Performance measures for upper gastrointestinal endoscopy
The Working Group agreed on 15 performance measures in total, after three rounds of
Delphi voting ([Fig. 1 ]). These were divided into eleven key and four minor performance measures, based
on their applicability and the magnitude of their impact on patient outcomes, although
all are relevant for quality improvement. In [Table 1 ], the current performance measures are displayed alongside the previous ones, for
comparison and easier detection of updates.
Fig. 1 Domains and performance measures for upper gastrointestinal endoscopy. MAPS, management of precancerous conditions and lesions in the stomach; SCC, squamous
cell carcinoma.
Table 1
Description of the performance measures in the current and previous position statements.
Current proposals
Previous proposals
Key performance measures
Appropriate indication
–
Fasting instructions received
Fasting instructions prior to UGI endoscopy
Visibility score recorded
–
Accurate photodocumentation
Accurate photodocumentation of anatomical landmarks and abnormal findings
Examination time ≥ 7 minutes
Documentation of procedure duration
Standardized terminology used
Accurate application of standardized disease-related terminology
Seattle protocol used for BE
Application of Seattle protocol in Barrett’s surveillance
MAPS protocol used for gastric precancerous assessment
Application of validated biopsy protocol to detect gastric intestinal metaplasia (MAPS
guidelines) (minor)
Complications recorded after therapeutic procedures
Accurate registration of complications after therapeutic UGI endoscopy
BE surveillance according to guidelines
Prospective registration of Barrett’s patients (minor)
Gastric precancerous conditions surveillance according to guidelines
–
Minor performance measures
Time slot of ≥ 20 minutes allocated for upper gastrointestinal endoscopy
–
Observation time of ≥ 1 minute/cm and chromoendoscopy in BE inspection
Minimum 1-minute inspection time per cm circumferential Barrett’s epithelium
Chromoendoscopy in patients at risk for squamous cell carcinoma
Use of Lugol chromoendoscopy in patients with a curatively treated ENT or lung cancer
to exclude a second primary esophageal cancer
Patientsʼ experiences measured
–
–
Minimum 7-minute procedure time for first diagnostic UGI endoscopy and follow-up of
gastric intestinal metaplasia
BE, Barrett’s esophagus; ENT, ear, nose, and throat; MAPS, management of precancerous
conditions and lesions in the stomach; UGI, upper gastrointestinal.
The evidence quality, as graded according to the Grading of Recommendations Assessment,
Development and Evaluation (GRADE) criteria, continues to be low in general, similarly
to our findings in the previous 2016 publication [1 ]
[2 ]. However, we continue to think that these performance measures are feasible to implement
and might impact on patients’ clinical outcomes and satisfaction. Endoscopy departments
with limited access to electronic software and dependent on manual monitoring might
prefer initially to take a limited approach to the key performance measures, until
a quality culture is implemented and automatic tools become available [3 ].
The PICO queries that were used during the modified Delphi process to develop the
performance measures can be found in Appendix 1 s , see online-only Supplementary material.
1 Domain: Pre-procedure
Key performance measure
Indications
Description
The upper gastrointestinal (UGI) endoscopy report should include an explicit appropriate
indication for the procedure
Domain
Pre-procedure
Category
Process
Rationale
UGI endoscopies with an appropriate indication are safer and associated with higher
diagnostic yield for relevant lesions than UGI endoscopies without an appropriate
indication, so preventing unnecessary discomfort and harm
Construct
Denominator : All UGI endoscopies
Numerator : UGI endoscopies with an explicit appropriate indication
Exclusions : None
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 100 %
Second round: 100 %
PICO number
1
Evidence grading
Very low quality
The acceptance of this performance measure is based on agreement with the following
statement:
UGI endoscopy is the gold-standard diagnostic examination for UGI diseases involving
the esophagus, the stomach, and the proximal duodenum, allowing a direct and excellent
view of the mucosal surfaces. It is a minimally invasive procedure, with very rare
complications in purely diagnostic situations, that is tolerated by many patients
without any sedation, and allows endoscopic diagnosis of most diseases, complemented
if necessary with the performance of biopsies for pathological diagnosis. Its correct
use as a diagnostic or screening examination is dependent on its performance on patients
with a proper indication based on broad clinical consensus, higher diagnostic yields
of clinically relevant findings, decades of procedures performed worldwide, and the
balance between benefits and harms for the patient [4 ]
[5 ]
[6 ]
[7 ]
[8 ]
[9 ]
[10 ]
[11 ]
[12 ]
[13 ]
[14 ]
[15 ].
Overuse of UGI endoscopy seems however to be emerging, and up to 58 % of examinations
may now be performed for inappropriate indications [16 ]. The performance of a UGI endoscopy without a proper indication exposes patients
to potential unnecessary risks and adverse events (AEs), with subsequent patient and
endoscopist dissatisfaction. In addition, it causes a significant overload on endoscopy
departments, resulting in inefficiency at work, longer waiting times, and delayed
diagnosis for correct procedures, greater and faster wear of the endoscopic equipment,
and increased costs and footprint of the endoscopic activity [9 ]
[17 ]. As such, if a procedure is performed for a reason outside of a consensus list of
indications, a clear justification for the procedure should be documented.
UGI endoscopy as a screening procedure may be appropriate for selected populations.
Screening of gastric cancer and/or gastric precancerous conditions may be appropriate
in high risk regions every 2–3 years, or every 5 years in intermediate risk regions,
if cost-effectiveness has been proven [11 ]. Barrett’s esophagus (BE) screening might be appropriate in selected populations,
such as patients aged ≥ 50 years with symptoms of chronic gastroesophageal reflux
disease and at least one of the following: white ethnicity, male sex, obesity, smoking,
or a first-degree relative with BE or esophageal adenocarcinoma [5 ]. Esophageal cancer screening may be appropriate in selected patients with previous
head and neck squamous cell carcinoma (SCC) that has been curably treated, based on
risk and life-expectancy [18 ].
Beyond endoscopic diagnostic exploration, therapy has emerged as a relevant part of
the UGI endoscopic activity. If necessary, UGI endoscopic therapy should in most cases
achieve hemostasis or resection of lesions, allow luminal patency or enteral feeding,
and resolve complications [6 ]
[8 ]
[9 ]
[15 ]
[19 ]
[20 ]
[21 ]
[22 ]
[23 ]
[24 ]
[25 ]. Finally, preoperative UGI endoscopy can identify anatomical modifications, asymptomatic
pathologies, and precancerous conditions, which might be relevant to detect before
scheduling a UGI surgery. [Table 2 ] shows the indications for UGI endoscopy based on broad clinical consensus.
Table 2
Indications for upper gastrointestinal (UGI) endoscopy.
Indication
References
Diagnostic indications
Upper abdominal symptoms that persist despite an appropriate therapy (persistent gastroesophageal
reflux, odynophagia, or dyspepsia unresponsive to 6 weeks treatment in primary care)
[10 ]
[12 ]
Upper abdominal symptoms associated with other symptoms or signs suggesting structural
disease (e. g. anorexia, dysphagia, or weight loss) or new-onset symptoms in patients
> 50 years of age
[10 ]
Persistent vomiting or recurrent nausea of unknown origin
[10 ]
Gastrointestinal bleeding (active or recent) as suspected chronic blood loss, or iron
deficiency anemia if the clinical situation suggests a UGI source of bleeding or colonoscopy
is negative
[8 ]
[10 ]
Diseases in which the presence of UGI involvement or pathology might modify the management
(e. g. ulcer or UGI bleeding in patients scheduled for organ transplantation, anticoagulation
or nonsteroidal anti-inflammatory drug therapy for arthritis, head and neck cancer,
Crohn’s disease)
[10 ]
Need for biopsy and/or fluid sampling (diagnosis/surveillance of eosinophilic esophagitis,
BE, esophageal or gastric ulcers, esophageal or gastric early neoplasia, staging of
gastritis, celiac disease, Crohn’s disease, other enteropathies)
[5 ]
[7 ]
[10 ]
[13 ]
Suspected portal hypertension to document or treat esophageal varices and/or congestive
gastropathy
[6 ]
[10 ]
Definition of acute and chronic caustic injury
[10 ]
[14 ]
Evaluation prior to bariatric treatment
[10 ]
[15 ]
Surveillance in subjects with precancerous conditions (BE, chronic atrophic gastritis
with intestinal metaplasia with/without dysplasia, polyposis syndromes, gastric adenomas,
tylosis, previous caustic ingestion, family history of gastric carcinoma, high risk
populations)
[5 ]
[10 ]
[11 ]
Screening for gastric cancer or gastric precancerous conditions, BE, or esophageal
cancer, in selected populations
[5 ]
[11 ]
[18 ]
Familial adenomatous polyposis syndromes and other genetic syndromes with UGI tract
involvement
[10 ]
Radiologically abnormal or suspicious findings requiring confirmation and specific
histological diagnosis (suspected neoplastic lesion, gastric or esophageal ulcer,
stricture, or obstruction), or selected cases of metastatic carcinoma of unknown origin
[10 ]
Intraoperative assessment (evaluation of anastomotic leak and patency, fundoplication
formation, pouch configuration)
[10 ]
Therapeutic indications
Resection of early neoplastic lesions
[4 ]
[10 ]
[19 ]
[20 ]
Coagulation (heater probe, argon plasma, laser), banding, or injection therapy for
bleeding lesions (ulcers, tumors, vascular abnormalities, varices)
[4 ]
[6 ]
[8 ]
[10 ]
Removal of foreign bodies
[10 ]
[25 ]
Placement of feeding or drainage tubes (percutaneous endoscopic gastrostomy or jejunostomy,
nasogastric tube)
[10 ]
[22 ]
Dilation or stenting of benign/malignant stenosis (transendoscopic balloon dilation,
over-the-wire or through-the-scope stenting, coagulation, incision)
[10 ]
[21 ]
Treatment of Zenker’s diverticulum, achalasia, or gastroparesis
[9 ]
[10 ]
Management of complications after diagnostic or therapeutic endoscopy or UGI surgery
[10 ]
[23 ]
BE, Barrett’s esophagus.
In conclusion, performing a UGI endoscopy with an appropriate indication is the first
and main step to obtaining the best result from the procedure, fulfilling both the
patient’s and doctor’s expectations, and minimizing unintended risks or harms.
Key performance measure
Fasting instructions
Description
Percentage of patients receiving proper instructions for fasting prior to UGI endoscopy
Domain
Pre-procedure
Category
Process
Rationale
Patient safety and comfort, and UGI endoscopy diagnostic efficacy depend on adequate
UGI tract visibility without luminal content, to achieve adequate visibility, allow
inspection of the whole mucosa, reduce the risk of missed lesions or aspiration, and
improve patientsʼ comfort
Construct
Denominator : All diagnostic UGI endoscopies (note: patients whose UGI endoscopies are postponed
because of lack of proper instructions should also be included in the calculation
of the denominator)
Numerator : Procedures in the denominator for which patients received proper instructions for
fasting (≥ 2 hours for liquids and ≥ 6 hours for solids)
Exclusions : Emergency procedures
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 96.6 %
Second round: 96.0 %
PICO number
2
Evidence grading
Low quality
A previous single statement did not reach consensus (agreement: 70.3 %). The acceptance
of this performance measure is based on agreement with the following updated statement:
Adequate preparation for a UGI endoscopy is fundamental in terms of safety but also
regarding adequate visibility for detection of lesions. Usually, safety depends on
the absence of relevant fluids or solids that can reflux and cause aspiration, while
adequate visibility is more demanding, requiring perfect mucosal visibility to allow
adequate detection of lesions.
Regarding safety, no new evidence regarding fasting for solids or liquids for the
general population was published in recent years, and the recommendation for fasting
remains the same as in the previous publication, with a recommended fasting time for
liquids of ≥ 2 hours and for solids of ≥ 6 hours [1 ]. These fasting intervals reportedly allow good gastric mucosal visibility, no aspiration,
and lower discomfort scores compared with longer fasting intervals [1 ].
Some concerns are emerging regarding patients prescribed glucagon-like peptide-1 receptor
agonists, owing to delayed gastric emptying, but randomized trials with diagnostic
accuracy and safety as major outcomes are lacking [26 ]. A new proposal for a 4-hour fasting period for semifluids was addressed in a single
trial, but the message for patients regarding the difference between solids, semifluids,
and liquids may not be clear. Also, the procedures were performed with the patients
unsedated, and anesthesiologists’ agreement has not been given for its widespread
clinical applicability [27 ].
Minor performance measure
Time slot for upper gastrointestinal endoscopy
Description
The time slot allocated for a diagnostic UGI endoscopy
Domain
Pre-procedure
Category
Process
Rationale
Any diagnostic UGI endoscopy needs an adequate time allocated for the entire procedure,
including discussion with the patient, sedation if applicable, performance of the
endoscopic procedure, writing of the endoscopy report and pathology request if applicable,
and preparation of the room for the next patient
Time pressure due to inadequate/shorter time slots may impair the quality of the endoscopic
procedure
Construct
Denominator : All diagnostic UGI endoscopies
Numerator : Diagnostic UGI endoscopies scheduled with a minimum time slot of 20 minutes
Exclusions : Therapeutic procedures, emergency procedures, procedures with a specific diagnostic
purpose without the need for a full evaluation
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 82.1 %
Second round: 96.0 %
PICO number
3
Evidence grading
Very low quality
The acceptance of this performance measure is based on agreement with the following
statement:
The time slot allocated to perform a diagnostic UGI endoscopy should be enough to
comply with all quality performance measures, without any rush, considering the time
from the patient entering the endoscopy room until the time for the next patient to
enter the same room. This “endoscopy room time” needs to take into account the discussion
with the patient regarding informed consent and clarification of any last minute doubt,
the sedation induction (including pre-sedation checklist) if applicable, the endoscopic
examination time itself, the performance of biopsies if applicable, the writing of
the endoscopy report and pathology request if applicable, the explanation of results
to the patient, and the cleaning of the endoscopy room, until available for the next
patient.
There is a general paucity of literature regarding the accounting of this “endoscopy
room time,” even for general diagnostic procedures. There are some studies reporting
on the examination time (see further information under “Examination time” in Domain
3: Identification of pathology) and recovery time (usually done in a recovery room
and not in the endoscopy room), but these are not the “endoscopy room time,” which
is the relevant time for the definition of an adequate allocated time slot.
A few Societies have proposed an allocated time slot for a diagnostic UGI endoscopy,
mainly based on the time proposed for the performance of the endoscopic procedures
themselves, plus some more minutes to accommodate all the other issues mentioned regarding
the pre-procedure and post-procedure phases.
The British recommendation, in 2017, suggested a minimum of 20 minutes be allocated
for a standard diagnostic UGI endoscopy, increasing as appropriate for surveillance
of high risk conditions [28 ]. The Spanish recommendation, in 2020, in the context of the resumption of endoscopic
activity after the peak phase of the COVID-19 pandemic, proposed 30 minutes when scheduling
a diagnostic UGI endoscopy, assuming that the disinfection/preparation of the endoscopy
rooms was much longer than before the pandemic [29 ]. The Italian recommendation, in 2022, proposed a total time of 30 minutes per diagnostic
UGI endoscopy, divided into a fixed time of 20 minutes, and an additional time of
10 minutes in case biopsies needed to be performed [30 ]. Other Societies recommend a minimum procedure time for performing a diagnostic
UGI endoscopy, or just report that a longer inspection improves detection of lesions,
but without any proposal regarding an allocated time slot [10 ]
[31 ]
[32 ]
[33 ].
The group debated about the time needed to perform all the proposed quality performance
measures in the present manuscript and concluded that, for most cases in daily life,
an allocated time slot of 20 minutes would be enough for a diagnostic UGI endoscopy.
This allocated time slot should be feasible in general (balancing quality performance
standards without increasing waiting lists), is intended for routine diagnostic procedures
(not certain specific surveillance or therapeutic UGI endoscopies), and seems adequate
compared with the proposed minimum of 30 minutes for a routine colonoscopy (also including
all the issues before, during, and after procedures, including therapy) [34 ].
The minimum 20-minute time slot would allow for 7–10 minutes for the UGI endoscopy
procedure itself, and 10–13 minutes to perform all of the other issues that surround
an endoscopic examination, and should be feasible, especially if the endoscopy service
adheres to several practices to facilitate the patient pathway through the endoscopy
service from attendance to departure, namely speeding up administrative issues like
admittance, and informed consent/safety checklist verification, having an adequately
staffed preparation/recovery room with dedicated personnel for patientsʼ reception,
preparation, and intravenous cannulation for those requiring sedation, use of endoscopy
reporting systems that facilitate data entry and collection of quality parameters,
and simplified complete post-procedure recovery, yet still allowing for adequate patient
information and discharge [35 ]
[36 ]
[37 ].
In a patient scheduled for a double consecutive endoscopic examination with a UGI
endoscopy and a colonoscopy in the same session, a 5-minute reduction in the overall
time slot is conceivable.
In conclusion, patients scheduled for a diagnostic UGI endoscopy should have an allocated
time slot of ≥ 20 minutes. This time should be different for some surveillance UGI
endoscopies, namely for patients with extensive gastritis ( ≥ 30 minutes) or BE (≥ 30
minutes, increasing to 40 minutes for ultralong segments) [5 ].
2 Domain: Completeness of procedure
Key performance measure
Visibility score
Description
Percentage of endoscopy reports that record the visibility of the mucosa by a validated
score
Domain
Completeness of procedure
Category
Process
Rationale
UGI endoscopy quality depends on the detection of mucosal lesions. Proper visibility
allows inspection of the entire mucosa of all segments of the UGI tract, a detailed
inspection with chromoendoscopy for suspicious lesions, and decreases the rate of
missed lesions
Construct
Denominator : All diagnostic UGI endoscopies
Numerator : Procedures in the denominator with mucosal visibility scored according to one of
the available validated scales:
GRACE scale (Gastroscopy Rate of Cleanliness Evaluation)
PEACE scale (Polprep Effective Assessment of Cleanliness in Esophagogastroduodenoscopy)
Barcelona cleanliness scale
Exclusions : Therapeutic procedures, emergency procedures, procedures with a specific diagnostic
purpose without the need for a full evaluation, early termination of a procedure owing
to patient intolerance or for reasons of safety, or alteration of the normal anatomy
due to previous surgical resection or bariatric surgery
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
Statement 1: First round: 88.9 %, Second round: 89.7 %
Statement 2: First round: 89.7 %, Second round: 92.0 %
PICO numbers
4 and 5
Evidence grading
Low quality
The acceptance of this performance measure is based on agreement with the following
statements:
A previous statement did not reach consensus (agreement: 70.3 %). The updated statement
is:
To achieve adequate cleanliness, patients should receive simethicone or a similar
antifoaming agent as a premedication 30 minutes before a UGI endoscopy. If foam, bubbles,
or biliary fluids still impair the visibility of the mucosa, water or simethicone
should be used during the procedure via the working channel. Agreement: 89.7 % (first
round), 92.0 % (second round)
Adequate visibility during a UGI endoscopy is fundamental for the adequate detection
and diagnosis of lesions, and improves communication among endoscopists, but no validated
scale was available at the time of the previous publication [1 ]. In recent years, several research groups have developed scales assessing the cleanliness
of the UGI tract. The main rationale was the existing scales for lower GI endoscopy
that are key performance measures, which highlight the importance of proper visualization
on lesion detection, and allow a standardized use of terminology to describe mucosal
visibility [34 ]. Historically, several scales for UGI visibility have been constructed to assess
the effectiveness of preparation agents in terms of visibility or to assess visibility
during emergency UGI endoscopy, but have lacked a full validation process or provide
only moderate interobserver agreement with kappa values of 0.58–0.73 [38 ]
[39 ]
[40 ]
[41 ]
[42 ]
[43 ]
[44 ]. In the last few years, five scales have been created and better validated.
The Crema scale or Crema Stomach Cleaning Score (CSCS) scale scores gastric mucosal
visibility in three sections (fundus, corpus, and antrum), each with three grades,
ranging from 1 to 3 (1 poor preparation needing extensive washing; 3 clean mucosa)
[45 ]. The scale was validated in a single round by four endoscopists in 20 videos and
resulted in a kappa value of 0.91. The main limitation of this score is that it only
measures visibility in the stomach, and it had a limited validation process.
The Toronto scale or Toronto Upper Gastrointestinal Cleaning Score (TUGCS) assesses
four segments (gastric fundus, corpus and antrum, and duodenum) with four grades,
ranging from 0 to 3 (0 poor visibility; 3 excellent visibility). The study consisted
of 55 live case assessments and two rounds of assessment of 12 videos by 13 worldwide
expert endoscopists, preceded by a Delphi process. The intraclass correlation coefficient
was 0.79 for interobserver reliability and 0.83 for test–retest reliability. Its main
limitation is that the scale does not measure visibility in the esophagus [46 ].
The Barcelona scale assesses five segments (esophagus, gastric fundus, corpus and
antrum, and duodenum) with three grades, ranging from 0 to 2 (0 poor visibility; 2
excellent visibility). The scale was validated based on the assessment of 100 photos
by 15 endoscopists from 13 Spanish centers [47 ]. The inter- and intraobserver agreements provided kappa values of 0.83 and 0.89,
respectively.
The PEACE scale or Polprep Effective Assessment of Cleanliness in Esophagogastroduodenoscopy
was constructed similarly to the Boston Bowel Preparation Scale, assessing three segments
(esophagus, stomach, and duodenum) with four grades, ranging from 0 to 3 (0 poor visibility;
3 excellent visibility), after cleaning. The retrospective validation of 18 photos
by 12 endoscopists showed good interobserver agreement, with an intraclass correlation
coefficient of 0.8, and good intraobserver agreement, with a kappa of 0.64 [48 ]. Also, segments scored as 3 tended to have a higher pathology detection rate than
those scored 1 (odds ratio [OR] 3.2, 95 %CI 1.1 to 9.0; P = 0.03). In a further prospective validation with 995 patients from five centers
mainly in Poland, adequate cleanliness, defined as scores of ≥ 2 for esophagus, stomach,
and duodenum, was an independent factor for UGI pathology detection (OR 1.78, 95 %CI
1.06 to 3.01; P = 0.03) and number of segments with lesions (OR 2.38, 95 %CI 1.17 to 4.82; P = 0.02) [49 ]. The next step was external reliability assessment of videos by a group of international
experts. This showed good agreement, with intraclass correlation coefficient of 0.82
(95 %CI 0.75 to 0.89) [50 ]. The agreement was comparable between endoscopists from Asia and Oceania (0.86,
95 %CI 0.79 to 0.92) and Western ones (0.80, 95 %CI 0.72 to 0.88).
The Gastroscopy Rate of Cleanliness Evaluation (GRACE) scale was designed similarly
to the Boston Bowel Preparation Scale and the PEACE scale, assessing three segments
(esophagus, stomach, and duodenum) with four grades, ranging from 0 to 3 (0 poor visibility;
3 excellent visibility), after cleaning. It has gone through a three-stage, prospective,
complete validation process, including a first phase with 60 photos assessed by four
expert endoscopists twice, a second phase with the same 60 images scored twice by
54 experts and nonexperts worldwide, and a final third phase with real-time scale
use in consecutive patients in each center [51 ]. It provided an interobserver agreement of 0.81 (95 %CI 0.73 to 0.87) in the first
phase, and 0.80 (95 %CI 0.72 to 0.86) in the second phase; a reliability of 0.73 (95 %CI
0.63 to 0.82) in the first phase and 0.72 (95 %CI 0.63 to 0.81) in the second phase.
In the real-time evaluation phase, the overall percentage of correct classifications
was 80 % (95 %CI 77 % to 82 %).
A relevant topic related to visibility is how to achieve the better scores, and whether
fasting is enough to achieve adequate UGI tract visibility. Since the last publication,
multiple randomized controlled trials (RCTs) and some meta-analyses have been published
comparing different UGI preparation agents to further enhance visibility beyond fasting.
The main rationale for the search for improved visibility results from the fact that
in randomized trials it was possible to move from rates of excellent visibility of
around 70 % in the esophagus and duodenum to 85 % and 90 %, respectively and, most
significantly, from 39 % to 76 % in the stomach, by adding simethicone or similar
agents to fasting alone [41 ].
The most commonly used agent was simethicone, which is an antifoaming agent, used
interchangeably with dimethicone [43 ]. Other agents used included mucolytic agents such as N-acetylcysteine and pronase
[44 ]. The use of antifoaming agents as a regular UGI preparation has been recommended
in Japanese, Australian, and British guidelines [28 ]
[52 ]
[53 ].
In a meta-analysis published in 2021, the use of preparation agents resulted in better
visibility scores in comparison with no preparation (–2.69, 95 %CI –3.50 to –1.88;
P < 0.01; I
2 = 93 %), while simethicone premedication specifically resulted in better visibility
scores compared with no preparation (–2.68, 95 %CI −4.94 to −0.43; P < 0.02; I
2 = 96 %) [44 ]. All recently published RCTs not included in the previous meta-analyses also reported
better visibility when simethicone premedication was used [45 ]
[54 ]
[55 ]
[56 ]
[57 ]
[58 ]
[59 ]
[60 ]
[61 ]. Nevertheless, it is important to realize that assessment of visibility scores used
in the presented studies was not standardized owing to the lack of a validated visibility
scale.
The effectiveness of simethicone preparation is related to the dose and timing of
administration. A dose of 133 mg resulted in better visibility compared with doses
of ≤ 100 mg [44 ]. The estimated impact of preparation agents on visibility tended to be higher if
administrated > 20 minutes before UGI endoscopy than only 0–10 minutes before [44 ]. In one study, simethicone administered between 31 and 60 minutes prior resulted
in better visibility in the stomach than regimens with shorter times [62 ]. In another study, the best visibility was observed when simethicone was administrated
20–30 minutes before examination [63 ]. No meta-analysis has been performed regarding the dose and timing of administration,
and we need to take into consideration that assessment of visibility used in the presented
studies was not standardized.
The combination of simethicone as a antifoaming agent with other agents, such as mucolytic
agents, like N-acetylcysteine or pronase, sodium bicarbonate, and peppermint oil,
was also investigated [42 ]
[43 ]
[44 ]
[55 ]
[56 ]
[58 ]
[60 ]
[61 ]
[64 ]
[65 ]
[66 ]. Regarding visibility scores, the combination of simethicone and N-acetylcysteine
was better than no preparation in both meta-analyses (−2.48, 95 %CI −4.45 to −0.51;
P < 0.01; I
2 = 96 %; and −2.83, 95 %CI −4.38 to −1.27; P < 0.01), but pooled effectiveness on visibility improvement tended to be similar
between simethicone, simethicone plus N-acetylcysteine, and simethicone plus pronase,
but without any direct comparison [42 ]
[44 ]. The efficacy of combined premedication is also related to the dose of the agents
as a dose of 20 mg of simethicone and 400 mg of N-acetylcysteine was not superior
to no preparation [65 ].
Another rationale for improved visibility is to hopefully detect more lesions. In
one meta-analysis, premedication with simethicone and N-acetylcysteine increased the
detection of UGI lesions (risk ratio [RR] = 1.31, 95 %CI 1.12 to 1.53; P < 0.01) [43 ]. RCTs published more recently, assessing detection of lesions as a secondary outcome,
have provided conflicting results: in three studies, more lesions such as dysplasia
or early cancers were detected in the premedication group versus fasting alone, although
the differences observed were not statistically significant as the studies were underpowered
for that outcome, while in two other studies, there were no differences in the detection
rates [60 ]
[61 ]
[64 ]
[66 ]
[67 ]. Finally, an outcome that might be relevant for unsedated patients is that premedication
with simethicone and N-acetylcysteine resulted in a decrease in the time needed for
cleaning the mucosa with no difference in the total UGI endoscopy time [45 ].
Regarding safety for the use of these premedication agents, no difference in AEs between
simethicone preparation groups and controls was found in one meta-analysis (RR 0.4,
95 %CI 0.2 to 1.0; P = 0.05; I
2 = 0 %); in the other meta-analysis (13 studies; 11 086 patients), no cases of aspiration
were reported [43 ]
[44 ].
Regarding safety specifically among sedated patients, recent studies with patients
receiving conscious sedation reported no AEs or were comparable between the prepared
and non-prepared individuals [45 ]
[56 ]
[57 ]
[58 ]
[59 ]
[64 ]. In one study with 205 patients under propofol sedation (101 prepared; 104 controls),
the median minimum oxygen saturation level was 98 % versus 100 %, and 0 % versus 4.6 %
of patients had a saturation level < 90 % [64 ]. In another study with 615 sedated patients, no differences in oxygen saturation
were observed between prepared and control patients [67 ]. In three other studies including 496, 800, and 7200 patients who underwent UGI
endoscopy with sedation, no serious AEs were reported regardless of premedication
[60 ]
[61 ]
[66 ]. This may be related to there being comparable amounts of residual gastric fluid
both in patients receiving premedication and those who did not [59 ]
[65 ].
In conclusion, the published data support the safety of premedication for UGI endoscopy,
even for patients under sedation, with better results using 133 mg of simethicone
in 100 mL of water, 30–60 minutes before the procedure. Therefore, the use of premedication
as part of the UGI endoscopy preparation protocol should be encouraged. Despite the
evidence, owing to concerns regarding applicability and implementation issues, the
group did not reach an agreement with regard to suggesting the use of simethicone
as a preprocedure performance measure.
The group did however agree and propose the reporting of UGI tract visibility by one
of the validated scales available, with visibility being a direct consequence of using
simethicone as a premedication. Because all segments in a diagnostic UGI endoscopy
are relevant, we propose the use of the GRACE scale, the PEACE scale, or the Barcelona
scale when describing the final visibility of the UGI mucosa achieved after cleaning.
Further studies are awaited to assess the need or not to achieve the highest scores
for adequate lesion detection, and worldwide applicability and reliability agreements.
Key performance measure
Photodocumentation
Description
Percentage of UGI endoscopy reports with accurate photodocumentation of anatomical
landmarks and all abnormal findings
Domain
Completeness of procedure
Category
Process
Rationale
Photodocumentation of all anatomical landmarks is an indicator of a complete examination.
Accurate photodocumentation of abnormal findings allows for better communication and
follow-up
Construct
Accurate photodocumentation includes at least one representative photo of each of
the following 10 anatomical landmarks, taken in the following proposed sequence: proximal
esophagus, distal esophagus, Z line and diaphragmatic indentation, duodenal bulb,
second part of duodenum, antrum, cardia and fundus in full inversion, lesser curvature
of corpus in partial inversion, incisura in partial inversion, and greater curvature
of corpus in forward view
Denominator : All diagnostic UGI endoscopies
Numerator : Procedures in the denominator that contain accurate photodocumentation, as detailed
above
Exclusions : Therapeutic procedures, emergency procedures, procedures with a specific diagnostic
purpose without the need for a full evaluation, early termination of procedure owing
to patient intolerance or for reasons of safety, or alteration of the normal anatomy
due to previous surgical resection or bariatric surgery
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 96.3 %
Second round: 100 %
PICO number
6
Evidence grading
Very low quality
The acceptance of this performance measure is based on agreement with the following
statements:
Two proposals regarding number of photos were voted on, the one from 2016 and a new
2024 proposal, without any clear preference: 48.1 % versus 51.9 %, respectively. Therefore,
the group decided to maintain the previous proposal.
2016 proposal 10 photos (proximal to distal): three in esophagus (proximal esophagus, distal esophagus,
and Z line and diaphragmatic indentation), five in stomach (cardia and fundus, lesser
curvature of corpus, greater curvature of corpus, incisura, and antrum), and two in
duodenum (duodenal bulb and second part of duodenum).
New 2024 proposal 16 photos (proximal to distal): proximal esophagus, distal esophagus including Z
line, cardia, fundus, lesser curvature of corpus, greater curvature of corpus, anterior
wall of corpus, posterior wall of corpus, incisura, lesser curvature of antrum, greater
curvature of antrum, anterior wall of antrum, posterior wall of antrum, pylorus, duodenal
bulb, and second part of duodenum.
Photodocumentation is a fundamental aspect for endoscopists to perform quality examinations,
providing further support of the description in the text report. Most of the endoscopic
equipment and reporting software currently available allows high quality digital photos
to be obtained, usually in a simple and friendly manner that does not demand much
time or effort during the endoscopic procedure. In addition, adequate photodocumentation
can be an indirect indicator of an exhaustive and detailed inspection of the esophageal,
gastric, and duodenal mucosa, and of complete examination [35 ].
To obtain the maximum possible sharpness, it is recommended to freeze the image before
saving the photo. In addition, it would be convenient for each endoscopist to establish
a systematic routine for photo acquisition, in order to not forget to capture all
the recommended landmark photos.
There is no clear consensus or evidence on the number or locations of photos that
should be taken in a UGI endoscopy, but most authors do agree that any lesion or abnormal
finding should be documented with a photo [28 ]
[68 ]. The greatest discrepancies are however related to the anatomical landmarks that
are proposed to be captured in a photo, differences in criteria that could be related
to the wide differences across settings with regard to the incidence of BE or gastric
cancer [69 ].
In 2016, in the previous version of these performance measures for UGI endoscopy,
we proposed taking at least 10 photos for any diagnostic UGI endoscopy (proximal to
distal): (i) proximal esophagus, (ii) distal esophagus, (iii) Z line and diaphragmatic
indentation, (iv) cardia and fundus, (v) lesser curvature of corpus, (vi) greater
curvature of corpus, (vii) incisura, (viii) antrum, (ix) duodenal bulb, and (x) second
part of duodenum [1 ].
In 2017, the British Society of Gastroenterology and the Association of UGI Surgeons
of Great Britain and Ireland stated that photodocumentation should be made of relevant
anatomical landmarks and any detected lesions, but without a formal recommendation
of the number and location of photos [28 ]. In 2018, the Korean Society of Gastrointestinal Endoscopy recommended taking only
eight photos [68 ]. In 2020, the World Endoscopy Organization recommended taking at least 28 photos,
including one of the hypopharynx, four of the esophagus, 21 of the stomach, and two
of the duodenum [70 ]. In 2025, the American Society for Gastrointestinal Endoscopy and the American College
of Gastroenterology proposed a set of just seven photos [10 ].
In very specific settings, but not for every diagnostic UGI endoscopy, more detailed
photodocumentation might be desirable, such as for surveillance of BE (one photo of
every 1–2 cm of Barrett’s) or surveillance of high risk patients for gastric cancer
(22 photos of the stomach) [5 ]
[71 ].
Our group considered increasing the number of recommended photos, balancing feasibility,
time spent, and lack of clear evidence beyond expert opinions, as any substantial
increase in the number of photos might not be feasible for all examinations, and is
not proven to increase diagnostic yield by itself (unlike increased time for inspection).
After voting, no clear majority nor consensus to increase the number of photos to
be taken was reached, and most comments were that striking a balance between comprehensive
photodocumentation and practical feasibility was crucial.
As a result, it was decided to maintain the previously given recommendation of a minimum
of 10 photos to be taken of the same landmarks for any normal diagnostic UGI endoscopy,
plus a photo of any lesion or abnormal finding.
It is recommended to take photos of the esophagus and duodenum during insertion to
avoid lesions caused by endoscope friction, especially in the cardia and duodenal
bulb, and photos of the stomach during withdrawal. As such, the following sequence
could be adopted as a proposal to systematically record the 10 photos, allowing correct
landmark identification and examination time measurement: (i) proximal esophagus,
(ii) distal esophagus, (iii) Z line and diaphragmatic indentation, (iv) duodenal bulb,
(v) second part of duodenum, (vi) antrum, (vii) cardia and fundus in full inversion,
(viii) lesser curvature of corpus in partial inversion, (ix) incisura in partial inversion,
(x) greater curvature of corpus in forward view ([Fig. 2 ]). When withdrawing from the esophagus, a repeated final photo of the upper esophagus
just below the sphincter would allow calculation of the examination time.
Fig. 2 The proposed sequence for the 10 recommended photos that should be captured during
any diagnostic upper gastrointestinal endoscopy is: a photo #1, proximal esophagus; b photo #2, distal esophagus; c photo #3, Z line and diaphragmatic indentation; d photo #4, duodenal bulb; e photo #5, second part of duodenum; f photo #6, antrum; g photo #7, cardia and fundus in full inversion; h photo #8, lesser curvature of corpus in partial inversion; i photo #9, incisura in partial inversion; j photo #10, greater curvature of corpus in forward view.
The Working Group would like to emphasize that an endoscopy report without photodocumentation
is no longer acceptable in 2025. All modern endoscopy systems are fully equipped for
digital photodocumentation and lack of digital storage capacity cannot be used as
an excuse. Similarly to a radiological examination, photos constitute an intrinsic
and invaluable part of the examination. Freezing the image prior to capturing the
photo allows the endoscopist to focus on findings and will increase inspection time
because it also documents the cleanliness of the UGI tract. In addition, it allows
reassessment of findings and also serves as a medicolegal protection should questions
be raised about the quality of the endoscopy (e.g. interval cancers).
A proposal for reporting a UGI endoscopy with the minimum information that should
be included, to unify, structure, and standardize the endoscopy report, is available
[72 ].
3 Domain: Identification of pathology
Key performance measure
Examination time
Description
Percentage of UGI endoscopies lasting ≥ 7 minutes from intubation to extubation
Domain
Identification of pathology
Category
Process
Rationale
Longer inspection times allow the detection of more lesions in the esophagus, stomach,
and duodenum
Construct
Record time from intubation to extubation of the endoscope
Denominator : All diagnostic UGI endoscopies
Numerator : Procedures in the denominator with the duration of the procedure documented as being
≥ 7 minutes from intubation to extubation (note: procedures without a recorded time
should be regarded as fails)
Exclusions : Therapeutic procedures, emergency procedures, procedures with a specific diagnostic
purpose without the need for a full evaluation, early termination of procedure owing
to patient intolerance or for reasons of safety, or alteration of the normal anatomy
due to previous surgical resection or bariatric surgery
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 96.3 %
Second round: 100 %
PICO number
7
Evidence grading
Low quality
The acceptance of this performance measure is based on agreement with the following
statement:
Adequate inspection for a diagnostic UGI should include the esophagus, stomach, and
duodenum, and should last ≥ 7 minutes from intubation to extubation. Agreement: 96.3 %
(first round), 100 % (second round)
At the time of the previous publication in 2016, only one retrospective study assessing
the inspection time of a UGI endoscopy was available, concluding that endoscopists
taking ≥ 7 minutes on average to perform a normal endoscopy from intubation to extubation
detected three times more cases of dysplasia or cancer (OR 3.42, 95 %CI 1.25 to 10.38)
than endoscopists taking < 7 minutes [73 ].
Since then, several studies have evaluated the procedure time of a diagnostic UGI
endoscopy as a measure to improve the diagnostic yield. Most studies are retrospective
[74 ]
[75 ]
[76 ]
[77 ]
[78 ]
[79 ]
[80 ]
[81 ]
[82 ]
[83 ] and show heterogeneity in the procedure time measurement: four studies assessed
the examination time, defined as the time from the first photo of the upper esophagus
until the last photo of the upper esophagus (from intubation to extubation) [74 ]
[75 ]
[76 ]
[77 ]; four studies assessed the withdrawal time, defined as the time from the first photo
of the second portion of the duodenum until the last photo of the upper esophagus
[78 ]
[79 ]
[80 ]
[81 ]; and two studies assessed gastric observation time, defined as the time between
the first and the last photo of the stomach, after the withdrawal from the duodenum
[82 ]
[83 ].
Regarding the four studies assessing examination time from intubation to extubation:
in a retrospective study with 15 763 patients, endoscopists who had a mean examination
time without biopsy of 5–7 minutes diagnosed more neoplastic lesions than those with
a time of < 5 minutes (0.97 % vs. 0.57 %; OR 1.90, 95 %CI 1.06 to 3.40; P = 0.03), but a longer mean time above 7 minutes narrowly failed to reach significance
(0.94 % vs. 0.57 %; OR 1.89, 95 %CI 0.98 to 3.64; P = 0.06) [74 ]. Another retrospective study with 3925 patients, comparing examination times of
< 7, 7–10, and > 10 minutes, failed to find any significant result, with UGI neoplasm
detection rates of 3.6 %, 3.3 %, and 3.1 %, respectively (P = 0.81) [75 ]. In a prospective multicenter study analyzing 847 and 1079 UGI endoscopies before
and after implementation of ≥ 6 minutes, without biopsy, as an institutional policy,
a higher rate of detection of high risk lesions (combining advanced atrophic gastritis
and neoplastic lesions) was achieved (OR 1.65, 95 %CI 1.04 to 2.64; P = 0.04) [76 ]. Finally, in a prospective study assessing the examination time from intubation
to extubation, but irrespective of biopsies, in 880 UGI diagnostic endoscopies, examinations
with a duration > 4.2 minutes were related to higher lesion detection (1.8 % vs. 0 %;
P = 0.01) [77 ].
Regarding the four studies assessing withdrawal time from duodenum to extubation:
in a retrospective study with 120 871 patients, endoscopists with a withdrawal time
without biopsy of ≥ 3 minutes diagnosed more neoplastic lesions (0.28 % vs. 0.20 %;
P = 0.01), especially for early lesions [78 ]. When the same group prospectively evaluated implementation of the institutional
policy of the withdrawal time in 30 506 asymptomatic patients, UGI endoscopies with
≥ 3 minutes of withdrawal resulted in higher lesion detection (OR 1.51, 95 %CI 1.21
to 1.90) [79 ]. This result was further confirmed in another retrospective study from the same
group in 67 683 patients, showing a higher gastric neoplasm detection rate within
UGI endoscopies lasting > 2.5 minutes (OR 1.49, 95 %CI 1.09 to 2.04; P = 0.01) [80 ]. Finally, in another retrospective study, analyzing 95 missed gastric adenomas,
defined as gastric adenomas diagnosed within 3 years of a negative screening UGI endoscopy,
shorter withdrawal time was associated with increased risk of a missed gastric adenoma
(β = −0.01; OR 0.99, 95 %CI 0.98 to 0.99; P < 0.01), with an average time of 3 minutes for the index endoscopy and 4.4 minutes
for the diagnostic endoscopy, and an optimal cutoff of 3.5 minutes for adenoma detection
[81 ].
Regarding the two studies assessing gastric examination time, in a retrospective study
analyzing 1257 interval gastric cancers diagnosed within 6–36 months of a “normal”
UGI endoscopy, a gastric observation time < 3 minutes was associated with higher risk
of interval gastric cancer (OR 2.27, 95 %CI 1.20 to 4.30) [83 ]. In another retrospective study with 13 477 patients, the gastric examination time
was an independent predictor for detecting gastric neoplasms or lymphomas in Helicobacter pylori -eradicated patients [82 ].
Despite this heterogeneity of inspection time measurement, the procedure time for
any diagnostic UGI endoscopy should be easily measured, by simply calculating the
difference in time between two photos. Setting the perfect calculation and threshold
is difficult as different definitions were used and most, but not all, studies calculated
the time without biopsies; this aspect seems to be relevant as the biopsy rate could
be high in certain settings owing to the Management of precancerous conditions and
lesions in the stomach (MAPS) protocol [11 ].
It is worthwhile mentioning that sedation might be needed to achieve a complete examination,
allow a detailed inspection, and fulfil all of the quality parameters associated with
a UGI endoscopic procedure, also providing better comfort and tolerance for the patient,
although this is an area lacking relevant randomized trials [84 ]
[85 ].
In conclusion, the proposed 7-minute examination time threshold for a full UGI diagnostic
endoscopic procedure, from intubation to extubation, is at present the one with more
supporting evidence from different settings, covering both the 5- and 6-minute thresholds,
based on the mean time without biopsies, with an eventual extra time spend for biopsies
if needed, and allowing ≥ 3 minutes to be spent just for gastric inspection. In the
near future, randomized or comparative prospective studies would be welcome, to better
define the best metric and threshold, the need for sedation, and also to assess patient
comfort and experience during UGI endoscopy.
Key performance measure
Standardized terminology
Description
Percentage of UGI endoscopy reports with accurate application of standardized disease-related
terminology
Domain
Identification of pathology
Category
Process
Rationale
Appropriate application of standardized disease-related terminology allows for uniformity
in communication. The severity of a specific pathology according to a validated classification
allows physicians to optimize the patient’s treatment
Construct
Record the use of the following classification, when applicable:
Los Angeles classification for erosive esophagitis
Prague classification for Barrett’s esophagus
Forrest classification for bleeding ulcers
Paris classification for visible lesions
Baveno classification for varices
Zargar classification for caustic lesions
Spigelman classification for duodenal adenomas in patients with familial adenomatous
polyposis
Denominator : All UGI endoscopies addressing one or more of the above groups of pathologies
Numerator : Procedures in the denominator where the report includes the appropriate use of all
disease-related terminology. The performance measure is only met when all applicable
disease-related terminology is used in a report so, for instance, in a patient with
esophagitis and Barrett’s esophagus, both the Los Angeles and Prague classifications
should be used
Exclusions : None
The following classifications are useful and clinically applicable; however, they
are not considered for the calculation of this performance measure:
Endoscopic Reference Score for eosinophilic esophagitis
Kodsiʼs classification for candida esophagitis
Hill's classification for the assessment of gastroesophageal flap valve
Kimura–Takemoto classification for grading extension of gastric atrophy
Endoscopic Grading for Gastric Intestinal Metaplasia (EGGIM) classification for grading
severity and extension of intestinal metaplasia
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 100 %
Second round: 100 %
PICO number
8
Evidence grading
Very low quality
The acceptance of this performance measure is based on agreement with the following
statement:
Each of the proposed classifications was voted on individually.
The use of validated classifications improves communication among physicians and most
of them help guide the patient’s treatment. Specifically in Barrett’s reporting, it
has been shown that systematic reporting of the landmarks and the Prague classification
in itself increased neoplasia detection [86 ]. In the previous publication and this updated consensus, an agreement of 100 % was
reached regarding the use of available standardized and validated classifications
when describing abnormal findings [1 ]. In this updated version, the consensus was confirmed for five of the following
classifications: Los Angeles classification for erosive esophagitis [87 ] (100 % agreement); Prague classification for BE [88 ] (100 % agreement); Forrest classification for bleeding ulcers [89 ] (100 % agreement); Paris classification for visible lesions [90 ] (96.3 % agreement); and Baveno classification for varices [91 ]
[92 ] (96.3 % agreement). Although agreement was not reached for the Zargar classification
for caustic lesions [93 ] (66.7 % agreement) and Spigelman classification for duodenal adenomas in patients
with familial adenomatous polyposis [94 ] (77.8 % agreement), these two classifications, applicable in rare and very specific
populations, are simple to apply and have an intrinsic clinical value in terms of
a patient’s management and follow-up.
Other existing classifications were proposed during the voting; however, they did
not achieve ≥ 80 % agreement for several reasons, mainly higher interobserver variability,
difficult training, or their complexity. These included: the Endoscopic Reference
Score for eosinophilic esophagitis [95 ]
[96 ] (51.9 % agreement); Kodsi’s classification for candida esophagitis [97 ] (14.8 % agreement); Hill’s classification for assessment of gastroesophageal flap
valve [98 ] (48.2 % agreement); the Kimura–Takemoto classification for severity of gastric atrophy
[99 ]
[100 ]
[101 ]
[102 ] (25.9 % agreement); and the Endoscopic Grading for Gastric Intestinal Metaplasia
(EGGIM) classification [103 ]
[104 ]
[105 ] (48.2 % agreement).
In conclusion, as a quality performance measure, the group continues to propose measurement,
when applicable, of the same seven endoscopic classifications previously proposed:
Los Angeles classification for erosive esophagitis, Prague classification for BE,
Forrest classification for bleeding ulcers, Paris classification for visible lesions,
Baveno classification for varices, Zargar classification for caustic lesions, and
Spigelman classification for duodenal adenomas in patients with familial adenomatous
polyposis [1 ]. Other existing classifications might be used at the discretion of the endoscopist
but would not be used for measuring quality at present (Appendix 2 s ). New evidence regarding clinical relevance or agreement of existing scales, or even
new scales, might change this proposal in future updates of this statement.
Minor performance measure
Observation time and chromoendoscopy in BE inspection
Description
Percentage of routine BE surveillance endoscopies lasting ≥ 1 minute of inspection
time per cm of Barrett’s epithelium and using chromoendoscopy
Domain
Identification of pathology
Category
Process
Rationale
Longer inspection time allows better detection of lesions in BE
Construct
Record the Prague classification
Record inspection time of the esophagus
Calculate the inspection time expressed as minutes per circumferential extent of Barrett’s
epithelium in cm
Record the use of chromoendoscopy (acetic acid and/or virtual) when inspecting BE
to guide targeted biopsies
Denominator : BE diagnostic surveillance UGI endoscopies
Numerator : Procedures in the denominator with an inspection time of ≥ 1 minute per cm of Barrett’s
epithelium Procedures in the denominator that report the use of chromoendoscopy (acetic acid
and/or virtual)
Exclusions : Early termination of procedure owing to patient intolerance or for reasons of safety,
alteration of the normal anatomy due to previous surgical resection, presence of severe
esophagitis defined as a Los Angeles classification of grade C or higher, or therapeutic
procedures for treatment of BE
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
Statement 1: First round: 96.3 %, Second round: 89.7 %
Statement 2: First round: 96.3 %, Second round: 86.2 %
PICO number
9 and 10
Evidence grading
Low quality
The acceptance of this performance measure is based on agreement with the following
statements:
Adequate inspection time in a surveillance UGI endoscopy for patients with nondysplastic
BE should take ≥ 1 minute per cm of circumferential extent of Barrett’s epithelium.
Agreement: 96.3 % (first round), 89.7 % (second round)
Adequate inspection in a surveillance UGI endoscopy for patients with nondysplastic
BE should include the use of chromoendoscopy (acetic acid and/or virtual). Agreement:
96.3 % (first round), 86.2 % (second round)
BE inspection is a very specific but demanding UGI diagnostic procedure, which might
need a longer inspection time, especially for longer segments, so the time allocated
for this type of UGI endoscopy is often inadequate. A fixed time slot of 20 minutes
that is suggested for a diagnostic endoscopy is insufficient for a specific BE surveillance
UGI endoscopy [28 ].
Although there are no direct data evaluating the impact of endoscopic examination
time on the dysplasia detection rate, two post-hoc analyses from RCTs support the
relevance of adequate inspection time for BE [106 ]
[107 ]. In another study an inspection time over 1 minute per cm of Barrett’s epithelium
provided higher detection rates of endoscopically visible lesions and high grade dysplasia/adenocarcinoma
[108 ]. Additionally, another study showed that a longer procedural time was associated
with increased dysplasia detection on both four-quadrant (OR 1.10, 95 %CI 1.00 to
1.20; P = 0.04) and targeted biopsies (OR 1.21, 95 %CI 1.04 to 1.40; P = 0.01) for patients with BE > 6 cm, when increasing the inspection by 0.9 minutes
for each additional 1 cm of Barrett’s epithelium, resulting in a median examination
time from intubation to extubation of 16.5 minutes [109 ].
Regarding chromoendoscopy, ESGE has recommended the use of virtual or acetic acid
chromoendoscopy in endoscopic surveillance for patients with BE [5 ]. Of note, neither technique can replace the additional use of the Seattle protocol
for biopsy sampling as sufficient evidence is lacking that chromoendoscopy can be
used as a standalone technique for dysplasia detection [110 ].
In a crossover trial of 123 patients undergoing screening or surveillance for BE in
a tertiary referral center, comparing high definition white-light endoscopy with targeted
and random biopsies according to the Seattle protocol versus virtual chromoendoscopy
with guided targeted biopsies, there was no difference in metaplasia detection, but
significantly fewer biopsies were needed in the virtual chromoendoscopy group [111 ]. These findings were confirmed in one prospective study, while in another comparative
trial of standard definition endoscopy versus virtual chromoendoscopy, fewer biopsies
were needed but also a significantly higher yield of dysplasia was found [112 ]
[113 ].
A meta-analysis of 14 prospective studies and clinical trials reported an increased
yield of dysplastic and neoplastic lesions by 34 % (95 %CI 14 % to 56 %; P < 0.01) in virtual chromoendoscopy and by 35 % (95 %CI 13 % to 56 %; P < 0.01) in acetic acid chromoendoscopy versus white-light endoscopy, with no significant
difference found between the two modalities (P = 0.45) [114 ]. This suggests an additive effect of chromoendoscopy that can be leveraged for targeted
biopsies when the Seattle protocol is performed.
In conclusion, in a routine BE surveillance UGI endoscopy, ≥ 1 minute of inspection
time per cm of Barrett’s is advised and chromoendoscopy, either virtual or with acetic
acid, should be used. This means that the time slot allocated to these specific BE
surveillance procedures should be anticipated and extended to 30–40 minutes according
to the estimated BE length, and high definition endoscopes should be available.
Minor performance measure
Chromoendoscopy in patients at risk for squamous cell carcinoma (SCC)
Description
Percentage of procedures with accurate application of virtual chromoendoscopy in patients
referred for screening for SCC after curative treatment of ear, nose, and throat,
or lung cancers
Domain
Identification of pathology
Category
Process
Rationale
Better detection of early esophageal SCC in patients with an increased risk, as virtual
chromoendoscopy is superior to Lugol staining
Construct
Record the use of virtual chromoendoscopy in patients with a history of ear, nose,
and throat, or lung cancer treated with a curative intent
Denominator : All diagnostic UGI endoscopies performed for screening for a second primary tumor
after curative treatment of ear, nose, and throat, or lung cancer
Numerator : Procedures in the denominator that report the use of virtual chromoendoscopy
Exclusions : Early termination of procedure owing to patient intolerance or for reasons of safety,
patients treated without curative intent, or patients that reached 75 years of age,
or with life-expectancy < 5 years
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 85.2 %, Second round: 82.8 %
PICO number
11
Evidence grading
Low quality
The acceptance of this performance measure is based on agreement with the following
statement:
Adequate inspection for a diagnostic UGI endoscopy in patients with a history of ear,
nose, and throat, or lung tumors treated with curative intent should include the use
of virtual chromoendoscopy. Agreement: 85.2 % (first round), 82.8 % (second round)
Screening for an esophageal second primary tumor in patients previously diagnosed
with SCC of the head and neck, or lung cancer can lead to the diagnosis of early squamous
esophageal cancers in up to 5.0 % (95 %CI 2.4 % to 8.9 %) of patients, showing a clinical
benefit in terms of resectable esophageal lesions compared with those evaluated because
of symptoms [18 ]
[115 ]. Given the significant reduction in overall survival once a second primary tumor
is detected, screening UGI endoscopy after a diagnosis of SCC of the head and neck
might be beneficial in patients who have been treated with curative intent [116 ].
One meta-analysis, including 12 studies, compared the diagnostic accuracy of virtual
chromoendoscopy versus Lugol staining for the detection of high grade dysplasia and
SCC of the esophagus [117 ]. While sensitivity for the detection of high grade dysplasia or esophageal cancer
was not significantly different between virtual chromoendoscopy and Lugol staining
(88 % [95 %CI 86 % to 93 %] vs. 92 % [95 %CI 85 % to 96 %]), specificity for virtual
chromoendoscopy was significantly higher (82 % [95 %CI 80 % to 85 %] vs. 88 % [95 %CI
86 % to 90 %]) in a per-patient analysis. Two recent randomized trials confirmed the
superiority of virtual chromoendoscopy. One study demonstrated equal negative predictive
value but superior positive predictive value, while another showed the need for fewer
biopsies and shorter examination times [118 ]
[119 ]. Finally, even in an expert tertiary center, Lugol staining led to a false-positive
rate of up to 84.3 % [18 ].
In conclusion, despite the limited data available and the scarce population in question,
in patients referred for an esophageal SCC screening UGI endoscopy, after curative
treatment of an SCC of the head and neck, or lung cancer, virtual chromoendoscopy
should be applied, preferably by an experienced endoscopist with a specific focus
in detection of early neoplasia. Lugol staining remains a validated technique that
can be used along with virtual chromoendoscopy.
4 Domain: Management of pathology
Key performance measure
Seattle protocol for BE
Description
Percentage of patients undergoing routine BE surveillance with proper application
of the Seattle protocol
Domain
Management of pathology
Category
Process
Rationale
Adequate inspection of certain conditions might imply taking biopsies for pathology
assessment
In BE surveillance, the Seattle protocol improves dysplasia detection, allowing an
interval between surveillance endoscopies according to guidelines
Construct
Record the Prague classification
In BE surveillance, record the use of the Seattle protocol, with four biopsies taken
every 2 cm along the circumferential extent of the Barrett’s epithelium. Biopsies
should be collected in separate jars for targeted biopsies and per level for random
biopsies
Denominator : BE surveillance endoscopies
Numerator : Procedures in the denominator where biopsies were taken according to the Seattle
protocol
Exclusions : Early termination of procedure owing to patient intolerance or for reasons of safety,
alteration of the normal anatomy due to previous surgical resection, presence of severe
esophagitis defined as a Los Angeles classification of grade C or higher, or therapeutic
procedures for treatment of BE, or contraindication for biopsies
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 92.6 %, Second round: 82.8 %
PICO number
12
Evidence grading
Moderate quality
The acceptance of this performance measure is based on agreement with the following
statement:
Regarding BE surveillance endoscopies, the Seattle protocol consists of targeted biopsies
of any visible lesion within the Barrett’s epithelium, followed by four-quadrant biopsies
taken at 2-cm intervals, all collected in different containers per level, and per
lesion [5 ]. Any suspicious areas should be biopsied before taking the random biopsies to avoid
bleeding that may impair adequate visibility. The Seattle protocol has been endorsed
in guidelines to be the standard method for BE surveillance. Despite these recommendations,
variability in adherence to the Seattle biopsy protocol is reported.
One multicenter study, with 20 155 UGI endoscopies from 153 practices and 572 endoscopists,
based on a population-based registry, showed adherence to the Seattle protocol of
86 % [120 ]; however, a meta-analysis of 56 studies including 14 002 patients and 4932 endoscopists
showed an adherence of only 49 % (95 %CI 36 % to 62 %) [121 ]. In a cohort study of 2245 BE patients under surveillance, the dysplasia detection
rate was reduced by almost half when there was nonadherence to the biopsy protocol
(OR 0.53, 95 %CI 0.35 to 0.82), and a longer BE segment was associated with significantly
reduced adherence (3–5 cm, OR 0.14, 95 %CI 0.10 to 0.19; 6–8 cm, OR 0.06, 95 %CI 0.03
to 0.09; ≥ 9 cm, OR 0.03, 95 %CI 0.01 to 0.07) [122 ]. Also, in another cohort study, a 13-fold higher detection rate of prevalent dysplasia
was obtained when the Seattle protocol was applied versus nonsystematic biopsies [123 ]. Finally, a meta-analysis confirmed that Seattle protocol adherence significantly
increased the detection of dysplasia compared with nonadherence (RR 1.90, 95 %CI 1.36
to 2.64; I
2 = 45 %); for both low grade dysplasia (RR 2.00, 95 %CI 1.49 to 2.69; I
2 = 0 %) and high grade dysplasia/adenocarcinoma (RR 2.03, 95 %CI 0.98 to 4.24; I
2 = 28 %) [124 ].
From a practical viewpoint, containers should be labelled according to the biopsy
location, as suggested in our previous statement, adopting a coding system that unequivocally
identifies the location allocated to each container using a two number combination
“xxyy” [1 ]. In this system, “xx” refers to the distance from the incisors and “yy” to the location
on a clock. By convention, the 3-o’clock position corresponds to the lesser curvature
(scope in neutral position), with “xx00” indicating random biopsies. For instance,
4000 would indicate random biopsies taken at 40 cm from the incisors, while 3805 stands
for a targeted biopsy taken from a lesion at 38 cm from the incisors and in the 5-o’clock
position.
In conclusion, applying the Seattle protocol for patients with BE is the recommended
strategy to follow and monitor.
Key performance measure
MAPS protocol for gastric precancerous assessment
Description
Percentage of patients in which it is relevant to address the risk of gastric cancer
during a first diagnostic UGI endoscopy, by combining the use of virtual chromoendoscopy
and proper histological characterization
Domain
Management of pathology
Category
Process
Rationale
Adequate inspection of certain conditions, including the use of virtual chromoendoscopy
might necessitate taking biopsies for pathology assessment. In patients where the
assessment of risk for gastric cancer is relevant, the MAPS protocol allows a more
detailed assessment of risk and a proposal for endoscopic surveillance in those who
will most benefit
Construct
In patients where the assessment of risk for gastric cancer is relevant, record the
use of the MAPS protocol after virtual chromoendoscopy inspection, with two biopsies
taken from the antrum in one vial and two biopsies taken from the corpus in a second
vial
Denominator : All diagnostic UGI endoscopies in patients where the assessment of risk for gastric
cancer is relevant
Numerator : Procedures in the denominator assessing risk for gastric cancer where biopsies were
taken according to the MAPS protocol
Procedures in the denominator that report the use of virtual chromoendoscopy
Exclusions : Therapeutic procedures, emergency procedures, early termination of procedure owing
to patient intolerance or for reasons of safety, or alteration of the normal anatomy
due to previous surgical resection or bariatric surgery, contraindications for biopsies,
or surveillance procedures in patients already identified with extensive gastric precancerous
conditions
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 96.3 %, Second round: 93.1 %
PICO number
13
Evidence grading
Low quality
The acceptance of this performance measure is based on agreement with the following
statement:
Regarding gastric cancer risk assessment, currently, population-based screening for
gastric cancer is not recommended in Europe as most countries have a low-to-intermediate
risk for this malignancy. Opportunistic screening and diagnosis of gastric lesions
or precancerous conditions that identify patients at higher risk should however be
performed during a routine diagnostic UGI endoscopy [125 ]
[126 ]. The main indications for a diagnostic UGI endoscopy are to study symptomatic patients
with various digestive complaints, such as dyspepsia, esophageal reflux, upper abdominal
pain, and iron deficiency anemia, among others [4 ]
[10 ]
[12 ]
[28 ].
Advances in endoscopic imaging, including the use of virtual chromoendoscopy, allow
endoscopists to perform a “real-time” characterization of the gastric mucosa, including
the detection of normal findings, inflammation, gastric atrophy, and intestinal metaplasia
[11 ]
[101 ]
[103 ].
A normal gastric mucosa is defined by certain endoscopic characteristics: (a) a homogeneously
distributed rose/pinkish color, (b) the absence of visibility of the atrophic border,
(c) regular and normal thickness of gastric folds in the corpus, and (d) a regular
arrangement of collecting venules in the corpus and fundus [101 ]
[127 ]. By applying optically magnified endoscopy, the normal pyloric and fundic glands
can be observed as ridge and round patterns, respectively [128 ]
[129 ].
The gastric mucosa can be damaged by various factors that lead to inflammatory changes
[130 ]. Inflammation in the gastric mucosa is characterized by a reddish mucosa (erythema),
edema, nodularity, enlargement of the gastric folds, and progressive disappearance
of the regular arrangement of the collecting venules in the corpus and fundus [131 ].
Recognizing gastric atrophy is important because it is the first step in the carcinogenesis
process, which can lead to the development of intestinal and diffuse types of adenocarcinomas
(mainly related to H. pylori infection) and type-1 neuroendocrine tumors (mainly related to autoimmune gastritis)
[130 ]. Endoscopic gastric atrophy can be detected by the pale color of the mucosa and
the easy visibility of submucosal vessels, features enhanced by virtual chromoendoscopy
[102 ]
[132 ]
[133 ]. Gastric atrophy caused by H. pylori typically begins in the distal compartment (the antrum/incisura) and progressively
moves toward the proximal compartment (the corpus/fundus). This progression has been
described as the advancement of the endoscopic atrophic border in the Kimura–Takemoto
classification, with the severity correlated with an increased risk of gastric cancer
[99 ]
[100 ]. Conversely, in cases of gastric atrophy caused exclusively by autoimmune gastritis,
endoscopic gastric atrophy is identified only in the proximal compartment [134 ]; however, these two etiologies can coexist and produce gastric atrophy affecting
both compartments.
Intestinal metaplasia is an additional step toward the development of most gastric
cancers, especially intestinal-type adenocarcinomas. Its endoscopic recognition is
feasible under white-light endoscopy alone, with signs such as slightly flat elevations
with whitish patches, map-like redness, mottled reddish depression, or a white opaque
substance [135 ], but it is better detected under high definition endoscopy and blue-light spectrum
virtual chromoendoscopy, where it is characterized by a typical whitish-bluish crest,
composed of two structures observable under magnification: the light-blue crest and
the marginal turbid band [135 ]
[136 ]
[137 ]
[138 ]
[139 ]. The extension and severity of intestinal metaplasia can be further assessed endoscopically
using the EGGIM classification, where a score of ≥ 5 indicates a higher risk for gastric
cancer [103 ]
[104 ]
[105 ]. Nevertheless, the endoscopic recognition of intestinal metaplasia in both the antrum/incisura
and corpus can be useful in identifying patients at higher risk for gastric cancer
[11 ]
[140 ]
[141 ].
Any diagnostic UGI endoscopy performed in patients for the assessment of digestive
symptoms can represent an opportunity to identify those at higher risk for gastric
cancer, where the diagnosis or suspicion of gastric atrophy or intestinal metaplasia
after the use of virtual chromoendoscopy should be complemented by targeted or random
biopsies according to the MAPS protocol, using two separated vials: one for the distal
compartment (antrum ± incisura) and another for the proximal compartment (corpus)
[11 ]. In cases with endoscopic inflammatory findings but without suspicion of gastric
atrophy or intestinal metaplasia, and only after the use of virtual chromoendoscopy
by an experienced endoscopist, biopsies may be taken from both antrum (± incisura)
and corpus in one single vial to rule out H. pylori and other etiologies [142 ]
[143 ]
[144 ]
[145 ]
[146 ].
In conclusion, applying the MAPS protocol to address gastric cancer risk, in a targeted
or random technique, after the use of virtual chromoendoscopy is the recommended strategy
to follow. An example of the sites to perform the biopsies is provided in [Fig. 3 ].
Fig. 3 Example of the sites to perform the targeted or random biopsies in patients being
evaluated for their risk of gastric cancer, with each single biopsy represented by
a dot, according to the Management of precancerous conditions and lesions in the stomach
(MAPS) protocol, using two separate vials: a greater curvature of antrum; b lesser curvature of antrum; c greater curvature of corpus; d lesser curvature of corpus.
5 Domain: Complications
Key performance measure
Complications after therapeutic procedures
Description
Percentage of patients monitored for complications (adverse events) after therapeutic
UGI endoscopy
Domain
Complications
Category
Outcome
Rationale
Monitoring the incidence of complications after therapeutic UGI endoscopy is important
to assess the safety of procedures, to identify targets for improvement, and to allow
patients to be accurately consented for procedures
Construct
Record any therapeutic procedures including:
Patient should be contacted 30 days after the procedure
Denominator : All therapeutic UGI procedures
Numerator : Therapeutic procedures in the denominator with accurate assessment of the existence
of complications or their exclusion
Exclusions : Emergency procedures or diagnostic procedures
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 96.3 %, Second round: 96.6 %
PICO number
14
Evidence grading
Very low quality
The acceptance of this performance measure is based on agreement with the following
statement:
While all other performance measures in this position statement are related to diagnostic
UGI endoscopy, this is the only one that refers specifically to therapeutic UGI endoscopy.
In contrast to diagnostic UGI endoscopy, in which AE rates are minimal, therapeutic
UGI endoscopy has a non-negligible rate of AEs that are part of the technique itself,
which should remain below a certain threshold. All AEs and harms related to any therapeutic
UGI procedure conducted in any endoscopy unit should be addressed and accounted for.
The AEs should be considered by procedure but also by organ involved and the type
of complication. The most common AEs are bleeding, perforation, stenosis, and stent
complications, which include migration, ingrowth, or overgrowth.
[Table 3 ]
[147 ]
[148 ]
[149 ]
[150 ]
[151 ]
[152 ]
[153 ]
[154 ]
[155 ]
[156 ]
[157 ]
[158 ]
[159 ] includes the AE rates for each complication, organ, and technique for the most usual
therapeutic procedures. Results were obtained from cohort studies, some of them prospectively
designed, but also reviews and meta-analyses [147 ]
[148 ]
[149 ]
[150 ]
[151 ]
[152 ]
[153 ]
[154 ]
[155 ]
[156 ]
[157 ]
[158 ]
[159 ]
[160 ]. For very specific and less frequently performed UGI therapeutic procedures, specific
guidelines or reviews should be consulted. Considering the reliability of the studies
selected, the reported complication rates should be regarded as the threshold, ideally
not to be exceeded, by endoscopic technique, by endoscopist, and by endoscopic center.
Table 3
Adverse event rates for each complication, organ, and therapeutic procedure.
Procedure
Organ
Complication
Rate, %
Reference
Polypectomy/endoscopic mucosal resection
Esophagus
Bleeding
3.1
[147 ]
Perforation
0.4
[147 ]
Stenosis
6.4
[147 ]
Stomach
Bleeding
6.9
[148 ]
Perforation
1.2
[148 ]
Duodenum
Bleeding
6.7
[149 ]
Perforation
0.9
[149 ]
Submucosal dissection
Esophagus
Bleeding
1.7–2.8
[150 ]
[151 ]
Perforation
1.5
[150 ]
[151 ]
Stenosis
6.3–11.6
[150 ]
[151 ]
Stomach
Bleeding
7.2
[148 ]
Perforation
2.6–3.2
[148 ]
[152 ]
Duodenum
Bleeding
8.9
[149 ]
Perforation
10.4
[149 ]
Dilation – pneumatic
Esophagus
Perforation
1–3
[153 ]
[154 ]
[155 ]
Dilation – Savary
Esophagus
Perforation
5
[154 ]
Dilation for achalasia
Esophagus
Perforation
5.3
[156 ]
Stenting for stenosis
Esophagus
Stent migration
11.4–16.3
[157 ]
Bleeding
5.4–9.2
[157 ]
Ingrowth/overgrowth
11.4–14.7
[157 ]
Stenting for leaks, fistulas, or perforations
Esophagus
Stent migration
16–24
[158 ]
Bleeding
0.6–1.0
[158 ]
Perforation
1–2
[158 ]
Percutaneous endoscopic gastrostomy
Stomach
Bleeding
0.3
[159 ]
Perforation
0.5
[159 ]
Peritonitis
0.5
[159 ]
Patients should be contacted after the procedure to assess post-procedural complications
in person, by phone, or by digitally secured e-services; ideally, the patient should
have been notified beforehand that this contact would be made. Expert consensus is
that 30 days after the procedure may be the ideal time gap to capture all possible
AEs.
When an AE has occurred, we suggest recording: (i) the type of procedure (resection
of lesion [specify], dilation [pneumatic or Savary], stent placement, percutaneous
endoscopic gastrostomy insertion, variceal band ligation, ablation, or other); (ii)
organ of procedure (esophagus, stomach, or duodenum); (iii) type of complication (bleeding,
perforation, stenosis, stent migration, infection, death, anesthesia related, environment
related, or other); (iv) time from therapeutic procedure to the onset of the complication,
in days; and (v) consequences of the complication (hospital admission, symptomatic
medication, antibiotics, laboratory or radiological tests, blood transfusion, endoscopic
intervention, radiological intervention, surgical intervention, organ dysfunction,
death, or other) [161 ]. This will allow comparison with published thresholds, root-cause analysis, and
classification of AEs according to the recently validated Adverse events GastRointEstinal
Endoscopy (AGREE) classification [162 ]
[163 ]
6 Domain: Patient experience
Minor performance measure
Patientsʼ experiences
Description
Patientsʼ experiences during and after UGI endoscopy should be routinely measured
and self-reported by the patients using validated scales
Domain
Patient experience
Category
Outcome
Rationale
Monitoring patient experience helps to identify areas for improvement and ensures
that the delivery of UGI endoscopy aligns with patient expectations, fostering a patient-centered
and quality-driven healthcare environment
Construct
Record patient experience by one of the following validated questionnaires:
Modified Group Health Association of America-9 (mGHAA-9)
Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ)
Newcastle ENDOscopic Patient-Reported Experience Measure (ENDOPREM)
Define a period within the annual endoscopy department activity to collect ≥ 100 questionnaires
that are representative of the UGI endoscopy activity
Define the metric the department will measure. For instance: best response, aggregate
of the two best responses, or other
Denominator : All UGI endoscopies where the patient experience was measured using a validated
scale
Numerator : Procedures in the denominator in which the patient reported his experience within
the defined metric (best response, aggregate of the two best responses, or other)
Exclusions : Emergency procedures
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 86.2 %, Second round: 100 %
PICO number
15
Evidence grading
Very low quality
A previous statement did not reach agreement (agreement 70.4 %). The acceptance of
this performance measure is based on agreement with the following updated statement:
Patients undergoing a diagnostic UGI endoscopy should have their experience measured
using a validated scale, to promote a patient-centered and quality-driven environment.
Agreement: 86.2 % (first round), 100 % (second round)
Patient experience as a performance measure is crucial for enhancing patient care,
engagement, and overall healthcare quality, including UGI endoscopy activity. Positive
patient experience can encourage participation in screening programs and repeated
attendance for recommended surveillance procedures. Conversely, dissatisfaction with
prior UGI endoscopic procedures (due to embarrassment, discomfort, or other) can deter
patients from returning [164 ]
[165 ].
Some patient-reported experience measures (PREMs) using questionnaires have been developed
and validated to assess patients’ experiences [166 ]. Examples are the modified Group Health Association of America-9 (mGHAA-9), the
Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ), and the Newcastle ENDOscopic
Patient-Reported Experience Measure (ENDOPREM) [167 ]
[168 ]
[169 ]. These tools cover various aspects of the patient experience, from pre-procedure
information to post-procedure care.
The modified mGHAA-9 questionnaire measures patient satisfaction across different
stages, from pre-procedure information and healthcare staff conduct, to post-procedure
care, with a nine-question questionnaire, each question rated on a 5-point scale [167 ].
The GESQ measures patient satisfaction again across different stages, also including
pre-procedure information, healthcare staff conduct, and post-procedure care, but
using a more detailed questionnaire with 24 questions, each question again rated on
a 5-point scale [168 ].
The Newcastle ENDOPREM, designed with a patient-centered approach, captures experiences
throughout the entire journey, including pre-procedure information, anxiety, communication,
post-procedure care, and overall experience [169 ]. It is a much more complex questionnaire with seven sections and 69 questions, most
of them using a 5-point scale, but also including 10-point scales and open questions
for free-text reply.
Studies assessing patients’ experience have reported some relevant findings. One study
interviewed patients who had undergone digestive endoscopy to assess the importance
of various aspects of satisfaction, highlighting significant factors for the patients
that are not included in the modified mGHAA-9 questionnaire, such as discomfort during
the procedure and the technical skill of the endoscopist, concluding that endoscopy
satisfaction assessments should cover access, appointments, information, procedure,
and discharge [170 ]. Other studies evaluating specifically the impact of sedation on patient experience
concluded that specific questionnaires may be needed for this situation, such as the
Patient Satisfaction with Sedation Instrument (PSSI) or the PROcedural Sedation Assessment
Survey (PROSAS) [171 ]
[172 ].
Regarding the delivery of the questionnaires, timing, method, and type (written paper
or digital) of questionnaire delivery can influence patient feedback, and recall bias
may affect responses, as well as sedation. According to a prospective study, most
patients initially appeared very satisfied after the endoscopy (possibly owing to
sedation and the survey setting), but satisfaction tended to decrease over time [173 ]. Another study compared satisfaction scores obtained by same-day on-site surveys
versus after-procedure (within 1 week) email surveys, with the on-site survey being
given after the endoscopist had discussed the results of the procedure and follow-up
plans with the patient [174 ]. The on-site surveys yielded higher satisfaction scores than email methods, influenced
by immediate discussion of results and follow-up plans by the endoscopist. Finally,
one study randomized 63 outpatients to receive the mGHAA-9 questionnaire by mail,
phone, or email within 1 week after their procedure, and nonresponders to the standard
mail and email surveys were subsequently contacted by telephone to determine their
level of satisfaction [175 ]. The phone survey response rate was higher (90 %) than email (70 %) or standard
mail (85 %), although email was the most cost-efficient mode; the nonresponders were
more satisfied, suggesting that feedback from responders might underestimate overall
satisfaction.
Another important factor to consider is who delivers the questionnaire to the patient,
a doctor, a nurse, or an assistant, and whether an assistant should be present or
not to help the patient during completion of the questionnaire. For instance, doctors
may lend importance to the survey, but might pressure patients to respond positively;
nurses, having closer patient rapport, might elicit more honest feedback [176 ].
Using trained assistants to provide neutral support to deliver the questionnaire can
ensure efficiency and consistency in high volume settings, as they can manage the
administrative workload, allowing clinical staff to focus on patient care. Having
an assistant to help patients to complete the questionnaires can improve response
rates and the completeness of data collected. This assistance is particularly beneficial
for patients who might have difficulties understanding the questionnaire or who need
physical assistance owing to health conditions. On the other hand, allowing patients
to complete the questionnaire independently can reduce potential bias, ensuring that
responses are entirely the patientʼs own.
Independently of the staff delivering the questionnaire, it seems important to have
meetings to review patient feedback to plan improvements [177 ]. In a prospective study of 202 patientsʼ self-reported preferences and expectations
for UGI endoscopy, the technical skill and personal manner of the endoscopist were
identified as top priorities, with environmental factors deemed less important [178 ].
In addition, it is important to note that patient comfort during an endoscopy might
be perceived differently by the staff and the patients. In a study validating the
Nurse-Assessed Patient Comfort Score (NAPCOMS) for colonoscopy, the score was compared
with endoscopists’ and patients’ reported global comfort using a visual 4-point Likert
scale [179 ]. There was a high agreement between the NAPCOMS and the endoscopists’ ratings, but
only a moderate agreement between the NAPCOMS or the endoscopists’ ratings and the
patients’ ratings.
In our digital age, using apps and artificial intelligence can streamline questionnaire
delivery and improve patient services, such as through educational videos before endoscopic
procedures [180 ]. Also, involving patients in shared decision-making, especially for therapeutic
procedures, can enhance the patient-centered approach [181 ].
Finally, language is an issue when delivering a questionnaire and these should be
validated for specific languages and not just translated from the original English
version and applied without a formal validation of the specific language version.
Therefore, we strongly encourage member societies and researchers to translate validated
questionnaires into their own language and also culturally adapt them where necessary,
and then validate them in patient groups and interviews.
In conclusion, evaluating patient experience with validated PREMs and adjusting delivery
details according to each center’s needs is crucial. To allow comparability, the endoscopy
department should choose one of the available questionnaires and always apply it in
the same way, choosing between one of several options: same-day or after-day delivery,
written paper or digital software, delivery by a doctor, nurse, or assistant, and
completion with or without the presence of an assistant. Regularly reviewing feedback
to implement necessary improvements can significantly enhance patient care and satisfaction.
7 Domain: Post-procedure
Key performance measure
BE surveillance according to guidelines
Performance measure
Patients with nondysplastic BE who are scheduled for endoscopic surveillance should
be monitored for guideline interval adherence
Description
Percentage of patients with nondysplastic BE who are scheduled for endoscopic surveillance
according to guideline intervals
Domain
Post-procedure
Category
Process/structural
Rationale
Proper assessment, stratification of risk, and allocation of correct endoscopic surveillance
interval for patients with nondysplastic BE allows accurate calculation of neoplasia
incidence and improves patient outcomes
Construct
Record all patients with a diagnosis of BE
Stratify the patient’s risk according to histological and/or endoscopic criteria
Record proposed endoscopic surveillance intervals and compare them with the recommended
guidelines
Denominator : All patients with a diagnosis of nondysplastic BE
Numerator : Patients in the denominator where the recommended endoscopic surveillance interval
is according to the respective guideline adopted
Exclusions : Therapeutic procedures, emergency procedures, and patients who reached 75 years
of age at the time of their last surveillance endoscopy, with life-expectancy < 5
years, or who do not wish to undergo surveillance or are judged to be medically unfit
for surveillance
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 96.6 %, Second round: 96.0 %
PICO number
16
Evidence grading
Low quality
Two previous statements did not reach agreement (agreement was between 70.4 % and
77.8 %). The acceptance of this performance measure is based on agreement with the
following updated and merged statement:
BE is defined as the presence of intestinal metaplasia of ≥ 1 cm extending into the
distal esophagus, either measured circumferentially or as the presence of a 1-cm tongue
[5 ]. Monitoring of adherence to recommended surveillance intervals allows for a reliable
estimation of the rates of dysplasia or esophageal adenocarcinoma detection; however,
the decision to include patients with BE in a surveillance program should be made
on a case-by-case basis, providing that the detection of any lesion would have a relevant
impact on the patient’s prognosis [5 ]
[182 ]. Updated evidence since the previous position statement includes a registry study
of 1066 patients from a population-based cohort, where the combined high grade dysplasia
or esophageal adenocarcinoma detection rate was just 4.9 % (95 %CI 3.8 % to 6.4 %),
lower than previously reported by referral centers [183 ].
Nonendoscopic risk factors for neoplasia detection include patient age, male sex,
and smoking status, but surveillance interval recommendations are mainly based on
the BE length [5 ]
[183 ]. However, no randomized clinical trial exists that has investigated the effect of
BE surveillance and, in cohort studies that suggested a survival benefit of BE patients
under surveillance, lead-/length-time bias might partially explain the observed differences
in prognosis [184 ].
In conclusion, given the scarcity of evidence for a patient outcome-focused performance
measure in BE management and real-life feasibility, the Working Group agreed that
only the adherence to the recommended intervals should be monitored, as not all endoscopy
centers with BE patients are linked to a dedicated surveillance registry.
Key performance measure
Gastric precancerous conditions surveillance according to guidelines
Performance measure
Patients with gastric precancerous conditions who are scheduled for endoscopic surveillance
should be monitored for guideline interval adherence
Description
Percentage of patients with gastric precancerous conditions who are scheduled for
endoscopic surveillance according to guideline intervals
Domain
Post-procedure
Category
Process/structural
Rationale
Proper assessment, stratification of risk, and allocation of correct endoscopic surveillance
intervals for patients with gastric precancerous conditions allows an accurate calculation
of neoplasia incidence and improves patient outcomes
Construct
Record all patients with a diagnosis of a gastric precancerous condition
Stratify the patient’s risk according to histological and/or endoscopic criteria
Record proposed endoscopic surveillance intervals and compare them with recommended
guidelines
Denominator : All patients with a diagnosis of a gastric precancerous condition
Numerator : Patients in the denominator where the recommended endoscopic surveillance interval
is according to the respective guideline adopted
Exclusions : Therapeutic procedures, emergency procedures, and patients who reached 75 years
of age at the time of their last surveillance endoscopy, with life-expectancy < 5
years, or who do not wish to undergo surveillance or are judged to be medically unfit
for surveillance
Standards
Minimum standard: ≥ 90 %
Target standard: ≥ 95 %
Consensus agreement
First round: 96.6 %, Second round: 92.0 %
PICO number
17
Evidence grading
Low quality
Two previous statements did not reach agreement (agreement was between 70.4 % and
77.8 %). The acceptance of this performance measure is based on agreement with the
following updated and merged statement:
For patients with gastric precancerous conditions, such as glandular atrophy or intestinal
metaplasia, the evidence to support endoscopic surveillance is variable and sometimes
contradictory [185 ]
[186 ]. This variation can be explained by differences in several aspects, such as the
biopsy-taking process, the quality of the specimen, and the pathologist’s assessment.
Despite this variability, various guidelines agree on differentiating low risk from
high risk patients. Based on this stratification, appropriate endoscopic surveillance
should be recommended. Generally, patients at lower risk are not recommended for surveillance,
while endoscopic surveillance every 3 years is advised for most high risk patients,
with even more intensive follow-up for patients with a first-degree family history
of gastric cancer [11 ].
To correctly stratify patients as low or high risk, two validated histological scores
exist, the OLGA (Operative Link for Gastritis Assessment) and OLGIM (Operative Link
on Gastric Intestinal Metaplasia Assessment) systems, which assess both the severity
and extension of atrophic changes or intestinal metaplasia, respectively [187 ]
[188 ]
[189 ]. In both classifications, patients are stratified into five stages grouped into
three categories: no risk (OLGA or OLGIM 0); low risk (OLGA or OLGIM I–II); and high
risk (OLGA or OLGIM III–IV). It has been suggested that histological risk stratification
could be done solely based on the extent of atrophic changes, regardless of severity
[190 ].
Patients may also be stratified as low or high risk based on two endoscopic scales
only, without histology, the Kimura–Takemoto classification for atrophy and the Endoscopic
Grading of Gastric Intestinal Metaplasia (EGGIM) classification for intestinal metaplasia
[99 ]
[100 ]
[101 ]
[103 ]
[104 ]
[105 ]. Both endoscopic classifications also allow patients to be stratified into three
categories.
The Kimura–Takemoto classification, based on identifying the atrophic border, stratifies
patients as: no risk (absence of atrophic border, C0); low risk (affecting only the
antrum or incisura, C1, with some studies including C2); and high risk (affecting
the corpus, from C3 to O3, with some studies also including C2) [99 ]
[100 ]. However, evidence for the routine application of the Kimura–Takemoto classification
is lacking in Western countries [191 ].
For the EGGIM classification, identification and grading of intestinal metaplasia
should be assessed in five areas: the lesser and greater curvature of the antrum,
the incisura, and the lesser and the greater curvature of the corpus [103 ]
[104 ]
[105 ]. Each area should be graded into three categories: 0 (absence of intestinal metaplasia);
1 (presence of intestinal metaplasia < 30 %); and 2 (presence of intestinal metaplasia
> 30 %). Patients with a score ≥ 5 have an increased risk for gastric cancer. The
EGGIM, based on the severity and extent of intestinal metaplasia, stratifies patients
as: no risk (EGGIM 0); low risk (EGGIM 1–4); and high risk (EGGIM 5–10).
[Table 4 ] summarizes the available classifications and risk groups. For other specific situations,
such as low risk patients with additional risk factors (surveillance might be considered)
or high risk patients with a first-degree relative with gastric cancer (might benefit
from a more intensive follow-up), a more detailed explanation is available [11 ].
Table 4
Risk stratification according to histological and endoscopic classifications and endoscopic
surveillance interval recommendation for patients with gastric precancerous conditions.
Validated classification
Gastric cancer risk
No risk
Low risk
High risk
OLGA
Stage 0
Stage I–II
Stage III–IV
OLGIM
Stage 0
Stage I–II
Stage III–IV
Kimura–Takemoto
C0
C1 and C2
C3 to O3
EGGIM
0
1–4
5–10
Surveillance recommendation
Not recommended
Not recommended
Every 3 years
EGGIM, Endoscopic Grading for Gastric Intestinal Metaplasia; OLGA, Operative Link
for Gastritis Assessment; OLGIM, Operative Link on Gastric Intestinal Metaplasia Assessment.
In conclusion, for patients diagnosed to be at high risk for gastric cancer, independently
of the stratification being by endoscopy only or histology, and the classification
used, only adherence to the recommended intervals should be monitored. This will allow
for epidemiological data collection and the gathering of evidence for an eventual
new future performance measure, such as the neoplasia detection rate.