Study Design. Retrospective, observational study of clinical outcomes at a single institution. Objective. To compare postoperative complication and readmission rates of payer groups in a cohort of patients undergoing anterior cervical discectomy and fusion (ACDF). Summary of Background Data. Studies examining associations between primary payer and outcomes in spine surgery have been equivocal. Methods. Patients at Mount Sinai having undergone ACDF from 2008 to 2016 were queried and assigned to one of five insurance categories: uninsured, managed care, commercial indemnity insurance, Medicare, and Medicaid, with patients in the commercial indemnity group serving as the reference cohort. Multivariable logistic regression equations for various outcomes with the exposure of payer were created, controlling for age, sex, American Society of Anesthesiology Physical Status Classification (ASA Class), the Elixhauser Comorbidity Index, and number of segments fused. A Bonferroni correction was utilized, such that alpha = 0.0125. Results. Two thousand three hundred eighty seven patients underwent ACDF during the time period. Both Medicare (P < 0.0001) and Medicaid (P < 0.0001) patients had higher comorbidity burdens than commercial patients when examining ASA Class. Managed care (2.86 vs. 2.72, P = 0.0009) and Medicare patients (2.99 vs. 2.72, P < 0.0001) had more segments fused on average than commercial patients. Medicaid patients had higher rates of prolonged extubation (odds ratio [OR]: 4.99; 95% confidence interval [CI]: 1.13–22.0; P = 0.007), and Medicare patients had higher rates of prolonged length of stay (LOS) (OR: 2.44, 95% CI: 1.13–5.27%, P = 0.004) than the commercial patients. Medicaid patients had higher rates of 30- (OR: 4.12; 95% CI: 1.43–11.93; P = 0.0009) and 90-day (OR: 3.28; 95% CI: 1.34–8.03; P = 0.0009) Emergency Department (ED) visits than the commercial patients, and managed care patients had higher rates of 30-day readmission (OR: 3.41; 95% CI: 1.00–11.57; P = 0.0123). Conclusion. Medicare and Medicaid patients had higher rates of prolonged LOS and postoperative ED visits, respectively, compared with commercial patients. Level of Evidence: 3
Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A in clinical development. Phase 2 data have shown it offers a more prolonged duration of response than onabotulinumtoxinA.Objective: To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines.Methods: Two identical, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies were performed (NCT03014622 and NCT03014635 on www.clinicaltrials.gov). Participants with moderate or severe glabellar lines were randomly assigned (2:1) to receive 40 U DAXI or placebo into the corrugator/procerus muscles. Glabellar line severity was assessed by investigators and participants for up to 36 weeks ($24 weeks).Results: Among 609 participants enrolled (405 DAXI, 204 placebo), 92% completed. DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks. It was also generally well tolerateddtreatment-related adverse effects were most commonly headache (6.4% vs 2.0%) and injection site pain (3.7% vs 3.9%).
BackgroundInjectable daxibotulinumtoxinA (an investigational botulinum toxin, RT002) may offer a more prolonged duration of response—and therefore less frequent dosing—than onabotulinumtoxinA.ObjectivesTo perform a phase 2, open‐label, dose‐escalation study to assess the efficacy and safety of daxibotulinumtoxinA in cervical dystonia.MethodsSubjects with moderate‐to‐severe isolated cervical dystonia were enrolled in sequential cohorts to receive a single open‐label, intramuscular dose of injectable daxibotulinumtoxinA of up to 200 U (n = 12), 200–300 U (n = 12), or 300–450 U (n = 13; https://clinicaltrials.gov identifier NCT02706795).ResultsOverall, 33/37 enrollees completed the trial. DaxibotulinumtoxinA was associated with mean reductions in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)‐Total score of 16.8 (38%) at week 4, 21.3 (50%) at week 6, and 12.8 (30%) at week 24. The proportion of subjects who were responders (achieved ≥ 20% reduction in TWSTRS‐Total score) was 94% at week 6 and 68% at week 24. The median duration of response (time until > 20% of the improvement in TWSTRS‐Total score achieved at week 4 was no longer retained or re‐treatment was needed) was 25.3 weeks (95% CI, 20.14–26.14 weeks). There were no serious adverse events and there was no apparent dose‐related increase in the incidence of adverse events. The most common treatment‐related adverse events were dysphagia (14%) and injection site erythema (8%).ConclusionsPreliminary assessments suggest that injectable daxibotulinumtoxinA at doses up to 450 U is well tolerated and may offer prolonged efficacy in the treatment of cervical dystonia. Further studies involving larger numbers of patients are now warranted.
This trial provides evidence that a 500 U/2 mL dilution is an effective treatment for cervical dystonia and exhibits a safety profile consistent with the known safety profile of abobotulinumtoxinA.
Background With increasing emphasis on value-based payment models for primary total joint arthroplasty (TJA), there is greater need for orthopaedic surgeons and hospitals to better understand the actual costs and resource use of TJA. Time-driven activity-based costing (TDABC) is a methodology for accurate cost estimation, but its application in the TJA care pathway across institutions/regions has not yet been analyzed. Questions/purposes In this systematic review of studies applying TDABC to primary TJA, we investigated the following: (1) Is there variation in TDABC methodology and cost estimates across institutions? (2) Is a standard set of direct and indirect costs included across studies? (3) Is there a difference in cost estimates derived from TDABC and traditional hospital cost-accounting approaches? and (4) How are institutions using TDABC (process and outputs) with respect to the TJA care pathway? Methods A comprehensive search strategy was developed that included the keywords “TDABC,” “time-driven activity-based cost,” “THA,” “TKA,” “THR,” “TKR,” and “TJR” in the PubMed/MEDLINE, EMBASE, Web of Science, Ovid SP, Scopus, and ScienceDirect databases for articles published between 2004 and 2018 as well as extensive hand searching and citation mining. Relevant studies (n = 15) were screened to include THA or TKA as the focus of the TDABC model, full-text articles, TDABC-based cost estimates for TJA, and studies written in English (n = 8). Due to the heterogeneity of outcomes/methodology in TDABC studies involving TJA, quality assessment was based on each study’s adherence to the seven steps delineated by Kaplan et al. in their original publication introducing TDABC in health care. Results There was substantial variation in TDABC methodology (especially in scope), adherence to the seven steps of TDABC, and data collection. Only five of eight studies incorporated indirect costs into their TDABC calculation, with notable differences in which direct and indirect expenses were included. TDABC-based cost estimates for TJA ranged from USD 7081 to USD 29,557, with variation driven by the TJA timeframe and whether implant costs were included in the costing calculation. TDABC was most frequently used to compare against traditional hospital accounting methods (n = 4), to increase operational efficiency (n = 4), to reduce wasted resources (n = 3), and to mitigate risk (n = 3). Conclusions TDABC-based cost estimates are more granular and useful in practice than those calculated via traditional hospital accounting; however, there is a lack of standardized principles to guide TDABC implementation (especially for indirect costs) due to institutional and regional differences in TDABC application. Although TDABC methodology will likely continue to vary somewhat between studies, standardized principles are needed to guide the definition, estimation, and reporting of costs to enable detailed examination of study methodology and inputs by readers. Level of Evidence Level III, economic and decision analysis.
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