Although the robustness of the full GRADE approach is not in question, adopting a full GRADE approach is time and resource intensive, and challenging for the breath of screening and prevention topics covered by the Red book. (For example, it is estimated that adopting a full GRADE approach to develop recommendations de novo across the 64 topics proposed for the Red Book would take more than two years and cost in excess of $1 million.) GRADE is designed to assess prespecified outcomes that are based on an underlying clinical question (usually developed in the PICO [population, intervention, comparator/control and outcomes] format). The development of guidance in the Red Book has not been framed in this way, and the Red Book instead relies on specification of the topics to be covered.

Based on the above, the RACGP decided to adopt a pragmatic approach for the development of the Red Book 10th edition, reflecting option six for the published criteria for using GRADE:

The strength of recommendations should be assessed using two categories (For or Against an option) and definitions for each category such as strong and conditional that are consistent with the definitions used by the GRADE Working Group (although different terminology may be used).^1,2

Details of the approach (methods and process) for using GRADE principles in a pragmatic meta-guideline approach to update the Red Book 10th edition are described below.

The approach for developing the recommendations in the Red Book 10th edition consisted of the following steps:

1. Scoping the topics to be covered by Red Book 10th edition
2. Identifying and assessing source guidelines (for recency, relevance and quality)
3. Extracting potentially suitable source recommendations (only those relevant to prevention and screening)
4. Assessing potentially suitable source recommendations with consideration of:
   • applicability to the Australian general practice context
   • the feasibility of implementing the recommendations
   • a comparison with 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
5. Adopting, adapting or discarding selected source recommendations through a considered judgement process involving the chapter leads, topic working groups and/or the Red Book Executive Committee

Where no source recommendations were available, advice was sought from chapter leads 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.

The list of topics to be covered in Red Book 10th edition was developed by reviewing the existing coverage in the Red Book 9th edition, and through deliberation and consensus of the Executive Committee. Consideration was given to areas that were not covered in the Red Book 9th edition, with a total of 20 new topics addressed in the Red Book 10th edition (see “What’s New in the 10^th edition of the Red book”).

In identifying prevention and screening recommendations contained within relevant evidence-based guidelines developed by others (referred to as ‘source guidelines’), preference was given to high-quality Australian guidelines, followed by high-quality international guidelines that were judged to be applicable to Australian general practice. This approach avoided duplicating existing syntheses of the research literature and avoided the need to critically appraise primary research that had already been assessed using reliable processes and tailored to the Australian setting.

Australian and international evidence-based guideline repositories were systematically searched. These repositories included websites of the following organisations:

• Australian NHMRC
• Australian Government Department of Health and Aged Care
• UK National Institute for Health and Care Excellence (NICE)
• New Zealand Guidance Group (NZGG)
• Scottish Intercollegiate Guidelines Network (SIGN)
• USPSTF
• Canadian Task Force on Preventive Health Care (CTFPHC)

 
The criteria for assessing the suitability and quality of source guidelines following their identification are detailed in the table below.

Source Guideline Selection Criteria

Publication type (i.e., a clinical practice guideline developed using a recognised, evidence-based approach such as GRADE, NICE methods, NHMRC FORM etc.)

Relevance to the clinical area that is in scope

Guidance applicable to a general practice setting

Published since 1 January 2016

 
 

Following acceptance of a guideline as a source guideline (either Australian or international), the following key information about the recommendation was entered into the data extraction template:

• the recommendation (including its strength and grade)
• the year of publication and date of evidence search
• the method used to identify and appraise evidence underpinning the recommendation
• the quality of the body of evidence/level of evidence (where reported by the source guideline).

Recommendations from multiple source guidelines were extracted where available.

For existing Red Book 9th edition topics with no new recommendations from source guidelines, targeted literature searches were conducted for landmark randomised controlled trials (RCTs) published since 2016. For new topics with no new source recommendations, targeted literature searches were conducted for high-quality systematic reviews published since 2010.

For existing Red Book 9th edition topics, the findings from the targeted literature searches were used to supplement the existing recommendation, and were mapped to a GRADE-like recommendation for the Red Book 10th edition.

For topics where no source guideline was identified, targeted searches of systematic reviews of evidence were conducted and consensus guidance (ie practice points) was developed where appropriate.

Extracted source recommendations were compared with existing recommendations and practice points from the Red Book 9th edition. Judgements regarding the suitability of new source recommendations were made in the context of any existing Red Book guidance. Key considerations in selecting the final list of source recommendations were that:

• source recommendations were applicable for Australian general practice
• source recommendations from different source guidelines were consistent with each other (ie advised actions in the same direction)
• differences between existing guidance and new source recommendations were highlighted and underlying reasons for the differences identified
• any aspects of care for that topic that were not addressed by the source recommendations (ie topic gaps) were identified.

In situations where inconsistencies across possible source recommendations could be resolved by the chapter lead and topic working group, the matter was raised with the Red Book Executive Committee for discussion and resolution.

In making the final selection of source recommendations for the chapter, the chapter lead and the Red Book Executive Committee actively considered whether any apparent changes in the direction of guidance since the Red Book 9th edition was reasonable. Changes were highlighted and documented; for example, the publication of new primary studies may have changed a recommendation from being neutral to being in favour of the use of an intervention. Another example of changes to recommendations may have been related to changes to public funding of preventative or screening activities since the publication of the Red Book 9th edition.

The relevant chapter lead and the Red Book Executive Committee met virtually throughout 2022 and 2023 to consider the existing recommendations and potential source recommendations, and to review the suitability of adopting or adapting or discarding source recommendations. At these meetings, the underlying grade of recommendations and the level of evidence supporting the recommendation were key parts of the review. Feedback on individual chapters was provided by the Red Book Executive Committee.

Each adopted/adapted source recommendation was mapped to a GRADE-like strength using a defined set of Red Book GRADE-like decision rules (see Grading conventions for recommendations in the Red Book 10th edition).

At times, developers of source guidelines used transparent methods to develop evidence-based recommendations but relied on the wording of each recommendation to convey strength rather than assigning a formal grade (typical in NICE guidelines from the UK). In these situations, the strength of the source recommendation was inferred, and this was used as the basis of the mapping for that recommendation.

Examples of mapping ungraded source recommendations to Red Book 10th edition GRADE-like recommendations are detailed below.

Assessing the suitability of potential recommendations from source guidelines and transitioning to GRADE-like recommendations occurred through a considered judgement process by chapter leads in collaboration with the Red Book Executive Committee for all chapters in the Red Book 10th edition.

Although the GRADE working group advises that the strength of recommendations should be assessed using two categories (for or against an option) and definitions for each category, such as ‘strong’ and ‘conditional’, for improved implementation across general practice settings, that terminology has been slightly modified for the Red Book 10th edition. ‘Recommended (Strong)’ or ‘Not recommended (Strong)’ was used in Red Book 10th edition for strong recommendations, and ‘Conditionally recommended’ or ‘Generally not recommended’ was used for conditional recommendations, where there may be uncertainty over the balance of benefits (eg when the evidence quality was low or very low or when personal preferences or costs were expected to impact the decision).

Strong recommendations are those for which the RACGP is very confident that the desirable effects of an intervention outweigh its undesirable effects (strong recommendation for an intervention) or that the undesirable effects of an intervention outweigh its desirable effects (strong recommendation against an intervention). A strong recommendation implies that most people will be best served by the recommended course of action. Strong recommendations are typically based on high-certainty evidence (ie high confidence in the estimate of the effect of an intervention). Strong recommendations may recommend in favour of an intervention (when there is high confidence of net benefit) or against an intervention (when there is high confidence of net harm). However, there are circumstances in which a strong recommendation could have been made based on low- or very low-certainty evidence or when there is absence of evidence.

Conditional recommendations are those for which the RACGP regards the desirable effects to probably outweigh the undesirable effects (conditional recommendation in favour of an intervention), or undesirable effects to probably outweigh the desirable effects (conditional recommendation against an intervention), but appreciable uncertainty exists. Conditional recommendations (termed ‘Conditionally recommended’ or ‘Generally not recommended’ in the Red Book 10th edition) are made when the certainty of evidence is lower, when the margin between desirable and undesirable consequences is small and the balance depends on patient values and preferences, or when there is high variability in the values and preferences of patients. In certain cases where a conditional recommendation for an intervention is made, clinicians are encouraged to engage in shared decision making to recognise that different choices will be appropriate for individual patients and to help each person arrive at a management decision consistent with their values and preferences.

Practice points have been provided to address important aspects of care that are not addressed by relevant source guidelines, or where evidence was lacking.

The Red book GRADE-like decision rules for consistently mapping grading across various source guidelines are described below.

Mapping grading from source recommendations developed using GRADE methods to Red book 10th edition GRADE-like recommendations

The tables below describe the mapping of source recommendations developed using the GRADE approach to GRADE-like recommendation grading in the Red Book 10th edition. The key domains from the GRADE evidence-to-decision table of the source guideline were explicitly considered (ie values and preferences of people receiving preventive care; equity considerations; acceptability; feasibility of implementation; resource use/cost implications). Modifications to the wording of source recommendations may have been proposed by chapter leads or the Red Book Executive Committee to reflect such considerations. If the wording of the source recommendation is changed but the intention of the recommendation is not, then it is likely that the same strength will apply to the recommendation in the Red Book 10th edition.

Where there were concerns regarding the directness of the source recommendation (eg it is from an international guideline and reflects a different health setting), the Red Book 10th edition recommendation may have been mapped to a lower strength than the source recommendation. Any downgrading of the strength of recommendations is clearly documented. The following table details the transition of GRADE source recommendations to Red Book 10th edition GRADE-like conventions:

Source recommendation (GRADE) strength and direction	Recommendation in Red book 10th edition strength and direction
Strong in favour	Recommended (Strong)
Conditional in favour	Conditionally recommended
Conditional against	Generally not recommended
Strong against	Not recommended (Strong)

 

Mapping grading from source recommendations developed using NHMRC FORM methods to Red book 10th edition GRADE-like recommendations

The table below describes the mapping of source recommendations developed using NHMRC FORM methods to GRADE-like recommendation grading in the Red Book 10th edition. As for mapping from GRADE source recommendations to the Red Book 10th edition GRADE recommendations (see above), when mapping a source recommendation from FORM, consideration was given to the directness/applicability of the source recommendation to Australian general practice.

Mapping ungraded source recommendations to Red book 10th edition GRADE-like recommendations

The table below describes the mapping of source recommendations that are ungraded to GRADE-like recommendation grading in the Red Book 10th edition. Some examples of the types of phrasing that can be used to convey the strength of recommendations in source guidelines are given below. Sometimes ‘recommendations’ are actually evidence statements (eg ‘There is insufficient evidence to recommend for or against xxx …’). If a source recommendation was phrased in this way, it was transformed into an active voice during the mapping process. The phrasing used across different source guidelines was inconsistent at times and some degree of interrogation of the source guideline was required to gain a sense of the underlying evidence base and the intention of the authors with their choice of wording. The following table details the transition of ungraded recommendations to Red Book 10th edition GRADE-like conventions:

Mapping grading from source recommendations developed using U.S. Preventive Services Task Force methods to Red book 10th edition GRADE-like recommendations

The USPSTF has a four-tiered grading system (Grades A–D) and an ‘insufficient evidence’ category. When mapping USPSTF to GRADE-like recommendations in the Red Book 10th edition, consideration was given to the directness/applicability of the source recommendation to Australian general practice. The following table details the transition of grading of USPSTF recommendations to Red Book 10th edition GRADE-like conventions:

Mapping from the Canadian Task Force on Preventive Health Care recommendations to Red book 10th editionth edition GRADE recommendations

The Canadian Task Force on Preventive Health Care (CTFPHC) recommendations are graded according to GRADE. Whether a recommendation is strong or conditional is based on considerations such as certainty in the effects of an intervention, including magnitude, as well as estimates of how patients value and prioritise outcomes, the variability of these estimates and the wise use of resources.

The CTFPHC previously used the term ‘weak recommendation’, but has replaced this with the term ‘conditional recommendation’ to improve understanding and facilitate implementation of guidance, based on feedback from clinician knowledge users. One reason for this change was the value that the CTFPHC places on shared decision making, together with a need to better clarify when implementation of a recommendation depends on circumstances such as patient values, resource availability or other contextual considerations. Conditional recommendations based on patient values and preferences require clinicians to recognise that different choices will be appropriate for different patients and that those decisions must be consistent with each patient’s values and preferences.

When mapping the CTFPHC recommendations to the Red Book 10th edition grading convention, consideration was given to the directness/applicability of the source recommendation to Australian general practice. The following table details the transition of grading of CTFPHC GRADE recommendations to Red Book 10th edition GRADE-like conventions: