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CERAD practice effects and attrition bias in a dementia prevention trial.

ABSTRACT: The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) set of tests is frequently used for tracking cognition longitudinally in both clinical and research settings. Repeated cognitive assessments are an important component in measuring such changes; however, practice effects and attrition bias may obscure significant clinical change over time. The current study sought to examine the presence and magnitude of practice effects and the role of attrition bias in a sample of cognitively normal older men enrolled in a prevention trial.Participants were grouped according to whether they completed five years of follow-up (n = 182) or less (n = 126). Practice effects were examined in these participants as a whole (n = 308) and by group.Findings indicate that moderate practice effects exist in both groups on the CERAD T-score and that attrition bias likely does not play a contributing role in improved scores over time.The current study provides additional evidence and support for previous findings that repeated cognitive assessment results in rising test scores in longitudinally collected data and demonstrates that these findings are unlikely to be due to attrition.

SUBMITTER: Mathews M

PROVIDER: S-EPMC4012228 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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CERAD practice effects and attrition bias in a dementia prevention trial.

Mathews Melissa M Abner Erin E Caban-Holt Allison A Kryscio Richard R Schmitt Frederick F

International psychogeriatrics 20130410 7

<h4>Background</h4>The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) set of tests is frequently used for tracking cognition longitudinally in both clinical and research settings. Repeated cognitive assessments are an important component in measuring such changes; however, practice effects and attrition bias may obscure significant clinical change over time. The current study sought to examine the presence and magnitude of practice effects and the role of attrition bias in a ...[more]

PMID: 23570673

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Project description:BackgroundAn important part of the systematic review methodology is appraisal of the risk of bias in included studies. Cochrane systematic reviews are considered golden standard regarding systematic review methodology, but Cochrane's instructions for assessing risk of attrition bias are vague, which may lead to inconsistencies in authors' assessments. The aim of this study was to analyze consistency of judgments and support for judgments of attrition bias in Cochrane reviews of interventions published in the Cochrane Database of Systematic Reviews (CDSR).MethodsWe analyzed Cochrane reviews published from July 2015 to June 2016 in the CDSR. We extracted data on number of included trials, judgment of attrition risk of bias for each included trial (low, unclear or high) and accompanying support for the judgment (supporting explanation). We also assessed how many Cochrane reviews had different judgments for the same supporting explanations.ResultsIn the main analysis we included 10,292 judgments and supporting explanations for attrition bias from 729 Cochrane reviews. We categorized supporting explanations for those judgments into four categories and we found that most of the supporting explanations were unclear. Numerical indicators for percent of attrition, as well as statistics related to attrition were judged very differently. One third of Cochrane review authors had more than one category of supporting explanation; some had up to four different categories. Inconsistencies were found even with the number of judgments, names of risk of bias domains and different judgments for the same supporting explanations in the same Cochrane review.ConclusionWe found very high inconsistency in methods of appraising risk of attrition bias in recent Cochrane reviews. Systematic review authors need clear guidance about different categories they should assess and judgments for those explanations. Clear instructions about appraising risk of attrition bias will improve reliability of the Cochrane's risk of bias tool, help authors in making decisions about risk of bias and help in making reliable decisions in healthcare.

Project description:ContextGinkgo biloba is widely used for its potential effects on memory and cognition. To date, adequately powered clinical trials testing the effect of G. biloba on dementia incidence are lacking.ObjectiveTo determine effectiveness of G. biloba vs placebo in reducing the incidence of all-cause dementia and Alzheimer disease (AD) in elderly individuals with normal cognition and those with mild cognitive impairment (MCI).Design, setting, and participantsRandomized, double-blind, placebo-controlled clinical trial conducted in 5 academic medical centers in the United States between 2000 and 2008 with a median follow-up of 6.1 years. Three thousand sixty-nine community volunteers aged 75 years or older with normal cognition (n = 2587) or MCI (n = 482) at study entry were assessed every 6 months for incident dementia.InterventionTwice-daily dose of 120-mg extract of G. biloba (n = 1545) or placebo (n = 1524).Main outcome measuresIncident dementia and AD determined by expert panel consensus.ResultsFive hundred twenty-three individuals developed dementia (246 receiving placebo and 277 receiving G. biloba) with 92% of the dementia cases classified as possible or probable AD, or AD with evidence of vascular disease of the brain. Rates of dropout and loss to follow-up were low (6.3%), and the adverse effect profiles were similar for both groups. The overall dementia rate was 3.3 per 100 person-years in participants assigned to G. biloba and 2.9 per 100 person-years in the placebo group. The hazard ratio (HR) for G. biloba compared with placebo for all-cause dementia was 1.12 (95% confidence interval [CI], 0.94-1.33; P = .21) and for AD, 1.16 (95% CI, 0.97-1.39; P = .11). G. biloba also had no effect on the rate of progression to dementia in participants with MCI (HR, 1.13; 95% CI, 0.85-1.50; P = .39).ConclusionsIn this study, G. biloba at 120 mg twice a day was not effective in reducing either the overall incidence rate of dementia or AD incidence in elderly individuals with normal cognition or those with MCI. Trial Registration clinicaltrials.gov Identifier: NCT00010803.

Project description:Introduction:Practice effects (PEs) present a potential confound in clinical trials with cognitive outcomes. A single-blind placebo run-in design, with repeated cognitive outcome assessments before randomization to treatment, can minimize effects of practice on trial outcome. Methods:We investigated the potential implications of PEs in Alzheimer's disease prevention trials using placebo arm data from the Alzheimer's Disease Cooperative Study donepezil/vitamin E trial in mild cognitive impairment. Frequent ADAS-Cog measurements early in the trial allowed us to compare two competing trial designs: a 19-month trial with randomization after initial assessment, versus a 15-month trial with a 4-month single-blind placebo run-in and randomization after the second administration of the ADAS-Cog. Standard power calculations assuming a mixed-model repeated-measure analysis plan were used to calculate sample size requirements for a hypothetical future trial designed to detect a 50% slowing of cognitive decline. Results:On average, ADAS-Cog 13 scores improved at first follow-up, consistent with a PE and progressively worsened thereafter. The observed change for a 19-month trial (1.18 points) was substantively smaller than that for a 15-month trial with 4-month run-in (1.79 points). To detect a 50% slowing in progression under the standard design (i.e., a 0.59 point slowing), a future trial would require 3.4 times more subjects than would be required to detect the comparable percent slowing (i.e., 0.90 points) with the run-in design. Discussion:Assuming the improvement at first follow-up observed in this trial represents PEs, the rate of change from the second assessment forward is a more accurate representation of symptom progression in this population and is the appropriate reference point for describing treatment effects characterized as percent slowing of symptom progression; failure to accommodate this leads to an oversized clinical trial. We conclude that PEs are an important potential consideration when planning future trials.

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CERAD practice effects and attrition bias in a dementia prevention trial.

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CERAD practice effects and attrition bias in a dementia prevention trial.

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