The Stoke CNEP Saga – how it damaged all involved

After one family made allegations about the way the study of an innovative strategy for providing nursing care was conducted, staff in the neonatal unit at North Staffordshire Hospital endured 11 years of disciplinary enquiry. And, because staff are barred from talking while under investigation, it has only recently become possible to describe in detail much of what then went on.

CNEP was a study of nursing care

Watching a tiny, preterm baby supported by invasive technology cling tentatively to life, or struggle to breathe for itself, is something most people have never seen. Providing these fragile infants with continuous negative extrathoracic pressure (CNEP) presented quite a nursing challenge, and the trial in which we participated was a test of what was basically a nursing procedure.¹ There was, as a result, substantial nursing input right from the start, much of which went unreported at the time. Had some of those who criticized the trial² been aware of this, their views about parental involvement, and the way consent was sought, might have been more balanced.³

Nurses realize just how bewildering the first few hours can be for the parents of any recently born sick or premature baby, and are trained to handle this sensitively and supportively. Their decision to try and advance neonatal care, and avoid some of the long-term consequences of conventional ventilation with a tube through the larynx, was taken with some care. It was a decision also balanced by a clear recognition that the need to get parental consent as soon as eligibility was confirmed (just four hours after birth) also presented a major challenge. This was highlighted by a small nurse-instigated survey, performed mid-way through the study, which showed that two-thirds of the mothers had not been able to visit the unit and see the various pieces of equipment, before agreeing to support the trial. To meet this need, the assistant research nurse⁴ produced a 14-page booklet with photographs of the unit and the equipment, to supplement the trial's information leaflet.

This small survey also showed that, although 90% of the parents understood that their baby was in a clinical trial, one-third did not fully understand what the trial was about. This highlighted the need for staff to make sure that families were kept fully informed, and given ample opportunity to ask questions over the subsequent days and weeks. A serious nursing concern from the outset was that families would have less access to their babies due to the complexity of the equipment, or concern that the CNEP equipment caused discomfort. A questionnaire about these and other issues was distributed to all parents in Stoke, and 79% (n=137) of these anonymized questionnaires were returned. The replies were very reassuring, suggesting that parents did not think that CNEP impeded access or cause more discomfort. Nor did it seem to reduce the chance of the baby being breastfed. Almost all the parents in both trial groups felt that neonatal staff had done a lot to help them relate to, and interact with, their baby.

As the lead research nurse, together with my assistant researcher Kate Lucking, I was responsible for collecting all the clinical data and, because I was also responsible for training the medical and nursing staff in the new equipment, I was on-call 24 hours a day, seven days a week, for much of the trial, to answer questions about eligibility, randomization and getting CNEP started. Luckily I found myself working with a team of highly-motivated nurses, and had the unstinted support of all the medical team. I also had excellent technical support from a senior member of the biomedical engineering team, Dave Evans, who played a vital role in the development and maintenance of equipment.

The first complaint surfaces

Mr and Mrs Henshall lodged a first complaint about their child's care with the Trust in August 1994. Initially this was dealt with by discussion using the hospital's complaints procedure, but allegations started to proliferate in May 1997 after a campaign was launched in the local press. Much of the publicity claimed that parents had not realized, or been told, that their baby was in a clinical trial. Eventually the claim was made that consent forms, including the Henshalls', had been forged. This aspect of the whole affair particularly puzzled and saddened the nursing staff, because they had always tried to work with families openly, honestly and closely, with an emphasis on continuity of care.

It is well-known that, when questioned after an interlude, recall of events can be fragile,⁵ but this only makes contemporaneous records an even more valuable way of showing that staff were diligent in the way that they took consent, and kept families briefed on progress after trial entry.⁶ Thirty-five junior doctors were involved in taking consent, and all had to try and establish their careers while knowing that allegations of dishonesty could come back to haunt them at any time. The Trust had 10 allegations of consent form fraud under review at one stage.⁷ Most of these allegations were later dropped, but for one family doctor this issue still remains unresolved because the GMC, for legal reasons, declined to rule on this issue when it finally got round to hearing the Henshalls' complaint in May 2008.

When the press onslaught went unrebutted, staff morale soon started to suffer. Indeed, as the second article in this series has documented,⁸ the press were soon linking our CNEP work with the child-abuse work being done elsewhere in the Trust. Banner headlines proclaiming that ‘Parents say guinea-pig trial killed their babies’,⁹ were soon followed by ‘Spy cameras capture torture of innocents’.¹⁰ Reports claimed that 43 babies died or ‘suffered permanent brain damage’ but failed to say that, because all had to be seriously ill to be eligible for the study, this was also true of 32 ‘control’ babies. In fact the true figures were 35 and 27, because double-counting failed to allow for the fact that many of the babies with a severe cerebral ultrasound abnormality died.

I had recently had a new baby and, within weeks, the nightmare began. Like other members of the nursing team, I found myself giving ‘statements’ to the Trust solicitor. The early months of family life were blighted by bewilderment, anxiety and the fact that it was all so public.

The Henshalls report the Trust's Medical Director to the GMC

By mid-1997, the press were repeatedly publicizing the most shocking of all the Henshalls' allegations – that their signature on Sofie's consent form had been forged – and totally ignoring all the Trust's vigorous denials. Finally, on hearing that the allegation was to be repeated yet again on Channel 4 News, Dr Keith Prowse, the Trust's Medical Director, decided to show the completed form to the press because of ‘fears for the morale, status and future of the paediatric department’. However, even this action was turned on its head, because the Henshalls promptly complained to the GMC that Dr Prowse had failed to obtain their consent before showing anyone this form. He remembers the ‘awful sinking feeling’ when he read that he was under investigation for serious professional misconduct, and might, if found guilty, be struck off.

Worse still was the fact that the preliminary hearing took nearly three years, while the full public hearing only took place almost four years after the initial complaint had been lodged.¹¹ While Dr Prowse had to endure this lengthy investigation, he did, however, have ‘immense support’ from within the Trust. More than 50 of his patients also took the trouble to write to him personally offering their support. When it was pointed out that certain families were ‘serial’ complainers, the GMC merely said that ‘it was their duty to investigate all complaints’ – a response that led most people in the Trust to conclude, like Dr Prowse, that the GMC seemed more concerned with its own survival and with public criticism, than with the facts of the case. It also seemed very clear that the continued press frenzy over anything remotely related to David Southall was having a widespread effect.

Facing the first Government-sponsored enquiry

Early in 1999 I was asked to attend the first of two interviews in connection with the Griffiths enquiry.² I was not told what the interview would be about, but I was told that it would be informal and I would not need to prepare for it. What actually happened left me deeply shocked. The questioning felt hostile and, because I was not allowed access to any research material, I found it very difficult to respond adequately.

My experience was not unique, however. Several of the medical team also reported a lack of information prior to interview, and ‘aggressive’ questioning.¹² Most staff appeared with no representation and no supporting documentation. No-one saw a draft of the report so they could make comments prior to publication, even though the Trust had a copy. My nurse colleague and I felt so misrepresented in the final report that we felt we had to respond in the BMJ and say ‘We strongly refute the suggestion that there was an inadequate protocol or means of documenting all of the material relating to each of the patients in the trial …’.¹³ It seemed as if the complainants' testimony was simply accepted at face value and never checked against medical notes. Nor were the doctors who witnessed the signing of consent forms ever asked to testify.

Facing yet further investigation

Soon after this interview was over I was told that the Henshalls had lodged a formal complaint with the United Kingdom Central Council (UKCC) – the regulatory body with the power to strike nurses off the register. The worst allegation was that I had ‘supplied inaccurate information and corrupt data, giving the trial a false conclusion’. I was told that I would have to wait for the Henshalls to provide evidence to support their allegations, but 16 months later I was informed that no supporting evidence had materialized. In parallel with this the Trust then launched their own internal enquiry, and I faced two more long, hostile interviews and was told not to speak to my medical colleagues. Indeed all the nurses who had helped to care for the Henshall babies were questioned, which was distressing because they could not understand what was supposed to have gone wrong.

Nine months later, I eventually took extended sick leave and never returned to work – a source of much regret. The press onslaught seemed relentless but it was my only source of information, because I heard nothing from the Trust. Just as the UKCC finally closed their investigation of the Henshalls' allegation of serious professional misconduct, I was told that yet another complaint about my involvement in the trial had been filed with the UKCC by another person. I had never had any contact with the complainant but was told that she was representing ‘other parents’ who had children involved in the CNEP trial. Yet again the UKCC only dropped this further investigation after seven months, when I was informed once again that no supporting evidence had been supplied.

This became a recognizable pattern as the press campaign gained momentum. At least 18 doctors were so targeted by one pressure group, allowing them to tell the press that those doctors ‘were under investigation by the GMC’.¹⁴ And when no further supporting evidence was submitted for more than a year those named, if they pressed the GMC, were merely told that the investigation was no longer ‘current’. Modified rules allowing ‘vexatious complaints’ to be dealt with more quickly were eventually agreed by the GMC seven years later, but their effectiveness has yet to be assessed.

One senior nursing colleague within the research team with an extremely promising career before her was in the unfortunate position of applying for posts in other Trusts when targeted in this way. A steady flow of complaints about her were reaching the regulatory body. This greatly complicated the whole appointments process as each complaint generated fresh correspondence with the Nursing and Midwifery Council. My close colleague throughout the trial, Kate Lucking, also eventually decided to leave the profession and says that her experience of the way the ‘CNEP Saga’ was managed certainly contributed to that decision.

Further problems for the whole Trust

One major problem was the amount of time the Trust had to spend responding to the press and to requests for information from the District and Regional Health Authorities, and the GMC. The media posed a particular problem because, each time a fresh allegation appeared, the Trust was asked for an immediate response and, for a while, fresh allegations were appearing almost daily. Management felt under ‘siege’ and were given no support by the District and Regional Health Authorities. External advisers were brought in to deal with the press, and this cost the Trust even more money. The reported cost at the time was around £1 million, but it is now thought that it was closer to £3 million. Dr Prowse, as Medical Director, tried very hard to rebut press lies, and felt great frustration that all the Trust's statements fell on deaf ears.

The Trust did, however, resist the pressure for suspension of Professor Southall until early November 1999 when there was an abrupt change of approach shortly after a meeting with the Director of the West Midlands NHS Executive.¹⁵ Two independent experts were then asked to examine the Paediatric Department's other research work. After holding just a single formal meeting, they quickly issued a verbal recommendation that Professor Southall should be suspended, and be referred to the GMC.¹⁶ The Trust also suspended Dr Samuels at the same time because of still unresolved child protection issues.

Two of my medical colleagues are suspended

As a result of this very quick investigation both the consultants were promptly interviewed by the Acting Medical Director and the Director of Human Resources, told that they were being suspended, and that they had to leave the hospital within an hour. They were expressly forbidden to talk to any hospital employee or return to the hospital site without permission. I was never formally told about this, and when I did hear through ‘the grapevine’ it only further increased my fear and confusion.

At no stage prior to suspension was Dr Samuels told that his conduct was under review, and the Trust were not, at first, able to give any reason for either of the suspensions. Once the inadequacy of the initial investigation became apparent seven weeks later after the two doctors did finally get to see copies of the preliminary reports, two more comprehensive investigations were started, but it was a full 12 months before the case-notes of one of the consultants were sent for expert review. The further externally-staffed inquiries eventually exonerated both doctors, recommending re-instatement because there was no valid case against them, but Dr Samuels only returned to work after 20 months, and Professor Southall only returned after 27 months. When the National Audit Office undertook a country-wide review of the way NHS staff suspensions were managed, they highlighted the way these two doctors had been treated as particularly gross examples of inappropriate Trust practice,¹⁷ but Trust management say that it was lawyers at the Regional Health Authority who made them handle the suspensions this way.

Dr Samuels has, not surprisingly, said that he felt ‘criminalized’ when told not to make contact with colleagues or enter any hospital building. Both the doctors received many letters of support from colleagues after their suspension and several also wrote to the Trust. Letters also came in from the parents of patients, and letters of support also appeared in the local paper,^18,19 but support from the Trust was conspicuous by its absence even though the press statement that they had put out stressed that the ‘suspensions are not a disciplinary action’.

The oft unrecognized family repercussions

One thing that is often forgotten is the impact that this has on the families of those involved. There is no ‘normal’ family life when one member is not working and is distracted by the need to defend themselves. Constant media reports only make things worse. ‘The press “informs” the community, within which they work, live, attend school and play.’^a ‘Being the wife or child of a doctor who kills, harms and experiments on babies, and who forges consent forms … does not make for a comfortable existence.’ It can be very difficult to interact with others in the local community when you know that this, though untrue, is what others are reading in the local paper week after week. The doctors themselves ‘have their own community and network of support’ but their family have none. The fact that the investigations took so long further exacerbated the feelings of frustration, anger and (in my own case) depression.

I know that this distress was ultimately responsible for the breakdown of at least one and possibly two marriages. The effect on the children also went largely unrecognized. Some were bullied and abused at school as children of ‘baby killers’ and, for one child, this had a serious and long-lasting psychological effect. What compounded this distress was the failure of the authorities to counter the exaggerated press claims, while simultaneously barring all staff from talking to the media. The families feel that the Trust failed ‘in its moral duty’ to the staff in its employ, and saddled them with a ‘life-long sentence’.^a

Knock-on consequences for others in the Trust

Inaccurate and sensationalist media reports also contributed to a lack of trust and suspicion in the local community. One mother whose baby was admitted with cyanotic episodes, became concerned that she had been ‘secretly filmed’ when the local press reported the child protection work that had been going on. In the absence of any balanced and informed reporting, she must have been one of many who imagined that every parent had been filmed, if their child had been under the care of the two consultants concerned.

And, long after an externally conducted review had shown that that the CNEP trial had been well-conducted, Whitehall was still refusing to accept this.¹⁵ In 2002, for example, the Paediatric Intensive Care Unit was initially denied a Charter Mark Award for Excellence simply because it was in the same hospital as the Neonatal Unit and was treated, in the eyes of the civil servants in the Department of Health, as being part of a unit that they still classified as being ‘of concern’. Although the Trust eventually managed, on appeal, to get this ruling withdrawn, the initial intervention had, by then, made many staff in the Paediatric Unit both cynical and angry.

The wider damage to research

Professors Neena Modi and Neil McIntosh, present and former Royal College of Paediatrics & Child Health Vice Presidents for Science & Research, comment that ‘the CNEP trial was well designed, and could have been used as a template for sensible and effective research govenance. Instead it was attacked by a lobby group and received a flawed evaluation, thus compromising the protection that babies and all patients deserve to receive from research to assess the effects of treatments’. It also remains a loss to the neonatal and paediatric community that the expertise gained in non-invasive ventilation was then squandered. Calls for further research and development continue to be made,²⁰ but clinicians in Stoke are still barred from using CNEP even in older children despite the interest in this type of treatment that persists elsewhere. As recently as 2008 an Italian team published a small trial using a hood-and-neck seal instead of ‘nasal prongs’ to deliver continuous positive airway pressure.²¹ This showed that pharyngeal pressure was more stable when a hood-and-neck seal device was used. The only difference between the approach that we had started to use in 1989 and the approach now being studied in Italy is that we used negative pressure round the chest and they are now using positive pressure round the head.

Paediatric research came to an almost complete halt, and the careers of several medical and nursing staff were abruptly ended or curtailed. Professor Southall was eventually forced to resign. Dr Samuels was made to ‘re-train’ before coming back to work, not because he had been found to have done anything wrong, but simply because he had been suspended from all work for 20 months. Dr Spencer, who had been deeply involved in a range of innovative research, has vowed to do no more. All three were only finally acquitted of any wrongdoing by the GMC in July 2008. The unit has been urged to join several important, nationally funded, multicentre trials in the last 10 years but turned all requests down. The scars still run deep.

Conclusion

Behind this very public story, the private cost to the individuals concerned has been painful and far-reaching. The ‘fall out’ did not only affect the doctors whose names appeared in the press, and their families, it also involved the nursing staff, and Unit and Trust managers as well as ‘shop floor’ clinicians. The way complaints were handled seemed grossly unfair and unjust – and this feeling was only reinforced when it eventually became clear that almost all had been misguided, if not overtly malicious. When clinical staff mismanage the care of patients they can, rightly, expect to be held to account, but when allegations are mishandled in the way that these allegations were, those responsible for that mismanagement never seem to be held to account.

Footnotes

DECLARATIONS —

Competing interests None declared

Funding None

Ethical approval Not applicable

Guarantor TW

Contributorship TW is the sole contributor