S2k-Leitlinie Qualitätsanforderungen in der gastrointestinalen Endoskopie, AWMF Register Nr. 021–022

Kap. 1 Leitlinienreport

1.1 Geltungsbereich und Zweck

Auswahl des Leitlinienthemas

Zur Sicherung der Qualität endoskopischer Untersuchungen müssen Qualitätsstandards definiert werden. Eine entsprechende Qualitätssicherungsvereinbarung wurde zuletzt 2002 durch die KBV formuliert. Eine interdisziplinäre Leitlinie, die sektorenübergreifend die Standards für die gastroenterologische Endoskopie definiert, existiert bisher nicht.

Zielorientierung der Leitlinie

Die Leitlinie definiert notwendige Voraussetzungen zur Verbesserung der Strukturqualität im Hinblick auf die technische, räumliche und personelle Ausstattung von Endoskopieeinheiten. Zur Verbesserung der Prozessqualität werden Empfehlungen zur Patientenvorbereitung, zur Dokumentation und Zeiterfassung sowie zur Hygiene und Aufbereitung gegeben. In weiteren Kapiteln werden die Standards für spezielle endoskopische Prozeduren incl. Kontraindikationen, prozessbezogene Nachsorge und Komplikationen festgelegt.

Patientenzielgruppe, Versorgungsbereich und Anwenderzielgruppe

Die Leitlinie gibt Empfehlungen für Erwachsene, die sich einer endoskopischen Untersuchung unterziehen müssen.

Sie gilt sowohl für ambulant als auch für stationär durchgeführte Endoskopien sowie für den primärärztlichen und der spezialfachärztlichen Bereich.

Die Leitlinie richtet sich an alle Endoskopie tätigen Gastroenterolgoen und Chirurgen sowie an Endoskopieassistenzpersonal.

1.2. Zusammensetzung der Leitliniengruppe und Beteiligung von Interessensgruppen

Die Leitlinie wurde federführend durch die Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) erstellt, die als Koordinatorin Frau Priv.-Doz. Dr. med Ulrike Denzer, Hamburg beauftragte. Frau Priv.-Doz. Dr. med. Petra Lynen-Jansen, DGVS-Geschäftsstelle, Berlin, stand bei methodischen Fragestellungen beratend zur Seite und übernahm organisatorische Aufgaben. Frau Dr. med. Monika Nothacker, AWMF, Berlin moderierte als neutrale Leitlinienexpertin die erste Konsensuskonferenz.

Bei der Verteilung der Themengebiete wurde auf eine für die klinischen Fragestellungen repräsentative Besetzung geachtet. Die für das Fachgebiet relevanten Fachgesellschaften wurden angeschrieben und gebeten, Mandatsträger für Ihre Organisationen zu benennen. Die Anmeldung der Leitlinie wurde am 23.10.2012 auf der Webseite der AWMF veröffentlicht, sodass weitere Fachgesellschaften/Vertreter sich zur Mitarbeit melden konnten. Experten und Anwender aus den verschiedenen Versorgungsstufen wurden berücksichtigt.

Als Patientenvertreterin wurde Frau S. In der Smitten als Mitglied der Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung e. V in die Leitlinienarbeit eingebunden.

Folgende Fachgesellschaften und Institutionen waren an der Erstellung der Leitlinie beteiligt:

• Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten

  Mandatsträger:

  U. Denzer, Hamburg; A. Eickhoff, Hanau; S. Faiss, Hamburg; R. Jacobs, Ludwigshafen; M. Keuchel, Hamburg; A. May, Wiesbaden; T. Rösch, Hamburg; U. Rosien, Hamburg; U. Weickert, Heilbronn; T. Wehrmann, Wiesbaden

• Deutsche Gesellschaft für Endoskopie und Bildgebende Verfahren (DGE-BV)

  Mandatsträger: C. Jenssen

• Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV), Chirurgische Arbeitsgemeinschaft für Endoskopie und Sonografie (CAES)

  Mandatsträger: R. Mennigen, Münster; T. Vowinkel, Münster

• Berufsverband niedergelassener Gastroenterologen Deutschlands e. V. (bng)

  Mandatsträger: G. Moog, Kassel

• Deutsche Gesellschaft für Thrombose und Hämostaseforschung

  Mandatsträger: F. Langer, Hamburg

• Deutsche Gesellschaft für Endoskopie-Assistenzpersonal e. V. (DEGEA)

  Mandatsträger: U. Beilenhoff, Ulm

• Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung e. V. (DCCV)

  Mandatsträger: S. In der Smitten, Berlin

P. Baltes, Hamburg, K. Fraedrich, Hamburg, A. Gaus, Hamburg, B. Hartmann, Ludwigshafen und M. Jung, Mainz wurden als weitere Experten bei der Erstellung der Beiträge eingebunden.

Für das Kapitel Aufklärung erfolgte eine juristische Beratung durch Dr. P. Hüttl, Rechtsanwaltskanzlei Dr. Heberer & Kollegen München, die allerdings an der Abstimmung der Empfehlungen nicht teilnahmen.

1.3. Methodologische Exaktheit

Schlüsselfragen, Literaturrecherche und Auswahl der Evidenz

Auf einem initialen Treffen der Leitliniengruppe im April 2012 wurden die Themengebiete festgelegt. Die Mitglieder der Leitliniengruppe wurden entsprechend ihrer fachlichen Qualifikation und/oder der interdisziplinäre Notwendigkeit diesen Themengebieten zugeordnet und waren sowohl für die Literaturrecherche als auch für die Formulierung der Empfehlungen und Kommentare verantwortlich. Die erweiterte Literatursuche erfolgte in Pubmed und Cochrane databases. Weitere Artikel und Studien konnten bei Bedarf mit einbezogen werden.

Alle Suchergebnisse sowie alle relevanten Publikationen im Volltext wurden über ein webbasiertes Leitlinienportal der Leitliniengruppe zur Verfügung gestellt.

Die Evidenz wurde auf der Konsensuskonferenz diskutiert und bewertet.

Neue Literatur konnte bis zum Termin der abschließenden Konsensuskonferenz im Dezember 2014 berücksichtigt werden.

Formulierung der Empfehlungen und strukturierte Konsensfindung

Auf Grundlage der Literatur wurden die Empfehlungen durch die jeweiligen Autoren erarbeitet. Eine Graduierung der Empfehlungen erfolgte über die Formulierung soll, sollte, kann ([Tab. 1]). Alle Empfehlungen wurden in einem Delphiverfahren von allen Leitlinienmitarbeitern mithilfe einer 3-stufigen Entscheidungsskala abgestimmt (ja, unentschieden, nein). Hierzu wurden 3 Delphiverfahren im Januar, Juli/August und Oktober 2015 durchgeführt, denen die Empfehlungen themenspezifisch zugeordnet wurden. Zu Empfehlungen, die nicht mit ja abgestimmt wurden, musste ein begründender Kommentar hinterlegt werden. Empfehlungen, die zu über 95 % mit ja abgestimmt wurden, wurden bereits zu diesem Zeitpunkt verabschiedet ([Tab. 2]).

Tab. 1 Schema zur Graduierung von Empfehlungen. Negative Empfehlungen werden entsprechend formuliert.

Syntax	Beschreibung
soll	starke Empfehlung
sollte	Empfehlung
kann	Empfehlung offen

Tab. 2 Konsensfindung.

Konsens	% Zustimmung
Starker Konsens	> 95
Konsens	> 75 – 95
mehrheitliche Zustimmung	50 – 75
kein Konsens	< 50

Die Kommentare und Änderungsvorschläge der Delphirunde wurden von der Koordinatorin und dem jeweiligen Autor des Kapitels gesichtet und ausgewertet. Alle Empfehlungen, die in der ersten Abstimmung weniger als 95 % Zustimmung erhalten hatten, wurden überarbeitet und auf einer Konsensuskonferenz (siehe 3.3) erneut diskutiert. Nutzen und nebenwirkungsrelevante Outcomes wurden besonders berücksichtigt. Die erste Konsensuskonferenz wurde durch Frau Dr. med. M. Nothacker, AWMF, die zweite Konsensuskonferenz durch Priv. Dr. med. P. Lynen Jansen als neutrale Leitlinienexpertin moderiert. In einem nominalen Gruppenprozess wurden Änderungsvorschläge gesammelt und dokumentiert und anschließend eine finale Version im Plenum mittels TED-System abgestimmt. Das Ergebnis der Abstimmung wurde dokumentiert und die Konsusstärke gemäß [Tab. 2] festgelegt. Im Anschluss an die Konsensukonferenz erfolgte die finale Überarbeitung der Kommentare durch die Autoren der Kapitel und die redaktionelle Zusammenstellung der Leitlinie durch die Koordinatorin.

Tab. 3 Zeitplan.

Oktober 2011	Ausschreibung der Leitlinie in der Zeitschrift für Gastroenterologie und Beauftragung der Koordinatoren durch die DGVS
April 2012	Kick-off-Treffen der Leitliniengruppe, Festlegung der methodischen Struktur und der inhaltlichen Gliederung der Leitlinie
Oktober 2012	Anmeldung bei der AWMF, Einladung der Fachgesellschaften
Oktober 2012–Januar 2014	erstellen der Empfehlungen
Januar 2014	Delphirunde
Juli/August 2014	Delphirunde
Oktober 2014	Delphirunde
4./5. September 2014	Konsensuskonferenz
27. November 2014	Konsensuskonferenz

1.4 Externe Begutachtung und Verabschiedung

Die Leitlinie wurde allen beteiligten Fachgesellschaften und der Patientenvertretung zur Stellungnahme vorgelegt und von diesen verabschiedet. Durch die AWMF erfolgte eine externe formale Beurteilung

1.5 Redaktionelle Unabhängigkeit und Umgang mit potenziellen Interessenskonflikten

Die Leitlinie wurde von der DGVS finanziert. Eine weitere Finanzierung durch Dritte erfolgte nicht, um Neutralität und Unabhängigkeit zu wahren.

Vor Beginn der Konsensuskonferenz legten alle Teilnehmer ihre potenziellen Interessenskonflikte offen (siehe Anhang) Hierfür wurden Interessenkonflikte schriftlich mithilfe eines Formblattes der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF), das materielle und immaterielle Interessen umfasst, erfasst und der Leitliniengruppe tabellarisch zur Verfügung gestellt. Potenzielle Interessenskonflikte wurden offen diskutiert und es wurde einstimmig beschlossen, dass Personen mit potenziellen Interessenskonflikten bei Abstimmungen über Empfehlungen, die von diesen Interessenskonflikten berührt werden könnten, sich ihrer Stimme enthalten. Es gab keine Enthaltungen.

1.6 Verbreitung und Implementierung

Die Leitlinie sowie der Methodenreport werden auf der Homepage der DGVS (www.dgvs.de) und der AWMF (www.dgvs.de) zum freien Download zur Verfügung gestellt. Die Langversion der Leitlinie wird in der „Zeitschrift für Gastroenterologie“ in deutscher Sprache publiziert. Zusätzlich soll eine Kompaktversion im „Deutschen Ärzteblatt“ in deutscher und englischer Sprache publiziert werden. Unterstützend wird eine Leitlinien-App zur Verfügung gestellt. Die Leitlinienempfehlungen werden darüber hinaus auf den Kongressen und themenbezogenen Fortbildungsveranstaltungen der DGVS vorgestellt.

1.7 Gültigkeitsdauer und Aktualisierungsverfahren

Die Gültigkeit der Leitlinie beträgt 5 Jahre (Juli 2020). Eine Überarbeitung der Leitlinie bei veränderter Datenlage erfolgt gegebenenfalls auch früher. Das Aktualisierungsverfahren wird koordiniert durch die DGVS-Geschäftsstelle.

Anhang: Interessenkonflikterklärungen – Tabellarische Zusammenfassung

1. 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.

2. Honorare für Vortrags- und Schulungstätigkeiten oder bezahlte Autoren- oder Co-Autorenschaften im Auftrag eines Unternehmens der Gesundheitswirtschaft, eines kommerziell orientierten Auftragsinstituts oder einer Versicherung.

3. Finanzielle Zuwendungen (Drittmittel) für Forschungsvorhaben oder direkte Finanzierung von Mitarbeitern der Einrichtung von Seiten eines Unternehmens der Gesundheitswirtschaft, eines kommerziell orientierten Auftragsinstituts oder einer Versicherung.

4. Eigentümerinteresse an Arzneimitteln/Medizinprodukten (z. B. Patent, Urheberrecht, Verkaufslizenz).

5. Besitz von Geschäftsanteilen, Aktien, Fonds mit Beteiligung von Unternehmen der Gesundheitswirtschaft.

6. Persönliche Beziehungen zu einem Vertretungsberechtigten eines Unternehmens der Gesundheitswirtschaft.

7. Mitglied von in Zusammenhang mit der Leitlinienentwicklung relevanten Fachgesellschaften/Berufsverbänden, Mandatsträger im Rahmen der Leitlinienentwicklung.

8. Politische, akademische (z. B. Zugehörigkeit zu bestimmten „Schulen“), wissenschaftliche oder persönliche Interessen, die mögliche Konflikte begründen könnten.

9. Gegenwärtiger Arbeitgeber, relevante frühere Arbeitgeber der letzten 3 Jahre.

Tab. 4

	Beilenhoff, Ulrike	Denzer, Ulrike	Eickhoff, Axel	Faiss, Siegbert
1	nein	nein	nein	Nein
2	nein	ja	ja	Ja
3	nein	ja	ja	Ja
4	nein	nein	nein	Nein
5	nein	nein	nein	Nein
6	nein	nein	nein	Nein
7	ja	ja	nein	Ja
8	nein	nein	nein	Nein
9	selbstständig, tätig als Fachdozentin und Praxisanleitung in den Endoskopiefachweiterbildungen für Pflegepersonal in Berlin, Heidelberg und München, organisiert vom Institut ekw-concept, stattlich anerkannte Weiterbildungsstätte, in Walldorf	seit 2010 Universitätsklinik Hamburg Eppendorf, Klinik für Endoskopie 2005 – 2010 Universitätsklinik Hamburg Eppendorf, Klinik für Gastroenterologie	Klinikum Hanau	Asklepios Klinik Barmbek
	Hüttl, Peter	In der Smitten, Susanne	Jakobs, Ralf	Jenssen, Christian
1	nein	nein	ja	Nein
2	ja	nein	ja	Ja
3	nein	nein	nein	Ja
4	nein	nein	nein	Nein
5	nein	nein	nein	Nein
6	nein	nein	nein	Nein
7	nein	nein	ja	Ja
8	nein	nein	nein	Nein
9	freiberuflicher Rechtsanwalt	Deutsches Zentrum für Hochschul- und Wissenschaftsforschung (DZHW) GmbH Goseriede 9 30 159 Hannover (ehemals HIS GmbH) seit 5,5 Jahren mein Arbeitgeber, daher keine weiteren Nennungen	Klinikum der Stadt Ludwigshafen gGmbH	Krankenhaus Märkisch Oderland GmbH, Starsusberg/Wriezen, Prötzeler Chaussee 5, 15 331 Strausberg
	Keuchel, Martin	Langer, Florian	Lynen Jansen, Petra	May, Andrea
1	ja	ja	nein	nein
2	ja	ja	nein	ja
3	ja	ja	nein	ja
4	nein	nein	nein	nein
5	nein	nein	nein	nein
6	nein	nein	nein	nein
7	ja	ja	nein	ja
8	nein	nein	nein	nein
9	Bethesda Krankenhaus Bergedorf, Hamburg	Universitätsklinikum Hamburg-Eppendorf	DGVS	HSK Wiesbaden, Sanaklinikum Offenbach
	Mennigen, Rudolf	Moog, Gero	Rosien, Ulrich	Rösch, Thomas
1	nein	nein	ja	ja
2	nein	nein	ja	ja
3	nein	nein	ja	ja
4	nein	nein	nein	nein
5	nein	nein	nein	nein
6	nein	nein	nein	nein
7	ja	nein	ja	ja
8	nein	nein	nein	nein
9	Universitätsklinikum Münster, Klinik für Allgemein- und Viszeralchirurgie	selbstständig	Israelitisches Krankenhaus in Hamburg, Orchideenstieg 14, 22 297 Hamburg	UKE Hamburg
	Vowinkel, Thorsten	Wehrmann, Till	Weickert, Uwe
1	nein	nein	ja
2	nein	ja	ja
3	nein	ja	nein
4	nein	nein	nein
5	nein	ja	nein
6	nein	nein	nein
7	nein	ja	nein
8	nein	nein	nein
9	Universitätsklinikum Münster	Stiftung Deutsche Klinik für Diagnostik GmbH, Wiesbaden	SLK-Kliniken Heilbronn

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