Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial.

ABSTRACT:

Background

When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated to the control group of a randomized controlled trial, and how it will affect their future engagement in the trial.

Methods

We included parents of newborns randomized to the control arm in the Danish Calmette study at Rigshospitalet in Copenhagen. The Calmette study is a randomized clinical trial investigating the non-specific effects of early BCG-vaccine to healthy neonates. Randomization is performed immediately after birth and parents are not blinded to the allocation. We set up a se

SUBMITTER: Meinich Petersen S 

PROVIDER: S-EPMC4022324 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature