What are clinical practice guidelines?

Clinical practice guidelines (or simply “clinical guidelines”) are recommendations on how to diagnose and treat a medical condition. They are mainly written for doctors, but also for nurses and other health care professionals.

Clinical guidelines are meant to help ensure that patients receive appropriate treatment and care. For instance, the guidelines on cervical cancer include recommendations on the and treatment, as well as recommendations concerning psychosocial support, rehabilitation and follow-up care.

Guidelines summarize the current medical knowledge, weigh the benefits and harms of diagnostic procedures and treatments, and give specific recommendations based on this information. They should also provide information about the scientific supporting those recommendations. Clinical practice guidelines must be updated regularly.

Unlike directives, guidelines aren’t legally binding. In other words, doctors don’t have to follow the recommendations if they don’t think they are suitable for certain patients. But deviations from guidelines must be justified.

For some medical conditions there are also easy-to-understand guidelines for patients. They are freely available on the internet. The German Association of the Scientific Medical Societies (AWMF) offers an overview of the currently available guidelines for patients in Germany.

How are clinical practice guidelines developed?

Ideally, clinical guidelines should be developed systematically – in other words, following a certain procedure:

  • First a guideline committee is formed, including specialists to cover all the important aspects of the medical condition in question. The committee is usually led by a member of the medical association responsible for the medical condition.
  • It collects as much information as possible from different sources and assesses the information based on predetermined criteria. The various assessments and opinions of the committee members are discussed and taken into consideration when writing the guidelines. In other words, the recommendations are "consensus-based."
  • The committee members have to declare any conflicts of interest. For instance, they have to say whether they have worked for a pharmaceutical company that makes medication to treat the medical condition that the clinical guidelines are being written about.

How can you recognize good clinical guidelines?

Good clinical guidelines should be based on up-to-date scientific knowledge, and it should be possible to follow the recommendations in daily medical practice. International uniform standards are now used worldwide for the assessment of clinical guidelines. In Germany, the Association of the Scientific Medical Societies (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, or AWMF) coordinates the development of clinical guidelines. It divides guidelines into four categories:

  • S1 guidelines: These guidelines summarize the recommendations of experts. They do not systematically compile and assess the medical knowledge in the area in question. So the recommendations made in S1 guidelines aren’t very reliable.
  • S2K guidelines: S2K guidelines are developed by a committee of specialists in the medical field in question. The recommendations made are consensus-based. Because medical information isn’t systematically collected and assessed here either, the information that the recommendations are based on isn’t very reliable.
  • S2e guidelines: Here the guideline committee systematically compiles the medical knowledge from different sources. But if the members of the committee disagree, they do not use a consensus-based approach to develop the guidelines.
  • S3 guidelines: This is the only category of guidelines that meets all of the following requirements: The guideline committee includes experts representing various areas of the field in question, and the medical knowledge is systematically collected and assessed. What’s more, if different members of the committee have different views, a specific procedure is followed in order to develop consensus-based recommendations.
    S3 guidelines are the most reliable kind of guidelines, but they also involve the most effort: It can take several years to develop them. When S3 guidelines are developed for doctors and health care professionals, patient guidelines are usually developed too.

Association of the Scientific Medical Societies (AWMF), German Agency for Quality in Medicine (AQuMed). Das Leitlinien-Manual.

Association of the Scientific Medical Societies , German Agency for Quality in Medicine . German Guideline Appraisal Instrument DELBI . Version 2005 / 2006 + Domain 8; 2008.

German Agency for Quality in Medicine. Leitlinien-Grundlagen.

German Cochrane Centre. Leitlinien.

German Cochrance Centre, Association of the Scientific Medical Societies, German Agency for Quality in Medicine. Manual Systematische Literaturrecherche für die Erstellung von Leitlinien.Freiburg, Berlin; 2013.

Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF). S3-Leitlinie Diagnostik, Therapie und Nachsorge der Patientin mit Zervixkarzinom. Kurzversion 1.0, 2014.

Thole H, Thalau F, Ollenschläger G., Kopp I, Lelgemann M. Kritische Bewertung von Leitlinien. In: Kunz R, Ollenschläger G, Raspe H, Jonitz G, Donner-Banzhoff N. Lehrbuch Evidenzbasierte Medizin in Klinik und Praxis. Cologne: Deutscher Ärzte-Verlag; 2007.

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on September 8, 2016
Next planned update: 2021

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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