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Biomedical subjects

R Lally

Publications and source records attributed to R Lally.

5 recordsLinked to original sources

Age, gender, and education norms on the CERAD neuropsychological battery in the oldest old.

OBJECTIVE: To evaluate the performance of nondemented subjects 85 years and older on the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neuropsychological battery, and to assess its relationship with sociodemographic variables. METHODS: We studied 196 subjects enrolled in an Alzheimer's Disease Research Center study who had a complete CERAD neuropsychological assessment. We used multiple regression analysis to predict performance on the neuropsychological tests from age, education, and sex. Eight representative hypothetical individuals were created (for example, an 87-year-old man, with high education). For each test, estimates of performance at the 10th, 25th, 50th, and 75th percentiles were reported for the eight representative hypothetical individuals. RESULTS: Mean age was 89.2 years (SD = 3.2), mean years of education was 14.9 (SD = 3.2), and 66% of the sample were women. For 11 of the 14 neuropsychological tests, there was a significant multiple regression model using education, age, and sex as predictors. Neither the models nor the predictors used individually were significant for Delayed Recall, Savings, or correct Recognition. Among the significant results, seven had education as the strongest predictor. Lower age and higher education were associated with better performance. Women performed better than men in three of four tests with significant results for sex. CONCLUSIONS: In a sample of oldest old whose primary language is English, neuropsychological testing is influenced mainly by education and age. Cutoff scores based on younger populations and applied to the oldest old might lead to increased false-positive misclassifications.

Aged, 80 and over↗

Private-label manufacturing.

Private, or own-brand, labelling of products is an attractive proposition for manufacturers who may have unique products but lack access to particular markets, or distributors who may have a strong brand identity but lack a suitable product. However, care must be taken to ensure that private-labelled products comply with the Medical Device Directive and confusion may arise over who takes responsibility for compliance issues. This article looks at the alternative proposals for resolving this confusion and at some of the requirements for compliance.

Equipment and Supplies↗

Achieving systematic compliance with the Medical Device Directive.

This article outlines key issues that will aid successful compliance with the requirements of the Medical Device Directive through ISO 9000/EN 46000. A well-constructed quality system that complies with these standards will also act as a good basis for ensuring compliance with many other global regulatory requirements.

Device Approval↗