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Abstract
Background: Clinical practice guidelines (CPGs) are documents to support decision-making in actual clinical situations. At present in Australia guideline recommendations in nationally endorsed CPGs are usually accompanied by an indication of the level of evidence (based on study design) supporting the recommendation, forcing users to rely on the levels, rather than the body, of evidence as a proxy for the strength of the recommendation.
Objective: To develop a system for assessing the body of evidence supporting a guideline recommendation that could be used as an interim measure until a full revision of the CPG development process is undertaken.
Methods: Using a commissioned literature review, methodological experts contracted by the National Health and Medical Research Council met to discuss suitable models for assessing a body of evidence and a working party was formed to modify these to produce a system which would be relatively easy for guideline developers (usually groups of clinical experts) to use.
Results: The SIGN 'considered judgement form' was identified as an appropriate model on which to base the new system. Five key components were identified as important in grading the body of evidence and each of these components is taken into consideration in assigning a grade to the recommendation, with the volume and consistency of evidence having more weight than clinical impact, applicability and generalisability, consistent with an evidence-based approach. The grades were formulated to express the degree to which the body of evidence could be trusted to guide clinical practice. At the same time a revised and expanded 'level of evidence' hierarchy was developed to assess study design by type of research question. Debates during the revision process and feedback received from piloting and public consultation will be presented.
Conclusions: The framework is ultimately intended to produce clearer and more evidence-based recommendations for clinical practice guidelines and is also likely to be relevant to those producing systematic reviews and health technology assessments.
Objective: To develop a system for assessing the body of evidence supporting a guideline recommendation that could be used as an interim measure until a full revision of the CPG development process is undertaken.
Methods: Using a commissioned literature review, methodological experts contracted by the National Health and Medical Research Council met to discuss suitable models for assessing a body of evidence and a working party was formed to modify these to produce a system which would be relatively easy for guideline developers (usually groups of clinical experts) to use.
Results: The SIGN 'considered judgement form' was identified as an appropriate model on which to base the new system. Five key components were identified as important in grading the body of evidence and each of these components is taken into consideration in assigning a grade to the recommendation, with the volume and consistency of evidence having more weight than clinical impact, applicability and generalisability, consistent with an evidence-based approach. The grades were formulated to express the degree to which the body of evidence could be trusted to guide clinical practice. At the same time a revised and expanded 'level of evidence' hierarchy was developed to assess study design by type of research question. Debates during the revision process and feedback received from piloting and public consultation will be presented.
Conclusions: The framework is ultimately intended to produce clearer and more evidence-based recommendations for clinical practice guidelines and is also likely to be relevant to those producing systematic reviews and health technology assessments.
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