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BMJ | 7 SEPTEMBER 2013 | VOLUME 347 1

Gareth Iacobucci BMJ The Royal College of Physicians is to review its training and assessment processes in light of the Francis inquiry, to ensure that trainee doc-tors are encouraged to focus on quality and that their competence in raising concerns and treating patients with dignity is assessed.

In a detailed response to Robert Francis’s pub-lic inquiry into failings at Mid-Staffordshire NHS Foundation Trust, the college has pledged to strengthen doctors’ leadership skills and to pub-lish new guidance on raising concerns, to help implement the inquiry’s recommendations.1-3

It also recommends a new accreditation system for general hospital wards that provide high qual-ity care for older people and a new hospital health check scheme that will use aggregated data on trusts to promote awareness of quality standards.

In response to Francis’s recommendations, the college said that it should have a “more formal role in quality assurance for education and train-ing.” It said that this could include its regional advisers identifying a pool of able, willing, and medically trained physicians to accompany the General Medical Council on its visits to medical schools, deaneries, and local education providers as part of the GMC’s quality assurance processes.

The college added that it was reviewing its own examinations process to “ensure competencies regarding raising concerns and treating patients with dignity are included.”

Guidance for physicians on how to raise con-cerns, including how this can be embedded in the

Hospitals should be rated on care of older people

Clare Dyer BMJMid Staffordshire NHS Foundation Trust is to be prosecuted by the Health and Safety Executive over the death of a patient who fell into a diabetic coma after staff failed to give her insulin.

The move is the first criminal prosecution over events at the trust between 2005 and 2008, when there were hundreds of excess deaths and staff delivered “appalling care,” according to two inquiries headed by Robert Francis QC.1 2

The Health and Safety Executive

(HSE) launched an investigation into the death of Gillian Astbury, who was admitted to Stafford Hospital after a fall in 2007. An inquest into her death, at the age of 66, found that omitting to give insulin to a patient who was known to have diabetes amounted to a gross failure to provide basic care.

Two nurses, Ann King and Jeannette Coulson, were found guilty of misconduct in July by the Nursing and Midwifery Council for failing to read Astbury’s notes and carry out blood sugar level tests.

Peter Galsworthy, the HSE’s head of operations in the West Midlands, said, “HSE will be charging Mid Staffordshire NHS Foundation Trust under Section 3(1) of the Health and Safety at Work Act. Gillian Astbury died on April 11 2007 of diabetic ketoacidosis when she was an in-patient at the hospital.

“The immediate cause of death was the failure to administer insulin to a known diabetic patient. Our case alleges that the trust failed to devise, implement, or properly manage

structured and effective systems of communication for sharing patient information, including in relation to shift handovers and record-keeping.”

Section 3(1) gives employers a duty to ensure that people not in their employment are not exposed to risks to their health or safety. A preliminary hearing will be held at Stafford Magistrates Court on 9 October.

The trust is in administration after a report concluded that it was not “clinically or financially sustainable.”3

Cite this as: BMJ 2013;347:f5375

revalidation system, is also being developed.The college’s response said that creating more

and better clinical leadership was “the key to maintaining high-quality care when the system is challenged.” In addition to encouraging fully qualified doctors to take on more leadership roles, it pledged to “investigate how to improve the emphasis on leadership within doctors’ training.”

To strengthen the focus on the care of older people, the college said that it would be develop-ing an “elder friendly ward quality mark” in part-nership with the Royal College of Psychiatrists, which would be awarded to hospital wards that provided high quality care to older people.

The college will also produce a hospital health check drawing on collated data it holds within its various departments, to “provide a snapshot of a given hospital trust.” The response also sets out plans to work with the Care Quality Commission to develop “a meaningful and effective system to inspect and rate hospital services.”

Patrick Cadigan, the college’s registrar, said, “Many of the instances of substandard care at Mid Staffordshire NHS Foundation Trust took place in medical wards caring for our most vul-nerable patients: frail older people with complex comorbidities.” Cite this as: BMJ 2013;347:f5389

Mid Staffs trust is to face its first criminal prosecution over a patient’s death

Wards providing good care for older patients should have an “elder friendly ward quality mark”

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UK news Multiple stenting after myocardial infarction offers more protection than single stents, p 3 World news Industry and drug agency disagree on which data should remain confidential, p 4

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bmj.com Ж Lack of atropine

in Syria hampers treatment after gas attacks

NEWS

Matthew Limb LONDONEngland’s healthcare watchdog the Care Qual-ity Commission has criticised major failings at a hospital trust after one of the first investigations made under its new inspection regime.

The commission identified shortcomings in the emergency department, elderly care, and children’s wards at Bedford Hospital NHS Trust, a 403 bed, acute district general hospital trust serving some 270 000 people. The trust also failed to meet eight of the nine standards it was measured against.1

The commission said that patients were not consistently treated with dignity and respect

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Tool calculates carbon footprint of pharmaceutical products: The Association of the British Pharmaceutical Industry and the Carbon Trust have launched a tool to enable companies to estimate the carbon footprint of drugs in blister packs to demonstrate the industry’s commitment to help reduce its impact on the environment. The tool incorporates calculations of carbon emissions for pharmaceutical ingredients, transport and distribution, formulation and packaging, retail and use, and the disposal of the packaging.

Eight new cases of Middle East respiratory syndrome coronavirus are confirmed: WHO has been told of an additional eight laboratory confirmed cases of Middle East respiratory syndrome coronavirus infection in Saudi Arabia. Since September 2012 there have been 102 laboratory confirmed cases of infection with the virus, including 49 deaths.

Immunisation clinic misled over MMR and autism: The Advertising Standards Authority has told a clinic in Cheshire selling separate measles, mumps, and rubella vaccines to remove “misleading” claims from its website implying a link between the MMR jab and autism. Complaints were made about the Children’s Immunisation Centre during the measles outbreak centred on Swansea.1 The authority decided that the clinic’s language “could have caused fear and distress.”

Only one hospital in Lisbon is to provide emergency services each night: From 2 September emergency services in tertiary hospitals (those offering the full range of specialties) in the metropolitan area of Lisbon will be concentrated in a single hospital overnight, down from four previously. Between 8 pm and 8 am services will alternate between two different hospitals. The Lisbon metropolitan area has about three million inhabitants.

MHRA warns on tanning products containing melanotan: The UK Medicines and Healthcare Products Regulatory Agency has warned against the use of unlicensed tanning injections and nasal sprays that contain the drug melanotan. The agency has received 18 reports detailing 74 separate reactions

that are suspected to be side effects linked to the use of the products. These include stomach and heart problems and blood and eye disorders.

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IN BRIEF

Stephen Conroy, acting chief executive of Bedford Hospital NHS Trust, apologised to patients

NewinspectionregimeuncoversmajorfailingsatBedfordhospitaltrust

and there was no evidence that staff caring for people with dementia had been trained properly to deal with their condition. Concerns were also raised over discharge systems, treatment delays, hospital food quality, and gaps in care records.

Many staff were not trained adequately to ensure service users were protected from the risks of abuse, said the commission’s report, which was published on 29 August.

Inspectors made unannounced visits to the hospital over four days in early July, including one overnight, after serious concerns were raised about the paediatrics department and complaints made about lack of consultant support, supervi-sion, and training opportunities for trainee doc-tors. Junior doctors were withdrawn from the department by Health Education East of England and the General Medical Council in July.2

The commission introduced a new inspec-tion regime in August after a review led by Bruce Keogh, the medical director of the NHS in England, found that its former processes had missed significant problems.3 In Bedford, inspectors spoke to trust staff, patients, carers, and family members, and reviewed information provided by the trust, commissioners, commu-nity groups, and local Healthwatch. An “expert by experience” familiar with the service helped with the inspection.

In its report, the commission said that although the trust had taken some steps to address problems in paediatrics these had not been sustained. It said, “During our inspection we identified major concerns in the systems to

Clare Dyer BMJA surgeon accused of botching operations over 18 years has won a High Court challenge against the General Medical Council over its refusal to let him remove his name voluntarily from the medical register.

A High Court judge has ruled that the GMC failed to give adequate reasons for not allowing David Jackson to opt for voluntary erasure on the grounds of illness and for insisting on a hearing.

Jackson faces 75 counts of inappropriate and incorrect treatment of 16 patients with breast or colon cancer or requiring cosmetic surgery across four hospitals in Kent from 1989 to 2007. He is charged with misconduct and deficient professional performance and also faces an allegation that his fitness to practise is impaired through “adverse physical or mental health.”

By May 2012 East Kent Hospitals NHS Trust had paid out £651 000 in negligence settle-ments to 15 of the surgeon’s former patients.

Jackson, 67, supplied medical evidence

that he was medically unfit to work again. But a panel of the Medical Practitioners Tribunal Service, part of the GMC, refused his application for voluntary erasure and decided that a hearing should go ahead.

The panel accepted that he had serious health problems and a low chance of recovery but decided that the GMC’s duty to maintain pub-lic confidence in the medical profession out-weighed the health concerns and required the serious allegations to be aired and scrutinised.

The GMC’s guidance states that voluntary erasure is likely to be appropriate only in excep-tional circumstances, including “situations in which medical evidence . . . gives a clear indica-tion that the doctor is seriously ill and would be unfit to participate in our . . . procedures.”

Expert medical evidence, which was accepted by the panel, was that Jackson was seriously ill and that attending a hearing would be likely to damage his health. Cite this as: BMJ 2013;347:f5386

SurgeonwinsHighCourtcaseagainstGMC

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Ingrid Torjesen LONDONStenting coronary arteries that have consider-able build up of plaque as a preventive measure in patients with acute ST segment elevation myocardial infarction at the same time as a stent is inserted into the artery where the infarct occurred can dramatically reduce the risk of fur-ther potentially fatal cardiovascular events, a UK study has found.1

Percutaneous coronary intervention (PCI) is recommended to treat the infarct artery (or cul-prit) lesion responsible for the infarct in acute ST segment elevation MI.2 But other plaques are currently treated medically rather than with preventive surgery.

From 2008 to 2013 465 patients with acute ST segment elevation myocardial infarction

who were undergoing infarct artery PCI at five hospitals were enrolled in the study. They were randomly assigned to either preventive PCI (234 patients) or infarct artery only PCI (231 patients).

During a mean follow-up of 23 months, 21 patients in the preventive PCI group and 53 in the infarct artery only PCI group died from car-diac causes or experienced non-fatal myocardial infarction or refractory angina. This worked out as nine events per 100 patients in the preventive PCI group and 23 per 100 in the infarct artery only PCI group (hazard ratios for the three com-ponents of the primary outcome were 0.34 (95% confidence interval 0.11 to 1.08) for death from cardiac causes, 0.32 (0.13 to 0.75) for non-fatal myocardial infarction, and 0.35 (0.18 to 0.69) for refractory angina. The findings were pub-lished in the New England Journal of Medicine.1

Until now there has been a lack of evidence on the value of preventive PCI, said the authors. leading to variations in practice.

“The results of this trial help resolve the uncertainty by making clear that preventive PCI is a better strategy than restricting a further intervention to those patients with refractory angina or a subsequent myocardial infarction,” they wrote.Cite this as: BMJ 2013;347:f5387

for £3000 damages, stating that he had saved £8000 on cigarettes and had gained health ben-efits from not smoking.

Patients at Rampton high security prison in Nottinghamshire lost a similar challenge to a smoking ban in the English courts in 2009, when the Court of Appeal said that there was no human right to smoke.

Lord Stewart said that he was allowing the application “with a degree of reluctance” and was not endorsing the idea of a human right to smoke.

He added, “The fundamental right in terms of this aspect of article 8 . . . is to have your identity, how you choose to express it, and other personal, private and intimate choices, whatever they may be, respected even if your choices are harmful to yourself, morally reprehensive or laughable.

“If you are an adult, the state cannot interfere with your choices in the private sphere except for weighty reasons to do with the protection of others and the good of the community as a whole.”Cite this as: BMJ 2013;347:f5343

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The trial makes clear the value of widening the use of preventive PCI, said the authors

The hospital failed to show a reasonable justification for treating the patient differently from prisoners who are allowed to smoke

NewinspectionregimeuncoversmajorfailingsatBedfordhospitaltrust

Smokingbaninhospitalbreachedpatient’shumanrights,judgerulesClare Dyer BMJA patient detained in Carstairs high security psy-chiatric hospital in Scotland has won a court rul-ing that a total ban on smoking in the hospital and its grounds breached his human rights.

Lord Stewart ruled at the Court of Session in Edinburgh that the decision that compelled Charles McCann to stop smoking in December 2011 was “flawed in every possible way.”

McCann, who has schizophrenia, has been detained in the hospital since 1995, when a sheriff made an order for his detention under mental health legislation. He was allowed unescorted access to the grounds at Carstairs.

The judge ruled that the ban infringed his right to respect for his private life under arti-cle 8 of the European Convention on Human Rights. The hospital had failed to show “an objective and reasonable justification” for treat-ing McCann differently from prisoners, who are allowed to smoke.

But the judge rejected McCann’s application

ensure each ward area was staffed with suf-ficient numbers of appropriately skilled and experienced staff and also concerns in the con-sistency of support provided.”

Records showed that the trust board was notified of concerns related to junior doctors in paediatrics in March 2012, but these were reported as “business as usual” and not given proper scrutiny. There was a “major failing in leadership” in managing the concerns raised, the report said.

The commission said that instead of recruit-ing more paediatric nurses, numbers had been reduced significantly over the past three years while activity had increased. “We also found major failings in the trust’s governance pro-cesses to ensure incidents and risks were iden-tified, reported and responded to in order to maintain safe, effective care delivery,” it added.

Bedford Hospital’s acting chief executive, Stephen Conroy, apologised “unreservedly” to patients for “unacceptable practice.”

Nina Fraser, the trust’s director of nursing, said that the trust was investing in more nurses and improving levels of support.

Conroy added, “We are addressing the issues identified through rigorous internal review, per-formance management, and in the case of pae-diatrics and medical education, independent external reviews. In paediatrics the issues are more complex. We have shared plans publicly and will release the findings of the two inde-pendent external reviews.”Cite this as: BMJ 2013;347:f5366

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The request for the trial meeting minutes from London’s Queen Mary College (above) should have been struck out as vexatious, said the tribunal

Clare Dyer BMJ The UK Information Rights Tribunal has ruled that the University of London’s Queen Mary col-lege was right not to disclose the discussions of research committees on a clinical trial of treat-ments for chronic fatigue syndrome (myalgic encephalomyelitis), in an important ruling con-cerning the importance of academic freedom.

The tribunal upheld the information commis-sioner’s decision that Queen Mary was entitled to withhold the minutes of meetings of the steering committee and management groups for the PACE (Pacing, Graded Activity, and Cognitive Behav-iour Therapy—a Randomised Evaluation) trial, which looked at the effectiveness of treatments for chronic fatigue syndrome.

The £5m trial, funded mainly by the Medical Research Council and led by Queen Mary, fol-lowed 641 patients, looking at the safety and effi-cacy of the various treatments available in the UK. A paper published in the Lancet in March 2011 concluded that cognitive behaviour therapy and graded exercise therapy could be effective.1

The paper resulted in what the Lancet described as “an outpouring of consternation and condemnation from individuals or groups outside our usual reach.”2 Much criticism came from people with chronic fatigue syndrome, some of whom resisted the suggestion that psychologi-cal therapies could help alleviate their condition.

John Mitchell made a request in July 2012 under the Freedom of Information Act for the meeting minutes, although he was aware that Queen Mary had previously received and rejected an identical request. His request was refused on the basis that disclosure would inhibit the free provision of advice and exchange of views.

Queen Mary’s principal, who made the deci-sion, took account of a submission that argued

IndustryanddrugagencydisagreeonwhichdatashouldremainconfidentialNigel Hawkes LONDONSharp differences of opinion have emerged over how much clinical trial data some drug compa-nies are willing to release as the clock ticks down to the transparency deadline of 1 January 2014 set by the European Medicines Agency (EMA).

A meeting in Brussels late last month showed that the industry itself is split, despite the publica-tion of a draft policy by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) which out-lined the principles their members should follow.1

At the meeting, Neal Parker, of the US company AbbVie, shocked data transparency campaign-ers and drug regulators by detailing a range of information AbbVie considered commercially confidential because its release would help competitors to make copies of its drugs. These included “internal tactical decisions on how we are going to run a study, engage with regulators, and confront and solve problems and challenges we have uncovered during clinical trials,” he said, according to Scrip Intelligence.3 This could include adverse drug reactions, he added.

The EMA’s Hans Georg Eichler responded by saying, “I have been a regulator for many years and I am totally flabbergasted.”

Aginus Kalis, head of the Dutch Medicines Evaluation Board, said, “Are you aware you are working in the healthcare industry, with patients and human beings?”

The director general of EFPIA, Richard Berg-ström, intervened to say that “most of our mem-bers are quite relaxed” about data disclosure. For most products there would be no issues, though for highly competitive fields such as biological there might be. Cite this as: BMJ 2013;347:f5390

Upto20privatehospitalsintheUKmayhavetobesoldtoincreasecompetitionMatthew Limb LONDONMany patients pay too much for private health treatment because of the “market power” exer-cised by big hospital groups, a major investiga-tion by the Competition Commission has found.1

The commission’s inquiry into private health-care found that 101 private hospitals faced little competition, with local markets dominated by the largest groups, BMI, HCA, and Spire. It said that insurers had little choice but to use their local operator, leading to higher premiums and excess profits for hospital groups.

The commission recommended that up to 20 private hospitals in 11 UK locations should be sold off to other operators to widen competition.

The inquiry found a range of anti-competitive restrictions and called for private hospitals to stop offering cash or other incentives to consultants to refer patients to their hospitals for treatment.

Reporting its findings on 28 August, the com-mission said that the private health groups BMI, HCA, and Spire were earning returns “substan-tially and persistently in excess of the cost of capital.” It estimated that between 2009 and

2011 their “market power” had cost consumers between £173m and £193m per year.

The commission’s chairman, Roger Witcomb, who led the inquiry, said, “The lack of compe-tition in the healthcare market at a local level means that most private patients are paying more than they should either for private medical insur-ance or for self-funded treatment.”

He said that private patients often had less information than NHS patients on the perform-ance of hospitals and consultants.Cite this as: BMJ 2013;347:f5347

that releasing the minutes could have major implications for how trials were conducted on a national level in the future; would alter the way trials were run; and would affect the quality of the minutes of meetings such as this one in dealing with controversial areas of medicine.

The information commissioner agreed that Queen Mary was entitled to withhold the minutes on the grounds of public interest, and Mitchell appealed to the Information Rights Tribunal.

The tribunal upheld the commissioner’s decision and went on to declare that the under-pinning of academic freedom by UK statute law and human rights conventions should be given appropriate weight in such decisions. It also had “no doubt” that the request should have been regarded as not a true request for information and should have been struck out as vexatious.Cite this as: BMJ 2013;347:f5355