Issue 42 / 29 October 2012

TRANSPARENCY problems continue to plague clinical practice guidelines, with experts in Australia and the US saying it is time to enforce disclosure by making it a condition of approving the guidelines.

The call comes on the back of a US survey of guidelines that found fewer than half included information on conflicts of interest (COI).

The survey, published in the Archives of Internal Medicine, also found that fewer than half of the guidelines met more than 50% of a new US guidelines standard. (1)

The reviewers randomly selected and scrutinised 130 guidelines published in the National Guidelines Clearinghouse and compared these to the new standard issued in March last year by the Institute of Medicine (IOM).

Their results echo Australian findings, published in the MJA last year, showing COI statements were found on only 15% of the guidelines from the most prolific developers on the NHMRC portal. (2)

The authors of that article called on the NHMRC to make COI disclosure a condition of guideline approval. A new NHMRC policy on COIs was released in July this year.

Associate Professor Bebe Loff, head of the Human Rights and Bioethics Unit at Monash University and a coauthor of the MJA article, told MJA InSight that the policy now needed to be given a chance to take effect.

Professor Loff said there would be very few clinical practice guidelines currently in existence that would meet the policy conditions, but it would be worth keeping a watching brief on how well the NHMRC implemented it.

However, for the policy to be enforced there would need to be some sort of capacity for monitoring and vetting, she said.

“This will happen to some extent because the NHMRC will have to approve the guidelines”, she said.

An NHMRC spokesperson told MJA InSight that the new policy recognised that many of the experts who brought experience and ideas to guideline development would also have interests.

“These interests must be transparent and appropriately managed to maintain the integrity of all guidelines seeking NHMRC endorsement”, the spokesperson said.

The US reviewers suggested a similar approach. “Of the possible approaches that might be taken in bringing about such improvement, vigorous enforcement of the IOM standards is the most logical”, they wrote.

An accompanying commentary said allowing only certified guidelines to be published in the National Guidelines Clearinghouse were a “necessary next step”. (3)

“The same problems that have plagued guideline development continue to plague guideline development; namely, their variable and opaque development methods, their often conflicted and limited panel composition, and their lack of significant external review by stakeholders throughout the development process. As a result, the trustworthiness of guidelines is limited”, the commentary said.

In the meantime, some organisations are tackling the disclosure problem in other ways. Cancer Council Australia, for instance, has built a web-based Wiki platform for the development of clinical practice guidelines.

Professor Ian Olver, the council’s CEO, said the electronic system was more flexible, which meant guidelines could be tweaked as new evidence emerged. A conflict of interest statement was provided by every author who contributed and anyone was free to comment on the guidelines, he said.

However, Professor Olver said the only catch was that at this stage, the system was incompatible with NHMRC processes.

“There are just some technical matters to work out before we can submit to the NHMRC”, he said.

The US reviewers concluded that there had been “little if any improvement over the past 2 decades” in compliance with standards.

They listed several ways in which most of the guidelines they surveyed failed to comply with the new standards, including criteria used to select committee members and the selection process rarely being described; differences of opinion among committee members not being aired, and benefits of recommendations enumerated more often than potential harms.

However, they said their results provided a useful baseline for monitoring the impact of the new US standards on future quality, transparency, and objectivity of clinical practice guidelines.

– Amanda Bryan

1. Arch Intern Med 2012; Online 22 October
2. MJA 2012; 195: 442-445
3. Arch Intern Med 2012; Online 22 October

Posted 29 October 2012

6 thoughts on “Conflicts still plague guidelines

  1. Jerome Gelb says:

    Misconduct in Scientific Research, including Medical Research, is rife, yet measures to combat it have been too little, too late. Investigation of misconduct, including undisclosed conflicts of interest is optional, not mandatory & is at the discretion of the parent institution or oversight bodies consisting of colleagues or others with vested interests in not finding against researchers so funding resources are not withdrawn.

    Until research misconduct & undisclosed conflicts of interest are brought under the umbrella of the criminal justice system & treated as fraud and lying to inquiries penalised as for perjury, we will continue to find misconduct whenever we choose to look hard enough. Unfortunately, numerous cases of misconduct are notified but ignored & whistleblowers are all too frequently vilified.

  2. Transparency? says:

    Do the guideline publishers themselves have conflicts of interest?

    Please see:
    An end to suppressing public health information
    C D’Arcy J Holman
    Med J Aust 2008; 188 (8): 435-436.

  3. Len Moaven says:

    My beef with the plethora of guidelines is not their veracity but the cost associated with increased pathology ordering. Pathology practices are currently working under a cap whereby any ‘additional’ cost results in a fee cut. I would like to see some sort of costing review of extra pathology requests before implementing new guidelines (and presumably this could be extended to additional consults etc). Len Moaven (pathologist in private practice).

  4. ex doctor says:

    Guidelines, along with advice from stock market analysts, financial advisers, weather forecasters and research and opinion in prestigious peer reviewed journals, could and probably will be proved wrong in time. As with all such advice, guidelines must be viewed and assessed by a working clinician with a view to the very big picture, the practical constraints of individual patient needs and preferences and with a highly skeptical and questioning attitude based on the “common sense layman” test.
    Thus it has always been. A pox on the guideline industry. Who has the time to read let alone study the damn things anyway?
    The lessons of clinical experience have been dustbinned in favour of an unhealthy obsession for credentialism, and attempts to impose from on high, strict compliance with “best practice” in the name of “quality”.
    It is high time a small part of the enormous cost of the quality industry was devoted to studying its effect on patient outcomes and cost benefit.

  5. Sue Ieraci says:

    Good point, “ex-doctor” – what we really need is much less focus on process and more on outcome. The question should not be “did you tick all the boxes?” but “are your patients achieving the best possible health outcomes, given all their individual circumstances?”.

  6. Cris Kerr says:

    For those committed to improving transparency, there is an effective remedy.

    Please read my submission to the Strategic Review of National Public Health and Medical Research:
    http://mckeonreview.org.au/sub/296_Cris_Kerr_Case_Health.pdf

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