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 on best practice in healthcare. A healthcare provider is obliged to know the medical guidelines of his or her profession, and has to decide whether or not to follow the recommendations of a guideline for an individual treatment.
Modern clinical guidelines identify, summarize and evaluate the highest quality 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 with 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.
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.
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.
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 (ÄZQ) coordinates a national program for disease management guidelines. All these organisations are now members of the Guidelines International Network (G-I-N), an international network 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 - and pursue a set of activities aiming at promoting best practice and reducing duplication.
Guidelines may lose 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.
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.
Guidelines may have both methodological problems and conflict of interest. As such, the quality of guidelines may vary substantially, especially for guidelines that are published on-line and have not had to follow methodological reporting standards often required by reputable clearinghouses.
- The American Heart Association Guidelines for the Prevention of Infective Endocarditis
- The BMJ Rapid Recommendation guideline on transcatheter aortic valve implantation versus surgical aortic valve replacement for aortic stenosis.
- Clinical formulation
- Clinical prediction rule
- Clinical trial protocol
- Medical algorithm
- Treatment Guidelines from The Medical Letter
- Burgers JS, Grol R, Klazinga NS, Mäkelä M, Zaat J, for the AGREE Collaboration. Towards evidence-based clinical practice: an international survey of 18 clinical guideline programs. Int J Qual Health Care 2003;15:31-45
- The AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care 2003;12:18-23.
- Institute of Medicine (edt.) Clinical practice guidelines we can trust. Washington DC, 2011
- Council of Europe. Developing a methodology for drawing up guidelines on best medical practice. Recommendation Rec(2001)13 and explanatory memorandum. Strasbourg: Council of Europe Publishing, 2002.
- GLIF website
- 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. doi:10.1001/jama.286.12.1461. 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.
- Gina Kolata "Program Coaxes Hospitals to See Treatments Under Their Noses". New York Times December 25, 2004.
- Reames BN; Krell RW; Ponto SN; Wong SL (2013). "Critical evaluation of oncology clinical practice guidelines". J Clin Oncol. 31 (20): 2563–8. doi:10.1200/JCO.2012.46.8371. PMID 23752105.
- Norberg MM, Turner MW, Rooke SE, Langton JM, Gates PJ. An Evaluation of Web-Based Clinical Practice Guidelines for Managing Problems Associated with Cannabis Use. J Med Internet Res 2012;14(6):e169; URL: http://www.jmir.org/2012/6/e169/; doi: 10.2196/jmir.2319; PMID 23249447
- Brito JP; Domecq JP; Murad MH; Guyatt GH; et al. (2013). "The Endocrine Society guidelines: when the confidence cart goes before the evidence horse". J Clin Endocrinol Metab. 98 (8): 3246–52. doi:10.1210/jc.2013-1814. PMID 23783104.
- Siemieniuk RA, Agoritsas T, Macdonald H, Guyatt GH, Brandt L, Vandvik PO (2016). "TIntroduction to BMJ Rapid Recommendations". BMJ. 354: i5191. doi:10.1136/bmj.i5191. PMID 27680768.
- Wilson W; Taubert KA; Gewitz M; et al. (October 2007). "Prevention of infective endocarditis: guidelines from the American Heart Association". Circulation. 116 (15): 1736–54. doi:10.1161/CIRCULATIONAHA.106.183095. PMID 17446442.
- Vandvik PO, Otto CM, Siemieniuk RA, Bagur R, Guyatt GH, Lytvyn L, Whitlock R, Vartdal T, Brieger D, Aertgeerts B, Price S, Foroutan F, Shapiro M, Mertz R, Spencer FA (2016). "Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline". BMJ. 354: i5085. doi:10.1136/bmj.i5085. PMID 27680583.
- British Columbia Medical Guidelines - In Canada, British Columbia's guidelines and protocols are developed under the direction of the Guidelines and Protocols Advisory Committee (GPAC), jointly sponsored by the B.C. Medical Association and the B.C. Ministry of Health Services.
- The Cochrane Collaboration - The Cochrane Collaboration is an international, independent, not-for-profit organisation of over 27,000 contributors from more than 100 countries, dedicated to making up-to-date, accurate information about the effects of health care readily available worldwide.
- GuiaSalud. Clinical Practice Guidelines for the National Health System (Spain) - Contains clinical practice guidelines developed in Spain translated into English.
- Guideline Elements Model - The Guideline Elements Model (GEM) is an ASTM standard for the representation of practice guidelines in XML format.
- Guideline Interchange Format - The Guideline Interchange Format (GLIF) is a specification for structured representation of guidelines.
- Guidelines International Network. Contains the largest online guideline library.
- Hospital Quality Alliance - A project of the Hospital Quality Initiative (HQI) of the Centers for Medicare and Medicaid Services.
- 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
- Scottish Intercollegiate Guidelines Network (SIGN). Contains 113 evidence-based clinical guidelines – published, in development, or under review.
- Samanta A; Samanta J; Gunn M (March 2003). "Legal considerations of clinical guidelines: Will NICE make a difference?". J R Soc Med. 96 (3): 133–8. doi:10.1258/jrsm.96.3.133. PMC 539423. PMID 12612117.