Improving the outcomes of carotid endarterectomy: Results of a statewide quality improvement project

AbstractObjective: The purpose of this study was to establish the statewide outcomes for carotid endarterectomy (CEA) and to facilitate improvement in outcomes through feedback, peer discussion, and ongoing process and outcome measurement. Methods: The Medicare Part A claims files were used to identify all Medicare patients undergoing CEA in Iowa during two 12-month time periods (January 1994–December 1994 and June 1995–May 1996). Medical record abstraction was used to obtain surgical indications, perioperative care process, and outcome information. Confidential reports were provided to each hospital (N = 30) where the procedure was performed. Surgeons performing the procedure (N = 79) were invited to meetings to discuss care process variation and outcomes. Voluntary participation was solicited in a standardized program of ongoing hospital-based data collection of CEA process and outcome data. Results: The statewide combined stroke or mortality rate decreased from 7.8% in 1994 to 4.0% in the 1995 to 1996 time period (P <.001). Fourteen hospitals, accounting for 74% of the statewide cases, participated in ongoing data collection. The combined stroke or mortality rate in these hospitals decreased significantly (P <.05) over time from 6.5% (1994) to 3.7% (1995-1996) to 1.8% (June 1997–May 1998). The use of intraoperative assessment of the operative site (20% in 1994, 46% in 1997-1998) and patch angioplasty (14% in 1994, 30% in 1997-1998) increased significantly during this time in the participating hospitals. Conclusions: Confidential feedback of outcome and process data for CEA may lead to change in perioperative care processes and improved outcomes. Standardized community-based outcome analysis should become routine for CEA to ensure that optimum results are being achieved. (J Vasc Surg 2000;31:918-26.

Multistate improvement in process and outcomes of carotid endarterectomy

AbstractObjectivesThe purpose of this study was to assess the effect of community-wide performance measurement and feedback on key processes and outcomes of carotid endarterectomy (CEA).MethodsComplete medical record (hospital chart) review for indications, care processes, and outcomes was performed on a random sample of Medicare patients undergoing CEA in 10 states (Arkansas, Georgia, Illinois, Indiana, Iowa, Kentucky, Michigan, Nebraska, Ohio, Oklahoma) during baseline (Jun 1, 1995 to May 31, 1996) and remeasurement (Jun 1, 1998 to May 31, 1999) periods. In addition to review of the index hospital stay, hospital admissions within 30 days of the procedure were reviewed and the Medicare enrollment database queried to identify out-of-hospital deaths, to determine 30-day outcome results. The baseline data by state were provided to the Medicare Quality Improvement Organizations (QIOs) in the respective states, and quality improvement initiatives were encouraged.ResultsWe reviewed 9945 primary CEA alone procedures, 236 CEA and coronary artery bypass grafting (CABG) procedures, and 380 repeat CEA operations during the baseline period (B), and 9745 primary CEA alone procedures, 233 CEA and CABG procedures, and 401 repeat CEA operations during the remeasurement period (R). There was a significant decrease in the combined event rate (30-day stroke or mortality) for CEA alone procedures between baseline and remeasurement (B, 5.6%; R, 5.0%). A decrease occurred in each of the indication strata; transient ischemic attack or stroke (B, 7.7%; R, 6.9%), nonspecific symptoms (B, 5.9%; R, 5.4%), and no symptoms (B, 4.1%; R, 3.8%). The combined event rate also decreased for CEA and CABG (B, 17.4%; R, 13.3%) and repeat CEA operations (B, 6.8%; R, 5.7%). The remeasurement period state-to-state variation in combined event rate for CEA alone ranged from 2.7% (Georgia) to 5.9% (Indiana) for all indications combined, from 4.4% (Georgia) to 10.9% (Michigan) in patients with recent transient ischemia or stroke, from 1.4% (Georgia) to 6.0% (Oklahoma) in patients with no symptoms, and from 3.7% (Georgia) to 7.9% (Indiana) in patients with nonspecific symptoms. There were significant increases in preoperative antiplatelet administration (62%-67%; P < .0001) and patching (29%-45%; P = .05) from baseline to remeasurement in the CEA alone subset. Preoperative antiplatelet administration and patching were associated with improved outcomes in the combined baseline and remeasurement data.ConclusionsCommunity-wide quality improvement initiatives with performance measurement and confidential reporting of provider level data can lead to improvement in important care processes and outcomes. There is considerable variation between states in outcome and process, and thus continued room for improvement. Quality improvement projects that include standardized confidential outcome reporting should be encouraged. Preoperative antiplatelet therapy administration and patching rates should be considered as evidence-based performance measures

Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19. In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978. Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88–1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90. Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19. US National Institutes of Health and Operation Warp Spee