The importance of defining standards for optical diagnosis
Optical diagnosis has an increasingly important role in current endoscopy practice
because of the development of advanced imaging techniques and breakthroughs in artificial
intelligence (AI). Accurate optical diagnosis is an important skill to guide clinical
decisions in endoscopy [1]. Accurate optical diagnosis helps in choosing the appropriate resection method and
surveillance interval, thereby avoiding under- and overtreatment, and saving costs.
ESGE has developed a core curriculum for optical diagnosis practice across Europe
for high quality optical diagnosis training [1]
[2]. The development of easy-to-measure competence standards that are focused on the
clinical consequences of optical diagnosis could help to optimize clinical management
in gastrointestinal endoscopy.
Initial process
In 2020, the ESGE board established an expert-derived task force in order to develop
a methodological framework for developing competence standards for optical diagnosis
in gastrointestinal endoscopy. This task force is a spin-off of the Curricula Working
Group for optical diagnosis training [1]
[2]. The aim of this Position Statement is to propose a methodological framework that
can be used to define easy-to-measure competence standards for optical diagnosis that
are focused on clinical consequences.
Task force on optical diagnosis competence standards
The ESGE task force on optical diagnosis competence standards comprises members who
were appointed by the chair after ESGE Governing Board approval. They include members
of the ESGE and, in selected cases, representatives of other medical or nonmedical
societies. The list of current members will be published on the ESGE website. The
main duty of the task force is to propose topics for new optical diagnosis standards
and to participate in their detailed preparation.
Selection of topics
The members of the task force on optical diagnosis competence standards will propose
optical diagnosis competence standards topics to the ESGE Governing Board, which will
select and prioritize them. Criteria for selection will include the clinical relevance
of the optical diagnosis competence standard. As a first step, in 2021, the ESGE task
force on optical diagnosis competence standards for diminutive colorectal polyps was
initiated (the resulting Position Statement is published in this issue [3]). We anticipate activating additional initiatives for other diseases managed by
upper and lower gastrointestinal endoscopy.
Selection of working group members
For the development of each optical diagnosis competence standard, a specific task
force will be formed. A task force generally will involve around 10 members, including
a leader. All groups will be composed of candidates who are selected by the task force
leader. Each task force will write a position statement manuscript that will be distributed
for review to ESGE members.
Methodological framework for the development of competence standards for optical diagnosis
in gastrointestinal endoscopy ([Table 1])
Table 1
Step-wise description of the roadmap for the development of competence standards for
optical diagnosis in gastrointestinal endoscopy.
|
Step 1
|
Definition of the main categories and clinical consequences of optical diagnosis
|
|
Step 2
|
Systematic review of the literature and/or simulation approach to assess the clinical
consequences for different competence standards of optical diagnosis
|
|
Step 3
|
Delphi consensus procedure to reach consensus on competence standards for optical
diagnosis
|
Step 1: Definition of the main categories and clinical consequences of optical diagnosis
For each topic, the main categories of optical diagnosis outcomes will be identified
according to their clinical usefulness and current ability to predict the histology.
In addition, the potential positive and negative clinical consequences of performing
optical diagnosis will be mapped ([Table 2]).
Table 2
Example main categories (input) and clinical consequences (output) for optical diagnosis
curriculum topics.
|
Topic
|
Main categories (input)
|
Potential positive consequences of correct optical diagnosis (output)
|
Potential negative consequences of incorrect optical diagnosis (output)
|
|
Esophageal squamous cell cancer (ESCC)
|
Non-neoplastic; intramucosal ESCC; ESCC invading muscularis mucosae/SM1; ≥ SM2 ESCC
|
Appropriate treatment
(i. e. no resection, endoscopic resection, surgery)
|
Inappropriate treatment (i. e. unnecessary surgery or an unnecessary endoscopic attempt)
|
|
Barrett’s esophagus
|
Non-neoplastic; neoplastic
|
Appropriate treatment
(i. e. no resection, endoscopic resection, surgery)
|
Inappropriate treatment (i. e. unnecessary surgery or an unnecessary endoscopic attempt)
|
|
Stomach
|
Non-neoplastic versus neoplastic lesion
|
Appropriate treatment
(i. e. no resection, endoscopic resection, surgery)
|
Inappropriate treatment (i. e. unnecessary surgery or an unnecessary endoscopic attempt)
|
|
Intestinal metaplasia versus no intestinal metaplasia (EGGIM score)
|
Appropriate selection of patients for surveillance
|
Inappropriate selection of patients for surveillance (overtreatment) or inappropriate
discharge of patients that need surveillance
|
|
Diminutive colorectal polyps
|
Adenoma; sessile serrated lesion; hyperplastic polyp
|
Neoplastic and non-neoplastic lesions that would be resected and discarded (i. e.
reduction in histopathological analysis); non-neoplastic lesions that would remain
in situ in the rectosigmoid (i. e. reduction in unnecessary polypectomies, reduction
in histopathological analysis)
|
Too long/too short surveillance intervals; neoplastic lesions that remain in situ
in the rectosigmoid
|
|
Early colorectal cancer (eCRC)
|
Low grade neoplasia; high grade neoplasia/eCRC (SM1 or < 1 mm); eCRC (SM2, 3, or > 1 mm)
|
Appropriate treatment
(i. e. piecemeal endoscopic mucosal resection, en bloc resection, surgery)
|
Inappropriate treatment (i. e. unnecessary surgery or an unnecessary or incorrect
endoscopic attempt)
|
|
Dysplasia in inflammatory bowel disease
|
Non-neoplastic; neoplastic
|
Appropriate treatment
(i. e. no resection, endoscopic resection, surgery)
|
Inappropriate treatment (i. e. unnecessary surgery or an unnecessary or incorrect
endoscopic attempt)
|
EGGIM, endoscopic grading of gastric intestinal metaplasia.
Step 2: Systematic review of the literature and/or simulation approach
In order to assess the potential clinical benefits or harms of implementing optical
diagnosis with different standards, a systematic literature search will be performed
or updated if available. When possible, and if needed, a simulation approach could
be performed to quantify the expected benefit and harm related to different optical
diagnostic competence standards. For diminutive colorectal polyps, a simulation approach
has already been extensively described [4].
Step 3: Delphi consensus procedure
To establish safe and easy-to-measure standards for optical diagnosis, clinically
acceptable consequences of implementing this standard need to be chosen. Therefore,
a panel of European experts in optical diagnosis will be asked to participate in a
minimum three-round Delphi process to reach consensus on competence standards [5]
[6]
[7], based on the literature search and, if available, a simulation model. All participating
experts will be asked to vote online on the potential options for competence standards
for optical diagnosis.
For each competence standard option, the evidence in the literature about the potential
clinical benefits or harms of implementing optical diagnosis will be shown. If available,
the clinical consequences, as estimated by a simulation study, will also be shown.
For a standard to be accepted, at least 10 experts have to vote on these options.
The standards with consensus will form the new competence standards for optical diagnosis.
A standard will be accepted if at least 80 % agreement is reached after a minimum
of two voting rounds. Participating experts will be asked to rate their agreement
using a five-point Likert scale: “Strongly Agree,” “Agree,” “Neither Agree nor Disagree,”
Disagree,” “Strongly Disagree.” Experts agree on the standard if they vote “Strongly
Agree” or “Agree.”
Standards will be adapted and/or excluded during iterative rounds of discussion of
the comments and suggestions made by the experts during the modified Delphi process.
If there is extensive discussion and if there are changes to or adaptation of a statement,
a new Delphi round will be initiated to test the consensus on the specific statement.
The evolution and adaptation of the minimum standards during the Delphi process will
be documented. Experts will be asked to leave a comment if they are undecided or disagree
on a specific standard. At the end, an open text box is provided for participants
to include comments relating to items, if desired. The final results will be circulated
to all experts for review and comment.
Conclusion and future prospects
This ESGE Position Statement provides a clear and comprehensive methodological framework
that can be used for the development of standards for optical diagnosis in gastrointestinal
endoscopy. The optical diagnosis standards that will be produced in the coming years
will be a first step in optimizing treatment and surveillance interval decisions.
After finalization of the development of competence standards, prospective evaluation
of these standards will be necessary. Eventually, incorporating these standards into
ESGE certification for optical diagnosis training could be the ultimate objective.
Disclaimer
ESGE Guidelines and Position Statements 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 and Position Statements are intended to be an educational device 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.
