Editor-In-Chief: C. Michael Gibson, M.S., M.D. 
A medical guideline (also called a clinical guideline, clinical protocol or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine. However, in contrast to previous approaches, which were often based on tradition or authority, modern medical guidelines are based on an examination of current evidence within the paradigm of evidence-based medicine. They usually include summarized consensus statements, but unlike the latter, they also address practical issues.
Modern clinical guidelines briefly identify, summarize and evaluate the best evidence and most current data about prevention, diagnosis, prognosis, therapy including dosage of medications, risk/benefit and cost-effectiveness. Then they define the most important questions related to clinical practice and identify all possible decision options and their outcomes. Some guidelines contain decision or computation algorithms to be followed. Thus, they integrate the identified decision points and respective courses of action to the clinical judgment and experience of practitioners. Many guidelines place the treatment alternatives into classes to help providers in deciding which treatment to use.
Additional objectives of clinical guidelines are to standardize medical care, to raise quality of care, to reduce several kinds of risk (to the patient, to the healthcare provider, to medical insurers and health plans) and to achieve the best balance between cost and medical parameters such as effectiveness, specificity, sensitivity, resolutiveness, etc. It has been demonstrated repeatedly that the use of guidelines by healthcare providers such as hospitals is an effective way of achieving the objectives listed above, although they are not the only ones.
Special computer software packages known as guideline execution engines have been developed to facilitate the use of medical guidelines in concert with an electronic medical record system. The Guideline Interchange Format (GLIF) is a computer representation format for clinical guidelines that can be used with such engines.
It has been found that some simple clinical practice guidelines are not routinely followed to the extent they might be. It has been found that providing a nurse or other medical assistant with a checklist of recommended procedures can result in the attending physician being reminded in a timely manner regarding procedures that might have been overlooked.
The guideline-based approach to healthcare is a relatively recent one and has originated in the United States in the 1990s. Guidelines are usually produced at national or international levels by medical associations or governmental bodies, such as the US Agency for Healthcare Research and Quality. Local healthcare providers may produce their own set of guidelines or adapt them from existing top-level guidelines.
The USA and other countries maintain medical guideline clearinghouses. In the USA, the National Guideline Clearinghouse maintains a catalog of high-quality guidelines published by various organizations (mostly professional physician organizations). In the United Kingdom, clinical practice guidelines are published primarily by the National Institute for Health and Clinical Excellence (NICE). In The Netherlands, two bodies (CBO and NHG) publish specialist and primary care guidelines, respectively. In Germany, the German Agency for Quality in Medicine (AEZQ) coordinates a national program for disease management guidelines. All these organisations are now members of the Guidelines International Network, an international not-for-profit association of organisations and individuals involved in clinical practice guidelines. G-I-N is owner of the International Guideline Library - the largest web based data base of medical guidelines worldwide.
Standards for the conduct of clinical practice guidelines are available at http://www.g-i-n.net/ .
Standards for reporting guidelines are available.
Part of creating a clinical practice guideline is to gather and assess all of the relevant research. This task can be done using a framework such as the GRADE system. Techniques such as decision analysis  and nominal group technique may improve the validity of clinical practice guidelines. The methods of guidelines are evolving.
Structure of guidelines
Guidelines are evolving to a computable structure to rapidly adapt to rapid evidence needs such as COVID-19. Details are available at https://www.gps.health/covid19_knowledge_accelerator.html
|Format||Narrative text||Organized text (decision trees, algorithms, etc||Computable||Executable|
|Purpose||Communication of policy||Precise communication||Implementation in a EHR|
|Adapted from |
Guidelines may loose their clinical relevance as they age and newer research emerges. Even 20% of strong recommendations, especially when based on opinion rather than trials, from practice guidelines may be retracted.
Guidelines can be summarized and mapped in a structured table to help examine conflicts.
National Academy of Medicine
The National Academy of Medicine (formerly, Institute of Medicine) has published recommendations for assessing quality. These recommendations have been summarized:
- Transparent process
- Conflicts of interest
- Guideline development group composition
- Systematic reviews
- Evidence quality and recommendation strength
- Articulating recommendations
- External review
An alternative framework is the AGREE II.
Role of guidelines in malpractice determinations
"When guidelines offer conflicting recommendations, physicians should strive to secure the patient's understanding that based on the current guidelines, there is more than one “right” answer". Recommendations for system changes in this setting include legislation to create safe harbors.
- Treatment Guidelines from The Medical Letter
- Medical decision making
- Evidence-based medicine
- Consensus (medical)
- Algorithm (medical)
- Clinical protocol (cf. first line of the present article)
- ↑ GLIF website
- ↑ Gina Kolata "Program Coaxes Hospitals to See Treatments Under Their Noses". New York Times December 25, 2004.
- ↑ Qaseem A, Forland F, Macbeth F, Ollenschläger G, Phillips S, van der Wees P; et al. (2012). "Guidelines International Network: toward international standards for clinical practice guidelines". Ann Intern Med. 156 (7): 525–31. doi:10.1059/0003-4819-156-7-201204030-00009. PMID 22473437.
- ↑ Chen et al. A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement. Ann Intern Med 2016. doi:10.7326/M16-1565
- ↑ Kavanagh, Brian P. (2009). "The GRADE System for Rating Clinical Guidelines". PLoS Med. 6 (9): e1000094. doi:10.1371/journal.pmed.1000094. Retrieved 2009-09-16.
- ↑ 6.0 6.1 Kuntz KM, Tsevat J, Weinstein MC, Goldman L (1999). "Expert panel vs decision-analysis recommendations for postdischarge coronary angiography after myocardial infarction". JAMA. 282 (23): 2246–51. PMID 10605977.
- ↑ Jacobs AK, Anderson JL, Halperin JL (2014). "The Evolution and Future of ACC/AHA Clinical Practice Guidelines: A 30-Year Journey: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines". J Am Coll Cardiol. doi:10.1016/j.jacc.2014.06.001. PMID 25103073.
- ↑ Dunn AG, Bourgeois FT (2020). "Is it time for computable evidence synthesis?". J Am Med Inform Assoc. 27 (6): 972–975. doi:10.1093/jamia/ocaa035. PMC 7309243 Check
|pmc=value (help). PMID 32337600 Check
- ↑ Tu SW, Campbell J, Musen MA (2003). "The structure of guideline recommendations: a synthesis". AMIA Annu Symp Proc: 679–83. PMC 1480008. PMID 14728259.
- ↑ Martínez García L, Juliana Sanabria A, García Álvarez E, Trujillo-Martín MM, Etxeandia-Ikobaltzeta I, Kotzeva A; et al. (2014). "The validity of recommendations from clinical guidelines: a survival analysis". CMAJ. doi:10.1503/cmaj.140547. PMID 25200758.
- ↑ Shekelle PG, Ortiz E, Rhodes S; et al. (2001). "Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated?". JAMA. 286 (12): 1461–7. PMID 11572738.
- ↑ Neuman MD, Goldstein JN, Cirullo MA, Schwartz JS (2014). "Durability of class I American College of Cardiology/American Heart Association clinical practice guideline recommendations". JAMA. 311 (20): 2092–100. doi:10.1001/jama.2014.4949. PMID 24867012.
- ↑ Sun Y, Gao Y, Chen J, Sun H, Cai YT, Ge L; et al. (2019). "Evidence mapping of recommendations on diagnosis and therapeutic strategies for diabetes foot: an international review of 22 guidelines". Metabolism. 100: 153956. doi:10.1016/j.metabol.2019.153956. PMID 31394109.
- ↑ Institute of Medicine (US) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines (2011). "Clinical Practice Guidelines We Can Trust". PMID 24983061.
- ↑ Graham R, ed, Mancher M, ed, Wolman DM, ed, Greenfield S, ed, Steinberg E, ed. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011
- ↑ Ransohoff DF, Pignone M, Sox HC (2013). "How to decide whether a clinical practice guideline is trustworthy". JAMA. 309 (2): 139–40. doi:10.1001/jama.2012.156703. PMID 23299601.
- ↑ Norris SL, Holmer HK, Ogden LA, Burda BU, Fu R (2013). "Conflicts of interest among authors of clinical practice guidelines for glycemic control in type 2 diabetes mellitus". PLoS One. 8 (10): e75284. doi:10.1371/journal.pone.0075284. PMC 3796568. PMID 24155870.
- ↑ Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G; et al. (2010). "AGREE II: advancing guideline development, reporting and evaluation in health care". CMAJ. 182 (18): E839–42. doi:10.1503/cmaj.090449. PMC 3001530. PMID 20603348.
- ↑ 19.0 19.1 Kachalia A, Mello MM (2013). "Breast cancer screening: conflicting guidelines and medicolegal risk". JAMA. 309 (24): 2555–6. doi:10.1001/jama.2013.7100. PMID 23722969.
- National Guideline Clearinghouse (NGC), a public resource for evidence-based clinical practice guidelines. NGC is an initiative of the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services
- The Cochrane Collaboration
- Guideline Interchange Format. The Guideline Interchange Format (GLIF) is a specification for structured representation of guidelines.
- Guideline Elements Model. The Guideline Elements Model (GEM) is an ASTM standard for the representation of practice guidelines in XML format.
- 2004 report Hospital Quality Alliance (HQA), a project of the Hospital Quality Initiative (HQI) of the Centers for Medicare and Medicaid Services (CMS)
- Scottish Intercollegiate Guidelines Network (SIGN). Contains 113 evidence-based clinical guidelines - published, in development, or under review.