title: Challenges and progress in adverse event ascertainment and reporting in clinical trials.
abstract: Toxicity, safety, and tolerability are integral facets of patient risk/benefit decisions, yet the capacity to define, measure, and compare these aspects is underdeveloped compared to aspects of efficacy. There are many reasons for this, scientific and administrative, but all are surmountable. Probably the greatest primary obstacle is the absence of a measurement instrument designed specifically for this purpose. There are increasing calls from various stakeholders for better evidence, and therefore better ascertainment, in this area, especially in randomized trials, and for these reasons OMERACT began deliberations about these concepts in 1994. A prototype coding instrument (the Rheumatology Common Toxicity Criteria) was developed and discussed at OMERACT 5. In the 2 years before OMERACT 7, a process of concept development and iterative design and testing were conducted to develop a patient self-report and investigator-reported adverse event instruments designed for use in trials at the time of visit. The predominant workload is performed by the patient in a self-report checklist, which is then mapped by the trialist onto a medically sophisticated version. This article presents background on the process of developing a dual adverse event instrument, which was presented and critically discussed in detail at OMERACT 7.
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: Thasia G
authors.initials: TG
authors.lastname: Woodworth
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
authors.forename: James F
authors.initials: JF
authors.lastname: Fries
authors.forename: John R
authors.initials: JR
authors.lastname: Kirwan
authors.forename: Peter S
authors.initials: PS
authors.lastname: Tugwell
authors.forename: Richard O
authors.initials: RO
authors.lastname: Day
authors.forename: Peter M
authors.initials: PM
authors.lastname: Brooks
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D006801:Humans; D010361:Patients; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012219:Rheumatology / Q000379:methods* / Q000592:standards; D011795:Surveys and Questionnaires