Standards for Trustworthy Clinical Practice Guidelines (CPG)
Table 1. Standards for Trustworthy Clinical Practice Guidelines (CPG) Standard Institute of Medicine (IOM)1 Guidelines Interational Network2 Methods and Scope The processes by which a CPG is developed and funded should be detailed explicitly and be publicly accessible. A guideline should specify its scope and objective and clearly describe the methods used for development in detail. Conflict of Interest (COI) Prior to selection of the guideline development group (GDG), individuals should declare, in writing, all interests and activities potentially resulting in COI; management of COI includes divestment and exclusions. A guideline should include disclosure of the financial and nonfinancial COIs for members of the GDG and should also describe how any identified conflicts were recorded and resolved. Guideline Development Group (GDG) Composition The GDG should be multidisciplinary and balanced, comprising methodological experts, clinicians, and populations expected to be affected by the CPG; patient and public involvement should be facilitated by including (at least at the time of clinical question formulation and CPG review) a current or former patient and a patient advocate or patient.consumer organization representative in the GDG. A GDG should diverse and relevant stakeholders, such as health professionals, methodologists, experts on a topic, and patients. Evidence Reviews CPG developers should use systematic reviews that meet standards set by the IOM. Guidelines developers should use systematic evidence review methods to identify and evaluate evidence. Decision-making Process Not specified A guideline should describe the process used to reach consensus among the panel members and, if applicable, the sponsoring organization; this process should be established a priority. Recommendation Wording Recommendations should be articulated in a standardized form detailing precisely what the recommended action is an under what circumstances it should be performed; strong recommendations should be worded so that compliance can be evaluated. A guideline recommendation should be clearly stated and based on scientific evidence of benefits, harms, and, if possible, costs. Recommendation Strength Reach recommendation should have a clear description of potential benefits and harms, a summary of relevant available evidence (quality, quantity, consistency), an explanation of the part played by other factors (values, opinion, theory, clinical experience), a rating of the level of confidence in (certainty regarding) the evidence, a description and explanation of any differences of opinion, and a rating of recommendation strength. A guideline should use a rating system to communicate the quality and reliability of both the evidence and the strength of its recommendations. External Review External reviewers should comprise a full spectrum of relevant stakeholders; reviews should be kept confidential; the GDG should consider all reviewer comments and keep a written record of disposition; a draft of the CPG should be made available to the general public for comment. Review by external stakeholders should be conducted before guideline publication. Updating The CPG publication date, date of evidence review, and proposed date for future CPG review should be documented in the CPG; literature should be monitored regularly and the CPG updated when new evidence suggests a need for modification. A guideline should include an expiration date and/or describe the process that the GDG will use to update the recommendations. Financial Support Not stated. A guideline should disclose financial support for the development of the evidence review and guideline recommendations.
Table 1. Standards for Trustworthy Clinical Practice Guidelines (CPG)
Standard | Institute of Medicine (IOM)1 | Guidelines Interational Network2 |
---|---|---|
Methods and Scope | The processes by which a CPG is developed and funded should be detailed explicitly and be publicly accessible. | A guideline should specify its scope and objective and clearly describe the methods used for development in detail. |
Conflict of Interest (COI) | Prior to selection of the guideline development group (GDG), individuals should declare, in writing, all interests and activities potentially resulting in COI; management of COI includes divestment and exclusions. | A guideline should include disclosure of the financial and nonfinancial COIs for members of the GDG and should also describe how any identified conflicts were recorded and resolved. |
Guideline Development Group (GDG) Composition | The GDG should be multidisciplinary and balanced, comprising methodological experts, clinicians, and populations expected to be affected by the CPG; patient and public involvement should be facilitated by including (at least at the time of clinical question formulation and CPG review) a current or former patient and a patient advocate or patient.consumer organization representative in the GDG. | A GDG should diverse and relevant stakeholders, such as health professionals, methodologists, experts on a topic, and patients. |
Evidence Reviews | CPG developers should use systematic reviews that meet standards set by the IOM. | Guidelines developers should use systematic evidence review methods to identify and evaluate evidence. |
Decision-making Process | Not specified | A guideline should describe the process used to reach consensus among the panel members and, if applicable, the sponsoring organization; this process should be established a priority. |
Recommendation Wording | Recommendations should be articulated in a standardized form detailing precisely what the recommended action is an under what circumstances it should be performed; strong recommendations should be worded so that compliance can be evaluated. | A guideline recommendation should be clearly stated and based on scientific evidence of benefits, harms, and, if possible, costs. |
Recommendation Strength | Reach recommendation should have a clear description of potential benefits and harms, a summary of relevant available evidence (quality, quantity, consistency), an explanation of the part played by other factors (values, opinion, theory, clinical experience), a rating of the level of confidence in (certainty regarding) the evidence, a description and explanation of any differences of opinion, and a rating of recommendation strength. | A guideline should use a rating system to communicate the quality and reliability of both the evidence and the strength of its recommendations. |
External Review | External reviewers should comprise a full spectrum of relevant stakeholders; reviews should be kept confidential; the GDG should consider all reviewer comments and keep a written record of disposition; a draft of the CPG should be made available to the general public for comment. | Review by external stakeholders should be conducted before guideline publication. |
Updating | The CPG publication date, date of evidence review, and proposed date for future CPG review should be documented in the CPG; literature should be monitored regularly and the CPG updated when new evidence suggests a need for modification. | A guideline should include an expiration date and/or describe the process that the GDG will use to update the recommendations. |
Financial Support | Not stated. | A guideline should disclose financial support for the development of the evidence review and guideline recommendations. |