Z Gastroenterol 2022; 60(04): 613-688
DOI: 10.1055/a-1741-5724
Leitlinie

S3-Leitlinie Divertikelkrankheit/Divertikulitis – Gemeinsame Leitlinie der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) und der Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV)

November 2021 – AWMF-Registernummer: 021-20in Zusammenarbeit mit
Ludger Leifeld
1   Medizinische Klinik 3 – Gastroenterologie und Allgemeine Innere Medizin, St. Bernward Krankenhaus, Hildesheim, apl. Professur an der Medizinischen Hochschule Hannover
,
Christoph-Thomas Germer
2   Klinik und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie, Zentrum für Operative Medizin, Universitätsklinikum Würzburg, Würzburg
,
Stephan Böhm
3   Spital Bülach, Spitalstrasse 24, 8180 Bülach, Schweiz
,
Franz Ludwig Dumoulin
4   Abteilung für Innere Medizin, Gemeinschaftskrankenhaus Bonn gGmbH, Bonn.
,
Thomas Frieling
5   Medizinische Klinik II, Klinik für Gastroenterologie, Hepatologie, Infektiologie, Neurogastroenterologie, Hämatologie, Onkologie und Palliativmedizin HELIOS Klinikum Krefeld
,
Martin Kreis
6   Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
,
Alexander Meining
7   Medizinische Klinik und Poliklinik 2, Zentrum für Innere Medizin (ZIM), Universitätsklinikum Würzburg, Würzburg
,
Joachim Labenz
8   Abteilung für Innere Medizin, Evang. Jung-Stilling-Krankenhaus, Siegen
,
Johan Friso Lock
2   Klinik und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie, Zentrum für Operative Medizin, Universitätsklinikum Würzburg, Würzburg
,
Jörg-Peter Ritz
9   Klinik für Allgemein- und Viszeralchirurgie, Helios Klinikum Schwerin
,
Andreas Schreyer
10   Institut für diagnostische und interventionelle Radiologie, Medizinische Hochschule Brandenburg Theodor Fontane Klinikum Brandenburg, Brandenburg, Deutschland.
,
Wolfgang Kruis
11   Medizinische Fakultät, Universität Köln, Köln, Deutschland
,
Kollaborateure
, Deutsche Gesellschaft für Ultraschall in der Medizin (DEGUM), Deutsche Gesellschaft für Ernährungsmedizin e. V. (DGEM), Deutsche Gesellschaft für Koloproktologie e. V. (DGK), Deutsche Gesellschaft für Neurogastroenterologie und Motilität (DGNM), Deutsche Gesellschaft für Pathologie e. V. (DGP)/Bundesverband Deutscher Pathologen e. V. (BDP), Deutsche Röntgengesellschaft e. V. (DRG), Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung (DCCV) e. V. › Author Affiliations

Kapitel 1: Einleitung und Methodik

1.1. Hintergrund

Die Divertikulose und die Divertikelkrankheit gehören zu den häufigsten gastroenterolgischen Erscheinungen und Krankheitsbildern. Jeder dritte bis zweite Deutsche muss damit rechnen im Laufe seines Lebens Divertikel zu entwickeln. Außerdem sind zunehmend komplikative Krankheitsverläufe zu beobachten. So konnte eine bedeutende Zunahme der Krankenhausaufenthalte in Deutschland in den letzten Jahren beobachtet werden [1]. Die erste deutsche Leitlinie aus dem Jahr 2014 war bereits, alleine durch die immense Menge der Betroffenen und der Vielfalt und Komplexität der damit einhergehenden diagnostischen und therapeutischen Entscheidungen, vielbeachtet und wegweisend für das Management der Divertikelkrankheit. Auch wenn die erste Leitlinie bereits in hohem Maß evidenzbasiert war, lag ein Schwerpunkt der aktuellen Leitlinie in der erweiterten Evidenzprüfung und der Befolgung der formellen Richtlinien einer S3 Leitlinie.

Seit der Erstellung der ersten Leitlinie hat es eine erhebliche Mehranstrengung der internationalen Forschergemeinde gegeben. Es sind mehrere Zulassungsstudien durchgeführt worden. Des Weiteren gibt es etliche prospektive Studien zum Thema der Operationsindikationen und Komplikationen. Dennoch bleibt die Leitlinie in sich stringent und stellt keinen grundsätzlichen Bruch mit den bisherigen Empfehlungen dar. So bleibt die 2014 etablierte Klassifikation bis auf ein Detail zur Größe des Mikroabszesses unangetastet, ebenso bleiben die Empfehlungen in der Antibiotikatherapie bei der unkomplizierten Divertikulitis zurückhaltend, verbessert allerdings durch neue Risikoindikatoren, bei denen eine Antibiotikatherapie auch bei der unkomplizierten Divertikulitis zu wählen ist. Die Prophylaxe der Divertikelkrankheit wird ausführlich behandelt mit konkreten Ernährungsempfehlungen sowie Vorschlägen zur Modifikation des Lebensstils Betroffener, die sich aus großen Kohortenstudien ableiten, aber auch aus Erkenntnissen zur Pathogenese der Erkrankung. Des Weiteren finden sich klare Empfehlungen zur Abwägung von Operationsindikationen, nun auch explizit unter Beachtung der Lebensqualität als relative Indikation für elektive Eingriffe bei der chronisch rezidivierenden Divertikulitis. Ein weiterer Schwerpunkt und Gegenstand intensiver Diskussionen ist die symptomatisch unkomplizierte Divertikelkrankheit (SUDD), die durch Schmerzen mit Bezug zum divertikeltragenden Darmabschnitt gekennzeichnet ist ohne bildmorphologischen oder laborchemischen Nachweis einer Divertikulitis.

Zusammenfassend war es von großer Bedeutung die Leitlinie auf das höchste Evidenzniveau zu heben und das aktuelle Wissen zur Divertikelkrankheit/Divertikulitis interdisziplinär zu erarbeiten und zu bewerten.


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1.2. Ziele der Leitlinie und Gültigkeitsdauer

Ziel der Leitlinie ist eine Zusammenfassung und Bewertung des aktuellen Erkenntnisstands zur Divertikelkrankheit, mit der Erarbeitung von Statements zur Diagnostik und Therapie der Erkrankung. Die Empfehlungen der Leitlinie richten sich dabei an alle an der Diagnostik und Therapie beteiligten Ärzte von Patienten mit einer Divertikelkrankheit, sowohl im ambulanten als auch im stationären Bereich und soll eine einfache Anwendung ermöglichen. Darüber hinaus soll sie dem Betroffenen die Möglichkeit geben sich über die Erkrankung zu informieren. Der behandelnde Arzt kann im individuellen Einzelfall von den Empfehlungen abweichen. Sie hat eine Gültigkeitsdauer von 5 Jahren.


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1.3. Organisatorischer Ablauf des Konsensusprozesses

1.3.1. Zusammensetzung der Leitliniengruppe und Beteiligung der Fachgesellschaften

Die Leitlinie wurde federführend durch die Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) gemeinsam mit der Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV) aktualisiert, die als Koordinierende Herrn Univ. Prof. Christoph-Thomas Germer (DGAV), Würzburg, Herrn Prof. Wolfgang Kruis (DGVS), Pulheim, und Prof. Ludger Leifeld (DGVS), Hildesheim, beauftragten. Methodisch verantwortlich waren Frau PD Dr. Petra Lynen Jansen und Frau Pia Lorenz, DGVS Geschäftsstelle, Berlin. Frau Dr. Susanne Blödt und Frau Dr. Monika Nothacker, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF), Berlin, standen zur methodischen Beratung zur Seite. Die Literaturarbeit wurde bibliothekarisch unterstützt von Frau Elisabeth Friedrich-Würstlein. Frau Dr. Nadine Steubesand führte die systematische Recherche durch und betreute die Leitliniengruppe bei methodischen Fragestellungen. Herr Torsten Karge stand für das Leitlinienportal zur Verfügung.

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

Insgesamt wurden sieben Arbeitsgruppen (AGs) gebildet, die jeweils von ein bis drei Leiter*innen geleitet wurden ([Tab. 1]). In den AGs haben universitäre und nichtuniversitäre Ärzt*innen, Klinikärzt*innen und niedergelassene Ärzt*innen Gastroenterolog*innen, Internist*innen, Chirurg*innen, Neurogastroenterolog*innen, Proktolog*innen, Patholog*innen, Radiolog*innen und Ernährungsmediziner*innen mitgearbeitet.

Tab. 1

Mitglieder der Leitliniengruppe.

AG 1: Anatomie, Pathologie, Pathogenese, Risikofaktoren, Komorbidität, Medikation

AG-Leitung

W. Kruis, Pulheim (DGVS)

AG-Mitglieder

H. Allescher, Garmisch-Partenkirchen (DGNM)

J. Hampe, Dresden (DGVS)

J. Keller, Hamburg (DGVS)

J. Langhorst, Bamberg (DGNM)

J. Neumann, München (DGP/BDP)

B. Siegmund, Berlin (DGVS)

AG 2: Klinisches Erscheinungsbild (Definitionen), natürlicher Verlauf, Komplikationen, Epidemiologie

AG-Leitung

F. Dumoulin, Bonn (DGVS)

T. Frieling, Krefeld (DGVS)

AG-Mitglieder

U. Helwig, Oldenburg (DGVS)

J. Hoffmann, Ludwigshafen (DGVS)

AG 3: Diagnostik und Stadieneinteilung

AG-Leitung

B. Lembcke, Frankfurt (DEGUM)

A. Schreyer, Brandenburg an der Havel (DRG)

AG-Mitglieder

J. Lauscher, Berlin (DGAV)

A. Meining, Würzburg (DGVS)

A. Schäfer, Leipzig (DRG)

W. Schwenk, Solingen (DGAV)

AG 4: Konservative Behandlung, Medikamente, Ernährung, Life-style

AG-Leitung

S. Böhm, Bülach (DGVS)

W. Kruis, Pulheim (DGVS)

L. Leifeld, Hildesheim (DGVS)

AG-Mitglieder

A. Madisch, Hannover (DGVS)

D. Rubin, Berlin (DGEM)

C. Sander, Berlin (DCCV)

M. Reinshagen, Braunschweig (DGVS)

AG 5: Indikationen zur chirurgischen Therapie

AG-Leitung

C. Germer, Würzburg (DGAV)

J. Labenz, Siegen (DGVS)

AG-Mitglieder

F. Hartmann, Frankfurt (DGVS)

J. Lock, Würzburg (DGAV)

J. Pelz, Hildesheim (DGAV)

C. Reißfelder, Mannheim (DGAV)

U. Tappe, Hamm (DGVS)

S. Willis, Ludwigshafen am Rhein (DGAV)

AG 6: Operationsverfahren

AG-Leitung

M. Kreis, Berlin (DGAV, DG Koloproktologie)

J. Ritz, Schwerin (DGAV)

AG-Mitglieder

F. Aigner, Berlin (DGAV)

C. Eckmann, Hann. Münden (DGAV)

T. Schiedeck, Ludwigsburg (DGAV)

W. Schwenk, Solingen (DGAV)

AG Qualitätsindikatoren

AG Leitung

L. Leifeld, Hildesheim (DGVS)

J. Ritz, Schwerin (DGAV)

AG Mitglieder

F. Aigner, Berlin (DGAV)

F. Dumoulin, Bonn (DGVS)

T. Frieling, Krefeld (DGVS)

U. Helwig (DGVS)

A. Madisch, Hannover (DGVS)

C. Reißfelder, Mannheim (DGAV)

U. Tappe, Hamm (DGVS)

Methodik

P. Lynen Jansen

P. Lorenz

N. Steubesand

T. Karge

E. Friedrich Würstlein

Koordinierende

C. Germer, Würzburg (DGAV)

W. Kruis, Pulheim (DGVS)

L. Leifeld, Hildesheim (DGVS)

Repräsentativität der Leitliniengruppe: Beteiligte Fachgesellschaften

  • Deutsche Gesellschaft für Ultraschall in der Medizin (DEGUM)
    B. Lembcke (Frankfurt)

  • Deutsche Gesellschaft für Ernährungsmedizin e. V. (DGEM)
    D. Rubin (Berlin)

  • Deutsche Gesellschaft für Koloproktologie e. V. (DGK)
    M. Kreis (Berlin)

  • Deutsche Gesellschaft für Neurogastroenterologie und Motilität (DGNM)
    H. Allescher (Garmisch-Partenkirchen), J. Langhorst (Bamberg)

  • Deutsche Gesellschaft für Pathologie e. V. (DGP)/Bundesverband Deutscher Pathologen e. V. (BDP)
    J. Neumann (München)

  • Deutsche Röntgengesellschaft e. V. (DRG)
    A. Schäfer (Leipzig), A. Schreyer (Brandenburg an der Havel)


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Repräsentativität der Leitliniengruppe: Beteiligung von Patient*innen

Direkte Mitarbeit von einer Vertreterin (C. Sander) der Deutschen Morbus Crohn/Colitis ulcerosa Vereinigung (DCCV) e. V.

Beteiligte Fachgesellschaften konnten jeweils mindestens einen Fachvertreter*in benennen. Außerdem ermöglichte die DGVS ihren Mitgliedern sich um die Beteiligung an der Leitlinie zu bewerben. Es wurde ein ausgewogenes Verhältnis der einzelnen Fachvertreter*innen hergestellt und sowohl Niedergelassene als auch Ärzt*innen von Kliniken aller Versorgungsstufen beteiligt.


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1.3.2. Literatursuche

Durchführung der Recherche

Die systematische Literaturrecherche wurde in der Medline Datenbank über die PubMed Suchoberfläche https://pubmed.ncbi.nlm.nih.gov/, sowie in der Cochrane Library https://www.cochranelibrary.com/ durchgeführt. Der Recherchezeitraum der PubMed Suche schließt an den der vorhergehenden Version der Leitlinie an (siehe Publikation Version 2014) und umfasst somit den Bereich vom 01.01.2012 bis 26.04.2019. Da in der Recherche 2013 die Cochrane Library nicht mit gesucht wurde, wird in der aktuellen Recherche der Suchzeitraum für die Cochrane Recherche auf 10 Jahre erweitert, und erstreckt sich somit auf den Zeitraum April 2009 bis 24.04.2019.

Bei der ersten S2k Leitlinie von 2014 wurden die Ergebnisse der PubMed Recherche in einem ersten Screening Schritt gesichtet ohne eine formelle Bewertung der Literatur vorzunehmen. Daher wird die damals gefundene Literatur und hinzugekommene Literatur nach dem ersten Screening-Schritt vereinigt und gemeinsam weiterbearbeitet und bewertet. Weitere Details der Literaturrecherche sind dem Leilinienreport zu entnehmen


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Screening sowie Handsuche

Die Auswahl der Evidenz erfolgte durch ein mehrstufiges Screening. Im Titel-Abstract Screening wurden die Suchtreffer durch Prof. L. Leifeld anhand der Ein- und Ausschlussgründe auf potenzielle Relevanz gesichtet. Von den 1163 Suchtreffern wurden 493 als potenziell relevant eingeordnet. Diese wurden mit den 489 Studien der PubMed Recherche 2013 vereinigt und, nach Relevanz, den einzelnen AGs zugeordnet. Im zweiten Schritt des Screenings wurden die Volltexte der ausgewählten Publikationen auf die Erfüllung der o. g. Ausschlussgründe durch die einzelnen Arbeitsgruppen überprüft. Weitere Details zu dem Vorgehen sind dem Leitlinienreport zu entnehmen.

Zu jedem Zeitpunkt der Recherche und bis zum abgeschlossenen Volltext Screening durch die Expert*innen, konnten die recherchierten Sammlungen durch die AG-Mitglieder auf Vollständigkeit geprüft und zusätzliche themenbezogene Studien nominiert werden.

Diese wurden direkt in die jeweilig zugehörigen Sammlungen eingefügt und der Evidenzbewertung zugeführt.


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1.3.3. Auswahl der Evidenz

Die Literaturarbeit wurde über das Leitlinienportal der CGS Clinical Guideline Services GmbH (CGS) durchgeführt. Die in den Suchen identifizierten Literaturstellen wurden nach dem Deduplizieren als Literatursammlung im Leitlinienportal (https://www.guideline-service.de) hinterlegt.

Ein und Ausschlussgründe

Folgende Ein- und Ausschlussgründe wurden für die Recherche und Auswahl der Evidenz festgelegt:

  • Deutsche und englische Veröffentlichungen

  • Probandenstudien (keine Tierversuche)

  • Publikation ist im Volltext verfügbar

  • Veröffentlichung ab April 2009 bis zum letzten Zeitpunkt der Recherchen (26.04.2019).

  • Case reports, Case series, in vitro Studien

Generelle Ausschlussgründe wurden ebenfalls zur Auswahl herangezogen:

  • Vorliegen einer Doppelpublikation

  • Verfügbarkeit einer aktuelleren Version (Folgepublikation, Update)

  • Primärstudie ist bereits in einer Übersichtsarbeit enthalten

  • Narrative Arbeiten ohne Beschreibung der Methodik

  • Nur Studiendesignbeschreibung oder -protokoll (aber keine Ergebnisse)


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Bewertung der Evidenz

Die Literaturbewertung wurde nach der Evidenzklassifizierung des Oxford Centre for Evidence-Based Medicine 2011 für Interventions- diagnostische und prognostische Studien [2] durchgeführt. Die methodische Qualität der Literaturstelle wurde von den Fachexperten der jeweiligen Arbeitsgruppen mit Hilfe von Checklisten überprüft. Es wurden die Checklisten ‘Critical Appraisal tools des Oxford Centre for Evidence-Based Medicine’ [3], bzw. die Newcastle-Ottawa Scale [4] für nicht-randomisierte Studien (Cohort and Case-control) herangezogen.

Der Evidenzlevel der Studien wurde ggf. auf Grund der Studienqualität, mangelnder Präzision, Indirektheit und/oder bedeutsamer Heterogenität um eine Note abgewertet. Bei Studien mit großem Effekt wurde der Evidenzlevel der Studie von den Experten ggf. um eine Stufe angehoben.

Nach der Bewertung der Literaturstellen wurden die Literaturstellen der jeweils passenden Schlüsselfrage zugeordnet.

Die im Volltext Screening ausgewählten Literaturstellen und von den Arbeitsgruppen zusätzlichen Literaturstellen aus Handsuchen wurden entsprechend dieser Systematik bewertet. Aus allen eingeschlossenen Literaturstellen wurden im nächsten Schritt Daten extrahiert und in Form von Evidenztabellen zusammengefasst [5] [6] [7].


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Erstellung von Evidenztabellen

Aus allen eingeschlossenen Literaturstellen wurden nach der positiven Bewertung die wichtigsten Daten extrahiert. Diese Daten sind in Form von Evidenztabellen geordnet nach Studientyp im Leitlinienportal zusammengefasst. Details zu den Evidenztabellen sind dem Leitlinienreport zu entnehmen.


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1.3.4. Formulierung der Empfehlungen und strukturierte Konsensfindung

Auf Grundlage der Evidenz wurden die Empfehlungen und Hintergrundtexte durch die AG-Leiter*innen erarbeitet und zunächst im E-Mail-Umlaufverfahren innerhalb der einzelnen AGs abgestimmt. Die Graduierung der Empfehlungen erfolgte über die Formulierung soll, sollte, kann (s. [Tab. 2]).

Tab. 2

Schema zur Graduierung von Empfehlungen.

Empfehlungsgrad (nur S3)[1]

Beschreibung

Syntax

A

starke Empfehlung

soll

B

Empfehlung

sollte

0

Offen

kann

1 Der Empfehlungsgrad sowie der Evidenzgrad werden nur bei evidenzbasierten Empfehlungen angegeben. Bei Expertenkonsensbasierten Empfehlungen erfolgt die Graduierung über soll/sollte/kann und über die in der Tabelle angegeben Beschreibung.


Anschließend wurden alle Empfehlungen, auch die Empfehlungen, die unverändert aus der Leitlinie von 2014 übernommen wurden, in einem Delphiverfahren von allen Leitlinienmitarbeitern mithilfe einer 3-stufigen Entscheidungsskala abgestimmt (ja, Enthaltung, nein). Zu Empfehlungen, die nicht mit „ja“ abgestimmt wurden, musste ein begründender Kommentar hinterlegt werden. Empfehlungen, die zu über 95 % mit „ja“ abgestimmt wurden, konnten bereits zu diesem Zeitpunkt verabschiedet werden.

Die Kommentare und Änderungsvorschläge der Delphirunde wurden von den Arbeitsgruppen und den Koordinierenden gesichtet und die Empfehlungen überarbeitet. Anschließend wurden alle überarbeiteten Empfehlungen in einer zweiten Delphi-Abstimmung mithilfe der 3-stufigen Entscheidungsskala erneut abgestimmt. Bei der zweiten Delphi-Abstimmung erhielten 9 Empfehlungen nicht die 95 % Zustimmung, wiesen aber dennoch allesamt mit über 90 % eine große Einigkeit auf. Mit Rücksprache der AWMF wurde auf eine Konsensuskonferenz verzichtet.

Die Konsensusstärke wurde gemäß [Tab. 3] festgelegt. Im Anschluss an die zweite Delphi-Abstimmung erfolgte die finale Überarbeitung der Kommentare durch die Arbeitsgruppen und die redaktionelle Zusammenstellung der Leitlinie durch die Koordinierenden.

Tab. 3

Einteilung der Konsensstärke.

Konsens

% Zustimmung

Starker Konsens

> 95

Konsens

> 75–95

Mehrheitliche Zustimmung

> 50–75

Kein Konsens

≤ 50

Empfehlungen, die unverändert aus der letzten Leitlinie übernommen wurden, wurden mit „geprüft 2021“ gekennzeichnet. Die mit „modifiziert 2021“ gekennzeichneten Empfehlungen wurden im Vergleich zur vorherigen Version von 2014 modifiziert.

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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Expertenkonsens

Als Expertenkonsens werden Empfehlungen bezeichnet, zu denen keine systematische Recherche nach Literatur durchgeführt wurde oder bei einer entsprechenden Recherche keine passende Literatur zu finden war. Die Graduierung der Empfehlung ergibt sich ausschließlich aus der verwendeten Formulierung (soll/sollte/kann) entsprechend der Abstufung in [Tab. 2].


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Klug Entscheiden

Empfehlungen, die mit „Klug entscheiden“ gekennzeichnet sind, wurden für die „Klug entscheiden“-Initiative der Deutschen Gesellschaft für Innere Medizin ausgewählt. Diese Empfehlungen sollen als konkrete Hilfestellung bei der Indikationsstellung zu diagnostischen und therapeutischen Maßnahmen dienen, um eine Unter- bzw. Überversorgung zu vermeiden. Weitere Informationen finden Sie unter https://www.klug-entscheiden.com/.


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1.3.5. Zeitplan

August 2018

Anmeldung bei der AWMF

Oktober 2018

Beauftragung der Koordinatoren durch die DGVS

April 2019

Einladung der zu beteiligenden Fachgesellschaften und Expert*innen

April 2019 bis Oktober 2020

Überarbeitung der Empfehlungen und Hintergrundtexte

November 2020 bis Dezember 2020

1. Delphi-Abstimmung

Bis Ende Februar 2021

Überarbeitung der Empfehlungen

März 2021

2. Delphi-Abstimmung

April 2021 bis Oktober 2021

Erstellung Gesamtmanuskript

Oktober bis November 2021

Freigabeverfahren


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1.4. Externe Begutachtung und Verabschiedung

1.4.1. Verabschiedung durch die Vorstände der herausgebenden Fachgesellschaften/ Organisationen

Die vollständige Leitlinie wurde von allen beteiligten Fachgesellschaften innerhalb von 3,5 Wochen (21. Oktober 2021 bis 15. November 2021) begutachtet und konsentiert und stand zur selben Zeit als Konsultationsfassung für die Fachöffentlichkeit zur Kommentierung auf der DGVS und AWMF Website zur Verfügung. Über den DGVS Newsletter wurde um Kommentierung gebeten. Es gab keine Änderungsvorschläge.


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1.4.2. Redaktionelle Unabhängigkeit und Finanzierung der Leitlinie

Die Erstellung der Leitlinie erfolgte redaktionell unabhängig. Die DGVS finanzierte die Nutzung des Leitlinienportals sowie die systematische Recherche und Evidenzbewertung. Die DGAV finanzierte die bibliothekarische Arbeit. Eine finanzielle Beteiligung Dritter erfolgte nicht. Mandatsträger*innen und Expert*innen arbeiteten ausschließlich ehrenamtlich.


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1.4.3. 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 gesichtet, gemäß den AWMF-Kriterien als gering, moderat oder hoch bezüglich der individuellen Empfehlung kategorisiert und bewertet.

Hohe Interessenkonflikte mit Bezug zur Leitlinie bestanden bei keinem der Teilnehmenden. 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

  • Eigentümerinteressen (Patent, Urheberrecht, Aktienbesitz): Besitz von Geschäftsanteilen, Aktien, Fonds mit Beteiligung von Unternehmen der Gesundheitswirtschaft

Bezahlte Vortrags-/oder Schulungstätigkeit und bezahlte Autoren-/oder Co-Autorenschaft wurden als geringe Interessenkonflikte gewertet.

Die Beeinflussung durch Interessenkonflikte wurde weiter auch durch die Erstellung der interdisziplinären Arbeitsgruppen reduziert.

Die Interessenerklärungen aller Expert*innen sind im Supplementary Material des Leitlinienreports dargestellt.


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1.5. Verbreitung und Implementierung

1.5.1. 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.


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1.5.2. Gültigkeitsdauer und Aktualisierungsverfahren

Die Gültigkeit beträgt etwa fünf Jahre (15. Oktober 2026). Die Überarbeitung wird durch den Leitlinienbeauftragten der DGVS initiiert werden. Die Steuergruppe der Leitlinie wird jährlich den Aktualisierungsbedarf der Leitlinie prüfen. Als Ansprechpartner steht Ihnen Frau Lorenz (leitlinien@dgvs.de) von der DGVS Geschäftsstelle zur Verfügung.


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Redaktioneller Hinweis

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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Partizipative Entscheidungsfindung

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


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Besonderer Hinweis

Die Medizin unterliegt einem fortwährenden Entwicklungsprozess, sodass alle Angaben, ins-besondere 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. 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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Publication History

Article published online:
06 April 2022

© 2022. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
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