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New Outcome Measure (new + outcome_measure)
Selected AbstractsThe Virtual International Stroke Trials Archive (VISTA): results and impact on future stroke trials and management of stroke patientsINTERNATIONAL JOURNAL OF STROKE, Issue 2 2010C. Weimar Background The Virtual International Stroke Trials Archive was established to improve stroke care and trial design through the collation, categorization and potential access to data sets from clinical trials for the treatment of stroke. Methods Virtual International Stroke Trials Archive currently provides access to a combined data set of 29 anonymised acute stroke trials and one acute stroke registry with data on >27 500 patients aged between 18 and 103 (mean 71) years. Results Virtual International Stroke Trials Archive has facilitated research across a broad canvas. The prognosis was poor in patients with very high blood pressure at the time of admission or with a wide variability of systolic blood pressure during the acute phase. The late occurrence of hyperthermia following an ischaemic stroke worsens the prognosis. Stroke lateralisation is not an important predictor of cardiac adverse events or 90-day mortality. Haemorrhagic transformation is seen frequently in patients with cardio-embolic strokes and is associated with a poor prognosis when occurring after the acute phase. Virtual International Stroke Trials Archive has allowed various prognostic models for patients with ischaemic or haemorrhagic stroke to be established and validated. More direct outcomes such as lesion volume can be useful in phase II clinical trials for determining whether a phase III trial should be undertaken. New outcome measures such as ,home time' may also strengthen future trials. On a worldwide level, the prognosis of stroke patients differs considerably between various countries. Conclusion Virtual International Stroke Trials Archive provides an excellent opportunity for analysis of natural history data and prognosis. It has the potential to influence clinical trial design and implementation through exploratory data analyses. [source] Overall self-rated health: a new quality indicator for primary careJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 1 2007James E. Rohrer PhD Abstract Rationale, aims and objectives, Patient ,empowerment' gives patients choices about their own care and about the outcomes they would most prefer. Many patients can be presumed to regard overall self-rated health as an important outcome. Therefore, overall self-rated health can be considered a relevant and important outcome measure for a patient-centred medical clinic. The purpose of this study was to use this new outcome measure as a dependent variable and to test the hypothesis that patients who are confident about their ability to manage their health will have better health, in comparison to more dependent patients. Methods, We conducted a randomized cross-sectional postal survey of 500 veteran patients from the Panhandle of Texas and the surrounding areas; and 302 participated in the study. Multiple logistic regression analysis was used to test the hypothesis that health confidence is positively related to self-rated health, controlling for obesity, cigarette smoking and participation in recreational activities. Results, Veterans who strongly disagreed with the statement that they usually could overcome illnesses on their own were less likely to report good, very good or excellent self-rated health (adjusted odds ratio = 0.25). Conclusions, Overall self-rated health as measured by a single question proved to be significantly related to behavioural risk factors in this sample of primary care patients, attesting to its validity as an outcome indicator. Furthermore, health confidence was associated with better health. Most primary providers believe that they can, through good communication and providing self-care tools, increase healthy behaviours in their patients. If we are indeed able to increase health confidence in our patients, this study would suggest that self-rated health would improve. [source] The 6-minute walk test as a new outcome measure in Duchenne muscular dystrophyMUSCLE AND NERVE, Issue 4 2010Craig M. McDonald MD Abstract Walking abnormalities are prominent in Duchenne muscular dystrophy (DMD). We modified the 6-minute walk test (6MWT) for use as an outcome measure in patients with DMD and evaluated its performance in 21 ambulatory boys with DMD and 34 healthy boys, ages 4 to 12 years. Boys with DMD were tested twice, ,1 week apart; controls were tested once. The groups had similar age, height, and weight. All tests were completed. Boys who fell recovered rapidly from falls without injury. Mean ± SD [range] 6-minute walk distance (6MWD) was lower in boys with DMD than in controls (366 ± 83 [125,481] m vs. 621 ± 68 [479,754] m; P < 0.0001; unpaired t -test). Test-retest correlation for boys with DMD was high (r = 0.91). Stride length (R2 = 0.89; P < 0.0001) was the major determinant of 6MWD for both boys with DMD and controls. A modified 6MWT is feasible and safe, documents disease-related limitations on ambulation, is reproducible, and offers a new outcome measure for DMD natural history and therapeutic trials. Muscle Nerve, 2010 [source] Long-interval T2-weighted subtraction magnetic resonance imaging: A powerful new outcome measure in multiple sclerosis trialsANNALS OF NEUROLOGY, Issue 5 2010Bastiaan Moraal MD Objective To compare long-interval T2-weighted subtraction (T2w-Sub) imaging with monthly gadolinium-enhanced T1-weighted (Gd-T1w) imaging for (1) detection of active lesions, (2) assessment of treatment efficacy, and (3) statistical power, in a multiple sclerosis (MS), phase 2, clinical trial setting. Methods Magnetic resonance imaging (MRI) data over 9 months from 120 patients (61 treatment, 59 placebo) from the oral temsirolimus trial were used. T2w-Sub images were scored for active lesions, independent of the original reading of the monthly Gd-T1w images. Treatment efficacy was evaluated using the nonparametric Mann-Whitney U test, and parametric negative binomial (NB)-regression and power calculations were conducted. Results Datasets from 116 patients (58 treatment, 58 placebo) were evaluated. The mean number of T2w-Sub lesions in the treatment group was 3.0 (±4.6) versus 5.9 (±8.8) for placebo; the mean cumulative number of new Gd-T1w lesions in the treatment group was 5.5(±9.1) versus 9.1(±17.2) for placebo. T2w-Sub imaging showed increased power to assess treatment efficacy compared with Gd-T1w imaging, when evaluated by Mann-Whitney U test (p = 0.017 vs p = 0.177), or NB-regression without (p = 0.011 vs p = 0.092) or with baseline adjustment (p < 0.001 vs p = 0.002). Depending on the magnitude of the simulated treatment effect, sample size calculations showed reductions of 22 to 34% in the number of patients (translating into reductions of 81,83% in the number of MRI scans) needed to detect a significant treatment effect in favor of T2w-Sub imaging. Interpretation Compared with monthly Gd-T1w imaging, long-interval T2w-Sub MRI exhibited increased power to assess treatment efficacy, and could greatly increase the cost-effectiveness of phase 2 MS trials by limiting the number of patients, contrast injections, and MRI scans needed. ANN NEUROL 2010;67:667,675 [source] | ||||||||||