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National Guideline Clearinghouse (NGC) Inclusion Criteria

Effective June 1, 2014, NGC used the 2011 definition of clinical practice guideline developed by the Institute of Medicine (IO).¹

Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.

2013 (Revised) Criteria for Inclusion of Clinical Practice Guidelines in NGC

Effective June 1, 2014: In order for NGC to accept a submitted clinical practice guideline, the guideline had to meet all the criteria below. In addition to the guideline, developers needed to provide NGC with documentation of the underlying systematic review*.

1. The clinical practice guideline contains systematically developed statements including recommendations intended to optimize patient care and assist physicians and/or other health care practitioners and patients to make decisions about appropriate health care for specific clinical circumstances.
2. The clinical practice guideline was produced under the auspices of a medical specialty association; relevant professional society; public or private organization; government agency at the Federal, State, or local level; or health care organization or plan. A clinical practice guideline developed and issued by an individual(s) not officially sponsored or supported by one of the above types of organizations does not meet the inclusion criteria for NGC.
3. The clinical practice guideline is based on a systematic review of evidence as demonstrated by documentation of each of the following features in the clinical practice guideline or its supporting documents.
   1. An explicit statement that the clinical practice guideline was based on a systematic review†.
   2. A description of the search strategy that includes a listing of database(s) searched, a summary of search terms used, and the specific time period covered by the literature search including the beginning date (month/year) and end date (month/year)‡.
   3. A description of study selection that includes the number of studies identified, the number of studies included, and a summary of inclusion and exclusion criteria.
   4. A synthesis of evidence from the selected studies, e.g., a detailed description or evidence tables.
   5. A summary of the evidence synthesis (see 3d above) included in the guideline that relates the evidence to the recommendations, e.g., a descriptive summary or summary tables.

NB: A guideline is not excluded from NGC if a systematic review was conducted that identifies specific gaps in the evidence base for some of the guideline's recommendations.

4. The clinical practice guideline or its supporting documents contain an assessment of the benefits and harms of recommended care and alternative care options.
5. The full text guideline is available in English to the public upon request (for free or for a fee). Upon submission of the guideline to NGC, it also must be noted whether the systematic review or other supporting documents are available in English to the public upon request (for free or for a fee).
6. The guideline is the most recent version published. The guideline must have been developed, reviewed, or revised within the past five years, as evidenced by appropriate documentation (e.g., the systematic review or detailed description of methodology).

1997 Criteria for Inclusion of Clinical Practice Guidelines in NGC (in effect through May 31, 2014)

NGC used the definition of clinical practice guideline developed by the IOM in 1990.³

Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.

All of the criteria below were met for a clinical practice guideline to be included in NGC.

1. The clinical practice guideline contains systematically developed statements that include recommendations, strategies, or information that assists physicians and/or other health care practitioners and patients to make decisions about appropriate health care for specific clinical circumstances.
2. The clinical practice guideline was produced under the auspices of medical specialty associations; relevant professional societies, public or private organizations, government agencies at the Federal, State, or local level; or health care organizations or plans. A clinical practice guideline developed and issued by an individual not officially sponsored or supported by one of the above types of organizations does not meet the inclusion criteria for NGC.
3. Corroborating documentation can be produced and verified that a systematic literature search and review of existing scientific evidence published in peer reviewed journals was performed during the guideline development. A guideline is not excluded from NGC if corroborating documentation can be produced and verified detailing specific gaps in scientific evidence for some of the guideline's recommendations.
4. The full text guideline is available upon request in print or electronic format (for free or for a fee), in the English language. The guideline is current and the most recent version produced. Documented evidence can be produced or verified that the guideline was developed, reviewed, or revised within the last five years.

References

1. Institute of Medicine. Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E, editor(s). Clinical practice guidelines we can trust. Washington (DC): National Academies Press; 2011. 2p. Also available: External Web Site Policy.
2. Institute of Medicine. Committee on Standards for Systematic Reviews. Eden J, Levit L, Berg A, Morton S, editor(s). Finding what works in health care: standards for systematic reviews. Washington (DC): National Academies Press; 2011 Mar 23. Also available: External Web Site Policy.
3. Institute of Medicine. (1990). Clinical Practice Guidelines: Directions for a New Program, M.J. Field and K.N. Lohr (eds.) Washington, DC: National Academy Press. page 38.

National Quality Measures Clearinghouse (NQMC) Inclusion Criteria

To be included in NQMC, a measure had to meet all of the following requirements:

1. Themeasure must address some aspect(s) of health care delivery or population health that can be classified into one of the domains described in the .
2. The measure must be in current use or have been pilot tested within the last three years and must be the most recent version if the measure has been revised. A measure is in current use if at least one health care organization has used the measure to evaluate or report on quality of care within the previous three years.
3. The submitter must provide English-language documentation that is available upon request in print or electronic format (for free or for a fee) that includes at least each of the four following items:
   • Rationale for the measure
     
     The rationale is a brief statement describing the specific aspect of health care and the recipients to which the measure applies. The rationale may also include the evidence basis for the measure, and an explanation of how to interpret results, if that information is provided.
      
   • Description of the denominator and numerator of the measure (including specific variables for inclusion or exclusion of cases/events from either the denominator or numerator)
     
     A continuous variable statement (e.g., "time to thrombolysis") may be an acceptable alternative and measures whose metric is other than a rate or percentage will be considered on an individual basis. If structure measures lack a numerator and/or denominator, evidence must be provided that an association exists between the structure measure and one of the other four domains of quality (e.g., process, outcome, access, and patient experience).
   • Data source(s) for the measure
   • Documentation of evidence supporting the measure and the criterion of quality is required for Quality Measures, and for the quality component of Efficiency Measures
     
     Note: Any Related Measures must be part of a set or collection that includes Quality Measures to be considered for inclusion.

4. At least one of the following criteria must be satisfied with specific information attached in each case (evidence from peer-reviewed literature is preferred)
   • The measure has been cited in one or more reports in a National Library of Medicine (NLM) indexed, peer-reviewed journal, applying or evaluating the measure's properties.
   • The submitter provides documented evidence evaluating the reliability and validity of the measure.
     
     Reliability is the degree to which the measure is free from random error.
     Validity is the degree to which the measure is associated with what it purports to measure.
   
   
   • The measure has been developed, adopted, adapted, or endorsed by an organization that promotes rigorous development and use of measurement in health care. Such an organization may be at the international, national, regional, state or local levels (e.g., a multi-state consortium, a state Medicaid agency, or a health organization or delivery system).
     
     Adapted measures are those measures developed by one organization, and then subsequently adopted and modified in some way by another organization.

Note: If the measure(s) does not meet one or more of these inclusion criteria, the submission forms will be returned to the submitter with a request for further documentation or development in the identified area. The submitter may revise and resubmit measures.

*Systematic reviews are literature reviews that summarize evidence by identifying, selecting, assessing, and synthesizing the findings of similar but separate studies. They can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services.²

†To allow for a transition to the 2013 (revised) NGC inclusion criteria, in the scenario where the NGC inclusion team agreed that all other criteria and subcriteria were met, if an explicit statement that the clinical practice guideline was based on a systematic review was not provided, that subcriterion was waived and the guideline included in NGC. Guideline developers were advised of this omission and requested to correct it in future guidelines submitted to NGC.

‡Effective May 2016, the exact date(s) when the literature search was performed was no longer required for a guideline to be included in NGC. Note that the specific time period covered by the literature search including the beginning date (month/year) and end date (month/year) was still required and was not waived.