Press releases Monday 11 October to Friday 15 October 2010
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 website (http://www.bmj.com).
(1) Patients and doctors are being misled by published data on medicines
(Research: Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished trials controlled with placebo and selective serotonin reuptake inhibitors)
http://www.bmj.com/cgi/doi/10.1136/bmj.c4737
(Analysis: Finding studies on reboxetine: a tale of hide and seek)
http://www.bmj.com/cgi/doi/10.1136/bmj.c4942
(Analysis: Data availability for industry sponsored trials: what should medical journals require?)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5391
(Editorial: Missing clinical trial data: setting the record straight)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5641
The drug reboxetine is, overall, an ineffective and potentially harmful antidepressant, according to a comprehensive study of the evidence published on bmj.com today.
The study also shows that nearly three quarters of the data on patients who took part in trials of reboxetine were not published until now, and that the published data on the drug overestimate the benefits and underestimate the harms of treatment - all underlining the urgent need for mandatory publication of all clinical trial results.
Reboxetine has been approved for the treatment of major depressive disorder in many European countries since 1997, but doubts have been raised about its effectiveness on the basis of recent studies and rejection of the application for approval in the United States in 2001. Published trials, however, show a favourable risk-benefit profile for reboxetine.
So a team of researchers at The German Institute for Quality and Efficiency in Health Care (IQWiG) set out to assess the benefits and harms of reboxetine compared with placebo or other antidepressants, known as selective serotonin reuptake inhibitors (SSRIs), for treating adults with major depression.
They also measured the impact of potential publication bias in trials of reboxetine (where positive trial results are more likely to be published than unfavourable results).
They analysed the results of 13 trials, including eight previously unpublished trials from the manufacturer of reboxetine (Pfizer). The overall quality of the trials was good, but the researchers noted that data on 74% of patients were unpublished.
They show that reboxetine is, overall, an ineffective and potentially harmful antidepressant. They found no significant difference in benefit (remission and response rates) versus placebo and inferior benefit versus SSRIs, as well as a higher rate of patients affected by adverse events than with placebo and higher withdrawal rates owing to adverse events than with placebo and the SSRI fluoxetine.
A further comparison of published and unpublished trials shows that published data overestimated the benefit of reboxetine and underestimated harm.
This, say the authors, is a striking example of publication bias, resulting in a distorted public record of a treatment. Publication bias can affect health policy decisions and the content of clinical guidelines, they warn. "Our findings underline the urgent need for mandatory publication of trial data."
In an accompanying analysis, the same authors argue that current regulations on the publication of trial results are insufficient. They believe several measures are required in order to provide patients, clinicians, and health policy makers with unbiased and verified evidence on which to base decisions.
These include mandatory public disclosure of data for all drugs, even for those never approved, public access to trials of older drugs not covered by current law, greater data sharing between regulatory authorities, as well as re-evaluation of a drug if approval is declined elsewhere, and a legal obligation for manufacturers to provide all requested data to official bodies without restrictions to publication.
In a second analysis, senior researchers Robert Steinbrook and Jerome Kassirer highlight several recent examples that illustrate the problems of trusting drug companies to provide the complete picture about the clinical trials they sponsor. They propose that journals should define full access to all the trial data and require that investigators and journal editors have full access. Editors should also take appropriate action if concerns about data arise after publication. "Trust in the medical literature, not just in industry sponsored trials, is at stake," they conclude.
In an accompanying editorial, BMJ Editors Dr Fiona Godlee and Dr Elizabeth Loder, argue that "the medical evidence base is distorted by missing clinical trial data" and that "urgent action is needed to restore trust in existing evidence."
They believe it is important to re-evaluate the integrity of the existing base of research evidence and, as such, the BMJ will devote a special theme issue to this topic in late 2011.
"Full information about previously conducted clinical trials involving drugs, devices and other treatments is vital to clinical decision-making," they say. "It is time to demonstrate a shared commitment to set the record straight."
Contacts:
Research and Analysis 1: Beate Wieseler, Deputy Head of Department of Drug Assessment, Institute for Quality and Efficiency in Health Care, Cologne, Germany
Email: beate.wieseler@iqwig.de
Analysis 2: Robert Steinbrook, Section of General Internal Medicine and Robert Wood Johnson Foundation Clinical Scholars Program, Dartmouth Medical School, Hanover, NH, and Yale School of Medicine, New Haven, CT, USA
Email: rsteinbrook@attglobal.net
Editorial: Dr Fiona Godlee, Editor in Chief, BMJ, London, UK
Email: edickinson@bmjgroup.com
(2) Are patient surveys a reliable way to assess the performance of doctors and practices?
(Research: Patients' experience and satisfaction in primary care: secondary analysis using multilevel modelling)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5004
(Editorial: Are measures of patient satisfaction hopelessly flawed?)
http://www.bmj.com/cgi/doi/10.1136/bmj.c4783
To assess the performance of general practices, it is better to ask patients about their actual experiences of care rather than ask for satisfaction ratings, according to new research published on bmj.com today.
The findings call into question the reliability of using surveys to evaluate practice performance.
Patient surveys are used to assess the performance of doctors and practices, and they increasingly enquire about specific patient experiences (e.g. waiting time for an appointment) as well as overall satisfaction.
In the UK, general practices receive some of their income according to survey scores. It is therefore important to be sure that patients' responses act as a reliable indicator of performance, yet few studies have looked into this.
Researchers from the University of Bristol set out to explore whether responses to survey questions reflect differences between the practices, the doctors, or the patients themselves.
Using mathematical models, they analysed data from 4,573 patients who consulted 150 different doctors at 27 general practices in England.
They found that specific questions about patients' experiences (particularly access to care) are a more accurate measure of practice and doctor performance than are questions about patients' general satisfaction.
This is largely due to differences in people's perceptions as well as random error, and suggests that the reliability of using surveys to assess an individual doctor's performance is questionable, say the authors.
They also found that responses vary according to patient characteristics such as age, sex, and ethnicity. However, adjusting for these characteristics made very little difference to practices' scores or the ranking of individual practices.
In conclusion, they support the concept that questions about specific experiences of care provide a more discriminating measure of a practice's performance than do subjective questions about general satisfaction. And they call for their findings to be replicated in a larger sample of practices.
An accompanying editorial argues that measures of patient satisfaction need to be refined, but they are not hopelessly flawed.
Contacts:
Research: Chris Salisbury, Professor of Primary Health Care, University of Bristol, UK
Email: c.salisbury@bristol.ac.uk
(3) Government plans to extend patient choice will be a challenge, says expert
(Analysis: Do patients want a choice and does it work?)
http://www.bmj.com/cgi/doi/10.1136/bmj.c4989
(Analysis: Implementing shared decision making in the NHS)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5146
The government's plans to introduce wider choice and shared decision making within the NHS may be challenging to implement, says an expert on bmj.com today.
In its new plans for the NHS, the government wants to extend the offer of choice beyond what is currently available to include choice of specialist team, choice of general practice, and choice of treatment.
But do patients want a choice and does it work?
Angela Coulter, Director of Global Initiatives at the Foundation for Informed Medical Decision Making in the USA reviews the evidence and finds that choice has intrinsic value to patients.
The evidence suggests that most patients like the idea that they should be offered a choice of provider and, in particular, a choice of treatment, she says. However, it also suggests reluctance on the part of clinicians to offer a choice.
Since choice of treatment location was introduced in 2005, regular surveys have shown that patients' awareness of the right to choose and general practitioners' willingness to offer a choice have been slow to grow.
More recent evidence confirms that most patients are keen on having a choice, even if they choose to remain at their local hospital, but many general practitioners remain ambivalent or antagonistic to the idea.
Clinicians have also been slow to respond to the evidence that most patients want to participate in decisions about their care, citing concerns about time constraints and doubts about its relevance to their patients, says Coulter. The government's new commitment to shared decision making tackles this directly and implies a challenge to entrenched attitudes and the need for big change in practice styles.
There is also little evidence that patients use performance data to inform their decisions, despite the government's promise to publish more detailed information on patients' experience, health outcomes, and safety indicators.
"The evidence reviewed here suggests a reluctance on the part of general practitioners, coupled with a gulf between what patients say they want and what general practitioners believe they want," concludes Coulter. "This is worrying because the government's plans assume that general practitioners understand patients' preferences and will commission services accordingly."
She believes implementation of the plans for extending choice will be "a major test of the effectiveness of general practitioner led commissioning."
This view is supported in a second article which looks at how to better involve patients in decisions about their care. Professor Glyn Elwyn and colleagues say that, despite considerable interest in shared decision making, and clear evidence of benefit, implementation within the NHS "has proved difficult and slow."
High quality decision aids for many conditions already exist, they say, but the challenge is how to embed the tools, attitudes and skills required into routine practice. This will require substantial investment and collaboration between many agencies but, if created, "it would go a long way towards developing a patient led revolution in health care - one that is fuelled by evidence," they conclude.
A recent article published by Student BMJ also asks: Is more choice always better?
Richard Bagshaw, a medical student at the University of Birmingham, recalls a recent visit to a travel clinic, where he was asked whether he wanted a rabies vaccination. He chose not to have it, but found the responsibility of making the decision alone difficult.
"Just assimilating the information needed to make an informed decision takes effort," he writes. "Also, the risk when faced with too complex a choice is that a person disengages and makes an essentially arbitrary decision just to be done with the ordeal."
Although patients stand to benefit from greater empowerment, "there's a price to be paid for shouldering the burden of self-determination," he warns.
Contacts:
Angela Coulter, Director of Global Initiatives, Foundation for Informed Medical Decision Making, Boston, MA, USA
Email: angela@angelacoulter.com
Professor Glyn Elwyn, Department of Primary Care and Public Health, Cardiff University, Cardiff, Wales
Email: elwyng@cardiff.ac.uk
(4) Dear Mr Lansley ... how to really save the NHS money
(Personal View: An open letter to the health secretary: how to really save money on the NHS)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5618
The planned shake-up of the NHS in England is unlikely to really save money on the NHS, argues a senior doctor in an open letter to the health secretary Andrew Lansley in this week's BMJ.
Instead, Peter Lachmann, Emeritus Professor of Immunology at the University of Cambridge, and past president of the Academy of Medical Sciences, believes that reducing the cost of drugs, making better use of medical facilities, and reforming end-of-life care would mean "very large sums of money could be saved in the delivery of health care, with improvement rather than detriment to the quality of service."
While none of these changes would be universally popular, "without them the future of health care, not just in the United Kingdom but elsewhere, will be imperilled by ever-rising costs," he claims.
Firstly, Lachmann suggests making drugs available once they are shown to be effective, rather than waiting for further trials to detect rare side effects. "There is a strong case for making drugs available after Phase II trials and to rely on post-marketing surveillance for detecting uncommon side effects," he writes. "This would have two big advantages: it would make drugs much cheaper; and it would make drugs available much earlier."
He also argues that the practice of suing drug companies "should really be reserved for cases where there has been negligence or other malfeasance." Reforms in this area "could save many hundreds of millions of pounds a year and are urgently required."
Secondly, he argues for more intensive use of expensive medical facilities like operating theatres, radiology departments, and pathology laboratories. "This would reduce capital expenditure and, in the longer term, the number of hospitals that need to be built," he writes.
Finally, he proposes reforming end-of-life care "to reduce heavy expenditure and interventionist methods that are often undignified and painful when there is no prospect of appreciable gain in quality adjusted life years (QALYs)."
He acknowledges that "there is no easy solution to this dilemma" but says "medicine does need to adjust to the paradigm that active intervention should be undertaken only in anticipation of improving, or at least maintaining, quality of life and not for prolonging life at all costs."
Implementing changes in these three areas "would allow health expenditure to be contained in a way that would make a real difference, unlike tinkering with management structures, which is more like rearranging the deckchairs on the Titanic," he concludes.
Contact:
Peter Lachmann, Emeritus Sheila Joan Smith Professor of Immunology, University of Cambridge, UK
[Please note, Professor Lachmann is at a conference in Athens this week. Please contact him via email and arrange a time to speak by telephone]
Email: pjl1000@cam.ac.uk
(5) GPs must take financial responsibility for practice budgets, says senior doctor
(Personal View: GPs should have to take financial responsibility)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5613
The proposed NHS reforms will fail unless GPs are legally obliged to take financial responsibility for practice budgets, argues a senior doctor in this week's BMJ.
Dr Danny Ruta, Joint Director of Public Health at Lewisham Primary Care Trust in London, believes that the real aim of the White Paper, Equity and Excellence: Liberating the NHS, is "to force doctors, once and for all, to consider the opportunity costs of their day to day clinical decisions."
He also believes that this has been the unstated aim of every major health policy initiative since the mid-1970s. "Because only by getting doctors to acknowledge that NHS resources are scarce, that every clinical decision has an opportunity cost, and that they should take financial responsibility for a finite envelope of resources can we shape a state funded healthcare system that reflects the health needs of the population rather than the interests of doctors, primarily hospital doctors, who have always wielded most of the power in the NHS."
This White Paper is trying, finally, to solve the problem at the heart of the NHS by shifting the power from one group of doctors, hospital consultants, to another group, GPs, he writes.
In effect the white paper's proposals "force the group of doctors whose interests are arguably most closely aligned with the needs of the population to consider the opportunity cost of their clinical decisions so that they can maximise health gain for that population and reduce health inequalities with the resources available to them," he adds.
He believes that this most radical (some would say revolutionary) policy intervention may succeed where all others have failed, but warns that "if the GPs in a consortium fail to manage their practice budget . . . they must lose their contract with the NHS."
Competition between consortiums "could promote efficiency and deliver better clinical outcomes, but only if GPs take financial responsibility for the budget," he says.
If this is achieved, "the NHS could quickly start to deliver maximum health gain for the resources available and may even do it equitably."
Contacts:
Danny Ruta, Joint Director of Public Health, Lewisham Primary Care Trust and Lewisham Borough Council, London, UK
Email: d.ruta@btinternet.com
(6) BMJ Group launches 3rd annual health care awards
The BMJ Group today launched its third annual Health Care Awards.
Nominations are now open for 13 Awards which will be presented at a special ceremony at the London Hilton on Park Lane on Wednesday, 18 May 2011.
The Awards are now well established for their recognition of excellence in health care both in the UK and internationally. Last year there were 780 entries and that number is set to increase. The Awards mix prizes for UK-based doctors and teams with those that are open to international nomination: six are UK-only and seven international, including the top prize, the BMJ Group Award for Lifetime Achievement.
This year there are 3 new Awards - Medical Team in a Crisis Zone, Innovation in Health Care and Sustainable Health Care.
The awards are already making an impact on health care. For example, Judith Mackay, a lifetime campaigner against smoking, said that winning the first-ever Lifetime Achievement Award in 2009 "meant more to me than any other award I have received. The Award put public health to the fore, whereas too often it has been an undervalued and underfunded discipline of medicine."
Andrew Vallance-Owen, Group Medical Director of BUPA, said that BUPA's sponsorship of the Medical Team in a Crisis Zone was in memory of Dr Karen Woo, a doctor who was killed in Afghanistan on 6 August this year.
Dr Woo had worked for BUPA as an associate medical director for a year between 2008 and 2009. "She was a lovely person who inspired people she met," Dr Vallance-Owen said. "This award was perfect for us to sponsor, because working with a medical team is a crisis zone was exactly what she was doing. She was passionate about medicine and believed she would be safe because she was a doctor. She made many friends in BUPA, and her death was a terrible loss."
Kevin Volpp from the team at the Leonard Davis Institute in the USA which won The Getting Research Into Practice Award said: "Winning this major international award has given our efforts to translate research into practice enhanced credibility among potential private and public sector partners."
Dr Melba Gomes who won The Research Paper of the Year Award on the treatment of malaria in children under five said: "The Award has given enormous prestige to the research project and has turned the spotlight on the important work being done in remote sites where the research was conducted - Bangladesh, Ghana and Tanzania. At least one co-investigator has been accepted for further training as a direct consequence of the Award."
Fiona Godlee, Editor-in-chief of the BMJ, said: "These awards are a great opportunity to celebrate excellence across the whole of health care. There are lots of unsung heroes in health care doing important work to improve life for patients and the public. I'm glad that the BMJ Group is able to give them the recognition they deserve."
For the second year, MDDUS (Medical and Dental Defence Union of Scotland) will be the headline sponsor for the Awards.
All awards are open to nominations from individuals/organisations or a third party. They can enter online at groupawards.bmj.com and entry is free. The deadline for entries is 4 January 2011.
Note to editors: There are 13 award categories altogether, which include:
Photographs and logos are available on request
FOR ACCREDITED JOURNALISTS
For more information please contact:
Emma Dickinson
Tel: +44 (0)20 7383 6529
Email: edickinson@bma.org.uk
Press Office telephone : 020 7383 6254 (Weekdays : 0900hrs - 1800hrs)
British Medical Association
BMA House, Tavistock Square, London WC1H 9JP
and from:
the EurekAlert website, run by the American Association for the Advancement of Science (http://www.eurekalert.org)
http://intranet.bmj.com/departments/dept-bmj/bmj-team-resources/web-team-resources/General_blogging_principles.doc