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Press releases Saturday 8 March 2008

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(1) Telling smokers their lung age improves quit rates
(2) Attending hospital at night or weekends may be associated with treatment delays
(3) Do we really know the truth about antidepressants?

(1) Telling smokers their lung age improves quit rates
(Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial)
http://www.bmj.com/cgi/short/bmj.39503.582396.25v1
(Editorial: Incentives to quit smoking in primary care)
http://www.bmj.com/cgi/short/bmj.39506.386759.80v1

Telling smokers their lung age significantly improves the likelihood of them quitting, finds a study published on bmj.com today.

The concept of lung age (the age of the average healthy person with similar lung function to the individual) was developed to help patients understand complex lung data and to show how smoking prematurely ages the lungs. But currently there is no evidence that this increases quit rates.

So researchers set out to test the theory that telling smokers their lung age would lead to successful smoking cessation, especially in those with most damage.

The study took place in five general practices in Hertfordshire and involved 561 current smokers aged over 35. Information such as age, smoking history, and medical conditions were recorded.

All participants had a lung function test using a spirometer (this records the volume and rate at which a patient exhales air from the lungs) before being split into two random groups. The intervention group received detailed information about their spirometry results and lung age, given a diagram of how smoking ages the lungs, and told that quitting would slow down the rate of deterioration. The control group were given a raw figure for forced expiratory volume in one second (FEV1) with no further explanation.

Both groups were told that their lung function would be measured again after 12 months to see if there had been any change. They were also strongly encouraged to quit and offered referral to local NHS smoking cessation services.

Twelve months later, breath and saliva tests confirmed that 13.6% of patients in the intervention group and 6.4% of patients in the control group had successfully quit. In other words, patients in the intervention group were around twice as likely to have stopped smoking than those in the control group.

However, people with worse spirometric lung age results were no more likely to have quit than those with normal lung age in either the intervention or the control group.

This unexpected finding suggests that knowing ones lung age helps a smoker to quit whatever the result, explain the authors, and more research is needed to investigate the psychological reasons behind this.

Smoking cessation rates can be improved by spirometry and lung age estimation in primary care, say the authors. This study supports the introduction of screening smokers over 35 years of age to reduce smoking and improve early diagnosis of chronic lung disease. They also suggest that formal economic evaluation of this new and simple intervention should be a research priority.

An accompanying editorial says that providing feedback on lung age with graphic displays seems to be the best option so far for communicating the results of spirometry. This strategy might also be an opportunity for general practitioners to tailor smoking cessation messages to the individual, as recommended in the recent NICE guidance on smoking cessation.

Contact:
Gary Parkes, General Practitioner, Hoddesdon, Hertfordshire, UK
Email: parkesko@hotmail.co.uk

(2) Attending hospital at night or weekends may be associated with treatment delays
(Letter: Consider time of presentation)
http://www.bmj.com/cgi/content/short/336/7643/522

The time of day or night at which severely injured patients attend hospital has a huge impact on their treatment and prognosis, warn two senior doctors in this week's BMJ.

This is because provision of key aspects of hospital trauma services such as staffing, access to operating theatres, and interventional radiology is reduced after normal working hours, say Paul Frost and Matt Wise, consultants in intensive care medicine at the University Hospital of Wales.

Their views follow the publication last month of a large trial to predict outcomes in patients with traumatic brain injury.

They point to a recent study that examined the process of care for 795 severely injured patients, 493 with head injury. Most presented to the accident and emergency department out of hours (18.00 - 07.59 hours or weekends).

It found that initial management of the patient was inappropriate in almost a quarter (23.5%) of cases when a senior house officer was the team leader or first reviewer compared with just 3% when a consultant performed this role.

Consultants were involved in 39.6% of cases during the day and only 11.5% of cases presenting at night. This trend was in the opposite direction for junior doctors, being highest during the night.

In addition to a lack of senior medical staff to coordinate management out of hours, immediate intervention for more specialised injuries was often unavailable.

Organisational deficiencies in out of hours care are not unique to the UK or to trauma care, they add. Increased mortality out of hours has also been identified in patients with heart attacks, cardiac arrest and patients being discharged from intensive care.

They believe that out of hours presentation to hospital may be associated with treatment delays and adverse outcomes and suggest that the time of hospital presentation should be considered when trying to predict outcome after severe injury.

Contact:
Paul Frost, Consultant in Intensive Care Medicine, University Hospital of Wales, Cardiff, Wales
Email: Paul.Frost@CardiffandVale.wales.nhs.uk

(3) Do we really know the truth about antidepressants?
(Feature: An untold story)
http://www.bmj.com/cgi/content/short/336/7643/532
(Editorial: Efficacy of antidepressants)
http://www.bmj.com/cgi/content/short/336/7643/516

Following last week's study suggesting that new generation antidepressants aren't all they’re cracked up to be, a special report in this week's BMJ asks do we really know the truth about antidepressants? Or statins? Or any other drug on the market?

Lack of access to data is an ongoing problem in the United States, despite passage of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which requires clinical trials to be registered in a public database, write journalists Jeanne Lenzer and Shannon Brownlee.

Although it's a positive step towards greater transparency, the act may not reduce the likelihood of dangerous or ineffective drugs remaining on the market as much as some people might have hoped, they warn. For example, not all trials have to be registered and access to full data is also constrained by trade secrecy laws.

To overcome this, researchers often request data under the Freedom of Information Act, but various rules can still prevent full access to underlying results.

Trade secrecy laws, for example, permit companies to withhold all information about drugs that do not win approval for a new indication, even when the drug is already on the market for other indications.

Such data are protected as trade secrets so that drug companies aren’t put at a "competitive disadvantage" when other companies, learning of the initial studies, aren’t forced to expend the same "wasted efforts."

This was the case with valdecoxib, a COX 2 inhibitor that failed to gain FDA approval to treat acute pain in 2001. As a result, some of the trial information was withdrawn from the FDA website, leaving researchers and the public in the dark about possible side effects.

But it is precisely these failed trials that should be made public, argue the authors.

One suggestion is to make the FDA database available to researchers. The FDA says that it is far too onerous to put all its material online. But, as a number of experts have pointed out, the burden on the FDA from future Freedom of Information requests would be lessened if it posted all its data.

Ultimately, redacting clinical information from studies, forcing companies to expend "wasted efforts," and failing to insist that data derived from trial participants be placed in the public domain simply cannot be reconciled with what is in the public interest, write the authors.

Trial participants, as well as patients who take drugs and doctors who prescribe them, deserve nothing less than the assurance that all the news - not just the good news - has been carefully assessed, they conclude.

An editorial, also published in this week's BMJ, suggests that before we embrace any treatment as first line, it is prudent to ask whether its efficacy is beyond question. It also calls for drug regulatory authorities such as the FDA to make their reviews publicly and retrospectively available on the world wide web.

Contacts:
Jeanne Lenzer, Freelance medical investigative journalist, Kingston, NY, USA
Email: jeanne.lenzer@gmail.com
Shannon Brownlee, Senior Fellow, New America Foundation, Washington, DC
Email: brownlee@newamerica.net

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