A kinder, gentler treatment. The words recur constantly in any discussion of the research trials at North Staffordshire Hospital trust, which some parents say left their babies dead or d isabled .
The official report into the tragedy, published last week, is not the last word on the issue.The regulatory bodies, the General Medical Council and the UK Central Council for Nursing, Midwifery and Health Visiting, have yet to start their investigations into claims against doctors and nurses involved in caring for premature babies at the hospital. Eminent paediatrician Professor David Southall is still suspended.
And the parents are unlikely to shut up and go away.They haven't got all the answers they wanted and there is still the prospect of legal action against the trust. Meanwhile, the trust is still involved in a wholesale reform of its procedures, not just for research but on patient involvement at every level.
And the rest of the NHS is going to have to go through a revolution in the way it manages trials.
Debbie Henshall, one of whose daughters died and another of whom was left with cerebral palsy, she believes as a result of taking part in trials of a new type of incubator, sparked the inquiry with a complaint to her MP.
The report by Professor Rod Griffiths, director of public health for West Midlands region, 'doesn't hold any surprises for us', she says. 'It is a brilliant report that shows where the inadequacies are, but it is not new.'She had hoped it might have access to new information, on the science of the study into the continuous negative extrathoracic pressure (CNEP) incubator.
Ms Henshall does not condemn Professor Southall: 'I try not to make it personal. Professor Southall is not a neonatologist.'
She is more critical of managers:
'The hospital was to blame. Their first consideration was not patients, it was how much money and reputation David Southall could bring to their unit, not patient care.' But even so, Ms Henshall tries to be fair: 'Initially it could have happened that managers didn't know about the doctors' clinical practice. But once people complain they should act.'
She says after Stacey's birth at 28 weeks' gestation, a nurse - who they later discovered was a trainee midwife - apparently told Carl Henshall: 'We can offer you a new incubator which is kinder and gentler - would you like your baby to go in it? Sign here.'
The report goes some way to backing the parents' claims, despite insisting it has 'not sought Continued from page 11 to determine whether allegations of poor practice are true or to apportion blame if practice could have been better'. Instead it examines the 'general framework' for approving and monitoring clinical research at the trust and the wider NHS in the early 1990s.
Yet it contains damning findings on the central issue of whether parents were told their babies were involved in a trial into CNEP incubators, or asked for permission. All 122 premature babies involved in the CNEP trial were already very vulnerable. Twenty-eight died and 15 suffered brain damage after being placed in the new ventilators.
Many parents - and at least one was familiar with research methodology - 'had no recollection of giving consent to randomisation in research'. They 'always used the words 'a kinder, gentler treatment', which were the same words as the research team used when describing the technique to us', the report points out.
'Members of the research team were very ready to tell us that parents were often poor at recalling what they were told. In effect they were asking us to believe that these parents could not remember consenting to randomisation but did remember that CNEP was 'a kinder, gentler treatment' .'
Professor Southall 'had no way of checking that consent had been obtained'.
The nursing sister assigned to the project worked very long hours, but had no protocol to make sure the consent forms were complete.Nurses had not been trained for the research job they were being asked to do.
The inquiry team concludes: 'Given these deficiencies it is not surprising that it is not possible now to be sure who completed some of the consent forms or to be sure that all of them were completed as intended.'
Ms Henshall disputes the consent form the hospital has produced for the CNEP used on her other daughter, Sofie. 'It has her name on it, it says Sofie, spelt like that.We didn't give her that name until the next day.' Stacey died and Sofie, now seven years old, is seriously disabled.
She says of her quest for answers to Stacey's death and Sofie's treatment:
'We have learnt a lot. It helps you come to terms with what has happened instead of crying 'injustice' all the time.' Her criticisms are mainly about the way research is managed and the slow disciplinary procedures at the GMC. A spokesperson says the GMC has yet to start collecting evidence, because it had been waiting for the official report. Even worse, two nurses facing UKCC investigations are still at work.And no, the UKCC isn't proceeding any faster.
Tr u s t c h i e f e x e c u t i v e D a v i d Fillingham is praised by the inquiry team for the way in which he has handled the case.The report points out he joined the hospital after the trials and 'has taken responsibility' for dealing with the investigation.Labour MP Llin Golding, who represents Newcastleunder-Lyme and took the Henshalls' complaint to the hospital, also praises Mr Fillingham, as well as Professor Southall.She has been 'very impressed' by Professor Southall's 'dedication to children but I felt the procedure was wrong'.
Mr Fillingham refuses to blame the previous chief executive. But he admits: 'There was a slightly complacent ethics committee, an enthusiastic researcher and no governance. That is not about individuals, but it is about the systems that didn't work.'
Mr Fillingham says there are ways hospitals, thrust into the spotlight for all the wrong reasons, can benefit.'It would be easy to see this just negatively and that would be a mistake. Positives are coming out of it: the framework for research governance and consent and practical improvements.' That includes a system of 'rolling consent' where permission is checked and renewed rather than taken once.
The trust is bidding for£300,000 from reg iona l office to offset the future costs of this revolution, including covering for the two suspended consultants and the ongoing internal investigation.
Other trusts will also have to put in a lot of work to meet the report's recommendations. The report reveals the main failing was in the overall guidance on the way research was carried out.Doctors and nurses at the hospital worked to governance systems 'broadly in line with DoH guidance that existed at the time'.
Junior health minister Lord Hunt greeted the inquiry by accepting all its findings and calling for a 'culture change in the NHS - a shift in the ba lance of power in favour of the patient'. Mr Fillingham says he is not just trying to 'get the detail right about consent and child protection but also wider issues like involving patient support groups'.'
The scandal, he says, 'highlights important issues about the relationship between the NHS and patients.
We need a radical change in the way the NHS sees patients.'
DoH response to the report of a rev iew of the research framework in North Staffordshire Hospital trust .
www. doh. gov. uk/wmro/northstaffs. htm.
Key recommendations for the NHS The NHS should develop formal guidance on managing research.
The DoH, professional and regulatory bodies should produce guidance on consent to clinical trials.
The DoH should consider putting in place a surveillance system for unexpected outcomes of treatments apart from medicines (which already exists).
The trust should carry out a 'substantial audit' of its experimental incubators.
The DoH should review and issue guidelines on the use of secret filming of parents suspected of child abuse by Munchausen Syndrome by Proxy.
Bristol on TV: 'it has to be true' Channel Four is shortly to screen The Innocents , a drama/documentary on the Bristol babies' tragedy.
Director Peter Kosminsky is the man responsible forShoot to Kill on the John Stalker investigation into the Royal Ulster Constabulary; Wa r r i o r s on post-traumatic stress disorder among veterans of peace-keeping operations in Bosnia; and No Child of Mine on the sexual abuse of children in care.
Mr Kosminsky says the Bristol film is 'pedantically accurate'.
The families are portrayed under their real names and the story is underpinned by accurate transcripts and records.
'If it is a true story it has to be performed to journalistic standards; it has to be true.'The programme is still in the cutting room, but includes sequences depicting heart massage performed on a dying baby in front of the mother.