Rivaroxaban

To demonstrate the utility of standardizing disparate data sources into a CDM, we replicated a published observational study protocol and evaluated the quality of a standardized approach and time-to-execution. As an exemplar, we used the Mini-Sentinel analysis of the comparative effectiveness of rivaroxaban versus warfarin on various outcomes in patients with atrial fibrillation.³⁰ We developed a standardized analytic routine that replicated the cohort definitions within the protocol and applied the analytic program across all 6 databases to compare the impact of the inclusion criteria on the proportion of patients qualifying for the study.
Specifically, we identified all new users of each target drug (warfarin and rivaroxaban) who satisfied the following 7 criteria of the original study: (1) had at least 183 days of nonexposure before the first target drug exposure; (2) had at least 1 atrial fibrillation or atrial flutter diagnosis code within the 183-day window prior to first exposure; (3) did not have any prior diagnosis or procedure codes indicative of long-term dialysis; (4) did not have any prior diagnosis or procedure codes indicative of kidney transplant; (5) did not have any prior diagnosis or procedure code indicative of mitral stenosis or mechanical heart valve; (6) did not have any prior procedure code indicative of joint replacement or arthroplasty surgery; and (7) did not have prior use of any anticoagulant (warfarin, rivaroxaban, dabigatran, or apixaban). For each target drug, we created 2 cohorts: new users of the drug (defined by satisfying criteria No. 1), and the subset of those new users of the drug who satisfied the remaining 6 criteria. For each cohort, we produced a standardized descriptive summary of the population, including demographics (gender and age distribution), comorbidities (prevalence of conditions in time window prior to cohort entry), concomitant medications (prevalence of drug exposure in time window prior to cohort entry), and service utilization (prevalence of procedures in time window prior to cohort entry). We measured the execution time for the standardized analytic routine when applied to each target drug across all 6 databases. Analyses were conducted on a Microsoft Server 2008 (Microsoft Corporation, Redmond, Washington) with an AMD Opteron 6172 (Advanced Micro Devices, Inc, Sunnyvale, California), 2.10 GHz, 2 processors, 24-core CPU, and 256 GB of RAM. Each CDM was stored in a separate database within an instance of Microsoft SQL Server 2012 (Microsoft Corporation, Redmond, Washington).
Appendix 1 contains the standard concepts and corresponding source codes that were used to define each of the core concepts required within the prespecified protocol.

We also evaluated the accuracy of the ORBIT, HAS-BLED, and ATRIA scores in an external AF population, ROCKET-AF, an international, randomized, double-blind, event-driven trial of 14 264 patients comparing rivaroxaban (20 mg daily) to dose-adjusted warfarin. Each score was recreated according to definitions given in the original derivation cohorts, using baseline values from the first trial visit, or from the first study visit in ORBIT-AF. Score components not collected in ROCKET-AF or ORBIT-AF were approximated using available data or contributed 0 points to the score if no approximation was available. The full list of definitions used to generate the scores in each dataset is provided in Supplementary materials online.
Statistical analysis was performed using SAS software (version 9.3, Cary, NC). All P-values presented are two sided, and P < 0.05 was considered to be statistically significant for all analyses. All ORBIT-AF study participants provided written informed consent prior to study entry. The ORBIT-AF Registry was approved by the Duke Institutional Review Board (IRB), and participating sites obtained approval from local IRBs as needed prior to entering patient data.

Postoperative management included: Conventional antibiotics were applied intraoperatively to prevent infection, and antibacterial drugs were applied prophylactically within 24 hours postoperatively. Tranexamic acid 1 was given intravenously 3 hours postoperatively. Subcutaneous anticoagulation with 4100 U of low-molecular heparin was started 10 hours after surgery, qd × 5 days. After discharge, the patient was given oral rivaroxaban 10 mg, qd × 14 days. Ice packs were applied intermittently for 48 hours after surgery, and the dressing was changed every other day. The incision was removed at 12 to 14 days postoperatively with outpatient review. The patient started normal weight-bearing walking with the aid of a walker 1 day after surgery THA. Patients were instructed to actively flex and extend the knee joint, perform ankle pump exercises and quadriceps isometric contraction exercises as well as passive exercises 1 day after surgery.
Validated updated version of diagnostic criteria for PJI in 2018 are as follows^{[13 (link)]} (based on the diagnostic criteria of PJI proposed by the Musculoskeletal infection society in 2011):
Two positive cultures or the presence of a sinus tract were considered major criteria and diagnostic of PJI. The calculated weights of an elevated serum CRP (>1 mg/dL), D-dimer(>860ng/mL) and ESR (>30mm/hour) were 2, 2 and 1 points, respectively. Elevated synovial fluid WBC count (>3000 cells/µL), alpha-defensin (signal-to cutoff ratio > 1), LE (++), PMN% (>80%) and synovial CRP (>6.9mg/L) received 3, 3, 3, 2 and 1 points, respectively. Patients with an aggregate score of greater than or equal to 6 were considered infected while a score between 2 and 5, required the inclusion of intraoperative findings for confirming or refuting the diagnosis. Intraoperative findings of positive histology, purulence and single positive culture were assigned 3, 3, and 2 points, respectively. Combined with the preoperative score, a total of greater than or equal to 6 was considered infected, a score between 4 and 5 was inconclusive, and a score of 3 or less was not infected.