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BMJ | 1 JUNE 2013 | VOLUME 346

1 GPs vote against taking back out of hours care
WHO to probe claims that access to novel
coronavirus was restricted
2 Hunt announces plan to make GPs accountable for
out of hours care
Doctors leader calls on Hunt to stop using GPs as
Implementation of NHS 111 has harmed patients,
admits safety chief
A&E crisis is not a result of GPs arrangements
3 Study nds critical care patients suer long term
health and nancial problems
4 Having your elective operation later in the week
increases the risk of dying
Woman with bipolar disorder can abort her baby
5 MP says choice of oseltamivir in u pandemic was
Study links iodine deciency in pregnancy with
lower IQ in kids
6 Spend more on treating hepatitis C, say campaigners
Nicholson to step down as chief executive of NHS
England by March 2014
7 CT radiation risks coming into clearer focus
Aaron Sodickson
8 Should we rethink
the scheduling of
elective surgery at
the weekend?
Janice L Kwan and
Chaim M Bell
9 Corporate involvement in public health policy is
being obscured
Jel Collin and Sarah Hill
10 Managing the health of prisoners
Alex Gatherer
16 The long road to
ensuring patient
safety in NHS
As part of a series
on compensation for
clinical errors, Clare
Dyer looks at elorts,
past and present, to
monitor and prevent
mistakes that harm
19 Promoting health in prison
Prisons contain some of societys most disadvantaged
people. In the last of his series Stephen Ginn looks at
how prison provides opportunities to improve their
health and asks whether earlier intervention could
keep them out of prison in the hrst place


11 All you need to read in the other general journals
12 Cancer risk in 680 000 people exposed to computed
tomography scans in childhood or adolescence:
data linkage study of 11 million Australians
John D Mathews et al
13 Diagnostic accuracy of conventional or age adjusted
D-dimer cut-o values in older patients with
suspected venous thromboembolism:
systematic review and meta-analysis
Henrike J Schouten et al
14 Day of week of procedure and 30 day mortality for
elective surgery: retrospective analysis of hospital
episode statistics
P Aylin et al
15 Derivation and validation of QStroke score for
predicting risk of ischaemic stroke in primary care
and comparison with other risk scores: a prospective
open cohort study
Julia Hippisley-Cox et al
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Tough on criminals health, p 19
Hope in Berwick?, p 16
Worse outcomes, p 8
Saudi criticises coronavirus patent, p 1
BMJ | 1 JUNE 2013 | VOLUME 346
Too much
information and
not enough time?
Soviet TB doctor dies, p 28
22 Telehealth and telecare; Drug combination for
obesity; Calcium and cardiovascular risk
23 Sharing data from clinical trials; Monitoring the
safety of devices; Adulteration of the food chain
24 Slip an extra locust on the barbie?
Tony Delamothe
25 Big Tobacco lights up e-cigarettes
Douglas Kamerow
26 Prots from pregnancy
Margaret McCartney
27 Integrated care is crucial to
prevent abuse
of patients
Billy Boland
28 Mikhail Izrailevich Perelman
Thoracic surgeon and specialist in pulmonary
tuberculosis who operated on Soviet leaders and
criticised WHOs TB programme
29 N Balakumar; John Barnes; Brian Cameron Campbell;
Michael Dean; Donald John Carr Horwood; Pradeep
Natarajan; John Andrew Pickering
39 Bad medicine: epilepsy Des Spence
Is clinical examination dead? Kinesh Patel
30 Diagnosis and management of recurrent urinary
tract infections in non-pregnant women
Kalpana Gupta and Barbara W Trautner
34 Recognition, assessment and treatment of social
anxiety disorder: summary of NICE guidance
Stephen Pilling et al
36 Acute leg ischaemia
Stephen Brearley
38 Quiz page for doctors in training
40 Lupus, and other
Joined up care, p 27
Pneumatosis coli, p 40
BMJ | 1 JUNE 2013 | VOLUME 346
Members of AutistiX, a rock band from north London, all of whom have autism. Currently touring
Spain, the band is about to release its first EP, Butterflies and Demons. Apparently, their disability
protects them from stage fright.
1 June 2013 Vol 346
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There are two interrelated obstacles to
continuity in primary care. The article usefully
highlights onethe tension between access and
continuitythe other is money.
Continuity requires some slack in the system . . .
So, to improve continuity I need to increase the
amount of time I spend being paid to do nothing,
occupying an expensive consulting room.
Highlighting the importance of continuity in
the care of people with multiple problems is a
good start. Next we need evidence about how
different ways of providing continuity compare
as regards both cost and effectiveness, and a
debate about what effects we value.
Louisa Polak, general practitioner and PhD student,
Colchester, UK, in response to Better management
of patients with multimorbidity
(BMJ 2013;346:f2510)
Seeing double: the low carb diet
Implementation of self management support
for long term conditions in routine primary care
settings: cluster randomised controlled trial
Statins and the risk of developing diabetes
Are MOOCs the future of medical education?
Am I missing something in the essay on the
science of obesity?
Our previous poll asked:
Should governments introduce plain packets
for cigarettes?
72% voted yes
(total 1002 votes cast) BMJ lu1!;!/6:f!u69
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BMJ | 1 JUNE 2013 | VOLUME 346
The rate of imprisonment in England, Wales, and
Scotlandat around 15/ per 1uu uuu peopleis one of
the highest in western Europe. While dwarfed by that of
the United States, the so called land of the free, where
roughly one in 1uu people is behind bars, the number of
prisoners in England and Wales has nearly doubled in the
past 2u years, even though recorded crime has fallen. In
the nal article of his ve part series on prison health
(p 19), Stephen Ginn asks whether prison is the right
place for many onenders and whether earlier assistance
in the community might prevent a prison sentence.
As Ginn writes, many of those held in British prisons
come from the most economically deprived and socially
disadvantaged groups within society. He adds: Many
prisoners have chaotic lifestyles and complex health
and social problems. They may also have limited health
aspirations and low expectations of health services,
which may not have the flexibility to respond enectively
to their needs.
Prisons, meanwhile, are vulnerable to infectious
disease because of overcrowding, poor ventilation,
shared facilities, and a high turnover of prisoners, stan,
and visitors. They have higher rates of tuberculosis,
hepatitis B, and HIV infection than in the outside
population, and very high levels of illegal drug use. Ginn
says: Prisons are not principally in the business of
promoting health and some people argue that there is
an inherent contradiction between the aims of care and
control. While prison has a role in meeting the health
needs of marginalised peoplefor example, in 2uu9-1u,
6u u67 prisoners received clinical treatment for drug
addiction in English and Welsh prisonsit is ultimately
not the best place to tackle poor health, writes Ginn.
Moreover, the average cost of a prison place in
England and Wales is about /u uuu (t/7 uuu;
$6u uuu), and in 2u12, UK total prison spend was
/.1bn. While some people clearly need to be in
prison, and society understandably demands a
custodial sentence for certainparticularly violent
crimes, in most cases couldnt the money be better
spent? Ginn says that community based drug
treatment, for example, was found to be particularly
enective at saving costs as onenders receiving
treatment were /3% less likely to reonend afer
release. If crime were a disease (and indeed some
in the public health community have seen it that
way), wouldnt the smart money be more on crime
prevention rather than the so called cure?
Ginn points out that around 8u% of prisoners in
England and Wales smoke, which is four times the
proportion of the general public. While there are no
plans for British prisons to become smoke free, the
switch to e-cigarettes, the topic of Douglas Kamerows
Observations column this week (p 25), might at least
improve the environment for non-smoking prisoners.
However, as Kamerow writes, e-cigarettes are worrying
the public health community. They appear to help
maintain the smoking habit and reduce incentives
to quit, and now Big Tobacco is moving into the
e-cigarette market. Now that the vapour is fully out of
the cartridge, were not going to be able to get it back
in, says Kamerow. We need to make the best of a
bad situation before it gets worse.
Trevor Jackson, deputy editor, BMJ
Cite this as: BMJ ;:f
The inside story on prison health
While some people
clearly need to be in
prison, and society
demands a custodial
sentence for certain
crimes, in most cases
couldnt the money be
better spent?
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BMJ | 1 JUNE 2013 | VOLUME 346 1
WHO to probe claims that access
to novel coronavirus was restricted
Gareth Iacobucci BMJ
UK general practitioners (GPs) have
overwhelmingly rejected a call to consider taking
back responsibility for out of hours medical
provision, following a debate at the annual
conference of local medical committees in London.
In an emergency debate announced to discuss
health secretary Jeremy Hunts proposed changes
to out of hours care, representatives were asked to
consider a motion accepting that GPs should take
back responsibility if important guarantees were
met, including all funding from the NHS 111 urgent
care helpline being transferred to out of hours
care, and private companies being blocked from
running services.
But the motion was overwhelmingly defeated
after a succession of impassioned speeches from
the floor, in which most speakers expressed their
opposition to altering the existing conference
policy, which opposes GPs taking back
responsibility for out of hours provision.
Hunts proposals, unveiled in a speech to the
Kings Fund last week, set out the governments
intention to make GPs more accountable for out
of hours care.
The plans, which were heavily trailed in the
media, came after the health secretary had
repeatedly blamed general practice for increased
demand in accident and emergency departments,
and hinted that he would push for changes to the
2004 GP contractwhich allowed GPs to opt out of
the direct provision of out of hours care.
But although Hunts speech suggested that
contractual changes for GPs could occur, he
stipulated that his proposals would not mean GPs
having to provide 24 hour care directly.
Those outlining their opposition to the plans
included Russell Brown, chair of East Sussex
local medical committee, who said: 94% of
my constituents [GPs] want nothing to do with
out of hours provision, and John Grenville, of
Derbyshire local medical committee, who said
that it was unnecessary to change existing policy,
because clinical commissioning groups were
already overseeing out of hours provision. I dont
think we need it. De facto, GPs are responsible for
commissioning it.
Cite this as: BMJ ;:f
Clare Dyer, Owen Dyer BMJ AND MONTREAL
The World Health Organization is to investigate
claims by Saudi Arabia that a Dutch labora-
torys patenting of a novel coronavirus variant
is hindering research into the pathogen that has
claimed lives in several countries.
Saudi deputy health minister Ziad Memish
told the World Health Assembly last week that
samples of the Middle East respiratory syndrome
(MERS) coronavirus, which rst emerged in his
country, had been sent abroad without permis-
sion. We are still struggling with diagnostics
and the reason is that the virus was patented by
scientists and is not allowed to be used for inves-
tigations by other scientists, he said.
WHO director general Margaret Chan prom-
ised to look at the legal implications together
with the Kingdom of Saudi Arabia. She added:
No IP [intellectual property] should stand in the
way of you, the countries of the world, to protect
your people.
Memish told the assembly that there was a
lag of three months [when] we were not aware
of the discovery of the virus. MERS coronavirus
was rst isolated in Saudi Arabia in June by
microbiologist Ali Zaki from a man who died of a
mysterious respiratory illness.
Zaki sent samples of the virus to Erasmus
Medical Centre in the Netherlands, where virolo-
gist Ron Fouchier sequenced it and in Septem-
ber identied it as a novel coronavirus strain.
Zaki then notified the medical alert website
ProMED that a novel virus had been identied.
Meanwhile, Memish told the WHO assembly,
which was held from to May, that it was
patented, and contracts were signed with vac-
cine companies and antiviral drug companies.
Zaki was later red from his post in Saudi Ara-
bia and has returned to work in his native Egypt.
I am happy to be red because I did a favour for
humankind, he told the Canadian Broadcasting
Corporation (CBC).
Erasmus strongly refuted the Saudi govern-
ments characterisation of its actions and denied
signing contracts with drug companies. Albert
Osterhaus, head of virology at Erasmus, told the
BMJ: We have patent applications submitted
and that is on the sequences and the possibilities
to eventually make diagnostics, vaccines, antivi-
rals, and the like. Its quite a normal thing if you
nd something new to patent it. So far we have
distributed the virus and also the sequences to all
the laboratories that would like to be working on
it for public health reasons, not only government
laboratories but also university laboratories. He
added, We have not struck any deal with any
company because we think its too premature.
Public Health England said that it had devel-
oped and shared a diagnostic test for MERS
coronavirus with unprecedented speed and
had not been impeded by patenting.
Cite this as: BMJ ;:f
GPs vote against taking
back responsibility
for out of hours care
A man in Khobar city, Saudi Arabia, where there have been 17 deaths from novel coronavirus
UK news A&E crisis is not the result of GPs out of hours arrangements, p
World news Spend more on treatment for Hepatitis C, say campaigners, p
References on news stories are in the versions on
Novel coronavirus
spreads to Tunisia
Gareth Iacobucci BMJ
The chairman of the BMAs General Practitioners
Committee has called on the government to end
its attacks on the profession and to stop blam-
ing GPs for the ongoing pressure on hospitals
accident and emergency departments.
In a defiant keynote speech to GPs at the
annual conference of local medical committees
in London, Laurence Buckman accused the
health secretary for England, Jeremy Hunt, of
spouting rubbish and of using the NHS as a
2 BMJ | 1 JUNE 2013 | VOLUME 346
Hunt announces plan to make GPs
accountable for out of hours care
Doctors leader calls on Hunt to
stop using GPs as scapegoats
A&E crisis is not a
result of GPs out of
hours arrangements
The rise in demand in A&E did not occur when
GPs contracts changed, said Mike Farrar
Englands health secretary Jeremy Hunt said that
primary care was not working for the public
GP committee chairman Laurence Buckman
accused Jeremy Hunt of spouting rubbish
Implementation of NHS
111 has harmed patients,
admits safety chief
Patients are likely to have been harmed by
implementation of the new NHS 111 urgent care
telephone system, a government expert on the
safety of patients has admitted.
Mike Durkin, director of patient safety for NHS
England, said that data on potentially serious
incidents were being collected but that it was
not yet known whether anyone was culpable.
Durkin was speaking at the Patient Safety
2013 Congress, which opened in Birmingham
on Tuesday 21 May.
The NHS 111 non-emergency advice line,
which was rolled out nationally from 1 April, has
come under herce criticism from many doctors
organisations, including the BMA.
NHS England launched an inquiry after
complaints of poor quality advice, inadequate
clinical support, slow response times, and inap-
propriate delays in treatment.
Asked whether patients could have been
harmed by the faulty implementation of the
service, Durkin replied, Yes.
Durkin said that the NHS was collecting data
from all parts of the system, including hospitals
and ambulance services, through its fantastic
incident reporting culture. But more data were
needed from primary care and general practice
to increase understanding of safety, he said.
Cite this as: BMJ ;:f
Matthew Limb LONDON
Englands health secretary, Jeremy Hunt, has
announced plans to overhaul primary care to
improve its quality, provoking calls for clarity
among doctors leaders.
Hunt said that the move was a more urgent
priority than improving standards in hospitals.
His measures include recruiting more GPs, mak-
ing them more accountable for out of hours
care, and creating a new chief inspector of gen-
eral practice within the Care Quality Commission.
Hunt said that there might be changes to the
GP contract introduced by Labour in 2004,
which he said had fatally undermined the per-
sonal link between GPs and their patients.
He said, Reclaiming the ideal of family doc-
toring in the 21st century means making sure
clinicians are accountable for people who are
unwellwhether inside or outside hospital. It
means responsibility for more proactive care.
Hunt announced his plans in a speech at the
third annual NHS leadership and management
summit held by the health think tank the Kings
Fund in London on 23 May. He said that primary
care was not meeting the challenges society
faced, was of variable quality, and didnt work
for the public.
The NHS Alliance, which represents primary
care professionals and organisations, said that
Hunts plans to make GPs accountable were
unclear. David Jenner, for the NHS Alliances gen-
eral practice network, said, If we are to recruit
and retain skilled GPs in the profession, Mr Hunt
urgently needs to clarify whether he means that
GPs will be accountable for commissioning out
of hours services, rather than directly providing
them through their GP contracts.
Cite this as: BMJ ;:f
political weapon at a time when the future of
the health service is under real threat.
In a herce response to recent criticism from the
health secretary, who has blamed recent pressure
on emergency departments on the 2004 GP con-
tract, which allowed GPs to opt out of the direct
provision of out of hours care, Buckman insisted
that other factors such as reductions in hospital
bed numbers, sta shortages, and the botched
introduction of the NHS 111 urgent care helpline
were the real root of the problem.
GPs have faced a series of hostile headlines in
the past few weeks, as the government stepped
up its rhetoric. But Buckman urged Hunt to
stop political point scoring and using GPs as
scapegoats. He told assembled colleagues, As
we have done over the last 65 years, doctors,
nurses, and other NHS sta can work together
to hnd a way through the current challenges. . .
But not if the government insists on denigrating
us and using the NHS as a political weapon, as it
increasingly has been doing in recent months.
Cite this as: BMJ ;:f


BMJ | 1 JUNE 2013 | VOLUME 346 3
Zosia Kmietowicz BMJ
Patients who have been treated in a high
dependency unit for more than two days face
serious social and medical problems 12 months
aher their discharge, a study has found.
Nearly three quarters (73%) of 293 patients
who were surveyed said that they had moder-
ate or severe pain a year aher leaving hospital,
and nearly half (44%) had signihcant anxiety
or depression. About half of the patients had
some problems with mobility 12 months aher
discharge that they didnt have before they went
to hospital.
The patients had been admitted to one of 22
UK hospitals between August 2008 and Febru-
ary 2010 and been treated for at least 48 hours
in level 3 dependency care, dehned as critical
care for multi-system organ failure. They com-
pleted two questionnaires about their health,
social, and economic circumstances six and 12
months aher being discharged. The study was
carried out by the Intensive Care Ahercare Net-
work, a group of healthcare professionals with
an interest in improving the long term outlook
for survivors of critical illness.
Most of the patients did not experience a
Adrian ODowd LONDON
Growing pressure on hospitals
accident and emergency departments
in England have not been directly
caused by GPs arrangements for out
of hours care, experts have told MPs.
Speaking at the parliamentary
health select committee on 21
May, expert witnesses said that
many factors had contributed to the
pressure on emergency departments.
The committee, holding the first
evidence session of its inquiry into
emergency services, asked witnesses
whether they agreed with the view
of the health secretary for England,
Jeremy Hunt, that the main reason
for rising attendances at emergency
departments was changes to the GP
contract in 2004 concerning out of
hours work.
Mike Farrar, chief executive of the
NHS Confederation, which represents
organisations that commission and
provide NHS services, said, I would
say the evidence of a direct correlation
between GP out of hours care
contractually being the requirement
of GPs and the A&E [accident and
emergency department] performance
isnt necessarily proven by statistics.
After the meeting, Farrar added,
With specific regards to the
contractual arrangements for GP out of
hours care, we do not see a correlation
between the changes to the 2004 GP
contract and the NHS four hour waiting
standard for A&E departments.
In fact, for the vast majority of
the last decade A&E waiting time
standards have been improving. It is
in recent years where the pressures
have started to bite, and there have
not been any discernible structural
changes to out of hours GP contracts
during that time.
During the meeting Mike Clancy,
president of the College of Emergency
Medicine, also giving evidence, said,
The deterioration in performance
[in emergency departments] hasnt
corresponded [to] an alteration in
the way out of hours has changed. Its
contribution to the present problem is
not obvious to me.
Fellow witness Patrick Cadigan,
registrar of the Royal College of
Physicians, said, One of the big
challenges is out of hours care,
and the problem is that A&E is the
recognisable brand, and thats where
patients will go because they will see
someone who is expert and will see
them often within four hours and they
will receive treatment.
Patients will go where the lights
are on. In many of the alternatives, the
lights are not on after 5 oclock in the
evening or at the weekends.
MPs asked the witnesses whether
they agreed with a recent view put
forward by David Prior, chairman
of the NHS regulator the Care
Quality Commission, that pressure
on emergency departments was
unsustainable and out of control.
All urgent care services had seen
rises in attendances especially in
the last year. Clancy said, There are
also a lack of clear alternatives to
emergency departments that patients
trust and want to use.
Cite this as: BMJ ;:f
Study finds critical care patients suffer
long term health and financial problems

Government support for people who have been in intensive care is lacking, said the Intensive Care Society

change in their relationship or housing aher
their time in hospital, but a third (33%) reported
an eect on their earning ability six months later,
because they lost their job, took early retirement,
switched to working part time, or took long term
sick leave. Twelve months aher discharge this
was still the case for 28% of patients.
Critical illness also aected the earning ability
of other family members, with a third (32%) of
families reporting a reduction in their monthly
income at 12 months.
Care needs of the patients aher discharge from
hospital were also found to be high. A quarter
of patients (25%) needed help with activities of
daily living at six months aher discharge, and
this proportion had fallen only slightly to 22%
at 12 months.
Most of the care to these patients (80%) was
provided by a family member, and in 23 cases
(8%) a family member was unable to work or
had to reduce their working hours 12 months
aher the patient came home. About a third of
patients who needed care had to delve into their
savings, borrow money, or sell their house to pay
for care.
Commenting on the hndings, Barry Williams,
a member of the critical care patient liaison com-
mittee of the Intensive Care Society, said, There
is ohen little or no support for these people once
discharged from hospital.
He urged the Department of Health for Eng-
land and the UK Department for Work and Pen-
sions to work with the society to produce a
policy to deal with the problems documented by
a well designed and properly conducted survey.
Cite this as: BMJ ;:f
For the vast majority of
the last decade A&E waiting
time standards have been
which takes decisions on behalf of people
who are incapable of deciding for themselves,
aher Miss B, whose pregnancy was originally
planned, decided not to go ahead with it. The
trust was backed by the womans husband and
mother, who were against the abortion.
But the judge said, There is
no doubt she has the capacity
to make a decision. It would be
a total affront to the autonomy
of this lady to conclude that
she lacks capacity to the level
required to make this decision.
Miss B is in a secure mental
health facility after being sec-
tioned under the Mental Health
Act for allegedly attacking her
husband with a knife while he
was sleeping. Her family and doctors said that
she was happy about the pregnancy until she
stopped her medication, which she did to protect
the unborn child.
She had booked appointments in April for an
abortion, but when they did not go ahead she
bought pills over the internet to induce a miscar-
riage. She was sectioned before she could take
them, and the case came to court as the 24 week
deadline for a termination loomed.
Clare Dyer BMJ
A woman with bipolar disorder
has been given the go ahead to
have an abortion aher a Court of
Protection judge ruled that she
was capable of taking the decision.
The unnamed NHS trust car-
ing for the 37 year old married
woman, named only as Miss B,
claimed that she had paranoid
and delusional beliefs that meant
she was incapable of weighing up
the factors for and against a termination.
A psychiatrist caring for her told Mr Justice
Holman that he was 100% certain that Miss
B lacked the capacity to make a decision about
termination. The judge said that psychiatric evi-
dence about capacity was normally determina-
tive in the Court of Protection, but aher hearing
from Miss B he said that there was no doubt
that she was capable of taking the decision.
The NHS trust brought the case to the court,
4 BMJ | 1 JUNE 2013 | VOLUME 346
General practitioners asked for their
views on assisted dying: The Royal College
of General Practitioners has launched a
consultation on whether it should change
its position on assisted dying, which since
2uu5 has been that with good palliative
care, a change in legislation is not required.
The consultation will run until 9 October
2u13, with a debate by the governing council
expected in early 2u1/.
Army launches campaign for new recruits:
The army has launched a recruitment drive for
1u uuu new soldiers and omcers. Research
has shown that nine of 1uu people who
wanted to join the army said that they were
interested in working for
Army Medical Services,
which provide medical
support to operations,
exercises, and adventurous
training expeditions all
over the world. The new Step Up campaign
( will feature
new television adverts that show the potential
journey that any soldier might take while
following a career in the army.
More hospitals to get Schwartz rounds: The
Department of Health is putting 65u uuu into
expanding the use of Schwartz Center Rounds
to an extra /u hospital trusts in England over
the next two years. The rounds, which are
currently held monthly in 15 trusts, allow stan
to get together to reflect on the stresses and
dilemmas in their work. Pilots have shown
that the rounds improve communication
between stan and patients and reduce stress.
Standard cigarette packets do not increase
serving time: Using a uniform colour, size,
and design on cigarette packets has not
caused confusion or queues in shops as
the tobacco industry predicted, a study
has found.
Australian researchers visited
small shops twice before and twice afer the
introduction of plain packaging in December
2u12. Immediately afer the new law, serving
time increased by two to three seconds but
returned to normal levels a week later.
Campaign launches to increase smoking
cessation services in hospitals: The British
Thoracic Society (
has launched a campaign to have a stop
smoking service in every UK hospital. It has
also developed a tool to enable each trust
to calculate its return on investing in such a
Cite this as: BMJ ;:f
Woman with bipolar
disorder can abort
her baby, judge rules
Mr Justice Holman: There
is no doubt she has the
capacity to make a decision
Having your elective operation later in
the week increases the risk of dying
Nigel Hawkes LONDON
The later in the week elective surgery takes
place, the greater the chance of the patient
dying, a study at Imperial College London has
The research team found marked dierences
in death rates between days; deaths within
30 days of the operation were 44% higher if it
occurred on a Friday rather than on a Monday
(odds ratio 1.44, 95% conhdence interval 1.39
to 1.50), and 82% higher if it occurred at the
weekend (1.82, 1.71 to 1.94). The absolute risk
of dying within 30 days was 6.7 per 1000 elec-
tive admissions.
The researchers also reviewed deaths aher
hve higher risk operations (excision of colon or
rectum, heart bypass grahing, repair of abdomi-
nal aneurysm, and excision of lung) and aher
high volume, low risk procedures such as hip
and knee replacement. For these procedures,
they found higher death rates later in the week
than on Mondays, except for aneurysm repair.
In the high volume, low risk group, the risk of
death (2.0 per 1000 admissions) rose by 28%
for operations on a Friday compared with those
on a Monday.
Paul Aylin and colleagues from the Dr Foster
Unit, Imperial College London, report in bmj.
com that this is the hrst study, to their knowl-
edge, to report a weekday eect in addition to
the well known weekend eect on mortality.
The reasons behind this remain unknown but
we know that serious complications are more
likely to occur within the hrst 48 hours aher an
operation, and a failure to rescue a patient could
be due to well known issues related to reduced
locum stamng and poorer availability of services
over a weekend, they add.
The data taken from hospital episode statis-
tics covered three years, 2008-09 to 2010-11,
and included all acute and specialist English
hospitals. There were 4 133 346 elective admis-
sions and 27 582 deaths within 30 days of the
procedure. The results could have been aected
by selection bias, but the analysis suggests that
patients operated on at the weekend are for
lower risk procedures, and would not account
for the hndings. Aylin said that although the
results do suggest a poorer quality of care at the
weekend, it is dimcult to draw those kinds of
conclusions from routinely collected data.
Cite this as: BMJ ;:f

Lola Loewenthal LONDON
A study of nearly 1000 pregnant women from
the United Kingdom has found that two thirds
were dehcient in iodine and that this dehciency
was associated with a lower IQ and poorer read-
ing ability in their children.
The Lancet study used stored urine samples
and data from the Avon Longitudinal Study of
Parents and Children (ALSPAC), also known as
the children of the 90s cohort.
Iodine concentrations were measured in 958
urine samples taken in the hrst trimester of preg-
nancy and correlated with the IQ of the chil-
dren when they were 8 years old and with
their reading ability at 9 years old.
The World Health Organization
says that women who have urinary
iodine concentrations below 150
micrograms per litre of urine have
a dehciency.
This was the case in
67% of the women in the study.
Children whose mothers had low
urinary iodine concentrations had lower scores
on verbal IQ (odds ratio 1.6 (95% conhdence
interval 1.1 to 2.3)), reading accuracy (1.7 (1.2
to 2.5)), and reading comprehension (1.5 (1.1 to
2.2)) than did children of mothers with normal
iodine concentrations.
Speaking at a press briehng on the study on
21 May, Margaret Rayman, professor of nutri-
tional medicine at the University of Surrey and
one of the studys authors, said that iodine was
a crucial component in thyroid hormone produc-
tion and was needed for gestational
neurodevelopment. She said that
in the UK dairy foods were the tradi-
tional source of iodine. In other devel-
oped countries seafood and ionised
salt were sources.
Pregnant women should have
three portions of dairy products a
day of around 200 ml each, said
Cite this as: BMJ 2013;346:f3365
Woman with bipolar
disorder can abort
her baby, judge rules
Zosia Kmietowicz BMJ
The MP Margaret Hodge has
expressed dismay at the
governments decision in 2009 to
stockpile oseltamivir (sold as Tamiflu)
in preparation for a flu pandemic
despite uncertainty over the drugs
Hodge, who chairs the House
of Commons Public Accounts
Committee, said she was also
appalled at the squandering of
74m of taxpayers money when 6.5
million doses of oseltamivir had to be
written off because of the NHSs poor
record keeping on how the drug was
stored. There is simply no excuse for
this waste, she said.
Hodge was responding to a
memorandum from the National Audit
Office written to inform members
of her committee on how drugs are
licensed and the reasoning behind
the decision of the Department
of Health for England to stockpile
oseltamivir for the treatment of
pandemic flu.
The committee is to hold a hearing
on clinical trials and oseltamivir on 17
June, at which it will cross examine,
among others, Sally Davies, Englands
chief medical officer since 2010.
The National Audit Office, which
scrutinises public spending, said that
there was a general consensus that
oseltamivir reduced the duration of
flu symptoms but less consensus
that it reduced complications,
hospitalisations, and deaths.
It said that the government spent
560m on antivirals between 2006-7
and 2012-13: 424m on oseltamivir
and 136m on zanamivir (Relenza).
Of the 40 million doses of
oseltamivir purchased, 2.4 million
were consumed, mainly during the
2009-10 pandemic. A further 10
million were written off, 6.5 million
of them (worth 74m) before their
shelf life was reached because it was
unsure how they were stored.
Hodge described the decision to
purchase oseltamivir at such a great
cost, despite there being question
marks over the effectiveness of the
drug, as extremely worrying. The
poor record keeping over storage of
oseltamivir was a shocking example
of incompetence, she added.
The audit office said that when
the health department decided
what drugs to stockpile for use in a
pandemic it should concentrate on
building up knowledge about the
added value of stockpiling through
reducing complications and deaths,
if necessary by commissioning
additional independent research.
And NHS England and Public
Health England should ensure that
there were robust procedures in
place during a pandemic to reduce
unnecessary write-offs.
Its memorandum explained
how the Medicines and Healthcare
Products Regulatory Agency and the
European Medicines Agency did not
ask manufacturers for patient level
data to conduct their own analyses
when considering licensing a drug
because they lacked the capacity
to do sounlike the Food and Drug
Administration in the United States.
Cite this as: BMJ 2013;346:f3371
MP says choice of oseltamivir
in flu pandemic was worrying
Poor record keeping led to 74m waste, said Margaret Hodge
Study links iodine deficiency in
pregnancy with lower IQ in kids
The woman told the judge that she planned
to divorce her husband, whom she had married
partly because he was undocumented and had
no right to be in the country. She did not believe
that she would be well enough to look aher the
baby as a single mother and was frightened that
if she had the baby her foreign husband would
send it abroad to live with his family.
Asked what she would do if she were forced to
go on with the pregnancy to term, she replied, I
would seek to kill myself and the baby.
The judge said, She is a lady of considerable
intelligence, is well educated, including hav-
ing a degree, and was previously working in a
demanding professional job. Shes articulate,
can clearly engage with her lawyers and the
legal process, and can express perfectly what
she wants to achieve.
I cannot agree that she is lacking capacity to
make such a decision.
By the time the judge delivered his ruling,
Miss Bs pregnancy had almost reached 24
weeks gestation, the upper time limit set for
abortions in England, Wales, and Scotland.
But in exceptional cases an abortion may be
performed later. This could include cases where
suicide was a real risk.
Cite this as: BMJ 2013;346:f3387
BMJ | 1 JUNE 2013 | VOLUME 346 5
6 BMJ | 1 JUNE 2013 | VOLUME 346


Spend more on treating hepatitis C, say campaigners
In April people with hepatitis C were among those who took part in a theatrical hanging in Kiev to demand treatment. A scheme was approved soon afterwards
Zosia Kmietowicz BMJ
Governments around the world are being called
on to redirect resources away from the war on
drugs and into public health schemes for pre-
venting and treating hepatitis C infection.
In a report published on 30 May the Global
Commission on Drug Policy, a panel of 22 politi-
cal and cultural leaders, estimated that 10 mil-
lion of the 16 million people who inject drugs
around the world are infected with hepatitis C.
Research has consistently shown that harsh
drug laws forced drug users away from public
health services and into hidden environments
where the risk of infection with hepatitis C and
HIV became markedly raised.
The report described the billions of dollars
spent each year on arresting and punishing
drug users as a gross misallocation of limited
resources. Because of such policies, very few
countries had reported signihcant declines in
new infections of hepatitis C among drug users.
The money would be better spent on harm
reduction services, such as the provision of ster-
ile needles and syringes and opioid substitution
therapy, as well as treatment schemes, it said.
Hepatitis C is more than three times as com-
mon as HIV in this population, said the report. In
some of the countries with the harshest drug pol-
icies over 90% of people who inject drugs have
hepatitis C, with the highest numbers reported in
China (1.6 million infected people), the Russian
Federation (1.3 million people), and the United
States (1.5 million people).
Hepatitis C has to be one of the most grossly
miscalculated diseases by governments on the
planet, said one of the commissioners, Michel
Kazatchkine, who is also the UN secretary gen-
erals special envoy on HIV and AIDS in Eastern
Europe and Central Asia. It is a disgrace that
barely a handful of countries can actually show
signihcant declines in new infections of hepatitis
C among people who inject drugs, he said.
The report also highlighted the fact that hep-
atitis C had not had the publicity that HIV had
attracted, which had helped to reduce the price
of antiretrovirals around the world. Drug treat-
ment of hepatitis C with pegylated interferon
is patented by the drug companies Roche and
Merck and in dierent countries costs between
$2000 (E1320; t1540) and $20 000 for a course
of treatment. Costs are likely to come down with
the expiry of patents in 2-4 years time, and the
World Health Organization has recently called for
drugs used to treat hepatitis C to be included in
lists of essential treatments.
However, the report said that in the meantime
countries could negotiate price reductions with
manufacturers. It gave the example of Ukraine,
where one million people have hepatitis C,
including 90% of injecting drug users. Pressure
from civil society groups there, such as the Inter-
national HIV/AIDS Alliance in Ukraine, led to an
agreement with the Global Fund to Fight AIDS,
Tuberculosis and Malaria to fund treatment of
injecting drug users, to be delivered alongside
opioid substitution therapy and antiretroviral
therapy. Drug companies have agreed to halve
the price of drugs for the deal.
The Global Commission on Drug Policy cam-
paigns to promote an evidence based global dis-
cussion on eective ways to reduce the harms
caused by drugs to people and societies. Its com-
missioners include Koh Annan, former secretary
general of the United Nations.
Cite this as: BMJ ;:f
Nigel Hawkes LONDON
David Nicholson, the chief
executive of the NHS in England,
has announced his intention to step
down by March 2014 at the latest,
when he will have completed seven
and a half years in the top job.
He may go sooner if a successor
has been chosen and the chairman
of NHS England, Malcolm Grant,
thinks that an earlier change
would be in the best interests of
the service. Nicholson has been
credited with maintaining control
of the service at a time of upheaval
during the introduction of Andrew
Lansleys reorganisations but has
also been criticised for his top-down
management style.
His involvement in the Mid
Staffordshire NHS Foundation Trust
scandal was indirect but, critics claim,
significant, because his insistence
on meeting financial targets took
managers minds off the central task
of providing care.
Julie Bailey, a leading Mid
Staffordshire campaigner, said that
it was time to celebrate, while
Roy Lilley, an outspoken blogger on
NHS management issues, said that
Nicholson should have gone before
Lansleys changes, when he would
have been remembered as the man
who made waiting times disappear.
Instead he will be remembered in the
same breath as patients drinking from
flower vases, Lilley wrote, a reference
to patients maltreatment at Mid
Since the publication of the second
report into Mid Staffordshire by
Robert Francis QC, Nicholson has
been the subject of sustained attack
from the Daily Mail but has retained
the support of the government.
Jeremy Hunt, health secretary for
England, paid tribute to his calmness
and focus, crediting him with
falling waiting times, lower rates of
hospital infections, and fewer mixed
sex wards. Mike Farrar, the chief
executive of the NHS Confederation,
which represents organisations
that commission and provide NHS
services, said that under Nicholson
access to treatment had improved
more quickly than in almost any
similar health system.
Cite this as: BMJ ;:f
Nicholson to step down as chief executive of NHS England by March 2014
BMJ | 1 JUNE 2013 | VOLUME 346 7

Editorials are usually commissioned. We are, however, happy to consider and peer review unsolicited editorials
See for more details
CT radiation risks coming into clearer focus
As we gather more direct evidence of the dose-response curve from childhood CT
Aaron Sodickson section chief of emergency radiology
and medical director of computed tomography , Brigham
and Womens Hospital, Harvard Medical School, Boston,
Recent attention to the cancer risks of ionizing
radiation has prompted vigorous debate about
how to quantify the risks of diagnostic imaging,
and whether or how these risks ought to be incor-
porated into our decision making process as we
participate in patient care.
In the past, models of the carcinogenic risks of
ionizing radiation have primarily relied on long term
surveillance of the Japanese atomic bomb survivors,
which showed signihcant increases in the incidence
of cancer aher eective doses greater than about
50 mSv.

The relative paucity of direct data in the
lower dose range delivered by diagnostic imaging
has led to conicting opinions about the shape and
slope of the radiation dose-response curve.
In a linked study, Mathews and colleagues
present compelling data on the magnitude of the
cancer risk attributable to ionizing radiation.

This well designed study examined a cohort of
nearly 11 million young patients in the Australian
national Medicare system and compared subse-
quent incidence of cancer in the 680 000 patients
exposed to computed tomography (CT) with that
in unexposed controls.
The hnding that will probably dominate media
headlines is that exposure to CT in childhood
increased the incidence of cancer by 24%. How-
ever, it is important to recognize that the baseline
incidence of cancer in a general pediatric popu-
lation is extremely small, so that a 24% increase
makes this risk just slightly less small. To put these
numbers in context, it is necessary to consider
absolute (rather than relative) cancer risk, and to
relate the increase to the degree of exposure. The
authors found an overall excess risk of about 0.125
cancers per Sievert, which equated to roughly one
excess cancer per 1800 head CTs (each with an
average estimated dose of around 4.5 mSv). This
would equate to roughly one excess cancer per
4000 head CTs at the more typical doses in use
with current day technology (around 2 mSv).
Mathews and colleagues compared their results
with those of the Life Span Study of Japanese
atomic bomb survivors
and those of the more
recent landmark UK study.
All three studies show
good concordance within the conhdence intervals
that their cohort sizes permit. Although the UK
study was powered to detect signihcant increases
in childhood leukemia and brain tumors,
current study, which is larger, shows signihcantly
increased risks across a large range of cancer types.
This observed increase in risk associated with
the low radiation doses delivered by CT scans sup-
ports the most widely adopted linear-no-threshold
dose-response model in which double the radia-
tion dose is assumed to impart double the can-
cer risk. The reported risks also roughly match
the lifetime attributable risks predicted by the
BEIR-VII (biological eects of ionizing radiation)
one of the most commonly used linear-no-
threshold models.
So what should physicians do with this informa-
tion and how can it be incorporated into practice?
There are many possible interventions to control
patients exposure to radiation, which can concep-
tually be grouped into timeframesbefore, during,
and aher the CT scan.
Before the scan, there are many opportunities
to control the use of imaging. Although the clinical
benehts of a medically indicated scan usually far
outweigh the small associated risk of developing
cancer, this is the time for critical assessment of
what impact the imaging result might have on the
patients care plan. Special attention should be
paid to patients undergoing recurrent imaging,
because if frequently repeated scans are found
to provide little clinical beneht, the cumulative
risk-beneht balance may support a decision not
to image again for the same clinical presentation.
Imaging algorithms or evidence based clinical
decision rules may be adopted for clearly dehned
clinical scenarios. Electronic decision support
embedded in the scan ordering process can sub-
stantially reduce utilization.
During the scan, there are many available
methods to reduce the radiation dose without
negatively aecting the diagnostic quality of the
Although CT radiation doses vary
considerably, existing dose reduction tools and
ongoing technological improvements allow CT
scans to be performed using substantially lower
radiation doses than was possible with previous
generations of scanners, such as those in place
during the period of the current study.
adoption of such tools is key, through collaborative
eorts of radiologists, CT manufacturers, medical
physicists, and CT technologists.
After the scan, opportunities for managing
radiation dose are increasing. Adoption of newly
developed informatics methods that enable large
scale data capture of CT scanner radiation output
has resulted in databases that will be vital for insti-
tutional benchmarking, optimization of CT proto-
cols, and quality control.
Such data capture would
also enable more accurate patient specihc dose
estimation than was possible from the data sources
available to Mathews and colleagues.
the authors assigned credible doses to the scans
in their study, future epidemiological work may be
greatly enhanced by improved capture of patient
specihc dosimetry.
With further validation of radiation risk models,
not only in children but also in adults, we will ulti-
mately be able to perform more accurate patient
specihc risk assessment to better inform imaging
decisions. Mathews and colleagues study is a vital
step towards this goal.
Competing interests: I have read and understood the BMJ
Group policy on declaration of interests and declare the
following interests: I have served as a consultant for Siemens
CT and Medrad (now Bayer) within the past three years.
Provenance and peer review: Commissioned; not externally
peer reviewed.
References are in the version on
Cite this as: BMJ ;:f
Response on
Most paediatric and much adult CT [computed
tomography] can and should be replaced by MR
[magnetic resonance imaging]. In Australia MR is
rationed by deliberate government policy. GPs cannot
order MR studies, with few exceptions . . . This policy
is the major factor behind the continuing quite
unnecessary radiation exposure inherent in CT.
Bob Dempster, radiologist, Australia
Visit the article online and click on Respond to this
article to have your say


8 BMJ | 1 JUNE 2013 | VOLUME 346
Should we rethink the scheduling of elective surgery at the weekend?
Higher 30 day mortality for elective procedures scheduled Friday through Sunday
Janice L Kwan chief medical resident, Department of
Medicine, Mount Sinai Hospital and University of Toronto,
Toronto, ON, Canada
Chaim M Bell associate professor, Department of
Medicine, Mount Sinai Hospital and University of Toronto,
Toronto, ON, Canada
Ideally, the quality of care that patients receive
should not dier according to the day of the
week. In reality, however, patients admit-
ted to hospital at the weekend seem to have
poorer outcomes than those admitted during
the working week. Many studies have shown
this so called weekend eect.
A proposed
explanation for this phenomenon is that qual-
ity of care at weekends is worse because of
reduced or altered stamng levels. Reassuringly,
this observation does not hold true across the
spectrum of care.

Most studies that have examined the out-
comes of medical care at the weekend have
focused on emergency care. In a linked paper,
Aylin and colleagues assessed the association
between day of elective surgical procedure
and 30 day postoperative mortality using ret-
rospective analysis of English national hospi-
tal administrative data.
They found that the
adjusted odds of death were 44% and 82%
higher, respectively, if the procedures were
carried out on Friday or at the weekend rather
than on Monday. These hndings suggest that
patients who have elective surgical procedures
scheduled later in the working week and at the
weekend may have a higher risk of death than
those scheduled during the week. The results
also add to the growing body of evidence on
the weekend eect and elective surgical pro-
cedures. Another recent study that also used
English national hospital administrative data
showed that weekend admission seemed to be
an independent risk factor for dying in hospi-
tal, with a risk that was more pronounced in
the elective versus emergency setting.
thermore, a cohort study of 188 212 patients
at 124 Veterans Aairs hospitals found that 30
day mortality was higher in patients admitted
to regular hospital oors aher non-emergency
major surgery if surgery was performed on Fri-
day rather than Monday to Wednesday.
Aylin and colleagues linkage of death cer-
tihcates with administrative data meant that
they were able to capture deaths that occurred
in and out of the hospital setting. Moreover,
they focused on day of procedure, rather than
day of admission, which provided a dierent
lens from which to analyse this phenomenon.
By choosing Friday as a day of interest, in
addition to Saturday and Sunday, the authors
were better able to capture the net eect of
weekend postoperative care and disentangle
it from the eect of undergoing surgery at the
weekend. Nevertheless, only a small propor-
tion of elective procedures occurs at the week-
end (4.5% in the United Kingdom).
begs the question: what makes these patients
undergoing elective surgery at the weekend
different? Interestingly, the authors found
that this cohort of patients had higher 30 day
postoperative mortality despite having a lower
index of comorbidity and despite undergoing
procedures with lower surgical risk. Of note,
they also had longer mean surgical wait-
ing times than their counterparts scheduled
during the working week. The question that
remains unanswered is whether there are any
dierences between the surgeons who operate
or the surgical teams who work at weekends
and those who work in the week.
Although emergency procedures, such as the
repair of ruptured aortic aneurysms, cannot
be controlled, the scheduling of elective pro-
cedures, such as knee replacements, is wholly
within our control. If weekend care proves to
deliver poorer outcomes than its weekday coun-
terpart, it might be argued that elective proce-
dures should not be scheduled at weekends at
all. Yet this would be dimcult to reconcile with
policies that aim to provide timely care along-
side quality care. It is a challenging balancing
act. We know that relatively few urgent proce-
dures are performed on patients admitted at the
weekend, and that these patients experience
longer stays.
Are we willing to sacrihce the
safe provision of care for shorter procedural
wait times and lengths of stay? This is an impor-
tant policy question that is not yet resolved.
Future research should better elucidate which
elective procedures follow the weekend eect
and which do not, as well as which patients,
surgeons, and surgical teams are best suited
for elective procedures at the weekend. Until
then, we are leh to think twice about the adage,
thank goodness its Friday.
Competing interests: We have read and understood the BMJ
Group policy on declaration of interests and declare the
following interests: None.
Provenance and peer review: Commissioned; not externally
peer reviewed.
1 Bell CM, Redelmeier DA. Mortality among patients admitted
to hospitals on weekends as compared with weekdays. N
Engl J Med luu1;!/':66!-S.
l Cram P, Hillis SL, Barnett M, Rosenthal GE. Effects of
weekend admission and hospital teaching status on
in-hospital mortality. Am J Med luu/;117:1'1-7.
! Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC,
Moreyra AE. Myocardial Infarction Data Acquisition System
(MIDAS 1u) Study Group. Weekend versus weekday
admission and mortality from myocardial infarction. N Engl J
Med luu7;!'6:1u99-1u9.
/ Nanchal R, Kumar G, Taneja A, Patel J, Deshmukh A, Tarima
S, et al. Milwaukee Initiative in Critical Care Outcomes
Research (MICCOR) group of investigators. Pulmonary
embolism: the weekend effect. Chest lu1l;1/l:69u-6.
' Kim SC, Hong KS, Hwang SI, Kim JE, Kim AR, Cho JY, et
al. Weekend admission in patients with acute ischemic
stroke is not associated with poor functional outcome than
weekday admission. J Clin Neurol lu1l;S:l6'-7u.
6 Luyt CE, Combes A, Aegerter P, Guidet B, Trouillet JL, Gibert
C, et al. Mortality among patients admitted to intensive care
units during weekday day shifts compared with off hours.
Crit Care Med luu7;!';!-11.
7 Aylin P, Alexandrescu R, Jen MH, Mayer EK, Bottle A. Day of
week of procedure and !u day mortality for elective surgery:
retrospective analysis of hospital episode statistics. BMJ
S Mohammed MA, Sidhu KS, Rudge G, Stevens AJ. Weekend
admission to hospital has a higher risk of death in
the elective setting than in the emergency setting: a
retrospective database study of National Health Service
hospitals in England. BMC Health Serv Res lu1l;1l:S7.
9 Zare MM, Itani KMF, Schifftner TL, Henderson WG, Khuri
SF. Mortality after nonemergent major surgery performed
on Friday versus Monday through Wednesday. Ann Surg
1u National Confidential Enquiry into Patient Outcome and
Death. Elective surgery in the NHS luu!.
11 Bell CM, Redelmeier DA. Waiting for urgent procedures on
the weekend among emergently hospitalized patients. Am J
Med luu/;117:17'-S1.
Cite this as: BMJ ;:f
BMJ | 1 JUNE 2013 | VOLUME 346 9
Corporate involvement in public health policy is being obscured
Plain packaging policy should be developed in plain sight
Jeff Collin professor of global health policy
Sarah Hill senior lecturer, Global Public Health Unit, School
of Social and Political Science, University of Edinburgh,
Edinburgh EHS 9LD, UK
The government in England, having previously
indicated its intention to follow Australias lead
in legislating for plain packaging for cigarettes,
has reportedly abandoned this public health ini-
This policy U turn was met with dismay
from tobacco control advocates,
jubilation by
the tobacco industry, and an increase in tobacco
share prices.
Plans to introduce a minimum unit
price for alcohol in England and Wales were also
recently jettisoned aher intensive lobbying by
industry. Furthermore, the government has aban-
doned its plan to introduce a statutory register of
lobbyists (signalled in its coalition agreement).

These public health casualties of the govern-
ments midterm travails reinforce concerns about
the role of the commercial sector in public health
policy. Corporate involvement in public health is
epitomised by a Public Health Responsibility Deal
that privileges initiatives favoured by the alcohol
and processed food industries.
The absence of a
statutory register of lobbyists underlines a con-
tinuing lack of transparency because it means
that private companies can petition to take over
health campaigns or reform the NHS without the
publics knowledge.
Doubts about the current direction of health
policy are exacerbated by the opaque nature
of the process through which the recent shih
has occurred. The retreat over plain packag-
ing of cigarettes reportedly followed counsel
from David Camerons adviser Lynton Crosby,
a former tobacco lobbyist, to scrape the bar-
nacles o the boat.
The government has yet
to respond to last years consultation on stand-
ardised packaging of tobacco productsa delay
that is itself being used to justify non-disclo-
sure of written submissions.
Surprisingly, our recent request under the
Freedom of Information Act 2000 for submis-
sions made by cigarette manufacturers and
their allies was rejected, with the Department
of Health citing the qualihed exemption (under
section 35 of the Act) for information relating
to the formulation or development of govern-
ment policy.Yet the Department of Health has
previously disclosed more obviously sensitive
documents following requests from the tobacco
industryincluding detailed correspondence
between health omcials in the United Kingdom,
Australia, and New Zealand.
In practice, freedom of information legis-
lation seems to have enabled corporations to
protect their interests more eectively than it
has enhanced public scrutiny. Tobacco compa-
nies have repeatedly used public record acts to
undermine health policy by ooding omcials
with requests for information, subjecting sta
to a high degree of scrutiny from an industry
with unlimited legal resources.
Philip Mor-
ris invoked the Freedom of Information Act
in repeated attempts to extract conhdential
records from researchers at the University of
In addition, Japan Tobacco Interna-
tional based its recent high prohle campaign
against plain packaging on correspondence
between government omcials obtained through
a freedom of information request.
It is ironic that minutes of a meeting in Janu-
ary 2013 attended by Department of Health
omcials and Imperial Tobacco include details
of assurances that conhdential data supplied
by the company would not normally need to
be disclosed under [freedom of information]
requests because of an exemption to protect
commercial interests.
In the specific con-
text of government interactions with tobacco
companies, however, obligations to ensure
transparency extend beyond the minimal
requirements of the Act. As a party to the World
Health Organization Framework Convention on
Tobacco Control (FCTC), the UK has recognised
its commitments under article 5.3 to protect
the development of public health policy from
the vested interests of the tobacco industry.

Full implementation of such commitments
would require the government to ensure that
any interaction with the tobacco industry on
matters related to tobacco control or public
health is accountable and transparent. This
would also have to be conducted in public, for
example through public hearings, public notice
of interactions, [and] disclosure of records of
such interactions to the public.
The govern-
ments interpretation of article 5.3 has been
more limited in, for example, exempting dis-
closure of details of discussions between the
tobacco industry and HM Revenue and Cus-
toms. But even within this narrow interpre-
tation, obligations under the framework are
surely breached by the rejection of a freedom
of information request for tobacco industry
submissions on the grounds that policy discus-
sions are ongoing.
Corporate opposition to minimum unit pric-
ing for alcohol and plain cigarette packaging
illustrates the inevitable tensions between
the interests of the commercial sector and the
protection of public health. The current UK
government is by no means unique in failing to
reconcile these competing interests, and there
is increasing international recognition of the
need to develop more coherent public health
responses to unhealthy commodity industries.

But whatever governments decide when adju-
dicating between competing priorities, both
public health and the wider public interest in
accountability require sumcient transparency
to enable clear understanding of the processes
by which decisions are reached and the evidence
on which they are based. By these standards, the
governments failure to decide on plain packag-
ing policy in plain sight clearly falls short of
minimal expectations. To adapt the metaphor
du jour, commitments to transparency are inte-
gral to good governmentnot mere barnacles.
Competing interests: We have read and understood the
BMJ Group policy on declaration of interests and declare
the following interests: Research from which this analysis
derives is supported by the National Cancer Institute of the US
National Institutes of Health (grant no l Ru1 CAu91ul1-u').
Provenance and peer review: Commissioned; not externally
peer reviewed.
References are in the version on
Cite this as: BMJ ;:f
OPersonal View: Introduce standard cigarette packets now (BMJ lu1!;!/6:f!1/')
ONews: Camerons cave-in on plain packaging is a boost to industry (BMJ lu1!;!/6:f!u69)
ONews: Government has lost credibility on public health for inaction on cigarettes and alcohol, campaigners say (BMJ lu1!;!/6:f!ul/)
ONews: FDA drops legal battle to introduce graphic pictures on cigarette packs (BMJ lu1!;!/6:f191!)
10 BMJ | 1 JUNE 2013 | VOLUME 346
Managing the health of prisoners
A challenge to our professionalism and commitment to protect public health
are widely available in the community in sev-
eral countries but have been denied for prisons
despite the international evidence of safety and
success. Finland is providing new community
orientated facilities that are conducive to the
rehabilitation of prisoners. The Netherlands has
introduced motivational interviewing in their
prisons through sta training, with encouraging
results in helping prisoners to change.
Some countries are encouraging prisoners to
take greater responsibility for improving their
health and habits. In Danish prisons, inmates
work and gain a salary that they use to buy their
own food in the prison shop, and they can do
their own cooking. In several countries (includ-
ing the UK) smoking cessation interventions
have been trialled among prisoners and in some
cases success rates have been equivalent to those
achieved in general community clinics. These
experiences are reported in a WHO guide to the
essentials in prison health,

which expands on
the subjects so well outlined by Ginns BMJ series.
It is necessary to stress, however, that improve-
ments in prison health services even among the
member countries of the WHO Health in Prisons
Programme have been slow and are oen patchy.
They are highly dependent on government sup-
port, available resources, a press that is willing
to encourage a positive discussion of what needs
to be done, and a public that shows insight and
awareness. Above all, political will and leader-
ship are needed.
Ginns series of articles reminds us that prison
healthcare is not only a test of our civilisation
but also a real test of our medical professional-
ism. It is a test of whether health for all really
means all, and a test of our dedication to
tackling the complex health and social needs of
disadvantaged and vulnerable people. To build a
healthier society we need to move beyond focus-
ing on quality of care for individuals towards the
genuine support of human rights and enthusi-
asm for social justice, both of which underpin
the delivery of quality care to marginalised
Competing interests: None declared.
Provenance and peer review: Commissioned; not externally
peer reviewed.
References are in the version on
Cite this as: BMJ ;:f
Alex Gatherer temporary adviser to WHO Health in
Prisons Programme, Appleton, Warrington WA/ 'QD, UK
It is too oen forgotten that prisoners are part of
society and that their health is an important public
health concern. Failure to pay due attention to the
health and social needs of prisoners is negligent,
undermines their human rights, and allows health
inequalities to persist. Prisons oen have old and
inadequate facilities, are overcrowded, contain
some of the most vulnerable people in society,
and tend towards poor regular data collection
and monitoring of health, which oen leads to
bypassing of health surveillance systems. All of
this means that they oen fail to carry out the rst
duty of public healththe protection of health.
Stephen Ginns series of ve articles on the
health of prisoners in England and Wales shone
a welcome spotlight on this problem.
The arti-
cles deal comprehensively with the main chal-
lenges that confront prison health and show the
complexity and wide range of ill health that can
exist. Most prisons have to cope with whoever is
sentenced by the courts and cannot choose which
prisoners they receive, even if they do not have
the facilities needed. Some progress has been
madefor example, in diverting prisoners with
serious mental illness to appropriate specialist
institutions. But specialist services are still patchy
and prisoners with other special needs are still
not cared for in specialist services. Prisoners with
drug and alcohol dependence need special treat-
ment, yet prisons are oen ill equipped to treat
these conditions.
The provision of healthcare to prisoners is far
from easy, even in countries such as England and
Wales, where prison health is part of the National
Health Service. Ginns rst article outlined clearly
the three main factors that make the protection
of health dicult in prison.

Firstly, poor prison

environments, such as old buildings still in use,
can undermine health. Secondly, most prison-
ers come from disadvantaged sectors of society
where their health and social needs have not
been adequately dealt with for years. Thirdly, in
many countries, including the United Kingdom,
criminal justice systems are hard on crime and
so on willing the means and the support for
appropriate care and rehabilitation.
Ginns work also highlights the main problems
confronting prisons today: the rise in elderly
prisoners and the lack of facilities to cope with
their needs; mental illness, which can be dicult
to assess and even more dicult to treat; prob-
lems unique to women prisoners; and the knock-
on eect on prisoners families.
Welcome improvements have occurred in
recent years in England and Wales, Scotland, and
other European countries where public health
takes responsibility for healthcare in prisons. As
required by internationally agreed human rights
recommendations, these countries are striving
to provide healthcare services in prisons that are
equivalent to those available in the community.
But challenges remain, and developments are
oen slow and implemented in a patchy way.
In most countries in Europe, prison healthcare
remains the responsibility of the government
department responsible for prisons, whose rst
duty is security. It is oen dicult to recruit and
retain well qualied health professionals and to
gain the professional independence so important
to the delivery of prison healthcare.
The UK can learn from developments in other
European countries that are among the mem-
bers of the World Health Organization (Europe)
Health in Prisons Programme (www.euro.who.
int/prisons ). The Netherlands and Germany,
notably, have successfully tackled and reduced
the problem of overcrowding in prisons, which
bedevils eorts in health protection and health
improvement. Although numbers of prisoners
continue to rise in the UK irrespective of the inci-
dence of crime, which is falling, these countries
have reduced their overall prison population.
Spain has made a needle and syringe exchange
service available in its prisons. Such services



Stephen Ginns prison health series
OPromoting health in prison (BMJ lu1!;!/6:fll1)
OWomen prisoners (BMJ lu1!;!/6:eS!1S)
OElderly prisoners (BMJ lu1l;!/':e6l6!)
OPrison environment and health (BMJ lu1l;!/':e'9l1)
ODealing with mental disorder in prisons (BMJ lu1l;!/':e7lS)
BMJ | 1 JUNE 2013 | VOLUME 346 11
The BMJ is an Open Access journal. We set no word limits on BMJ research articles, but they
are abridged for print. The full text of each BMJ research article is freely available on
Scan this image with your
smartphone to read our
instructions for authors
RESEARCH NEWS All you need to read in the other general medical journals Alison Tonks, associate editor, BMJ
hazard ratio 0.93, 0.4 to 2.2). Lung function and
symptoms improved at the same speed and to
the same extent in both groups, and patients had
comparable quality of life. Overall, those treated
for hve days had 65% less corticosteroid than con-
trols (200 v 560 mg).
These heavy smokers and ex-smokers had
severe COPD. They received other recommended
treatments alongside their assigned course of
prednisolone, including antibiotics, inhaled glu-
cocorticoids and 2 agonists, and tiotropium. The
trial had a non-inferiority design and was power-
ful enough to rule out any clinically meaningful
dierence between treatment groups.
Most guidelines recommend 10-14 days of cor-
ticosteroids for people with exacerbations, says a
linked editorial (doi:10.1001/jama.2013.5644).
This trial provides convincing evidence that a hve
day course works just as well and limits exposure
to a drug with serious and cumulative side eects.
JAMA lu1!;doi:1u.1uu1/jama.lu1!.'ul!
Cite this as: BMJ ;:f
Another trial challenges uid and salt
restriction in acute heart failure
Adults admitted with acute decompensated heart
failure are ohen put on diets that restrict their
intake of salt and uids, but there is mounting
evidence that such diets dont work. The latest
trial was small, but it found that tight control of
salt and water intake didnt help relieve conges-
tion, promote weight loss, or prevent readmission
within a month. Patients allowed just 800 mL a
day of uid and 800 mg a day of salt were signih-
cantly thirstier than controls given an unrestricted
hospital diet.
Researchers at one hospital in Brazil recruited
75 patients shortly aher they were admitted with
acute heart failure. They were mostly men, with a
history of chronic heart failure and a leh ventricu-
lar ejection fraction below 30%. Patients in both
groups lost more than 4 kg in weight during the
hrst three days of treatment (which almost always
included intravenous diuretics), and congestion
scores improved by 3 or 4 points on a scale run-
ning from 1 to 22. There was a non-signihcant half
a point dierence in score between the groups.
Aggressive restriction of salt and uids looks
unnecessary at best, say the researchers.
JAMA Intern Med lu1!; doi:1u.1uu1/jamainternmed.lu1!.''l
Cite this as: BMJ ;:f
Maternal iodine deciency may
threaten childrens IQ
Researchers have urged public health authorities
in the UK to develop a more coherent policy on
iodine dehciency in pregnancy. Their cohort study
found that the children of mothers with low uri-
nary concentrations of iodine in early pregnancy
had signihcantly worse verbal IQ and reading abil-
ity than children of mothers with adequate con-
centrations. In analyses adjusted for more than 20
confounders, urinary ratios of iodine to creatinine
less than 150 g/g were associated with signih-
cantly higher odds of poor performance in one of
three measures of IQ (odds ratio for verbal IQ 1.58,
95% CI 1.09 to 2.3) and three of four measures
of reading ability. The researchers also noticed a
dose-response eect. Children were 8 or 9 years
old when tested.
Two thirds of the 1040 women in these analy-
ses had mild or moderate iodine dehciency. They
were pregnant in the early 1990s, but the authors
are conhdent that little has changed since then.
Iodine dehciency has been overlooked in the UK,
and we may be taking risks with the nations IQ,
they write. Iodine is a key component of thyroid
hormone and essential to the developing brain.
Moderate iodine dehciency is re-emerging in
other developed countries too, says a linked com-
ment (doi:10.1016/S0140-6736(13)60717-5).
Falling consumption of dairy products, patchy use
of iodised salt, and no guidance from government
are all contributory factors.
Lancet doi lu1!; doi:1u.1u16/Su1/u-67!6(1!)6u/!6-'
Cite this as: BMJ ;:f
CT screening for lung cancer nds more
cancers, after more investigations
We know that screening for lung cancer with
computed tomography (CT) prevents more
deaths from lung cancer than screening with a
chest radiograph, but what happens to adults
screened by one or other modality? A descrip-
tive account of the hrst round from a landmark
screening trial reports that a quarter of high risk
adults screened with CT had some kind of abnor-
mality (27.3% (7191/26 309)), compared with
a 10th of controls screened with chest radiog-
raphy (9.2% (2387/26 035)). More positive CT
scans meant more follow-up imaging (5717
v 2010), biopsies (155 v 83), bronchoscopies
(306 v 107), and surgery (297 v 121). Ultimately,
more cancers were diagnosed in adults screened
with CT (1.1% (292) v 0.7% (190)). The extra
cancers were mainly stage 1A.
One round of CT screening was more sensi-
tive than radiography (93.8% v 73.5%) but less
specihc (73.4% v 91.3%). The positive predic-
tive value was low for both tests (3.8% v 5.7%).
All participants were screened for the hrst time
between 2002 and 2004, at age 55-74 years.
About half were former smokers. The rest were
still smoking when recruited. All had a history of
at least 30 pack years, the equivalent of smoking
20 cigarettes a day for 30 years.
N Engl J Med lu1!;!6S:19Su-91
Cite this as: BMJ ;:f
Five days of corticosteroid for
exacerbations of COPD
Five days of oral prednisolone is enough for most
people with an acute exacerbation of chronic
obstructive pulmonary disease (COPD), accord-
ing to a head to head trial from Switzerland.
Patients given 40 mg daily for hve days or 14 days
had almost identical outcomes during the next
six months. Just over a third of each group had
another exacerbation (37.2% v 38.4%; dierence
1.2%, 95% CI 12.2% to 9.8%) and 8% of each
group died (7.7% (12/156) v 8.4% (13/155);

Adapted from Lancet 2u13; doi;1u.1u16/Su1/u-6736(13)6u/36-5
Dose-response eect
Maternal iodine to creatinine ratio
in the rst trimester (g/g)

<5u 5u-15u 15u
12 BMJ | 1 JUNE 2013 | VOLUME 346
School of Population and Global
Health, University of Melbourne,
Carlton, Vic !u'!, Australia
Department of Radiology, Alfred
Health, Prahran, Vic, Australia
Medical Benefits Scheme Analytics
Section, Department of Health and
Ageing, Canberra, ACT, Australia
Department of Diagnostic Imaging,
Southern Health, and Monash
University Southern Clinical School,
Clayton, Vic, Australia
Biostatistics Group, International
Agency for Research on Cancer,
Lyon, France
Cancer Epidemiology Centre,
Cancer Council Victoria, Carlton, Vic,
Diagnostic Imaging and Nuclear
Medicine Section, Australian
Radiation Protection and Nuclear
Safety Agency, Yallambie, Vic,
Data Linkage Unit, Australian
Institute of Health and Welfare,
Canberra, Australia
Faculty of Health, University of
Canberra, Canberra, Australia
Clinical Trial Service Unit and
Epidemiological Studies Unit,
University of Oxford, Oxford, UK
Medical Imaging, Royal Childrens
Hospital Melbourne, Parkville, Vic,
Correspondence to: J Mathews
Cite this as: BMJ ;:f
doi: 1u.11!6/bmj.fl!6u
This is a summary of a paper that
was published on as BMJ
STUDY QUESTION Does ionising radiation from computed
tomography (CT) scans lead to an increased risk of cancer?
SUMMARY ANSWER For people exposed to at least one CT
scan before age years, cancer incidence was increased
by % on average; the proportional increase in cancer risk
was greater after scans at younger ages.
The carcinogenic effect of ionising radiation has been well
documented at larger doses, but not at the doses typically
delivered by CT scans (- mGy per organ imaged). This
study reports increases for most types of cancer following CT
scan exposure, and confirms an earlier report of increases in
leukaemia and brain cancer.
Participants and setting
The cohort included all people with an Australian Medicare
record, aged 0-19 years on 1 January 1985 or born during
1985-2005. All Medicare funded CT scans of cohort mem-
bers aged 0-19 years during 1985-2005 were identihed.
Cohort members were followed to 31 December 2007 by
record linkage to national cancer and death registers.
Design, size, and duration
For the 680 211 people with a Medicare record of a CT
scan, we compared cancer incidence from one year aher
the hrst scan with rates for 10 259 469 unexposed people,
by means of Poisson regression with stratihcation for sex,
age, and year of birth. Mean length of follow-up in exposed
individuals was 9.5 years.
Main results and the role of chance
The study cohort had 60 674 cancers, including 3150 in
the exposed group. Overall cancer incidence was 24%
greater for exposed people than for unexposed people
(incidence rate ratio (IRR) 1.24 (95% conhdence inter-
val 1.20 to 1.29); P<0.001). We saw a dose-response
association, with an IRR increase of 0.16 (0.13 to 0.19)
for each additional CT scan. IRRs were greater following
exposures at younger ages (P<0.001 for trend). At 1-4,
5-9, 10-14, and 15 or more years after first exposure,
IRRs were 1.35 (1.25 to 1.45), 1.25 (1.17 to 1.34), 1.14
(1.06 to 1.22), and 1.24 (1.14 to 1.34), respectively. IRRs
increased significantly for many types of solid cancer
(digestive organs, melanoma, soh tissue, female genital,
urinary tract, brain, and thyroid), and for leukaemias,
myelodysplasias, and other lymphoid cancers. For all
cancers, the absolute excess incidence rate was 9.38 per
100 000 person years at risk. An excess of 608 cancers was
associated with exposure (147 brain, 356 other solid, 34
leukaemia, 14 myelodysplasia, and 57 other lymphoid or
Bias, confounding, and other reasons for caution
Some people would have been wrongly classihed as unex-
posed because we had no information about CT exposures
not billed to Medicare (including exposures outside Aus-
tralia) and exposures aher the age of 19 years. Such mis-
classihcation would have weakened slightly the observed
association between exposure and subsequent cancer risk.
Although symptoms of some brain cancers could have led
to brain scans several years before they were correctly diag-
nosed, such reverse causation is unlikely to explain the
increased risks at longer periods aher exposure.
Generalisability to other populations
In this cohort, most of the increased cancer incidence fol-
lowing CT scan exposure was likely to be due to irradiation.
Similar risks aher scans would be expected in other popu-
lations. Future risks could be reduced in all populations by
restricting scans to cases with a dehnite clinical indication,
and by improving procedures to provide a diagnostic image
at the lowest possible radiation dose.
Study funding/potential competing interests
This study was supported by funds from the Australian
government via the National Health and Medical Research
Council, and by in-kind contributions of researchers
funded by the Cancer Research Campaign UK or employed
by other agencies. We declare no competing interests.
Cancer risk in 680 000 people exposed to computed tomography
scans in childhood or adolescence: data linkage study of 11 million
John D Mathews,
Anna V Forsythe,
Zoe Brady,
1 l
Martin W Butler,
Stacy K Goergen,

Graham B Byrnes,
Graham G Giles,
Anthony B Wallace,
Philip R Anderson,
S 9
Tenniel A Guiver,

Paul McGale,
Timothy M Cain,
James G Dowty,
Adrian C Bickerstaffe,
Sarah C Darby
EDITORIAL by Sodickson
Incidence of all cancers in exposed versus unexposed
cohorts, based on one year lag period
No of CT scans per individual




OListen to a podcast about this
research paper
BMJ | 1 JUNE 2013 | VOLUME 346 13
STUDY QUESTION What is the diagnostic value of
D-dimer testing in older patients with suspected venous
thromboembolism when the conventional cut-off value
is applied, and is the use of an age adjusted cut-off value
(age g/L in patients aged or more) a safe and more
efficient strategy?
SUMMARY ANSWER D-dimer testing is of limited utility
in older patients when the conventional cut-off value is
applied. Application of age adjusted cut-off values increases
the specificity without modifying the sensitivity, thereby
largely increasing the proportion of older patients with a
non-high clinical probability in whom imaging can be safely
D-dimer levels increase with age, D-dimer testing is less
useful to exclude venous thromboembolism in older
patients if the conventional cut-off value ( g/L) is used.
The specificity of D-dimer testing increased substantially
when the age adjusted cut-off value was applied and was
more than doubled in the eldest patients (> years).
This would result in imaging examinations being correctly
avoided in % to % of elderly patients with a non-high
probability of venous thromboembolism.
Selection criteria for studies
We searched Medline and Embase for studies published
before 21 June 2012 and contacted the authors of primary
studies. We selected studies that enrolled older patients
with suspected venous thromboembolism in whom
D-dimer testing (using both conventional (500 g/L) and
age adjusted (age10 g/L in patients aged >50 years)
cut-o values) and reference testing were performed. 22
tables were reconstructed and stratihed by age category
and D-dimer cut-o value.
Primary outcomes
Sensitivity and specihcity of D-dimer testing in patients
aged over 50 years.
Main results and role of chance
13 cohorts including 12 497 patients with a non-high
clinical probability were included in the meta-analysis.
The specihcity of the conventional cut-o value decreased
with increasing age, from 58% (95% conhdence interval
51% to 64%) in patients aged 51-60 years to 39% (34%
to 46%) in those aged 61-70 years, 25% (20% to 30%) in
those aged 71-80 years, and 15% (11% to 19%) in those
aged >80 years. Age adjusted cut-o values revealed higher
specihcities over all age categories: 62% (56% to 68%),
50% (43% to 56%), 44% (38% to 51%), and 35% (30% to
42%), respectively. Sensitivities of the age adjusted cut-o
remained above 97% in all age categories.
Bias, confounding, and other reasons for caution
The results of this meta-analysis are not applicable to
patients with a high clinical probability of venous throm-
boembolism, as additional imaging is warranted in these
patients to conhrm or refute the diagnosis, irrespective of
the D-dimer test results. Additional analyses showed that
the relative merit of application of the age adjusted instead
of the conventional cut-o value is higher in the case of
a low prevalence of venous thromboembolism compared
with a higher prevalence. We found some heterogeneity in
sensitivity and specihcity of D-dimer among studies, partly
explained by the application of dierent D-dimer assays. In
12 of the 13 included cohorts, venous thromboembolism
was excluded without imaging examination in patients
who were not at high risk, with a negative D-dimer (<500
g/L) test result and no recurrence of symptoms during
follow-up. This could have introduced small overestima-
tions of the diagnostic accuracy of the D-dimer test, as
small thrombi might have been missed in these patients.
Study funding/potential competing interests
This study was supported by the Netherlands Organization
for Scientihc Research. The authors were independent of
the funders for all aspects of the study.
Diagnostic accuracy of conventional or age adjusted D-dimer
cut-off values in older patients with suspected venous
thromboembolism: systematic review and meta-analysis
Henrike J Schouten,
1 l
G J Geersing,
H L Koek,
Nicolaas P A Zuithoff,
Kristel J M Janssen,

Rene A Douma,
Johannes J M van Delden,
Karel G M Moons,
Johannes B Reitsma
Julius Center for Health Sciences
and Primary Care, University Medical
Center Utrecht, PO Box S''uu,
!'uSGA Utrecht, Netherlands
Department of Geriatrics,
University Medical Center Utrecht,
Utrecht, Netherlands
Mapi Consultancy, Houten,
Department of Vascular Medicine,
Academic Medical Centre,
Amsterdam, Netherlands
Correspondence to: H J Schouten
Cite this as: BMJ ;:f
doi: 1u.11!6/bmj.fl/9l
This is a summary of a paper that
was published on as BMJ
Pooled estimates of diagnostic accuracy of D-dimer testing in older patients suspected of having venous thromboembolism with a
non-high clinical probability, per age category and cut-off value ( study cohorts)
Age (years) No of patients
Pooled sensitivity (% CI) Pooled specificity (% CI)
Conventional cut-off (%) Age adjusted cut-off (%) Conventional cut-off (%) Age adjusted cut-off (%)
'u ''lS 97.6 (9'.u to 9S.9) NA 66.S (61.! to 7l.u) NA
'1-6u lu/! 1uu.u (NA) 99./ (97.! to 99.9) '7.6 ('1./ to 6!.6) 6l.! ('6.l to 6S.u)
61-7u 1S1' 99.u (96.7 to 99.7) 97.! (9!.S to 9S.S) !9./ (!!.' to /'.6) /9.' (/!.l to ''.S)
71-Su 1S/l 9S.7 (96.' to 99.') 97.! (9/.! to 9S.S) l/.' (lu.u to l9.7) //.l (!S.u to 'u.')
>Su 1l69 99.6 (96.9 to 99.9) 97.u (9l.9 to 9S.S) 1/.7 (11.! to 1S.6) !'.l (l9./ to /1.')
Age adjusted cut-off value (age'u g/L) does not apply (NA) to patients aged 'u years.
OResearch: Validation of two
age dependent D-dimer cut-ol
values for exclusion of deep
vein thrombosis in suspected
elderly patients in primary care:
retrospective, cross sectional
diagnostic analysis (BMJ
OResearch: Excluding venous
thromboembolism using point of
care D-dimer tests in outpatients:
a diagnostic meta-analysis
(BMJ luu9;!!9:bl99u)
OResearch: Safe exclusion
of pulmonary embolism using
the Wells rule and qualitative
D-dimer testing in primary care:
prospective cohort study
(BMJ lu1l;!/':e6'6/)
14 BMJ | 1 JUNE 2013 | VOLUME 346
Day of week of procedure and 30 day mortality for elective
surgery: retrospective analysis of hospital episode statistics
P Aylin,

R Alexandrescu,

M H Jen,

E K Mayer,

A Bottle

STUDY QUESTION Is there any association between

postoperative mortality and the day of the week on which
the procedure is carried out?
SUMMARY ANSWER The risk of death is higher for patients
who undergo elective surgical procedures later in the
working week and at the weekend compared with those who
have their operations carried out on Mondays. This does not
seem to be explained by variations in case mix.
research has suggested a significantly higher risk of
death if patients are admitted as an emergency at the
weekend compared with weekdays, but no large nationally
representative studies have examined the day of elective
procedure while also accounting for deaths after discharge.
Our study suggests a potentially much stronger weekday
and weekend effect for elective procedures than is seen in
emergency admissions.
Participants and setting
Patients undergoing elective operating room procedures
in English public hospitals over three hnancial years from
2008-09 to 2010-11.
A retrospective analysis of national hospital administra-
tive data.
Primary outcome
Death in or out of hospital within 30 days of the procedure.
Main results and the role of chance
There were 27 582 deaths by 30 days aher 4 133 346 inpa-
tient admissions for elective operating room procedures
(overall crude mortality rate 6.7 per 1000). The number of
weekday and weekend procedures decreased over the three
years (by 4.5% and 26.8%, respectively). The adjusted
odds of death were 44% and 82% higher, respectively, if
the procedures were carried out on Friday (odds ratio 1.44,
95% conhdence interval 1.39 to 1.50) or at the weekend
(1.82, 1.71 to 1.94) compared with Monday.
Bias, confounding, and other reasons for caution
One of the weaknesses of using administrative data is that
we were unable to completely adjust for the selection bias
that probably exists for elective procedures that are sched-
uled at weekends. Our hndings around weekend mortal-
ity should therefore be interpreted with caution. Weekday
procedures are less prone to such extreme selection bias,
and our hndings of higher adjusted 30 day mortality for
patients who have procedures carried out closer to the end
of the week are more robust. Daily variation in those risk
factors that we were able to account for seemed to suggest
that patients operated on towards the end of the week and
at the weekend actually had a lower risk prohle than Mon-
day patients. Without more detailed information related to
surgical care processes, it remains unclear if the estimated
risks can be entirely attributed to dierences in quality of
Generalisability to other populations
Our analysis was based on national administrative data
from English hospitals and is therefore likely to be gen-
eralisable to the rest of the United Kingdom. We did hnd
some heterogeneity by procedure, and there is also likely
to be some heterogeneity by hospital. As a result of this
work, other countries with healthcare systems operating
reduced services/stamng at weekends could beneht from
looking at their own outcomes by weekday.
Study funding
The Dr Foster Unit at Imperial College London is funded
by a research grant from Dr Foster Intelligence (an inde-
pendent health service research organisation) and joint
venture with the Department of Health. The Dr Foster Unit
at Imperial is amliated with the Imperial Centre for Patient
Safety and Service Quality at Imperial College Healthcare
NHS Trust, which is funded by the National Institute of
Health Research.

Dr Foster Unit at Imperial College,

Department of Primary Care and
Public Health, School of Public
Health, Imperial College, London

Department of Surgery and Cancer,

St Marys Hospital, Imperial College,
London W NY, UK
Correspondence to: P Aylin
Cite this as: BMJ ;:f
doi: ./bmj.f
This is a summary of a paper that
was published on as BMJ
EDITORIAL by Kwan and Bell
Adjusted odds of death by day of procedure in English
hospitals for - to -
Days of week

Mon Tue Wed Thu Fri Sat/Sun
BMJ | 1 JUNE 2013 | VOLUME 346 15
STUDY QUESTION How well does a new risk algorithm
(QStroke) estimate risk of stroke or transient ischaemic
attack in patients without prior stroke events, including
patients with atrial fibrillation?
SUMMARY ANSWER QStroke provides a valid measure of
absolute stroke risk in the general population of patients
and in the subset with atrial fibrillation, as shown by its
performance in a validation cohort.
to classify patients at high or low risk of stroke are needed
to identify those for whom interventions may be required,
especially those with atrial fibrillation, who might need
anticoagulation. QStroke shows some improvement on
current risk scoring methods for the subset of patients with
atrial fibrillation.
Participants and setting
In the derivation cohort for QStroke, we studied 3.5 mil-
lion patients aged 25-84 years with 24.8 million person
years who experienced 77 578 hrst stroke events. For the
validation cohort, we identihed 1.9 million patients aged
25-84 years with 12.7 million person years who experi-
enced 38 404 hrst stroke events. We excluded patients with
a prior diagnosis of stroke or transient ischaemic attack
and those prescribed oral anticoagulants at study entry.
Design, size, and duration
This prospective open cohort study used routinely col-
lected data from QResearch general practices in England
and Wales. We used 451 practices to develop the scores
(derivation cohort) and a separate set of 225 practices
to validate the scores (validation cohort). We used Cox
proportional hazards models in the derivation cohort to
derive risk equations. Risk factors considered included
self assigned ethnicity, age, sex, smoking status, systolic
blood pressure, ratio of total serum cholesterol to high
density lipoprotein cholesterol, body mass index, history
of coronary heart disease in a hrst degree relative aged
<60 years, Townsend deprivation score, treated hyperten-
sion, type 1 and type 2 diabetes, renal disease, rheuma-
toid arthritis, coronary heart disease, congestive cardiac
failure, valvular heart disease, and atrial hbrillation. We
tested the performance of the QStroke algorithm in the
validation dataset and made comparisons with other risk
scores for stroke.
Main results and the role of chance
The QStroke algorithm explained 57% of the variation
in women and 55% in men without a prior stroke. The
D stat istic (a measure of discrimination) for QStroke was
2.4 in women and 2.3 in men. QStroke had improved
performance on all measures of discrimination and cali-
bration compared with the Framingham risk score for
stroke in patients without a prior stroke. In patients with
atrial hbrillation, levels of discrimination were lower, but
QStroke had some improved performance on all meas-
ures of discrimination compared with current risk scoring
methods CHADS
and CHA
Bias, confounding, and other reasons for caution
Limitations include lack of formally adjudicated outcomes,
information bias, potential for bias due to missing data,
and residual confounding.
Generalisability to other populations
A strength of our study is that we have developed the
algorithms in one cohort and validated in a separate
cohort representative of the patients likely to be consid-
ered for preventive measures.
The algorithm is based on simple clinical variables that
patients will know or that are routinely recorded in UK
general practices. The algorithm could be integrated into
GP clinical computer systems and used to assess risk of
stroke in patients.
Study funding/potential competing interests
JHC is co-director of QResearch, a partnership of University
of Nottingham and EMIS (commercial supplier of IT for UK
general practices), and is director of ClinRisk, which pro-
duces sohware for clinical risk algorithms. CC works for
University of Nottingham and is a consultant statistician
for ClinRisk.
Derivation and validation of QStroke score for predicting risk of
ischaemic stroke in primary care and comparison with other risk
scores: a prospective open cohort study
Julia Hippisley-Cox,
Carol Coupland,
Peter Brindle
Division of Primary Care, University
Park, Nottingham NGl 7RD, UK
Avon Primary Care Research
Collaborative, Bristol Clinical
Commissioning Group, Bristol
Correspondence to: J Hippisley-Cox
Cite this as: BMJ 2013;346:f2573
doi: 1u.11!6/bmj.fl'7!
This is a summary of a paper that
was published on as BMJ
Validation statistics for the QStroke prediction algorithm in the validation cohort
Prediction algorithm and validation statistic
Mean (95% CI)
Women Men
All patients (n=962 083) (n=935 085)
QStroke (l'-S/ years) R
(%)* '7.! ('6.S to '7.S) ''.1 ('/.6 to ''.7)
D statistic* l.!7 (l.!' to l./u) l.l7 (l.l/ to l.!u)
ROC statistic* u.S77 (u.S7' to u.S79) u.S66 (u.S6/ to u.S6S)
QStroke (!'-7/ years) R
(%)* /!.7 (/l.9 to //.') /1.9 (/1.1 to /l.7)
D statistic* 1.Su (1.77 to 1.S!) 1.7/ (1.71 to 1.77)
ROC statistic* u.S1/ (u.S1u to u.S1S) u.Su6 (u.Sul to u.Su9)
Framingham stroke
equation (!'-7/ years)
(%)* !S.' (!7.7 to !9./) !'.7 (!/.S to !6.')
D statistic* 1.6l (1.'9 to 1.6') 1.'l (1.'u to 1.'')
ROC statistic* u.79S (u.79/ to u.Sul) u.7SS (u.7S/ to u.791)
Patients with atrial fibrillation at baseline (n=3180) (n=4509)
QStroke R
(%)* 1/.u (9.l to 1S.7) l/.1 (19.! to lS.9)
D statistic* u.Sl (u.66 to u.99) 1.1' (1.uu to 1.!u)
Harrells C statistic* u.6' (u.6l to u.67) u.71 (u.69 to u.7!)
(%)* 9.6 ('.' to 1!.S) 1S.! (1!.7 to ll.S)
D statistic* u.67 (u.'1 to u.S!) u.97 (u.Sl to 1.1l)
Harrells C statistic* u.6l (u.'9 to u.6') u.67 (u.6' to u.69)
(%)* 9.1 (/.9 to 1!.l) 1!.' (9.1 to 17.9)
D statistic* u.6/ (u./9 to u.S1) u.S1 (u.66 to u.96)
Harrells C statistic* u.61 (u.'9 to u.6/) u.6! (u.61 to u.66)
*Measures of discrimination, higher values indicate better discrimination.
OStroke updates from the
BMJ Group are at
16 BMJ | 1 JUNE 2013 | VOLUME 346
patients would expect. It has not happened as
quickly as many would like but has been given
a new impetus by the events at Mid Staord-
shire NHS Trust, where a public inquiry found
hundreds of excess deaths between 2005 and
2009, unnoticed by regulators or Department
of Health omcials.

Since Bristol clinical audit has greatly
improved and much more data are available,
enabling problems to be detected more quickly
and corrected. But the Mid Staordshire inquiry
has highlighted the danger that the data may be
ignored or questioned. So can the health service
learn from its mistakes and stop the same errors
happening over and over again?
Past attempts
Serious eorts have been made in the past to
introduce safety nets, with limited success.
More than a decade ago, Liam Donaldson,
then chief medical omcer for England, set out
to put a new emphasis on safety. His landmark
publication, An Organisation with a Memory,
published in 2000, estimated that more than
850 000 adverse events occur in NHS hospitals
each year in which patients are harmed, with a
cost in additional hospital stays alone of more
than E2bn (t2.4bn; $3bn).
The Department of
Health announced the creation in 2001 of the
National Patient Safety Agency with a system
for reporting adverse events and near misses.
Donaldson suggested that the agencys system
of identifying and analysing adverse events
would lead to a more blame-free, open NHS
In 1995, 18 month old Joshua Loveday was
scheduled to undergo a complicated switch
heart operation at Bristol Royal Infirmary.
But behind the scenes, desperate last minute
attempts were being made by an anaesthetist, a
surgeon from outside Bristol, and a senior om-
cial from the Department of Health to persuade
the hospital not to go ahead with the operation.
Unknown to Joshuas parents and the public
generally, hgures kept by Bristol anaesthetist
Stephen Bolsin suggested that the hospitals
mortality rates for such operations were much
higher than those at other units. The operation
went ahead anyway, and Joshua died on the
operating table.
His death led to a public inquiry, which in
2001 found that 30 to 35 more babies under 1
year old died having open heart surgery at Bristol
between 1991 and 1995 than would have died
if they had had their operations at a typical unit.
The mortality rates for children under 1 year were
probably double the rate in England as a whole,
the inquiry found, and even higher for children
younger than 30 days.
Bristols poor results were
an open secret in the hospital: Bolsin had been
trying to raise concerns about them for years. In
the end, he found himself frozen out in the UK
and took a job in Austrialia. At the Bristol inquiry,
the chair of the regional health authority respon-
sible for the Bristol Royal Inhrmary admitted that
from the data available she would not know how
many patients had died in a particular hospital;
her concern was throughput.
Spool forward to 2013 and the day aher NHS
Englands medical director Bruce Keogh learnt
of preliminary data suggesting that death rates
during paediatric heart surgery at Leeds General
Inhrmary might be twice as high as the national
average. He ordered childrens cardiac surgery
to be immediately suspended while concerns
were investigated. It was not restarted until 11
days later, aher the hospital supplied missing
data and surgery was pronounced safe. For the
national medical director to intervene so rapidly,
proactively, and transparently marks a huge shih
from the way the NHS has traditionally operated.
In the 18 years between the two episodes, the
NHS has been groping its way towards a culture
in which safety is accorded the priority most
The long road to
ensuring patient safety
in NHS hospitals
As part of a series on compensation for clinical errors, Clare Dyer
looks at efforts, past and present, to monitor and prevent mistakes
that harm patients
OResearch: Patient safety, satisfaction, and quality of hospital care: cross sectional surveys of nurses and
patients in 1l countries in Europe and the United States (BMJ lu1l;!//:e1717)
OResearch: Multiple component patient safety intervention in English hospitals: controlled evaluation of
second phase (BMJ lu11;!/l:d199)
OResearch: Patient safety indicators for England from hospital administrative data: case-control analysis and
comparison with US data (BMJ luuS;!!7:a17u)
Liam Donaldson suggested identifying and
analysing adverse events would lead to a
more blame free, open NHS
BMJ | 1 JUNE 2013 | VOLUME 346 17
where lessons would be shared and learnt.
In 2003-4 the agency introduced the National
Reporting and Learning System to enable trusts
and, anonymously, healthcare stato report
patient safety incidents. Donaldson had recom-
mended a mandatory system for organisations,
but in the event it was voluntary. The result, as
Robert Francis, QC, chairman of the Mid Staf-
fordshire public inquiry, pointed out in his report
in February, was that NHS
organisations can choose
whether to report, how much
to report and what to report.
The scheme sends health-
care providers regular patient
safety alerts derived from
analysing incident reports
and other safety information.
Reporting is mandatory for
never events: a list of serious, preventable
incidents, such as operating on the wrong site
or leaving a foreign body inside the patient aher
surgery, that should never happen. More than
300 never events were reported in 2011-12.
Reporting has also been mandatory since 2010
for serious patient safety incidentsthose lead-
ing to severe harm or death, which topped 10
000 in 2011-12.
The 2006 Department of Health report Safety
First concluded that safety was not always given
the same priority as other major issues such as
reducing waiting times, implementing national
secure frameworks and achieving hnancial bal-
However, since the early 2000s concern
has grown, both in the UK and internationally,
that healthcare is an inherently dangerous
enterprise that has not focused as strongly on
safety as have other high risk industries such as
aviation. Researchers are busy trying to identify
what factors aect the riskiness of healthcare
and how it can be made safer. One suggestion
is that lessons learnt from the aviation industry
could be applied to healthcare. These include an
emphasis on human factors,
the discipline that studies the
relations between human
behaviour, system design,
and safety. But healthcare is
more complex than aviation
and everybody involved in
this area underestimated the
challenge of the improve-
ment side and why its so
dimcult, Charles Vincent, professor of clinical
safety research at Imperial College London, told
the Mid Staordshire inquiry.
Aviation and other high risk industries rely on
a safety culture where the organisation acknowl-
edges that mistakes will happen, wants to know
about things that go wrong, and acts to try to
prevent recurrence. Too ohen in the NHS safety
warnings have gone unheeded, and those who
have brought problems to light have been blamed
and scapegoated.
Safety was deemed the responsibility of indi-
vidual clinicians rather than seen as an organi-
sational issue, noted the Health Foundation,
an independent charity. In 2004 it launched the
four year Safer Patients Initiative to test ways of
improving safety in intensive care, general ward
care, perioperative care, medicines management,
and critical care. Later work has looked at how to
reduce harm in maternity services, mental health
services, and general practice.
Cost of mistakes
Failing to prioritise safety is expensive, not
only in extra care for patients who experience
adverse incidents, but in spiralling compensa-
tion costs. The bill for clinical negligence claims
has ballooned, reaching E1.28bn in 2011-
This year the NHS Litigation Authority
launched an initiative to learn safety lessons
from legal claims, with the appointment of
Suzette Woodward, former director of patient
safety at the National Patient Safety Agency, to
a new post as the Litigation Authoritys director
of learning, safety, and people.
Surgery is the area giving rise to the largest
number of clinical negligence claims against
NHS trusts in Englandtwice as many as the next
highest, obstetrics and gynaecology. The World
Health Organizations surgical safety checklist,
issued in 2008, has been shown to reduce deaths
and complications,
and the National Patient
Safety Agency required all NHS organisations
to adopt it by February 2010. But the checklists
were handed down on high by diktat . . . with-
out frontline clinicians being convinced of their
eectiveness, suggested a 2009 report on patient
safety from the Commons Health Committee.
some operating theatres it is absolutely routine;
in others not at all, Vincent told the Mid Staord-
shire public inquiry.
Lessons from Mid Staffordshire
In his 2008 Next Stage Review Ara Darzi, profes-
sor of surgery at Imperial College London and
then a health minister in the House of Lords,
set out a long term vision for the NHS, making
the quality of services, including safety, a top
Since then the NHS has been focusing
more on clinical audit of outcomes and trying to
develop the information sources that can help it
expose and tackle unsafe variations in care. As
events at Mid Staordshire laid bare, there is still
much progress to be made.
Mid Staordshire stood out in the league
table of hospital standardised mortality ratios
produced by the Dr Foster Unit at Imperial Col-
lege. Yet managers were in denial, insisting
the poor hgures were down to coding errors.
The reliability of hospital mortality hgures
as a warning signal that something might be
wrong was questioned by omcials and NHS
managers for years, yet it was these hgures
that hnally persuaded the Healthcare Com-
mission to go into Staord Hospital in 2009
The new architecture, with
a bigger role for clinicians
in commissioning
healthcare services, could
provide another chance to
put safety at the heart of
the NHS




18 BMJ | 1 JUNE 2013 | VOLUME 346
NHS, rather than of learning, innovation and
enthusiastic participation in improvement,
and warned that fear impedes learning and
dampens co-operation.
Vincent, a member of the Berwick advisory
panel, told the BMJ, If youve got people
saying I dont want to hear bad news, then
youve got a dangerous organisation immedi-
ately. He believes NHS organisations need to
mount their own safety programmes locally,
looking hard at whats going on day to day
rather than just responding to regulators. The
balance is wrong at the moment in the NHS.
We need more eort, more safety improvement
generated and led by clinicians and managers
in the organisations they work for, rather than
simply saying if weve met what the regulator
says then thats it, were safe.
Nevertheless, he hnds the transformation
in the landscape unbelievable since he
started working on healthcare safety in the
mid-1980s and is hopeful for the future. I
think whats happening now is were realis-
ing this is much tougher than people thought
and theres a certain realism coming across
the boardclinicians, managers, every-
bodybut no particular loss of eort. So Im
more optimistic now than I would have been
a few years ago.
Clare Dyer is legal correspondent, BMJ, London WC1H 9JR
Competing interests: I have read and understood the BMJ
Group policy on declaration of interests and have no relevant
interests to declare.
Provenance and peer review: Commissioned; not externally
peer reviewed.
1 Bolsin S. Too many babies were damaged and dying.
Medical Harm lu11 July l7.
l Kennedy I. Learning from Bristol: the report of the public
inquiry into childrens heart surgery at the Bristol Royal
Infirmary 19S/199'. HMSO, luu1.
! Francis R. Report of the Mid Staffordshire NHS Foundation
Trust public inquiry. lu1!. www.midstaffspublicinquiry.
/ Department of Health. An organisation with a memory. DH,
' Department of Health. Safety first: a report for patients,
clinicians and healthcare managers. DH, luu6.
6 NHS Litigation Authority. Report and accounts lu11-1l.
NHSLA, lu1l.
7 Haynes A, Weiser T, Berry W, Lipsitz SR, Breizat AH,
Dellinger EP, et al. A surgical safety checklist to reduce
morbidity and mortality in a global population. N Engl J Med
S House of Commons Health Committee. Patient safety.
Sixth report of session luuS/u9. HC1'1-1. luu9. www.
9 Darzi A. High quality care for allNHS next stage review final
report. Department of Health, luuS.
1u NHS Litigation Authority. Ten years of maternity claims: an
analysis of NHS Litigation Authority data. NHSLA, lu1l.
11 Pasupathy D, Wood AM, Pell JP, Mechan H, Fleming M,
Smith GCS. Time of birth and risk of neonatal death at term:
retrospective cohort study. BMJ lu1u;!/1:c!/9S.
1l Institute for Healthcare Improvement. Achieving the
vision of excellence in quality. luuS.
Cite this as: BMJ ;:f
and uncover appalling standards of care.
More attention is now being paid to mor-
tality data. Fourteen other trusts with higher
than expected mortality rates for two years are
being reviewed by a team headed by Keogh.
Brian Jarman, director of the Dr Foster Unit
and an adviser to the investigation into the
14 trusts, estimated in a BBC interview that
there had been tens of thousands of avoid-
able deaths in those hospitals alone over the
last 10 years.
Keogh pledged in April when giving the go
ahead for childrens heart surgery to resume
at Leeds, I want to be clear that NHS England
will do everything in its power to make sure
that measuring clinical outcomes will be given
priority in the new NHS. Organisations cannot
know they are providing eective or safe care
unless they are measuring and monitoring
their services. Heart surgeons have taken the
lead in publishing the outcomes of individual
surgeons, a move which has driven up stand-
ards. NHS Englands mandate for the next two
years includes shining a spotlight on variation
and unacceptable practice, starting with pub-
lishing outcomes in eight more surgical spe-
cialties as well as cardiology.
The quality, reliability, safety, and team-
work group at Oxford University is conduct-
ing a range of studies, including one looking
at ways of reducing preventable complications
of surgery. The unit is testing a range of inter-
ventions from other industriessuch as crew
resource management training from aviation,
lean manufacturing from process engineer-
ing at Toyota, and standard operating proce-
duresand applying them to healthcare.
At Mid Staffordshire, a key factor in the
dangerous care provided was inadequate
stamng levels, particularly of nurses, as the
trust strove to cut its dehcit to win founda-
tion trust status. And there are warning signs
that stamng is a more general problem. Legal
claims over birth errors cost the NHS E3.1bn
between 2000 and 2010, according to an
analysis by the NHS Litigation Authority.

Many claims arose from the interpretation of
cardiotocographs when women were cared
for by midwives alone or with junior doctors.
There is evidence that deliveries outside the
normal working week are associated with a
higher risk of neonatal death,
and the Royal
College of Obstetricians and Gynaecologists
has called for more consultants to be available
round the clock on labour wards. Information
governance puts hurdles in the way of linking
dierent NHS databases, but a research team
has applied for funding to look at the link
between time of birth and adverse outcomes
in England and Wales.
Risks are high with NHS trusts under pres-
sure to achieve cost savings at the same time
as the health service undergoes the largest
reorganisation in a generation. Yet the new
architecture, with a bigger role for clinicians
in commissioning healthcare services, could
provide another chance to put safety at the
heart of the NHS. Keogh has established a
reference group to identify how human fac-
tors could be embedded in the future NHS.
He told the hrst meeting, Weve been talking
about human factors for 10 years, but done
nothing . . . Given the current changes in the
NHS and the obvious need for improvement,
now is a good time to explore how we can
embed human factors in the new landscape.
Ending a culture of fear
The Department of Health has set up a new
national advisory panel on the safety of
patients, headed by Don Berwick, former
head of the US based Institute for Healthcare
Improvement and a world authority on patient
safety. The panel is due to report its recom-
mendations in July. Berwick will be working
with NHS England to ensure a robust safety
culture and a zero tolerance of avoidable harm
is embedded in the DNA of the NHS, the gov-
ernment has promised.
His key role holds out some hope of action
on what may be the biggest challengeensur-
ing that NHS sta can raise safety concerns
in the future without risking career suicide.
Berwicks team from the Institute for Health-
care Improvement produced a report for the
Department of Health in 2008, Achieving the
Vision of Excellence in Quality. It highlighted a
culture of fear and top-down control in the
Don Berwick highlighted a culture of fear and
top-down control in the NHS, rather than
of learning, innovation and enthusiastic
participation in improvement
BMJ | 1 JUNE 2013 | VOLUME 346 19
Promoting health
in prison
Prisons contain some of societys most disadvantaged people.
In the last of his series Stephen Ginn looks at how prison
provides opportunities to improve their health and asks
whether earlier intervention could keep them out of prison in
the first place
n previous articles I have set out the chal-
lenges of providing healthcare in prisons
and have examined the problems in British
prisons of elderly prisoners, women prison-
ers, and prisoners with mental disorders.

In this hnal article of the series I highlight how
prison contributes to the treatment of people who
are hard to reach.
Many British prisoners come from the most
economically deprived and socially disadvan-
taged groups within society. They share with
these groups the experience of being raised
in care, low educational attainment, unem-
ployment, and homelessness (table 1).
minority ethnic groups are substantially over-
represented (table 2). Many prisoners have
chaotic lifestyles and complex health and social
problems. They may also have limited health
aspirations and low expectations of health
services, which may not have the exibility to
respond eectively to their needs.

Prison can provide an opportunity for the
orderly assessment and treatment of those whose
lifestyle has previously prevented engagement.
Prisoners can be encouraged to adopt healthier
behaviours, and prison can provide an oppor-
tunity to address health inequalities.
prisons are not principally in the business of pro-
moting health and some people argue that there
is an inherent contradiction between the aims of
care and control.
Prisons have values, rules, and
rituals that enable prisoners to be observed, con-
tained, and disempowered
; these are at odds
with any notion that prisoners can be encour-
aged to take charge of their health.
In addition,
any discussion about the health of prisoners
cannot ignore the broader question of whether
prison is the right place for many oenders.
Health promotion in prison
The hrst dedicated health promotion strategy for
prisons in England and Wales was published in
Because few resources have been invested
in evaluating it, its impact is largely unknown.


In 2008-09 Her Majestys Inspectorate of Prisons
and the Care Quality Commission examined
a sample of 21 primary care trusts and found
that all undertook health promotion in prisons.
Although there was evidence of good practice,
the information on provision was not always suf-
hciently detailed to allow proper appraisal.
Around 80% of prisoners in England and
Wales smoke,
four times the proportion of the
general public.
Reasons for prisoners smok-
ing include relief from boredom and stress.

Smoking in UK prisons has been restricted since
2007: prisoners may smoke in their cells but are
not allowed to smoke in their workplace or dur-
ing educational programmes or activities.
governments 2010 tobacco control strategy for
Table | Social characteristics of prisoners

Characteristic % of prison population

Taken into care as a child l/ (!1 for women, l/ for men)
Experienced abuse as a child l9 ('! for women, l7 for men)
Observed violence in the home as a child /1 ('u for women, /u for men
Regularly truanted from school '9
Excluded from school /l (!l for women, /! for men)
No qualifications /7
Unemployed in the four weeks before custody 6S (S1 for women, 67 for men)
Never had a job 1!
Homeless before entering custody 1'
Have children under the age of 1S '/
Having both anxiety and depression l' (/9 for women, l! for men)
Have a physical disability 1S
Used drugs in the four weeks before custody 6/
Drank alcohol every day in the four weeks before custody ll
OAnalysis: Promoting health in prison (BMJ lu1!;!/6:fll16)
OAnalysis: Women prisoners (BMJ lu1!;!/6:eS!1S)
OAnalysis: Elderly prisoners (BMJ lu1l;!/':e6l6!)
OAnalysis: Prison environment and health (BMJ lu1l;!/':e'9l1)



20 BMJ | 1 JUNE 2013 | VOLUME 346
England mentions prisoners as one of the vul-
nerable and disadvantaged groups whose high
rates of smoking should be tackled.
An evalu-
ation study of the use of nicotine replacement
therapy in 16 prisons in north east England,
found that quit rates similar to those in the com-
munity are possible.
There are, however, no plans for British pris-
ons to become smoke-free. This is in contrast to
the United States, where 60% of surveyed prisons
reported total tobacco bans, with 27% having an
indoor ban on tobacco use.
Non-smoking pris-
oners have successfully sued several states for
exposing them to second hand smoke.

Infectious disease
Prisons are vulnerable to infectious disease as
they are ohen overcrowded, with poor ventila-
tion, shared facilities such as showers, and high
turnover of prisoners, sta, and visitors.
breaks of seasonal inuenza and gastrointestinal
disease are common,
although prisons in Eng-
land and Wales did not experience signihcant
outbreaks during the 2009 u pandemic.
oners have higher rates of tuberculosis, hepatitis
B, and HIV infection than a similar population
outside prison.
A 1997 survey in England and
Wales found that 0.3% of male prisoners and
1% of female prisoners were positive for HIV,
and that 8% of adult males and
12% of adult females had hepa-
titis B antibodies.
Hepatitis C
antibodies were found in 9% of
men and 11% of women.
Resources available to pre-
vent spread of blood borne
viruses in prisons include dis-
infectant tablets to decontaminate needles,
syringes, and tattooing equipment. Condoms,
dental dams, and water based lubricants are
available on request. A hepatitis B vaccination
programme is in place. As injecting drug use is
the most common risk factor for hepatitis B in the
community, and 61% of injecting drug users are
imprisoned at some point, vaccination in prison
helps to protect this group.
Tuberculosis is associated with drug use,
incarceration, and homelessness,
and prison
offers an opportunity for identifying people
who are infected. A proposed national system
in England and Wales to allow screening at
reception is not yet in place, but eight prisons
receiving prisoners from areas of high preva-
lence have x ray machines, and tuberculosis
case hnding in prisons has increased (46 cases
in 2007 versus 91 cases in 2012).

ensuring completion of treat-
ment is dimcult. Pentonville
prison found that in 2005
62% of prisoners on directly
observed therapy were
homeless on release, with
less than half completing a
full course of treatment.
Drug misuse
Illegal drug use in prison is a substantial problem,
with some prisons having very high levels.
one study 48% of male and 38% of female sen-
tenced prisoners reported using drugs during
their current prison term.
Drugs may be posted
into prisons, brought in by visitors or prison omc-
ers, or thrown over the perimeter.
in prison treatment in England and Wales has
increased from E7m (t8m; $11m) in 1997-98 to
E80m in 2007-08 (not adjusted for ination).
In 2009-10, 60 067 prisoners received clinical
treatment for drug addiction in prison in England
and Wales.
Sixty per cent of these were entered
on a detoxihcation programme and the remain-
der on a maintenance programme.
care is planned using the integrated drug treat-
ment system,
which aims to combine clinical
and psychosocial approaches and to bridge
prison and community care.
Standards of treatment vary greatly across the
prison service.
Particular problems are recog-
nised in addressing the needs of those serving
short sentences, for whom serious drug or alcohol
problems are an abiding feature.
support on release is also a problem,
and pris-
oners are at a substantially increased risk of death
by drug overdose in the hrst month aher release.
Health on release
Release from prison can be a health depleting
For instance, one study of male
probationers found the suicide rate to be nine
times that of the local community population.

The operational guidelines for prisoner resettle-
ment in England and Wales include considera-
tion of the need for follow-up healthcare in the
but the quality of planning for post
Table | Proportion of people (%) of different ethnic backgrounds at various stages of the criminal justice system compared with general population, England and

White Black Asian Mixed Chinese or other Unknown Total No
Population aged 1u years, luu9 SS.6 l.7 '.6 1./ 1.6 - /S /17 !/9
Stop and searches luu9-1u 67.l 1/.6 9.6 !.u 1.l /./ 1 1/1 S!9
Arrests luu9-1u 79.6 S.u '.6 l.9 1.' l./ 1 !S6 u!u
Cautions lu1u* S!.1 7.1 '.l 1.S l.S l!u 1u9
Court order supervisions lu1u S1.S 6.u /.9 l.S 1.! !.l 161 6S7
Prison population (including foreign nationals) lu1u 7l.u 1!.7 7.1 !.' 1./ l.l S' uul
*Data based on ethnic appearance and therefore do not include mixed category.
62% of prisoners on
directly observed therapy
[for TB] were homeless
on release, with less than
half completing a full
course of treatment



BMJ | 1 JUNE 2013 | VOLUME 346 21
release care is variable, and continuity of care
can be poor.
Half of prisoners have no general
practitioner when they are released.
Former prisoners do not necessarily pri-
oritise their health on release, instead focusing
on basic needs such as accommodation .
a 2003 survey in England and Wales only two
thirds of adult prisoners said they had accom-
modation arranged for their release.
determinants of health such as poor prospects for
employment and lack of social
support are also problems.
Is this the only way?
Prison clearly has a part to play
in meeting the health needs of
a marginalised group of people.
However, it is ultimately not the
best place to tackle poor health. Some newspa-
pers delight in caricaturing prisons as holiday
but even if prisons shared some of
their characteristics, the harms of imprisonment
would remain. Custody separates families, and
former prisoners experience social disadvan-
tages such as a high unemployment rate.
ons enforced passivity and conscious wasting of
life also cause acute distress.
The average yearly cost of a prison place in
England and Wales is E39 573.
In 2012 UK total
prison spend was E4.1bn.
Despite this expense,
prison does little to deter oending and almost
half of those sentenced to custody are reconvicted
within a year.
It is important to ask whether the
resources allocated to imprisonment could be
spent more wisely, whether custody is the best
way of dealing with people who oend, and how
prison numbers can be kept to a minimum.
People who commit crimes ohen come into
contact with health and social services because
of their problematic behaviour. Management
revolves around sanctions such as custody

rather than earlier assistance in the community
that might prevent a prison sentence. Innovative
thinking is required to allow resources currently
allocated to prisons to be deployed more con-
structively and at all stages of the lives of people
at risk of future imprisonment. Many of Britains
most vulnerable citizens now pass at some point
through the criminal justice system.
People in
the community with multiple needs and exclu-
sions have not been a government priority, and
there is no overarching strategy to tackle their
health and social needs
with the explicit aim
of avoiding custody.
Although recorded crime is falling,
number of British prisoners continues to climb.
Arguably, many of them should not be there. This
is because of the relative harmlessness of their
oences, the vulnerability of the oenders, and
the harmful consequences of imprisonment. This
is not to say that people who break the law should
not be punished, but that prison and punishment
should not be synonymous. Alternatives to prison
may oer better outcomes and save money. One
economic analysis found that community sen-
tences save E3437 to E88 469 per sentenced
oender, rising to as much as E200 000 if longer
term changes to oending patterns are also con-
sidered. Community based drug treatment was
found to be particularly eective at saving costs as
oenders receiving treatment were
43% less likely to re-offend after
Court ordered commu-
nity sentences are reported to be 8%
more eective at reducing reoend-
ing rates than custodial sentences.
Continued and increasing reli-
ance on imprisonment is a moral
and political choice, a path that politicians
choose and society implicitly condones. During
1997-2009 the British government introduced
1036 new offences punishable by imprison-
and the prison population in England and
Wales has almost doubled since the early 1990s.

Electorally, no major political party seems able
to abandon a populist stance of being tough on
crime. Yet everyone is aected by the increasing
human and economic costs of an ever more puni-
tive criminal justice system.
Stephen Ginn Roger Robinson editorial registrar, BMJ,
London WCH JR, UK
Competing interests: I have read and understood the BMJ
Group policy on declaration of interests and have no relevant
interests to declare.
Provenance and peer review: Commissioned; not externally
peer reviewed,
References are in the version on
Cite this as: BMJ ;:f
BMJ BLOG Peter Bailey
Galley slaves, rebel!
Jeremy Hunts speech to the Kings Fund
on May made me wonder if someone in
the Department of Health had had an Oh
my God! moment. His speech seemed
to suggest a dawning understanding that
those working in the front line of medicine in
general practice, the out of hours service, and
emergency departments are the good guys,
not the enemy. Slagging them off, starving
them of funds, setting impossible targets, and
beating them about the head with lurid stories
of failure has not, after all, improved the NHS.
The effect has instead been an erosion of
morale, a steady increase in morbid cynicism,
and a haemorrhage of talent away from the
beleaguered work places. Small wonder that
emergency medicine vacancies cannot be filled
and % of trainees leave the speciality. Who is
surprised that general practitioners over are
eyeing up the prospects for early retirement?
So, with this dreadful awakening to reality,
what is Jeremy Hunt actually saying? Is
he proposing a significant increase in the
workforce in primary care and emergency
medicine? Is he calling for longer appointments
in general practice?
No. Once again, the Department of Health
is asking for the impossible. Hunt said that
Every patient is the only patient. Is the man
mad? It is no longer possible to practice good
medicine in minute slots. The quick
patients are now seen by nurses, making the
case complexity of the people who consult the
doctors much greater.
He says that there has been a betrayal of
general practice ideals. The effrontery of
this is breathtaking. Is he trying to make us
feel guilty? Who exactly has committed this
betrayal? Who forced general practitioners
to give up in-house out of hours care by
imposing regulations that made it impossible
for individuals to meet targets designed for
corporate care providers? Who was it who said
that front line staff are coasting. Who erodes
practice income year on year while imposing
ever more onerous targets, slicing chunks off
resources and expecting us to run faster to stay
in the same place? We already feel like galley
slaves chained to the rowing bench, out in all
weathers, unable to attend to bodily functions,
whipped by the slave master, and working
endlessly to the beat of a merciless target drum.
So here is my advice to Mr Hunt: fund the
front line. Give us your support to give patients
more time. What we really want to do, Mr
Hunt, is to listen to the dying, the sick, and the
frightened and meet their needs. And we want
to be left alone to get on with it.
Peter Bailey is a freelance general practitioner,
The quality of planning
for post release care is
variable, and continuity
of care can be poor.

of prisoners have no GP
when they are released

22 BMJ | 1 JUNE 2013 | VOLUME 346
22 BMJ | 1 JUNE 2013 | VOLUME 346

Letters are selected from rapid responses posted on Aher editing, all letters are
published online ( and about half are published in print
To submit a rapid response go to any article on and click respond to this article
plus third and fourth generation combined oral

All eyes are on the EMAwill the precautionary
principle prevail and the lessons learnt from past
public health disasters be taken on board? Will
the agency follow suit, stick to its guns, and first,
do no harm?
Bruno Toussaint editorial director, Prescrire, Paris,
Cedex 11, France
Competing interests: None declared.
1 European Medicines Agency. Refusal for the marketing
authorisation for Qsiva (phentermine/topiramate).
Questions and Answers. lu1!.
authorisation/human/uul!'u/WC'uu1!9l1'.pdf .
l Prescrire Editorial Staff. Topiramate+phentermine, an
excessively dangerous appetite-supressant combination.
Prescrire Int lu1!;ll:6/-7.
! Prescrire. Medicinal products used in weight control:
first, do no harm! lu1l.
/ SCRIP. Fragrance or folly: 1' drug events will resolve before
April. Informa News ll February lu1!.
' European Medicines Agency. PRAC: Agendas, minutes and
highlights webpage.
Cite this as: BMJ ;:f
What is the appropriate MHRA
regulatory response?
Concern has been expressed repeatedly in recent
years about inadequate oversight by regulatory
authorities of drugs and medical devices.
Recently, the Medicines and Healthcare Products
Regulatory Agency (MHRA) recommended
restricting the prescription of strontium ranelate
for osteoporosis.
This was because strontium
increased the risk of myocardial infarction
(relative risk 1.6, 95% CI 1.u7 to 2.38), although
it did not increase mortality, in a pooled analysis
of about 75uu participants in randomised
controlled trials.
Strontium is a divalent cation that mimics many
chemical and biological properties of calcium
and binds to the calcium receptor. Its effects on
fracture are similar to those of calcium. Strontium
decreases the risk of non-vertebral fractures by
1/% but does not prevent hip fractures.
calcium decreases the risk of total fractures by
12% but does not prevent hip fractures.
with or without vitamin D, also increased the risk
of myocardial infarction (1.25, 1.u8 to 1./5) in
pooled analyses of 13 trials (n=29 277).
The MHRAs response to the finding of
increased cardiovascular risk with calcium was
strikingly different from its response to that for
Over-claiming the evidence for
telehealth and telecare?
It would seem that the emperor has few clothes.

Telehealth and telecare have been relentlessly
plugged in the Health Service Journal for the
past year or so in a succession of features, some
accompanied by the sector manufacturing the
technology. At no point did the journal have an
open, balanced BMJ style head to head debate so
that the sceptics could have their say and restore
balance to the narrative.
Despite the Department of Health being the
sponsor of the Whole Systems Demonstrator
(WSD) trial, the government selectively revealed
the more positive pieces of data from this work
before it had been published in a peer reviewed
journal, accompanied by exhortations now we
know that it works to adopt at pace and scale.
This showed little respect for the integrity of the
research process. There has been an unseemly
rush to push us towards a 3 million lives uptake
of the technology (why 3 million?), perhaps
driven by a too cosy relationship with the limited
companies that manufacture it. Meanwhile
technologies that do have a substantial,
mature body of peer reviewed evidence base
behind them, such as comprehensive geriatric
assessment for frail older people,
are not
promoted with the same, concerted vigour,
perhaps because there is no margin to be made
from them for the medical industrial complex.
I note that the WSD researchers pointedly
distanced themselves from some of the early
spinning of the findings
and that respected
commentators have expressed similar

And of course, they knew what
subsequent WSD results would go on to show. I
do not claim that these technologies could not
provide a range of benefits. But to promote a
policy, commission research to support it, and
then prematurely over-claim the benefits is an
abuse of research process. Better to say we are
innovating because we think its a good idea.
Even then, in a time of austerity in health and
social care, there is surely an onus to commission
services that are known to work before innovating
for its own sake.
David Oliver visiting professor of medicine for older
people, City University, London, UK
Competing interests: None declared.
1 Henderson C, Knapp M, Fernndez J-L, Beecham J, Hirani
SP, Cartwright M, et al; for the Whole System Demonstrator
evaluation team. Cost effectiveness of telehealth for patients
with long term conditions (Whole Systems Demonstrator
telehealth questionnaire study): nested economic
evaluation in a pragmatic, cluster randomised controlled
trial. BMJ lu1!;!/6:f1u!'. (ll March.)
l Ellis G, Whitehead MA, Robinson D, ONeill D, Langhorne
P. Comprehensive geriatric assessment for older adults
admitted to hospital: meta-analysis of randomised
controlled trials. BMJ lu11;!/!:d6''!.
! Steventon A. Rapid responses. Re: Effect of telehealth on
use of secondary care and mortality: findings from the
Whole System Demonstrator cluster randomised trial. bmj.
com lu1l. l August.!///bmj.
/ Greenhalgh T. Whole System Demonstrator trial: policy,
politics, and publication ethics. BMJ lu1l;!/':e'l3u.
' McCartney M. Show us the evidence for telehealth. BMJ
Cite this as: BMJ ;:f
First do no harm with anti-
obesity and other drugs
We welcome the decision by the European
Medicines Agency to refuse marketing
authorisation for the fixed dose combination of
topiramate (an antiepileptic) and phentermine
(an appetite suppressant amphetamine).

The loss of a few kilograms cannot justify
exposing patients to the known adverse effects
of the two drugs combined, such as psychiatric
disorders, cardiac arrhythmias, and metabolic
Yet, given the attractiveness of the
antiobesity market, submissions for marketing
approval are expected for other similarly
dangerous appetite suppressants, such as
lorcaserin, lisdexamfetamine, liraglutide, and
combined bupropion-naltrexone.
The EMA has clearly prioritised patient safety
and public health by saying no to this hazardous
combination and issuing a diametrically opposed
recommendation to that of the US Food and Drug
But plenty of other risky drugs are under review
by the EMA, including the respiratory stimulant
almitrine, the anti-inflammatory diclofenac,
the antiemetic domperidone, the anti-anaemia
iron dextran, the benzodiazepine tetrazepam,
BMJ | 1 JUNE 2013 | VOLUME 346 23
For calcium, the MHRA recommended
that no changes to prescribing practice were
needed. It concluded that calcium should be
prescribed to postmenopausal women who
receive treatment for osteoporosis unless
the prescriber was confident that the patient
had an adequate calcium intake
in effect, a
recommendation to continue the widespread
prescribing of calcium supplements.
We disagree with the MHRAs interpretation
of our analyses. We are particularly worried that,
by dismissing safety concerns about calcium
supplements that it acknowledges are legitimate,
the MHRA is endorsing clinical practice that
causes net harm. The MHRA should be consistent
in its handling of these matters and show the
same concern for the welfare of potential calcium
users as it does for those taking strontium.
Mark J Bolland senior research fellow , Department of
Medicine, University of Auckland, Private Bag 9l
u19, Auckland 11/l, New Zealand
Alison Avenell clinical research fellow , Health
Services Research Unit, University of Aberdeen,
Aberdeen ABl' lZD, UK
Andrew Grey associate professor
Ian R Reid distinguished professor , Department of
Medicine, University of Auckland, Private Bag 9l
u19, Auckland 11/l, New Zealand
Competing interests: None declared.
Full response with link to correspondence with the MHRA at .
1 Medicines and Healthcare Products Regulatory Agency.
Strontium ranelate (Protelos): risk of serious cardiac
disordersrestricted indications, new contraindications,
and warnings. Drug Safety Update lu1! ; 6 : S1 .
l ODonnell S, Cranney A, Wells GA, Adachi JD, Reginster
JY. Strontium ranelate for preventing and treating
postmenopausal osteoporosis. Cochrane Database Syst Rev
luu6 ; ! : CDuu'!l6 .
! Reid IR, Bolland MJ, Grey A. Effect of calcium
supplementation on hip fractures. Osteoporos Int
luuS ; 19 : 1119 -l!.
/ Bolland MJ, Grey A, Avenell A, Gamble GD, Reid IR.
Calcium supplements with or without vitamin D and risk of
cardiovascular events: reanalysis of the Womens Health
Initiative limited access dataset and meta-analysis. BMJ
lu11 ; !/l : dlu/u .
' Medicines and Healthcare Products Regulatory Agency.
Calcium and vitamin D: studies of cardiovascular risk do
not support prescribing changes. Drug Safety Update
lu11 ; ' : H1 .
Cite this as: BMJ 2013;346:f3413
Should we always share data?
Not many clinicians or scientists would argue with
the campaign by AllTrials to register and report
the full methods and results of clinical trials.
is it sensible to go so far as to encourage authors
of all BMJ papers to share their datasets publicly,
so that all may see?

We routinely reassure participants in clinical
trials that their data will be held securely and
confidentially. Research ethics committees rightly
insist on locked filing cabinets and ensuring that
only the researchers have access to digital data. Is
this reassurance consistent with public release of
patients confidential data without their consent?
Although only anonymised data are proposed
for public release, are data truly anonymous when
details of age, sex, and perhaps locality are linked
to past and current medical details?
And what will potential trial participants of the
future think of the reassurance of confidentiality
when they know that their anonymised data will
be publicly available for anyone to access? Will
this encourage more patients to take part in trials
or will it have the opposite effect?
I prefer the Medical Research Councils current
policy on access to research data. The council
considers release only to bona fide researchers,
who work for bona fide research organisations,
and who sign up to the same standards of
respecting the confidentiality of the data as did
the original researchers.

Peter D White professor of psychological medicine ,
Queen Mary University London, St Bartholomews
Hospital, London EC1A 7BE, UK
Competing interests: PDW has received several Freedom of
Information requests from members of the public for all the
data from a recent trial of non-pharmacological treatments of
chronic fatigue syndrome.
1 Groves T, Godlee F. The European Medicines Agencys plans for
sharing data from clinical trials. BMJ lu1! ; !/6 : fl961 . (S May.)
l AllTrials. All trials registered. All results reported. www. .
! Medical Research Council. Data sharing requirements
for population and patient studies.
PHSpolicy/requirements/index.htm .
Cite this as: BMJ 2013;346:f3379
Tracking devices with bar codes
is a start
The important matter of obtaining high quality
routine data to monitor the safety of devices
and procedures is worthy of urgent action and

Device tracking is certainly a start. All devices
should be bar coded. For inpatients, the bar code
should be scanned and added to the procedure
(or a new) field in the computerised data. This has
several benefits:

It facilitates recall: centrally held computer
records are easy to scan if and when required

The cost of additional data collection is
minimised. No new registry needs to be
established and the only additional cost is
that of setting up scanning facilities at relevant
locations. These facilities should ideally be
where the devices are inserted, but they
could be located centrally in patient records

Any researcher who wants to track particular
types of devices as a special research project,
on a regular basis, or as part of other research
could gain access to the data

Keeping a record of which specic devices
have been inserted also improves costing of
Stephen Duckett director, health programme ,
Grattan Institute, Melbourne, Vic, Australia
Competing interests: None declared.
1 Campbell B, Stainthorpe AC, Longson CM. How can we get
high quality routine data to monitor the safety of devices
and procedures? BMJ lu1! ; !/6 : fl7Sl . (7 May.)
Cite this as: BMJ 2013;346:f3380
Fake meat scandals add to
Chinese food fears
First there
were 2u uuu
dead pigs
floating down
the Huangpu
a main
source of water
for Shanghai
city. That was
followed by
thousands of
dead ducks
in the Nanhe river in the southwest province
of Sichuan. Dead pigs and ducks had been
used in the production of fake meat. Farmers in
Fujian province who were contracted to destroy
diseased pigs have been detained for allegedly
selling the carcasses collected from farms
and roadsides to restaurants in neighbouring
Now the Ministry of Public Safety says that it has
apprehended meat traders in eastern China who
were passing rat off as lamb. The police arrested
63 suspects accused of selling rat labelled as
lamb for more than $1.6m (1.1m; t1.2m). As
well as the scandals involving pigs, ducks, and
lamb, the Public Security Ministry says there have
been at least another 1u meat scandals recently
involving cattle and chickens. If this state of affairs
does not change, the consequences of similar
cases could be extremely serious.
Meat smuggling and food adulteration are
rampant in China. In these cases, the suspects are
accused of using gelatin, red pigment, and nitrates
to alter the dead pigs, ducks, and rats. Chinese
food production is now on a larger scale and more
technological, and sophisticated technology
is being used to beat regulators and cheat
customers. Tainted meats are an ongoing problem.
Chinas government says it is making food safety a
top priority in the first year of president Xi Jinpings
Cong Dai ward doctor
Min Jiang professor, department of gastroenterology ,
First Al liated Hospital, China Medical University,
Heping District, Shenyang City, Liaoning Province,
Peoples Republic of China
Competing interests: None declared.
1 Liu CY, Hua J. Dead pigs scandal questions Chinas public
health policy. Lancet lu1! ; !S1 : 1'!9 .
Cite this as: BMJ 2013;346:f3385
24 BMJ | 1 JUNE 2013 | VOLUME 346
Following in the footsteps of John the
Baptist, Ive eaten honeyed locusts,
although in my case from a tin. Ive
sucked formic acid directly from the
abdomens of green ants (quite lemony
in flavour). And Ive devoured sorrel
leaves with a paste made of crickets at
Noma, a Copenhagen restaurant.
Far from such gastronomic
exhibitionism setting me apart from
the rest of humanity, it places me
firmly with the majority. According
to Dutch entomologist Marcel Dicke,
more than half the worlds population
consumes insectsnot out of
necessity, but because they regard
them as delicacies. Dicke was on hand
at Exploring the Deliciousness of
Insects, an evening organised by the
Wellcome Collection, London. While
he provided the theory, the Nordic
Food Lab, set up by Nomas founders,
provided the practice.
Dickes message was that insects are
nutritionally rich and low in production
resource, which matters in a world
where the population is steadily
increasing, people are eating more
meat, and % of agricultural land
is being used for grazing. Traditional
supplies of animal protein soon wont
be able to keep up with demand. Could
insects be the answer?
In an update of his TED talk,

Dicke says of the planets six million
species of insects about are
eaten. We already consume insect
products: crab sticks and Campari
depend for their colour on cochineal,
derived from insects that live off cacti.
But its time we moved on to the insects
themselves, Dicke believes, reeling off
the advantages.
Firstly, insects are far enough away
from us genetically that were unlikely
to acquire their diseases by eating
thema risk with eating mammals
such as pigs and cows. Secondly,
theres the favourable conversion
factor: kg of feed yields only kg
of beef compared with kg of locust.
With cows, much of the remaining
kg is manure. By comparison, insects
produce less manure, carbon dioxide,
other greenhouse gases, and ammonia
en route to making protein.

And insect meat is apparently of

good quality. Protein, fats, vitamins,
and minerals obtainable from
mealworms are comparable with
those from beef. One kilogram of
grasshoppers contains the same
amount of calories as hot dogs,
or six Big Macs. A couple of crickets
contain as much calcium as a glass of
milk, and so on. I havent been able to
check these claims: lets hope the next
edition of McCance and Widdowsons
Composition of Foods casts its net a
little wider than before.
Clearly, its Western attitudes to
insect eating that need shifting,
which was what the Nordic Food Lab
was trying to achieve with its tasting
menu. The lab described its goal as
post-gimmick entomophagy, citing
the scorpion lollipop as an example
of what it was trying to avoid. While
not entirely escaping the charge
of gimmickry, the organisers had
nevertheless thought hard about
not scaring off the timid with a big
insect to chomp down on early in the
In the generous sized aperitif, Anty-
Gin and Tonic, wood ants had been
distilled into invisibility. For the first
course, two species of ants were visible
on chimp sticks (modelled on those
used by Jane Goodalls chimpanzees
to hoick termites from their homes).
The ants distinctive citrusy flavours
had to work hard against liquorice root,
flax seed, buckwheat, raspberries, and
coriander cress.
The next dish was described as a bit
more classical: a mousseline of wax
moth larvae with morels, swimming in
a thick sauce of fermented grains. And
then came the big insects to chomp
down on: butter roasted desert locusts
served with a wild garlic and ant
emulsion. This was paired with a house
cricket broth and grasshopper garum,
which tasted how you imagine boiled
up windscreen scrapings might taste.
To wash this down was oatmealworm
stout (brewed from oatmeal and
ON THE CONTRARY Tony Delamothe
Slip an extra locust on the barbie?
More than half the world already eats insects; why not everyone?
mealworms). Uncontentious icecream,
decked out with every bee product you
knew and several you didnt, ended
the meal.
For the boffins from the food lab, the
problem was not creating the menu
but sourcing the ingredientsjust as
it is for top flight restaurants. Whisper
it softly, but pet shops and zoos may
have been roped in to help feed the five
dozen at the Wellcome. The problem
of scarcity is ironic given that there are
between and kg of insect per
person on the planet. Its also likely
to be a substantial barrier to further
uptake in the West.
When it comes to supply, the
Netherlands is furthest ahead, with
one entrepreneur selling migratory
locusts, mealworms, and buffalo
worms in supermarkets (although
freeze drying plays havoc with insect
fats). The Netherlands is ahead in other
ways, too, as Dicke was proud to report.
The Dutch agriculture minister has put
insects on the menu at her ministrys
restaurant and taken her European
Union counterparts out to a dinner
of insects. Dicke showed a picture of
Crown Princess (now Queen) Mxima,
looking delighted to be presented
with the first copy of Dickes Het
Insectenkookboek (English translation
due later this year).
The idea of insect cookbooks may
seem faddish and new, but Englishman
Vincent M Holt got there a long time
ago with his classic, Why Not Eat
Insects? I am confident, wrote Holt,
that on finding out how good they are
we shall some day right gladly cook and
eat them.
Apparently, the Victorians were
partial to chocolate dipped ants, so we
seem to have gone backwards since
Holts day. Maybe well only be driven
to shed our inhibitions by necessity.
And that may not be a long time
Processionary moth souffl, anyone?
Tony Delamothe deputy editor, BMJ
References are in the version on
Cite this as: BMJ ;:f
The ants distinctive
citrusy flavours had
to work hard against
liquorice root, flax
seed, buckwheat,
raspberries, and
coriander cress.
Previous articles by
Tony Delamothe are
available on
BMJ | 1 JUNE 2013 | VOLUME 346 25
E-cigarettes, more formally electronic
nicotine delivery systems, were
introduced in 2uu7 but remain a
relatively tiny market. In the United
States they accounted for about
$5uum (33um) in sales last year,
perhaps u.5% of tobacco receipts.
That is changing. The tobacco
company Lorillard purchased the
leading e-cigarette maker Blu
last year. Reynolds American is
expanding marketing of its Vuse
e-cigarettes; and Altria, the largest
US tobacco company, has announced
that it will enter the e-cigarette market
later this year with its own product.

Marlboro e-cigarettes, anyone? The
game is on.
This, of course, has public health
advocates terrified. Just when we had
Big Tobacco on the run, with US sales
falling 3-/% a year, along comes a
new product that may save them
as well as maintain the nicotine
addiction that they depend on for
sales. In fact, tobacco industry sales
were down more than 6% last year,
due in no small part to the increase
in e-cigarette sales. Hence the recent
acquisitions and announcements.
Let us count the ways that
e-cigarettes are upsetting. First
and foremost, they are increasingly
available and cheap. You can buy
them, singly or in packets, in many
US convenience stores for about half
the price of conventional cigarettes.
They are flavoured, leading to
fears that they will attract younger,
first time smokers, or vapers, as
they call themselves (because the
smoke is actually vaporised liquid
nicotine solution). They have a high
tech image: rechargeable cigarettes
with batteries, what could be more
desirable? They are not as offensive
to others as tobacco cigarettes: their
vapour doesnt smell bad, it produces
no ash, and they dont give you bad
breath. They are being promoted on
cable TV and the web (see examples
on YouTube at
and by sexy
movie and rock stars, who urge
us to take our freedom back.
Further, we dont really know what
is in e-cigarette cartridges; some
manufacturers list ingredients, others
dont. Studies measuring the content
of the cartridges have found varying
nicotine levels as well as unlisted,
dangerous ingredients.

What permits most of the above is
that in the US e-cigarettes are almost
completely unregulated and untaxed.
The US Food and Drug Administration
tried and failed to classify them
as drug delivery devices, which it
could regulate. Now the FDA says
that it will regulate e-cigarettes as
tobacco products, but it has already
missed one deadline for announcing
these rules and recently opined that
further research is needed before
it proposes regulations.
stiff taxation, a potent weapon
against conventional cigarettes,
barely applies to e-cigarettes. Only
one state currently taxes e-cigarettes,
and there is no federal excise tax on
them at all.
Many of the ways smokers use
e-cigarettes are worrisome. Some
people use them as a substitute for
tobacco cigarettes when they need
nicotine but cant smoke because
they are at work, at a bar, or at home
with objecting family members.
E-cigarettes thus help maintain
the smoking habit and reduce
incentives to quit. Others use them
as a way to cut down but revert to
tobacco cigarettes on finding them
unsatisfactory. Younger vapers start
smoking with e-cigarettes, lured by
the movie star adverts, implied safety,
flavoured choices, and permissibility
of use anytime and anywhere.
But we can envisage helpful uses
for e-cigarettes too, generally as
smoking cessation aids. Although
it is strictly forbidden to advertise
such uses (which would immediately
put them under FDA jurisdiction),
the e-cigarette companies subtly
imply such a use for their products.
Pilot studies have started to appear
that use e-cigarettes in smoking
Big Tobacco lights up e-cigarettes
Is this good or bad news for public health?
cessation efforts, and doubtless full
clinical trials are to come.
Finally, as with the extended
use of other nicotine replacement
products, which is discouraged but
clearly better than resuming smoking,
even we public health nuts have to
admit that if youre going to smoke it
is probably a lot better to be a vaper
than a tobacco smoker. If the content
of the nicotine cartridges is regulated
and under FDA control, Id much
rather put relatively pure nicotine into
my lungs than the mix of ingredients
found in burned tobacco. Further,
if they are produced by a regulated
industry, which has deep pockets
and understands the consequences
of running afoul of (yet to come)
regulation, you can hope that what
you get is whats on the ingredient list.
Which is why I asked the question
at the outset whether it is a good or
a bad thing that the major tobacco
companies are jumping into the
e-cigarette market. It seems to me
that the best possible outcome at
this point is for the FDA to regulate
the crap out of e-cigarettesin both
senses of that coarse construction:
regulate them heavily, and get the
poisons, flavourings, and everything
but nicotine out of them.
Meanwhile, television advertising
should be banned, age and
availability restrictions enforced, and
e-cigarettes heavily taxed, at levels
similar to those for tobacco products.
And we desperately need clinical
trials and observational studies to
learn more about how e-cigarettes
are being used and whether they are
helpful in smoking cessation efforts.
Now that the vapour is fully out of the
cartridge, were not going to be able to
get it back in. We need to make the best
of a bad situation before it gets worse.
Douglas Kamerow is chief scientist, RTI
International, and associate editor, BMJ
DK is a former US assistant surgeon general and
the author of Dissecting American Health Care
References are in the version on
Cite this as: BMJ ;:f
The best possible
outcome is for the
FDA to regulate
the crap out of
regulate them
heavily, and get
the poisons,
flavourings, and
everything but
nicotine out of them
Feature: Electronic
cigarettes: medical
device or consumer
product? (BMJ
Editorial: Electronic
cigarettes as a method
of tobacco control (BMJ
Personal View:
Electronic cigarettes:
miracle or menace?
(BMJ lu1u;!/u:c!11 )
26 BMJ | 1 JUNE 2013 | VOLUME 346
Profits from pregnancy
The NHS and some UK royal colleges profit by selling commercial advertisers access to pregnant women through promotions
such as Bounty bags. These potential conflicts of interests are unacceptable, considers Margaret McCartney
Bagsful of freebies are given to expectant
parents from companies keen to promote their
productsnappy creams, vouchers for photos,
washing powder samples, and special oers
to buy bibs, workout books, and buggies.
Whats wrong with that?
The point is that the UK National
Health Service, Royal College of General
Practitioners, Royal College of Obstetricians
and Gynaecologists, and government have
embedded commercial advertising into routine
contact with pregnant women during antenatal
and postnatal care.
The RCOG is setting up Baby and You
magazine, which it plans to give for free to
pregnant women. Mark Green, managing
director of the commercial company Bednest,
which sells bedside cribs for newborn babies,
was contacted by a sales representative from B+Y
Publishing, using the RCOG logo, which oered
a guaranteed minimum audience of 500 000
parents through their Obstetrician/midwife
. . . the most trusted and inuential person
throughout this entire time.
The representative oered Green an
educational/advertorial piece, presenting
you as a thought leader, as well as a trusted
solution provider. The package, costing E15 000
(t17 500; $22 500) for six months, included an
up to date database of 100 000 families.
Green, horrihed at how easy it seemed to pay
for inuence, contacted the RCOG. The college is
investigating and told the BMJ, If such practice is
happening, it is unacceptable and the RCOG in no
way approves. It said that it is concerned to be
associated with this practice, which it described
as ethically questionable, and that it has strict
policies on its advertising and sponsorship and
does not seek advertorials for any
of its publications.
The college receives E90 000
a year from B+Y Publishing
Limited, the company that
publishes the magazines. The
RCOG told the BMJ that senior
clinicians vet all adverts and
editorial content.
Bounty is another promotions
company, with several points of contact with
new families. It gives out a total of 2.6 million
baby bags a year. Some are distributed by NHS
healthcare professionals and others by Bounty
representatives in postnatal wards.
Most NHS hospitals condone the giving of
812 000 newborn packs each year, and the
NHS benehts from allowing access to its wards.
Bounty told the BMJ that it pays E2.3m to the NHS
annually for access. Bounty said that over 90% of
mothers are satished with the packs, citing its
own survey of 4000 parents in January 2013.
However, Belinda Phipps, chief executive omcer
of the National Childbirth Trust, is angry about
the way that the NHS allows Bounty access to new
mothers. Within hours of giving birth, they are
being asked questionstheir name and address,
details of life insuranceand they give them in
good faith, thinking theyre speaking to a hospital
person. In fact its a commercial person. The NHS
is condoning a sales team
collecting data from mothers
in order to sell their name on
to commercial interests.
Bounty prohts by selling
the parents details to
companies. Although the
section on contact details
that parents hll in includes
the information that by
providing your email
address and/or telephone
number you agree to be
contacted by these channels
as well as post, many
parents have told Phipps
that they did not understand what they were
signing up to. Bounty told the BMJ that 3% of
parents opt out; the details of those who do not
are sold on to other companies.
Additionally, the Bounty packs have an air of
omcialdom: the bag given aher birth contains
application forms for child beneht, together with
samples of washing powder,
nappies, and advertising yers.
But child beneht forms are
available online, and they could
be distributed by midwives or
hospitals. Bizarrely, HM Revenue
and Customs pays Bounty more
than E90 000 pounds a year to
distribute the child beneht forms.
So families supply their details,
which can be sold on by a commercial company,
which in turn is paid by the government to supply
freely available child beneht claim forms. Why?
A spokesman for Bounty told the BMJ that
over a decade ago Bounty oered to conduct
a small scale pilot which satished HMRC that
Bounty could distribute child beneht forms
directly and quickly into the hands of parents as
soon as they need them.
HM Revenue and Customs told the BMJ that
Bounty distributed 82% of all child beneht
claim forms in 2011-12, averaging about
10p for each claim. If HMRC posted the forms
individually the cost would rise to around 33p
for each claim.
A survey done by the National Childbirth
Trust in January 2010 tells a dierent story from
Bountys. It found that half of just over 1000
parents did not know, and were unhappy, that
their details could be used to target advertising
to them. A further 37% knew
that their details would be used
in this way and were unhappy
with it; the remainder were
Over at the Royal College of
General Practitioners, Emmas
Diary is posted in bulk to general
practices to pass on to pregnant
women. It also oers gih packs
on the receipt of information
such as the womans and her
familys dates of birth, which
supermarket the family usually
shops at, and a telephone
number and email address.
Emmas Diary is validated by the large RCGP
stamp on the front, and inside says, Presented
with the compliments of your General
Practitioner. It comprises 25 pages of medical
information and 119 pages of adverts.
In the RCGPs accounts, more than E214 000
is entered as other income including grants
and sponsorships; the RCGP would not tell
the BMJ how much of this was the net gain
from advertising through Emmas Diary. In a
statement it said that all content is quality
assured by our RCGP editorial board.
Is it right that the NHS imply its approval
for the thousands of products being promoted
at parents? Do we really want parents placed
under advertising pressure and for NHS doctors,
radiographers, and midwives to be the conduit?
Some conicts of interest in medicine are hard
to avoid. Others are not. These should be easy.
Margaret McCartney is a general practitioner, Glasgow
Cite this as: BMJ ;:f

The Bounty packs have
an air of officialdom:
the bag given after birth
contains application
forms for child benefit,
together with samples of
washing powder, nappies,
and advertising flyers
BMJ | 1 JUNE 2013 | VOLUME 346 27

Integrated care is crucial to prevent abuse of patients
Too many adult patients at risk of harm are lost into the gulf between healthcare and social care, says Billy Boland
On 14 May 2013 the health minister Norman
Lamb announced the UK governments
intention for health and social care to be fully
integrated by 2018.
A cohort of experimental
sites will be unveiled in September to trial
new ways of delivering care, he announced.
Healthcare providers and local authorities
will forge new partnerships to tackle unmet
need with the aim of avoiding patients falling
between two stools.
Support for integration from patients and
their carers is strong. National Voices, the
national coalition of health and social care
charities in England, champions this cause,
calling for integrated care to develop quickly
and at scale.
Its inuence is considerable
and growing: for example, it has worked
closely with the NHS Leadership Academy
in developing new programmes to make
sure the patient experience is central to the
From the perspective of patients, integrated
care makes complete sense. In 2010-11, 95 000
adults were referred for safeguarding because
of suspected abuse in England and Wales, with
44% referred by social care sta and only 22%
by healthcare sta. Referrals from primary
and community care made up a mere 9.4% of
the total.
This may represent a relative lack of
awareness among healthcare sta about abuse
and a bias in reporting of concerns.
Healthcare providers have much to learn
from colleagues in social care. Abuse passes
through clinics unrecognised, and harms are
being allowed to continue. Lamb is advocating
that clinical commissioning groups spend
about E1bn of their budget to fund integration,
already angering some commentators.

Opponents of integration say that it is
expensive and unnecessary and wont bring
the changes that are needed. But with the scale
of abuse occurring, can we aord not to?
The distinction between healthcare
and social care is artihcial because needs
are inevitably interwoven. Social ills
such as abuse, poverty, and lack of social
connectedness are indelibly linked to poor
health outcomes. Conversely, social initiatives
such as the governments ht note scheme
(statement of htness to work) introduced by
Carol Black, former president of the Royal
College of Physicians, shows medicines
fascination with improving health through
social means.
Individual needs can aect each other,
amplifying disabilities, resulting in more
complex and profound harms. Immobility
breeds isolation, and isolation breeds
depression. Health and social needs are two
halves of a whole person. As Lamb has put it,
People dont want health care or social care
they just want the best care. This is a vital step
in creating a truly joined-up system that puts
people hrst.
The UKs attention has already been turned
to abuses inicted by those delivering care in
a system that is supposed to protect patients.
The horrihc abuse of patients at Winterborne
View Hospital, exposed
by a recent BBC Panorama
programme, highlighted what
can happen when things go
A lack of cohesion between
NHS commissioners and the hospitals local
authority made sharing concerns about care
dimcult. Events at Winterborne might not
have occurred had scrutiny of health and
social care been integrated. A review has
criticised NHS commissioners for failing to
ask searching questions of the care provided
by the hospital and calls on the Department of
Health to bring clarity across the health and
social care spectrum about commissioning
responsibilities for hospital based care.
The Francis report on Mid Staordshire
NHS Foundation Trust also captured this
mood. Blinkered working practices and silo
mentalities meant that needs of patients and
carers at Mid Stas were routinely neglected or
ignored. A failure to share information about
serious incidents made it easier for sta to turn
a blind eye to bad practice and allow harms
to occur. Recommendation 35 in the Francis
report calls on regulators to go further than
sharing of existing concerns identihed as risks.
It should extend to all intelligence which when
pieced together with that possessed by partner
organisations may raise the level of concern.
The evolution of services has created an
unnecessary gulf into which people who need
both health and social care are being lost.
Local authorities and NHS providers have
developed independent empires, minding
their own businesses and staying on task.
Inexible working practices have resulted in
elderly patients laid unnecessarily in hospital
beds for want of a care home: transfers to care
homes now take an average three days longer
than when the coalition government formed,
despite eorts to reduce delays.
Once in
care, patients (and their families) are raising
concerns that their physical health needs are
being neglected.
We desperately need integration of
health and social care if we are to take the
protection of people at risk of harm seriously.
Safeguarding adults at risk currently requires
multi-agency working.
Merging healthcare
and social care providers would promote
dialogue that would advance patient safety.
Harms ourish where communication is
neglected, as we have seen. A single provider
model would ensure that healthcare and social
care sta know how to identify
harm and make it easier for
them to share intelligence and
do something about concerns.
Integration oers the promise
of a holistic service that
safeguards against bad practice and care. And
patients and carers are crying out for it.
Billy Boland is a consultant psychiatrist and lead doctor
in safeguarding adults at Hertfordshire Partnership NHS
Foundation Trust, St Albans
Competing interests: I work for a partnership NHS trust that
provides both health and social care.
Provenance and peer review: Not commissioned; not
externally peer reviewed.
References are in the version on
Cite this as: BMJ ;:f
People dont want
health care or social
carethey just want
the best care
OLetter: Helping people die at home
(BMJ lu1!;!/6:f!1Sl)
ONews: Integrated care scheme for older people and
people with diabetes has not reduced emergency
admissions in its hrst year (BMJ lu1!;!/6:f!l'')
ONews: Without integrated care within hve years we
risk another Mid Stals, warns government
(BMJ lu1!;!/6:f!1'l)
28 BMJ | 1 JUNE 2013 | VOLUME 346
Mikhail Izrailevich Perelman
Thoracic surgeon and specialist in pulmonary tuberculosis who operated on Soviet leaders and criticised WHOs TB programme
State Medical Institute. In 1998 he was
appointed director of the Research Institute
for Phthisiopulmonology and chief phthisiolo-
gist of the Russian Ministry of Health, and in
the following year he became editor in chief of
Tuberkulyoz i bolezni
legkikh [Tuberculosis
and Lung Diseases],
a leading Russian
specialist journal.
It was a time when
WHO actively pro-
moted the directly
observed treatment,
short course (DOTS)
programme in Rus-
sia, which was based
on outpatient, stand-
ard, short course
treatment of patients
with open lung tuber-
culosis. If the results
of bact er i ol ogi -
cal examination of
sputum were nega-
tive patients were
considered healthy.
Perelman called this
WHO programme absurd, insisting that TB
should be treated surgically. He was named a
saviour of Russian phthisiology because he
managed to preserve the existing system of TB
Perelman performed more than 3500 surgi-
cal procedures and deliberately stopped oper-
ating aher he was 75. He was a work fanatic.
A man survives if he knows how to work,
was one of his favourite sayings. He said he
was resting during his business trips, having
visited 45 countries where he delivered talks,
consulted patients, and undertook surgery.
Predeceased by one of his twin sons from
his hrst marriage and divorced from his hrst
wife, he leaves his second wife, two sons, two
grandsons, and his sister. His hrst wife, Tatiana
Boguslavskaya, was a surgeon and anatomist,
and his second wife, Inna Makarova, was a well
known hlm actor. At the age of 63, Perelman
fathered a third son, Alexei, with his scrub
nurse. His ashes are buried at Novodevichy
cemetery, near the graves of some of his famous
patients and his mentor, Boris Petrovsky.
Boleslav Lichterman
Cite this as: BMJ ;:f
Mikhail Izrailevich Perelman was a pioneer
of cardiac and thoracic surgery in the former
Soviet Union. He was born in Minsk and gradu-
ated from Yaroslavl Medical Institute in 1945,
aher which he worked at the institute as an
assistant professor of anatomy and surgery
until 1951. In Yaroslavl he defended his kan-
didatskaya (PhD) dissertation, and performed
one of the hrst successful cardiac operations in
the former Soviet Unionligation of a patent
arterial duct.
From 1951 to 1954 he was a chief surgeon
in Stcherbakov (now Rybinsk) and medical
director of a municipal hospital. He was widely
respected even by local criminals as described
in his book of memoirs, Grazhdanin Doctor
[A Citizen Doctor] (Moscow, 2009).
In 1954 Perelman moved to Moscow and
began his career as an assistant professor of
operative surgery and topographic anatomy at
the First Moscow State Medical Institute (now
the I M Sechenov First Moscow State Medi-
cal University). He continued as an associate
professor at a course for lung surgery of the
Central Postgraduate Medical Institute (now
the Russian Postgraduate Medical Academy)
from 1955 to 1958. Between 1958 and 1962 he
headed the department of pulmonary circula-
tion at the Research Institute for Experimental
Biology in Novosibirsk before returning to Mos-
cow, where he spent the rest of his career. His
doctorskaya dissertation (professorial thesis),
defended in 1962, was on the subject of lung
resection in tuberculosis.
In 1963 Boris Petrovsky (obituary at BMJ
2004;328:1381) proposed Perelman as
the head of the chest surgery department at
the newly organised Research Institute for
Clinical and Experimental Surgery (now the
R ussian S cientific
Centre of Surgery B V
P etrovsky). P erelman
held this position for
18 years. He became
a professor of surgery
in 1964 and a corre-
sponding member of
Academy of Medical
Sciences of the Soviet
Union in 1980, obtain-
ing full membership
in 1986. He achieved
international recog-
nition for his work in
the surgery of trachea
and bronchi, lung, and
mediastinal tumours,
and experimental lung
The results were pub-
lished in international
surgical periodicals,
and some of his books and book chapters were
translated into E nglish. Perelman invented a
lateral intercostal, less traumatic, approach
to lung lesions that became known as the
R ussian thoracotomy. A method he developed
to achieve precise removal of lung tumours
became known as the P erelman operation.
New methods, techniques, and equipment
including ultrasound and cryogenic devices,
laser surgery, and microsurgeryfound their
way into th oracic surgery. Perelman became
a secretary general of the All-Union Society of
Surgeons and an honorary member of many
national and in ternational surgical societies.
In 1964 Petrovsky introduced Perelman
into the elite fourth main administration at the
Soviet health ministry. His patients included
Soviet leaders, writers, actors, and conduc-
tors. In 1971 he operated on a hrst deputy of
Yuri Andropov, head of the KGB. Aherwards
A ndropov asked him if he needed anything.
Instead of an apartment or a car, Perelman
requested a visit to the US (at the time, travel-
ling abroad was extremely restricted, especially
for a J ewish doctor).
In 1982 Perelman took the chair of phthisio-
pulmonology at the I M Sechenov First M oscow
Perelman invented a lateral intercostal,
less traumatic, approach to lung
lesions that became known as the
Russian thoracotomy
Mikhail Izrailevich Perelman, thoracic surgeon
(b ; q Yaroslavl State Medical
Institute ), died from a pulmonary
thromboembolism on March .
BMJ | 1 JUNE 2013 | VOLUME 346 29
in South Sudan. His proudest, most
nerve-wracking memory there was the
night he relied on his previous surgical
training to perform an emergency
caesarean section, where he acted
as both anaesthetist and surgeon,
dealing simultaneously with a major
haemorrhage and a failed spinal block
(mother and baby both did well). He
died while riding a motorcycle to work
a night shift at Queen Charlottes
Hospital, London. He leaves his
parents; a brother; a sister; two
nephews; and his fiance.
Pavithra Natarajan
Cite this as: BMJ 2013;346:f2763
John Andrew Pickering
Former general practitioner (b 1938;
q Sheffield 1961; OAM, Grad DipHA,
FRACGP, FRACMA), d 27 August 2012.
John Andrew Pickering went to
Australia to work as a resident medical
officer and then general practitioner
in 196/. Moving to Dimboola in
1979, he ran the general practice and
hospital with the assistance of many
general practice registrars. He received
several awards for his work in rural and
regional areas. John retired from full
time practice in lu1u after developing
a rare form of bladder cancer, although
he continued to do short term locums
around Australia. Dimboola created
the Pickering Gardens in honour of
the dedication of John and his wife,
Annette, to the town and named the
medical clinic the John Pickering
Medical Centre in his memory. He
leaves Annette as well as two children
and three grandchildren from a
previous marriage.
Alan Wolff
Cite this as: BMJ 2013;346:f2759
N Balakumar
Former general practitioner
Huddersfield (b 1939; q Colombo
University, Sri Lanka, 1967),
d 9 December 2012.
After obtaining his medical degree, N
Balakumar (Bala) worked in several
posts in Sri Lanka before moving to
the UK, initially with the aim of further
training and returning to Sri Lanka.
However, the ensuing civil unrest in his
native country forced him to change
his mind. After preliminary posts in
orthopaedics, he became a general
practitioner, working in Salendine
Nook, Huddersfield. Bala was a devout
Hindu, and his dream of setting up a
temple in the north of England became
reality in 199u. He leaves Sakunthala,
his wife of /! years; two daughters; a
son; and two grandchildren.
Mahen Muthiah
Cite this as: BMJ 2013;346:f2758
John Barnes
Specialist in public health and
tropical diseases (b 1928;
q St Bartholomews Hospital,
London, 1951; MRCS Eng, DPH
Lond, MSc Lond, DTM&H Eng, DIH,
MFCM RCO (UK)), d 5 February 2013.
John Barnes joined the army, for
national service and subsequent officer
training. In the Royal Army Medical
Corps he specialised in public health
and tropical diseases and went on
many overseas postings. He left the
army and became a civil servant,
working in public health at the then
Department of Health and Social
Security in London. He took early
retirement in the mid 19Sus after a
crash left him permanently disabled. He
undertook his final trip to hospital with
an acceptance that all might not end
well. Predeceased by his second wife,
John leaves his first wife, three children,
two stepchildren, eight grandchildren,
and five step grandchildren.
John Barnes, Susan Barnes
Cite this as: BMJ 2013;346:f2756
Brian Cameron Campbell
Consultant in general medicine
(b 1947; q Glasgow 1971; MD,
FRCP Glas, FRCP Ed), died
from pulmonary embolus and
septicaemia on 10 September 2012.
Brian Cameron Campbell specialised
in cardiovascular disease and clinical
pharmacology, publishing widely on
the therapeutics of hypertension and
haem metabolism. Brian left Glasgow in
19S' and was employed in a series of
locum consultant positions for several
years. In 199S he became a consultant
in general medicine at the Royal
Infirmary of Edinburgh before moving
to the citys Western General Hospital.
He loved fine food, fine wine, cars,
and overseas travel. He had a strong
faith and was also keenly interested in
politics and applied to be a prospective
parliamentary candidate for his local
constituency. His application was
declined because Brian was felt to be
too conservative for the Conservative
Party. He leaves a wife, Anne.
Anne E Campbell, Mark W J Strachan
Cite this as: BMJ 2013;346:f2752
Michael Dean
Interventional radiologist (b 1937;
q Jesus College, Cambridge, and
Westminster Medical School 1961;
from complications of heart disease
on 28 February 2013.
Michael Dean was appointed consultant
radiologist at the Royal Shrewsbury
Hospital in 1967 and worked there
until his final retirement in lu11. He
developed an early interest in the newly
emerging subspecialty of interventional
radiology, with particular expertise in
the difficult area of salvage angioplasty
for severe peripheral vascular disease.
An effective committee man and
negotiator, he was involved with
the Royal College of Radiologists
and produced several textbooks. A
keen advocate of the professional
partnership between doctors and
patients and of transparency, he played
a major part in implementing the Data
Protection Act 199S, the Health and
Social Care Act, and the Freedom of
Information Act luu1, ensuring that
x ray reporting was regarded as part of
diagnostic evidence. He leaves his wife,
Vera, and their children.
John Reidy
Cite this as: BMJ 2013;346:f2760
Donald John Carr Horwood
Former general practitioner and
surgeon (b 1924; q London 1951;
MRCS), d 1 April 2013.
Donald John Carr Horwood (Don) and
his young dentist wife, Ruth, moved
to Uganda in 19''. The family moved
to New Zealand in 196! and returned
there in 1971, after further spells in
Africa and Canada. Don took a full
time position as Opotikis then only
general practitioner in 197/. He is
remembered as a doctor who freely
gave of his time and energy; who
helped families deal with poverty and
disability; who saw a limping child
in the street and stopped, made her
take him to her mother, explained
the slipped epiphysis, and arranged
surgery to repair the damage; who
supported families with budgeting
advice; and who set up a scholarship
that still helps Maori women in tertiary
education. He leaves Ruth and two
Jo Scott-Jones
Cite this as: BMJ 2013;346:f2754
Pradeep Natarajan
Anaesthetist (b 1973; q St Marys
Hospital Medical School, London,
1998; MRCS), died in a road traffic
accident on 8 July 2012.
Pradeep Natarajan (Prad) initially
completed a surgical SHO rotation and
was subsequently appointed to the
anaesthetics SHO rotation between
Barts, the Royal London, and Homerton
hospitals. In late lu11 Prad took time
out to work with the charity Mdecins
Sans Frontires as an anaesthetist
30 BMJ | 1 JUNE 2013 | VOLUME 346
of 0.3-7.6 infections per patient per year, with an average
rate of 2.6 infections per year.

Another recurrence will
occur in 50% of women who have had two episodes of
cystitis in six months. Multiple recurrences ohen follow
an initial infection, resulting in clustering of episodes.
Which women are at risk of recurrent UTI?
The identihcation of risk factors can help pinpoint modi-
hable factors amenable to a disease prevention strategy.
Known risk factors for recurrence in premenopausal women
include the use of spermicidal products and being sexually
active. In a well powered case-control study, women aged
18-30 years, without known abnormalities of the urinary
tract, who had experienced more than three UTIs in the past
year or more than two in the past six months were com-
pared with women without UTI in the past year and no his-
tory of recurrent UTI.
Women reporting recurrent UTI were
10 times more likely to have had sexual intercourse more
than nine times a month in the previous year, and almost
twice as likely to have used a spermicide in the previous
year than control women.
Having a new sexual partner was
also an independent risk factor for recurrence.
Factors that were not correlated with recurrence
included postcoital voiding, douching, caeine intake,
history of chronic disease or sexually transmitted disease,
body mass index, wearing cotton underwear, and taking
bubble baths. Also of note, behavioral factors such as
voiding aher intercourse and increased uid consump-
tion did not protect against recurrence. However, these
risk factors have not been robustly evaluated, and many
Recurrent acute cystitis, or recurrent urinary tract infec-
tion (UTI), is common in women, and most primary care
providers will encounter this clinical entity many times in
their practice. Women who have two or more infections in
six months or three or more in one year meet the traditional
dehnition of recurrent UTI that has been used for studies on
prophylaxis, risk factors, and self initiated management.

However, from a clinical perspective, any second episode of
UTI warrants consideration as a recurrence and requires an
informed approach to diagnosis and management. Most of
these recurrences are considered to be reinfections rather
than relapse or failure of initial therapy, although reinfec-
tion with the same strain can occur. Modihable risk factors
are few, and retrospective case-control observational studies
indicate that genetic predisposition may play a role.


This review will focus on the causes of recurrent UTI,
when and how to investigate women who present with this
problem, and how to manage and prevent recurrent infec-
tions. The recommendations are limited to non-pregnant
adult women without comorbidities apart from diabetes.
It is important to distinguish between this population and
othersincluding prepubertal girls, men, and patients with
known anatomical or functional abnormalities of the urinary
tract. This is because recurrent UTI in otherwise healthy adult
women is part of a natural and expected disease process
that does not imply failure of therapy or inherently require
more intensive investigation. We also discuss the available
evidence on recurrent UTI in women with diabetes because
this is a common problem in general practice.
How common is recurrent UTI?
Acute uncomplicated cystitis occurs in 50-80% of women
in the general population. Natural history studies show
that 30-44% of women who have an episode of acute cys-
titis will have a recurrence, ohen within three months.
Observational cohort studies have found a recurrence rate

Departments of Medicine, VA
Boston Healthcare System and
Boston University School of
Medicine, Boston, MA and
National Center for Occupational
Health and Infection Control, Office
of Public Health, Veterans Health
Administration, Gainesville, FL

Health Services Research and

Development (HSR&D) Center of
Excellence, Michael E DeBakey
Veterans Affairs (VA) Medical Center
and Section of Infectious Diseases,
Department of Medicine, Baylor
College of Medicine, Houston,
Correspondence to: K Gupta
Cite this as: BMJ ;:f
doi: ./bmj.f
Diagnosis and management of
recurrent urinary tract infections in
non-pregnant women
Kalpana Gupta,

Barbara W Trautner

Recurrent urinary tract infection is common in otherwise healthy women
Use of products containing spermicide and sexual intercourse increase the risk of recurrences
No studies have shown that hygiene, direction of wiping, or tightness of clothing increase
the risk of recurrence
Management can include self initiated antibiotics for each episode but depends on good
communication between patient and physician
Recurrences can be prevented with regular low dose antibiotics. The choice and dose of
antibiotic should be decided on the basis of previous infections and local microbiological
guidance and availability of antibiotics
Non-antimicrobial prevention strategies are promising but have not yet been shown to be as
effective as antimicrobial prophylaxis
Follow the linkfrom the
online version of this article
to obtain certied continuing
medical education credits
We searched PubMed for each topic heading. Only
articles available in English were included. Cochrane
and other expert reviews were also studied for relevant
references. Recurrent urinary tract infection (UTI) has been
investigated with high quality clinical trials, so the quality
of evidence is generally strong. Most of the comments on
risk factors, epidemiology, and overall management are
derived from observational studies and expert opinion.
Recommendations from evidence based guidelines from
the Infectious Diseases Society of America, European
Society of Clinical Microbiology and Infectious Diseases,
Society of Obstetricians and Gynaecologists of Canada,
and the Canadian Urological Association are also included.
Most antimicrobial treatment recommendations are
derived from randomized clinical trials and evidence
based guidelines. Data on management of recurrent
UTI in women with diabetes and non-antimicrobial
approaches to prophylaxis of recurrence are sparse, and
recommendations on these topics are less robust.
BMJ | 1 JUNE 2013 | VOLUME 346 31
experts r ecommend postcoital voiding because it removes
uropathogens from the urethra and is a low risk practice.
Genetic factors also seem to play a role in a womans
susceptibility to recurrent UTI. A history of hrst UTI occur-
ring before 15 years of age and a maternal history of UTI
are independent risk factors for recurrence.
A case-control
study in 431 women with recurrent UTI found that a history
of the disease in the womans mother, sister, or daughter
was associated with recurrent UTI, and having a hrst degree
female relative who experienced hve or more UTIs was also
associated with recurrent disease.
In cases, 70.9% reported
one or more female relative with cystitis, compared with
42.4% of controls without recurrent UTI. Variations in the
innate immune response, including polymorphisms in the
toll-like receptors that recognize pathogens in the urinary
tract, are associated with adult susceptibility to recurrent
Women who are non-secretors of certain blood group
antigens may be at higher risk for Escherichia coli binding to
their uroepithelial cells and thus at higher risk for recurrent
CXC chemokine receptors are also implicated. The
expression of these receptors on neutrophils is essential for
proper activation and migration of neutrophils to the site of
infection. Low CXCR1 expression has been linked to recur-
rent pyelonephritis,
and low CXCR1 and CXCR2 were iden-
tihed in premenopausal women with recurrent disease.

Ongoing advances in molecular techniques and personal-
ized genomic studies are likely to facilitate greater under-
standing of the genetic predisposition to recurrent UTI.
In postmenopausal women, incontinence, premenopau-
sal history of UTI, non-secretor status, and residual urine
aher voiding have been associated with recurrent disease
in well conducted case-control studies.

In a study of
149 postmenopausal women with recurrent disease versus
53 age matched controls, women with recurrent UTI had
higher postvoid residual volume (23% recurrent UTI v 2%
control; P <0.001) and reduced urine ow (45% recurrent
uncomplicated UTI v 23% control; P=0.004).
pausal women also have a relative depletion of vaginal
lactobacilli and an increase in vaginal E coli compared with
premenopausal women. This age related alteration of the
normal vaginal ora, especially loss of hydrogen peroxide
producing lactobacilli, may predispose women to introital
colonization with E coli and also to UTI.
When should you consider underlying urinary tract
disease in recurrent UTI?
Guidance on when to refer women for further evaluation
of recurrent disease is based mainly on expert opinion and
clinical judgment. There are no randomized trials of refer-
ral versus no referral to identify robust factors associated
with anatomical abnormalities that would warrant further
Observational studies of women who have been referred to
urological specialists have shown that cystoscopy and imag-
ing have limited value in women with recurrent UTI. A study
of 100 women referred to urology for recurrent disease found
no abnormalities on cystoscopy except conhrmation of cys-
These hndings conhrmed those of similarly designed
A retrospective database evaluation of 118 women
with a mean age of 55 years who were referred for cystoscopy
found that nine (8%) had an abnormality including uretheral
stricture or bladder calculus or hstula.
In this study, nega-
tive imaging by ultrasound or computed tomography was
highly predictive of negative hndings on cystoscopy (99%).
Clinical factors that may be indications for further inves-
tigation, including imaging and referral, are outlined by
the Canadian urological guidelines.
The guidelines rec-
ommend further evaluation of recurrent disease in women
with a history of urinary tract surgery, known anatomical
abnormalities, immunocompromise, calculi, urea splitting
or multidrug resistant organisms, documented abnormali-
ties of ow, pneumaturia, fecaluria, or persistent gross
hematuria or asymptomatic microscopic hematuria aher
treatment of acute cystitis. Again, these recommendations
are mainly based on expert opinion.
Clinically, if recurrence occurs within two weeks of a pre-
vious episode, it is classihed as a relapse, which suggests
failure of the initial therapy, either because of antimicro-
bial failure or a persisting nidus of infection. A urine cul-
ture should be performed in these patients to show that the
drug was active against the uropathogen. Further referral
or imaging should be considered if the woman meets any
of the criteria above or if there is clinical deterioration.
Which organisms are responsible for recurrent UTI?
The pathogenesis of recurrent UTI is similar to that of spo-
radic infection, and 68-77% of recurrences caused by E coli
involve strains genetically indistinguishable from those that
caused previous infections.

Prospective studies have
shown that the same E coli strain can cause recurrence one
to three years later, even with negative urine cultures in
between the initial infection and the recurrence. This hnd-
ing supports the idea of a vaginal or rectal reservoir for the
causative organisms, with recurrence occurring when the
uropathogen from the intestinal ora colonizes the periu-
rethral area and ascends into the bladder. An alternative
and more recent hypothesis stemming from animal experi-
ments is that bacteria invade and persist within the bladder
epithelium and cause recurrences by re-emerging into the
bladder. Intracellular niches of infecting organisms within
the bladder epithelium have been shown in mouse models
of UTI, but the importance of this phenomenon in humans
is unclear. This concept raises the question of whether char-
acteristics of the bacterial strain itself, such as propensity for
cellular invasion, predispose the host to recurrent disease.
How do you diagnose recurrent UTI and confirm the diagnosis?
The clinical presentation of recurrent UTI is the same as
for sporadic acute cystitis. Local genitourinary symptoms
of dysuria, frequency, and urgency or hesitancy come on
suddenly. Gross hematuria and suprapubic pain may also
be present as part of uncomplicated cystitis. The symptoms
are ohen the same as in previous episodes; ambulatory
women with recurrent, uncomplicated UTI have a high
accuracy of correct self diagnosis.
Although a urine culture is not usually needed to diag-
nose sporadic cystitis, expert opinion suggests that urine
culture is useful in women presenting with recurrent dis-
ease, particularly if no culture was obtained previously.

The purpose of the urine culture is to conhrm the diagno-
sis and direct antimicrobial therapy. This is important in
recurrent disease to distinguish infection from overactive
Previous articles in this
Investigation and
treatment of imported
malaria in non-endemic
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(BMJ lu1!;!/6:fl716)
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32 BMJ | 1 JUNE 2013 | VOLUME 346
bladder or interstitial cystitis, both of which can present
with urgency and bladder discomfort.

In observational
studies of recurrent disease, E coli still predominates, but
the likelihood of a resistant uropathogen or a non-E coli
pathogen is increased.

Future episodes can be managed

without urine cultures if they respond well to empiric regi-
mens. As outlined above, observational studies show that
radiographic imaging is rarely useful, but computed tom-
ography or ultrasound can be considered if a nidus (such
as a stone) of infection is suspected.
Is duration of treatment for recurrent UTI the same as for
uncomplicated sporadic disease?
Recurrent episodes can be treated with the same antibi-
otic regimens as used for sporadic cystitis. Empiric initial
therapy is subsequently tailored according to urine culture
results or clinical response. The gure shows the regimens
most commonly used for acute cystitis and recommended
in evidence based clinical practice guidelines published
jointly by the Infectious Diseases Society of America and
European Society of Clinical Microbiology and Infectious

These international guidelines were devel-

oped by consensus of a multidisciplinary group of experts
in urology, primary care, family practice, infectious dis-
eases, obstetrics and gynecology, and emergency medi-
cine. Recommendations are intended to be a guide, with
further renement depending on local resistance patterns,
availability of specic agents, and individual patient fac-
tors. Examples of geography specic caveats include use of
trimethoprim in the UK rather than trimethoprim-sulfame-
thoxazole (co-trimoxazole). The British National Formulary
warns that co-trimoxazole should be used in UTI only if
there is good bacteriological evidence of sensitivity to this
drug and good reason to prefer this combination to a single
antibiotic. In addition, pivmecillinam is not available in
North America and fosfomycin is unavailable in the UK.
The concepts of preferring uoroquinolone sparing regi-
mens and judicious use of antimicrobials are universal.

Most recurrences can be treated for the same short dura-

tion as for standard acute cystitis, although few studies
are available to guide duration of therapy in women with

The argument for treating these women for

seven days is that data from observational studies indi-
cate that they are at a higher risk of complications, such as
pyelonephritis. However, it is unclear whether longer treat-
ment courses decrease this risk. In the absence of specic
evidence regarding optimal duration of therapy in these
women, a three to seven day course is reasonable, depend-
ing in part on any urological sequelae of the diabetes, such
as neurogenic bladder.
In addition to antimicrobial treatment, patients with
recurrent UTI should be educated about modiable risk
factors, such as avoiding the use of a diaphragm and of
spermicides, including spermicidal condoms, for contra-
ception. The possibility of future recurrences should be
discussed in the context of choosing a preventive strategy
that best suits the individual woman.
What preventive measures exist for recurrent UTI?
The diversity of eective strategies to prevent recurrences
makes a patient centered approach possible (gure). The
main decision is whether to use antimicrobial prophylaxis
or patient initiated therapy. The second approach is not
truly a preventive one but oers the advantages of minimiz-
ing antibiotic exposure while giving the patient a high level
of control over recurrences. In patient initiated therapy, the
physician provides the woman with a course of antibiotics
so that she can start therapy if symptoms of UTI develop.
She should be counseled to seek care if her symptoms
are dierent from previous episodes, if her symptoms do
Acute management
Obtain urine culture if no previous culture
Start empiric oral therapy
Trimethoprim (in UK) mg twice daily
(or TMP-SMX DS in USA) for days
Nitrofurantoin mg twice daily for
Fosfomycin g, single dose (not
available in UK)
Alternative regimens
Ciprofloxacin mg twice daily for days
lactam (cefpodoxime, cefuroxime;
dose varies by regimen) for days
The choice between these agents should
be individualized and based on patient
history (microbiology, tolerance, previous
Alternative agents should be reserved for
cases when a preferred agent cannot be
used for example, in patients with in vitro
resistance, allergy, or lack of response
Recurrent cystitis
Provide patient education regarding natural course of recurrent UTI
Assess potential modiable risk factors and family history
Discuss patient preference regarding antimicrobial management
Discuss non-antimicrobial measures
Antimicrobial prophylaxis
Trimethoprim (in UK) mg at bedtime
TMP-SMX SS (in USA) at bedtime, three
times a week, or postcoitally
Nitrofurantoin - mg at bedtime or
Cephalexin mg at bedtime or
Cefaclor mg at bedtime
The choice of agent and dosing regimen
(daily, three times a week, postcoitally)
should be individualized and based on
patient history (previous microbiology;
timing of UTI to coitus; ease of daily
versus intermittent dosing)
Expectant management
Consider patient initiated therapy
Trimethoprim (in UK) mg twice daily
(or TMP-SMX DS in USA) for days
Nitrofurantoin mg twice daily for
Other previously successful regimen
Strategy for management
of recurrent urinary
tract infection (UTI) in
women derived from
recommendations from the
Infectious Diseases Society
of America, European Society
of Clinical Microbiology
and Infectious Diseases,
Society of Obstetricians and
Gynaecologists of Canada,
and the Canadian Urological
Association. Not all listed
agents are available or
approved in the UK or in all
locales. Acute episodes can
be managed the same as
sporadic cystitis. Prophylaxis
or self initiated management
should be individualized
according to the preferences
of patients and providers and
individual circumstances.
See text for further details on
management strategy and
evidence for listed agents.
(co-trimoxazole), SS=single
strength (/ mg),
DS=double strength
(/ mg)
BMJ | 1 JUNE 2013 | VOLUME 346 33
can cause pulmonary toxicity, even at the lower doses used
for prophylaxis; whether intermittent regimens for shorter
periods result in pulmonary toxicity is unknown. Fortu-
nately, reports suggest that pulmonary toxicity reverses on
discontinuation of nitrofurantoin.

What are the nonantibiotic options for prevention in
recurrent UTI?
Nonantimicrobial prevention strategies include use of
vaginal probiotics, use of cranberry products, and estrogen
repletion. A recent Cochrane review of 24 clinical trials,
including 14 published since 2008, concluded that cran-
berry products do not oer signihcant protection (relative
risk 0.74, 0.42 to 1.31) from recurrences, whereas another
meta-analysis found that the number of events halved
(0.53, 0.33 to 0.83).

The potential beneht of cranberry
in terms of product type (solid v liquid), dosing, and opti-
mal patient population therefore remains to be elucidated.
Oral lactobacillus was inferior to trimethoprim-sulfameth-
oxazole prophylaxis in a placebo controlled randomized
trial in terms of time to recurrence, but antimicrobial resist-
ance occurred more ohen in the antibiotic group.
ever, vaginal lactobacilli suppositories were superior to
placebo at preventing recurrences.
Oral estrogens do not
have a role in prevention, particularly given their poten-
tially harmful systemic eects, but vaginal estrogens show
promise in postmenopausal women.
A randomized pla-
cebo controlled trial in 93 women of eight months of vagi-
nal estrogen cream reported 0.5 recurrences per patient
year in the estrogen group versus 5.9 per patient year in the
placebo group (P<0.001).
A trial of an estrogen releasing
vaginal ring (Estring) versus control in 103 women over 36
weeks found a signihcantly delayed time to hrst recurrence
in the vaginal ring group (P=0.008).
By contrast, a trial
of estrogen vaginal pessaries versus nitrofurantoin in 171
women found a higher incidence of symptomatic UTI in the
estrogen group.
Adverse events associated with vaginal
estrogen creams include itching, burning, and occasional
blood spotting.
Does treating asymptomatic bacteriuria help prevent
recurrent UTI?
Convincing evidence from one or more well conducted ran-
domized trials shows that screening for, and treatment of,
asymptomatic bacteriuria does not prevent symptomatic
disease in premenopausal nonpregnant women, women
with diabetes, and other populations not covered in this
review. Women with asymptomatic bacteriuria are at
higher risk of recurrent UTI,
but treating the bacteriuria
leads to antimicrobial resistance without preventing recur-
Observational cohort studies from as far back as
the 1970s,

and a randomized uncontrolled study in the
past year, suggest that treating asymptomatic bacteriuria
may predispose women to a recurrence of cystitis.
In fact,
any antimicrobial exposure may increase the risk of acute
cystitis by altering the normal vaginal ora.
Contributors: KG had the idea for the article. Both authors performed the
literature search, wrote the article, and are guarantors.
Funding and competing interests are in the version on
Provenance and peer review: Commissioned; externally peer reviewed.
References are in the version on
not resolve with therapy or worsen while on therapy, or if
the diagnosis or adherence to birth control methods is in
doubt. This approach has been shown to be safe and eec-
tive in longitudinal observational studies and oers many
potential advantages for women who have few recurrences,
such as reduced use of antibiotics, increased convenience,
and reduced overall costs.

What is the best prophylactic antimicrobial approach to
recurrent UTI?
Antimicrobial prophylaxis involves giving a low dose of anti-
biotic postcoitally, three times a week, or daily, depending
on whether the patient can temporally relate recurrences to
sexual intercourse (hgure).


This strategy can be antibi-
otic sparing if sexual intercourse is infrequent and antibiot-
ics are given only postcoitally. Typically, prophylaxis is used
for six months and then stopped. If the frequency of recur-
rences returns to the preprophylaxis level, a longer duration
of prophylaxis can be given. More than 10 randomized clini-
cal trials have shown low dose antibiotic prophylaxis to be
highly eective for the duration of antibiotic use compared
with placebo.
A meta-analysis of seven clinical trials found
an 85% reduced risk of recurrences compared with placebo,
and the number of women needed to treat for beneht was
The choice of antimicrobial agent should be guided
by the patients microbiological history and drug toler-
ance, cost to the patient, and the aim of minimizing eects
on the intestinal ora. Randomized trials have compared
nitrofurantoin, trimethoprim, cinoxacin, and trimetho-
prim-sulfamethoxazole. Although one trial showed beneht
of nitrofurantoin 100 mg daily over trimethoprim 100 mg
daily (relative risk 3.58, 1.33 to 9.66), no antibiotic class is
clearly favored for prophylaxis on the basis of randomized
comparisons and meta-analyses.
In another randomized
trial, no signihcant dierence in the rate of recurrences was
seen for 125 mg of postcoital ciprooxacin compared with
125 mg of daily ciprooxacin, suggesting that postcoital
dosing was as eective as daily dosing.
The most common adverse events were nausea and can-
didiasis. Importantly, years of daily use of nitrofurantoin
Resources for healthcare professionals
Epp A, Larochelle A, Lovatsis D, Walter JE, Easton W,
Farrell SA, et al. Recurrent urinary tract infection. J Obstet
Gynaecol Can ;:-. Guidelines on recurrent
urinary tract infection from the Society of Obstetricians and
Gynaecologists of Canada
Dason S, Dason JT, Kapoor A. Guidelines for the diagnosis
and management of recurrent urinary tract infection in
women. Can Urol Assoc J ;:-
Infectious Diseases Society of America (www.idsociety.
org/Organ_System/)Guidelines on treatment of acute
cystitis and pyelonephritis and asymptomatic bacteriuria
Resources for patients (
cystitis-in-women)Patient information on recurrent
cystitis in women
New York Times Health Guide (http://health.nytimes.
html)Advice on recurrent cystitis
34 BMJ | 1 JUNE 2013 | VOLUME 346
National Collaborating Centre for
Mental Health, University College
London, London WC1E 7HB, UK
Centre for Outcomes Research and
Effectiveness, University College
London, London WC1E 7HB, UK
Research Department of Clinical,
Educational and Health Psychology,
University College London, London
Cochrane Airways Group,
Population Health Sciences and
Education, St Georges, University of
London, London SW17 uRE, UK
National Collaborating Centre for
Mental Health, Royal College of
Psychiatrists, London E1 SAA, UK
Department of Experimental
Psychology, University of Oxford,
Oxford OX1 !UD, UK
Correspondence to: S Pilling
Cite this as: BMJ ;:f
doi: 1u.11!6/bmj.fl'/1
This is one of a series of BMJ
summaries of new guidelines
based on the best available
evidence; they highlight important
recommendations for clinical
practice, especially where
uncertainty or controversy exists.
Further information about the
guidance, a list of members of the
guideline development group,
and the supporting evidence
statements are in the full version
Social anxiety disorder is one of the most persistent and
common of the anxiety disorders, with lifetime preva-
lence rates in Europe of 6.7% (range 3.9-13.7%).
ohen coexists with depression, substance use disorder,
generalised anxiety disorder, panic disorder, and post-
traumatic stress disorder.
It can severely impair a per-
sons daily functioning by impeding the formation of
relationships, reducing quality of life, and negatively
aecting performance at work or school. Despite this,
and the fact that eective treatments exist, only about
half of people with this condition seek treatment, many
aher waiting 10-15 years.
Although about 40% of those
who develop the condition in childhood or adolescence
recover before adulthood,
for many the disorder per-
sists into adulthood, with the chance of spontaneous
recovery then limited compared with other mental
health problems.
This article summarises the most recent recommen-
dations from the National Institute for Health and Care
Excellence (NICE) on recognising, assessing, and treat-
ing social anxiety disorder in children, young people,
and adults.
NICE recommendations are based on systematic reviews
of the best available evidence and explicit considera-
tion of cost eectiveness. When minimal evidence is
available, recommendations are based on the Guide-
line Development Groups experience and opinion of
what constitutes good practice. Evidence levels for the
recommendations are in the full version of this article
Principles for working with all people with social
anxiety disorder

When a person is hrst oered an appointment,
provide clear information in a letter about:

Where to go on arrival and where they can wait
(oer the use of a private waiting area or the
option to wait elsewherefor example, outside
the services premises)

Location of facilities available at the service (for
example, the car park and toilets)

What will happen and what will not happen
during assessment and treatment.
When the person arrives for the appointment, oer to
meet them or alert them (for example, by text message)
when their appointment is about to begin.

Oer to provide treatment in settings where
children and young people and their parents or
Recognition, assessment. and treatment of social anxiety disorder:
summary of NICE guidance
Stephen Pilling,
1 2 3
Evan Mayo-Wilson,
1 2 3
Ifigeneia Mavranezouli,
1 2 3
Kayleigh Kew,

Clare Taylor,
David M Clark,
On behalf of the Guideline Development Group
carers feel most comfortablefor example, at home
or in schools or community centres.
Identification of adults with possible social anxiety

Ask the identihcation questions using the two-item
generalised anxiety disorder scale (GAD-2)
in line
with NICE guidance
, and if social anxiety disorder
is suspected:

Use the three-item mini-social phobia inventory

Consider asking the following two questions:
Do you hnd yourself avoiding social situations
or activities? Are you fearful or embarrassed in
social situations?
If the person scores 6 or more on the Mini-SPIN or
answers yes to either of the two questions above, refer
for or conduct a comprehensive assessment for social
anxiety disorder.
Identification of children and young people with
possible social anxiety disorder
Professionals in primary care and education and in com-
munity settings should be alert to possible anxiety dis-
orders in children and young people, particularly those
who avoid school, social or group activities, or talking
in social situations, or are irritable, excessively shy, or
overly reliant on parents or carers. Consider asking the
child or young person (or their parents or carers) about
their feelings of anxiety, fear, avoidance, distress, and
associated behaviours, to help establish if social anxi-
ety disorder is present, using the following statement
and questions:
Sometimes people get very scared when they have
to do things with other people, especially people
they dont know. They might worry about doing
things with other people watching. They might
get scared that they will do something silly or that
people will make fun of them. They might not want
to do these things or, if they have to do them, they
might get very upset or cross. Then ask:

Do you/does your child get scared about doing
things with other people, like talking, eating,
going to parties, or other things at school or with

Do you/does your child hnd it dimcult to do
things when other people are watching, like
playing sport, being in plays or concerts, asking
or answering questions, reading aloud, or giving
talks in class? Psychiatry updates from BMJ Group are at
BMJ | 1 JUNE 2013 | VOLUME 346 35
cognitive behavioural interventions and try to resolve
any concerns.

If the person wishes to proceed with a drug
intervention, oer a selective serotonin reuptake
inhibitor (escitalopram or sertraline). Monitor
carefully for adverse reactions.
Third line treatments

For adults who decline cognitive behavioural
interventions and drug treatment, consider short
term, psychodynamic psychotherapy specically
developed for social anxiety disorder. However,
bear in mind the more limited clinical and cost
eectiveness of this intervention.
The components of the recommended psycho logical
therapies for children and young people can be found in
the full NICE gu ideline.

Interventions for children and young people with social

anxiety disorder

Oer individual or group CBT focused on social
anxiety. Consider involving parents or carers for
eective delivery of the intervention, particularly in
young children.
The components of the recommended psycho logical
therapies for children and small children can be found
in the full NICE g uideline.

Do not routinely oer drug interventions to treat
social anxiety disorder in children and young people.
Overcoming barriers
The guideline deals with several potential barriers to peo-
ple seeking treatment for social anxiety disorder: people
may think that the social anxiety is part of their personal-
ity and cannot be changed (or, in the case of children, that
they will grow out of it); they may fear negative evalu-
ation by healthcare professionals if they disclose their
problem; even aer presentation, the disorder may not be
recognised by healthcare professionals, especially in pri-
mary care.

The guideline advises healthcare profession-

als to be aware of barriers to people seeking treatment,
and on how to identify the disorder in all age groups and
how services can make themselves more accessible. It
also recommends eective treatments and seeks to help
commissioners identify the services that should be made
Contributors: All authors contributed to the conception and drahing of this
article and revising it critically. They have all approved this version. SP is
the guarantor.
Competing interests: All authors have completed the Unihed Competing
Interest form at (available on request
from the corresponding author) and declare: (1) SP, EM-W, IM, KK, and CT
had support from the National Collaborating Centre for Mental Health,
which was in receipt of funding from NICE, for the submitted work; (l) DMC
developed one of the psychological therapies under consideration so was
excluded from discussion of recommendations related to that treatment;
(!) no other relationships or activities that could appear to have influenced
the submitted work.
Provenance and peer review: Commissioned; not externally peer
References are in the version on
Accepted: 16 April lu1!

Do you/does your child ever feel that you/your
child cant do these things or tries to get out of
If the child or young person or parents or carers
answer yes to one or more of the questions consider a
comprehensive assessment for social anxiety disorder.
Comprehensive assessment for children, young
people, and adults

Obtain a detailed description of the persons
current social anxiety and associated problems and
circumstances including:

Feared and avoided social situations, and what
they are afraid might happen in social situations
(for example, looking anxious, blushing,
sweating, trembling, or appearing boring)

Anxiety symptoms

View of self

Safety seeking behaviours

Anticipatory and post-event processing

Occupational, educational, nancial, and social
circumstances in adults

Family circumstances and support, friendships
and peer groups, educational and social
circumstances in children and young people

Medication, alcohol, and recreational drug use.
Delivering interventions for children, young people,
and adults
All interventions should be delivered by competent
practitioners. Psychological interventions should be
based on the relevant treatment manual(s), which
should guide their structure and duration. Practition-
ers should consider using competence frameworks
developed from the relevant treatment manual(s) and
for all interventions should receive regular, high quality,
outcome informed supervision; use routine sessional
outcome measures; and monitor treatment adherence
and practitioner competence (for example, using video
and audio recordings, and external audit and scrutiny
if appropriate).
Interventions for adults with social anxiety disorder
First line treatment

Oer adults individual cognitive behavioural
therapy (CBT) that has been specically developed
to treat social anxiety disorder (based on the Clark
and Wells model or the Heimberg model


Do not routinely oer group CBT in preference
to individual CBT. Although there is evidence
that group CBT is more eective than most other
interventions, it is less clinically and cost eective
than individual CBT.
Second line treatments

For adults who decline CBT and wish to consider
another psychological intervention, oer CBT based,
supported self help.

For adults who decline cognitive behavioural
interventions and express a preference for a drug
intervention, discuss their reasons for declining Previous
articles in this series
Long term follow-up
of survivors of childhood
cancer: summary of
updated SIGN guidance
(BMJ lu1!;!/6:f119u)
intervention, and
management of antisocial
behaviour and conduct
disorders in children and
young people: summary
of NICE-SCIE guidance
(BMJ lu1l;!/6:f1l93)
Fertility (update):
summary of NICE
(BMJ lu1!;!/6:f6'u)
Recognition and
management of psychosis
and schizophrenia in
children and young
people: summary of NICE
(BMJ lu1!;!/6:f1'u)
Ectopic pregnancy and
miscarriage: summary of
NICE guidance
(BMJ lu1l;!/':e31!6)
36 BMJ | 1 JUNE 2013 | VOLUME 346
Acute leg ischaemia
Stephen Brearley
Whipps Cross University Hospital,
London E11 1NR, UK
Cite this as: BMJ ;:f
doi: 1u.11!6/bmj.fl631
This is one of a series of occasional
articles highlighting conditions
that may be more common than
many doctors realise or may
be missed at first presentation.
The series advisers are Anthony
Harnden, university lecturer in
general practice, Department of
Primary Health Care, University
of Oxford, and Richard Lehman,
general practitioner, Banbury.
To suggest a topic for this series,
please email us at easilymissed@
A 55 year old man consulted his general practitioner com-
plaining of persistent pain in his leh leg for three days
and a numb feeling in the foot. He was taking treatment
for hypertension, had a history of low back pain, and was
a smoker of 20 cigarettes a day. His foot looked normal,
but sensation seemed mildly reduced. The general prac-
titioner noted a weak dorsalis pedis pulse. A diagnosis
of sciatica was made, diclofenac was prescribed, and the
patient was invited to return a week later if no better. Six
days later he presented to a local emergency department
because of intolerable pain and was found to have a pro-
foundly ischaemic leh leg necessitating an above knee
Missed diagnoses of acute leg ischaemia, as in the case
above, are common.

An analysis of data held by the
NHS Litigation Authority (NHSLA), the Medical Defence
Union (MDU), and the Medical Protection Society (MPS)
identihed 224 cases of acute leg ischaemia leading to limb
loss over a 10 year period,
in all of which litigation had
been initiated. Fihy one cases in which there had been
delay in detecting and treating acute limb ischaemia were
reported to the National Reporting and Learning System
(NRLS) between 2003 and 2010.
I have written almost
30 medicolegal reports on cases in which there were alleg-
ationsusually against general practitioners or casualty
officersof a negligent delay in diagnosing acute leg
ischaemia, ohen resulting in the avoidable loss of a limb.
What is acute leg ischaemia?
Leg ischaemia results from thrombotic, embolic, or trau-
matic arterial occlusion. It is considered to be acute if the
symptoms and signs have developed over less than two

The term acute ischaemia does not of itself
imply severe ischaemia, but the survival of an acutely
ischaemic limb is ohen in immediate jeopardy.
The hall-
marks of acute ischaemia that is limb threatening are
reduced muscular power and reduced sensation in the
How common is it?
In a 1996 questionnaire survey of members of the Vascular
Surgical Society of Great Britain and Ireland, 86 out of 182
hospitals reported 539 episodes of acute lower limb ischae-
mia in a three month period.
In this study, acute lower
limb ischaemia was dehned as a previously stable limb
with sudden deterioration in the arterial supply for less
than two weeks. In another study, an incidence as high
as one per 7000 per annum has been quoted.
show that over 20 legal actions are initiated each year
in the UK in relation to acute leg ischaemia, with delay in
diagnosis or treatment hguring in 73% of the claims.
Why is it missed?
In the cases reported to the NRLS, the National Patient
Safety Agency stated that causes of delay in detecting
and treating acute limb ischaemia included diagnostic
errors (such as misdiagnosis as a Bakers cyst or disc
problem, as in the case scenario), acute limb ischaemia
not being recognised as a surgical emergency, and appar-
ently inconsistent clinical diagnosis and assessment. My
own clinical and medicolegal experience indicates that
there is ohen a failure to consider a diagnosis of acute leg
ischaemia at all, especially if the patient is under 60 years
old (as in the case scenario). By no means all patients
with acute leg ischaemia have risk factors (such as atrial
hbrillation, a history of smoking, or diabetes). It should
therefore be considered in the dierential diagnosis of
all patients presenting with leg pain of sudden onset,
irrespective of age and risk factors, and all such patients
should undergo an assessment of the circulation to the
The extent to which acutely ischaemic legs are pale
(or discoloured) or cold or exhibit diminished power or
sensation is variable, and subtle changes can be missed
(as in the case above) if the examination is cursory. An
error encountered in almost all cases of missed acute leg
ischaemia, however, is that one or more doctors have
purported to feel pulses that could not possibly have
been present. Pulse palpation is an unreliable physical
sign, with false positive palpation occurring in 14% of
observations carried out by non-specialists.
A weak
or faint ankle pulse, or one which the doctor thinks
he or she can feel, is probably not present at all (as in the
case history above). A simple rule will protect against this
common error: If you can feel a pulse you can count it; if
you cannot count it, you are not feeling it.
Why does it matter?
Delay in diagnosis or referral was the sole or the princi-
pal cause of amputation in 59% of the patients identihed
from medicolegal data.
The interval between the onset of
symptoms and irretrievable damage to the leg is variable
but may be as little as six hours.

Acute leg ischaemia is
associated with an amputation rate of 13% and a mortal-
ity of 10%.
Both are increased by delay in diagnosis and
How is it diagnosed?
Acute leg ischaemia can only be diagnosed if it is included
in the dierential diagnosis of leg pain of recent onset. It
should be considered in patients of all ages. Although
usually encountered in patients over 60 years old, rare
disorders (such as popliteal entrapment syndrome, cystic
adventitial disease, and thrombophilias) may occasion-
ally lead to its development in much younger individuals.
In all patients presenting with leg pain of sudden
onset, look for the symptoms and signs of limb threaten-
ing ischaemia as characterised by the six Ps (see box).
The patient will always have persistent pain and the ankle
pulses will always be absent. The other Ps may or may Previous
articles in this series
Pelvic inflammatory
(BMJ lu1!;!/6:f!139)
Colorectal cancer
(BMJ lu1!;!/6:f!17l)
Delirium in older adults
(BMJ lu1!;!/6:flu!1)
Cushings syndrome
(BMJ lu1!;!/6:f9/')
Chronic exertional
compartment syndrome
(BMJ lu1!;!/6:f!!)
BMJ | 1 JUNE 2013 | VOLUME 346 37
In an immediately threatened limb, emergency
surgery will be required. Regrettably, some patients present
with limbs that are already dead (profound paralysis and
numbness, hxed mottling of the skin). In this situation
revascularisation may be not merely futile but harmful,
and primary amputation is necessary.
Contributors: The articles content was developed in discussion with J
Murray Longmore, and the hrst drah was revised in the light of comments
from Longmore.
Competing interests: I have read and understood the BMJ Group policy on
declaration of interests and have no relevant interests to declare.
Provenance and peer review: Commissioned; externally peer reviewed.
Patient consent: Patient consent not required (patient anonymised, dead,
or hypothetical).
1 Shearman A, Shearman C. Failure to diagnose acute limb ischaemia
(ALI); an avoidable cause of limb loss. Association of Surgeons of Great
Britain and Ireland, lu1l International Surgical Congress. In: www.
abstract uS1l.
l National Patient Safety Agency. Early detection and treatment
of acute limb ischaemia. Signal. lu11.
! Creager MA, Kaufman JA, Conte MS. Acute limb ischaemia. N Engl J Med
/ Campbell WB, Ridler BMF, Szymanska TH. Current management of acute
leg ischaemia: results of an audit by the Vascular Surgical Society of
Great Britain and Ireland. Br J Surg 199S;S':1/9S-'u!.
' Trummer G, Brehm K, Siepe M, Heilmann C, Schlensak C, Beyersdorf F. The
management of acute limb ischemia. Minerva Chir lu1u;6':!19-lS.
6 Brearley S, Shearman CP, Simms MH. Peripheral pulse palpation: an
unreliable physical sign. Ann Roy Coll Surg Engl 199l;7/:169-71.
7 Earnshaw JJ. Acute ischaemia: evaluation and decision making. In:
Cronenwett JL, Johnston KW, eds. Rutherfords vascular surgery. 7th ed.
Saunders Elsevier, lu1u:l!S9-9S.
S Henke P. Contemporary management of acute limb ischaemia: factors
associated with amputation and in-hospital mortality. Semin Vasc Surg
9 National Institute for Health and Clinical Excellence. Lower limb
peripheral arterial disease: diagnosis and management. (Clinical
guideline 1/7.) lu1l.
not be present, depending on severity, and if present may
be subtle (as in the case above). The presence or absence
of risk factors for peripheral arterial disease is of limited
usefulness. Limb threatening ischaemia may develop in
individuals who have no known risk factors and are well
under the age of 60.
The presence of acute leg ischaemia can be quickly,
simply, and reliably conhrmed or ruled out by measuring
the ankle blood pressure with a pocket Doppler machine
and a blood pressure cu.
The absence of Doppler signals
indicates a threatened limb, and the patient requires emer-
gency referral to a vascular centre. Doppler assessment
can be quickly learnt, is reproducible, and is easier than
many other procedures routinely carried out in primary
care (such as funduscopy). Pocket Doppler machines are
cheap (approximately E300).
How is it managed?
If a patient has leg pain of recent onset and has impalpa-
ble pulses, immediate referral to a vascular surgical unit
is mandatory. The management undertaken there will
depend on the immediacy of the threat to the survival of
the limb. The key clinical indicators of this are the pres-
ence and severity of reduced muscular power and reduced
sensation. Depending on the urgency of the situation, the
vascular unit may carry out imaging studies of the arter-
ies supplying blood to the leg (duplex ultrasound, mag-
netic resonance angiography, computed tomographic
angio graphy or intra-arterial angiography) as a basis for
planning treatment. The options for treatment comprise
endovascular procedures (angioplasty, thrombectomy, and
intra-arterial thrombolysis) and surgery (embolectomy and
Leg ischaemiathe Ps
PainAlways present,
Pallor or cyanosis or
Perishing with cold
present. Can you count it?
Paraesthesia or reduced
sensation or numbness*
Paralysis or reduced
*May be subtle. Compare left and
right legs
ANSWERS TO ENDGAMES, p 38 For long answers go to the Education channel on
A man with bilateral loin pain
1 Loin pain.
2 Factors that contribute to stone formation
include age, sex, genetics (such as cystinuria,
as in this case), climate, geographical location,
occupation, and diet.
3 Renal tract stones are the main cause of
loin pain. However, other causes need to
be considered. Non-enhanced computed
tomography is the ideal modality for the
investigation of loin pain.
/ Staghorn calculi are best managed by
percutaneous nephrolithotomy or nephrectomy.
PICTURE QUIZ The acute abdomen
1 The erect chest radiograph shows a pneumoperitoneum with free gas under the
diaphragm bilaterally.
2 The diagnostic sensitivity of this sign depends on its cause, varying from 8% in
perforated appendicitis to 9/% in perforated peptic ulcer disease. The overall sensitivity
of detecting gas under the diaphragm on erect chest radiography in the context of a
perforated hollow viscus is 69%.
3 Free gas on erect chest radiography in the context of acute onset abdominal pain
indicates perforation of a hollow viscus until proved otherwise. The most common
causes are perforated peptic ulcer (16%), perforated diverticular disease (16%),
perforated carcinoma (sigmoid, rectal, or caecal; 1/%), and perforation secondary to
ischaemia (1u%). Perforated appendix secondary to appendicitis is common, but is less
likely to cause a substantial amount of gas under the diaphragm.
/ The patient should be resuscitated according to advanced life support principles of
airway, breathing, and circulation (ABC), and sepsis should be treated according to
the sepsis six care bundle. When stable, computed tomography may be performed to
aid in diagnosis and guide further management; alternatively, the patient may require
an emergency laparotomy without further imaging.
5 Definitive treatment depends on the cause. Patients often need surgeryeither a
laparoscopic wash-out or laparotomy. In some instances, a confined perforation is self
limiting and can be treated non-operatively with antibiotics, bowel rest, and regular
surgical review.
Selection bias versus allocation bias
Statements a and c are true, whereas b and d are
38 BMJ | 1 JUNE 2013 | VOLUME 346
We welcome contributions that would help doctors with postgraduate examinations
OSee for details
The effectiveness of supported self management in reducing hospital
readmissions and death in patients with chronic obstructive pulmonary
disease was evaluated. Researchers performed a randomised
controlled trial. The intervention consisted of training patients to detect
and treat exacerbations promptly, with ongoing support for 12 months.
Patients in the control group continued to be managed by their general
practitioner, hospital based specialists, or both.
Participants were patients admitted to one of six hospitals in the
west of Scotland with an acute exacerbation of chronic obstructive
pulmonary disease. In total, /6/ patients were recruited and allocated
to the treatment group using stratified randomisation based on
demographic and disease severity factors. The main outcome measures
included time until first hospital readmission or death owing to
chronic obstructive pulmonary disease. The researchers reported that
supported self management had no effect on time to first hospital
readmission or death from chronic obstructive pulmonary disease.
Which of the following statements, if any, are true?
a) The method of patient recruitment meant there was the potential for
selection bias
b) Selection bias would result if patients were selected for treatment
groups on the basis of a preference by one of the researchers
c) The randomisation of patients to treatment group minimised
allocation bias
d) The randomisation of patients to treatment group minimised
selection bias
Submitted by Philip Sedgwick
Cite this as: BMJ 2013;346:f3345
Go to the Education channel on
A 65 year old man presented with
a 12 month history of bilateral
flank pain but no fever or lower
urinary tract symptoms. Over the
preceding 1u years he had had
multiple interventions, including
extracorporeal shock wave
lithotripsy and ureteroscopic
laser stone fragmentation, for
cystine renal stones. He had type
2 diabetes and hypertension, and
he was also obese.
A plain radiograph showed
a large renal pelvic calculus
measuring 3./ cm in the right
kidney and a /./ cm partial
staghorn calculus projected
over the left kidney. A
dimercaptosuccinic acid scan
showed a relative function of
/7.5% for the right kidney and
52.5% for the left kidney.
A staged percutaneous
nephrolithotomy was performed
successfully on the simpler right
stone, but postoperatively he
developed pain in the right loin.
A nephrostogram showed debris
partially occluding the right
ureter, which resulted in a filling
defect; this was thought to be
a clot and it later passed.
Stone analysis confirmed
cystine stones. Three months
later a percutaneous
nephrolithotomy was undertaken
on the left side. Postoperative
recovery was uneventful and
radiography showed no residual
1 What is the most common
clinical presentation of renal
tract stones?
2 What are the causative factors
for renal tract stones?
3 What are the causes of loin pain
and what investigations are
used to differentiate them?
/ What is the best management
approach for staghorn calculi?
Submitted by Mohammed Hayat Ashrafi,
Usman Bhatty, Katie Hall, and Moeketsi
Cite this as: BMJ 2013;346:f2850
A /5 year old woman presented to the
emergency department with an eight hour
history of sudden onset abdominal pain.
The pain was severe, sharp, and worse on
movement. She felt nauseous but had not
vomited. She had last opened her bowels earlier
that day, passing a small amount of hard stool.
Her medical history included osteogenesis
imperfecta, which caused hip pain, and for
which she took 1/u mg of oxycodone daily.
On examination she was in obvious distress.
She was tachypnoeic at 22 breaths/min and
tachycardic at 11u beats/min. Blood pressure,
peripheral oxygen saturation, and temperature
were all in the normal range. Her abdomen was
exquisitely tender to palpation, with maximum
tenderness in the right iliac fossa, localised
guarding, and percussion tenderness. Digital
rectal examination identified hard faeces in the
rectum. Bowel sounds were absent. Initial blood
tests showed haemoglobin 1/.5 g/L (reference
range 12.u-15.u), white cell count 17.51u
(/.u-11.u), C reactive protein 5.5 mg/L (u-8).
Urea, electrolytes, and liver function tests were
normal. A venous blood gas showed a raised
lactate of /.2 mmol/L (u.5-2.u; 1 mmol/L=9.u1
mg/dL). Urgent chest radiography (in the erect
position) was performed (figure).
1 What abnormality is apparent on the erect
chest radiograph?
2 What is the sensitivity of this radiological sign?
3 What is the differential diagnosis?
/ What immediate management should be
implemented for this patient?
5 What definitive treatment options should be
Submitted by B H van Duren, M Moghul, S G Appleton, and
G I van Boxel
Cite this as: BMJ 2013;346:f2549
Selection bias versus allocation bias
PICTURE QUIZ The acute abdomen
A man with bilateral loin pain
BMJ | 1 JUNE 2013 | VOLUME 346 39
Epilepsy is
profitable, with
lifelong multiple
medication, so
a huge range of
putatively new
drugs have been
developed to seek a
slice of the profits
There are, however, no national initia-
tives to withdraw anticonvulsant drugs.
Some of the rationale for more pre-
scribing in epilepsy is to protect against
the rare but devastating sudden unex-
pected death in epilepsy (SUDEP).
SUDEP is most commonly associated
with people with tonic-clonic epilepsy
activity, not partial non-generalised
Undoubtedly seizure control
reduces SUDEP,
but there is no evi-
dence that this massive increase in anti-
epileptic treatment has had an eect on
SUDEP. Lastly, predictably, and depress-
ingly, the educational agenda of epilepsy
is a gravy train of international confer-
ences and drug industry sponsorship.

The numbers for antiepileptic pre-
scribing just dont stack up clinically,
demand further research, and risk over-
treatment. This is bad medicine.
Des Spence is a general practitioner, Glasgow
Competing interests: None declared.
Provenance and peer review: Commissioned;
externally peer reviewed.
References are in the version on
Cite this as: BMJ ;:f
Money is the great motivator. The anti-
convulsant drug phenytoin was recently
replaced by a generic drug, in exploita-
tion of a loophole in UK policy and
increasing the cost to the NHS by E40m.

Epilepsy is prohtable, with lifelong
multiple medication, so a huge range
of putatively new drugs have been
developed to seek a slice of the prof-
its. They are all pitched at the same
price, in the drug industrys tradition-
ally sham competition. Anticonvul-
sants have an additional big business
bonus, too. The industry has been
hned billions for promoting anticon-
vulsants o licence in pain and psy-
chiatry specialties.

Antiepileptic prescriptions in Eng-
land rose from seven to 17 million in
a decade, with annual costs tripling to
These large rises are attribut-
able to the new antiepileptics, despite
these having no proved benefit over
older drugs such as valproate and lamo-

Evidence is also emerging that
the new drugs are being used inappropri-
These prescribing patterns must
also reect increasing polypharmacy in
epilepsy. Yet monotherapy is the treat-
ment goal, and polypharmacy adds little
to control seizures.

Rapid and unexplained increases in
prescribing are a sign of over diagnosis.
So is this happening in epilepsy, espe-
cially partial or focal epilepsy? In
partial epilepsy, unlike generalised
tonic-clonic seizures, the diagnosis
is ohen only clinical,
with dehning
symptoms such as dj vu, detachment,
feeling frightened, memory problems,
tingling, and many more subjective
effects. All diagnoses based on self
reporting and clinical judgment are
open to overdiagnosis phenomena.
Yet there is scant epidemiological data
on changes in the prevalence of epilepsy
in adults, and concerns about overdiag-
nosis are merely anecdotal. Paradoxi-
cally, in children, for whom a diagnosis
of epilepsy is less subjective, incidence
has halved since the mid-1990s.
rate diagnosis is fundamental in epilepsy
because treatment is life long, although
epilepsy ohen spontaneously resolves.

I tried to listen to some heart sounds
last week. Couldnt hear a thing. So an
eminent professor of medicine told me
recently. Its all quackery, you know.
This is something Id thought for
a while, but Id not heard it summed
up with such frankness. Although I
continue to teach undergraduates the
distinction between reverse and hxed
splitting of the second heart sound, I
have never detected these conditions
myself. And Ive got a strong suspicion
that most cardiologists conhdently
declare a clear case of a loud P2
only aher furtively inspecting the
echocardiogram report.
So why do we promulgate this
quackery? Perhaps its a sense of
tradition: its the way things have
always been done. Perhaps its a bit
of pride at the perceived superiority of
British medicine: We know best.
The truth is that the sensitivity of
what does it matter if we go through the
rigmarole of examination? I remember
my hrst clinical hrm as a medical
student. The consultant used to have
the nurse strip each patient naked aher
taking the history before examining
them thoroughly. He would see at most
six patients in an ahernoon.
Now the consultant is expected to see
twice as many patients, and something
has to give in the race for emciency.
The inevitable result is that the hrst
nails are already in the comn of clinical
examination. We just need to have the
courage to admit it to ourselves and,
more importantly, to our students.
Kinesh Patel is a junior doctor, London
Competing interests: Norgine Pharmaceuticals
paid my travel and accommodation expenses for
a conference in May .
Provenance and peer review: Commissioned; not
externally peer reviewed.
Cite this as: BMJ ;:f
such tests is atrocious. As another
example, I cant remember the last
time I felt an abdominal mass in a new
patient who turned out to have cancer,
yet I diagnose an abdominal cancer
every couple of weeks endoscopically.
We teach our students charades.
Kneeling on the oor like a supplicant
to examine the abdomen, percussing
the lung bases as part of breast
examination, and using a piece of
paper placed on outstretched hands to
check for thyrotoxicosis all hark back to
a bygone age.
These clinical tests and others had
use in an era when diagnostic tests
were unavailable or unreliable, but they
are exceptionally operator dependent,
and today they are redundant. It is no
longer acceptable to use only clinical
examination to screen for conditions,
because the miss rate is just too high.
If we plan on formal testing anyway,
Bad medicine: epilepsy
Is clinical examination dead?
Follow Des Spence on
Twitter @des_spence
If we plan on formal
testing anyway,
what does it matter
if we go through
the rigmarole of
40 BMJ | 1 JUNE 2013 | VOLUME 346

Send comments or suggest ideas to Minerva:
The acute abdomen
Try the picture quiz in
By a nice irony, systemic lupus erythematosus
first became widely known to the public when
Dr Greg House, the curmudgeonly hero of
the television series House, kept declaring
that its never lupus. For the editors of the
journal Lupus, the opposite is trueand sadly,
this also goes for patients whose lives are
completely dominated by the condition. As
with most severe chronic conditions, fatigue
is a prominent feature in systemic lupus
erythematosus, and a paper in Lupus (2u13,
doi:1u.1177/u9612u3313/869/8) shows that
levels of fatigue are closely related to levels
of pain and depression, and not to markers
of disease activity. The authors suggest that
by treating these symptoms more effectively
we should also be able to alleviate fatigue in
systemic lupus erythematosus.
The commonest reason for healthy people to
see doctors regularly is because they have
been found on two or three occasions to have
blood pressure above a certain arbitrary level.
Most of these individuals then take two or
more drugs for the rest of their lives, while
others fail to respond to three or even four and
are deemed to have resistant hypertension.
A lifetime cure and a drug free existence now
seem tantalisingly close for some of these
asymptomatic patients. Renal nerve ablation
and long term carotid baroreflex activation
are two options under investigation. In a
study in Hypertension (2u13, doi:1u.1161/
HYPERTENSIONAHA.113.u1159), researchers
looked at the effect of carotid baroreflex
activation on renal function at 12 months. They
observed a slight fall in the glomerular filtration
rate, in keeping with a sustained fall in blood
pressure. For important outcomes in the long
term, we will just have to wait.
Taking aim at the ventricular septum with a
syringe full of alcohol sounds a bit of a heart-
stopping procedure, but apparently it is done
with great success in many patients with
hypertrophic obstructive cardiomyopathy.
Results from an eight year follow-up of /7u
patients with hypertrophic obstructive
cardiomyopathy treated with alcohol septal
ablation are reported in Heart (2u13,
doi:1u.1136/heartjnl-2u12-3u3339). Survival of
these patients was actually slightly better than
that of the matched general population, and
there was a marked reduction in their symptoms.
Emollients! Children with eczema need lots of
them, and parents need to be encouraged to
use them and be given generous supplies. This
is the messagenot new, but so important
from a trial of a multifaceted support
programme for parents in BMC Dermatology
(2u13;13:7, doi:1u.1186/1/71-59/5-13-7).
Unguents! Minerva prefers that word with its
lovely cool slithery sound. Call them what
you will, but they made kids feel better, sleep
better, and use less steroid cream. And the
whole programme turned out to be cost neutral
to the NHS.
Minerva takes a rather dim view of nature,
considering it to be the enemy of doctors and
gardeners alike. A naturopath, by contrast,
is a health practitioner who applies natural
therapies, according to the College of
Naturopathic Medicine. These therapies
can range from herbal mixtures to colonic
irrigation, which is actually a phenomenon
rare in nature. In a Canadian trial published
in CMAJ (2u13, doi:1u.15u3/cmaj.12u567),
naturopaths subjected some of the more
orthodox facets of their treatment regimens
to a randomised trial to see if they reduced
cardiovascular risk factors and body mass
index more than usual care: and they did. The
natural therapies methodological failings
were not any worse than those of many similar
trials using orthodox treatments, but these
findings have given rise to lively debate in the
fraternity of evidence based medicine and
Fish, molluscs, and crustaceans are foods for
the gods, as Minerva can testify. For mortals,
too, there can be few better pleasures than
consuming sea creatures in abundance. Now
pleasure and health do not always consort
together, but in this case they do, especially
if a suitable wine is at hand. I am not referring
to the well known cardiovascular benefits of
oily fish and alcohol, but to a recent study in
the Annals of Oncology (2u13, doi:1u.1u93/
annonc/mdt168). An analysis of the European
Prospective Investigation into Cancer and
Nutrition shows that fish consumption is
associated with a reduction in the risk of
hepatocellular carcinoma. Molluscs and
crustaceans come top, with a 1/% reduction.
The authors dont talk about wine. Never
mindfruits de mer for two please, and a
bottle of your best Chablis.
One day in July 195/ Robert Lowell opened
a window, dropped his spectacles outside,
and waited for them to shatter on the stones
of the courtyard below. So begins an essay by
Stephen James on Lowells afflicted vision
in Essays in Criticism (2u13;63:177-2u2,
doi:1u.1u93/escrit/cgtuu3)the scene here
being set in a psychiatric unit as the poet
wrestles with his overwhelming wish to die.
The fog of myopia comes as a blessed relief at
this moment in his life, but in his poetry the
eye forms a constantly changing metaphor
as indeed it does in all poetry, for every
poet knows that the eye altering alters all
(William Blake, Auguries of Innocence).
Cite this as: BMJ ;:f
An 8u year old man presented with an
infective exacerbation of chronic obstructive
pulmonary disease. His chest radiograph
revealed free air below his diaphragm. He had
no abdominal symptoms or signs. Computed
tomography confirmed intraperitoneal free air
and extensive pneumatosis coli (air within the
bowel wall). Pneumatosis coli is associated
with chronic obstructive pulmonary disease
but its pathophysiology remains unclear.
Patients are usually asymptomatic, although
submucosal blebs of air could rupture into
the peritoneal cavityas seen in this patient.
In the absence of abdominal signs, there
is no indication for surgical intervention
despite this apparently alarming radiological
Sananda Haldar (,
specialty registrar in clinical radiology, Samuel S
Turner, specialty registrar in general surgery, Babajide
Olubaniyi, specialty registrar in clinical radiology,
David C Howlett, consultant radiologist, Eastbourne
District General Hospital, Eastbourne BN UD, UK
Patient consent obtained.
Cite this as: BMJ ;:f