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Score Change (score + change)
Selected AbstractsChanges in Quality of Life in Epilepsy: How Large Must They Be to Be Real?EPILEPSIA, Issue 1 2001Samuel Wiebe Summary: ,Purpose: The study goal was to assess the magnitude of change in generic and epilepsy-specific health-related quality-of-life (HRQOL) instruments needed to exclude chance or error at various levels of certainty in patients with medically refractory epilepsy. Methods: Forty patients with temporal lobe epilepsy and clearly defined criteria of clinical stability received HRQOL measurements twice, 3 months apart, using the Quality of Life in Epilepsy Inventory-89 and -31 (QOLIE-89 and QOLIE-31), Liverpool Impact of Epilepsy, adverse drug events, seizure severity scales, and the Generic Health Utilities Index (HUI-III). Standard error of measurement and test-retest reliability were obtained for all scales and for QOLIE-89 subscales. Using the Reliable Change Index described by Jacobson and Truax, we assessed the magnitude of change required by HRQOL instruments to be 90 and 95% certain that real change has occurred, as opposed to change due to chance or measurement error. Results: Clinical features, point estimates and distribution of HRQOL measures, and test-retest reliability (all > 0.70) were similar to those previously reported. Score changes of ±13 points in QOLIE-89, ±15 in QOLIE-31, ±6.3 in Liverpool seizure severity,ictal, ±11 in Liverpool adverse drug events, ±0.25 in HUI-III, and ±9.5 in impact of epilepsy exclude chance or measurement error with 90% certainty. These correspond, respectively, to 13, 15, 17, 18, 25, and 32% of the potential range of change of each instrument. Conclusions: Threshold values for real change varied considerably among HRQOL tools but were relatively small for QOLIE-89, QOLIE-31, Liverpool Seizure Severity, and adverse drug events. In some instruments, even relatively large changes cannot rule out chance or measurement error. The relation between the Reliable Change Index and other measures of change and its distinction from measures of minimum clinically important change are discussed. [source] A Randomized Controlled Trial of Mist in the Acute Treatment of Moderate CroupACADEMIC EMERGENCY MEDICINE, Issue 9 2002Gina M. Neto MD Abstract Objective: To determine whether the use of mist improves clinical symptoms in children presenting to the emergency department (ED) with moderate croup. Methods: Children 3 months to 6 years of age were eligible for the study if they presented to the ED with moderate croup. Moderate croup was defined as a croup score of 2-7. The patients were randomly assigned to receive either mist (humidified oxygen) via mist stick or no mist. The patients had croup scores measured at baseline and every 30 minutes for up to two hours. At these intervals the following parameters were also measured: heart rate, respiratory rate, oxygen saturation, and patient comfort score. The patients were treated until the croup score was less than 2 or until two hours had elapsed. All patients initially received a dose of oral dexamethasone (0.6 mg/kg). Other treatments, such as racemic epinephrine or inhaled budesonide, were given at the discretion of the treating physician. The research assistants were unaware of the assigned treatments. Results: There were 71 patients enrolled in the study; 35 received mist and 36 received no mist. The two treatment groups had similar characteristics at baseline. The median baseline croup score was 4 in both groups. The outcomes were measured as the change from baseline at 30, 60, 90, and 120 minutes. The change in the croup score from baseline in the mist group was not statistically different from the croup score change in the group that did not receive mist (p = 0.39). There was also no significant difference in improvement of oxygen saturation, heart rate, or respiratory rate at any of the assessment times. There was no adverse effect from the mist therapy. Conclusions: Mist therapy is not effective in improving clinical symptoms in children presenting to the ED with moderate croup. [source] Quantitative description of loss of clinical benefit following withdrawal of levodopa,carbidopa and bromocriptine in early Parkinson's diseaseMOVEMENT DISORDERS, Issue 5 2002Robert A. Hauser MD Abstract In Parkinson's disease, effects of medications on the progression of the underlying disease can be assessed clinically by evaluating patients at baseline prior to treatment and at endpoint following medication washout. With this design, it is critical to employ a washout of sufficient duration to ensure elimination of all symptomatic effects. To assess the time course of resolution of symptomatic effects, we evaluated 31 patients with early Parkinson's disease for 2 weeks following discontinuation of levodopa,carbidopa and bromocriptine after 14 months of treatment. Patients had previously been randomly assigned to treatment with selegiline or placebo, and these had been discontinued 2 months earlier. Data from 20 patients with a clear washout of clinical benefit were used to investigate quantitative models describing the time course of total (Activities of Daily Living + motor) Unified Parkinson's Disease Rating Scale score change. The mean half-life of loss of clinical benefit was 7.9 days (95% confidence interval, 2.2,30.4 days). This indicates that a washout period of 32 days (4 half-lives) may be required to eliminate approximately 90% of the long-term symptomatic effects of levodopa,carbidopa and bromocriptine following their withdrawal from patients with early Parkinson's disease. © 2002 Movement Disorder Society [source] Validity and responsiveness of the Osnabrück Hand Eczema Severity Index (OHSI): a methodological studyBRITISH JOURNAL OF DERMATOLOGY, Issue 1 2009M. Dulon Summary Background, The Osnabrück Hand Eczema Severity Index (OHSI) is a scoring system for the assessment of the severity of hand eczema (HE). Objective, To assess the clinimetric value of the OHSI and to validate the longitudinal responsiveness of the OHSI using the Manuscore as a gold standard. Methods, OHSI and Manuscore scores were compared before and after 3 weeks' inpatient treatment of 62 patients with occupational HE. Correlation coefficients and 95% limits of agreement were calculated and the ability of OHSI to identify severe HE was analysed. The responsiveness of the OHSI in monitoring skin changes over time was evaluated by calculating effect sizes. Results, High correlation was found between the OHSI and Manuscore at both scoring occasions (around rs = 0·77). Differences between both measurements were within the 95% limits of agreement for 94% of patients, with a tendency for the OHSI to underestimate the severity at very low and at very high values compared with the Manuscore. Responsiveness to change was good. Both instruments showed significant improvement between the scoring occasions. Using the OHSI values, the proportion of classification to the correct tertile of score change was 69%. Effect size from untreated to treated was 0·6 for the Manuscore and 1·1 for the OHSI, with higher effect sizes in individuals with severe HE. Conclusions, Even though the OHSI allows less differentiation than the Manuscore, it shows adequate validity and responsiveness to change. Thus the OHSI is suitable for both monitoring the severity of HE and the effects of treatment. [source] Relation between change of hearing and (modified) Amsterdam Inventory for Auditory Disability and Handicap ScoreCLINICAL OTOLARYNGOLOGY, Issue 6 2004A.G.W. Meijer This study investigates the test,retest distributions and the interval for true score change of the (modified) Amsterdam Inventory for Auditory Disability and Handicap [(m)AIAD], when the latter is used to measure the effect of an intervention. In a previous study the reliability and validity of the (m)AIAD in a cohort of hearing impaired patients were found to have satisfactory high values. In this prospective study, 66 patients underwent a tympanoplasty operation. Preoperatively and postoperatively pure tone audiometry was performed, and at the same time the subjective hearing ability was established by means of the (m)AIAD. The correlation between threshold change and score change was 0.35 (Pearson's r). Scores on the (m)AIAD had to change by at least 16 to be qualified as a true change. For only nine of 66 subjects this criterion was fulfilled. No clear relation exists, except for these nine subjects, between threshold change and score change in this patient population. The study also shows that disability questionnaires have their limitations, when using them to measure the result of a medical intervention in an individual patient. [source] What changes in health-related quality of life matter to multiple myeloma patients?EUROPEAN JOURNAL OF HAEMATOLOGY, Issue 4 2010A prospective study Abstract Objective: To determine the clinical significance of changes in quality-of-life scores in patients with multiple myeloma (MM), we have estimated the minimal important difference (MID) for the health-related quality-of-life instrument, the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. The MID is the smallest change in a quality-of-life score considered important to patients. Methods: Between 2006 and 2008, 239 patients with MM completed the EORTC QLQ-C30 at inclusion (T1) and after 3 months (T2). At T2, a structured quality-of-life interview was also performed. MIDs were calculated by using mean score changes (T2,T1) for patients who in the interview stated they had improved, deteriorated or were unchanged. MIDs were also estimated by the receiver-operating characteristic (ROC) curve method as well as by calculation effect sizes using standard deviations of baseline scores. Results: MIDs varied slightly depending on the method used. Patients stating in the interview that they had ,improved' or ,deteriorated' had a corresponding change in EORTC QLQ-C30 score ranging from 6 to15 (improvement) and from 9 to17 (deterioration) (scale range 0,100). The ROC analysis indicated that changes in score from 7 to17 represent clinically important changes to patients. The effect size method suggested 5,6 to be a small and 11,15 to be a medium change. Conclusion: Calculation of MIDs as mean score changes or by ROC analysis suggested that a change in the EORTC QLQ-C30 score in the range of approximately 6,17 is considered important by patients with MM. These MIDs are closer to a medium effect size than to a small effect size. Our findings imply that mean score changes smaller than 6 are unlikely to be important to the patients, even if these changes are statistically significant. [source] Glucosamine sulphate in the treatment of knee osteoarthritis: cost-effectiveness comparison with paracetamolINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 6 2010S. Scholtissen Summary Introduction:, The aim of this study was to explore the cost-effectiveness of glucosamine sulphate (GS) compared with paracetamol and placebo (PBO) in the treatment of knee osteoarthritis. For this purpose, a 6-month time horizon and a health care perspective was used. Material and methods:, The cost and effectiveness data were derived from Western Ontario and McMaster Universities Osteoarthritis Index data of the Glucosamine Unum In Die (once-a-day) Efficacy trial study by Herrero-Beaumont et al. Clinical effectiveness was converted into utility scores to allow for the computation of cost per quality-adjusted life year (QALY) For the three treatment arms Incremental Cost-Effectiveness Ratio were calculated and statistical uncertainty was explored using a bootstrap simulation. Results:, In terms of mean utility score at baseline, 3 and 6 months, no statistically significant difference was observed between the three groups. When considering the mean utility score changes from baseline to 3 and 6 months, no difference was observed in the first case but there was a statistically significant difference from baseline to 6 months with a p-value of 0.047. When comparing GS with paracetamol, the mean baseline incremental cost-effectiveness ratio (ICER) was dominant and the mean ICER after bootstrapping was ,1376 ,/QALY indicating dominance (with 79% probability). When comparing GS with PBO, the mean baseline and after bootstrapping ICER were 3617.47 and 4285 ,/QALY, respectively. Conclusion:, The results of the present cost-effectiveness analysis suggested that GS is a highly cost-effective therapy alternative compared with paracetamol and PBO to treat patients diagnosed with primary knee OA. [source] The Brief Pain Inventory and Its "Pain At Its Worst in the Last 24 Hours" Item: Clinical Trial Endpoint ConsiderationsPAIN MEDICINE, Issue 3 2010Thomas M. Atkinson PhD Abstract Context., In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it may provide a blueprint for evaluations of PRO measures that can be considered by sponsors and investigators involved in PRO research and drug registration trials. Objective., In this review we examine the short form of the Brief Pain Inventory (BPI) and particularly the "pain at its worst in the last 24 hours" item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint. Results and Conclusions., After a systematic evaluation of the psychometric aspects of the BPI, we conclude that the BPI and its "pain at its worst in the last 24 hours" item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect. Nonetheless, when the BPI is being considered for assessment of pain endpoints in a registration trial, sponsors and investigators should consult with the appropriate FDA division early during research design to discuss whether there is sufficient precedent to use the instrument in the population of interest or whether additional evaluations of measurement properties are advisable. [source] Safety, tolerability and efficacy of a rapid dose escalation of quetiapine in bipolar I mania: the FATIMA studyACTA NEUROPSYCHIATRICA, Issue 3 2009Eric Constant Objective: The FATIMA study (FAst TItration of quetiapine fumarate in bipolar I MAnia) evaluated the safety, tolerability and efficacy of a rapid dose escalation of quetiapine in acutely ill bipolar I patients experiencing a manic episode. Methods: In an open-label, phase II pilot study, 29 patients aged 18 years or older, hospitalised with a bipolar I manic episode, received quetiapine twice daily for 21 days. Quetiapine was administered at 200, 400, 600, then 800 mg/day on the first 4 days, with flexible dosing (400,800 mg/day) subsequently. The primary endpoint was the proportion of patient dropouts because of adverse drug reactions during the first 7 days. Secondary safety assessments included incidences of adverse drug reactions and significant changes in vital signs. Efficacy assessments included Young Mania Rating Scale (YMRS) and Clinical Global Impressions Severity of Illness (CGI-S) score changes from day 1 to day 21. Results: Twenty patients (69%) completed the study. No patients withdrew as a result of drug-related adverse events (AEs) during the first 7 days. Twenty-three patients reported 58 adverse events, and most of the adverse events were mild or moderate. No clinically relevant abnormalities in vital signs were reported. Mean YMRS and CGI-S scores decreased significantly from baseline to day 21 (p < 0.001). Response and remission rates were 78 and 70%, respectively, at the end of the study. Conclusion: Rapid dose escalation of quetiapine to 800 mg/day over 4 days was well tolerated and effective in reducing symptoms within 5 days in acutely ill bipolar I patients with a manic episode. [source] A double blind, randomized, controlled clinical trial to assess the efficacy of a new coal tar preparation (Exorex) in the treatment of chronic, plaque type psoriasisCLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 8 2000C. H. Smith Exorex is a new topical formulation for the treatment of psoriasis; it contains 1% coal tar and a synthetic analogue resembling components identified in banana skin (a complex of esterified essential fatty acids). To determine whether the esterified essential fatty acid complex confers any therapeutic advantage over coal tar alone, patients with chronic plaque psoriasis (n = 20) were entered into a double-blind, randomized, right/left comparison of Exorex, and Exorex without the essential fatty acid component (known hereafter as coal tar control) for 8 weeks. Target plaques were scored (0,4) for erythema, desquamation and infiltration at day 0 and at 2 week intervals throughout the study. No significant differences were detected between Exorex and coal tar control with respect to changes in the summed scores at baseline and following 8 weeks of treatment (mean difference in summed score changes from baseline between Exorex and coal tar control 0.2, 95% confidence interval ,,0.44 to 0.84; P = 0.52) or in the area under the response,time curve (P = 0.16). Mean percentage improvement in summed scores of target plaques were 53.9% (SE = 4%) and 56.1% (SE = 4.9%) for Exorex and coal tar control, respectively. Results suggest that the complex of esterified essential fatty acids is not exerting any clinically important therapeutic effect in the treatment of chronic plaque psoriasis. [source] | |||||||||||||||||||