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

TY - JOUR

T1 - Disappointment and adherence among parents of newborns allocated to the control group

T2 - a qualitative study of a randomized clinical trial

AU - Meinich Petersen, Sandra

AU - Zoffmann, Vibeke

AU - Kjærgaard, Jesper

AU - Graff Steensballe, Lone

AU - Greisen, Gorm

PY - 2014/3

Y1 - 2014/3

N2 - 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/) with trial number 2010-021979-85.

AB - 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/) with trial number 2010-021979-85.

KW - Adult

KW - Altruism

KW - BCG Vaccine

KW - Comprehension

KW - Denmark

KW - Emotions

KW - Female

KW - Focus Groups

KW - Health Knowledge, Attitudes, Practice

KW - Humans

KW - Infant, Newborn

KW - Interviews as Topic

KW - Male

KW - Middle Aged

KW - Motivation

KW - Patient Compliance

KW - Patient Selection

KW - Patients

KW - Qualitative Research

KW - Random Allocation

KW - Randomized Controlled Trials as Topic

KW - Vaccination

U2 - 10.1186/1745-6215-15-126

DO - 10.1186/1745-6215-15-126

M3 - Journal article

C2 - 24731249

SN - 1745-6215

VL - 15

SP - 1

EP - 11

JO - Trials

JF - Trials

M1 - 126

ER -