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Press releases Saturday 4 March 2006

Please remember to credit the BMJ as source when publicising an article and to tell your readers that they can read its full text on the journal's web site (http://bmj.com).

(1) SCREENING MAY OVER-DIAGNOSE 1 IN 10 BREAST CANCERS

(2) BREAST SCREENING INFORMATION SHOULD BE MORE BALANCED

(3) BETTER PROCEDURES NEEDED ON CARE OF PRISONERS IN HOSPITALS

(4) WHAT'S NEEDED FOR TERMINALLY ILL PATIENTS TO DIE AT HOME?

(5) FUTURE OF CANCER RESEARCH IN EUROPE UNDER THREAT

(1) SCREENING MAY OVER-DIAGNOSE 1 IN 10 BREAST CANCERS

Online First
(Rate of overdiagnosis of breast cancer 15 years after the end of Malmö mammographic screening trial: follow-up study)
http://bmj.bmjjournals.com/cgi/rapidpdf/bmj.38764.572569.7C

Commentary: Commentary: Over-diagnosis in breast cancer screening
http://bmj.bmjjournals.com/cgi/rapidpdf/bmj.38768.401030.7C

(Editorial: Screening for breast cancer in England)
http://bmj.com/cgi/content/full/332/7540/499

Screening women for breast cancer could result in a 10% rate of over-diagnosis, finds a study published online by the BMJ today.

Although it is widely agreed that breast screening can reduce deaths, more discussion around this negative side effect of screening is needed, say the authors.

Researchers analysed the rate of over-diagnosis of breast cancer using data from a large breast screening trial conducted in Sweden between 1976 and 1986. Over-diagnosis is defined as cases that would never have come to clinical attention without screening.

They followed trial participants until December 2001, 15 years after the trial ended using national registries to track survival and detection of breast cancer.

Fifteen years after the end of the trial, the rate of over-diagnosis of breast cancer was 10% in women randomised to screening at age 55-69 years compared with an unscreened control group.

Although earlier studies on over-diagnosis have shown rates of up to 54%, a recent study suggests a much lower rate of 1%. But none of these studies were based on direct observations, like the present one, say the authors.

“It is widely agreed that screening using mammography can reduce mortality in breast cancer. The rate of over-diagnosis is another issue to be considered in the ongoing discussion about clinical and public health implications of breast cancer screening,” they conclude.

An editorial in this week’s BMJ discusses the UK breast screening programme and concludes that, although breast screening by mammography is far from perfect, it does save lives.

Contact:

Sophia Zackrisson, Epidemiological Research Group, Malmö University Hospital, Malmö, Sweden
Email: sophia.zackrisson@med.lu.se

(2) BREAST SCREENING INFORMATION SHOULD BE MORE BALANCED

(Content of invitations for publicly funded screening mammography)
http://bmj.com/cgi/content/full/332/7540/538

(Editorial: Screening for breast cancer in England)
http://bmj.com/cgi/content/full/332/7540/499

The information sent to women about breast screening needs to be more balanced to ensure women are adequately informed about the benefits and harms, say researchers in this week’s BMJ.

Invitations to screening mammography play a central part in the process of obtaining informed consent, but conflict of interest exists for publicly funded screening, since organisers want a high uptake. Research also shows that women generally exaggerate the benefits and are unaware of the harms of screening.

The researchers examined mammography invitations from English speaking and Scandinavian countries with publicly funded screening to assess whether they provide sufficient information to enable women to make an informed decision.

Thirty invitations (97%) mentioned the main benefit of screening, a reduction in breast cancer mortality, but only seven gave the size of the benefit and none of them in a helpful way. In contrast, no invitation mentioned the major harm of screening, over-diagnosis and subsequent over-treatment.

Six invitations argued that screening leads to less invasive surgery and another four stated that it leads to simpler treatment. None of the invitations noted that research has shown that screening leads to increased use of surgery and radiotherapy arising from over-diagnosis.

Fifteen invitations (48%) recommended regular breast self examinations, despite doubts over their benefit and documented harms.

Although it is good news that the invitations often included an information pamphlet, the focus on the benefits of screening is problematic, say the authors. The most important harms, over-diagnosis and over-treatment, were not mentioned and other important harms were often either omitted or downplayed.

Two-thirds (68%) of invitations gave an appointment date, but they warn that this gives the impression that participation is a public duty. They believe that information material should convey the message that a decision not to attend is not irresponsible.

“We believe that the information included with invitations should be more balanced, using absolute numbers to describe the likelihood of benefits and harms, and applying to the same time span if possible.”

“Furthermore, we suggest that the responsibility for the programmes should be separated from the responsibility for the information material and that consumer groups be involved in the process of developing balanced information material,” they conclude.

An editorial on the UK breast screening programme outlines recent efforts to provide women with sufficient information to make an informed choice.

Contacts:

Peter C Gøtzsche or Karsten Juhl Jørgensen, Nordic Cochrane Centre, Rigshospitalet Department, Copenhagen, Denmark
Email: pcg@cochrane.dk or kj@cochrane.dk

(3) BETTER PROCEDURES NEEDED ON CARE OF PRISONERS IN HOSPITALS

(Letter: Prisoners in general hospitals: doctors’ attitudes and practice)
http://bmj.com/cgi/content/full/332/7540/548

Better procedures and training are needed to improve the care of prisoners in general hospitals, argue doctors in a letter to this week’s BMJ.

They surveyed 76 consultants and 139 junior doctors at a hospital near a large prison in Dublin to assess practices towards prisoners.

Guidelines from the BMA recommend examination and treatment without constraints, and without prison officers present, unless the risk of escape is high or the prisoner is a threat to himself or herself, the healthcare team, or others. The new Ethics Guide from the Irish Medical Council is consistent with this, stating that prisoners must be treated with courtesy and respect and afforded confidentiality but with due regard for security.

A total of 184 responded (60% of consultants and all junior doctors). In all, 181 were unaware of any guidelines in place for the treatment of prisoners in general hospitals. Almost all (180) had treated prisoners as patients at some stage in their career, and almost two thirds (111) felt uncomfortable while examining prisoners.

Only six doctors believed that breaches of confidentiality never occurred whereas 13 thought that they always happened and 162 sometimes. Consistent adherence to BMA guidelines was carried out by a minority.

This survey shows that hospital doctors have low awareness of guidelines for due preservation of confidentiality and also report patterns of professional conduct which militate against confidentiality, say the authors.

They suggest that hospital and prison authorities need to develop procedures to allow for reasonable levels of medical confidentiality between prisoners and healthcare staff. They also believe that those who teach ethics and professional conduct need to incorporate routine training on the care of prisoners.

Contact:

Professor Desmond O’Neill, Department of Medical Gerontology, Trinity Centre for Health Sciences, Adelaide and Meath Hospital, Dublin, Republic of Ireland
Email: arhc@amnch.ie

(4) WHAT'S NEEDED FOR TERMINALLY ILL PATIENTS TO DIE AT HOME?

(Factors influencing death at home in terminally ill patients with cancer: systematic review)
http://bmj.com/cgi/content/full/332/7540/515

Family support and better home-based care are two of the key priorities needed to enable terminally ill cancer patients to die at home, say researchers in this week’s BMJ.

The study, by a team at King’s College London, follows the recent announcement by the UK government to shift the emphasis of care from acute hospitals to primary care.

Well over half of people with a progressive illness want to die at home and several countries, including the UK, are making substantial reforms to enhance home care. But despite these efforts, most people in the UK, the US, Germany, Switzerland, and France die in hospitals. In the UK, the proportion of home deaths for patients with cancer is falling, from 27% in 1994 to 22% in 2003.

To determine what factors influence where patients with cancer die, the researchers analysed 58 studies involving over 1.5 million patients from 13 countries.

The most important factors linked to dying at home were patients’ limited function and mobility, patients’ preferences, availability and level of home care, presence of live-in relatives, and extended family support.

Future policies to enable people to die at home should focus on empowering families, public education, and improving home care, say the authors. Risk assessment and training doctors in end of life care are also important priorities.

In the last three years the UK has invested £12m in its end-of-life care programme but has so far failed to stop the trend of hospital deaths. Professor Higginson explains: “We have compared the current policies of the Government with the results of our review. All of the actions the Government is recommending and funding in its end-of-life care programme fall short in some ways.

In particular, they are not paying enough attention to assessing who is at risk of experiencing problems, in supporting families and in educating people about what they can expect from care. In Canada they have a new system of providing compassionate leave - like maternity leave - for carers, and perhaps the government needs to think of something like that in addition to ensuring home support.”

“This model represents an evidence based answer to the rights of terminally ill patients to die at home with dignity,” says author, Barbara Gomes. “We strongly encourage its use in the development and evaluation of future strategies by policy makers to enable more home deaths and by practitioners to enable their patients to die at home if they wish so.”

Contacts:

Professor Irene Higginson, The Cicely Saunders Foundation/Department of Palliative Care, Policy, and Rehabilitation, King’s College London, UK
Email: jennifer.lunan@kcl.ac.uk / irene.higginson @kcl.ac.uk

or

King’s College Public Relations, London, UK
Email: pr@kcl.ac.uk

(5) FUTURE OF CANCER RESEARCH IN EUROPE UNDER THREAT

(Editorial: Harmful impact of EU clinical trials directive)
http://bmj.com/cgi/content/full/332/7540/501

A new European directive is threatening the future of cancer research in Europe, warn experts in this week’s BMJ.

The EU clinical trials directive, implemented in 2004, was intended to protect patients and improve research standards. But many investigators were worried that the labour intensive, bureaucratic, and expensive endeavour of running a clinical trial would become worse under the new rules.

In particular, academic researchers funded by grants, who have so far performed most cancer trials, were worried that their resources might no longer suffice to meet the requirements of the new directive.

An analysis of research since the directive suggests that many of those fears have been realised. For example, the number of new trials fell from 19 in 2004 to 7 in 2005 (63% decrease), and a third fewer patients were enrolled.

Simultaneously, trial costs increased by 85% and insurance costs from 70 to 140 million euros. Trial initiation was about five months slower than in 2004, while paperwork and documentation increased.

Instead of benefiting patients, the analysis suggests that the directive had hindered their access to new treatments.

“Our own experiences are in accordance with these findings,” say the authors. The number of approved applications for both academic and company sponsored cancer trials in Helsinki has steadily decreased from 120 in 2002 to 70 in 2005 (42% decrease), but the workload of the ethics committee has increased.

These numbers seem to confirm the initial worries about the future of investigator initiated clinical cancer research, say the authors. Current and future patients with metastatic cancer should be worried. If research is thwarted the newest or most effective therapies may not become available rapidly, they warn.

New directives on clinical research are in preparation. Therefore, now is the time for action by physicians, patients, universities, and politicians to ensure that academic research can continue in Europe. It is in no one’s interest if only commercial corporations have the resources to plan and carry out clinical trials, they conclude.

Contacts:

Akseli Hemminki, Group Leader, Cancer Gene Therapy Group, University of Helsinki and Department of Oncology, Helsinki University Central Hospital, Finland
Email: akseli.hemminki@helsinki.fi

or

Pirkko-Liisa Kellokumpu-Lehtinen, Professor of Radiotherapy and Oncology, Tampere University Hospital, Tampere, Finland
Email: Pirkko-Liisa.Kellokumpu-lehtinen@uta.fi

FOR ACCREDITED JOURNALISTS

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(contact: pressoffice@bma.org.uk)

and from:

the EurekAlert website, run by the American Association for theAdvancement of Science(http://www.eurekalert.org)