The CFI is useful to identify individuals with poor physical function and at greater risks of adverse health outcomes in Medicare data.

Recent legislation mandates that the US Food and Drug Administration issue guidance regarding when real‐world evidence (RWE) could be used to support regulatory decision making. Although RWE could come from randomized or nonrandomized designs, there are significant concerns about the validity of RWE assessing medication effectiveness based on nonrandomized designs. We propose an initiative using healthcare claims data to assess the ability of nonrandomized RWE to provide results that are comparable with those from randomized controlled trials (RCTs). We selected 40 RCTs, and we estimate that approximately 30 attempted replications will be completed after feasibility analyses. We designed an implementation process to ensure that each attempted replication is consistent, transparent, and reproducible. This initiative is the first to systematically evaluate the ability of nonrandomized RWE to replicate multiple RCTs using a structured process. Results from this study should provide insight on the strengths and limitations of using nonrandomized RWE from claims for regulatory decision making.

ObjectiveTo investigate the rate of serious bacterial, viral or opportunistic infection in patients with rheumatoid arthritis (RA) starting tocilizumab (TCZ) versus tumour necrosis factor inhibitors (TNFi) or abatacept.MethodsUsing claims data from US Medicare from 2010 to 2015, and IMS and MarketScan from 2011 to 2015, we identified adults with RA who initiated TCZ or TNFi (primary comparator)/abatacept (secondary comparator) with prior use of ≥1 different biologic drug or tofacitinib. The primary outcome was hospitalised serious infection (SI), including bacterial, viral or opportunistic infection. To control for >70 confounders, TCZ initiators were propensity score (PS)-matched to TNFi or abatacept initiators. Database-specific HRs were combined by a meta-analysis.ResultsThe primary cohort included 16 074 TCZ PS-matched to 33 109 TNFi initiators. The risk of composite SI was not different between TCZ and TNFi initiators (combined HR 1.05, 95% CI 0.95 to 1.16). However, TCZ was associated with an increased risk of serious bacterial infection (HR 1.19, 95% CI 1.07 to 1.33), skin and soft tissue infections (HR 2.38, 95% CI 1.47 to 3.86), and diverticulitis (HR 2.34, 95% CI 1.64 to 3.34) versus TNFi. An increased risk of composite SI, serious bacterial infection, diverticulitis, pneumonia/upper respiratory tract infection and septicaemia/bacteraemia was observed in TCZ versus abatacept users.ConclusionsThis large multidatabase cohort study found no difference in composite SI risk in patients with RA initiating TCZ versus TNFi after failing ≥1 biologic drug or tofacitinib. However, the risk of serious bacterial infection, skin and soft tissue infections, and diverticulitis was higher in TCZ versus TNFi initiators. The risk of composite SI was higher in TCZ initiators versus abatacept.

Background There has been increasing effort to measure frailty in the U.S. Medicare data. The performance of claims-based frailty measures has not been compared. Methods This cross-sectional study included 3,097 community-dwelling fee-for-service Medicare beneficiaries (mean age 75.6 years) who participated in the 2008 Health and Retirement Study examination. Four claims-based frailty measures developed by Davidoff, Faurot, Segal, and Kim were compared against frailty phenotype, a deficit-accumulation frailty index (FI), and activities of daily living (ADL) dependence using Spearman correlation coefficients and C-statistics. Results Claims-based frailty measures were positively associated with frailty phenotype (prevalence in ≤10th vs >90th percentile: 8.0% vs 41.3% for Davidoff; 5.9% vs 53.1% for Faurot; 3.3% vs 48.0% for Segal; 2.9% vs 51.0% for Kim) and FI (mean in ≤10th vs >90th percentile: 0.17 vs 0.33 for Davidoff; 0.13 vs 0.37 for Faurot; 0.12 vs 0.31 for Segal; 0.10 vs 0.37 for Kim). The age and sex-adjusted C-statistics for frailty phenotype for Davidoff, Faurot, Segal, and Kim indices were 0.73, 0.74, 0.73, and 0.78, respectively, and partial correlation coefficients with FI were 0.18, 0.32, 0.26, and 0.55, respectively. The results for ADL dependence were similar (prevalence in ≤10th vs >90th percentile: 3.7% vs 50.5% for Davidoff; 2.3% vs 55.0% for Faurot; 3.0% vs 38.3% for Segal; 2.3% vs 50.8% for Kim). The age and sex-adjusted C-statistics for the indices were 0.79, 0.80, 0.74, and 0.81, respectively. Conclusions The choice of a claims-based frailty measure can influence the identification of older adults with frailty and disability in Medicare data.

Aim:The present ex vivo study aimed to evaluate the debris extrusion after instrumenting the root canals by three different files systems.Materials and Methods:Sixty extracted human mandibular premolars with single canals were selected and randomly divided into three groups (n = 20) for instrumentation with three different files. Group 1: WaveOne (primary) single reciprocating file (WO; Dentsply Maillefer, Ballaigues, Switzerland) (25/08), Group 2: Self-adjusting file (SAF; ReDent-Nova, Ra’anana, Israel) (1.5 mm), and Group 3: ProTaper NEXT X1 and X2 (PTN; Dentsply Tulsa Dental, Tulsa, OK) (25/06). Debris extruding by instrumentation were collected into pre-weighed Eppendorf tubes. These tubes were then stored in an incubator at 70°C for 5 days. The tubes were then weighed to obtain the final weight, with the extruded debris. Statistical analysis for the debris extruded apically was performed using one-way analysis of variance and post hoc Tukey's test.Results:The statistical analysis showed a significant difference between all the three groups tested (P < 0.01). The following post hoc Tukey's test confirmed that Group 2 (SAF) exhibited significantly least (P < 0.01) debris extrusion between the three groups tested.Conclusions:The SAF resulted in significantly less extrusion of debris when compared to reciprocating WO and rotary PTN.

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Objective. To evaluate the risk of venous thromboembolism (VTE) in rheumatoid arthritis (RA) patients receiving tofacitinib versus those receiving tumor necrosis factor (TNF) inhibitors.Methods. RA patients who were initiating treatment with tofacitinib or a TNF inhibitor and had not previously received any biologic agent or tofacitinib were identified from the Truven MarketScan database (2012)(2013)(2014)(2015)(2016) or Medicare claims (parts A, B, and D) database (2012)(2013)(2014)(2015). Patients were followed up until treatment discontinuation, treatment switch, insurance disenrollment, or administrative censoring. The outcome of VTE was identified using inpatient claims for pulmonary embolism or deep vein thrombosis. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) were determined using a Cox proportional hazards model after accounting for confounding through propensity score-based fine-stratification weighting. HRs were pooled across databases using the inverse variance meta-analytic method.Results. A total of 34,074 RA patients (mean age 50 years; 5.6% tofacitinib initiators) and 17,086 RA patients (mean age 71 years; 5.8% tofacitinib initiators) were identified from the Truven and Medicare databases, respectively. The crude incidence rates of VTE per 100 person-years were 0.60 (95% CI 0.26-1.19) and 0.34 (95% CI 0.27-0.41) in Truven and 1.12 (95% CI 0.45-2.31) and 0.92 (95% CI 0.76-1.11) in Medicare for patients receiving tofacitinib and patients receiving TNF inhibitors, respectively. Propensity score-adjusted HRs showed no significant differences in the risk of VTE between tofacitinib-treated and TNF inhibitor-treated patients in either database, with a pooled HR of 1.33 (95% CI 0.78-2.24).Conclusion. Occurrence of VTE in a total of 50,865 RA patients initiating treatment with tofacitinib or a TNF inhibitor was infrequent (<1 per 100 person-years). We observed a numerically higher, but statistically nonsignificant, risk of VTE in RA patients receiving tofacitinib versus those receiving TNF inhibitors.

Root canal morphology can demonstrate variations based on race and sex of patients. Clinicians must always consider the possible variations to ensure successful endodontic treatment.