THIS WEEK

BMJ | 4 MAY 2013 | VOLUME 346

!CLINICAL REVIEW, p "#

NEWS1 Nearly half of UK young doctors say stress levels

rose last year New trials of gene therapy for heart failure start

2 BMA calls for meeting after health secretary blames GPs for pressure on emergency care

Children to get vaccines against flu and rotavirus

Peers reject bid to annul new NHS rules on competition

3 Blood test detects genes that drive breast cancer

4 Private Eye sends up tobacco industry’s attack on plain packets

Medical leaders are considered to have gone over to “dark side”

5 Makers of anticancer drugs are “profiteering,” say 100 specialists

Checklists can reduce errors in intraoperative emergencies

6 Health effects of Greece’s austerity are “worse than imagined”

Evening primrose oil and borage oil do not help eczema symptoms

Belfast children’s heart surgery unit should close, says health board

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 w!, w", etc) and be labelled as extra on bmj.com. Please cite all articles by year, volume, and elocator (rather than page number), eg BMJ "#!$; $%&:f"'&. 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 Measles in the UK: a test of public health competency in a crisisFelix Greaves and Liam Donaldson ! OBSERVATIONS, p $%

8 Orlistat: should we worry about liver inflammation?John Wilding! RESEARCH, p &$

9 Recognising and responding to victims of human traffickingSharon Doherty and Rachel Morley

10 Understanding patterns in maternity care in the NHS and getting it rightLucy C Chappell et al

FEATURES16 Research Paper of the Year award 2013

This annual BMJ award recognises outstanding original research with potential to contribute considerably to improving health and healthcare. Trish Groves introduces the shortlist

17 Making the digital future a realityJon Hoeksma looks at the candidates for the Transforming Patient Care Using Technology award

ANALYSIS18 Innovate or die

Health systems must innovate to survive the pandemic of non-communicable disease but many innovations do not spread easily. Paul Corrigan, Christopher Exeter, and Richard Smith examine why this is so and how to help them spread

JUST

IN H

ARRI

S

RESEARCHRESEARCH NEWS

11 All you need to read in the other general journals

RESEARCH PAPERS12 Orlistat and the risk of acute liver injury: self

controlled case series study in UK Clinical Practice Research Datalink Ian J Douglas et al! EDITORIAL, p '

13 When to remeasure cardiovascular risk in untreated people at low and intermediate risk: observational study Katy J L Bell et al

14 Predictive value of S-100! protein for prognosis in patients with moderate and severe traumatic brain injury: systematic review and meta-analysisEric Mercier et al

15 Can trial quality be reliably assessed from published reports of cancer trials: evaluation of risk of bias assessments in systematic reviews Claire L Vale et al

Caption, p xx

Orlistat is still a useful option in some patients, p '

China has introduced innovative measures to fight NCDs, p &'

A half of young doctors say workplace stress is rising, p &

THIS WEEK

BMJ | 4 MAY 2013 | VOLUME 346

Join yourcolleagues.

masterclasses.bmj.com

The MMR vaccine, p !"

COMMENTLETTERS

21 Doctors and the alcohol industry

22 Clarithromycin’s adverse effects; Patient reported outcome measures; Health and Social Care Act

OBSERVATIONSPUBLICATION ETHICS

23 The UK should lead the way on research integrityElizabeth WagerMEDICINE AND THE MEDIA

24 The private clinics advertising unlicensed measles jabsMary McCartneyBMJ BLOG

25 An immensely delicate balance: the challenges for CCGsRichard Vize

PERSONAL VIEW26 No doctor should be untouchable

Peter Wilmshurst27 Caring for patients with dementia:

an exceptional caseKate Sartain

OBITUARIES28 Thomas Dormandy

Chemical pathologist who studied free radicals and wrote an acclaimed book on tuberculosis

29 James Reginald Searle Barton; David James Martins Buddery; John Denys Campling; David Malcolm Milne; John Joseph Smirke Herbert Ruston; Carl Ludwig Scholtz; Julian Stanley Martyn Toms

LAST WORDS39 Bad medicine: the way we manage diabetes

Des Spence Portfolio of pap Oliver Ellis

EDUCATION CLINICAL REVIEW

30 Adolescent idiopathic scoliosisFarhaan Altaf et al

PRACTICEA PATIENT’S JOURNEY

35 Visual agnosia Anonymous and Anna Basu10-MINUTE CONSULTATION

36 Vasectomy S Jamel et al

ENDGAMES38 Quiz page for doctors in training

MINERVA40 Army musicians, and other storiesMeasures to make dementia patients happy in hospital, p !#

Scoliosis testing, p $%

THIS WEEK

BMJ | 4 MAY 2013 | VOLUME 346

PICTURE OF THE WEEK A three dimensional computer simulation of a man’s head and neck is unveiled by Paul Anderson, director of the Digital Design Studio at the Glasgow School of Arts. The project, funded by NHS Education in Scotland, could revolutionise anatomical training, its creators say. Data from scans of individual patients can be overlaid on the simulation, which could help surgeons during difficult operations, they add.

ANDR

EW M

ULLI

GAN/

PA

4 May 2013 Vol 346The Editor, BMJ BMA House, Tavistock Square, London WC!H "JR Email: editor@bmj.com Tel: +!! (")#" $%&$ !!'" Fax: +!! (")#" $%&% (!'& BMA MEMBERS’ ENQUIRIES Email: membership@bma.org.uk Tel: +!! (")#" $%&% ()** BMJ CAREERS ADVERTISING Email: sales@bmjcareers.com Tel: +!! (")#" $%&% (*%' DISPLAY ADVERTISING Email: sales@bmjgroup.com Tel: +!! (")#" $%&% (%&( REPRINTS UK/Rest of worldEmail: ngurneyrandall@bmjgroup.comTel: +!! (")#" &!!* *&#* USAEmail: mfogler@medicalreprints.comTel: + ' (&*() !&) !!!( SUBSCRIPTIONS BMA Members Email: membership@bma.org.uk Tel: +!! (")#" $%&% ()** Non-BMA Members Email: support@bmjgroup.com Tel: +!! (")#" $''' ''"* 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 #"'% 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, %(* Blair Road, Avenel, NJ "$""', USA. +$)(. WeeklyPrinted by Polestar Limited

RESPONSE OF THE WEEKPalliative care has shown us a lot of good things—holistic and realistic care, integration across community and hospital, and a framework of well-judged and appropriate use of medical intervention. End of life care is within the skill set of most geriatricians, and other physicians, but they need an environment and working systems that are radically different from those current in UK hospitals. Not least, they need considerably more time to communicate, make decisions, and engage families. Providing this would benefit numerous vulnerable groups, such as those who are cognitively impaired, who populate our hospitals.Rowan H Harwood, consultant geriatrician, Nottingham University Hospitals, UK, in response to “Caring for a dying patient in hospital” (BMJ 2013;346:f2174)

BMJ.COM POLLLast week’s poll asked: “Do patients need to know they are terminally ill?”

87.5% voted yes (total 1 172 votes cast)

This week’s poll asks:“Should the legal age for buying tobacco be raised to 21?”

!BMJ #"'%;%!(:f#()& !Vote now on bmj.com

MOST SHAREDDoctor who lied on his CV is allowed to return to work Liverpool care pathway is a nice idea—pity about the practiceReducing sodium and increasing potassium intake Vitamin D sufficiency in pregnancy Publishing your research study in the BMJ

BMJ | 4 MAY 2013 | VOLUME 346

THIS WEEK

“The question society has to answer is whether it is ethically acceptable to tolerate any serious complication, or death, from measles when an e!ective vaccine is available.” So say public health specialists Felix Greaves and Liam Donaldson in their editorial reflecting on the recent epidemic of measles in south Wales and the prospect of large outbreaks in England (p "). With large cohorts of children and teenagers unvaccinated against measles, mumps, and rubella, health systems have been playing catch up as measles cases soar. Greaves and Donaldson turn the spotlight on the public health sector as it undergoes fundamental change.

“In a public health emergency, which is what the current measles threat is, it is vital that the response is well coordinated,” they say. But strategic health authorities and primary care trusts that have been key in previous crises have been “devolved and swept away” and public health teams are scattered across local authorities. While Public Health England is charged with protecting the population’s health, “resources for immunisation are with NHS England, an entity devoid of public health expertise at board level,” say Greaves and Donaldson.

They are also concerned that if England fails to act resolutely, it will set a poor example to other countries, given the UK’s history of calling for better vaccination in low and middle income countries. “More dynamism and innovation as well as good organisation is needed,” they say.

From communicable to non-communicable diseases, and another call for innovation. Paul Corrigan and colleagues say that the pandemic of chronic diseases threatens the sustainability of health systems worldwide

(p #$). The main reason is the escalating costs of looking a%er people with multiple chronic conditions such as diabetes and asthma. Corrigan and colleagues look at seven innovative approaches to reducing the burden of such diseases, including widespread uptake of the polypill (containing aspirin, a statin, and folic acid), an idea that was launched in the BMJ a decade ago (BMJ &''(;(&):#*&"). The polypill, which is currently undergoing trials for primary prevention, “could promote the sustainability of health systems by reducing the burden from stroke and myocardial infarction,” they say. They acknowledge that drug companies might be resistant to something that could undercut markets, and that public health professionals may regard the pill as “an alternative rather than a supplement to a healthy lifestyle.” But they say, “If as some studies suggest, half of heart attacks and strokes could be prevented, the savings could be enormous.”

Pills for modern ills come under scrutiny elsewhere in this week’s BMJ. A paper by Douglas and colleagues +nds an association between orlistat, the only prescription drug available to treat obesity, and abnormalities in liver function (p #&). But in an accompanying editorial, John Wilding concludes that orlistat remains useful for the treatment of obesity, “with an overall positive bene+t-risk pro+le” (p $). And in his weekly column, Des Spence takes issue with the drug model of type & diabetes, “a modern plague largely brought on by lifestyle” (p (,). “The therapeutic approach in diabetes is upside down,” he says.Trevor Jackson, deputy editor, BMJtjackson@bmj.comCite this as: BMJ !"#$;$%&:f!'#(

EDITOR’S CHOICE

Measles and stroke show why healthcare must innovate

“The question society has to answer is whether it is ethically acceptable to tolerate any serious complication, or death, from measles when an effective vaccine is available”

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

)To receive Editor’s Choice by email each week, visit www.bmj.com/newaccount

Rapid responsesFAO: the editor

Read e-letter responses to the latest articles or submit your own and get published.

bmj.comVisit

fao: the editor

NEWS

BMJ | 4 MAY 2013 | VOLUME 346 1

Geoff Watts LONDONThe British Heart Foundation has announced the launch of two new trials of gene therapy for heart failure. They represent the culmination of 20 years of laboratory research by staff at Imperial College London and the Royal Brompton Hospital, London, and will be the first of their kind carried out in the United Kingdom, the researchers said.

Alexander Lyon, a consultant cardiologist at the Royal Brompton and the UK lead investigator, said: “In the UK alone we have somewhere between 750 000 and a million patients we know about. And there’s a 30% mortality in the first year.”

The therapy itself relies on the use of a modified adenovirus as a vector to insert a gene, SERCA2a, directly into the heart. SERCA2a plays a part in the control of calcium signalling in heart cells. Introducing extra copies of the gene into failing heart cells should, in theory, boost their activity.

Sian Harding, professor of cardiac pharmacology at Imperial, has studied the performance of individual myocytes in the laboratory and shown that a protein called SERCA can fail in its task of moving enough calcium through the cell. “We’ve used an adenovirus to convey the gene for SERCA into myocytes from a failing human heart,” she said. “We put in a gene rather than the protein because a gene will keep on producing SERCA.” The technique restores the failing myocytes to normality.

The two trials are intended to find out whether laboratory success can be replicated in patients. One of the two, called CUPID2, has just recruited its first patients. It will assess the benefits of a single dose of gene therapy in some 200 patients with severe chronic heart failure.

The second and smaller trial, SERCA-LVAD, will test the effects of the same therapy in 24 other heart failure patients fitted with left ventricular assist devices to allow researchers to measure the quantity of the gene successfully introduced into the patients’ heart muscle.

CUPID1, a safety trial carried out in the US, offers grounds for optimism. “There were fewer deaths or requirements for an urgent transplant . . . and improvement in the symptoms and exercise capacity of the patients,” said Lyon. Cite this as: BMJ !"#$;$%&:f!'()

Helen Jaques BMJ CAREERSSpecialty trainees and newly quali!ed GPs are experiencing rising levels of stress and a deter-iorating work-life balance, while changes to the structure of the NHS and to the NHS pension scheme are eroding morale, research published on Thursday " May has found.

Nearly half (##%) of the $%& doctors that the BMA surveyed last September said that their stress levels were worse or much worse than they were a year before, while similar proportions said that work-life balance and morale had worsened ($'% and #(%, respectively).

The BMA suggests that the “rapid, evolving change” that the NHS experienced in "()) and "()"—with the reorganisation of the NHS and of medical education in England—and poor job security for trainee doctors could have a role in these !ndings.

Each year the BMA surveys a group of doctors who quali!ed in "((% to assess trends in the UK medical workforce. The "()" survey, which was completed by $%& of the #$* doctors in the cohort (&*% response rate), included for the !rst time questions about doctors’ workplace morale, work related stress, and work-life balance.

A quarter ("%%) of the specialty trainees and a third ($#%) of the newly quali!ed GPs who com-pleted the BMA’s seventh annual cohort study said that they had experienced high or very high levels of work related stress.

Almost half (##%) of the doctors in the cohort reported that their stress levels had risen during "()". One in !ve ("(%) respondents said that

they experienced unacceptable levels of stress in the workplace.

More than a quarter ("&%) of respondents said that they did not have enough time to deliver the quality of care that patients deserved, a !nding the BMA describes as “troubling.” Just over half (*#%) said that there were problems with sta+-ing shortages in their workplace; and a shortage of doctors in the workplace was one of the top three sources of stress for the cohort doctors.

The BMA said that the reported sta,ng short-ages could be a product of poor rota planning by employers, although it was possible that sta,ng shortages were a result of doctors not training in the right specialties.

A half (*#%) of the newly quali!ed GPs and a third ($"%) of the specialty trainees surveyed said that they had a good or very good work-life balance, but a third ($'%) said that their work-life balance had worsened.

Three quarters (-'%) of the cohort doctors said that their working hours interfered with their private life, with work related administra-tion the biggest factor.

Forty !ve per cent of doctors rated their work-place morale as moderate, while #(% said that morale had deteriorated over the past )" months and $"% said that morale had improved and was now much better.

Changes to the NHS pension scheme and to the structure of the NHS were the factors that respondents said were most likely to negatively a+ect their morale (%&% and %"%, respectively).Cite this as: BMJ !"#$;$%&:f!*!&

New trials of gene therapy for heart failure start recruiting patients

Two in five young doctors said their work-life balance had worsened in the past year

HANS

NEL

EMAN

/STO

NE+/

GETT

Y IM

AGES

UK news Private Eye sends up tobacco industry’s attack on plain packets, p ! World news Health effects of Greece’s austerity measures are “worse than imagined”, p "

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

bmj.com +Report reveals wide

variation in outcomes among English maternity units

Nearly half of UK young doctors say stress levels rose last year

NEWS

Zosia Kmietowicz BMJThe BMA has written to secretary of state Jeremy Hunt asking for an urgent meeting to discuss the best way to manage increasing demands on emergency departments and rising emergency care admissions.

In a speech to Age UK on !" April, Hunt blamed “disastrous” changes to general prac-titioners’ contracts made in !##$ under the Labour government for the “decline in the qual-ity of out of hours care” and four million extra people a year using emergency services.

He said that it was time “to rethink the role of primary care” to prevent emergency admis-sions and to “make sure people with long term conditions are better looked a%er outside the hospital system.” Hunt said that there would be an announcement on “plans for local pioneer sites to lead the way on this” shortly.

“Too o%en people with long term conditions are le% to their own devices, without the help, care, and guidance that local services should provide,” Hunt said. “Then something goes wrong and they end up straight back in hospital needing emergency care.”

However, earlier in the day, Hunt denied that there was a crisis in emergency departments during an interview on Radio $’s Today pro-gramme, although he admitted that services were “very much under pressure.” He said: “We’re still seeing &#% of people within the four hour target, and the average wait is "' minutes.”

The shadow health secretary, Andy Burnham, told Today: “Jeremy Hunt needs to ask himself why two million more people are coming to [emergency departments]. Might it be because they’ve closed NHS walk-in centres, might it be that they’ve broken up a successful NHS Direct service, or might it be that they’ve cut social care funding to the bone?”

Mark Porter, chair of BMA Council, accused Hunt of taking a “completely simplistic” view of what has caused increased pressure on emer-gency care.

“Singling out individual parts of the health service and engaging in a blame game is unhelp-ful and misses the point. Spending on health-care is squeezed, patient demand is rising, and sta(ng levels are o%en inadequate,” he said.

Porter said that general practitioners were conducting more consultations, and hospitals were facing similar levels of high demand that were likely to rise as the population grows and people live longer. He said that the BMA had written to the secretary of state, asking for an urgent meeting to discuss the best way of meet-ing this challenge.

Clare Gerada, chair of the Royal College of General Practitioners, said: “Once again, gen-eral practitioners are being used as a scapegoat and it is not acceptable.”Cite this as: BMJ !"#$;$%&:f!'!(

2 BMJ | 4 MAY 2013 | VOLUME 346

Children to get vaccines against flu and rotavirus starting from July

BMA calls for meeting after health secretary blames GPs for pressure on emergency care

There is no evidence that the 2004 GP contract has increased pressure on A&E, said Clare Gerada

JANI

NE W

IEDE

L PH

OTOL

IBRA

RY/A

LAM

Y

Peers reject bid to annul new NHS rules on competitionAdrian O’Dowd LONDONPeers have rejected a motion that would have annulled new rules governing competition when GPs are commissioning health services.

In a vote in the House of Lords on 24 April 254 peers rejected the motion put forward by Labour’s health spokesman, Philip Hunt, to annul the regulations, while 146 voted to support him.

During a two and a half hour debate peers put forward arguments about the extent to which the section 75 regulations in the Health and Social Care Act would open up all NHS services to market competition and result in possible legal challenges to clinical commissioning groups (CCGs) from the private sector.

There has been significant opposition to the regulations from the BMA,1 the Royal College of General Practitioners, and other bodies, which claim that they will force almost every part of the NHS to be opened up to compulsory competition.

Last month the health minister Norman Lamb said that the regulations would be rewritten to make clear that “no CCG will be forced into competitive tendering,” and new regulations were published on 11 March.2 However, critics said that the rewritten rules showed no significant improvement on the previous version; and on the day of the debate the Daily Telegraph published a letter signed by more than 60 doctors, professors, healthcare workers, and NHS campaigners calling for the regulations to be dropped.3

Zosia Kmietowicz BMJAll children aged ! years in the UK—around )"# ### in total—will be offered a nasal flu vaccine from September !#*' as part of new vaccines schedules announced by the Depart-ment of Health and Public Health England.

A small number of pilots to vaccinate primary and pre-school aged children will also run this year, and pilots for secondary school children will run in !#*$, to make sure that the NHS is ready to roll out the programme to vaccinate

these two groups of children in !#*$ and !#*" respectively.

Infants under $ months old are also to be vaccinated against rotavirus from July. Every year rotavirus causes around *$# ### cases of diarrhoea in under "s and around *$ ### hospitalisations. It is estimated that the rota-virus vaccine will halve the number of cases caused by rotavirus and reduce hospital stays by up to +#%.

Mary Ramsay, head of immunisation at Public Health England, said, “In the countries where the vaccine has already been introduced, the uptake has been high and has resulted in rapid and sustained reductions in childhood rotavirus hospitalisations.”

A%er evaluating the evidence the Joint Com-

mittee on Vaccination and Immunisation has also decided to recommend a shingles vaccina-tion programme for people aged +#, starting in September. There will also be a catch-up pro-gramme for those aged up to and including +&; an estimated ,## ### people will be eligible for the vaccine in the -rst year. A !##" study found that vaccinating adults +# years or older reduced the incidence of shingles by ',% and reduced the burden of illness by ""% in those who developed shingles.*

A change is also being introduced to the meningitis C schedule. Starting in September a new teenage booster jab at age *!-*' years will replace the booster that is currently given at $ months.Cite this as: BMJ !"#$;$%&:f!'(!

NEWS

New blood test can detect genes that drive breast cancerThe new blood test, dubbed “liq-

uid biopsy,” builds on previous research showing that patients’ blood samples contained trace amounts of DNA from their tumour cells. Researchers at the Institute of Cancer Research in London and the Royal Marsden NHS Foundation Trust took this one step further and investigated whether analysing cir-culating free DNA could detect gene ampli!cations known to cause cancer growth.

They took blood samples from "# women with recurrent breast cancer and used digital polymer-

ase chain reaction techniques to detect HER$ amplification. The test was able to accurately identify HER$ positive breast cancer %&% of the time and HER$ negative cancer '&% of the time.(

Alan Ashworth, chief execu-tive of the Institute of Cancer Research, said, “This new liquid

biopsy has exciting potential as a means of analysing tumour DNA

in the bloodstream, allowing clinicians to track genetic changes as they happen.”Cite this as: BMJ !"#$;$%&:f!'!(

BMJ | 4 MAY 2013 | VOLUME 346 3

From left: Philip Hunt, Sheila Hollins, and David Owen, who voted to annul the regulations, and Norman Warner and Shirley Williams, who voted to keep them

FELI

PE T

RUEB

A/PH

OTOS

HOT

The BMA said last week that the regulations should be replaced with new rules that “unambiguously reflect government assurances that commissioners will not be forced to use competition when making their commissioning decisions.”

Opening the debate in the Lords, Hunt said, “There is a genuine fear in the system among advisers to clinical commissioning groups and in a lot of other organisations that the regulations will create a culture of defensive contracting, where commissioners will go out to tender if there is any doubt that a failure to do so will expose them to a possible damages claim.

“They [the regulations] are part of the government’s drive to shift the culture of the NHS from a public service into a public marketplace and are at a piece with a number of other ominous developments which is sending the NHS along the same path.” NHS services were likely to be placed “in the middle of a costly bidding war” with private companies cherry picking discrete services for profit while the NHS would be left to run the more complex and expensive services with less money.

Responding, the Liberal Democrat peer Timothy Clement Jones said, “The rules in the regulations simply and accurately reflect the rules that are already imposed by EU [European Union] law on the NHS. These rules were put in place long before the coalition came to power in May 2010.

“The fact is that these revised regulations are as good as it gets within the constraints of EU

procurement law. Commissioners will not be forced to tender and will not be forced to create a market where none exists.”

The Labour peer Norman Warner, a former health minister, who voted to keep the regulations, said, “This set of contexts in which the NHS has to operate means that we have rather a complex area for NHS commissioners to operate in. They need a clear set of rules to guide their conduct on procurement and competition, and that is provided for in section 75 of the legislation, which we passed after a great deal of discussion and debate.”

The crossbench peer David Owen, who voted to annul the regulations, said, “In this regulation we are presented with the full impact of the 2012 act. It has been hitherto denied, but within this act is the potential—and I agree somewhat with the remarks that it will take some years for it to evolve—to have a fully marketised NHS. If that is the choice, the people of this country should be told about it.

“I warn this house: do not think that this is a minor step. If this goes through, the NHS as we have seen it, believed in it, and persuaded the electorate that we support it, will be massively changed.”

The Liberal Democrat peer Shirley Williams, who voted to keep the regulations, said, “I cannot find in the most careful reading of the regulations and our long debate on these two sets of regulations anything that bears out the widely spread view—extensively spread by the social networks—that this is all about bringing to an end the NHS as a public

How some leading peers voted on the motionForPhilip Hunt (Labour) David Owen (crossbench) Sheila Hollins (crossbench) Leslie Turnberg (Labour) John Davies (Labour) AgainstEarl Howe (Conservative) Timothy Clement Jones (Liberal Democrat) Shirley Williams (Liberal Democrat) John Walton (crossbench) Norman Warner (Labour) Judith Jolly (Liberal Democrat)

service and introducing overall privatisation.”The crossbench peer Sheila Hollins, the current

BMA president, who voted to annul the regulations, said, “Given that major NHS change took place earlier this month, there is a pressing urgency to address once and for all the issue of whether commissioners will be forced to use competition.

“We cannot risk commissioners being unclear about what they can and cannot do.”

Speaking after the vote, Clive Peedell, co-leader of the National Health Action Party,4 told the BMJ, “The result is disappointing but expected because of the government majority.”Cite this as: BMJ !"#$;$%&:f!)"&

Zosia Kmietowicz BMJResearchers have developed a new blood test that they say could be used to identify women whose breast cancer was being driven by the HER$ gene and who could bene!t from treatment with trastuzumab (Herceptin) and similar drugs. They believe that the test could be adapted to a range of other cancers and drug targets.

At the moment women whose breast cancer relapses need to have a biopsy to determine which treatments the cancer will respond to. But cancers can acquire and lose genes over time, and because biopsies cannot be repeated too o)en the genes driving their growth can be missed.

Herceptin binds to breast cancer cell (pink)

NEWS

Zosia Kmietowicz BMJ The magazine Private Eye (right) couldn’t resist sending up Japan Tobacco International’s e! orts (le" ) to derail the UK government’s plan to reduce the take-up of smoking among young people by introducing plain packaging.

The antismoking group Ash has complained to the Advertising Standards Authority about advertisements from JTI (the trading name for Gallagher) that have appeared recently in the national press. The advertisement features an email from the Department of Health to the Australian Government and highlights in pink the phrase, “there isn’t any hard evidence to show that it [plain packaging] works.” The advertisement said: “We couldn’t have put it better ourselves.” But Ash said that the email is two years out of date and is mislead-ing. Last April a systematic review commis-sioned by the Department of Health for England con-cluded that there was “strong evi-dence” that plain packaging would help to reduce the prevalence of smoking.

In the fake Pri-vate Eye advertise-ment “Big Fags Inc,” also highlighted in pink, declares: “We are trying to pretend

4 BMJ | 4 MAY 2013 | VOLUME 346

Scottish doctors can refuse role in abortions: Conscientious objectors to abortion can refuse to delegate, supervise, or support sta! carrying out terminations, as well as refusing to perform terminations themselves, three appeal judges in Scotland have ruled. The Court of Session Inner House ruled in favour of two Catholic midwives in a judgment that also applies to doctors.

Inequality in breast cancer diagnosis costs lives: If breast cancer in women living in England’s poor areas was diagnosed at the same stage as that in women in a! luent areas, "#$ more women every year would survive % ve years with the disease, researchers have shown. & They analysed data on '$ ()* women with complete stage information from the east of England and extrapolated the % ndings.

Inspections start of hospital trusts with higher than expected mortality: Teams of doctors, nurses, and patients’ representatives are set to visit the &" trusts in England whose mortality ratios have been higher than expected for the past two years, ' starting on ( May. The inspections are the prime minister’s response to part of Robert Francis QC’s inquiry into the Mid Sta! s scandal and are being led by the medical director of the NHS, Bruce Keogh. )

Taiwan reports case of H7N9 avian fl u: A #" year old man who had returned to Taiwan from Jiangsu province was con% rmed on '" April as the % rst human case of H(N+ avian flu outside mainland China. Since the % rst infections were announced on )& March, China has con% rmed &$* cases and '' deaths. Hong Kong is stepping up screening of visitors at its border ahead of the May day holiday week, when thousands of mainland Chinese visitors are expected to arrive.

Practice manager is jailed for fraud: A general practice manager in Manchester who defrauded her employer of ,&#$ $$$ has been sentenced to &* months in prison a- er an investigation supported by NHS Protect. Alison Westley, .', was employed % rst at the Archwood Medical Practice, Woodley, and then at Woodley Health Centre, Hyde Road, a- er a merger. She created large numbers of % ctitious invoices to the practice, had been consistently paying herself an inflated salary and overtime payments, and drew cheques made payable to herself from practice accounts. Cite this as: BMJ !"#$;$%&:f!'()

IN BRIEF Private Eye sends up tobacco industry’s attack on plain packets

sioned by the Department of Health for

help to reduce the prevalence of

Pri- advertise-

ment “Big Fags Inc,” also highlighted in pink, declares: “We are trying to pretend

it better ourselves.” But Ash said that the email is two years out of date and is mislead-ing. Last April a systematic review commis-

50--��

Gareth Iacobucci BMJ The NHS must # ll the vacuum in medical leader-ship in the health service by creating more desir-able and attractive leadership roles for doctors, a new report has concluded. $

Research by the University of Birmingham’s Health Services Management Centre and the health think tank the King’s Fund aimed to pro-vide an up to date picture of medical leadership structures in NHS trusts in England. It said that progress had been made in involving doctors in leadership roles since the Gri% ths report in $&'( (the # rst report of its kind). But the study,

funded by the National Institute for Health Research, added that the journey was “by no means complete” and that the health service needed to initiate a “step change” to break down the barriers to involving doc-tors e! ectively in leadership roles.

The researchers used a ques-tionnaire survey of NHS trusts in England; case studies of nine NHS trusts that responded to the survey; and a “medical engagement scale” in the case studies to establish the extent to which doctors felt engaged in the work of their organisations.

Medical leaders are considered to have gone over to “dark side”

hits [plain packaging] won’t work and that mar-keting and advertising aren’t a big deal.”

In March the advertising watchdog banned another campaign by Gallagher claiming that there was “no credible evidence” that plain packets would reduce smoking in young people. And in April another ruling said that Gallagher had misled the public in advertise-ments claiming that plain packaging would be easier to fake and that switching to plain pack-ets would cost taxpayers “more than the )(bn in unpaid duty last year” because of increased sales on the black market. Cite this as: BMJ !"#$;$%&:f!''&

NEWS

They found that several fac-tors put off doctors taking on

leadership positions. These included a preference for

clinical work, a lack of adequate training and support, an absence of defined career paths, and a culture in the NHS that failed to value and reward doctors who took on

leadership roles.T h e r e p o r t

also identified an “engage-

ment gap” b e t w e e n m e d i c a l

leaders and their colleagues who chose to focus on service provision, education, and research and said it was vital that the NHS moved beyond the perception that doctors who took on lead-ership roles were going “over to the dark side.”

Chris Ham, chief executive of the King’s Fund and coauthor of the report, said that the research supported Robert Francis QC’s !ndings in his report into failings of care at Mid Sta"ordshire NHS Foundation Trust suggesting that poor medical leadership could weaken the quality and safety of patient care.#

In a blog post accompanying the research Ham wrote, “There are clear echoes of Robert Francis’ warnings of doctors and other clini-cians being disengaged from management and of the risks this poses to the quality and safety of patient care.”$

Ham said that every NHS trust should place a

“high priority” on promoting medical leadership and engagement and commit time and resources to make it happen, such as by “investing in the development of medical leaders, and pairing them with experienced managers.”

He added, “Above all, there is a need to move beyond the perception that doctors who go into leadership roles are going ‘over to the dark side.’ This can be done by attracting credible individu-als into these roles, rewarding them both !nan-cially and in other ways, and supporting them through expert mentoring and coaching.

“Becoming a medical leader must [be] seen as a prize to be won, rather than a burden to be borne, in organisations where there is an expectation that those in leadership are among the brightest . . . A few NHS trusts are moving in this direction but most have a long way to go.”Cite this as: BMJ !"#$;$%&:f!'"&

Krishna Chinthapalli BMJDealing with intraoperative emergencies can be much improved by use of a checklist, says Atul Gawande, the lead adviser on the World Health Organization’s Safe Surgery Saves Lives pro-gramme and a surgeon at Brigham and Women’s Hospital in Massachusetts.

At a talk at University College London’s Insti-tute of Child Health in London on #% April, Gawande outlined the results of his group’s study earlier this year.& He said, “We tested this in a randomised trial by bringing teams into a simulator . . . They went from a #'% likelihood of missing key lifesaving steps to a %% likeli-hood: a ('% reduction in errors.”

He said he believed that crisis checklists were the next step in surgical safety, following on from his earlier development of WHO surgi-cal safety checklists, which are used for routine checks before, during, and a)er an operation. WHO believes that the use of these checklists in every operation would prevent over half a mil-lion deaths, a)er a number of studies con!rmed reductions in complications and mortality.#

“If we are getting our act together about how we handle prevention in our normal cases, then how do we do when things go abnormal, when an emergency crisis develops? Multiple studies have shown how chaotic and how poorly dis-organised we typically !nd ourselves,” he said.

“And so we worked with the same team and then a wide range of experts to identify the most common ways in which disasters happen in the operating room. Using the same design format

and structure of cockpit checklists, we designed them to be easily read and walked through so that steps might not be forgotten.”

Gawande and colleagues developed the new operating room crisis checklists at Ariadne Labs, part of the Harvard School of Public Health. Twelve checklists cover topics such as anaphy-laxis, cardiac arrest, failed airway, haemorrhage, hypotension, and unstable tachycardia.$ How-ever, there has been criticism that they require clinicians to undergo instruction and training, especially for use during an emergency, and that even with checklists key steps were missed.*

Gawande said that the checklists and an implementation guide were now being rolled out in three organisations in the US.Cite this as: BMJ !"#$;$%&:f!(&(

Checklists can reduce errors in intraoperative emergencies

Atul Gawande (above) said surgeons who tested the checklist in a simulator reduced errors by 75%

BMJ | 4 MAY 2013 | VOLUME 346 5

Medical leaders are considered to have gone over to “dark side”

Makers of anticancer drugs are “profiteering,” say 100 specialistsJeremy Laurance THE INDEPENDENTMore than &++ specialists in chronic myeloid leukaemia from around the world, including nine from the United Kingdom, have warned that the high prices that drug companies charge for anticancer drugs are leaving patients without access to treatments that could save their lives.

The group said that the drug industry was guilty of “pro!teering” and compared its actions to those of unethical speculators who raise the price of grain a)er a natural disaster.

“What determines a morally justi!able ‘just price’ for a cancer drug?” they asked in a paper published in Blood.& “A reasonable drug price should maintain healthy pharmaceutical indus-try pro!ts without being viewed as ‘pro!teering.’”

Of the &# anticancer drugs approved by the US Food and Drug Administration in #+&#, && were priced above ,&++ +++ (-%' +++; ./+ +++) per patient a year, they wrote. In addition, the price of existing drugs of proved e"ectiveness has been increased by up to threefold.

Three new drugs for chronic myeloid leu-kaemia—ponatinib, bosutinib, and omacetax-ine—were approved by the FDA last year and are awaiting a licence in the United Kingdom and Europe. But their prices were “astronomi-cal,” the authors said. Imatinib, one of the best known and most e"ective of the modern anti-cancer drugs, has been on the market for over a decade and recouped its development costs in two years, said Daniel Vassella, former chief executive of Novartis, its manufacturer. Cite this as: BMJ !"#$;$%&:f!'#"

NEWS

6 BMJ | 4 MAY 2013 | VOLUME 346

PANA

YIOT

IS T

ZAM

AROS

/DEM

OTIX

/PA

Health effects of Greece’s austerity are “worse than imagined”

A 35 year old deaf woman threatened to commit suicide in Omonia Square, Athens, in December after her disability allowance was cut. Firefighters persuaded her to come down

Sophie Arie LONDONGreece’s severe economic crisis has had a substan-tially negative e!ect on public health that provides a warning for other countries faced with similar challenges, the authors of a report published in the American Journal of Public Health have said."

Researchers at the Aristotle University of Thessaloniki in Greece and the University of New Mexico in the United States said that a sharp deterioration in major indicators of public health had accompanied the worsening of the Greek economy over recent years, as incomes fell and unemployment soared.

Suicide and murder rates rose by ##.$% and #$.%%, respectively, between #&&$ and #&&', while deaths from infectious diseases rose by "(.#% in the same period. Sharp increases in substance abuse and mental health problems were also recorded.

The authors said that evidence from Greece and from previous economic crises elsewhere implied that reduced household incomes and purchasing power, as a result of unemployment and cuts in real wages, could lead to reduced

health expenditure by households, lower use of private health services, and greater use of public sector services, especially those that are free or low cost at the point of delivery.

In Greece, these trends have happened at a time when government spending on healthcare has been slashed. Compared with #&"&, use of public inpatient and primary care services in #&"" rose by %.#% and #".'%, respectively. Meanwhile, government health spending was cut by #(.$% between #&&' and #&"", with many services being privatised and sta! levels in the public sector being cut dramatically.

Elias Kondilis of Aristotle University, lead author of the study, said: “We were expecting that these austerity policies would negatively a!ect health services and health outcomes, but the results were much worse than we imagined.” The authors said their )ndings indicated austerity policies were likely to cause deteriorating health conditions elsewhere in Europe and in the US. Cite this as: BMJ !"#$;$%&:f!'%"

Evening primrose oil and borage oil do not help eczema symptomsZosia Kmietowicz BMJEvening primrose oil and borage oil do not improve the symptoms of eczema, a review of the evidence has found. Furthermore, both can cause harm, mainly to the gastrointestinal tract.

The authors, who published their review in the Cochrane Library, concluded that it would be hard to justify further studies on the treatments."

Some people take evening primrose oil and borage oil because they contain * linolenic acid, which was once thought to have anti-in+am-matory properties. The Cochrane review cites research that found that in #&&$ nearly four in "& adults ((,%) and one in "& children with eczema took some form of complementary treatment.

The researchers found #$ randomised con-trolled trials that looked at the e!ects of either evening primrose oil ("' trials) or borage oil (,) in "-'% adults or children with eczema. They were treated for between three and #. weeks.

The researchers were able to carry out a meta-analysis of some studies of evening primrose oil. They found that patients and doctors did not judge symptoms to have improved in compari-son with placebo on a visual analogue scale of & to "&& (mean di!erence for patients /#.# ('-% con)dence interval "&.- to %); doctors /(.( (/$ to &.-)). Treatment with borage oil also failed to improve symptoms, although the researchers were unable to conduct a meta-analysis because of the di!erent way the results were reported.

The review’s lead author, Joel Bamford, said, “Given the strength of the evidence in our review, we think further studies on the use of these complementary therapies to treat eczema would be hard to justify.”Cite this as: BMJ !"#$;$%&:f!'#!

Belfast children’s heart surgery unit should close, says health boardClare Dyer BMJChildren born with congenital heart defects in Northern Ireland should have their surgery carried out in future in Dublin rather than Belfast, a report from the province’s Health and Social Care Board has recommended.

Northern Ireland’s health minister, Edwin Poots, is expected to make a final decision within a few weeks,

but his approval is thought to be a formality.

Campaigners have battled to keep the surgery in Northern Ireland, and more than 80 members of the legislative assembly have signed a petition to retain services at the Royal Belfast Hospital for Sick Children.

But the board’s report said that although no immediate safety

concerns had been identified, the surgical services in Northern Ireland were not sustainable because of the small population served. Standards developed for England’s Safe and Sustainable review recommended that a unit should perform at least 400 surgical procedures a year,1 but Belfast’s number falls short of that.

The report, from a working group

that included clinicians, recommends that children requiring surgery or interventional cardiology should travel to Dublin but that cardiology services in Northern Ireland should be expanded and enhanced. Around 110 children a year are expected to travel to Dublin for surgery and some 40 for interventional cardiology.Cite this as: BMJ !"#$;$%&:f!'!#

bmj.com ( Open letter to the Greek government (BMJ !"#$;$%&:f!'"()

BMJ | 4 MAY 2013 | VOLUME 346 7

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

Measles in the UK: a test of public health competency in a crisisCan new agencies work effectively together to meet the challenge?

Felix Greaves honorary clinical research fellow, Department of Primary Care and Public Health, Imperial College London, London W! "RF, UK felix.greaves!"@imperial.ac.ukLiam Donaldson professor of health policy, Institute for Global Health Innovation, Imperial College London, London, UK

The recent surge in measles cases in south Wales signals a discom!ting failure by a G8 nation to control an easily preventable disease. Far from the measles virus being holed up in outposts in poor countries, the spectre of large outbreaks of mea-sles in England is now looming large. By contrast, elimination of endemic measles in the Americas has been achieved by treating it as an emergency.1 Prevention of more measles cases in the United Kingdom, and avoidance of embarrassment for the government, will turn on the e$ectiveness of the public health delivery system.

In the north of England there have been 354 cases in 2013 so far.2 The pool of vulnerable chil-dren nationally is worrying: 8% of those aged 10-16 years have had no measles, mumps, and rubella (MMR) vaccine, and 8% have had only one of the required two doses.3 Susceptible children are distributed throughout the country, making the site of the next outbreak impossible to predict. In London, where immunisation levels for all vac-cines are traditionally lower,4 there have been few cases so far. However, London is a prime location for a major outbreak, with its transient and diverse population and its pockets of low MMR vaccination coverage.

It is hard to manage risk in epidemics, is even harder to explain risk to the public. In a well nour-ished population, with good healthcare services, measles has a much lower mortality rate than in developing countries. Furthermore, within living memory, it was seen as a natural part of child-hood. For most of those who catch it, measles is an unpleasant self limiting illness. That said, so far in England in 2013, 18% of patients with the dis-ease have been admitted to hospital, and in a small but important minority,3 the possibility of further complications and permanent disability, or even death, is real. The question society needs to answer is whether it is ethically acceptable to tolerate any

serious complication, or death, from measles when an e$ective vaccine is available.

In a public health emergency, which is what the current measles threat is, it is vital that the response is well coordinated. All organisations and professionals involved in managing it must know their own role and each other’s, and they must work well together. Strong leadership, excel-lent communication, and a modicum of command and control are also essential. There is a concern that, with the recent health system reforms in England, bodies that were key in crises like severe acute respiratory syndrome, pandemic in+uenza, and foot-and-mouth disease (such as strategic health authorities and primary care trusts) have been devolved and swept away. Public health teams are now spread across local authorities, with links to the NHS much weaker than in the past. A newly established agency, Public Health England, is charged with protecting the popula-tion’s health, but resources for immunisation are with NHS England,5 an entity devoid of public health expertise at board level. It is not acceptable for the elements of this new public health system to learn on the job. An agreed operating relationship is needed quickly. There is the opportunity for a natural experiment to compare the performance of the more mature Welsh system and its brand new English equivalent. Rigorous evaluation of health sector reforms in their early stages would be a novel event in recent British public policy.

Although the risks of serious complications from measles are low, it is not easy for public health policy makers in modern times to justify inaction on grounds of low risk, because public

expectation is rightly that any avoidable child death should be secured. And measles will almost certainly be the next disease to be targeted for global eradication once polio has followed small-pox into the history books. Moreover, the current cohort of unvaccinated teenagers is also vulner-able to mumps and rubella, and as they edge towards adulthood the threat of the devastating congenital rubella syndrome is also a real danger.

A,er the in+uenza A/H1N1 epidemic of 2009, the government was accused of over-reaction because of the mildness of the disease, as money was spent buying unused vaccine and stockpiling antivirals. Yet 70 children died in England.6 With-out the robust action that was taken more may have died. Seventy child deaths is a major incident, particularly in light of the new national patient safety initiative’s aim of zero harm. It would be complacent and irresponsible if we failed to act res-olutely in the current threat on grounds of low rela-tive severity. It would set a poor example to other countries given the UK’s global health positioning as a voice calling for better vaccination perform-ance in low and middle income countries. It would sit uneasily with the UK’s prominent commitment to initiatives such as the “decade of v accination.”7

The government’s catch-up immunisation cam-paigns must build on the lessons learnt from other vaccination programmes around the world. The !rst phase of the emergency response in England, which will target a third of a million older chil-dren, will probably take some months to achieve. In India, millions are vaccinated in a few days, which is a powerful demonstration of what it takes to get ahead of the proverbial curve. Perhaps more dynamism and innovation as well as good organi-sation is needed in the UK if Wake!eld’s legacy is to become a footnote in public health history rather than a tragedy writ large in the public psyche.Competing interests: LD has previously served as chief medical o#cer for England and is currently chair of the independent monitoring board for the Global Polio Eradication Initiative. FG has an honorary contract with Public Health England and takes part in regular on-call activity.Provenance and peer review: Commissioned; not externally peer reviewed.References are in the version on bmj.com.Cite this as: BMJ "#$%;%&':f"()%

!OBSERVATIONS, p "&

$ News: Government launches campaign to give MMR vaccine to a million children in England (BMJ %&'(;()!:f%!*!) $ Observations: MMR, measles, and the South Wales Evening Post (BMJ %&'(;()!:f%+*")

Catch-up campaign to target 1/3 million children

AFP/

GETT

Y IM

AGES

8 BMJ | 4 MAY 2013 | VOLUME 346

EDITORIALS

Orlistat: should we worry about liver inflammation?Events are rare and a causal link unproved; still a useful option for some obese patients

John Wilding professor of medicine and head , Department of Obesity and Endocrinology, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University Hospital Aintree, Liverpool L* ,AL, UK j.p.h.wilding@liv.ac.uk

In a linked paper, Douglas and colleagues used data from the UK Clinical Practice Research Data-link and Hospital Episodes Statistics to explore the possible association between orlistat use and abnormalities of liver function in 94 695 patients who received orlistat over a 12 year period.1 Orli-stat is an inhibitor of intestinal and pancreatic lipases that was !rst licensed for the treatment of overweight and obesity in 2008 and became avail-able in the United Kingdom in 2009. It is currently the only prescription drug available for the treat-ment of obesity and is also available over the coun-ter in a lower strength form, with slightly reduced e/cacy. The drug acts within the gastrointestinal tract and less than 1% is absorbed systemically. As a result, circulating concentrations of orlistat are low (<0.02 μmol/L), and at this concentration it has no systemic e$ects on other lipases.

A meta-analysis of more than 10 000 patients in clinical trials showed a mean placebo sub-tracted weight loss of 2.9 kg over 12 months of treatment.2 Weight loss was maintained long term for subjects in one study, as long as four years for some.3 As with all weight loss drugs, weight regain is common when orlistat is stopped.4 Other clini-cally important outcomes associated with orlistat use are improved lipid pro!le (for example, 0.26 mmol/L reduction in low density lipoprotein cho-lesterol), lowered blood pressure (about 1.5 mm Hg in systolic and diastolic blood pressure), and a 0.38% reduction in glycated haemoglobin (HbA1c) in patients with diabetes.2

Adverse e$ects that relate to orlistat’s mecha-nism of action include gastrointestinal side e$ects due to increased faecal fat; these include fatty stools (14% of patients) and faecal incontinence (4% of patients). Small reductions in circulating concentrations of the fat soluble vitamins (A, D, E, K) and β carotene (mostly within the reference ranges) are also seen. These are not thought to be clinically important for most patients, however, especially because relevant markers such as cal-cium, parathyroid hormone, and international normalised ratio are not altered during treat-ment. Orlistat may interfere with the absorption

of some drugs—notably warfarin, thyroxine, oral contraceptives, anticonvulsants, and ciclosporin. Appropriate precautions such as monitoring of international normalised ratio or thyroid func-tion and institution of additional or alternative contraception are needed in patients taking these agents. Orlistat should not be used in patients ta king ciclosporin.5

Use of orlistat in the NHS was supported by a National Institute for Health and Care Excellence (then the National Institute for Clinical Excellence) technology appraisal in 2001, which was updated when orlistat was included as a recommended option for the treatment of obesity in the more comprehensive guideline published in 2006.6 This recommendation was made on the basis of projected reductions in obesity related comorbid-ity with long term orlistat treatment. The drug was considered clinically and cost e$ective overall when used within its licensed indications.

Concerns about potential liver toxicity with orli-stat were !rst raised in 2001, and sporadic case reports have appeared in the literature since.7 The most recent comprehensive review from the Euro-pean Medicines Agency in 2012 identi!ed a total of 21 reports of severe liver injury worldwide asso-ciated with orlistat use between 2007 and 2011. However, in many of these cases an alternative cause could not be excluded, and these have to be put in the context of widespread use of the drug—more than 53 million people worldwide have taken orlistat since its introduction.8 It seems that if idiosyncratic reactions that cause severe liver

injury do occur with orlistat, they are very rare. Obesity itself is also associated with non-alcoholic fatty liver disease, and evidence from case series suggests that orlistat might improve liver function in such patients,9 although the only randomised trial found no bene!t.10

Douglas and colleagues found that, although patients who were prescribed orlistat had a higher rate of liver function abnormalities, these abnor-malities were as likely to occur in the 90 days before starting the drug as in the period a,er its initiation. They also found no evidence of a higher rate of severe events of liver impairment in those using orlistat.1 The study provides reassurance that, although abnormal liver function is com-mon in patients who are obese, it is unlikely to be caused by orlistat. This study would, however, be unlikely to detect very rare idiosyncratic events of severe liver toxicity that, on the available evi-dence, might be expected to occur in less than one in two million people taking the drug.

Because obesity can have substantial adverse e$ects on health and quality of life, interventions to support body weight reduction are important. These should always incorporate lifestyle and behaviour changes but, for many, lifestyle modi-!cation does not result in weight loss, and if it does weight regain is common. Although orlistat has some limitations, about a third of obese and overweight patients who start treatment as an adjunct to lifestyle changes can lose and main-tain clinically meaningful weight loss, with asso-ciated improvements in disease risk and quality of life.6 Most of the adverse e$ects and potential interactions with orlistat are well characterised, and as long as prescribing guidelines are fol-lowed (including stopping the drug if a clinically worthwhile weight loss is not achieved), it remains useful for the treatment of obesity, with an overall positive bene!t-risk pro!le.Competing interests: : I have given lectures and acted as consultant for Roche (manufacturers of orlistat) and have also received a research grant for my institution (not related at all to the drug), although my last contact with Roche in relation to orlistat was more than -ve years ago. I have consulted for Roche and other companies in relation to obesity and diabetes drug development. Provenance and peer review: Commissioned; not externally peer reviewed.References are in the version on bmj.com.Cite this as: BMJ "#$%;%&':f"(((

!RESEARCH, p $"

Although orlistat has some limitations, about a third of obese and overweight patients who start treatment as an adjunct to lifestyle changes can lose and maintain clinically meaningful weight loss

bmj.com !Gastroenterology articles from the BMJ Group are at bmj.com/specialties/gastroenterology

<1% of orlistat is absorbed systemicallySA

TURN

STI

LLS/

SPL

BMJ | 4 MAY 2013 | VOLUME 346 9

EDITORIALS

Recognising and responding to victims of human traffickingNew guidance for health professionals in the UK

Sharon Doherty consultant clinical psychologist sharon.doherty#@ggc.scot.nhs.ukRachel Morley consultant child and adolescent clinical psychologist, Compass Team for Asylum Seekers and Refugees, NHS Greater Glasgow and Clyde, Glasgow G%' )SF, UK

Recent data suggest that 2077 people, almost a quarter of whom were children, were victims of human tra/cking in the United Kingdom in 2011.1 Because tra/ckers go to great lengths to maintain secrecy, these !gures are probably an underestimate.1 The tra/cking of human beings for sexual and labour exploitation is one of the most highly pro!table illegal trades worldwide.2 Human tra/ckers prey on the vulnerable and use abduction, deception, threat, violence, and other abuses of power to control their victims. Victims are forced to work in the sex industry or in fac-tories, agriculture, or domestic servitude, o,en over prolonged periods.3 Recognising the “gross violation of human rights” that tra/cking repre-sents,4 the UK government rati!ed the Council of Europe Convention on Action against Tra/cking in Human Beings in 2009,4 and it opted in to the European Union Directive on Preventing and Combating Trafficking in Human Beings and Protecting its Victims in 2011.5 This EU direc-tive, which becomes law in the UK in April 2013, requires that member states provide “necessary medical treatment [and] psychological assist-ance” to those who have been tra/cked.

As outlined in a BMJ editorial in 2009,6 human tra/cking is clearly a health issue. Victims of traf-!cking may experience severe physical, sexual, and psychological abuse. This may result in sexually transmitted diseases and unwanted pregnancies, and in health complications linked to injury, untreated chronic medical conditions, chronic deprivation, and exposure to hazardous working environments.7 Research suggests that depression, anxiety, and post-traumatic stress disorder are prevalent in those tra/cked for sex-ual exploitation.8 Victims of tra/cking may also display a complex trauma presentation similar to that seen in those who have experienced other forms of repeated trauma, such as torture.9

Front line health professionals may come into contact with victims of trafficking during the course of their work and may therefore be well placed to identify victims and to o$er information

on available support services.10 To raise aware-ness of tra/cking, the Scottish government has issued guidance for health workers.11 Drawing on international guidance,7 this advice highlights “red +ags” that should arouse suspicion that a patient has been tra/cked, and provides local advice and referral options. The guidance is to be followed by an e-learning module.

The Department of Health in Northern Ireland has also issued guidance for sta$, jointly with the Department of Justice, Social Services and Public Safety,12 and guidance and an e-learning module have recently been issued by the Department of Health in England.13 Wales is likely to follow with its own guidance, which will include local refer-ral options.

Red +ags include symptoms associated with physical abuse, untreated chronic medical con-ditions, and symptoms and signs of psycho-logical trauma. A patient’s demeanour and the circumstances around the consultation may arouse suspicion. Patients may seem fearful and mistrustful; they may be accompanied by a “boy-friend” or “friend” who prefers to speak or inter-pret for them and to whom they defer. Details of personal history may be vague, and there may be a mismatch between a patient’s reported medical history and the clinical presentation.

As with any situation where ongoing abuse is possible, it is important to explain that a private examination is normal practice and to ensure that any interpreting is carried out through a profes-sional interpreter. It is good practice for clinicians to conduct a full physical examination, to ask about history of sexual trauma, and to assess the patient’s mental health.

The use of gentle inquiry around health and liv-ing circumstances is advised. For example, ques-tions such as, “Are you being forced to do things you don’t want to do?”, “Are you free to leave your situation or job if you wish?”, or “Are you paid for the work you do?” may be appropriate. However, be aware that victims of tra/cking may face seri-ous risks if they disclose their situation. They may have been threatened with deportation, imprison-ment, or death, and the lives of family members may have been threatened. Care should be taken to prioritise the safety of the patient and to take seriously the risks they say they face.

When a child is a suspected victim of tra/ck-ing, it is important to follow local child protec-tion guidelines.14-16 For adult victims, follow local guidance.11-13 If possible, arrange a follow-up appointment. In case patients are unable to return, let them know that they are entitled to healthcare and that support is available to help them escape their situation. In Scotland, health professionals are advised to seek the consent of the patient before calling the police “unless the threat or danger to the patient is such that you need to do so.”11

Health professionals play an important role in recognising and responding to the needs of vulnerable patients. Victims of tra/cking are exceptionally vulnerable, have important health needs, and they can and do come into contact with health services. By helping to identify potential victims of tra/cking and by treating their physical and psychological injuries, health professionals challenge this form of exploita-tion. Our collective responses may go some way towards making the UK less hospitable to human tra/ckers.Competing interests: SD’s current post and part of RM’s current post is funded by the Scottish Government. Both authors currently work in the COMPASS Mental Health Team, NHS Greater Glasgow and Clyde. We both work with victims of tra#cking for sexual and labour exploitation of all ages in the COMPASS mental health team. We also work in partnership with the Tra#cking Awareness Raising Alliance Project (Glasgow Community and Safety Services) in Glasgow. This joint initiative has involved co-locating a psychological service within an anti-tra#cking support service to identify and respond to the mental health needs of women who have been tra#cked for sexual exploitation.Provenance and peer review: Not commissioned; externally peer reviewed.References are in the version on bmj.com.Cite this as: BMJ "#$%;%&':f"'*(Red flag: signs of physical abuse

bmj.com $ Editorial: Meeting the health needs of tra#cked persons (BMJ %&&*;((*:b((%!) $ Editorial: Fears of an influx of sex workers to major sporting events are unfounded (BMJ %&'%;()+:e+")+)

KARE

N RO

BINS

ON/P

ANOS

10 BMJ | 4 MAY 2013 | VOLUME 346

EDITORIALS

Understanding patterns in maternity care in the NHS and getting it rightIt’s important to choose the right indicators, use high quality data, and engage all stakeholders

Lucy C Chappell clinical senior lecturer in maternal and fetal medicine, Women’s Health Academic Centre, King’s College London, London SE' ,EH, UK lucy.chappell@kcl.ac.ukCatherine Calderwood national clinical director for maternity and women’s health, NHS England , NHS England, PO Box '!,(", Redditch, UK Sara Kenyon senior lecturer, School of Health and Population Sciences, University of Birmingham, Birmingham, UK Elizabeth S Draper professor of perinatal and paediatric epidemiology , Department of Health Sciences, University of Leicester, Leicester, UK Marian Knight National Institute for Health Research professor in public health , National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK

This week, the Royal College of Obstetricians and Gynaecologists published its report on patterns of maternity care in English NHS hospitals during 2011 to 2012.1 The stated aim was to “examine the validity of potential performance indicators, and to determine how successfully these could be used to compare performance between maternity units using available data.” Data from inpatient admissions and day cases collected routinely from English NHS trusts through Hospital Episode Sta-tistics (HES) were analysed to provide an initial 11 performance indicators, all related to intrapartum care (box). The report presents the data as risk adjusted estimates for each maternity unit within a funnel plot showing the national mean. If variation occurred at random, only one in 20 or one in 500 units would be expected to lie outside the limits repre-senting two (inner funnel limits) or three (outer lim-its) standard deviations, respectively.

The launch of this drive is welcome, and a great amount of work has gone into devising the indica-tors, collating the data, and producing the report, but what does it tell us about current maternity care in England? The report acknowledges the wide disparity in the qual-ity of data. Units were excluded if data for an indica-tor were missing, inconsistent, or implausible (even though up to 45% of units had to be dropped for some indicators). Completeness of maternity data in the HES dataset is still alarmingly low, with key data !elds such as gestational age and birthweight missing in over 20% of records.1 Despite this data cleaning step, 16-56% of units still lay outside

the outer funnel limits for all indicators relating to induction of labour and mode of delivery, with vari-ability far greater than expected. The report stated that the funnel plots are “only to show where there are substantial systematic (non-random) di$er-ences between maternity units,” but it is likely that this complex analysis using data of limited quality will be used out of context and be open to misinter-pretation. Until data quality greatly improves, HES data cannot be used to for this kind of analysis.

Although the report states that the intention is not to label hospitals outside the outer limits as out-liers, it is debatable whether those who read it will follow that suggestion. There is already an accepted and validated protocol from the Healthcare Qual-ity Improvement Partnership for engaging with a unit that has potentially outlying performance.2 The !rst stage, before publishing data, is to contact units directly and allow them to correct any data quality problems. This method is already used rou-tinely by the Paediatric Intensive Care Network.3 We suggest that similar protocols are adopted for mater-nity care data. In the new era of the NHS Outcomes

Framework,4 it should be fundamental that all units submit complete accurate data, as the report recom-mends. Clinicians must take ownership of their own data so that they can-not argue that the derived indicators are wrong. Reg-ular audits of the quality of units’ data would facilitate this process and the col-lege is right to engage its members directly in this. One key objective already established for NHS Eng-land is the development of a national clinical audit for maternity services (to include stillbirths), concurrent with the intro-duction of a national maternity dataset.5 It is

only through using these data that we will achieve outcome driven improvements in the new NHS, with users and clinicians as the drivers

The indicators chosen are principally process measures, justi!ed as a reasonable alternative to direct measurement of outcomes. However, pro-cess indicators are not without their problems; it is unclear whether they provide a meaningful measure of quality, what the “correct” rate should be, and how they can be interpreted without

a cc ompanying outcome data. Several outcome measures are already available in relation to maternity care. Stillbirth and neonatal death are regrettably not rare events, with a rate of 5.2 and 2.9 per 1000 in 2011, respectively.6 Maternity units already have direct access to these outcome data and they should be included. There are also several neonatal outcome datasets and a National Neona-tal Audit Programme,7 elements of which could be incorporated. The report states that maternal mor-tality is too rare to be used as an outcome indicator; the alternative is to use measures of maternal mor-bidity, which have already been developed and val-idated using routinely collected data in Australia.8

In developing the indicators to be included, wider representation could be sought, includ-ing consultation with women themselves, mid-wives, anaesthetists, and those who commission maternity care. A more inclusive and consultative approach might have led to a more varied and bal-anced list of indicators. Integration with patient reported measures, such as results from the sur-vey currently being undertaken by the Care Quality Commission on women’s experiences of maternity care,9 will provide additional context for interpre-tation of numerical indicators. A positive experi-ence of care is a high level national outcome for NHS England.

Despite the many caveats on data quality, when this report enters the public domain, commission-ers, healthcare professionals, and women them-selves may use the data to try to identify outlying units (although no unit is named) to help inform choice of maternity unit or patient referral path-way. There is always considerable interest from professionals and the public when an outlier is identi!ed, even if subsequent events provide an explanation for temporarily outlying data. To avoid units disowning indicators based on the pro-vided data, sta$ must be engaged to provide high quality source data through a mandated national dataset. Once this is achieved, further work across multidisciplinary and multiagency teams—includ-ing service users, professional bodies, and exist-ing data sources—is needed to identify the most appropriate indicators and to use these in context to drive up quality and safety across the new NHS. See COI statement on bmj.com.Provenance and peer review: Commissioned; not externally peer reviewed.References are in the version on bmj.com.Cite this as: BMJ "#$%;%&':f"+$"

Indicators chosen for inclusion in the reportInduction of labour rateProportion of induced labours resulting in emergency caesarean sectionProportion of spontaneous labours resulting in emergency caesarean sectionElective caesarean section rateProportion of elective caesareans performed before $% weeks of gestation without clinical indicationInstrumental delivery rateProportion of instrumental deliveries carried out by vacuum extraction (vacuum to forceps delivery ratio)Proportion of attempted instrumental deliveries resulting in emergency caesarean sectionThird and fourth degree perineal tear rate after unassisted vaginal deliveryThird and fourth degree perineal tear rate after assisted vaginal deliveryEmergency maternal readmission within $! days of delivery

Clinicians must take ownership of their own data so that they cannot argue that the derived indicators are wrong

BMJ | 4 MAY 2013 | VOLUME 346 11

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 atonks@bmj.com

with later and more serious disease. The authors did a series of analyses accounting for dozens of confounding factors including smoking and exposure to ultraviolet radiation. They studied !" #$% male health professionals and &'% $$( female nurses who developed almost $' ''' new cancers during follow-up.

People with non-melanoma skin cancers still have a low absolute risk of a second primary, say the authors (&%"/&'' ''' person years for men; &)#/&'' ''' person years for women), so there’s no need for active surveillance yet. PLoS Med !"#$;#";e#""#%$$Cite this as: BMJ !"#$;$%&:f!'#(

Biventricular pacing for adults with AV block and heart failure

Patients with atrioventricular (AV) block, heart failure, and le* ventricular dysfunction usually need a ventricular pacemaker. Right ventricular pacing restores heart rate but may disturb le* ventricular function in the long term. Biven-tricular pacing is technically harder to achieve but worked better in a head to head trial that tracked patients over three years. A primary outcome combining deaths, emergency visits for heart failure, and worsening heart failure was signi+cantly less common in patients managed with biventricular pacing (!,.)% (&"'/$!() v ,,."% (&('/$!#); hazard ratio '.%!, (,% cred-ible interval '."' to '.('). Two secondary com-posite outcomes—death or hospital admission for heart failure, and death or urgent care visit for heart failure—were also less common in the biventricular pacing group.

The trial began in #''$, and the protocol was adjusted in #'', to allow implantable cardio-verter de+brillators for eligible patients. Primary results were less secure for this subgroup (haz-ard ratio '.%,, '.,% to &.'#). All participants were given a device capable of pacing one or both ventricles and were randomised one to two months a*er a run in period of right ventricu-lar pacing and stabilisation of drug treatments. One in seven participants had a serious adverse event within $' days of the procedure (&!%; &&$/)'(). One in &" had complications related to the le* ventricular lead (".!%). The trial was funded by Medtronic.N Engl J Med !"#$;$&':#('(-)$Cite this as: BMJ !"#$;$%&:f!'#)

Swimming improves fitness in children with asthma

Swimming is a good way for children with asthma to keep +t, according to a systematic review of eight trials. Swimming was well tol-erated by children with stable symptoms and helped improve aerobic +tness and lung func-tion compared with no prescribed exercise or golf (one trial). Swimming training made no di-erence to quality of life in one small study and little di-erence to asthma symptoms in two small studies. Trial data on exacerbations were limited and inconclusive.

In combined analyses, swimming several times a week for at least half an hour improved children’s FEV& (forced expiratory volume in one second) by &'' mL more than usual care ((,% CI ' to #''). The di-erence was modest but clinically meaningful, say the authors, and comparable to the kind of improvements associ-ated with low dose .uticasone. Swimming had a more noticeable impact on +tness (#,% greater improvement than controls in maximal oxygen consumption: an extra (."% mL/kg/min, (,% CI ,.)! to &$.,&).

The #"# children and adolescents in these trials had stable asthma of varying severity. Tri-als reported few side e-ects, although only four of the eight speci+ed whether pools contained chlorine. Bigger, better trials looking at quality of life and asthma control are now needed, say the authors. Parents and children still want to know how swimming compares with other forms of exercise.Cochrane Database Syst Rev !"#$;%:CD"")&"*Cite this as: BMJ !"#$;$%&:f!'#%

Emerging epidemiology of H7N9 avian flu

Enhanced surveillance for the new H%N( avian .u identi+ed )# con+rmed cases in six areas of China between #, March and &% April #'&$. Seventeen infected people died of respiratory complications or multiorgan failure a median of && days a*er the +rst signs of illness, according to the +rst epidemiological study of the outbreak. Sixty others were still critically ill on &% April.

Most of those affected were older (median age "$ years, interquartile range ,'-%$), men

("'/)#), and had a history of recent exposure to live animals (,(/%%), usually chickens or ducks. Fi*y four of the %& cases with data available had underlying medical conditions, most commonly hypertension, diabetes, or heart disease. Only two patients were under , years old and both had mild upper respiratory symptoms only. Researchers identi+ed three clusters of cases within families and can’t rule out human to human transmission.

Infected poultry is the most likely source of the outbreak, and public health authorities should consider early control measures, such as disinfecting or even closing live poultry mar-kets, while we wait for further con+rmation, say the researchers. A separate study reported close genetic similarities between H%N( viruses iso-lated from cases and from local chickens.N Engl J Med !"#$; doi:#".#"(&/NEJMoa#$"%&#*Lancet !"#$; doi:#".#"#&/S"#%"-&*$&(#$)&")"$-%Cite this as: BMJ !"#$;$%&:f!'#'

Slightly higher risk of another cancer after a first non-melanoma skin cancer

White men and women with non-melanoma skin cancers have a slightly increased risk of subse-quently developing other cancers. A nalyses of two long running cohorts from the US report an overall relative risk of &.&& ((,% CI &.', to &.&)) for men and &.#' (&.&, to &.#,) for women during more than #' years of follow-up. These +gures exclude melanomas from the count of second cancers.

The new study con+rms and +ne tunes previ-ous work linking non-melanoma skin cancers

Adapted from N Engl J Med !"#$; doi:#".#"%&/NEJMoa#$"'&#(

Geographical distribution of H!N" cases in China

" km #"""

Beijing

Henan

AnhuiZhejiang

Shanghai

Jiangsu

12 BMJ | 4 MAY 2013 | VOLUME 346

RESEARCH

Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC!E "HT, UK Correspondence to: I Douglas ian.douglas@lshtm.ac.ukCite this as: BMJ !"#$;$%&:f#'$&doi: !#.!!$%/bmj.f!&$%

This is a summary of a paper that was published on bmj.com as BMJ '#!$;$(%:f!&$%

STUDY QUESTION Is treatment with orlistat (Xenical; Roche) associated with hepatic injury?

SUMMARY ANSWER The incidence of acute liver injury was higher in the periods both immediately before and immediately after the start of orlistat treatment.

WHAT IS KNOWN AND WHAT THIS PAPER ADDS Since early !""" reports of liver injury associated with orlistat have accumulated, raising concerns about its safety. In a large population based cohort, the rate of adverse liver events was temporarily increased both immediately before and immediately after treatment with orlistat started, suggesting the risk is associated with underlying health changes associated with the decision to begin treatment rather than a causal effect of the drug.

Participants and settingParticipants were all patients registered in the UK Clini-cal Practice Research Datalink between !""" and #$!!, receiving prescribed orlistat and having a recorded inci-dent liver injury event.

Design, size, and durationOf "% &"' patients prescribed orlistat, "(( were identi)ed as having incident liver injury, with a mean observation time of !$.! years and mean duration of orlistat use of $." years. A self controlled case series analysis compared the incidence of liver injury during periods of orlistat use with periods of non-use.

Main results and the role of chanceAn increased incidence of liver injury was detected during the "$ day period before orlistat was )rst started compared with other periods of non-use of orlistat (incidence rate ratio !.'$, "'% con)dence interval !.!$ to #.$&). The inci-dence remained raised during the )rst *$ days of treatment (#.#!, !.%* to *.%#), before reverting to baseline levels with prolonged treatment. No increase in the incidence of liver injury was seen when the risk during the )rst "$ days of

treatment was compared with the "$ days preceding )rst treatment (!.$#, $.&+ to !.'&). Over ""% of the events occurring during orlistat use were of raised liver function test results or jaundice, with few cases of severe liver events (one case of hepatitis).

Bias, confounding, and other reasons for cautionWe accounted for confounding by using a design where each patient acts as his or her own control, so we can be con)dent the results are not explained by important dif-ferences between participants. Drug use may have been misclassi)ed to some extent, as it is based on prescribing rather than consumption. The most likely e,ect of this would be to bias the results towards the null.

Generalisability to other populationsThe study was UK population based and the results are likely to be generalisable to other similar populations.

Study funding/potential competing interestsIJD is funded by a Medical Research Council methodol-ogy fellowship, KB is funded by a National Institute for Health Research postdoctoral fellowship, and LS is funded by a Wellcome Trust fellowship. IJD holds stock in Glaxo-SmithKline and consults for GlaxoSmithKline, Takeda, and Gilead on topics not related to orlistat. LS consults for GlaxoSmithKline on topics not related to orlistat.

Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research DatalinkIan J Douglas, Julia Langham, Krishnan Bhaskaran, Ruth Brauer, Liam Smeeth

(EDITORIAL by Wilding Self controlled case series analysis for orlistat use and risk of liver injury in definite and probable cases (n=')))

Orlistat usePatient years

No of events

Age adjusted rate ratio ('*% CI)

Primary analyses: Absence of orlistat ))"' )*' — &# days before prescription '(! (' !.*# (!.!# to '.#%) !-$# days )! '! '.'! (!.($ to $.(') $!-%# days )# !# !.#% (#.*" to !.&&) %!-&# days ") !' !.$' (#."* to '.$() >&# days &)% *! #.") (#.*) to !.#*)Secondary analyses: &# days before prescription '(! (' — !-&# days '(# ($ !.#' (#.%" to !.*%) $# days before prescription )! !& — !-$# days )! '! !.!! (#.*& to '.#%)

bmj.com ( Gastroenterology updates from BMJ Group are at bmj.com/specialties/gastroenterology

BMJ | 4 MAY 2013 | VOLUME 346 13

RESEARCH

STUDY QUESTION To estimate the probability of becoming at high risk of cardiovascular disease for low and intermediate risk people not receiving treatment for raised blood pressure or lipid levels.

SUMMARY ANSWER Repeat cardiovascular risk estimation before eight to !" years is not warranted for most people unless their initial risk is !#-$"%, when remeasurement within a year is warranted.

WHAT IS KNOWN AND WHAT THIS PAPER ADDS Increasingly decisions to start blood pressure and lipid lowering treatment are made on the basis of an individual’s absolute cardiovascular risk rather than their blood pressure or cholesterol level, and people are regularly screened for a raised risk level. Remeasurement of cardiovascular risk may be safely done much less often than most guidelines recommend: eight to !" years for those initially at <!"% risk for a cardiovascular event.

Participants and settingWe included !" #$# and "%$$ participants of two stud-ies: the Tokyo health check-up and Framingham studies. Included participants were aged "& to #' years, had com-plete data on risk equation covariates, were not receiving blood pressure or lipid lowering treatment, and had an estimated risk of cardiovascular disease within !& years <(&%. We strati)ed participants on the basis of baseline risk: <$%, $-<!&%, !&-<!$%, and !$-<(&%.

Design, size, and durationObservational study of two cohorts not at high cardio-vascular risk at baseline. Follow-up measurements in the Tokyo study were done annually over three years ((&&*-!&), whereas follow-up visits in the Framingham study were done between eight (!+*%-#$) and !+ years (!++&-+$) a,er baseline. We used these visit measures to estimate and track changes in the !& year risk of a cardio-vascular event >(&% using the Framingham equation for both cohorts.

Main results and the role of chanceAt baseline most participants had <$% risk (*!% and '*% of Tokyo and Framingham cohorts) or $-<!&% risk (('% and (%%) of a cardiovascular event within !& years. A,er three years for both the very low (<$%) and low baseline risk ($-<!&%) groups the proportion crossing the treat-ment threshold was less than !%. For the intermediate baseline risk (!&-<!$%) group the proportion crossing the threshold was $.#% (+$% con)dence interval '.$% to #.&%). By contrast in the high-intermediate baseline risk (!$-<(&%) group !*.!% (!".'% to !+.&%) had crossed the threshold by one year. A,er eight years +.!% (#.!% to !!."%) of the low baseline risk group had crossed the treatment thr eshold, whereas for the intermediate and high inter mediate baseline risk groups it was over !&% ("(.!%, (#.*% to "*.%% and #".$%, *#.(% to #+.!%, respectively). For those with an initial very low baseline risk, even a,er !+ years of follow-up the proportion cross-ing the treatment threshold remained low, with *.%% ($.$% to %.(%) crossing the treatment threshold.

Bias, confounding, and other reasons for cautionThe )ndings are based on two separate cohorts with di-er-ent lengths of follow-up.

Generalisability to other populationsWhile further examination is warranted in other popula-tions, repeat risk estimation before %-!& years is not war-ranted for most people. However, remeasurement within a year seems warranted in those initially at !$-(&% risk.

Study funding/potential competing interestsThe authors declare that: KJLB, AH, LI, and PG have sup-port from the Australian National Health and Medical Research Council (program grant No *""&&", early career fellowship No APP!&!""+&) for the submitted work; no )nancial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have in.uenced the submitted work.

When to remeasure cardiovascular risk in untreated people at low and intermediate risk: observational studyKaty J L Bell,! Andrew Hayen," Les Irwig,# Osamu Takahashi,$ % Sachiko Ohde,$ Paul Glasziou!

!Centre for Research in Evidence Based Practice, Bond University, QLD $""&, Australia"School of Public Health and Community Medicine, University of New South Wales, NSW, Australia#Screening and Test Evaluation Program, School of Public Health, University of Sydney, NSW, Australia$Centre for Clinical Epidemiology, St Luke’s Life Science Institute, Tokyo, Japan%Internal Medicine, St Luke’s International Hospital, Tokyo, JapanCorrespondence to: K J L Bell katy.bell@sydney.edu.auCite this as: BMJ !"#$;$%&:f#'()doi: !'.!!#(/bmj.f!)&%

This is a summary of a paper that was published on bmj.com as BMJ "'!#;#$(:f!)&%

Probability of crossing !"% cardiovascular diseasetreatment threshold for #" year cardiovascular eventrisk over #$ years of follow-up

Years of follow-up

Perc

enta

ge w

ith ri

sk %!

"%

Baseline risk

! " #! #" $!!

$!

%!

&!

'!

#!!

High intermediate (#"-<$!%)

Tokyo health check-up Framingham study

Intermediate (#!-<#"%)Low ("-<#!%)Very low (<"%)

bmj.com * Research: Comparisons

of established risk prediction models for cardiovascular disease (BMJ "'!";#$$:e##!))

bmj.com * Cardiology updates from BMJ Group are at bmj.com/specialties/cardiology

14 BMJ | 4 MAY 2013 | VOLUME 346

RESEARCH

Predictive value of S-100` protein for prognosis in patients with moderate and severe traumatic brain injury: systematic review and meta-analysisEric Mercier,! Amélie Boutin,! François Lauzier,! " # Dean A Fergusson,$ Jean-François Simard,! Ryan Zarychanski,% Lynne Moore,! & Lauralyn A McIntyre,$ ' Patrick Archambault,( François Lamontagne,) France Légaré,( !* Edward Randell,!! Linda Nadeau,!" François Rousseau,!* !" Alexis F Turgeon! "

STUDY QUESTION Is the concentration of S-!""# protein a valid and accurate predictor of prognosis after moderate or severe traumatic brain injury?

SUMMARY ANSWER Raised serum S-!""# protein concentrations are significantly associated with unfavourable prognosis after moderate or severe traumatic brain injury, though optimal discrimination thresholds remain unclear.

WHAT IS KNOWN AND WHAT THIS PAPER ADDS S-!""# protein concentrations increase in blood and cerebrospinal fluid after a wide range of diseases or conditions leading to brain damage. The review shows that concentrations are significantly correlated with unfavourable prognosis in patients with moderate or severe traumatic brain injury, as defined by mortality, score $% on the Glasgow outcome scale, or brain stem death, with and without concomitant traumatic injuries. This finding could inform a decision aid in the evaluation of patients with traumatic brain injury.

!Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Québec (Hôpital de l’Enfant-Jésus), Traumatologie - Urgence - Soins Intensifs (Trauma - Emergency - Critical Care Medicine), Université Laval, Québec City, QC, Canada"Department of Anesthesiology, Division of Critical Care, Université Laval, Québec City, QC, Canada#Department of Medicine, Université Laval, Québec City, QC, Canada$Clinical Epidemiology Unit, Ottawa Hospital Research Institute, Ottawa, ON, Canada%Department of Internal Medicine, Section of Critical Care Medicine, University of Manitoba, Winnipeg, MB, Canada&Department of Social and Preventive Medicine, Université Laval, Québec, QC, Canada'Department of Medicine, Division of Critical Care, University of Ottawa, Ottawa, ON, Canada(Department of Family and Emergency Medicine, Université Laval, Québec, QC, Canada)Centre de Recherche Clinique Étienne-Le Bel du CHUS, Université de Sherbrooke, Sherbrooke, QC, Canada!*Centre de Recherche du CHU de Québec, Knowledge Transfer and Health Technology Assessment, Université Laval, Québec City, QC, Canada!!Department of Laboratory Medicine, Memorial University, St John’s, NF, Canada!"Department of Molecular Biology, Medical Biochemistry and Pathology, Université Laval, Québec City, QC, CanadaCorrespondence to: A F Turgeon, Centre de Recherche du CHU de Québec (Hôpital de l’Enfant-Jésus), Traumatologie - Urgence - Soins Intensifs (Trauma - Emergency - Critical Care Medicine), !$*!, !(e rue, local H-*!"a, QC, Canada G!J !Z$ alexis.turgeon@fmed.ulaval.caCite this as: BMJ !"#$;$%&:f#'('doi: !*.!!#&/bmj.f!'%'

This is a summary of a paper that was published on bmj.com as BMJ "*!#;#$&:f!'%'

Raabe !""#$%

Raabe !""#$&

Jackson '(((%!

Chat)eld '(('%$

Woertgen '(('%*

Li '(($&'

Ucar '(($&+

Vos '(($&$

Sawauchi '((%&%

Wang '((&&*

Ghori '((*&#

Lavicka '((**(

Olivecrona '(("*+

Rainey '(("*$

Wiesmann '(!( Murillo-Cabezas '(!(*&

Vos '(!(**

Stein '(!'#!

Total ("%% CI)Test for heterogeneity: !'=(.'$, "'=#(.%$, df=!*, P<(.((!, I'=*"%Test for overall e,ect: z=*.(&, P<(.((!

&'('%#

'$!#+$$(!'!%!+$!'+%(+#+'+&*

$$'

"'$%

!'+(''!$$$'"!"!%%*'%%(''%%$+!&

$"!

!.$% ((.$*)!.+( ((.*%)(.&% ((.%$)!.$' ((.'!)!.+# ((.'$)(.%% ((.+()(.$! ((.'+)(.&" ((.+()'.&& ((.+$)(."* ((.$%)(.&$ ((.'$)!.(# ((.!#)(.!+ ((.'*)!.($ ((.!")!.!* ((.'!)(.!" ((.!&)(.*% ((.!#)!.*( ((.%")

(.' ! % '(

Unfavourableoutcome

Study

!" >"

Mean (SE)di#erence in

In concentration (µg/L)

Geometric meanratio ($%% CI)

No of patients by Glasgow

outcome score

Association between S-&''( protein and Glasgow outcome score !" in patients with moderate and severe traumatic brain injury

(.(%

Favourableoutcome

Selection criteria for studiesWe included cohort studies and randomised controlled trials evaluating the prognostic value of S-!""# protein in patients with moderate or severe traumatic brain injury.

Primary outcomesOutcomes evaluated were mortality, score on Glasgow out-come scale, and brain stem death.

Main results and role of chanceForty one studies were eligible for inclusion. There was a signi$cant positive association between S-!""# protein con-centrations and mortality (!% studies with &&" participants: geometric mean ratio %.'', ('% con$dence interval %."% to ).%!, I%='*%) and Glasgow outcome score +) (!, studies with ()) participants: %.*%, %."! to ).-%, I%=&(%). Sensitiv-ity analyses based on sampling time, sampling type, blind-

ing of outcome assessors, and timing of outcome assessment yielded similar results. Ranges of serum threshold values of !.),-!".'" µg/L and %.!*-!-."" µg/L were associated with !""% speci$city for mortality and a Glasgow outcome score +), respectively.

Bias, confounding, and other reasons for caution We observed signi$cant heterogeneity for all outcomes of interest. Sensitivity analyses did not fully explain the observed heterogeneity for the Glasgow outcome score. We could not perform sensitivity analyses related to age, pupil-lary reactivity, or the motor component of the Glasgow coma scale, which are known indicators of prognosis in such patients, because of the variable presentations or absence of these data in included studies. The quality of evidence of the association between S-!""# protein concentrations and both mortality and neurological outcome was moderate.

bmj.com + Research: Predicting

outcome a,er traumatic brain injury (BMJ "**(;##&:$"%)

BMJ | 4 MAY 2013 | VOLUME 346 15

RESEARCH

STUDY QUESTION How reliable are risk of bias assessments based on publications of randomised controlled trials in cancer, for use in systematic reviews?

SUMMARY ANSWER Use of trial publications alone to assess risk of bias could be unreliable, therefore systematic reviewers should be cautious about their use as a basis for trial inclusion in meta-analysis.

WHAT IS KNOWN AND WHAT THIS PAPER ADDS Poor reporting of randomised controlled trials does not necessarily reflect poor methodological quality of the trial design, conduct, or analysis. Obtaining additional information from trials could ensure a more accurate assessment of risk of bias and, if available, summary statistics can reduce or overcome some potential biases.

Participants and setting We included !" published randomised controlled trials in cancer that had been included in #$ systematic reviews and meta-analyses based on individual participant data (IPD), and for which publications and completed forms or trial protocols had been collected during the IPD process.

DesignTwo authors completed risk of bias assessments using the Cochrane risk of bias tool and following guidance from the Cochrane Handbook. Assessments were conducted for individual domains, and overall for each trial, %rst using information from trial publications alone and then using supplementary information alongside the published information.

Primary outcome(s)We compared the two approaches to assessing risk of bias by calculating percentage agreement (low <&&%; fair '&&%; good '!(%). The approaches were considered to be similarly reliable only when agreement was good.

Main results and the role of chancePercentage agreement between the two methods for sequence generation and incomplete outcome data was fair. For allocation concealment, selective outcome report-ing, and overall risk of bias, percentage agreement was low. Supplementary information reduced the proportion of unclear assessments for all individual domains. This reduced proportion increased the number of trials assessed as having a low risk of bias, and therefore available for inclusion in meta-analyses, from )$ ()$%) based on pub-lications alone to && (&&%).

Bias, confounding, and other reasons for cautionThe included cancer trials represented a selected group. Risk of bias assessments were for overall survival—a sin-gle, objective and commonly well reported outcome—rather than all possible outcomes, as is recommended. Our results might therefore represent an optimistic view of the reliability of the risk of bias assessments using published information alone. Also, the additional infor-mation supplied was sometimes limited; even with additional information, around a third of the included studies were still classi%ed as having unclear risk of bias.

Generalisability to other populationsAll of the included trials were cancer trials. These are, in general, well conducted and o*en well reported. Therefore, for some other healthcare areas, where trials are less well conducted or reported, risk of bias assessments based on publications alone could be even less reliable.

Study funding/potential competing interestsThis work was supported by the United Kingdom’s Medi-cal Research Council. None of the authors have received support from any organisation for the submitted work, nor do they have any %nancial relationships with any organisations that might have an interest in the submit-ted work in the previous three years, or any other relation-ships or activities that could appear to have in+uenced the submitted work.

Can trial quality be reliably assessed from published reports of cancer trials: evaluation of risk of bias assessments in systematic reviews Claire L Vale, Jayne F Tierney, Sarah Burdett

Meta-analysis Group, MRC Clinical Trials Unit, London WC!B "NH, UKCorrespondence to: C L Vale cv@ctu.mrc.ac.ukCite this as: BMJ !"#$;$%&:f#'()doi: #$.##%"/bmj.f#&'(

This is a summary of a paper that was published on bmj.com as BMJ !$#%;%)":f#&'(

Outcomes and comparison of risk of bias assessments

Risk of bias domain

No of assessments based on publications only

No of assessments based on publications plus supplementary information Percentage agreement

(%; (*% CI)Low Unclear High Low Unclear HighSequence generation )! *% $ "' !" $ "'.* ("$.! to &(.&)Allocation concealment )$ ** $ (' " $ )(.) (%(.) to *(.*)Incomplete outcome data &) #$ ## '$ # ) ($.$ (&!.$ to ((.$)Selective outcome reporting %& #$ )( '$ $ * )!.# (%!.! to *!.$)Overall risk of bias for trial !% &$ ! ") %# $ *).& ()).& to ").&)

bmj.com + Research: Assessment of

publication bias, selection bias, and unavailable data in meta-analyses using individual participant data (BMJ !$#!;%)):d&&"!)

+ Research: Observer bias in randomised clinical trials with binary outcomes (BMJ !$#!;%)):e###')

+ Research Methods and Reporting: The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews (BMJ !$#$;%)$:c%"*)

16 BMJ | 4 MAY 2013 | VOLUME 346

BMJ GROUP IMPROVING HEALTH AWARDS 2013

included online and practical training as well as feedback on each practice’s dispensing and resistance data. Christopher Butler and colleagues’ study found that practices randomised to the programme signi!cantly reduced their total oral antibiotic dispensing over the next year compared with control practices." The intervention did not increase the rate of admission to hospital or of reconsultation for a respiratory tract infection within the next week.

The external judges who have to choose just one Research Paper of the Year from this formidable shortlist are Richard Lehman, journal blogger and former general practitioner in Oxfordshire; Dinesh Selvarajah, honorary con-sultant diabetologist at She#eld Teaching Hos-pital and $%&& BMJ Award winner; and Sarah Hedderwick, consultant in infectious disease at the Royal Victoria Hospital Belfast and deputy chair of the BMA Consultants Committee.Trish Groves deputy editor, BMJ tgroves@bmj.comThe Research Paper of the Year award is sponsored by GlaxoSmithKline.

! Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, et al. for the PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med "#!";$%%:!%&%-'#(.

" Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, et al for the Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med "#!";$%':"#$-!$.

$ Krogsbøll LT, Jørgensen KJ, Grønhøj Larsen C, Gøtzsche PC. General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis. BMJ "#!";$():e'!&!.

( Simmons RK, Echouffo-Tcheugui JB, Sharp SJ, Sargeant LA, Williams KM, Prevost AT, et al. Screening for type " diabetes and population mortality over !# years (ADDITION-Cambridge): a cluster-randomised controlled trial. Lancet "#!";$*#:!'(!-*.

) Zauber AG, Winawer SJ, O’Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, et al. Colonoscopic polypectomy and long term prevention of colorectal cancer deaths. N Engl J Med "#!";$%%:%*'-&%.

% Butler CC, Simpson SA, Dunstan F, Rollnick S, Cohen D, Gillespie D, et al. Effectiveness of multifaceted educational programme to reduce antibiotic dispensing in primary care: practice based randomised controlled trial. BMJ "#!";$((:d*!'$.

Cite this as: BMJ !"#$;$%&:f!'#!

This year’s judges of the Research Paper of the Year award have to choose between six very di'erent papers. All six papers tackle common and important challenges in healthcare in well resourced settings, and several show that we need less medicine, not more. Which study will the judges decide has the greatest potential to improve health and healthcare; to help doctors make better decisions about clinical practice, public health, research methods, or health policy; and to improve health outcomes for patients or populations?

Transcatheter aortic valve replacement for inoperable severe aortic stenosisIn the original Placement of Aortic Transcatheter Valves (PARTNER) trial patients in their (%s with a greater than )%% risk of death or serious irreversible complications from conventional aortic valve surgery were randomised to either transcatheter aortic valve replacement or standard medical therapy: survival at one year was signi!cantly higher a*er valve replace-ment. Raj R Makkar and colleagues’ report of the two year outcomes of this international trial was shortlisted for the BMJ award because it provides patients and doctors with high quality, real life evidence to weigh up the bene!ts and risks of this procedure.& Patients with replaced valves were still at high risk (and +,.,% had died), but they were doing signi!cantly better than patients in the control group (of whom "(% had died).

Radical prostatectomy versus observation for localised prostate cancerObservational studies suggest that most men with early stage prostate cancer die with, rather than from, their tumours and that early treat-ment o*en has serious harms. Timothy J Wilt and colleagues’ randomised controlled trial with &$ years’ follow-up, found that mortality from all causes was the same among men who had radical prostatectomy as among those who were simply observed.$ And men who had surgery

were signi!cantly more likely to report urinary and erectile dysfunction two years a*er their operations.

General health checks in adultsChecking adults to see if they have signs, symptoms, or risk factors for disease might seem a good idea. But Lasse T Krogsbøll and colleagues’ Cochrane review and meta-analysis of &+ randomised trials with more than &(% %%% people in the US and Europe found no evidence to support general health checks., Harms were not well studied in the trials, but routine health checks almost certainly lead to some overdiag-nosis and overtreatment.

Screening for type 2 diabetesPopulation screening for type $ diabetes—another intervention that might seem worth-while—didn’t fare well in Rebecca K Simmons and colleagues’ randomised controlled trial in UK primary care.+ Screening of more than &) %%% patients at increased risk did not reduce all cause, cardiovascular, or diabetes related mortality within the next &% years.

Surveillance of colorectal cancerWhile we’re waiting for the results of large trials of colonosopic screening for colorectal cancer, follow-up data from old studies can provide useful guidance. Ann G Zauber and colleagues’ long term follow-up of the US National Polyp Study looked at the death rate among patients who had had adenomatous polyps removed compared with mortality from colorectal cancer in the general population and in an internal concurrent control group of patients with non-adenomatous polyps.) Median follow-up was &) years, and the study suggested that polypec-tomy signi!cantly reduced the risk of death from colorectal cancer.

Training to reduce antibiotic prescribingThe Stemming the Tide of Antibiotic Resistance (STAR) programme for general practitioners

bmj.com + Feature: Safer sport,

shock treatment, stroke care, and safety triumph at the BMJ Group awards (BMJ "#!";$((:e$'(!)

Research Paper of the Year award !"#$This annual BMJ award recognises outstanding original research with potential to contribute considerably to improving health and healthcare. Trish Groves introduces the shortlist

Raj R Makkar; Timothy J Wilt and colleagues; Lasse T Krongsbøll; Type 2 diabetes screening; Ann G Zauber; Christopher Butler and colleagues

BMJ | 4 MAY 2013 | VOLUME 346 17

BMJ GROUP IMPROVING HEALTH AWARDS 2013

measures (PROMs) provide a remote clinical assessment of the patient’s pain and function a!er the procedures.

Orthopaedic surgeons can use these assessments in conjunction with radiographs to advise patients and GPs on whether further follow-up—either in person or remotely—is needed. Data generated by the PROM tool has been assessed as more robust than previous pen and paper collection.

Using the PROM tool, Royal Cornwall Hospitals NHS Trust has created a new patient pathway, generating "" ### assessments from $$## patients, which it estimates will save "### follow-up patient appointments a year—a saving of %&' ### (("## ###; )"*# ##). Clinic appointments can be used for those patients who most need them.

HIV screeningChelsea and Westminster Hospital’s Dean Street at Home shows how existing web based services can be fused together to create an entirely new model for HIV screening. The new service provides a true online extension of the physical Dean Street Centre, in Soho. Gay men at high risk of HIV who live within the M$+ London orbital are targeted through social media network Gaydar, plus the smartphone application Grindr, and o,ered a postal mouth swab HIV sampling kit; samples are

Health secretary Jeremy Hunt has committed the National Health Service to becoming paperless by $#"&, using the term as shorthand for adopting digital technologies to improve the quality and e-ciency of healthcare.

It’s a huge challenge, but examples of the future digital health service can already be found in many parts of the country. The four shortlisted entries for the Transforming Patient Care Using Technology category provide a snapshot of what is already being achieved by leading healthcare providers.

Local eye careThe shortlist included the i-van, a general practice led initiative by Saxmundham Health in Su,olk. This set out to shi! ophthalmic services into the community, by taking them out on the road in a van equipped to provide a comprehensive assessment in a single appointment. Bringing care closer to home is particularly important for older patients with chronic stable glaucoma, a condition that accounts for "#% of blindness registrations in the UK.

As tests are done in a single appointment, i-van halves the number of patient appointments needed annually. Clinical data and images are stored digitally and can be assessed remotely, improving monitoring and audit.

Faster test results West Middlesex Hospital shows the e-ciencies that can be achieved by networking point of care testing machines in emergency departments with the hospital’s Integrated Clinical Environment (ICE) system for ordering tests. In most hospitals, there is no direct electronic link between the two and patient data have to be printed o, or transcribed into case notes, with an obvious risk of errors. The bene.ts of connectivity include improved speed and accuracy, which is particularly important in managing patients with sepsis.

For patients with sepsis, the proximity of the point of care analysers enabled doctors to receive a full blood count result within three minutes of delivery of the blood sample. The same three minute turnaround time was achieved for serum potassium results in patients presenting with dangerous cardiac arrhythmias.

With $## NHS trusts currently using the ICE order communications system, the bene.ts of integration have the potential to be widely replicated.

Remote follow-upMyclinicaloutcomes, meanwhile, shows how web based remote follow-up of patients who have had total hip or knee replacement, reported live to their general practitioners, can contribute to better patient outcomes. The online patient reported outcomes

Making the digital future a realityJon Hoeksma looks at the candidates for the Transforming Patient Care Using Technology award

returned by post. Patients with positive results are contacted for con.rmatory testing and care by an NHS HIV specialist.

The National Institute for Health and Care Excellence (NICE) estimates that preventing one onward HIV transmission saves between %$& ### and %*'# ### in lifetime treatment costs. Dean Street at Home compared favourably with other Department of Health pilots to increase HIV diagnosis. The service performed "/*0 tests and identi.ed /$ new cases at a cost of %"""* per diagnosis. The cost of an HIV diagnosis in primary care is %*&##. Of those tested, */% had never been tested for HIV before. NICE guidance recommends that men who have sex with men test at least once a year.

Turning these innovative ideas into new models of healthcare that are delivering proven bene.ts to patients has required dedication and hard work. To paraphrase science .ction writer William Gibson: the digital future NHS is already here, it’s just unevenly spread.Jon Hoeksma editor, eHealth Insider, London, UK Jon@e-health-media.comCompeting interests: None declared.

! For more about the BMJ Group awards go to http://groupawards.bmj.com.The Transforming Patient Care Using Technology Award is sponsored by Datix.

Cite this as: BMJ !"#$;$%&:f!&%'

The i-van; faster test results in West Middlesex; Myclinicaloutcomes; Dean Street at Home

18 BMJ | 4 MAY 2013 | VOLUME 346

ANALYSIS

INNOVATE OR DIEHealth systems must innovate to survive the pandemic of non-communicable disease, but many innovations do not spread easily. Paul Corrigan, Christopher Exeter, and Richard Smith examine why this is so and how to help them spreadThe pandemic of non-communicable disease (NCD) a!ecting low and middle income countries is well recognised.1  2 In high income countries multiple chronic conditions already account for the lion’s share of expenses.3  4 Health systems are threatened by the escalating costs of NCD and must innovate to keep their systems func-tioning and deliver improved care. We discuss the drivers and di!usion mechanisms needed to promote the spread of innovations using seven novel approaches to reducing the burden of NCD.

Examples of innovations to counter NCDIn preparing the report from which this article is derived we compiled over 200 innovations aimed at reducing the burden of NCD and cat-egorised them under a new taxonomy (table, see bmj.com).5 Box 1 (see bmj.com) describes how we devised the taxonomy and collected the innovations.

From our database we selected seven innova-tions (box 2) that illustrate di!erent problems in spreading innovations, which we discuss below. All have evidence to support them, but as we deliberately selected early stage innovations, this mostly falls short of randomised trials. Clearly further evaluation is needed. Innovations that seem promising may not deliver value in the long term and resources may be wasted by pu rsuing them for too long.

Professionals may feel threatenedDi!using new methods of service delivery for patients, such as nurse led care in Primary Care 101 or encouraging self management in the Tonga programme, are likely to prove most dif-)cult in countries that have long established and well entrenched health systems. Community

Box ! | Seven innovations to reduce the burden of non-communicable diseaseWeqaya programme6  7—The United Arab Emirates has measured the risk of cardiovascular disease in every Emirati citizen in Abu Dhabi aged over 18. The results are fed back to individuals together with advice on action to take. Anonymised data can be provided to the government, local authorities, and employers to develop and monitor public health and workplace programmes.China Rural Health Initiative8—A platform to test low cost sustainable interventions for the prevention and management of cardiovascular disease in 120 villages in northern China, using village doctors (once known as “barefoot doctors”) and community health workers.Tonga asthma self management programme9  10—The programme aims to enable patients to manage their condition with little or no clinical supervision. Patients are given instruction on using peak expiratory flow (PEF) meters, a plan on how to manage their asthma according to their PEF rates, and guidelines on how to respond to problems.Polypill11  12—The polypill combines drugs that work in different ways to reduce the risk of heart attack and stroke into one tablet. Trials have shown that the polypill will reduce blood pressure, blood lipids, and platelet stickiness as effectively as drugs given individually and that adherence is much improved. The polypill is available in several low and middle income countries but not yet in a high income country, although it may be licensed soon in the US for secondary prevention of cardiovascular disease. Some have advocated offering the polypill to everybody when they reach age 55 without any testing or monitoring.CollaboRhythm13—A speech and touch controlled collaborative interface that can be accessed by phone, tablet, or computer and allows doctor and patient to make shared decisions based on the patient’s data. Importantly, patients own their data, and everything they see in the doctor’s office is available at home or when they visit another doctor or are travelling. The idea is that continuous monitoring helps patients to live a healthier life, making them less likely to need more intensive therapy.Primary Care !"!, South Africa14  15—A set of evidence based guidelines that cover all the conditions likely to affect adults attending primary care clinics in South Africa. These clinics are staffed mainly by nurses, who have considerable experience of treating patients with HIV infection but little training in managing patients with NCD and other conditions common in primary care. Unlike most guidelines, they are symptom based rather than disease based. The nurses also receive non-didactic, case based training in their places of work.Discovery Vitality, South Africa16- 18—The Vitality programme of the South African insurance company Discovery provides incentives for people to live a healthier life. Those in the programme begin with a full health review, which assigns them a “Vitality age” and prescribes a pathway to better health—covering disease management, smoking, mental health, preventive health, nutrition, and physical activity. The Vitality age is easy for patients to understand: a Vitality age higher than your chronological age is clearly a bad thing, and the reverse is clearly good. Through following their prescribed pathway, participants can reduce their Vitality age and earn Vitality points, which can be exchanged for benefits.

In China a rural health programme tested low cost interventions to manage cardiovascular disease

BMJ | 4 MAY 2013 | VOLUME 346 19

ANALYSIS

services led by non-physicians may be viewed as a threat, especially in countries where hos-pital care dominates. Hospital based services for patients with NCD enjoy high status in many systems, and the professionals who run them are likely to feel a!ronted by the suggestion that com-munity based care led by non-physicians might be equally e!ective as well as cheaper. So long as community services remain local, clashes are avoidable, but expanding community based serv-ices nationally, as the Chinese project aims to do, requires a new strategy to reassure or overcome the objections of existing service providers.

This must include a case for change that is sci-enti"cally sound and resonates with the public and, as far as possible, with clinicians. Evidence is needed that the new service can reduce mortal-ity and morbidity and provide a return on invest-ment. Leading professionals need to champion the new approach and to get patient groups to argue the case with existing providers.

Programmes that promote self management, such as the Tonga project for patients with asthma, tend to remain small because health professionals see them as a threat to job security. Professionals may react defensively by question-ing the safety of the new approach, which could undermine the con"dence of patients and hinder the di!usion of innovations. Finding profession-als who will argue in favour of self management is important.

Sound economic case for change The widespread uptake of the polypill (contain-ing aspirin, a statin, and folic acid) to prevent coronary heart disease could promote the sus-tainability of health systems by reducing the burden from stroke and myocardial infarction. Its

role in secondary prevention is widely accepted, and trials are underway to test its role in primary prevention. If, as some studies suggest, half of heart attacks and strokes could be prevented, the savings would be enormous. But to be most cost e!ective polypills need to be manufactured in volume from the beginning (large scale pro-duction lowers unit cost) and adherence must be promoted.

Similarly, innovations to improve self manage-ment will help health systems only if potential savings are realised. Increasing patients’ capac-ity to self manage in the Tonga asthma initiative resulted in a fall in emergency visits and hospi-tal admissions. This suggests savings from roll-ing out this innovation may be appreciable and could free resources for other health activities. It’s worth noting, however, that in many health systems, resources that are “saved” are o#en in di!erent budgets from the investment and are not attributed to the initial investment.

Most health systems undervalue new forms of communication between patient and medical sta!, such as the CollaboRhythm platform. Use of mobile phones in healthcare is mainly being developed outside normal payment systems. If greater use of e-technologies reduces the need for face to face consultation it represents not just a challenge to orthodox methods but also, poten-tially, a loss of income for health professionals.

Consumer demand and social movements Traditionally, healthcare is less driven by con-sumer demand than other activities, but this might be changing. Better self management o!ers people with NCD much greater control over their lives, less reliance on medical inter-ventions, and reduced morbidity$%—so patients are likely to want more of it. Some patient groups, notably in the UK the Richmond Group of C harities, are organising patients to demand more self m anagement.&'

Innovations that use mobile phones to facili-tate the search for diagnosis or treatment may become popular with patients and should dif-fuse easily and rapidly. Resistance to their use by health professionals, in high income countries in particular, will have to be overcome.

Similarly, uptake of the polypill could meet resistance from drug companies that see markets being undercut, and public health professionals, who regard the polypill as an alternative rather than a supplement to a healthy lifestyle. It might take an international clinical and social move-

ment to establish its legitimacy. The argument will have to be made in di!erent parts of health sys-tems and a wide range of champions mobilised, including patients, patient groups, clinicians, and scientists.

The advantage of social movements as agents of change is that they can challenge existing healthcare business models from the plausible perspective of a large patient population. They can also spur interest in and demand for a new model of disease prevention, which avoids hav-ing to mount an expensive marketing campaign.

Buy-in from local communitiesIn some Chinese communities many people still believe that developing cardiovascular disease is inevitable and interest in prevention is low. Strong public health leadership will be needed to convince the public that there will be bene"ts to health (and wealth) from adopting innovations in the China Rural Health Initiative.

Di!usion may also fail if the innovation seems to be imposed from outside. When the salt reduc-tion and health promotion part of the project in China was implemented “community health educators” strove to represent themselves as local community leaders rather than as external agents.

New innovations also need to be promoted. Promoters must not assume that a national pro-gramme will gain the same support from com-munity leaders as a successful local programme. When local leaders have less in(uence, commu-nities may bene"t from the help of social mar-keting organisations. Social marketing changes behaviour because precise messages reach tar-geted groups through speci"c channels of com-munication. This segmentation is most useful when the innovation is focused on a high risk group, such as people with hypertension.

Over the past decade the communication and culture sector has been successful in changing the consumption behaviour of many hundreds of millions of people. Given this success the pri-vate sector has considerable expertise in the use of persuasive communications to change con-sumer behaviour, and it usually makes sense for government and health organisations to use their skills rather than try to change behaviour alone.

Patients add valueThe innovations that we were sent show grow-ing professional and public support for self management of NCD. The Tongan, Chinese, and

bmj.com ! Editorial: How to judge the value of innovation (BMJ "#$";%&&:e$&'() ! Editorial: Cost e)ectiveness of interventions to tackle non-communicable diseases

(BMJ "#$";%&&:d(**%) ! Analysis: Global response to non-communicable disease (BMJ "#$$;%&":d%*"%)

CUHK

20 BMJ | 4 MAY 2013 | VOLUME 346

ANALYSIS

Co llaboRhythm examples suggest that patients can add considerable value to their healthcare by improving their capacity to self manage. But it requires investment in improving the capacity of patients and their communities to add that value.

If governments are to make the case for uni-versal screening linked to targeted personal interventions, such as in the Weqaya project, they may need the support of relevant patient organi-sations. Visible government support for a health policy is necessary, but probably not su!cient to di"use the innovations across the healthcare system.

Role of governmentsNew innovations, along with established service delivery models, depend on having an adequate workforce with the required skills. The China Rural Health Initiative teaches local primary healthcare workers to screen, classify, and man-age high risk patients. It has also set up simple case management record systems within local clinics and a digitised central database and per-formance feedback system for health workers.

Governments need to assess the skills mix and distribution of their workforce, their resources for training, and ability to monitor performance. Attempts to introduce new national policies must also take account of local, regional, and cultural di"erences. Economic incentives may be more e"ective in poorer parts of country than in a#u-ent areas, for example. Although village health workers in the Chinese initiative were prepared to take on the care of high risk patients, it cannot be guaranteed that workers in other areas will do the same.

Then there are regulatory considerations. In many countries, the use of medical devices is subject to regulation, but mobile communications and the increasing use of “apps” have given rise to new forms of screening, diagnosis, self manage-ment, and therapy, and these developments call for new types of regulation.

Finally, governments must take con$dentiality of health data seriously—and be seen to be doing so. To succeed in scaling up universal interven-tions, such as the Weqaya cardiovascular risk assessment programme, governments need to engage with their populations and argue strongly for the bene$ts of collecting universal data, guar-antee its security, and understand that individu-als have a right to own their own data.

International organisationsEach national healthcare system has distinctive national and regional characteristics. Attempts to transplant innovations from one national sys-tem to another o%en fail. International organisa-tions need to pay more attention to these national di"erences when advocating di"usion across

nations. They also need to recognise the scope for promoting di"usion of innovations from low and middle income countries, which promise much greater value for money and sustainability than those being pursued in high income countries.&'

BusinessesCompanies that insure their workforce against ill health and promote healthy behaviour bene$t the company as well as individual workers. The same is true for health insurers. The South Afri-can insurance company Discovery is seeking to improve the health of its customers by providing them with incentives to do so. When incentives work, the insurer is encouraged to extend the programme to a larger section of the population. Competition between health insurance compa-nies may promote the spread of incentives for behavioural change.

ConclusionThe NCD pandemic threatens the sustainability of health systems. They must identify and imple-ment new evidence based policies to survive. But to have a major impact innovations must spread. Professionals, markets, consumers, governments, international organisations, and businesses can encourage the spread of innovation—but can also block spread. We need perhaps to spend less time studying innovations and more time studying—and when appropriate promoting—their spread.Paul Corrigan adjunct professorChristopher Exeter senior fellowRichard Smith adjunct professor, Imperial College Institute of Global Health Innovation, London, UKCorrespondence to: R Smith richardswsmith@yahoo.co.ukContributors and sources: The authors wrote the !rst dra" of di#erent sections of the report from which this paper is derived. Many written and verbal comments were received from the working group (listed in acknowledgments), and the report then revised. RS shortened and edited the report to the present paper, and all three authors approved the !nal version.Competing interests: All authors have completed the uni!ed competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: CE is an employee of Imperial College Institute for Global Health Innovation. PC and RS are unpaid adjunct professors. RS works for the UnitedHealth Group, which helped sponsor the Global Health Policy Summit where the report from which this article is derived was presented. The UnitedHealth Group together with the National Heart, Lung, and Blood Institute funds the China Rural Health Initiative and Primary Care $%$. RS is an enthusiast for the polypill, takes the pill, and participated in a recently reported trial. PC was health adviser to Tony Blair when he was prime minister of the UK.Members of the NCD working group: Paul Corrigan (cochair), Imperial College London; Richard Smith (cochair), UnitedHealth Chronic Disease Initiative; Stephen Bloom, Imperial College London; Richard Bohmer, Harvard Business School; Kacey Bonner, British Consulate-General, Los Angeles; Andres Cabrera, University of Granada; Catalina Denman Champion, El Colegio de Sonora, Mexico; Prabhakaran Dorairaj, Centre for Chronic Disease Control, India: Christopher Exeter, Imperial College London; Catherine Gordon, US Centers for Disease Control and Prevention; Sian Gri&ths, Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong; John Grumitt, Diabetes UK and International Diabetes Federation; Christine Hancock, C' Collaborating for Health; Oliver Harrison, Abu Dhabi Health Authority; Mike Hobday, Macmillan Cancer Support; Alex Jadad, Centre for Global E-Health Innovation, University of Toronto; Desmond Johnson, Imperial College London; Sneh Khemka, BUPA;

Dinky Levitt, University of Cape Town; Lijing Yan, George Institute for Global Health, China; Michael Macdonnell, Global Health Policy Forum; Stephen MacMahon, George Institute for Global Health, Australia; Victor Matsudo, Physical Fitness Research Laboratory of Sao Caetano do Sul, Brazil; Sarah Morgan, KPMG; Andy Murdock, Lloydspharmacy; Venkat Narayan, Rollins School of Public Health; Robyn Norton, George Institute for Global Health, Australia; Anand Parekh, US Department of Health and Human Services; Parashar Patel, Boston Scienti!c Corporation; Neil Pearce, London School of Hygiene and Tropical Medicine; Rodamni Peppa, Boston Scienti!c Corporation; Cristina Rabadan-Diehl, O&ce of Global Health, National Heart, Lung and Blood Institute, US National Institutes of Health; Hilary Thomas, KPMG; Denis Xavier, St.John’s National Academy of Health Sciences, India.

Provenance and peer review: Not commissioned; externally peer reviewed.$ UN. Political declaration of the high-level meeting of the general

assembly on the prevention and control of non-communicable diseases. (%$$. www.un.org/ga/search/view_doc.asp?symbol=A/))/L.$

( WHO. Global status report on non communicable disease (%$%. (%$$. www.who.int/nmh/publications/ncd_report(%$%/en.

' Center for Medicare and Medicaid Services. Chronic conditions among Medicare beneficiaries, chart book. CMS, (%$$.

* Barnett K, Mercer SW, Norbury M, Watt GCM, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet (%$(;'+%:',-*'.

- Smith R, Corrigan P, Exeter C. Countering non communicable disease through innovation. (%$(. www.georgecentre.ox.ac.uk/news/GHPS(%$(NCDREPORT.pdf.

) Weqaya. www.weqaya.ae/en/index.php., Hajat C, Harrison O, Shather Z. A profile and approach to chronic

disease in Abu Dhabi. Global Health (%$(;+:$+.+ George Institute. The China rural health initiative. www.

georgeinstitute.org/global-health/improving-healthcare-poor-rural-communities-china.

. Gibson PG, Powell H, Wilson A, Abramson MJ, Haywood P, Bauman A, et al. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev $..);(:CD%%$$$,.

$% Foliaki S, Fakakovokaetau T, D’Souza W, Latu S, Tutine V, Cheng S, et al. Reduction in asthma morbidity following a community-based asthma self-management programme in Tonga. Int J Tuberc Lung Dis (%%.;$':$*(-,.

$$ Lonn E, Bosch J, Teo KK, Pais P, Xavier D, Yusuf S. The polypill in the prevention of cardiovascular diseases. Circulation (%$%;$((:(%,+–++.

$( Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than +%%. BMJ (%%';'():$*$..

$' Health and wellness innovation (%$'. CollaboRhthym. http://newmed.media.mit.edu/collaborhythm.

$* Fairall L, Bachmann MO, Lombard C, Timmerman V, Uebel K, Zwarenstein M, et al. Task shifting of antiretroviral treatment from doctors to primary care nurses in South Africa (STRETCH): a pragmatic cluster randomised trial. Lancet (%$(;'+%:++%-.+.

$- Fairall LR, Zwarenstein M, Bateman ED, Bachmann M, Lombard C, Majara BP, et al. Effect of educational outreach to nurses on tuberculosis case detection and primary care of respiratory illness: pragmatic cluster randomised controlled trial. BMJ (%%-;''$:,-%-*.

$) Lambert EV, da Silva R, Fatti L, Patel D, Kolbe-Alexander T, Derman W, et al. Fitness-related activities and medical claims related to hospital admissions, South Africa, (%%). Prev Chronic Dis (%%.;):A$(%.

$, Patel DN, Lambert EV, da Silva R, Greyling M, Nossel C, Noach A, et al. The association between medical costs and participation in the vitality health promotion program among .*+,.,* members of a South African health insurance company. Am J Health Promot (%$%;(*:$..-(%*.

$+ Patel D, Lambert EV, da Silva R, Greyling M, Kolbe-Alexander T, Noach A, et al. Participation in fitness-related activities of an incentive-based health promotion program and hospital costs: a retrospective longitudinal study. Am J Health Promot (%$$;(-:'*$-+.

$. Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med (%%';():$-,.

(% Richmond Group of Charities. www.richmondgroupofcharities.org.uk/.

($ Syed S, Dadwal V, Rutter P, Storr J, Hightower J, Gooden R, et al. Developed-developing country partnerships: benefits to developed countries? Global Health (%$(;+:$,.

Cite this as: BMJ !"#$;$%&:f#&''

BMJ | 4 MAY 2013 | VOLUME 346 21

LETTERS Letters are selected from rapid responses posted on bmj.com. A!er editing, all letters are published online (www.bmj.com/archive/sevendays) and about half are published in print ! To submit a rapid response go to any article on bmj.com and click “respond to this article”

Competing interests: None declared." World Bank. The growing danger of non-communicable

diseases. Acting now to reverse change. #$"".Cite this as: BMJ "#$%;%&':f"'("

What “partnership working” means to the alcohol industryIt is an oversimplification to say that the “ideological schism” that divides the public health community is between those who are prepared to work alongside the industry and those who are not.1 The community recognises that the alcohol industry is a stakeholder and can help reduce harm in its role as producer and retailer. However, the industry seeks a role in areas that go beyond its responsibilities and in which it has no expertise. It promotes “partnerships” because this allows it to influence policy in ways that favour business interests.2

The most effective strategies involve the reduction of alcohol consumption at the population level.3 A senior Diageo spokesperson said recently, “We need to tackle alcohol harm but population approaches don’t work.”4

In Scotland, the industry was enthusiastic about “partnership working” that resulted in responsible drinking campaigns. When the Scottish government signalled its intention to introduce minimum pricing legislation, the industry immediately launched a campaign against the measure, calling on the government to drop minimum pricing and work in partnership with the industry. Unable to prevent the legislation, the industry followed in the footsteps of the tobacco industry and mounted a legal challenge.

Marcus Grant says the industry cannot increase taxation or limit availability because these are government actions. But that doesn’t stop it lobbying against these measures.5

In reality, what partnership working means for the alcohol industry is steering discussion away from effective measures like controls on price and availability and ensuring that governments adopt less effective measures.

If the alcohol industry is serious about reducing harm, it should stop lobbying against the most effective measures. It is entirely reasonable for the public health community to insist on this as a precondition for any partnership working.Evelyn Gillan chief executive, Alcohol Focus Scotland, Glasgow G" #LW, UK evelyn.gillan@alcohol-focus-scotland.org.ukCompeting interests: None declared.

DOCTORS AND THE ALCOHOL INDUSTRY

WHO’s response to article

WHO agrees with many, but not all, points made in the BMJ articles on the alcohol industry.1  2 References to the WHO Global Strategy to Reduce the Harmful Use of Alcohol require clarification, particularly claims that industry is simply doing “what WHO asked for in the strategy.” Not so.

The strategy, which was unanimously endorsed by WHO member states in 2010, restricts the actions of “economic operators” in alcohol production and trade to their core roles as “developers, producers, distributors, marketers, and sellers” of alcohol. It stipulates that member states have a primary responsibility for formulating, implementing, monitoring, and evaluating public policies to reduce harmful use of alcohol. The development of alcohol policies is the sole prerogative of national authorities. In WHO’s view, the alcohol industry has no role in formulating policies, which must be protected from distortion by commercial or vested interests.

WHO is grateful to the many researchers and civil society organisations that carefully watch over the behaviour of the alcohol industry. This behaviour includes direct industry drafting of national alcohol policies, or drafting through the International Center for Alcohol Policies, other entities, or “public health consultants,” which it funds. As recent reports document, some of the most effective policy options to reduce the harmful use of alcohol, as defined by WHO, are absent in these policies.3  4

WHO appreciates the Global Alcohol Policy Alliance’s statement of concern and has invited author representatives to meet senior WHO management to explore the concerns in detail. Conflicts of interest are an inherent risk in any relationship between a public health agency and industry; conflict of interest safeguards are in place at WHO and have recently been strengthened. WHO intends to use these safeguards stringently in its interactions with the alcohol industry.

Margaret Chan director-general, World Health Organization, "#"" Geneva #%, Switzerland chanm@who.intCompeting interests: None declared." Gornall J. Doctors and the alcohol industry: an unhealthy mix?

BMJ #$"&;&'(:f"))*. (# April.)# Groves T. Promises, promises [Editor’s Choice]. BMJ

#$"&;&'(:f#""'. (& April.)& Bakke O, Endal D. Alcohol policies out of context: drinks

industry supplanting government role in alcohol policies in sub-Saharan Africa. Addiction #$"$;"$+:##-).

' Jernigan DH. Global alcohol producers, science, and policy: the case of the International Center for Alcohol Policies. Am J Public Health #$"#;"$#:)$-*.

Cite this as: BMJ "#$%;%&':f"'&)

Industry’s reply to WHOWe are disappointed by Chan’s negative reaction to the commitments of leading beer, wine, and spirits producers, which are a sincere contribution to reducing harmful use of alcohol (previous letter). The “commitments” were developed in response to WHO, and Chan personally, encouraging the alcohol industry to do more in this area.

We agree that national authorities are primarily responsible for developing their alcohol policies. In our experience, however, many governments do not agree with WHO’s view that the private sector has no role in policy formulation—governments often invite private companies from many sectors to contribute their views and expertise to this process.

It is increasingly recognised that the involvement and mobilisation of a range of actors, including the private sector, is needed to tackle serious societal problems effectively. The World Bank recently acknowledged this, saying that non-communicable disease risk factors can “rarely be modified through policies and interventions within the health sector alone. Rather, prevention measures that address these risk factors typically embrace a range of different sectors . . . along with civil society and the private sector.”1

We welcome constructive debate on the most effective policies to reduce harmful alcohol use and believe in the merit of including a range of stakeholders in discussions. Groups such as the Global Alcohol Policy Alliance, which seek to exclude those with views different from their own, do a disservice to the serious work of tackling harmful drinking worldwide, and we encourage them to adopt a more inclusive approach.Mark R Leverton director general, Global Alcohol Producers Group, London SW) "RL, UK mark.leverton@gapg.org

PA

22 BMJ | 4 MAY 2013 | VOLUME 346

LETTERS

! Gornall J. Doctors and the alcohol industry: an unhealthy mix? BMJ "#!$;$%&:f!''(. (" April.)

" Babor T, Robaina K. Public health, academic medicine, and the alcohol industry’s corporate social responsibility activities. Am J Public Health "#!$;!#$:"#&-!%.

$ Babor T, Caetano R, Casswell S, Edwards G, Giestrecht N, Graham K, et al. Alcohol: no ordinary commodity: research and public policy. "nd ed. Oxford University Press, "#!#.

% Parsons R. Q&A with Diageo’s global CMO Andy Fennell. Marketing Week "#!$. www.marketingweek.co.uk/news/qa-with-diageos-global-cmo-andy-fennell/%##)((".article.

) Jernigan DH. Global alcohol producers, science and policy: the case of the International Center for Alcohol Policy. Am J Public Health "#!";!#":'#-(.

Cite this as: BMJ !"#$;$%&:f!&''

CLARITHROMYCIN’S ADVERSE EFFECTS

Reconsider in rhinosinusitis?Schembri and colleagues found an increased risk of cardiovascular events and acute coronary syndromes with the use of clarithromycin in patients with acute exacerbations of chronic obstructive pulmonary disease.! Although the length of treatment correlated with the increase in risk, the dose of clarithromycin was not mentioned, only the duration of treatment.

Chronic rhinosinusitis is one of the most prevalent otolaryngological conditions in the UK, affecting an estimated !".#% of the population.$ European guidelines on the management of chronic rhinosinusitis without nasal polyps recommend, among other drugs, low dose macrolides for !$ weeks.%

This recommendation is based on one randomised controlled trial where symptom scores and endoscopic appearances were significantly improved in patients receiving low dose daily roxithromycin for three months compared with those given placebo.# However, a more recent trial using azithromycin in a similar number of patients recalcitrant to standard treatment found no evidence of benefit.&

It may therefore be prudent to reconsider the guidelines on prescription of clarithromycin for chronic rhinosinusitis, especially in patients who have concurrent lower respiratory and cardiovascular disease, until a retrospective review of patients is performed.

As we change to clinical commissioning group financing, it is imperative that indications for the use of long term macrolides in chronic rhinosinusitis are robust. We suggest avoiding the use of clarithromycin for this disease in primary care until endoscopic and radiological investigations are performed.Nicholas E Gibbins consultant otolaryngologist, nicholas.gibbins@nhs.netChris Theokli specialist registrar in otolaryngology, University Hospital Lewisham, London SE!$ &LH, UK Claire Hopkins consultant otolaryngologist, Guy’s and St Thomas’ Hospitals NHS Trust, London SE! (RT,UKCompeting interests: None declared.! Schembri S, Williamson PA, Short PM, Singanayagam A, Akram

A, Taylor J, et al. Cardiovascular events after clarithromycin use in lower respiratory tract infections: analysis of two prospective cohort studies. BMJ "#!$;$%&:f!"$). ("" March.)

" Jarvis D, Newson R, Lotvall J, Hastan D, Tomassen P, Keil T, et al. Asthma in adults and its association with chronic rhinosinusitis: the GA"LEN survey in Europe. Allergy "#!";&*:(!-'

$ Fokkens WJ, Lund VJ, Mullol J, Bachert C, Bachert C, Alobid I, et al. European position paper on rhinosinusitis and nasal polyps. Rhinology Suppl "#!";"$;!-"('.

% Wallwork B, Colman W, Mackay-Sim A, Greiff L, Cervin A. A double-blind, randomized, placebo-controlled trial of macrolide in the treatment of chronic rhinosinusitis. Laryngoscope "##&;!!&:!'(-($.

) Viedeler WJ, Badia L, Harvey RJ. Lack of effectiveness of long-term clarithromycin in chronic rhinosinusitis: a randomized controlled trial. Allergy "#!!;&&:!%)*-&'.

Cite this as: BMJ !"#$;$%&:f!&()

PATIENT REPORTED OUTCOME MEASURES

More harm than good?Black points out that patient reported outcome measures (PROMs) were developed for use in research and subsequently adopted to support clinical management.! I have advocated the use of these measures in Child and Adolescent Mental Health Services (CAMHS) for the past decade (www.corc.uk.net). However, I have become increasingly worried that unless the tension between the two aims of data collection (informing generalisable findings v informing individual care) is resolved, widespread mandatory implementation of PROMs may harm rather than help individual patient care.

The NHS is currently rolling out a new form of monitoring with the use of PROMs, but without training people in the use of these data in individual patients. Clinicians do not know the answers to key questions, including how best to safely interpret and report the data, how often to use these data in clinical practice, and when not to use them.$

Although PROMs may have a role in clinical practice to help enhance collaborative working,% this needs careful support and training, and recognition that we are in the early stage of our knowledge about appropriate clinical use.# The situation is not helped by trusts imposing measures without adequate input from clinicians and patients on the usefulness of these measures, the lack of appropriate information technology infrastructure, or the inappropriate use of PROMs data as stand alone measures of performance.

Unless we develop the evidence base on how to use PROMs in direct clinical work they may

continue to be just one more bureaucratic burden and may end up doing more harm than good.Miranda Wolpert Director, CAMHS Evidence Based Practice Unit (EBPU), Anna Freud Centre and University College London, London NW$ )SD, UK miranda.wolpert@annafreud.orgCompeting interests: MW is a founding member and paid director (one day a week) of the CAMHS Outcomes Research Consortium (CORC), a not-for-pro+t learning collaboration committed to using PROMs to inform service development. She has developed with colleagues a training package in the clinical use of PROMs—Using Patient Reported Outcome Measures to Improve Service E,ectiveness (UPROMISE).! Black N. Patient reported outcome measures could help

transform healthcare. BMJ "#!$;$%&:f!&*. ("' January.)" Glasziou P, Irwig L, Aronson JK. Evidence-based medical

monitoring: from principles to practice. Blackwell, "##'.$ Wolpert M, Fugard AJB, Deighton J, Görzig A. Routine

outcomes monitoring as part of children and young people’s improving access to psychological therapies (CYP IAPT)—improving care or unhelpful burden? Child Adolesc Ment Health "#!";!*:!"(-$#.

% Freely available training materials and emergent thinking on use of outcome measures and data in context of child and adolescent mental health provided by EBPU. UCL. www.ucl.ac.uk/clinical-psychology/EBPU/presentations/presentations.php.

Cite this as: BMJ !"#$;$%&:f!&&*

HEALTH AND SOCIAL CARE ACT

Training in the brave new NHSHaving recently been on a course entitled “How does the NHS work . . . quick before it changes again” (yes, really), I am worried about the impact of the latest changes on doctors’ training and doctors’ and medical students’ ignorance of how the NHS works.!

Will commissioning bodies have an obligation for medical training or will this come down to providers? How will this work for private companies competing for tender? What about the impact of moving “routine” surgical cases out of NHS hospitals on surgical trainees’ exposure to different conditions? Where do our deaneries fit into this?

The latest version of the General Medical Council’s Best Medical Practice reminds us to check our privacy settings; shouldn’t there also be a section dealing with the need for doctors to understand the system within which they work? Is it not rather late to consider this only when consultant interviews are approaching?

The BMA champions junior doctors as agents for change. To maintain training high on the agenda, I think that we need to be more involved in the changes. We must consider generations of doctors yet to come, how their training will be influenced, and ultimately what kind of service they will be providing. We risk missing the opportunity to shape future healthcare.Abigail T Clark-Morgan orthopaedic registrar, Salisbury District Hospital, Salisbury SP" 'BJ, UK abigailclarkmorgan@gmail.comCompeting interests: None declared.! Edwards N. Implementation of the Health and Social Care Act.

BMJ "#!$;$%&:f"#(#. ($ April.)

Cite this as: BMJ !"#$;$%&:f!&&)

BMJ | 4 MAY 2013 | VOLUME 346 23

OBSERVATIONS

A recent study from the University of Leuven bemoaned the lack of regulation of research integrity in European countries.1 Twelve countries had no guidelines, it found, and even when guidelines existed they were often hard to locate or inconsistent. A map categorising countries by how they handled misconduct neatly illustrated the confusion. Along with Germany and Sweden, the United Kingdom fell into the second best category: countries with a “national framework.” Only Denmark and Norway were in the top category of countries that had a framework established by law.

There is clearly no room for complacency in Europe, but can we at least take comfort from the fact that the UK is doing better than some other countries? Before we start congratulating ourselves, we should remember that the so called “national framework” in the UK actually consists of a voluntary agreement that doesn’t cover all funders and has no central mechanism or funding for enforcement. Along with many others I welcomed Universities UK’s publication of the Concordat to Support Research Integrity in July 2012.2  3 It’s an excellent document, but that’s all it is: a piece of paper. It’s good that it has been endorsed by many major funders, such as the National Institute for Health Research, the Higher Education Funding Council for England, and the Wellcome Trust.4-6 It’s even better that some funders propose making adherence to the concordat a condition of grant. These are all positive moves, but they hardly merit the title of a national framework.

The concordat states that research institutions should be responsible for investigating misconduct, echoing guidelines of the international Committee on Publication Ethics (COPE).7  8 However, a decentralised system, relying on individual institutions, raises the age old question, “Who guards the guardians?” Doubtless many UK universities take their responsibility seriously, but anecdotal evidence indicates that

not all do.9 Investigating misconduct properly is an onerous responsibility, and institutions have few incentives to devote scant resources to such tasks. Universities may also fear negative publicity if research misconduct is proved, so the temptation to cover up is great.

Even if most UK universities handle suspected research misconduct well, they should be publicly accountable and open to scrutiny. Although confidentiality is required during an investigation, information should be shared when it has concluded. One reason that COPE developed guidance on cooperation between institutions and journals7 was that editors reported difficulties in getting information from universities.9

Another area of concern is that employers may be unaware of findings of research misconduct when hiring researchers. The UK currently has no system for checking the credentials of applicants except by contacting previous employers. Anecdotal evidence suggests that a better system is needed. For example, Jatinder Ahluwalia, who was found to have fabricated data by an investigation at University College London, had been dismissed from the University of Cambridge for a similar offence but later obtained a post at the University of East London, from which he was subsequently dismissed.10  11

It is therefore excellent news that the concordat recommends that institutions make a “high-level statement on any formal investigations of research misconduct that have been undertaken . . . publicly available.” This would be wonderful, but it will probably only happen if funders monitor it as a condition of grant.

Looking beyond Europe, the United States, with its Office of Research Integrity, is often cited as an example of strong regulation, yet even it does not have a truly national system. With a staff of 24 and an annual budget of just under $10m (£6.5m), the office covers only federally funded health research and relies on institutions to investigate.

PUBLICATION ETHICS Elizabeth Wager

The UK should lead the way on research integrityThe United Kingdom does better than some other European countries, but there is no room for complacency

But a recent case shows the importance of having a body that can ensure that institutions investigate misconduct properly. In late 2012 the office forced Ohio State University to reinvestigate a case, resulting in six articles being retracted for image manipulation, although the initial university inquiry had found no misconduct.12  13

Another important role of the US Office of Research Integrity is to provide guidance and promote good practice—running an inquiry is no easy matter, and institutions often need advice. Here again the UK system looks weak: we have the UK Research Integrity Office (UKRIO), which does sterling work but has no national recognition or funding. UKRIO is a charity that relies on donations from universities and short term funding from the Department of Health and employs just two people. In 2011 the UK Research Integrity Futures Working Group recognised the need for a national body to “lead on . . . research integrity.” 14 The fact that UKRIO receives over 70 cases a year from all academic disciplines and its guidelines are used by at least 50 UK universities also indicate the demand for a such a body.

Given the increasingly international scope of science, global alignment of guidelines on research integrity is essential.15 Before we can seek such a unified approach we need to set high standards in research integrity in the UK. I want to be proud of British research and institutions. I want us to be recognised as world leaders in research and in its governance and integrity. I would love to be able to say that we have a properly funded national framework for research integrity, but I’m afraid that’s simply not the case.Elizabeth Wager is a publications consultant, Princes Risborough, UK liz@sideview.demon.co.ukCompeting interests: EW is a member of the UKRIO advisory board and has received expenses to attend meetings; is in discussion with Universities UK about funding for a small study to investigate the concordat’s implementation; and chaired COPE !""#-$!.A version of this article originally appeared as a blog. See http://blogs.bmj.com/bmj/A longer version with references is on bmj.com.Cite this as: BMJ !"#$;$%&:f!$%'

Investigating misconduct properly is an onerous responsibility, and institutions have few incentives to devote scant resources to such tasks

bmj.com ( Editorial: Research

misconduct in the UK (BMJ !"$!;%&&:d'%())

24 BMJ | 4 MAY 2013 | VOLUME 346

OBSERVATIONS

MEDICINE AND THE MEDIA

The private clinics advertising unlicensed measles jabsSome private clinics advertising the single measles jab to parents have upped their activity since the measles outbreak in south Wales, even though the combined MMR vaccine is safe and effective. Margaret McCartney reports

In the midst of the measles outbreak in Swansea, the Children’s Immunisation Centre, a private company with clinics in several UK cities, set up a temporary clinic in the city over the weekend of !" April; it is

still advertising availability in Swansea. Unlike the free mass vaccination offered by Public Health Wales, the centre o#ers single measles vaccinations at $%%" each.

On its website it says that the single vacci-nation is for children “whose parents had con-cerns regarding the safety of the MMR [measles, mumps, and rubella] vaccination o#ered to them by their NHS GPs.” The website goes on to say that single vaccination is the “only safe way for MMR.”% Under the question “Does the MMR jab cause autism?” the site links to three newspaper reports that allege a link between autism and MMR!-& but not to NHS or Cochrane review advice about safety. Beneath these links is the line “for peace of mind.”

Use of the single measles vaccine comes with potential problems. It does not have a licence from the Medicines and Healthcare Products Regulatory Agency (MHRA). More vaccina-tions are needed for complete coverage than with the combined MMR vaccine, meaning that the default rate is likely to be higher. The total cost of the vaccinations is several hundred pounds. Mumps vaccine is not available singly in the United Kingdom, meaning that the com-plication of mumps, including the risks of male infertility, meningitis, and deafness, are carried by an unprotected group, and outbreaks have occurred in the recent past in the UK.'

The Chi ldren’s Immunisation Cen-tre is not the only private clinic advertising single vaccines in the UK. Independent Fam-ily Healthcare o#ers single measles vaccines while announcing that there is a “measles outbreak warning,”( and Clarion Health says, “We believe that every parent should have the right to choose what they feel is best for their

investigating the claims of the Children’s Immuni-sation Centre which seem to suggest this. We will act against any clinic that advertises medicines with false and potentially misleading claims.”

The MHRA explained that a doctor may use an unlicensed medicine only when there is a “special clinical need,” and this action would be bound by the principles of good medical prac-tice as de)ned by the General Medical Council.%" So what would such a special clinical need be? David Elliman, spokesman for the Royal College of Paediatrics and Child Health, told the BMJ, “There is no good medical indication to give one or other single vaccine and never has been.”

In other words, clinically there is no good rationale behind the use of single vaccines rather than the triple vaccine. Niall Dickson, the chief executive of the GMC, told the BMJ, “Any doctor who makes false and misleading claims

child. To this end, we offer a comprehensive Single Vaccination Programme as an alternative to the MMR.”* Another clinic, the MMR Private Vaccination Clinic, confusingly asks customers to sign a form to “con)rm that unless my/our child is immunised using measles, mumps and rubella

vaccines separately, I/we will not have him/her vaccinated with the com-bined MMR vaccine.”+

An MHRA spokesper-son said, “We agree with

the Department of Health [for England] that the combined MMR vaccine is the best way to protect people from the potentially serious consequences of measles, mumps, and rubella.

“There is no evidence to show that the sin-gle measles vaccination gives better protection against measles than the MMR vaccine. We are

Single vaccination clinics exist because of fear and misinformation. This is compounded by misleading advertising on some websites

Fear of the combined MMR vaccine, being given here, is still pushing some parents to seek alternatives

REBE

CCA

NADE

N/RE

UTER

S/CO

RBIS

bmj.com ! Medicine and the Media: MMR, measles, and the South Wales Evening Post (BMJ !"#$;$%&:f!'()) ! News: Government launches campaign to give MMR vaccine to a million children in England (BMJ !"#$;$%&:f!&(&) ! News: Largest group of children a*ected by measles outbreak in Wales is #"-#) year olds (BMJ !"#$;$%&:f!'%') ! News: Wales sets up drop-in vaccination clinics to tackle measles outbreak (BMJ !"#$;$%&:f!%'!)

BMJ | 4 MAY 2013 | VOLUME 346 25

OBSERVATIONS

BMJ BLOG Richard Vize

An immensely delicate balance: the challenges for CCGsThe mood among clinical commissioners less than a month into the new system in England is characterised by a determination to move care out of hospitals, frustration at legal and financial impediments to change, and considerable confidence that they can make a difference.

At the first conference of NHS Clinical Commissioners (an independent group launched by the NHS Alliance, NHS Confederation, and National Association of Primary Care) introspection was refreshingly absent. While there were concerns about workload and the risk of conflicts of interest as commissioners invest in primary care, the focus was on the big picture of their new role. In particular, fears voiced by the BMA that commissioning could lose GPs the trust of their patients did not surface as a major issue.

Instead, commissioners recognise that one of their risks is a divide opening between themselves and their member practices. Winning GPs’ trust and involvement is already proving tough. If the new emphasis on providing care in the community and reducing emergency hospital admissions is not to lead to excessive GP workloads, clinical commissioning groups (CCGs) know they have to encourage practices to adopt new ways of working, such as greater collaboration, a bigger role for practice nurses and pharmacies, and more effective use of technology to interact with patients and other clinicians, notably hospital consultants.

So CCGs need to get GPs to see advantages in the new system, feel part of developing a new patient centred approach, take on new work, and change the way they run their practices. And they have to do all this while GPs are angry about changes to their contracts. So it was not surprising to hear concerns among commissioners that they risked being braver in reforming hospitals than changing GP services.

Alongside the competition regulations, the greatest object of loathing for CCGs is the Payment by Results system. At the NHS Clinical Commissioners conference they left the health secretary, Jeremy Hunt, in no doubt that as long as the system continued, trusts would have an incentive to game the system and be uncooperative with

commissioners. Hunt agreed that it was a barrier to integrating care. NHS England is reviewing the funding allocation system for CCGs, but their appetite for radical change is far from clear.

The determination among commissioners to move care out of hospitals is palpable, but for some CCGs building a meaningful picture of existing services is being severely hampered by inadequate financial and clinical data. It is impossible to plan change if you don’t trust the numbers. As well as increasing the danger of service failures, data weaknesses stand in the way of beginning a discussion with local people and trusts about what needs to change.

One thing that needs to change is the attitude of NHS England. There are already numerous examples from around the country of demands for data without offering a reason, instructions to attend meetings at short notice, and a general lack of recognition that the hierarchical relationship that existed between the centre and primary care trusts is supposed to have been replaced by a more balanced and mutually respectful approach. NHS England is going to build up resentment if that sort of behaviour continues. GPs will quickly express their dissatisfaction if the promise of local autonomy lacks substance.

The need to engage with the public and local MPs and councillors early and relentlessly is almost universally recognised. Some commissioners detect a subtle change in public perceptions about the NHS in the wake of the Mid Staffordshire scandal. There is anecdotal evidence of greater sensitivity to questions around quality and safety and somewhat less willingness to assume that everything is perfect in their local hospital.

Such a change would of course be helpful to commissioners as they try to generate discussion around the future of local services, but it must not tip into undermining confidence as a means to secure change—an immensely delicate balance.Richard Vize is a journalist and communications consultant specialising in health and local government. He was the editor of the Health Service Journal from !""# to !"$".

% Read this blog in full and other blogs at bmj.com/blogs.

about the treatments or services they provide should be in no doubt that they are putting their registration at risk. We are unequivocal on this—when advertising services, doctors must always make sure the information they publish is factual, can be checked, and does not exploit their patients’ vulnerability or lack of medical knowledge.”

In addition, when it comes to unlicensed medications, he said that “it must be in the patient’s best interest, and the doctor must be satis!ed that there is su"cient evidence to show that it is safe and e#ective.”

Meanwhile, the Children’s Immunisation Centre says on its website, “All our thousands of patients are healthy, with no autism, no hospitalizations or !ts (anaphylaxis shock), no febrile convulsions. We have a 100% Safety Record and have given over 70 000 vaccina-tions (over 18 000 patients).”11

In support of this claim Fiona Dickson, the centre’s director, told the BMJ that the centre would know if any of its patients later had a diagnosis of autism because “parents are spending £600 on vaccines—they would sue us if they did.” She was unable to cite any audit or follow-up study that the clinics had done to support the claim, saying that they relied on parents to tell them of any diagnoses a*er vaccination.

In September 2012 the MHRA upheld a complaint about the Children’s Immunisation Centre’s advertising when its website pub-lished an “unbalanced view of the safety and e"cacy of an unlicensed mumps vaccine.” Its website was subsequently amended.12

Additionally, the MHRA told the Breakspear Medical Group and Clarion Health to amend their advertising when it was found to be mis-leading or incomplete.13 14 The BabyJabs clinic, based in London, had three complaints against it upheld by the Advertising Standards Author-ity in 2012 a*er it falsely claimed that the MMR vaccine “could be causing autism in up to 10% of autistic children in the UK.”15

Single vaccination clinics exist because of fear and misinformation. This is compounded by misleading advertising on some websites. Their argument is that single vaccines o#er a valid choice to parents who are concerned about the triple vaccine. Yet the ethics of using an unlicensed and expensive product that leaves gaps in vaccination coverage, when an evidence based and licensed one is available, should require the GMC to investigate now.Margaret McCartney is a general practitioner, Glasgow margaret@margaretmccartney.comCompeting interests: None declared.References are in the version on bmj.com.Cite this as: BMJ !"#$;$%&:f!'$"

(EDITORIALS, p )

26 BMJ | 4 MAY 2013 | VOLUME 346

PERSONAL VIEW

No doctor should be untouchableEven very senior doctors must be

subject to the same codes of conduct, and to the same sanctions when

they are breached, says seasoned whistleblower Peter Wilmshurst

Allegations that Jimmy Savile sexually abused children and vulnerable hospital patients surfaced a!er his death, when he was no longer protected by

the English defamation laws. These laws were designed to protect the wealthy and famous from allegations by poorer citizens by making it di"cult and expensive to defend a defamation claim, even if you are telling the truth. Should we blame the cover-up entirely on the libel laws?

There were those in authority at the BBC (where Savile had star status), in hospitals where he had unprecedented access, and in the criminal justice system who had heard reports of his misconduct but failed to act. Victims were told that their testimony would count for little compared with the word of the television star and charity fundraiser. Savile was valuable to the organisations and his victims were not. Savile himself bragged that he was untouchable. Other organisations that have covered up misconduct include the Catholic church over child abuse by priests, and the South Yorkshire Police over their failings at the Hillsborough disaster. Organisations protect their members, and senior members are, like Savile, o!en powerful and untouchable.

I believe, based on observation of the outcomes in several cases in which I have been involved, that the medical establishment is no di#erent, with senior doctors being untouchable. Indeed, once, when I raised concerns at a meeting at the Department of Health about a senior doctor, I was even told that he was “untouchable.” I know that over many years the General Medical Council had refused three times to investigate allegations about him from other doctors (not from me). On 23 November 2012, the Department of Health wrote to me that the current chief medical o"cer is unable to discuss the issue with me “due to pressure on her time.” Refusal to hear allegations will allow later denial of knowledge of them.

The GMC investigates serious allegations about doctors, but in my experience it will o!en refuse to investigate the most senior doctors.

I reported Clive Handler to the GMC for (nancial misconduct. When he appeared before the professional conduct committee, the chairman of the committee, Peter Richards, had to stand down from the hearing because, in his role as medical director of Handler’s hospital, Richards had agreed to conceal Handler’s misconduct from the GMC.1  2 The GMC refused requests from its own solicitors and from me to take action against Richards,

who had clearly broken the GMC’s rules on reporting misconduct by other doctors. Richards, who held many senior positions, including chairman of the Council of Deans of UK Medical Schools and Faculties, returned to chair hearings at the GMC a!er Handler was suspended from the medical register.

Senior managers at the Royal Brompton Hospital knew that over many years Professor Peter Collins had used quali(cations he had not been awarded.1  2 They knew that he had obtained three posts using false quali(cations

and that he put them on his letters. The whistleblower was informed by letter from the chairman of the board of governors that unless he dropped the matter his career might su#er. I reported Collins to the GMC. The GMC informed me that no public hearing was required because it had accepted a private assurance from Collins that he would not use false quali(cations again. In the few years before and a!er the GMC’s decision on Collins, seven more junior doctors faced public hearings for claiming quali(cations they had not been awarded. Six (Rashid Rhalife-Rahme, Seth Atardo, Ashoka Prasad, Afolabi Ogunlesi, Abu Sha(, and Ashutosh Jain) were removed from the medical register and one (Sahmin Pandor) received a reprimand.2 They di#ered from Collins (educated at Cambridge and St Thomas’) in many respects, including the fact that most had only once claimed quali(cations they had not been awarded.

The GMC does not allow a doctor to voluntarily remove his or her name from the medical register when he or she is under investigation. However, twice, when I reported heads of medical institutions to the GMC for concealing research misconduct within their institutions, the GMC informed me that, as a result of administrative errors, each had been allowed to remove their names voluntarily, so the GMC could not investigate my allegations.

Despite legislation meant to protect whistleblowers, I am aware that an NHS trust and a health authority spent more than £2.5m in legal fees before getting a whistleblower (a junior doctor) to accept a legal settlement that included a gagging clause preventing the whistleblower from revealing illegal activity by a senior doctor. A deanery was complicit in the victimisation of the trainee. Allowing for additional management time and the (nancial settlement with the doctor, the protection of this senior doctor probably cost the NHS more than £5m.

If we are genuinely going to put patients (rst, then nobody, no matter how senior they are, can be untouchable. However, this will only happen when we have a cultural change in healthcare, with promotion of real openness and real protection for whistleblowers, together with reform of the English libel laws to provide a genuine public interest defence.Peter Wilmshurst is an honorary consultant cardiologist, University Hospital of North Staffordshire, Stoke on Trent peter.wilmshurst@tiscali.co.ukCompeting interests: I have defended three libel claims brought by a US medical device company, and I have reported several doctors to the GMC.

References are in the version on bmj.com.Cite this as: BMJ !"#$;$%&:f!$$'

An NHS trust and a health authority spent more than £2.5m in legal fees before getting a whistleblowing doctor to accept a gagging clause preventing the whistleblower from revealing illegal activity by a senior doctor

JOHN

FED

ELE/

BLEN

D IM

AGES

/GET

TY

BMJ | 4 MAY 2013 | VOLUME 346 27

PERSONAL VIEW

Caring for patients with dementia: an exceptional caseSpecialist wards for patients with dementia can benefit patients, carers, and staff, says Kate Sartain

Rowan Williams, former archbishop of Canterbury, said in his last speech to the House of Lords in December !"#!, “Old people are too often treated with con-tempt and exasperation . . . too o$en we

want older citizens to accept a marginal and humil-iating status, tolerated but not valued, while we look impatiently . . . for them to be o% our hands.”

In September !"## it became obvious that Dad was developing dementia. Mum had died six months before. Her dementia was diagnosed in !""&, a$er years of us not quite realising what we were dealing with. The second time round it was easier to detect.

During the years when Dad cared for Mum, the government produced the national strategy Living Well with Dementia. Local strategic health authori-ties ran workshops where medical professionals, social workers, commissioners, and providers met with service users and carers to determine how best to deliver care for people with dementia. People were encouraged to tell their stories of living with dementia. I attended as a carer.

A picture emerged that caring for people with dementia is a highly skilled job in very short supply. One consultant commented that “living well” was impossible. Through tears, elderly carers spoke in desperation about isolation and exhaustion cop-ing with a spouse whose character changed from minute to minute. A woman with dementia shared fears of losing her capacity and identity.

People with dementia 'nd change particularly challenging, so stories of deterioration in physical health and hospital admissions were heartbreak-ing. It was therefore with trepidation that I accom-panied my very confused father to hospital one day a$er he had fallen. In the emergency department

he was treated e(ciently, and a$er !) hours in an admissions unit he was moved to a ward.

What a relief. This ward had a striking sense of order, peace, and calm professionalism. A large sign gave the day and date and described the weather. By each bed stood a glass-fronted cabinet where visitors could securely place per-sonal e%ects; reminding patients of something familiar, these things gave a sense of security. A nurse approached me, gently explaining that Dad had dementia and a problem with his blood pressure. She explained the treatment for the physical illness but also wanted to understand who my dad was; what he liked and disliked; and what I knew about dementia. Did I realise what this really meant for him in the long term? I was amazed that a busy ward sister had the time and patience to deal not only with her patients but also to assess their carers. The two words voiced most by people who are involved with dementia care, I found, are “time” and “patience,” and these are in short supply. For the 'rst time for many months, I was able to relax. Dad was being treated by people who understood the problems. I even dared to consider that perhaps the outcomes of the workshops were being put into practice.

During his three week admission, Dad was treated as a whole person. The sta% treated him medically but also with compassion and respect as a human being. And they did the same for my sister and me. They had time to treat the family unit, not just a confused man with wobbly blood pressure to tick a box. When he was discharged into a care home, Dad was at ease. It had been wonderful.

We didn’t realise the true value of this experi-ence until weeks later, however. A$er another fall, Dad was admitted to a di%erent, non-specialist ward in the same hospital. Here, we were struck by the reality of sta% trying desperately to deliver good care but in an atmosphere so fraught it was exhausting. I wrote to the hospital asking why these two experiences were so di%erent. The chief execu-tive explained that the 'rst ward was funded by

research to investigate ways of treating people with both physi-cal and mental health problems.

This 'rst, specialist ward had found ways to understand and put into place care that bene-'ts patients, sta%, and carers.

Maybe it was the provision of an activities room, a place of stimulation, where patients are o%ered a variety of recreations. I was comforted by the time and space I was given to 'nd a “new home” for Dad, and the discharge direct from the ward to the new home with Dad accompanied by a face he had become accustomed to eased that change enormously. Whatever, throughout Dad’s stay, sta% o%ered “that something,” which all the workshop storytellers were seeking for their loved ones, and for themselves. This “something” is intangible, p ossibly unmeasurable, but is immeasurable.

Dad did fall again, his health deteriorated, and, at *! years old, he had multiple physical problems. The time he spent on the specialist ward was an excellent experience during which we were able to calm down and come to terms with what the future meant, and we were prepared for what we all knew would be a gradual decline. Patients with dementia are not going to “get better,” but they can be enabled to be ill with dignity. The research ward made huge progress in de'ning how to deliver excellent care. Carers became part of the whole package. Hospital sta% can deliver patient centred care and leave their shi$s ful'lled and satis'ed.

If we are to develop good practice so that patients can live well with dementia, experiences such as ours must be celebrated and disseminated, sooner rather than later. We learnt that care of ill older people with dementia is di(cult, time consuming, and skilled. But it is not impossible. Hospital care can be inspiring.Kate Sartain is a carer, Southwell, Nottinghamshire Acknowledgment: I thank Margaret Kerr, my sister.Competing interests: None declared.Since writing this article I have become a volunteer in dementia care with the University of Nottingham Public and Patient Involvement Group at the Queen’s Medical Centre Nottingham.Cite this as: BMJ !"#$;$%&:f!'#$

I was amazed that a busy ward sister had the time and patience to deal not only with her patients but also to assess their carers

! bmj.com Clinical Review: Dementia (BMJ 2009;338:b75)

FION

A BL

AIR

Each patient on the ward had a glass-fronted cabinet to display familiar objects, giving a sense of security

28 BMJ | 4 MAY 2013 | VOLUME 346

OBITUARIES

Thomas Dormandy Chemical pathologist who studied free radicals and wrote an acclaimed book on tuberculosis

if he had just operated on someone he would be up half the night worrying about them and go and see their relatives.”

Dormandy wrote leaders for the Lancet in the !"#$s and ’%$s and continued writing clinical papers, the last of which was published in &$!$. But it was not until his retirement that he was able to give full rein to his writing. He wanted to write a book on talent in old age, as displayed by art-ists such as Michelangelo, Goya, and Monet, all of whom did major work in their '$s.

However, publishers were not interested at (rst, so he wrote The White Death: A History of Tuberculosis (!""") instead, which considers the disease’s social, artistic, and human impact and which reviewers acclaimed. A review in the Spectator said it “could well be the de(nitive his-tory of tuberculosis” and described Dormandy’s “)ashes of wit” and “impressive intellectual ver-satility which is forever spilling over into a stream of erudite and entertaining footnotes.”& The writer Peter Ackroyd described it as “a model of how medical history ought to be written, lucid in its analysis and perspicacious in its commentary.”*

This erudition didn’t surprise colleagues or family. Dormandy was a real polymath and intel-lectual, who was also a talented painter, and would give lectures without the aid of slides but with the aid of a steady stream of cigarettes.

A+er the critical success of his book on tuber-culosis he got a publishing deal for his original literary baby, Old Masters: Great Artists in Old

Age (&$$$). More books fol-lowed: Moments of Truth: Four Creators of Modern Medicine (&$$*) and The Worst of Evils: the Fight against Pain (&$$%).

His final book was pub-lished last year, Opium: Real-ity’s Dark Dream, and he was

working on a short history of medicine when he died. His book on opium harked back to his The White Death as it covered society and culture as well as disease.

A Daily Telegraph reviewer wrote: “Thomas Dormandy has written an unrhapsodic, sceptical, vividly documented history of the drug. He has an eye for quotation . . . and a man of the world tone, dry, witty, not easily impressed.”,

He leaves his wife, Elizabeth, a public health specialist; two sons; and two daughters.Anne Gulland freelance journalist, London annecgulland@yahoo.co.ukReferences are in the version on bmj.com.Cite this as: BMJ !"#$;$%&:f!$!!

Thomas Dormandy was the newly appointed consultant chemical pathologist at the Whit-tington Hospital in north London when he (rst started to work on the study of free radicals. These had been recognised by chemists work-ing in industrial research, but it was not until the !"%$s that their role in biology or clinical medicine was acknowledged.

Dormandy’s research was focused mainly on the study of trace metals in health when he began to look at the link with free radicals. He appointed a postgraduate biochemist, and they undertook a clinical study on red blood cells taken from patients with blood disorders in which cells broke down.!

When these red blood cells were incubated with hydrogen, peroxide free radicals spontane-ously formed. The potential damaging e-ect of free radicals is limited by the presence of anti-oxidants, and Dormandy studied the di-erent antioxidants present in normal human plasma.

Professor Malcolm Jackson, head of the Insti-tute of Ageing and Chronic Disease at Liverpool University, undertook collaborative work with Dormandy, examining the potential role of sele-nium in skeletal muscle disorders. He says that Dormandy’s role was important as he was one of the (rst people in the early days of research into free radicals who recognised their potential role in medicine. “The fact he was working in the NHS was important as he had access to clinical sam-ples, and he was one of the (rst to look for evi-dence in samples. There was an assumption that free radicals had to be damaging, and Tom was one of the people active in the early days to under-stand the role of anti oxidants,” says Jackson.

Dormandy became president of the Society for Free Radical Research and was recognised inter-nationally for his work. Professor Joseph Lunec, a biochemist whose PhD was supervised by Dormandy, describes him as a “father (gure” on the subject. “Tom had this hypothesis that free radicals were mediators for many diseases, although that may be overegging the pudding a bit. I myself have spent the past &# years work-ing on free radicals, and there are many others who are now professors and who were my PhD students. And that’s quite a legacy,” he says.

Dormandy carried out research into how changes in the joints of people with rheuma-

toid arthritis were caused by free radicals and changed the way people thought about how the disease came about, says Lunec. He also devel-oped an interest in reperfusion injuries, when the blood supply returns to the tissues a+er it has been restricted. During reperfusion a large amount of free radicals are generated, and Dor-mandy worked on ways of studying this.!

Dormandy was born in Budapest, Hungary, in !"&%. With his younger brother and sister and his parents he went into hiding when the Germans occupied Hungary in !",, as the family had a Jewish back-ground. When the Russians arrived the family went to Cluj (now in Romania but at the time in Hungary) and then to Geneva and Paris before set-tling in London in !",..

Dormandy sat his medical examinations once in Cluj, again in French in Geneva, and, for a third time, in English at the Royal Free Hospital in Hampstead, where he met his wife Katharine. She became a haematologist but died of breast cancer at the age of #&; the Katharine Dormandy Haemophilia Centre and Thrombosis Unit at the Royal Free was named a+er her. They had three children together, one of whom died from cancer at the age of &&.

Dormandy trained at Guy’s Hospital and the Middlesex and started a career in surgery, although his younger brother, John, who went on to become a surgeon, said that he found it too much of a strain: “He got very involved with his patients, and

Dormandy was a real polymath and intellectual who would give lectures without the aid of slides but with the aid of a steady stream of cigarettes

Thomas Louis Dormandy, consultant chemical pathologist (b #'!&; q Society of Apothecaries of London #'(!), died from respiratory failure on !" February !"#$.

BMJ | 4 MAY 2013 | VOLUME 346 29

OBITUARIES

Carl Ludwig Scholtz trained in pathology in Sydney and Manchester. At the London Hospital, he ran a service worthy of a prestigious department, gained a PhD, and made many contributions to neuropathology and its literature. He was diagnosed as having motor neurone disease in !"#" and returned to Australia in !""$, with a wheelchair and voice synthesizer (“to crack jokes with my children again”). Family, several caring organisations, and his own spirit shown in his poetry sustained him through increasing paralysis. He leaves his wife, Geraldine, and two children.Anne Marshall Cite this as: BMJ !"#$;$%&:f!#$'

Julian Stanley Martyn Toms

Former general practitioner (b #(%&; q Cambridge #('"; MA (Cantab), FRCP, FRCGP, DCH, DRCOG), died from glioblastoma on $ January !"#$.Julian Stanley Martyn Toms took his first GP post in the singlehanded practice at Muasdale in Kintyre, where he worked for eight years. However, to the disappointment of the practice population, he then re-entered hospital medicine, working in neurology in Dundee and obtaining his MRCP. Subsequently, he moved to join the Portree medical practice and community hospital team on the Isle of Skye in !"#%, where he was integral to the development of new premises and the enlargement of the practice. After retiring in $&&' he did much out of hours and GP locum work, but he also increased his active commitment to community works. He leaves his wife, Christine; four daughters; and four grandchildren.Charles L Crichton Cite this as: BMJ !"#$;$%&:f!#%#

James Reginald Searle BartonOphthalmic surgeon Taunton (b #(!%; q #(&); FRCS Edin), d #& November !"#!.When newly qualified as a consultant ophthalmic surgeon, James Reginald Searle Barton (“Jim”) moved his family from Manchester to rural Somerset. During Jim’s career, intracapsular cataract surgery to place intraocular lenses came into common use, which improved patient outcomes. Jim had on his appointment introduced the Amoils cryoprobe (used in the cryoextraction method of cataract surgery) to Taunton after its development in !"'$; he continued with intracapsular surgery, using anterior chamber intraocular lenses as these became mainstream in the !"#&s. His wife, Sheila (“Flick”), predeceased him in !""$. He left four sons, one daughter, and !( grandchildren. Andrew Barton Cite this as: BMJ !"#$;$%&:f!#%(

David James Martins BudderyClinical assistant department of oral surgery, James Paget University Hospital, Gorleston (b #(!!; q #(%)), died from pneumonia on !$ January !"#$.David James Martins Buddery trained at the University of Sheffield in the early !"%&s and established a practice initially on the Cliffs of Scratby in Norfolk and then at Great Yarmouth. He was subsequently appointed as clinical assistant in Great Yarmouth and later at the James Paget Hospital. He was extremely successful in treating patients with seemingly intractable facial pain and similar neuralgia-like symptoms. In retirement he became voluntary curator of the hospital museum and was a keen amateur radio enthusiast and Savoyard. Predeceased by his wife, Joycelyn, in $&&%, he leaves a son, a daughter, two grandchildren, and two brothers.Caroline Buddery Cite this as: BMJ !"#$;$%&:f!#%!

John Denys Campling

Former general practitioner (b #(!(; q St Mary’s Hospital Medical School #()$; MRCS, FRCGP), d ( February !"#$.John Denys Campling was the first GP trainer in Northampton and medical officer at the local college of education. As county surgeon for St John Ambulance and a Hospitaller, he supported the St John Eye Hospital in Jerusalem and was awarded commander of the Order of St John in $&&). He was a past master of the Worshipful Company of Pewterers and, as a parish councillor and deacon at the local Baptist church, for many years also school governor and active amateur actor and director. He leaves his wife, Angela; three children; and four grandchildren.Angela Campling Cite this as: BMJ !"#$;$%&:f!#%&

David Malcolm Milne

Former general practitioner London (b #()"; q Bristol #('$), d !# December !"#!. David Malcolm Milne’s early medical interest was pathology, which brought him work in Jamaica, New Zealand, and London. Later he joined a general practice near Heathrow, where he also looked after guests at the airport hotels. Subsequently he worked as an out of hours doctor in Perth, Australia, and later in London and Newcastle. Ill health forced him to retire, and he settled in Mallorca. A literary man, he enjoyed classic authors, such as Somerset Maugham. His great knowledge and intimate relationship with the fermented grape made him

a bon viveur, who was never happier than in good company in a restaurant. A seasoned and adventurous traveller, he had visited !&( countries. He leaves his wife, Marlene; a daughter; and a sister.John Taylor Cite this as: BMJ !"#$;$%&:f!#$(

John Joseph Smirke Herbert Ruston

Consultant anaesthetist Royal Free Hospital, London (b #()); q Royal Free Hospital, London, #('*), d !# January !"#$.During his first house job in Hastings, John Joseph Smirke Herbert Ruston developed an interest in anaesthesia and met his wife, Mandy. He moved to London to work at Barts and then became a senior registrar at the Royal Free, where he was appointed as consultant in !""(. Calm, methodical, and totally unflappable, he could quickly resolve a clinical crisis. John was extremely well informed, often about the most surprising, diverse, and quirky topics. He had cardiac surgery in $&!$ and seemed to have made a full recovery. Having returned to work, he was undertaking a full clinical workload. He died unexpectedly in his sleep. He leaves Mandy and their two sons. Richard Marks, Michael Pegg Cite this as: BMJ !"#$;$%&:f!#%"

Carl Ludwig Scholtz

Former senior lecturer in neuropathology Royal London Hospital (b #($(; q St Vincent’s Hospital, Melbourne, #(&%; MD, PhD), died from motor neurone disease on % January !"#$.

30 BMJ | 4 MAY 2013 | VOLUME 346

CLINICAL REVIEW

50° progressed at an average of 1° a year, thoracolumbar curves progressed at 0.5° a year, and lumbar curves pro-gressed at 0.24° a year. Thoracic curvatures of less than 30° did not progress.7

Previous long term retrospective observational studies of idiopathic scoliosis presented a poor prognosis (respira-tory failure, cardiovascular risk, and mortality).8 This has created a misinterpretation that all types of idiopathic sco-liosis inevitably lead to disability from back pain and seri-ous cardiopulmonary compromise. These studies included patients with mixed diagnoses, which could explain the poor outcomes reported. In a more recent prospective case-control study describing the 50 year natural course of untreated idiopathic scoliosis, there was no evidence link-ing untreated AIS with increased rates of mortality in gen-eral, and cardiopulmonary compromise in particular.9

Progressive scoliosis can result in the development of a worsening deformity and cosmesis.10 The physical deformi-ties seen include the development of chest wall abnormal-ity, rib prominences, asymmetry in shoulder height, and truncal shi*.

How does adolescent idiopathic scoliosis present?Patients with AIS most o*en present with unlevel shoul-ders, waist line asymmetry (one hip “sticking out” more than the other), or a rib prominence. This is usually +rst identi+ed by the patient, family member, general practi-tioner, or a school nurse.

Back pain is sometimes the presenting complaint. The association between scoliosis and back pain has been dem-onstrated in a retrospective study of 2442 patients with idiopathic scoliosis,11 which found that 23% of patients with AIS had back pain at initial presentation, and another 9% developed back pain during the study. An underlying pathological condition was identi+ed in 9% (48/560) of the patients with back pain, mainly spondylolysis and spondylolisthesis and only one case of an intraspinal tumour.11

How is adolescent idiopathic scoliosis diagnosed?On presentation of a patient with scoliosis to primary care, a detailed history, examination, and radiological investiga-tions should be undertaken before referral to a specialist.

The history should include a detailed birth history, developmental milestones, family history of spinal deform-ity, and assessment of physiological maturity. Di-culties

Scoliosis is a three dimensional deformity of the spine de+ned as a lateral curvature of the spine in the coronal plane of more than 10°.1 It can be categorised into three major types—congenital, syndromic, and idiopathic. Congenital scoliosis refers to spinal deformity caused by abnormally formed vertebrae. Syndromic scoliosis is asso-ciated with a disorder of the neuromuscular, skeletal, or connective tissue systems; neuro+bromatosis; or other important medical condition. Idiopathic scoliosis has no known cause and can be subdivided based on the age of onset—infantile idiopathic scoliosis includes patients aged 0-3 years, juvenile idiopathic scoliosis includes patients aged 4-10 years, and adolescent idiopathic scoliosis a.ects people aged >10 years.

Adolescent idiopathic scoliosis (AIS) is the most common spinal deformity seen by primary care physicians, paedia-tricians, and spinal surgeons.2 This review is focused on AIS and reviews the diagnosis, management, and contro-versies surrounding this condition based on the available literature.

What causes adolescent idiopathic scoliosis?The diagnosis of AIS is one of exclusion, and is made only when other causes of scoliosis, such as vertebral malfor-mations, neuromuscular disorders, and other syndromes have been ruled out. According to epidemiological studies, 1-3% of children aged 10-16 years will have some degree of spinal curvature, although most curves will not require surgical intervention.3  4

Suggested causes of AIS include mechanical, metabolic, hormonal, neuromuscular, growth, and genetic abnormali-ties.5  6 These factors are not yet well accepted as a direct cause for this condition. The current view is that AIS is a multifactorial disease with genetic predisposing factors.

What is the natural course of adolescent idiopathic scoliosis?The natural course of scoliosis was studied in a prospective case series of 133 patients. The patients were followed for an average of 40.5 years (range 31-53 years), and 68% of adolescent idiopathic curvatures were found to progress beyond skeletal maturity. Thoracic curvatures greater than

Spinal Surgery Unit, Royal National Orthopaedic Hospital, Stanmore, London HA! "LP, UKCorrespondence to: F Altaf farhaanaltaf@hotmail.comCite this as: BMJ !"#$;$%&:f!'"(doi: #$.##%&/bmj.f'($)

Adolescent idiopathic scoliosisFarhaan Altaf, Alexander Gibson, Zaher Dannawi, Hilali Noordeen

SUMMARY POINTSScoliosis is a lateral curvature of the spine measuring >!"° in the coronal planeSeveral different types of scoliosis exist, and idiopathic scoliosis occurs in ".#-$."% of the paediatric populationInitial evaluation should involve a focused history and physical examination. The Adam’s forward bend test is particularly useful for detectionFactors predicting curve progression include maturity (age at diagnosis, menarchal status, and the amount of skeletal growth remaining), curve size, and position of the curve apexBracing is used to treat scoliosis in many European countries, but practice is divided in the UK and US, and elsewhereSurgery is recommended in adolescents with a curve of a Cobb angle more than %#°-#"°

!Follow the link from the online version of this article to obtain certi"ed continuing medical education credits

SOURCES AND SELECTION CRITERIAWe searched Medline and the Cochrane Library using MeSH terms “adolescent idiopathic scoliosis”, and “scoliosis bracing”. We included systematic reviews, randomised controlled trials, and good quality prospective observational studies mainly from the past !# years but did not exclude seminal papers from before this time.

bmj.com Previous articles in this series

) Diagnosis and management of hidradenitis suppurativa (BMJ '$#%;%"&:f'#'#)

) Pulmonary hypertension: diagnosis and management (BMJ '$#%;%"&:f'$'))

) Leukaemia update. Part ': managing patients with leukaemia in the community (BMJ '$#%;%"&:f#*%')

) Leukaemia update. Part #: diagnosis and management (BMJ '$#%;%"&:f#&&$)

) Outpatient parenteral antimicrobial therapy (BMJ '$#%;%"&:f#()()

BMJ | 4 MAY 2013 | VOLUME 346 31

CLINICAL REVIEW

during labour can be associated with a diagnosis of cer-ebral palsy, which can lead to neuromuscular scoliosis. A history of developmental delay can be indicative of a non-idiopathic cause for the scoliosis.

Assessment of maturity includes inquiry about the growth spurt and the menarchal status in girls, as menarche indicates a point at which the growth starts to decrease over a period of two years from its onset.!"

The patient’s presenting complaint should be elicited, including back pain, neurological symptoms, and any con-cerns regarding cosmesis. The presence of constant pain, night pain, or radicular pain indicates that further investi-gations are required to exclude underlying pathology.!#

When examining a patient with suspected scoliosis, adequate exposure is required to assess the spine appro-priately. Boys should be examined in their underwear or shorts; girls should be wearing underwear and a bra. Gait and posture should be evaluated, looking in particular for a short-leg gait due to leg length discrepancy and listing to one side seen in severe curves.

The patient’s upright posture should be evaluated from the front, back, and sides. The relative heights of the iliac crests and the shoulders should be observed for any asym-metry that could be indicative of curve severity. The pelvis should be level and any lower limb discrepancy compen-sated with a li$ (a series of wooden blocks may be placed under the short leg until the hips are level). If a curvature of the spine is seen, the location and direction of the curve(s) should be noted. The curve is designated according to the direction of the curve convexity.

The back should be inspected for the presence of cafe

au lait spots, subcutaneous nodules, and axillary freck-les, which are seen in neuro%bromatosis. The presence of hairy patches or skin dimples over the lower back can be an underlying sign of spinal dysraphism (a constellation of congenital abnormalities including defects of the spinal cord and vertebrae).

The balance of the thorax over the pelvis is assessed by dropping a plumb line from the C& spinous process, which normally falls within the gluteal cle$. In cases of coronal imbalance the distance from the plumb line to the gluteal cle$ is measured in centimetres and the direction of devia-tion noted.

The Adam’s forward bend test!' is carried out to assess the degree of rotational deformity associated with the sco-liosis. The patient is asked to bend forward at the waist with the knees straight and the palms together (%g !). The examiner looks down the back for the presence of asymme-try in the rib cage (rib prominence) or deformities along the back indicative of a structural scoliosis. A non-structural curve (postural scoliosis) normally disappears on bending forwards.

A scoliometer is an instrument that is placed on the back and can be used to provide an objective measure of curve rotation.!( In primary care the use of a scoliometer is not required for the diagnosis of scoliosis, and suspected cases should be referred for specialist opinion on diagnosis.

A detailed neurological examination should be per-formed testing motor and sensory function and re)exes. Asymmetries in re)exes can be a sign of an intraspinal disorder.!* The abdominal re)ex refers to the neurologi-cal re)ex stimulated by stroking the abdomen around the umbilicus. This usually involves a contraction of the abdominal muscles, resulting in the umbilicus mov-ing towards the source of the stimulation. An abnormal abdominal re)ex may be suggestive of an intraspinal disor-der and is o$en absent on the convex side of the curve.

What imaging is required?Full length standing posteroanterior and lateral radio-graphs of the spine are required in order to assess the degree of deformity. These are taken with the patient in a standing position in order to assess the e+ect of gravity on the deformity. Patients are instructed to remove their shoes, and any lower limb discrepancy is compensated with a shoe lift before the radiograph is taken. Radio-graphs are taken with the patient looking straight ahead, legs apart for stability and with their hands on clavicles. If a radiograph is normal the patient and family can be reassured that there is no scoliosis. A referral can still be made if there is concern about pain, axial tenderness, or neurological abnormalities. If x ray facilities are not avail-able, the patient may be referred directly to the specialist without radiographs.

On a full length posteroanterior plain radiograph, the magnitude of a scoliosis curvature is determined with the Cobb technique (%g "). Firstly, it is important to identify the superior and the inferior end vertebrae—the vertebrae with the greatest tilt at the proximal and distal ends of the curve. The angle between them is measured by drawing a line from the top of the superior end vertebra parallel to the upper endplate, and another line from the bottom

Fig ! | The Adam’s forward bend test performed by (left) a patient without scoliosis, and (right) a patient with scoliosis showing a rib prominence

a˚

b˚

Fig " | Cobb technique for determining size of a scoliosis curvature. On a posteroanterior view of the spine, tangents (dashed-dotted lines) are drawn along the superior endplate of the superior end vertebra and the inferior endplate of the inferior end vertebra. The angle formed (angle a) by the intersection of these two lines is the Cobb angle. This is more conveniently measured as the angle (b) formed by the intersection of two lines drawn perpendicular to the tangents. Adapted from Kim et al!#

32 BMJ | 4 MAY 2013 | VOLUME 346

CLINICAL REVIEW

of the inferior end vertebra parallel to the lower endplate. Perpendicular lines are then constructed at right angles to the lines along the endplates. The angle formed by the intersection of the perpendicular lines de!nes the Cobb angle (!g ").

If surgery is considered, !lms of lateral bending view (full length posteroanterior plain radiographs with patient bending to the right and to the le#) are !rst taken to deter-mine curve $exibility, which is important in the preopera-tive evaluation and surgical planning.

The presence of a le# thoracic curve or an abnormal neurological !nding are most predictive of the presence of an underlying disease and warrant referral for further imaging.%% Magnetic resonance imaging is useful for the identi!cation of tumours and other pathological lesions—associated neural axis abnormalities such as syrinx (a $uid !lled cavity within the spinal cord) and Arnold-Chiari malformations.%&

What are the risk factors for curve progression?For decisions about choosing conservative or surgical treat-ment, the child’s maturity and the severity of the curvature are the two most important factors. It is important to evalu-ate maturity because the younger the child the greater is the likelihood of curve progression, equally the larger the curve magnitude the greater is the risk of progression.'

Scoliosis with a high risk for rapid progression must be detected as early as possible. In a retrospective case series of "() patients (%*+ girls and ," boys) with idiopathic scolio-sis at skeletal maturity, the surgical risk for a curve of "(° at the onset of puberty was at %*%. This surgical risk increased to %((% for curves -+(° at the onset of puberty.%' The table summarises the risk factors for curve progression.

Scoliosis curve progression increases markedly at the time of the adolescent growth spurt in idiopathic curves and markedly slows or ceases at the time of completion of growth."(-"" Spinal growth is closely associated with increase in height, but the measurement of height veloc-ity at sequential visits is o#en associated with inaccura-cies. Other maturity markers are therefore o#en used to measure the growth rate. The use of these maturity markers allows us to determine which curves are at risk of progres-sion. This information allows the clinician to di.erentiate between curves that require careful regular monitoring and ones that require active treatment.

The total growth spurt has a duration of about ".)-+.( years,+ with the mean age for peak height velocity being about %, years in boys and %" years in girls."+

Sexual maturity can be evaluated with the Tanner grad-ing scale,", which is based on the extent of development

of secondary sexual characteristics. It is important to ask about menarche because curve progression is less common a#er its onset.

Skeletal age is a more accurate marker of maturity. The Risser sign,") which refers to the appearance of the iliac apophysis of the pelvis, can be used to determine skeletal age. There are six Risser stages, from zero to !ve, denot-ing the course of the apophysis from the anterior to the posterior iliac spine, and then the fusion with the iliac bone (!g +, see bmj.com)."+ The incidence of progression of untreated AIS has been correlated with Risser sign and curve magnitude."* For curves of "(°-"'° in a immature child with a Risser sign of ( or %, the incidence of progres-sion was *&%. For curves <%'° in a mature adolescent with a Risser sign of -", the incidence of progression was %.*%. For small curves <%'° in an immature child (Risser sign ( or %), and larger curves ("(°-"'°) in a mature child (Risser sign -"), the incidence of progression was about the same, at ""% and "+% respectively."* The disadvan-tages of the Risser sign are that it correlates with skeletal age di.erently in boys and girls and it typically appears a#er the peak height velocity.

Skeletal age can also be assessed by evaluating the development of the le# hand and wrist on a radiograph: the bones are compared with those of a standard atlas compiled by Greulich and Pyle."/ Sanders found that the scoring of the metacarpals and phalanges more closely related to scoliosis progression than other maturity indi-cators, including Tanner stage and Risser sign."+ Dimeglio et al described elbow maturation as being more precise than hand maturation."&

How is adolescent idiopathic scoliosis managed?Observation for AIS is the most common approach used for patients with mild deformity (such as a Cobb angle measurement <")°). Depending on the degree of skeletal maturity, patients are assessed every four to six months at a specialist clinic to watch for curve progression. The interval of follow-up will be determined on an individual basis, based on the age of the patient, degree of curve, and skeletal maturity. Posteroanterior radiographs only are taken during each follow-up visit in order to minimise the exposure to radiation.

BracingBracing in AIS is controversial, with treatment e.ective-ness remaining questionable based on available evidence, with most published studies being of low methodological quality. The rationale for the use of braces has been that external forces can guide the growth of the spine. Brace treatment is not necessarily benign in terms of the psy-chosocial and body image concerns it causes for many patients and their families. Bracing is used for the treat-ment of scoliosis in many centres in continental Europe, but practice is divided in the UK and US, and elsewhere.

Advocates of bracing quote level " evidence based infor-mation from prospective controlled studies"'-+% as well as other studies with level + and , information+"-+, in sup-port of bracing e0cacy. In a meta-analysis a total of %'%( patients had non-operative treatment for idiopathic scol-iosis, with %"' patients managed with observation only.+,

Risk factors for curve progression in adolescent idiopathic scoliosisRisk factor CommentAge The younger the age at diagnosis, the greater potential for curve progression at the

onset of adolescent growth spurtSex Progression is more common in girlsMenarche Progression is least common after menarcheRemaining skeletal growth More skeletally immature the greater risk of curve progressionCurve pattern Double curves are more likely to progress than single curvesCurve magnitude The risk of progression increases with curve magnitude

BMJ | 4 MAY 2013 | VOLUME 346 33

CLINICAL REVIEW

parents is needed to improve adherence. Families must be counselled that there is a risk that bracing may not be successful, but that the chances of success are improved with discipline and adherence to wearing the brace for the recommended time. Patients who have passed the peak height velocity, are within a year of skeletal maturity, or are a year or more a!er menarche are unlikely to bene"t from use of a brace.

When should surgery be considered?About #$% of adolescents with idiopathic scoliosis will progress to a level requiring consideration of surgery.%& Surgery is generally indicated to treat a signi"cant clinical deformity or to correct a scoliotic deformity that is likely to progress. Surgery is recommended in adolescents with a curve that has a Cobb angle greater than '(°-($°. This recommendation is derived from studies that have shown that curves >($° tend to progress slowly a!er maturity.## The decision to proceed with surgical correction therefore needs to take into consideration the clinical assessment, comorbid conditions, the wishes of the patient, and the e)ects the scoliosis has on the patient’s quality of life. It is not clear that surgery is an e)ective treatment for back pain associated with scoliosis.

The aims of surgery may be to arrest curve progression by achieving a solid fusion, to correct the deformity, and to improve cosmetic appearance. If the decision is taken to operate, the usual approach in AIS is posterior ("g ). In this approach a longitudinal posterior midline incision is used. Pedicle screws are inserted into the spine and two metal rods are measured and contoured. Curve correc-tion is achieved as the two metal rods are attached and tightened on to the pedicle screws. An anterior fusion is used in AIS either as the sole approach in thoracolumbar or lumbar curves or in conjunction with posterior fusion in special cases.

Surgical treatment of AIS has a low rate of non-union and other complications. The incidence of neurological complications for spinal deformity surgery has been esti-mated by the Scoliosis Research Society at <#%.#$ A more recent prospective clinical case series of #%$# patients reported a neurological complication rate of $.&*%.%+ A long term case-control study of scoliosis curves fused to the lumbar spine evaluated pain and functional status of AIS patients with a minimum of #$ years’ follow-up (average #* years).%, These patients were compared with a control population matched for work, age, and recreational activi-ties. The two groups did not di)er with respect to func-tional status or pain.

The analysis concluded that bracing was e)ective in alter-ing the natural course of scoliosis. In #**(, a prospective, multicentre, non-randomised, non-blinded study also showed the e)ectiveness of bracing in girls with curves of -(°-%(°.%$

Other studies have shown less positive results. A pro-spective case series of #$- immature patients with idi-opathic scoliosis reported that bracing provided curve correction in only #(% of patients, while '-% later became surgical candidates.%(

The primary goal of bracing for scoliosis is to halt curve progression. The most widely accepted practice for brace treatment suggests that patients with curves of -(°-'(° and in the most rapidly growing stage (Risser stage $ or #) should be o)ered a brace on initial evaluation. Curve progression is de"ned as an increase in the magnitude of the deformity by more than (° at consecutive follow-up appointments of between four and six months.

Various factors can hinder successful brace treatment. Poor adherence is common. A meta-analysis reported that a protocol of -% hours/day was more successful than protocols of #& hours/day or night time use.%' A multi-disciplinary team approach involving the patient’s gen-eral practitioner, surgeon, orthotist, physiotherapist, and

Fig ! | Preoperative (left) and postoperative (right) radiographs of an adolescent boy with idiopathic scoliosis, showing correction of the scoliosis by posterior instrumented fusion of the spine

ADDITIONAL EDUCATIONAL RESOURCESResources for healthcare professionalsScoliosis Research Society website. www.srs.orgAAOS American Academy of Orthopaedic Surgeons. Adolescent idiopathic scoliosis: etiology, anatomy, natural history, and bracing. Instructional Course Lectures !""#;#$:#!%-&'.Resources for patientsScoliosis Association United Kingdom (SAUK). www.sauk.org.uk—Provides patient information on the condition and treatmentsScoliosis Research Society. www.srs.org/patient_and_family—Patient and family section provides information on the condition, treatments, and outcome

TIPS FOR NON"SPECIALISTSPostural scoliosis can be differentiated from structural scoliosis with the Adam’s forward bend test: the curvature will disappear on forward bending in postural scoliosisIf scoliosis is seen in a premenarchal female there is a higher risk of curve progression, and early referral to a specialist is advisedPatients undergoing brace treatment for scoliosis must be encouraged to adhere with brace treatment. Patients must be informed that the brace can be removed for washing and swimming

34 BMJ | 4 MAY 2013 | VOLUME 346

CLINICAL REVIEW

!" Zadeh HG, Sakka SA, Powell MP, Mehta MH. Absent superficial abdominal reflexes in children with scoliosis. An early indicator of syringomyelia. J Bone Joint Surg Br !##$;%%:%"&-%.

!% Kim H, Kim HS, Moon ES, Yoon CS, Chung TS, Song HT, et al. Scoliosis imaging: what radiologists should know. Radiographics &'!';(': !)&(-*&.

!) Barnes PD, Brody JD, Jaramillo D, Akbar JU, Emams JB. Atypical idiopathic scoliosis: MR imaging evaluation. Radiology !##(;!)":&*%-$(.

!# Charles YP, Dimeglio A. Progression risk of idiopathic juvenile scoliosis during pubertal growth. Spine &''";(!:!#((-*&

&' Duval-Beaupere G. Maturation indices in the surveillance of scoliosis [in French]. Rev Chir Orthop Reparatrice Appar Mot !#%';$":$#-%".

&! Duval-Beaupere G. Pathogenic relationship between scoliosis and growth. In: Zorab PA, ed. Scoliosis and growth. Churchill Livingstone, !#%!:$)-"*.

&& Duval-Beaupere G. Maturation parameters in scoliosis. Rev Chir Orthop !#%';$":$#.

&( Sanders JO. Maturity indicators in spinal deformity. J Bone Joint Surg &''%;)#-A(suppl !):!*-&'.

&* Buckler JM. A longitudinal study of adolescent growth. Springer, !##'.&$ Risser JC. The iliac apophysis: an invaluable sign in the management of

scoliosis. Clin Orthop !#$);!!:!!!-&'.&" Lonstein JE, Carlson JM. The prediction of curve progression in untreated

idiopathic scoliosis during growth. J Bone Joint Surg !#)*;""A:!'"!-%!.&% Greulich WW, Pyle SI. Radiographic atlas of skeletal development of the

hand and wrist. &nd ed. Stanford University Press, !#$#.&) Dimeglio A, Canavese F, Charles P. Growth and adolescent idiopathic

scoliosis: when and how much? J Pediatr Orthop &'!!;(!(suppl !): S&)-(".

&# Weiss HR, Weiss G, Petermann F. Incidence of curvature progression in idiopathic scoliosis patients treated with scoliosis inpatient rehabilitation (SIR): an age and sex matched controlled study. Ped Rehab &''(;":&(-('.

(' Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis. A prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am !##$;%%:)!$-&&.

(! Danielsson AJ, Hasserius R, Ohlin A, Nachemson AL. A prospective study of brace treatment versus observation alone in adolescent idiopathic scoliosis: a follow-up mean of !" years after maturity. Spine &''%;(&:&!#)-&'%.

(& D’Amato CR, Griggs S, McCoy B. Night-time bracing with the providence brace in adolescent girls with idiopathic scoliosis. Spine &''!;&":&''"-!&.

(( Wiley JW, Thomson JD, Mitchell TM. Effectiveness of the Boston brace in treatment of large curves in AIS. Spine &''';&$:&(&"-(&.

(* Rowe DE, Bernstein SM, Riddick MF, Adler F, Emans JB, Gardner-Bonneau D. A meta-analysis of the efficacy of nonoperative treatments for idiopathic scoliosis. J Bone Joint Surg Am !##%;%#:""*-%*.

($ Noonan KJ, Weinstein SL, Jacobson WC, Dolan LA. Use of the Milwaukee brace for progressive idiopathic scoliosis. J Bone Joint Surg Am !##";%):$$%-"%

(" Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg Am !#)*;"":!'"!-%!.

(% Diab M, Smith AR, Kuklo TR; Spinal Deformity Study Group. Neural complications in the surgical treatment of adolescent idiopathic scoliosis. Spine &''%;(&:&%$#-"(.

() Bartie BA, Lonstein JE, Winter RB. Long-term follow-up of idiopathic scoliosis patients fused to the lower lumbar spine. Orthop Trans !##(;!%:!%".

A!er surgery it is important to check for abnormal neu-rology and for bowel and bladder symptoms. Back pain a!er surgery is not uncommon, especially if it is mechani-cal in nature. In the presence of continuous or night pain, infection or non-union should be considered, and referral to a specialist is advised.

Postoperative follow-up o!en involves clinical and radio-logical reviews at six weeks, three months, six months, and one year. These intervals will vary between institutions, but follow-up until completion of growth is common.Contributors: All authors contributed to the design and writing of the article.Competing interests: We have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.Provenance and peer review: Not commissioned; externally peer reviewed.! Terminology Committee of the Scoliosis Research Society. A glossary of

terms. Spine !#%";!:$%-).& Lonstein JE. Adolescent idiopathic scoliosis. Lancet !##*;(**:)#(*.( Kesling KL, Reinker KA. Scoliosis in twins: a meta-analysis of the literature

and report of six cases. Spine !##%;&&:&''#-!*, discussion &'!$.* Parent S, Newton PO, Wenger DR. Adolescent idiopathic scoliosis: etiology,

anatomy, natural history, and bracing. Instructional Course Lectures &''$;$*:$&#-(".

$ Wang S, Qiu Y, Zhu Z, Ma Z, Xia C, Zhu F. Histomorphological study of the spinal growth plates from the convex side and the concave side in adolescent idiopathic scoliosis. J Orthop Surg &''%;&:!#.

" Do T, Fras C, Burke S, Widmann RF, Rawlins B, Boachie-Adjei O. Clinical value of routine preoperative magnetic resonance imaging in adolescent idiopathic scoliosis. A prospective study of three hundred and twenty-seven patients. J Bone Joint Surg Am &''!;)(-A:$%%-#.

% Weinstein SL, Ponseti IV. Curve progression in idiopathic scoliosis. J Bone Joint Surg Am !#)(;"$:**%-$$.

) Pehrsson K, Larsson S, Oden A, Nachemson A. Long-term follow-up of patients with untreated scoliosis. A study of mortality, causes of death, and symptoms. Spine !##&;!%:!'#!-".

# Weinstein SL, Dolan LA, Spratt KF, Peterson KK, Spoonamore MJ, Ponseti IV. Health and function of patients with untreated idiopathic scoliosis. A $'-year natural history study. JAMA &''(;&)#:$$#-"%.

!' Scoliosis Research Society. Report of Morbidity Committee !""#. SRS, !##(.

!! Ramirez N, Johnston CE, Browne RH. The prevalence of back pain in children who have idiopathic scoliosis. J Bone Joint Surg Am !##%;%#:("*-).

!& Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg !#)*;"":!'"!-!'%.

!( Feldman DS, Straight JJ, Badra MI, Mohaideen A, Madan SS. Evaluation of an algorithmic approach to pediatric back pain. J Pediatr Orthop &''";&":($(-%.

!* Fairbank MJ. Historical perspective: William Adams, the forward bending test, and the spine of Gideon Algernon. Spine &''*;&#:!#$(-$.

!$ Lee CF, Fong DY, Cheung KM, Cheng JC, Ng BK, Lam TP, et al. Referral criteria for school scoliosis screening. Assessment and recommendations based on a large longitudinally followed cohort. Spine &'!';($:E!*#&-).

ANSWERS TO ENDGAMES, p 38 For long answers go to the Education channel on bmj.com

STATISTICAL QUESTIONCorrelation versus linear regressionStatements a, c, and d are true, whereas b is false.

! Haemorrhage within the midline of the pons and large prominent lateral ventricles." Hypertension, cerebrovascular malformations, trauma, primary or secondary tumours.# Magnetic resonance imaging of the brain, cerebral angiography, computed tomography angiography, and

magnetic resonance imaging angiography. Blood tests to identify vasculitic, haematological, and coagulopathic causes are indicated if the diagnosis is unclear.

$ Assess with the ABC (airway, breathing, circulation) approach and manage the patient in a centre with immediate access to neurosurgical expertise. The Glasgow coma scale score and pupil size should be monitored regularly to allow for reimaging and prompt action if deterioration occurs. Consider treatment of associated hydrocephalus with an external ventricular drain if the patient has signs of increased intracranial pressure. Conservative treatment with serial imaging and watchful waiting. Longer term management includes blood pressure management (also important in the primary phase) and consideration of surgical intervention after initial recovery.

PICTURE QUIZ A pain in the neck type of headache

BMJ | 4 MAY 2013 | VOLUME 346 35

PRACTICE

!Northumberland, UK"Sir James Spence Institute, Royal Victoria Infirmary, Newcastle upon Tyne NE! #LP, UKCorrespondence to: A Basu anna.basu@ncl.ac.ukCite this as: BMJ !"#!;$%&:e'$%!doi: !$.!!%&/bmj.e'%#"

This is one of a series of occasional articles by patients about their experiences that offer lessons to doctors. The BMJ welcomes contributions to the series. Please contact Peter Lapsley (plapsley@bmj.com) for guidance.

This patient was left with visual agnosia after developing herpes simplex encephalitis at a young age. She describes her strategies for coping with this visual disabilityWhen I was !! months old I developed herpes simplex encephalitis a"er coming into contact with a cold sore, which damaged the areas of the brain responsible for processing vision. I was le" with visual agnosia and had severe di#culties in recognising people by their faces. I cannot remember the details of the earliest events sur-rounding my illness, but I have talked about them a lot with my family and this is my story.

During the illness I lost my sight as well as my ability to sit and walk. It took me about six months to relearn to walk unaided. During this time my vision gradually improved, but I had to rely on my other senses to interact with the environment. I would sni$, touch, and taste things around me, including the %oor, furniture, and people’s clothing, which some found unnerving.

My speech development was good. I found changes in routine upsetting and puzzling. Mum had the support of medical and educational professionals and on their advice I was taught at home by an educational service (Portage) for preschool children with additional support needs and their families, and I had a support assistant at play school. Around this time mum noticed I was making mistakes in recognising family members. Once I was seen talking to my brother’s friend, mistaking him for my brother (who looks completely di$erent).

A PATIENT’S JOURNEY

Visual agnosia Anonymous,1 Anna Basu2

It wasn’t just a problem with recognising family mem-bers, or people in general—mum had painted a Postman Pat mural on my wall and despite being familiar with his character through books and DVDs I just could not rec-ognise him. However, it was when mum realised that I couldn’t even recognise her that things came to a head. This happened on a Portage course for parents. As the parents entered the crèche, the children got up and went to their mums and dads. I got up too, studied the adults and then returned to my carer rather than going to my mum. Although mum had been standing close to me, it wasn’t until she spoke that I got up and took her hand. Mum talked about this to a teacher for visually impaired people at my nursery. He said he thought I might have a facial agnosia. This was discussed with the child neurolo-gist at my next appointment, and subsequently with a neuropsychologist.

My lack of recognition of family members caused all sorts of di#culties. Mum will never forget the time I was on a child’s amusement ride in the supermarket while she was close by paying for her shopping. When the ride had &nished she heard me calling for her and then saw me being li"ed out by a woman. This stranger was reluctant to hand me back to my mum because she didn’t see the %ash of recognition she was expecting from me.

I also had problems with object recognition. No one could understand how I managed to &nd small objects dropped on the %oor but wasn’t able to recognise pictures of everyday objects. When given a verbal clue I would always get the object right. I couldn’t visually distin-guish between animals such as a cat and dog or a cow and sheep. This problem only improved a"er many visits to farms and zoos.

When I &rst started school my eye contact was poor and despite constant encouragement from my family, teach-ers, and carers to li" my head I found it hard to look at people. My con&dence was lowered further by the reper-cussions when I misread facial expressions.

Some aspects of my condition have improved but not the facial agnosia and I continue to &nd the recognition and identi&cation of faces di#cult. Recognition is even harder when people are out of context or a particular feature such as hair colour has changed. School was on occasions frustrating, not least because everyone wore the same uniform. Finding friends both in and out of the classroom could be di#cult, so I had to rely on my other senses. Things became easier when I moved into sixth form, as students could wear casual clothing. Teach-ers found my disability di#cult to understand. Some believed it didn’t exist and others didn’t understand that the problem arose from my brain not my eyes. Unbeliev-ably, at a parents’ evening a teacher asked mum whether all her children were blind, to which (after taking a deep breath) she replied “On my last count, none of my ch ildren is blind.”

A DOCTOR’S PERSPECTIVEVisual agnosia is a specific failure of visual recognition of objects not explained by elementary visual deficits. The agnosia can be category specific—for example, prosopagnosia is a specific agnosia for faces. Pure visual agnosia is a rare condition, particularly in young people, but visual agnosias can also occur as part of neurodegenerative conditions.

This patient’s visual agnosia was secondary to early acquired herpes simplex encephalitis, which caused bilateral damage to the occipitotemporal regions. Those brain areas specifically involved in processing faces were affected, and although the patient made a good recovery overall, face recognition remains problematic on a day to day basis. Her story is remarkable on several levels. One of the most striking aspects is the “invisible” nature of the condition. It is not surprising that people may be confused by the fact that someone can see well enough to go horse riding but cannot distinguish between family members by their faces. What people don’t understand they often refuse to believe and this has clearly led to some awkward situations. This patient’s drive to study the condition in detail and to explain it to others is both understandable and commendable. Her ability to perceive the world differently can also be viewed as a strength and has led to some original artwork.

Doctors can help those with visual agnosia by being alert to the possibility of disorders of higher visual function, facilitating appropriate neuropsychological assessments, and providing explanations and accessible strategies for families and schools. To achieve all this, however, requires awareness of such conditions.

Most remarkable of all are the sheer courage and determination shown by this patient and her family to help overcome her difficulties, enabling her to succeed both in and out of school and in holding down a job. I have learned much from sharing this part of her journey and am proud to know her.Anna Basu

36 BMJ | 4 MAY 2013 | VOLUME 346

PRACTICE

tional magnetic resonance imaging scans to look for any changes in the brain. When babies and children study faces intently their brains are learning to calculate the distance between eyes, nose, and mouth and the width and length of faces, which are the basics of expertise in recognising faces. The training programme required me to categorise faces based on di!erences in these distances. Involvement in the study has improved my eye contact and con"dence. My training scores have also improved but I still have trouble recognising faces. Despite this I am becoming more con"dent in my day to day recognition of friends and family using all available means.Competing interests: The authors declare: AB received funding from the Special Trustees, Newcastle Healthcare Charity as well as funding for a Wellcome Trust vacation student and a Newcastle University vacation student for the study of the e!ect of face training on face perception in prosopagnosia and in healthy controls; no "nancial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.

Provenance and peer review: Not commissioned; not externally peer reviewed.

Accepted: #$ August #%&#

Getting teachers to complete the simplest of tasks, such as using a black pen on the whiteboard and enlarging worksheets, was a test all of its own and made life in the classroom problematic. Despite these challenges I was successful at GCSE level, with 10 good grades. Subse-quently I studied English language, art, and psychology at A level. As part of my psychology course I studied face perception and its disorders and was asked to give a series of talks to the other psychology classes. For my art A level I brought together elements of Cubism and still life and incorporated texture to give my work a more original and interesting direction, re%ecting the importance of touch in helping me to understand my su rroundings in my early life.

Over time I have built up my own strategies for rec-ognising my family and friends and those I am in daily contact with like my work colleagues; for example, by remembering their style of walk, hairstyle, and hair col-our. I have also become good at recognising voices and scents, including the perfume worn by particular people. Recently I have become more sensitive to sounds such as those made by jewellery and keys. I am able to "nd mum in crowded places by the sound of her bangles and dad by the sound of his car keys. This has increased my c on"dence in public places. I remember when I was around seven years old being perturbed at meeting iden-tical twins who were also identically dressed. Although neither I nor anybody else could distinguish the twins by sight, for once my personal strategies for distinguishing between people by voice, scent, etc, failed me. I was le& so scarred by this experience that months later I avoided a close family friend “because she might have a twin.”

A few years ago I was approached by my neurolo-gist, Professor Eyre. She asked if I would take part in a research study of face training, with the aim of relearn-ing the mathematics of face recognition and using func-

USEFUL RESOURCES FOR PATIENTS AND CLINICIANSFarah M. Visual agnosia. !nd ed. MIT Press, !""#—A classic text on disorders of visual recognitionNational Portage Association (www.portage.org.uk/)—A home-visiting educational service for preschool children with additional support needs and their familiesNational Institute of Neurological Disorders and Stroke (www.ninds.nih.gov/disorders/prosopagnosia/Prosopagnosia.htm)—Patient information on prosopagnosia, or “face-blindness” Faceblind.org (www.faceblind.org/)—Information from researchers and opportunities for those affected to take part in research

10!MINUTE CONSULTATION

VasectomyS Jamel,1 S Malde,1 I M Ali,2 S Masood1

&Department of Urology, Medway NHS Foundation Trust, Gillingham ME' $NY, UK#Halfway Surgery, Chatham ME( (QR, UKCorrespondence to: S Malde sachmalde@gmail.comCite this as: BMJ !"#$;$%&:f#&'%doi: &%.&&)*/bmj.f&*'(

This is part of a series of occasional articles on common problems in primary care. The BMJ welcomes contributions from GPs.

A 40 year old man attends your clinic with his 37 year old wife to discuss long term contraceptive options. They inform you that they have three children and have com-pleted their family. The wife has been taking oral contra-ception for the past "ve years but does not want to continue with this. They have both considered other contraceptive options and have decided on vasectomy.

What you should coverPatient selection and counselling is crucial. To determine if vasectomy is suitable for them, consider the following points.•  Ideally both partners should be present.•  Establish the patient’s age, relationship status or

stability, and number of children. Young, single men with no children are more likely to regret their decision and request a reversal later in life.

•  Discuss other contraceptive methods. Female sterilisation (tubal ligation) can be done hysteroscopically under local anaesthesia; or laparoscopically or through a mini-laparotomy, under general anaesthesia. Consequently, the morbidity of the procedure is higher than for vasectomy, and some studies suggest that the reported lifetime failure rate is higher, at 1 in 200.

•  Emphasise the need to use alternative contraception a&er vasectomy until semen analysis con"rms the absence of sperm (usually three months).

•  Ask about any current systemic or sexually transmitted infection, coagulation or other blood disorders, and chronic testicular pain, as these will in%uence the timing of and preparation for surgery. A small number of patients will develop chronic testicular pain a&er this procedure, which can interfere with their quality of life. This typically occurs in 1-2% of men.

bmj.com Previous articles in this series

( Lessons from patients’ journeys (BMJ #%&);)(*:f&+,,)

( Klinefelter’s syndrome—a diagnosis mislaid for (* years (BMJ #%&#;)($:e*+),)

( Kallmann syndrome (BMJ #%&#;)($:e*+'&)

( Non-coeliac gluten sensitivity (BMJ #%&#;)($:e'+,#)

( Restless legs syndrome (BMJ #%&#;)($:e'$+#)

BMJ | 4 MAY 2013 | VOLUME 346 37

PRACTICE

•  Examine the testis and both vasa deferentia for any abnormality that may interfere with the procedure, such as a large hydrocele, inguinoscrotal hernia, or testis tumour.

•  Emphasise the need for post-vasectomy semen analysis three months a"er vasectomy. Some sperm may still be present in the semen for a few months, and so the patient should continue other methods of contraception until the semen analyses show azoospermia.

•  Inform the patient that 100% guarantee cannot be given of permanent sterility as there is a rare chance of early failure (0.2-5.3%) and late recanalisation (0.03-1.2%).

•  Explain the operation and complications (box).•  Provide the couple with lea(ets or booklets or other

printed material outlining the information covered in the counselling session.

•  If there is any doubt, ask the couple to return for a further consultation once they have had time to make their decision.

How it worksVasectomy is an e)ective, reliable, and permanent form of male sterilisation with no serious long term side e)ects. It is usually done under local anaesthesia and very occa-sionally under general anaesthesia. In the conventional incisional technique one or two small incisions are made with a scalpel on the scrotum and both vasa deferentia are exposed. The no-scalpel method involves puncturing the skin with a sharp haemostat. A small segment of vas is removed from both sides and the ends are ligated with sutures. So" tissue is interposed between the two ends of vas to prevent recanalisation.

AftercareA"er the procedure there is usually some discomfort and bruising for a few days, which can be improved by wear-ing tight *tting underwear. Patients are advised not to work on the day a"er the operation and that a return to normal activity is usual within a week. Three months a"er va sectomy a semen analysis is required. If no spermatozoa are detected in the ejaculate, give the patient clearance to stop using other methods of contraception. If motile sper-matozoa persist at the six month follow-up, a repeat vasec-tomy is advisable. Other contraceptive methods should be continued until clearance is given.Contributors: SJ was involved in the initial conception and dra!ing of the article and was involved in "nal approval of the version to be published. S Malde and IMA were involved in revising the article critically for important intellectual content and in "nal approval of the version to be published. S Masood is guarantor for the paper and was involved in initial conception, literature review, revising the article critically for important intellectual content, and in "nal approval of the version to be published.Competing interests: All authors have completed the Uni"ed Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no "nancial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.Provenance and peer review: Not commissioned; externally peer reviewed.Accepted: #$ December %&#%

ComplicationsVasectomy has an associated low complication rate; patients should be informed about the following complications.Common• Scrotal bruising, haematoma• Chronic testis pain affecting quality of life (!-"%) and sperm granulomaOccasional• Bleeding requiring further surgeryRare• Infection of testis or epididymis requiring antibiotics• Early recanalisation resulting in persistence of motile sperm in the ejaculate for which repeat

vasectomy is indicated (#."-$.%%)• A risk of about ! in "### of pregnancy resulting from late recanalisation after previous

clearance

FREQUENTLY ASKED QUESTIONSQ: How effective is vasectomy?A: Vasectomy is a safe and reliable procedure. However, ! in "### men can become fertile again due to rejoining of the two ends of the vas, so vasectomy is not !##% effective.Q: Can I stop using contraception immediately after the procedure?A: No. Sperm can still be present for a few months and so a semen analysis is done three months after vasectomy. If it is clear of sperm you can stop using contraception.Q: Will it affect my sex drive?A: No. The sex hormones will still be produced by the testes so libido and erectile function are unaffected.Q: What will happen to the sperm?A: Sperm will still be produced by the testis but will get dissolved in the body.Q: What if I change my mind after the operation?A: You should regard vasectomy as a permanent procedure. The success rate of vasectomy reversal is only %#-&#%, with a lower success rate in men who have a later reversal.Q: Does the operation hurt?A: It is done under local anaesthesia. You may experience some discomfort during the injection and the procedure but not severe pain.Q: How soon after the operation can I have sexual intercourse?A: You can resume sexual activity as soon as it is comfortable. You have to use other methods of contraception until the semen analysis shows no sperm in the specimen.Q: Is there any risk of prostate or testis cancer after vasectomy?A: No. Several studies have shown no relation between vasectomy and cancer.

FURTHER READINGFor patients• Patient.co.uk (www.patient.co.uk/health/Vasectomy.htm)• NHS Choices (www.nhs.uk/conditions/vasectomy/pages/introduction".aspx)• British Association of Urological Surgeons (www.baus.org.uk/Resources/BAUS/Documents/

PDF%"#Documents/Patient%"#information/Vasectomy.pdf)For healthcare professionals• European Association of Urology Guidelines on Vasectomy (www.europeanurology.com/

article/S#%#"-"'%'%"'!!%"(#!!#!-'/fulltext)• American Urological Association Guidelines on Vasectomy (www.auanet.org/content/

media/vasectomy.pdf)

bmj.com Previous articles in this series

! Assessment and management of renal colic (BMJ %&#';'():f$*+)

! Dry eye (BMJ %&#%;'(+:e,+'')

! Minor incised traumatic laceration (BMJ %&#%;'(+:e)*%()

! Adult trigger "nger (BMJ %&#%;'(+:e+,(')

! Myalgia while taking statins (BMJ %&#%;'(+:e+'(*)

38 BMJ | 4 MAY 2013 | VOLUME 346

ENDGAMESWe welcome contributions that would help doctors with postgraduate examinations

! See bmj.com/endgames for details

PICTURE QUIZA pain in the neck type of headacheA !" year old right hand dominant chef presented to the emergency department with a four day history of feeling “not normal.” He was sent home from work because of a gradual onset of dull pain on the left side of his neck radiating up into his head, which was getting progressively worse, as well as “seeing two of everything.” The pain was not influenced by changes in posture. In addition, his right side felt numb and he was dropping things at work. He felt unsteady on his feet, which prompted him to seek medical advice. He thought all his symptoms had come on suddenly and were gradually getting worse. He denied any recent alcohol consumption, illicit drug use, seizure activity, head injury, or loss of consciousness. He had no medical history of note, apart from hypothyroidism, for which he was taking thyroxine.

On examination, he was alert and orientated. His blood pressure was #$#/"$ mm Hg and other vital signs were normal. He had moderate weakness on the right side (Medical Research Council grade $), mainly in the upper limb, with pronator drift, and reduced sensation to pinprick, light touch, and proprioception on the same side. There was evidence of a resting and intention tremor, with dysdiadochokinesia of the upper limbs, which was more evident on the right side than the left. Furthermore, he had a broad based gait consistent with cerebellar ataxia when attempting to walk. He had an upgoing plantar response on the right and a downgoing one on the left. His pupils were equal and reactive to light, but he had diplopia on both extremes of gaze, although there was no clinical evidence of ocular palsy. Papilloedema was not detected on examination of his fundi.

Given his history and the constellation of findings on examination, a posterior fossa lesion was suspected. Because computed tomography was the only imaging modality available out of hours, a head scan was performed to rule out any serious disease (figs # and !).

# What abnormalities does the computed tomogram show?! What are the causes of this pathology?% What other investigations would be useful?$ How should this condition be managed generally?

Submitted by Rafiqu Rahman ShabiyullaCite this as: BMJ "#$%;%&':f"(#)

FOLLOW ENDGAMES ON TWITTER @BMJEndgamesFOR SHORT ANSWERS See p 34FOR LONG ANSWERS Go to the Education channel on bmj.com

STATISTICAL QUESTIONCorrelation versus linear regressionA recent statistical question described how researchers investigated the association between right ventricular size and pulmonary hypertension. A cross sectional study design was used. Participants were #"& patients referred to a pulmonary hypertension clinic.

Measurements of right ventricular size included right ventricular end systolic area (RVESA) recorded echocardiographically. Pulmonary artery systolic pressure (PASP) was used to indicate the extent of pulmonary hypertension. A scatter plot of pulmonary artery systolic pressure against right ventricular end systolic area was presented (figure). Linear regression analysis was used to examine the association between right ventricular size and degree of pulmonary hypertension, with the resulting fitted linear regression line given by PASP=!.'#%%RVESA+#(.'#'. A significant correlation existed between right ventricular end systolic area and pulmonary artery systolic pressure (r=&.'$; P<&.&&#).Which of the following statements, if any, are true?a) The regression line facilitated the prediction of pulmonary

artery systolic pressure from right ventricular end systolic area

b) The regression line implied there was a causal association between pulmonary artery systolic pressure and right ventricular end systolic area

c) Correlation quantified the strength of the linear association between pulmonary artery systolic pressure and right ventricular end systolic area

d) Pearson’s correlation coefficient may be used to quantify the variability in pulmonary artery systolic pressure described by right ventricular end systolic area

Submitted by Philip SedgwickCite this as: BMJ "#$%;%&':f"'*'

RVESA (cm!)PA

SP (m

m H

g)! "! #! $! %! &!!

"&!

#!!

"!!

&!

PASP=!."#$$RVESA + #%."#"r=&."', P<&.&&#

Scatter plot of pulmonary artery systolic pressure (PASP) against right ventricular end systolic area (RVESA).

Fig $ Fig "

BMJ | 4 MAY 2013 | VOLUME 346 39

LAST WORDS

Billions of pounds are being spent chasing a ghostly surrogate endpoint: low blood sugar

been withdrawn; pioglitazone has been linked to bladder cancer; and exenatide and sitagliptin double the risk of acute pancreatitis.13  14 All this is an exam-ple of the scienti%c illusion that is so called evidence based medicine, where research is just mechanically reclaimed statistics pulped into junk educational nuggets—mere marketing by another name.

There remains another fundamen-tal question. Can diabetes be reversed or cured by weight loss? A small, well designed study of 11 patients irrefu-tably showed that it can.15 And clini-cal e'ect is more important than any statistically significant yet clinically undetectable e'ect that a huge study funded by the drug industry might %nd. The therapeutic approach in diabetes is upside down. The complicity of doc-tors and lack of dissent against the drug model of diabetes care is bad medicine.Des Spence is a general practitioner, Glasgow destwo@yahoo.co.ukReferences are in the version on bmj.com.Cite this as: BMJ !"#$;$%&:f!&'(

Type 2 diabetes is a modern plague largely brought on by lifestyle and is considered a progressive, non-revers-ible condition. The polypharmacy of chronic disease is the drug indus-try’s lottery win, and no more so than in diabetes, with new drugs and the increasing use of analogue insulin in type 2 diabetes worth tens of billions of pounds worldwide.1

The drug industry’s business plan for diabetes follows a familiar pattern:1) Conduct questionable research and control the original data. 2) Schmooze the politicians, health regulators, and patient groups to suggest undertreatment and need for “urgent action.” 3) Recruit tame diabetologists, mas-sage them with cash, and get them to present at marketing events that mas-querade as postgraduate education. 4) Pay doctors to switch to newer drugs in dubious international post-marketing “trials.”2 5) Seek endorsement from the National Institute for Health and Care

Excellence to bully doctors to treat diabetes aggressively with drugs.3

And so the complexities of diabetes are reduced to simply lowering blood sugar.

What is the annual cost of this approach? In the past decade, spending on insulin in the UK has risen 300%, to £311m,4 and on oral anti-diabetes drugs 400%, to £277m. And have you ever wondered why companies gener-ously give away glucose meters? Test strips are a £166m market, the value of which has risen 300% in 15 years.4

But do analogue insulins, new drugs, and self monitoring of blood glucose improve outcomes? Does even tight glycaemic control make a di'erence? No data on mortality or morbidity exist for the new therapeutics.5-11 Likewise inten-sive glycaemic control is not superior with respect to mortality and cardiovas-cular disease.12 So billions of pounds are being spent chasing a ghostly surro-gate endpoint: low blood sugar. Worse, there is evidence that these new drugs cause harm. Rosiglitazone has already

“We lived for three months in a rolled up newspaper in a septic tank. We used to have to get up every morning at six o’clock and clean the newspaper, go to work down the mill, fourteen hours a day, week-in week-out, for sixpence a week, and when we got home our Dad would thrash us to sleep with his belt.”1

Every time doctors tell me about their working hours before the European working time directive came into force I think of the At Last The 1948 Show sketch.

A bit of exaggerating aside, working 100 hour shi/s sounds like a pretty horrible existence. Good riddance to it. But at least you got high quality, on the job training, and you got paid for it.

Unfortunately, it’s been partially replaced with silly online quizzes and fatuous portfolios that need to be done in your own time. Here is an actual quote from the e-LfH (e-Learning for Healthcare)

too enraged to properly take it in. You could strip out most of the material and lose nothing of value.

Junior doctors want a decent education. We don’t want our time wasted with box ticking work. It feels as though whoever is in control of junior doctors’ training has too little regard for our time and is all too willing to throw another acronymed assessment onto the pile.

We must demand a more active role in designing our curriculum. We need to scrap the quantity and focus on the quality. Those who set the standards must be made to justify every minute of training they ask of us. Box ticking doesn’t help anyone.Oliver Ellis is a foundation year ! doctor, Mersey Deanery oli.ellis@googlemail.comCompeting interests: None declared.References are in the version on bmj.com.Cite this as: BMJ !"#$;$%&:f!)"*

online training course, as endorsed by the UK Foundation Programme: “Click on the Poetry Archive website and choose a poem from the sections on Death and Grief. Listen to it and then consider these questions: How did it make you feel? . . . These mild feelings may help you to understand how complex overwhelming untreated grief can bring about quite profound physical changes and have an impact on health over months or years.”2

How did it make me feel? Mostly patronised. A little outraged. The aim was to simulate feeling sad, so you can empathise with bereaved patients and relatives. Anyone who needs “sadness” explained to them won’t be %xed by an online course.

There are some useful bits in that module, and scattered throughout the e-LfH site, but it’s so padded out with this sort of pap that my brain becomes

FROM THE FRONTLINE Des Spence

Bad medicine: the way we manage diabetes

LAYING FOUNDATIONS Oliver Ellis

Portfolio of pap

Twitter " Follow Des Spence on

Twitter @des_spence!

Anyone who needs “sadness” explained to them won’t be fixed by an online course

40 BMJ | 4 MAY 2013 | VOLUME 346

MINERVASend comments or suggest ideas to Minerva: minerva@bmj.com

A pain in the neck type of headacheTry the picture quiz in ENDGAMES, p !"

“We’ve damp coming down our walls, doctor, and my chest’s never been so bad. Can you do us a note for housing?” Doctors responding to such requests can now cite a good longitudinal study to back them up: the European Community Respiratory Health Survey (Occupational and Environmental Medicine !"#$;%":$!&-$#, doi:#".##$'/oemed-!"#!-#""('$). In the study, %#") young adults from #$ countries who did not report respiratory symptoms or asthma at baseline were followed prospectively for nine years. There was an excess of new asthma in participants in homes with reports of water damage (relative risk #.)', (&% confidence interval #."( to #.()) and indoor moulds (#.$", #."" to #.'*) at baseline, and a dose-response effect was observed. Dickensian landlords take note.

For decades, the tablets that doctors have given people with osteoarthritis have damaged their upper gastrointestinal tracts, predisposed them to have heart attacks, and made little difference to their pain. What if there was a substance that actually reversed the disease process and promoted the repair of articular cartilage? A study from Japan reports on a novel disease modifying drug that seems to repair cartilage when injected into joints (Annals of the Rheumatic Diseases !"#$;%!:%)*-&$, doi:#".##$'/annrheumdis-!"#!-!"#%)&). It works by upregulating the expression of Runx#. For those of you who think this probably refers to the mating call of the Vietnamese pot bellied pig, I should explain that Runx# and other runt related transcription factors are vital for collagen differentiation. And for people with arthritis waiting for a quick fix, I might opine that another #" years will be needed to test the long term efficacy and safety of these compounds.

Many medical terms date from the time when textbooks were written in Latin; many more from the time when most doctors learnt Latin and Greek at school; still others have been invented in our own time, simply to baffle us. An article in the Journal of Allergy and Clinical Immunology (!"#$;#$#:#")#-%.e$, doi:#".#"#'/j.jaci.!"#!."(."!*) seeks “to determine whether the clearance of apoptotic inflammatory cells (efferocytosis) by airway macrophages was associated with altered inflammation and reduced glucocorticoid sensitivity in obese asthmatic patients.” Macrophage is a reasonable #(th century word from the Greek meaning big eater. “Apoptotic” is a late !"th century coinage, also

based on Greek and meaning “liable to give up and die.” And now for efferocytosis. Think Latin for bear (“fero”) and away (“e”). Bearing away cells. Minerva has never heard of this word before, but evidently efferocytosis happens less often in the airways of obese people with asthma, than in non-obese people with asthma. Their air passages get clogged up with dead gunk, if you’ll pardon my Greek.

Perfection is not attainable by mortals, and even Minerva herself sometimes has trouble reaching it. But in Italian, “perfezionamento” can mean improvement rather than perfection. The Parkinson Institute of the Istituti Clinici di Perfezionamento in Milan looks at ways of improving the lot of patients with Parkinson’s disease who have developed dopamine dysregulation syndrome (Journal of Neurology, Neurosurgery and Psychiatry with Practical Neurology !"#$, doi:#".##$'/jnnp-!"#!-$"$(**). The institute found that better outcomes were strongly related to good caregiving. The technical fixes were tricky: duodenal levodopa infusion can be used, or deep brain stimulation of the subthalamic nucleus.

If you strain any chamber of the heart, the myocytes will produce a surge of short lived peptide hormone: atrial natriuretic peptide if it’s a strained atrium, or B type natriuretic peptide (BNP) if it’s a ventricle. And with heart failure being the largest cause of hospital admission and

readmission throughout the developed world, it’s tempting to think that daily measurement of BNP in high risk patients at home might be a good way of anticipating (and hence preventing) cardiac decompensation. In the HABIT trial reported in the Journal of the American College of Cardiology (!"#$;'#:#%!'-$&, doi:#".#"#'/j.jacc.!"#$."#."&!), patients were given a finger stick test to measure their BNP every day. But in people with heart failure, natriuretic peptide levels go up and down from hour to hour: so although this study found that daily BNP certainly gives a signal, it is difficult to separate from noise.

The shrinkage of modern standing armies means that army musicians, when not playing dirges for dead prime ministers, are increasingly deployed in combat roles. The occupational health department of the United Kingdom’s Ministry of Defence thought that it was important to determine whether its musicians were experiencing hearing loss as a result of their day job (Occupational Medicine !"#$, doi:#".#"($/occmed/kqt"!'). Sampling of *) military musicians suggested that they were at no greater risk of hearing loss than their administrative counterparts after *-#! years in service, and that there was no difference between the various instruments played. It seems to Minerva, however, that it is essential to be deaf before taking up the bagpipes. Cite this as: BMJ !"#$;$%&:f!'"(

A young woman presented with painful vesicular and ulcerative lesions on her oral mucosa, tongue, and lips with associated crusting. She also had low grade pyrexia and vesicular lesions on her fingertips with an erythematous base, which had appeared a few days after the oral lesions. Swabs from both sites were positive for herpes simplex virus type # (HSV#) using polymerase chain reaction. She was managed symptomatically. The course of primary HSV# infection is usually uncomplicated in an immunocompetent host, and the lesions last #"-#) days. Lesions are usually at one anatomical site, although autoinoculation can cause lesions at different sites.Suneeta Teckchandani (suneetatec@doctors.org.uk), consultant physician, C Papafio, consultant dermatologist, Medical Assessment Unit, Calderdale and Huddersfield NHS Foundation Trust, Huddersfield Royal Infirmary, Lindley HD! !EA, UKPatient consent obtained.Cite this as: BMJ !"#$;$%&:f!&)$