Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
1997-7-17
pubmed:abstractText
Progression of Parkinson's disease (PD) can be detected through changes in clinical ratings or disability assessments. A clinical trial, Deprenyl and Alpha-Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP), used a novel study end point: increase in parkinsonian disability to the extent that investigators determined the need for treatment with levodopa. We analyzed DATATOP results to learn if this operationally defined end point could be reproduced from elements of the Unified PD Rating Scale (UPDRS) and other conventional clinical scales. Our analysis involved UPDRS, Schwab and England Activities of Daily Living (S-E ADL), and Hoehn and Yahr (H-Y) scores when DATATOP subjects reached the study end point. Various UPDRS components were examined, including subscores measuring severity of impaired ADL, bradykinesia, postural instability and gait difficulty, tremor, and rigidity. Data from subjects reaching the end point were compared with assessments of those DATATOP subjects who did not, matched for the same duration of enrollment. All measures showed subjects who reached the end point had significantly greater mean impairment than did controls, although the two groups had substantial overlap. Multivariate analysis by using conditional logistic regression suggested that the end point was determined more by functional (S-E ADL and the UPDRS ADL scores) than by clinical examination criteria. The method of classification and regression trees suggested a simple decision tree splitting, respectively, on S-E ADL, UPDRS ADL, H-Y score, and UPDRS ADL again, with an estimated overall misclassification probability of 18%. We conclude that the DATATOP end point cannot be fully reproduced from the traditional clinical measures, although it can give results that are consistent with these scales in a well-designed clinical trial.
pubmed:grant
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
0885-3185
pubmed:author
pubmed:issnType
Print
pubmed:volume
12
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
183-9
pubmed:dateRevised
2007-11-14
pubmed:meshHeading
pubmed:year
1997
pubmed:articleTitle
The need for levodopa as an end point of Parkinson's disease progression in a clinical trial of selegiline and alpha-tocopherol. Parkinson Study Group.
pubmed:affiliation
Clinical Neuroscience Center, Sinai Hospital, West Bloomfield, Michigan, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Research Support, U.S. Gov't, P.H.S., Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study