Article type
Abstract
Background
Guidelines include a variety of types of normative statements (NSs) concerning interventions. “Recommendations” are based on 1 or more systematic reviews (SRs) of research evidence. Guidelines may also include other types of NSs such as GRADE Good Practice Statements (GPSs), which are not appropriate for formal ratings of quality of evidence and are typically supported by high-certainty, indirect evidence.
There are conceptual and methodological problems with GPS, leading to both inappropriate over- and underuse and unclear interpretation and impact. This is due to a lack of clarity in, and misunderstanding of, GRADE guidance and limitations in GRADE’s approach to linked bodies of evidence and because many NSs are appropriately based on inputs other than SRs of research evidence.
Objectives
To develop a new typology for NSs designed to assist both guideline developers and end users.
Methods
This typology was developed via a review of the literature on GPSs and their usage, with input from guideline experts internationally.
Results
This proposed typology differentiates NSs by their basis and includes the range of NSs encompassed by GPS while providing a more nuanced categorization.
There are 2 main types of NSs: 1) statements that indicate if, when, and how to use (or not to use) an intervention (appropriately based on empirical data and evidence) and 2) the principles, practices, or norms that inform or underpin such interventions (based on human rights, ethics, or norms).
The first type includes: 1) recommendations based on SRs of research evidence on effectiveness and harms (at a minimum), including linked bodies of evidence; 2) NSs based on scientific fundamentals (eg, physical/biological/chemical properties, theories, laws, or principles); and 3) implementation guidance commonly based on experiential evidence (eg, case studies).
The second type includes: 1) guiding principles, based on human rights standards and conventions and/or ethics principles and 2) practice norms and standards based on clinical and public health norms and/or professional standards.
Conclusions
There are conceptual and methodological problems with GRADE GPS. The proposed typology for NSs encompasses and replaces GPS, providing a more nuanced categorization. Testing of the feasibility and effectiveness of this typology is needed among guideline developers and end users.
Guidelines include a variety of types of normative statements (NSs) concerning interventions. “Recommendations” are based on 1 or more systematic reviews (SRs) of research evidence. Guidelines may also include other types of NSs such as GRADE Good Practice Statements (GPSs), which are not appropriate for formal ratings of quality of evidence and are typically supported by high-certainty, indirect evidence.
There are conceptual and methodological problems with GPS, leading to both inappropriate over- and underuse and unclear interpretation and impact. This is due to a lack of clarity in, and misunderstanding of, GRADE guidance and limitations in GRADE’s approach to linked bodies of evidence and because many NSs are appropriately based on inputs other than SRs of research evidence.
Objectives
To develop a new typology for NSs designed to assist both guideline developers and end users.
Methods
This typology was developed via a review of the literature on GPSs and their usage, with input from guideline experts internationally.
Results
This proposed typology differentiates NSs by their basis and includes the range of NSs encompassed by GPS while providing a more nuanced categorization.
There are 2 main types of NSs: 1) statements that indicate if, when, and how to use (or not to use) an intervention (appropriately based on empirical data and evidence) and 2) the principles, practices, or norms that inform or underpin such interventions (based on human rights, ethics, or norms).
The first type includes: 1) recommendations based on SRs of research evidence on effectiveness and harms (at a minimum), including linked bodies of evidence; 2) NSs based on scientific fundamentals (eg, physical/biological/chemical properties, theories, laws, or principles); and 3) implementation guidance commonly based on experiential evidence (eg, case studies).
The second type includes: 1) guiding principles, based on human rights standards and conventions and/or ethics principles and 2) practice norms and standards based on clinical and public health norms and/or professional standards.
Conclusions
There are conceptual and methodological problems with GRADE GPS. The proposed typology for NSs encompasses and replaces GPS, providing a more nuanced categorization. Testing of the feasibility and effectiveness of this typology is needed among guideline developers and end users.