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Improving the reliability of stroke disability grading in clinical trials and clinical practice: the Rankin Focused Assessment (RFA).

ABSTRACT: 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.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.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 kappa was 0.99 (95% CI, 0.99 to 1.0), and the unweighted kappa was 0.93 (95% CI, 0.85 to 1.00). Among the 43 surviving patients, the percent agreement was 93%, the weighted kappa was 0.99 (0.98 to 1.0), and the unweighted kappa was 0.91 (0.82 to 1.00).The Rankin Focused Assessment yields high interrater reliability in the grading of final global disability among consecutive patients with stroke participating in a randomized clinical trial. The Rankin Focused Assessment is brief and practical for use in multicenter clinical trials and quality improvement activities.

SUBMITTER: Saver JL

PROVIDER: S-EPMC2930146 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature

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Improving the reliability of stroke disability grading in clinical trials and clinical practice: the Rankin Focused Assessment (RFA).

Saver Jeffrey L JL Filip Bogdan B Hamilton Scott S Yanes Anna A Craig Sharon S Cho Michelle M Conwit Robin R Starkman Sidney S

Stroke 20100401 5

<h4>Background and purpose</h4>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.<h4>Methods</h4>The Rankin Focused Assessment was developed by selecting and refining ...[more]

PMID: 20360551

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Project description:BackgroundClinical examination of trachoma is used to justify intervention in trachoma-endemic regions. Currently, field graders are certified by determining their concordance with experienced graders using the kappa statistic. Unfortunately, trachoma grading can be highly variable and there are cases where even expert graders disagree (borderline/marginal cases). Prior work has shown that inclusion of borderline cases tends to reduce apparent agreement, as measured by kappa. Here, we confirm those results and assess performance of trainees on these borderline cases by calculating their reliability error, a measure derived from the decomposition of the Brier score.Methods and findingsWe trained 18 field graders using 200 conjunctival photographs from a community-randomized trial in Niger and assessed inter-grader agreement using kappa as well as reliability error. Three experienced graders scored each case for the presence or absence of trachomatous inflammation-follicular (TF) and trachomatous inflammation-intense (TI). A consensus grade for each case was defined as the one given by a majority of experienced graders. We classified cases into a unanimous subset if all 3 experienced graders gave the same grade. For both TF and TI grades, the mean kappa for trainees was higher on the unanimous subset; inclusion of borderline cases reduced apparent agreement by 15.7% for TF and 12.4% for TI. When we assessed the breakdown of the reliability error, we found that our trainees tended to over-call TF grades and under-call TI grades, especially in borderline cases.ConclusionsThe kappa statistic is widely used for certifying trachoma field graders. Exclusion of borderline cases, which even experienced graders disagree on, increases apparent agreement with the kappa statistic. Graders may agree less when exposed to the full spectrum of disease. Reliability error allows for the assessment of these borderline cases and can be used to refine an individual trainee's grading.

Project description:BackgroundThe modified Rankin Scale (mRS) is the most common endpoint in acute stroke trials, but its power is limited when analyzed dichotomously and its indication of effect size is challenging to interpret when analyzed ordinally. To address these issues, the utility-weighted-mRS (UW-mRS) has been developed as a patient-centered, linear scale. However, appropriate data visualizations of UW-mRS results are needed, as current stacked bar chart displays do not convey crucial utility-weighting information.Design/methodsTwo UW-mRS display formats were devised: (1) Utility Staircase charts, and (2) choropleth-stacked-bar-charts (CSBCs). In Utility Staircase displays, mRS segment height reflects the utility value of each mRS level. In CSBCs, mRS segment color intensity reflects the utility of each mRS level. Utility Staircase and CSBC figures were generated for 15 randomized comparisons of acute ischemic/hemorrhagic stroke therapies, including fibrinolysis, endovascular reperfusion, blood pressure moderation, and hemicraniectomy. Display accuracy in showing utility outcomes was assessed with the Tufte-lie-factor and ease-of-use assessed by formal ratings completed by a panel of 4 neurologists and emergency physicians and one nurse-coordinator.ResultsThe Utility Staircase and CSBC displays rapidly conveyed patient-centered valuation of trial outcome distributions not available in conventional ordinal stacked bar charts. Tufte-lie-factor (LF) scores indicated "substantial distortion" of utility-valued outcomes for 93% (14/15) of conventional stacked bar charts, vs. "no distortion" for all Utility Staircase and CSBC displays. Clinician ratings on the Figural Display Questionnaire indicated that utility information encoded in row height (Utility Staircase display) was more readily assimilated than that conveyed in segment hue intensity (CSBC), both superior to conventional stacked bar charts.ConclusionsUtility Staircase displays are an efficient graphical format for conveying utility weighted-modified Rankin Scale primary endpoint results of acute stroke trials, and choropleth-stacked-bar-charts a good alternative. Both are more accurate in depicting quantitative, health-related quality of life results and preferred by clinician users for utility results visualization, compared with conventional stacked bar charts.

Project description:ObjectiveTo identify features of clinical decision support systems critical for improving clinical practice.DesignSystematic review of randomised controlled trials.Data sourcesLiterature searches via Medline, CINAHL, and the Cochrane Controlled Trials Register up to 2003; and searches of reference lists of included studies and relevant reviews.Study selectionStudies had to evaluate the ability of decision support systems to improve clinical practice.Data extractionStudies were assessed for statistically and clinically significant improvement in clinical practice and for the presence of 15 decision support system features whose importance had been repeatedly suggested in the literature.ResultsSeventy studies were included. Decision support systems significantly improved clinical practice in 68% of trials. Univariate analyses revealed that, for five of the system features, interventions possessing the feature were significantly more likely to improve clinical practice than interventions lacking the feature. Multiple logistic regression analysis identified four features as independent predictors of improved clinical practice: automatic provision of decision support as part of clinician workflow (P < 0.00001), provision of recommendations rather than just assessments (P = 0.0187), provision of decision support at the time and location of decision making (P = 0.0263), and computer based decision support (P = 0.0294). Of 32 systems possessing all four features, 30 (94%) significantly improved clinical practice. Furthermore, direct experimental justification was found for providing periodic performance feedback, sharing recommendations with patients, and requesting documentation of reasons for not following recommendations.ConclusionsSeveral features were closely correlated with decision support systems' ability to improve patient care significantly. Clinicians and other stakeholders should implement clinical decision support systems that incorporate these features whenever feasible and appropriate.

Project description:Most tobacco-focused clinical trials are based on locally conducted studies that face significant challenges to implementation and successful execution. These challenges include the need for large, diverse, yet still representative study samples. This often means a protracted, costly, and inefficient recruitment process. Multisite clinical trials can overcome some of these hurdles but incur their own unique challenges. With recent advances in mobile health and digital technologies, there is now a promising alternative: Remote Trials. These trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, or even nation. The remote approach affords many of the benefits of multisite trials (more efficient recruitment of larger study samples) without the same barriers (cost, multisite management, and regulatory hurdles). The Coronavirus Disease 2019 (COVID-19) global health pandemic has resulted in rapid requirements to shift ongoing clinical trials to remote delivery and assessment platforms, making methods for the conduct of remote trials even more timely. The purpose of the present review is to provide an overview of available methods for the conduct of remote tobacco-focused clinical trials as well as illustrative examples of how these methods have been implemented across recently completed and ongoing tobacco studies. We focus on key aspects of the clinical trial pipeline including remote: (1) study recruitment and screening, (2) informed consent, (3) assessment, (4) biomarker collection, and (5) medication adherence monitoring. Implications With recent advances in mobile health and digital technologies, remote trials now offer a promising alternative to traditional in-person clinical trials. Remote trials afford expedient recruitment of large, demographically representative study samples, without undo burden to a research team. The present review provides an overview of available methods for the conduct of remote tobacco-focused clinical trials across key aspects of the clinical trial pipeline.

Project description:Background:Nonadherence to treatment remains high among patients with musculoskeletal conditions with negative impact on the treatment outcomes, use of personal and cost of care. An active knowledge translation (KT) strategy may be an effective strategy to support practice change. The purpose of this study was to deliver a brief, interactive, multifaceted and targeted KT program to improve physiotherapist knowledge and confidence in performing adherence enhancing activities related to risk, barriers, assessment and interventions. Methods:We utilised a 2-phase approach in this KT project. Phase 1 involved the development of an adherence tool kit following a synthesis of the literature and an iterative process involving 47 end-users. Clinicians treating patients with musculoskeletal conditions were recruited from two Physiotherapy and Occupational therapy national conferences in Canada. The intervention, based on the acronym SIMPLE TIPS was tested on 51 physiotherapists in phase 2. A pre- and post-repeated measures design was used in Phase 2. Graham's knowledge-to-action cycle was used as the conceptual framework. Participants completed a pre-intervention assessment, took part in a 1-h educational session and completed a post-intervention assessment. A questionnaire was used to measure knowledge of evidence-based treatment adherence barriers, interventions and measures and confidence to perform evidence-based adherence practice activities. Data was analysed using descriptive statistics (frequency and percentage), Fisher's exact test and Wilcoxon Sign-Ranked tests. Results:Barriers and facilitators of adherence were identified under three domains (therapist, patient, health system) in phase 1. Seventy percent of the participants completed the questionnaire. Results indicated that 46.8% of respondents explored barriers including the use of behaviour change strategies and 45.7% reported that they measured adherence but none reported the use of validated outcomes. A significant improvement in post-self-efficacy scores for the four adherence enhancing activities was observed immediately after the workshop. Conclusion:The use of a multi-modal KT intervention is feasible in an educational setting. A brief interactive educational session was successfully implemented using a toolkit and caused a significant increase in physiotherapists' knowledge and confidence at performing adherence enhancing activities in the very short-term. Further testing of SIMPLE TIPS on long-term adherence practices could help advance best practices specific to treatment adherence in MSK practice.

Dataset Information

Improving the reliability of stroke disability grading in clinical trials and clinical practice: the Rankin Focused Assessment (RFA).

Publications

Improving the reliability of stroke disability grading in clinical trials and clinical practice: the Rankin Focused Assessment (RFA).

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