This week's embargoed articles may not be available until 09:00 (UK time) Thursday.

Press releases Monday 5 January 2009 to Friday 9 January 2009

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://www.bmj.com).

(1) New NICE guidance may do little to improve availability of expensive drugs
(2) Presumed consent may increase donor rates in the UK
(3) Many patients prefer telephone follow-up after breast cancer treatment
(4) Postnatal depression can be effectively treated and possibly prevented

(1) New NICE guidance may do little to improve availability of expensive drugs
(Analysis: NICE and the challenge of cancer drugs)
http://www.bmj.com/cgi/doi/10.1136/bmj.b67

New NICE guidelines to help improve access to end of life drugs for terminally ill patients are unlikely to lead to acceptance of all the drugs provisionally refused, argues a senior researcher on BMJ com today.

James Raftery, Professor of Health Technology Assessment at Southampton University, says that the new arrangements from the National Institute for Health and Clinical Excellence (NICE) will do little to improve availability of expensive drugs and may result in other patient groups being denied treatment.

During 1999-2008, NICE rejected 11 drugs on the grounds of cost effectiveness (their cost per quality adjusted life year or QALY was well above NICE's threshold of £30,000). A QALY is a combined measure of quantity and quality of life.

These decisions sparked ethical, legal and political dilemmas, and prompted a review which recommended that NICE should revise its cost effectiveness threshold for end of life drugs. The new advice applies to treatments that affect small numbers of patients who are not expected to live more than 24 months, and that offer demonstrable survival benefits (at least an extra three months of life) compared with current NHS practice.

Professor Raftery examined the effect the new arrangements would have had on all cancer drugs that NICE has refused or proposed to refuse because of cost effectiveness.

He found that few of the rejected drugs would qualify under the new criteria, with most failing to meet the criterion that no alternative treatment with comparable benefits existed.

He also warns that making an exception for any group sets a precedent for other groups, and that setting the threshold higher for some groups within a fixed overall budget results in other patient groups being denied treatment.

He concludes: "NICE will celebrate its 10th birthday in 2009 having had to make a major change in its methods. Its attempt to minimise the effects of these changes will no doubt be tested in future appeals against its findings."

Contact:
James Raftery, Professor of Health Technology Assessment, Southampton University, Southampton, UK
Email: j.p.raftery@soton.ac.uk

A system of presumed consent for organ donation may increase the number of donors available in the UK, according to research published on bmj.com today.

In 2006, the UK Organ Donation Taskforce was set up to identify barriers to organ donation. At the end of 2008, the Taskforce recommended an overhaul of UK transplant services to boost donor rates but advised against introducing a system of presumed consent.

The research team at the Centre for Reviews and Dissemination (CRD), focused on 13 studies that either assessed organ donation rates before and after the introduction of presumed consent in a single country or compared rates between countries with similar systems.

Several studies assessed by CRD showed a significant link between increased organ donation rates and presumed consent - in one of these estimated donation rates were 25-30% higher with presumed consent.

However, the authors emphasise that it is unlikely that presumed consent alone is responsible for higher donation rates, and that other important factors need to be taken into account. These include mortality from road traffic accidents, the number of transplant centres and coordinators, health expenditure, public awareness and religion.

The authors also analysed 13 surveys that focused on public and professional attitudes towards presumed consent, eight of which were of the UK public. While support in the UK for presumed consent varied, it has been steadily growing since 2000 - in the most recent survey undertaken in 2007, 64% of respondents were in favour of moving to presumed consent.

Dr Catriona McDaid and colleagues believe that this study is a useful stepping stone to future research: "Further work is required to investigate factors at the personal level that may modify donor rates such as how families are approached to discuss donation of a relative's organs. A review of qualitative research addressing these issues would be useful."

Contact:
Dr Catriona McDaid, Research Fellow, Centre for Reviews and Dissemination (CRD), University of York, York, UK
Email: ab42@york.ac.uk

(3) Many patients prefer telephone follow-up after breast cancer treatment
(Research: Comparing hospital and telephone follow-up after treatment for breast cancer: randomised equivalence trial)
http://www.bmj.com/cgi/doi/10.1136/bmj.a3147
(Editorial: Follow-up by telephone after treatment for breast cancer)
http://www.bmj.com/cgi/doi/10.1136/bmj.a2753

Telephone follow-up after breast cancer treatment is more acceptable to patients than traditional hospital follow-up, finds a study published on bmj.com today. It may also help to reduce the burden on busy hospital clinics.

Clinical examination, consultation and routine breast screening (mammography) are the norm in breast cancer follow-up although UK national guidelines currently recommend that intensive follow-up to detect metastatic disease is not beneficial.

Professor of Nursing, Kinta Beaver and colleagues identified 374 women treated for breast cancer at two NHS hospitals in the North West of England who were at low to moderate risk of recurrence.

Participants were randomly split into two groups. One received traditional hospital follow-up (ten minute consultations and breast examination by doctors at hospital clinics) while the other received telephone follow-up (20 minute consultations with no clinical examination by trained specialist nurses). Both groups received mammograms as per hospital policy.

The researchers found that the telephone group were no more anxious as a result of foregoing clinical examinations and face-to-face consultations, and reported higher levels of satisfaction than those attending hospital clinics. The number of clinical investigations ordered did not differ between groups and there were no differences between groups for time taken to detect recurrent disease.

The results of this study show the positive benefits of telephone follow-up by specialist breast care nurses, say the authors. The service was well received, especially by patients with long travelling distances or mobility problems, with no evidence of physical or psychological detriment.

They suggest that telephone follow-up may have a broader applicability to other patient groups in the cancer field and beyond, while also reducing the burden on busy hospital clinics.

This study adds to the growing body of evidence that alternative methods of follow-up can be as or more acceptable to patients and can usefully provide the psychological support needed after diagnosis and treatment of breast cancer, writes David Montgomery in an accompanying editorial.

However, it does not bring us closer to definitive proof that routine clinical breast examination is unnecessary. He believes that, only with such evidence will we see widespread implementation of novel alternatives, to the benefit of our patients. This, he says, would require a big trial, but it must happen.

Contacts:
Research: Kinta Beaver, Professor of Nursing, School of Nursing, Midwifery & Social Work, University of Manchester, UK
Email: kinta.beaver@manchester.ac.uk

(4) Postnatal depression can be effectively treated and possibly prevented
(Clinical effectiveness of health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care)
http://www.bmj.com/cgi/doi/10.1136/bmj.a3045
(The effect of peer support on the prevention of postnatal depression among high risk women: randomised controlled trial)
http://www.bmj.com/cgi/doi/10.1136/bmj.a3064
(Editorial: Preventing and treating postnatal depression)
http://www.bmj.com/cgi/doi/10.1136/bmj.a2975

Health visitors can be trained to identify women with postnatal depression and offer effective treatment, while telephone peer support (mother to mother) may halve the risk of developing postnatal depression, suggests research published on bmj.com today.

About 13% of women experience postnatal depression in the year following the birth of their child. But postnatal depression is frequently undetected and untreated, often because of poor recognition of symptoms, unawareness of treatment options or fear of stigmatisation.

Antidepressants have been shown to be an effective treatment for postnatal depression, but many women are reluctant to take drugs, especially when breast feeding. Psychological therapies may provide an alternative treatment, but their effectiveness is unclear.

In one of the largest trials of postnatal depression, Dr Jane Morrell and colleagues analysed whether psychological interventions were effective in treating the symptoms of postnatal depression. Over 4,000 mothers from 101 general practices in England consented to take part. Practices were randomised so women received either a cognitive behavioural approach or a person centred approach from specially trained health visitors or health visitor usual care.

Health visitors in the intervention group were trained to identify depressive symptoms and deliver cognitive behavioural or person centred sessions for an hour per week for up to eight weeks. Validated scales were used to assess depressive symptoms among the mothers. A threshold score of 12 or more identified women with symptoms of depression. Participants were followed up for 18 months and assessed every six months using a postal questionnaire.

At both six months and 12 months postnatally, the mothers who received care from the specially trained health visitors showed significantly greater reductions in depressive symptoms than those who received health visitor usual care. Mothers in the intervention group with depressive symptoms at six weeks were 40% less likely to have depressive symptoms at six months than those receiving health visitor usual care.

The researchers found no benefit of one psychological approach over the other.

In a second study, Dr Cindy-Lee Dennis and colleagues from Canada examined the effectiveness of telephone based peer support to prevent postnatal depression in high risk women.

After web-based screening of more than 21,000 women from seven health regions in Ontario, Canada, 701 were identified at high risk of postnatal depression and randomised to receive standard postnatal care or standard care and the support of a peer volunteer (who had experienced postnatal depression themselves).

Mothers who received peer support had half the risk of developing postnatal depression at 12 weeks after birth than those in the control group. Mothers were receptive to receiving telephone-based peer support and over 80% said they were satisfied with their experience and would recommend this support to a friend.

Women and family members need to be educated about postnatal depression so they can recognise the symptoms, and treatment needs to be convenient and accessible to new mothers, says Dr Cindy-Lee Dennis in an accompanying editorial.

She calls for a coordinated multidisciplinary approach to identify postnatal depression involving all health professionals who come into contact with new mothers including midwives, doctors, nurses and health visitors.

Contacts:
Dr Jane Morrell, Research Leader, University of Huddersfield, UK
Email: j.morrell@hud.ac.uk

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