title: Data and safety monitoring in social behavioral intervention trials: the REACH II experience.
abstract: BACKGROUND
  Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials.
  
  
  OBJECTIVE
  This paper summarizes how issues associated with safety monitoring and adverse event reporting were handled in the Resources for Enhancing Alzheimer's Caregiver Health (REACH II) program, a multi-site randomized clinical trial, funded by the National Institutes on Aging (NIA) and the National Institutes of Nursing Research (NINR), that tested the efficacy of a multicomponent social/behavioral intervention for caregivers of persons with Alzheimer's disease.
  
  
  METHODS
  A task force was formed to define adverse events for the trial and protocols for reporting and resolving events that occurred. The task force conducted a review of existing polices and protocols for data and safety monitoring and adverse event reporting and identified potential risks particular to the study population. An informal survey regarding data and safety monitoring procedures with investigators on psychosocial intervention trials was also conducted.
  
  
  RESULTS
  Two categories of events were defined for both caregivers and patients; adverse events and safety alerts. A distinction was also made between events detected at baseline assessment and those detected post-randomization. Standardized protocols were also developed for the reporting and resolution of events that occurred and training of study personnel. Results from the informal survey indicated wide variability in practices for data safety and monitoring across psychosocial intervention trials.
  
  
  CONCLUSIONS
  Overall, the REACH II experience demonstrates that existing guidelines regarding safety monitoring and adverse event reporting pose unique challenges for social/behavioral intervention trials. Challenges encountered in the REACH II program included defining and classifying adverse events, defining "resolution" of adverse events and attributing causes for events that occurred. These challenges are highlighted and recommendations for addressing them in future studies are discussed.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Center on Aging, University of Miami Miller School of Medicine, 1695 N.W. 9th Ave., Suite 3204, Miami, Florida 33136, USA. sczaja@med.miami.edu
authors.forename: Sara J
authors.initials: SJ
authors.lastname: Czaja
authors.forename: Richard
authors.initials: R
authors.lastname: Schulz
authors.forename: Steven H
authors.initials: SH
authors.lastname: Belle
authors.forename: Louis D
authors.initials: LD
authors.lastname: Burgio
authors.forename: Nell
authors.initials: N
authors.lastname: Armstrong
authors.forename: Laura N
authors.initials: LN
authors.lastname: Gitlin
authors.forename: David W
authors.initials: DW
authors.lastname: Coon
authors.forename: Jennifer
authors.initials: J
authors.lastname: Martindale-Adams
authors.forename: Julie
authors.initials: J
authors.lastname: Klinger
authors.forename: Sidney M
authors.initials: SM
authors.lastname: Stahl
mesh_terms: D000544:Alzheimer Disease / Q000628:therapy*; D017028:Caregivers; D026661:Clinical Trials Data Monitoring Committees; D006801:Humans; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012919:Social Behavior