[Legal relevance of guidelines : Contextualization exemplified by international recommendations for treatment of inguinal hernia in adults]

Chirurg. 2018 Aug;89(8):624-630. doi: 10.1007/s00104-018-0671-9.
[Article in German]

Abstract

Background: Guidelines aim to standardize treatment concepts based on evidence from the literature and may thus be viewed as collegial support; however, there is a lack of clarity about the legal relevance and legal validity of international guidelines compared to the Association of the Scientific Medical Societies in Germany (AWMF) recommendations.

Material and methods: A literature search was conducted on German AWMF guidelines and on international guidelines for inguinal hernia in adults. Differences in the structure of the guidelines were analyzed and legal terms, such as the medical standard, the Patients' Rights Act and the current legal literature are defined and commented on with respect to guideline-compliant treatment.

Results: Since 2003 a total of 15 guidelines and recommendations for the treatment of inguinal hernia have been published. There are no AWMF guidelines on one of the procedures most frequently performed in Germany. Among the relevant judgments and laws passed from 1994 onwards, § 630 of the German Civil Code (BGB) passed in 2013 seems to be particularly significant, since it standardizes the term "medical standard" and explicitly allows values falling short of the standard after clarification.

Discussion: From a legal point of view, the basic prerequisites for medical treatment are patient consent and intervention education. In principle, a non-guideline-compliant treatment procedure can be agreed. The patient must be informed about the treatment options that are relevant to the medical standard, the procedure must be indicated according to the medical standard and the operation must be performed in accordance with the national medical specialist standard. Thus, international guidelines cannot a priori claim to be followed unobserved and are therefore not legally comparable to the German S3 guidelines of the AWMF. It is strongly advised to expressly point out and explicitly explain anything falling short of the standard, individual healing attempts and so-called outsider methods.

Keywords: Guidelines; HerniaSurge; Inguinal hernia; Legal validity.

Publication types

  • Review

MeSH terms

  • Adult
  • Germany
  • Hernia, Inguinal*
  • Humans
  • Patient Rights
  • Societies, Medical