factors contributing to complications after outpatient ALIF.Summary of Background: While lumbar fusion is traditionally performed inpatient, outpatient spinal surgery is becoming more commonplace as surgical techniques improve. Methods:The study population included all patients below 85 years of age who underwent elective ALIF (CPT-22558). Patients were then divided into those who underwent single-level fusion and multilevel fusion using the corresponding additional level fusion codes (CPT-22585). These resulting populations were then split into outpatient and inpatient cohorts by using a service location modifier. To account for selection bias, propensity score matching was performed; the inpatient cohorts were matched with respect to the outpatient cohorts based on age, sex, and Charlson Comorbidity Index. Statistical significance was set at P < 0.05 and the Bonferroni correction was used for each multiple comparison (P < 0.004).Results: Patients undergoing outpatient procedure had decreased rates of medical complications following both single-level and multilevel ALIF. In addition, age above 60, female sex, Charlson Comorbidity Index > 3, chronic obstructive pulmonary disease, diabetes mellitus, coronary artery disease, hypertension, and tobacco use were all identified as independent risk factors for increased complications. Finally, the cost of outpatient ALIF was $12,013 while the cost of inpatient ALIF was $27,271 (P < 0.001). Conclusion:The findings add to the growing body of literature advocating for the utilization of ALIF in the outpatient setting for a properly selected group of patients.