title: 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 semi-structured focus group with six parents from four families. Afterwards we telephone-interviewed another 19 mothers to achieve saturation. Thematic analysis was used to identify themes across the data sets.
  
  
  RESULTS
  The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated to the control group was developed based on the participants' different positions along two continuities from 'Our participation in trial is not important' to 'Our participation in trial is important', and 'Vaccine not important to us' to 'Vaccine important to us'. Four very disappointed families had thought of getting the vaccine elsewhere, and one had actually had their child vaccinated. All parents involved in the focus group and the telephone interviews wanted to participate in the follow-ups planned for the Calmette study.
  
  
  CONCLUSIONS
  This study identified an almost universal experience of disappointment among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The trial staff might use the model of reactions in understanding the parents' disappointment and in this way support their motives for participation. A generalized version might be applicable across randomized controlled trials at large.
  
  
  BACKGROUND
  The Calmette study is registered in EudraCT (https://eudract.ema.europa.eu/) with trial number 2010-021979-85.
authors.affiliation: Department of Neonatology, the Danish National Hospital - "Rigshospitalet", Blegdamsvej 9, 2100 København Ø, Copenhagen, Denmark. sandrameinich@gmail.com.
authors.forename: Sandra
authors.initials: S
authors.lastname: Meinich Petersen
authors.forename: Vibeke
authors.initials: V
authors.lastname: Zoffmann
authors.forename: Jesper
authors.initials: J
authors.lastname: Kjærgaard
authors.forename: Lone
authors.initials: L
authors.lastname: Graff Stensballe
authors.forename: Lone
authors.initials: L
authors.lastname: Graff Steensballe
authors.forename: Gorm
authors.initials: G
authors.lastname: Greisen
mesh_terms: D000328:Adult; D000533:Altruism; D001500:BCG Vaccine / Q000008:administration & dosage*; D032882:Comprehension; D003718:Denmark; D004644:Emotions; D005260:Female; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007231:Infant, Newborn; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010349:Patient Compliance; D018579:Patient Selection; D010361:Patients / Q000523:psychology*; D036301:Qualitative Research; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014611:Vaccination
chemical_list: D001500:BCG Vaccine
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