Medical guidelines are systematically developed statements designed to assist physicians, dentists, other health professionals, and patients in making decisions about appropriate healthcare in specific clinical circumstances. Unlike guidelines , they are not binding and must be adapted to the individual case. Sometimes they take into account economic aspects of treatment. As a rule, they do not contain any evaluation of the achievable treatment results ( outcomes ).
The concept of the guideline is not subject to any standardization (for a differentiation, see guideline ). Therefore, medical guidelines can vary in quality.
Ideally, medical guidelines are subject to a systematic and transparent development process; they are scientifically sound, practice-oriented recommendations for action. Its main purpose is to present the technical level of development ( state of science ). They give doctors, patients and others involved in medical care orientation in terms of options for decision-making and action. The implementation lies in the case-specific consideration at the discretion of the practitioner; Likewise, the preferences of the patient are to be included in the decision-making in individual cases.
An evidence-based and consensus-based guideline is the consensus of multidisciplinary expert groups on certain approaches in medicine, taking into account the best available evidence . The consensus is achieved through a defined, transparent procedure. It is based on systematic research and the analysis of scientific evidence from clinics and practice as well as their division into evidence classes .
In Germany, medical guidelines are primarily developed by the Working Group of the Scientific Medical Societies in Germany (AWMF), by the medical self-administration (German Medical Association [BÄK] and the National Association of Statutory Health Insurance Physicians [KBV] or the German Dental Association [BZÄK] and the National Association of Statutory Health Insurance Dentists [KZBV]) or by professional associations and spread. Information on and access to international guideline projects and agencies is offered by the Guidelines International Network with the world's most extensive guideline database.
Guidelines for structured medical care (i.e. for integrated care and for disease management programs ) are called National Care Guidelines (NVL). The program for National Care Guidelines, supported by the German Medical Association, the National Association of Statutory Health Insurance Physicians and the Working Group of Scientific Medical Societies, is edited by the Medical Center for Quality in Medicine (ÄZQ). In addition, the Dental Quality Center (ZZQ), which is supported by the German Dental Association and the National Association of Statutory Health Insurance Dentists , creates guidelines.
In addition to the medical guidelines, which are primarily created for doctors, there is corresponding specialist information for patients, so-called patient guidelines. In interdisciplinary care (care of the elderly, sick, children) there are some expert standards related to the guidelines .
Medical guidelines are not legal norms that bind the judiciary . On a case-by-case basis, you can specify the care required in traffic in accordance with German Civil Code (BGB) if you define the perception of the public in a way that makes a deviation appear unreasonable and increasing the risk. If guidelines relate to the core of medical practice, they are only indicative. In no case, their uncritical compliance can replace the individual decision-making process in each individual case.
The Federal Supreme Court ruled that
"The use of not generally recognized forms of therapy and even pronounced para-medical forms of treatment is generally legally permitted. It can be left open whether this has to be the case because a restriction of the freedom of method for legal reasons would represent an obstacle to medical progress or a standstill in medicine. In any case, this follows from the right of self-determination of a patient who is aware of the scope of his decision. Because the doctor has the right to choose any treatment method that does not violate common decency, the fact that the medical practitioner has left the field of conventional medicine cannot be inferred from the outset that there has been a treatment error. "
The freedom of method ( freedom of therapy ) does not mean a license for unscrupulousness; the doctor's freedom of choice is limited by the patient's interest in careful treatment. In the context of statutory health insurance , the economic efficiency principle must also be observed. At the same time, an obligation to “treat according to guidelines” against the patient's will ( right of self-determination ) is unthinkable.
According to the AWMF system, guidelines are developed and classified in four development levels from S1 to S3, with S3 being the highest quality level of the development methodology.
- S1: The guideline was drawn up by a group of experts based on informal consensus.
- S2k: A formal consensus has been reached.
- S2e: A systematic evidence search has taken place.
- S3: The guideline has gone through all elements of a systematic development (logic, decision and outcome analysis, evaluation of the clinical relevance of scientific studies and regular reviews).
The methodological quality of an S3 guideline is accordingly higher than that of an S2 or S1 guideline. The guidelines listed at the AWMF are divided into approx. 37% S1 guidelines / recommendations for action, approx. 37% S2 guidelines and approx. 26% S3 guidelines (as of June 2020).
The evidence included in a medical guideline is differentiated according to a classification ( level of evidence ). Guidelines are individually assigned to such evidence classes. Different classification systems are used, there is no international or European standard. The classification of Cochrane Germany , which ranges from the highest evidence level Ia (at least one systematic review based on methodologically high-quality controlled, randomized studies) to the lowest evidence level IV (opinions and convictions of respected authorities with clinical experience and of expert committees, descriptive) has broad recognition Studies) is enough.
Treatment recommendations with a certain level of recommendation (synonym: strength of recommendation) are developed. The following distinction is common in Germany:
- Grade A, "should" recommendation: at least one randomized controlled study of overall good quality and consistency, which relates directly to the respective recommendation and was not extrapolated (evidence levels Ia and Ib)
- Grade B, “should” recommendation: well-conducted but non-randomized clinical studies with direct reference to the recommendation (evidence level II or III) or extrapolation from evidence level I if there is no reference to the specific question
- Grade C, “Can” recommendation: reports from expert groups or expert opinion and / or clinical experience of recognized authorities (evidence category IV) or extrapolation from evidence level IIa, IIb or III if no directly applicable clinical studies of good quality were available
If there are no experimental scientific studies for a treatment method, if these are not possible or not aimed for, but the treatment method is still generally accepted and an agreement on the method could be reached within the consensus group, this method is recommended as Good Clinical Practice ( GCP, synonymous: KKP = clinical consensus point ).
- In practice, guidelines are often poorly implemented.
- Guidelines can lead to a narrowing of the medical decision-making latitude.
- High-quality S3 or NVL guidelines are only available for common clinical pictures.
- The scientific consensus process in the creation of guidelines means that only a few of the treatment steps considered relevant are included in the guidelines.
- Evidence-based medicine : The publication bias , i.e. H. the statistically distorted presentation of scientific results as a result of the preferred publication of studies with positive or significant results leads to important research results being falsified, since z. B. negative studies are published less often.
- In March 2013, Der Arzneimittelbrief criticized the - in its view - too rapid inclusion of new drugs in the medical guidelines and suspected that the interests of the pharmaceutical companies were behind this .
- If one considers the duration of the preparation of guidelines, a minimum of two years can be assumed. This results in the question of topicality in the well-known progress in science, especially in medicine.
- Too high a scientific level reduces acceptance in everyday clinical practice. It is therefore a matter of balancing the desirable with the feasible.
- Guidelines are always a relative snapshot of medical knowledge.
- Guidelines are not suitable for answering questions that arise when innovations are introduced. The creation process is too complex and therefore too lengthy for this.
- Many guidelines, even if they are supposedly evidence-based, are of inadequate methodological quality so that there is a risk that the recommendations contained in them will not achieve the desired effect of improving care when implemented. On the contrary, there is a risk that they will cause harm.
- Guidelines from different editors give different recommendations on the same topics. This becomes a problem in particular when it comes to large international and nationally renowned organizations and users are thus faced with contradicting recommendations.
- Lack of valid comparative studies on ethically unjustifiable alternative methods.
- Guidelines have their limits where the patient does not consent to treatment in accordance with the guidelines.
- Guidelines can remain purely theoretical requirements if, due to the economic efficiency requirement or the economic limits of the patient, implementation is not possible for financial reasons.
To avoid conceptual conflicts, the guidelines for nursing are published as expert standards , a form of nursing standard , which has been developed, written and published by the German Network for Quality Development in Nursing . With the Long-term Care Development Act , the creation and updating of the expert standards were handed over to the representatives of the long-term care insurance funds and care facilities, i.e. the contracting parties in accordance with Section 113 SGB XI. The medical societies largely ignore this topic in the course of the increasingly independent scientification of nursing.
Patient guidelines convey the content of evidence-based guidelines to patients and relatives. In addition to information that is identical in content to the corresponding care guidelines, but reformulated in a way that is understandable to laypersons, they contain additional information that corresponds to the needs of patients. They explain the optimal care structures, convey background information on the functioning of the respective body organ or system and its pathological changes, provide guidance for self-management, support doctor-patient communication (e.g. through checklists) and provide further help.
Comprehensibility and relevance for the target groups are usually checked in consultation phases; the creation process is documented in method reports.
In Germany, the ÄZQ prepares patient guidelines and brief information for patients for each national care guideline. The list of topics in October 2015 included asthma , COPD , depression , diabetes (five sub-topics), cardiac insufficiency , coronary artery disease and low back pain . In addition, the ÄZQ has drawn up patient guidelines on cancer on behalf of the German Cancer Society (as of August 2015: ten patient guidelines, including on breast cancer , colon cancer , cervical cancer , stomach cancer and prostate cancer ). These are available online in full text or can be obtained as brochures.
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