RT Journal Article
SR Electronic
T1 Measuring disease-specific quality of life in clinical trials
JF Canadian Medical Association Journal
JO CMAJ
FD Canadian Medical Association
SP 889
OP 895
VO 134
IS 8
A1 G. H. Guyatt
A1 C. Bombardier
A1 P. X. Tugwell
YR 1986
UL http://www.cmaj.ca/content/134/8/889.abstract
AB While measurement of quality of life is a vital part of assessing the effect of treatment in many clinical trials, a measure that is responsive to clinically important change is often unavailable. Investigators are therefore faced with the challenge of constructing an index for a specific condition or even for a single trial. There are several stages in the development and testing of a quality-of-life measure: selecting an initial item pool, choosing the "best" items from that pool, deciding on questionnaire format, pretesting the instrument, and demonstrating the responsiveness and validity of the instrument. At each stage the investigator must choose between a rigorous, time-consuming approach to questionnaire construction that will establish the clinical relevance, responsiveness and validity of the instrument and a more efficient, less costly strategy that leaves reproducibility, responsiveness and validity untested. This article describes these options and outlines a pragmatic approach that yields consistently satisfactory disease-specific measures of quality of life.