S2k-Leitlinie Lebertransplantation der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) und der Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV)

A) Allgemeiner Teil

1 Informationen zur Leitlinie

Der Leitlinienreport dokumentiert die Erstellung der Leitlinie von August 2016 bis April 2023.

1.1 Herausgeber

 

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1.2 Federführende Fachgesellschaften

Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankrankheiten (DGVS)
Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie e. V. (DGAV)

 

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1.3 Geltungsbereich und Zweck

Die Lebertransplantation stellt häufig eine lebensrettende Therapieoption eines akuten oder chronischen Funktionsausfalls der Leber dar und zählt nach der Niere zu den zweithäufigsten Organtransplantationen. Da hierbei nicht nur der operative Eingriff, sondern auch die lebenslange Nachsorge und mögliche Komorbiditäten abgewogen werden müssen, handelt es sich bei der Transplantationsmedizin um ein Querschnittsfach mit hoher interdisziplinärer Vernetzung, welches auf die fachliche Expertise in der Gastroenterologie und Hepatologie zurückgreift [1].

Ziel der Leitlinie ist, die Diagnostik und Therapie der Lebertransplantation zu standardisieren und zu verbessern.

Darüber hinaus sollen mit der Leitlinie diagnostische und therapeutische Pitfalls sowie neue Therapieoptionen und Perspektiven dargestellt werden.

 

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1.4 Zielorientierung der Leitlinie

Ziel der Leitlinie ist, in der internistischen, chirurgischen, gastroenterologischen, nephrologischen, ernährungsmedizinischen, pathologischen, infektiologischen, kardiologischen, anästhesiologischen, bildgebenden, psychosomatischen und psychologischen Praxis Empfehlungen zu geben, die die Versorgung der Patienten verbessern. Darüber hinaus soll die Leitlinie einen Handlungskorridor für häufige Entscheidungen liefern.

Patientenzielgruppe sind erwachsene Patienten mit Leberversagen.

 

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1.5 Versorgungsbereich

Ambulant und stationär, internistisch, chirurgisch, gastroenterologisch, nephrologisch, ernährungsmedizinisch, pathologisch, infektiologisch, kardiologisch, anästhesiologisch, bildgebend, psychosomatisch und psychologisch.

 

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1.6 Anwenderzielgruppe/Adressaten

Die Leitlinie richtet sich an alle an der Diagnostik und Therapie beteiligten Berufsgruppen (Internisten, Gastroenterologen, Chirurgen, Nephrologen, Ernährungsmediziner, Pathologen, Infektiologen, Kardiologen, Anästhesisten, Radiologen, Psychosomatiker und Psychologen), Patientenvertreter sowie Betroffene und Angehörige. Sie dient zur Information für Pädiater und Leistungserbringer (Krankenkassen, Rentenversicherungsträger).

 

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1.7 Zusammensetzung der Leitliniengruppe: Beteiligung von Interessensgruppen

Die Leitlinie wurde federführend durch die Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) und die Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie e. V. (DGAV) erstellt, die als Koordinierende Herrn Prof. Thomas Berg (DGVS), Leipzig, Herrn Prof. Christian Trautwein (DGVS), Aachen, Herrn Prof. Thomas Becker (DGAV), Kiel und Herrn Prof. Wolf O. Bechstein (DGAV), Frankfurt am Main, beauftragte. Methodisch verantwortlich waren Frau PD Dr. Petra Lynen Jansen und Frau Pia Lorenz, DGVS Geschäftsstelle, Berlin. Frau Dr. Monika Nothacker, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF), Berlin, stand zur methodischen Beratung zur Seite und moderierte als neutrale Leitlinienexpertin die Konsensuskonferenz. Herr Torsten Karge stand für das Leitlinienportal zur Verfügung und übernahm die technische Betreuung der Konsensuskonferenz.

Das Leitlinienvorhaben wurde in der Zeitschrift für Gastroenterologie ausgeschrieben und auf der Webseite der AWMF veröffentlicht, so dass weitere Fachgesellschaften/Vertreteren sich zur Mitarbeit melden konnten. Die für das Fachgebiet relevanten Fachgesellschaften und Patientengruppen wurden angeschrieben und um Nennung von Mandatsträgeren gebeten.

 

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1.8 Repräsentativität der Leitliniengruppe: Beteiligte Fachgesellschaften

• Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie e. V. (DGAV)
  W. Bechstein (Frankfurt am Main), T. Becker (Kiel), M. Glanemann (Homburg), M. Guba* (München), I. Klein (Würzburg), H. Lang (Mainz), S. Manekeller (Bonn), A. Mehrabi (Heidelberg), U. Neumann (Essen), A. Pascher* (Münster), J. Pratschke* (Berlin), F. Rauchfuß (Jena), P. Schemmer (Bern), H. Schlitt (Regensburg), M. Schmelzle (Hannover), H. Schmidt (Essen), A. Schnitzbauer (Frankfurt am Main), W. Schöning (Berlin), D. Seehofer (Leipzig), U. Settmacher* (Jena), M. Sterneck (Hamburg), R. Sucher (Leipzig)

• Deutsche Gesellschaft für Chirurgie e. V. (DGCH)
  P. Schemmer (Bern)

• Deutsche Gesellschaft für Ernährungsmedizin e. V. (DGEM)
  M. Plauth (Dessau)

• Deutsche Gesellschaft für Nephrologie e. V. (DGfN)
  Gäckler (Essen), A. Kribben (Essen)

• Deutsche Gesellschaft für Innere Medizin e. V. (DGIM)
  R. Günther (Kiel)

• Deutsche Gesellschaft für Pathologie e. V. (DGP)/Bundesverband Deutscher Pathologen (BDP)
  H. Baba (Essen), C. Flechtenmacher (Heidelberg)

• Deutsche Gesellschaft für Infektiologie e. V. (DGI)
  C. Lübbert (Leipzig), O. Witzke (Essen)

• Deutsche Gesellschaft für Kardiologie – Herz- und Kreislaufforschung e. V. (DGK)
  C. Jung (Düsseldorf)

• Deutsche Röntgengesellschaft, Gesellschaft für Medizinische Radiologie e. V. (DRG)
  K. Ringe (Hannover), A. Schreyer (Brandenburg an der Havel)

• Deutsche Gesellschaft für Klinische Chemie und Laboratoriumsmedizin e. V. (DGKL)
  T. Kaiser (Leipzig)

• Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin e. V. (DGAI)
  T. Schürholz (Aachen), B. Sinner (Regensburg), R. von Haken (Heidelberg), M. Weigand (Heidelberg)

• Deutsche Gesellschaft für Psychiatrie und Psychotherapie, Psychosomatik und Nervenheilkunde e. V. (DGPPN)
  Batra (Tübingen), D. Eser-Valeri (München)

• Deutsche Gesellschaft für Psychosomatische Medizin und Ärztliche Psychotherapie e. V. (DGPM)
  Y. Erim (Erlangen)

• Deutsches Kollegium für Psychosomatische Medizin e. V. (DKPM)
  Y. Erim (Erlangen)

• Deutsche Gesellschaft für Internistische Intensivmedizin und Notfallmedizin e. V. (DGIIN)
  V. Fuhrmann (Duisburg)

• Deutsche Gesellschaft für Suchtforschung und Suchttherapie e. V. (DG-Sucht)
  A. Batra (Tübingen)

• Deutsche Transplantationsgesellschaft (DTG)
  F. Braun* (Kiel), Y. Erim (Erlangen), S. Nadalin (Tübingen), K. Staufer (Wien)

• Deutsche Stiftung Organtransplantation (DSO)
  A. Barreiros (Mainz)

• Bundesverband der Organtransplantierten e. V. (BDO)
  H. Wohn (Wiesbaden)

*Mitglieder der Ständigen Kommission Organtransplantation (StäKo) der Bundesärztekammer (BÄK)

 

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1.9 Repräsentativität der Leitliniengruppe: Beteiligung von Patienten

• Gastro-Liga Deutschland
  A. Geier (Würzburg)

• Selbsthilfe Lebertransplantierte Deutschland e. V.
  J. Riemer (Bretzfeld)

• Deutsche Leberhilfe
  H. Wohn (Wiesbaden)

Neben der Steuergruppe ([Tab. 1]) wurden 13 Arbeitsgruppen (AGs) gebildet, die jeweils von zwei Leitenden geleitet wurden ([Tab. 2]). In den AGs arbeiteten neben Gastroenterologen und Chirurgen Internisten, Nephrologen, Ernährungsmediziner, Pathologen, Infektiologen, Kardiologen, Anästhesisten, Radiologen, Psychosomatiker, Psychologen und Patientenvertreter mit.

Tab. 1 Steuergruppe.

Name	Ort	Zuständigkeit
N. Aehling	Leipzig	DGVS
W. Bechstein	Frankfurt am Main	DGAV
T. Becker	Kiel	DGAV
T. Berg	Leipzig	DGVS
T. Bruns	Aachen	DGVS
C. Trautwein	Aachen	DGVS

Tab. 2 Mitglieder der Leitliniengruppe.

AG 1 A: Akutes Leberversagen	AG-Leitung	A. Canbay, Bochum (DGVS) J. Pratschke, Berlin (DGAV)
	AG-Mitglieder	N. Aehling, Leipzig (DGVS) C. Lange, München (DGVS) M. Schmelzle, Hannover (DGAV) W. Schöning, Berlin (DGAV) T. Schürholz, Aachen (DGAI) R. von Haken, Heidelberg (DGAI)
AG 1 B/C: Indikation bei Leberzirrhose und ACLF	AG-Leitung	D. Seehofer, Leipzig (DGAV) J. Trebicka, Münster (DGVS)
	AG-Mitglieder	S. Beckebaum, Essen (DGVS) M. Berres, Aachen (DGVS) A. Geier, Würzburg (Gastro-Liga) A. Gerbes, München (DGVS) C. Jansen, Bonn (DGVS) C. Ripoll, Jena (DGVS) P. Schemmer, Bern (DGAV, DGCH)
AG 1 D/E: Spezielle Indikationen bei anderen Lebererkrankungen und sekundären hepatischen Malignomen	AG-Leitung	M. Guba, München (DGAV) T. Weismüller, Berlin (DGVS)
	AG-Mitglieder	V. Fuhrmann, Duisburg (DGIIN) I. Kabar, Münster (DGVS) A. Potthoff, Hannover (DGVS) E. Roeb, Gießen (DGVS) M. Wörns, Dortmund (DGVS)
AG 2: Kombinierte und Multiviszeral-Transplantation	AG-Leitung	F. Lammert, Hannover (DGVS) A. Pascher, Münster (DGAV)
	AG-Mitglieder	A. Gäckler, Essen (DGFN) G. Lamprecht, Rostock (DGVS) A. Mehrabi, Heidelberg (DGAV) F. Rauchfuß, Jena (DGAV)
AG 3: Evaluation zur Lebertransplantation und Patienten auf der Warteliste	AG-Leitung	F. Braun, Kiel (DTG) E. Schott, Berlin (DGVS)
	AG-Mitglieder	D. Eser-Valeri, München (DGPPN) C. Jung, Düsseldorf (DGKardiologie) T. Kaiser, Leipzig (DGKL) A. Kribben, Essen (DGFN) A. Schreyer, Brandenburg an der Havel (DRG) H. Wohn, Wiesbaden (Dt. Leberhilfe, BDO)
AG 4: Welche Untersuchungen sind bei Patienten auf der Warteliste notwendig?	AG-Leitung	M. Glanemann, Homburg (DGAV) F. Tacke, Berlin (DGVS)
	AG-Mitglieder	M. Cornberg, Hannover (DGVS) D. Eser-Valeri, München (DGPPN) R. Günther, Kiel (DGIM) H. Hinrichsen, Kiel (DGVS) A. Kribben, Essen (DGFN) R. Taubert, Hannover (DGVS)
AG 5: Transplantation	AG-Leitung	G. Kirchner, Regensburg (DGVS) S. Manekeller, Bonn (DGAV)
	AG-Mitglieder	C. Flechtenmacher, Heidelberg (DGPathologie/BDP) H. Heinzow, Trier (DGVS) B. Sinner, Regensburg (DGAI)
AG 6: Immunsuppression nach Lebertransplantation	AG-Leitung	H. Schmidt, Essen (DGAV) A. Schnitzbauer, Frankfurt am Main (DGAV)
	AG-Mitglieder	E. Jaeckel, Hannover (DGVS)
AG 7: Diagnostik und Management von postoperativen Komplikationen	AG-Leitung	C. Engelmann, Berlin (DGVS) I. Klein, Würzburg (DGAV)
	AG-Mitglieder	J. Albert, Stuttgart (DGVS) H. Baba, Essen (DGPathologie/BDP) K. Ringe, Hannover (DRG) M. Weigand, Heidelberg (DGAI)
AG 8: Nachsorge – Der Patient im Langzeitverlauf nach Transplantation	AG-Leitung	H. Schlitt, Regensburg (DGAV) M. Sterneck, Hamburg (DGAV, DGVS)
	AG-Mitglieder	T. Bruns, Aachen (DGVS) C. Lübbert, Leipzig (DGI) J. Riemer, Bretzfeld (Selbsthilfe Lebertransplantierte) C. Rupp, Heidelberg (DGVS) A. Schreyer, Brandenburg an der Havel (DRG) K. Staufer, Wien (DTG, DGVS)
AG 9: Rezidiv der Grunderkrankung – Therapie und Prophylaxe	AG-Leitung	C. Berg, Tübingen (DGVS) U. Neumann, Essen (DGAV)
	AG-Mitglieder	H. Baba, Essen (DGPathologie/BDP) A. Batra, Tübingen (DGPPN, DG-Sucht) D. Eser-Valeri, München (DGPPN) G. Moog, Kassel (DGVS) J. Vermehren, Wiesbaden (DGVS) O. Witzke, Essen (DGI)
AG 10: Retransplantation im Langzeitverlauf	AG-Leitung	H. Lang, Mainz (DGAV) P. Strnad, Aachen (DGVS)
	AG-Mitglieder	B. Appenrodt, Köln (DGVS) M. Sterneck, Hamburg (DGAV, DGVS) R. Sucher, Leipzig (DGAV)
AG 11: Leberlebendspende	AG-Leitung	U. Settmacher, Jena (DGAV) M. Welker, Groß-Umstadt (DGVS)
	AG-Mitglieder	Y. Erim, Erlangen (DTG, DKPM, DGPM) S. Nadalin, Tübingen (DTG, DGAV) K. Ringe, Hannover (DRG) H. Tautenhahn, Jena (DGVS) C. Wilms, Münster (DGVS)
AG übergreifend		A. Barreiros, Mainz (DSO) M. Plauth, Dessau (DGEM)
Koordinierende		W. Bechstein, Frankfurt am Main (DGAV) T. Becker, Kiel (DGAV) T. Berg, Leipzig (DGVS) C. Trautwein, Aachen (DGVS)

 

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2 Methodologisches Vorgehen

2.1 Evidenzsynthese

2.1.1 Grundlagen der Methodik

2.1.1.1 Literaturrecherche und Schema der Evidenzbewertung

Ursprünglich wurde die Leitlinie als S2k-Leitlinie geplant. Nach Gesprächen mit der AWMF und der Bundesärztekammer sollte die Erstellung einer S3-Leitlinie mit einer systematischen Recherche und einer Literaturbewertung nach der Evidenzklassifizierung des Oxford Centre for Evidence-based Medicine 2011 geprüft werden ([Tab. 3]). Jedoch ergab die systematische Recherche, dass nicht ausreichend Evidenz vorliegt, so dass nach Rücksprache mit der AWMF die Klassifizierung der Leitlinie als S2k beibehalten wurde. Die weitere Literaturrecherche erfolgte entsprechend individuell in den einzelnen Arbeitsgruppen. Die Details zur Suche der Evidenz sowie die individuelle Literaturrecherche sind im Leitlinienreport dargestellt.

Tab. 3 Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence [2].

Question	Step 1 (Level 1[*])	Step 2 (Level 2[*])	Step 3 (Level 3[*])	Step 4 (Level 4[*])	Step 5 (Level 5)
How common is the problem?	Local and current random sample surveys (or censuses)	Systematic review of surveys that allow matching to local circumstances[**]	Local non-random sample[**]	Case-series[**]	n/a
Is this diagnostic or monitoring test accurate? (Diagnosis)	Systematic review of cross sectional studies with consistently applied reference standard and blinding	Individual cross sectional studies with consistently applied reference standard and blinding	Non-consecutive studies, or studies without consistently applied reference standards[**]	Case-control studies, or “poor or non-independent reference standard[**]	Mechanism-based reasoning
What will happen if we do not add a therapy? (Prognosis)	Systematic review of inception cohort studies	Inception cohort studies	Cohort study or control arm of randomized trial[*]	Case-series or casecontrol studies, or poor quality prognostic cohort study[**]	n/a
Does this intervention help? (Treatment Benefits)	Systematic review of randomized trials or n-of-1 trials	Randomized trial or observational study with dramatic effect	Non-randomized controlled cohort/follow-up study[**]	Case-series, case-control studies, or historically controlled studies[**]	Mechanism-based reasoning
What are the COMMON harms?  (Treatment Harms)	Systematic review of randomized trials, systematic review of nested case-control studies, nof-1 trial with the patient you are raising the question about, or observational study with dramatic effect	Individual randomized trial or (exceptionally) observational study with dramatic effect	Non-randomized controlled cohort/follow-up study (post-marketing surveillance) provided there are sufficient numbers to rule out a common harm. (For long-term harms the duration of follow-up must be sufficient.)[**]	Case-series, case-control, or historically controlled studies[**]	Mechanism-based reasoning
What are the RARE harms?  (Treatment Harms)	Systematic review of randomized trials or n-of-1 trial	Randomized trial or (exceptionally) observational study with dramatic effect
Is this (early detection) test worthwhile?  (Screening)	Systematic review of randomized trials	Randomized trial	Non -randomized controlled cohort/follow-up study[**]	Case-series, case-control, or historically controlled studies[**]	Mechanism-based reasoning

^* Level may be graded down on the basis of study quality, imprecision, indirectness (study PICO does not match questions PICO), because of inconsistency between studies, or because the absolute effect size is very small; Level may be graded up if there is a large or very large effect size.

^** As always, a systematic review is generally better than an individual study.

OCEBM Levels of Evidence Working Group*. “The Oxford 2011 Levels of Evidence”.
Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653
* OCEBM Table of Evidence Working Group = Jeremy Howick, Iain Chalmers (James Lind Library), Paul Glasziou, Trish Greenhalgh, Carl Heneghan, Alessandro Liberati, Ivan Moschetti, Bob Phillips, Hazel Thornton, Olive Goddard and Mary Hodgkinson

 

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2.1.1.2 Schema der Empfehlungsgraduierung

Die Stärke der Empfehlung ergibt sich aus der verwendeten Formulierung (soll/sollte/kann) entsprechend der Abstufung in [Tab. 4]. Die Konsensusstärke wurde gemäß [Tab. 5] festgelegt.

Tab. 4 Schema zur Graduierung von Empfehlungen.

Beschreibung	Syntax
starke Empfehlung	soll
Empfehlung	sollte
offen	kann

Tab. 5 Einteilung der Konsensstärke.

Konsens	% Zustimmung
Starker Konsens	≥ 95
Konsens	≥ 75–95
Mehrheitliche Zustimmung	≥ 50–75
Kein Konsens	< 50

 

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2.1.1.3 Statements

Als Statements werden Darlegungen oder Erläuterungen von spezifischen Sachverhalten oder Fragestellungen ohne unmittelbare Handlungsaufforderung bezeichnet. Sie werden entsprechend der Vorgehensweise bei den Empfehlungen im Rahmen eines formalen Konsensusverfahrens verabschiedet und können entweder auf Studienergebnissen oder auf Expertenmeinungen beruhen.

 

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2.2 Externe Begutachtung und Verabschiedung

2.2.1 Verabschiedung durch die Vorstände der herausgebenden Fachgesellschaften/Organisationen

Die vollständige Leitlinie wurde durch die Vorstände aller beteiligten Fachgesellschaften begutachtet und konsentiert. Die Leitlinie stand als Konsultationsfassung für sechs Wochen vom 23. Januar 2023 bis 05. März 2023 der Fachöffentlichkeit zur Kommentierung auf der DGVS Website zur Verfügung. Über die DGVS Webseite und über den DGVS Newsletter wurde um Kommentierung gebeten. Alle Änderungsvorschläge werden im Leitlinienreport dargestellt.

Die finale Version der Leitlinie wurde durch die Vorstände aller beteiligten Fachgesellschaften verabschiedet.

 

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2.2.2 Redaktionelle Unabhängigkeit und Finanzierung der Leitlinie

Die Erstellung der Leitlinie erfolgte redaktionell unabhängig. Die DGVS finanzierte die Nutzung des Leitlinienportals, das Kickoff-Treffen sowie alle weiteren Treffen inkl. Reisekosten und die Online-Konsensuskonferenz. Eine finanzielle Beteiligung Dritter erfolgte nicht. Mandatsträgeren und Experten arbeiteten ausschließlich ehrenamtlich.

 

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2.2.3 Darlegung von und Umgang mit Interessenkonflikten

Im Einklang mit dem AWMF-Regelwerk zum Umgang mit Interessenskonflikten gaben alle Teilnehmenden ihre Erklärungen auf dem entsprechenden AWMF-Formular (Formblatt 2018) ab. Die Interessenkonflikte wurden von den Koordinierenden der Leitlinie und von Frau Nothacker (AWMF) gesichtet, gemäß den AWMF-Kriterien als gering, moderat oder hoch bezüglich der individuellen Empfehlung kategorisiert. Der Vorschlag zum Management wurde zu Beginn der Konsensuskonferenz mit allen beteiligten Experten diskutiert, konsentiert und umgesetzt.

Bezahlte Vortrags-/oder Schulungstätigkeit und bezahlte Autoren-/oder Co-Autorenschaft wurden als geringe Interessenkonflikte gewertet und hatten keine Konsequenzen in Bezug auf die Abstimmungen.

Als moderat wurden nachfolgende Interessenkonflikte eingestuft:

• Berater- bzw. Gutachtertätigkeit oder bezahlte Mitarbeit in einem wissenschaftlichen Beirat eines Unternehmens der Gesundheitswirtschaft (z. B. Arzneimittelindustrie, Medizinproduktindustrie), eines kommerziell orientierten Auftragsinstituts oder einer Versicherung

• Mitarbeit in einem Wissenschaftlichen Beirat (advisory board)

• Forschungsvorhaben/Durchführung klinischer Studien: finanzielle Zuwendungen (Drittmittel) für Forschungsvorhaben oder direkte Finanzierung von Mitarbeitern der Einrichtung vonseiten eines Unternehmens der Gesundheitswirtschaft, eines kommerziell orientierten Auftragsinstituts oder einer Versicherung

Moderate Interessenkonflikte betrafen die in [Tab. 6] aufgeführten Produktklassen und Empfehlungen ([Tab. 6]). Experten, die hiervon betroffen waren (siehe COI-Tabelle im Leitlinienreport), verpflichteten sich, sich bei den Abstimmungen zu den jeweiligen Empfehlungen zu enthalten.

Tab. 6 Übersicht aller Empfehlungen, bei denen moderate Interessenkonflikte vorlagen.

Produkt	Empfehlungen
Hersteller von Immunsuppressiva	Empfehlung 6.1, Statement 6.2, Empfehlung 6.3, Empfehlung 6.4, Empfehlung 6.5, Empfehlung 6.6, Empfehlung 6.7
Hersteller von antiviralen Substanzen	Empfehlung 1.1.4, Empfehlung 8.20, Empfehlung 8.22, Empfehlung 8.23, Empfehlung 8.24, Empfehlung 9.7 Empfehlung 9.8
Hersteller von Impfstoffen	Empfehlung 8.27 und nachfolgende [Tab. 31], Empfehlung 8.28
Hersteller von Antimykotika	Empfehlung 7.20 und nachfolgende [Tab. 26], Empfehlung 7.21 und nachfolgende [Tab. 27], Empfehlung 10.5
Hersteller von Antihypertensiva	Empfehlung 8.14
Hersteller von Lipidsenkern	Empfehlung 8.15, Empfehlung 8.18
Hersteller von Bisphosphonaten und RANKL-Antikörpern	Empfehlung 5.4, Empfehlung 8.20, Empfehlung 8.22, Empfehlung 8.23, Empfehlung 8.24, Empfehlung 9.7, Empfehlung 9.8
Hersteller von Antibiotika	Empfehlung 8.25 Empfehlung 8.26
Hersteller von therapeutischen Gallensäuren und PPAR-delta-Agonisten	Empfehlung 9.4, Empfehlung 9.5
Hersteller von Antikoagulantien	Empfehlung 9.15
Hersteller von Impfstoffen	Empfehlung 8.27 und nachfolgende [Tab. 31], Empfehlung 8.28
Hersteller von Antimykotika	Empfehlung 7.20 und nachfolgende [Tab. 26], Empfehlung 7.21 und nachfolgende [Tab. 27], Empfehlung 10.5

Als hohe Interessenkonflikte wurden Eigentümerinteressen (Patent, Urheberrecht, Besitz von Geschäftsanteilen, Aktien, Fonds mit Beteiligung von Unternehmen der Gesundheitswirtschaft) eingestuft. Hohe potentielle Interessenkonflikte mit Bezug zur Leitlinie wurden nicht identifiziert.

Im Ergebnis wurden bei 38 von 89 Experten moderate Interessenkonflikte zu unterschiedlichen Themen festgestellt, die eine Enthaltung bei der Abstimmung davon betroffener Empfehlungen zur Folge hatten. Als schützende Faktoren vor Verzerrung werden darüber hinaus die interdisziplinäre, repräsentative Zusammensetzung der Leitliniengruppe sowie die strukturierte Konsensfindung unter neutraler Moderation eingeschätzt.

Die Interessenerklärungen aller Experten sind im Anhang des Leitlinienreports dargestellt.

Teilnehmende der Konsensuskonferenz 

Leitlinienexperten: Niklas Aehling (DGVS), Jörg Albert (DGVS), Beate Appenrodt (DGVS), Hideo, Andreas Baba (DGPathologie/BDP), Ana-Paula Barreiros (DSO), Anil Batra (DGPPN, DG-Sucht), Wolf Otto Bechstein (DGAV), Susanne Beckebaum (DGVS), Thomas Becker (DGAV), Christoph Berg (DGVS), Thomas Berg (DGVS), Marie-Luise Berres (DGVS), Felix Braun (DTG), Tony Bruns (DGVS), Ali E. Canbay (DGVS), Markus Cornberg (DGVS), Cornelius Engelmann (DGVS), Yesim Erim (DTG, DKPM, DGPM), Daniela Eser-Valeri (DGPPN), Christa Flechtenmacher (DGPathologie/BDP), Valentin Fuhrmann (DGIIN), Anja Gäckler (DGFN), Andreas Geier (Gastro-Liga), Alexander L. Gerbes (DGVS), Matthias Glanemann (DGAV), Markus Guba (DGAV), Rainer Günther (DGIM), Hauke Heinzow (DGVS), Holger, Hinrichsen (DGVS), Elmar Jaeckel (DGVS), Christian Jansen (DGVS), Christian Jung (DGKardiologie), Iyad Kabar (DGVS), Thorsten Kaiser (DGKL), Gabriele Kirchner (DGVS), Ingo Klein (DGAV), Andreas Kribben (DGFN), Frank Lammert (DGVS), Georg Lamprecht (DGVS), Hauke Lang (DGAV), Christian Lange (DGVS), Christoph Lübbert (DGI), Steffen Manekeller (DGAV), Arianeb Mehrabi (DGAV), Gero Moog (DGVS), Silvio Nadalin (DTG, DGAV), Ulf Neumann (DGAV), Andreas Pascher (DGAV), Mathias Plauth (DGEM), Andrej Potthoff (DGVS), Johann Pratschke (DGAV), Falk Rauchfuß (DGAV), Jutta Riemer (Selbsthilfe Lebertransplantierte), Kristina Ringe (DRG), Cristina Ripoll (DGVS), Elke Roeb (DGVS), Christian Rupp (DGVS), Peter Schemmer (DGAV, DGCH), Hans Jürgen Schlitt (DGAV), Moritz Schmelzle (DGAV), Hartmut H. Schmidt (DGAV), Andreas Anton Schnitzbauer (DGAV), Wenzel Schöning (DGAV), Eckart Schott (DGVS), Andreas G. Schreyer (DRG), Tobias Schürholz (DGAI), Daniel Seehofer (DGAV), Utz Settmacher (DGAV), Barbara Sinner (DGAI), Katharina Staufer (DTG, DGVS), Martina Sterneck (DGAV, DGVS), Pavel Strnad (DGVS), Robert Sucher (DGAV), Frank Tacke (DGVS), Richard Taubert (DGVS), Hans-Michael Tautenhahn (DGVS), Christian Trautwein (DGVS), Jonel Trebicka (DGVS), Johannes Vermehren (DGVS), Rebecca von Haken (DGAI), Markus A. Weigand (DGAI), Tobias Weismüller (DGVS), Martin-Walter Welker (DGVS), Christian Wilms (DGVS), Oliver Witzke (DGI), Hans-Peter Wohn (Dt. Leberhilfe, BDO), Marcus-Alexander Wörns (DGVS)

Organisation und Methodik: Monika Nothacker (AWMF), Torsten Karge (CGS-Usergroup), Lars Klug (DGVS), Pia Lorenz (DGVS)

Die Beeinflussung durch Interessenkonflikte wurde weiter auch durch die formale zweistufige Konsensbildung und durch die Erstellung der interdisziplinären Arbeitsgruppen reduziert.

 

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2.3 Verbreitung und Implementierung

2.3.1 Konzept zur Verbreitung und Implementierung

Die Leitlinie wird neben der Zeitschrift für Gastroenterologie bei AMBOSS und auf den Homepages der DGVS (www.dgvs.de) und der AWMF (www.awmf.de) veröffentlicht. Eine englische Übersetzung wird angestrebt.

 

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2.3.2 Gültigkeitsdauer und Aktualisierungsverfahren

Die Gültigkeit der Leitlinie beträgt fünf Jahre (31. Oktober 2028). Die Überarbeitung wird durch die Leitlinienbeauftragten der DGVS initiiert werden. Die Steuergruppe wird jährlich den Aktualisierungsbedarf der Leitlinie prüfen. Als Ansprechpartner steht die DGVS Geschäftsstelle ([e-mail]) zur Verfügung.

 

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2.3.3 Unterscheidung von den im gesetzlichen Auftrag erstellten Richtlinien zur Lebertransplantation der Bundesärztekammer

Der Aufbau der Leitlinie basiert auf rein wissenschaftlichen Erkenntnissen. Die Kompetenz zum Erlass der unmittelbar verbindlichen Richtlinien zur Organtransplantation liegt jedoch allein bei der Bundesärztekammer (§ 16 Abs. 1 TPG).

 

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3 Redaktioneller Hinweis

3.1 Geschlechtsneutrale Formulierung

Ausschließlich zum Zweck der besseren Lesbarkeit wird auf die geschlechtsspezifische Schreibweise verzichtet. Alle personenbezogenen Bezeichnungen in diesem Dokument sind somit geschlechtsneutral zu verstehen.

 

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3.2 Partizipative Entscheidungsfindung

Alle Empfehlungen der Leitlinie sind als Empfehlungen zu verstehen, die im Sinne einer partizipativen Entscheidungsfindung zwischen Ärzten und Patienten und ggf. den Angehörigen getroffen werden und umzusetzen sind.

 

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4 Besonderer Hinweis

Die Medizin unterliegt einem fortwährenden Entwicklungsprozess, sodass alle Angaben, insbesondere zu diagnostischen und therapeutischen Verfahren, immer nur dem Wissensstand zur Zeit der Drucklegung der Leitlinie entsprechen können. Hinsichtlich der angegebenen Empfehlungen zur Therapie und der Auswahl sowie Dosierung von Medikamenten wurde die größtmögliche Sorgfalt beachtet. Gleichwohl werden die Benutzer aufgefordert, die Beipackzettel und Fachinformationen der Hersteller zur Kontrolle heranzuziehen und im Zweifelsfall einen Spezialisten zu konsultieren. Fragliche Unstimmigkeiten sollen bitte im allgemeinen Interesse der DGVS mitgeteilt werden. Der Benutzer selbst bleibt verantwortlich für jede diagnostische und therapeutische Applikation, Medikation und Dosierung. In dieser Leitlinie sind eingetragene Warenzeichen (geschützte Warennamen) nicht besonders kenntlich gemacht. Es kann also aus dem Fehlen eines entsprechenden Hinweises nicht geschlossen werden, dass es sich um einen freien Warennamen handelt. Das Werk ist in allen seinen Teilen urheberrechtlich geschützt. Jede Verwertung außerhalb der Bestimmung des Urhebergesetzes ist ohne schriftliche Zustimmung der DGVS unzulässig und strafbar. Kein Teil des Werkes darf in irgendeiner Form ohne schriftliche Genehmigung reproduziert werden. Dies gilt insbesondere für Vervielfältigungen, Übersetzungen, Mikroverfilmungen und die Einspeicherung, Nutzung und Verwertung in elektronischen Systemen, Intranets und dem Internet.

 

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^* Die Autoren haben in gleicher Weise zur Erstellung des Manuskripts beigetragen.

Publikationsverlauf

Eingereicht: 23. Januar 2024

Angenommen: 26. Januar 2024

Artikel online veröffentlicht:
09. September 2024

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• 1657 Dachverband der Deutschsprachigen Wissenschaftlichen Osteologischen Gesellschaften e. V. (DVO), S3-Leitlinie zur Prophylaxe, Diagnostik und Therapie der Osteoporose bei postmenopausalen Frauen und bei Männern, AWMF-Reg.-Nr. 183-001. 2017 Zugriff am 24. März 2024 unter: https://leitlinien.dv-osteologie.org/wp-content/uploads/2024/02/Finale-Version-Leitlinie-Osteoporose-2017_end.pdf