BMJ - 6 April 2013

THIS WEEK
BMJ | 6 APRIL 2013 | VOLUME 346

Leukaemia blood cells
magnification x5000 on SEM
OCLINICAL REVIEW, p 29
NEWS
1 Public satisfaction with emergency care rises
Doctors leaders urge government to amend
commissioning regulations
2 Commissioners need clearer expectations and
longer funding rounds
Cross specialty training would improve academic
psychiatry
Hospitals plant trees to mark NHS sustainability day
3 Controversy rages over paediatric heart surgery
in Leeds
Indian Supreme Court rejects Novartiss appeal on
drug patent
4 New public health system is marred by confusion,
say MPs
Healthwatch must be properly resourced for
its job, charities say
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COMMENT
EDITORIALS
5 Implementation of the Health and Social Care Act
Nigel Edwards
6 Taking the sting out of lumbar puncture
Paul Rizzoli
O RESEARCH, p 11
7 Vitamin D suciency in pregnancy
Robyn Lucas et al
O RESEARCH, p 10
8 Sex selection and abortion in India
Anita Jain
FEATURES
14 Goodbye (and good
riddance?) to PCTs
As Englands primary
care trusts give way to
clinical commissioning
groups, Richard Vize pens
their obituary.
Did PCTs make
a dilerence to
inequalities of care,
reduce the dominance of acute providers, or make
primary care safer for patients?
16 Doctors and the alcohol industry: an unhealthy mix?
Jonathan Gornall reports on an ideological schism
over working alongside the alcohol industry that is
dividing the public health community
ANALYSIS
19 What should follow the millennium
development goals?
Debate on what should replace the United Nations
millennium development goals when their target
date of lu1' is reached is hotting up. Charles Kenny
comments on lessons learnt from their success and
failure and looks at the suggestions for the post-lu1'
development agenda
22
COMMENTARY

New development goals must focus on social
determinants of health
David Legge and David Sanders
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RESEARCH
RESEARCH NEWS
9 All you need to read in the other general journals
RESEARCH PAPERS
10 Association between maternal serum
25-hydroxyvitamin D level and pregnancy and
neonatal outcomes: systematic review and meta-
analysis of observational studies
Fariba Aghajafar et al
O EDITORIAL, p 7
11 Ultrasound imaging for lumbar punctures and
epidural catheterisations: systematic review and
meta-analysis
Furqan Shaikh et al
O EDITORIAL, p 6
12 Cardiovascular events after clarithromycin use in
lower respiratory tract infections: analysis of two
prospective cohort studies
Stuart Schembri et al
13 Cost eectiveness of telehealth for patients with
long term conditions (Whole Systems Demonstrator
telehealth questionnaire study): nested economic
evaluation in a pragmatic, cluster randomised
controlled trial
Catherine Henderson et al
The future of development goals in poorer countries, p 21
Publics satisfaction with emergency NHS care has risen, p 1
THIS WEEK
Missing evidence
for your appraisal
folder?
masterclasses.bmj.com
COMMENT
LETTERS
23 Cardiac surgery mortality rates; Medical devices;
Incidental thrombocytopenia
24 Pulmonary embolism; Acceptable face of big
pharma?; An unsafe ward
OBSERVATIONS
BODY POLITIC
25 Take me to your leader
Nigel Hawkes
MEDICINE AND THE MEDIA
26 How do we know whether medical apps work?
Margaret McCartney
PERSONAL VIEW
27 Not all patients will
benet from paperless
records
Rupert Fawdry
OBITUARIES
28 Norman Kreitman
Psychiatrist and
suicide expert, poet,
philosopher
Norman Kreitman obituary, p 28
LAST WORDS
39 Immigrant song Des Spence
How to encourage compassion Kinesh Patel
EDUCATION
CLINICAL REVIEW
29 Leukaemia update. Part 1: diagnosis and
management Nicholas F Grigoropoulos et al
PRACTICE
GUIDELINES
33 Recognition, intervention, and management of
antisocial behaviour and conduct disorders in
children and young people: summary of NICE-SCIE
guidance Stephen Pilling et al
RATIONAL TESTING
35 Interpreting an isolated raised serum alkaline
phosphatase level in an asymptomatic patient
Kate Elizabeth Shipman et al
ENDGAMES
38 Quiz page for doctors
in training
MINERVA
40 Clopidogrel, and other
stories
Paper records advantages, p 27 Stridor on eating a banana, p 40
THIS WEEK
RESPONSE OF THE WEEK
In 1968 Garrett Hardin wrote of the
tragedy of the commons, a social/
economic dilemma exploring the tension
between common cost and private
profit . . . The private gain of the
individual from grazing an extra cow [on
common land] is at the common cost of
the entire group.
Before the introduction of the internal
market most people working within the
NHS had the common profit of wanting
the NHS to give an excellent standard of
patient care with a maximum utilisation
of its limited resourceswe had common
costs and shared the common profit.
The internal market and allowing
private companies to enter the common
land of the NHS will lead to a common
cost-private profit scenario, which may
well result in the tragedy of the commons
for the NHS.
S J McNulty, consultant endocrinologist,
St Helens and Knowsley Hospitals NHS Trust,
Prescot, UK, in response to Act now against
new NHS competition regulations
(BMJ 2013;346:f1819)
PICTURE OF THE WEEK
An image created by Professor Jimmy Bell and his team at the Medical Research Councils (MRC)
Clinical Sciences Centre made up of MRI fat maps to look at external and internal fat distribution
(shown in white). The images show how different body shapes, here all a UK size 12, have different
patterns of fat distribution. The picture can be seen at an exhibition to mark 100 years of the MRC
called Strictly Science (www.strictlyscience.mrc.ac.uk).
6 April 2013 Vol 346
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BMJ. COM POLL
Will 1 April mark
the end of the
NHS in England?
58% voted yes
(total 761 votes cast)
This weeks poll asks:
Should GPs on the boards of clinical
commissioning groups in England stand
down if they have conflicts of interest?
Vote now on bmj.com
MOST SHARED
Getting serious about obesity
Is paracetamol hepatotoxic at normal doses?
Effect of behavioural-educational intervention
on sleep for primiparous women and their infants
in early postpartum: multisite randomised
controlled trial
Achilles tendon disorders
Sleepwalking into the market
THIS WEEK
I always felt when I was in WHO, dealing with illicit
drugs and alcohol, that there was a role for the private
sectornot necessarily a controlling role, but a role with
respect to alcohol policy. So says Marcus Grant, who lef
WHO 1u years ago to set up the International Center for
Alcohol Policies for the alcohol industry (p 16). Jonathan
Gornall examines that role just as the Global Alcohol
Policy Alliance (GAPA) publishes a statement of concern
and calls industrys commitments to WHO weak, rarely
evidence-based, and unlikely to reduce harmful alcohol
use.
This debate will sound familiar to many BMJ readers
because the BMA, the Royal College of Physicians,
Alcohol Concern, the British Association for the Study
of the Liver, the British Liver Trust, and the Institute of
Alcohol Studies refused to endorse the UK governments
similar public health responsibility deal in 2u11.
Yet many other medical bodies signed up, and some
good has come from the deal, including manufacturers
agreement to remove a billion units of alcohol from the
UK market by 2u15. Will doctors do more harm than
good by refusing to cooperate? GAPA doesnt think so,
and it calls on the public health community to avoid
funding from industry sources for prevention, research,
and information dissemination, and to refrain from any
association with industrys education programmes
(www.globalgapa.org/news/whou8u213.html).
We should soon hear WHOs response, if any, as its
global strategy to reduce the harmful use of alcohol is
on the agenda for the 66th World Health Assembly in
Geneva in late May. But WHO will almost certainly be
preoccupied by its proposal to make universal health
coverage and increasing healthy life years global
priorities, as the UNs millennium development goals
(MDGs) approach their due date in 2u15. Theres
been immense progress in development over the past
decade, Charles Kenny concludes (p 19). The MDGs
did some good, and Kenny argues that well need
another set of specic and measurable goals: WHOs
broad proposal wont sumce. David Legge and David
Sanders go further, calling for regulation of transnational
corporations, especially in banking, agriculture, food,
and pharmaceuticals (p 22).
WHO denes universal health coverage as a system
in which all people can use health services while being
protected against nancial hardship associated with
paying for them. Thats not the same thing as universal
healthcare, which is usually paid for by taxation.
Which system does England have now, given the huge
redisorganisation of its NHS on 1 April? Richard Vizes
obituary of primary care trusts (PCTs) may shed some
light, but wont alleviate much of the gloom (p 1/). It
is inescapable, he says, that afer 22 years of the
purchaser-provider split in the NHS, commissioners have
been unable to seize power from the providers on behalf
of patients . . . the obstacles that PCTs endured, and the
imbalance between enort and achievement, expose the
extraordinary dimculties commissioners face in making
a dinerence to patients outcomes. And that was when
there was plenty of money.
Trish Groves deputy editor, BMJ troves@bmj.com
Follow Trish Groves at twitter.com/trished and the BMJs
latest at twitter.com/latest
Cite this as: BMJ ;:f
EDITORS CHOICE
Promises, promises
Richard Vizes obituary
of primary care trusts
(PCTs) may shed
some light, but wont
alleviate much of the
gloom
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NEWS
BMJ | 6 APRIL 2013 | VOLUME 346 1
Gareth Iacobucci BMJ
The publics satisfaction with the NHS has
changed little in the past 12 months after a
record fall in 2011, show the latest results of
the British social attitudes survey.
The health policy think tank the Kings Fund
said that the results, published this week, show
that the record fall in satisfaction recorded in
2011 was not a blip.
The annual survey, which tracks the British
publics changing attitudes towards social, eco-
nomic, political, and moral issues, shows that in
2012 just under two thirds (61%) of respondents
were satished with the NHS. This is up slightly
from the 58% satisfaction rate in 2011 but still
some way below the 70% reported in 2010.
The steep fall in public satisfaction in 2011
coincided with the start of an unprecedented
NHS spending squeeze and controversy over the
governments proposals to change the health-
care system in England. But the Kings Fund,
which sponsored the health section of the survey
for the second year, said that satisfaction may
struggle to return to earlier levels in the face of
ongoing pressure on the health service.
The survey showed an increase in the publics
satisfaction with NHS emergency services, from
54% to 59%. Satisfaction with outpatient serv-
ices (64%) and inpatient services (52%) showed
Public satisfaction with emergency care rises
Clare Dyer BMJ
Doctors and nurses leaders are
urging the government to amend
controversial regulations on
commissioning NHS health services
in England amid fears that they could
require competitive tendering for
most services.
The BMA and the Royal College of
Nursing called on the government
on 28 March to take urgent action
to clarify the uncertainty, just days
before the new section 75 rules
came into force on 1 April, amid the
biggest shake-up of the NHS for a
generation.
John Ashton, president elect
of the UK Faculty of Public Health,
and 33 other senior public health
specialists have written to Stephen
Dorrell, chairman of the health select
committee, expressing concern that
the NHS (Procurement, Patient Choice
and Competition) (No 2) Regulations
2013 were coming into force with
inadequate consultation and
confusion over their legal impact.
Department of Health officials have
already redrafted the regulations
once after pressure from GPs, royal
colleges, and opposition politicians.
But legal opinions obtained by the
campaigning group 38 Degrees say
that the regulations would still oblige
the new clinical commissioning
groups to put every service out to
tender unless there was only a single
capable provider available to provide
the service.
The group says that the rules
conflict with assurances given by the
health minister Simon Burns that it
would be for commissioners to decide
which services to put out to tender.
The health department issued an
eight page reply to the legal opinions
from the healthcare law expert David
Lock QC and the competition lawyer
Ligia Osepciu, denying that the
regulations would have the effect the
lawyers assert.
In its response the department
said, The purpose of the regulations
is simply to transfer to the new NHS
commissioners the procurement
requirements that currently apply to
primary care trusts and to provide for
Monitora sector specific regulator
with expertise in healthcareto
enforce the rules rather than action
through the courts.
The rules for awarding contracts
will be identical to the requirements
of existing procurement law, the
department said.
Lock told the BMJ, This response
appears to duck the main problem
with the regulations. Commissioners
presently work under guidance, not
rules. From 1 April they will work under
rules, from which there is no escape.
no signihcant change from last year, while sat-
isfaction with GP services (74%) and dentists
(56%) was also unchanged.
In a departure from previous surveys, satisfac-
tion with the NHS did not dier with respond-
ents political amliation. The results showed a
64% satisfaction rate among Conservative and
Labour supporters and 63% among Liberal
Democrats. These results represented a slight
decrease in satisfaction among Conservatives
and Liberal Democrats from the previous year
but a seven percentage point increase in satisfac-
tion among Labour supporters.
Commenting on the results, John Appleby,
chief economist at the Kings Fund, said, The
British social attitudes survey has provided an
important barometer of how the public views the
NHS since 1983. With no real change in satis-
faction with the NHS in 2012, this suggests that
the record fall in 2011 was not a blip and that
the ground lost may take some time to recover.
Doctors leaders urge government to amend commissioning regulations
Satisfaction with the NHS is still below 2010 levels, but approval of emergency care has increased
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UK news New public health system is marred by confusion, MPs say, p
World news Indian Supreme Court rejects Novartiss appeal on drug patent, p
References on news stories are in the versions on bmj.com
bmj.com
Ambitious plan
for tobacco-free
Scotland by
NEWS
Zosia Kmietowicz BMJ
Training of psychiatrists
needs to be more exible to
encourage doctors to take
up the specialty and pur-
sue a career in academia,
a report has said.
Wi t hout a f r e s h
approach to training, the
advances being made in
science were less likely to be translated into
developments in diagnosis and management,
because doctors were not choosing to teach
future generation of psychiatrists, said Nick
Craddock, professor of psychiatry at C ardiff
U niversitys department of psychological
m edicine and neurology.
He was speaking at the launch of the report
from the Academy of Medical Sciences, Strength-
ening Academic Psychiatry in the UK.
1
The number of posts in academic psychiatry
in the United Kingdom has fallen by 27% since
2000. And although mental ill health accounts
for some 15% of the disease burden, spending
on mental health research makes up just 5% of
the total UK health research budget.
Part of the problem was that psychiatry was
not projected sumciently well enough, said
Simon Wessely, vice dean in academic psychia-
try at the Institute of Psychiatry in London.
Much UK academic activity was funded by
the NHS, and, with demands for emciency sav-
ings, managers saw academia as an area that
they could cut without attracting unfavourable
headlines, he said.
Training places in psychiatry also continued to
be undersubscribed. In 2011 only 83% of the 478
hrst year training posts in psychiatry in England
were hlled, rising only slightly to 85% in 2012.
Trainees ohen wrongly believed that noth-
ing could be done for psychiatric patients, said
Wessely. And stigmatisa-
tion of patients with psy-
chiatric problems meant
that they were seen as dif-
hcult and challenging, he
added.
One of the reports
recommendations is to
remove unhelpful and
constraining boundaries
between psychiatry and related specialties by
developing integrated training programmes.
This would allow psychiatrists in training to
undertake modules in neurology, paediatrics,
immunology, and other related disciplines and
bring these skills to patients and other doctors if
they chose to take up teaching posts.
Craddock said, It is a fantastic time in the
science of the brain. We have a fabulous oppor-
tunity to bring together a lot of disciplines to
understand psychiatric illness, develop diag-
nosis and management, and take forward these
skills to deliver better care and train doctors to
deliver better care.
He added that the current system of specialty
training was delivered with the short term
requirements of the NHS in mind. This was dif-
ferent from the situation in the United States,
where doctors training was run by universities
with a greater focus on the individual doctors
training needs.
The report also calls for improving research
capacity in academic psychiatric and ensuring
that trainees in the specialty can carry out doc-
toral research in optimal settings. At the moment
many trainees may do their clinical training at
some distance from their research basea situ-
ation that the Academic Faculty of the Royal
College of Psychiatry has described as deeply
concerning.
2 BMJ | 6 APRIL 2013 | VOLUME 346
Simon Wessely and Nick Craddock want
to see broader training to widen skills
Cross specialty training would
improve academic psychiatry
Hospitals plant trees to mark NHS sustainability day
Commissioners need
clearer expectations and
longer funding rounds
Zosia Kmietowicz BMJ
Commissioners of healthcare should be given
budgets for more than a year so that they do not
need to renew contracts with providers annually,
the health regulator for England has said. This
would give them greater hnancial stability and
planning ability, it said.
The recommendation on how the NHS Com-
missioning Board should promote commission-
ing was included in a review by the regulator,
Monitor, of what constitutes a fair playing held
for providers of NHS healthcare.
1
The review was commissioned last May in
response to the Health and Social Care Act
2012, which places a legal requirement on the
government that health providers should not be
discriminated against on the basis of their own-
ership structure.
A discussion paper published by Monitor
in January found evidence that strongly sug-
gested that a number of issues were distorting
the playing held.
2
Most of these related to com-
missioning and tendering, with many healthcare
providers complaining that there were too few
opportunities to bid to run services.
To tackle this Monitor said that the NHS Com-
missioning Board needed to set clear expecta-
tions on how commissioners procured services,
including emphasising the importance of com-
missioners considering all available options
for improving services, especially when a cur-
rent provider was underperforming. The board
should also provide commissioners with better
evidence of risks, costs, and benehts of dierent
approaches to procurement; case histories; and
tools to help them identify the best solutions.
The board should also speed up the develop-
ment of standardised currencies (descriptions of
what is being purchased for a given price) and
provide better data on providers costs, to give
commissioners greater leverage to bundle or
unbundle contracts so that they could be sure
they were getting the best providers for a service,
said Monitor.
It also recommended that the Department of
Health should evaluate the eectiveness of the
commissioning system in April 2014.
In its response to the recommendations the
government said that it has asked Monitor to
set up a high level group to review progress
in creating a fairer playing held in the interests
of patients. This will include looking at the rec-
ommendations further and then deciding what
policy changes should be made.
Ingrid Torjesen LONDON
Several NHS organisations
planted trees on 28 March to
promote NHS sustainability day.
The aim of the day, launched
in 2012, is to encourage
organisations to take action to
combat climate change and to
raise awareness of sustainability
in the health service.
The Royal London Hospital
was one of 25 sites in England
to plant trees. Pictured (left to
right) are Sarah Dandy, NHS
forest coordinator at the Centre
for Sustainable Healthcare,
Oxford; Georgie Delaney, from
the Great Outdoor Company,
which sponsored some of the
tree planting; and Fiona Daly,
environmental manager at Barts
and the London NHS Trust.
The tree planting is part of the
NHS forest initiative, coordinated
by the Centre for Sustainable
Healthcare, which plans to
make NHS estates greener by
planting one tree for every NHS
employee1.3 million trees.
NEWS
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Roger Boyle: A senior surgeon was away on holiday, another surgeon was suspended,
and that left the service [at Leeds] being offered by two relatively junior locum surgeons.
Controversy rages over paediatric heart surgery in Leeds
Indian Supreme Court rejects Novartiss appeal on drug patent
Sophie Arie LONDON
Indias highest court has rejected eorts by the
Swiss drug hrm Novartis to patent its anticancer
drug imatinib mesilate (marketed as Glivec) in a
ruling in favour of Indias generic drug industry.
Aher a seven year legal battle the Supreme
Court ruled that the drug was only an updated
version of an existing one and as such was not
innovative enough to merit a patent.
The ruling is seen as a crucial victory for
manufacturers of generic drugs in the battle for
Indias large and fast growing market. It means
that international drug companies cannot
acquire fresh patents on existing drugs in India
by making minor changes to them, a process
known as evergreening.
The aid charity Mdecins Sans Frontires
hailed the decision as a huge relief for millions of
patients and doctors in developing countries who
depend on aordable medicines from India.
Glivec, which is used to treat chronic myeloid
leukaemia and other cancers, costs about $2600
(E1710) a month. The generic equivalent is cur-
rently available in India for just $175.
But Novartis said that the Supreme Courts rul-
ing discourages future innovation by denying
the hrm the fair return on its product that it needs
to carry out research into the drugs of the future.
Ranjit Shahani, vice chairman and manag-
ing director of Novartis India, told reporters in
M umbai that the company would be cautious
about investing in India from now on.
India, which produces most of the generic
drugs used in developing countries, only intro-
duced patent laws in 2005 under pressure from
the World Trade Organization, and it awards pat-
ents only for drugs created since 1995.
Novartis had patented a version of imatinib in
1993. But the hrm argued that it was entitled to a
patent on the newer version of the drug because
it took several years more work to develop the
original patented compound into a pill.
Clare Dyer BMJ
Childrens heart surgery at Leeds General
In hrmary was suspended last week on the day
after campaigners won a High Court ruling
quashing a decision to close the unit as part of a
plan to concentrate services in fewer, larger, and
more specialised units.
Surgery at the Leeds unit was put on hold
pending an internal review, after the NHSs
medical director, Bruce Keogh, visited Leeds
Teaching Hospitals NHS Trust on Thursday 28
March, along with representatives of the Care
Quality Commission. He acknowledged that
the timing of his intervention looked suspicious,
coming only the day aher Leeds campaigners
won a High Court ruling that the Safe and Sus-
tainable review would have to redo part of its
consultation process.
1
But he told BBC Radio 4s Today news pro-
gramme that he could not refrain from taking
action just because the timing was embarrass-
ing. He had been telephoned on Tuesday by two
highly respectable, temperate surgeons from
outside Leeds, one alleging that the unit was
refusing to refer complex cases elsewhere and
the other raising concerns about stamng levels.
These were followed by a phone call on
Wednesday from an extremely agitated senior
cardiologist who had a preliminary report of
mortality data showing that the Leeds hgures for
2010-11 and 2011-12 were considerably higher
than any other unit in the country, he added.
Keoghs intervention sparked a war of words
in the media. A local MP called for his resigna-
tion, and John Gibbs, chairman of the paediat-
ric cardiac clinical audit, which supplied the
mortality data, was quoted as saying that he
was furious that the hgures had been used,
because they were in the very early stages.
The next day Roger Boyle, director of the
National Institute of Clinical Outcomes Research
at University College London, defended Keogh
on the BBC Breakfast television programme, say-
ing that he had advised suspension of surgery
at the unit himself. I was aware last weekend
of other concerns being raised about Leeds
concerns raised by distinguished surgeons who
dont work in the area, concerns raised by fami-
lies through the Childrens Heart Federation that
they werent being given the opportunity to be
transferred to other units when theyd requested
that, he said.
And I was also aware that a senior surgeon
was away on holiday, another surgeon was sus-
pended, and that leh the service being oered by
two relatively junior locum surgeons.
NEWS
New public health system is
marred by confusion, say MPs
Adrian ODowd LONDON
The new public health system which started
this month in England is awed in several ways,
including confused accountability and questions
over who would be in charge during health emer-
gencies, MPs have warned.
Overall, MPs on the parliamentary Communities
and Local Government Committee have welcomed
the return of responsibility for improving the gen-
eral health and wellbeing of local people from the
NHS to local government, but they say that many
issues still have to be resolved.
In its new report the committee said that it had
concerns over the complex accountability mecha-
nisms of the new system.
1
One example was the lack of clarity over who
would be in charge in the event of a local or
national health emergency such as an outbreak
of a disease. Under the new structures, various
bodies will organise and be involved in public
health, including local health and wellbeing
boards, clinical commissioning groups, and the
national bodies Public Health England and the
NHS Co mmissioning Board.
Many [organisations] are still unclear who
will be in charge locally in the event of a health
emergency, and the government needs to set out
the lines of responsibility between these organisa-
tions and conhrm that Public Health England will
have sumcient sta in its local teams to deal with
contingencies, says the report.
The committees chairman, Clive Betts, the
Labour MP for Shemeld South East, said, Without
clarity there is only confusion, and a health emer-
gency is no time for muddle. The government must
set out unambiguously the lines of responsibility,
and it must do so now as a matter of urgency. These
arrangements need to be clear and in place on day
one, 1 April. Anything else is unacceptable.
Arrangements for screening and immunisa-
tion services will be the responsibility of the
NHS C ommissioning Board, but the MPs said the
arrangements lacked a local dimension.
They argued that it was a good idea to devolve
these services, along with public health services
for children up to 5 years old and childhood immu-
nisation services, to public health sta within local
government under directors of public health.
It was unclear, said the MPs, as to whom clini-
cal commissioning groups (CCGs) would be held
accountable, and they rejected the governments
arguments for not allowing local authority council-
lors to sit on them. Local areas should be allowed
to decide who was able to sit on a CCG board.
How the new health and wellbeing boards were
to be held accountable, and to whom, was another
area of confusion, said the MPs, so it was impor-
tant that the government clarihed this.
Betts said, Under the . . . system, considerable
power is to be invested in a range of new bodies.
With such power must come accountability.
With these changes it is clear that there is a
shih of power and money from Whitehall to local
government. I welcome that. But the new arrange-
ments are complex, and responsibilities are shared
across several bodies. The result is that lines of
local accountability are fragmented and blurred.
Other problems had become apparent, said the
committee, in the new arrangements, such as the
fact that, under the current funding formula, areas
that performed well would have their funding cut.
Caroline White LONDON
An independent consumer watchdog for adults
and childrens health and social care services has
now been set up in each of the 152 local authorities
across England, in time for the 1 April deadline, the
Local Government Association has told the BMJ.
Under the terms of the Health and Social Care
Act 2012 it is a statutory requirement from 1 April
for local authorities to commission, fund, and per-
formance manage the local Healthwatch bodies.
They are the fourth reconhguration in 12 years of
bodies intended to represent the interests of local
patients and the public.
Most will be run by voluntary groups and chari-
ties, but seven are being run with the private sector
as social enterprises. All will be supported nation-
ally by Healthwatch England.
The government has chipped in with E40m over
two years, an amount that is based on the previous
spend of the outgoing Local Involvement Networks
(LINKs). But the money has not been ringfenced.
It is feared that cash strapped local authorities
may not invest enough to give Healthwatch the
clout to inuence and challenge the provision of
local services, as intended.
As well as acting as an information hub for
local communities, their remit will include r aising
concerns about the quality of local services
n ationallya role that has assumed more impor-
tance in the wake of the inquiry into the failings at
Mid St aordshire NHS Foundation Trust.
1
The issue of how well resourced they are is
one of overriding concern, said Tom Gentry, a
policy adviser for the charity Age UK. Some [local
authorities] might grasp the nettle and put in the
budget, but others will provide the bare minimum
and box tick.
CORRECTION
Issue 16 March, pp 4-6: More than a third of
GPs on commissioning groups have conflicts of
interest, BMJ investigation shows
This recent BMJ investigation by Gareth Iacobucci
(BMJ 2013;346:f1569) stated that five GPs on
the governing body of NHS Blackpool Clinical
Commissioning Group (CCG) listed interests in
Virgin Care. This statement was based on a list of
registered interests provided by NHS Blackpool
CCG via a Freedom of Information request. The
BMJ would like to clarify that the local practices
in question have now resigned from Assura
Blackpool, the limited liability partnership jointly
owned by Virgin Care and local practices.
A
D
R
I
A
N

B
R
O
O
K
S
/
R
E
X
Healthwatch must be
properly resourced for
its job, charities say
MPs said it was
unclear who would
be in charge during
a health emergency,
such as the 2009
swine flu outbreak

Editorials are usually commissioned. We are, however, happy to consider and peer review unsolicited editorials
See http://resources.bmj.com/bmj/authors/types-of-article/editorials for more details
EDITORIALS
Implementation of the Health and Social Care Act
Dogged by financial pressures, role uncertainty, and gaps in leadership
Nigel Edwards senior fellow, leadership development
and health policy, Kings Fund, London WG AN, UK
n.edwards@kingsfund.org.uk
The reforms that come into place aher implemen-
tation of the Health and Social Care Act on 1 April
represent the largest set of changes the NHS in
England has seen since its formation. The pre-
election promise notwithstanding, there have
been two huge top down reorganisationsin the
NHS and in public health. A vast amount of time
and money has been spent on reorganisation and
redundancies. Even if the NHS were in a robust
hnancial position this would be a major concern.
The hrst striking feature is the number of organ-
isations that are new or that have substantially
redehned roles. There are 211 clinical commis-
sioning groups (CCGs), 27 area teams, 23 clinical
support units, 12 clinical senates, 13 local edu-
cation and training boards, and 152 health and
wellbeing boards. Few of these exactly match any
previous jurisdictions and the talk of restructuring
further has already begun. The national Commis-
sioning Board (now renamed NHS England), Trust
Development Authority, Public Health England,
HealthWatch, Health Education England, and
academic health science networks are all new. In
addition, local authorities will take responsibil-
ity for health and wellbeing boards and public
health, including sexual health. Monitor and the
Care Quality Commission have had their respon-
sibilities redehned, and the Omce of Fair Trading
and the Competition Commission take on new
responsibilities for m arket regulation.
There is much uncertainty about the relations
between these new organisations and the rules
of engagement and accountability. Responsi-
bility for commissioning has been fragmented,
and in some cases CCGs will be accountable for
outcomes that will be commissioned by other
bodies. Although this will provide an impetus
for more collaborative working, such approaches
take time to develop and depend on having the
time to build relationships. This will be dimcult
in the many places that have vacancies: even
the NHS Commissioning Board has two director
level vacancies.
Several areas require large scale change that
has been led by regional authorities in the past.
Because these no longer exist, either CCGs will
quickly need to learn to collaborate or the regional
omces of the NHS Commissioning Board will need
to expand into this power vacuum and in doing so
will reassert traditional hierarchies. In some cases
there will be stasis, and change will be driven by
providers themselves or by invoking the failure
regimethe process used for the hrst time recently
in response to longstanding hnancial problems in
south east London.
The rules of the new system are still being
written. For example, guidance on safeguarding
children has been issued less than two weeks
before the start of the new system. Rules relat-
ing to procurement and competition (section 75)
remain contentious and confusing, with reas-
suring messages from government being contra-
dicted by experts just days before they come into
eect. Some CCGs are unclear about exactly what
resources they have because money and control
have been clawed back as the NHS Commission-
ing Board has redehned its scope, particularly in
the area of specialist commissioning (vascular
surgery and cancer, for example).
Trusts that have not yet achieved foundation
trust status will probably experience pressure
to change, merge, or otherwise accelerate their
progress. Whether this is possible is doubtful,
and mergers are increasingly being questioned by
the competition authorities because of their poor
record. The act brings new powers for Monitor to
use a failure regime, and it already seems to be
preparing to spend a large amount of money to
bring this to bear on several distressed foundation
trusts. This is compounded by the problem of key
leadership roles not being hlled.
Relatively little attention has been paid to the
transfer of public health responsibilities to local
government, which will be trying to incorporate
these services at a time when it is also under
unprecedented pressure. There is concern about
whether local authorities will protect the budget,
whether posts can be hlled, and whether smaller
authorities can sustain the infrastructure needed to
deliver appropriate public health services.
There are, however, reasons to be positive. It
seems that CCGs are bringing a new perspective to
their role. Creative and productive conversations
are taking place, although there are questions
about the level of engagement by general prac-
titioners.
1
Health and wellbeing boards working
with CCGs oer the prospect of new and positive
approaches.
Even the most charitable would admit that NHS
structures are now in an incoherent mess, and that
the process that produced this mess was close to
disastrous. Even now it is not clear how the reforms
will improve the service delivered by the NHS,
and the Health Select Committee has found that
the pressure to improve emciencies and reduce
costs is cause for profound concern.
2
Although the
Department of Health continues to assert that the
reforms are the solution to the NHSs problems, it
oers little more than assertion and pious hopes.
Integration is seen by many as an important part
of the solution to many of the challenges facing the
NHS, but the new rules on competition and pro-
curement, and the fragmentation of commission-
ing, work against this.
3
The promise of liberation
of the NHS through reduced central control seems
to be slipping away. Time that could have been
better spent on tackling the serious outstanding
challenges is consumed by reorganisation.
The NHS is good at making awed arrange-
ments work. The question is whether it has been
so badly disrupted by the current reforms that it
will no longer be able to do this eectively. Was
this the intention all along? Strong and visionary
leadership is usually the answer to this type of
problem, but this time the lack of such leadership
is part of the problem.
Competing interests: None declared.
Provenance and peer review: Commissioned; not externally
peer reviewed.
References are in the version on bmj.com.
Although the Department of Health
continues to assert that the reforms
are the solution to the NHSs
problems, it offers little more than
assertion and pious hopes
bmj.com Poll: Should GPs on the boards of clinical commissioning groups in England stand down if they have conflicts of interest?
bmj.com/blogs A new and very dierent type of NHS in England. New beginnings and new risks in English public health
EDITORIALS
Taking the sting out of lumbar puncture
Ultrasound guided procedures seem less likely to fail
Paul Rizzoli clinical director, JR Graham Headache Center,
Brigham and Womens Faulkner Hospital, Boston, MA
ul1!u, USA prizzoli@partners.org
Lumbar puncture remains an important and
commonly performed diagnostic procedure,
1
but
training for its performance is not standardized.
2

Although most diagnostic lumbar punctures are
performed by neurologists, hospitalists, emer-
gency department physicians, and pediatricians,
physicians in many dierent specialties should
have some experience with lumbar punctures and
may on occasion need to perform one.
A well designed linked systematic review and
meta-analysis by Shaikh and colleagues inves-
tigates the beneht of using ultrasound guidance
when performing lumbar puncture in routine
diagnostic and therapeutic settings and in the
performance of epidural catheterizations, mainly
for giving anesthesia.
3
The meta-analysis looked
at 14 randomized studies with results from more
than 1300 participants. It found a significant
risk reduction for the primary outcome measure
of failed procedures for ultrasound guided com-
pared with the traditional anatomic approach to
lumbar puncture. Failed procedures were dehned
conservatively as any failure to achieve the goals
intended for the procedure. Epidural catheteri-
zations were judged equivalent to subarachnoid
punctures for assessing ultrasound guidance, and
studies of either when combined achieved statis-
tical signihcance. Six of 624 procedures failed in
the ultrasound group compared with 44 of 610 in
the control group (risk ratio 0.21, 95% conhdence
interval 0.10 to 0.43). Summary estimates for sec-
ondary outcomes of traumatic procedures, needle
reinsertions, and needle redirections all supported
the primary outcome hnding. Time considerations
in performance of the procedures could not be
assessed owing to variability of reporting in the
component studies.
Strengths of this meta-analysis include its com-
prehensive search for relevant studies and the
high quality and low (modest) heterogeneity of
the included studies. Methodological limitations
involved variability in reporting of outcomes in the
included studies. Complete blinding was logisti-
cally dimcult. Most studies included young women
receiving obstetric anesthesia administered by
highly experienced practitioners, so generalizabil-
ity to non-obstetric populations is limited. How-
ever, ultrasound guidance for lumbar puncture
might oer even more benehts in non-obstetric
populations. In these groups, lumbar puncture is
more likely to be performed by practitioners with
less procedural experience than obstetric anesthet-
ists. The benehts shown may underestimate the
potential benehts of a more general application of
ultrasound guidance.
The authors point out that ultrasound guidance
is now used at the bedside in the performance of
many medical and surgical procedures, so its
extension to lumbar puncture seems an inevita-
ble trend towards improving procedural outcomes.
Lumbar puncture is probably underused in the
investigation of many problems, including chronic
headache disorders, where identihcation of low or
high pressure headaches with the measurement of
opening pressure (which should almost always be
obtained) may strongly aect treatment. Though
the baseline failure rate for lumbar puncture was
low in the studies even without ultrasound guid-
ance, the same may not be true for less experienced
operators. Furthermore, this analysis cannot pro-
vide information about lumbar punctures that
were indicated but not performed. Because lumbar
punctures may be refused by patients out of fear, or
deferred by reluctant providers, ultrasound guid-
ance may improve patient acceptance and reduce
failure rate in this wider population.
This analysis provides no data on the impact of
ultrasound guided lumbar puncture on the com-
mon complication of postdural puncture head-
ache. This is a question of great clinical interest
that merits further research. Unconhrmed clinical
impressions suggest that cleaner less traumatic
taps may paradoxically increase the risk of such
headaches. This might be due to lower levels of
clotting factors in the area of the tap that could
help prevent a spinal uid leak. Though this mat-
ter should be investigated in future research, other
factors such as needle type may be more important
determinants of this complication.
Identihcation of anatomic landmarks before
lumbar puncture does not seem to be as accurate
as ultrasound guidance, and it does not provide
adequate information about optimal angle of
needle insertion or required depth for the proce-
dure. Pre-procedural static ultrasound can help
by showing the midline, optimal vertebral level,
and target depth. Dynamic ultrasound scanning
allows the operator to follow progression of needle
insertion. The use of ultrasound guidance does not
mean that the performance of lumbar punctures
will become the province of specialized clinicians.
Ultrasound guided lumbar puncture is not dimcult
to master and does not greatly increase the time
needed to perform the procedure.
4
The results of this analysis suggest one way to
modernize and standardize the performance of
lumbar puncture. Further research should inves-
tigate potential barriers to its implementation,
conhrm and quantify beneht, identify appropriate
settings and patient populations, and investigate
appropriate protocols and possible amendments
to practice standards. Taken as a whole, the hnd-
ings of this meta-analysis are compelling and
support further investigation of the routine use
of ultrasound to aid the performance of lumbar
punctures. Ultrasound guidance shows promise as
a way to take the sting out of lumbar punctures
for patients and clinicians.
peer reviewed.
1 Lavi R, Rowe JM, Avivi I. Lumbar puncture: it is time to change
the needle. Eur Neurol lu1u;6/:1u3-1!.
l Williams J, Lye DC, Umapathi T. Diagnostic lumbar puncture:
minimizing complications. Intern Med J luu3;!3:'37-91.
! Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JCA,
Beyene J, et al. Ultrasound imaging for lumbar punctures
and epidural catheterisations: systematic review and meta-
analysis. BMJ lu1!;!/6:f17lu.
/ Nomura, JT, Leech SJ, Shenbagamurthi S, Sierzenski PR,
OConnor RE, Bollinger M, et al. A randomized controlled trial
of ultrasound-assisted lumbar puncture. J Ultrasound Med
luu7;l6:1!/1-3.
RESEARCH, p
bmj.com
Letter: Bacterial meningitis and lumbar puncture (BMJ lu1!;!/6:f!61)
Better performance could widen indications
S
P
L
EDITORIALS
Vitamin D sufficiency in pregnancy
Better evidence is required to establish optimal levels and need for supplementation
Robyn Lucas associate professor
robyn.lucas@anu.edu.au
Fan Xiang research fellow, National Centre for
Epidemiology and Population Health, Australian National
University, Canberra, ACT uluu, Australia
Anne-Louise Ponsonby professor, Murdoch Childrens
Research Institute, Royal Childrens Hospital, Melbourne,
Vic, Australia
One year ago, the chief medical omcers of the
United Kingdom recommended that All preg-
nant and breastfeeding women should take a
daily supplement containing 10 g (400 IU) of
vitamin D, to counter the high prevalence of
vitamin D dehciency in pregnant women. This
was aimed at reducing the associated conse-
quences of dehciency, such as rickets in chil-
dren and osteomalacia in adults.
1
In a linked meta-analysis, Aghajafari and
colleagues look beyond bone health to other
adverse health outcomes for mother and baby.
2

Previous systematic reviews have highlighted
challenges in combining data from dierent
studies, including diverse dehnitions of vita-
min D dehciency, variations in vitamin D assays
used, use of non-representative samples, and
varying study designs and study quality.
3

4

A review published in 2011 found insum-
cient high quality studies to conduct quantita-
tive meta-analysis
3
; in the qualitative review
the evidence was inconsistent. In a subsequent
review, rigorous assessment of study quality
resulted in quantitative meta-analyses of only
two observational studies and hve randomised
controlled trials, with additional studies
reviewed qualitatively.
4
Combined data from
trials suggested that bolus high dose vitamin
D supplementation (but not daily dosing) was
associated with reduced risk of low birth weight
(risk ratio 0.40; 95% conhdence interval 0.23 to
0.71). Combined trial data found no signihcant
protective eect of vitamin D supplementation
on the outcome small for gestational age (0.77,
0.35 to 1.66), although observational studies
supported a protective eect. Results for mater-
nal outcomes were inconsistent. In a 2012
Cochrane systematic review, meta-analysis of
three trials of daily vitamin D supplementation
during pregnancy found a reduced risk of low
birth weight (0.48, 0.23 to 1.01), although this
was not signihcant.
5

In a recent combined analysis of two ran-
domised controlled trials, higher vitamin D
(measured as serum concentration of 25-hydrox-
yvitamin D; 25-OHD) at delivery was associated
with a signihcantly (P<0.006) decreased risk of
comorbidities of pregnancy. Comorbidities were
gestational diabetes, hypertension, infection,
bacterial vaginosis, and preterm birth without
pre-eclampsia, but the study did not have enough
power to analyse individual outcomes.
6
Meta-analysis overcomes the problems of
small sample sizes and insumcient power. But
challenges arise in combining data from studies
of dierent designs, inclusion and exclusion cri-
teria, and dehnitions of exposure and outcome.
Aghajafari and colleagues review contains no pri-
mary data from vitamin D intervention studies.
2

Only one trial was considered, but was excluded
from analysis. The largest eect sizes derive from
case-control studies, some with minimal or no
adjustment for confounding; comparisons of
extreme groups (such as <50 v >75 mmol/L), so
that data from most of the sample (the middle
group) are omitted
7
; and blood sampling aher
disease onset. Serum 25-OHD concentration
is labile. It depends on recent intake of vitamin
D and sun exposure, both of which may change,
and may even be aected by preclinical disease
(disease induced vitamin D dehciency).
Gestational age at sampling is also relevant
to causal interpretations if low vitamin D status
at late sampling is linked to outcomes that are
usually associated with earlier gestational onset.
Aghajafari and colleagues found that vitamin D
dehciencyvariously dehned and measured at
dierent gestational agesis adverse for maternal
and infant health. If lower vitamin D status causes
these outcomes in a linear way, more severe deh-
ciency (<50 nmol/L) would be expected to have
a stronger eect than less severe dehciency (<75
nmol/L). The opposite eect seems to occur for
pre-eclampsia.
2
Despite these challenges to interpreting
the evidence, these studies have clear clinical
im plications. In 2010 the US Institute of M edicine
recommended that a serum concentration of
25-OHD of 50 nmol/L or more should be consid-
ered sumcient for bone health.
8
Although optimal
maternal 25-OHD levels at dierent gestational
times are not known, levels below 50 nmol/L are
common during pregnancy, particularly in popu-
lations at high latitudes and in specihc subpopu-
lations. Evidence of a causal association between
vitamin D dehciency and some maternal and neo-
natal outcomes is insumcient, but the evidence for
bone health is clear cut. The hndings of this meta-
analysis support a goal of vitamin D sumciency
for all pregnant women.
2
Supplements, diet, and
sunlight exposure all inuence 25-OHD levels
and should be used together, with care, because
U shaped dose-response curves are reported for
a range of health outcomes, including small for
gestational age,
9
with disease risk increasing at
both low and high 25-OHD levels.
Most studies are undertaken in developed coun-
tries. Yet Asian and African countries have higher
infant mortality and represent half of the global
population. Where it has been measured, vitamin
D dehciency is common in these countries, under
the combined inuences of darker skin, cultural
practices that limit sun exposure, and, in some
locations, urban air pollution blocking ultravio-
let radiation. For example, median 25-OHD levels
of pregnant women living in Beijing were only 26
nmol/L.
10
If there is a causal association between
vitamin D dehciency and adverse maternal and
neonatal outcomes, gains from ensuring sum-
ciency may be great in these countries.
Current evidence on vitamin D status and neo-
natal and pregnancy health derives largely from
observational studies, small trials, low doses of
vitamin D supplementation, unclear study proc-
esses of randomisation and blinding, or low
adherence. In their editorial, Harvey and Cooper
called for large well designed randomised control-
led trials to clarify the causal association between
vitamin D supplementation and health.
11
This is
particularly needed to delineate the importance
of vitamin D in pregnancy, with its potentially life-
long eects on the health of ospring.
12
peer reviewed.
Cite this as: BMJ 2013;346:f1675
ORESEARCH, p 10
bmj.com
OResearch: Elect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants
in India up to age 6 months (BMJ lu11;!/l:dl97')
OResearch: Calcium supplements with or without vitamin D and risk of cardiovascular events (BMJ lu1!;!/l:dlu/u)
OResearch: Elects of vitamin D supplementation on bone density in healthy children (BMJ lu11;!/l:c7l'/)
Although optimal maternal 25-OHD
levels at different gestational times
are not known, levels below 50 nmol/L
are common during pregnancy
EDITORIALS
Sex selection and abortion in India
Efforts to curb sex selection must not retard progressive safe abortion policies
recently recommended extending termination up
to 24 weeks, from the current 20 weeks.
13
While
the country looks towards liberalising abortion in
the interests of the safety and health of women,
regressive policies by the Maharashtra govern-
ment to curb sex selection run the risk of crimi-
nalising abortion.
Evidence has consistently shown that liberal
abortion laws coupled with government com-
mitment lead to a decline in unsafe abortions
and associated complications.
14
In 2011, more
than 620 000 abortions were reported in India.
The real numbers may be well over six million,
largely performed in non-registered institutions,
by untrained people, and in unhygienic condi-
tions.
15
Unsafe abortions account for nearly 8%
of all maternal deaths in India.
16
As India tries
to reduce maternal mortality as part of the mil-
lennium development goals, fostering womens
access to safe medical abortion is crucial.
With increasing availability of techniques such
as preimplantation genetic diagnosis and blood
tests to determine the sex of a baby,
17

18
targeting
abortion services would not solve the problem.
Sex selection is common among the affluent
and educated in India, as well as those of Indian
descent who live abroad.
19
What really needs to
change is the fabric of the patriarchal Indian soci-
ety that undervalues girls and women.
Provenance and peer review: Not commissioned; not
externally peer reviewed.
Anita Jain India editor, BMJ, India ajain@bmj.com
Abortions for the purpose of sex selection in
India have again caught the attention of Indian
policy makers and the global press aher the 2011
Indian census showed a decline in the sex ratio.
The number of girls per 1000 boys dropped from
927 in 2001 to 914 in 2011 for children aged 0-6
years.
1
Most notable was Maharashtra state, which
recorded a decline in the sex ratio from 913 in
2001 to 883 in 2011. Under an intense media spot-
light, the state has set out to save the girl child
under the tenets of the Pre-Conception and Pre-
Natal Diagnostic Techniques (Prohibition of Sex
Selection) Act. There have been waves of suspen-
sions of doctors for violating this act.
2
However, a
parallel stream of ill informed directives may result
in the victimisation of women seeking abortion.
The act
3
, passed in 1994 and amended before
coming into effect in 2003, regulates prenatal
diagnostic techniques in India and prohibits their
misuse for sex determination. The act lays out
minimum requirements for registration of clinics
that use these techniques and the documentation
that doctors must maintain. Designated authori-
ties may conduct random search and seize
operations at clinics and use decoys with hidden
cameras or tape recorders to identify violations.
The act does, however, recognise its links with
the Medical Termination of Pregnancy Act and
reinforcement of its provisions. The Medical Ter-
mination of Pregnancy Act is a progressive piece
of national legislation that ensures that the law
will not hinder women choosing to terminate
pregnancy. The core objective is to reduce anguish
and health risks to women due to unintended
pregnancies. The Prohibition of Sex Selection
Act in no way infringes on the provisions of the
Medical Termination of Pregnancy Act or permits
state authorities to act in ways that may restrict a
womans right to abortion.
4
In light of this, the Maharashtra governments
recent spate of policy directives, aimed at curb-
ing sex selection, seem to be misdirected. These
directives include recommendations to reduce
the abortion limit to 10 weeks
5
; introduction of
a silent observer technology that relays ultra-
sound images from pregnant women to authori-
ties to track potential sex selective abortions
6
; and
the requirement that doctors take digital images of
the fetus aher abortion.
7
Such policies are a blatant
intrusion of womens privacy and may drive them
to seek unsafe methods of abortion.
Furthermore, policy directives seeking to restrict
the availability of abortion pills have recently been
proposed. In India a combination of mifepristone
and misoprostol is approved for termination of
pregnancy up to seven weeks.
8
The state, how-
ever, seeks to ban retail sale of these pills or place
them on schedule X,
9
which requires rigorous
record keeping of women who purchase the pills,
with the potential to trace their whereabouts.
10

A clampdown on manufacturers and retailers of
abortion pills has led to the withdrawal of these
pills from the market and an ensuing shortage.
11

This has occurred despite World Health Organiza-
tion recommendations to phase out surgery for
hrst trimester abortions in favour of medical meth-
ods.
12
The government also seeks to mandate a
three visit schedule to the hospital for termination
using abortion pills. This ies in the face of current
guidelines that permit doctors to prescribe these
pills at their clinic, provided women have access
to a registered facility for abortion.
9
Such measures clearly have little to do with
preventing sex selection but do hinder provision
of safe abortion services. By seeking to implement
them the state ignores recommendations from
gynaecologists and social scientists, as well as the
law as framed in the Prohibition of Sex Selection
Act and Medical Termination of Pregnancy Act.
The Federation of Obstetric and Gynaecological
Societies of India has repeatedly advocated for
access to abortion pills and extension of abortion
limits. The National Commission for Women has
bmj.com
ONews: Death of baby with anencephaly aher mother was refused an abortion sparks controversy in India (BMJ lu1l;!/':e7!lu)
OFeature: Is abortion worldwide becoming more restrictive? (BMJ lu1l;!/':e3161)
Sex ratio in India continues to decline
The BMJ is an Open Access journal. We set no word limits on BMJ research articles, but they
are abridged for print. The full text of each BMJ research article is freely available on bmj.com
RESEARCH
RESEARCH NEWS
RESEARCH NEWS All you need to read in the other general medical journals Kristina Fiter, associate editor, BMJ kfister@bmj.com
Scan this image with your
smartphone to read our
instructions for authors
Chelation therapy may improve
cardiovascular health
Chelation has been used by alternative thera-
pists to treat atherosclerosis for over half a
century, with little evidence to back it. Usually
given with a vitamin infusion, disodium EDTA
binds divalent and trivalent cations such as cal-
cium, magnesium, lead, zinc, and aluminum
to facilitate their excretion in urine. More than
100 000 adults undergo this treatment annu-
ally in the US.
A study used a 22 factorial design to test 40
infusions of a 500 mL chelation solution (con-
taining disodium EDTA, ascorbate, B vitamins,
electrolytes, procaine, and heparin) against an
infusion placebo, as well as an oral regimen of
vitamins and minerals against oral placebo.
The 1708 participants, recruited from 134 US
and Canadian centres, were people over 50
years who had experienced myocardial infarc-
tion and had a serum creatinine of 2 mg/dL (1
mg/dL=88.4 mol/L) or less.
During a median follow-up of more than four
years, an eect was seen on the composite out-
come of death, recurrent heart attack, stroke,
coronary revascularisation, or admission to
hospital for angina. This outcome was seen
in 222 (26%) people randomised to chelation
versus 261 (30%) of those who received pla-
cebo (hazard ratio 0.82, 95% CI 0.69 to 0.99).
A similar eect was seen for the individual com-
ponents of the composite outcome, although
not for deaths (10% v 11% with placebo; 0.93,
0.70 to 1.25).
The authors warn that this evidence does not
justify routine use of chelation, as do two linked
editorials. In one (p 1291), the journals editors
explain why they decided to publish the paper
despite this 10 year, $31m (E20.5m; t24.2m)
trial having been controversial since its incep-
tion. The other editorial discusses the studys
shortcomings, arguing that its results are not
reliable (p 1293). Concerns include marginal
statistical significance for the main finding,
unbalanced dropout rates289 (17%) of par-
ticipants withdrew consent during the trial, 115
of those receiving chelation versus 174 with pla-
ceboas well as unblinding of the sponsors and
possibly researchers and participants.
JAMA lu1!;!u9:1l/1-'u
Miravirsen works against
hepatitis C virus
Hepatitis C virus is dependant for growth on
microRNA-122 in the liver of infected people. A
new drug, miravirsen, binds to microRNA-122,
disabling the binding and growth of the virus.
A phase IIa study tested three doses (3 mg,
5 mg, and 7 mg/kg body weight) against
pl acebo in 36 people with previously untreated
chronic hepatitis C infection. The drug was
injected weekly for a month.
Over the four and a half months of the
study, a dose dependent reduction was seen
in plasma levels of viral RNA. Compared with
baseline, the mean maximum reduction in
viral RNA (log
10
IU per mL) was 1.2 with 3 mg,
2.9 with 5 mg, and 3.0 with 7 mg. In the pla-
cebo group, this hgure was 0.4 log
10
IU per mL.
Four of nine patients randomised to the
maximum dose were clear of the virus at the
end of treatment. Still, once the drug was
stopped, levels of viral RNA rebounded in par-
ticipants who were not taking interferon and
ribavirin.
The drug was well tolerated and no signs of
drug resistance were noted. A linked editorial
notes that miravirsen could become part of a
future drug cocktail that can control hepatitis
C virus (doi:10.1056/NEJMe1301348).
N Engl J Med lu1!; doi:1u.1u'6/NEJMoa1lu9ul6
Shorter life expectancies in eastern
versus western Europe
The gap in life expectancy between eastern and
western Europe is 12 years for men and eight
years for women, and it is greater today for
men than it was four decades ago. Whereas life
expectancy has continuously improved in the
west over that time, patterns have been incon-
sistent in the east.
The rise in the west is thought to be linked
with economic growth and improvements
in healthcare and policy. Success was seen
in relation to perinatal and maternal health,
immunisations, detection and treatment of
hypertension, screening for cancer, and more
eective treatment of many diseases. Policies
such as tobacco control, road tramc safety, and
reductions in air pollution have also contributed
to better health, although success has varied
between countries.
In the eastin this study, central and east-
ern Europe as well as the whole of the former
Soviet Unioneconomic problems coupled
with the lack of eective health policies have
led to poorer health. Before the fall of the Berlin
Wall, tobacco and alcohol control were almost
non-existent in large parts of the region, as
was awareness of the role of nutrition in pre-
vention of chronic diseases. Smoking rates are
still high, especially in young women. In some
countries surrogate alcoholssold as after-
shaves and medicinal tinctures and containing
70-90% ethanolare consumed widely. Con-
trol of infectious diseases broke down in some
countries, with re-emergence of diphtheria and
tu berculosis.
Care may have improved in central and east-
ern Europe since the fall of communism, but
it has worsened in the former Soviet Union,
where the newly introduced formal and infor-
mal payments now mean many people dont get
the care they need.
Also of concern are rising health inequali-
ties within countries, and common challenges
remain in both eastern and western Europe,
such as policies on food and alcohol.
This is the hrst time the Lancet has published
a series of papers on health in Europe (www.the-
lancet.com/series/health-in-europe).
Lancet lu1!; doi:1u.1u16/Su1/u-67!6(1l)6lu3l-u
Adapted from Lancet 2u13; doi:1u.1u16/Su1/u-6736(12)62u82-u
Year of birth
L
i
f
e

e
x
p
e
c
t
a
n
c
y

(
y
e
a
r
s
)
196u 197u 198u 199u 2uuu 2u1u
55
6u
65
7u
75
8u
Trends in life expectancy in men
Selected countries in western Europe
L
i
f
e

e
x
p
e
c
t
a
n
c
y

(
y
e
a
r
s
)
55
6u
65
7u
75
8u
Selected countries in central and eastern Europe
Finland
Western Germany
Italy
Portugal
Sweden
UK
Eastern Germany
Croatia
Hungary
Estonia
Russia
RESEARCH
1
Department of Community Health
Sciences, University of Calgary,
Calgary, Alberta, Canada TlN /N1
l
Department of Family Medicine,
University of Calgary, Canada
!
Calgary Institute for Population and
Public Health, University of Calgary,
Canada
/
Department of Paediatrics,
University of Calgary, Canada
'
Department of Medicine, University
of Calgary, Canada
Correspondence to: D M Rabi
Doreen.Rabi@
albertahealthservices.ca
doi: 1u.11!6/bmj.f1169
This is a summary of a paper that
was published on bmj.com as BMJ
lu1!;!/6:f1169
STUDY QUESTION
What is the association between maternal levels of serum
-hydroxyvitamin D (-OHD; the best measure of vitamin
D status in humans) and pregnancy and neonatal outcomes?
SUMMARY ANSWER
Vitamin D insufficiency is associated with adverse
pregnancy outcomes and birth variables.
WHAT IS KNOWN AND WHAT THIS PAPER ADDS
Existing data support the hypothesis that vitamin D
insufficiency during pregnancy may be associated with
an increased risk of pregnancy related diseases. This
systematic review and meta-analysis of observational
studies found that vitamin D insufficiency is associated with
an increased risk of gestational diabetes, pre-eclampsia,
and small for gestational age infants. Pregnant women
with low -OHD levels had an increased risk of bacterial
vaginosis and lower birth weight infants, but not delivery by
caesarean section.
Selection criteria for studies
We carried out an electronic search of Medline (1966 to
August 2012), PubMed (2008 to August 2012), Embase
(1980 to August 2012), CINAHL (1981 to August 2012),
the Cochrane database of systematic reviews, and the
Cochrane database of registered clinical trials, supple-
mented with manual searches of bibliographies and
conference proceedings. Two reviewers independently
selected studies that reported on the association between
serum 25-OHD level during pregnancy and the outcomes
of interest.
Primary outcomes
We assessed the association between low 25-OHD level
and pregnancy outcomes (pre-eclampsia, gestational dia-
betes, bacterial vaginosis, caesarean section) and birth
variables (small for gestational age, birth weight, birth
length, and head circumference).
Main results and role of chance
Of 3357 citations, 31 studies met our criteria for inclu-
sion in the hnal analysis. We used random eects models
to pool adjusted odds ratio for low 25-OHD levels com-
pared with sumcient levels. Insumcient 25-OHD levels
were associated with gestational diabetes (pooled odds
ratio 1.49, 95% conhdence interval 1.18 to 1.89), pre-
eclampsia (1.79, 1.25 to 2.58), and small for gestational
age infants (1.85, 1.52 to 2.26). Pregnant women with
low 25-OHD levels had an increased risk of bacterial vagi-
nosis and lower birth weight infants, but not delivery by
caesarean section.
Bias, confounding, and other reasons for caution
The studies varied in their dehnitions of 25-OHD insuf-
hciency. Our analysis used cut-os that were most com-
monly reported among studies eligible for inclusion in
our review. The identihed studies used a cut-o of less
than 75 nmol/L to dehne insumciency for pregnancy
outcomes and less than 37.5 nmol/L for birth variables.
The included studies varied in study quality and did not
always control for important potential confounding vari-
ables. Furthermore, many of the studies included were of
case-control design, which could overestimate the eect
size of the associations. Clinical and statistical heteroge-
neity were identihed across studies, and a variety of sensi-
tivity analyses were conducted to evaluate the robustness
of our pooled estimates and to identify possible sources of
heterogeneity. These analyses showed that pool estimates
did vary when stratihed by study design and 25-OHD
quantihcation method, suggesting the importance of
these two factors in contributing to heterogeneity.
Study funding/potential competing interests
FA and TN received studentship funding from the Univer-
sity of Calgary Institute for Public Health (Markin Fund
for Health and Society); DMR is supported by an AISH
(Alberta Innovate Health Solutions) population health
investigator award; SCT is supported by an AISH salary
support; and MOB is supported by AISH, the Canadian
Institute of Health Research, and the Canadian Founda-
tion for Healthcare Improvement. These agencies had no
role in the design and conduct of the study; collection,
management, analysis, and interpretation of the data;
and preparation, review, or approval of the manuscript.
Association between maternal serum 25-hydroxyvitamin D
level and pregnancy and neonatal outcomes: systematic review
and meta-analysis of observational studies
Fariba Aghajafari,
1 l
Tharsiya Nagulesapillai,
1
Paul E Ronksley,
1 !
Suzanne C Tough,
1 /

Maeve OBeirne,
l
Doreen M Rabi
1 ! '
OEDITORIAL by Lucas et al
Summary of pooled odds ratio and weighted mean difference
for low 25-hydroxyvitamin D levels and pregnancy outcomes
and birth variables
Outcome
No of
studies
Pooled odds ratio
(95% CI)
Gestational diabetes 1u 1./9 (1.1S to 1.S9)
Pre-eclampsia 7 1.79 (1.l' to l.'S)
Small for gestational age 6 1.S' (1.'l to l.l6)
bmj.com
OResearch: Elect of weekly
vitamin D supplements on
mortality, morbidity, and growth
of low birthweight term infants
in India up to age 6 months
(BMJ lu11;!/l:dl97')
OResearch: Calcium
supplements with or without
vitamin D and risk of
cardiovascular events
(BMJ lu1!;!/l:dlu/u)
OResearch: Elects of vitamin
D supplementation on bone
density in healthy children
(BMJ lu11;!/l:c7l'/)
OResearch: Fall prevention
with supplemental and active
forms of vitamin D
(BMJ luu9;!!9:b!69l)
RESEARCH
STUDY QUESTION
Can ultrasound imaging reduce the risk of failed lumbar
punctures and epidural catheterisations, when compared
with standard palpation methods?
SUMMARY ANSWER
Ultrasound imaging can significantly reduce the risk of failed
lumbar punctures and epidural catheterisations.
Many randomised controlled trials have evaluated the
role of ultrasound imaging for lumbar punctures and
epidural catheterisations, but none was powered to show a
significant effect on the ability to reduce failed procedures.
This meta-analysis shows a significant beneficial effect of
ultrasound imaging.
Selection criteria for studies
We identified clinical trials that randomly allocated
patients to either ultrasound imaging or a non-imaging
technique for the performance of a lumbar puncture
or epidural catheterisation. We searched for trials in
Medline, Embase (from inception to May 2012), and the
Cochrane Central Register of Controlled Trials (to the sec-
ond quarter of 2011), without restriction by language or
publication status.
Primary outcome(s)
The primary outcome of interest was the number of failed
procedures, dehned as a lumbar puncture with an inabil-
ity to obtain cerebrospinal uid or an epidural catheteri-
sation with an inability to place a catheter or provide
adequate analgesia. Secondary outcomes included the
number of traumatic procedures, number of insertion
attempts, number of needle redirections, and time taken
to perform the procedure.
Main results and role of chance
We identihed 14 randomised trials. In total, 674 patients
were assigned to the ultrasound group and 660 to the
control group. Twelve studies were meta-analysed for
our primary outcome. There were six failed procedures
of 624 in the ultrasound group compared with 44 failed
procedures of 610 in the control group. Ultrasound imag-
ing reduced the risk of failed procedures with a risk ratio
of 0.21 (95% conhdence interval 0.10 to 0.43, P<0.001).
The number needed to treat with ultrasound imaging to
reduce one failed procedure was 16. Subgroup analysis
showed that the eect of ultrasound imaging on reduction
of failed lumbar punctures versus epidural catheterisa-
tions was similar (P=0.92 for interaction). For secondary
outcomes, ultrasound imaging reduced the risk of trau-
matic procedures with a risk ratio of 0.27 (0.11 to 0.67,
P=0.005) and a number needed to treat of 17. Ultrasound
imaging also reduced the number of insertion attempts
by a mean dierence of 0.44 (0.64 to 0.24, P<0.001)
and the number of needle redirections by a mean dier-
ence of 1.00 per procedure (1.24 to 0.75, P<0.001).
Time to perform the procedure could not be meta-ana-
lysed because reported measures were too heterogeneous
across studies.
Our meta-analysis was limited by the methodological
quality and outcome reporting of its component studies.
Only one study fulhlled all seven quality measures in a
modihed version of the CLEAR-NPT, a quality assessment
tool. Only one study was double blinded. Individuals per-
forming the ultrasound imaging were study investigators
who generally had high levels of experience and special
interest in the technique. Many of the studies were in
the setting of obstetric anaesthesia, and thus included
a patient population composed of young, collaborating,
healthy women. These features could limit the external
validity of our hndings. Other important outcomes, such
as postdural puncture headaches, were not ohen reported
and could not be synthesised.
FS is supported by a research fellowship from the Pediatric
Oncology Group of Ontario (POGO) Research Unit. LS is
supported by a New Investigator Award from the Canadian
Institutes of Health Research. All researchers were inde-
pendent from funders and declare no other interests.
Ultrasound imaging for lumbar punctures and epidural
catheterisations: systematic review and meta-analysis
Furqan Shaikh,
1
Jack Brzezinski,
1
Sarah Alexander,
1
Cristian Arzola,
l
Jose C A Carvalho,
l

Joseph Beyene,
!
Lillian Sung
1
1
Division of Haematology and
Oncology, Hospital for Sick Children
and University of Toronto, Toronto,
ON, Canada M'G 1XS
l
Department of Anaesthesia and
Pain Management, Mount Sinai
Hospital and University of Toronto,
Toronto, ON, Canada
!
Department of Clinical
Epidemiology and Biostatistics,
McMaster University, Hamilton, ON,
Canada
Correspondence to: F Shaikh
furqan.shaikh@sickkids.ca
doi: 1u.11!6/bmj.f17lu
lu1!;!/6:f17lu
OEDITORIAL by Rizzoli
Summary of outcomes for ultrasound imaging groups versus
control groups
Effect (95% CI) P I
2
(%)
No of failed procedures (12 studies)
Risk ratio u.l1 (u.1u to u./!) <u.uu1 u
Absolute risk reduction u.u6! (u.u/1 to u.uS/)
Number needed to treat 16 (1l to l')
No of traumatic procedures (5 studies)
Risk ratio u.l7 (u.11 to u.67) u.uu' u
Absolute risk reduction u.u'9 (u.ul! to u.u9')
Number needed to treat 17 (11 to //)
No of insertion attempts (8 studies)
Mean difference u.// (u.6/ to u.l/) <u.uu1 7!
No of needle redirections (8 studies)
Mean difference 1.uu (1.l/ to u.7') <u.uu1 69
RESEARCH
Cardiovascular events after clarithromycin use in lower respiratory
tract infections: analysis of two prospective cohort studies
Stuart Schembri,
1
Peter A Williamson,
l
Philip M Short,
1 !
Aran Singanayagam,
/
Ahsan Akram,
'

Joanne Taylor,
'
Anika Singanayagam,
6
Adam T Hill,
' 7
James D Chalmers
1 !
STUDY QUESTION Is the use of clarithromycin in the setting
of acute exacerbations of chronic obstructive pulmonary
disease (COPD) or community acquired pneumonia
associated with excess cardiovascular events?
SUMMARY ANSWER In our cohorts, the use of clarithromycin
in the setting of acute exacerbations of COPD or community
acquired pneumonia was associated with increased
cardiovascular events.
WHAT IS KNOWN AND WHAT THIS PAPER ADDS Previous
observational studies have suggested an increased risk
of cardiovascular events at the time of clarithromycin
administration, and a meta-analysis of antibiotic trials in
coronary heart disease showed that macrolides increased
long term mortality. Clarithromycin may be associated with
increased cardiovascular events over the following year when
it is used to treat acute exacerbations of COPD or community
acquired pneumonia.
Participants and setting
We analysed two prospectively collected datasets: a multicen-
tre observational study of patients admitted to hospital with
acute exacerbations of COPD and the Edinburgh pneumonia
study. The COPD dataset includes patients admitted to one
of 12 hospitals around the United Kingdom between 2009
and 2011. The Edinburgh pneumonia study cohort includes
patients admitted between 2005 and 2009.
Design, size, and duration
The COPD cohort included 1343 patients, and the com-
munity acquired pneumonia cohort included 1631. We
classihed all patients who received at least one dose of
clarithromycin during their hospital admission as mac-
rolide users and compared them with patients who did
not receive any macrolide antibiotics during their admis-
sion. Cardiovascular events (hospital admission for acute
coronary syndrome, myocardial infarction, arrhythmia,
decompensated heart failure, or cardiac arrest) were identi-
hed from national records in the case of the COPD cohort
or case note review in the community acquired pneumonia
cohort. We used Cox proportional hazards regression to
calculate hazard ratios aher adjustment for covariates.
Primary outcome
The primary outcome was association between use of clari-
thromycin and hrst hospital admission due to a cardiovas-
cular event within one year.
Main results and the role of chance
During one year of follow-up, 268 cardiovascular events
occurred in the COPD cohort and 171 in the community
acquired pneumonia cohort. Aher multivariable adjust-
ment, clarithromycin use was associated with an increased
risk of cardiovascular events aher acute exacerbation of
COPD (hazard ratio 1.50, 95% conhdence interval 1.13
to 1.97) or community acquired pneumonia (1.68, 1.18
to 2.38). This association persisted aher matching for the
propensity to receive clarithromycin. Longer durations of
clarithromycin use were associated with more cardiovas-
cular events. Use of lactam antibiotics or doxycycline
was not associated with increased cardiovascular events,
s uggesting a clarithromycin specihc eect.
We attempted to limit bias by adjusting for all measured
confounders, but bias due to unrecorded factors may
remain. Patients with more severe illness are more likely
to be prescribed clarithromycin in community acquired
pneumonia, so clarithromycin may be a marker for more
severe infection rather than a direct cause of cardiovascular
events, although we attempted to limit this by adjusting for
severity scores. The results of this study show an associa-
tion, but its methods cannot prove causation.
Generalisability to other populations
The results are likely to be generalisable to similar popula-
tions, as the data were from unselected hospital admissions
and a similar eect was seen in both cohorts and in a previ-
ous randomised controlled study.
This study received no specihc funding.
1
Ninewells Hospital, Dundee
DD1 9SY, UK
l
Perth Royal Infirmary, Perth
PH1 1NX, UK
!
University of Dundee, Dundee, UK
/
Imperial College London, London
SW7 lAZ, UK
'
Royal Infirmary of Edinburgh,
Edinburgh EH16 /SA, UK
6
Chase Farm and Barnet Hospitals
NHS Trust, London E1 1BB, UK
7
University of Edinburgh,
Edinburgh, UK
Correspondence to: J D Chalmers
jameschalmers@nhs.net
doi: 1u.11!6/bmj.f1l!'
lu1!;!/6:f1l!'
Cox adjusted survival curves for cardiovascular events
in two cohorts
Time (months)
Community acquired pneumonia
Chronic obstructive pulmonary disease
E
v
e
n
t
-
f
r
e
e

s
u
r
v
i
v
a
l

(
%
)

E
v
e
n
t
-
f
r
e
e

s
u
r
v
i
v
a
l

(
%
)
Clarithromycin users
Non-clarithromycin users
bmj.com
ORespiratory medicine
updates from BMJ Group
are at bmj.com/specialties/
respiratory-medicine
OCardiovascular medicine
updates from BMJ Group
are at bmj.com/specialties/
cardiovascular-medicine
RESEARCH
STUDY QUESTION
Is it cost effective to add telehealth services to standard
support and treatment for people with long term conditions?
SUMMARY ANSWER
There is a low probability that telehealth is a cost effective
addition to standard support and treatment for people with
long term conditions.
Evidence on the economic effect of telehealth is scarce, and
some recent reviews have described the quality of economic
evaluations as poor. It is unlikely that the community based
telehealth intervention evaluated in this study is cost effective,
based on analysis of health and social care costs and
outcomes after months, and with reference to the National
Institute for Health and Clinical Excellences recommended
willingness to pay threshold of per QALY.
Design
An economic evaluation was nested within a pragmatic,
cluster randomised controlled trial. The primary outcome
was incremental cost per QALY gained.
Main results
We undertook net beneht analyses of costs and outcomes for
965 patients (534 receiving telehealth; 431 usual care). The
adjusted mean dierence in QALY gain between groups at 12
months was 0.012. Incremental cost of the telehealth inter-
vention per QALY gained was E92 000 (t106 700; $142 600).
The probability of telehealth being cost eective was 11% at
a willingness to pay threshold of E30 000 per QALY gained,
and exceeded 50% only if willingness to pay values exceeded
about E90 000.
Source(s) of effectiveness
A telehealth trial conducted in three English regions recruited
3230 participants with a long term condition (heart failure,
chronic obstructive pulmonary disease, or diabetes). A nested
questionnaire study examined telehealth acceptability,
eectiveness, and cost eectiveness. Participants oered the
intervention received a package of telehealth equipment and
monitoring services for 12 months, in addition to standard
health and social care available in their area.
Data sources
The evaluation took a health and social services perspec-
tive, including costs of hospitals, primary care, community
healthcare, medications, social care, and the intervention.
Participants completed questionnaires measuring primary
and secondary outcomes and service use in health and
social care. The time horizon was one year.
Results of sensitivity analysis
We explored the eect of varying telehealth equipment
costs and telehealth support costs if telehealth services
had operated at maximum capacity. Total annual mean
costs for the telehealth group were less under these new
scenarios, and in some cases seemed more cost eective.
For example, reducing equipment costs by 80% in combi-
nation with reduced support costs resulted in a 61% likeli-
hood that telehealth was cost eective for a willingness to
pay threshold of E30 000 per QALY.
Limitations
Limitations included the use of self reported data: partici-
pants may have under-reported service use if they were
frequent users. We assumed that costs between nine and
12 months of treatment could be multiplied up to a yearly
cost. The timeframe of the evaluation could have been too
short to show improvements in health related quality of life.
The extent to which costs and outcomes diered between
participants who completed 12 month follow-up and those
who did not (38% of the baseline sample) was not known.
The analyses were adjusted for baseline demographic and
cost covariates that might inuence participants decision
to complete at long term follow-up.
Study funding /potential competing interests
This is an independent report commissioned and funded
by the Policy Research Programme in the Department of
Health. Some authors have carried out evaluative work
funded by government or public agencies but these have
not created competing interests.
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
Catherine Henderson,
1
Martin Knapp,
1 2
Jos-Luis Fernndez,
1
Jennifer Beecham,
1
Shashivadan P
Hirani,
3
Martin Cartwright,
3
Lorna Rixon,
3
Michelle Beynon,
3
Anne Rogers,
4
Peter Bower,
5
Helen
Doll,
6
Ray Fitzpatrick,
7
Adam Steventon,
8
Martin Bardsley,
8
Jane Hendy,
9
Stanton P Newman,
3
for
the Whole System Demonstrator evaluation team
1
London School of Economics and
Political Science, London
WClA lAE, UK
l
Kings College London, London, UK
!
School of Health Sciences, City
University London, London, UK
/
University of Southampton,
Southampton, UK
'
University of Manchester,
Manchester, UK
6
University of East Anglia, Norwich,
UK
7
University of Oxford, Oxford, UK
S
The Nuffield Trust, London, UK
9
University of Surrey, Guildford, UK
Correspondence to: C Henderson
C.Henderson@lse.ac.uk
doi: 1u.11!6/bmj.f1u!'
lu1!;!/6:f1u!'
Cost eectiveness acceptability curve: QALY
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telehealth on quality of life and
psychological outcomes over
1l months (Whole Systems
Demonstrator telehealth
questionnaire study)
(BMJ lu1!;!/6:f6'!)
OResearch: Elect of telehealth
on use of secondary care and
mortality
(BMJ lu1l;!//:e!S7/)
NHS REORGANISATION
there were successes in areas as diverse as Hert-
fordshire and Manchester, but progress was
excruciatingly slow. PCTs learnt harsh lessons
about the dimculty of prising the hngers of the
public o the gates of their beloved hospitals.
While this was always going to be dimcult,
commissioners made life tougher for them-
selves by repeatedly presenting closure plans to
the public and asking what they thought, rather
than involving them from the beginning in shap-
ing a new service. There is clear evidence that
when PCTs talked with the public and developed
trusting relationships with key opinion formers
such as councillors and MPs, progress could
be made. For example, the Delivering Qual-
ity Healthcare for Hertfordshire plan unveiled
in 2007 to reconhgure hospital services in the
county was led by clinicians, with a consultation
exercise that included meetings in 32 towns and
villages, the distribution of more than 400 000
leaets, 120 events for NHS sta, and the close
involvement of MPs and councillors. The NHS
team developed a strong relationship with the
county councils health scrutiny committee,
explaining in detail the rationale for the com-
plex proposals and providing evidence for why
services needed to change.
PCTs largely failed to rein in the growth in
demand for hospital servicesalthough this was
a much lower priority during the years of Labour
largess. They could never have succeeded. The
payment by results system served as a conveyor
belt to carry the sharply increasing NHS budget
from the Treasury to the acute trusts. The hospi-
tals played their part in slashing
waiting times and waiting lists,
but the system incentivised them
to keep doing more.
There were some modest vic-
tories. When funding for emer-
gency admissions was capped
PCTs, GPs, hospital consultants,
and community care clinicians
ohen managed to cut admissions. But the under-
lying problem of the funding system remains.
Quality of care
In some areas tension between GPs and PCTs
were increased by the fraught, time consuming,
and dimcult work commissioners undertook
to unseat substandard local doctors. In many
D
id primary care trusts improve
healthcare? It took just 13 years for
them to be created, merged, clustered,
and abolished. During that time they
were responsible for about 80% of the
NHS budget in England.
The original 303 PCTs across England began
taking over from district health authorities and
primary care groups in 2000. In 2006 they were
merged to form 152 organisations and instructed
to begin withdrawing from running community
servicesknown in the artless syntax of White-
hall as separating out their provider armto
focus on commissioning. As the local system
leader they were charged with driving up qual-
ity, improving public health, and reducing
inequalities.
In 2010 the health select committee delivered
a devastating critique of their commissioning
performance, condemning them for failing to
tackle quality issues such as variations in clinical
practice. It attributed their weaknesses to their
lack of skills, notably poor analysis of data,
lack of clinical knowledge, and the poor quality
of much PCT management. All this was exacer-
bated by the Department of Healths imposition
of constant reorganisation, it added.
Lack of power
One of the myths of commissioning is that
commissioners wield considerable power. The
macho rhetoric of the Department of Health gave
the impression that the relationship between
commissioners and providers was increasingly
one of equals as PCTs ramped up their skills and
conhdence, hred by the hyperbole strewn world
class commissioning development programme.
The reality is that the providers have always
been in charge. While in theory PCTs could strip
poorly performing services of their contracts and
award the work elsewhere, in practice commis-
sioners were generally faced with few palatable
options beyond making the existing service work
as best they could, and even then there was lit-
tle they could do to compel improvements or
changes.
As the health select committee pointed out:
Commissioners do not have adequate levers to
enable them to motivate providers.
The solution the MPs oeredrigid, enforce-
able quality and emciency measures written into
Goodbye (and good riddance?) to PCTs
As Englands primary care trusts give way to clinical commissioning groups, Richard Vize
pens their obituary. Did PCTs seize power from providers for patients?
all contractsmissed the point that improving
services is almost always about time, eort, and
relationships.
But PCTs ohen failed to build the strong, eec-
tive relationships with clinicians in both primary
and secondary care that were needed to make
improvements happen.
In theory, clinicians were well represented on
the commissioning side. The professional execu-
tive committee provided a voice for GPs and other
clinicians in the area while medical, nursing, and
public health directors were generally inuential
hgures on the PCT board.
But too ohen there was a distant, or even antag-
onistic, relationship between local GPs and PCT
management. This failure to bring an authentic
clinical voice to PCT strategies made it more dif-
hcult for commissioners to engage clinical sta
in the trusts. An NHS Confederation study to be
published this month exploring the legacy of
PCTs and the implications for clinical commis-
sioning groups highlights the problem.
Did the frontline of clinicians feel ownership
of the commissioning agenda? No they didnt.
The opportunity for the CCGs is to get genuine
frontline ownership of what they do, says David
Stout, former chief executive of Newham PCT.
Reconfiguration
The push for safer, higher quality care accelerated
the need to reconhgure services, ohen by focus-
ing work on fewer, more specialist sites. The sharp
improvements in London in reducing deaths and
serious disability from stroke is one of the most
celebrated examples.
But major services changes
almost invariably drew in the
strategic health authority,
and national politics began to
interfere. As Robert Creighton,
chief executive of Ealing PCT,
puts it: Over 10 years we tried
three times to address those
issues and each time we were unsuccessful.
The governments ambition for us as commis-
sioners was to be bold and change the system,
but when push came to shove those attempts
got derailed because politically they were not
supported.
Other changes focused on shutting hospital
services and opening community ones. Again,
One of the myths of
commissioning is that
commissioners wield
considerable power.
The reality is that the
providers have always
been in charge
NHS REORGANISATION
areas the PCTs biggest success was making
primary care safer. The move was driven both
by contractual changes and the murders by GP
Harold Shipman. The introduction of personal
medical services contracts in 1997 allowed
local commissioners to negotiate on service
specihcations. This was followed in 2003 by
the ending of GPs monopoly in primary care;
PCTs could now commission anyone.
1
Meanwhile the conviction of Shipman in
2000 exposed risks and concerns around clini-
cal governance in general practice.
In the NHS Confederation study Stout says:
There are some extraordinary stories about
the frankly dangerous and appalling quality of
general practice . . . It was incredibly time con-
suming taking action, to some extent against
the will of the GP leadershipthey certainly
didnt get behind it even though they knew it
needed doing.
It could take two years to persuade a GP, ohen
working alone, that it was time to go. Bucking-
hamshire GP Johnny Marshall, who is now also
the confederations policy director, could see
why it was so hard: It needed a greater partner-
ship between local GP communities and PCTs,
and in some areas that simply didnt exist . . . In
many it was quite an adversarial, contractual
relationship.
PCT leaders are adamant that general prac-
tice is now much safer. As Sophia Christie, who
was chief executive of Birmingham East and
North PCT, puts it: There are a small number
of PCT medical directors . . . who have spent 10
years of their lives putting huge personal and
emotional commitment into trying to protect
patients from dangerous practice.
One of the great hopes for PCTs was that they
would hnally begin to reduce the inequalities in
health between wealthy and poor people. The
idea was that, working with their local author-
ity, PCTs would not only be able to commission
services to meet clinical needs but also begin to
work with other local services to address wider
determinants such as housing, health educa-
tion, sexual health, and exercise.
There were some successes, such as Liverpool
leading the country in smoke-free public places
and work in east London to tackle tuberculosis.
But taken together, the immense amount of
eort thrown at inequalities made virtually no
discernible dierence to the national picture of
a profound dehcit in life expectancy and years of
healthy life in the most deprived areas.
The legacy
Overall, it is easy to come to a critical judgment
on the record of PCTs, but that is to belie the
adversities they faced and the successes.
They played their part in improving the qual-
ity and safety of services, including driving
through the virtual wiping out of waiting lists.
Their share of the credit for these and other
improvements, such as the sharp reduction in
hospital acquired infections, now has to be bal-
anced against the wider failures that have been
exposed in the quality of basic care. CCGs will
hnd that, with the imposition of tight running
cost limits, they are likely to be even more
dependent than PCTs on hospital trusts supply-
ing reliable data on issues such as dignity and
nutrition if they are to avert serious failures.
Local successes in addressing aspects of
health inequality add up to a national failure.
This highlights the profound difficulties the
health service faces in addressing lifestyle and
poverty related diseases. And 13 years is simply
not long enough to build and sustain improve-
ments that will show in the hgures.
Under the new system commissioners have
been stripped of responsibility for primary care
and most specialist services, which go to the
NHS Commissioning Board, while public health
has gone to councils. This leaves CCGs with the
E60bn part of the NHS budget that is most dif-
hcult to controlgeneral acute care.
The PCT legacy to CCGs includes a greater
understanding of the health needs of the local
area, a firmer grasp of what commissioning
involves, and ohen strong relationships with
the local authority. Generous NHS funding set-
tlements allowed them to expand services in
deprived areas. The high performing PCTs leave
good foundations for further improving care.
But it is inescapable that aher 22 years of the
purchaser-provider split in the NHS, commis-
sioners have been unable to seize power from
the providers on behalf of patients. Will clini-
cal commissioners fare better? If they can use
insights from individual patient consultations
to drive strategic improvements in services, and
build a shared understanding between primary
and acute clinicians of what needs to change,
then they have a chance.
But the obstacles that PCTs endured, and the
imbalance between effort and achievement,
expose the extraordinary dimculties commis-
sioners face in making a dierence to patients
outcomes. And that was when there was plenty
of money.
Richard Vize freelance journalist, London, UK
richard.vize@gmail.com
Competing interests: I am the author of the NHS
Confederation study.
The NHS Confederation study of lessons for CCGs from
years of PCT commissioning is published on April.
peer reviewed.
1 Pollock A, Price D, Viebrock E, Miller E, Watt G. The market
in primary care. BMJ luu7;!!':/7'.
It took just 13 years for PCTs to be created, merged, clustered, and abolished
bmj.com
OEditorial: Primary care trusts
(BMJ luu/;!l9:371)
OEditorial: Primary care trusts: do they
have a future? (BMJ luu';!!1:11'6)
OPrimary care: Will primary care trusts lead
to US-style health care?
(BMJ luu1;!ll:96/.1)
ORead Richard Vizes blogs at
bmj.com/blogs
ALCOHOL
industry no authority to engage in public health
activities on behalf of WHO or in support of the
public health community.
For the record, the industry says the charge of
misrepresentation is nonsense and quotes para-
graph 45(d) of the WHO alcohol strategy, which
states that the producers, distributors, and sellers
of alcohol, are especially encouraged to consider
eective ways to prevent and reduce harmful
use of alcohol within their core roles mentioned
above, including self-regulatory actions and
initiatives.
In fact, says Marcus Grant, president of the
International Center for Alcohol Policies, the
industrys mouthpiece in much of its dialogue
with WHO and the scientihc and public health
communities, it was that paragraph that led the
companies to make the commitments. They
were meticulous, he says, about making sure
they werent promising to do anything that wasnt
encompassed by the role that was given to them
by WHO.
It remains to be seen how, if at all, WHO will
respond to the statement of concern. But perhaps
the true value of the document lies in the spot-
light it has thrown on the ideological schism that
is dividing the public health community, between
those who are prepared to work alongside the
industry in the eort to reduce alcohol harm and
those who are not.
Divided opinion
To some extent, the statement echoes the con-
cerns expressed by the BMA and hve other UK
bodies (the Royal College of Physicians, Alcohol
Concern, the British Association for the Study of
the Liver, the British Liver Trust, and the Institute
of Alcohol Studies) in 2011, when they walked
out of the governments public health responsi-
bility deal. They claimed that the deal focused
on voluntary interventions by the industry that
lacked evidence for eectiveness while failing to
tackle issues such as availability and the promo-
tion of alcohol.
O
ver two days in October last year, key
hgures in the international alcohol
industry gathered in Washington,
DC, to take stock of how the business
had responded to the World Health
Organizations Global Strategy to Reduce the
Harmful Use of Alcohol, endorsed by the World
Health Assembly 28 months earlier.
1
For an industry well aware that it was in danger
of following tobacco down the road to pariah sta-
tus, the conference on global initiatives to reduce
harmful drinking was an opportunity to show o
what it had accomplished as a corporate good
neighbour who could be trusted to self regulate.
On the final day of the conference, in
response to the call by WHO, the chief execu-
tives of 13 of the worlds leading alcohol compa-
nies announced a collective commitment to 10
targeted actions in hve areas over the next hve
years. The hve areas they picked were reducing
under-age drinking; strengthening and expand-
ing marketing codes of practice; providing con-
sumer information and responsible product
innovation; reducing drinking and driving [and]
enlisting the support of retailers to reduce harm-
ful drinking.
2
On the surface, it seemed like a positive devel-
opment. The commitment built on what the
signatory companies called their longstanding
eorts to reduce the harmful use of alcohol. Fur-
thermore, it showed that they supported WHOs
global strategy and welcomed the positive role it
identihes for producers, distributors, marketers,
and sellers of beer, wine, and spirits.
Yet for a sizeable proportion of the international
public health community the announcement
served as a red rag to a bull.
An ad hoc group of public health professionals,
health scientists, and representatives of non-gov-
ernmental organisations, brought together under
the auspices of the Global Alcohol Policy Alliance
(a network of organisations and individuals work-
ing in public health) drahed a statement of con-
cern, condemning the industrys commitments as
weak, rarely evidence-based, and unlikely to
reduce harmful alcohol use.
The 16 page document, bearing over 500
signatures from 60 countries, was presented to
WHO this week and suggests that the 13 chief
executives are misrepresenting their roles with
respect to the implementation of the WHO Global
Strategy. The strategy, it says, had given the
DOCTORS AND THE
ALCOHOL INDUSTRY:
AN UNHEALTHY MIX?
Jonathan Gornall reports on an ideological schism over
working alongside the alcohol industry that is dividing the
public health community
POACHER TURNED GAMEKEEPER
It might come as a surprise to
some working in public health
although he makes no secret of
it himselfto learn that Marcus
Grant (right), who founded the
industry funded International
Center for Alcohol Policies, is a
gamekeeper turned poacher.
Between and he
ran the Alcohol Education Centre
at the Maudsley Psychiatric
Hospital in London, offering
training programmes for health
and social staff dealing with
alcohol problems. He was then
recruited by WHO and, after
spells in Copenhagen and
Manila, spent years at its
headquarters in Geneva, where
he was chief of global activities
on the prevention of substance
misuse, including alcohol.
In , after addressing an
alcohol industry conference
on public health issues, he
resigned from WHO to set up the
International Center for Alcohol
Policies for the alcohol industry.
So should those tackling alcohol
issues in the public health
community see anything sinister
in his having gone over to the
other side?
No, quite the opposite, he
says. Ive always been very
transparent about that. I always
felt when I was in WHO, dealing
with illicit drugs and alcohol,
that there was a role for the
private sectornot necessarily
a controlling role, but a role with
respect to alcohol policy.
ALCOHOL
At the time, Vivienne Nathanson, the BMAs
director of professional activities, said the govern-
ment had chosen to rely on the alcohol industry
to develop policies. Given the inherent conict of
interest, these will do nothing to reduce the harm
caused by alcohol misuse.
3
Yet not everyone in the public health sector
believes it is advisableor even possible to
tackle the problems of alcohol without giving the
industry a role in the search for solutions. Dozens
of other bodies have not walked out on the deal
charities such as Addaction, the Alcohol Educa-
tion Trust, Cancer Research UK, and Heart UK
and organisations including the Royal College of
Paediatrics and Child Health, the College of Emer-
gency Medicine, and no fewer than 40 NHS trusts.
Thomas Babor, professor of community medi-
cine and public healthcare at the University of
Connecticut, who led the 18 strong international
committee that drahed the statement of concern,
is among those who believe that the industrys
efforts to reduce the harm caused by alcohol
should not be taken at face value.
The problem is that when they have examples
of partnering with civil society to do activities that
appear to be prevention related and addressing
the problems connected with alcohol, its very
good public relations for them and distracts atten-
tion from the other activities they are doing, like
spending a million dollars lobbying the World
Health Organization against policies that are
demonstrably eective, he told the BMJ.
WHO, says the statement he cowrote, should
clarify the roles and responsibilities of economic
operators in the implementation of the WHO
Global Strategy. The industry should refrain
from engaging in health related prevention,
treatment, and research activities, as these tend
to be ineective, self-serving and competitive with
the activities of the WHO and the public health
community and the public health community
should avoid funding from industry sources for
prevention, research and information dissemina-
tion activities.
4
Alcohol companies, says Babor, are engaging
with WHO and other health initiatives solely in
an attempt to inuence policy makers, so that
it appears they are doing something construc-
tive and therefore other more eective remedial
action does not have to be taken. At heart, they
are adamantly opposed to policies that restrict
access to alcohol, restrict marketing or put con-
straints on pricing.
This much is true, says Nick Sheron, the head
of clinical hepatology at the University of South-
ampton who, alongside the chief executive of
the alcohol industrys Portman Group, co-chairs
the Responsibility Deal Alcohol Network Group,
which oversees the programmes action on
alcohol.
Theres nothing in the statement of concern
with which I disagree, he says. There is a fun-
damental problem in dealing with the drinks
industry, which is that obviously theres a con-
flict of interest. They exist to make money for
their shareholders. They are not in the business
of public health.
But that, he says, does not mean the indus-
try cant be persuaded to make proht neutral
changes that beneht public health.
There are some members of the public health
community who think the government should
never speak to industry. I just dont think that is
a pragmatic reality. I generally believe that it is
better for people to talk to each other, and I also
believe it is really important to talk to people who
totally disagree with you. And the things were
discussing are really important for society.
Sheron made the decision to remain part of the
responsibility deal even when the Royal College
of Physicians, for which he is the representative at
the EUs Alcohol and Health Forum, pulled out.
I get ak, he says, from both sidesprob-
ably more from the public health community. But
I see myself as an honest broker. If the govern-
ment is going to speak to the drinks industry
then I would much rather it is in an open forum
at which health advocates are present and can
put a view that is based on evidence.
For example, I would prefer that labelling
changes were achieved by legislation, but the
government isnt prepared to do that. Therefore is
it better, in the absence of legislation being likely,
to have a voluntary initiative whereby labelling is
improved? I think it probably is.
Positive steps
The responsibility deal has, he says, found com-
mon ground on a range of programmes, including
Challenge 21 and Challenge 25, an industry sup-
ported initiative to ask for proof of age from any-
one who looks under 21 or 25, which I think has
been very eective at reducing underage sales,
and the industrys unit reduction pledge, a win-
win situation for everybody.
Last year, as part of the responsibility deal,
manufacturers agreed to remove a billion units
of alcohol from the market by 2015some 2%
of all alcohol consumed in the UK. It has been
estimated that this would prevent 1000 alcohol
related deaths, in addition to saving NHS costs
and reducing the burden on society of drink
related crimes.
5
Even before the deal was conceived, Heineken,
which has committed to removing 100 million
units of alcohol from sale, had announced in
April 2009 that it was reducing the alcohol con-
tent of White Lightning, a cider that had become
synonymous with cheap, irresponsible drinking,
from 7.5% to 5.5% alcohol by volume. Eight
months later, the company scrapped the brand
altogether, to reinforce its stance on irresponsi-
ble drinking and went further in August 2010 by
de-listing Strongbow Black, another cider with
7.5% alcohol.
6

7
Both decisions, insists Jeremy Beadles, direc-
tor of corporate relations for Heineken UK, were
driven by a sense of social responsibility.
Alcohol companies are engaging with
WHO and other health initiatives solely
in an attempt to influence policy makers
P
A
ALCOHOL
that industry can do. Industry cant limit avail-
ability, cant increase taxationthese are govern-
ment actions. Now it may be that the signatories
of this statement of concern believe these are more
eective measures, but theyre not measures that
industry can take.
Sheron believes the alcohol industry faces two
possible futures. You will see statements regard-
ing minimum pricing, for example, that are the
same sort of disinformation and pseudoscience
that the tobacco industry has used in the past. So
one possibility is that the drinks industry ends
up being viewed like the tobacco industry by the
majority of not only the public health community
but also governments.
This, Sheron believes, is the dark path on
which the industry is currently travelling. But it
has a choice, he says, as shown by the experience
and evolution of the car industry.
In the 60s and 70s it was in a very similar
position with regard to health. The idea that you
would sell motor cars based on the fact that they
were safe to drive was a complete anathema.
Thirty years on, we have an
industry saying, If we make
safe and reliable cars our
business will prosper, and
it has.
Sheron also points to the
experience of the wine indus-
try in France, where manufacturers have shihed
from a marketing model based on quantity to one
of quality. As a result, as he documented in a paper
published in 2010, France has seen a threefold to
hvefold decrease in deaths from liver disease at a
time when the UK has seen a similar sized increase
in alcohol related deaths.
14
Yet the prohtability
of the French wine industry has increased at the
same time as there has been a massive improve-
ment in public health.
For Addaction, the recommendations in the
statement of concern that the industry should not
engage in health related prevention and treatment
activities, and that the public health community
should decline industry funding, make no sense
and oer no hope.
I dont think anybody wins from that kind of
statement, says Antrobus. We do need checks
and balances; we do need to make sure that any
kind of support is appropriate and right and
proper. But we have far too many pressing issues
here around alcohol to be turning away funding.
When we see the consequences of alcohol addic-
tion every day, we want to do something about it.
Jonathan Gornall freelance journalist, Suffolk, UK
jgornall@mac.com
peer reviewed.
These were big, prohtable brands, and this
was not custom that we were going to make up
with the rest of our range, [but] we looked at how
those two products were being misused by people
and we decided that that was not something we
wanted to be part of, he says. The company could
only hope that other hrms would follow us out
of that sector, and in fact we know at least one of
our competitors has indicated they are planning
to do that.
Such initiatives, he says, rarely generate good
PR. When Heineken went on to reduce the alco-
hol content of two of its major brands as part of its
commitment to the responsibility deal it got some
very dimcult publicity, in media ranging from the
Financial Times to the Daily Mail, suggesting the
company was prohteering by watering down
John Smiths bitter from 3.8% to 3.6% alcohol.
8

9

It is, says Beadles, a serious disincentive for busi-
nesses when you get criticised for doing what the
government and the public health lobby would
like you to do.
Beadles says decisions taken by the company
have been inuenced by its long term involvement
with the drugs and alcohol charity Addaction. The
management team visited an alcohol treatment
centre and that was inuential in their decision
making process to scrap the Strongbow product.
Its a relationship, says Simon Antrobus, chief
executive of Addaction, that makes a persuasive
case for working with industry.
Addaction, founded in 1967, helps over 35 000
people a year in centres all over England and Scot-
land. The bulk of its E45m (t53; $68m) income is
derived from contracts with local authorities, but
the charity says it relies on donations from com-
panies, trusts and individuals to fund the devel-
opment of new projects and to address emerging
problems.
I think that the alcohol industry has a vital role
to play in dealing with the consequences of addic-
tion, says Antrobus, who is also a member of the
Responsibility Deal Alcohol Network Group.
This isnt an open opportunity to assuage
their guilt; there has to be a genuine commitment
to what we are trying to do and an understand-
ing of the impact alcohol has on the people were
supporting. But how can we change perceptions,
at the very least, without engaging with industry?
We dont want them to put up the shutters and
carry on; we want them to think dierently about
the way they produce and market their goods
and, as much as they can, contribute to minimis-
ing and reducing harm. We
have a valuable role to play
in educating and supporting
them as well.
The industry as a whole,
however, believes the debate
with some sections of the
public health sector is becoming more polarised.
There is a more adversarial tone to exchanges
now than in the past, in part because it has
become a much more visible issue, concedes
industry representative Grant.
A decade ago it was tobacco. Now that the
Framework Convention on Tobacco Control exists
its not surprising that WHO should be concerned
about other public health issues, and alcohol
clearly is one and so it has moved on to the agenda
of the international community.
Government failure
Peter Anderson, professor of substance use,
policy, and practice at Newcastle Universitys
Institute of Health and Society, who helped drah
the statement of concern, sees the incursion
of the industry into policy areas as a failure of
governments.
Many governments dont accept that they
should regulate these industries. Too many say,
You, the industry, have to be part of the solution.
But of course these industries cant do that: its not
in their interests, he says.
And, in a way, the industry agrees. It rejects the
criticism in the statement of concern that the com-
mitments it has made are weak but, says Grant,
They are at least actions, and they are actions the
industry can take, because thats what WHO asked
for in the strategy: that industry should do things
If the government is going to
speak to the drinks industry
then I would much rather it
is in an open forum at which
health advocates are present
GHOSTS FROM THE PAST?
The debate over industry
involvement in reducing alcohol
harm is entering a gloves-off
phase. Almost the first thing
Marcus Grant of industry body the
International Center for Alcohol
Policies tells the BMJ is that several
signatories on the statement of
concern have strong links with
the temperance movement.
This is a reference to the roots of
the Global Alcohol Policy Alliance
and its partner the Institute of
Alcohol Studies in the history of
the temperance movement, which
flourished in Britain in the th
century. The institute is funded by
the Alliance House Foundation,
which is now an educational
charity but began life in the s
as the United Kingdom Alliance for
the Suppression of the Traffic in all
Intoxicating Liquors.

-
Some in the industry doubtless
suspect that a secret prohibition
agenda lies behind the activities
of the alliance and the institute,

but all of that, says Katherine
Brown, director of policy at the
Institute of Alcohol Studies, is
just so much history. IAS is
open about its funding body,
that has historical associations
with the UK Temperance
Movement, she says. However,
IAS was established as an
independent organisation with
the aim of promoting the scientific
understanding of effective alcohol
policies. We do not take a view on
whether or not individuals choose
to drink.
ANALYSIS
What should follow the
millennium development goals?
Debate on what should replace the millennium development goals when their target date of
2015 is reached is hotting up. Charles Kenny comments on lessons learnt from their success
and failure and looks at the suggestions for the post-2015 development agenda
bal poverty, for example, has stemmed largely
from rapid economic growth in Chinaa coun-
try where the goals are not well known and aid
has had only a small role in development. On the
other hand, the goals may have had a positive
eect in some areasthis despite the fact that
T
he millennium development goals
were an oshoot of the United Nations
Millennium Declaration agreed by
world leaders at the UN General
Assembly in 2000.
1
The eight goals
that were subsequently adopted in 2001 set tar-
gets for progress to reduce poverty and improve
outcomes in nutrition, education, health, equal-
ity, the environment, and global partnerships by
2015 (box). With that end date fast approaching
debate on what should follow them is mounting,
and later this year the UN secretary general will
set out a drah agenda based on recent consulta-
tions. As discussion continues it is important to
consider the successes and failures of the goals
learnt from the lessons these provide, and look
at the desirability and feasibility of new goals
that have been suggested.
Setting the development agenda
Soon aher they were set, the millennium devel-
opment goals became a dominant framework for
thinking about global development. Seven years
ago the phrase millennium development goals
overtook references to the human development
index in the development literature.
2

3
The high prohle of the goals has not merely
been because the worlds heads of state signed
up to them. It is also because the goals were
based on easily understood and self evidently
important indicators and included numeri-
cal and time bound targets. Furthermore, they
said something new (much of the rest of the
M illennium Declaration rehashed paragraphs
from previous General Assembly statements).
In addition, they provided a framework to target
development aid and so have been widely cited
in strategies for donor programmes.
4
What effect have the goals had so far?
Twelve years on, progress towards meeting the
goals has been mixed. According to the latest
accounting by the United Nations (table) targets
for income poverty and access to clean water have
been met, but the world is considerably o-track
on under 5 mortality and maternal mortality.
5
Much of the success we have seen has not
been a result of the goals. Progress against glo-
bmj.com
OFeature: Child mortality: will India achieve the target? (BMJ ;:f)
ONews: UN urges more progress to meet MDG targets on maternal and child health (BMJ ;:d)
ONews: UN chief urges world leaders to put development goals back on track (BMJ ;:c)
MILLENNIUM DEVELOPMENT GOALS
Goal 1: Eradicate extreme poverty and hunger
Halve the proportion of people living on less than . a day
Achieve decent employment for women, men, and young people
Halve the proportion of people who suffer from hunger
Goal 2: Achieve universal primary education
Ensure that all girls and boys can complete a full course of primary schooling
Goal 3: Promote gender equality and empower women
Eliminate gender disparity in primary and secondary education, preferably by ,
and at all levels by
Goal 4: Reduce child mortality rates
Reduce by two thirds the mortality rate for children under years
Goal 5: Improve maternal health
Reduce by three quarters the maternal mortality ratio
Achieve universal access to reproductive health
Goal 6: Combat HIV/AIDS, malaria, and other diseases
Have halted and begun to reverse the spread of HIV/AIDS
Achieve universal access to treatment for HIV/AIDS
Have halted and begun to reverse the incidence of malaria and other major diseases
Goal 7: Ensure environmental sustainability
Integrate the principles of sustainable development into country policies and
programmes; reverse loss of environmental resources
Reduce biodiversity loss, achieving, by , a significant reduction in the rate of loss
Halve the proportion of the population without sustainable access to safe drinking
water and basic sanitation
By , achieve a significant improvement in the lives of at least million
slum dwellers
Goal 8: Develop a global partnership for development
Develop further an open, rule based, predictable, non-discriminatory trading and
financial system
Address the special needs of the least developed countries, landlocked
developing countries, and small island developing states
Deal comprehensively with the debt problems of developing countries through
national and international measures to make debt sustainable in the long term
In cooperation with pharmaceutical companies, provide access to affordable,
essential drugs in developing countries
In cooperation with the private sector, make available the benefits of new
technologies, especially information and communications
ANALYSIS
they were a purely aspirational set of targets.
Aher the Millennium Declaration was signed
in 2000, overseas development assistance
increasedclimbing by more than $50bn
(E33bn; t38bn) over the following decade, and
more aid was provided for health and education.
There is also evidence that progress in social sec-
tors has been more rapid than would be expected
from historical trends. For example, it is esti-
mated that the proportion of children complet-
ing primary education in the developing world
would have been expected to reach 76% in 2010.
In fact, the completion rate reached 81% in that
year.
2
The number of girls enrolled in primary
school as a percentage of boys was predicted to
be 96%, but it reached 98%. The maternal mor-
tality rate in 2010 was 203/100 000 births com-
pared with a predicted value of 221/100 000;
the child mortality rate was 5.1% rather than
the expected 5.4%.
2
Criticisms of the goals
Despite their widespread adoption in the dis-
course around development the goals have faced
criticism. Firstly, what were originally seen as
global targets were rapidly interpreted to apply
at the regional and country level. A target for the
average country to reduce child mortality by two
thirds became a target for all countries to reduce
mortality by that amount.
6
This created a cottage
industry of national report writing to create coun-
try programmes designed to meet the goals, with
funding requests attached.
Secondly, once the global goals were reborn
as country goals they ohen called for unrealisti-
cally fast progress. Progress reports suggested
countries were failing, or o-track, despite the
fact they were making incredibly rapid progress
on the basis of any historical norm.
7
Burkina
Faso, for example, increased the proportion of
children completing primary school from 24%
to 45% between 2000 and 2010an impressive
performance. But it is still clearly o track for
100% completion by 2015.
Thirdly, some goals were wrongly targeted,
inadequate, or simply missing. The education
goal for example, has been widely criticised for
measuring inputs (presence in school) rather
than outputs (learning). Indias experience
shows the extent to which this is a major concern.
While grade eight enrolment increased from 82%
to 87% between 2006 and 2011, national tests
suggest that the proportion of grade eight chil-
dren who could do division actually fell from
70% to 57%.
8
The imbalance between dierent elements of
development has also been criticised. There were
three and a half health goals (covering child mor-
tality, maternal mortality, infectious disease, and
water and sanitation) as well as a goal 8 commit-
ment to access to aordable essential medicines
but no attention was given to roads or energy.
And the gender equality goal focused only on
school enrolment. Other key concerns including
income equality, national governance, violence,
and climate change were not mentioned.
In addition, the goals are heavily focused
towards progress in the least developed coun-
tries. This has let middle and high income coun-
tries o the hook since many of these had already
achieved universal primary school enrolment
and gender equity in access to secondary educa-
tion and had seen absolute poverty or stunting
reduced to near zero.
Current ideas on the post-2015 development
agenda
The UN secretary general has set up a high level
panel on the post-2015 development agenda,
co-chaired by the heads of state of Liberia, Indo-
nesia, and the United Kingdom. The panel, made
up of politicians, academics, and civil society rep-
resentatives from a range of countries, will issue
a report to the secretary general in the middle of
2013. Meanwhile, the closing declaration of the
UN Rio summit last year called for the creation of
an open working group of UN member states to
discuss the creation of sustainable development
goals, and this group, made up of 30 UN member
countries, was launched in January.
UN agencies have produced a joint paper
Realizing the Future We Want for All as an input
to the deliberations.
9
and the UN Development
Programme conducted a series of consultations
under the banner of The World We Want.
10
Current debate centres not only on what the
post-2015 goals should be but what they are for,
and who should be involved in drawing them up.
To add to the challenge it is evident that there is
some disagreement within the UN about framing
new development goals, with both the secretary
generals high level panel and the UNs sustain-
able development goals open working group
charged with coming up with a set of new glo-
bal goals.
Although it is widely agreed that the post-2015
agenda should remain focused on the worlds
poorest and most disadvantaged people, some
commentators argue that a declaration of where
we want to be in 2030, signed by all of the worlds
leaders, should speak to the concerns of rich and
poor alike. Some also suggest the most useful con-
tribution of a UN document of global aspirations
would be to focus on the global commons
issues like climate change, loss of biodiversity,
and communicable disease.
11
What has been agreed is that the post-2015
agenda should stretch beyond aid. Although
financial aid is a powerful way of improving
quality of life in poor countries, its contribution is
declining as developing countries become richer.
China, Brazil, Russia, and Mexico are all now
richer than Italy was when it joined the Organi-
sation for Economic Cooperation and Develop-
ments development assistance committee in
1960.
12
And even in low income countries trade,
Progress on selected targets in the millennium development goals

Target Status in developing countries
Goal 1: Halve proportion of world living on <51.l'/day Met in lu1u
Goal 1: Halve, between 199u and lu1', the proportion of
people who suffer from hunger
Off track: malnourished were 19.S% of developing country
population in 199u-9l, 1'.'% in luu6-uS
Goal l: Ensure that, by lu1', all children will be able to complete
a full course of primary schooling
Considerable progress but off track: adjusted net enrolment
rate in primary education Sl% in 1999, 9u% in lu1u
Goal !: Eliminate gender disparity in primary and secondary
education, preferably by luu', and in all levels of education no
later than lu1'
Broadly on track for lu1': ratios are 97% primary, 96%
secondary, 9S% tertiary
Goal /: Reduce by two thirds, between 199u and lu1', the
under ' mortality rate
Off track: mortality fell from 9.7% to 6.!% during 199u-
lu1u
Goal ': Reduce by three quarters, between 199u and lu1',
the maternal mortality ratio
Off track: deaths fell from //u/1uu uuu live births in 199u
to l/u/1uu uuu in lu1u
Goal 6: Have halted by lu1' and begun to reverse the spread
of HIV/AIDS
Mixed: HIV incidence and deaths falling, number living with
HIV rising
Goal 6: Halve, by lu1', the proportion of the population without
sustainable access to safe drinking water and basic sanitation
Mixed: drinking water goal met, sanitation goal off track
Goal 7: By lulu, to have achieved a significant improvement in
the lives of at least 1uu million slum dwellers
Already met: luu million lives have been improved
ANALYSIS
money sent home by migrants, and private invest-
ment ohen dwarf omcial assistance. According
to World Bank data, foreign direct investment
and portfolio equity ows to developing coun-
tries were worth $444bn in 2009 compared with
$120bn in overseas development assistance.
With world trade talks moribund, increased
opposition to migration and hnancial integration
from recession hit citizens in the West, and talks
on hnancing measures to combat climate change
stalled, it may seem optimistic to think that we
can achieve a post-2015 declaration with strong,
measurable commitments on global cooperation.
But this has not deterred international agen-
cies and organisations from putting forward
a rah of ideas for new global goals, including
those aimed at improving employment rates and
reducing income equality; learning (literacy and
numeracy targets); global greenhouse gas emis-
sions, forestry, and biodiversity; governance;
and rates of violence.
10
Producing easily under-
stood and self evidently important indicators
with numerical and time bound targets in some
of these areas is a challengeas is the fact that
they also have to be agreed by consensus in the
UN General Assembly.
13
With respect to health, the World Health Organ-
ization has proposed universal health coverage
and healthy life years as the anchors for post-
2015 health goals and completed a consultation
process around that proposal.
12

14
While healthy
life years pose statistical dimculties (because good
data are sparse for many of the worlds poorest
countries) and it may be hard to dehne a realistic
goal for progress by 2030, the metric does have
the merit of being easily understood.
More problematic is the idea of a goal to
achieve universal health coverage. Just as pres-
ence in school does not guarantee learning,
access to health professionals by no means
guarantees wellness. It is a repeated hnding, for
example, that the number of doctors and nurses
or hospital beds per capita is not correlated with
life expectancy or child mortality outcomes at
the country level.
15
The quality of healthcare
remains an ongoing concern. A recent World
Bank survey suggested that doctors in Tanzania
took fewer than a quarter of the diagnostic steps
needed to conhrm malaria in patients showing
symptoms.
16
A study in India found that the aver-
age number of questions in an interaction with
a public sector doctor in India was one (usually
Whats wrong with you?).
16
Universal health-
care might, some argue, be seen as a goal of insti-
tutional development (much like the primary
education goal) that could result in (primarily)
dysfunctional institutional expansion rather
than improved health.
Aiming for universal health coverage also risks
downplaying the huge importance of the wider
determinants of health, including socioeconomic
status and health literacy (where knowledge of
good practice from hand washing and safe care
of the newborn to sanitation, sound nutrition,
and the adverse impact of smoking and drink-
ing on health is important). It also has no clear
dehnition. What constitutes a plausible package
of health coverage available to all depends on a
countrys economic circumstances so it is hard
to crah and agree on a universal global goal that
is easy to understand and measure, especially
if universal coverage were to includes interven-
tions outside the health sectorfor example, the
provision of water and sanitation and hnancial
risk protection.
17
Setting targets will be important
Whatever indicators are eventually chosen, those
who frame the post-2015 agenda will have to set
targets for progress. A recent study using country
projections for a range of potential goals suggests
that the targets might plausibly include

To reduce the proportion of the worlds
people whose income is less than $2 a day or
who are undernourished to below 1 in 10

To increase global completion of secondary
schooling in the population aged 25 by 50%

To increase global average life expectancy to
75 years

To reduce global maternal mortality to below
1/1000 births

To reduce global mortality among children
under 5 to half its level in 2010

To halt, and have begun to reverse, trends
towards greater population disparities in
the number of girls and boys at age 5 in
every country where such trends have been
manifest

To have reversed the global trend towards
deforestation.
13
The idea of getting to zero on a range of
indicators has gained political traction, and our
forecasts suggest that, for absolute poverty at
the level of $1.25 a day, eectively wiping out
poverty is achievable.
13
However, in some areas
where a zero goal has been proposed (no chil-
dren failing to complete secondary education,
for example) this would require a historically
unprecedented rate of progress in many coun-
tries and, once again, result in some countries
(especially in Africa) being branded as devel-
opment failures, even were they to make giant
strides in enrolling students.
Conclusion
Despite the limitations of the millennium devel-
opment goals and the challenges of developing
a post-2015 agenda one thing is worth bearing
in mind. The past 20 years have seen immense
and ubiquitous progress on development across
a wide range of measures from income through
health and education to civil and political rights
and security. While the credit for this must
largely go to the people and institutions of the
developing world, the international community
has played a part. If a post-2015 development
framework can be agreed and the UN can mus-
ter the motivation to continue and strengthen its
supporting role, a new set of goals could deliver
worthwhile dividends.
Charles Kenny is senior fellow, Center for Global
Development, Washington, DC
ckenny@CGDEV.ORG
Accepted: 1/ February lu1!
Contributors and sources: CK has 1S years of experience
researching and writing about development as well as
managing aid projects at the World Bank and the Center for
Global Development.
Provenance and peer review: Not commissioned; externally
peer reviewed.
1 United Nations General Assembly. ''/l. United Nations
millennium declaration. luuu. www.un.org/millennium/
declaration/ares''le.pdf.
l Kenny C, Sumner A. More money or more development?
What have the MDGs achieved? Center for Global
Development Working Paper l7S. CGD, lu11.
! Michel J-B, Shen YK, Aiden AP, Veres A, Gray MK, Pickett JP, et
al. Quantitative analysis of culture using millions of digitized
books. Science lu11;!!1:176-Sl.
/ Fukuda-Parr S. Are the MDGs priority in development
strategies and aid programmes? Only few are! luuS. www.
ipc-undp.org/pub/IPCWorkingPaper/S.pdf.
' United Nations. The millennium development goals report
lu1l. www.un.org/en/development/desa/publications/
mdg-report-lu1l.html.
6 UN Development Programme. Assessing progress in Africa
toward the millennium development goals. lu1l. www.
undp.org/content/undp/en/home/librarypage/mdg/mdg-
reports/africa-collection/.
7 Clemens M, Kenny C, Moss T. The trouble with the MDGs:
confronting expectations of aid and development success.
World Dev luu7;!':7!'-'1.
S Pritchett L. The rebirth of education: from universal schooling
to universal learning. Center for Global Development, lu1!.
Although financial aid is a powerful
way of improving quality of life in poor
countries, its contribution is declining
as developing countries become richer
M
I
K
K
E
L

O
S
T
E
R
G
A
A
R
D
/
P
A
N
O
S
ANALYSIS
COMMENTARY
New development goals must focus on
social determinants of health
Although the millennium development
goals (MDGs) addressed some of the starkest
manifestations of the contemporary global
health crisis, they failed to confront the
underlying structures that maintain the crisis,
including globalisation. In reecting on the
post-2015 development agenda,
1
we need to
challenge some key assumptions about the
genesis and eect of the current goals.
Much of the discourse around the MDGs
since 2000 has suggested that attainment
would be secured by creating a global
partnership for development (goal 8) and
would require more of the same, including
increased development assistance. An
alternative interpretation is that both the goals
and the increased development assistance
since 2000 were motivated, at least in part,
by the need to shore up the legitimacy of what
was increasingly seen as an inequitable and
unsustainable economic regime. The goals
were adopted in the context of powerful
civil society campaigns around debt relief
and access to treatmentcampaigns that
challenged the legitimacy of the International
Monetary Funds structural adjustment
policies and the restrictive provisions of the
international agreement on trade related
intellectual property rights (TRIPS). The weight
of the challenge to economic globalisation
is shown by the fact that the World Trade
Organisations 2001 Doha Declaration
included reassurances that trade agreements
should not over-ride public health objectives.
2

We also need to re-evaluate the assumption
that increased development assistance
has contributed to meaningful social and
economic development. While there have
been improvements in some of the global
health indicators, the averages disguise wide
inequalities in many countries, both rich and
poor
3

4
; there are large populations that have
experienced little or no improvement. In some
countries increased aid has enhanced access to
treatment, but healthcare based on donor
funding is neither secure nor sustainable.
New approach
As well as the health crisis (untreated AIDS,
escalating tuberculosis, avoidable child
and maternal deaths), humanity faces a
more complex set of global crises, including
global warming, hnancial instability, food
insecurity, an unsustainable population, and
environmental degradation. These crises are
all underpinned by structured inequalities
and an unsustainable economic system. If we
are to exercise intentional control over this
unbalanced runaway system the structures
and norms of national and global governance,
including of trade and hnancial markets, need
reform.
The United Nations Development Programme
states that the central goal of human
development is providing opportunities and
choices for all.
5
This must involve building the
institutions and systems that give communities
control over their futures: in Sens terms,
the freedom to choose how they will live.
6

Development must include, but go well beyond,
aid.
The Peoples Health Movement has argued
that the post-2015 development agenda will
need to confront the underlying dynamics
that are driving widening inequality, creating
avoidable suering, and accelerating
global warming.
7
We need to confront and
change the structural determinants of ill
health and malnutrition.
8

9
This will include
regulating transnational corporations,
especially in banking, agriculture, food, and
pharmaceuticals. Universal health coverage
is a priority but it should be clearly dehned as
including equitable access to quality care and
strengthening public health systems.
Consensus on these issues is a long way
o, and a critical item on the post-2015
development agenda will be to cultivate
new modes of dialogue between deeply
divergent interests across dierent countries,
constituencies, and corporations. Such
reconciliation and consensus building will
require inspiring leadership, participatory
policy development, and (as with the impetus
behind the original MDGs) continuing
mobilisation of civil societynot just
international hnancial assistance.
David Legge scholar emeritus, La Trobe University,
Melbourne
David Sanders emeritus professor, School of Public
Health, University of the Western Cape, Belville, South
Africa
Correspondence to: D Legge dglegge@gmail.com
Competing interests: We are members of the steering
council of the Peoples Health Movement.
peer reviewed.
1 Kenny C. What should follow the millennium development
goals? BMJ lu1!;!/6:f119!.
l World Trade Organisation Ministerial Council. Doha
ministerial declaration. luu1. www.wto.org/english/
thewto_e/minist_e/minu1_e/mindecl_e.htm.
! Moser KA, Leon DA, Gwatkin DR. How does progress towards
the child mortality millennium development goal affect
inequalities between the poorest and least poor? Analysis of
Demographic and Health Survey data. BMJ luu';!!1:11Su.
/ Gwatkin DR. How much would poor people gain from faster
progress towards the millennium development goals for
health? Lancet luu';!6':S1!-7.
' UN Development Programme. Human development report
lu11: sustainability and equity: a better future for all. lu11.
www.undp.org/content/dam/undp/library/corporate/
HDR/lu11%luGlobal%luHDR/English/HDR_lu11_EN_
Complete.pdf .
6 Sen A. Development as freedom. Oxford University Press,
1999.
7 Peoples Health Movement. Health in the post-lu1'
development agenda. www.phmovement.org/sites/
www.phmovement.org/files/PHM%lustatement%lu
submitted%luto%luthe%luWHO.pdf.
S Friel S, Labonte R, Sanders D. Measuring progress on diet-
related NCDs: the need to address the causes of the causes.
Lancet lu1!;!S1:9u!-/.
9 Commission on Social Determinants of Health. Closing the
gap in a generation: health equity through action on the
social determinants of health. WHO, luuS.
9 United Nations. Realizing the future we want for all.
lu1l. www.undp.org/content/undp/en/home/librarypage/
poverty-reduction/realizing-the-future-we-want.
1u Health in the Post-lu1' Development Agenda. www.
worldwewantlu1'.org/health.
11 Von der Hoeven R. MDGs post lu1': beacons in
turbulent times or false lights paper. lu1l. www.un.org/
millenniumgoals/pdf/rolph_van_der_hoeven.pdf.
1l Kenny C. Wealth of nations. Foreign Policy lu1l Jul/
Aug. www.foreignpolicy.com/articles/lu1l/u6/1S/
thank_god_for_the_nouveau_riche.
1! Karver J, Kenny C, Sumner A. MDGs l.u What goals targets
and timeframe? Center for Global Development Working
Paper l97. CGD, lu1l.
1/ WHO. Health in the post-lu1' UN development agenda.
lu1l. www.who.int/topics/millennium_development_
goals/postlu1'/en/index.html.
1' Kenny C, Casabonne U. The best things in life are (nearly)
free: technology, knowledge and global health. World
Development lu1l;/u:l1-!'.
16 Das J, Hammer J, Leonard K. The quality of medical
advice in low-income countries. J Econ Perspect
luuS;ll:9!-11/.
17 Glassman A, Fan VY, Savedoff WD. A post lu1'
development goal for healthshould it be universal
health coverage? l' Sep lu1l. http://blogs.bmj.com/
bmj/lu1l/u9/l'/amanda-glassman-et-al-a-post-
lu1'-development-goal-for-health-should-it-be-
universal-health-coverage/?utm_.
Increased aid has enhanced access
to treatment, but healthcare
based on donor funding is neither
secure nor sustainable

LETTERS
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Gervase Vernon general practitioner, John Tasker House
Surgery, Dunmow CM6 1BH, UK gvernon@nhs.net
Patient consent obtained.
Full response at www.bmj.com/content/3/2/bmj.d3123/
rr/631/55.
1 Jefferies S, Weatherall M, Young PF, Beasley R. A systematic
review of the accuracy of peripheral thermometry in estimating
core temperatures among febrile critically ill patients. Crit Care
Resusc lu11;1!:19/-9.
l Teran CG, Torrez-Llanos J, Teran-Miranda TE, Balderrama C,
Shah NS, Villarroel P. Clinical accuracy of a non-contact infrared
skin thermometer in paediatric practice. Child Care Health Dev
lu1l;!3:/71-6.
! Hausfater P, Zhao Y, Defrenne S, Bonnet P, Riou B. Cutaneous
infrared thermometry for detecting febrile patients. Emerg
Infect Dis luu3;1/:1l''-3.
/ Nimah MM, Bshesh K, Callahan JD, Jacobs BR. Infrared
tympanic thermometry in comparison with other temperature
measurement techniques in febrile children. Pediatr Crit Care
Med luu6;7:/3-''.
INCIDENTAL THROMBOCYTOPENIA
Test for HIV if indicated,
regardless of risk factors
Bradbury and Murray list HIV infection as a cause
of thrombocytopenia in asymptomatic patients
and include HIV testing in their list of suggested
investigations,
1
although they favour limiting
testing to patients with identified risk factors.
Isolated abnormalities in the full blood count
(thrombocytopenia, anaemia, neutropenia,
and lymphopenia) are clinical indicators of HIV
infection and can be the first presentation in a
patient with a normal CD/ count. In the presence
of a clinical indicator, diagnostic testing for HIV is
appropriate, regardless of risk factors, and an HIV
test should be requested.
2
HIV testing is relatively cheap (around 1u;
t11.7; $15.2). An early diagnosis can prevent
serious long term morbidity and death. Those
diagnosed late (CD/ count <35u1u
6
cells/L)
have a 1u-fold increased risk of dying within a
year of diagnosis. In 2u11, /7% of patients were
diagnosed late.
3
A letter from the chief medical officer in 2uu7
highlighted best practice around HIV testing
and the importance of testing in all healthcare
settings.
/
Lengthy pretest counselling is not a
requirement unless requested by the patient.
If the differential diagnosis includes HIV
infection, HIV testing should not be limited to
people with identified risk factors. In addition to
non-disclosure, a growing number of infections
occur in heterosexual men and women/8%
of new diagnoses in 2u11 were in heterosexual
CARDIAC SURGERY MORTALITY RATES
A lesson in ensuring good
clinical practice
The leadership shown by UK cardiac surgeons
through the Society for Cardiothoracic Surgery
in Great Britain and Ireland offers the best way
to ensure good clinical practice for all patients
in the future.
1
To understand why, it is worth
highlighting the essentials of their achievement.
1. As experts in their eld, they have taken
collective responsibility for their clinical
standards. For them, the buck stops here.
2. Their chosen measure of clinical outcome
is at the level of the individual surgeon.
That degree of granularity is essential to
have condence in the performance of
every clinician. When patient experience
data of comparable granularity are added,
as they will be, the picture will be virtually
complete.
3. They have embraced complete transparency
through the publication of their results.
/. They have set the bar high, reflecting the
optimal standard of practice achievable
under normal operational circumstances.
This gold standard is exactly what
patients hope for.
5. The surgeons themselves took the
initiatives described above because they
thought it the right thing to do for patients.
6. One important consequence is that the
standards of evidence and performance
that they will oner for revalidation, and
therefore for meaningful licensure, will be
driven by conviction rather than coercion.
If every medical royal college and specialist
society took this kind of responsibility for
professional standards, we would go a long way
towards achieving the consistency of clinical
quality we all want to see in the NHS. This would
also make many of the more bureaucratic
recommendations in the excellent Francis report
unnecessary.
Donald H Irvine former president, General Medical
Council, Morpeth, UK
donald@donaldirvine.demon.co.uk
1 Bridgewater B, Hickey GL, Cooper G, Deanfield J, Roxburgh
J; on behalf of the Society for Cardiothoracic Surgery in
Great Britain and Ireland and the National Institute for
Clinical Outcomes Research, UCL. Publishing cardiac
surgery mortality rates: lessons for other specialties. BMJ
lu1!;!/6:f11!9. (l3 February.)
MEDICAL DEVICES
Inaccuracy of forehead
thermometers
I wish to alert readers, both hospital doctors
and general practitioners, to the increasing use
of forehead thermometers in hospitals in the
UK. These thermometers are bought because,
not needing probe covers, they are cheaper.
No formal health technology assessment of
these devices has been performed, in the UK
or elsewhere. A 2u11 systematic review of the
accuracy of peripheral thermometry in critically
ill patients found no studies of forehead
thermometers used in this context.
1
As a general practitioner, my concern arose
after a patient of ours was an inpatient on a
general surgical ward. She had high swinging
fevers and rigors that were missed by forehead
thermometry. This was because she was seriously
ill with peripheral shut-down. After extensive
investigation, the hospitals medical director has
reassured me that these thermometers work well,
except in critically ill patients. This seems to
me about as useful as a boiler that works only in
summer.
The medical literature on peripheral
thermometry is scant and, to my mind, does
not warrant a wholesale change from tympanic
thermometry. A good correlation between
peripheral and tympanic thermometry has been
reported in children,
2
but authors have reported
a poor correlation in adults and decreased
accuracy with age.
3
All peripheral sitestympanic
membrane, forehead, and axillaare imperfect;
oral and rectal thermometers are more
accurate; a pulmonary artery catheter is the gold
standard.
/
I recommend a halt for evaluation
before any more forehead thermometers are
bought. Where hospitals have bought them,
staff should be made aware of their limitations,
and an alternative method of measuring core
temperature should be available in each clinical
area.
LETTERS
men and women, half of whom were infected in
the UK.
Aparna Briggs specialist registrar, genitourinary

medicine
aparna.briggs@sth.nhs.uk
Alison Wright consultant in genitourinary medicine,
Royal Hallamshire Hospital, Sheleld Teaching
Hospitals NHS Foundation Trust, Sheleld S1u lJF, UK
1 Bradbury C, Murray J. Investigating an incidental finding of
thrombocytopenia. BMJ lu1!;!/6:f11. (11 January.)
l BASHH/BHIVA. UK National guidelines for HIV testing
luuS. www.bhiva.org/documents/Guidelines/Testing/
GlinesHIVTestuS.pdf.
! Health Protection Agency. HIV in the United Kingdom:
lu1l report. lu1l. www.hpa.org.uk/webc/hpawebfile/
hpaweb_c/1!171!7luuu16.
/ Donaldson L. Improving the detection and diagnosis of HIV
in non-HIV specialties including primary care. luu7. https://
www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.
aspx?AlertID=1uuS1S.
PULMONARY EMBOLISM
Use of surgical embolectomy
Pulmonary embolism remains a major healthcare
burden and some patients still die from this
preventable disease, perhaps because of limited
knowledge about available treatments for
massive pulmonary embolism.
Systemic thrombolysis has been the mainstay

for massive pulmonary embolism. Other options
include transcatheter clot removal and locally
directed thrombolysis, but their application
is limited by availability of local expertise and
absence of long term outcome data. Surgery,
barely considered by many clinicians or in Takach
Lapner and Kearons review, is another option.

Long term survival and functional outcome after
surgical embolectomy are encouraging.
Surgery has clearcut indications in massive

pulmonary embolism, including patients in
whom thrombolysis is contraindicated, those
with a large right atrial or ventricular clot, and
those with a clot lying across an interatrial
foramen. However, perhaps the most important
indication is in patients who do not respond
to thrombolysis. Many perceive surgery to be
impossible in this setting. Although the ensuing
coagulopathy can be a problem, requiring skilled
haematological input to reverse it, many of these
patients will die without intervention. If operated
on before cardiac arrest, current mortality is just
over %.
Evidence also suggests that surgery

gives a better outcome than repeat thrombolysis.

Finally, the review also overlooked the potential
of stabilisation with extracorporeal membrane
oxygenation for acute unstable massive
pulmonary embolism.
To reduce mortality in patients with acute

massive pulmonary embolism, frontline clinicians
need greater awareness of the potential benefits
of surgery and direct lines of communication with
surgeons familiar with the procedure.
Ed W K Peng specialty registrar in cardiothoracic

surgery epeng@nhs.ne
John Simpson professor in respiratory medicine
Logan Thirugnanasothy specialty registrar in
respiratory medicine
Patrick Kesteven consultant haematologist
John H Dark professor in cardiothoracic surgery
and cardiopulmonary transplant, Freeman Hospital,
Newcastle upon Tyne NE! lXZ, UK
1 Goldhaber SZ. Surgical pulmonary embolectomy: the
resurrection of an almost discarded operation. Tex Heart Inst
J lu1!;/u:'-S.
l Takach Lapner S, Kearon C. Diagnosis and management of
pulmonary embolism. BMJ lu1!;!/6:f7'7. (lu February.)
! Samoukovic G, Malas T, deVarennes B. The role of pulmonary
embolectomy in the treatment of acute pulmonary
embolism: a literature review from 196S to luuS. Interact
Cardiovasc Thorac Surg lu1u;11:l6'-7u.
/ Meneveau N, Seronde MF, Blonde MC, Legalery P, Didier-
Petit K, Briand F, et al. Management of unsuccessful
thrombolysis in acute massive pulmonary embolism. Chest
luu6;1l9:1u/!-'u.
' Malekan R, Saunders PC, Yu CJ, Brown KA, Gass AL, Spielvogel
D, et al. Peripheral extracorporeal membrane oxygenation:
comprehensive therapy for high-risk massive pulmonary
embolism. Ann Thorac Surg lu1l;9/:1u/-S.
ACCEPTABLE FACE OF BIG PHARMA?
Only time will tell
The timing of your
profile on Andrew
Witty is somewhat
bemusing.
Certainly, GSKs
recent moves have
been exciting. Simply
signing up to the
alltrials.net campaign
is a huge step for such
a large drug company,
and we can only hope
that this will shame other companies into taking
similar action.
But your article misses two important points.
Firstly, we have seen this all before. Time and
again drug companies have promised to publish
data, only to drag their feet. This is true of Roche,
and it was true of GSK in the rosiglitazone
scandal, which overlaps with Wittys tenure as
executive officer.
Secondly, we should not look to a member

of industry to prevent the transgressions of the
past occurring again. Stopping big pharma from
partaking in fraudulent activities, hiding trial
data, or promoting drugs inappropriately must be
the role of regulators and the legal system, not the
whims of whoever happens to be in charge.
If we ever do see real actionall of GSKs
clinical trial data being available in an accessible
analysable formatthen it might be appropriate
to portray an industry leader on the front cover
of your journal as a symbol of hope for our
profession.
Until that day, we should withhold our praise.
Omar Jundi anaesthetics trainee, Leeds Teaching
Hospitals Trust, St Jamess University Hospital,
Leeds LS9 7TF, UK
omar.jundi@leedsth.nhs.uk
Competing interests: OJ is a member of Healthy Skepticism UK.
1 Coombes R. Andrew Witty: the acceptable face of big pharma?
BMJ lu1!;!/6:f1/'S. (9 March.)
l Smith J. On behalf of Roche, luu9. Point-by-point response
from Roche to BMJ questions. BMJ luu9;!!9:b'!7/.
! Hawkes N. GlaxoSmithKline pays 5!bn to settle dispute over
rosiglitazone and other drugs. BMJ lu11;!/!:d7l!/.
AN UNSAFE WARD
Separation of basic and nursing
care may be to blame
I have received more than supportive
comments on my article about the death of
my father.
Many people were not surprised by

my experiences and described their own sad
stories. This suggests that poor basic care for
older patients is endemic within the NHS, with
mid-Staffs just a scapegoat for a widespread
institutional malaise.
Food, water, cleanliness, and simple human
kindness are cheap and effective treatments for
older inpatients. The modern NHS seems to have
separated the concepts of basic and nursing care;
catering services are part of basic care and have
been subcontracted out to private companies,
so nurses may no longer see eating and drinking
as their responsibility. This fragmentation may
explain some of the problems. But expensive
interventions and treatments are wasted unless
the basics for human life are supplied.
Useful suggestions on how to deal with the
problem included the butterfly scheme (www.
butterflyscheme.org.uk/) and intentional
comfort rounding,
but neither has been

evaluated scientifically. Evaluating projects that
could reduce suffering and harm in NHS hospitals
should be a priority.
The suggestion that relatives could help with
basic nursing care was recently endorsed by the
think tank health.

The core of any change needs to be with
nursing culture and practice. All clinicians need
to feel able to challenge and improve poor
standards without blame or reproach. I hope this
is recognised before many more elderly patients
die unnecessarily.
Judy Shakespeare retired general practitioner,
Oxford, UK
judy.shakespeare@virginmedia.com
1 Shakespeare J. An unsafe ward. BMJ lu1!;!/6:f1l/!.
(l' February.)
l Intentional rounding: what is the evidence? Policy+
lu1!. http://stp.nhslocal.nhs.uk/uploads/
resources/1!'17SuS'l_national_nursing_research_unit_
policy_+_article_on_intentional_rounding.pdf.
! Beer G. Too posh to wash? Reflections on the future of nursing.
health lu1!. www.luluhealth.org/luluhealth/
Publications/Publications-lu1!/Too-posh-to-wash.html.
346:1-42 No 7898 ISSN 1759-2151
9 March 2013 | bmj.com
Non-oral hormonal contraceptives
Parkinsons disease and physical activity
Penile cancer: Clinical Review
Alcohol marketing to children
JOBS, COURSES, AND CAREERS
GSKS ANDREW WITTY
The acceptable face of big pharma?
OBSERVATIONS
For an organisation that sets a lot
of store by evidence, the NHS is
easily swayed by fashion. An idea
takes hold, gains purchase, and
becomes the accepted wisdom so
swiftly you have to be on the alert to
keep up. Currently, integrated care
is it. The health select committee
strongly endorses it, the think tank
the Kings Fund proselytises about
it, and the Labour Partys shadow
health secretary, Andy Burnham, has
proposed yet another reorganisation
of the NHS in England in an attempt
to achieve it.
I may just have

a suspicious nature, but when
everybody is in such warm agreement
my instinct is to take to the hills.
A US psychologist, Carl Rabstejnek,
has identified at least
management fads since the second
world war, from acceptable risk
at one end of the alphabet to zero
defects at the other. He argues that
fads reflect managers need to appear
to be in the know and to talk the
language of change even when actual
change is imperceptible. The largest
financial support for fads comes, he
argues, from large companies that are
actually slow to change: no parallel to
the NHS, clearly.
The NHS has not embraced all
these fads, though it does have a
weakness for those that include the
word leadership. Im sure you will be
as pleased as I was to learn that the
NHS is to train new leaders,
starting in September. This is the
largest ever leadership programme
to transform NHS culture, the NHS
Leadership Academy declared. A
huge cast has been assembled to
carry out the task, including the
consultancy firms KPMG and the
Hay Group, six universities (four of
them outside the United Kingdom),
and various other facilitators and
assorted hangers on. If the target
is reached the NHS will have nearly
as many leaders as the Duke of
Wellington had followers at Waterloo.
In the wake of the Francis report,
the NHS portrays this programme
as a means of achieving a culture of
dignity, compassion, and respect
through better leadership. Its a
worthy aim that perhaps doesnt
merit my scorn, but if you have to
teach people who already work in
healthcare these values, were in a
bad place. At the same time, we have
the respected US guru Don Berwick
providing guidance to the NHS on
zero harm, a management tool so
newly minted that it doesnt even
make it on to Rabstejneks list.
As for integrated care, it would

be a start if everybody agreed on
what it means. Maximalists argue
that it involves the integration of
health and social care, minimalists
that it is about providing a seamless
programme of healthcare without
any awkward transitions across
primary, secondary, and community
care. Burnham has recently adopted
the maximalist position, calling for
local authorities to swallow the new
clinical commissioning groups to
become the commissioners of both
health and social care.
This is an idea that would have
delighted Herbert Morrison,
Labours postwar champion of local
government, who argued unavailingly
that councils should be given control
of the hospitals in the new NHS.
The minister of health, Nye Bevan,
disagreedand won the argument,
setting up regional boards that were
appointed rather than elected and
had no political accountability.
He was swayed by the countrys
consultants, who didnt want to
work for local authorities, but its
arguable that the outcome produced
a system so opaque and detached
from local politics that people had
little idea of the costs and realities of
delivering their local healthcare. Over
the years this opacity has made any
change in existing provision, such as
integrating care, more difficult
to achieve.
So Burnhams proposal
has virtues, if we overlook the
reorganisation involved and the
BODY POLITIC Nigel Hawkes
Take me to your leader
Management fads come and go, and integrated care may be just the latest fashionable policy in the NHS
fact that it is incompatible with
his opposition to any qualified
provider providing care. Local
authorities have contracted out
services through competitive tender
for the past years, to the point
where roughly a third of their services
are provided externally by private
sector, third sector, or mutual based
organisations. Healthcare under
the local authority banner would
be no different, with Conservative
councils likely to contract out more
services than those led by Labour or
the Liberal Democrats. It would be an
interesting experimentbut Im not
sure that Labour would think it a very
attractive one.
More modest care only
integration is assumed to
improve care and cut costs, but
a characteristic of management
fashions is that everybody accepts
them as true without arguing.
Research findings present a more
nuanced picture. The evaluation of
integrated care pilots launched
in showed that staff were
happier in their jobs and believed
that the care they were providing had
improved, but patients were not so
sure.
There were suggestions that

care became professionalised and
that focus on the individual patient
was lost. Emergency admissions of
patients in the pilot areas were higher
than in the control group, and it was
hard to draw any clear conclusions
about overall costs.
To my eye the existing evidence
falls some way short of justifying
integrated care as a panacea for the
NHSs ills, attractive as it may seem.
To call it a fad would be unfair; at the
moment its a fashionable policy in
search of persuasive evidence that it
really works.
Given the obstacles to change in
the NHS, its time may pass before it
has even been tried.
Nigel Hawkes is a freelance journalist, London
nigel.hawkes@btinternet.com
To call integrated
care a fad would
be unfair; at
the moment its
a fashionable
policy in search of
persuasive evidence
that it really works
OBSERVATIONS
MEDICINE AND THE MEDIA
How do we know whether medical apps work?
Smartphone apps may transform management of health, says Margaret McCartney, but regulation is so far scarce
Angry Birds, Cut the Rope, and Fruit Ninja are
favourite games among smartphone owners, but
many apps are for function rather than fun. These
include medical apps claiming to offer ways
to better health. Some are aimed at healthcare
professionals but are available to all. The National
Institute for Health and Clinical Excellence, the
Scottish Intercollegiate Guidelines Network, and
the BNF have free apps allowing easy access to
advice. But other apps dont just reproduce advice.
In January the UK Medicines and Healthcare
Products Regulatory Agency (MHRA) approved its
hrst app: Mersey Burns is a free tool that calculates
burn area percentages and uid requirements.
Other medical apps are aimed at the public.
Many advise on diet and exercise, and these vary
widely in quality,
1

2
but newer apps purport to help
diagnosis. The NHS Healthcare Innovation Expo
this month featured an app from Skin Analytics
that tracks changes in skin moles to raise early
warning signs by comparison with previous
images of the same mole.
3
Its website says that,
for E30 a year for an individual or E50 for a family,
the app can baseline you and your family using
patent pending technology that can detect
small changes in both the geometrical structure
and colour composition of your moles with an
exceptional 95% accuracy.
4
A recent study in JAMA Dermatology showed
that most previously marketed apps had a failure
rate in melanoma diagnosis of about 30%.
5

Julian Hall, director of Skin Analytics, said that
this app, which is not yet available to buy, was
not a diagnostic service but was instead trying
to implement the self examination advice from
public health bodies and answer the question, Has
the lesion changed or not changed?prompting
people to see their GP or dermatologist. Clinical
trial data on the app are lacking, but Hall says a
trial is planned for later this year. Yet the question
of evidence is crucial. Do apps oer to gather more,
or misleading, data for little useful signal?
Several apps oer to use a phones camera light
to check pulse rate. One app claims 25 million
users aher promotion in the United States,
6
with
the ability to record serial pulse rates, but it is
not clear what advantage this oers over manual
pulse measurement. It is also possible to buy a
small plug-in device that turns your phone into a
pulse oximeter, although this is described as not
for medical use and is marketed as useful for
mountain climbers or private pilots and retails at
about $250 (E165).
7
Some free apps oer health
checks but are just adverts for cosmetic surgery.
Specsavers, which the BMJ recently reported
had been advertising for contracted NHS services,
8

offers a free app described as a sight check.
Users cover an eye and test their visual acuity with
images on the phone. (Despite having had a recent
prescription, I was still strongly recommended to
speak to my optometrist.)
Apps interactivity distinguishes them from
books or leaets, and the handheld nature and
additional recording oered are dierent from the
reach of websites. This can widen the potential for
unintended outcomes. The NHS Commissioning
Board last week launched a library of NHS-
reviewed phone apps to keep people healthy
because it is committed to
improving outcomes for patients
through the use of technology.
More than 70 have been approved
in a review that includes a
clinical assurance team, to
ensure that they comply with
trusted sources of information,
such as NHS Choices, with
assessment of potential to cause
harm to a persons health or
condition.
9
However, a high standard of
evidence should surely be crucial
in a product approved by the NHS.
The charity Beat Ovarian Cancer
offers a symptom tracker to
help women recognise the signs
and symptoms of ovarian cancer,
but without real world trials to
show eects and quantify harms
we do not know whether this is benehcial. The
NHS Commissioning Board said that, through its
review process, it is ensuring that the apps listed
in the Library are clinically safe and suitable for
people who are living in the UK and that apps
have been checked by the NHS and adhere to NHS
safety standards. Yet why not test these apps in
a real life situation for evidence of beneht and to
check that they dont have unintended harms?
Another NHS recommended app is iBreastcheck,
which can be set to remind women to check their
breasts weekly, fortnightly, or monthly. The app
includes videos of women examining themselves
and a link to donate to the charity Breakthrough
Breast Cancer, which devised it. It would be
possible to trial this app to hnd evidence of beneht
and harm in the same way that other trials have
investigated breast self examination,
10
but this has
not been done. Breakthrough Breast Cancer said
that the content was reviewed by a panel of experts
and that it was not a breast self examination app.
It is a breast awareness app.
The US Food and Drug Administration
published draft guidance for medical apps in
2011.
11
Straightforward information or recording
devices are not subject to its guidance, as long
as these apps do not oer to diagnose, treat, or
cure a condition. Instead, it suggested that its
oversight should apply to apps that, for example,
turn a smartphone into a stethoscope or that
oer risk assessments of disease or diagnosis on
the basis of information entered. In the UK apps
that are medical devices must be registered
with the MHRA. It has the power
to withdraw products from the
market, but what constitutes a
medical device is a grey area.
For example, the agency said an
app that charted changes in skin
moles would not be a device, but
one that oered diagnosis would
be.
But registration with the MHRA
does not imply emcacy. Approval
of emcacy is granted by Europe-
wide notified bodies, which
can award the CE quality mark
if their standards are met. These
are principally trade measures
designed to remove technical
barriers to trade,
12
and for apps
they do not insist on evidence of
better outcomes, such as from
randomised controlled trials.
It would be a pity if apps with solid evidence
behind themsuch as several decision making
aids approved by the NHS app librarybecome
confused with ones that lack evidence. Apps are
likely to be a new source of information that enable
patients to interact with the NHS in a dierent
way. We need to ensure they are safe, useful, and
eective. If they work we should use them, but, as
with any medical intervention, they need fair tests
in the real world before we can know.
Margaret McCartney is a general practitioner, Glasgow
margaret@margaretmccartney.com
BNF s app offers only
Why not test these apps in a real life
situation for evidence of benefit and to
check that they dont have unintended
harms?
PERSONAL VIEW
R
O
B

W
H
I
T
E
PERSONAL VIEW
Not all patients will benefit
from paperless records
A unified system of paper records across health and social
care would improve communication, says Rupert Fawdry
P
regnant women
throughout Britain have
a paper care record
that is openly readable,
easily updatable, and
immediately correctable. I assumed
that housebound patients would
have something similar. With
so many comorbidities, when
else would a single paper record
make such sense? My 99 year
old mothers recent experience
highlighted my naivety.
She still lives in her own home.
Besides friends and family, those
involved in her care include her
family doctor, district nurses,
several social care departments,
Age UK, and a private home
care company. These provide
food, company, and help with
complex medication. But each
party insists on a separate set of
records, making it necessary at my
every visit to check four binders
without bookmarks, two separate
drug charts, and several huge
ambulance forms of mind boggling
complexity.
My suggestion that a unihed
system of care records might be
better has been met with such
comments as, We dont have
permission to write in each others
notes, and, Were not sure if
were even allowed to look at
documentation created by others.
Recently, aher one of her
recurrent falls, my mother was with
dimculty persuaded by familiar
paramedics to let them take her
to the emergency department.
Within hours, she was insisting
on going home. I soon received a
phone call from the private home
care company: What had been
happening? Where was her new
medication? Her tablets were
eventually discovered in her
pocket. A letter had been emailed
digitalised, stored using battery
power, and later transmitted
to centralised databases, but
such solutions still feed into
incompatible electronic silos.
Despite the enthusiasm of many,
it will never be cost eective to try
to make complex databases talk
to each other. Integrating any two
complex digital records cannot be
done without expensive and time
consuming rewriting of thousands
of lines of sohware code. In
banking, the failure of Santanders
proposed takeover of RBS branches
was attributed to massive problems
of cost and speed in migrating and
integrating data,
4
and the recent
Bank of Scotland E4.2m hne came
aher its failure to reconcile just two
incompatible mortgage systems.
5

Data collection must never
be prioritised above improving
individual patient care,
6
and record
systems that put individual care
hrst will always be unavoidably
complex, partly because dierent
disciplines have dierent needs.
Improving paper systems is cheap
compared with upgrading sohware.
We hrst need to facilitate high
quality paperwork. Only aherwards
should we concrete our knowledge
into digital formats.
Experience creating Britains
most popular maternity record
system has convinced me that the
best way forward is to consider
all the current paperwork used,
posting it on an openly accessible
website for all to analyse.
7
The
Paper records have many other advantages over digital
ones, and it is time to reject the idea of a paperless NHS
to her general practitioner on a
Sunday and was inaccessible to
her carers. How much better if she
had had her own paper record used
by everyone, including hospital
sta. This would have low cost; it
would reduce errors at handovers;
and individuals, rather than
organisations, would become the
hub of their own medical and social
care.
1
I have had to complete many
forms on my mothers behalf, each
asking similar questions. I reduced
my irritation by creating sticky
labels that detail legal next of kin,
language and other handicaps,
allergies, current drugs, and so
on, but this did nothing to reduce
the hours healthcare sta spent
re-entering data digitally at the
expense of providing direct patient
care. Why not print QR codes on
sticky labels for the repetitive data
that are needed in several places?
Incompatible computer systems
could use smartphone technology
to read them.
How many times have we heard
that the NHS will soon be totally
paperless? One recent omcial
statement is that this will happen
by the end of 2015.
2
In its recent
strategy document the Department
of Health called for information
to be recorded once, at our hrst
contact with professional sta,
and shared securely between those
providing our care.
3

But this presupposes universal,
secure access to integrated
multidisciplinary electronic records.
True interoperability and openness
of care records cannot be achieved
unless ways are found to include
those patients and carers who
do not have immediate access to
the internet. Technologies now
allow data entered on preprinted
proformas to be automatically
Electronic Encyclopaedia of
Perinatal Data, which I created
and maintain, is one such example
(http://eepd.org.uk). A similar
approach is being used in the
development of a national paper
drug chart,
8
and will eventually be
essential in every subspecialty.
For this approach to work we
must, as in the United States, have
a legal declaration that blank forms
cannot be copyrighted.
9
And every
publicly funded computer system
must openly document the exact
wording of every question and every
answer option.
Paper records have many other
advantages over digital ones,
10
and
it is time for politicians, clinicians,
and healthcare managers to
reject the idea of a paperless NHS.
Instead, clinical commissioning
groups should insist that all
housebound patients and those
with long term conditions have
a single personal paper drug
chart and a unihed paper daily
care record to accompany them
wherever they go.
Rupert Fawdry is honorary consultant
obstetrician,
University Hospitals Coventry &
Warwickshire NHS Trust
rupertfawdry@gmail.com
I thank Helga Perry for help with the
preparation of the manuscript and references.
Competing interests: I maintain the non-
prot making websites www.eepd.info, www.
eepdtalk.org.uk, and www.wisdam.info.
Patient consent obtained.
OBITUARIES
Norman Kreitman
Psychiatrist and suicide expert, poet, philosopher
He became friends with Welsh poet Dannie Abse
(www.bmj.com/content/336/7640/391) and
later wrote a paper entitled Medical themes in
the poetry of Dannie Abse.
3
He entered psychiatry aher a chance encoun-
ter six years aher qualifying. One evening as he
was leaving Metropolitan Hospital, he passed
through the outpatient department. Benches
had been removed and replaced with mattresses,
on which were semiconscious patients who had
just undergone electroconvulsive treatment.
Kreitman was curious and introduced himself
to the person in charge, the psychiatrist Edward
Larkin, with whom he subsequently spoke
ohen.
Kreitman was accepted for psychiatry train-
ing at Maudsley Hospital. It was an exciting if
somewhat stressful period, he later said.
4
A
number of towering hgures were on the sta at
the time. The towering hgures included the
dominating Aubrey Lewis, as well as Eliot
Slater, Erwin Stengel, and Felix Post.
In 1959 he joined the clinical psychiatry
research unit of the Medical Research Council
(MRC) in Graylingwell Hospital in Chichester,
working under Peter Sainsbury.
In 1966 he moved to Scotland to join the
MRC unit for epidemiological psychiatry in
Edinburgh, later becoming its director. The
Edinburgh scene at that time was humming,
he later noted.
4
He added that he eventually
came to feel as a naturalised Scot, even cheering
for the Scottish rugby team at matches against
England in Murrayheld Stadium in Edinburgh.
Kreitmans love of poetry endured during his
decades as a doctor. He was closely amliated
with the Scottish Poetry Library and served as
chair of the Poetry Association of Scotland. He
published four volumes of poetry. He retired
from psychiatry in 1990 at the age of 62, devot-
ing his remaining years to his old love, poetry,
and a newer love, philosophy, and aesthetics.
He retired early because he had so much
else to do: his poetry, his interest in aesthet-
ics, his hshing, and his friendships, says Lady
Joyce Caplan, chair of the Poetry Association of
Scotland. He led a life rich in intellectual and
emotional experience, always moving forward
into what life had to oerright until the end.
Kreitman leaves his wife, Susan; a son; a
daughter; a sister; and four grandchildren.
Ned Stafford, freelance journalist, Hamburg
ns@europefn.de
The shadow of a leaf falls upon the page
and as the breeze moves the shape skitters
as if writing my notes.
Yes I am listening, really,
although what I hear matters much less
than what you say . . .
Those words came from the heart of a poet named
Norman Kreitman. The words are the opening
lines of his 1984 poem Therapist.
1
At the time,
although a poet at heart, Kreitman was profes-
sionally a psychiatrist at the University of Edin-
burghrecognised globally for his work in suicide,
alcoholism, and depression. The poem reects
what Kreitman the psychiatrist felt was one of his
most important tools.
Normans recognition of the importance of lis-
tening skills in research and therapeutic encoun-
ters was captured in those lines of the poem,
says Stephen Platt, who worked with Kreitman
in the late 1970s and 1980s. He was a man
without a trace of narcissism or egotism. He was
genuinely interested in how others experienced the
world, and wanted to give them time to articulate
these experiences rather than put words in their
mouths.
Kreitmans research interests were wide ranging.
He investigated alcohol consumption and its asso-
ciated health and adverse social consequences;
depression in women, including precipitating
and vulnerability factors; and the role of poor self
esteem and other psychological variables, includ-
ing pathways to their treatment, says Platt, now a
professor at the Centre for Population Health Sci-
ences, University of Edinburgh.
Perhaps Kreitmans most important contribu-
tions were his studies on suicidal behaviour. He
introduced the concept and coined the term par-
asuicideintentional self harm that does not result
in death and is a strong indicator of future success-
ful suicides.
Keith Hawton, director of the University
of Oxfords Centre for Suicide Research, sees
Kreitmans most inuential piece of work as the
paper, The coal gas story. United Kingdom suicide
rates, 1960-71.
2
Kreitman showed that a huge
reduction in suicide rates corresponded to the
change from toxic coal gas in domestic supplies to
non-toxic North Sea gas.
This study is perhaps the most impressive
demonstration worldwide that suicide is h eavily
inf luenced by availability of means and that
r educing access to a dangerous method can
p revent s uicides, he says.
Hawton, who hrst met Kreitman in the 1970s,
says that his painstaking approach to epidemio-
logical research was a major inuence on the next
generation of suicide researchers.
He would take seriously suggestions, how-
ever naive, from the most junior of researchers
and help reframe them in the context of existing
knowledge, says Hawton, adding, I will not for-
get intense discussions in smoke hlled rooms as he
chewed on his favourite pipe.
Norman Kreitman was born in London on
5 July 1927, the grandson of poor immigrants
from eastern Europe. He attended Kings
College, London, training at Westminster Hospi-
tal and earning his medical degree in 1949. Aher
spending 18 months in general medicine at a
tuberculosis hospital on the Isle of Wight, he did a
one year fellowship in pulmonary physiology at the
Carlo Forlanini Institute in Rome. He returned to
London as a registrar at Metropolitan Hospital.
In his spare time during the 1950s, he wrote
poetry and socialised with other young poets.
Kreitman introduced the concept of
suicidal behaviour and coined the
term parasuicideintentional self
harm that is a strong indicator of
future successful suicides
Norman Kreitman (b 1927, q Westminster
Hospital, Kings College, London, 1949),
died from cancer on 15 December 2012.
CLINICAL REVIEW
classic B symptomsfevers, night sweats, and unex-
plained weight loss. Signs of leukaemia are usually related
to le ucocytic inhltration of lymphatic nodes and organs.
The resulting lymphadenopathy, hepatomegaly, or spleno-
megaly can cause symptoms owing to organ bulk. Less
commonly, meningeal involvement can result in headache
as well as cranial and peripheral nerve defects, particu-
larly in acute leukaemias. Cutaneous inhltration and gum
swelling may also occur. Hyperviscosity symptoms from a
raised white cell count are rare. Notably, 75% of CLL cases
are diagnosed incidentally in asymptomatic patients aher
a full blood count is performed for other reasons.
2
What investigations are needed in suspected leukaemia?
Recognition of abnormal blood count patterns is crucial
in instigating specialised investigations. Typically, leuco-
cytosis is present, which may be accompanied by one or
more cytopenias. Aggressive leukaemias may present with
only a mild increase in the white cell count, whereas some
indolent forms are ohen accompanied by dramatic leuco-
cytosis. Therefore, unlike cytopenia, the degree of leuco-
cytosis is a poor indicator of disease severity. Importantly,
the absence of leucocytosis does not exclude a diagnosis
of leukaemia. These aleukaemic leukaemias can have a
normal or low white cell count but are usually accompanied
by cytopenias. Leukaemia is unlikely in the presence of a
normal full blood cell count.
2
In patients with an abnormal blood count, a blood hlm is
essential to help decide whether leucocytosis is likely to be
About 8000 people in the United Kingdom are diagnosed
with leukaemia each year, and in 2010, 4504 people died
in the UK from this disease.
1
Leukaemia encompasses a
clinically and pathologically diverse set of conditions
whose incidence and prevalence are rising. In the past,
leukaemia was classihed on the basis of the morphologi-
cal characteristics of abnormally proliferating leucocytes
in the blood and bone marrow. Emerging genetic data,
however, have shown genomic heterogeneity in what
were thought to be homogeneous disorders, prompting
the World Health Organization to revise the classihcation.
2

Despite these advances, the profound immunological and
haematological disturbances inherent in most leukaemias
and the systemic side eects of chemotherapy remain
complex challenges. This is a two part review with the hrst
part focusing on the current diagnosis and management
of leukaemia. The second part will consider the types of
support patients need in the community.
What is leukaemia?
Leukaemia is a cancer of circulating white blood cells.
Leukaemias are divided into acute and chronic types.
When immature white blood cells or blasts proliferate,
presentation is usually acute, whereas leukaemias aris-
ing from mature cells tend to be chronic. Leucocytes are
usually of lymphoid origin (T and B cells) or myeloid origin
(neutrophils, basophils, eosinophils, and monocytes). Box
1 summarises the four main types of leukaemia: chronic
lymphocytic leukaemia (CLL), chronic myeloid leukaemia
(CML), acute lymphoblastic leukaemia (ALL), and acute
myeloid leukaemia (AML).
2
What are the symptoms and signs of leukaemia?
Patients with leukaemia ohen present with symptoms
related to bone marrow failure: recurrent infections as a
result of neutropenia, spontaneous bruising or abnormal
bleeding secondary to thrombocytopenia, or symptoms
of anaemia (box 2). Non-specihc symptoms are common.
These include somnolence and fatigue, as well as the
Department of Pathology, Division

of Molecular Histopathology,
University of Cambridge, Cambridge
University Hospitals NHS
Foundation Trust, Cambridge, UK
Linton Health Centre, Cambridge,

UK
Department of Haematology,
Cambridge University Hospitals
NHS Foundation Trust, Cambridge
CB QQ, UK
Correspondence to: G A Follows
george.follows@addenbrookes.
nhs.uk
doi: ./bmj.f
Leukaemia update.
Part 1: diagnosis and management
Nicholas F Grigoropoulos,
Roger Petter,
Mars B Van t Veer,
Mike A Scott,

George A Follows
SUMMARY POINTS
Chronic lymphocytic leukaemia is the most common leukaemia in adults
Patients with acute leukaemia can deteriorate rapidlyurgent discussion with a
haematologist is recommended if acute leukaemia is suspected
Risk is best stratified according to the genetic abnormalities of the leukaemia
Diagnosis of leukaemia requires a multidisciplinary approach
Most chronic leukaemias are not curable but can be treated with non-intensive chemotherapy
Acute leukaemias are curable if patients are fit enough for intensive chemotherapy;
palliation is indicated for frail patients
Follow the linkfrom the
online version of this article
to obtain certied continuing
medical education credits
SOURCES AND SELECTION CRITERIA
We searched PubMed for clinical trials and the Cochrane
Library for meta-analyses. We also sought expert opinion
from experienced consultant haematologists. Keywords
used were leuk(a)emia, chemotherapy, supportive care,
and community care. We also reviewed guidelines from the
British Committee for Standards in Haematology and the
National Institute for Health and Clinical Excellence.
Box | Classification of leukaemias
Acute leukaemias: proliferation of immature blast cells
Acute lymphoblastic leukaemia: lymphoblasts
Acute myeloid leukaemia: myeloblasts
Chronic leukaemias: proliferation of mature cells
Chronic lymphocytic leukaemia: lymphocytes
Chronic myeloid leukaemia: myelocytes (for example,
neutrophils, eosinophils, basophils)
Less common chronic leukaemias: large granular
lymphocytic leukaemia, hairy cell leukaemia
CLINICAL REVIEW
caused by malignancy or inammation. Most accredited UK
laboratories perform a blood hlm automatically when blood
count abnormalities are found, but this practice is not uni-
versal, and general practitioners may have to request a hlm
aher review of blood count results. Communication between
the haematologist and the GP is vital at this stage, because
clinical and pathological information must be combined to
establish whether urgent admission is needed for further
investigation and treatment. If the blood hlm is suggestive
of leukaemia, specialist investigations are carried out to
conhrm the diagnosis. These are performed in a regional
haemato-oncology diagnostic unit, which incorporates serv-
ices dedicated to blood and bone marrow microscopy, the
characterisation of cell surface antigens by ow cytometry,
cytogenetics, and DNA mutation analysis.
The discovery of recurrent cytogenetic abnormalities in
acute leukaemias, such as the t(8;21) translocation in AML,
has led to changes in the way these diseases are diagnosed
and treated. Until recently, a diagnosis of AML required the
presence of at least 20% immature undierentiated myeloid
cells, or myeloblasts, in the bone marrow as determined
manually. A normal bone marrow should have fewer than
5% myeloblasts. AML can now be diagnosed with fewer
blasts if the blasts carry a chromosomal aberration associ-
ated with AML.
2
The reclassihcation of acute leukaemias on
the basis of genetics rather than solely on microscopy has
diversihed the skill sets required for accurate diagnosis, and
biomedical scientists specialising in leukaemia genetics and
immunophenotyping now have a vital role in diagnosis. The
clinical, morphological, immunophenotypic, and genetic
data are integrated at a multidisciplinary team meeting and
the leukaemia is assigned to a WHO category.
Figure 1 provides a management algorithm for patients in
the community with suspected leukaemia, and the red ags
box summarises the clinical features of greatest concern.
How are leukaemias managed?
Chronic lymphocytic leukaemia
CLL is the most common leukaemia in adults, with an inci-
dence of 4.2 per 100 000 population and a median age of
71 years at diagnosis. Because CLL is associated with a long
overall survival, it has a high prevalence, and most GP prac-
tices will probably see patients with this disease. Patients
may have chronic fatigue, which can be marked. Stage B
symptoms and bone marrow failure are typically less com-
mon at presentation but may be seen in more advanced
cases, where lymphadenopathy is common, particularly
in the cervical, axillary, and inguinal regions. An enlarged
spleen may be palpable.
Lymphocytosis is the most common blood abnormal-
ity associated with CLL. Malignant lymphocytes in CLL
express CD5 and CD23 membrane antigens, so usually
have a distinctive immunophenotype.
2
Recommenda-
tions are available that provide a diagnostic approach to
an isolated lymphocytosis for GPs.
3
If the blood hlm raises
the suspicion of CLL we recommend ow cytometry of the
peripheral blood, particularly when unexplained lymphocy-
tosis persists for more than three months. Flow cytometry
is usually performed on blood collected into an EDTA tube.
Additional investigations for suspected CLL include a direct
Coombs test to exclude autoimmune haemolysis (which
is associated with CLL), routine biochemistry, and serum
immunoglobulins.
Most patients newly presenting with CLL are classihed as
stage A (box 3). A meta-analysis of randomised controlled
trials with more than 2000 patients showed that chemother-
apy does not improve overall survival in patients with stage
A disease and can cause serious toxicity. Hence, most newly
diagnosed patients with stage A disease are not treated with
chemotherapy but are observed on a watch and wait pro-
gramme. Most patients with stage A CLL have a life expect-
ancy similar to that of age matched healthy people, and the
mean overall survival is greater than 10 years.
4

Specialist referral of patients with stage A disease is not
clinically mandatory, but some patients may beneht from a
discussion about CLL with a specialist. A visit to an oncology
unit is potentially stressful, however, and can reinforce the
negative connotations of a diagnosis of leukaemia.
It may be preferable for the diagnosis to be given by a
specialist, particularly if the diagnosis is in doubt, with
the GP resuming management if appropriate. In line with
recent guidelines from the British Committee of Standards
in Haematology, we recommend a repeat full blood count
and clinical review in the community aher three months.
Patient febrile, unwell, or
with serious cytopenias?
Discuss with haematologist
for possible urgent admission
Leukaemia suspected on full blood cell count
Request urgent blood lm
Blasts present?
Treat or monitor accordingly or contact haematologist for advice
No
No
No
Yes
Yes
Blood lm suggestive of
chronic lymphocytic leukaemia?
Request flow cytometry in EDTA tube
and refer if appropriate (see text)
Yes
Blood lm suggestive of other leukaemia?
No
Outpatient haematology referral
Yes
Fig | Proposed management algorithm for suspected leukaemia in the community
Box | Presentation of leukaemia
Acute leukaemias
Short history of feeling unwell
May present with neutropenic fever or bleeding
Organ infiltration may occur: skin, gums, testes, meninges
Peripheral blood usually shows leucocytosis with circulating
blasts and cytopenias
Chronic leukaemias
Often diagnosed incidentally
Usually long history of non-specific symptoms
Splenomegaly is common
Lymphadenopathy is common in chronic lymphocytic
leukaemia
Peripheral blood usually shows leucocytosis with circulating
mature lymphocytes or myeloid cells; blasts are rare
CLINICAL REVIEW
At the hrst visit, advise patients to report any stage B symp-
toms that develop and to check their temperature if they
are unwell. Most patients will have stable disease and can
be reviewed every six months, then every 12 months if the
disease remains stable aher a year. Clinical deterioration,
recurrent infections, new or worsening cytopenias, and an
estimated lymphocyte doubling time of less than 12 months
usually prompt specialist referral.
5

Although most patients are initially assigned to a watch
and wait strategy, this is not without its problems. A qual-
ity of life substudy of the large randomised CLL4 trial has
reported that patients on such a programme ohen report
fatigue and anxiety, particularly in relation to the lack of
treatment.
6
Patients may beneht from interaction with a sup-
port association such as the UK CLL Support Association
(www.cllsupport.org.uk), which works closely with the UK
CLL Forum (www.ukcllforum.org), a collaborative network
of CLL patients and doctors.
Patients who present with stage B or C disease as well
as those with symptoms require specialist referral to assess
the need for treatment. In the UK, cytogenetic analysis is
performed at this time because patients with certain abnor-
malities, such as TP deletion, have a much worse progno-
sis and need to be treated dierently.
7
Treatments recently
approved by the National Institute for Health and Clinical
Excellence (NICE) range from less intensive oral chemo-
therapy with chlorambucil to combination regimens that
require intravenous infusions, such as bendamustine or the
anti-CD20 monoclonal antibody, rituximab, combined with
udarabine and cyclophosphamide.
8
Chronic myeloid leukaemia
Chronic myeloid leukaemia is rare, with an incidence of
1 per 100 000 population. Symptoms are usually chronic
and non-specihc, but splenomegaly is common and may
extend beyond the umbilicus. Lymphadenopathy is not
usually prominent. Neutrophilia is common and may be
accompanied by thrombocytosis, basophilia, monocytosis,
or eosinophilia. Blood hlm appearances are typical, ohen
showing neutrophilia, thrombocytosis, basophilia, and
eosinophilia. The t(9;22) translocation, also known as the
Philadelphia chromosome, is the genetic hallmark of this
disease; it results in fusion of the BCR and ABL proteins and
leads to uncontrolled myeloid proliferation.
2

Until recently, this condition progressed inexorably
through acute transformation aher a chronic phase of vari-
able duration and was universally fatal without stem cell
transplantation. The development of the targeted tyrosine
kinase inhibitor, imatinib, has revolutionised the manage-
ment of these patients. Lifelong treatment with this drug
remains the standard of care. The pivotal IRIS trial showed
that more than 80% of patients achieve a durable remission
and require only outpatient follow-up.
9
In other patients
remission is less durable, ohen because the leukaemic cells
acquire mutations that confer resistance to imatinib.
10
NICE
has recently approved second generation tyrosine kinase
inhibitors to treat patients who acquire imatinib resistance
and those who cannot tolerate imatinib.
11
However, acquisi-
tion of a mutation that results in the substitution of tyrosine
for isoleucine in amino acid position 315 (T315I) in the BCR-
ABL fusion protein causes resistance to all currently avail-
able tyrosine kinase inhibitors, leaving intensive cytotoxic
chemotherapy with transplantation as the only treatment
option. Novel third generation tyrosine kinase inhibitors
that can target T315I mutants are in development.
12
Acute leukaemias
Patients with acute leukaemia typically deteriorate quickly.
They may initially present with generalised fatigue and
malaise but usually develop bone marrow failure. Patients
may have B symptoms and coagulopathy, with mucocutane-
ous bleeding or bruising. Untreated acute leukaemias are
among the most rapidly fatal cancers.
2
ALL is the most common cancer in children. Global inci-
dence is about three per 100 000 population, with around
three of four cases occurring in children under 6 years.
2
It is
ohen dimcult to elicit a comprehensive history, and parents
may describe the child as being somnolent or performing
poorly at school over recent weeks. Timely recognition of
the disease is paramount because childhood ALL is one of
the most curable cancers, with intensive chemotherapy regi-
mens yielding a long term survival rate of 85%.
13

14
ALL is much less common in adults but has a poor prog-
nosis. This is because a higher proportion of adults than
children have unfavourable cytogenetic abnormalities,
such as the t(9;22) translocation, and many cases present
in patients over 60 years, who are unlikely to tolerate inten-
sive chemotherapy. In the recent Medical Research Coun-
cil trial of intensive chemotherapy in adults with ALL, just
under half of those without t(9;22) were considered cured,
whereas less than a third with the translocation were alive
at two years. In suitable adults, allogeneic transplantation
oers the best chance of survival. This involves administra-
tion of high doses of chemotherapy followed by rescue of the
bone marrow with stem cell infusions from a matched donor.
Because of the intensity of this treatment, about one in three
patients does not survive owing to toxicity.
15
AML is the most common acute leukaemia in adults, with
about 2000 new cases each year in the UK and a median
age at presentation of 67 years. Patients typically present
Box | Staging of chronic lymphocytic leukaemia
Stage A: Lymphocytosis with fewer than three groups of
enlarged lymph nodes
Stage B: Lymphocytosis with three or more groups of
enlarged lymph nodes
Stage C: Lymphocytosis with anaemia (haemoglobin <
g/L), thrombocytopenia (platelets <
/L), or both
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RED FLAGS
Symptoms of leukaemia include unexplained fevers, night
sweats, weight loss, and fatigue
Symptoms of bone marrow failure include infections,
bleeding, bruising, and anaemia
A rapid onset of symptoms is suggestive of acute
leukaemia and usually requires urgent investigation
A febrile patient with suspected leukaemia should be
treated as a medical emergency
Circulating blasts often indicate acute leukaemia, which
requires prompt management
CLINICAL REVIEW
realistic chance of cure in acute leukaemias, but for selected
patients only, because of the morbidity and mortality associ-
ated with these regimens. Chronic leukaemias are usually
treated non-intensively. Treatment options for patients not
deemed ht for intensive chemotherapy, which include blood
product transfusions and low dose chemotherapy, aim to
minimise hospital admissions. Regardless of treatment
intensity, many patients could beneht from community
based services, recommendations for which are provided
in the second part of this review.
Contributors: GAF and MAS conceived the project and helped edit the
manuscript. NFG and GAF wrote the manuscript. RP and MBvtV provided
expert opinion and helped edit the manuscript.
Funding: None received.
Competing interests: None declared
Provenance and peer review: Not commissioned; externally peer reviewed.
1 Cancer Research UK. Leukaemia incidence statistics. www.
cancerresearchuk.org/cancer-info/cancerstats/types/leukaemia/
incidence/.
l Swerdlow SH, Campo E, Harris NL, Jaffe ES, Pilleri SA, Stein H, et al, eds.
WHO classification of tumours of haematopoietic and lymphoid tissues.
/th ed. IARC Press, luuS.
! Grove CS, Follows GA, Erber WN. Incidental finding of lymphocytosis in an
asymptomatic patient. BMJ luu9;!!S:bl119.
/ CLL Trialists Collaborative Group. Chemotherapeutic options in chronic
lymphocytic leukemia: a meta-analysis of the randomized trials. J Natl
Cancer Inst 1999;91:S61-S.
' Oscier D, Dearden C, Erem E, Fegan C, Follows G, Hillmen P, et al.
Guidelines on the diagnosis, investigation and management of chronic
lymphocytic leukaemia. Br J Haematol lu1l;1'9:'/1-6/.
6 Else M, Cocks K, Crofts S, Wade R, Richards SM, Catovsky D, et al. Quality of
life in chronic lymphocytic leukemia: '-year results from the multicenter
randomized LRF CLL/ trial. Leuk Lymphoma lu1l;'!:1lS9-9S.
7 Pettitt AR, Jackson R, Carruthers S, Dodd J, Dodd S, Oates M, et al.
Alemtuzumab in combination with methylprednisolone is a highly
effective induction regimen for patients with chronic lymphocytic leukemia
and deletion of TP'!: final results of the national cancer research institute
CLLlu6 trial. J Clin Oncol lu1l;!u:16/7-''.
S National Institute for Health and Clinical Excellence. Bendamustine for the
first-line treatment of chronic lymphocytic leukaemia. lu11. www.nice.
org.uk/nicemedia/live/1!!/!/'!1Su/'!1Su.pdf.
9 Hochhaus A, OBrien SG, Guilhot F, Druker BJ, Branford S, Foroni L, et al. Six-
year follow-up of patients receiving imatinib for the first-line treatment of
chronic myeloid leukemia. Leukemia luu9;l!:1u'/-61.
1u Ng KP, Hillmer AM, Chuah CT, Juan WC, Ko TK, Teo AS, et al. A common
BIM deletion polymorphism mediates intrinsic resistance and
inferior responses to tyrosine kinase inhibitors in cancer. Nat Med
lu1l;1S:'l1-S.
11 National Institute for Health and Clinical Excellence. Dasatinib, high-dose
imatinib and nilotinib for the treatment of imatinib-resistant chronic
myeloid leukaemia (CML) (part review of NICE technology appraisal
guidance 7u) and dasatinib and nilotinib for people with CML for whom
treatment with imatinib has failed because of intolerance. lu1l. www.
nice.org.uk/nicemedia/live/1!6/'/'7Sl!/'7Sl!.pdf.
1l Cortes JE, Kantarjian H, Shah NP, Bixby D, Mauro MJ, Flinn I, et al. Ponatinib
in refractory Philadelphia chromosome-positive leukemias. N Engl J Med
lu1l;!67:lu7'-SS.
1! Hann I, Vora A, Richards S, Hill F, Gibson B, Lilleyman J, et al. Benefit of
intensified treatment for all children with acute lymphoblastic leukaemia:
results from MRC UKALL XI and MRC ALL97 randomised trials. UK Medical
Research Councils working party on childhood leukaemia. Leukemia
luuu;1/:!'6-6!.
1/ Mitchell C, Hall G, Clarke RT. Acute leukaemia in children: diagnosis and
management. BMJ luu9;!!S: bllS'.
1' Sive JI, Buck G, Fielding A, Lazarus HM, Litzow MR, Luger S, et al. Outcomes
in older adults with acute lymphoblastic leukaemia (ALL): results
from the international MRC UKALL XII/ECOGl99! trial. Br J Haematol
lu1l;1'7:/6!-71.
16 Roboz GJ. Current treatment of acute myeloid leukemia. Curr Opin Oncol
lu1l;l/:711-9.
17 Sanz MA, Montesinos P, Vellenga E, Rayon C, de la Serna J, Parody R, et
al. Risk-adapted treatment of acute promyelocytic leukemia with all-
trans retinoic acid and anthracycline monochemotherapy: long-term
outcome of the LPA 99 multicenter study by the PETHEMA Group. Blood
luuS;11l:!1!u-/.
1S Burnett AK, Hills RK, Milligan D, Kjeldsen L, Kell J, Russell NH, et al.
Identification of patients with acute myeloblastic leukemia who benefit
from the addition of gemtuzumab ozogamicin: results of the MRC AML1'
trial. J Clin Oncol lu11;l9:!69-77.
Accepted: l1 February lu1!
with complications of bone marrow failure. Many patients
present with infections and bleeding, and the diagnosis
is usually suspected from the blood count and hlm.
2
Most
patients are admitted acutely to a specialist unit for further
management. For patients who are ht enough, the standard
management is intensive inpatient chemotherapy. For spe-
cihc patients allogeneic transplantation may be indicated,
as described in a recent review.
16
Curative chemotherapy regimens for AML and ALL are
very intensive. Treatment is usually delivered in hospital.
Most patients will have severe side eects that require hos-
pital admission. Hospital stays can last several weeks and
intensive care may be needed. Older patients are unlikely
to tolerate curative regimens and ohen have unfavourable
cytogenetics. Palliative treatment is usually oered to these
patients, and the median survival is less than one year.
2
Subclassihcation of AML on the basis of cytogenetics has
largely superseded classihcations based solely on morphol-
ogy. For example, patients with the t(15;17) translocation
are likely to have a promyelocytic morphology, and cure
rates of over 80% were achieved in a large trial using a
combination of idarubicin and the vitamin A analogue, all-
trans retinoic acid, which is much less toxic than standard
chemotherapy.
17
Patients with low risk cytogenetics ohen
respond well to standard chemotherapy and are least likely
to beneht from allogeneic transplantation. Furthermore,
according to the recent AML15 trial, addition of the anti-
CD33 monoclonal antibody, gemtuzumab ozogamycin, may
improve survival in this group.
18
Summary
Advances in our understanding of the genetics of leukae-
mia have led to the hrst wave of targeted cancer treatments.
Intensive cytotoxic chemotherapy combined with targeted
treatments and potentially allogeneic transplantation oer a
TIPS FOR NONSPECIALISTS
A blood film is crucial for investigating suspected
leukaemia: acute leukaemias typically have circulating
blasts at presentation
The white blood cell count is not always a good indicator
of disease severitythe presence of cytopenias is more
reliable
Symptomatic cytopenias usually indicate clinical urgency
Childhood leukaemias can present non-specifically
ADDITIONAL EDUCATIONAL RESOURCES
Resources for healthcare professionals
National Institute for Health and Clinical Excellence (www.
nice.org.uk)Guidelines on the management of all types
of leukaemia
British Committee for Standards in Haematology (www.
bcshguidelines.com)Free guidelines; no registration
required
Resources for patients
Macmillan (www.macmillan.org.uk)Information on
treatment
Leukaemia and Lymphoma Research (www.
leukaemialymphomaresearch.org.uk)General
information on leukaemia
PRACTICE
1
National Collaborating Centre for
Mental Health, University College
London, London WC1E 7HB, UK
l
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
WC1E 7HB, UK
/
Social Care Institute for Excellence,
London SW1Y 'BH, UK
'
Department of Social and Policy
Sciences, University of Bath, Bath
BAl 7AY, UK
6
School of Human Services and
Social Work, Griffith University, QLD
/1!1, Australia
7
National Collaborating Centre for
Mental Health, Royal College of
Psychiatrists, London E1 SAA, UK
S
Institute of Psychiatry, Kings
College London, London
SE' SAF, UK
9
National Conduct Problems
Clinic and National Adoption and
Fostering Clinic, Maudsley Hospital,
London BR! !BX, UK
1u
National Academy for Parenting
Research, Kings College London,
London SE' SAF, UK
Correspondence to: S Pilling
s.pilling@ucl.ac.uk
doi: 1u.11!6/bmj.f1l9S
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
on bmj.com.
Antisocial behaviour and conduct disorders (including
oppositional dehant disorder and conduct disorder) are
the most common mental and behavioural problems in
children and young people globally, with the frequency
increasing in Western countries.
1
In the United Kingdom
5% of mental and behavioural problems in children and
young people (18 years) meet criteria for a conduct dis-
order, as do almost 40% of looked-aher children, children
who have been abused, and those on child protection or
safeguarding registers.
2
Conduct disorders are strongly
associated with poor performance at school, social iso-
lation, substance misuse, and involvement with the
criminal justice system.
3
A large proportion of children
and young people with a conduct disorder will go on to
be antisocial adults with impoverished and destructive
lifestyles,
3
especially if the conduct problems develop
early,
4
and a large minority will be diagnosed with anti-
social personality disorder.
5
Antisocial behaviour and
conduct disorders ohen coexist with other mental health
problems, place a heavy personal and economic burden
on individuals and society,
6
and involve a wide range
of health, social care, educational, and criminal justice
services.
This article summarises the most recent recommenda-
tions from the National Institute for Health and Clinical
Excellence (NICE) on recognising and managing anti-
social behaviour and conduct disorders in children and
young people.
7
The guideline was developed jointly with
the Social Care Institute for Excellence (SCIE).
Recommendations
NICE recommendations are based on systematic reviews
of the best available evidence and explicit consideration
of cost eectiveness. When minimal evidence is available,
recommendations are based on the Guideline Development
Groups experience and opinion of what constitutes good
practice. Evidence levels for the recommendations are in
the full version of this article on bmj.com.
Working safely and effectively
Health and social care professionals working with children
and young people who present with behaviour suggestive
of a conduct disorder, or who have a conduct disorder,
should be trained and competent to work with children
and young people of all levels of learning ability, cognitive
capacity, emotional maturity, and development.
Selective prevention
Oer classroom based emotional learning and problem
solving programmes for children typically aged 3-7 years
GUIDELINES
Recognition, intervention, and management of antisocial
behaviour and conduct disorders in children and young people:
summary of NICE-SCIE guidance
Stephen Pilling,
1 2 3
Nick Gould,
4 5 6
Craig Whittington,
1
Clare Taylor,
7
Stephen Scott,
8 9 10

on behalf of the Guideline Development Group
in schools where classes have a high proportion of chil-
dren identihed to be at risk of developing oppositional
dehant disorder or conduct disorder resulting from any
of the following factors:

Low socioeconomic status

Low school achievement

Child abuse or parental conict

Separated or divorced parents

Parental mental health or substance misuse
problems

Parental contact with the criminal justice system.
Provide these programmes in a positive atmosphere
and ensure the interventions are designed to:

Increase childrens awareness of their own and
others emotions

Teach self control of arousal and behaviour

Promote a positive self concept and good peer
relations

Develop childrens problem solving skills.
Typically the programmes should consist of up to 30
classroom based sessions over the course of one school
year.
Initial assessment of children and young people with a
possible conduct disorder
Undertake an initial assessment for a suspected conduct
disorder if parents or carers, healthcare or social care pro-
fessionals, school or college, or peer group raise concerns
about persistent antisocial behaviour.
Consider using the strengths and dimculties question-
naire
8
(completed by a parent, carer, or teacher) and
assess for the following complicating factors:

A coexisting mental health problem (for example,
depression, post-traumatic stress disorder)

A neurodevelopmental condition (in particular,
attention-dehcit/hyperactivity disorder and autism)

A learning disability or dimculty

Substance misuse.
If there are complicating factors, refer the child or
young person to specialist child and adolescent mental
health services for a comprehensive assessment.
If there are no complicating factors, consider direct
referral for an intervention.
Comprehensive assessment
Standard components of this should include asking about
and assessing:

Core conduct disorders symptoms, including:

Patterns of negativistic, hostile, or dehant
behaviour in children aged under 11 years
PRACTICE

Are based on a social learning model using
modelling, rehearsal, and feedback to improve
parenting skills

Typically consist of 12-16 meetings, each lasting 90
to 120 minutes

Adhere to the developers manual (which should
have been positively evaluated in a randomised
controlled trial) and use all of the necessary
materials to ensure consistent implementation of the
programme.
Child focused programmes
Offer group social and cognitive problem solving pro-
grammes to those aged between 9 and 14 years at high
risk of or with oppositional dehant disorder or conduct
disorder or if they are in contact with the criminal justice
system because of antisocial behaviour.
Adapt these group programmes to the childrens or
young peoples developmental level and ensure that
they:

Are based on a cognitive behavioural problem solving
model

Use modelling, rehearsal, and feedback to improve
skills

Typically consist of 10-18 weekly meetings, each
lasting two hours

Adhere to the developers manual (which should have
been positively evaluated in a randomised controlled
trial) and use all of the necessary materials to ensure
consistent implementation of the programme.
Multimodal interventions
Oer multimodal interventions (for example, multisys-
temic therapy, in which a designated professional pro-
vides intensive support to the young person and their
family in the home, school, and community, with the
aim of reducing their antisocial behaviour) to those aged
11-17 years for the treatment of conduct disorder.
In multimodal interventions, involve the child or young
person and their parents and carers, and ensure that the
interventions:

Have an explicit and supportive focus on the family

Are based on a social learning model with
interventions provided at individual, family, school,
criminal justice, and community levels

Are provided by specially trained case managers

Typically consist of three to four meetings a week for
three to hve months

Adhere to the developers manual (which should
have been positively evaluated in a randomised
controlled trial) and use all of the necessary
materials to ensure consistent implementation of the
programme.
Improving access to services
Provide information about the services and interventions
in the local care pathway, including the:

Range and nature of the interventions provided

Settings in which services are delivered

Processes by which a child or young person moves
through the pathway

Aggression to people and animals, destruction
of property, deceitfulness or theh, and serious
violations of rules in children aged over 11 years

Current functioning at home, school, or college and
with peers

Parenting quality

History of any past or current mental or physical
health problems.
Assess for:

The risks faced by the child or young person. If
needed, develop a risk management plan for self
neglect, exploitation by others, self harm or harm to
others

The presence or risk of physical, sexual, and
emotional abuse in line with local protocols for the
assessment and management of these problems.
Conduct a comprehensive assessment of parents or
c arers, covering:

Positive and negative aspects of parentingin
particular, any use of coercive discipline

The parent-child relationship

Positive and negative adult relationships in the
family, including domestic violence

Parental wellbeing, encompassing mental health,
substance misuse (including whether alcohol or
drugs were used during pregnancy), and criminal
behaviour.
Parent training programmes
Oer a group parent training programme to the parents
of those aged 3-11 years who have or are at high risk of
oppositional dehant disorder or conduct disorder or are in
contact with the criminal justice system because of anti-
social behaviour.
In these programmes, involve both parents if possible
and if in the best interests of the child or young person;
and ensure that the programmes:

Typically have 10-12 parents in a group

Are based on a social learning model, using
modelling, rehearsal, and feedback to improve
parenting skills

Typically consist of 10-16 meetings, each lasting
90-120 minutes

Adhere to the developers manual (which should have
been positively evaluated in a randomised controlled
trial) and use all of the necessary materials to ensure
consistent implementation of the programme.
Foster carer/guardian training programmes
Oer a group foster carer/guardian training programme to
foster carers and guardians of those aged 3-11 years who
have or are at high risk of oppositional dehant disorder or
conduct disorder or are in contact with the criminal justice
system because of antisocial behaviour.
In these programmes, involve both of the foster carers or
guardians if possible and if in the best interests of the child
or young person; and ensure that the programmes:

Modify the intervention to take account of the care
setting in which the child is living

Typically have 8-12 foster carers or guardians in a
group
bmj.com
series
Long term follow-up
of survivors of childhood
cancer: summary of
updated SIGN guidance
(BMJ lu1!;!/6:f119u)
Fertility (update):
summary of NICE guidance
(BMJ lu1!;!/6:f6'u)
Recognition and
management of psychosis
and schizophrenia in
children and young
people: summary of NICE
guidance
(BMJ lu1!;!/6:f1'u)
Ectopic pregnancy and
miscarriage: summary of
NICE guidance
(BMJ lu1l;!/':e31!6)
Assessment and
management of psoriasis:
summary of NICE guidance
(BMJ lu1l;!/':e671l)
PRACTICE
for the submitted work; (l) SP receives funding from NICE to support
guideline development work at the NCCMH; (!) NG receives funding from
the Social Care Institute for Excellence to support guideline development
work with NICE; (/) no other relationships or activities that could appear to
have influenced the submitted work.
Provenance and peer review: Commissioned; not externally peer reviewed.
1 Collishaw S, Maughan B, Goodman R, Pickles A. Time trends in
adolescent mental health. J Child Psychol Psychiatry luu/;/':1!'u-6l.
l Green H, McGinnity A, Meltzer H, Ford T, Goodman R. Mental health of
children and young people in Great Britain, luu/: summary report.
Office for National Statistics, luu'.
! Fergusson DM, Horwood LJ, Ridder EM. Show me a child at seven:
consequences of conduct problems in childhood for psychosocial
functioning in adulthood. J Child Psychol Psychiatry luu';/6:S!7-/9.
/ Moffitt T. Life-course-persistent versus adolescence-limited antisocial
behaviour: a 1u-year research review and a research agenda. In:
Cicchetti D, Cohen DJ, eds. Developmental psychopathology. Volume !:
risk, disorder, and adaptation. Wiley, luu6:'7u-9S.
' National Collaborating Centre for Mental Health. Antisocial personality
disorder: treatment, management and prevention. British Psychological
Society, Royal College of Psychiatrists, lu1u.
6 Scott S, Knapp M, Henderson J, Maughan B. Financial cost of social
exclusion: follow up study of antisocial children into adulthood. BMJ
luu1;!l!:191.
7 National Institute for Health and Clinical Excellence. Antisocial
behaviour and conduct disorders in children and young people:
recognition, intervention and management. (Clinical guideline 1'S.)
lu1!. http://guidance.nice.org.uk/CG1'S.
S Goodman R, Meltzer H, Bailey V. The strengths and difficulties
questionnaire: a pilot study on the validity of the self-report version. Eur
Child Adolesc Psychiatry 199S;7:1l'-!u.
9 National Institute for Health and Clinical Excellence. Common mental
health disorders: identification and pathways to care. (Clinical guideline
1l!.) lu11. http://guidance.nice.org.uk/CG1l!.
1u Barber AJ, Tischler VA, Healy E. Consumer satisfaction and child
behaviour problems in child and adolescent mental health services. J
Child Health Care luu6;1u:9-l1.
11 National Collaborating Centre for Mental Health. Antisocial behaviour
and conduct disorders in children and young people: recognition,
intervention and management. British Psychological Society, Royal
College of Psychiatrists [forthcoming].

Means by which progress and outcomes are assessed

Delivery of care in related health and social care
services.
Overcoming barriers
Accessing care for antisocial behaviour and conduct dis-
orders can be a potential barrier.
10
To overcome this, there
hrst needs to be wider recognition by teachers, social work-
ers, community workers, primary care sta, and parents
that persistent antisocial behaviour does not just result
from naughty or dimcult character traits but ohen
has psychological and biological causes and responds to
eective treatment.
11
The possibility of a conduct disorder
should be considered, particularly in higher risk groups
such as looked-aher children, children subject to harsh
parenting, and those with attention-dehcit/hyperactivity
disorder. Evidence based interventions, such as parent
training programmes, need to be oered at times when
parents can attend, including evenings and weekends,
and be delivered by well trained sta who receive ongoing
supervision. If the antisocial behaviour or conduct disor-
der is not responding to intervention, consider the mental
health needs of parents. Finally, service delivery needs
to be well coordinated across agencies, including youth
oending teams.
Contributors: All authors contributed to the conception and drahing of this
article and revising it critically. They have all approved the hnal version. SP
is the guarantor.
Competing interests: All authors have completed the ICMJE unihed
disclosure form at www.icmje.org/coi_disclosure.pdf (available on request
from the corresponding author) and declare: (1) SP, CW, and CT had
support from the National Collaborating Centre for Mental Health (NCCMH)
RATIONAL TESTING
Interpreting an isolated raised serum alkaline phosphatase level
in an asymptomatic patient
Kate Elizabeth Shipman, Ashley David Holt, Rousseau Gama
New Cross Hospital, Clinical
Chemistry, Wolverhampton
WV1u uQP, UK
Correspondence to: K E Shipman
kate.shipman@doctors.net.uk
doi: 1u.11!6/bmj.f976
This series of occasional articles
provides an update on the best
use of key diagnostic tests in the
initial investigation of common or
important clinical presentations.
The series advisers are Steve Atkin,
professor, head of department of
academic endocrinology, diabetes,
and metabolism, Hull York Medical
School; and Eric Kilpatrick, honorary
professor, department of clinical
biochemistry, Hull Royal Infirmary,
Hull York Medical School. To suggest
a topic for this series, please email
us at practice@bmj.com.
This article discusses the most common
causes of raised alkaline phosphatase
levels in an asymptomatic patient
and provides advice on the relevant
investigations.
A 51 year old asymptomatic woman presented to her
general practitioner for cascade screening for familial
hypercholesterolaemia. Blood tests revealed a normal full
blood count, renal function, thyroid function, lipid prohle,
glucose levels, bone prohle, and liver prohle except for an
isolated increased alkaline phosphatase (ALP) concentra-
tion at 171 U/L (reference interval 30-130).
What is the next investigation?
ALP is found in high concentrations in liver, bone, kidney,
intestine, and placenta. In adults, circulating ALP is pre-
dominantly of hepatic and bony origin. Serum ALP levels
increase in pregnancy and by the third trimester can be
twofold to fourfold higher as a result of a physiological
increase in placental ALP. Reference intervals are age and
sex related, gradually increasing from age 40 to 65 years,
LEARNING POINTS
If alkaline phosphatase is raised in an asymptomatic
patient and serum bilirubin, liver transaminases,
creatinine, adjusted calcium, thyroid function, and blood
count are normal:
Consider growth spurts in adolescents, pregnancy in
women, drugs, and age related increases
As most likely sources are either bone or liver, differentiate
by measuring -glutamyltransferase (raised in liver) and
investigate accordingly
For liver cases investigate with abdominal ultrasound scan
(cholestasis and hepatic space occupying lesion) and
antimitochondrial antibodies (primary biliary cirrhosis)
For bone cases investigate vitamin D
PRACTICE
especially in women, and can be up to threefold to seven-
fold higher in rapidly growing adolescents.
1
Reference inter-
vals contain 95% of the population, therefore 2.5% of the
normal population have values above the upper reference
limit. The combined analytical and biological variation for
serum ALP is around 8%,
1

2
and levels increase by up to
6% if analysis is delayed for 96 hours in samples stored
at room temperature.
3
For example, an ALP result of 125
U/L could be between 108 U/L and 143 U/L, spanning the
upper reference limit. Minor increases in serum ALP levels
are therefore more likely to be analytical, physiological, or
statistical anomalies rather than indicating disease.
An evidence base is lacking on the differential diag-
nosis and outcome of an isolated increased serum ALP
levelthat is, a raised serum ALP level in the presence of
normal serum levels of bilirubin, transaminases (alanine
aminotransferase or aspartate aminotransferase, or both),
and calcium. It is reassuring that over 95% of ambulatory
patients with an unexplained raised serum ALP level dur-
ing a multiphasic screening examination developed no
overt disease during a two year follow-up.
4
Furthermore,
all important disease in the remaining 5% would have been
detected by simple history, examination, and routine labo-
ratory investigations.
4
In a case series of patients admitted to hospital, an iso-
lated raised serum ALP level was associated with a variety
of medical illnesses, including congestive cardiac failure
(16%), benign bone disease (8%; fractures and osteomy-
elitis), hyperthyroidism (2%), and end stage renal disease
(5%).
5
In over 50% of patients, serum ALP levels returned
to the normal range within one year and mostly within
three months. Usually there was a known clinically obvi-
ous cause, such as metastatic malignancy, for a persist-
ently isolated raised serum ALP level, which was more
likely if the initial level was more than 1.5 times the upper
reference limit.
5
The next step
A reasonable approach in adults with an isolated raised
serum ALP level is therefore a careful medical and drug
history (table) and physical examination.
4

6

7
Key features
include abdominal pain or swelling, unintentional weight
loss, back pain, bone pain, clinical indicators of liver dis-
ease, congestive cardiac failure, and end stage chronic
kidney disease.
4

5
If patients are asymptomatic but have
raised ALP levels of unknown cause, then the test for ALP
should be repeated with -glutamyltransferase to conhrm
and dehne the abnormality and adjusted calcium levels,
thyroid function tests, renal prohle, and haemoglobin lev-
els
4
checked within four weeks if not part of the original
prohle. These tests should identify the major pathological
causes, with anaemia indicating potential systemic illness.
Haematological, renal, thyroid, and calcium abnormalities
should be further investigated and managed appropriately;
however, if the results are normal then the raised ALP level
is isolated (further investigations are discussed below).
Raised hepatic ALP level: raised serum ALP with raised
serum -glutamyltransferase level
Raised -glutamyltransferase levels indicate a hepatic
rather than bony origin for raised ALP levels.
6
In some
patients a raised level may originate from both liver and
bone (for example, in metastatic cancer), but they are likely
to have symptoms or a history of cancer.
If the serum ALP level is raised but less than 1.5 times
the upper reference limit then the test should be repeated
in three months. If the level is more than 1.5 times the
upper reference limit or persistently raised, then appro-
priate investigations would be a liver ultrasound exami-
nation to detect cholestasis or an inhltrative liver lesion
8

and measurement of antimitochondrial antibodies to
detect primary biliary cirrhosis, and any abnormalities
should be investigated accordingly.
8

9
Although primary
biliary cirrhosis is uncommon, if diagnosed early treatment
improves outcome. If these tests produce normal results
and the serum ALP level is less than 1.5 times the upper
reference limit, then patients should be evaluated clini-
cally for symptoms in six months as further investigation
is not cost eective.
4

10
If, however, the serum ALP level is
persistently more than 1.5 the upper reference limit and
ultrasound examination and serology give normal results,
the patient should be referred to a hepatologist for consid-
eration of a liver biopsy and further specialist imaging.
8

9
Raised non-hepatic ALP level: raised serum ALP but
normal serum -glutamyltransferase level
A normal serum -glutamyltransferase level indicates that
the raised serum ALP level is non-hepatic and most likely
bony in origin and due to vitamin D dehciency,
11
Pagets
disease of bone (increasing in incidence from age 55 years
onwards and becoming particularly signihcant in those
over 75 years of age),
12

13
or growth spurts in adolescents.
Other uncommon causes of increased serum bony ALP lev-
els, such as bone tumours and healing fractures, will be
clinically evident. The hypercalcaemia of primary hyper-
parathyroidism may be masked by vitamin D dehciency and
only become apparent aher vitamin D replacement.
14
Common drug causes of raised alkaline phosphatase levels
Drugs Mechanism
Antibiotics:
Penicillin derivatives Intrahepatic cholestasis
Erythromycin Intrahepatic cholestasis
Aminoglycosides Enzyme induction
Antiepileptic drugs:
Carbamazepine Intrahepatic cholestasis
Phenobarbital Enzyme induction
Phenytoin Enzyme induction
Antihistamines:
Cetirizine Intrahepatic cholestasis
Cardiovascular drugs:
Captopril Intrahepatic cholestasis
Diltiazem Enzyme induction
Felodipine Enzyme induction
Disease modifying agents:
Penicillamine Intrahepatic cholestasis
Sulfa drugs Intrahepatic cholestasis
Polycyclic aromatic hydrocarbons:
Oral contraceptive pill (oestrogen) Enzyme induction
Steroids Enzyme induction
Psychotropic drugs:
Monoamine oxidase inhibitors Intrahepatic cholestasis
Chlorpromazine Intrahepatic cholestasis
bmj.com
series
Interpreting arterial
blood gas results
(BMJ lu1!;!/6:f16)
Investigating an
incidental hnding of
thrombocytopenia
(BMJ lu1!;!/6:f11)
Monitoring
aminoglycoside level
(BMJ lu1l;!/':e6!'/)
Investigating an
incidental hnding of a
paraprotein
(BMJ lu1l;!//:e!u!!)
Investigating asthma
symptoms in primary care
(BMJ lu1l;!//:el7!/)
PRACTICE
Contributors: All authors performed the literature search. KES wrote the hrst
drah of the manuscript, with RG and ADH involved in revisions. All authors
approved the hnal article. RG is the guarantor.
Competing interests: None declared
Provenance and peer review: Commissioned; externally peer reviewed.
Patient consent not required (patient anonymised, dead, or hypothetical).
1 Schiele F, Henny J, Hitz J, Petitclerc C, Gueguen R, Siest G. Total bone and
liver alkaline phosphatases in plasma: biological variations and reference
limits. Clin Chem 19S!;l9:6!/-/1.
l Rics C, Iglesias N, Garca-Lario JV, Simn M, Cava F, Hernndez A, et al.
Within-subject biological variation in disease: collated data and clinical
consequences. Ann Clin Biochem luu7;//:!/!-'l.
! Lott JL, Wolf PL. Clinical enzymology: a case-orientated approach. Field,
Rich and Associates, 19S6.
/ Rubenstein LV, Ward NC, Greenfield S. In pursuit of the abnormal serum
alkaline phosphatase: a clinical dilemma. J Gen Intern Med 19S6;1:!S-/!.
' Lieberman D, Phillips D. Isolated elevation of alkaline phosphatase:
significance in hospitalized patients. J Clin Gastroenterol 199u;1l:/1'-9.
6 Aragon G, Younossi Z. When and how to evaluate mildly elevated liver
enzymes in apparently healthy patients. Cleve Clin J Med lu1u;77:19'-lu/.
7 Green RM, Flamm S. AGA technical review on the evaluation of liver
chemistry tests. Gastroenterology luul;1l!:1!67-S/.
S American Gastroenterological Association. AGA technical review on the
evaluation of liver chemistry tests. Gastroenterology luul;1l!:1!67-S/.
9 Collier J, Bassendine M. How to respond to abnormal liver function tests.
Clin Med luul;l:/u6.
1u Sorbi D, McGill DB, Thistle JL, Therneau TM, Henry J, Lindor KD. An
assessment of the role of liver biopsies in asymptomatic patients with
chronic liver test abnormalities. Am J Gastroenterol luuu;9':!lu6-1u.
11 Pearce SH, Cheetham TD. Diagnosis and management of vitamin D
deficiency. BMJ lu1u;!/u:b'66/.
1l Josse RG, Hanley DA, Kendler D, Ste Marie LG, Adachi JD, Brown J. Diagnosis
and treatment of Pagets disease of bone. Clin Invest Med luu7;!u:
El1u-l!.
1! Kotowicz KK. Paget disease of bone. Diagnosis and investigation for
treatment. Aust Fam Physician luu/;!!:1l7-!1.
1/ Mikhail N. Clinical significance of vitamin D deficiency in primary
hyperparathyroidism, and safety of vitamin D therapy. South Med J
lu11;1u/:l9-!!.
1' Smellie WSA, Forth J, Ryder S, Galloway MJ, Wood AC, Watson ID. Best
practice in primary care pathology: review '. J Clin Pathol luu6;'9:
1ll9-!7.
16 McTaggart MP, Rawson C, Lawrence D, Raney BS, Jaundrill L, Miller LA, et al.
Identification of a macro-alkaline phosphatise complex in a patient with
inflammatory bowel disease. Ann Clin Biochem lu1l;/9:/u'-7.
17 Young DS. Effects of drugs on clinical laboratory tests, vol 1: listing by test
('th ed). American Association for Clinical Chemistry Press, luuu.
In patients with raised or persistently isolated increases
in non-hepatic serum ALP levels and no symptoms, serum
vitamin D levels should be measured and any hypovita-
minosis D managed. If vitamin D levels are in the normal
range and the serum ALP level is less than . times the
upper reference limit, then observation of the patient
should be continued, with further investigations if patients
develop symptoms.
It is questionable whether the absence

of symptoms in the presence of non-hepatic serum ALP lev-
els more than . times the upper reference limit should be
investigated further,
but bone scintigraphy may be con-

sidered in patients who are vitamin D replete to identify
asymptomatic Pagets disease, as some
but not all
sug-
gest that this is an indication for active treatment.
Studies to clarify the ALP isoform may be considered
in the presence of diagnostic uncertainty and notice-
able increases in serum ALP levels. Outside pregnancy,
increased levels of serum placental ALP may be due to
tumour secretion but rarely increases the total serum
level. Increased serum intestinal ALP levels may occur with
intestinal disease or as a familial benign entity. Increased
serum renal ALP levels may be encountered in renal dis-
eases. Rarely, ALP binds to an immunoglobulin to form
macroALP, which may be detected by precipitation studies.
MacroALP is of no signicance but has been associated
with inammatory bowel disease.
Outcome
As the patient was asymptomatic, took no drugs, and
had no abnormal physical ndings, her general practi-
tioner repeated the test for serum ALP level. Her serum
-glutamyltransferase level was also checked. This was
normal, as was her serum ALP, now at U/L. The patient
was reassured and needed no further follow-up.
ANSWERS TO ENDGAMES, p 38
For long answers go to the Education channel on bmj.com
ANATOMY QUIZ
Magnetic resonance angiography of the
posterior circulation
A: Left vertebral artery
B: Basilar artery
C: Right posterior cerebral artery
D: Right posterior inferior cerebellar artery
E: Right superior cerebellar artery
F: Right anterior inferior cerebellar artery
STATISTICAL QUESTION
Variables, sample estimates, and population
parameters
The mean SF- physical function scores at month
follow-up are known as point estimates (answer a) or sample
estimates (answer c).
PICTURE QUIZ
A man with tingling fingers
Pseudoathetosis and Lhermittes sign,
respectively. Pseudoathetosis localises the
pathology to the proprioceptive sensory
pathway and Lhermittes sign localises it to
the cervical spinal cord.
Abnormal high signal in the dorsal columns
of the cervical spinal cord.
Imaging shows an intramedullary tract
specific lesion and macrocytic anaemia.
The most likely diagnosis is subacute
combined degeneration of the cord (vitamin
B
deficiency). The differential diagnoses

include copper deficiency, inflammatory
myelitis including multiple sclerosis,
neuromyelitis optica, and dorsal root
ganglionopathies.
ENDGAMES
We welcome contributions that would help doctors with postgraduate examinations
OSee bmj.com/endgames for details
FOLLOW ENDGAMES ON TWITTER
@BMJEndgames
FOR SHORT ANSWERS See p 37
FOR LONG ANSWERS
Go to the Education channel on bmj.com
Fig 1 | T2 weighted axial magnetic
resonance imaging scan of the
cervical spine
Fig 2 | T2 weighted sagittal
magnetic resonance imaging scan
of the cervical spine
PICTURE QUIZ A man with tingling fingers
STATISTICAL QUESTION
Variables, sample estimates, and population parameters
ANATOMY QUIZ
Magnetic resonance angiography of the
posterior circulation
T2 weighted
sagittal magnetic
resonance
imaging scan of
the cervical spine
A 73 year old man with a three month history of
bilateral persistent tingling in the index and middle
fingers presented to his general practitioner. He was
referred for an injection for suspected carpal tunnel
syndrome. When he attended, as well as the tingling
sensation, he described loss of fine motor function
in his hands, with altered sensation in both legs and
his inner thighs. Examination at this time showed no
objective sensory loss in either hand. Phalens test
and Tinels test were both negative. His upper limb
tendon reflexes were normal.
Because of his new motor and lower limb symptoms,
his GP referred him to an outpatient neurology clinic. At
the clinic, he said that he had first noticed his symptoms
while gardening. The tingling in his fingers was now
present constantly. When he bent down to tie his shoes
it worsened in his arms and travelled down his back.
Lately he had struggled to fasten buttons and was having
trouble writing. He also had slight numbness in both
legs. He denied loss of power or perineal numbness and
had no bowel, bladder, or erectile problems. He had no
medical history of note and was taking no drugs.
On examination, his fundi and cranial nerves were
normal. He had weakness of the right abductor
pollicis brevis and abductor pollicis opponens
muscles. Touch, pinprick, temperature, vibration,
and proprioception were not impaired. With his arms
outstretched and eyes closed, his fingers moved
constantly. All his tendon reflexes were present and
equal, including the supinators. His plantars were
downgoing. Lower limb neurological examination
demonstrated normal power, coordination, and
sensation, except for an unsteady gait.
A full blood count showed that he had macrocytic
anaemia (mean corpuscular volume 118.9 fL;
reference range 77-95; haemoglobin 1u2 g/L; 13u-
18u). Magnetic resonance imaging was performed
(figs 1 and 2).
1 What are the names of the two signs (constant finger
movement and exacerbation of symptoms on looking
down) described and to where do they localise the
patients disease?
2 What do the magnetic resonance imaging scans
show?
3 How do the imaging and blood results further narrow
the differential diagnosis suggested from the clinical
history and examination?
Submitted by Neal Larkman, Oliver Hulson, and Mark Gilhooly
Researchers evaluated the effect of
initial trophic feeding compared with full
enteral feeding on physical function in
patients with acute lung injury. A cluster
randomised controlled trial study design
was used. In total, 525 patients with
acute lung injury admitted to hospital
were recruited. Participants were
randomised to low energy permissive
underfeeding (trophic feeding) or full
energy enteral feeding (full feeding)
for up to six days; thereafter, all patients
still receiving mechanical ventilation
received full feeding.
The primary outcome was blind
assessment of the physical function
domain of the SF-36 instrument,
adjusted for age and sex, 12 months
after acute lung injury. Secondary
outcome measures included survival;
physical, psychological, and cognitive
functioning; quality of life; and
employment status at six and 12 months.
No significant difference was seen
between initial trophic and full enteral
feeding in mean SF-36 physical function
at 12 months (55 (standard deviation
33) v 55 (31)). It was concluded that, in
survivors of acute lung injury, there was
no difference in physical function at 12
month follow-up after initial trophic or
full enteral feeding.
Which of the following describe the
mean SF-36 physical function scores at
12 month follow-up?
a) Point estimates
b) Population parameters
c) Sample estimates
d) Variables
Submitted by Philip Sedgwick
Identify the structures labelled A-F in this image from
magnetic resonance angiography of the posterior
circulation.
Submitted by Michael A Kadoch and Thomas J Ward
Cite this as: BMJ 2012;345:e7400
LAST WORDS
Immigrants are
agents of change,
offering something
that political
initiatives do not:
change from within
was the only game in town, with medi-
cine leh sweeping up the body parts of
hopelessness.
But in recent times the UK has sucked
in immigrants, even into places like
Glasgow. People without choice, eco-
nomic migrants or asylum seekers, have
been forced into concrete social hous-
ing and failing inner city schools to live
among the marginalised. And like previ-
ous waves of immigration it is changing
the psyche of our depressed cities.
Immigrants ohen have strong val-
ues and culture and are hard working,
driven, and focused on education.
Their children do well at school. Immi-
grants are agents of change, oering
something that political initiatives do
not: change from within. The current
abrasions from immigration will heal.
Immigrations real gih is not economic
but what it oers our poor: hope.
Des Spence is a general practitioner, Glasgow
destwo@yahoo.co.uk
My family landed in a closed rural
Scottish community in the 1970s, in
Afghan coat and beads, something
truly alien, the first of the English
white settlers. I know something of
immigration, something of the hostil-
ity and mistrust it generates. Humanity
has two equal but opposite forcesto
strive to conform and to strive to be dif-
ferent. So the outsider is to be feared
and welcomed in equal measure.
Immigration is again rising up the
political agenda. The truth is that
immigration does put pressure on
public services, housing, health, edu-
cation, and employment. And these
pressures land squarely on the most
deprived in society. Yet immigration
is an abstract concept to the middle
class, which is personally untouched
by its negative consequences.
Immigration is a real problem, with
real potential for conict and resent-
ment. There is a need for real debate
about resources. But immigration has
a much more fundamental, profound,
and long term impact.
Glasgow, like every postindustrial-
ised northern city, is a place to leave.
And hundreds of thousands of people
ed in the 1970s, 80s, and 90s, never
looking back, and leaving a scale and
complexity of social problems that is
dimcult to articulate. Although the
rest of the country and the economy
roared on, the northern cities were
stagnant, our forgotten untoucha-
bles trapped in a prison of housing
schemes, benehts, drink, drugs, and
violence.
Inner city youths were either
knocked up or banged up. Men and
women of an underclass were cast as
just chavs and neds to the major-
ity, under a national social segrega-
tion policy that was based on class.
Britains single greatest social issue
has been the subject of mere political
tokenism and ignored by successive
governments of all colours. Despair
He looked at me through newly opened
eyes as if I were half crazed. I know
this look well: its one Ive seen quite a
few times in my career. How are you,
Frank? Its been quite a while, I said,
rubbing him on the upper arm as a
measure of my aection.
Fine, he mumbled groggily, no
doubt wondering who the lunatic
stroking him was.
He had come in for a coronary
artery bypass grah three weeks
before. The procedure had gone well,
but his age and comorbidity led to
complications aher the operation,
and he had had to be ventilated for
three weeks. I had looked aher him
every day I was there, presenting
him to the consultant twice a day,
examining him from head to toe daily
and changing his lines.
While he was asleep I used talk to
him while performing my duties. For
the hrst few days I addressed him
dont care at all, but it is not humanly
possible to replicate the depth of
feeling that comes with time spent with
a patient.
The famous Stanford prison
experiment of the 1970s, in which
seemingly normal students who were
made to guard other students in a mock
prison turned truly wicked, shows the
importance of environment to how we
perceive and treat other people.
Of course, such a topic is distinctly
unsexy and wouldnt make headlines.
Far better to ensure that all sta
attend compassion classes and
get a beautiful certihcate for their
e-portfolio than to announce that the
best way to ensure compassion is to
allow time and continuity of care.
Kinesh Patel is a junior doctor, London
kinesh_patel@yahoo.co.uk
Patient consent not required (patient
anonymised, dead, or hypothetical).
For the first few
days I addressed
him as Mr Trisk,
but then this
seemed strangely
formal for a man I
spent hours with
each day and who
had felt my hands
all over his body
as Mr Trisk, but then this seemed
strangely formal for a man I spent
hours with each day and who had felt
my hands all over his body. Frank just
seemed more appropriate. Of course,
a heady cocktail of morphine and
midazolam meant he was blissfully
unaware of any of this.
Over the weeks, as Frank got better,
something else happened. I began to
care more and more for him. He felt
like an old friend, not just another
patient. And all this without him
saying a word or moving a muscle.
What precipitated this change
in my emotions? Was I being told
from on high to care more? In fact,
it was the simple combination of
spending time with the patient and
a pleasant working environment.
Both are important. It is sad but true
that I care less for the patient I see in
a quick follow-up appointment in an
overbooked clinic. Thats not to say I
FROM THE FRONTLINE Des Spence
Immigrant song
STARTING OUT Kinesh Patel
How to encourage compassion
Twitter
Follow Des Spence on
Twitter @des_spence

MINERVA
Send comments or suggest ideas to Minerva: minerva@bmj.com
A year old man with
tingling ngers
Try the picture quiz in
ENDGAMES, p
Clopidogrel has brought great wealth to its
manufacturers, but envious competitors have
sought to stain its reputation by using data from
in vitro studies to argue for an interaction with
commonly prescribed drugs, such as proton
pump inhibitors. In this way, more than 8uuu
academic papers have been generated, and
companies have developed platelet testing
kits, genotyping products, and competing
thienopyridine antiplatelet drugs. But when
these have been brought to trial against
simple fixed dose clopidogrel they dont affect
outcomes. And as prospective trials have tested
the interaction with proton pump inhibitors, its
clinical significance has disappeared, as shown
in a new systematic review (Heart 2u13;99:52u-
7; doi:1u.1136/heartjnl-2u12-3u2371). So,
beware of mechanistic reasoning.
The only oral hypoglycaemic agent that doesnt
make outcomes worse is metformin, and even
that hasnt been proved. Yet it may have true
benefits. In a nationwide case-control study from
Taiwan, this drug seems to decrease the risk of
hepatocellular carcinoma in a dose dependent
manner (Gut 2u13:62:6u6-5; doi:1u.1136/
gutjnl-2u11-3u17u8). As for the latest class of
antidiabetes drugs, the incretin mimetics, a
post mortem study in Diabetes (2u13 published
online 22 March, not yet in print; doi:1u.2337/
db12-1686) showing widespread pancreatic
abnormalities leads Minerva to think that the
wrathful thunderbolts of her father Jupiter may
soon be loosed upon these substances.
Adalimumab is currently very expensive,
but it blocks tumour necrosis factor in a
unique way and will probably be used long
term in an increasing number of patients
with rheumatoid arthritis, juvenile idiopathic
arthritis, ankylosing spondylitis, psoriasis,
and Crohns disease. In a survey of 23 /58
patients who took part in trials throughout the
world, adalimumab proved remarkably safe
after a mean of about 12 years use (Annals
of the Rheumatic Diseases 2u13;72:517-2/;
doi:1u.1136/annrheumdis-2u11-2u12//).
Infections increased, but cancers and mortality
remained at general population levels.
All children get fevers, and until the last century
they often died. As serious sepsis gets rarer,
we have to look for it harder, and one sign can
be a prolonged capillary refill time (3 sec).
But which capillaries should be assessed?
Those on the finger and the sternum empty at
different rates, and doctors who want to do
the job properly should choose either site,
record which, press it for 5 seconds, and then
count aloud until it refills (Archives of Disease
in Childhood 2u13;98:265-8; doi:1u.1136/
archdischild-2u12-3u3u/6).
Azithromycin has become the chest physicians
favourite antibiotic and is widely used to
prevent infective exacerbations in chronic
obstructive airways disease. A small Belgian
double blinded trial looked at its effect on
severe exacerbations and lower respiratory
infections in adults with severe asthma
(Thorax 2u13;68:322-9; doi:1u.1136/
thoraxjnl-2u12-2u2698). It found little effect
in patients with high blood eosinophil counts,
but a significant benefit in those without
eosinophilia.
Over the past couple of decades, there has
been much interest in the heart as an endocrine
organ. The natriuretic peptides are the stars of
the show, providing an easy way to measure
atrial or ventricular strain, but there are many
others, including catestatin (Postgraduate
Medical Journal 2u13;89:193-6; doi:1u.1136/
postgradmedj-2u12-131u6u). This may sound
like something that vets use to lower feline
cholesterol, but its actually a peptide released
at the time of acute myocardial infarction that is
associated with adverse ventricular remodelling.
The admirable people of the Netherlands
sometimes need help in coping with life and
end up on long term benzodiazepines. The
Calvinist view is that they are then forever
doomed to dependency and to increasing
their dosage. Yes, they may be condemned to
dependency, but then so also are most people
who take serotonin reuptake inhibitors. But
a study from Dutch primary care shows that
dosage does not drift upwards in chronic
benzodiazepine users (Family Practice 2u13;
doi:1u.1u93/fampra/cmtu1u).
For demyelination, it matters when you are
born. April is the cruellest month, bringing forth
multiple sclerosis in 5% more than the average,
whereas if you are born among the mists and
mellow fruitfulness of October and November,
your risk is lowered. There is a latitude effect
as wellall grist to the mill of the maternal
vitamin D hypothesis of multiple sclerosis
causation (Journal of Neurology, Neurosurgery,
and Psychiatry 2u13;8/:/27-32; doi:1u.1136/
jnnp-2u12-3u393/).
Minerva is very fond of her little owl, Athene
noctua, and although this owl is immortal like
herself, breeding owls are needed to replenish
the stock of mortal birds. Such owls can be hard
put to choose which of their hungry chicks to
feed and so resort to favouritism. Diurnal birds
often use beak colour to choose among their
fledglings, but this was thought impossible
for owls. Not so, according to Oecologia (2u13
published online 27 Feb, not yet in print;
doi:1u.1uu7/suu//2-u13-2625-8). Parent
birds with large broods of A noctua can see
enough in the dark to favour their children with
orange beaks. It is a cruel world for pale beaked
owlets desperate for a scrap of minced vole.
A 39 year old fit and well man attended casualty
with a first presentation of stridor after eating
a banana, which resolved spontaneously.
Computed tomography confirmed oesophageal
dilation and tracheal compression in keeping
with achalasia.
Achalasia typically presents with dysphagia
and regurgitation. Stridor is a rare but
recognised presentation. The cricopharyngeal
sphincter acts as a one way valve, allowing air
to enter the oesophagus during inspiration but
none to escape during expiration. Distension
of the oesophagus impinges on the posterior
membranous portion of trachea causing airway
obstruction. In an emergency, decompressing
the oesophagus with a nasogastric tube would
prove life saving.
A Kamalasanan (anukamalasanan@nhs.net), core
surgical trainee, year , C McGowan, foundation
year trainee, S Su Sivarajah, speciality trainee,
year , P Witherspoon, general surgery consultant,
Department of General Surgery, Southern General
Hospital, Glasgow, UK

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THIS WEEK

BMJ | 6 APRIL 2013 | VOLUME 346

Aparna Briggs specialist registrar, genitourinary

Systemic thrombolysis has been the mainstay

Surgery has clearcut indications in massive

Evidence also suggests that surgery

To reduce mortality in patients with acute

Ed W K Peng specialty registrar in cardiothoracic

Secondly, we should not look to a member

Many people were not surprised by

but neither has been

I may just have

As for integrated care, it would

There were suggestions that

Department of Pathology, Division

Linton Health Centre, Cambridge,

Mars B Van t Veer,

It is questionable whether the absence

but bone scintigraphy may be con-

but not all

deficiency). The differential diagnoses

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