title: Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution.
abstract: Adverse events (AEs) and serious adverse events (SAEs) are important outcomes of any intervention study yet are under-researched. Vague and variable definitions and substantial underreporting make comparisons of risk between studies difficult and evaluation of the safety of a particular intervention almost impossible. These realities may deter researchers from studying at-risk populations. Suicidal behavior is an adverse event in any study, and potentially a very serious one. Thus the issues of reporting and definition are particularly salient for researchers who work with populations at risk for suicidal behavior, especially when the suicidal behavior is the outcome of interest. We conducted a qualitative study with experienced suicide researchers and intervention experts to delineate the issues related to reporting serious adverse events faced by investigators conducting trials in suicide prevention. Participants from multiple sites were interviewed by phone, interviews transcribed and coded for definition and reporting issues and suggested solutions. A narrative synthesis was prepared and validated by all participants. Participants highlighted the difficulties in defining AEs and SAEs and stressed the importance and complexity of ensuring the AE was related to the study and reported properly, and were in agreement about the consequences of AEs to both institutions and individuals. Participants identified the need for the development of clear and consistent AE definitions and reporting requirements. Clear and consistently applied definitions of adverse and serious adverse events and reporting requirements would enhance the comparability of intervention studies in suicidal populations.
authors.affiliation: New York State Psychiatric Institute, Columbia University, New York, 10032, USA. mao4@columbia.edu
authors.forename: Maria A
authors.initials: MA
authors.lastname: Oquendo
authors.forename: Sarah
authors.initials: S
authors.lastname: Feldman
authors.forename: Emily
authors.initials: E
authors.lastname: Silverman
authors.forename: Dianne
authors.initials: D
authors.lastname: Currier
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Brown
authors.forename: Donna
authors.initials: D
authors.lastname: Chen
authors.forename: Page
authors.initials: P
authors.lastname: Chiapella
authors.forename: Ruth
authors.initials: R
authors.lastname: Fischbach
authors.forename: Madelyn
authors.initials: M
authors.lastname: Gould
authors.forename: Barbara
authors.initials: B
authors.lastname: Stanley
authors.forename: David
authors.initials: D
authors.lastname: Strauss
authors.forename: Jamie
authors.initials: J
authors.lastname: Zelazny
authors.forename: Jane
authors.initials: J
authors.lastname: Pearson
mesh_terms: D032763:Behavior Control / Q000379:methods* / Q000523:psychology; D017408:Guidelines as Topic; D006801:Humans; D010043:Outcome and Process Assessment, Health Care / Q000379:methods; D036301:Qualitative Research; D012107:Research Design / Q000592:standards; D012108:Research Personnel / Q000193:education / Q000523:psychology / Q000592:standards; D035842:Research Subjects / Q000523:psychology; D018570:Risk Assessment / Q000379:methods; D059020:Suicidal Ideation; D013405:Suicide / Q000523:psychology; D000092864:Suicide Prevention