Guidelines: The power tools of modern health care

Guideline development is an essential part of keeping patient care both high quality and cost-effective. But creating evidence-based treatment protocols ethically and without bias comes with its own set of requirements said Dr Fergus Macbeth at the recent ICON conference.

Guidelines, argues Dr Fergus Macbeth, are not just educational tools and quality tools – they are power tools. And in an increasingly digital age, guideline recommendations will become embedded in decision support systems and automated quality audits – so it’s essential to ask probing questions surrounding their development.

Speaking at the recent ICON conference, Dr Macbeth, who was a member of the original guidelines advisory committee for NICE (the National Institute for Health and Care Excellence, UK) and has more than two decades of experience in the field, provided a compelling argument for meticulously developed, evidence-based treatment protocols and guidelines. His presentation powerfully validated the work ICON has been doing over the past seven years in developing protocols and guidelines for cancer care in South Africa. He provided insight into how guidelines can be developed, and how to structure the groups developing them so that they are not only ethical but also provide a better balance between outcomes for patients and cost-effectiveness.

The days of GOBSAT (Good Old Boys Sat Around a Table) guideline development, he warned, are numbered.

“All clinical decisions are resource decisions and all resource decisions are clinical decisions,” Dr Macbeth noted, quoting Peter Degeling. For this reason, it’s essential that guidelines should be developed according to best practice. In short, he argued, guideline recommendations should result in the most positive good; balancing the most beneficial outcome for the individual patient with the most beneficial outcome for society. They should not take into consideration the most beneficial outcome for the individual health professional.

Ethics should remain central to the process. Where professional bodies develop best practice guidelines and funders (national bodies or insurance companies) are expected to pay for it, the potential for abuse of power exists. Dr Macbeth noted some of the central principles of NICE guidance development, which is an open and transparent process, has social values and equity as key considerations. This is achieved by the use of the best evidence available, expert input, patient and carer involvement, independent and advisory committees, genuine consultation as well as regular review.

All of these factors depend in part on moving beyond the ‘GOBSAT’ structure. Macbeth discussed the best size and composition of a guideline development group, as well as who should chair it and how recommendations should be formulated. Some important points included the observations that small groups risk narrow thinking or not being representative while big groups that are too large risk the development of factions and subgroups or dominant individuals. Representation is critical: the guideline development group should include individuals from all relevant professional groups (medical and financial) as well as patients.

Crucially, the views of the target population – whether patients only or the public more generally – should be considered, Dr Macbeth added. The Guidelines International Network (GIN), of which Dr Macbeth has also been a key member, argues that all of the above factors are necessary to reduce the risk of ‘groupthink’, cognitive bias, professional dominance, unchallenged cultural and professional norms, undeclared financial interests or other factors that could result in abuse of power.

To this end, perhaps controversially, Dr Macbeth argued that a guideline chair need not be a topic expert, nor well-known; in fact, it’s arguably better if the chair is not a leading researcher or author, so as not to be biased. It is more important for the chair to be trusted internally and externally as a credible leader. This also means being able to impartially promote fair and open debate and discussion and to facilitate group functions. The skill of drafting recommendations is critical and should be– based on reliability of evidence, weighing up of outcomes and relevance to current practice. The social context, including the local healthcare system, cultural norms, and affordability need to be considered.

In summary, Dr Macbeth argued, guideline development is far more than a technical process. It involves considering resource implications as well as taking into account a web of complex human interactions which can endanger rational judgement and result in abuse of power, if bias is not guarded against. These considerations are crucial to effective protocol and guideline development.

Speaking after the conference, Dr David Eedes, Clinical Advisor at ICON said that the lessons learned from Dr Macbeth will be used in the ongoing refinement of the ICON protocol development process.

“Currently at ICON the clinical treatment protocols are re-drafted annually, using the latest clinical evidence while taking into account local conditions and the complexities of the funding of cancer treatment in South Africa. This drafting is a collaborative effort that includes the countrywide network of oncologists (about 80% of all oncologists locally) as well as local academic input,” he said.