Background and Purpose-The modified Rankin Scale rates global disability after stroke and is the most comprehensive and widely used primary outcome measure in acute stroke trials. However, substantial interobserver variability in modified Rankin Scale scoring has been reported. This study sought to develop and validate a short, practicable structured assessment that would enhance interrater reliability. Methods-The Rankin Focused Assessment was developed by selecting and refining elements from prior instruments. The Rankin Focused Assessment takes 3 to 5 minutes to apply and provides clear, operationalized criteria to distinguish the 7 assignable global disability levels. The Rankin Focused Assessment was prospectively validated 3 months poststroke among 50 consecutive patients enrolled in the Phase 3 National Institutes of Health Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Trial. Results-Among the 50 patients, mean age was 71.5 years (range, 43 to 93 years), 48% were female, and stroke subtype was hemorrhagic in 24%. At Day 90, 43 patients were alive and 7 had died. The modified Rankin Scale median was 2.0 and mean was 2.8. When pairs of 14 raters assessed all enrolled patients, the percent agreement was 94%, the weighted was 0.99 (95% CI, 0.99 to 1.0), and the unweighted was 0.93 (95% CI, 0.85 to 1.00). Among the 43 surviving patients, the percent agreement was 93%, the weighted was 0.99 (0.98 to 1.0), and the unweighted was 0.91 (0.82 to 1.00). Key Words: cerebral infarction Ⅲ clinical trial Ⅲ disability Ⅲ outcomes Ⅲ scales T he modified Rankin Scale (mRS) is the most comprehensive and most widely used primary outcome measure in contemporary acute stroke trials. [1][2][3] The mRS is an ordinal, hierarchical scale that assigns patients among 7 global disability levels ranging from 0 (no symptoms) to 5 (severe disability) and 6 (death). Formal clinometric investigations have demonstrated that the mRS has good responsiveness and excellent construct and convergent validity. However, substantial interobserver variability in mRS scoring has been reported. 4 -6 Interrater variability introduces noise into trial outcome assessments and reduces the power of clinical trials to detect treatment effects. Conclusions-TheA variety of approaches to minimize interrater variation of the mRS have been described or proposed, including (1) use of a formal structured interview 7 ; (2) training and certification programs using written and video case vignettes 8 ; and (3) central panel adjudication of local site-recorded video assessments. 6 However, the instruments and approaches developed to date have not consistently been shown to reduce interrater variability.The purpose of this study was to develop and validate a systematic, structured assessment tool to guide raters in assigning mRS grades. Methods Assessment Tool ConstructionThe Rankin Focused Assessment (RFA) was developed by a working group consisting of physicians with extensive stroke clinical trial experience (J.L.S., S.S.), the head nurse coordinato...
BackgroundThe aim of this study was to assess the efficacy and safety of totally implanted vascular devices (TIVAD) using different techniques of insertion.MethodsWe performed a retrospective study using a prospective collected database of 796 consecutive oncological patients in which TIVADs were inserted. We focused on early and late complications following different insertion techniques (surgical cutdown, blind and ultrasound guided percutaneous) according to different techniques.ResultsUltrasound guided technique was used in 646 cases, cephalic vein cutdown in 102 patients and percutaneous blind technique in 48 patients. The overall complication rate on insertion was 7.2% (57 of 796 cases). Early complications were less frequent using the ultrasound guided technique: arterial puncture (p = 0.009), technical failure (p = 0.009), access site change after first attempt (p = 0.002); pneumothorax occurred in 4 cases, all using the blind percutaneus technique. Late complications occurred in 49 cases (6.1%) which required TIVAD removal in 43 cases and included: sepsis (29 cases), thrombosis (3 cases), dislocation (7 cases), skin dehiscence (3 cases), and severe pain (1 case).ConclusionUltrasound guided technique is the safest option for TIVAD insertion, with the lowest rates of immediate complications.
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