Development and methodology
The previous version of the Red Book (9th edition) was developed by a team of GPs and experts using the NHMRC FORM framework. Evidence-based recommendations were developed by adopting or adapting relevant existing guideline recommendations (with preference given to Australian NHMRC-approved guidelines), or by using systematic reviews of the evidence to inform recommendations where no suitable existing recommendations were identified.
Given the broad scope of the Red Book, the current 10th edition was developed using a similar pragmatic approach of adopting or adapting existing recommendations from high-quality guidelines where possible (referred to as a meta-guideline approach), rather than the time- and resource-intensive process of developing new recommendations with de novo systematic reviews across all topics. This meta-guideline approach drew on the GRADE principles of considered judgement and the grading conventions used by the GRADE approach.1,2
Development of Red book 10 recommendations
The process for developing the Red Book 10th edition recommendations consisted of the following steps:
- Scoping the topics to be covered by Red Book 10th edition
- Identifying and assessing source guidelines (for recency, relevance, and quality)
- Extracting potentially suitable source recommendations (only those relevant to prevention and screening)
- Assessing potentially suitable source recommendations with consideration of:
- applicability to the Australian general practice context
- the feasibility of implementing the recommendations
- a comparison with the recommendations and practice points in the Red Book 9th edition
- consistency with recommendations in other guidelines on the same topic
- the evidence base underpinning the recommendations
- Adopting, adapting or discarding selected source recommendations through a considered judgement process involving the clinical leads for each topic, topic working groups and/or the Red Book Executive Committee
Where no source recommendations were available, advice was sought from clinical leads for each topic about possible landmark studies, or whether any trials were underway, and targeted literature searches may have been undertaken where necessary. Where evidence was identified, it was assessed and de novo recommendations were developed if appropriate.
Grading of Red book 10 recommendations
Updating from the 9th to the 10th edition of the Red Book involved a transition from using NHMRC FORM methods to a pragmatic meta-guideline approach based on the principles of GRADE, an internationally recognised systematic and transparent approach to the development of guideline recommendations that is considered the gold standard in guideline development. This approach mainly affected the way in which the guideline recommendations were written (to be more actionable) and how they were graded in terms of strength and direction.
Source guidelines used different methodologies, and therefore the strength of recommendations, reflecting the strength of the underlying evidence base, was conveyed in different ways. These differing systems of grading of source recommendations were harmonised using a common language as defined in a set of decision rules, developed specifically for the Red Book 10th edition. These rules helped ensure consistency in the assessment of source recommendations and grading of Red Book 10th edition recommendations across the guideline topics (for more detail, see Appendix 1: Methods report).
Assessing the suitability of all potential source recommendations and grading the Red Book 10th edition recommendations occurred through a considered judgement process by relevant clinical leads for each topic in collaboration with the Red Book Executive Committee.
Grading conventions for recommendations in the Red book 10th edition
The terminology used to communicate the strength and direction of each recommendation in the Red Book 10th edition is based on that recommended by the GRADE working group (eg a ‘strong’ or ‘conditional’ recommendation ‘for’ or ‘against’ an option).1 This terminology has been modified for the Red Book 10th edition for improved implementation across general practice settings. Practice points have also been developed to address important aspects of care that are not addressed by relevant source guidelines, or where evidence is lacking. The categories and their meaning are presented in the table below.
Strength of recommendations in Red book 10
Recommendation |
Description |
Recommended (Strong) |
Denotes strong confidence that the benefits of an intervention clearly outweigh the harms |
Not recommended (Strong) |
Denotes strong confidence that the harms of an intervention clearly outweigh the benefits |
Conditionally recommended |
Denotes uncertainty over the balance of benefits (e.g. when the evidence quality is low or very low or when personal preferences or costs are expected to impact the decision) and, as such, refers to decisions where consideration of personal preferences is essential for decision making |
Generally not recommended |
Denotes uncertainty over the balance of harms (e.g. when the evidence quality is low or very low or when personal preferences or costs are expected to impact the decision) and, as such, refers to decisions where consideration of personal preferences is essential for decision making |
Practice points |
Used to address important aspects of care that are not addressed by relevant source guidelines, or where evidence is lacking.
These were developed by consensus of the Red book working groups or Executive Committee |