2016 NHMRC Standards for Guidelines
Standard 1 - Be relevant and useful for decision making
1. To be relevant and useful for decision making guidelines will:
1.1. Address a health issue of importance
1.2. Clearly state the purpose of the guideline and the context in which it will be applied
1.3. Be informed by public consultation
1.4. Be feasible to implement.
Organisations and groups invest significant time, energy and resources into guidelines with the expectation that they will be used. To be relevant and useful, guidelines need to address issues that are important to their target audience. The relative importance of health issues depends on many factors such as prevalence, the burden of disease (the impact of living with illness and injury and dying prematurely) and cost.
It is important for developers to clearly articulate the purpose of their guidelines. Not doing so could likely cause misinterpretation of key messages, unintended application of the recommendations, or create issues during implementation. This risks not just wasted resources but an increased risk of causing harm.
Standard 2 - Be transparent
2. To be transparent guidelines will make publicly available:
2.1. The details of all processes and procedures used to develop the guideline
2.2. The source evidence
2.3. The declarations of interest of members of the guideline development group and information on how any conflicts of interest were managed
2.4. All sources of funding for the guideline.
Guideline transparency refers to the inclusion of information that enables the reader to understand how recommendations were developed and who developed them (IOM 2011). It is necessary so that people using it can be confident about a guideline's trustworthiness. Thorough documentation of the process of identifying and assessing relevant evidence is an important step in doing this.
Guidelines in Australia perform poorly at including the level of documentation required to engender trust in their recommendations; of a sample of more than 1000 Australian guidelines published between 2004 and 2013, no description of the development process was included in 66% of them (NHMRC 2014). This is a significant problem as it is this information that allows users of a guideline to have confidence in implementing its recommendations. Many methods and tools are available to help guideline developers improve the transparency of their guidelines; these are referred to in further detail throughout Guidelines for Guidelines.
Standard 3 – Be overseen by a guideline development group
3. The guideline development group will:
3.1. Be composed of an appropriate mix of expertise and experience, including relevant end users
3.2. Have clearly defined, documented processes for reaching consensus
The composition of the guideline development group should reflect the range of individuals and organisations whose activities, services or care will be covered by the guideline (NICE 2014).
Development groups must include a mix of expertise and experience and be representative of those most likely to be affected by the guideline, such as consumers, researchers, clinicians, policymakers and others expected to use or implement the guideline. It is important to get the membership and functioning of the development group right, since it is their judgement that influences the interpretation of evidence and the wording and strength of recommendations.
Thorough documentation of the composition and decision making of the development group is also essential for a trustworthy guideline. For example, a guideline should state who the development group members were, how they were selected, their affiliations and disciplines, and any conflicts of interest that were identified and how they were managed. This is poorly done in Australian guidelines. In only 34% of guidelines in NHMRC's audit was it possible to fully identify members of the development group (NHMRC 2014).
Standard 4 - Identify and manage conflicts of interest
4. To identify and manage conflicts of interest guideline developers will:
4.1. Require all interests of all guideline development group members to be clarified
4.2. Establish a process for determining if a declared interest represents a conflict of interest, and how a conflict of interest will be managed
Credible and trustworthy guidelines are unbiased.
When forming recommendations, guideline development groups will consider the available evidence and interpret how it should be applied in practice. Because there are often limitations in this evidence, considered judgement becomes an integral part of a guideline's development. To ensure a guideline's recommendations are objective and unbiased all members must declare their interests and careful steps must be taken to manage any conflicts.
Policies on declaration and management of competing interests in guideline development are designed to protect the integrity of guidelines and the individuals involved in their development.
Unfortunately conflict of interest is not well managed in Australia as the NHMRC audit found that only 7% of guidelines fully declared conflict of interest management procedures. In more than 60% of guidelines conflict of interest was not mentioned at all (NHMRC 2014).
Standard 5 - Be focused on health and related outcomes
5. To be focused on health and related outcomes guidelines will:
5.1. Be developed around explicitly defined clinical or public health questions
5.2. Address outcomes that are relevant to the guideline’s expected end users
5.3. Clearly define the outcomes considered to be important to the person/s who will be affected by the decision, and prioritise these outcomes
Focusing on the right outcomes ensures that guidelines will address the needs of the target population and those of other stakeholders and the general public. Chalmers and Glasziou (2009) suggest that considerable research waste could be avoided by more effectively involving consumers in research planning and by addressing higher priority questions and outcomes.
Rates of stakeholder engagement are relatively low in Australian guidelines, with a sample of over 1,000 guidelines showing that just 30% reported adequate representation of expected users on the guideline development group and only 14% reported the involvement of consumers at any stage (NHMRC 2014). This is consistent with similar data showing poor rates of consumer and public involvement in guideline development in the United States, despite international standards calling for improvement in this area (Armstrong and Bloom 2017).
Standard 6 - Be evidence informed
6. To be evidence informed guidelines will:
6.1. Be informed by well conducted systematic reviews
6.2 Consider the body of evidence for each outcome (including the quality of that evidence) and other factors that influence the process of making recommendations including benefits and harms, values and preferences, resource use and acceptability.
6.3 Be subjected to appropriate peer review.
The cornerstone of guideline development is that recommendations about practice and policy should be based on the best available evidence. Although this is an expectation held by health professionals and the public alike, a lot of health advice is developed with little or no evidence to support its claims. In some cases these claims may mislead people to reject policies or treatments that are proven to be effective in favour of non-evidence-based alternatives.
Poor documentation of the use of evidence in Australian guidelines indicates that many of them are not based on evidence. In the NHMRC audit only 7% of guidelines included a replicable description of the evidence review and only 17% clearly linked their recommendations to specific evidence (NHMRC 2014).
Standard 7 - Make actionable recommendations
7. To make actionable recommendations guidelines will:
7.1. Discuss the options for action
7.2 Clearly articulate what the recommended course of action is, and when it should be taken
7.3 Clearly articulate what the intervention is so it can be implemented
7.4 Clearly link each recommendation to the evidence that supports it
7.5 Grade the strength of each recommendation
For all the complexity of guideline development, the usability of guidelines comes down to the clarity of their recommendations. Recommendations must be concise and clearly worded but contain enough information so allow informed decisions about health.
Standard 8 - Be up-to-date
8. To be up-to-date guidelines will:
8.1. Ensure that the recommendation is based on an up to date body of evidence
8.2 Propose a date by which the evidence and the guideline should be updated. This may be specific to each recommendation.
Guidelines can quickly become out of date, particularly in areas with an active research program. Keeping the evidence in guidelines up-to-date ensures that their recommendations are derived from current evidence, which is critical for their ongoing relevance and reliability. It is also one of the biggest challenges facing guideline developers in Australia.
Standard 9 - Be accessible
9. To be accessible guidelines will:
9.1. Be easy to find
9.2 Ideally be free of charge to the end user
9.3 Be clearly structured, easy to navigate and in plain English
9.2 Be available online.
This is important because guidelines have to be easily located and accessible if they are to be used. Guideline developers write guidelines with the expectation that they will be used, but too often they publish them in ways that make them inaccessible to their intended users. For example, developers may set financial barriers by choosing to publish their guidelines in journals where they sit behind expensive paywalls, or on the websites of organisations which are only accessible to members, or by selling them directly to users.
Guidelines can also be difficult to find, a problem which can be made worse by practices such as publishing guidelines without serial numbers and by allowing old and outdated versions to remain in circulation without rescindment.
Armstrong, M. J. and J. A. Bloom (2017). "Patient involvement in guidelines is poor five years after institute of medicine standards: review of guideline methodologies." Research Involvement and Engagement 3(1):19.
Chalmers, I. and P. Glasziou (2009). "Avoidable waste in the production and reporting of research evidence." Lancet 374(9683): 86-8.
Institute of Medicine (2011). Clinical Practice Guidelines We Can Trust. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, National Academies Press.
NHMRC (2014). Australian Clinical Practice Guidelines 2014 Annual Report, NHMRC.
NICE (2014). Developing NICE guidelines: the manual. October 2014. UK, National Institute for Health and Care Excellence.