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.
