Press releases Monday 31 August to Friday 3 September 2010

Please remember to credit the BMJas 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) Long term use of oral bisphosphonates may double risk of oesophageal cancer
(Research: Oral bisphosphonates and risk of cancer of the oesophagus, stomach and colorectum: case-control analysis within a UK primary care cohort)
http://www.bmj.com/cgi/doi/10.1136/bmj.c4444
(Editorial: Oral bisphosphonates and oesophageal cancer)

http://www.bmj.com/cgi/doi/10.1136/bmj.c4506

People who take oral bisphosphonates for bone disease over five years may be doubling their risk of developing oesophageal cancer (cancer of the gullet), according to a new study published on bmj.com today.

Oral bisphosphonates are a type of drug used to treat osteoporosis and other bone diseases and are the most commonly recommended treatment for such conditions.

Case reports suggest an association between use of oral bisphosphonates for osteoporosis and increased risk of oesophageal cancer. But the evidence is limited, and no adequately large study with information on potential confounding factors and long follow-up has been published.

So researchers from the University of Oxford's Cancer Epidemiology Unit and the Medicines and Healthcare products Regulatory Agency carried out a large-scale study to look into the possibility of an association.

They analysed data from the UK General Practice Research Database, which has anonymised patient records for around six million people registered with a NHS GP.

They focused on men and women aged over 40 years - 2,954 with oesophageal cancer, 2,018 with stomach cancer and 10,641 with colorectal (bowel) cancer diagnosed between 1995 and 2005. Each case was compared with five controls matched for age, sex, general practice and observation period.

They found that people with 10 or more prescriptions, or with prescriptions over about five years, had nearly double the risk of oesophageal cancer compared with people with no bisphosphonate prescriptions.

There was no such increased risk for stomach or bowel cancer.

Typically, oesophageal cancer develops in one per 1000 people at age 60-79 over five years. Based on their findings, the authors estimate that with five years' use of oral bisphosphonates this would increase to two cases per 1000 people taking bisphosphonates over five years.

Although these results appear to contradict another recently published study using the same database, which reported no increased risk of oesophageal cancer with oral bisphosphonate use, today's report tracked patients for nearly twice as long, and also had greater statistical power.

The study's lead author, Dr Jane Green, says: "Oesophageal cancer is uncommon. The increased risks we found were in people who used oral bisphosphonates for about five years, and even if our results are confirmed, few people taking bisphosphonates are likely to develop oesophageal cancer as a result of taking these drugs. Our findings are part of a wider picture. Bisphosphonates are being increasingly prescribed to prevent fractures, and what is lacking is reliable information on the benefits and risks of their use in the long term."

In an accompanying editorial, Dr Diane Wysowski, an epidemiologist at the US Food and Drug Administration, discusses the differences between the two studies. She says: "The possibility of adverse effects on the oesophagus should prompt doctors who prescribe these drugs to consider risks versus benefits." She also suggests doctors "tell patients to report difficulty in swallowing and throat, chest, or digestive discomfort so that they can be promptly evaluated and possibly advised to discontinue the drug."

Contacts:
Research: Jane Green, Clinical epidemiologist, Cancer Epidemiology Unit, Nuffield Department of Clinical Medicine, University of Oxford, UK
Email: jane.green@ceu.ox.ac.uk
Editorial: Dr Diane Wysowski, Epidemiologist, Food and Drug Administration, Maryland, USA
Tel (via FDA Public Affairs Office): Crystal Rice at +1 301 796 3111 or Karen Mahoney at +1 301 796 3112

(2) Roll-out of electronic patient records likely to be a long and complex process
(Research: Implementation and adoption of nationwide electronic health records in secondary care in England: qualitative analysis of interim results from a prospective national evaluation)
http://www.bmj.com/cgi/doi/10.1136/bmj.c4564

Interim results from the first comprehensive evaluation of the implementation of electronic health records in secondary care in England have found delays and frustration with the system, according to research published on bmj.com today.

The authors, led by Professor Aziz Sheikh from The University of Edinburgh (and which included researchers from The London School of Economics and Political Science, The School of Pharmacy and The University of Nottingham), say experiences from the first-wave implementation site "indicate that delivering improved healthcare through nationwide electronic health records is likely to be a long, complex and iterative process."

Professor Sheikh and his team assessed the implementation of electronic records in five NHS acute hospital and mental health trusts throughout England. Their evaluation consisted of undertaking interviews, making observations and reviewing key documents.

The evaluation reveals that hospital electronic health records are being developed and implemented far more slowly than was originally hoped. The authors believe this is because "the top-down standardised approach has needed to evolve to permit greater flexibility and local choice in electronic health records systems and their delivery."

Despite the substantial delays and frustrations "there remains strong support for electronic health records, including from NHS clinicians," says the study.

Electronic health records are being introduced in Europe, North America, Australasia, the Middle East and elsewhere. Globally there have been varying approaches to developing electronic care records systems.

In 2002 the government in England opted for a top-down, government-driven strategy that used standardised, commercial software applications. In contrast, Australia and the USA have chosen more devolved strategies.

The nationwide implementation of electronic health records in England, known as the NHS Care Records Service, is the cornerstone of the £12.7bn National Programme for IT.

Given the planned widespread cuts to public spending and government plans to restructure the NHS in England, the authors anticipate major policy revisions affecting the National Programme. The priority, according to the authors, is to clarify the type and scale of nationwide electronic health records that are now wanted and affordable.

The authors argue that the English experience shows that having a 'vision' of nationwide electronic health records can be successful in kick-starting such an ambitious programme, but realising this vision is likely to be a process that evolves over many years, perhaps even decades.

They conclude that "while there is no clear evidence as yet that a middle-out approach will achieve the goal of large scale nationwide electronic health records, international experience, including England's, suggests that neither a purely top-down nor bottom-up approach will likely do so."

Contacts:
Aziz Sheikh, Professor of Primary Care Research and Development, eHealth Research Group, Centre for Population Health Sciences, University of Edinburgh, UK
Email: aziz.sheikh@ed.ac.uk

Dr Tony Cornford, Senior Lecturer in Information Systems, Department of Management, London School of Economics and Political Science, London, UK
Email: t.cornford@lse.ac.uk

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