BMJ March 2013 magazine

THIS WEEK
BMJ | 16 MARCH 2013 | VOLUME 346
NEWS,p4
NEWS
1 Antimicrobial resistance presents an “apocalyptic”
threat, CMO warns
Financial strains must not risk work of volunteers in
the NHS
2 Judge rules that
decision to close three
children’s heart units
was unfair
New rules on
competition are still a
concern
3 Case against doctor
from Stafford hospital
set to start next week
Britons are making
healthier lifestyle
choices than 40 years
ago
4 More than a third of
GPs on CCG boards
have conflicts of
interest
Articlesappearing in thisprint
journalhave alreadybeen
publishedon bmj.com, andthe
version in printmayhave been
shortened.bmj.comalsocontains
materialthatissupplementaryto
articles: thiswillbe indicatedin
the text(referencesare given as
w1, w2, etc) andbe labelledas
extra on bmj.com.
Please cite allarticlesbyyear,
volume, andelocator (rather than
page number), eg BMJ 2013;
346:f286.
Anoteonhowtociteeacharticle
appearsattheendofeacharticle,
andthisistheformthereference
willtakeinPubMedandother
indexes.
COMMENT
EDITORIALS
7 Is an EMA review on hormonal contraception and
thrombosis needed?
Frans M Helmerhorst and Frits R Rosendaal
8 Cognitive deficits and mild traumatic brain injury
V F J Newcombe and D K Menon
RESEARCH, p 15
9 Regulating the NHS market in England
Chris Ham
10 The new UK antimicrobial resistance strategy and
action plan
Anthony S Kessel and Mike Sharland
FEATURES
16 The hospital bed: on its way out?
John Appleby examines trends in the number of
hospital beds and wonders how low we can go
HEAD TO HEAD
18 Should GPs be fined for rises in avoidable
emergency admissions to hospital?
Commissioning organisations in England face losing
a quarter of the “quality premium” if they do not
keep down their emergency admissions for specific
conditions. Martin McShane supports the plan, but
Chaand Nagpaul worries about possible unintended
consequences
ANALYSIS
20 Antimicrobial resistance: the true cost
Richard Smith and Joanna Coast argue that current
estimates of the cost of antibiotic resistance are
misleading and may result in inadequate investment
in tackling the problem
MALCOLMWILLET
RESEARCH
RESEARCH NEWS
11 All you need to read in the other general journals
RESEARCH PAPERS
12 Influence of initial severity of depression on
effectiveness of low intensity interventions: meta-
analysis of individual patient data
Peter Bower et al
13 Comparative effect sizes in randomised trials from
less developed and more developed countries:
meta-epidemiological assessment
Orestis A Panagiotou et al
14 Features of effective computerised clinical
decision support systems: meta-regression of 162
randomised trials
Pavel S Roshanov et al
15 Cognitive function and other risk factors for mild
traumatic brain injury in young men: nationwide
cohort study
Anna Nordström et al
EDITORIAL, p 8
Captio
pxx
Sufficient evidence for the oral pill exists,p 7
UKsmoking, p 3
More new antibiotics needed, p 20
King’s Fund reports on volunteers in the NHS p 1

THIS WEEK
LAST WORDS
41 Scrap the royal colleges’ fellowships
Des Spence
On first name terms
Oliver Ellis
EDUCATION
CLINICAL REVIEW
29 Achilles tendon disorders
Chad A Asplund and Thomas M Best
PRACTICE
QUALITY IMPROVEMENT REPORT
34 Maximising opportunities for increased
antiretroviral treatment in children in an
existing HIV programme in rural South Africa
Ruth M Bland et al
ENDGAMES
40 Quiz page for doctors in training
MINERVA
42 Generating energy from crematoriums, and other
stories
COMMENT
LETTERS
23 Predicted fracture risk; Bisphosphonates and
GI cancers
24 Paracetamol hepatotoxicity; Cap on social care
in England
OBSERVATIONS
MEDICINE AND THE MEDIA
25 Hype and the HIV cure
Margaret McCartney
PERSONAL VIEW
26 After Mid Staffs: NHS must look to care of
its own staff
Anonymous
OBITUARIES
27 Ian Greville Tait
Pioneering polymath and Benjamin Britten’s general
practitioner
28 Joseph Footitt; Alan William Fowler; Frank Neville
Garratt; Athol Noble Hepburn; William Philip Dowie
Logan; Muhammad Shafiq
Time for a break?
Refresh yourself.
masterclasses.bmj.com
Angry NHSstaff, p 26
An infected heel ulcer, p 42

THIS WEEK
9.7%
7.1%
6.3%
4.2%
Eschericha coli - 36%
Klebsiella spp - 7.8%
Other Gram negative - 6.4%
Pseudomonas spp - 4.3%
Proteus spp - 3.1%
Enterobacter spp - 2.2%
Bacteroides spp - 1.5%
Serratia spp - 1.0%
Acinetobacter spp - 0.7%
4.2%
Gram negative
Gram positive
1.6%
1.4%
1.4%
1.2%
36%
7.8%
6.4%
4.3%
3.1%
2.2%
1.5%
1.0%
0.7%
Staphylococcus aureus (MRSA) - 9.7%
Non-pyogenic streptococci - 7.1%
Enterococcus spp - 6.3%
Streptococcus pneumoniae - 4.2%
Other Gram positive - 4.2%
Staphylococcus aureus (MRSA) - 1.6%
Group B streptococci - 1.4%
Group A streptococci - 1.4%
Diphtheroids - 1.2%
GRAPHIC OF THE WEEK
GramnegativebacteriasuchasKlebsiellaandEscherichiacoli(Ecoli)haveovertakenGrampositivebacteria
suchasStaphylococcusaureustobecomethemainorganismscausingbloodstreaminfectionsinadults
inEngland,Wales,andNorthernIreland,accordingtotherecentannualreportofthechiefmedicalofficer
forEngland(datafromtheEnglishNationalPointPrevalenceSurveyonHealthcareRelatedInfections
andAntimicrobialUse,2011,HPAEngland,2012).Thereportpointsoutthatthethreattohealthposedby
Enterobacteriaceae(EcoliandKlebsiellarelatedspecies),whicharenowthemostfrequentagentsofhospital
acquiredinfection(36%and7.8%respectively),issubstantial.KesselandSharlandwarn,intheireditorial,that
10-20%oftheseGramnegativebloodstreaminfectionsareantibioticresistantand 30%ofpatientswhoacquire
amultidrugresistantGramnegativebloodstreaminfectionarelikelytodie.
SEENEWS,p1,EDITORIAL,p10,ANALYSIS,p20
16 March 2013Vol346
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RESPONSE OF THE WEEK
It may be significant that students,
lowest in the medical hierarchy, are
able to break into our over-regulated
NHS culture with the simple question
‘What can I do to improve your stay?’
While following prescribed guidelines
will almost always be necessary in
modern practice, it’s vital that all
staff—not just learners—retain their
authority to attend directly to patient
experience while doing so. And
sometimes the protocol misleads.
As George Orwell said about his own
guidance for writing good English,
‘Break any of these rules sooner than
say anything outright barbarous.’
Sebastian Kraemer, child and adolescent
psychiatrist, Whittington Hospital,
London, UK, in response to “IHI Open
School’s quality improvement initiative”
(BMJ 2013;346:f1371)
BMJ.COM POLL
Last week’s poll asked:
“Should GPs be fined for rises in avoidable
emergency admissions?”
65%voted no
(total 858 votes cast)
BMJ 2013;346:f1389 and
BMJ 2013;346:f1391
This week’s poll asks:
“Are the dangers of antibiotic resistance exaggerated?”
BMJ 2013;346:f1493
Vote now on bmj.com
MOST SHARED
Locum GP from India is jailed for manslaughter in UK after
failing to spot diabetic ketoacidosis
Health reform alone is pointless
Francis interview: what doctors must learn from my report
Drug company gifts to medical students: the hidden
curriculum
Winding back the harms of too much medicine

THIS WEEK
Attheendofthe1960s,thethenUSsurgeongeneral
WilliamHStewardfamouslydeclared:“Thewaragainst
infectiousdiseaseshasbeenwon.”Hisoptimismmight
wellhavebeenjustifiedatthetime.Thediscoveryof
antibioticsandtheirwidespreadintroductionhad
transformedbothmedicalpracticeandlifeexpectancy.
Antibiotics still transform lives, but—as with so many
of the world’s resources—we now know that they are not
limitless, and that unless we are careful, their beneficial
effects will run out. We have become so accustomed to
the availability of antibiotics that a world without them is
almost inconceivable. Yet this is the world that England’s
chief medical officer,Sally Davies, demands we
contemplate in the secondvolume of her annual report
(p 1).The causes of this unfolding catastrophe are many:
overuse of existing antibiotics, increasing resistance
to them, a “discoveryvoid” regarding new drugs, and a
change in the types of organisms presenting the greatest
threat. “If we don’t get this right we will find ourselves in
a health system not dissimilar to the early 19th century,”
she says.
Is Davies being overdramatic?Sadly not. Her decision
to focus on antimicrobial resistance has been broadly
welcomed. And this weekwe publish a report from
RichardSmith and Joanna Coast, long term analysts of
the economics of resistance (p 20).They suggest that
the picture she paints may even be too rosy. “Resistance
is said to present a riskthat we will fall backinto the
pre-antibiotic era,” they say. “However, this is perhaps
optimistic.”
Their argument is that we have badly underestimated
the cost of resistance.Studies that have tried to
estimate the economic impact have looked at the extra
cost of treating a resistant infection compared with a
susceptible one. But this ignores the bigger picture.The
whole of modern healthcare, including invasive surgery
and immunosuppressive chemotherapy, is based on the
assumption that infections can be prevented or treated.
”Resistance is not just an infectious disease issue,”
they say. “It is a surgical issue, a cancer issue, a health
system issue.”
Their revised assessment of the economic burden
of resistance encompasses the possibility of not
having any effective antimicrobial drugs. Under these
circumstances they estimate that infection rates after
hip replacement would increase from about 1% to
40-50%, and that about a third of people with an
infection would die. It seems likely that rates of hip
replacement would fall, bringing an increased burden of
morbidity from hip pain.
The CMO’s 17 recommendations include better
hygiene measures and surveillance, greater efforts
to preserve the effectiveness of existing drugs, and
encouragement to develop new ones. As Anthony
Kessel and MikeSharland point out, only one or two
new antibiotics that target Gram negative organisms
are likely to be marketed in the next decade (p 10).
Recognising this as a global problem, the CMO’s report
also calls for antimicrobial resistance to be put on the
national riskregister and taken seriously by politicians
internationally.
As for the cost of such action,Smith and Coast see it
as an essential insurance policy against a catastrophe
that we hope will never happen. And they share the
CMO’s urgency. “Waiting for the burden to become
substantial before taking action may mean waiting until
it is too late.”
Fiona Godlee, editor, BMJ
fgodlee@bmj.com
Cite thisas: BMJ 2013;346:f1663
EDITOR’S CHOICE
Drugresistance—anunfoldingcatastrophe
“Resistance is said
to present a risk that
we will fall back into
the pre-antibiotic era
. . . However, this is
perhaps optimistic”
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NEWS
BMJ | 16 MARCH 2013 | VOLUME 346 1
Ingrid Torjesen LONDON
Action is needed at both a national and interna-
tional level to avert the “ticking time bomb” of
antimicrobial resistance, which presents a threat
as grave as climate change, the chief medical
officer for England has warned.
In the second volume of her annual report for
2011, Infections and the rise of antimicrobial
resistance,1
Sally Davies spelt out the threat—
overuse of existing antibiotics and increasing
resistance to them, a “discovery void” of new
antibiotics, a change in the types of organism
presenting the greatest threat, and the need
for better training of NHS staff in hygiene and
infection control.
“If we don’t get this right we will find our-
selves in a health system not dissimilar to the
early 19th century,” where deaths from infec-
tions will be commonplace because of a lack of
effective treatments, Davies told a press briefing
at the Department of Health. The department
would publish a five year strategy for action in
the next couple of weeks, she said.
At the chief medical officer’s recommenda-
tion, the Department of Health and the Depart-
ment for Environment, Food, and Rural Affairs
have added antimicrobial resistance to their
strategic risk registers. Davies has also requested
that it be added to the National Security Risk
Assessment, alongside pandemic flu and
terrorism, to ensure cross government action.
“Governments and organisations across the
world, including the World Health Organization
and G8, need to take this seriously,” she said.
This included finding some way of incentivis-
ing the pharmaceutical industry to develop new
antibiotics. No new antibiotic classes have been
discovered since 1987, and Davies said that no
pharmaceutical companies had any new anti-
biotic classes in their pipeline, and that there
were few new antibiotics of existing classes in
development.
With the pipeline drying up, stewardship of
antibiotics in health, fisheries, and farming had
become increasingly important, she said. In
health, that meant prescribing antibiotics only
when appropriate and ensuring that the patient
completed the course.
Zosia Kmietowicz BMJ
Commissionersandservice
providersneedtobetterplan
theroleofvolunteersinboththe
healthandsocialcaresectorsif
theyaretoavoidalienatingthe
swathesofpeoplewhoprovide
theirtimeforfreeandease
growingtensionswiththosein
paidjobs,areportfromaleading
thinktankhassaid.1
Anestimatedthreemillion
peopleinEnglandvolunteerin
theNHS,healthcharities,and
socialcareorganisations—
thesamenumberinpaid
employmentintheNHSand
socialcaresystems,saysthe
reportfromtheKing’sFund.
Volunteersplayavitalrole
indeliveringservicessuch
asassistingwithmealtimes,
providingsupportforbereaved
families,andbefriendingolder
peopleincarehomes.
TheInstituteforVolunteering
Researchhassuggestedthat
volunteersarewortharound
£700000ayeartohospital
trusts,£500000ayeartomental
healthtrusts,and£250000a
yeartoaprimarycaretrust.
Thelatestreportwas
commissionedbythe
DepartmentofHealthtolookat
theeffectofthecurrentchanges
tohealthandsocialcaresectors
onvolunteering.Thegovernment
seesvolunteeringashelping
toachieveitswiderambitions
todecentralisepower,reduce
relianceonthestate,and
encouragepeopletotakean
activeroleintheircommunities.
However,thecurrent
economicclimatemeansthat
some“tensionshavealready
emerged,”saidthereport.Some
peoplearequestioningthevalue
ofvolunteers,andresearchhas
shownthatstaffaresometimes
unclearaboutwhatvolunteers
do.Financialpressuresalso
riskcreatingstrainswithpaid
employeeswhoareconcerned
abouttheirjobs.
Itisforthesereasons,the
reportsaid,thatcommissioners
andserviceprovidersneed
tofocusonhowvolunteers
willhelpimprovequalityand
bringbenefitstoorganisations,
patients,andcommunities.
Tomakethemostof
volunteers,commissionersand
providersmustacknowledge
thevalueofvolunteers,develop
aclearvisionofhowvolunteers
canhelporganisationsand
patients,measuretheirinput,
andclarifytheboundaries
betweenprofessionaland
volunteerrolestoallayconcerns
ofjobsubstitution.
Thereportsaid,“Itismore
importantthanevertothink
strategicallyabouttheroleof
volunteering.Thehealthand
socialcaresystemwillfindit
increasinglydifficulttomeetits
objectiveswithoutdoingso.”
ChrisNaylor,fellowat
theKing’sFund,saidthat
volunteeringshouldbeused
toimprovequalityandnotto
reduceshorttermcosts.
Without volunteers the NHS will find it increasingly difficult to meet its objectives, said the King’s Fund
Financial strains must not risk
work of volunteers in the NHS
Antimicrobial resistance
presents an “apocalyptic”
threat, CMO warns
LIFEINVIEW/SPL
UKnewsFirstcaseagainstdoctorfromStaffordhospitalsettostartnextweek,p3
BMJinvestigationMorethanathirdofGPsonCCGboardshaveconflictsofinterest,p4
References on news stories are in the versions on bmj.com
bmj.com
Judge overturns
New York’s ban
on supersize
sweet drinks

NEWS
2 BMJ | 16 MARCH 2013 | VOLUME 346
Clare Dyer BMJ
Campaigners fighting the decision to close the
children’s heart surgery unit in Leeds as part of
an exercise to concentrate operations in fewer
but larger centres have scored a comprehensive
victory at the High Court in London.
Mrs Justice Nicola Davies ruled that the “Safe
andSustainable”consultationthatrecommended
closing three units was flawed by procedural
unfairnessandafailuretotakeintoaccountmate-
rial considerations.
The success for the campaigning group,
Save our Surgery Limited, on both grounds
of its challenge is a significant setback for the
plans to concentrate surgery at only seven sites:
Bristol, Birmingham, Southampton, Liverpool,
Newcastle, and two in London. Units in Leeds
and Leicester and at London’s Royal Brompton
Hospital in London would be axed under the
consultation recommendations.1
The judge ruled that the consultation process
was unlawful in the first instance because the
Joint Committee of Primary Care Trusts, which
Zosia Kmietowicz BMJ
The UK government has redrafted regulations
on procurement, in an attempt to allay concerns
raised by several medical bodies and MPs in the
pastfewweeksthatclinicalcommissionerswould
beforcedtoputouttocompetitivetendermostof
the services they wanted for their patients.
However, both the BMA and the Royal College
of General Practitioners are still concerned that
commissionersarenotcompletelyfreetochoose
when to use competition and when not to.
Therevisedregulations,whichwerelaidbefore
parliament on 11 March, mean that the position
on competition is unchanged from now, said the
Department of Health—commissioners are able
to offer contracts to a single provider where only
thatprovideriscapableofprovidingtheservices.
In explanatory notes, it said, “We have
removedthewordsthatinadvertentlycreatedthe
impression that there were only very narrow cir-
cumstancesinwhichcommissionerscouldaward
a contract without a competition.”
Thedepartmentsaidthattherewordingmakes
itclearthatMonitor,theeconomicregulatorofthe
NHS, has no power to force the competitive ten-
deringofserviceswhentheregulationscomeinto
force on 1 April, and that decisions about how
and when to introduce competition are solely up
to doctors and nurses in clinical commissioning
groups.Itadded,“Competitionshouldnottrump
integration—commissioners are free to commis-
sion an integrated service where it is in the inter-
est of patients.”
The UK Labour Party and the new National
Healthpartycriticisedtheoriginalsecondaryleg-
islation published in February.1
More than 1000
doctors also urged MPs to force a debate on the
regulations2
and the Academy of Medical Royal
Collegesexpressed“considerableconcern”atthe
regulations,whichwerepublishedtosupplement
section 75 of the Health and Social Care Act.
Clare Gerada, chair of the Royal College of
GeneralPractitioners,saidtherevisedregulations
were “a step in the right direction but . . . do not
gofarenoughinensuringthatcommissionersare
genuinelyfreetodecidewhetherornottoexpose
services to competition.”
MarkPorter,chairoftheBMACouncil,said,“It
is vital that competition is not allowed to under-
mine integration, innovation, or clinical auton-
omy. There still needs to be a full parliamentary
debatetoprovideabsoluteclaritythatCCGs[clini-
calcommissioninggroups]willhavethefreedom
todecidehowbesttosecurehighqualityservices
for local populations,” he said.
Judge rules that decision
to close three children’s
heart units was unfair
New rules on competition are still a concern
Campaigners to keep services in Leeds said the
reform process had been “flawed and unjust”
SDSPHOTO/DEMOTIX/PA
Services are failing people with dementia:
Peoplewithdementiawholiveincarehomes
inEnglandaremorelikelythansimilar
peoplewithoutdementiatogotohospital
withavoidableconditionssuchasurinary
infections,theCareQualityCommissionhas
said.Onceadmitted,peoplewithdementia
aremorelikelythanthosewithoutdementia
tostayinhospitallonger,bereadmitted,and
dieinhospital.
Disclosure of pharma sponsorship
made compulsory in Portugal: Alaw
thatwasenactedon15Februaryrequires
doctors,scientificsocieties,andpatient
associationsinPortugaltopubliclydisclose
allsponsorshipfromthepharmaceutical
industrytothenationaldrugregulator
(Infarmed).Failuretodiscloseconflictsof
interestscouldresultinfinesof€2000
(£1740)to€45000.
Regulator rules that
advertisements on plain
packs are misleading: The
AdvertisingStandardsAuthority
hasruledthatadsrunby
JapanTobaccoInternational—
againsttheintroductionof
plain,standardpackaging—aremisleading
andmustnotbepublishedagain.Theads,
placedinthenationalpressin2012,stated
thatin2008thegovernmenthad“rejected”
plainpackagingfortobaccobecause“there
wasnocredibleevidence”tosupportsucha
policy.Theregulatorconcludedthattheclaim
breachedtheadvertisingcodeofpractice.
Smoking to be banned from all Dutch cafes:
DutchhealthministerMartinvanRijnhas
confirmedtoMPsthathewillbringforward
changestothelawenforcingasmoking
banthroughouttheNetherlands’hospitality
industry.MostMPsrecentlyvotedfora
totalban.Currentlysomesmallercafésare
exempt.Lastyear,smokingincreasedfrom
25%to26%inadults.
Partners agree to vaccinate 400 million
children: TheGlobalAllianceforVaccines
andImmunisation(GAVI)andtheIslamic
DevelopmentBank(IDB)havesigneda
memorandumofunderstandingtohelp
savechildren’slivesbyacceleratingthe
introductionofvaccinesinIDBmember
countries.By2020,GAVIplanstovaccinate
morethan400millionchildreninatleast29
membercountrieswiththeaimofpreventing
3.2milliondeathsatanestimatedcostof
$7bn.
Cite this as: BMJ 2013;346:f1622
IN BRIEF
took the decision, had refused to disclose the
sub-scores that an expert committee had given
in a scoring exercise. Units were given only the
overall scores.
“I am satisfied that fairness did require disclo-
sureofthesub-scorestoenableLeedstoprovidea
properlyfocusedandmeaningfulresponse,”said
thejudge,whodescribedthecommittee’srefusal
to hand over the sub-scores as “ill judged.”
In addition, the joint committee also failed to
take into account the sub-scores when carrying
out the consultation, although the overall scores
wereacknowledgedtobeclose,shesaid.Thesub-

NEWS
Ingrid Torjesen LONDON
British adults are half as likely to smoke as they
were four decades ago and are drinking less
heavily and less frequently, show data from the
OfficeforNationalStatistics(ONS)2011General
Lifestyle Survey.
The survey’s report, launched at a press con-
ference in London on 7 March, also shows that
despite the ageing population, the proportion of
peopleinGreatBritainlivingwithalongstanding
illnessordisabilityhasremainedsteadyoverthe
past 20 years at just under a third.1
The 2011 report marks 40 years of the survey.
When the ONS survey first included questions
about smoking in 1974, it found that 45% of
adults smoked (51% of men, 41% of women).
Since then, smoking has more than halved and
the gap in prevalence of smoking between men
and women has narrowed; in 2011, 20% of
adults smoked (21% of men, 19% of women).
Although fewer people smoke now than in
the 1970s, women who still do smoke consume
similarnumbersofcigarettes(12perdayin2011
compared with 13 in 1974), and consumption
has fallen only slightly in men—from 18 ciga-
rettes per day in 1974 to 13 in 2011.
Alongside smoking, the proportion of adults
drinking heavily or frequently has also fallen.
Among 16-24 year olds, the proportion of men
drinking more than eight units (double the rec-
ommendedmaximumformen)inonedayinthe
pastweekfellbyalmostathirdinfouryears(from
32% in 2007 to 22% in 2011).
Theproportionofwomendrink-
ing more than six units (double
the recommended maximum
for women) in any one day
fell by a quarter over the
same time period, from
24% to 18%.
The proportion of men
drinking on five or more
days in a week fell from 23%
in 1998 to 16% in 2011,
while the proportion of
women drinking at least five
times per week fell from 13%
to 9%. However, the survey
foundthatolderpeoplewere
far more likely than younger
peopletodrinkfrequently.In
2011,menaged45yearsormore
were more than twice as likely to drink five times
or more per week as those aged 16-44 years.
While lifestyle has improved the population
has aged. Between 1971 and 2011, the pro-
portion of the population aged 65 years or over
increased from 13.3% to 16.5%.2
However, this ageing has not
been reflected in the overall
prevalence of longstand-
ing illness or disability. In
1972, 21% of the popula-
tion reported living with
a longstanding illness or
disability.Thisproportion
rose to 32% in 1991 and
has remained steady. The
most common longstand-
ing illnesses reported were
musculoskeletal illnesses,
followed by heart and cir-
culatoryconditions,respira-
toryillnesses,andendocrine
andmetabolicconditions.How-
ever, the proportion of people
living with a longstanding ill-
ness or disability has increased
from15%in1975to19%in2011.
Clare Dyer BMJ
A surgeon who worked at Stafford Hospital,
where inquiries uncovered hundreds of excess
deaths and “appalling” standards of care
between 2005 and 2008, is to face a fitness to
practise hearing at the Medical Practitioners
Tribunal Service next week.
Roderic Hutchinson faces allegations of defi-
cient professional performance at a 10 day hear-
ing, which opens at the tribunal in Manchester
on 18 March.
Three medically qualified managers at Mid
Staffordshire NHS Foundation Trust are also set
to appear before the tribunal, although no dates
have yet been fixed. They have been named as
JohnGibson,medicaldirectorfrom2003to2006;
hissuccessor,ValerieSuarez,whowasappointed
in September 2006 and stepped down in March
2009; and their deputy, David Durrans.
ThehearingsfollowinvestigationsbytheGeneral
MedicalCouncil(GMC)into42doctorswhoworked
forMidStaffstrustatthetime.1
Hutchinson’scaseis
thefirsttobesentforahearing.
A consultant general surgeon and colorectal
surgeon, he underwent a GMC assessment of
his professional performance in June 2011. The
charges allege that his performance was “unac-
ceptable in the area of working with colleagues,
andacauseforconcernintheareasofothergood
clinical care and relationships with patients.”
The surgeon was allowed to continue work-
ing under conditions including supervision by a
namedconsultant,buttheconditionswerelifted
in October 2011. He left Mid Staffs in September
2012.
A review of the general surgery department
at Stafford Hospital by the Royal College of
Surgeons in 2009 concluded that the service
provided was “inadequate, unsafe, and at times
frankly dangerous.”2
NHS managers who are not doctors are not
subject to regulation, but GMC guidance makes
it clear that those who are medically qualified
may be held to account on how they fulfil their
management roles.
Case against doctor from Stafford
hospital set to start next week
scoresprovidedthebasisforwhatwasultimately
the difference of one point in the critical quality
scoring between Leeds and Newcastle.
“In my view, and commensurate with their
dutytoproperlyscrutiniseandassessallrelevant
evidence,theJCPCT[thejointcommittee]should
have considered the sub-scores,” she said.
At a further hearing on 27 March to decide
what remedy should be granted, the Leeds cam-
paigners are expected to argue that the decision
on4July2012toconcentratechildren’sheartsur-
gery at the seven sites should be quashed. The
joint committee is expected to seek an appeal.
The Royal Brompton initially succeeded in
a High Court challenge to the plans but lost on
appeal.2
Ifthedecisionisquashed,theLeedscampaign-
ers would argue that surgery should continue at
Leeds and Newcastle, the judge said.
LastOctoberthehealthsecretary,JeremyHunt,
referred the decision to close the three units to
the independent reconfiguration panel, which
advises on contested changes to health services
inEngland.Thepanelwasexpectedtodeliverits
decision by the end of March.3
The units earmarked for closure have argued
that the consultation, which began in 2008, has
been working with outdated figures.
Britons are making healthier lifestyle choices than 40 years ago
In 1974 the survey found that
41% of women smoked; in 2011
it was 19%

BMJ INVESTIGATION
commissioners who run their own private com-
panies” and called on GP commissioners to “be
barred from being involved in companies that
they are giving contracts to.”2
But others have said that conflicts are an
inevitable by-product of allowing more clini-
cians into management positions and said that
focusing too much on the issue may prevent
commissioners redesigning services effectively.
The BMJ analysed the registered interests of
176 of the 211 commissioning group boards,
obtained through requests made under free-
dom of information legislation and from CCG
websites. The remaining groups were not able
to disclose their lists, though they must main-
tain and publish them from 1 April.3
Our analysis also showed that 4% of GPs
on CCG boards were consultants to or advised
private health or pharmaceutical companies,
while 5% were employed by a private health
company as well as working as a GP.
Some 12% of GPs declared links with not for
profit voluntary or social enterprise providers
that represented a conflict of interest with their
commissioning role, while 9% of GPs declared
a conflict of interest through a family member.
MorethanathirdofGPsontheboardsofthenew
clinicalcommissioninggroups(CCGs)inEngland
haveaconflictofinterestresultingfromdirector-
shipsorsharesheldinprivatecompanies,anew
analysisbytheBMJhasshown.
An examination of the registered interests of
almost 2500 board members across 176 CCGs
providestheclearestevidencetodateofthecon-
flictsthatmanydoctorswillhavetomanagefrom
1April,whentheGPledgroupsarehandedstat-
utory responsibility for commissioning around
£60bnofNHShealthcareservices.
Ourinvestigationshowsthatconflictsofinter-
est are rife on CCG governing bodies, with 426
(36%) of the 1179 GPs in executive positions
having a financial interest in a for-profit private
provider beyond their own general practice—a
providerfromwhichtheirCCGcouldpotentially
commissionservices.
The interests range from senior directorships
inlocalfor-profitfirmssetuptoprovideservices
such as diagnostics, minor surgery, out of hours
GP services, and pharmacy to shareholdings
in large private sector health firms that provide
care in conjunction with local doctors, such as
HarmoniandCircleHealth.
May 2010
Coalition governmentis
elected. Andrew Lansley
(right), who had served as
the Conservatives’ shadow
health secretaryfor sixand
a halfyears, isappointed
secretaryofstate for health.
Butitisunderstood that
the Conservatives’ policy
chief, Oliver Letwin, and the
LiberalDemocratMP Danny
Alexander drew up the new
government’shealth policy
aspartoftheir hastilydevised
“programme for government”
(BMJ 2012;345:e4833).
July 2010
Government
publishes
its NHS
white paper
Equity and Excellence:
Liberating the NHS. This
proposes handing sweeping
powers to GPs in a major
shake-up of the NHS. The
radical proposals include
the abolition of primary care
trusts and the establishment
of new consortiums, led
by GPs, to manage NHS
commissioning budgets
(BMJ 2010;341:c3796).
January 2011
Department of Health pub-
lishes the Health andSocial
Care Bill, outlining itsvision
for healthcare. An accom-
panying impact assessment
identifies potential conflicts
of interest as a key risk
associated with the proposed
changes
(BMJ 2011;342:d507).
April 2011
Government announces
“pause” in the passage of
the Health and Social Care
Bill, prompted by concerns
from the Liberal Democrats,
the Labour Party, and the
medical profession. Steve
Field, former RCGP chairman
(below), is put in charge of
the Future Forum set up to
hear such concerns during
the pause
(BMJ 2011;342:d2216).
June 2011
After the listening exercise
conducted during the
“pause” the government
announces that the GP
consortiums will be renamed
clinical commissioning
groups (CCGs) to reflect
the wider clinical
involvement beyond GPs.
It says that each CCG must
have at least two other
clinicians on its governing
body, including at least one
secondary care specialist
doctor
(BMJ 2011;342:d3777).
InsomecasesmostoftheGPsontheCCGgov-
erning body have financial interests in the same
privatehealthcareprovider.
Some doctors have relinquished interests in
private enterprises because of their new roles
as commissioners. These include GPs linked to
RichardBranson’sVirginCare,whichannounced
in October 2012 that it planned to end its joint
venture partnerships with over 300 GPs in Eng-
land,1
afteradmittingthatmanywerebecoming
“increasingly worried about the perception of
potentialconflictsofinterest.”
Calls for doctors with interests to step down
Butouranalysisfoundthat,intotal,555(23%)
of 2426 clinical, lay, and managerial members
ofCCGgoverningbodieshadafinancialstakein
a for-profit company.
Leading GPs, including a senior government
adviser on commissioning, have called for doc-
tors with conflicts that were “too great” to step
down and have urged the NHS Commissioning
Board to offer tougher guidance to those with
multipleinterests.LastweektheBMA’sUKcon-
sultants’conferencepassedamotionexpressing
concern at “the clear conflict of interest of GP
More than a third of
GPs on CCG boards have
conflicts of interest
On the eve of one of the biggest upheavals in the history
of the NHS, Gareth Iacobucci looks at the conflicts at the
heart of clinical commissioning groups
Membership of CCG governing bodies
GPs (n=1179)
Other (n=87)
Total number of board members in 176 CCGs
analysed (n=2426)
Lay and
managerial
members (n=915)
Other clinical
members (n=245)
3%
49%
38%
10%
2010 2011
COMMISSIONING—WHAT HAPPENED WHEN
>>> >>> >>> >>> >>>>

NoofGPs
0
100
200
300
400
Consult with or advise a private
company or drug company
500 Key
Types of interests registered by GPs on CCG boards
Employed by a private company
(aside from their GP practice)
Declared a conflict of interest
relating to a family member
Personal links with not for profit
voluntary or social enterprise
organisations
Directors or have shares in private
companies
426
144
106
55
43
BMJ INVESTIGATION
The NHS Commissioning Board has issued
rules to CCGs stating that board members must
remove themselves from decisions from which
they could materially benefit.4
Some CCGs have responded to this by includ-
ing a provision to co-opt additional members
if doctors on the governing body have to
remove themselves from decisions. Others
have increased the number of lay members on
boards to try to alleviate potential conflicts.
But doctors’ leaders have expressed concern
that clinical input into commissioning deci-
sions might become diluted if too many doc-
tors were forced to remove themselves from
particular decisions.
CCGs with notable conflicts
Governingbodieswithnotableconflictsinclude
NHS Leicester City CCG, where seven GPs on
the board have a financial interest in the LLR
(Leicester,LeicestershireandRutland)GPProvider
Company; NHS Oldham CCG, where five of the
eightGPshaveaninterestintheproviderPrimary
CareOldhamLLP;andNHSBlackpoolCCG,where
sixoftheeightGPshaveaninterestinthelocalout
ofhoursproviderFyldeCoastMedicalServices.
Ian Wilkinson, a GP and chief clinical officer
atNHSOldhamCCG,whodoesnothaveafinan-
cial stake in a private provider company, said
that the CCG’s board had also recruited addi-
tional lay and clinical members to ensure that
decisions could be made if members needed
to remove themselves. He added that so far no
voting members had removed themselves from
governing body or committee proceedings.
Richard Gibbs, a lay board member at NHS
Southwark CCG, told the BMJ that his CCG had
attempted to deal with conflicts by appointing
him as a “guardian” who would judge when it
might be appropriate for members to remove
themselves from decisions (box).
A spokeswoman for Leicester City CCG said
that a significant proportion of its local general
practices were members of the LLR GP Provider
Company and said that it would co-opt mem-
bers from neighbouring CCGs if its governing
body were conflicted. She said, “They have to
remain neutral, so we would bring in members
from our fellow CCGs—East Leicestershire and
Rutland/West Leicestershire—or bring in a GP
member from a neighbouring county such as
Northamptonshire.”
In NHS Chiltern CCG, in Buckinghamshire,
twoofthethreeGPsonthegoverningbodyhold
shares in the for-profit provider Chiltern Health,
while in NHS Aylesbury Vale CCG, also in Buck-
inghamshire, both GP voting members of the
board have interests in the private provider Vale
Health. In NHS Southwark CCG, in London, five
ofnineGPsonthegoverningbodyhaveastakein
variousfor-profitprovidercompanies.
All these CCGs told the BMJ that they had
robust systems in place for managing potential
conflicts, including publishing their policies on
conflictsofinterestandregularlyupdatingmem-
bers’declarationsofinterest.
Amanda Doyle, a GP and chief clinical officer
at NHS Blackpool CCG, told the BMJ that her
CCG had sought to tackle potential conflicts by
opting to double the number of lay members on
itsgoverningbodyfromtheminimumsetbythe
government,includingalaychairperson(box).
Doyle acknowledged that most of the GPs on
the board would have to “step away” if the local
out of hours service were to be retendered. But
she warned that the benefits of having doctors
leading commissioning might be lost if conflicts
ofinterestgainedtoomuchattention.
September 2011
RCGP and NHS
Confederation,
the membership
body for
organisations
that commission
and provide NHS services,
publish joint guidance
on “managing conflicts
of interest in clinical
commissioning groups”
(BMJ Careers,
http://bit.ly/W7y9wK).
2012 2013>>> >>> >>> >>> >>>>
February 2012
House of Lords agrees
amendments to the Health
and Social Care Bill stating
that CCGs would have to
publish registers of board
members’ interests
(http://bit.ly/ wqDqVP).
June 2012
NHS Commissioning Board
Authority publishes a code
of conduct. This states that
members must remove
themselves from decisions
from which they could
materially benefit
October 2012
The private sector company
Virgin Care, owned by
Richard Branson (top
right), announces plans to
dissolve its joint venture
provider partnerships
with GPs, in response to
concerns from GPs over
conflicts of interest in
the new commissioning
landscape
(BMJ 2012;345:e7227).
November 2012
NHS Commissioning Board
rejects a call from GP
commissioning leaders for
conflicts of interest to be
treated with leniency
(BMJ 2012;345:e7967).
February 2013
In its response to its
consultation “Securing the
BestValue for Patients,”
health department says that it
will strengthen the powers of
Monitor, headed
byDavid Bennett
(right), to act
where conflicts
“may affect the
integrity of a
commissioner’s
decision.”

BMJ INVESTIGATION
A spokesman for NHS Chiltern CCG said that
the group had co-opted additional members to
a decision making panel for the recent procure-
ment of a GP led minor illness and injury unit
wheretherewas“potentialforperceivedconflict
of interest,” while NHS Aylesbury Vale CCG said
that it had written the ability to co-opt members
into its constitution.
Declaring an interest “not enough”
However, despite the measures being taken,
James Kingsland, the government’s national
clinicalleadforNHSclinicalcommissioningand
a GP on Merseyside, said that he believed some
doctors on local commissioning boards should
step down from one of their roles if they had a
substantial stake in a local private healthcare
company,becausetheirconflictsweretooacute.
Hesaid,“Ifitissomebodywhohasgotamajor
stake in some of the provider services which
the CCG commissions, I don’t think excluding
[himself or herself] or declaring an interest is
enough—notforthepublic.Ithinktheyhavegot
tostepdown.”
Kingsland said that his stance had been criti-
cisedbysomedoctors,whowereconcernedthat
forcingpeopletostepdowncouldleadtoashort-
ageofclinicianswillingtositonCCGboards.
Buthesaid,“Thatisn’tanexcusetoallowcon-
flict to go. If they are enthusiasts as both senior
provider and senior commissioner, my answer
wouldbe:makeyourchoiceandbeaccountable
forthatchoice.
“If you can justify a marginal amount of con-
flictthatcanbedeclaredandmanaged,thenfine.
If you can’t marginalise a conflict, and you are
excludingyourselffromtheboardweekin,week
out because you’ve got an interest, ultimately it
becomes unaccountable. Where you draw the
line is difficult; if somebody is going to be the
arbiterofthat,itshouldbethepublic.”
The “local newspaper test”
Michael Dixon, chairman of the NHS Alliance,
which represents organisations and individual
professionals in primary care, has previously
called for “more leniency” in handling conflicts
of interest in the new system.5
He warned that
placing too much emphasis on the issue might
prevent clinical commissioners from bringing
morecareintocommunitysettings.
He said, “The priority is to move services out
ofhospitalandintoprimarycare.Thereasonthis
hasn’t happened to date is because of blocks in
the system. It’s more important to remove those
blocks than be preoccupied with conflicts of
interest. Dixon said that he believed that “trans-
parency is all you need” to handle conflicts and
urged doctors to use “the local newspaper test”
when assessing their own interests: “You have
gottobehappyforeverythingyoudoasaGPand
acommissionertoappearonthefrontpage.”
Chaand Nagpaul, the BMA’s lead GP negotia-
toroncommissioningandaGPinHarrow,called
fortheNHSCommissioningBoardtoissuemore
robustguidanceonhandlingconflicts.
“The Commissioning Board’s guidance has
not gone far enough. Their guidance is all about
declaring and managing conflicts, rather than
recognising that some conflicts of interest are
toogreat,”hesaid.
Nagpaul said that he supported the idea of
CCGs co-opting additional members to help
make decisions where conflicts existed, but he
said that it was crucial that this extra help did
notjustfocusonlaymembers,asitcould“dilute”
clinicalcommissioning.
“It would undermine the whole concept of
clinicallyledcommissioningtonothaveclinical
input,”hewarned.
A spokeswoman for the NHS Commissioning
Board said that it had already published “com-
prehensive guidance” on managing conflicts of
interest,which“clearlysetsoutthatthedecision
on whether an individual’s conflicts of interest
arelikelytobesogreatastoprecludethemfrom
taking a role on the governing body should be
madebytheCCG.”
But she said that the board was reviewing its
existingguidanceandwouldshortlybepublish-
ing“final,comprehensiveguidanceonmanaging
conflictofinterest.”
Strengthening the rules
The Department of Health acknowledged in its
response to its consultation “Securing the Best
Value for Patients” that concerns about con-
flicts needed to be answered, and it pledged to
strengthen the power of the healthcare regula-
torMonitortoactwhereconflicts“mayaffectthe
integrityofacommissioner’sdecision.”6
The department said that this would mean
that “Monitor is able to take action where con-
flicts have not been managed appropriately
in awarding a contract, and not only where
Monitor is able to establish that the decision to
award a contract was the result of an interest in
theprovider.”
Niall Dickson, chief executive of the General
Medical Council, said that there were “no new
principles involved” as far as doctors’ ethical
conduct was concerned. He added, “The con-
siderable additional responsibilities about to be
undertaken by GPs does mean that some face
conflictsofinterestsmoreoftenthaninthepast.
Weexpectdoctorstobeopenaboutanyfinancial
andcommercialinterestslinkedtotheirwork.”
NHSBlackpoolCCG
NHSSouthwarkCCG
RichardGibbs,laymemberof
theboardoftheNHSSouthwark
CCG,saidthathisgroup
hadtriedtotacklepotential
conflictsbyappointinghimas
a“guardian”—withtheremitof
exercisingjudgmentonwhen
itmightbeappropriatefor
memberstoremovethemselves
fromdecisions.
Gibbs,whohasnofinancial
interestsinanyprivateproviders,
saidthattheCCGhadalsoset
upathreepersonevaluation
panel,comprisinghimself,the
chiefofficer,andthedirector
ofpublichealth,toarbitrate
oncommissioningdecisions
wheretwoormoremembers
havetoremovethemselvesfrom
decisionsbecauseofconflicts.
“Wehaveconvenedthepanel
onthreeorfouroccasions,”
Gibbssaid.“Ifweneededtoget
additionalexpertisethenwe
wouldco-optinsomeonewho
isn’tconflicted,presumablyfrom
outsideSouthwark.”
Amanda Doyle, chiefclinical
officer atNHSBlackpoolCCG,
who hasdeclaredan interestin
the localprovider ofoutofhours
services, saidthather CCG had
soughtto dealwith potential
conflictsbyopting to have four
laymemberson itsgoverning
body—double the minimum set
bythe government—including a
laychairperson.
“Wewereveryconsciousof
theneedtodemonstratethat
wewerenotlettingconflicts
interferewithourdecisions,”
sheexplained.
ButDoyleaddedthatitwas
importanttostrikea“balance”
betweenmanagingconflicts
appropriatelyand“ensuring
thatwegetafullrangeofclinical
inputintoserviceredesignand
commissioningdecisions.”
Shewarned,“Thereisariskof
gettingsotiedupwithworrying
aboutconflictsofinterestthat
youdon’tgoaheadandreap
thebenefitsofhavingclinicians
leadingcommissioning.”
Doyleacknowledgedthatmost
GPsontheboardwouldhaveto
stepawayifthelocaloutofhours
serviceweretoberetendered.
Shesaidthatitwas“unlikely”
thattheboardwouldco-opt
additionalcliniciansontothe
boardinsuchacasebutsaid
thatitmaytake“clinicalinput
andadvice”fromoutsidethe
areaifthiswasneeded.
TACKLING THE ISSUE OF CONFLICTS OF INTEREST

Editorials are usually commissioned. We are, however, happy to consider and peer review unsolicited editorials
See http://resources.bmj.com/bmj/authors/types-of-article/editorials for more details
EDITORIALS
Is an EMA review of hormonal contraception and thrombosis needed?
Sufficient evidence exists to recommend lightest tolerable second generation pill for all indications
Frans M Helmerhorst professor in clinical
epidemiology of fertility
F.M.Helmerhorst@LUMC.nl
Frits R Rosendaal professor in clinical epidemiology,
Leiden University Medical Center, 2300 RC Leiden,
Netherlands
Four recently reported deaths in women using
the Diane-35 contraceptive and a lawsuit against
the French drug authority (L’Agence Nationale de
Sécurité du Médicament) after it banned Diane-
35 led the authority to request that the European
Medicines Agency (EMA) review the safety of
combined oral contraceptives.1 2
Of particular
concern were third and fourth generation drugs,
including Diane-35 and its generics. This review
was granted on 7 February 2013.3 4
The Dutch
College for the Evaluation of Medicines (Dutch
“EMA”) decided that a new study on Diane-35
was in order.
Most oral contraceptives are combination
preparations, containing a progestogen, to
prevent ovulation, and an oestrogen to prevent
breakthrough bleeding. Since the introduction
of the pill, the oestrogen dose, in the form of
ethinylestradiol, has been reduced (heavy v light
pills) and the type of progestogen has changed
several times (indicating the generation). The
categorisation is imprecise and incomplete. For
example, cyproterone acetate, the progestogen
in Diane-35, does not belong to a generation.
Furthermore, the categorisation assumes that
all side effects of oral contraceptives are class
effects. In our recent network meta-analysis of
all combined oral contraceptives (unpublished
data), we found that the risk of venous thrombo-
sis depended on the dose of oestrogen and the
type of progestogen, even within generations.
Many studies have shown that oral contra-
ceptive users have an increased risk of venous
thrombosis (deep vein thrombosis, pulmonary
embolism) and arterial thrombosis.5 6
Venous
thrombosis is more common than arterial throm-
bosis,butinyoungwomentheincidenceofthese
side effects is low. Even the “safest” oral contra-
ceptive increases the risk of venous thrombosis,
however, and the risk is twice as high for oral
contraceptives containing a third generation
progestogen, drospirenone (sometimes called
fourth generation), or cyproterone acetate.5
This
knowledge is not new—the increased risk for
pills containing third generation progestogens,
cyproterone acetate, and drospirenone has been
known since 1995, 2001,7
and 2003, respec-
tively.8
TheEMA’spublicreportatthebeginningofthe
review states that Diane “works by blocking the
effectsofaclassofhormonescalledandrogens,”3
and that this is responsible for its supposed ben-
efits on acne and hirsutism. However, as early as
2004 (and in three updates) a systematic review
concluded that all types of monophasic com-
bined oral contraceptives are effective against
acne.9
All combined oral contraceptives are equally
effective in preventing pregnancy. Their side
effects (such as weight gain10
) and benefits (in
terms of acne and hirsutism) are also similar, so
the only rational strategy is to use the safest one
with regard to venous thrombosis. The common
arguments that the risk of thrombosis is low or
that the risk of thrombosis during pregnancy
is higher than when using oral contraceptives
are flawed. Millions of women in Europe use
oral contraceptives, so use of the pill with the
best safety profile in terms of thrombosis would
probablypreventthousandsofthromboticevents
and hundreds of deaths a year. Because the pill
with the safest thrombosis profile is as effective
at preventing pregnancy as the less safe ones,
the risk of thrombosis in pregnancy is irrelevant
in the choice of oral contraceptive. The safest
oral contraceptive is one that contains the low-
est tolerable dose of ethinylestradiol (lowest
dose that prevents breakthrough bleeding—30
μg11
) together with the second generation pro-
gestogen, levonorgestrel.
Sufficient evidence is already available on
which clinicians and regulatory agencies can
base their decisions, so lengthy evaluations, let
alone new studies, are not needed.
In his 2011 BMJ editorial, Nick Dunn recom-
mended prescribing an oral contraceptive that
contains levonorgestrel unless “there is a persist-
ent reason to use another type.”12
Because oral
contraceptives containing levonorgestrel and
the lowest tolerable dose of oestrogen are also
adequate for the treatment of acne or hirsutism,
we can see no reason to use another type. Third
and fourth generation oral contraceptives are
widely overprescribed.
Competinginterests: None declared.
Provenanceandpeerreview: Commissioned; not externally
peer reviewed.
Referencesareintheversiononbmj.com.
Response on bmj.com
“It is wise to consider all of the many serious conditions caused by use of hormonal contraception including the increased risks of suicide
and breast cancer.” Ellen CG Grant, retired medical gynaecologist, Kingston-upon-Thames, Surrey
Visit the article online and click “Respond to this article” to have your say.
French drug authority L’Agence Nationale de Sécurité du Médicament recently banned Diane-35
BSIP,BBOISSONNET/SPL

EDITORIALS
Cognitive deficits and mild traumatic brain injury
Newstudyidentifiesriskfactorsandraisesquestionsaboutthenatureofanyimpliedcausalassociation
VFJNewcombeacademicclinicalfellowinemergency
andintensivecaremedicine
DKMenonprofessorofanaesthesia,Divisionof
Anaesthesia,UniversityofCambridge,Addenbrooke’s
Hospital,CambridgeCB22QQ,UK
Between 7% and 33% of patients who have
“mild” traumatic brain injury (sometimes called
concussion) develop persistent post-concussion
syndrome, which may last weeks to months
after injury.1
More than 15% have a measurable
cognitive deficit at one year.2 3
There is grow-
ing interest in the syndrome of post-traumatic
encephalopathy,4 5
which may follow a blast
injury or repeated sports related concussion.
However, despite this growing literature on the
cognitive consequences of mild traumatic brain
injury, our knowledge of risk factors that predis-
pose people to sustaining such injury is limited.
In a linked paper, Nordström and colleagues
examine the associations and temporal associa-
tions between a history of concussion, cognitive
function, academic achievement, and measures
of social wellbeing in a cohort of more than
300000 Swedish conscripts.6
Given the paucity
of data on premorbid neurocognitive testing in
traumatic brain injury, this paper draws on an
impressivelylargedatasetthatallowscomparison
of neurocognitive function before and after such
injury in a nationwide cohort of Swedish men.
The results complement an earlier study from
the same group, which examined the association
between cognitive performance and incidence
of a subdural haematoma.That study concluded
that low global intelligence in adolescence was
a risk factor for subsequent development of a
subdural haematoma.
Although the current study investigates a
more common diagnosis, case ascertainment
was probably less precise than the more clearly
definable endpoint of subdural haematoma.
The case ascertainment of “concussion” that
the authors used was based on the International
Classification of Diseases and probably repre-
sents the best epidemiological approximation
achievable in the administrative databases that
were searched. However, a substantial propor-
tion of patients with mild traumatic brain injury
are never admitted to hospital or seen in the
outpatient setting. Therefore, this study prob-
ably underestimated the incidence of this con-
dition in the study population. Conversely, the
approaches used may not have fully excluded
subjects who sustained a moderate or severe
injury. Cross correlating multiple sources of data
could mitigate against this source of confound-
ing, which is common when administrative data-
sets are analysed.8
Despitethesecaveatsrelatedtocaseascertain-
ment,Nordströmandcolleagues’studyprovides
unique insights into the epidemiology of mild
traumatic brain injury. Unsurprisingly, poor cog-
nitivefunction,loweducationalstatus,andother
risk factors were associated with mild traumatic
brain injury. However, surprisingly, the associa-
tion between cognitive function and concussion
did not depend on the temporal association
between the two and was just as common when
poor cognitive performance preceded concus-
sion. In addition, similar cognitive scores were
seen before and after injury in twins discordant
for mild traumatic brain injury, which suggests
that both genetic and environmental influences
contributed to the low cognitive function found.
Other strong independent (but not unexpected)
risk factors for development of mild traumatic
braininjuryincludedapreviousepisodeofbrain
injury, hospital admission for intoxication, and
low education and socioeconomic status. Sur-
prisingly,theanalysisfoundnosignificantdiffer-
ences in cognitive performance before and after
the index event in men who sustained an injury.
These results are important for several rea-
sons. Firstly, they identify potential risk factors
for mild traumatic brain injury and could help
guide attempts to investigate prevention strate-
gies, perhaps through education initiatives (par-
ticularly in accessible populations such as the
military conscripts investigated here). Secondly,
they provide a context for interpreting studies
that measure cognitive function after injury only
and compare it with matched controls from the
general population, with the assumption that
those with brain injury have similar pre-injury
characteristics to the general population. The
results of this study suggest that such assump-
tions may be incorrect. Finally, those who subse-
quently sustained a mild traumatic brain injury
had similar cognitive performance to that of
those who had previously sustained such an
injury, which implies that the injury itself may
not reduce cognitive function. However, the tests
used (word recollection; visuospatial geometric
perception; logical and inductive performance;
and mathematical and physics problem solving)
have not been validated as sensitive measures
of changing performance in cognitive areas
thought to be affected by mild traumatic brain
injury. These tests may therefore have missed
important changes.
It is important that additional studies attempt
to replicate these findings. Suitable populations
for such studies include other military cohorts
and cohorts of people who practise contact
sports, which are associated with a relatively
high incidence of mild traumatic brain injury.
Such studies must take account of “gaming”
by soldiers and sportspeople, who allegedly
choose to perform suboptimally on pre-injury
cognitive screening to hide evidence of any post-
injury cognitive decrement, thus enabling them
to stay with their units and teams. Although it
may not be easy to control for such confounding,
more studies like the current one will increase
our understanding of the epidemiology, patho-
physiology, and outcome impact of traumatic
brain injury.
peer reviewed.
bmj.com Neurology updates from BMJ Group are at
www.bmj.com/specialties/neurology
Poor cognitive performance linked to concussion
JAMESDAVIES/ALAMY

EDITORIALS
Regulating the NHS market in England
The government must make its intentions clear as it rewrites the regulations on competition
ChrisHamchiefexecutive,King’sFund,LondonW1G0AN,
UK C.Ham@kingsfund.org.uk
The government’s draft regulations on procure-
ment, patient choice, and competition, pub-
lished in February, have opened up old wounds
in the debate about NHS reform. The regulations
set out in detail how commissioners should pro-
cure NHS services under section 75 of the Health
and Social Care Act 2012. The stated aim of the
regulations, which will be enforced by Monitor
as the economic regulator, is to ensure that the
NHS Commissioning Board and clinical commis-
sioning groups act to protect patients’ rights and
to prevent anti-competitive behaviour.1
The government claims that the regulations
follow from commitments given during the
passage of the 2012 act and are consistent
with the “Principles and rules for cooperation
and competition” put in place by the previous
administration. Its critics contend that they go
much further and represent a major extension
of market principles in the NHS. In this they
are supported by legal advice, which argues
that commissioners of NHS services will be
expected to make greater use of tendering, with
competition becoming “the norm for placing
NHS contracts.”2
The government’s critics comprise general
practitioner leaders who are worried that clini-
cal commissioning groups will have to use ten-
dering to procure all services; Liberal Democrat
MPs and peers who fear this will make it more
difficult to promote integrated care; and oppo-
sition politicians who interpret the regulations
as confirmation that ministers are hell bent on
opening the NHS up to the private sector. In
the face of these concerns, the government has
announced that it will amend the regulations
to ensure that they are not open to misinterpre-
tation. Statements made by ministers indicate
that this means commissioners will not have to
tender all services, Monitor will not force com-
missioners to tender competitively, and compe-
tition will not take precedence over cooperation
and integration.3
The decision to make these changes less than
a month before the provisions of the 2012 act
come into effect is embarrassing for the govern-
ment. It reflects both the influence of the Liberal
Democrats within the coalition and the need to
retain the support of GP leaders, who will play
a key role in the work of clinical commission-
ing groups. If these leaders had walked away at
this stage, the edifice on which the reforms are
based might well have crumbled to the ground
even before it had come into being.
Underlying the debate about the precise
wording of the regulations is the more impor-
tant question of the government’s intentions
regarding the role of markets in the NHS. On
this question there is room for legitimate doubt
in the light of the debate on the 2012 act and the
amendments made after the work of the NHS
Future Forum. Particularly important was the
change to Monitor’s role from an original duty
to promote competition to a revised duty to pro-
tect and promote the interests of people who use
healthcare services, and in so doing to prevent
anti-competitive behaviour.
These amendments may have watered down
Andrew Lansley’s ambitious plans to apply
market principles to the NHS, but the architec-
ture of economic regulation set out in part 3 of
the 2012 act remains in place. A key element in
this architecture is the role that the Office of Fair
Trading (OFT) and the Competition Commission
will play in the future NHS. In the debate about
the regulations, the involvement of the OFT in
assessing the proposed merger of two NHS foun-
dation trusts in the south of England has gone
largely unnoticed. The OFT is also investigating
the proposed merger of an NHS foundation trust
and an NHS trust in Torbay, which is designed
to bring about closer integration of services in
an area well known for its innovative approach
to the care of older people.
The question this raises is whether this kind
of market regulation is needed in the NHS in
addition to the new role of Monitor? There are
many differences between healthcare and the
industries that OFT and the Competition Com-
mission regulate, and there is a danger that
regulators with experience in other sectors will
adopt an approach that is not sensitive to these
differences. Overexuberant regulation of merg-
ers could delay the implementation of service
changes that may benefit patients—for example,
by preventing the full integration of care as is
being proposed in Torbay.
It is worrying that fundamental questions of
this kind are unresolved so close to the date of
implementation of the reforms. Evidence that
competition in healthcare is beneficial is both
equivocal and contested.4 5
Even where benefits
can be delivered, these have to be set against the
considerable transaction costs involved in con-
tract negotiations between commissioners and
providersandtheworkoftheregulators.Thewell
knownlimitstomarketsinhealthcaremeanthat
planning, collaboration, and clinical networks6
should also play a major role in bringing about
improvements in care.
Wheremarketsareused,regulatorsneedtobe
sensitive to the different forms of competition in
healthcare. Competition in the market has a role
in situations where patients have the time and
inclinationtodecidewheretoobtaintreatment—
for example, when receiving planned care. Com-
petition for the market should be the preferred
approach when commissioners want different
providers to work together under long term con-
tracts to deliver integrated urgent care and care
for groups such as older people and those with
complex needs.7
A nuanced approach that com-
bines the right kind of competition alongside
planning, collaboration, and clinical networks,
where appropriate, is most likely to deliver the
desired results.
If GP leaders and Liberal Democrats are to
withdraw their opposition, the government
needs to provide reassurance on its intentions
with regard to regulating the NHS market. To
avoiddoubt,ministersmustbeexplicitaboutthe
place of markets in the NHS, including the role
of the OFT and Competition Commission, when
they publish the revised regulations. Without
absoluteclarityonthesequestions,thereisarisk
ofuncertaintyandmisinterpretationbythecom-
missionersandregulatorstaskedwithmakingthe
regulations and the 2012 act work in practice.
There is also every possibility that old wounds
will not heal and will cause even deeper rifts
within the coalition, which will create politi-
cal difficulties for the government as well as
unwelcome confusion for the NHS.
peer reviewed.
Underlying the debate about the precise wording of the
regulations is the much more important question as to the
government’s intentions on the role of markets in the NHS

EDITORIALS
The new UK antimicrobial resistance strategy and action plan
A major societal, political, clinical, and research challenge
New challenges will include screening (by rec-
tal swab) and isolation of any patient admitted to
the NHS who has received inpatient care outside
the UK, with rigorous control of any outbreaks
of multidrug resistant infection inside the NHS.
Acute trusts and their boards will need to con-
sider how to strengthen infection prevention and
control practice using new methods of organisa-
tional and behavioural change.
Antimicrobial prescribing needs to be more
evidence based and more efficiently targeted.
New NHS initiatives to provide antimicrobial
stewardship guidance in secondary care (Start
Smart then Focus) and primary care (TARGET
antimicrobial toolkit)8
need to develop into more
formal quality indicators.
This strategy makes the UK the first country to
explicitlyannounceitsintentiontodevelopnational
outcomemeasuresinAMRusingspecificdrug-bug
combinationresistancerates(forexample,ratesof
Ecoliresistancetothirdgenerationcephalosporins).
Thisisabravemoveandshouldbewelcomed.The
chief medical officer has taken a clear leadership
rolebytacklingtheinternationaldimensionsofthe
problem,addingAMRtotheDepartmentofHealth
riskregisterandcallingforAMRtobeaddedtothe
nationalriskregister(NationalSecurityRiskAssess-
ment)topromotecrossgovernmentaction.Impor-
tantareasthatwillbecoveredincludeantimicrobial
useinanimalsandnewinitiativestoencouragethe
developmentofnovelantimicrobials.1
The wider application of molecular microbiol-
ogy, particularly whole genome sequencing, to
detectclonalspreadofMDRGramnegativebacteria
within hospitals is providing a rapid explosion of
new data. It is still unclear if this will lead to effec-
tive new control policies. The research agenda is
extensive,buttheNHSinformationtechnologyand
National Institute of Health Research infrastruc-
tures are well placed to provide global leadership
in this area.9
New technology focusing on rapid
diagnosisofspecificbacteriaandresistancegenes,
along with combination biomarkers indicating
bacterial or viral infections, especially if adapted
to near patient testing, could have a major impact
on targeting appropriate antibiotic treatment.
Improved surveillance by Public Health England,
using large dataset linkage combined efficiently
withobservationalstudiesfocusedonclinicalout-
comes, including all infection related deaths, will
alsohelptodefinenewtargetsforintervention.
Competinginterestsareintheversiononbmj.com.
Provenanceandpeerreview: Not commissioned; externally
peer reviewed.
Referencesare in theversion on bmj.com.
AnthonySKesselhonoraryprofessor,FacultyofPublic
HealthandPolicy,LondonSchoolofHygieneandTropical
Medicine,London,UK
MikeSharlandprofessorinpaediatricinfectiousdiseases,
PaediatricInfectiousDiseasesResearchGroup,StGeorge’s
UniversityLondon,LondonSW170RE,UK
mike.sharland@stgeorges.nhs.uk
This week the chief medical officer highlighted in
her report how the rise of antimicrobial resistance
(AMR) poses a threat to healthcare delivery in the
United Kingdom.1
This will be followed shortly by
theDepartmentofHealth’snewUKFiveYearAnti-
microbial Resistance Strategy and Action Plan,
whichwillreflecttheneedforaclearchangeinthe
understandingandresponsetoAMRbythepublic,
theNHS,andthegovernmentintheUK.Theriseof
AMR as a serious health threat is due to the inter-
nationalspreadofmultidrugresistant(MDR)Gram
negativebacteria,theglobaloveruseofantibiotics
in humans and animals, and the almost complete
lack of new antibiotic development.2
All of these
arenowofdirectconcerntotheNHS.
The85%reductioninratesofmeticillinresistant
Staphylococcus aureus (MRSA) bloodstream infec-
tions seen in England between 2003 and 2011
has been remarkable. MRSA is now responsible
for less than 2% of all bloodstream infections in
England. Less remarked on has been the inexora-
ble rise in the number of bloodstream infections
attributable to Gram negative organisms (particu-
larly Escherichia coli), which now comprise more
thanhalfofthearound100000oftheseinfections
reported in England annually.3
Most large NHS
hospitalsnowidentify50-100timesmorepatients
with Gram negative bloodstream infections than
those with MRSA, with antibiotic resistance rates
of10-20%andmortalityratesof30%reportedfor
MDR forms.4
In England the successful introduc-
tion of conjugate pneumococcal vaccine means
thatthenumberofreportedKlebsiellapneumoniae
bloodstream infections in England is now higher
thanforStreptococcuspneumoniae.
InmanyEuropeancountriesAMRratesaremuch
worse.In2011theEuropeanCentreforDiseasePre-
ventionandControlreportedasignificantincrease
inmultidrugresistantEcoliandKpneumoniae(for
example, resistance to third generation cepha-
losporins,fluoroquinolones,andaminoglycosides)
inmorethanathirdofEuropeanUnion/European
Economic Area countries.5
Klebsiella is an impor-
tantpathogeninthespreadofresistance.Manyanti-
bioticresistancegenesgrouptogetherinplasmids
easilytransferredbetweenbacteria,withparticular
clonescarryingmultipleresistancegenes(forexam-
ple,OXA-48andCTX-M15).ManyEUcountriesare
nowreportingKlebsiellaMDRratesof25-40%.
Globally, rates of MDR Gram negative bacterial
infection can be even higher.6
This has inevita-
bly led to a rapid rise in the use of carbapenem
antibiotics (for example, meropenem) as empiri-
cal treatment for suspected sepsis. In turn, this
has led to a rapid increase in hospital outbreaks
of carbapenemase producing organisms, which
are usually sensitive to only one or two older less
effectiveantibiotics.IntheUK,therehasalsobeen
a sharp rise in meropenem use and increasing
reports of carbapenemase producing organisms.
Only one or two new antibiotics that target Gram
negative organisms are likely to be marketed in
the next decade (http://antibiotic-action.com),
whichraisestheconcernthatvirtuallyuntreatable
infections will threaten routine NHS care.7
ThenewUKstrategyisanimportantstepinrec-
ognising and responding to these concerns. At its
core the strategy recognises that AMR, infection
preventionandcontrol,andantimicrobialsteward-
shiparecloselyinterconnectedandallneedtobe
strengthened.Thesevenaims(table)reflectthatall
individuals and organisations have unique roles
and responsibilities. Enhanced infection preven-
tionandcontrolarecrucialtolimitingthespreadof
MDRGramnegativebacteria,bothintoandacross
theNHS.
UKantimicrobialresistancestrategy:sevenaction
areasandlikelystakeholderinvolvementinthe
healthsector
Sevenkeyareasoffocus Stakeholders
Promoteresponsibleevidence
basedprescribing
Individualprescribers,NHS
providers,nationalandlocal
commissioningboards,
ARHAI,PHE,Departmentof
Health,professionalbodies
Improveinfectionprevention
andcontrol
Individualclinicalstaff,NHS
providers,nationalandlocal
commissioningboards,
ARHAI,DepartmentofHealth,
PHE,professionalbodies
Raisepublicandprofessional
awarenessofantimicrobial
resistancethreatandpromote
behaviourchange
Professionalbodies,
DepartmentofHealth,
ARHAI,patientgroups
Researchprogrammeintonew
diagnostics,alternativesto
antibiotics(suchasantiseptics),
pathogenesis,effective
behaviouralchangetoimprove
infectionpreventionandcontrol
andprescribingpractice
NIHR,universities,
DepartmentofHealth,ARHAI
Facilitatedevelopmentofnew
antimicrobials,vaccines,and
immunomodulators
DepartmentofHealth,drug
industry,EuropeanUnion
Improvesurveillanceanddata
linkage
PHE,ARHAI,Departmentof
Health
Encourageinternational
collaborationanddatasharing
andlearningfrombestpractice
internationally
DepartmentofHealth,PHE
ARHAI=Department of Health Expert Advisory Committee on
Antimicrobial Resistance and Healthcare Associated Infection;
PHE=PublicHealthEngland.NIHR=NationalInstituteforHealthResearch.

TheBMJisanOpenAccessjournal.WesetnowordlimitsonBMJresearcharticles,butthey
areabridgedforprint.ThefulltextofeachBMJresearcharticleisfreelyavailableonbmj.com
Scan this image with your
smartphone to read our
instructions for authors
RESEARCH
RESEARCH NEWS
RESEARCH NEWS All you need to read in the other general medical journals Alison Tonks, associate editor, BMJ atonks@bmj.com
violencehasleftuswithoutthemeanstofindout.
These authors did what they could with the data
available,butthedataarewoefullyinadequatein
the face of an epidemic of gun violence that has
killed more than 300000 US citizens since 2001
and seems to be intensifying. No more than a
handful of researchers are currently working in
the field, thanks to a concerted political effort by
the National Rifle Association in the early 1990s,
says the editorial. Research must resume now, to
deepen our understanding of this complex prob-
lemandfindwaystofixit.
JAMA Intern Med 2013; doi:10.1001/
jamainternmed.2013.1286
Six women pilot deep brain
stimulation for anorexia nervosa
Six women with intractable and life threatening
anorexia nervosa have been treated with deep
brain stimulation in a preliminary study from
Toronto, Canada. Doctors selected the women for
deepbrainstimulationaftermanyyearsofunsuc-
cessful conventional management. They had
average body mass indices (BMIs) of 11 to 15 in
theyearsleadinguptothestudy,accompaniedby
multiplemedicalcomplicationsofchronicstarva-
tion.Fivehadpsychiatriccomorbidities,mostoften
major depression and obsessive compulsive
disorder.
Surgeons placed electrodes just beneath the
corpus callosum. One patient had a self limiting
panic attack during the local anaesthetic phase
of the procedure and one developed a cardiac air
embolusthatresolvedwithinfiveminutesafterthe
operating table was repositioned. A third patient
had a seizure during device programming two
weeksaftertheprocedure.Itwasswitchedoffthen
restartedoneweeklaterwithnofurtherproblems.
Three of the six women gained weight during
nine months of stimulation (BMIs increased from
11.1 to 21, 14.2 to 16, and 15.1 to 20). They also
reportedimprovedqualityoflife.Symptomscores
measuring mood, anxiety, and anorexia nervosa
related obsessions and compulsions improved in
fourpatients.
The pilot was designed to assess safety, not
effectiveness. The authors judge deep brain stim-
ulationtobesafeenoughforfurtherevaluation.
Lancet2013;doi:10.1016/S0140-6736(12)62188-6
Treating depression after acute
coronary syndrome
Depression is common after hospital admission
for acute coronary syndrome and international
guidelines recommend screening and treat-
ment. A recent trial tested a programme of care
that allowed people with depression symptoms
to choose between psychotherapy, antidepres-
sant drugs, or a combination of the two. The
programme worked well, reducing symptoms
significantlymorethanusualcareoversixmonths
(anextra3.5pointdropinBeckdepressioninven-
toryscore,95%CI−6.1to−0.7).
All 150 participants had symptoms of
depression two to six months after treatment for
acutecoronarysyndrome.Among73assignedto
the new programme, 41 chose psychotherapy,
nine chose drugs, and 17 chose the combina-
tion. Their care was organised by a remote team
of mental health professionals who met once a
weektodiscusscasesandadvisealocaldoctoror
nurseprescriber.Acentralisedteamalsoprovided
psychotherapy(problemsolvingtherapy)overthe
telephoneorbyvideolinkandfollowedastepped
carealgorithmthatintensifiedtreatmenteverysix
toeightweeksifrequired.
This programme contained all the elements
known to work from previous trials and intro-
duced the idea that organisation, coordination,
and support does not have to be local to be suc-
cessful, says a linked comment (doi:10.1001/
jamainternalmed.2013.925).
JAMA Intern Med 2013;doi:10.1001/
jamainternalmed.2013.915
“Whole mummy” scans conﬁrm
ancient atherosclerosis
An international team of researchers has found
clear evidence of atherosclerosis among 137
mummies from diverse ancient cultures. Com-
puted tomography showed vascular calcification
in 29 of 76 mummies from ancient Egypt, 13 of
51fromancientPeru,twooffivemummiesfroma
PuebloanpeoplewholivedinsouthwestAmerica
between 1500 BC and AD 1500, and three of five
mummies from a population of hunter gatherers
who lived more recently on remote islands 500
milesoffmoderndayAlaska.
Overall,athirdofthemummiesexaminedhad
definite or probable atherosclerosis in at least
one vascular bed, usually more. Two mummies
had disease in all five vascular beds—an ancient
Egyptianprincess,Ahmose-Meritamun,whodied
in early middle age, and a slightly older woman
fromtheAleutianislandswhowouldhavebeena
huntergatherereatingmainlyfishandshellfish.
The researchers and a linked comment agree
thatatherosclerosisisnotasmodernaswethinkit
is (doi:10.1016/S0140-6736(13)60639-X). Sim-
ilar disease was common in geographically and
culturally different populations that spanned at
least4000yearsofhumanhistory.
Lancet 2013; doi:10.1016/S0140-6736(13)60598-X
Stronger gun laws, fewer deaths
US states with the strongest gun laws have the
lowest rates of death caused by firearms, accord-
ing to a nationwide cross sectional analysis. The
authors ranked 50 states using a score of legis-
lative strength that counted then weighted gun
controllawsuptoamaximumscoreof28.States
inthehighestquarter,suchasMassachusettsand
Illinois, had 6.6 fewer deaths per 100000 each
year than states in the lowest quarter, such as
LouisianaandUtah(incidentrateratio0.58,95%
CI0.37to0.92).Thedifferencesurvivedmultiple
adjustments for state demographics, including
poverty and population density.
Didguncontrolsavethoseextralives?It’simpos-
sible to say, says a linked editorial (doi:10.1001/
jamainternmed.2013.1292). The systematic and
deliberateerosionoffundingforresearchintogun
Adapted from JAMA Intern Med 2013; doi:10.1001/jamainternmed.2013.1286
Legislative strength and mortality by state
2.9-8.0 8.1-10.1 10.2-13.0 13.1-18.0
III
III
III III
III
III
III
III
III
I
I
I
I
II
II
II
II
III
III
III
III
II
II
II
II
II
II
I
I
I
I
I
I
I I
I
IIV
IV
IV
IV
IV
IV
IV
IV
IV
IV
IV
IV
I
II
Hawaii
Mortality rate per 100 000, mean
First quarter: 0-2 laws
Second quarter: 3-4 laws
Third quarter: 5-8 laws
Fourth quarter: 9-24 laws
Legislative strength score, median
Alaska
IV
I
I

RESEARCH
Correspondenceto:PBower,NIHR
SchoolforPrimaryCareResearch,
ManchesterAcademicHealth
ScienceCentre,Universityof
Manchester,Manchester
M139PL,UK
peter.bower@manchester.ac.uk
doi:10.1136/bmj.f540
Detailsofthe authors’ affiliations
are given in the fullarticle on bmj.
com
Thisisa summaryofa paper that
waspublishedon bmj.com asBMJ
2013;346:f540
STUDY QUESTION Do patientswith more severe depression
benefitlessfrom “low intensity” psychologicaltherapythan
those with milder depression?
SUMMARY ANSWER No, patientswith more severe
depression show atleastasmuch clinicalbenefitfrom low
intensityinterventionsaslessdepressedpatients.
WHAT IS KNOWN AND WHAT THIS PAPER ADDS
To better manage the high prevalence ofdepression in the
community, manyservicesseekto provide simple forms
ofpsychologicaltherapy(low intensityinterventions), but
whether patientswith more severe depression are suitable
for such interventionsisnotknown.We foundno clinically
meaningfuldifferencesin treatmenteffectsbetween
more andlessseverelyillpatientsreceiving low intensity
interventions.
SELECTION CRITERIA FOR STUDIES We searched
published systematic reviews, updated with a search of
the Cochrane Library, for randomised controlled trials
of low intensity interventions (such as interventions
provided through written materials or the internet with
limited professional support) in patients with depression.
Primary outcome(s)
Our primary outcome was the relation between initial
depression severity (measured with the Beck Depression
Inventory or Center for Epidemiologic Studies Depres-
sion Scale) and the amount of clinical benefit (change in
depression score) that patients received from low intensity
interventions.
Main results and role of chance
We used individual patient data from 16 trials including
2470 patients. We found a significant interaction between
baseline severity and treatment effect (coefficient −0.1
(95% CI −0.19 to −0.002)), suggesting that patients who
are more severely depressed at baseline demonstrate
larger treatment effects from low intensity interventions
than those who are less severely depressed. However, the
magnitude of the interaction was small and may not be
clinically significant.
Bias, confounding, and other reasons for caution
We were unable to access all published data on low inten-
sity interventions, obtaining individual patient data from
just over half of the 29 eligible studies. Although we found
no clinically meaningful differences in treatment effects
between more and less severely ill patients receiving low
intensity interventions, patients with more severe depres-
sion are more likely to continue to show clinically signifi-
cant levels of distress after low intensity treatments and
may require additional care.
Study funding/potential competing interests
The study was funded as part of the UK National Insti-
tute of Health Research (NIHR) School for Primary Care
Research. BM is an employee of GAIA AG, Hamburg, which
owns one of the low intensity interventions considered in
this paper. PB has been a paid consultant to the British
Association for Counselling and Psychotherapy.
Influence of initial severity of depression on effectiveness of low
intensity interventions: meta-analysis of individual patient data
Peter Bower, Evangelos Kontopantelis, AlexSutton, Tony Kendrick, David A Richards,
Simon Gilbody, Sarah Knowles, Pim Cuijpers, Gerhard Andersson, Helen Christensen,
Björn Meyer, Marcus Huibers, Filip Smit, Annemieke van Straten, Lisanne Warmerdam,
Michael Barkham, Linda Bilich, Karina Lovell, EmilyTung-Hsueh Liu
Interactions between baseline severity of depression and
effect of low intensity interventions
CBT=cognitive behavioural therapy; TAU=treatment as usual;
PST=problem solving therapy; Edu=education
Mead 2005
Willemse 2004
Warmerdam 2008 CBT
Warmerdam 2008 PST
Lovell 2008
Christensen 2004 CBT
Christensen 2004 Edu
Van Straten 2008
Meyer 2009
Richards 2003
Andersson 2005
Vernmark 2010
De Graaf 2009 CBT+TAU
De Graaf 2009 CBT
Liu 2009
Bilich 2008
Overall effect
Pooled coefficient
-0.1 (-0.19 to -0.002)
-1.0 -0.5 0 0.5 1.0 1.5
Effect size (95% CI) for interaction effect
bmj.com Psychiatry updates from BMJ Group are at www.bmj.com/specialties/psychiatry

RESEARCH
STUDYQUESTIONDorandomisedtrialsinlessdeveloped
countriesgivedifferentresultsfromthoseinmoredeveloped
countriesand,ifso,towhatextent?
SUMMARYANSWERRandomisedtrialsfromlessdeveloped
countriesoccasionallyshowsignificantlydifferenttreatment
effectsfromthosefrommoredevelopedcountries,andon
averagetreatmenteffectsaremorefavourableintheless
developedcountries.
WHATISKNOWNANDWHATTHISPAPERADDS
Anincreasingnumberoftrialsareperformedinlessdeveloped
countrieswithnolongstandingtraditionofclinicalresearch.
Discrepanciesintreatmenteffectsbetweentrialsfrommore
developedversuslessdevelopedcountriesmayoftenreflect
biasesaswellasgenuinedifferencesandshouldbetakeninto
accountwhengeneralisingevidenceacrossdifferentsettings.
Selection criteria for studies
Ameta-epidemiologicalassessmentwasperformedoftrials
from less and more developed countries identified through
the Cochrane database of systematic reviews. We selected
Cochranemeta-analyseswithmortalityoutcomesincluding
quantitative data from at least one randomised trial from a
less developed country and at least one trial from a more
developedcountry.Foreachmeta-analysiswecomparedthe
relative risk estimates of more developed versus less devel-
opedcountriesbycalculatingtherelativerelativerisk(RRR)
foreachtopicandthesummaryrelativerelativerisk(sRRR)
across all topics. Additionally, we performed similar analy-
ses for the primary binary outcome of each eligible topic.
Primary outcome
The primary outcome of the current study was the discrep-
ancyineffectestimatesonmortalitybetweentrialsfromless
developed and more developed countries.
Main results and role of chance
139 meta-analyses with mortality outcomes were eligible.
No nominally significant differences between the country
types were found for 128 (92%) meta-analyses. However,
differences were beyond chance in 11 (8%) cases (ante-
natal corticosteroids, preventive antioxidants, admissions
to hospital for bed rest in multiple pregnancy, steroids in
sepsis, antioxidants for the prevention of gastrointestinal
cancer, antifungals for critically ill patients, postopera-
tive radiotherapy for non-small cell lung cancer, calcium
antagonists in aneurysmal subarachnoid haemorrhage,
intravenous immunoglobulin for preventing infection in
preterm or low birthweight infants, transarterial emboli-
sation in unresectable hepatocellular carcinoma, and
altered fractionation radiotherapy for oral cavity and
oropharyngeal cancer), always showing more favourable
treatment effects in trials from less developed countries.
The sRRR was 1.12 (95% confidence interval 1.06 to 1.18;
P<0.001; I2
=0%), suggesting significantly more favourable
mortality effects in trials from less developed countries.
Results were similar when focusing on meta-analyses
with nominally significant treatment effects for mortality
(sRRR 1.15), excluding meta-analyses of old trials (1.14),
and excluding trials from less developed countries subse-
quently becoming more developed (1.12). For the primary
meta-analysis binary outcomes (127 eligible meta-anal-
yses), 20 topics had differences in treatment effects in
more developed versus less developed countries beyond
chance (more favourable in less developed countries in
15/20 cases).
Publication bias or selective analysis and outcome report-
ing biases may be influential in shaping these findings. A
higher barrier to publication for authors from less devel-
oped countries with no longstanding tradition in clinical
research may further boost selective reporting. Large, well
conducted trials are needed to probe the claims for coun-
try specific major benefits and they may show that many of
these claims are spurious. Moreover, differences in treat-
ment effects between less developed and more developed
countries may also be due to genuine differences rather
than to biases. Low income and middle income countries
face substantial financial barriers to their total healthcare
budget, which may limit the implementation of expensive
interventions. However, we did not identify any discrepan-
cies where the implicated intervention was expensive or
difficult to administer and its efficacy may have depended
largely on sophisticated background standards of care.
Nevertheless, differentiating between bias and genuine
differences in baseline risks or treatment implementa-
tion might be difficult. These concerns should be taken
into account when generalising evidence across different
settings.
Comparative effect sizes in randomised trials from less developed
and more developed countries: meta-epidemiological assessment
Orestis A Panagiotou,1
Despina G Contopoulos-Ioannidis,2 3
John P A Ioannidis4 5
1
ClinicalTrialsandEvidence-
BasedMedicineUnit,Department
ofHygieneandEpidemiology,
UniversityofIoanninaSchoolof
Medicine,UniversityCampus,
Ioannina,Greece
2
DivisionofInfectiousDiseases,
DepartmentofPediatrics,Stanford
UniversitySchoolofMedicine,
Stanford,CA,USA
3
HealthPolicyResearch,PaloAlto
MedicalFoundationResearch
Institute,PaloAlto,CA,USA
4
StanfordPreventionResearch
Center,DepartmentofMedicine
5
DepartmentofHealthResearch
andPolicy,StanfordUniversity
SchoolofMedicine,Stanford,CA
94305,USA
Correspondenceto: J P A Ioannidis
jioannid@stanford.edu
doi:10.1136/bmj.f707
2013;346:f707
Statisticallysignificantdifferencesintreatmenteffectsonmortalitybetweentrialsfromless
developedandmoredevelopedcountries
Topic
Experimental
intervention Outcome
Relativerelativerisk
(95%CI)formorevless
developedcountries
Antenatalpreventioninpretermbirth Corticosteroids Fetalandneonataldeaths 2.08(1.30to3.33)
Antioxidantsupplementsforprevention Antioxidants Mortality 1.13(1.01to1.27)
Multiplepregnancy Admissionto
hospitalforbedrest
Perinataldeath 4.42(1.03to18.99)
Treatmentofsepsisandsepticshock Corticosteroids Allcausemortalityat28days 2.58(1.01to6.63)
Preventionofgastrointestinalcancers Antioxidants Mortality 1.15(1.03to1.29)
Non-neutropeniccriticallyillpatients Systemicantifungals Mortality 3.18(1.08to9.40)
Treatmentofnon-smallcelllung
cancer
Postoperative
radiotherapy
Mortality 1.61(1.03to2.53)
Aneurysmalsubarachnoid
haemorrhage
Calciumantagonists
alone
Casefatality 5.73(1.13to28.3)
Preventionofinfectioninpretermor
lowbirthweightinfants
Intravenous
immunoglobulin
Allcausemortality 1.93(1.01to3.66)
Unresectablehepatocellular
carcinoma
Transarterial(chemo)
embolisation
Allcausemortality 1.76(1.05to2.97)
Oralcavityandoropharyngealcancer Alteredfractionation
radiotherapy
Totalmortality 1.60(1.03to2.48)

RESEARCH
Features of effective computerised clinical decision support
systems: meta-regression of 162 randomised trials
PavelS Roshanov,1
Natasha Fernandes,2
Jeff M Wilczynski,3
Brian J Hemens,4
John J You,4 6 7
Steven M Handler,5
Robby Nieuwlaat,4 5
Nathan M Souza,4
Joseph Beyene,4 5
Harriette G CVan Spall,6 7
Amit X Garg,4 8 9
R Brian Haynes4 7 10
STUDY QUESTION
Whatcharacteristicsdifferentiate computerisedclinical
decision supportsystemsthatsuccessfullyimprove clinical
care or patientoutcomesfrom those thatdo not?
SUMMARY ANSWER
Presenting advice within electroniccharting or order
entrysystemsisnotsufficientto derive clinicalbenefit
andisassociatedwith failure, perhapsfrom alertfatigue.
Demanding reasonsfrom cliniciansbefore theycan over-
ride advice andalso providing recommendationsto patients
mightimprove chancesofsuccess.
WHAT IS KNOWN AND WHAT THIS PAPER ADDS
Computerisedclinicaldecision supportsystemsoften fail
to improve the processofcare andare even lesslikelyto
improve patientoutcomes. Our studyfoundthatpresenting
decision supportwithin electroniccharting or order entry
systemsisnotsufficientto derive clinicalbenefitandis
associatedwith failure. Demanding reasonsfrom clinicians
before theycan over-ride electronicadvice andproviding
advice to patientsandcliniciansmightimprove chances
ofsuccess. Mostevaluationshave been conductedbythe
developersofthe systemsandsuch evaluationsare more
likelyto show benefitthan those conductedexternally.
Studies and setting
Wecreatedadatabaseofcharacteristicsandeffectivenessof
computerised support systems in 162 randomised control-
led trials from a recent systematic review.
Design
In this cross sectional study, we conducted logistic regres-
sionanalysestodeterminetheassociationbetweencharac-
teristicsandeffectivenessofcomputerisedclinicaldecision
support systems. We used several statistical methods for
sensitivity analysis.
Primary outcomes
We defined effectiveness as a significant difference in
favour of the system over control for process of care (such
as adherence to prescribing recommendations) or patient
outcomes (such as reduction in blood pressure, mortal-
ity). In a multivariable model, we looked for associations
between system effectiveness and whether the system pro-
vided advice that was automatically within clinical work-
flow, given at the time of care, presented in an electronic
charting or order entry system, required reasons to be given
for over-riding advice, and was also given to patients, and
whether some of the study’s authors were also the system’s
developers.
Main results and the role of chance
Computerisedclinicaldecisionsupportsystemspresenting
advice in electronic charting or order entry interfaces were
less likely to succeed than their counterparts (odds ratio
0.37, 95% confidence interval 0.17 to 0.80). Systems more
likely to succeed than their counterparts provided advice
forpatientsinadditiontopractitioners(2.77,1.07to7.17),
required practitioners to give a reason when over-riding
advice (11.23, 1.98 to 63.72), or were evaluated by their
developers (4.35, 1.66 to 11.44).
Thoughourstudywasbasedondatafromrandomisedcon-
trolled trials, our analyses were observational. We did not
find significant associations for the remaining 17 factors
testedinexploratoryanalysesbutcannotruleoutconfound-
ing by factors that we could not test directly, such as leader-
shipandacultureofqualityimprovement.Ourfindingswere
generally robust across different statistical methods and in
internalvalidation,buttheestimatesofeffectwereimprecise.
Additionalstudiesareneeded—ideallyrandomisedcontrol-
ledtrialsdirectlycomparingdifferentfeatures.
Generalisability to other populations
Commercial products represent only 21% of systems tested
inourtrialsbutwillaccountfornearlyallsystemsclinicians
willuse.Whilewefoundnoassociationbetweencommercial
status and success, we did not have sufficient data to test
interactionsbetweencommercialstatusandsystemfeatures
and cannot determine if the associations we discovered are
generalisabletocommercialproducts.Overathird(37%)of
trials were conducted at institutions with an academic his-
tory in medical informatics, but we found no link between
thisandeffectiveness.
1
SchulichSchoolofMedicineand
Dentistry,UniversityofWestern
Ontario,1151RichmondSt,
London,ON,CanadaN6A3K7
2
FacultyofMedicine,Universityof
Ottawa,451SmythRd,Ottawa,ON,
CanadaK1H8M5
3
DepartmentofHealth,Aging,and
Society,McMasterUniversity,1280
MainStW,Hamilton,ON,Canada
L8S4K1
4
DepartmentofClinical
EpidemiologyandBiostatistics,
McMasterUniversity,1280MainSt
W,Hamilton,ON,CanadaL8S4K1
5
DepartmentofBiomedical
Informatics,UniversityofPittsburgh,
Pittsburgh,USA
6
PopulationHealthResearch
Institute,237BartonStE,Hamilton,
CanadaL8L2X2
7
DepartmentofMedicine,McMaster
University,1280MainStW,
Hamilton,ON,CanadaL8S4K1
8
DepartmentofMedicine,
UniversityofWesternOntario,1151
RichmondSt,London,ON,Canada
N6A3K7
9
DepartmentofEpidemiologyand
Biostatistics,UniversityofWestern
Ontario,1151RichmondSt,
London,ON,CanadaN6A3K7
10
HealthInformationResearchUnit,
McMasterUniversity,1280MainSt
W,Hamilton,ON,CanadaL8S4K1
Correspondenceto: R B Haynes,
McMaster University, Department
of Clinical Epidemiology and
Biostatistics, 1280 Main Street
West, CRL-133, Hamilton, Ontario,
Canada L8S 4K1
bhaynes@mcmaster.ca
doi:10.1136/bmj.f657
2013;346:f657
Oddsratios(95%confidenceintervals)andPvaluesforadjustedassociationsbetweeneffectivenessandfeaturesofcomputerised
clinicaldecisionsupportsystems
Factors Prespecifiedmodel(148trials) Finalprimarymodel(150trials)
Developedbyauthors 3.52(1.34to9.27),0.008 4.35(1.66to11.44),0.002
Adviceautomaticallyinworkflow 1.48(0.62to3.52),0.38 —
Adviceattimeofcare 0.61(0.21to1.77),0.35 —
Advicepresentedinelectronicchartingororderentry 0.33(0.14to0.76),0.008 0.37(0.17to0.80),0.01
Providesadviceforpatients 2.54(0.98to6.57),0.05 2.77(1.07to7.17),0.03
Requiresreasonforover-ride 10.69(1.87to61.02),0.001 11.23(1.98to63.72),<0.001
Response on bmj.com
“Can the authors provide a list of
excluded articles? For example,
why was the positive study by
Kucher et al not included?”
Robert G Badgett, physician,
Kansas
Visit the article online and
click “Respond to this article”
to have your say.
bmj.com
Editorial:The road to
effective clinical decision
support: are we there yet?
(BMJ 2013;346:f1616)

BMJ March 2013 magazine

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