Data wars

The plan by NHS England to upgrade its patient data system is eminently sensible. Without accurate data, the NHS is flying blind and has no chance of delivering the highest quality care and spotting unsafe care, and the opportunities to use the data for research to benefit patients are potentially huge. So why has it met with such opposition?

The simplest answer is that the government and NHS England aren’t universally trusted to keep such large volumes of confidential  medical information safe or not to sell it off for commercial gain. The government promised no major top down reorganization of the NHS and then imposed the largest in its history, leading many to conclude the resultant chaos is simply a Trojan horse for privatization. Selling patient data – identifiable or not – onto private companies just amplifies the mistrust even if it is claimed to be for patient benefit.

The default option is ‘opt in’ (you have to tell your GP if you don’t want your data to be used) but the choice  is ‘all or nothing’ – you can’t select where your data might end up but have to trust the NHS to make decisions in your best interests without consulting you. However, the fear that insurance companies will get hold of the data is a red herring since patients who have health insurance have to fully disclose all their medical details directly to the insurer, and any inaccuracy (deliberate or not) can nullify their policy.

NHS England is however very keen to collaborate with the private sector. Tim Kelsey, the NHS England director for patients and information, came from the private data-mining company Dr Foster and Kingsley Manning, founder and managing director of health and information consultancy firm Newchurch, has been appointed chair of the Health and Social Care Information Centre (HSCIC), which NHS England has trusted to oversee the ‘care.data’ program. HSCIC’s new chief executive Andy Williams has worked for IBM, Alcatel-Lucent and CSC.

Most patients haven’t got a clue what care.data or the HSCIC is, and the leaflet destined to drop on your doorstep is very simplistic. Kelsey recently went on Radio 4 to promise there was ‘no risk of patients of confidential information being identified as a result of care.data…. Can I be categorical? No one who uses this data will know who you are.’ Alas, there is no such thing as zero risk and it is possible (though probably illegal) to re-identify patients from some of the data.

Three types of data are collected – anonymous or aggregated (green) data, pseudonymised  (amber) data and personal confidential (red) data. Green data is published free of charge for all to see, and allows anonymous comparisons of how different diseases are managed in different parts of the country. (e.g. your chances of having a limb amputation if you have diabetes varies widely across the NHS). For very rare conditions, it might be possible to deduce who the patients in a particularly area are because there aren’t many of them, so the HSCIC shouldn’t publish these.

For pseudonymised (amber) data, patient’s identifiers (e.g. date of birth, postcode, NHS number) are replaced  them with a meaningless pseudonym that bears no relationship to their identity. Amber data is very useful because it tracks how individual patients interact with the different parts of the NHS and social care over time. However, it is theoretically possible for analysts  to re-identify individuals within amber data by linking them to other data sets. The HSCIC shouldn’t publish amber data, but such hospital data is already made available to universities and private companies  under a legal contract  ‘to approved analysts for approved purposes’. The contract stipulates how the data must be stored and protected, and how the data must be destroyed afterwards. But that of course doesn’t guarantee it will happen in all cases.

Red data does identify you and the HSCIC may pass it on in a public health emergency such as an epidemic when legally required to do so. It is proposed that such data may also be made available ‘to an organisation that has obtained the patient’s explicit consent or has been granted legal approval by the Secretary of State for Health or the Health Research Authority following independent advice from the Confidentiality Advisory Group (CAG).’ The CAG members are here¹ and you can decide if you trust them to override confidentiality when the research benefit warrants it  and it is not possible to use information that does not identify patients.

The NHS has been keeping hospital data safe for 25 years and it’s important to complete the data by linking it to care provided outside hospital. However, to state that there is ‘no risk’ that patients will be identified is simply wrong, particularly as applications to access the data from a wide variety of interested parties are likely to increase dramatically. It would have been far better to argue that the potential benefits vastly outweigh the risks. And bullying GPs into releasing their patients’ data as required by the Health Act when they have yet to be convinced it is safe to do so is simply wrong. GPs have been ordered to release pseudonymous information to the HSCIC for sorting, and some are worried about  breaches of confidentiality. It would have been far more sensible to give patients easy access to their own data first so they can decide if they wish to pass it on.

A bigger issue for an NHS already swimming with data is whether it will be used to benefit patients. From the Bristol heart scandal to Mid Staffs, the NHS has shown itself incapable of acting swiftly on outlying data to protect patients from avoidable harm, and keeping data ‘in house’ has often meant burying scandals. Independent analysis and scrutiny of what the NHS is up to is no bad thing. As for drug companies, MD has no objection to  his data going to them provided they have signed up to www.alltrials.net and agree to publish all of their clinical trials. The hallmark of any safe data system is publishing disappointing or distressing data even if it is politically or commercially embarrassing. The bottom line? No more dirty secrets in the NHS.

There is ‘a dedicated patient information line’ about care.data on 0300 456 3531. Or you can try to talk to your GP

1 http://www.hra.nhs.uk/about-the-hra/our-committees/section-251/cag-members/

Another Bristol Inquiry

NHS clinical director Brice Keogh ordered an inquiry into the safety of child heart surgery in Bristol last week, based on concerns raised by a group of parents about the care of their children – but failed to say whether the current service is safe for babies having operations now.

If he has concerns, he must surely suspend surgery now pending an urgent independent investigation, or he must state publicly that the service is no less safe than other UK units. To do neither has caused enormous stress to the parents of those babies currently due for surgery who may – or may not – be at unacceptable risk.

Bristol’s current ‘outcome’ figures are comparable to any other NHS unit but due to the failure to reorganise heart surgery after the initial scandal exposed in the Eye in 1992, every NHS unit is now struggling to recruit enough qualified staff, particularly nurses, to cope with the increase in surgery. Keogh must sort this out urgently.

Update: On the day of publication of Private Eye, NHS England issues a safety statement about child heart surgery in Bristol now.

http://www.england.nhs.uk/2014/02/19/childrens-heart-surgery/

You can also hear me interview Miss Bryony Strachan, Clinical Chair of the Division of Women’s and Children’s Services at University Hospitals Bristol NHS Foundation Trust, and Professor of Paediatric Cardiology Rob Tulloh here, between 10.05 And 10.30 AM. They talk openly and at length about the safety of the unit and the complexities of the work they do.

http://www.bbc.co.uk/programmes/p001d79q

What concerns me is the disconnect between the outcome figures for Bristol, which are within the range of the other units, and the very worrying experiences of some parents. In my view, there needs to be a swift investigation by independent clinical and human factors experts that is published in full. And until child heart surgery is sensibly recognised in the NHS, most units will continue to struggle with understaffing and suboptimal supervision and training. Parents can in theory choose to go to another unit if they have concerns about their local one, but this is not without additional stress and difficulty. Far better to ensure all NHS units are safe and up to standard, and to publish real time patient/parent experiences alongside retrospective death rates which remain a fairly crude way of judging quality of care.

Hunt’s Law

Hidden away near the back of the government’s Care Bill, which is supposed to be about improving the care of the most vulnerable patients, is an incendiary clause that could give enormous power to the Health Secretary, via one of his Trust Special Administrators (TSAs), to reorganise failing hospitals and their neighbours without much in the way of consultation. Ironically, this could jeopardise the care of the very patients the Care Bill aims to protect.

Clause 118 is seen by many as payback for Jeremy Hunt’s failure to push through the downscaling of Lewisham hospital to bail out a neighbouring South London healthcare trust (SLHT), a failing hospital with huge debts, mainly as the result of a Private Finance Initiative mortgage with unaffordable interest payments. (Eyes passim)  TSA Matthew Kershaw and Hunt tried to downgrade the thriving and solvent Lewisham hospital to take some of the pain for its failing neighbour. But the High Court and Court of Appeal found using such an approach – where one hospital is used as collateral damage for another, when it had no connection to the cause of the debt – to be unlawful.  So Hunt is trying to change the law.

A TSA is only supposed to be appointed under the most dire of circumstances when a hospital’s balance sheet is beyond the point of no return but under Clause 118, failing hospitals can be defined more broadly, and many are now in debt due to the flat line funding in the NHS. And once a hospital is defined as ‘failing’, any hospital or community provision which has a relation to that failing hospital could in theory be reorganised, asset-stripped or even privatised. The ability of local Clinical Commissioning Groups  to contest the plans can be overridden, local people’s ability to challenge is also restricted and – in the initial reading, Local Authority Scrutiny is disallowed.

The government has now published amendments to the Bill that will make the TSA consult more widely, and hold a few more meetings, but both the King’s Fund and the Nuffield Trust have warned of the power that  Clause 118 could give the Secretary of State to mandate change in NHS services without the support of local commissioners or the public. And Hunt can say he’s only acting on the advice of a  TSA who the public may not trust or agree with.

The promise of the Health and Social Care Act was that decision making would be devolved locally, with patients and local NHS staff having most power in deciding how services were run.  Or as Andrew Lansley was fond of pretending, ‘No decision about me without me.’ Clause 118 pulls back power to the centre and largely excludes local people from anything but a cursory conversation about the future of their local hospital.

In the NHS, it always comes down to trust.  Do patients trust Jeremy Hunt and whatever Trust Special Administrator he appoints to sort out their failing hospital and to  reach a decision that is in their best interests, given the dire financial circumstances in the NHS? Politicians have repeatedly blown their chance to have an honest and open debate about what the NHS can and can’t afford by imposing expensive and unnecessary reforms that have neither a mandate nor an evidence base. The suspicion that the NHS is being sold off has become a reality (Eye last), and Hunt has probably realised he has no hope of convincing the public of the need for reconfiguration, particularly as his most high profile attempt so far was deemed illegal. So he is changing the law and  give him, NHS England and the market regulator Monitor  far more power to make changes with a minimum of consultation. Some of the changes might even be quite sensible. But it’s no way to restore trust or unite the NHS.

Still not for sale?

The debate over whether the NHS is being sold off, privatised or improved by putting services out to competitive tender even reached the BBC last week, thanks to evidence collected by the NHS Support Federation. Their research found over £5 billion worth of contracts to run or manage ‘clinically related NHS services’ have been advertised in the first 9 months since the competition regulations (section 75) were passed by Parliament in April 2013. 70% of the contracts  have gone to commercial companies (38 to the private sector, 15 to the NHS and two to charities and one shared between the public and private sectors). The contracts cover over 70 different services across the NHS.

Supporters of the Health Act argue that the NHS will raise its game from this ‘constructive discomfort’ of private competition. The phrase was coined by Simon Stevens, Blair’s (and Dobson’s and Milburn’s) former health adviser who is returning as CEO/Messiah of NHS England in April, having cut his teeth with American health giant UnitedHealth. UnitedHealth’s incursions into the NHS market, particularly in GP services, and subsequent withdrawals having failed to make a profit (and posted substantial losses), highlight the danger of this approach. Large private companies have the up-front muscle to win NHS contracts but pull their services if there is no profit to be made, leaving holes for the NHS to fill.

If the trend of private companies winning NHS tenders continues, NHS trusts will lose business and face an even bigger challenge balancing the books. Although Foundation Trusts do not pay money to shareholders, they – and hospitals that aspire to become FTs – are now very ‘profit focused’, prioritising treatments that make the most money. Treatment becomes less about satisfying the needs of patients and more about satisfying the needs of Monitor, the economic regulator of the NHS. Last September, Peter Gladwell, a Clinical Specialist Physiotherapist at Frenchay Hospital in Bristol, wrote to Monitor asking it to explain whether handing over taxpayers’ money to shareholders’ of private NHS providers satisfied the promise in the NHS Constitution that all NHS spending must be ‘for the benefit of patients.’

The answer, from Claire Upton (Enquiries and Complaints Officer) was both unhelpful and very illuminating: ‘I am afraid I cannot confirm whether your interpretation of item 6 of the NHS constitution is correct. I understand the NHS Constitution was produced by the Department of Health (DH), who may be able to assist you further. However, we know the NHS needs to change to meet the challenges of the future and that, as the sector regulator, Monitor must facilitate that change. This means we will encourage new ways of delivering care and will use the tools we have, such as pricing incentives, to encourage innovation. We will also be pragmatic and flexible in applying rules. We are not pre-disposed to any particular solution to the challenges facing the NHS; instead our decisions and actions will be based on the available evidence. Where relevant evidence is scarce, we will commission research to establish the facts. What matters to us is that all our work helps to improve the quality of services so they are clinically effective, safe and provide a positive experience for everyone who uses them. Where we have complex decisions or trade-offs to make we will be guided by one simple principle: we will do whatever is ultimately in the best interests of patients.’

The trouble for Monitor is that many NHS staff and patients doubt it has the ability and wisdom to act in the best interests of patients, rather than the market, and they don’t trust it either. To simply pass the buck for such an insightful question back to the DH, when the whole of the NHS is supposed to be beholden to the Constitution, is pitiful. GPs are also private providers of NHS care, but they treat patients and are mostly of benefit to them. Shareholders clearly are not.

Tim Kelsey, NHS England’s National Director for Patients and Information recently dismissed the idea that the English NHS could ever be privatized as ‘bollocks’, presumably meaning that it will always be tax-payer funded. But where public money ends up matters. Kelsey is responsible for publishing outcomes in the NHS, which should eventually show if private providers improve NHS care or not. In the 2 years to March 2012, a year before the competition regulations were passed, NHS productivity and quality of care both improved with very little private competition. There is no evidence it is needed.

The Unraveling of the GMC

The New Year Honours for Julie Bailey and Helene Donnelly for repeatedly raising concerns about horrendous care failings at Mid Staffordshire hospital are welcome,  although it remains to be seen whether this represents a genuine change in NHS culture where whistleblowers are praised, encouraged and listened to, or a political gimmick to give the appearance of change.

Most NHS whistleblowers championed in the Eye, such as Ed Jesudason, Raj Mattu and Gary Walker, are still facing a horrendous struggle to clear their names, get their jobs back and get their concerns  properly investigated (Eyes passim ad nauseum). Evidence submitted to the Health Select Committee by Private Eye for its annual accountability review of the General Medical Council on December 10 was accepted and circulated, and helped demonstrate just how unsupportive the GMC is for whistleblowers, how slow, secretive and unaccountable it can be and how it doesn’t follow its own basic rules for investigation.  At the hearing, Charlotte Leslie, the MP for Bristol North exposed the hypocrisy and incompetence of the GMC in the Barbara Hakin case (Eyes   ) with devastating simplicity.

Leslie (to Niall Dickson, chief executive of the GMC): If one person has one set of evidence and that is presented to somebody else who has another set of evidence, will you share the counter-evidence with the person who provides the first set of evidence so that they can come back on it and challenge it? Do you share conflicting evidence? Is that part of the procedure?

Dickson: Yes, it is.

Leslie: You always share conflicting evidence.

Dickson: Yes.

Leslie: And then discuss it through.

Dickson: Yes.

Leslie: I am being a bit slow. The first person says that x, y and z has happened; the second person says, no, no, no, a, b and c has happened. Do you then give the first person the conflicting evidence and say, “What do you say to that?”, and they say, “They’re wrong, because I can prove the claims they make are false because of this evidence”? Is that what you do?

Dickson: Yes

When Dickson was subsequently asked by Leslie why the GMC had not shared disputed evidence in the Barbara Hakin case (Eyes ), he had no credible answer and was told to go away and think about it.  Hakin – now deputy chief executive of the NHS – was referred to the GMC by MD and fellow Eye journalist Andrew Bousfield. The heart of the complaint is about who is telling the truth and whether deliberate deception has occurred in an attempt to protect reputations, cover up problems in Lincolnshire and not heed the warnings of a hospital’s chief executive and chair about a dire lack of capacity and the potential danger to patients of an order from Hakin – then chief exec of the SHA – that ‘100% of targets must be met.’

All our evidence, and the evidence of whistleblowers Gary Walker and David Bowles, was shared with Dr Hakin and her lawyers, but none of Hakin’s evidence was shared with us. On reading the GMC’s reasoning for not holding a public hearing, we strongly challenge Hakin’s evidence but were not given the opportunity to do so. How can the GMC make such a fundamental error in proper process when it has spent 15 months ‘investigating’?  Is it incompetent, can it not cope with its workload or is it protecting the most senior and powerful doctor in the NHS?

Niall Dickson was asked by the HSC acting chair David Tredinnick to write a letter to the committee explaining why it failed to follow its most basic rule of fair and proper investigation in the Hakin case. MD has already written to the Registrar of the GMC demanding a review of the decision. The case is being handled by John Barnard, Rule 12 Investigation Manager, who warns that ‘the process takes some time.’ If the GMC refuses to reconsider, a judicial review may follow.

The GMC has allowed itself to be sidetracked into arguing that bullying is subjective and proving a direct link between a politically enforced directive on targets and actual patient harm is hard. What the GMC must focus in it who is telling the truth about what happened, based on an open cross examination of the evidence. Anyone – manager or  doctor – who can be shown to have lied to or in other ways deceived the GMC cannot, in MD’s view, be trusted and is an ongoing threat to patients. If Niall Dickson cannot grasp this, he is not fit for office either.

Justice for Robert Henderson at last

In October, the Eye campaigned for justice for Robert Henderson, an agricultural officer, who died after substandard care at Treliske Hospital in Cornwall on October 7, 1999. His cousin John, an Emeritus physician at the Ottawa Hospital, has spent a vast amount of time and money trying to get the hospital to acknowledge the serious failures that led to Robert’s death. John meticulously reviewed and analysed Robert’s medical records, which were then thoroughly reviewed by a panel of medico-legal experts (3 university professors and a coroner). Their conclusion was grave negligence. Robert Henderson died shortly after perforating a duodenal ulcer, which may have been caused by his medication and certainly should have been investigated, diagnosed and operated on a lot sooner, given the amount of pain he was in, extreme tenderness on examination and the documented suspicions of a referring GP. John wrote to Lezli Boswell, current Chief Executive of Royal Cornwall Hospital Trust (RCHT) on the fourteenth anniversary of Robert’s death, and the Eye promised to publish the response. (Eye 1350).

‘Thank you for your letter dated October 7, 2013. I have now had the opportunity to review the file of earlier correspondence between you and the Trust since the death of your cousin, Mr Robert Henderson. Firstly I would like to apologise again for the Trust’s historic failure to address your concerns between 1999 and 2009. I believe, however, that you may not have received a copy of a letter sent to your solicitors which was sent to them on 25 November 2009 which sets out the process and findings of the Trust review of the circumstances surrounding Robert’s death. I have enclosed this letter, which clearly sets out that there were a number of elements of the care which the Trust provided to Robert were below the expected standard and that our mortality review committee concluded that there were areas of concern that ‘may have contributed to the patient’s death.’ For the Trust’s failure in the care given to Robert, I apologise unreservedly.’  

Robert Henderson’s death has all the elements of a Greek tragedy. He and his wife Marjorie, a plant pathologist, were involved in a car accident on August 30, 1999, which left Mr Henderson with a fractured pelvis and unable to walk. He was given Voltarol for his pain, which is likely to have contributed to his gut perforation, a surgical emergency which was missed until 52 hours after his pain started. Delayed surgery found a perforated duodenal ulcer, and ‘4-6 litres of bile + muck + tablets’ were removed from the abdominal cavity. He was transferred to ITU where his treatment was further complicated by post operative respiratory failure, failed extubation, pneumonia, cardiac arrhythmias, anaemia and MRSA infection at several sites. He had a fatal cardiac arrest on October 7, and the autopsy report submitted to the coroner found ‘a natural cause of death.’

Robert’s wife Marjorie knew he had received substandard care, on one occasion finding him unshaven and unwashed, but she too had been injured in the crash and only felt able to take her concerns to the sister and not his consultant. The denial of this poor care and mistakes in the management of his abdominal pain lasted a decade and when it was finally acknowledged in a letter to the family’s solicitor in 2009, the solicitors, Stevens and Scown, filed the letter and failed to pass it on. Marjorie Henderson has been left in the dark, without an honest explanation of her husband’s death, for 14 years and John Henderson has devoted hundreds of hours trying to get to the truth. They now have an unreserved apology and as much acceptance as the NHS ever offers: poor care ‘may have contributed’ to Robert’s death.

Proving cause and effect in medicine is notoriously difficult, which is why most medical litigation cases flounder. But Marjorie Henderson, now 83, only ever wanted the hospital to be honest about its mistakes and to show that they’d learned from them to prevent poor care happening to others. She has met two other women locally who are unhappy about how their husbands died in Treliske, but such is the culture of cover up in the NHS most people give up seeking the truth. The new chief RCHT executive, Lezli Boswell, is to be commended for her honest and transparent approach. But the lesson again for the NHS is that the harm of poor care is greatly increased by covering up, and it can scar for life. As Marjorie puts it; ‘I met Robert when I was 22, and he was my life. There has not been a day in the last 14 years when I haven’t missed him terribly.’