London School of Hygiene & Tropical Medicine

The parents of babies involved in clinical trials who die during the trial period may be more willing to agree to their children undergoing post-mortem (PM) examinations than doctors believe them to be, new research from the London School of Hygiene & Tropical Medicine (LSTHM) reveals today.

The research is published in a series of three papers in the Fetal and Neonatal Edition of the latest Archives of Disease in Childhood, and was produced by staff from LSHTM's Medical Statistics Unit, and the Centre for Family Research, University of Cambridge.

There has been a sustained decline in PM rates around the world and perinatal PM rates are also dropping in line with this downward trend. Perinatal pathology in the UK has also been undermined by the controversy surrounding events at Alder Hey Children's Hospital in Liverpool and the Bristol Royal Infirmary. Within the context of randomised controlled trials (RCTs), an absence of samples for pathology studies makes it difficult for trial data monitoring committees to make recommendations about whether or not to continue trials, and undermines the scientific rigour of the pathology study.

A review of the literature by the authors, outlined in the first paper, reveals that the dominant view among doctors of perinatal PMs of children who have been involved in RCTs is that they are only warranted in certain circumstances (for example if there is a query over the cause of death). There is a reluctance to broach the subject even though various studies have shown that PMs can provide unexpected findings that do not support the initially stated cause of death.

A further study conducted by the authors which aimed at determining the attitudes of both neonatologists and pathologists, and bereaved parents to perinatal PMs within the context of clinical trials revealed 'an uneasy climate in which the tensions between the expectations of the trials community and the everyday practicalities of caring for families have not always been fully worked through'.

Neonatologists were found to be reluctant to ask bereaved parents to consent to a potentially disturbing procedure, with some fearing that requesting a PM for the benefit of others might be seen as 'emotional blackmail'. Many said that they backed down as soon as they sensed parents' discomfort. Pathologists saw their profession as being in crisis because of the sharp decline in perinatal PM rates. They spoke of being unable to make diagnoses or help parents, and worried that they would not be able to keep their skills up to date.

Yet when bereaved parents were interviewed, they expressed a range of feelings in relation to perinatal PMs, by no means all of which were negative. While some were opposed to the idea, others articulated an understanding of the benefits a PM might bring. They expressed altruistic feelings, believing that the information gained from a PM might be helpful not just in terms of clarifying the cause of death for themselves, but also for furthering research, helping others and improving the life-chances of babies in the future.

The authors comment: 'The data from this small study of the views of bereaved parents provide support for [a] careful approach, but also suggest that it may be possible to approach more parents without undermining their wellbeing. The parents who were interviewed show the variety of reactions to PMs that one would expect, from those who were clear that they did not want a PM to others who felt they needed the information from the examination'.

They continue: 'The data also suggest that, for some parents, the degree of caution and selectivity exercised by the neonatologists may not be entirely appropriate. . . Although these parents are not necessarily typical, their views may be shared, but in a more private way, by other parents who are not always given the option of a PM. If bereaved parents are not given the information about the value of PM samples, even those from a limited PM, they may be denied the chance to make their own decisions about contributing to research'. The authors conclude by recommending that the trials community explores the issue further to determine whether or not trial-related pathology studies are considered by professionals and by lay people to be worth while and feasible. If there is support, they say, then the challenge will be developing a means of approaching more parents in the most sensitive way.

Ends.

For full copies of the papers, please contact the London School of Hygiene & Tropical Medicine's Press Office on 020 7927 2073.

To interview Diana Elbourne, one of the reports' authors, please contact Sarah Thorne on 020 7927 2230 (until 5.30 pm today, and tomorrow morning). Diana Elbourne can also be contacted direct from 5.30 pm until 10.30 pm today on 020 7927 2629.

Perinatal pathology in the context of a clinical trial: a review of the literature, C Snowdon, D R Elbourne, J Garcia. Arch. Dis. Child. Fetal Neonatal Ed.2004; 89: F200-F203

Perinatal pathology in the context of a clinical trial: attitudes of neonatologists and pathologists, C Snowdon, D R Elbourne, J Garcia. Arch. Dis. Child. Fetal Neonatal Ed.2004; 89: F204-F207

Perinatal pathology in the context of a clinical trial: attitudes of bereaved parents, C Snowdon, D R Elbourne, J Garcia. Arch. Dis. Child. Fetal Neonatal Ed.2004; 89: F208-F211