Abbreviations
ASGE:
American Society of Gastrointestinal Endoscopy
AUC:
area under the curve
BE:
Barrett’s esophagus
BLI:
blue light imaging
BORN:
Barrett’s esophagus-related neoplasia
CRC:
colorectal cancer
EGC:
early gastric cancer
EMR:
endoscopic mucosal resection
ESCC:
esophageal squamous cell carcinoma
ESD:
endoscopic submucosal dissection
ESGE:
European Society of Gastrointestinal Endoscopy
FICE:
Flexible Spectral Imaging Color Enhancement
GI:
gastrointestinal
GRADE:
Grading of Recommendations Assessment, Development and Evaluation
IBD:
inflammatory bowel disease
JES:
Japan Esophageal Society
JNET:
Japanese NBI Expert Team
LGI:
lower gastrointestinal
NBI:
narrow-band imaging
NICE:
NBI International Colorectal Endoscopic
NPV:
negative predictive value
PIVI:
Preservation and Incorporation of Valuable Endoscopic Innovations
UGI:
upper gastrointestinal
VS:
vessel plus surface classification
WASP:
Workgroup on serrAted polypS and Polyposis
WLE:
white-light endoscopy
This position statement is an official statement of the European Society of Gastrointestinal
Endoscopy (ESGE). It provides recommendations for a European core curriculum aimed
at providing high quality training in optical diagnosis. The recommendations presented
are based on a consensus among endoscopists considered to be experts in optical diagnosis
who are involved in optical diagnosis training and training courses in Europe.
Introduction
Real-time optical diagnosis emerged more than 40 years ago, with the application of
dyes such as indigo carmine and methylene blue during endoscopic examination, and
further developed with the introduction of high definition imaging, optical magnification,
and virtual chromoendoscopy. All these developments allow detailed inspection of the
digestive mucosa, visualizing the mucosal pattern and enhancing the microvasculature,
which are of pivotal importance in characterizing carcinogenesis and inflammation.
Optical diagnosis during endoscopy is an important skill for predicting histology
to guide optimal treatment and surveillance decisions. Choosing the appropriate treatment
method should balance under- and overtreatment of patients and reduce treatment-related
costs. Furthermore, recent studies have demonstrated that implementing an optical
diagnosis strategy for diminutive colorectal lesions could reduce the colonoscopy-associated
costs for histopathology and polypectomy substantially, besides reducing patient burden
[1 ]
[2 ]
[3 ].
In expert hands, optical diagnosis has been demonstrated to be very helpful in predicting
the histology of various disorders, including diminutive colorectal lesions, early
colorectal cancer (CRC), early gastric cancer (EGC), esophageal squamous cell carcinoma
(ESCC), and Barrett’s esophagus (BE). However, the performance of optical diagnosis
by endoscopists varies greatly and depends on training, experience, and equipment
[4 ]
[5 ]
[6 ]
[7 ]
[8 ]
[9 ]. At the moment, standardized training courses based on validated classification
systems, aiming to reach and maintain optical diagnosis skills for endoscopists, are
very rare. The available training courses demonstrate a huge variability in their
content, the endoscopy system, and the setting of the training. Training is generally
done by classroom teaching or computer-based training, and may consist of images,
videos, or real-time endoscopies. Endoscopists attending such courses may have varying
experience and access to different types of endoscopic equipment and enhanced imaging
techniques, with or without magnification. Optimization of the current practice of
optical diagnosis and concurrent training curricula are therefore warranted.
The recommendations presented in this curriculum ([Table 1 ] and [Table 2 ]) are based on a consensus among optical diagnosis experts who are involved in optical
diagnosis training.
Table 1
Summary of the ESGE training curriculum recommendations for optical diagnosis in general.
A. Pre-adoption requirements to start optical diagnosis training
Personal experience of at least 300 UGI and/or 300 LGI endoscopies
Meeting the ESGE key quality performance measures for UGI and/or LGI endoscopy
Being able and competent to perform UGI/LGI endoscopy with high definition white-light
endoscopy combined with virtual and/or dye-based chromoendoscopy
B. Training/learning steps optical diagnosis
Attending a validated training course based on a validated classification (including
an in vivo part)/Attending an onsite training course of 1 week’s duration with an
expert (including training on techniques and any validated classification)
Self-learning by assessing a minimum number of lesions with histopathology as the
reference
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
Meeting pre-adoption requirements and training/learning steps for optical diagnosis
Meeting competence thresholds by assessing a minimum number of lesions prospectively
during real-time endoscopy with histopathology as the reference (if not incorporated
in training)
Maintaining competence in optical diagnosis
Ongoing in vivo practice
Repeating the learning and competence phases if it is not possible to perform optical
diagnosis on a regular basis
UGI, upper gastrointestinal; LGI, lower gastrointestinal.
Table 2
Summary of the ESGE training curriculum recommendations for optical diagnosis in specific
conditions.
Early squamous cell carcinoma (ESCC)
Barrett’s esophagus (BE)
Early gastric cancer (EGC)
Diminutive colorectal lesions
Early colorectal cancer
Inflammatory bowel disease (IBD) dysplasia
A. Pre-adoption requirements to start optical diagnosis training
Meeting the general pre-adoption requirements for optical diagnosis
Meeting the general pre-adoption requirements for optical diagnosis
Meeting the general pre-adoption requirements for optical diagnosis
Meeting the general pre-adoption requirements for optical diagnosis
Meeting the general pre-adoption requirements for optical diagnosis
Meeting the general pre-adoption requirements for optical diagnosis
Attending a validated training course for the detection of Barrett’s neoplasia: BORN
and/or Chedgy
B. Training/ learning steps for optical diagnosis
As a validated training course is not yet available, attending an onsite 1-week training
course with an expert in optical diagnosis of ESCC (including training on techniques
and the validated JES classification[* ])
As a validated training course is not yet available, attending an onsite training
course using a validated classification: BING/BLINC/PREDICT
As a validated training course is not yet available, attending an online or onsite
training course with an expert in optical diagnosis of gastric dysplasia/EGC (including
training on techniques and the VS[* ]/simplified NBI classification[1 ])
Attending a validated training course using the validated NICE[* ]/WASP[* ]/BASIC[* ] classification
As a validated training course is not yet available (other than NICE), attending an
onsite 1-week training course with an expert in optical diagnosis of large (≥ 20 mm)
colorectal lesions (including training on techniques and the validated classifications:
NICE[* ]/JNET[* ]/Sano[* ]/Hiroshima[* ]/Kudo[* ])
As a validated training course is not yet available, attending an onsite 1-week training
course with an expert in optical diagnosis of IBD (including training on techniques
and the validated classifications: FACILE/Kudo[* ])
Self-learning by assessing at least 20 esophageal lesions in high risk ESCC patients
prospectively with histological feedback
Self-learning by assessing at least 20 esophageal lesions in high risk BE patients
prospectively with histological feedback
Self-learning by assessing at least 20 gastric lesions in high risk gastric dysplasia/EGC
patients prospectively with histological feedback
Self-learning by assessing at least 120 diminutive colorectal lesions prospectively
with histological feedback
Self-learning by assessing at least 20 large (≥ 20 mm) colorectal lesions prospectively
with histological feedback
Self-learning by performing at least 20 pan-chromoendoscopy procedures in IBD surveillance
patients with at least 20 targeted biopsies with histological feedback; a back-up
of four quadrant random biopsies every 10 cm is suggested whilst learning curve is
surmounted and performance is confirmed
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
Meeting pre-adoption requirements and learning criteria in optical diagnosis
Meeting pre-adoption requirements and learning criteria in optical diagnosis
Meeting pre-adoption requirements and learning criteria in optical diagnosis
Meeting pre-adoption requirements and learning criteria in optical diagnosis
Meeting pre-adoption requirements and learning criteria in optical diagnosis
Meeting pre-adoption requirements and learning criteria in optical diagnosis
Achieving ≥ 80 % accuracy for characterizing neoplasia in 20 esophageal lesions in
high risk ESCC patients
Meeting internationally endorsed competence thresholds in 20 prospectively assessed
esophageal lesions in high risk BE patients
Achieving ≥ 80 % accuracy for characterizing neoplasia in 10 gastric lesions in high
risk gastric dysplasia/EGC patients
Meeting internationally endorsed competence thresholds in 60 prospectively assessed
diminutive colorectal lesions
Achieving ≥ 80 % accuracy for identifying submucosal invasion in 20 large (≥ 20 mm)
colorectal lesions
Achieving a neoplasia detection rate of ≥ 10 % in 20 IBD pan-chromoendoscopy colonoscopies
with targeted biopsies only
Maintaining competence in optical diagnosis
Audit and review of at least 10 esophageal lesions in high risk ESCC patients within
1 year
In vivo audit and review of at least 20 esophageal lesions in BE patients within 1
year
Audit and review of at least 10 gastric lesions in high risk gastric dysplasia/EGC
patients within 1 year
In vivo audit and review of at least 120 diminutive colorectal lesions within 1 year
In vivo audit and review of at least 10 large (> 20 mm) colorectal lesions within
1 year
In vivo audit and review of at least 10 IBD endoscopic lesions within 1 year
If it is not possible to perform optical diagnosis on a regular basis, learning and
competence phases should be repeated
If it is not possible to perform optical diagnosis on a regular basis, learning and
competence phases should be repeated
If it is not possible to perform optical diagnosis on a regular basis, learning and
competence phases should be repeated
If it is not possible to perform optical diagnosis on a regular basis, learning and
competence phases should be repeated
If it is not possible to perform optical diagnosis on a regular basis, learning and
competence phases should be repeated
If it is not possible to perform optical diagnosis on a regular basis, learning and
competence phases should be repeated
Completing additional online assessment modules with feedback
Completing additional online assessment modules with feedback
Completing additional online assessment modules with feedback
BASIC, BLI Adenoma Serrated International Classification; BING, Barrett’s International
NBI group; BLINC, BLI New Classification; BORN, Barrett’s Oesophagus-Related Neoplasia;
ESCN, esophageal squamous cell neoplasia; FACILE, Frankfurt Advanced Chromoendoscopic
IBD Lesions; JES, Japan Esophageal Society; JNET, Japan NBI Expert Team; NBI, narrow-band
imaging; NICE, NBI International Colorectal Endoscopic; PREDICT, Portsmouth acetic
acid classification; VS, vessel plus surface; WASP, Workgroup on serrAted polypS and
Polyposis.
* Internally and externally validated.
Aims
The aim of this Position Statement is to establish practical guidance to optimize
optical diagnosis training in Europe, based on the currently published evidence and
knowledge. This manuscript focuses on training and aims to help gastroenterologists
in general practice to develop and maintain skills in optical diagnosis during endoscopy
([Fig. 1 ]). Specifically, it was not intended for it to look at accreditation or practice
standards, which are the remit of advanced imaging guidelines.
Fig. 1 A summary of the optical diagnosis training performance principles. A, pre-adoption
requirements; B, training/learning steps; C1 , achieving competence; C2 , maintaining competence.
Methods
This curriculum was developed through a Delphi consensus method among European experts
in optical diagnosis [10 ]. As chair of the European Society of Gastrointestinal Endoscopy (ESGE) curricula
working group [11 ], R.B. invited E.D. and J.E. to be the section chairs for the optical diagnosis training
curriculum. After a call for participants in July 2017, R.B., E.D., and J.E. selected
the members, based on curriculum, optical diagnosis experience, publications, and
motivation, in December 2017. During a face-to-face meeting in February 2018, all
members were introduced to the methodology, and subtopics for optical diagnosis training
were selected: BE, ESCC, EGC, diminutive colorectal lesions, early CRC, and inflammatory
bowel disease (IBD). The term “optical diagnosis” in this curriculum relates exclusively
to the differentiation between non-neoplastic lesions and neoplastic lesions, and
the prediction of (invasive) cancer within a neoplastic lesion. Taskforces for the
six subtopics were formed (Appendix 1s ; see online-only Supplementary material).
Three key areas of interest were decided upon for each main topic.
A. What are the pre-adoption requirements to start optical diagnosis training?
B. What are the training/learning steps to achieve competence in optical diagnosis?
C. What are the assessment criteria for optical diagnosis proficiency (being competent
and maintaining competence)?
Different PICO questions (where P stands for population/patient, I for intervention/indicator,
C for comparator/control, and O for outcome) were defined. An evidence-based Delphi
process was used to develop consensus statements. The working group chairs (E.D. and
J.E.) and B.H. worked with the other members of the working group (I.P., M.B., E.C.,
D.D., R.K., H.N.) to carry out a systematic collective search in the online Cochrane
Library, Embase, and PubMed from 1990 to 1 March 2018, under the supervision of a
medical librarian (Appendix 2s ). Technologies considered for use for optical diagnosis were narrow-band imaging
(NBI), linked color imaging (LCI), blue light imaging (BLI), blue laser imaging (BLI-laser),
i-scan digital chromoendoscopy (i-scan), i-scan optical enhancement (i-scan OE), conventional
chromoendoscopy; white-light endoscopy (WLE), and Flexible spectral Imaging Color
Enhancement (FICE; also known as Fujinon Intelligent Chromo Endoscopy).
For each statement, articles were individually assessed using the Grading of Recommendations
Assessment, Development and Evaluation (GRADE) system for grading evidence levels
and recommendation strengths [12 ]. The statements derived from the research questions of each key area of interest
were adapted and/or excluded during iterative rounds of comments and suggestions from
the working group members and former candidates during the Delphi process. Where evidence
was limited or not available, expert opinions were derived and then refined based
on the Delphi process. The evolution and adaptation of the clinical statements during
the Delphi process was documented. A statement was accepted if at least 80 % agreement
was reached after at least three voting rounds. Sentences were voted on online by
all optical diagnosis training group members, along with the ESGE curriculum group
for endoscopic submucosal dissection (ESD) and the ESGE guideline group for advanced
imaging for the detection and differentiation of colorectal neoplasia until a consensus
was reached.
Because of the paucity of evidence, all statements should be considered GRADE weak,
with low or very low quality evidence or expert opinion, with the exception of optical
diagnosis for diminutive colorectal lesions [12 ].
Optical diagnosis training in general
Optical diagnosis training in general
A. Pre-adoption requirements to start optical diagnosis training
ESGE suggests that every endoscopist should have achieved general competence in upper
gastrointestinal (UGI) endoscopy before commencing training in optical diagnosis of
the UGI tract, meaning personal experience of at least 300 UGI endoscopies and meeting
the ESGE quality measures for UGI endoscopy.
Level of agreement 89 %.
ESGE suggests that every endoscopist should have achieved general competence in lower
gastrointestinal (LGI) endoscopy before commencing training in optical diagnosis of
the LGI tract, meaning personal experience of at least 300 LGI endoscopies and meeting
the ESGE quality measures for LGI endoscopy.
Level of agreement 89 %.
Lesion assessment requires a stable position. This means avoiding loops, optimizing
patient position, cleaning the lesion extensively, and managing the endoscope without
the need of an assistant. Only if an endoscopist has mastered these standard technical
skills, can mucosa and lesions be observed and diagnosed accurately. Sufficient technical
proficiency in performing a standard gastrointestinal (GI) endoscopy, such as avoiding
loops, should therefore be a prerequisite before commencing training in optical diagnosis
[13 ].
The number of upper GI (UGI) and/or lower GI (LGI) endoscopies needed to achieve technical
competence is uncertain and probably highly variable. It has been proposed that at
least 200 LGI endoscopies should be performed during training to achieve competency
in LGI endoscopy [14 ]. Past multicenter studies have shown that between 150 and 275 LGI endoscopies are
required in order to consistently achieve a 90 % success rate for cecal intubation
[15 ]
[16 ]
[17 ]
[18 ]
[19 ]
[20 ]
[21 ]. However, much higher numbers – perhaps as many as 450 cases – may be needed to
be competent in lesion detection, and competency to this level with WLE should precede
attempts to focus on optical diagnosis [22 ]. While data on the exact number of UGI endoscopies required to achieve competency
in optical diagnosis of lesions of the UGI tract are scarce, a recent study showed
that > 90 % of trainees were able to achieve a 95 % completion rate (i. e. passage
of the endoscope to the duodenum without physical assistance) after performing 200
procedures [23 ]. Because optical diagnosis also requires correct positioning and stabilization of
the endoscope, higher numbers may be needed for all endoscopists wishing to perform
optical diagnosis of esophageal or gastric lesions.
The ESGE and United European Gastroenterology have presented a short list of key performance
measures for UGI and LGI endoscopy [24 ]
[25 ]. Because optical diagnosis also requires high quality endoscopy, in order to ensure
basic competence in both UGI and LGI endoscopy, it is recommended that the same quality
measures are adopted. For UGI endoscopy, a procedure time of ≥ 7 minutes and inspection
time of ≥ 1 minute/cm of the circumferential extent of the Barrett’s epithelium are
recommended. To assess performance measures, a total of 100 consecutive procedures
should be used, or all procedures if < 100 have been performed [24 ]. For LGI endoscopy, a cecal intubation rate ≥ 95 %, adenoma detection rate ≥ 25 %,
and a minimum mean withdrawal time of 6 minutes [25 ]
[26 ]
[27 ]
[28 ]
[29 ]
[30 ] are recommended. In addition, validated competency assessment tools, such as the
Direct Observation of Procedural Skills (DOPS) assessment tools developed by the Joint
Advisory Group (JAG) on GI endoscopy, can be used to assess technical proficiency
[31 ]
[32 ].
ESGE suggests that every endoscopist should be able and competent to perform UGI/LGI
endoscopy with high definition white light combined with virtual and/or dye-based
chromoendoscopy before commencing training in optical diagnosis.
Level of agreement 96 %.
The ESGE recently presented an update of the advanced imaging guideline for LGI endoscopy
[33 ]. ESGE suggests that high definition endoscopy, and dye or virtual chromoendoscopy,
as well as add-on devices, can be used in average risk patients to increase the endoscopist’s
adenoma detection rate. Because optical diagnosis also requires high quality equipment
to ensure optimal endoscopist performance, it is recommended that endoscopists are
able and competent to perform endoscopies with this equipment. In addition, the optimal
equipment for the process of acquiring and storing images and/or video capture are
mandatory for performing optical diagnosis. This equipment includes an appropriate
video processor, a large high definition monitor, suitable cables for transporting
the high definition digital signal, and high definition (video) capture to save the
(video) images. When performing optical diagnosis to replace pathology diagnosis,
clear unequivocal photo storage following national regulations is required.
B. Training/learning steps for optical diagnosis
ESGE suggests competency in optical diagnosis can be learned by: (1) attending a validated
optical diagnosis training course; and (2) self-learning with a minimum number of
lesions. If no validated training course is available, optical diagnosis can only
be learned by attending a non-validated onsite training course and self-learning with
a minimum number of lesions.
Level of agreement 89 %.
If available, ESGE suggests the use of optical diagnosis training courses that: (1)
are based on a validated classification system; (2) have undergone internal and external
validation; and (3) include an in vivo phase in which the endoscopists perform optical
diagnosis during real-time endoscopy procedures.
Level of agreement 100 %.
Although it is possible to learn new skills through clinical experience, there is
a risk that this will not cover the full breadth of pathology and potential mimics
that may be encountered. Therefore, in line with other areas of medical training,
formal training courses that ensure the full curriculum is covered are required as
part of surmounting the learning curve to achieve full competence.
For optical diagnosis, many training courses have been developed. Most are linked
to studies on the accuracy of optical diagnosis, others are promoted by companies.
However, the vast majority of courses have not undergone internal and external validation,
which should be the standard ([Table 3 ]).
Table 3
Different optical diagnosis classifications and training courses for each condition.
Organ
Condition
Classification systems
Imaging technique
Training available (Yes/No)
Training includes an in vivo assessment phase (Yes/No)
Training externally validated (Yes/No)
Esophagus
Barrett’s esophagus
BING [34 ]
NBI near focus
No
No
No
BLINC [35 ]
M-BLI
Yes [35 ]
No
No
PREDICT [36 ]
AA-CE
Yes [36 ]
No
No
Squamous cell carcinoma
JES[* ]
[37 ]
[38 ]
[39 ]
M-NBI
Yes [40 ]
No
No
Inoue [41 ]
[42 ]
[43 ]
M-NBI
No
NA
NA
Arima [44 ]
[45 ]
[46 ]
M-NBI
No
NA
NA
Stomach
Early gastric cancer
VS[* ]
[47 ]
[48 ]
M-NBI/M-BLI
Yes [49 ]
[50 ]
No
No
NBI-simplified[* ]
[51 ]
NBI
Yes [52 ]
No
No
Colon etc.
Diminutive lesions
BASIC[* ]
[53 ]
[54 ]
BLI
Yes [53 ]
[54 ]
No
Yes [54 ]
CONECCT [55 ]
NBI
Yes [55 ]
No
No
ICE [56 ]
OE
Yes [56 ]
No
No
NICE[* ]
[57 ]
[58 ]
NBI
Yes [58 ]
[59 ]
No
No
SIMPLE [60 ]
OE/NBI
Yes [60 ]
No
No
WASP[* ]
[61 ]
NBI
Yes [9 ]
[61 ]
Yes [9 ]
Yes [9 ]
Early CRC
NICE[* ]
[57 ]
[62 ]
NBI
Yes [58 ]
[59 ]
No
No
Kudo[1 ]
[63 ]
M-CE
No
NA
NA
Sano[1 ]
[64 ]
[65 ]
[66 ]
[67 ]
M-NBI
No
NA
NA
Hiroshima[1 ]
[68 ]
[69 ]
[70 ]
[71 ]
M-NBI
No
NA
NA
JNET[1 ]
[72 ]
[73 ]
[74 ]
[75 ]
[76 ]
M-NBI
No
NA
NA
Neoplasia IBD
FACILE [77 ]
WLE, NBI, dye-based CE, i-scan
No
NA
NA
Kudo [63 ]
Dye-CE and NBI
No
NA
NA
AA-CE, acetic acid chromoendoscopy; BASIC, BLI Adenoma Serrated International Classification;
BING, Barrett’s International NBI group; BLI, blue light imaging; BLINC, BLI New Classification;
CONECCT, COlorectal Neoplasia Endoscopic Classification to Choose the Treatment; CRC,
colorectal cancer; FACILE, Frankfurt Advanced Chromoendoscopic IBD Lesions; IBD, inflammatory
bowel disease; ICE, i-scan classification for endoscopic diagnosis; JES, Japan Esophageal
Society; JNET, Japan NBI Expert Team; M-BLI, magnifying blue-light imaging; M-CE,
magnifying chromoendoscopy; M-NBI, magnifying narrow-band imaging; NA, not applicable;
NBI, narrow-band imaging; NICE, NBI International Colorectal Endoscopic; OE, optical
enhancement; PREDICT, Portsmouth acetic acid classification; SIMPLE, Simplified Identification
Method for Polyp Labeling during Endoscopy for i-scan OE and NBI; VS, vessel plus
surface; WASP, Workgroup on serrAted polypS and Polyposis; WLE, white-light endoscopy.
* Internally and externally validated.
Internal validation is more or less a test for reproducibility. External validation
with different lesions and different endoscopists is important to assess the robustness
of the classification system and should also include assessment of face and content
validation. “Face validity” is the extent to which a test is subjectively viewed as
covering the concept it purports to measure, whereas “content validity” is the extent
to which a test measures all facets of a given construct [78 ]
[79 ].
Many optical diagnosis studies have assessed only ex vivo performance [5 ]
[6 ]
[7 ]
[9 ]
[49 ]
[52 ]
[67 ]
[80 ]
[81 ]
[82 ]
[83 ]
[84 ]. The main problem with optical diagnosis learning is the transition from evaluating
still pictures to real-time endoscopy. Previous studies have suggested that training
using still images and videos may not translate into high accuracy during real-time
endoscopy [5 ]
[8 ]
[85 ]. A standardized training course design should therefore ideally include an in vivo
phase as well.
If no validated training course exists, a “learner” endoscopist should start to practice
optical diagnosis in vivo after attending an onsite training course with an optical
diagnosis expert. Self-learning with feedback from histology and occasionally from
the optical diagnosis expert (sending videos or pictures) will help to achieve competency.
Although this period can take a long time, based on experience, we believe that assessing
a minimum number of lesions prospectively is needed before competence should be assessed.
Because there is no evidence available, the expert committee for this optical diagnosis
training curriculum suggests that each subtopic should have a minimum caseload to
learn optical diagnosis. Future studies should investigate these different caseloads
in order to provide more evidence-based recommendations.
ESGE suggests that both classroom and online training courses can be used to improve
the optical diagnosis accuracy of endoscopists.
Level of agreement 100 %.
No clear statement can be made on which type of training course is best. Different
training course designs (classroom, self-directed web- or computer-based programs,
etc.) have all shown efficacy for the initial steps of optical diagnosis learning
[5 ]
[6 ]
[7 ]
[9 ]
[49 ]
[52 ]
[67 ]
[80 ]
[81 ]
[82 ]
[83 ]
[84 ]. In two head-to-head comparisons, no difference in optical diagnosis performance
was found between trainees randomized to online self-learning or didactic classroom
teaching [86 ]
[87 ]. In the study of Smith et al. [87 ], 16 trainees were randomized to receive online self-learning (n = 8) or didactic
training (n = 8) using identical teaching materials and videos. No difference in diagnostic
accuracy for the prediction of diminutive/small polyp histology was found between
trainees who received didactic training and those who followed the computer-based
program. Allen et al. [86 ] also found no difference in the accuracy of distinguishing adenomatous versus hyperplastic
colon polyps between in-class teaching and online learning.
ESGE suggests that, for diseases with a low prevalence, online training should be
considered a good alternative to onsite training to achieve and maintain competence.
Level of agreement 93 %.
Because the incidence of EGC, ESCC, and early CRC during daily practice is very low,
endoscopists should be exposed to more cases in a standardized training program, with
the aim of obtaining a more extensive experience in optical diagnosis of these lesions
[88 ]. In order to compensate for this lack of experience, a self-exercise online training
course could be a good alternative for achieving and maintaining competence in optical
diagnosis. Yao and colleagues developed an original self-exercise e-learning program,
the so-called “100 cases for EGC detection training” [89 ]. During this online training course, the endoscopist predicts the diagnosis of 100
cases (50 cancer, 50 non-cancer) and receives feedback directly. Participants can
repeat the training and mock tests as often as they wish until they feel sufficiently
confident to perform optical diagnosis and draw clinical conclusions. We believe that
similar repetitive online training courses could be a good alternative for low incidence
optical diagnosis diseases.
The availability of adequate online teaching courses could enable widespread implementation
of optical diagnosis in clinical practice. However, they are not a substitute to real-time
endoscopy experience, which is the optimal method to develop excellence in optical
diagnosis. The exposure to optical diagnosis of conditions with a low prevalence could
also be increased by attending (expert) meetings to discuss cases from many endoscopists.
During these meetings, the optical diagnosis and therapeutic plan can be discussed,
and the histology results can be shown afterwards.
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
ESGE suggests endoscopists are competent in optical diagnosis after: (1) meeting the
pre-adoption and learning criteria; and (2) meeting competence thresholds by assessing
a minimum number of lesions prospectively during real-time endoscopy.
Level of agreement 93 %.
People learn at different rates. For instance, studies during real colonoscopies have
shown that, despite successfully completing a training course, some endoscopists never
achieve a specific threshold [5 ]
[9 ]. Therefore, if endoscopists wish to perform optical diagnosis, they should demonstrate
that the learning curve has been surmounted. The competence of endoscopists can be
assessed by meeting competence thresholds in a minimum number of prospectively collected
lesions during real-time endoscopy.
ESGE suggests objective and measurable parameters be implemented for assessing competence
in optical diagnosis.
Level of agreement 100 %.
Currently, the only available benchmark for assessing competence are the PIVI criteria
(Preservation and Incorporation of Valuable Endoscopic Innovations) [90 ]
[91 ]. Clear assessment of an objective and measurable parameter (externally reviewed)
is necessary to demonstrate that the learning curve has been surmounted. Therefore,
other objective and measurable parameters for assessing optical diagnosis competence
should be developed. The working group of this optical diagnosis training curriculum
have suggested a threshold to assess optical diagnosis competence for each subtopic.
These thresholds should be examined to set more evidence-based recommendations.
Maintaining competence in optical diagnosis
ESGE suggests ongoing in vivo practice by endoscopists to maintain competence in optical
diagnosis. If a competent endoscopist does not perform in vivo optical diagnosis on
a regular basis, ESGE suggests repeating the learning and competence phases to maintain
competence.
Level of agreement 89 %.
Competence is not static and may deteriorate over time, especially if a skill is rarely
used. Mabe et al. [50 ] indicated that the learning effect might decrease if endoscopists do not continue
their learning practice, but the required frequency of training is unclear. The recently
published study of Bustamante-Balén et al. [92 ] shows that, following a non-practice period of 6 months, a drop in performance parameters
occurs, and that it takes 150 lesions to get back to previous “expert” levels. Repetitive
practice therefore seems crucial for maintaining competence. Thus, in order to remain
competent in optical diagnosis, regular clinical application of this skill is required
[6 ]
[9 ]
[93 ]
[94 ]
[95 ].
There is a scarcity of data on how many endoscopies or lesions evaluated with optical
diagnosis are needed to maintain competence, partly because there is great variability
in the learning speed between endoscopists [6 ]
[9 ] The only evidence comes from the study of Vleugels et al. [9 ]. This study showed that assessing 120 or more diminutive lesions in a period of
1 year was independently associated with more accurate histology prediction. Studies
assessing how many lesions an endoscopist has to assess with optical diagnosis to
maintain competence are lacking for the other optical diagnosis subtopics.
Although no evidence is available, the expert committee of this optical diagnosis
training curriculum has suggested a minimum caseload within 1 year for each topic
or that there should be repetition of the training/learning and competence phases
in order to maintain proficiency in optical diagnosis. Ideally, these caseloads per
year should be audited and reviewed during real-time endoscopies. Owing to the low
prevalence of some optical diagnosis conditions, endoscopists may have limited opportunity
to achieve the recommended number of cases, and therefore additional online training
is suggested for maintaining competence in optical diagnosis.
Future studies should compare the outcomes of endoscopists with different caseloads
in order to set a more evidence-based recommendation for a minimum volume of cases
per year.
A logbook for optical diagnosis training is available for trainees on the ESGE website
(https://www.esge.com/optical-diagnosis-training-curriculum/ ).
Optical diagnosis training for esophageal squamous cell cancer
Optical diagnosis training for esophageal squamous cell cancer
ESCC remains the most common type of esophageal cancer in the world [96 ]. Predicting the depth of infiltration is of pivotal importance when deciding on
the appropriate treatment [37 ]. Because superficial mucosal lesions (stages T1m1 or T1m2) that are well to moderately
differentiated and without lymphovascular invasion have a risk of lymph node metastases
of less than 2 %, endoscopic resection is the preferred treatment option for these
lesions. Recent data suggest the utility of optical diagnosis to guide clinical decisions
in ESCC management, providing the Asian classifications can be easily learned and
mastered by most endoscopists.
A. Pre-adoption requirement to start optical diagnosis training
There are no additional requirements over and above the general pre-adoption requirements
to start optical diagnosis training for ESCC.
B. Training/learning steps for optical diagnosis
As a validated training course is not yet available for optical diagnosis of esophageal
squamous cell carcinoma (ESCC), ESGE suggests attending an onsite training course
using a validated classification of 1 week’s duration with an expert in optical diagnosis
of ESCC to achieve competence. To date the only validated classification is the Japan
Esophageal Society (JES) classification.
Level of agreement 89 %.
In order to achieve competence in optical diagnosis of ESCC, ESGE suggests self-learning
by assessing at least 20 esophageal lesions prospectively in high risk ESCC patients
with histological feedback.
Level of agreement 93 %.
Lugol chromoendoscopy was recommended by the ESGE Quality Improvement Initiative for
patients with an increased risk of ESCC [24 ]. However, the use of high definition endoscopes was not strictly recommended and
the potential role of NBI was not mentioned. New data suggest that NBI or other virtual
chromoendoscopy techniques, especially combined with magnification, might in expert
hands replace Lugol chromo-endoscopy to identify and characterize esophageal squamous
cell neoplasia) [97 ].
Optical diagnosis for elevated (Paris 0-Is), slightly depressed (Paris 0-IIc), or
ulcerated (Paris 0-III) esophageal lesions is not useful as these lesions are at very
high risk of submucosal invasion and therefore are not candidates for endoscopic resection
[98 ]. For flat lesions, intrapapillary capillary loop morphology visualized by NBI can
help to predict the depth of invasion and choice for therapy. This is not feasible
with Lugol chromoendoscopy. Classifications that help analyze intrapapillary capillary
loop morphology, such as the Inoue classification and Arima classification, have seldom
been used because of their relative complexity [41 ]
[42 ]
[43 ]
[44 ]
[45 ]
[46 ]. In 2017, the Japan Esophageal Society (JES) proposed a new simplified classification
of four grades (A, B1, B2, and B3) based on the running pattern of microvessels or
degree of dilation of severely irregular microvessels [37 ]
[38 ]
[39 ]. The JES classification has been externally validated in a retrospective multicenter
Korean study performed in 69 patients from 2010 until 2016 [40 ]. The overall accuracy of magnifying NBI for estimating the depth of invasion of
superficial ESCC was 79 %. These results support the use of the JES classification
for ESCC, although few data are available on its use in the Western world.
The JES classification is helpful for predicting invasion depth, and thus guides the
physician in deciding whether an endoscopic resection should be performed or not.
Indeed, the following clinical decisions can be applied:
non-neoplastic lesion → no resection
intramucosal ESCC → appropriate for endoscopic mucosal resection (EMR) or ESD
ESCC invading muscularis mucosae/SM1 → relative contraindication for endoscopic resection
≥ SM2 ESCC → formal contraindication for endoscopic resection.
Training courses with the validated JES classification are scarce. Recently, a Chinese
study proposed a training course (1-hour video course) focusing on the JES classification
[99 ]. The results of this study showed an improvement in accuracy for WLE combined with
magnifying NBI versus WLE alone. Multivariate analyses revealed that the educational
course, but not experience in endoscopy, NBI, or magnification, significantly improved
the diagnostic accuracy. Therefore, these results suggest a moderate, but potentially
clinically relevant, benefit for such training courses. Where no validated training
course exists, a “learner” endoscopist should start to use optical diagnosis in vivo
after acquiring suitable knowledge from the literature and attending an onsite training
course with an expert in optical diagnosis of ESCC. Self-learning with feedback from
histology will help to achieve competence.
Studies assessing how many UGI endoscopies an endoscopist has to assess with optical
diagnosis in patients with an increased risk for ESCC to achieve competence are lacking.
Based on personal experience, the curriculum committee suggests assessment of at least
20 esophageal lesions prospectively in high risk ESCC patients.
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
As a threshold is not available, ESGE suggests that an endoscopist is competent in
optical diagnosis of ESCC after: (1) meeting the pre-adoption and learning criteria;
and (2) achieving ≥ 80 % accuracy in characterizing neoplasia in 20 esophageal lesions
in high risk ESCC patients.
Level of agreement 89 %.
No formal competence criteria for optical diagnosis in ESCC are available. In line
with other criteria for competence in optical diagnosis where few data are available,
the expert committee of this optical diagnosis training curriculum suggests, based
on personal experience, an accuracy of ≥ 80 % in characterizing neoplasia in 20 esophageal
lesions in high risk ESCC patients.
Maintaining competence in optical diagnosis
ESGE suggests competence in optical diagnosis to predict ESCC can be maintained by
audit and review of at least 10 esophageal lesions in high risk ESCC patients within
1 year. If it is not possible to perform optical diagnosis in high risk ESCC patients
on a regular basis, the learning and competence phases should be repeated. Owing to
the low prevalence of ESCC, ESGE suggests completing additional online assessment
modules with feedback to maintain competence in optical diagnosis of ESCC.
Level of agreement 93 %.
Optical diagnosis training for Barrett’s esophagus
Optical diagnosis training for Barrett’s esophagus
The detection of high grade dysplasia and esophageal adenocarcinoma with improved
survival rates is the aim of optical diagnosis in BE. Advanced endoscopic imaging
technologies improve the characterization of dysplastic BE by mucosal visualization
and enhancement of the fine structural and microvascular details and may guide targeted
biopsies for the detection of dysplasia during surveillance of patients with previously
non-dysplastic BE [100 ]
[101 ].
A. Pre-adoption requirement to start optical diagnosis training
ESGE suggests that endoscopists performing optical diagnosis in Barrett’s esophagus
(BE) patients should attend one of the following validated training courses for the
detection of Barrett’s neoplasia: (1) BORN training course for high definition white-light
endoscopy; or (2) Chedgy training course for chromoendoscopy using acetic acid.
Level of agreement 96 %.
BE patients undergo regular endoscopic surveillance to detect curable lesions that
are at high risk of developing into invasive esophageal adenocarcinoma. Detection
is needed before characterization can begin. Training courses to improve early neoplasia
detection are therefore an essential pre-adoption requirement for endoscopists optically
diagnosing BE patients.
The only fully validated training course available is the “Barrett’s Oesophagus-Related
Neoplasia” (BORN) training course [102 ]. The results of the validation study demonstrate that general endoscopists with
a wide range of experience and from different countries can substantially increase
detection and delineation skills for early lesions (between baseline and the end of
the trial, detection increased by 46 %, delineation increased by 129 %, agreement
delineation increased by 105 %, and relative delineation increased by 106 % [P < 0.01]). The condensed, final phase 2 BORN training module is now accredited for
Continuing Medical Education and is available at no cost from www.iwgco.net , www.ueg.eu, or www.best-academia.eu .
Chedgy et al. developed a validated training tool for acetic acid chromoendoscopy-assisted
lesion recognition in BE in 2018 [103 ]. The online training intervention significantly improved endoscopists’ sensitivity
to 95 % from 83 % at baseline and negative predictive value (NPV) to 94 % from 83 %
at baseline. Further improvement was seen after a 1-day interactive seminar including
live cases, with sensitivity increasing to 98 % and NPV to 97 %.
B. Training/learning steps for optical diagnosis
As a validated training course is not yet available for optical diagnosis in BE, ESGE
suggests attending an onsite training course using one of the following validated
classifications for characterization of Barrett’s epithelium: (1) BING or (2) BLINC
classifications for image-enhanced endoscopy (NBI, BLI); or (3) PREDICT classification
for chromoendoscopy using acetic acid.
Level of agreement 89 %.
In order to achieve competence in optical diagnosis of BE, ESGE suggests self-learning
by assessing at least 20 esophageal lesions prospectively in patients at high risk
of BE with histological feedback.
Level of agreement 93 %.
For BE surveillance with NBI magnification, three different optical diagnosis classifications
of mucosal and vascular pattern have been proposed: the Nottingham, Amsterdam, and
Kansas classifications [104 ]
[105 ]
[106 ]
[107 ]. These three classifications have not been universally adopted because of their
relative complexities and fair-to-moderate interobserver agreement.
More recently, the simpler Barrett’s International NBI group (BING) classification
for NBI with near-focus has been developed and validated by an international group
of experts for the prediction of dysplastic BE, with > 90 % accuracy and high interobserver
agreement [34 ]. The validated classification system known as PREDICT (Portsmouth acetic acid classification),
for the diagnosis of Barrett's neoplasia using acetic acid chromoendoscopy, demonstrates
improvements in the sensitivity and NPV from 79 % and 80 % to 98 % and 97 %, respectively
(P < 0.001) [36 ]. Regarding BLI, Bhandari’s group validated, in an image-based study, the BLINC classification
(BLI New Classification) for the characterization of neoplastic and non-neoplastic
BE, based on color, pits, and vessels [35 ]. When BLINC was used by 10 expert endoscopists, the overall sensitivity, specificity,
and accuracy of neoplasia identification were 96 %, 94.4 %, and 95.2 %, respectively.
Currently, no training courses are available to improve optical diagnosis in BE. As
no validated training course exists to improve optical diagnosis in BE, a “learner”
endoscopist should start to use optical diagnosis in vivo after following the BORN
and/or Chedgy training course for detection of BE and attending an onsite training
course with an expert in optical diagnosis of BE. Although this learning period can
take a long time, the expert committee suggests, based on personal experience, that
assessment of at least 20 esophageal lesions prospectively in patients at high risk
of BE is needed before competence should be assessed.
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
ESGE suggests an endoscopist is competent in performing optical diagnosis of BE after
attending a validated training course, which should include an in vivo phase, and
reaching the internationally endorsed competence criteria during real-time UGI endoscopies.
Level of agreement 89 %.
ESGE suggests competence in optical diagnosis of BE can be evaluated by meeting the
internationally endorsed competence criteria in 20 prospectively assessed esophageal
lesions in high risk BE patients.
Level of agreement 93 %.
The American Society of Gastrointestinal Endoscopy (ASGE) Technology Committee performed
a meta-analyses in which they established competence thresholds for surveillance of
patients with non-dysplastic BE: (1) sensitivity of ≥ 90 % and NPV of ≥ 98 % for detecting
high grade dysplasia or esophageal adenocarcinoma compared with the current standard
protocol (WLE and targeted and random 4-quadrant biopsies every 2 cm), and (2) specificity
of ≥ 80 % (compared with random biopsies) [101 ]
[108 ]. These PIVI thresholds can be used to assess competence. Their meta-analysis indicated
that targeted biopsies with acetic acid chromoendoscopy and virtual chromoendoscopy
using NBI met the thresholds set by the ASGE PIVI criteria. Most of the studies evaluated
in this meta-analysis were performed by experts in BE, which could be a potential
limitation of the results. The use of NBI for optical diagnosis in BE surveillance
was also supported by another meta-analysis with similar results: per-patient pooled
sensitivity and specificity of 91 % for detection of high grade dysplasia [109 ]. Regarding the dual focus system by Olympus, one study indicated an overall 86 %
reduction in the need for biopsies in high grade dysplasia [110 ].
The evidence for the use of acetic acid chromoendoscopy in the detection and characterization
of Barrett’s neoplasia is compelling. The large studies from the Portsmouth and Wiesbaden
groups demonstrated that experts are able to meet the ASGE PIVI criteria [111 ]
[112 ]. The new BLI technology seems to have additional value for visualization of Barrett’s
neoplasia but up to now there are not enough data to support this [113 ]
[114 ].
Studies assessing how many esophageal lesions an endoscopist has to assess in high
risk BE to evaluate optical diagnosis competence are lacking. Based on experience,
it is suggested competence can be evaluated by assessing optical diagnosis performance
in 20 prospectively detected esophageal lesions in high risk BE patients.
Maintaining competence in optical diagnosis
ESGE suggests competence in optical diagnosis of BE can be maintained by in vivo audit
and review of at least 20 esophageal lesions in BE patients within 1 year. If it is
not possible to perform optical diagnosis in BE on a regular basis, the learning and
competence phases should be repeated.
Level of agreement 89 %.
Optical diagnosis training for early gastric cancer
Optical diagnosis training for early gastric cancer
Gastric cancer is the one of the most common cancers with a significant mortality
rate [88 ]. Early detection is key to improving the survival of gastric cancer patients [115 ]. UGI endoscopy is considered the best diagnostic procedure for early detection of
gastric dysplasia and EGC. Advanced endoscopic imaging can improve mucosal visualization
and endoscopic diagnosis of gastric dysplasia and cancer [100 ]
[116 ]; however, these advanced imaging techniques require additional training [117 ].
A. Pre-adoption requirements to start optical diagnosis training
There are no additional requirements over and above the general pre-adoption requirements
to start optical diagnosis training for early gastric cancer (EGC).
B. Training/learning steps for optical diagnosis
ESGE suggests that endoscopists performing optical diagnosis in patients at high risk
of gastric dysplasia/EGC should attend a training course using one of the following
validated classifications: (1) the VS classification for virtual chromoendoscopy with
magnification; (2) the simplified NBI classification for high definition NBI endoscopy.
Level of agreement 85 %.
High definition chromoendoscopy improves the diagnosis of gastric precancerous conditions
and early neoplastic lesions [118 ]. Whenever available, and after proper training, virtual chromoendoscopy, with or
without magnification, should be used for the diagnosis of gastric precancerous conditions
by guiding biopsies to stage atrophic and metaplastic changes and to target neoplastic
lesions [118 ]
[119 ].
Irregular vascular and/or surface patterns with the presence of a demarcation line
are key criteria for the optical diagnosis of gastric neoplasia using virtual chromoendoscopy
combined with magnification [120 ]. The “vessel plus surface” (VS) classification system is based on the ability of
magnifying NBI or BLI to clearly visualize three categories of microvascular and microsurface
patterns: regular, irregular, and absent [47 ]
[48 ]. Moreover, pattern irregularity identified using high definition NBI without magnification
appears to be an accurate and reproducible feature for the diagnosis of gastric dysplasia
and early cancer [51 ]
[121 ]. A simplified NBI classification for high definition NBI endoscopy was created by
Pimentel-Nunes et al. [51 ].
As a validated training course is not yet available for optical diagnosis in gastric
dysplasia/EGC, ESGE suggests attending an online and onsite training course using
a validated classification of 1 week’s duration with an expert in optical diagnosis
of gastric dysplasia/EGC to achieve competence.
Level of agreement 93 %.
In order to achieve competence in optical diagnosis of gastric dysplasia/EGC, ESGE
suggests self-learning by assessing at least 20 gastric lesions prospectively in patients
at high risk gastric dysplasia/EGC with histological feedback.
Level of agreement 89 %.
In countries with a low prevalence of gastric cancer, endoscopists have limited opportunities
to acquire sufficient optical diagnosis experience, and therefore onsite and additional
online training is required. Currently no validated onsite training course based on
a validated classification is available.
Multiple online training courses have however been developed. Two image-based studies
demonstrated the efficacy of dedicated online training courses in improving practitioners’
abilities to distinguish between gastric cancer and non-cancer using magnifying NBI
with the validated VS classification [49 ]
[50 ]. Another study with high definition NBI videos showed a 10 % increase in global
accuracy after an online training course on a simplified NBI classification [52 ]. After 200 videos, sensitivity and specificity of 80 % and higher for intestinal
metaplasia were observed in half the participants, with a specificity for dysplasia
of greater than 95 %. Yao and colleagues developed an online training course to diagnose
gastric cancer at an early stage using high definition WLE [89 ]. The study reported a significant improvement in EGC diagnosis for 166 doctors trained
with the online course composed of video lectures about basic techniques and knowledge,
and self-exercise tests with high definition endoscopic images of 100 cases [122 ]. The training module is available at no cost from www.higan-npo.com/e-learning-endoscopy . A limitation of this large well-designed study is that the training was not based
on a validated optical diagnosis classification system.
Studies assessing how many UGI endoscopies an endoscopist has to assess with optical
diagnosis in patients at high risk for gastric dysplasia and cancer to achieve competence
are lacking. The curriculum committee suggests, based on personal experience, that
assessment of at least 20 gastric lesions prospectively in patients at high risk of
gastric dysplasia/EGC is needed before competence should be assessed
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
As a threshold is not available, ESGE suggests that an endoscopist is competent in
optically diagnosing gastric dysplasia/EGC after: (1) meeting the pre-adoption and
learning criteria; and (2) achieving ≥ 80 % accuracy in characterizing neoplasia in
10 gastric lesions in high risk gastric dysplasia/EGC patients.
Level of agreement 93 %.
No formal competence criteria for optical diagnosis in gastric dysplasia/cancer are
available; however, in line with other criteria for competence in optical diagnosis
where no evidence is available, an expert opinion has been given. The expert committee
of this optical diagnosis training curriculum suggests that an endoscopist is competent
in optical diagnosis of EGC after meeting the pre-adoption and learning criteria and
achieving ≥ 80 % accuracy in characterizing neoplasia in 10 gastric lesions in high
risk gastric dysplasia/cancer patients.
Maintaining competence in optical diagnosis
ESGE suggests competence in optical diagnosis of gastric dysplasia/EGC can be maintained
by in vivo audit and review of at least 10 gastric lesions in high risk gastric dysplasia/EGC
patients within 1 year. If it is not possible to perform optical diagnosis in high
risk gastric dysplasia/EGC patients on a regular basis, the learning and competence
phases should be repeated. Owing to the low prevalence of gastric dysplasia/EGC, ESGE
suggests completing additional online assessment modules with feedback to maintain
competence in optical diagnosis of gastric dysplasia/EGC.
Level of agreement 89 %.
Optical diagnosis training for diminutive colorectal lesions
Optical diagnosis training for diminutive colorectal lesions
Real-time optical diagnosis of diminutive (1 – 5 mm) colorectal lesions during endoscopy
could have important time and cost-saving potential [1 ]
[2 ]
[3 ]. This is the rationale for the “optical diagnosis strategy,” in which diminutive
polyps are resected and discarded without histopathological analysis, and non-neoplastic
lesions in the rectosigmoid are left in place without resection, as they have no malignant
potential.
As misdiagnosis of diminutive lesions can result in inappropriate surveillance intervals
and neoplastic lesions being left in situ, endoscopists have to be sufficiently competent
in performing optical diagnosis before implementing the optical diagnosis strategy.
The learning process for diminutive polyp optical diagnosis may be a key point in
achieving and maintaining a high performance level.
A. Pre-adoption requirements to start optical diagnosis training
There are no additional requirements over and above the general pre-adoption requirements
to start optical diagnosis training for diminutive colorectal lesions.
B. Training/learning steps for optical diagnosis
ESGE recommends that endoscopists performing optical diagnosis of diminutive colorectal
lesions should attend a validated training course using the externally validated NICE,
WASP, and BASIC classifications. Other classifications could be incorporated into
this recommendation provided that they have been fully validated.
Level of agreement 93 %.
Up to now, the NICE (NBI International Colorectal Endoscopic) classification, based
on color, vessel, and surface pattern, and the WASP (Workgroup on serrAted polypS
and Polyposis) classification, as an add-on for sessile serrated lesions, have been
fully validated for NBI in clinical practice [57 ]
[61 ]
[62 ]. Recently, the BASIC (BLI Adenoma Serrated International Classification) classification
for BLI was externally validated in clinical practice [53 ]
[54 ]. Other proposed classifications, such as ICE (i-scan classification for endoscopic
diagnosis using i-scan OE), SIMPLE (Simplified Identification Method for Polyp Labeling
during Endoscopy for i-scan OE and NBI), and CONECCT (COlorectal Neoplasia Endoscopic
Classification to Choose the Treatment), have not been fully validated [55 ]
[56 ]
[60 ].
In order to achieve competence in optical diagnosis of diminutive colorectal lesions,
ESGE suggests self-learning by assessing at least 120 diminutive colorectal lesions
prospectively with histological feedback.
Level of agreement 93 %.
It is difficult to find evidence to support a specific number of cases to achieve
competence. Studies evaluating the learning curve of endoscopists starting to use
optical diagnosis demonstrate that learning has a huge individual variability [5 ]
[9 ]. For instance, in the study of Ladabaum et al. [5 ], only 25 % of the students met the PIVI competence criteria, one after evaluating
50 polyps and two after 120 polyps. In this article, the authors mention that 250
polyps are needed to achieve competence. A Spanish study demonstrated that, following
a non-practice period of 6 months, a drop in performance parameters occurs, and that
it takes 150 lesions to get back to previous “expert” levels [92 ].
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
ESGE suggests an endoscopist is competent in performing optical diagnosis of diminutive
colorectal lesions after attending a validated training course on the WASP, NICE,
or BASIC classification, including an in vivo phase, and after reaching the internationally
endorsed competence levels during real-time colonoscopies.
Level of agreement 89 %.
For optical diagnosis of diminutive polyps, the only fully validated training course
with an in vivo assessment phase is the training based on the WASP classification
[61 ]. However, this course is not yet publicly available. Other training courses have
not yet been validated, are not based on a validated classification, or did not include
an in vivo assessment phase during training ([Table 3 ]).
ESGE suggests competence in optical diagnosis of diminutive colorectal lesions can
be evaluated by meeting the internationally endorsed competence levels in at least
60 prospectively collected diminutive colorectal lesions.
Level of agreement 93 %.
Currently, the PIVI criteria proposed by the ASGE are the standard benchmark to assess
the competence of endoscopists in differentiating diminutive colorectal lesions [90 ]
[91 ]. For diminutive polyps, ≥ 90 % agreement between surveillance intervals predicted
by optical diagnosis and histology should be achieved. In addition, ≥ 90 % NPV for
diminutive neoplastic lesions in the rectosigmoid should be achieved. A weakness of
the PIVI criteria on the agreement of surveillance intervals lies in the fact that
the assessment is based on the combination of optical diagnosis of diminutive polyps
and any larger polyps, if present. Therefore, mistakes in the optical diagnosis of
diminutive polyps can be blurred by the effect of larger polyps when recommending
the surveillance intervals. Moreover, concordance in surveillance intervals to some
extent depends on the guideline used to set the intervals. Therefore, alternative
benchmarking criteria should be developed [123 ]. In addition, the proportion of high confidence diagnoses should be recommended
as a benchmark because only a substantial high rate of high confidence diagnoses would
result in time and cost savings.
Maintaining competence in optical diagnosis
ESGE suggests competence in optical diagnosis of diminutive colorectal lesions can
be maintained by in vivo audit and review of at least 120 diminutive lesions within
1 year. If it is not possible to optically diagnose diminutive lesions on a regular
basis, the learning and competence phases should be repeated.
Level of agreement 85 %.
Optical diagnosis training for early colorectal cancer
Optical diagnosis training for early colorectal cancer
As the prevalence of early CRC increases, optimization of optical diagnosis of early
CRC is becoming more and more important to estimate the correct histology and choose
the appropriate resection technique, with the ultimate aim of avoiding under- and
overtreatment [124 ]
[125 ]
[126 ]
[127 ]
[128 ]. According to their clinical usefulness and current ability to predict histology,
the main outcomes in optical diagnosis of early CRC are:
early CRC with deep submucosal invasion (SM2, 3, or > 1 mm), because surgery is required
as the risk of lymph node metastasis is increased five-fold [129 ]
[130 ]
high grade neoplasia / superficial early CRC (SM1 or < 1 mm), because en bloc resection
would be preferable to confirm that invasion is confined to the shallow submucosa
or muscularis mucosae and to obtain free vertical and horizontal margins, and to accurately
assess the risk factors for lymph node metastasis when there is submucosal invasion
[131 ]
low grade neoplasia, because piecemeal EMR would be sufficient therapy.
A. Pre-adoption requirements to start optical diagnosis training
ESGE suggests that all endoscopists performing colonoscopy within bowel cancer screening
programs, as well as those resecting lesions ≥ 20 mm, should learn optical diagnosis
for early colorectal cancer (CRC).
Level of agreement 96 %.
The implementation of bowel cancer screening programs has resulted in a growing number
of diagnosed and early-treated (T1) CRCs worldwide [132 ]
[133 ]
[134 ]. Successful treatment of these colorectal lesions starts with the prediction of
submucosal or deep submucosal invasion. A recent study performed in the Dutch national
bowel cancer screening program showed that endoscopists optically diagnosed submucosal
invasion in only 39 % of 92 cases (95 % confidence interval [CI] 30 % – 49 %) [128 ]. This limited accuracy for optical diagnosis of early CRC resulted in adjuvant surgical
treatment in 11 % of patients with lesions with submucosal invasion that were endoscopically
correctly diagnosed and resected locally, compared with 41 % of lesions with submucosal
invasion that were endoscopically not recognized as cancer (P = 0.02). In another real-time Dutch study, which only included ≥ 20-mm non-pedunculated
lesions, a much higher sensitivity for optical diagnosis was reported, namely 79 %
(95 %CI 64 % – 89 %) [124 ]. However, the positive predictive value (PPV) in this study was rather low at 69 %
(95 %CI 57 % – 78 %), which might have resulted in unnecessary surgery. Hence, we
can conclude that incorrect optical diagnosis when predicting submucosal and deep
submucosal invasion results in suboptimal use of endoscopic and surgical treatment
options [124 ]
[125 ]
[126 ]
[127 ]
[128 ].
Endoscopists performing colonoscopies on patients at high risk for early CRC (i. e.
screening colonoscopy after fecal immunochemical test [FIT] or for the assessment
of advanced therapeutic endoscopy techniques in large (≥ 20 mm) colorectal lesions)
should therefore learn optical diagnosis for early CRC:
to safely perform piecemeal EMR in lesions with low grade neoplasia and low risk of
submucosal invasion
to safely refer the patient to surgery because deep submucosal invasion is predicted
to be able to recognize polyps with uncertain diagnosis (which might be early CRC)
in order to perform a diagnostic and possibly therapeutic en bloc resection if feasible,
tattoo the site, and take special care of the specimen (preserve integrity and send
it to the pathologist well-orientated) and, if an en bloc resection is not feasible
(i. e. by EMR), to refer the patient for additional assessment by an experienced endoscopist
to evaluate the mucosal pattern in detail (i. e. with magnification), to perform an
advanced endoscopic en bloc resection (i. e. endoscopic full-thickness resection [eFTR],
ESD), or to safely refer the patient to surgery
to be able to perform en bloc EMR instead of cold snare polypectomy to preserve the
muscularis mucosae in small polyps with suspicion of high grade neoplasia or shallow
submucosal invasion
to visualize and identify remnant polyp tissue that could have been left after EMR/piecemeal
resection
to know when to bring the patient back for surveillance.
B. Training/learning steps for optical diagnosis
ESGE suggests that endoscopists performing optical diagnosis on patients at high risk
of early CRC should attend a validated training course using one of the following
validated classifications: the NICE classification when no magnification is used;
the JNET, Sano, Hiroshima, or Kudo classifications when magnification is used.
Level of agreement 92 %.
Two recent meta-analyses were performed to find out which characteristics are associated
with the presence of early CRC and the prediction of deep submucosal invasion [135 ]
[136 ]. The sensitivity of the optical assessment improved particularly with the use of
advanced imaging techniques such as chromoendoscopy or NBI. These techniques should
therefore be an important part of the assessment of a polyp for the presence of early
CRC. Nevertheless, morphological characteristics can make the endoscopist aware of
an increased risk of malignancy and indicate how to investigate a polyp. Many optical
diagnosis classification systems with different advanced imaging techniques have been
developed to predict the risk of early CRC ([Table 3 ] and [Table 4 ]). Currently, there is insufficient evidence to express a preference for one specific
classification.
Table 4
Most likely pathology for predicting early colorectal cancer and for the prediction
of deep submucosal invasion in non-pedunculated polyps according to different classifications
systems.
Classification system
Hyperplastic polyp/sessile serrated lesion
Low grade adenoma
High grade adenoma
Superficial submucosal invasion
Deep submucosal invasion
NICE [57 ]
[62 ]
Type 1
Type 2
Type 2
Type2
Type 3
JNET [72 ]
[73 ]
[74 ]
[75 ]
[76 ]
Type 1
Type 2A
Type 2B
Type 2B
Type 3
Sano [65 ]
I
II
IIIA
IIIA
IIIB
Hiroshima [69 ]
[70 ]
A
B
C1
C1/C2
C2/C3
Kudo [63 ]
I/II
IIIL / IIIS / IV
Vi
Vi
VN /Vi + demarcated area
NICE, NBI International Colorectal Endoscopic; JNET, Japan NBI Expert Team; IIIL , III large tubular or roundish pits; IIIS , III small tubular or roundish pits; Vi, irregular arrangement and sizes of IIIL / IIIS / IV; VN , loss or decrease of pits with an amorphous structure.
Recently, Puig et al. [85 ] developed an easy decision rule to choose the most appropriate treatment when NBI
without magnification is used: endoscopic treatment; refer for surgery; or refer for
an accurate optical diagnosis with magnifying endoscopy or advanced procedure (i. e.
ESD, eFTR) at an expert center. Based on this study, optical diagnosis using the validated
NICE classification is useful firstly to rule out deep submucosal invasion in NICE
type 1 and 2 lesions without nodules or depressed areas (NPV 99 %), and secondly to
predict deep submucosal invasion when a non-pedunculated lesion (NICE type 3) is ulcerated
(PPV 93 %) [85 ]. If an endoscopist detects a non-pedunculated NICE type 3 lesion without ulceration
or a NICE type 1 or 2 lesion with depressed areas or nodular-mixed type, the lesion
should be assessed with magnifying virtual chromoendoscopy using the JNET, the Sano,
or Hiroshima classification to perform an accurate optical diagnosis [63 ]
[65 ]
[69 ]
[70 ]
[71 ]
[72 ]
[73 ]
[135 ]
[136 ]
[137 ]
[138 ]
[139 ], because the prevalence of deep submucosal invasion is 44 %, 10 %, and 9 %, respectively.
Recent studies have suggested that the Kudo pit pattern with crystal violet should
be assessed in JNET 2B (Sano IIIA) lesions, as they have been shown to include lesions
with deep submucosal invasion too [74 ]
[75 ]
[76 ]
[140 ]
[141 ]
[142 ]
[143 ]. Finally, optical diagnosis for the prediction of deep submucosal invasion in pedunculated
polyps is not useful and endoscopic treatment should be the first option [85 ]
[144 ].
Two models for predicting deep submucosal invasion can help endoscopists in the endoscopic
assessment of invasive carcinoma [124 ]
[145 ]. Based on these models, a select subgroup can be identified with an increased risk
of invasive carcinoma. It is advised that endoscopists be aware of these prediction
models. Although not validated in the model, the Hiroshima classification may be replaced
by the JNET or the Sano classification.
As a validated training course is not yet available for optical diagnosis in early
CRC (other than NICE), ESGE suggests attending an onsite training course using a validated
classification of 1 week’s duration with an expert in optical diagnosis of large (≥ 20 mm)
colorectal lesions to achieve competence.
Level of agreement 89 %.
In order to achieve competence in optical diagnosis of early CRC, ESGE suggests self-learning
by assessing at least 20 large (≥ 20 mm) colorectal lesions prospectively with histological
feedback.
Level of agreement 96 %.
Unfortunately, dedicated and validated training courses on this subject are lacking.
Published literature is scarce regarding the content of training on optical diagnosis
of early CRC. A recent study showed that an easy-learning course of 20 minutes, using
slides with examples, was enough to obtain high diagnostic accuracy values (area under
the curve [AUC] 0.91, 95 %CI 0.89 – 0.92) in an image-based test with selected pictures,
and to increase the number of lesions assessed with high confidence (70.9 % vs. 81.4 %,
P < 0.001) [85 ]. However, the accuracy of the same endoscopists was much lower in real life (AUC
0.77, 95 %CI 0.72 – 0.83). Therefore, a real-time phase should be included in any
training course.
As no validated training course exists, a “learner” endoscopist should start to use
optical diagnosis in vivo after acquiring suitable knowledge from the literature (published
papers and available atlas) and attending an onsite training course with an expert
in optical diagnosis of large (≥ 20 mm) colorectal lesions [146 ]. Self-learning with feedback from histology and occasionally from the optical diagnosis
expert (sending videos or pictures) will help to achieve competency. Although this
period can take a long time (6 – 12 months), based on personal experience, the expert
committee believes that the assessment of at least 20 large colorectal lesions prospectively
is needed to learn optical diagnosis of early CRC.
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
As a threshold is not available, ESGE suggests that an endoscopist is competent in
optical diagnosis of early CRC after: (1) meeting the pre-adoption and learning criteria;
and (2) achieving ≥ 80 % accuracy for identifying submucosal invasion in 20 large
(≥ 20 mm) colorectal lesions.
Level of agreement 85 %.
No specific requirement for accuracy threshold in clinical practice to assess optical
diagnosis competence for early CRC is available. When defining a competence level
for optical diagnosis of early CRC, it should be taken into consideration that incorrect
optical diagnosis in lesions < 20 mm can lead to an unnecessary en bloc EMR and/or
not placing a tattoo. However, incorrect optical diagnosis in lesions ≥ 20 mm can
lead to inconclusive histology because piecemeal EMR is performed, an unnecessary
ESD being performed when only low grade neoplasia is subsequently identified, or unnecessary
surgery when the lesion is in fact benign. Although no evidence is available, the
expert committee of this optical diagnosis training curriculum suggests that an endoscopist
is competent in optically diagnosing early CRC after achieving ≥ 80 % accuracy in
identifying submucosal invasion in 20 large colorectal lesions.
Maintaining competence in optical diagnosis
ESGE suggests competence in optical diagnosis to predict early CRC can be maintained
by in vivo audit and review of at least 10 large (≥ 20 mm) colorectal lesions within
1 year. If it is not possible to perform optical diagnosis in large colorectal lesions
on a regular basis, the learning and competence phases should be repeated. Owing to
the low prevalence of early CRC, ESGE suggests completing additional online assessment
modules with feedback to maintain competence in optical diagnosis of early CRC.
Level of agreement 89 %.
Optical diagnosis training for inflammatory bowel disease
Optical diagnosis training for inflammatory bowel disease
Patients with IBD have an increased risk of developing colitis-associated cancer,
which has been reported to be as high as 18 % after 30 years of disease [147 ]
[148 ]. Surveillance colonoscopy with (virtual) chromoendoscopy is recommended in order
to detect and treat the precursor lesions of cancer [149 ]
[150 ]
[151 ]
[152 ], because random biopsies are not effective for the detection of neoplasia [150 ]
[153 ]. Recommendations for training are lacking however.
A. Pre-adoption requirements to start optical diagnosis training
There are no additional requirements over and above the general pre-adoption requirements
to start optical diagnosis training for neoplasia recognition in IBD (dye-based chromoendoscopy).
B. Training/learning steps for optical diagnosis
As a validated training course is not yet available for optical diagnosis of neoplasia
in inflammatory bowel disease (IBD), ESGE suggests attending an onsite training course
of 1 week’s duration with an expert in optical diagnosis of IBD to achieve competence.
Level of agreement 85 %.
There is strong evidence that the use of dye-based chromoendoscopy for surveillance
in IBD increases dysplasia detection [149 ]
[150 ]
[152 ]. The interpretation of chromoendoscopy findings in IBD is often challenging, resulting
in prolonged procedure times and redundant biopsies. Accordingly, every endoscopist
performing dye-based chromoendoscopy in IBD should undergo a dedicated training course
to acquire the skills necessary for optical diagnosis of IBD-related lesions. Specific
knowledge of the principles of both lesion detection and delineation should ideally
be acquired under supervision by an expert in optical diagnosis of IBD, supported
by atlases, videos, and web-based learning [154 ]
[155 ]
[156 ].
No optical diagnosis classification for IBD neoplasia has been fully validated. The
classification commonly used to characterize visible lesions in IBD is the Kudo’s
classification [63 ]. Recent meta-analyses have suggested specific features (Kudo pit pattern type I
or II, chromoendoscopy, or NBI) can be effective in enhancing the negative predictive
value to 88 % – 94 % [157 ]
[158 ]. Subsequent data using high definition dye-based chromoendoscopy and endoscopic
trimodal imaging support this [159 ]
[160 ]. An older study suggested a honeycomb-like or villous pattern was very unlikely
to harbor dysplasia [161 ]. FICE using Kudo pit pattern also has acceptable diagnostic performance; however,
it should be noted that Kudo pit pattern was not designed for use in IBD [162 ].
In 2019, the multimodal Frankfurt Advanced Chromoendoscopic IBD Lesions (FACILE) classification,
based on visual characteristics, was proposed to identify colitis-associated neoplasia
[77 ]. The results of multivariate analyses showed that the most relevant criteria for
predicting dysplasia were flat (or non-polypoid) lesions, irregular surface and vessels,
and signs of inflammation (AUC 0.76, 95 %CI 0.73 – 0.78). The classification was validated
by assessing the diagnostic performance of experts and non-experts after completing
an image-based training module. This classification deserves to be validated in vivo.
In order to achieve competence in optically diagnosing neoplasia in IBD, ESGE suggests
self-learning by performing at least 20 pan-chromoendoscopy procedures in IBD surveillance
patients with at least 20 targeted biopsies with histological feedback. During this
phase, we suggest a back-up of four quadrant random biopsies every 10 cm whilst the
learning curve is surmounted and performance is confirmed.
Level of agreement 92 %.
ESGE suggests that the transition from dye-based chromoendoscopy to virtual chromoendoscopy
in IBD patients should be executed gradually.
Level of agreement 88 %.
Endoscopists performing optical diagnosis on IBD patients should be able and competent
to perform colonoscopy with dye-based or virtual chromoendoscopy with targeted biopsies
for neoplasia as this is regarded as the standard of care for neoplasia surveillance
in IBD, following the recent update of the ESGE advanced imaging guideline [33 ]. Although the evidence on advanced imaging in the detection of colitis-associated
neoplasia is sometimes contradictory, the additional value of dye-based chromoendoscopy
seems acceptable [151 ]
[152 ]. Recent evidence with high definition endoscopes shows that virtual chromoendoscopy
may be equivalent [163 ]
[164 ].
Studies assessing how many IBD pan-chromoendoscopy or virtual chromoendoscopy procedures
an endoscopist has to perform to achieve optical diagnosis competence are lacking.
Based on experience and expert opinion, we suggest the progression of IBD chromoendoscopy
training should be:
a dye-based chromoendoscopy training course of 1 week’s duration with an expert in
optical diagnosis
use of dye-based chromoendoscopy in at least 20 IBD surveillance patients with at
least 20 biopsies targeted at suspicious lesions and normal-appearing mucosa with
histological feedback; during this phase, we suggest a back-up of four quadrant random
biopsies every 10 cm whilst the learning curve is surmounted and performance is confirmed
use of dye-based chromoendoscopy with targeted biopsies only, with histological feedback
in 20 cases; random four quadrant biopsies can be abandoned
use of virtual chromoendoscopy in at least 20 IBD surveillance patients with at least
20 biopsies targeted at suspicious lesions and normal-appearing mucosa with histological
feedback; during this phase, we suggest a back-up of four quadrant random biopsies
every 10 cm whilst the learning curve is surmounted and performance is confirmed
use of virtual chromoendoscopy with targeted biopsies only with histological feedback
in 20 cases; random four quadrant biopsies can be abandoned.
C. Assessment criteria for optical diagnosis proficiency
Being competent in optical diagnosis
As a threshold is not available, ESGE suggests that an endoscopist is competent in
optically diagnosing neoplasia in IBD after: (1) meeting the pre-adoption and learning
criteria; and (2) achieving a neoplasia detection rate of ≥ 10 % in 20 IBD pan-chromoendoscopy
colonoscopies with targeted biopsies only.
Level of agreement 80 %.
No formal competence criteria for optical diagnosis of IBD dysplasia are available
but, in line with other criteria for competence in optical diagnosis where few data
are available, a combination of training and assessment was recommended by the expert
committee. As neoplasia is found in < 15 % of IBD cases using dye-spray in the community,
the expert committee of this optical diagnosis training curriculum suggests a neoplasia
detection rate of ≥ 10 % in at least 20 pan-chromoendoscopy colonoscopies with targeted
biopsies only should be achieved [158 ].
Maintaining competence in optical diagnosis
ESGE suggests competence in optically diagnosing neoplasia in IBD can be maintained
by in vivo audit and review of at least 10 IBD endoscopic lesions within 1 year. If
it is not possible to perform optical diagnosis in IBD on a regular basis, the learning
and competence phases should be repeated.
Level of agreement 89 %.
Conclusions
This ESGE Position Statement comprehensively addresses the major steps of optical
diagnosis training. Optical diagnosis needs specific meticulous skills and dedicated
training to achieve and maintain proficiency. The ability to perform a correct optical
diagnosis allows us to provide optimal treatment for our patients.
The diverse topics covered in this curriculum include: the pre-adoption requirements
prior to starting optical diagnosis training; the basic endoscopy skills, and the
basic skills with advanced imaging techniques; the training/learning steps to achieve
optical diagnosis competency; attendance at a validated optical diagnosis training
course; and self-learning with a minimum number of lesions/cases with histopathology
as the reference. As learning curves may be different from one trainee to another,
this ESGE curriculum states assessment criteria to evaluate optical diagnosis proficiency;
endoscopists are competent in optical diagnosis after meeting the pre-adoption and
training/learning steps, and after meeting competence thresholds by assessing a minimum
number of prospectively collected lesions during real-time endoscopy; endoscopists
can maintain competency by ongoing practice with a minimum number of lesions/cases
([Table 1 ] and [Table 2 ]).
Throughout this ESGE curriculum, areas without evidence are highlighted, providing
future research opportunities. We look forward to incorporating the results of these
future studies into updates of this curriculum in the years to come.
Disclaimer
ESGE Position Statements represent a consensus of best practice based on the available
evidence at the time of preparation. This is NOT a guideline but a proposal for training
in optical diagnosis. The statements may 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. This ESGE Position Statement
is intended to be an educational device to provide information that may assist endoscopists
in providing care to patients. The recommendations 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. The legal disclaimer for ESGE
guidelines applies to the present position statement [10 ].
Curriculum for optical diagnosis training in Europe: European Society of Gastrointestinal
Endoscopy (ESGE) Position Statement
Dekker E, Houwen BBSL, Puig I et al. Endoscopy 2020, 52: 899–923. In the above-mentioned article, one sentence on page 912 (Optical diagnosis training
for early gastric cancer, Part B) has been corrected. Correct is: The curriculum committee
suggests, based on personal experience, that assessment of at least 20 gastric lesions
prospectively in patients at high risk of gastric dysplasia/EGC is needed before competence
should be assessed.
This was corrected in the online version on September 23, 2020.