Patient Safety and Adjunctive Services to Prevent Study
Attrition
Participant safety was a foremost consideration, and
from a public health point of view, the ascertainment of
adverse events in each treatment condition was a critical
aspect of the trial. Primary concerns included possible
untoward reactions to study treatments and the risk that
the participant may not improve or may deteriorate during
treatment. CAMS protocols for monitoring safety
and providing additional treatment visits to manage
clinical crises and concerns that inevitably arise during
the course of a trial facilitated standardized, yet flexible,
clinically appropriate “best practice” standards and maximized
participant retention.
Side effects and adverse events were assessed immediately
before each treatment visit by the study coordinator
by asking both the child and parent if they had
experienced or noticed any health or other problems
since the last treatment visit. Responses were recorded