1. Publication types
Because of the new educational and other activities launched by the ESGE Governing Board and its Committees/Working Groups, ESGE now publishes a greater range of documents than described in the 2012 policy document on ESGE guideline development [1]. [Table 1] presents details of the current types of ESGE publications and the corresponding responsible Committees/Working Groups:
Table 1
ESGE documents and responsible committee/working group.
|
Document type
|
Aim
|
Number of members involved
|
Methodology used
|
Review/Revision
|
Responsible Committee
|
|
PICO
|
Review of evidence
|
GRADE [2]
|
Consensus
|
Other
|
|
Guideline
|
To provide evidence-based recommendations on the clinical and technical applications of GI endoscopy. Guideline development is based on AGREE II criteria [3]
|
10 – 15
|
+
|
+
|
+
|
+ (Face-to-face meeting, Delphi)
|
AGREE II
|
Peers, MS, IM, GB
|
Guidelines
|
|
Quality Improvement Initiative
|
To establish performance measures to assess quality of endoscopic procedures
|
TBD
|
+
|
+
|
+
|
+ (Face-to-face meeting, Delphi)
|
ISFU [4]
|
MS, IM, GB
|
Quality
|
|
Curriculum
|
To develop training curricula for advanced endoscopic procedures
|
TBD
|
+
|
+
|
+
|
+ (Face-to-face meeting, Delphi)
|
–
|
Peers, MS, IM, GB
|
Curriculum Working Group
|
|
Position Statement
|
To provide the opinion of the Governing Board on political and strategic issues or on those scientific fields where there is lack of adequate evidence
|
TBD
|
–/+
|
–/+
|
–
|
–/+
|
TBD
|
GB +/–MS +/–IM +/–
|
GB, all Committees
|
|
Technical Review
|
To provide review of new GI endoscopy techniques/ technologies
|
TBD
|
–/+
|
+
|
–/+
|
–/+
|
–
|
Peers, GB, MS, IM
|
Research
|
|
Cascade Guideline
|
To adapt ESGE Guidelines to developing countries
|
4 – 5
|
–
|
–
|
–
|
+ (Delphi)
|
Resource-sensitive levels
|
GB
|
IAWG
|
|
Other
|
Nonstructured documents such as surveys, research questions, etc
|
TBD
|
–/+
|
–/+
|
–/+
|
–/+
|
TBD
|
Peers, GB, MS, IM
|
GB, All committees
|
AGREE: Appraisal of Guidelines Research and Evaluation; GB: Governing Board; GI: gastrointestinal; GRADE: Grading of Recommendations Assessment, Development and Evaluation; IAWG: International Affairs Working Group; IM: Individual Members; MS: Member Societies; ISFU: Importance, Scientific acceptability, Feasibility, Usability; PICO: Population, Intervention, Comparison, Outcome; TBD: To be decided.
2. Methodology[*]
a. Selection of topics and timeline plan
Each Committee is responsible for defining criteria to select topics for their scientific outputs. The general policy of ESGE is to select topics according to a broad classification of endoscopic procedures or management in the different GI tracts, namely ERCP/EUS, upper or lower GI tracts, or the small bowel, or according to other endoscopic topics (e. g. sedation, monitoring, reprocessing, etc.), whilst a multidisciplinary disease-related approach is to be reserved to a few exceptions (e. g. primary sclerosing cholangitis).
Topics should be proposed by the Committee members and, possibly, by active calls to ESGE Member Societies and ESGE Individual Members. Selected topics must be proposed to the ESGE Governing Board, which is responsible for prioritizing and final approval. So that adequate resources may be allocated for publication, the responsible Committee should present a 2- to 5-year publication schedule to the Governing Board; the latter should approve it after discussion. Possible exceptions are topics for Position Statements. As the latter may represent a political position of the Governing Board on any issue, they may be proposed by any member of the Governing Board or Committees, as well as by Member Societies or Individual Members.
b. Formation of working groups/task forces
Each Committee is responsible for selecting the members of a working group/task force for the development of each document and for identifying one leader. The number of ESGE members involved varies according to the type of document, as reported in [Table 1]. Possible exceptions must be approved by the Governing Board. Selection of ESGE members should be primarily based on predefined criteria, including expertise and professional qualifications. Other criteria, such as geographical representation and previous activities for ESGE may be taken into account. Calls to Member Societies and Individual Members for participants should be made for part/all the working group, and should require at least the submission of the curriculum vitae of applicants. When updating a previous document, the Chair of the Committee must re-evaluate and revise the working group/task force according to the current situation. Six months after finalization and publication of the document, the working group/task force will be disbanded.
Before inclusion in the working group/task force, each member should report any conflicts of interest. The Committee Chair is responsible for conflict of interest evaluation and selection of members.
c. Review of the evidence
As a general rule, ESGE documents should be based on a systematic search of the literature according to a PICO format (population, intervention, comparison, outcome of interest). The output of such a search must be explicit, in the final document or on the ESGE website as supporting material. At a minimum, MEDLINE and the Cochrane Library should be used, while other databases may be added according to the specific need. Possible exceptions (i. e., publications with no systematic search/reporting) might be position statements addressing political/strategic initiatives of the Society, topics where there is little or no direct evidence, and “cascade” guidelines that are based on the systematic search done for the source guideline.
d. Criteria: Level of evidence
Analysis of the level of evidence of the retrieved literature for each PICO question should be based on the four levels of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system (namely, high/moderate/low/very low). These take into account the study design, the directness of the relationship between the study results and the selected outcome, consistency across different studies, evidence of a dose – response gradient, and the limitation or bias of the available studies. According to the GRADE system, high quality meta-analyses/systematic reviews should be prioritized, with additional searching for subsequent studies.
e. Criteria: Strength of recommendation
When enough evidence is available (i. e., other than very low level), ESGE recommendations should be based on a balance between efficacy and safety according to the GRADE system. For this reason, a summary of benefit and risk (burden), as appropriate for each PICO item, should be clearly reported. Based on the level of uncertainty on the balance between benefit and risks (burden), the grade of recommendation may be strong or weak. Possible adaptations of such a system are represented by documents on performance measures where other frameworks, such as ISFU (importance, scientific acceptability, feasibility, and usability), are taken into account.
f. Criteria: Consensus
The consensus process for development of ESGE documents may be based on unstructured methodology, such as face-to-face meetings, when substantial evidence is available, or a more structured approach, such as a modified Delphi consensus process, when evidence is limited.
g. Criteria: Publication of new methodologies
Each Committee is expected to tailor all the above steps to the type of the intended document. When major adaptations as compared to usual ESGE documents (e. g. guidelines) are to be introduced, the Committee should publish a separate document reporting solely on the methodology proposed for the new type of document.
h. Criteria: Collaboration with other societies
In selected cases, collaboration or endorsement with other medical/nonmedical societies should be encouraged according to the topic of the document. In this case, a formal request should be made by the Committee Chair to the ESGE Executive Committee who will review the request and, if it is approved, guide the subsequent process.
3. Publication process
a. Title format
This should include the topic addressed, the source (i. e., ESGE) and the type of document. Examples can be found in [Table 2].
Table 2
Title format for ESGE publications.
|
Publication type
|
Example title
|
|
Guideline
|
Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) Guideline
|
|
Quality Improvement Initiative
|
Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative
|
|
Curriculum
|
Curriculum for endoscopic submucosal dissection training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement
|
|
Position Statement
|
Requirements and standards facilitating quality improvement for reporting systems in gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement
|
|
Technical Review
|
Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review
|
|
Cascade Guideline
|
Nonvariceal upper gastrointestinal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Cascade Guideline
|
b. Abstract
ESGE guidelines should include the main recommendations in the abstract. For other types of publications, each Committee/Working Group is responsible for identifying the most suitable abstract for each type of document.
c. Document template and length
Should include a brief rationale, a detailed methodology (including the list of PICO questions), the summary of the retrieved evidence (as tables or online Supplementary material), and the main recommendations. In addition, it must include: a competing interest statement; hyperlinks to online appendices; references; and tables. Inclusion of algorithms, short summaries for social media, and future research/e-learning questions is encouraged.
As a legal disclaimer, the following explanation about the use of ESGE policy documents has been included in recent ESGE Guidelines and should be adapted for each type of document:
“ESGE Guidelines represent a consensus of best practice based on the available evidence at the time of preparation. They might not apply in all situations and should be interpreted in the light of specific clinical situations and resource availability. Further controlled clinical studies may be needed to clarify aspects of these statements, and revision may be necessary as new data appear. Clinical considerations may justify a course of action at variance with these recommendations. ESGE Guidelines are intended to be an educational device for providing information that may assist endoscopists in providing care to patients. They are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment.”
Because of space constraints, in future guidelines this disclaimer will be noted and referenced but not reproduced in full. For other ESGE publications the disclaimer must be adjusted as necessary and given in full.
Each Committee is responsible for identifying the most suitable template for each type of document. Each Committee should also identify the most appropriate length of each document type in terms of number of words. Although there may be variations in the length of documents, authors should generally adhere to the Committee’s directive.
d. Revision process
External review/revision is required for most ESGE documents namely guidelines, quality improvement, and curricular publications. This should involve at least two reviewers who may or may not belong to the Governing Board. These individuals should be named before the process starts and acknowledged in the final document. In addition, the revised draft should be distributed to the Individual Members and Member Societies for additional comments. The detailed process for each document is reported in [Table 1].
e. Journal selection and dual publication
The reference journal for ESGE documents is Endoscopy.
This applies to all the original documents that are based on the abovementioned criteria. There are possible exceptions, namely:
-
Cascade guidelines to be published in Endoscopy International Open (EIO)
-
The systematic review of literature performed for the purpose of drafting ESGE documents may be published by each working group in independent journals.
-
Translation of an ESGE guideline by a Member Society. In this case, the translation may be published in a local journal, referring to/citing the original published document.
In cases where ESGE collaborates with other scientific medical or nonmedical societies for the production of multidisciplinary documents, the decision for a possible dual publication should be taken by the ESGE Executive Committee, and must be planned before work is started on the document.
f. Authorship
Only individuals who have made substantial intellectual, scientific, and practical contributions to the document should be regarded as authors.
g. Dissemination
All ESGE policy documents will be made freely available from the ESGE website, in addition to publication in the journal Endoscopy. As representatives of various countries have indicated the desire to translate ESGE documents at their national level (into their local language), it has been decided by the ESGE Governing Board and Thieme representatives that this privilege would be automatically granted with no fee, after a formal request to the ESGE Governing Board. In its title, the translated document should include the title (in English) of the original ESGE document, the names of the authors of the original document, and its original citation.
h. Update of ESGE documents
The date scheduled for document revision will be stated in each ESGE document. If new evidence becomes available that would require earlier revision, updates to the ESGE document in the interim period will be noted on the ESGE website.
The Chair of each Committee/Working Group will select the new task force members (see above).
Conclusions
The expansion of the types of documents produced by ESGE is aimed at providing a more analytical and detailed approach for the different aspects of each of the main endoscopic techniques. This should improve the educational content of ESGE’s offer and testify to the level of knowledge of the ESGE endoscopic community.
