bmj - 16 march 2013

THIS WEEK

BMJ | 16 MARCH 2013 | VOLUME 346

!NEWS, p 4

NEWS1 Antimicrobial resistance presents an apocalyptic

threat, CMO warns

Financial strains must not risk work of volunteers in the NHS

2 Judge rules that decision to close three childrens heart units was unfair

New rules on competition are still a concern

3 Case against doctor from Staord hospital set to start next week

Britons are making healthier lifestyle choices than 40 years ago

4 More than a third of GPs on CCG boards have conflicts of interest

Articles appearing in this print journal have already been published on bmj.com, and the version in print may have been shortened. bmj.com also contains material that is supplementary to articles: this will be indicated in the text (references are given as w1, w2, etc) and be labelled as extra on bmj.com. Please cite all articles by year, volume, and elocator (rather than page number), eg BMJ 2013; 346:f286. A note on how to cite each article appears at the end of each article, and this is the form the reference will take in PubMed and other indexes.

COMMENTEDITORIALS

7 Is an EMA review on hormonal contraception and thrombosis needed?Frans M Helmerhorst and Frits R Rosendaal

8 Cognitive deficits and mild traumatic brain injury V F J Newcombe and D K Menon ! RESEARCH, p 15

9 Regulating the NHS market in EnglandChris Ham

10 The new UK antimicrobial resistance strategy and action planAnthony S Kessel and Mike Sharland

FEATURES16 The hospital bed: on its way out?

John Appleby examines trends in the number of hospital beds and wonders how low we can go

HEAD TO HEAD18 Should GPs be fined for rises in avoidable

emergency admissions to hospital?Commissioning organisations in England face losing a quarter of the quality premium if they do not keep down their emergency admissions for speci(c conditions. Martin McShane supports the plan, but Chaand Nagpaul worries about possible unintended consequences

ANALYSIS20 Antimicrobial resistance: the true cost

Richard Smith and Joanna Coast argue that current estimates of the cost of antibiotic resistance are misleading and may result in inadequate investment in tackling the problem

MAL

COLM

WIL

LET

RESEARCHRESEARCH NEWS

11 All you need to read in the other general journals

RESEARCH PAPERS12 Influence of initial severity of depression on

eectiveness of low intensity interventions: meta-analysis of individual patient dataPeter Bower et al

13 Comparative eect sizes in randomised trials from less developed and more developed countries: meta-epidemiological assessment Orestis A Panagiotou et al

14 Features of eective computerised clinical decision support systems: meta-regression of 162 randomised trialsPavel S Roshanov et al

15 Cognitive function and other risk factors for mild traumatic brain injury in young men: nationwide cohort study Anna Nordstrm et al! EDITORIAL, p 8

Caption, p xx

Sufficient evidence for the oral pill exists,p 7

UK smoking, p 3

More new antibiotics needed, p 20

Kings Fund reports on volunteers in the NHS p 1

THIS WEEK


LAST WORDS41 Scrap the royal colleges fellowships

Des Spence On first name terms

Oliver Ellis

EDUCATION CLINICAL REVIEW

29 Achilles tendon disordersChad A Asplund and Thomas M Best

PRACTICEQUALITY IMPROVEMENT REPORT

34 Maximising opportunities for increased antiretroviral treatment in children in an existing HIV programme in rural South AfricaRuth M Bland et al

ENDGAMES40 Quiz page for doctors in training

MINERVA42 Generating energy from crematoriums, and other

stories

COMMENTLETTERS

23 Predicted fracture risk; Bisphosphonates and GI cancers

24 Paracetamol hepatotoxicity; Cap on social care in England

OBSERVATIONSMEDICINE AND THE MEDIA

25 Hype and the HIV cureMargaret McCartney

PERSONAL VIEW

26 After Mid Stas: NHS must look to care of its own staAnonymous

OBITUARIES27 Ian Greville Tait

Pioneering polymath and Benjamin Brittens general practitioner

28 Joseph Footitt; Alan William Fowler; Frank Neville Garratt; Athol Noble Hepburn; William Philip Dowie Logan; Muhammad Shafiq

Time for a break?Refresh yourself.

masterclasses.bmj.com

Angry NHS staff, p 26

An infected heel ulcer, p 42

THIS WEEK


9.7%7.1%

6.3%

4.2%

Eschericha coli - 36%Klebsiella spp - 7.8%Other Gram negative - 6.4%Pseudomonas spp - 4.3%Proteus spp - 3.1%Enterobacter spp - 2.2%Bacteroides spp - 1.5%Serratia spp - 1.0%Acinetobacter spp - 0.7%

4.2%

Gram negative

Gram positive

1.6%1.4%1.4%1.2%

36%

7.8%

6.4%

4.3%

3.1%

2.2%1.5%1.0%0.7%

Staphylococcus aureus (MRSA) - 9.7%Non-pyogenic streptococci - 7.1%Enterococcus spp - 6.3%Streptococcus pneumoniae - 4.2%Other Gram positive - 4.2%Staphylococcus aureus (MRSA) - 1.6%Group B streptococci - 1.4%Group A streptococci - 1.4%Diphtheroids - 1.2%

GRAPHIC OF THE WEEK Gram negative bacteria such as Klebsiella and Escherichia coli (E coli) have overtaken Gram positive bacteria such as Staphylococcus aureus to become the main organisms causing bloodstream infections in adults in England, Wales, and Northern Ireland, according to the recent annual report of the chief medical officer for England (data from the English National Point Prevalence Survey on Healthcare Related Infections and Antimicrobial Use, 2011, HPA England, 2012). The report points out that the threat to health posed by Enterobacteriaceae (E coli and Klebsiella related species), which are now the most frequent agents of hospital acquired infection (36% and 7.8% respectively), is substantial. Kessel and Sharland warn, in their editorial, that 10-20% of these Gram negative bloodstream infections are antibiotic resistant and 30% of patients who acquire a multidrug resistant Gram negative bloodstream infection are likely to die.

!SEE NEWS , p 1, EDITORIAL, p 10, ANALYSIS, p 20

16 March 2013 Vol 346The Editor, BMJ BMA House, Tavistock Square, London WC1H 9JR Email: [email protected] Tel: +44 (0)20 7387 4410 Fax: +44 (0)20 7383 6418 BMA MEMBERS INQUIRIES Email: [email protected] Tel: +44 (0)20 7383 6642 BMJ CAREERS ADVERTISING Email: [email protected] Tel: +44 (0)20 7383 6531 DISPLAY ADVERTISING Email: [email protected] Tel: +44 (0)20 7383 6386 REPRINTS UK/Rest of worldEmail: [email protected]: +44 (0)20 8445 5825 USAEmail: [email protected]: + 1 (856) 489 4446 SUBSCRIPTIONS BMA Members Email: [email protected] Tel: +44 (0)20 7383 6642 Non-BMA Members Email: [email protected] Tel: +44 (0)20 7383 6270 OTHER RESOURCES For all other contacts: resources.bmj.com/bmj/contact-us For advice to authors:resources.bmj.com/bmj/authorsTo submit an article:submit.bmj.com

The BMJ is published by BMJ Publishing Group Ltd, a wholly owned subsidiary of the British Medical Association.The BMA grants editorial freedom to the Editor of the BMJ. The views expressed in the journal are those of the authors and may not necessarily comply with BMA policy. The BMJ follows guidelines on editorial independence produced by the World Association of Medical Editors (www.wame.org/wamestmt.htm#independence) and the code on good publication practice produced by the Committee on Publication Ethics (www.publicationethics.org.uk/guidelines/).The BMJ is intended for medical professionals and is provided without warranty, express or implied. Statements in the journal are the responsibility of their authors and advertisers and not authors institutions, the BMJ Publishing Group, or the BMA unless otherwise specified or determined by law. Acceptance of advertising does not imply endorsement.To the fullest extent permitted by law, the BMJ Publishing Group shall not be liable for any loss, injury, or damage resulting from the use of the BMJ or any information in it whether based on contract, tort, or otherwise. Readers are advised to verify any information they choose to rely on.BMJ Publishing Group Ltd 2012 All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any other means, electronic, mechanical, photocopying, recording, or otherwise, without prior permission, in writing, of the BMJPublished weekly. US periodicals class postage paid at Rahway, NJ. Postmaster: send address changes to BMJ, c/o Mercury Airfreight International Ltd Inc, 365 Blair Road, Avenel, NJ 07001, USA. $796. WeeklyPrinted by Polestar Limited

RESPONSE OF THE WEEKIt may be significant that students, lowest in the medical hierarchy, are able to break into our over-regulated NHS culture with the simple question What can I do to improve your stay? While following prescribed guidelines will almost always be necessary in modern practice, its vital that all staffnot just learnersretain their authority to attend directly to patient experience while doing so. And sometimes the protocol misleads. As George Orwell said about his own guidance for writing good English, Break any of these rules sooner than say anything outright barbarous.

Sebastian Kraemer, child and adolescent psychiatrist, Whittington Hospital, London, UK, in response to IHI Open Schools quality improvement initiative (BMJ 2013;346:f1371)

BMJ.COM POLLLast weeks poll asked: Should GPs be fined for rises in avoidable emergency admissions?

65% voted no (total 858 votes cast)

!BMJ 2013;346:f1389 and BMJ 2013;346:f1391

This weeks poll asks:Are the dangers of antibiotic resistance exaggerated?

!BMJ 2013;346:f1493 !Vote now on bmj.com

MOST SHAREDLocum GP from India is jailed for manslaughter in UK after failing to spot diabetic ketoacidosis Health reform alone is pointless Francis interview: what doctors must learn from my report Drug company gifts to medical students: the hidden curriculum Winding back the harms of too much medicine


THIS WEEK

At the end of the 1960s, the then US surgeon general William H Steward famously declared: The war against infectious diseases has been won. His optimism might well have been justi%ed at the time. The discovery of antibiotics and their widespread introduction had transformed both medical practice and life expectancy.

Antibiotics still transform lives, butas with so many of the worlds resourceswe now know that they are not limitless, and that unless we are careful, their bene%cial e&ects will run out. We have become so accustomed to the availability of antibiotics that a world without them is almost inconceivable. Yet this is the world that Englands chief medical o'cer, Sally Davies, demands we contemplate in the second volume of her annual report (p 1). The causes of this unfolding catastrophe are many: overuse of existing antibiotics, increasing resistance to them, a discovery void regarding new drugs, and a change in the types of organisms presenting the greatest threat. If we dont get this right we will %nd ourselves in a health system not dissimilar to the early 19th century, she says.

Is Davies being overdramatic? Sadly not. Her decision to focus on antimicrobial resistance has been broadly welcomed. And this week we publish a report from Richard Smith and Joanna Coast, long term analysts of the economics of resistance (p 20). They suggest that the picture she paints may even be too rosy. Resistance is said to present a risk that we will fall back into the pre-antibiotic era, they say. However, this is perhaps optimistic.

Their argument is that we have badly underestimated the cost of resistance. Studies that have tried to estimate the economic impact have looked at the extra cost of treating a resistant infection compared with a susceptible one. But this ignores the bigger picture. The

whole of modern healthcare, including invasive surgery and immunosuppressive chemotherapy, is based on the assumption that infections can be prevented or treated. Resistance is not just an infectious disease issue, they say. It is a surgical issue, a cancer issue, a health system issue.

Their revised assessment of the economic burden of resistance encompasses the possibility of not having any e&ective antimicrobial drugs. Under these circumstances they estimate that infection rates a)er hip replacement would increase from about 1% to 40-50%, and that about a third of people with an infection would die. It seems likely that rates of hip replacement would fall, bringing an increased burden of morbidity from hip pain.

The CMOs 17 recommendations include better hygiene measures and surveillance, greater e&orts to preserve the e&ectiveness of existing drugs, and encouragement to develop new ones. As Anthony Kessel and Mike Sharland point out, only one or two new antibiotics that target Gram negative organisms are likely to be marketed in the next decade (p 10). Recognising this as a global problem, the CMOs report also calls for antimicrobial resistance to be put on the national risk register and taken seriously by politicians internationally.

As for the cost of such action, Smith and Coast see it as an essential insurance policy against a catastrophe that we hope will never happen. And they share the CMOs urgency. Waiting for the burden to become substantial before taking action may mean waiting until it is too late.Fiona Godlee, editor, [email protected] this as: BMJ 2013;346:f1663

EDITORS CHOICE

Drug resistancean unfolding catastropheResistance is said to present a risk that we will fall back into the pre-antibiotic era . . . However, this is perhaps optimistic

Sign up today using your smartphone follow these steps:

(Download a free QR reader from your handset's app store

(Hold your smartphone over the QR code

(You will then be forwarded to the email sign up page

bmj.com/archiveVisit

The archiveDates from 1840

Delve into the complete back archive from the first issue and read BMJ articles written by eminent authors such as David Livingstone, Joseph Lister, Arthur Conan Doyle, Florence Nightingale, Richard Doll, and Alice Stewart.

(To receive Editors Choice by email each week, visit www.bmj.com/newaccount

Twitter (Follow the editor, Fiona

Godlee, at twitter.com/fgodlee, and the BMJ at twitter.com/bmj_latest

NEWS

BMJ | 16 MARCH 2013 | VOLUME 346 1

Ingrid Torjesen LONDONAction is needed at both a national and interna-tional level to avert the ticking time bomb of antimicrobial resistance, which presents a threat as grave as climate change, the chief medical o!cer for England has warned.

In the second volume of her annual report for 2011, Infections and the rise of antimicrobial resistance,1 Sally Davies spelt out the threatoveruse of existing antibiotics and increasing resistance to them, a discovery void of new antibiotics, a change in the types of organism presenting the greatest threat, and the need for better training of NHS sta% in hygiene and infection control.

If we dont get this right we will &nd our-selves in a health system not dissimilar to the early 19th century, where deaths from infec-tions will be commonplace because of a lack of e%ective treatments, Davies told a press brie&ng at the Department of Health. The department would publish a &ve year strategy for action in the next couple of weeks, she said.

At the chief medical o!cers recommenda-tion, the Department of Health and the Depart-ment for Environment, Food, and Rural A%airs have added antimicrobial resistance to their strategic risk registers. Davies has also requested that it be added to the National Security Risk Assessment, alongside pandemic flu and t errorism, to ensure cross government action.

Governments and organisations across the world, including the World Health Organization and G8, need to take this seriously, she said. This included &nding some way of incentivis-ing the pharmaceutical industry to develop new antibiotics. No new antibiotic classes have been discovered since 1987, and Davies said that no pharmaceutical companies had any new anti-biotic classes in their pipeline, and that there were few new antibiotics of existing classes in development.

With the pipeline drying up, stewardship of antibiotics in health, &sheries, and farming had become increasingly important, she said. In health, that meant prescribing antibiotics only when appropriate and ensuring that the patient completed the course. Cite this as: BMJ 2013;346:f1597

Zosia Kmietowicz BMJCommissioners and service providers need to better plan the role of volunteers in both the health and social care sectors if they are to avoid alienating the swathes of people who provide their time for free and ease growing tensions with those in paid jobs, a report from a leading think tank has said.1

An estimated three million people in England volunteer in the NHS, health charities, and social care organisationsthe same number in paid employment in the NHS and social care systems, says the report from the Kings Fund. Volunteers play a vital role in delivering services such as assisting with mealtimes, providing support for bereaved families, and befriending older people in care homes.

The Institute for Volunteering Research has suggested that volunteers are worth around 700 000 a year to hospital

trusts, 500 000 a year to mental health trusts, and 250 000 a year to a primary care trust.

The latest report was commissioned by the Department of Health to look at the effect of the current changes to health and social care sectors on volunteering. The government sees volunteering as helping to achieve its wider ambitions to decentralise power, reduce reliance on the state, and encourage people to take an active role in their communities.

However, the current economic climate means that some tensions have already emerged, said the report. Some people are questioning the value of volunteers, and research has shown that staff are sometimes unclear about what volunteers do. Financial pressures also risk creating strains with paid employees who are concerned about their jobs.

It is for these reasons, the report said, that commissioners

and service providers need to focus on how volunteers will help improve quality and bring benefits to organisations, patients, and communities.

To make the most of volunteers, commissioners and providers must acknowledge the value of volunteers, develop a clear vision of how volunteers can help organisations and patients, measure their input, and clarify the boundaries between professional and volunteer roles to allay concerns of job substitution.

The report said, It is more important than ever to think strategically about the role of volunteering. The health and social care system will find it increasingly difficult to meet its objectives without doing so.

Chris Naylor, fellow at the Kings Fund, said that volunteering should be used to improve quality and not to reduce short term costs.Cite this as: BMJ 2013;346:f1595

Without volunteers the NHS will find it increasingly difficult to meet its objectives, said the Kings Fund

Financial strains must not risk work of volunteers in the NHS

Antimicrobial resistance presents an apocalyptic threat, CMO warns

LIFE

IN V

IEW

/SPL

UK news First case against doctor from Stafford hospital set to start next week, p 3 BMJ investigation More than a third of GPs on CCG boards have conflicts of interest, p 4

* References on news stories are in the versions on bmj.com

bmj.com * Judge overturns

New Yorks ban on supersize sweet drinks

NEWS

2 BMJ | 16 MARCH 2013 | VOLUME 346

Clare Dyer BMJCampaigners !ghting the decision to close the childrens heart surgery unit in Leeds as part of an exercise to concentrate operations in fewer but larger centres have scored a comprehensive victory at the High Court in London.

Mrs Justice Nicola Davies ruled that the Safe and Sustainable consultation that recommended closing three units was flawed by procedural unfairness and a failure to take into account mate-rial considerations.

The success for the campaigning group, Save our Surgery Limited, on both grounds of its challenge is a signi!cant setback for the plans to concentrate surgery at only seven sites: Bristol, Birmingham, Southampton, Liverpool, Newcastle, and two in London. Units in Leeds and Leicester and at Londons Royal Brompton Hospital in London would be axed under the consultation recommendations.1

The judge ruled that the consultation process was unlawful in the !rst instance because the Joint Committee of Primary Care Trusts, which

Zosia Kmietowicz BMJThe UK government has redra#ed regulations on procurement, in an attempt to allay concerns raised by several medical bodies and MPs in the past few weeks that clinical commissioners would be forced to put out to competitive tender most of the services they wanted for their patients.

However, both the BMA and the Royal College of General Practitioners are still concerned that commissioners are not completely free to choose when to use competition and when not to.

The revised regulations, which were laid before parliament on 11 March, mean that the position on competition is unchanged from now, said the Department of Healthcommissioners are able to o$er contracts to a single provider where only that provider is capable of providing the services.

In explanatory notes, it said, We have removed the words that inadvertently created the impression that there were only very narrow cir-cumstances in which commissioners could award a contract without a competition.

The department said that the rewording makes it clear that Monitor, the economic regulator of the NHS, has no power to force the competitive ten-dering of services when the regulations come into force on 1 April, and that decisions about how and when to introduce competition are solely up

to doctors and nurses in clinical commissioning groups. It added, Competition should not trump integrationcommissioners are free to commis-sion an integrated service where it is in the inter-est of patients.

The UK Labour Party and the new National Health party criticised the original secondary leg-islation published in February.1 More than 1000 doctors also urged MPs to force a debate on the regulations2 and the Academy of Medical Royal Colleges expressed considerable concern at the regulations, which were published to supplement section 75 of the Health and Social Care Act.

Clare Gerada, chair of the Royal College of General Practitioners, said the revised regulations were a step in the right direction but . . . do not go far enough in ensuring that commissioners are genuinely free to decide whether or not to expose services to competition.

Mark Porter, chair of the BMA Council, said, It is vital that competition is not allowed to under-mine integration, innovation, or clinical auton-omy. There still needs to be a full parliamentary debate to provide absolute clarity that CCGs [clini-cal commissioning groups] will have the freedom to decide how best to secure high quality services for local populations, he said.Cite this as: BMJ 2013;346:f1634

Judge rules that decision to close three childrens heart units was unfair

New rules on competition are still a concern

Campaigners to keep services in Leeds said the reform process had been flawed and unjust

SDS

PHOT

O/DE

MOT

IX/P

A

Services are failing people with dementia: People with dementia who live in care homes in England are more likely than similar people without dementia to go to hospital with avoidable conditions such as urinary infections, the Care Quality Commission has said. Once admitted, people with dementia are more likely than those without dementia to stay in hospital longer, be readmitted, and die in hospital.

Disclosure of pharma sponsorship made compulsory in Portugal: A law that was enacted on 15 February requires doctors, scienti#c societies, and patient associations in Portugal to publicly disclose all sponsorship from the pharmaceutical industry to the national drug regulator (Infarmed). Failure to disclose conflicts of interests could result in #nes of 2000 (1740) to 45 000.

Regulator rules that advertisements on plain packs are misleading: The Advertising Standards Authority has ruled that ads run by Japan Tobacco Internationalagainst the introduction of plain, standard packagingare misleading and must not be published again. The ads, placed in the national press in 2012, stated that in 2008 the government had rejected plain packaging for tobacco because there was no credible evidence to support such a policy. The regulator concluded that the claim breached the advertising code of practice.

Smoking to be banned from all Dutch cafes: Dutch health minister Martin van Rijn has con#rmed to MPs that he will bring forward changes to the law enforcing a smoking ban throughout the Netherlands hospitality industry. Most MPs recently voted for a total ban. Currently some smaller cafs are exempt. Last year, smoking increased from 25% to 26% in adults.

Partners agree to vaccinate 400 million children: The Global Alliance for Vaccines and Immunisation (GAVI) and the Islamic Development Bank (IDB) have signed a memorandum of understanding to help save childrens lives by accelerating the introduction of vaccines in IDB member countries. By 2020, GAVI plans to vaccinate more than 400 million children in at least 29 member countries with the aim of preventing 3.2 million deaths at an estimated cost of $7bn. Cite this as: BMJ 2013;346:f1622

IN BRIEF

took the decision, had refused to disclose the sub-scores that an expert committee had given in a scoring exercise. Units were given only the overall scores.

I am satis!ed that fairness did require disclo-sure of the sub-scores to enable Leeds to provide a properly focused and meaningful response, said the judge, who described the committees refusal to hand over the sub-scores as ill judged.

In addition, the joint committee also failed to take into account the sub-scores when carrying out the consultation, although the overall scores were acknowledged to be close, she said. The sub-

NEWS


Ingrid Torjesen LONDONBritish adults are half as likely to smoke as they were four decades ago and are drinking less heavily and less frequently, show data from the O!ce for National Statistics (ONS) 2011 General Lifestyle Survey.

The surveys report, launched at a press con-ference in London on 7 March, also shows that despite the ageing population, the proportion of people in Great Britain living with a longstanding illness or disability has remained steady over the past 20 years at just under a third.1

The 2011 report marks 40 years of the survey. When the ONS survey 'rst included questions about smoking in 1974, it found that 45% of adults smoked (51% of men, 41% of women). Since then, smoking has more than halved and the gap in prevalence of smoking between men and women has narrowed; in 2011, 20% of adults smoked (21% of men, 19% of women).

Although fewer people smoke now than in the 1970s, women who still do smoke consume similar numbers of cigarettes (12 per day in 2011 compared with 13 in 1974), and consumption has fallen only slightly in menfrom 18 ciga-rettes per day in 1974 to 13 in 2011.

Alongside smoking, the proportion of adults drinking heavily or frequently has also fallen.

Among 16-24 year olds, the proportion of men drinking more than eight units (double the rec-ommended maximum for men) in one day in the past week fell by almost a third in four years (from 32% in 2007 to 22% in 2011). The proportion of women drink-ing more than six units (double the recommended maximum for women) in any one day fell by a quarter over the same time period, from 24% to 18%.

The proportion of men drinking on five or more days in a week fell from 23% in 1998 to 16% in 2011, while the proportion of women drinking at least 've times per week fell from 13% to 9%. However, the survey found that older people were far more likely than younger people to drink frequently. In 2011, men aged 45 years or more

were more than twice as likely to drink 've times or more per week as those aged 16-44 years.

While lifestyle has improved the population has aged. Between 1971 and 2011, the pro-portion of the population aged 65 years or over

increased from 13.3% to 16.5%.2 However, this ageing has not been reflected in the overall

prevalence of longstand-ing illness or disability. In 1972, 21% of the popula-tion reported living with a longstanding illness or disability. This proportion

rose to 32% in 1991 and has remained steady. The most common longstand-ing illnesses reported were musculoskeletal illnesses, followed by heart and cir-culatory conditions, respira-tory illnesses, and endocrine

and metabolic conditions. How-ever, the proportion of people living with a longstanding ill-

ness or disability has increased from 15% in 1975 to 19% in 2011.Cite this as: BMJ 2013;346:f1583

Clare Dyer BMJA surgeon who worked at Stafford Hospital, where inquiries uncovered hundreds of excess deaths and appalling standards of care between 2005 and 2008, is to face a 'tness to practise hearing at the Medical Practitioners Tribunal Service next week.

Roderic Hutchinson faces allegations of de'-cient professional performance at a 10 day hear-ing, which opens at the tribunal in Manchester on 18 March.

Three medically quali'ed managers at Mid Sta-ordshire NHS Foundation Trust are also set to appear before the tribunal, although no dates have yet been 'xed. They have been named as John Gibson, medical director from 2003 to 2006; his successor, Valerie Suarez, who was appointed in September 2006 and stepped down in March 2009; and their deputy, David Durrans.

The hearings follow investigations by the General Medical Council (GMC) into 42 doctors who worked for Mid Sta-s trust at the time. 1 Hutchinsons case is the 'rst to be sent for a hearing.

A consultant general surgeon and colorectal surgeon, he underwent a GMC assessment of his professional performance in June 2011. The charges allege that his performance was unac-ceptable in the area of working with colleagues, and a cause for concern in the areas of other good clinical care and relationships with patients.

The surgeon was allowed to continue work-ing under conditions including supervision by a named consultant, but the conditions were li.ed in October 2011. He le. Mid Sta-s in September 2012.

A review of the general surgery department at Stafford Hospital by the Royal College of Surgeons in 2009 concluded that the service provided was inadequate, unsafe, and at times frankly dangerous.2

NHS managers who are not doctors are not subject to regulation, but GMC guidance makes it clear that those who are medically quali'ed may be held to account on how they ful'l their management roles. Cite this as: BMJ 2013;346:f1632

Case against doctor from Stafford hospital set to start next week

scores provided the basis for what was ultimately the di-erence of one point in the critical quality scoring between Leeds and Newcastle.

In my view, and commensurate with their duty to properly scrutinise and assess all relevant evidence, the JCPCT [the joint committee] should have considered the sub-scores, she said.

At a further hearing on 27 March to decide what remedy should be granted, the Leeds cam-paigners are expected to argue that the decision on 4 July 2012 to concentrate childrens heart sur-gery at the seven sites should be quashed. The joint committee is expected to seek an appeal.

The Royal Brompton initially succeeded in a High Court challenge to the plans but lost on appeal.2

If the decision is quashed, the Leeds campaign-ers would argue that surgery should continue at Leeds and Newcastle, the judge said.

Last October the health secretary, Jeremy Hunt, referred the decision to close the three units to the independent recon'guration panel, which advises on contested changes to health services in England. The panel was expected to deliver its decision by the end of March.3

The units earmarked for closure have argued that the consultation, which began in 2008, has been working with outdated 'gures.Cite this as: BMJ 2013;346:f1575

Britons are making healthier lifestyle choices than 40 years ago

In 1974 the survey found that 41% of women smoked; in 2011 it was 19%

BMJ INVESTIGATION

commissioners who run their own private com-panies and called on GP commissioners to be barred from being involved in companies that they are giving contracts to. 2

But others have said that conflicts are an inevitable by-product of allowing more clini-cians into management positions and said that focusing too much on the issue may prevent commissioners redesigning services e" ectively.

The BMJ analysed the registered interests of 176 of the 211 commissioning group boards, obtained through requests made under free-dom of information legislation and from CCG websites. The remaining groups were not able to disclose their lists, though they must main-tain and publish them from 1 April. 3

Our analysis also showed that 4% of GPs on CCG boards were consultants to or advised private health or pharmaceutical companies, while 5% were employed by a private health company as well as working as a GP.

Some 12% of GPs declared links with not for pro) t voluntary or social enterprise providers that represented a con* ict of interest with their commissioning role, while 9% of GPs declared a con* ict of interest through a family member.

More than a third of GPs on the boards of the new clinical commissioning groups (CCGs) in England have a con* ict of interest resulting from director-ships or shares held in private companies, a new analysis by the BMJ has shown.

An examination of the registered interests of almost 2500 board members across 176 CCGs provides the clearest evidence to date of the con-* icts that many doctors will have to manage from 1 April, when the GP led groups are handed stat-utory responsibility for commissioning around 60bn of NHS healthcare services.

Our investigation shows that con* icts of inter-est are rife on CCG governing bodies, with 426 (36%) of the 1179 GPs in executive positions having a ) nancial interest in a for-pro) t private provider beyond their own general practicea provider from which their CCG could potentially commission services.

The interests range from senior directorships in local for-pro) t ) rms set up to provide services such as diagnostics, minor surgery, out of hours GP services, and pharmacy to shareholdings in large private sector health ) rms that provide care in conjunction with local doctors, such as H armoni and Circle Health.

May 2010 Coalition government is elected. Andrew Lansley (right), who had served as the Conservatives shadow health secretary for six and a half years, is appointed secretary of state for health. But it is understood that the Conservatives policy chief, Oliver Letwin, and the Liberal Democrat MP Danny Alexander drew up the new governments health policy as part of their hastily devised programme for government ( BMJ 2012;345:e4833).

July 2010 Government publishes its NHS white paper Equity and Excellence: Liberating the NHS . This proposes handing sweeping powers to GPs in a major shake-up of the NHS. The radical proposals include the abolition of primary care trusts and the establishment of new consortiums, led by GPs, to manage NHS commissioning budgets ( BMJ 2010;341:c3796) .

January 2011 Department of Health pub-lishes the Health and Social Care Bill, outlining its vision for healthcare. An accom-panying impact assessment identifi es potential confl icts of interest as a key risk associated with the proposed changes ( BMJ 2011;342:d507).

April 2011 Government announces pause in the passage of the Health and Social Care Bill, prompted by concerns

from the Liberal Democrats, the Labour Party, and the medical profession. Steve Field, former RCGP chairman (below), is put in charge of the Future Forum set up to hear such concerns during the pause ( BMJ 2011;342:d2216).

June 2011 After the listening exercise conducted during the pause the government announces that the GP consortiums will be renamed clinical commissioning groups (CCGs) to refl ect the wider clinical involvement beyond GPs. It says that each CCG must have at least two other clinicians on its governing body, including at least one secondary care specialist doctor ( BMJ 2011;342:d3777).

In some cases most of the GPs on the CCG gov-erning body have ) nancial interests in the same private healthcare provider.

Some doctors have relinquished interests in private enterprises because of their new roles as commissioners. These include GPs linked to Richard Bransons Virgin Care, which announced in October 2012 that it planned to end its joint venture partnerships with over 300 GPs in Eng-land, 1 a. er admitting that many were becoming increasingly worried about the perception of potential con* icts of interest.

Calls for doctors with interests to step down But our analysis found that, in total, 555 (23%) of 2426 clinical, lay, and managerial members of CCG governing bodies had a ) nancial stake in a for-pro) t company.

Leading GPs, including a senior government adviser on commissioning, have called for doc-tors with con* icts that were too great to step down and have urged the NHS Commissioning Board to o" er tougher guidance to those with multiple interests. Last week the BMAs UK con-sultants conference passed a motion expressing concern at the clear con* ict of interest of GP

More than a third of GPs on CCG boards have conflicts of interest


On the eve of one of the biggest upheavals in the history of the NHS, Gareth Iacobucci looks at the conflicts at the heart of clinical commissioning groups

Membership of CCG governing bodies

GPs (n=1179)

Other (n=87)

Total number of board members in 176 CCGs analysed (n=2426)

Lay andmanagerialmembers (n=915)

Other clinicalmembers (n=245)

3%

49%38%

10%

2010 2011COMMISSIONINGWHAT HAPPENED WHEN

>>> >>> >>> >>> >>>>

No o

f GPs

0

100

200

300

400

Consult with or advise a private company or drug company

500 Key

Types of interests registered by GPs on CCG boards

Employed by a private company (aside from their GP practice)

Declared a conflict of interest relating to a family member

Personal links with not for pro't voluntary or social enterprise organisations

Directors or have shares in privatecompanies

426

144

106

55 43

BMJ INVESTIGATION

The NHS Commissioning Board has issued rules to CCGs stating that board members must remove themselves from decisions from which they could materially bene! t. 4

Some CCGs have responded to this by includ-ing a provision to co-opt additional members if doctors on the governing body have to remove themselves from decisions. Others have increased the number of lay members on boards to try to alleviate potential con# icts.

But doctors leaders have expressed concern that clinical input into commissioning deci-sions might become diluted if too many doc-tors were forced to remove themselves from particular decisions.

CCGs with notable conflicts Governing bodies with notable con# icts include NHS Leicester City CCG, where seven GPs on the board have a financial interest in the LLR (L eicester, Leicestershire and Rutland) GP Provider Company; NHS Oldham CCG, where ! ve of the eight GPs have an interest in the provider Primary Care Oldham LLP; and NHS Blackpool CCG, where six of the eight GPs have an interest in the local out of hours provider Fylde Coast Medical Services.

Ian Wilkinson, a GP and chief clinical o$ cer at NHS Oldham CCG, who does not have a ! nan-cial stake in a private provider company, said that the CCGs board had also recruited addi-tional lay and clinical members to ensure that decisions could be made if members needed to remove themselves. He added that so far no voting members had removed themselves from governing body or committee proceedings.

Richard Gibbs, a lay board member at NHS Southwark CCG, told the BMJ that his CCG had attempted to deal with con# icts by appointing him as a guardian who would judge when it might be appropriate for members to remove themselves from decisions (box).

A spokeswoman for Leicester City CCG said that a signi! cant proportion of its local general practices were members of the LLR GP Provider Company and said that it would co-opt mem-bers from neighbouring CCGs if its governing body were con# icted. She said, They have to remain neutral, so we would bring in members from our fellow CCGsEast Leicestershire and Rutland/West Leicestershireor bring in a GP member from a neighbouring county such as Northamptonshire.

In NHS Chiltern CCG, in Buckinghamshire, two of the three GPs on the governing body hold shares in the for-pro! t provider Chiltern Health, while in NHS Aylesbury Vale CCG, also in Buck-inghamshire, both GP voting members of the board have interests in the private provider Vale Health. In NHS Southwark CCG, in London, ! ve of nine GPs on the governing body have a stake in various for-pro! t provider companies.

All these CCGs told the BMJ that they had robust systems in place for managing potential con# icts, including publishing their policies on con# icts of interest and regularly updating mem-bers declarations of interest.

Amanda Doyle, a GP and chief clinical o$ cer at NHS Blackpool CCG, told the BMJ that her CCG had sought to tackle potential con# icts by opting to double the number of lay members on its governing body from the minimum set by the government, including a lay chairperson (box).

Doyle acknowledged that most of the GPs on the board would have to step away if the local out of hours service were to be retendered. But she warned that the bene! ts of having doctors leading commissioning might be lost if con# icts of interest gained too much attention.


September 2011 RCGP and NHS Confederation, the membership body for organisations that commission and provide NHS services, publish joint guidance on managing confl icts of interest in clinical commissioning groups (BMJ Careers, http://bit.ly/W7y9wK ).

2012 2013>>> >>> >>> >>> >>>>February 2012 House of Lords agrees amendments to the Health and Social Care Bill stating that CCGs would have to publish registers of board members interests ( http://bit.ly/ wqDqVP ).

June 2012 NHS Commissioning Board Authority publishes a code of conduct. This states that members must remove themselves from decisions from which they could materially benefi t

October 2012

The private sector company Virgin Care, owned by Richard Branson (top right), announces plans to dissolve its joint venture provider partnerships

with GPs, in response to concerns from GPs over confl icts of interest in the new commissioning landscape ( BMJ 2012;345:e7227).

November 2012

NHS Commissioning Board rejects a call from GP commissioning leaders for confl icts of interest to be treated with leniency ( BMJ 2012;345:e7967).

February 2013 In its response to its consultation Securing the Best Value for Patients, health department says that it will strengthen the powers of Monitor, headed by David Bennett (right), to act where confl icts may affect the integrity of a commissioners decision.


BMJ INVESTIGATION

A spokesman for NHS Chiltern CCG said that the group had co-opted additional members to a decision making panel for the recent procure-ment of a GP led minor illness and injury unit where there was potential for perceived con!ict of interest, while NHS Aylesbury Vale CCG said that it had written the ability to co-opt members into its constitution.

Declaring an interest not enoughHowever, despite the measures being taken, James Kingsland, the governments national clinical lead for NHS clinical commissioning and a GP on Merseyside, said that he believed some doctors on local commissioning boards should step down from one of their roles if they had a substantial stake in a local private healthcare company, because their con!icts were too acute.

He said, If it is somebody who has got a major stake in some of the provider services which the CCG commissions, I dont think excluding [himself or herself] or declaring an interest is enoughnot for the public. I think they have got to step down.

Kingsland said that his stance had been criti-cised by some doctors, who were concerned that forcing people to step down could lead to a short-age of clinicians willing to sit on CCG boards.

But he said, That isnt an excuse to allow con-!ict to go. If they are enthusiasts as both senior provider and senior commissioner, my answer would be: make your choice and be accountable for that choice.

If you can justify a marginal amount of con-!ict that can be declared and managed, then "ne. If you cant marginalise a con!ict, and you are excluding yourself from the board week in, week out because youve got an interest, ultimately it becomes unaccountable. Where you draw the line is di#cult; if somebody is going to be the arbiter of that, it should be the public.

The local newspaper testMichael Dixon, chairman of the NHS Alliance, which represents organisations and individual professionals in primary care, has previously called for more leniency in handling con!icts of interest in the new system.5 He warned that placing too much emphasis on the issue might prevent clinical commissioners from bringing more care into community settings.

He said, The priority is to move services out of hospital and into primary care. The reason this hasnt happened to date is because of blocks in the system. Its more important to remove those blocks than be preoccupied with conflicts of interest. Dixon said that he believed that trans-parency is all you need to handle con!icts and urged doctors to use the local newspaper test when assessing their own interests: You have

got to be happy for everything you do as a GP and a commissioner to appear on the front page.

Chaand Nagpaul, the BMAs lead GP negotia-tor on commissioning and a GP in Harrow, called for the NHS Commissioning Board to issue more robust guidance on handling con!icts.

The Commissioning Boards guidance has not gone far enough. Their guidance is all about declaring and managing con!icts, rather than recognising that some con!icts of interest are too great, he said.

Nagpaul said that he supported the idea of CCGs co-opting additional members to help make decisions where con!icts existed, but he said that it was crucial that this extra help did not just focus on lay members, as it could dilute clinical commissioning.

It would undermine the whole concept of clinically led commissioning to not have clinical input, he warned.

A spokeswoman for the NHS Commissioning Board said that it had already published com-prehensive guidance on managing con!icts of interest, which clearly sets out that the decision on whether an individuals con!icts of interest are likely to be so great as to preclude them from taking a role on the governing body should be made by the CCG.

But she said that the board was reviewing its

existing guidance and would shortly be publish-ing "nal, comprehensive guidance on managing con!ict of interest.

Strengthening the rulesThe Department of Health acknowledged in its response to its consultation Securing the Best Value for Patients that concerns about con-!icts needed to be answered, and it pledged to strengthen the power of the healthcare regula-tor Monitor to act where con!icts may a%ect the integrity of a commissioners decision.6

The department said that this would mean that Monitor is able to take action where con-flicts have not been managed appropriately in awarding a contract, and not only where M onitor is able to establish that the decision to award a contract was the result of an interest in the p rovider.

Niall Dickson, chief executive of the General Medical Council, said that there were no new principles involved as far as doctors ethical conduct was concerned. He added, The con-siderable additional responsibilities about to be undertaken by GPs does mean that some face con!icts of interests more o'en than in the past. We expect doctors to be open about any "nancial and commercial interests linked to their work.Cite this as: BMJ 2013;346:f1569

NHS Blackpool CCG

NHS Southwark CCGRichard Gibbs, lay member of the board of the NHS Southwark CCG, said that his group had tried to tackle potential conflicts by appointing him as a guardianwith the remit of exercising judgment on when it might be appropriate for members to remove themselves from decisions.

Gibbs, who has no financial interests in any private providers, said that the CCG had also set up a three person evaluation

panel, comprising himself, the chief officer, and the director of public health, to arbitrate on commissioning decisions where two or more members have to remove themselves from decisions because of conflicts.

We have convened the panel on three or four occasions, Gibbs said. If we needed to get additional expertise then we would co-opt in someone who isnt conflicted, presumably from outside Southwark.

Amanda Doyle, chief clinical officer at NHS Blackpool CCG, who has declared an interest in the local provider of out of hours services, said that her CCG had sought to deal with potential conflicts by opting to have four lay members on its governing bodydouble the minimum set by the governmentincluding a lay chairperson.

We were very conscious of the need to demonstrate that we were not letting conflicts interfere with our decisions,

she explained.But Doyle added that it was

important to strike a balance between managing conflicts appropriately and ensuring that we get a full range of clinical input into service redesign and commissioning decisions.

She warned, There is a risk of getting so tied up with worrying about conflicts of interest that you dont go ahead and reap the benefits of having clinicians leading commissioning.

Doyle acknowledged that most

GPs on the board would have to step away if the local out of hours service were to be retendered. She said that it was unlikely that the board would co-opt additional clinicians onto the board in such a case but said that it may take clinical input and advice from outside the area if this was needed.

TACKLING THE ISSUE OF CONFLICTS OF INTEREST


Editorials are usually commissioned. We are, however, happy to consider and peer review unsolicited editorials ! See http://resources.bmj.com/bmj/authors/types-of-article/editorials for more details

EDITORIALS

Is an EMA review of hormonal contraception and thrombosis needed?Sufficient evidence exists to recommend lightest tolerable second generation pill for all indications

Frans M Helmerhorst professor in clinical epidemiology of fertility [email protected] R Rosendaal professor in clinical epidemiology, Leiden University Medical Center, 2300 RC Leiden, Netherlands

Four recently reported deaths in women using the Diane-35 contraceptive and a lawsuit against the French drug authority (LAgence Nationale de Scurit du Mdicament) a#er it banned Diane-35 led the authority to request that the European Medicines Agency (EMA) review the safety of combined oral contraceptives.1 2 Of particular concern were third and fourth generation drugs, including Diane-35 and its generics. This review was granted on 7 February 2013.3 4 The Dutch College for the Evaluation of Medicines (Dutch EMA) decided that a new study on Diane-35 was in order.

Most oral contraceptives are combination preparations, containing a progestogen, to prevent ovulation, and an oestrogen to prevent breakthrough bleeding. Since the introduction of the pill, the oestrogen dose, in the form of ethinyl estradiol, has been reduced (heavy v light pills) and the type of progestogen has changed several times (indicating the generation). The categorisation is imprecise and incomplete. For example, cyproterone acetate, the progestogen in Diane-35, does not belong to a generation. Furthermore, the categorisation assumes that all side e*ects of oral contraceptives are class e*ects. In our recent network meta-analysis of all combined oral contraceptives (unpublished data), we found that the risk of venous thrombo-sis depended on the dose of oestrogen and the type of progestogen, even within generations.

Many studies have shown that oral contra-ceptive users have an increased risk of venous thrombosis (deep vein thrombosis, pulmonary embolism) and arterial thrombosis.5 6 Venous thrombosis is more common than arterial throm-bosis, but in young women the incidence of these side e*ects is low. Even the safest oral contra-ceptive increases the risk of venous thrombosis, however, and the risk is twice as high for oral

contraceptives containing a third generation progestogen, drospirenone (sometimes called fourth generation), or cyproterone acetate.5 This knowledge is not newthe increased risk for pills containing third generation progestogens, cyproterone acetate, and drospirenone has been known since 1995, 2001,7 and 2003, respec-tively.8

The EMAs public report at the beginning of the review states that Diane works by blocking the e*ects of a class of hormones called androgens,3 and that this is responsible for its supposed ben-e.ts on acne and hirsutism. However, as early as 2004 (and in three updates) a systematic review concluded that all types of monophasic com-bined oral contraceptives are e*ective against acne.9

All combined oral contraceptives are equally effective in preventing pregnancy. Their side e*ects (such as weight gain10) and bene.ts (in terms of acne and hirsutism) are also similar, so the only rational strategy is to use the safest one with regard to venous thrombosis. The common arguments that the risk of thrombosis is low or that the risk of thrombosis during pregnancy is higher than when using oral contraceptives are flawed. Millions of women in Europe use oral contraceptives, so use of the pill with the best safety pro.le in terms of thrombosis would

probably prevent thousands of thrombotic events and hundreds of deaths a year. Because the pill with the safest thrombosis pro.le is as e*ective at preventing pregnancy as the less safe ones, the risk of thrombosis in pregnancy is irrelevant in the choice of oral contraceptive. The safest oral contraceptive is one that contains the low-est tolerable dose of ethinylestradiol (lowest dose that prevents breakthrough bleeding30 g11) together with the second generation pro-gestogen, levonorgestrel.

Sufficient evidence is already available on which clinicians and regulatory agencies can base their decisions, so lengthy evaluations, let alone new studies, are not needed.

In his 2011 BMJ editorial, Nick Dunn recom-mended prescribing an oral contraceptive that contains levonorgestrel unless there is a persist-ent reason to use another type.12 Because oral contraceptives containing levonorgestrel and the lowest tolerable dose of oestrogen are also adequate for the treatment of acne or hirsutism, we can see no reason to use another type. Third and fourth generation oral contraceptives are widely overprescribed.Competing interests: None declared.Provenance and peer review: Commissioned; not externally peer reviewed.References are in the version on bmj.com.Cite this as: BMJ 2013;346:f1464

Response on bmj.comIt is wise to consider all of the many serious conditions caused by use of hormonal contraception including the increased risks of suicide and breast cancer. Ellen CG Grant, retired medical gynaecologist, Kingston-upon-Thames, Surrey

! Visit the article online and click Respond to this article to have your say.

French drug authority LAgence Nationale de Scurit du Mdicament recently banned Diane-35

BSIP

, B B

OISS

ONNE

T/SP

L


EDITORIALS

Cognitive deficits and mild traumatic brain injury New study identifies risk factors and raises questions about the nature of any implied causal association

V F J Newcombe academic clinical fellow in emergency and intensive care medicine D K Menon professor of anaesthesia, Division of Anaesthesia, University of Cambridge, Addenbrookes Hospital, Cambridge CB2 2QQ, UK

Between 7% and 33% of patients who have mild traumatic brain injury (sometimes called concussion) develop persistent post-concussion syndrome, which may last weeks to months a#er injury.1 More than 15% have a measurable cognitive de&cit at one year.2 3 There is grow-ing interest in the syndrome of post-traumatic encephalopathy,4 5 which may follow a blast injury or repeated sports related concussion. However, despite this growing literature on the cognitive consequences of mild traumatic brain injury, our knowledge of risk factors that predis-pose people to sustaining such injury is limited.

In a linked paper, Nordstrm and colleagues examine the associations and temporal associa-tions between a history of concussion, cognitive function, academic achievement, and measures of social wellbeing in a cohort of more than 300 000 Swedish conscripts.6 Given the paucity of data on premorbid neurocognitive testing in traumatic brain injury, this paper draws on an impressively large dataset that allows comparison of neurocognitive function before and a#er such injury in a nationwide cohort of Swedish men.

The results complement an earlier study from the same group, which examined the association between cognitive performance and incidence of a subdural haematoma.That study concluded that low global intelligence in adolescence was a risk factor for subsequent development of a subdural haematoma.

Although the current study investigates a more common diagnosis, case ascertainment was probably less precise than the more clearly de&nable endpoint of subdural haematoma. The case ascertainment of concussion that the authors used was based on the International Classi!cation of Diseases and probably repre-sents the best epidemiological approximation achievable in the administrative databases that were searched. However, a substantial propor-tion of patients with mild traumatic brain injury are never admitted to hospital or seen in the outpatient setting. Therefore, this study prob-ably underestimated the incidence of this con-

dition in the study population. Conversely, the approaches used may not have fully excluded subjects who sustained a moderate or severe injury. Cross correlating multiple sources of data could mitigate against this source of confound-ing, which is common when administrative data-sets are analysed.8

Despite these caveats related to case ascertain-ment, Nordstrm and colleagues study provides unique insights into the epidemiology of mild traumatic brain injury. Unsurprisingly, poor cog-nitive function, low educational status, and other risk factors were associated with mild traumatic brain injury. However, surprisingly, the associa-tion between cognitive function and concussion did not depend on the temporal association between the two and was just as common when poor cognitive performance preceded concus-sion. In addition, similar cognitive scores were seen before and a#er injury in twins discordant for mild traumatic brain injury, which suggests that both genetic and environmental in,uences contributed to the low cognitive function found. Other strong independent (but not unexpected) risk factors for development of mild traumatic brain injury included a previous episode of brain injury, hospital admission for intoxication, and low education and socioeconomic status. Sur-prisingly, the analysis found no signi&cant di-er-ences in cognitive performance before and a#er

the index event in men who sustained an injury.These results are important for several rea-

sons. Firstly, they identify potential risk factors for mild traumatic brain injury and could help guide attempts to investigate prevention strate-gies, perhaps through education initiatives (par-ticularly in accessible populations such as the military conscripts investigated here). Secondly, they provide a context for interpreting studies that measure cognitive function a#er injury only and compare it with matched controls from the general population, with the assumption that those with brain injury have similar pre-injury characteristics to the general population. The results of this study suggest that such assump-tions may be incorrect. Finally, those who subse-quently sustained a mild traumatic brain injury had similar cognitive performance to that of those who had previously sustained such an injury, which implies that the injury itself may not reduce cognitive function. However, the tests used (word recollection; visuospatial geometric perception; logical and inductive performance; and mathematical and physics problem solving) have not been validated as sensitive measures of changing performance in cognitive areas thought to be a-ected by mild traumatic brain injury. These tests may therefore have missed important changes.

It is important that additional studies attempt to replicate these &ndings. Suitable populations for such studies include other military cohorts and cohorts of people who practise contact sports, which are associated with a relatively high incidence of mild traumatic brain injury. Such studies must take account of gaming by soldiers and sportspeople, who allegedly choose to perform suboptimally on pre-injury cognitive screening to hide evidence of any post-injury cognitive decrement, thus enabling them to stay with their units and teams. Although it may not be easy to control for such confounding, more studies like the current one will increase our understanding of the epidemiology, patho-physiology, and outcome impact of traumatic brain injury.Competing interests: None declared.Provenance and peer review: Commissioned; not externally peer reviewed.References are in the version on bmj.com.Cite this as: BMJ 2013;346:f1522

bmj.com ( Neurology updates from BMJ Group are at www.bmj.com/specialties/neurology

Poor cognitive performance linked to concussion

JAM

ES D

AVIE

S/AL

AMY


EDITORIALS

Regulating the NHS market in EnglandThe government must make its intentions clear as it rewrites the regulations on competition

Chris Ham chief executive, Kings Fund, London W1G 0AN, UK [email protected]

The governments dra! regulations on procure-ment, patient choice, and competition, pub-lished in February, have opened up old wounds in the debate about NHS reform. The regulations set out in detail how commissioners should pro-cure NHS services under section 75 of the Health and Social Care Act 2012. The stated aim of the regulations, which will be enforced by Monitor as the economic regulator, is to ensure that the NHS Commissioning Board and clinical commis-sioning groups act to protect patients rights and to prevent anti-competitive behaviour.1

The government claims that the regulations follow from commitments given during the passage of the 2012 act and are consistent with the Principles and rules for cooperation and competition put in place by the previous administration. Its critics contend that they go much further and represent a major extension of market principles in the NHS. In this they are supported by legal advice, which argues that commissioners of NHS services will be expected to make greater use of tendering, with competition becoming the norm for placing NHS c ontracts.2

The governments critics comprise general practitioner leaders who are worried that clini-cal commissioning groups will have to use ten-dering to procure all services; Liberal Democrat MPs and peers who fear this will make it more di'cult to promote integrated care; and oppo-sition politicians who interpret the regulations as con(rmation that ministers are hell bent on opening the NHS up to the private sector. In the face of these concerns, the government has announced that it will amend the regulations to ensure that they are not open to misinterpre-tation. Statements made by ministers indicate that this means commissioners will not have to tender all services, Monitor will not force com-missioners to tender competitively, and compe-tition will not take precedence over cooperation and integration.3

The decision to make these changes less than a month before the provisions of the 2012 act come into e*ect is embarrassing for the govern-ment. It re+ects both the in+uence of the Liberal

Democrats within the coalition and the need to retain the support of GP leaders, who will play a key role in the work of clinical commission-ing groups. If these leaders had walked away at this stage, the edi(ce on which the reforms are based might well have crumbled to the ground even before it had come into being.

Underlying the debate about the precise wording of the regulations is the more impor-tant question of the governments intentions regarding the role of markets in the NHS. On this question there is room for legitimate doubt in the light of the debate on the 2012 act and the amendments made a!er the work of the NHS Future Forum. Particularly important was the change to Monitors role from an original duty to promote competition to a revised duty to pro-tect and promote the interests of people who use healthcare services, and in so doing to prevent anti-competitive behaviour.

These amendments may have watered down Andrew Lansleys ambitious plans to apply market principles to the NHS, but the architec-ture of economic regulation set out in part 3 of the 2012 act remains in place. A key element in this architecture is the role that the O'ce of Fair Trading (OFT) and the Competition Commission will play in the future NHS. In the debate about the regulations, the involvement of the OFT in assessing the proposed merger of two NHS foun-dation trusts in the south of England has gone largely unnoticed. The OFT is also investigating the proposed merger of an NHS foundation trust and an NHS trust in Torbay, which is designed to bring about closer integration of services in an area well known for its innovative approach to the care of older people.

The question this raises is whether this kind of market regulation is needed in the NHS in addition to the new role of Monitor? There are many di*erences between healthcare and the industries that OFT and the Competition Com-mission regulate, and there is a danger that regulators with experience in other sectors will adopt an approach that is not sensitive to these di*erences. Overexuberant regulation of merg-ers could delay the implementation of service changes that may bene(t patientsfor example, by preventing the full integration of care as is being proposed in Torbay.

It is worrying that fundamental questions of this kind are unresolved so close to the date of implementation of the reforms. Evidence that competition in healthcare is bene(cial is both equivocal and contested.4 5 Even where bene(ts can be delivered, these have to be set against the considerable transaction costs involved in con-tract negotiations between commissioners and providers and the work of the regulators. The well known limits to markets in healthcare mean that planning, collaboration, and clinical networks6 should also play a major role in bringing about improvements in care.

Where markets are used, regulators need to be sensitive to the di*erent forms of competition in healthcare. Competition in the market has a role in situations where patients have the time and inclination to decide where to obtain treatmentfor example, when receiving planned care. Com-petition for the market should be the preferred approach when commissioners want di*erent providers to work together under long term con-tracts to deliver integrated urgent care and care for groups such as older people and those with complex needs.7 A nuanced approach that com-bines the right kind of competition alongside planning, collaboration, and clinical networks, where appropriate, is most likely to deliver the desired results.

If GP leaders and Liberal Democrats are to withdraw their opposition, the government needs to provide reassurance on its intentions with regard to regulating the NHS market. To avoid doubt, ministers must be explicit about the place of markets in the NHS, including the role of the OFT and Competition Commission, when they publish the revised regulations. Without absolute clarity on these questions, there is a risk of uncertainty and misinterpretation by the com-missioners and regulators tasked with making the regulations and the 2012 act work in practice.

There is also every possibility that old wounds will not heal and will cause even deeper ri!s within the coalition, which will create politi-cal difficulties for the government as well as u nwelcome confusion for the NHS.Competing interests: None declared.Provenance and peer review: Commissioned; not externally peer reviewed.References are in the version on bmj.com.Cite this as: BMJ 2013;346:f1608

Underlying the debate about the precise wording of the regulations is the much more important question as to the governments intentions on the role of markets in the NHS


EDITORIALS

The new UK antimicrobial resistance strategy and action planA major societal, political, clinical, and research challenge

New challenges will include screening (by rec-tal swab) and isolation of any patient admitted to the NHS who has received inpatient care outside the UK, with rigorous control of any outbreaks of multidrug resistant infection inside the NHS. Acute trusts and their boards will need to con-sider how to strengthen infection prevention and control practice using new methods of organisa-tional and behavioural change.

Antimicrobial prescribing needs to be more evidence based and more e!ciently targeted. New NHS initiatives to provide antimicrobial stewardship guidance in secondary care (Start Smart then Focus) and primary care (TARGET antimicrobial toolkit)8 need to develop into more formal quality indicators.

This strategy makes the UK the #rst country to explicitly announce its intention to develop national outcome measures in AMR using speci#c drug-bug combination resistance rates (for example, rates of E coli resistance to third generation cephalosporins). This is a brave move and should be welcomed. The chief medical o!cer has taken a clear leadership role by tackling the international dimensions of the problem, adding AMR to the Department of Health risk register and calling for AMR to be added to the national risk register (National Security Risk Assess-ment) to promote cross government action. Impor-tant areas that will be covered include antimicrobial use in animals and new initiatives to encourage the development of novel antimicrobials.1

The wider application of molecular microbiol-ogy, particularly whole genome sequencing, to detect clonal spread of MDR Gram negative bacteria within hospitals is providing a rapid explosion of new data. It is still unclear if this will lead to e%ec-tive new control policies. The research agenda is extensive, but the NHS information technology and National Institute of Health Research infrastruc-tures are well placed to provide global leadership in this area.9 New technology focusing on rapid diagnosis of speci#c bacteria and resistance genes, along with combination biomarkers indicating bacterial or viral infections, especially if adapted to near patient testing, could have a major impact on targeting appropriate antibiotic treatment. Improved surveillance by Public Health England, using large dataset linkage combined e!ciently with observational studies focused on clinical out-comes, including all infection related deaths, will also help to de#ne new targets for intervention.Competing interests are in the version on bmj.com.Provenance and peer review: Not commissioned; externally peer reviewed.References are in the version on bmj.com.Cite this as: BMJ 2013;346:f1601

Anthony S Kessel honorary professor, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK Mike Sharland professor in paediatric infectious diseases, Paediatric Infectious Diseases Research Group, St Georges University London, London SW17 0RE, UK [email protected]

This week the chief medical o!cer highlighted in her report how the rise of antimicrobial resistance (AMR) poses a threat to healthcare delivery in the United Kingdom.1 This will be followed shortly by the Department of Healths new UK Five Year Anti-microbial Resistance Strategy and Action Plan, which will re'ect the need for a clear change in the understanding and response to AMR by the public, the NHS, and the government in the UK. The rise of AMR as a serious health threat is due to the inter-national spread of multidrug resistant (MDR) Gram negative bacteria, the global overuse of antibiotics in humans and animals, and the almost complete lack of new antibiotic development.2 All of these are now of direct concern to the NHS.

The 85% reduction in rates of meticillin resistant Staphylococcus aureus (MRSA) bloodstream infec-tions seen in England between 2003 and 2011 has been remarkable. MRSA is now responsible for less than 2% of all bloodstream infections in England. Less remarked on has been the inexora-ble rise in the number of bloodstream infections attributable to Gram negative organisms (particu-larly Escherichia coli), which now comprise more than half of the around 100 000 of these infections reported in England annually.3 Most large NHS hospitals now identify 50-100 times more patients with Gram negative bloodstream infections than those with MRSA, with antibiotic resistance rates of 10-20% and mortality rates of 30% reported for MDR forms.4 In England the successful introduc-tion of conjugate pneumococcal vaccine means that the number of reported Klebsiella pneumoniae bloodstream infections in England is now higher than for Streptococcus pneumoniae.

In many European countries AMR rates are much worse. In 2011 the European Centre for Disease Pre-vention and Control reported a signi#cant increase in multidrug resistant E coli and K pneumoniae (for example, resistance to third generation cepha-losporins, 'uoroquinolones, and aminoglycosides) in more than a third of European Union/European Economic Area countries.5 Klebsiella is an impor-tant pathogen in the spread of resistance. Many anti-biotic resistance genes group together in plasmids easily transferred between bacteria, with particular clones carrying multiple resistance genes (for exam-ple, OXA-48 and CTX-M15). Many EU countries are now reporting Klebsiella MDR rates of 25-40%.

Globally, rates of MDR Gram negative bacterial infection can be even higher.6 This has inevita-bly led to a rapid rise in the use of carbapenem antibiotics (for example, meropenem) as empiri-cal treatment for suspected sepsis. In turn, this has led to a rapid increase in hospital outbreaks of carbapenemase producing organisms, which are usually sensitive to only one or two older less e%ective antibiotics. In the UK, there has also been a sharp rise in meropenem use and increasing reports of carbapenemase producing organisms. Only one or two new antibiotics that target Gram negative organisms are likely to be marketed in the next decade (http://antibiotic-action.com), which raises the concern that virtually untreatable i nfections will threaten routine NHS care.7

The new UK strategy is an important step in rec-ognising and responding to these concerns. At its core the strategy recognises that AMR, infection prevention and control, and antimicrobial steward-ship are closely interconnected and all need to be strengthened. The seven aims (table) re'ect that all individuals and organisations have unique roles and responsibilities. Enhanced infection preven-tion and control are crucial to limiting the spread of MDR Gram negative bacteria, both into and across the NHS.

UK antimicrobial resistance strategy: seven action areas and likely stakeholder involvement in the health sectorSeven key areas of focus StakeholdersPromote responsible evidence based prescribing

Individual prescribers, NHS providers, national and local commissioning boards, ARHAI, PHE, Department of Health, professional bodies

Improve infection prevention and control

Individual clinical staff, NHS providers, national and local commissioning boards, ARHAI, Department of Health, PHE, professional bodies

Raise public and professional awareness of antimicrobial resistance threat and promote behaviour change

Professional bodies, Department of Health, ARHAI, patient groups

Research programme into new diagnostics, alternatives to antibiotics (such as antiseptics), pathogenesis, effective behavioural change to improve infection prevention and control and prescribing practice

NIHR, universities, Department of Health, ARHAI

Facilitate development of new antimicrobials, vaccines, and immunomodulators

Department of Health, drug industry, European Union

Improve surveillance and data linkage

PHE, ARHAI, Department of Health

Encourage international collaboration and data sharing and learning from best practice internationally

Department of Health, PHE

ARHAI=Department of Health Expert Advisory Committee on Antimicrobial Resistance and Healthcare Associated Infection; PHE=Public Health England. NIHR=National Institute for Health Research.


The BMJ is an Open Access journal. We set no word limits on BMJ research articles, but they are abridged for print. The full text of each BMJ research article is freely available on bmj.com

Scan this image with your smartphone to read our instructions for authorsRESEARCH

RESEARCH NEWS

RESEARCH NEWS All you need to read in the other general medical journals Alison Tonks, associate editor, BMJ [email protected]

violence has le! us without the means to "nd out. These authors did what they could with the data available, but the data are woefully inadequate in the face of an epidemic of gun violence that has killed more than 300 000 US citizens since 2001 and seems to be intensifying. No more than a handful of researchers are currently working in the "eld, thanks to a concerted political e'ort by the National Ri(e Association in the early 1990s, says the editorial. Research must resume now, to deepen our understanding of this complex prob-lem and "nd ways to "x it.JAMA Intern Med 2013; doi:10.1001/jamainternmed.2013.1286Cite this as: BMJ 2013;346:f1570

Six women pilot deep brain stimulation for anorexia nervosa

Six women with intractable and life threatening anorexia nervosa have been treated with deep brain stimulation in a preliminary study from Toronto, Canada. Doctors selected the women for deep brain stimulation a!er many years of unsuc-cessful conventional management. They had average body mass indices (BMIs) of 11 to 15 in the years leading up to the study, accompanied by multiple medical complications of chronic starva-tion. Five had psychiatric comorbidities, most o!enmajor depression and obsessive compulsive disorder.

Surgeons placed electrodes just beneath the corpus callosum. One patient had a self limiting panic attack during the local anaesthetic phase of the procedure and one developed a cardiac air embolus that resolved within "ve minutes a!er the operating table was repositioned. A third patient had a seizure during device programming two weeks a!er the procedure. It was switched o' then restarted one week later with no further problems.

Three of the six women gained weight during nine months of stimulation (BMIs increased from 11.1 to 21, 14.2 to 16, and 15.1 to 20). They also reported improved quality of life. Symptom scores measuring mood, anxiety, and anorexia nervosa related obsessions and compulsions improved in four patients.

The pilot was designed to assess safety, not e'ectiveness. The authors judge deep brain stim-ulation to be safe enough for further evaluation.Lancet 2013; doi:10.1016/S0140-6736(12)62188-6Cite this as: BMJ 2013;346:f1566

Treating depression after acute coronary syndrome

Depression is common a!er hospital admission for acute coronary syndrome and international guidelines recommend screening and treat-ment. A recent trial tested a programme of care that allowed people with depression symptoms to choose between psychotherapy, antidepres-sant drugs, or a combination of the two. The programme worked well, reducing symptoms signi"cantly more than usual care over six months (an extra 3.5 point drop in Beck depression inven-tory score, 95% CI 6.1 to 0.7).

All 150 participants had symptoms of depression two to six months a!er treatment for acute coronary syndrome. Among 73 assigned to the new programme, 41 chose psychotherapy, nine chose drugs, and 17 chose the combina-tion. Their care was organised by a remote team of mental health professionals who met once a week to discuss cases and advise a local doctor or nurse prescriber. A centralised team also provided psychotherapy (problem solving therapy) over the telephone or by video link and followed a stepped care algorithm that intensi"ed treatment every six to eight weeks if required.

This programme contained all the elements known to work from previous trials and intro-duced the idea that organisation, coordination, and support does not have to be local to be suc-cessful, says a linked comment (doi:10.1001/jamainternalmed.2013.925).JAMA Intern Med 2013;doi:10.1001/jamainternalmed.2013.915Cite this as: BMJ 2013;346:f1567

Whole mummy scans confirm ancient atherosclerosis

An international team of researchers has found clear evidence of atherosclerosis among 137 mummies from diverse ancient cultures. Com-puted tomography showed vascular calci"cation in 29 of 76 mummies from ancient Egypt, 13 of 51 from ancient Peru, two of "ve mummies from a Puebloan people who lived in south west America between 1500 BC and AD 1500, and three of "ve mummies from a population of hunter gatherers who lived more recently on remote islands 500 miles o' modern day Alaska.

Overall, a third of the mummies examined had de"nite or probable atherosclerosis in at least one vascular bed, usually more. Two mummies had disease in all "ve vascular bedsan ancient Egyptian princess, Ahmose-Meritamun, who died in early middle age, and a slightly older woman from the Aleutian islands who would have been a hunter gatherer eating mainly "sh and shell "sh.

The researchers and a linked comment agree that atherosclerosis is not as modern as we think it is (doi:10.1016/S0140-6736(13)60639-X). Sim-ilar disease was common in geographically and culturally di'erent populations that spanned at least 4000 years of human history.Lancet 2013; doi:10.1016/S0140-6736(13)60598-XCite this as: BMJ 2013;346:f1591

Stronger gun laws, fewer deaths

US states with the strongest gun laws have the lowest rates of death caused by "rearms, accord-ing to a nationwide cross sectional analysis. The authors ranked 50 states using a score of legis-lative strength that counted then weighted gun control laws up to a maximum score of 28. States in the highest quarter, such as Massachusetts and Illinois, had 6.6 fewer deaths per 100 000 each year than states in the lowest quarter, such as Louisiana and Utah (incident rate ratio 0.58, 95% CI 0.37 to 0.92). The di'erence survived multiple adjustments for state demographics, including poverty and population density.

Did gun control save those extra lives? Its impos-sible to say, says a linked editorial (doi:10.1001/jamainternmed.2013.1292). The systematic and deliberate erosion of funding for research into gun

Adapted from JAMA Intern Med 2013; doi:10.1001/jamainternmed.2013.1286

Legislative strength and mortality by state

2.9-8.0 8.1-10.1 10.2-13.0 13.1-18.0

III

III

III IIIIII

III

III

III

IIII

I

I

I

II

IIII

IIIII

III

IIIIII

II

II

II

II

II

II

I

I I I

I

II I

IIIV

IVIV

IVIVIVIV

IVIVIV

IV

IVIII

Hawaii

Mortality rate per 100 000, mean

First quarter: 0-2 lawsSecond quarter: 3-4 laws

Third quarter: 5-8 lawsFourth quarter: 9-24 laws

Legislative strength score, median

Alaska

IV

I

I


RESEARCH

Correspondence to: P Bower, NIHR School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Manchester M13 9PL, UK [email protected] this as: BMJ 2013;346:f540doi: 10.1136/bmj.f540

Details of the authors affiliations are given in the full article on bmj.comThis is a summary of a paper that was published on bmj.com as BMJ 2013;346:f540

STUDY QUESTION Do patients with more severe depression benefit less from low intensity psychological therapy than those with milder depression?

SUMMARY ANSWER No, patients with more severe depression show at least as much clinical benefit from low intensity interventions as less depressed patients.

WHAT IS KNOWN AND WHAT THIS PAPER ADDS To better manage the high prevalence of depression in the community, many services seek to provide simple forms of psychological therapy (low intensity interventions), but whether patients with more severe depression are suitable for such interventions is not known. We found no clinically meaningful differences in treatment effects between more and less severely ill patients receiving low intensity interventions.

SELECTION CRITERIA FOR STUDIES We searched published systematic reviews, updated with a search of the Cochrane Library, for randomised controlled trials of low intensity interventions (such as interventions provided through written materials or the internet with limited professional support) in patients with depression.

Primary outcome(s)Our primary outcome was the relation between initial depression severity (measured with the Beck Depression Inventory or Center for Epidemiologic Studies Depres-sion Scale) and the amount of clinical bene!t (change in depression score) that patients received from low intensity interventions.

Main results and role of chanceWe used individual patient data from 16 trials including 2470 patients. We found a signi!cant interaction between baseline severity and treatment e(ect (coe)cient 0.1 (95% CI 0.19 to 0.002)), suggesting that patients who are more severely depressed at baseline demonstrate larger treatment e(ects from low intensity interventions than those who are less severely depressed. However, the magnitude of the interaction was small and may not be clinically signi!cant.

Bias, confounding, and other reasons for cautionWe were unable to access all published data on low inten-sity interventions, obtaining individual patient data from just over half of the 29 eligible studies. Although we found no clinically meaningful di(erences in treatment e(ects between more and less severely ill patients receiving low intensity interventions, patients with more severe depres-sion are more likely to continue to show clinically sign

bmj - 16 march 2013

Documents

p xxsufficient evidence

staord hospital

number of hospital beds

cost of antibiotic resistance

new antibiotics

unfair new rules

avoidable emergency

cognitive deficits