Linked Life Data

7851109

Source:http://linkedlifedata.com/resource/pubmed/id/7851109

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
1995-3-15
pubmed:abstractText
There is some controversy over the need for double data entry in clinical trials. In particular, does the number and types of errors identified with this approach justify the extra effort involved? We report the results of a study carried out to address this question. Our main outcome measure was the frequency and types of errors involved in the entry of data for the CHART (continuous, hyperfractionated, accelerated radiotherapy) trials. Data were reentered for a sample of 44 patients by a data manager other than the one making the initial entry. The second entry was then compared with the first entry. The error rate for the two entries combined was 14 per 10,000 data items (fields) (95% confidence interval 10, 19). The error rate for the initial entry alone was 15 per 10,000 fields (95% confidence interval 9.5, 22), and the vital/important error rate (defined as any error on a principal outcome measure or a major error on any other endpoint or variable) was 2.5 per 10,000 fields (95% confidence interval 0.68, 6.4). On this evidence double data entry is not performed for the CHART trials.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
0197-2456
pubmed:author
pubmed:issnType
Print
pubmed:volume
15
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
482-8
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
1994
pubmed:articleTitle
Is double data entry necessary? The CHART trials. CHART Steering Committee. Continuous, Hyperfractionated, Accelerated Radiotherapy.
pubmed:affiliation
Medical Research Council, Cancer Trials Office, Cambridge, England.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Multicenter Study