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THIS WEEK

BMJ| 6 APRIL 2013 | VOLUME 346

Leukaemia blood cells

magnification x5000 on SEMCLINICAL REVIEW, p

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

Articles appearing in this printjournal have already beenpublished on bmj.com, and theversion in print may have beenshortened. bmj.com also containsmaterial that is supplementary toarticles: this will be indicated inthe text (references are given asw, w, etc) and be labelled asextra on bmj.com.

Please cite all articles by year,volume, and elocator (rather thanpage number), eg BMJ;:f.

A note on how to cite each articleappears at the end of each article,and this is the form the referencewill take in PubMed and otherindexes.

COMMENT

EDITORIALS5 Implementation of the Health and Social Care Act

Nigel Edwards

6 Taking the sting out of lumbar puncture

Paul RizzoliRESEARCH, p

7 Vitamin D sufficiency in pregnancy

Robyn Lucas et al

RESEARCH, p

8 Sex selection and abortion in India

Anita Jain

FEATURES14 Goodbye (and good

riddance?) to PCTs

As Englands primary

care trusts give way toclinical commissioninggroups, Richard Vize pens

their obituary.Did PCTs makea dierence to

inequalities of care,reduce the dominance of acute providers, or makeprimary care safer for patients?

16 Doctors and the alcohol industry: an unhealthy mix?

Jonathan Gornall reports on an ideological schismover working alongside the alcohol industry that isdividing the public health community

ANALYSIS19 What should follow the millennium

development goals?

Debate on what should replace the United Nationsmillennium development goals when their target

date of is reached is hotting up. Charles Kennycomments on lessons learnt from their success andfailure and looks at the suggestions for the post-

development agenda

22 COMMENTARY

New development goals must focus on social

determinants of health

David Legge and David Sanders

STEVEGSCHMEISSNER/SP

L

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

EDITORIAL, p

11 Ultrasound imaging for lumbar punctures andepidural catheterisations: systematic review and

meta-analysis

Furqan Shaikh et al

EDITORIAL, p

12 Cardiovascular events after clarithromycin use in

lower respiratory tract infections: analysis of two

prospective cohort studies

Stuart Schembri et al

13 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 trialCatherine Henderson et al The future of development goals in poorer countries, p

Publics satisfaction with emergency NHS care has risen, p

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THIS WEEK

BMJ| 6 APRIL 2013 | VOLUME 346

Missing evidence

for your appraisalfolder?

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 willbenefit from paperless

records

Rupert Fawdry

OBITUARIES

28 Norman Kreitman

Psychiatrist and

suicide expert, poet,

philosopher

Norman Kreitman obituary, p

LAST WORDS39 Immigrant song Des Spence

How to encourage compassion Kinesh Patel

EDUCATION

CLINICAL REVIEW29 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

ENDGAMES38 Quiz page for doctors

in training

MINERVA40 Clopidogrel, and other

storiesPaper records advantages, p Stridor on eating a banana, p

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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 privateprofit . . . 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

(BMJ2013;346:f1819)

PICTURE OF THE WEEKAn 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

The Editor, BMJBMA House, Tavistock Square,London WCH JR

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Editor of the BMJ. The views expressed inthe journal are those of the authors andmay not necessarily comply with BMApolicy. TheBMJfollows guidelines oneditorial independence produced by theWorld Association of Medical Editors (www.wame.org/wamestmt.htm#independence)and the code on good publication practiceproduced by the Committee on PublicationEthics (www.publicationethics.org.uk/guidelines/).

The BMJis intended for medicalprofessionals and is provided withoutwarranty, express or implied. Statementsin the journal are the responsibility of theirauthors and advertisers and not authorsinstitutions, the BMJ Publishing Group,or the BMA unless otherwise specifiedor determined by law. Acceptance ofadvertising does not imply endorsement.

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BMJ Publishing Group LtdAll Rights Reserved. No part of thispublication may be reproduced, stored ina retrieval system, or transmitted in anyform or by any other means, electronic,mechanical, photocopying, recording, orotherwise, without prior per mission, inwriting, of the BMJ

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BMJ.COM POLL

Will 1 April mark

the end of the

NHS in England?

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This weeks poll asks:

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THIS WEEK

I always felt when I was in WHO, dealing with illicit

drugs and alcohol, that there was a role for the privatesectornot necessarily a controlling role, but a role with

respect to alcohol policy. So says Marcus Grant, who le

WHOyears ago to set up the International Center for

Alcohol Policies for the alcohol industry (p ). 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 manyBMJreaders

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 ofAlcohol Studies refused to endorse the UK governments

similar public health responsibility deal in .

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. 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/who.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 th 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 . Theres

been immense progress in development over the past

decade, Charles Kenny concludes (p ). The MDGs

did some good, and Kenny argues that well need

another set of specic and measurable goals: WHOs

broad proposal wont suce. David Legge and David

Sanders go further, calling for regulation of transnational

corporations, especially in banking, agriculture, food,

and pharmaceuticals (p).

WHO denes universal health coverage as a system

in which all people can use health services while being

protected againstnancial hardship associated with

paying for them. Thats not the same thing as universalhealthcare, which is usually paid for by taxation.

Which system does England have now, given the huge

redisorganisation of its NHS onApril? Richard Vizes

obituary of primary care trusts (PCTs) may shed some

light, but wont alleviate much of the gloom (p). It

is inescapable, he says, that aeryears 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 eort and achievement, expose the

extraordinary diculties commissioners face in making

a dierence to patients outcomes. And that was whenthere was plenty of money.

Trish Groves deputy editor, BMJtroves@bmj.com

Follow Trish Groves at twitter.com/trished and the BMJs

latest at twitter.com/latestCite this as:BMJ;:f

EDITORS CHOICE

Promises, promisesRichard Vizes obituary

of primary care trusts(PCTs) may shedsome light, but wontalleviate much of thegloom

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NEWS

BMJ| 6 APRIL 2013 | VOLUME 346 1

GarethIacobucci BMJ

The publics satisfaction with the NHS has

changed little in the past months after a

record fall in , 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

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

just under two thirds (%) of respondents

were satised with the NHS. This is up slightly

from the % satisfaction rate in but still

some way below the % reported in .

The steep fall in public satisfaction in

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 ofongoing pressure on the health service.

The survey showed an increase in the publics

satisfaction with NHS emergency services, from

% to%. Satisfaction with outpatient serv-

ices (%) and inpatient services (%) showed

Public satisfaction with emergency care rises

ClareDyer BMJ

Doctors and nurses leaders are

urging the government to amend

controversial regulations oncommissioning 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 thatthe 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 rulesconflict 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 regulatorwith 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 theBMJ, 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.

Cite this as: BMJ;:f

no signicant change from last year, while sat-

isfaction with GP services (%) and dentists

(%) was also unchanged.

In a departure from previous surveys, satisfac-

tion with the NHS did not dier with respond-

ents political aliation. The results showed a

% satisfaction rate among Conservative and

Labour supporters and % 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 . With no real change in satis-

faction with the NHS in , this suggests that

the record fall in was not a blip and that

the ground lost may take some time to recover.

Cite this as:BMJ;:f

Doctors leaders urge government to amend commissioning regulations

Satisfaction with the NHS is still below 2010 levels, but approval of emergency care has increased

JONCHALLICOM/ALAMY

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

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NEWS

ZosiaKmietowicz BMJ

Training of psychiatrists

needs to be moreexible to

encourage doctors to take

up the specialty and pur-

sue a career in academia,

a report has said.

W i t h o u t 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 Cardiff

Universitys department of psychological

medicine and neurology.

He was speaking at the launch of the report

from the Academy of Medical Sciences, Strength-

ening Academic Psychiatry in the UK.

The number of posts in academic psychiatry

in the United Kingdom has fallen by % since

. And although mental ill health accounts

for some % of the disease burden, spending

on mental health research makes up just % of

the total UK health research budget.

Part of the problem was that psychiatry was

not projected suciently well enough, saidSimon 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 eciency 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. Inonly% of the

rst year training posts in psychiatry in England

werelled, rising only slightly to% in.

Trainees oen 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-

cult 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.

Cite this as:BMJ;:f

2 BMJ| 6 APRIL 2013 | VOLUME 346

Simon Wessely and Nick Craddock want

to see broader training to widen skills

Cross specialty training wouldimprove academic psychiatry

Hospitals plant trees to mark NHS sustainability day

Commissioners needclearer expectations andlonger funding rounds

ZosiaKmietowicz 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 nancial 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 eld

for providers of NHS healthcare.

The review was commissioned last May in

response to the Health and Social Care Act

, 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 playingeld. 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 benets 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 orunbundle 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 .

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 eld in the interests

of patients. This will include looking at the rec-

ommendations further and then deciding what

policy changes should be made.Cite this as:BMJ;:f

IngridTorjesen 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.

Cite this as: BMJ;:f

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NEWS

BMJ| 6 APRIL 2013 | VOLUME 346 3

AXELHESS/ALAMY

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 patentSophieArie LONDON

Indias highest court has rejected eorts by the

Swiss drugrm Novartis to patent its anticancer

drug imatinib mesilate (marketed as Glivec) in a

ruling in favour of Indias generic drug industry.

Aer 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 formanufacturers 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

() a month. The generic equivalent is cur-rently available in India for just .

But Novartis said that the Supreme Courts rul-

ing discourages future innovation by denying

therm 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

Mumbai 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 inunder pressure from

the World Trade Organization, and it awards pat-

ents only for drugs created since .

Novartis had patented a version of imatinib in

. But therm 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.Cite this as:BMJ;:f

ClareDyer BMJ

Childrens heart surgery at Leeds General

Inrmary 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

March, along with representatives of the Care

Quality Commission. He acknowledged that

the timing of his intervention looked suspicious,

coming only the day aer Leeds campaignerswon a High Court ruling that the Safe and Sus-

tainable review would have to redo part of its

consultation process.

But he told BBC Radio s Todaynews 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 stang 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 gures for

-and-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 gures 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 theBBC Breakfasttelevision 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 surgeonwas away on holiday, another surgeon was sus-

pended, and that le the service being oered by

two relatively junior locum surgeons.

Cite this as:BMJ;:f

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NEWS

4 BMJ| 6 APRIL 2013 | VOLUME 346

New public health system ismarred by confusion, say MPsAdrianODowd 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.

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 thenational bodies Public Health England and the

NHS Commissioning 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 conrm that Public Health England will

have sucient stain its local teams to deal with

contingencies, says the report.

The committees chairman, Clive Betts, the

Labour MP for Sheeld South East, said, Without

clarity there is only confusion, and a health emer-

gency is no time for muddle. The government mustset 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,April. Anything else is unacceptable.

Arrangements for screening and immunisa-

tion services will be the responsibility of the

NHS Commissioning 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 servicesfor children up toyears old and childhood immu-

nisation services, to public health stawithin 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 claried 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

shiof 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.Cite this as:BMJ;:f

CarolineWhite LONDON

An independent consumer watchdog for adults

and childrens health and social care services has

now been set up in each of the local authorities

across England, in time for theApril deadline, the

Local Government Association has told theBMJ.

Under the terms of the Health and Social Care

Act it is a statutory requirement fromApril

for local authorities to commission, fund, and per-

formance manage the local Healthwatch bodies.

They are the fourth reconguration inyears 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 withm 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 raising

concerns about the quality of local servicesnationallya role that has assumed more impor-

tance in the wake of the inquiry into the failings at

Mid Staordshire NHS Foundation Trust.

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.

Cite this as:BMJ;:f

CORRECTIONIssue 16 March, pp 4-6: More than a third of

GPs on commissioning groups have conflicts of

interest,BMJinvestigation shows

This recentBMJinvestigation by Gareth Iacobucci

(BMJ2013;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

BMJwould 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.

ADRIANB

ROOKS/REX

Healthwatch must beproperly resourced forits job, charities say

MPs said it was

unclear who would

be in charge during

a health emergency,

such as the 2009

swine flu outbreak

7/28/2019 BMJ - 6 April 2013

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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 ActDogged by financial pressures, role uncertainty, and gaps in leadership

NigelEdwards senior fellow, leadership developmentand health policy, Kings Fund, London WGAN, UKn.edwards@kingsfund.org.uk

The reforms that come into place aer implemen-

tation of the Health and Social Care Act onApril

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

nancial position this would be a major concern.

Therst striking feature is the number of organ-

isations that are new or that have substantially

redened roles. There are clinical commis-

sioning groups (CCGs),area teams,clinical

support units, clinical senates, local edu-

cation and training boards, andhealth andwellbeing 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 redened, and the Oce of Fair Trading

and the Competition Commission take on newresponsibilities for market 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 dicult

in the many places that have vacancies: even

the NHS Commissioning Board has two directorlevel 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

oces 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 rst time recently

in response to longstandingnancial problems in

south east London.

The rules of the new system are still beingwritten. 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)

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 redened 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 beinglled.

Relatively little attention has been paid to thetransfer 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 lled, 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. 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 eciencies and reduce

costs is cause for profound concern.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. The promise of liberation

of the NHS through reduced central control seems

to be slipping away. Time that could have beenbetter 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 externallypeer reviewed.

References are in the version on bmj.com.

Cite this as: BMJ;:f

Although the Department of Healthcontinues to assert that the reformsare the solution to the NHSsproblems, it offers little more thanassertion 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/blogsA new and very dierent type of NHS in England. New beginnings and new risks in English public health

7/28/2019 BMJ - 6 April 2013

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EDITORIALS

Taking the sting out of lumbar punctureUltrasound guided procedures seem less likely to fail

PaulRizzoliclinical director, JR Graham Headache Center,Brigham and Womens Faulkner Hospital, Boston, MA, USA prizzoli@partners.org

Lumbar puncture remains an important and

commonly performed diagnostic procedure, but

training for its performance is not standardized.

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 benet 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. The meta-analysis looked

at randomized studies with results from more

than 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 dened

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 signicance. Six ofprocedures failed in

the ultrasound group compared withofin

the control group (risk ratio.,% condence

interval.to.). Summary estimates for sec-

ondary outcomes of traumatic procedures, needle

reinsertions, and needle redirections all supportedthe primary outcomending. 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 dicult. 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 benets 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 benets shown may underestimate the

potential benets of a more general application ofultrasound 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 identication 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 waslow 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 interestthat merits further research. Unconrmed 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.

Identication 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 dicult

to master and does not greatly increase the time

needed to perform the procedure.

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,

conrm and quantify benet, identify appropriate

settings and patient populations, and investigate

appropriate protocols and possible amendments

to practice standards. Taken as a whole, the nd-

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 puncturesfor patients and clinicians.Competing interests: None declared.

Provenance and peer review: Commissioned; not externallypeer reviewed.

Lavi R, Rowe JM, Avivi I. Lumbar puncture: it is time to changethe needle. Eur Neurol;:-.

Williams J, Lye DC, Umapathi T. Diagnostic lumbar puncture:minimizing complications. Intern Med J;:-.

Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JCA,Beyene J, et al. Ultrasound imaging for lumbar puncturesand epidural catheterisations: systematic review and meta-analysis. BMJ;:f.

Nomura, JT, Leech SJ, Shenbagamurthi S, Sierzenski PR,OConnor RE, Bollinger M, et al. A randomized controlled trialof ultrasound-assisted lumbar puncture.J Ultrasound Med;:-.

Cite this as: BMJ;:f

RESEARCH, p

bmj.com

Letter: Bacterial meningitis and lumbar puncture (BMJ;:f)

Better performance could widen indications

SPL

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EDITORIALS

Vitamin D sufficiency in pregnancyBetter evidence is required to establish optimal levels and need for supplementation

RobynLucas associate professorrobyn.lucas@anu.edu.auFanXiangresearch fellow, National Centre forEpidemiology and Population Health, Australian NationalUniversity, Canberra, ACT, AustraliaAnne-LouisePonsonbyprofessor, Murdoch ChildrensResearch Institute, Royal Childrens Hospital, Melbourne,Vic, Australia

One year ago, the chief medical ocers of the

United Kingdom recommended that All preg-

nant and breastfeeding women should take a

daily supplement containing g ( IU) of

vitamin D, to counter the high prevalence of

vitamin D deciency in pregnant women. This

was aimed at reducing the associated conse-

quences of deciency, such as rickets in chil-

dren and osteomalacia in adults.

In a linked meta-analysis, Aghajafari and

colleagues look beyond bone health to other

adverse health outcomes for mother and baby.

Previous systematic reviews have highlighted

challenges in combining data from dierent

studies, including diverse denitions of vita-min D deciency, variations in vitamin D assays

used, use of non-representative samples, and

varying study designs and study quality.

A review published in found insu-

cient high quality studies to conduct quantita-

tive meta-analysis; 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 ve randomised

controlled trials, with additional studies

reviewed qualitatively. Combined data from

trials suggested that bolus high dose vitaminD supplementation (but not daily dosing) was

associated with reduced risk of low birth weight

(risk ratio.;% condence interval. to

.). Combined trial data found no signicant

protective eect of vitamin D supplementation

on the outcome small for gestational age (.,

. to .), although observational studies

supported a protective eect. Results for mater-

nal outcomes were inconsistent. In a

Cochrane systematic review, meta-analysis of

three trials of daily vitamin D supplementation

during pregnancy found a reduced risk of low

birth weight (., . to.), although thiswas not signicant.

In a recent combined analysis of two ran-

domised controlled trials, higher vitamin D

(measured as serum concentration of-hydrox-

yvitamin D;-OHD) at delivery was associated

with a signicantly (P

7/28/2019 BMJ - 6 April 2013

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EDITORIALS

Sex selection and abortion in IndiaEfforts to curb sex selection must not retard progressive safe abortion policies

recently recommended extending termination up

toweeks, from the current weeks. 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. In, more

than 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. Unsafe abortions account for nearly %

of all maternal deaths in India. 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, 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. What really needs to

change is the fabric of the patriarchal Indian soci-

ety that undervalues girls and women.

Competing interests: None declared.

Provenance and peer review: Not commissioned; notexternally peer reviewed.

References are in the version on bmj.com.Cite this as:BMJ;:f

AnitaJainIndia 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 aer the

Indian census showed a decline in the sex ratio.

The number of girls per boys dropped from

in to in for children aged-

years.Most notable was Maharashtra state, which

recorded a decline in the sex ratio from in

to in. 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. However, a

parallel stream of ill informed directives may result

in the victimisation of women seeking abortion.

The act, passed in and amended before

coming into effect in , 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 documentationthat 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 SelectionAct 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.

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 weeks; introduction of

a silent observer technology that relays ultra-

sound images from pregnant women to authori-

ties to track potential sex selective abortions; and

the requirement that doctors take digital images ofthe fetus aer abortion.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. The state, how-ever, seeks to ban retail sale of these pills or place

them on schedule X, which requires rigorous

record keeping of women who purchase the pills,

with the potential to trace their whereabouts.

A clampdown on manufacturers and retailers of

abortion pills has led to the withdrawal of these

pills from the market and an ensuing shortage.

This has occurred despite World Health Organiza-

tion recommendations to phase out surgery for

rst trimester abortions in favour of medical meth-

ods. The government also seeks to mandate a

three visit schedule to the hospital for termination

using abortion pills. Thisies in the face of currentguidelines that permit doctors to prescribe these

pills at their clinic, provided women have access

to a registered facility for abortion.

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 abortionlimits. The National Commission for Women has

bmj.com

News: Death of baby with anencephaly aer mother was refused an abortion sparks controversy in India (BMJ;:e) Feature: Is abortion worldwide becoming more restrictive? (BMJ;:e)

Sex ratio in India continues to decline

7/28/2019 BMJ - 6 April 2013

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TheBMJis an Open Access journal. We set no word limits onBMJresearch articles, but they

are abridged for print. The full text of each BMJresearch 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 yoursmartphone to read ourinstructions 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

adults undergo this treatment annu-

ally in the US.

A study used a factorial design to test

infusions of a 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 participants, recruited from US

and Canadian centres, were people over

years who had experienced myocardial infarc-

tion and had a serum creatinine of mg/dL (

mg/dL=. 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 (%) people randomised to chelation

versus (%) of those who received pla-

cebo (hazard ratio ., % CI . to .).

A similar eect was seen for the individual com-

ponents of the composite outcome, although

not for deaths (% v% with placebo; .,

. to .).

The authors warn that this evidence does not

justify routine use of chelation, as do two linked

editorials. In one (p ), the journals editorsexplain why they decided to publish the paper

despite this year, m (.m;.m)

trial having been controversial since its incep-

tion. The other editorial discusses the studys

shortcomings, arguing that its results are not

reliable (p ). Concerns include marginal

statistical significance for the main finding,

unbalanced dropout rates (%) of par-

ticipants withdrew consent during the trial,

of those receiving chelation versuswith pla-

ceboas well as unblinding of the sponsors and

possibly researchers and participants.

JAMA;:-Cite this as:BMJ;:f

Miravirsen works against

hepatitis C virus

Hepatitis C virus is dependant for growth on

microRNA- in the liver of infected people. A

new drug, miravirsen, binds to microRNA-,

disabling the binding and growth of the virus.

A phase IIa study tested three doses ( mg,

mg, and mg/kg body weight) against

placebo inpeople 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 IU per mL) was .with mg,

. with mg, and . with mg. In the pla-

cebo group, this gure was . log 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:./NEJMe).

N Engl J Med; doi:./NEJMoa

Cite this as:BMJ;:f

Shorter life expectancies in eastern

versus western Europe

The gap in life expectancy between eastern andwestern Europe is 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. Policiessuch as tobacco control, road trac 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 haveled 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

-% ethanolare consumed widely. Con-

trol of infectious diseases broke down in some

countries, with re-emergence of diphtheria and

tuberculosis.

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 rst time theLancethas published

a series of papers on health in Europe (www.the-

lancet.com/series/health-in-europe).

Lancet; doi:./S-()-Cite this as: BMJ;:f

Adapted from Lancet; doi:./S-()-

Year of birth

Life

expectancy

(years)

Trends in life expectancy in men

Selected countries in western Europe

Life

expectancy

(years)

Selected countries in central and eastern Europe

FinlandWestern Germany

ItalyPortugal

SwedenUK

Eastern GermanyCroatia

HungaryEstonia

Russia

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RESEARCH

Department of Community HealthSciences, University of Calgary,Calgary, Alberta, Canada TN NDepartment of Family Medicine,University of Calgary, CanadaCalgary Institute for Population andPublic Health, University of Calgary,CanadaDepartment of Paediatrics,University of Calgary, Canada

Department of Medicine, Universityof Calgary, Canada

Correspondence to: D M RabiDoreen.Rabi@albertahealthservices.ca

Cite this as:BMJ;:fdoi: ./bmj.f

This is a summary of a paper thatwas published on bmj.com as BMJ;:f

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 ( to

August ), PubMed ( to August ), Embase( to August ), CINAHL ( to August ),

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-OHD level during pregnancy and the outcomes

of interest.

Primary outcomes

We assessed the association between low -OHD level

and pregnancy outcomes (pre-eclampsia, gestational dia-

betes, bacterial vaginosis, caesarean section) and birthvariables (small for gestational age, birth weight, birth

length, and head circumference).

Main results and role of chance

Of citations, studies met our criteria for inclu-

sion in the nal analysis. We used random eects models

to pool adjusted odds ratio for low -OHD levels com-

pared with sucient levels. Insucient -OHD levels

were associated with gestational diabetes (pooled odds

ratio ., % condence interval . to .), pre-

eclampsia (., . to .), and small for gestational

age infants (., . to .). Pregnant women with

low-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 denitions of-OHD insuf-

ciency. Our analysis used cut-os that were most com-

monly reported among studies eligible for inclusion in

our review. The identied studies used a cut-oof less

than nmol/L to dene insuciency for pregnancy

outcomes and less than . 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 identied 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 stratied by study design and -OHD

quantication 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, Tharsiya Nagulesapillai, Paul E Ronksley, Suzanne C Tough,Maeve OBeirne, Doreen M Rabi

EDITORIAL by Lucas et al Summary of pooled odds ratio and weighted mean differencefor low-hydroxyvitamin D levels and pregnancy outcomesand birth variables

OutcomeNo ofstudies

Pooled odds ratio(% CI)

Gestational diabetes . (. to .)

Pre-eclampsia . (. to .)

Small for gestational age . (. to .)

bmj.com

Research: Eect of weekly

vitamin D supplements on

mortality, morbidity, and growth

of low birthweight term infants

in India up to age months

(BMJ;:d)

Research: Calcium

supplements with or withoutvitamin D and risk of

cardiovascular events

(BMJ;:d)

Research: Eects of vitamin

D supplementation on bone

density in healthy children

(BMJ;:c)

Research: Fall prevention

with supplemental and active

forms of vitamin D

(BMJ;:b)

7/28/2019 BMJ - 6 April 2013

15/44BMJ| 6 APRIL 2013 | VOLUME 346 11

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.

WHAT IS KNOWN AND WHAT THIS PAPER ADDS

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 ), and the

Cochrane Central Register of Controlled Trials (to the sec-

ond quarter of), without restriction by language or

publication status.

Primary outcome(s)

The primary outcome of interest was the number of failed

procedures, dened 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 identied randomised trials. In total, patientswere assigned to the ultrasound group and to the

control group. Twelve studies were meta-analysed for

our primary outcome. There were six failed procedures

of in the ultrasound group compared with failed

procedures of in the control group. Ultrasound imag-

ing reduced the risk of failed procedures with a risk ratio

of. (% condence interval . to., P

7/28/2019 BMJ - 6 April 2013

16/44

7/28/2019 BMJ - 6 April 2013

17/44BMJ| 6 APRIL 2013 | VOLUME 346 13

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.

WHAT IS KNOWN AND WHAT THIS PAPER ADDS

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 aftermonths, and with reference to the National

Institute for Health and Clinical Excellences recommended

willingness to pay threshold ofper 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 benet analyses of costs and outcomes for

patients (receiving telehealth;usual care). The

adjusted mean dierence in QALY gain between groups at

months was.. Incremental cost of the telehealth inter-

vention per QALY gained was(;).

The probability of telehealth being cost eective was% at

a willingness to pay threshold ofper QALY gained,

and exceeded% only if willingness to pay values exceeded

about.

Source(s) of effectivenessA telehealth trial conducted in three English regions recruited

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 formonths, 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 meancosts for the telehealth group were less under these new

scenarios, and in some cases seemed more cost eective.

For example, reducing equipment costs by % in combi-

nation with reduced support costs resulted in a% likeli-

hood that telehealth was cost eective for a willingness to

pay threshold ofper 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

months of treatment could be multiplied up to a yearly

cost. The timeframe of the evaluation could have been tooshort to show improvements in health related quality of life.

The extent to which costs and outcomes diered between

participants who completed month follow-up and those

who did not (% 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 havenot created competing interests.

Cost effectiveness of telehealth for patients with long term conditions(Whole Systems Demonstrator telehealth questionnaire study): nestedeconomic evaluation in a pragmatic, cluster randomised controlled trial

Catherine Henderson,1

Martin Knapp,1 2

Jos-Luis Fernndez,1

Jennifer Beecham,1

Shashivadan PHirani,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

London School of Economics andPolitical Science, LondonWCAAE, UKKings College London, London, UKSchool of Health Sciences, CityUniversity London, London, UKUniversity of Southampton,Southampton, UK

University of Manchester,Manchester, UKUniversity of East Anglia, Norwich,UKUniversity of Oxford, Oxford, UKThe Nuffield Trust, London, UKUniversity of Surrey, Guildford, UK

Correspondence to: C HendersonC.Henderson@lse.ac.uk

Cite this as:BMJ;:f

doi:./bmj.f

This is a summary of a paper thatwas published on bmj.com as BMJ;:f

Cost eectiveness acceptability curve: QALY

Willingness to pay per additional QALY (s)

Probab

ility

thattelehealth

is

costeective

.

.

.

.

.

Total health and social care costs

Total health and social care costs(minus costs relating to projectmanagement posts and contracts)

bmj.com

Research: Eect of

telehealth on quality of life and

psychological outcomes over

months (Whole Systems

Demonstrator telehealth

questionnaire study)

(BMJ;:f)

Research: Eect of telehealth

on use of secondary care and

mortality(BMJ;:e)

7/28/2019 BMJ - 6 April 2013

18/4414 BMJ| 6 APRIL 2013 | VOLUME 346

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 diculty of prising the ngers of the

public othe gates of their beloved hospitals.

While this was always going to be dicult,

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 to recongure hospital services in the

county was led by clinicians, with a consultation

exercise that included meetings intowns and

villages, the distribution of more than

leaets, 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 themto 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

oen 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 dicult work commissioners undertookto unseat substandard local doctors. In many

Did primary care trusts improve

healthcare? It took just years for

them to be created, merged, clustered,

and abolished. During that time they

were responsible for about% of the

NHS budget in England.

The originalPCTs across England began

taking over from district health authorities and

primary care groups in. In they were

merged to formorganisations 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 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 th