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

Trials

Gorm Greisen²  Lone Graff Steensballe³  Jesper Kjærgaard²  Vibeke Zoffmann¹  Sandra Meinich Petersen² 

[1] NK LMS, Oslo Universitetssykehus HF, Ullevål, Postboks 4956, Nydalen, 0424 Oslo, Norway;Department of Neonatology, the Danish National Hospital – “Rigshospitalet”, Blegdamsvej 9, 2100 København Ø, Copenhagen, Denmark;The Child and Adolescent Clinic, the Danish National Hospital – “Rigshospitalet”, Blegdamsvej 9, 2100 København Ø, Copenhagen, Denmark

关键词: Randomized controlled trial;    Parents;    Newborns;    Motives;    Disappointment;    Clinical trial;    Control group;    Altruism;    Allocation;    Adherence;   

Others  :  806895
DOI  :  10.1186/1745-6215-15-126

 received in 2013-10-25, accepted in 2014-03-27,  发布年份 2014

【 摘 要 】

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.

Trial registration

The Calmette study is registered in EudraCT (https://eudract.ema.europa.eu/ webcite) with trial number2010-021979-85.

【 授权许可】

   
2014 Meinich Petersen et al.; licensee BioMed Central Ltd.

【 图 表 】

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