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Press releases Saturday 14 July 2007

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(1) The 'two-week wait rule' is failing breast cancer patients
(2) Evidence underlying repeated courses of steroids for preterm birth is unsound
(3) More NHS restructuring likely to lead to disarray
(4) HIV testing should not have special status

(1) The 'two-week wait rule' is failing breast cancer patients

(Referral patterns, cancer diagnoses, and waiting times after introduction of two week wait rule for breast cancer: prospective cohort study)
BMJ Online First

The 'two week wait rule' is failing breast cancer patients and needs to be reviewed urgently say the authors of a seven year study examining the impact of the target, published today on bmj.com.

At the end of the last century death rates from breast cancer in the UK were among the highest in Europe. Long waiting lists, resulting in delayed diagnosis and treatment, were thought to be partly responsible. In 1998 the Department of Health brought in the '2 week wait rule' which stipulated that by April 1999 all patients with suspected breast cancer should be seen by a specialist within two weeks of referral by a GP.

Many studies have questioned the validity of the 2 week wait rule, but this is the first to assess the long term impact. Dr Shelley Potter and her colleagues gathered data on the number, route and outcome of Primary Care referrals to the Frenchay Brest Care Centre in Bristol between 1999 and 2005.

There were 24,999 referrals to the centre during this period, with GPs classifying each patient as being either 'urgent' according to 2 week wait criteria or 'routine'. Between 1999 and 2005 the number of annual referrals to the centre increased by 9%.

Routine referrals decreased by 24% but 2-week wait referrals increased by 42%. Despite the changes in referral patterns the total number of cancers remained constant over the 7 year period.

Yet the researchers found the percentage of patients diagnosed with cancer in the 2-week wait group decreased from 12.8% to 7.7% whilst the number of cancers detected in the 'routine' group increased from 2.5% to 5.3% over the same time period. In 2005 more than 1 in 4 (27%) patients ultimately diagnosed with cancer in 2005 was referred non-urgently. Dr Potter describes the increase in cancers diagnosed from the routine population as ±alarming± and says:

±These patients are also potentially being disadvantaged by longer clinic waits and delays in diagnosis as waiting times for routine referrals have increased in the face of increasing service demands from the dramatically increased number of patients referred under the two week rule, over 90% of whom have benign disease.±

Despite increasing numbers of referrals, waiting times for the 2 week wait group were always well maintained say the authors. However waiting times for routine referrals increased, these patients currently have to wait 30 days.

They conclude by saying: ±The system is failing patients and a change is urgently needed.±

Contacts:
Dr Shelley Potter, Department of Clinical Sciences at South Bristol, Bristol Royal Infirmary, Bristol, UK
Email: shelleypotter289@hotmail.com

Mr Simon Cawthorn, Consultant Surgeon, Frenchay Breast Care Centre, Bristol, UK

(2) Evidence underlying repeated courses of steroids for preterm birth is unsound

(Decline in effectiveness of antenatal corticosteroids with time to birth: real or artefact?)
http://www.bmj.com/cgi/content/short/335/7610/24

Researchers in this week's BMJ question whether giving repeated courses of steroid drugs to mothers at risk of preterm delivery is based on sound evidence.

Babies born before 32 weeks of pregnancy often have neonatal lung disease, a major cause of illness and death - the earlier the birth, the greater the risk.

In the 1990s, the benefit of giving antenatal corticosteroids to prevent lung disease in preterm babies was established. Several analyses concluded that steroids were most effective when given within a week of delivery and this led to repeated treatment for women who did not deliver within this time frame. Many mothers received multiple courses of corticosteroids during the 1990s and early 2000s.

But now two researchers warn that methodological problems in these analyses mean that this conclusion may be wrong and the practice of repeating courses was not based on any good evidence. We do not yet know whether this practice was beneficial or harmful.

The main problem, they say, is that the analyses of subgroups of people in the research studies were not done correctly and may have been misleading.

Several trials are now underway to determine the efficacy and safety of repeated courses of steroids. Results so far have shown no conclusive evidence of short-term benefit but long-term follow-up is needed to fully understand the benefits and risks, say the authors.

Until then, they suggest that reanalysis of the data from the original trials may help to clarify whether effectiveness declines with time to delivery, and if so, over what timescale this occurs.

But they warn that these new trials should avoid making the same errors in subgroup analyses ±or we risk repeating the errors made in the conclusions of the original antenatal steroid trials.±

Contact:
Simon Gates, Principal Research Fellow, Warwick Medical School Clinical Trials Unit, University of Warwick, Coventry, UK
Email: s.gates@warwick.ac.uk

(3) More NHS restructuring likely to lead to disarray

(Personal View: How to restructure-proof your health service)
http://www.bmj.com/cgi/content/short/335/7610/99

Another major review of the NHS, announced last week by prime minister Gordon Brown and new health secretary Alan Johnson, is likely to lead to confusion rather than clarity, argues a researcher in this week's BMJ.

Mr Brown and Mr Johnson promised an NHS that is ±clinically driven, patient centred, and responsive to local communities.± They also pledged to stop giving top down instructions and ceasing centrally dictated restructuring.

Yet this review will surely try to reorganise from the top the way predecessor reviews did, argues Professor Jeffrey Braithwaite from the University of New South Wales.

In politicians, he says, the strong desire to be seen to be in charge invariably wins over the weak desire to be at arm's length or encourage bottom-up measures, especially from something that determines votes as much as the NHS does. So, despite the denials, you can feel it in the air ± reorganisation is being signalled.

But the evidence indicates that top-down measures and restructuring can cause disarray, he writes. Rather than accelerating organisational progress, research has found that merging can put trusts back by 18 months or more.

Research has also shown that the gains in efficiency sought through restructuring are elusive at best, and may even result in inefficiencies.

Furthermore, anecdotal accounts suggest that restructuring is disruptive for most staff, threatening for many, and morale sapping overall, in part because of the uncertainty created and also because everyone is tired of change.

Undertaking structural change clearly sends mixed messages, he says. The feelings of disempowerment linger, and, increasingly, there are reports that confusion rather than clarity results from reorganisations. Continuously rearranging things exacerbates this, creating bewilderment and even incredulity.

Professor Braithwaite believes that clinical staff need a strategy to counterbalance any disruptive effects from this review and suggests that if you develop your services in a positive direction, you will be likely to take the review's findings, whatever they are, in your stride.

The "delicious irony" here is you are likely to find your services are more ±clinically driven, patient centred, and responsive to local communities± without restructuring under external pressure, he concludes.

Contact:
Jeffrey Braithwaite, Professor and Director, Centre for Clinical Governance Research, Faculty of Medicine, University of New South Wales, Sydney, Australia Tel
Email: j.braithwaite@unsw.edu.au

(4) HIV testing should not have special status

( Letter: HIV exceptionalism must end )
http://www.bmj.com/cgi/content/short/335/7610/60-a

( The societal costs of failing to develop a vaccine )
http://www.bmj.com/cgi/content/short/335/7610/60-b

HIV testing should not be accorded any special status in the UK as knowledge about HIV status can be lifesaving, argues a doctor in a letter to this week's BMJ.

Such opinions are seemingly ignored by the UK government and medical establishment, whereas in the United States reform is under way, writes retired general practitioner, Dr Martin Brewster.

He refers to the cases of two apparently healthy babies who presented later with established HIV because the mothers' infection had escaped detection. Abolishing exceptionalism would prevent such failure, he argues.

And he warns that, if reform does not come soon, legal liability and negligent practice court action will become a reality.

A high court judgement in 1999 ruled that an infant's human rights to HIV testing outweigh parental rights of choice, and it can only be a matter of time before another court finds the right to be born free of HIV infection outweighs all other considerations, he says.

Doctors and politicians failing to take note do so at their future peril, he warns. Waiting for cost effectiveness evidence is unethical.

A second letter argues that policymakers should consider not the cost of developing a vaccine against HIV, but the cost to society if it fails to develop one.

Public policy expert, Jeremiah Norris says that if the rate of HIV drug resistance in the developing world is around 10% then 200,000 people would be drug resistant by 2010 and would move on to second line therapies. But second line treatments are over 20 times as expensive as first line ones, and patients on such treatments need care from skilled and relatively well paid medical professionals, he warns.

Failing to focus on developing an AIDS vaccine will lead to a sequential increase in the number of chronically sick people whose care and maintenance will prove financially unsustainable for donors and affected governments, he concludes.

Contacts:
Martin Brewster, retired general practitioner, Wigtown,
Email: forrie@brewsterweb.co.uk

Jeremiah Norris, Director, Center for Science in Public Policy, Hudson Institute, Washington DC, USA
Email: Jnorris289@aol.com

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