title: Generic patient self-report and investigator report instruments of therapeutic safety and tolerability.
abstract: 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.
authors.affiliation: Department of Rheumatology, University of New South Wales, St. George Hospital, Belgrave Street, Kogarah, Sydney, 2127 NSW, Australia. lasserem@sesahs.nsw.gov.au
authors.forename: Marissa N D
authors.initials: MN
authors.lastname: Lassere
authors.forename: Kent R
authors.initials: KR
authors.lastname: Johnson
authors.forename: Susanne
authors.initials: S
authors.lastname: Van Santen
authors.forename: Kerri
authors.initials: K
authors.lastname: Carlton
authors.forename: Joy
authors.initials: J
authors.lastname: Rappo
authors.forename: Rachel
authors.initials: R
authors.lastname: Michael
authors.forename: John R
authors.initials: JR
authors.lastname: Kirwan
authors.forename: John P
authors.initials: JP
authors.lastname: Edmonds
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D006304:Health Status; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012219:Rheumatology / Q000379:methods* / Q000592:standards; D012650:Self Disclosure