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How the Guideline was developed
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Process for developing the guideline
In June 2020, the Australian Government Department of Health and Aged Care contracted the National Heart Foundation of Australia, on behalf of the Australian Chronic Disease Prevention Alliance (ACDPA), to update the 2012 Guidelines for the management of absolute cardiovascular disease risk.5
The new guideline has been developed according to the processes and standards outlined in the 2016 National Health and Medical Research Council’s (NHMRC) Guidelines for Guidelines.6 While the development of this guideline has been informed by the NHMRC standards for guidelines, this does not imply formal approval of this guideline by the NHMRC itself.
The guideline was developed under the direction and governance of nine expert advisory groups with multidisciplinary clinical and consumer input (see Appendix 1). Expertise was sourced across the disciplines of cardiology, general practice, nephrology, neurology, endocrinology, stroke care, epidemiology, Indigenous health, nutrition, behavioural science, nursing and pharmacy. Special attention was given to First Nations people’s health, and the Indigenous Health Expert Subgroup advised on every aspect of the guideline development.
Developing the recommendations
An independent clinical evidence review was conducted. The Expert Steering Group was responsible for developing the clinical questions for the evidence review, which addressed areas of relevance to primary care in Australia, greatest uncertainties, value to current practice and significant developments in research since the previous guideline publication. Questions were expressed in PICO format (patient/population, intervention, comparison and outcomes). For the evidence synthesis report, see Evidence synthesis to support the development of Guidelines for Absolute Cardiovascular Disease Risk.
Guideline recommendations were developed and scored based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology and the evidence generated by the clinical evidence review. The GRADE approach offers a transparent and structured process for developing and presenting evidence summaries and recommendations (see GRADE handbook).
Using the GRADE approach, guideline developers explicitly state the strength of each recommendation for or against an intervention. The strength is determined by considering the quality of evidence, balance between benefits and harms, trade-offs between improving survival and quality of life, uncertainty or variability in patient values and preferences, and resource considerations. Table 2 provides a summary of GRADE definitions.
Table 2: GRADE definitions
Source: GRADE handbook7
In this guideline, the strength of each recommendation (either strong or conditional) was assigned based on considerations in each of the four domains outlined in Table 3. A strong recommendation was made when judgements in all domains supported a recommendation either for or against an intervention or clinical action. A conditional recommendation was made if judgements were equivocal or contradictory. A conditional recommendation applies to most situations, but there may be exceptions (specified where possible), or the decision may depend on the judgement of the healthcare practitioner and patient after considering the potential benefits and risks for the individual.
Table 3: Domains that contribute to the strength of a recommendation
Adapted with permission from GRADE Handbook
The certainty of evidence on which each recommendation was based is indicated as either high, moderate, low or very low (see Table 2). These categories were assigned according to GRADE methodology. Certainty of evidence reflects the degree of confidence in the estimate of effect, including whether it is adequate to support a recommendation for or against an intervention.
A consensus recommendation was made when the supporting evidence was insufficient or of low quality. Consensus recommendations were based on the expert opinion of guideline working group members, with consideration of relevant available evidence, values, preferences and resource use, in consultation with the expert committees.
GRADE methodology takes into account the importance of outcomes. This approach allows for a strong recommendation to be made even if the certainty of the evidence is low, in view of the potential impact of a clinical decision on patients’ health status or quality of life. For example, a strong recommendation for or against a clinical action might be made due to safety considerations, even when actual risk cannot be quantified.
A dedicated Consumer Advisory Panel, representing Australian consumers, was drawn upon to help determine the values and preferences domains.
Further details of the guideline development process can be found in Appendix 2.
Conflict of Interest
The Guideline Expert Steering Group acknowledges the importance of both transparency and appropriate management of conflicts of interest.
Conflicting interests were considered within a framework of both the relationship (direct or indirect) of the participating individual to any third party with interest in the topic under consideration within the guideline development process, and the nature (financial and non-financial) of the potential conflict.
The Conflict of Interest Policy was based on the NHMRC’s Policy on the disclosure of interests requirements for prospective and appointed NHMRC committee members8 and the NHMRC Guidelines for Guidelines Handbook.9 A copy of the Conflict of Interest Policy can be supplied upon request.
Conflicting interests among the guideline development groups required appropriate management to ensure clinical recommendations were not compromised. Processes employed by the Heart Foundation aimed to ensure the integrity of guideline developers and to strike an appropriate balance between the existence of interests in a topic under review and the expertise required to make sound and meaningful recommendations.
Conflicts of interests were managed by the following processes:
- All guideline working group members were required to disclose potential conflicts of interest at commencement of membership, and to update the working group during the project if there were any changes to this declaration.
- Conflict of interest declarations were revisited at each working group meeting (including the Guideline Advisory Group and Expert Steering Group meetings) to ensure new disclosures were recorded.
- If a declared conflicting interest was deemed significant, the individual was to be restricted from involvement in discussions and decisions on related topics. In circumstances where a conflict of interest was identified, it was managed by ensuring that the member had limited involvement in the working group’s deliberation of the evidence (with the possibility of bias noted), or in discussions on the wording, structure, intent or formulation of the clinical recommendation relevant to disclosure of a conflict.
All conflict of interest declarations were regularly reviewed by the Guideline Advisory Group. More information about conflict of interest handling and a summary of the Declarations of Interest register can be found in Appendix 3.