RT Journal Article
SR Electronic
T1 Generic patient self-report and investigator report instruments of therapeutic safety and tolerability.
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2033
OP 2036
VO 32
IS 10
A1 Marissa N D Lassere
A1 Kent R Johnson
A1 Susanne Van Santen
A1 Kerri Carlton
A1 Joy Rappo
A1 Rachel Michael
A1 John R Kirwan
A1 John P Edmonds
YR 2005
UL http://www.jrheum.org/content/32/10/2033.abstract
AB A patient self-report instrument was designed as a patient event index that maps to a parallel investigator instrument. Event importance (a composite of severity, frequency, and duration) was reported, but attribution was not required. The patient instrument used a checklist but also allowed for spontaneous reporting for new or unusual events. The investigator instrument (also a checklist) includes all events reported by the patient, as well as events such as signs, investigations, and diagnoses that would not generally be known to the patient. Presently, both patient and investigator instruments are to be used alongside current methods of adverse event reporting in clinical trials. The patient instrument would serve as a safety/tolerability index, whereas the investigator instrument would be a fully quantifiable (appropriately weighted), standardized adverse event index. As in many methodological projects in medicine, the overriding problem was the tradeoff between validity (comprehensiveness and accuracy) and feasibility (clarity and short administration time) in instrument development. A summary of pilot studies and results of instrument reliability and validity are presented.