Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2004-3-18
pubmed:abstractText
Assessment of health-related quality of life (QOL) has become increasingly common in clinical trials. Because QOL has multiple dimensions and is assessed repeatedly over time, multiple comparisons and missing data must be addressed in the design and analysis of these trials. While the development of an analysis plan will be a continuous process, described here are three critical phases in the ideal development of a statistical analysis plan for the QOL component of a clinical trial: concept, initial design, and final analysis plans. A clinical trial designed to evaluate a new therapy for the prevention of migraines was used to illustrate the critical decisions that are made during the design and analysis phases of a trial that incorporates QOL in the assessment procedure. Specifically addressed are clearly defining goals and objectives, endpoints, multiple comparisons, analysis of longitudinal data with dropout, and estimation of power.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Feb
pubmed:issn
1054-3406
pubmed:author
pubmed:issnType
Print
pubmed:volume
14
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
31-51
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2004
pubmed:articleTitle
Planning analyses of quality-of-life studies: a case example with migraine prophylaxis.
pubmed:affiliation
Colorado Health Outcomes Program and Department of Preventive Medicine and Biometry, University of Colorado Health Sciences Center, Denver, Colorado 80210, USA. dianefairclough@earthlink.net
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't