Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2001-1-10
pubmed:abstractText
The increasing complexities of clinical trials have led to increasing costs for investigators and organizations that author and administer those trials. The process of authoring a clinical trial protocol, the document that specifies the details of the study, is usually a manual task, and thus authors may introduce subtle errors in medical and procedural content. We have created a protocol inspection and critiquing tool (PICASSO) that evaluates the procedural aspects of a clinical trial protocol. To implement this tool, we developed a knowledge base for clinical trials that contains knowledge of the medical domain (diseases, drugs, lab tests, etc.) and of specific requirements for clinical trial protocols (eligibility criteria, patient treatments, and monitoring activities). We also developed a set of constraints, expressed in a formal language, that describe appropriate practices for authoring clinical trials. If a clinical trial designed with PICASSO violates any of these constraints, PICASSO generates a message to the user and a list of inconsistencies for each violated constraint. To test our methodology, we encoded portions of a hypothetical protocol and implemented designs consistent and inconsistent with known clinical trial practice. Our hope is that this methodology will be useful for standardizing new protocols and improving their quality.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
1531-605X
pubmed:author
pubmed:issnType
Print
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
724-8
pubmed:dateRevised
2009-11-18
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
Knowledge representation and tool support for critiquing clinical trial protocols.
pubmed:affiliation
Center for Health Care Evaluation, VA Palo Alto Health Care System, Palo Alto, CA, USA.
pubmed:publicationType
Journal Article