S2k-Leitlinie: Gastroösophageale Refluxkrankkheit unter Federführung der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS)^[*]

Kapitel 1: Einleitung und Methodik

1. Einleitung

Die gastroösophageale Refluxkrankheit ist eine häufige Erkrankung in den Industrieländern der westlichen Welt mit einer Prävalenz von bis zu 15 % und einer zunehmenden Inzidenz. Aufgrund ihrer Häufigkeit führt die Erkrankung zu einer erheblichen Inanspruchnahme von Ressourcen im Gesundheitswesen. Das klinische Spektrum der Refluxkrankheit hat sich in den letzten Jahren signifikant erweitert und extraösophageale Manifestationen werden intensiv – wenn auch kontrovers – diskutiert. Der Barrett-Ösophagus, der sich aufgrund einer langjährigen Refluxsymptomatik entwickeln kann, ist darüber hinaus als Präkanzerose für das Adenokarzinom des distalen Ösophagus einzustufen.

Dies alles hat hohe finanzielle Aufwendungen für Arztbesuch und Diagnostik, aber auch für Medikamente in der Langzeittherapie bzw. für Antirefluxoperationen zur Folge. Aufgrund der Entwicklung der therapeutischen und diagnostischen Möglichkeiten in den letzten Jahren wurde die 2005 erstmalig publizierte Leitlinie (Z Gastroenterol 2005; 43: 163 – 164) nach dem aktuellen Stand der Wissenschaft nun grundlegend überarbeitet.

2. Zielorientierung der Leitlinie

Ziel der Aktualisierung ist eine Anpassung der Empfehlungen zu den Bereichen Epidemiologie, Diagnostik, konservative und operative Therapie sowie der Folgekrankheiten und der extraösophagealen Manifestationen. Hierbei lag der Fokus auf der Formulierung praxisorientierter Empfehlungen, die gut implementierbar und umsetzbar sein sollen. Um den methodischen Aufwand in angemessenem Rahmen zu halten, wurde die Klassifikation S2k gewählt.

Durch die Aktualisierung soll die Qualität der ambulanten und stationären Versorgung verbessert und eine systematische Fort- und Weiterbildung unterstützt werden. Letztendliches Ziel der Leitlinie ist eine Verbesserung der Lebensqualität und des Erkrankungsausgangs Betroffener durch eine bessere Aufklärung und durch einen verbesserten und zugleich ressourcenschonenden Umgang mit medikamentösen sowie operativen Therapien.

Die Leitlinie gibt Empfehlungen für Erwachsene und Kinder mit Refluxsymptomen, Refluxkrankheit und Refluxösophagitis sowie deren Folgekrankheiten. Spezifische Aspekte der Erkrankung bei Kindern werden in einem gesonderten Kapitel behandelt.

Sie gilt sowohl für die ambulante als auch die stationäre medizinische Versorgung und behandelt Prävention, Diagnostik und Therapie in der primärärztlichen und der spezialfachärztlichen Versorgung.

Alle an der Beratung, Diagnostik und Therapie der Erkrankung beteiligten Ärzte werden adressiert.

3. Zusammensetzung der Leitliniengruppe und Beteiligung von Interessensgruppen

Die Leitlinie wurde federführend durch die Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) erstellt, die als Koordinatoren Prof. Koop, Berlin, Prof. Schepp, München und Prof. Miehlke, Hamburg beauftragten. Frau PD Dr. med. Dathe und Frau PD Dr. Lynen, DGVS-Geschäftsstelle, Berlin, standen bei methodischen Fragestellungen beratend zur Seite und übernahmen organisatorische Aufgaben.

Bei der Zusammenstellung der Arbeitsgruppe 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 15.3.2011 auf der Webseite der AWMF veröffentlicht, sodass weitere Fachgesellschaften/Vertreter sich melden konnten. Experten und Anwender aus den verschiedenen Versorgungsstufen wurden berücksichtigt.

Folgende Fachgesellschaften waren an der Erstellung der Leitlinie beteiligt:

• Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS)

• Arbeitsgemeinschaft Leitender Gastroenterologischer Krankenhausärzte (ALGK)

• Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV)

• Deutsche Gesellschaft für Pathologie und Bundesverband Deutscher Pathologen (DGP/BDP)

• Gesellschaft für Pädiatrische Gastroenterologie (GPGE)

Die Deutsche Gesellschaft für Allgemein- und Familienmedizin (DEGAM) sagte eine Beteiligung ab. Ein Patientenvertreter wurde über die GASTRO-Liga in den Leitlinienprozess einbezogen.

Am 1.3.2011 wurde ein erstes Treffen der Arbeitsgruppe abgehalten, zu dem die Koordinatoren gemeinsam mit den Mandatsträgern insgesamt sechs Arbeitsgruppen zusammen und benannten die Leiter und Mitarbeiter der Arbeitsgruppen. Bei der personellen Besetzung der einzelnen Arbeitsgruppen wurden Fachkompetenz, eine interdisziplinäre Verteilung und der jeweilige Tätigkeitsbereich (Niedergelassene und stationär) berücksichtigt ([Tab. 1]).

Tab. 1 Themengebiete und Arbeitsgruppenbesetzung.

AG1 Epidemiologie und Diagnostik
Prof. Dr. Wolfgang Schepp, München (Leiter)	[e-mail]
Prof. Dr. Hans-Dieter Allescher, Garmisch-Partenkirchen	[e-mail]
Dr. Jens Aschenbeck, Berlin	[e-mail]
Prof. Dr. Stefan Müller-Lissner, Berlin	[e-mail]
PD Dr. med. Christian Pehl, Vilsbiburg	[e-mail]
PD Dr. med. Holger Seidl, München (Mitarbeit)	[e-mail]
AG2 Konservative Therapie
Prof. Dr. Joachim Labenz, Siegen (Leiter)	[e-mail]
Dr. Albin Lütke, Koblenz	[e-mail]
Prof. Dr. Ahmed Madisch, Hannover	[e-mail]
Prof. Dr. Peter Malfertheiner, Magdeburg	[e-mail]
Prof. Dr. Joachim Mössner, Leipzig	[e-mail]
Prof. Dr. Christian Prinz, Wuppertal	[e-mail]
AG3 Chirurgische Therapie
Prof. Dr. Karl-Hermann Fuchs, Frankfurt (Leiter)	[e-mail]
PD. Dr. Mario Anders, Hamburg	[e-mail]
Prof. Dr. Hubertus Feussner, München	[e-mail]
Prof. Dr. Till Wehrmann, Wiesbaden	[e-mail]
AG4 Extraösophageale Manifestationen
Prof. Dr. Stephan Miehlke, Hamburg (Leiter)	[e-mail]
PD Dr. Monther Bajbouj, München	[e-mail]
Prof. Dr. Daniel Jaspersen, Fulda	[e-mail]
Dr. Peter Kardos, Frankfurt	[e-mail]
Dr. Andreas Leodolter, Herne	[e-mail]
AG5 Barrett-Ösophagus
Prof. Dr. Helmut Messmann, Augsburg (Leiter)	[e-mail]
Prof. Dr. Arnulf H. Hölscher, Köln	[e-mail]
Prof. Dr. Herbert Koop, Berlin	[e-mail]
Prof. Dr. Alexander Meining, München	[e-mail]
PD Dr. Oliver Pech, Regensburg	[e-mail]
Prof. Dr. Martin Werner, Freiburg	[e-mail]
PD Dr. Esther Endlicher, Regensburg	[e-mail]
Dr. Christine Schürmann, Berlin (Mitarbeit)	[e-mail]
AG6 Reflux bei Kindern
Prof. Dr. Tobias Wenzl, Aachen (Leiter)	[e-mail]
Prof. Dr. Thomas Frieling, Krefeld	[e-mail]
Dr. Denisa Pilic, Bochum	[e-mail]
PD Dr. Anjona Schmidt-Choudhury, Bochum	[e-mail]

4. Methodik

4.1 Literaturrecherche und Auswahl der Evidenz

Grundlage für die Literaturrecherche waren die Schlüsselfragen, die sich aus den Empfehlungen der Leitlinie von 2005 ergaben. Auf einem initialen Treffen der Leitliniengruppe am 1.3.2011 wurden als Limitation für die Literatursuche festgelegt:

Humans, English, German, Publication Date from 2000/01/01

Literatur wurde bis zum Termin der Konsensuskonferenz im Juni 2013 berücksichtigt. Folgende Quellen wurden primär für die Literaturssuche genutzt:

Suche nach existierenden Leitlinien: www.awmf.de, www.guidelines.gov, www.sign.ac.uk, www.snfge.asso.fr, www.ahrq.gov, www.cma.ca.

Suche nach systematischen Übersichtsarbeiten: www.thecochranelibrary.com.

Suche in bibliografischen Datenbanken: MedLine, Basis-Suchalgorithmus: (“Gastroesophageal Reflux”[Mesh] OR “Barrett Esophagus”[Mesh]) OR “Esophagitis, Peptic”[Mesh] NOT (editorial[PT] OR historical article[PT] OR comment[PT] OR case reports[PT]).

Die Literatursuche wurde innerhalb der Arbeitsgruppen in Abhängigkeit der Fragestellungen modifiziert, gesichtet und auf Ihre Relevanz hin bewertet. Neue Literatur, die bis zur Konsensuskonferenz im Juni 2013 publiziert wurde, wurde nachgemeldet und floss ebenfalls in die Erstellung der Leitlinie ein. Eine systematische Evidenzbewertung wurde nicht durchgeführt.

4.2 Formulierung der Empfehlungen und strukturierte Konsensfindung

Auf Grundlage der Literatur wurden die Empfehlungen der Leitlinie von 2005 überarbeitet und gegebenenfalls neue Empfehlungen ergänzt. Die Formulierung und Graduierung der Empfehlungen erfolgte hierbei zunächst über die Formulierung soll, sollte, kann ([Tab. 2]).

Tab. 2 Schema zur Graduierung von Empfehlungen. Negative Empfehlungen werden entsprechend formuliert.

Syntax	Beschreibung
soll	starke Empfehlung
sollte	Empfehlung
kann	Empfehlung offen

Die Empfehlungen wurden in einem Delphiverfahren vom 1.2.2013 bis zum 31.2.2013 von allen Leitlinienmitarbeitern mithilfe einer 5-stufigen Entscheidungsskala abgestimmt (ja, eher ja, unentschieden, eher nein, nein). 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. Alle anderen Empfehlungen wurden inklusive der Kommentare in die jeweiligen Arbeitsgruppen zurückgespiegelt und überarbeitet.

Die abschließende Konsensuskonferenz fand am 17.6.2013 in Frankfurt statt. Die überarbeiteten Empfehlungen wurden von den jeweiligen AG-Leitern vorgestellt und von der Leitliniengruppe diskutiert. Die Konsensuskonferenz wurde durch die Leitlinienkoordinatorin der DGVS 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 ebenfalls dokumentiert. Im Anschluss an die Konsensukonferenz erfolgte die finale Überarbeitung der Kommentare durch die AG-Leiter und die redaktionelle Zusammenstellung der Leitlinie durch die Koordinatoren. Vier Empfehlungen mussten in einem erneuten Delphiprozess nachträglich abgestimmt werden, da aufgrund eines technischen Fehlers das TED-Ergebnis nicht erfasst wurde. Die Graduierung der Empfehlungen in der Endversion wurde durch die Angabe der Konsensusstärke ergänzt ([Tab. 3]).

Tab. 3 Konsensfindung.

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

5. Externe Begutachtung und Verabschiedung

Die Leitlinie wurde allen beteiligten Fachgesellschaften zur Stellungnahme vorgelegt und von diesen verabschiedet. Durch die AWMF erfolgte eine externe formale Prüfung vor Aufnahme in das Leitlinienregister.

6. Redaktionelle Unabhängigkeit und Umgang mit potenziellen Interessenskonflikten

Die Leitlinie wurde von der DGVS finanziert. Vertreter der pharmazeutischen Industrie wurden nicht am Prozess der Leitlinienentwicklung beteiligt, um Neutralität und Unabhängigkeit zu wahren.

Vor Beginn der Leitlinienkonferenz haben alle Teilnehmer ihre potenziellen Interessenskonflikte offengelegt. Hierfür wurden Interessenkonflikte schriftlich mithilfe eines Formblatts der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF), 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. Eine zusammenfassende Auflistung der Interessenskonflikterklärungen ist im Anhang des Leitlinienreports enthalten.

7. Verbreitung und Implementierung

Die Leitlinie sowie der Methodenreport werden auf der Homepage der DGVS (www.dgvs.de) und der AWMF (www.awmf.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.

8. Gültigkeitsdauer und Aktualisierungsverfahren

Die Gültigkeit der Leitlinie beträgt 5 Jahre (Dezember 2019). Eine Überarbeitung der Leitlinie bei veränderter Datenlage erfolgt gegebenenfalls auch früher.

Das Aktualisierungsverfahren wird koordiniert durch die DGVS-Geschäftsstelle.

^* Version 14. Juni 2014. Aktualisierung der Vorgängerversion von 2005. Weiterführende Dokumente: Leitlinienreport unter www.dgvs.de und www.awmf.de

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