Draft clinical practice guidelines for preventing serious blood clots in hospital patients have been released today by the NHMRC for public comment.

The NHMRC’s processes in developing the guidelines stand in stark contrast to those used in the production of another set of controversial, commercially-funded Australian and NZ guidelines that are in widespread use.

The controversy, whose history is outlined here, is the subject of a series of articles in the latest edition of The Medical Journal of Australia.

The MJA editor, Dr Martin Van Der Weyden, wrote that the commercially-funded guidelines could be criticised on several grounds, including the apparent lack of independent peer review, the lack of comprehensive declarations of conflicts of interests and a failure to divulge details of the relationships between those involved in funding and producing the guidelines.

An interesting aspect of the new NHMRC draft guidelines (“for the prevention of venous thromboembolism — deep vein thrombosis and pulmonary embolism — in patients admitted to Australian hospitals”) is the detailed attention given to declaring the interests of Committee members (two of whom were also involved in the Australian and NZ document). It is made very clear that many members have close ties to companies making products in the area.

In an interview with Crikey last night, Professor Michael Frommer, who chaired the NHMRC Committee, was diplomatic about the controversy surrounding the Australian and NZ Guidelines. But he did note that the new NHMRC guidelines draw largely from evidence-based guidelines — ones from the UK and the US, in particular — and that the Australian and NZ ones had not been a source document.

Professor Frommer, who is also a member of the Pharmaceutical Benefits Advisory Committee (PBAC), said he had been meticulous in requiring committee members’ conflicts of interests to be declared, in line with the expectations of PBAC members. This was not in response to the controversy about the Australian and NZ guidelines, but because it “is necessary generally”.

“One of the great problems of doing anything in this country is that when you get a group of experts together, they will have conflicts of interest,” he said. “I wanted to make sure we did this honestly and openly.”

The new draft guidelines are relevant for surgical, medical and trauma patients and are targeted at clinicians looking after hospital patients.

They cite evidence that pharmacological and mechanical methods for preventing blood clots in hospital patients are under-utilised and inconsistently applied. They say that about 30,000 people are hospitalised in Australia each year and about 2,000 die each year as a result of venous thromboembolism (VTE), while pulmonary embolism is one of the most common causes of death in hospital, accounting for 10 percent of all hospital deaths.

The guidelines are broken down into detailed recommendations for different types of patients, including those having hip and knee replacements and various types of surgery, as well as pregnant patients. The issues are complex, notes Professor Frommer, because of the potential for the preventative drugs to also do harm.

However, the draft guidelines are unlikely to resolve debate, about either the associated clinical issues, or the management of conflicts of interest.

A leading cancer expert, Professor Ian Olver, writes in Croakey today that guideline authors should not have conflicts of interest.

“Given that guidelines are designed to have widespread influence on clinical practice, simply having authors being transparent about their relationships with industry is not enough, and we should insist that guideline authors have no potential conflicts to declare,” he says.

Dr Alasdair Millar, who has been a strong critic of the Australian and New Zealand guidelines, also writes about his concerns about guideline development generally.

“Medical practice has become subject to the influence of a Quality Assurance industry that means well but whose approach is to ensure that for each activity there is a guideline, that there should be a process for adherence to these guidelines, that this process should be audited, and that a satisfactory audit means that patients are being given quality treatment,” he says.

“Broadly speaking, this industry is satisfied when all the boxes are ticked and they can say “Ah, we can now report 90% compliance with this guideline” (orgasmic pleasure at 100%!). This approach is unscientific, relies entirely on the guidelines being good in the first place, and can (and I believe, does) place patients at risk.”

Nonetheless, if you or yours are heading to hospital anytime soon, it may be worth having a read of the new draft guidelines, or at least raising the issue with those caring for you.

Peter Fray

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