Bereaved parents of babies in clinical trials want ongoing involvement in research

Parents of critically ill babies who die while enrolled in clinical trials should be offered ongoing information about the trial and its results, according to a new report.

The team behind the study, led by the London School of Hygiene & Tropical Medicine with researchers from UCL, Oxford, Newcastle, Cambridge, and Harvard, calls on clinicians and trial teams to develop a coordinated response to bereavement for relatives of trial participants, which should be considered as a trial and its processes are developed.

Clinical trials in neonatal and paediatric intensive care units are crucial to improve the care of critically ill babies and children. In recent decades researchers have been working to understand the experiences of parents with a baby enrolled in these trials, but until now only the views of parents with surviving babies and children have been explored. How bereaved parents feel about their involvement has often been seen as too sensitive an area for research, so little has been known about how parents in this situation might want to be treated.

The Bereavement and Randomised Controlled Trials Study (BRACELET) is the first study to look at death and bereavement in the context of clinical trials involving babies and children.

As part of the seven year study, the researchers conducted over 100 interviews with clinicians, trial team members and bereaved parents from five neonatal clinical trials to find out about their experiences.

The interviews with bereaved parents showed that for most, their involvement in a trial was of minimal importance to them around the time their baby died; it was largely overtaken by other events. However, parents' interest in the trial could re-emerge over time, and some years after the death of their baby, parents could have new questions about the trial.  At the time of the interviews, most of the parents had separated the trial from their baby's death, feeling that their baby had been simply too sick or too small to survive.

The BRACELET Study found that opportunities for parents to engage with a trial later on varied. For many reasons, most of the parents had not had access to ongoing contact with the trial team and had not discussed trial participation with their clinician after their baby's death.  The different trial teams described varied policies about contact with bereaved parents, from no further contact after the death of a baby to a well-developed package of contact including access to trial newsletters and a web-based message board for parents.

Parents in the BRACELET Study were positive about the option of contact and almost all wanted access to the trial results, whatever they would show and however difficult they might be to receive.  These parents attached a high level of importance to being sent the trial results as an acknowledgement of their baby's contribution to research for a complex array of reasons, including as a basic courtesy from the researchers, and as an opportunity for further remembrance and commemoration.    

Dr Claire Snowdon, Lecturer at the London School of Hygiene & Tropical Medicine and lead author of the BRACELET report, said:  "Bereaved parents whose children were involved in a trial had often had limited contact with the research after the death of their baby.  While this could be the 'right thing' for parents around the time of their bereavement, many reported that in time they became interested in the trial again. They often valued opportunities to engage with a trial and were interested in more contact and information than was sometimes available.

"Keeping in touch with bereaved parents over a long period while a trial is running and until the results are available can be complicated, but the parents in this study attached a lot of importance to having the option of communications about the trial, particularly hearing the trial results.  We therefore suggest that co-ordinated, collaborative and ongoing strategies to facilitate such contacts should be further developed by trial teams and clinicians.  The impact of any new processes would of course need to be evaluated. 

"The BRACELET Study has also shown that bereaved parents of babies in clinical trials are important stakeholders in research, and the practice of routinely excluding them from studies of how trials should be conducted should be changed."

The authors highlight a potential limitation of the study, as the sample may have been skewed towards those who were more comfortable with discussing their bereavement. Others who would not be comfortable talking about their experiences may not share the same views about the research.

The BRACELET study was funded by the National Institute for Health Research Health Technology Assessment Programme.


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