95 research outputs found

    The continued yin and yang of uric acid

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    Reliability of the modified Rankin Scale: a systematic review

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    <p><b>Background and Purpose:</b> A perceived weakness of the modified Rankin Scale is potential for interobserver variability. We undertook a systematic review of modified Rankin Scale reliability studies.</p> <p><b>Methods:</b> Two researchers independently reviewed the literature. Crossdisciplinary electronic databases were interrogated using the following key words: Stroke*; Cerebrovasc*; Modified Rankin*; Rankin Scale*; Oxford Handicap*; Observer variation*. Data were extracted according to prespecified criteria with decisions on inclusion by consensus.</p> <p><b>Results:</b> From 3461 titles, 10 studies (587 patients) were included. Reliability of modified Rankin Scale varied from weighted κ=0.95 to κ=0.25. Overall reliability of mRS was κ=0.46; weighted κ=0.90 (traditional modified Rankin Scale) and κ=0.62; weighted κ=0.87 (structured interview).</p> <p><b>Conclusion:</b> There remains uncertainty regarding modified Rankin Scale reliability. Interobserver studies closest in design to large-scale clinical trials demonstrate potentially significant interobserver variability.</p&gt

    Variability in modified rankin scoring across a large cohort of observers

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    <br>Background and Purpose— The modified Rankin scale (mRS) is the most commonly used outcome measure in stroke trials. However, substantial interobserver variability in mRS scoring has been reported. These studies likely underestimate the variability present in multicenter clinical trials, because exploratory work has only been undertaken in single centers by a few observers, all of similar training. We examined mRS variability across a large cohort of international observers using data from a video training resource.</br> <br>Methods— The mRS training package includes a series of “real-life” patient interviews for grading. Training data were collected centrally and analyzed for variability using kappa statistics. We examined variability against a standard of “correct” mRS grades; examined variability by country; and for UK assessors, examined variability by center and by professional background of the observer.</br> <br>Results— To date, 2942 assessments from 30 countries have been submitted. Overall reliability for mRS grading has been moderate to good with substantial heterogeneity across countries. Native English language has had little effect on reliability. Within the United Kingdom, there was no significant variation by profession.</br> <br>Conclusion— Our results confirm interobserver variability in mRS assessment. The heterogeneity across countries is intriguing because it appears not to be related solely to language. These data highlight the need for novel strategies to improve reliability.</br&gt

    Exploring the reliability of the modified Rankin Scale

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    <p><b>Background and Purpose:</b> The modified Rankin Scale (mRS) is the most prevalent outcome measure in stroke trials. Use of the mRS may be hampered by variability in grading. Previous estimates of the properties of the mRS have used diverse methodologies and may not apply to contemporary trial populations. We used a mock clinical trial design to explore inter- and intraobserver variability of the mRS.</p> <p><b>Methods:</b> Consenting patients with stroke attending for outpatient review had the mRS performed by 2 independent assessors with pairs of assessors selected from a team of 3 research nurses and 4 stroke physicians. Before formal assessment, interviewers estimated disability based only on initial patient observation. Each patient was then randomized to undergo the mRS using standard assessment or a prespecified structured interview. The second interviewer in the pair reassessed the patient using the same method blinded to the colleague’s score. For each patient assessed, one rater was randomly assigned to video record their interview. After 3 months, this interviewer reviewed and regraded their original video assessment.</p> <p><b>Results:</b> Across 100 paired assessments, interobserver agreement was moderate (k=0.57). Intraobserver variability was good (k=0.72) but less than would be expected from previous literature. Forty-nine assessments were performed using the structured interview approach with no significant difference between structured and standard mRS. Researchers were unable to reliably predict mRS from initial limited patient assessment (k=0.16).</p> <p><b>Conclusions:</b> Despite availability of training and structured interview, there remains substantial interobserver variability in mRS grades awarded even by experienced researchers. Additional methods to improve mRS reliability are required.</p&gt

    Reliability of the modified rankin scale

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    Time spent at home poststroke: “home-time” a meaningful and robust outcome measure for stroke trials

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    <p><b>Background and Purpose:</b> Stroke outcome assessment requires some measure of functional recovery. Several instruments are in common use but all have recognized limitations. We examined duration of stay in the patient’s own home over the first 90 days since stroke—"home-time"—as an alternative outcome likely to show graded response with improved reliability.</p> <p><b>Methods:</b> We examined prospectively collected data from the GAIN International trial using analysis of variance with Bonferroni contrasts of adjacent modified Rankin scale score categories.</p> <p><b>Results:</b> We had full outcome data from 1717 of 1788 patients. Increasing home-time was associated with improved modified Rankin scale scores (P<0.0001). The relationship held across all modified Rankin scale grades except 4 to 5.</p> <p><b>Conclusions:</b> Home-time offers a robust, useful, and easily validated outcome measure for stroke, particularly across better recovery levels.</p&gt

    Deriving modified rankin scores from medical records

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    <p><b>Background and Purpose:</b> Modified Rankin score (mRS) is traditionally graded using a face-to-face or telephone interview. Certain stroke assessment scales can be derived from a review of a patient’s case-record alone. We hypothesized that mRS could be successfully derived from the narrative within patient case-records.</p> <p><b>Methods:</b> Sequential patients attending our cerebrovascular outpatient clinic were included. Two independent, blinded clinicians, trained in mRS, assessed case-records to derive mRS. They scored “certainty” of their grading on a 5-point Likert scale. Agreement between derived and traditional face-to-face mRS was calculated using attribute agreement analysis.</p> <p><b>Results:</b> Fifty patients with a range of disabilities were included. Case-record appraisers were poor at deriving mRS (k=0.34 against standard). Derived mRS grades showed poor agreement between observers (k=0.33). There was no relationship between certainty of derived mRS and proportion of correct grades (P=0.727).</p> <p><b>Conclusion:</b> Accurate mRS cannot be derived from standard hospital records. Direct mRS interview is still required for clinical trials.</p&gt

    Allopurinol use yields potentially beneficial effects on inflammatory indices in those with recent ischemic stroke: a randomized, double-blind, placebo-controlled trial

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    <p><b>Background and Purpose</b>: Elevated serum uric acid level is associated with poor outcome and increased risk of recurrent events after stroke. The xanthine oxidase inhibitor allopurinol lowers uric acid but also attenuates expression of inflammatory adhesion molecules in murine models, reduces oxidative stress in the vasculature, and improves endothelial function. We sought to investigate whether allopurinol alters expression of inflammatory markers after acute ischemic stroke.</p> <p><b>Methods</b>: We performed a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, and effect of 6 weeks’ treatment with high- (300 mg once a day) or low- (100 mg once a day) dose allopurinol on levels of uric acid and circulating inflammatory markers after ischemic stroke.</p> <p><b>Results</b>: We enrolled 50 patients with acute ischemic stroke (17, 17, and 16 in the high, low, and placebo groups, respectively). Mean (±SD) age was 70 (±13) years. Groups had similar characteristics at baseline. There were no serious adverse events. Uric acid levels were significantly reduced at both 7 days and 6 weeks in the high-dose group (by 0.14 mmol/L at 6 weeks, P=0.002). Intercellular adhesion molecule-1 concentration (ng/mL) rose by 51.2 in the placebo group, rose slightly (by 10.6) in the low-dose allopurinol group, but fell in the high-dose group (by 2.6; difference between groups P=0.012, Kruskal-Wallis test).</p> <p><b>Conclusion</b>: Allopurinol treatment is well tolerated and attenuates the rise in intercellular adhesion molecule-1 levels seen after stroke. Uric acid levels were lowered with high doses. These findings support further evaluation of allopurinol as a preventive measure after stroke.</p&gt

    Association between disability measures and healthcare costs after initial treatment for acute stroke

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    <p><b>Background and Purpose:</b> The distribution of 3-month modified Rankin scale (mRS) scores has been used as an outcome measure in acute stroke trials. We hypothesized that hospitalization and institutional care home stays within the first 90 days after stroke should be closely related to 90-day mRS, that each higher mRS category will reflect incremental cost, and that resource use may be less clearly linked to the National Institutes of Health Stroke Scale (NIHSS) or Barthel index.</p> <p><b>Methods:</b> We examined resource use data from the GAIN International trial comparing 90-day mRS with total length of stay in hospital or other institutions during the first 90 days. We repeated analyses using NIHSS and Barthel index scores. Relationships were examined by analysis of variance (ANOVA) with Bonferroni contrasts of adjacent score categories. Estimated costs were based on published Scottish figures.</p> <p><b>Results:</b> We had full data from 1717 patients. Length of stay was strongly associated with final mRS (P<0.0001). Each mRS increment from 0 to 1–2 to 3–4 was significant (mean length of stay: 17, 25, 44, 58, 79 days; P<0.0005). Ninety-five percent confidence limits for estimated costs (£) rose incrementally: 2493 to 3412, 3369 to 4479, 5784 to 7008, 7300 to 8512, 10 095 to 11 141, 11 772 to 13 560, and 2623 to 3321 for mRS 0 to 5 and dead, respectively. Weaker relationships existed with Barthel and NIHSS.</p> <p><b>Conclusions:</b> Each mRS category reflects different average length of hospital and institutional stay. Associated costs are meaningfully different across the full range of mRS outcomes. Analysis of the full distribution of mRS scores is appropriate for interpretation of treatment effects after acute stroke and more informative than Barthel or NIHSS end points.</p&gt
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