This article is being published jointly in United European Gastroenterology Journal and Endoscopy . Copyright © 2018 by United European Gastroenterology and Georg Thieme Verlag KG
Abbreviations
ACG:
American College of Gastroenterology
ASGE:
American Society for Gastrointestinal Endoscopy
CI:
confidence interval
ERCP:
endoscopic retrograde cholangiopancreatography
ESGE :
European Society of Gastrointestinal Endoscopy
EUS:
endoscopic ultrasound
EUS-FNA:
endoscopic ultrasound-guided fine needle aspiration
FNB:
fine needle biopsy
GI:
gastrointestinal
GRADE:
Grading of Recommendations Assessment, Development and Evaluation
ISFU:
Importance, Scientific acceptability, Feasibility, Usability
N/A:
not available
NSAID:
nonsteroidal anti-inflammatory drug
PEP:
post-ERCP pancreatitis
PICO:
Population/Patient; Intervention/Indicator; Comparator/Control; Outcome
PSC:
primary sclerosing cholangitis
PTCD:
percutaneous transhepatic choledochal drainage
RCT:
randomized controlled trial
QIC:
Quality Improvement Committee
UEG:
United European Gastroenterology
Introduction
The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology
(UEG) have identified quality of endoscopy as a major priority. The rationale for
this priority and the methodology of the quality initiative process have been described
elsewhere [1 ]. The aim of the ESGE pancreatobiliary endoscopy working group was to identify a
list of key performance measures for EUS and ERCP that would be universally applicable.
As with previous ESGE performance measures [2 ]
[3 ] the focus was on metrics that met the following requirements: proven impact on clinically
relevant outcomes or quality of life; well-defined, and amenable to simple and robust
measurement; and applicability to all levels of endoscopy services. This paper describes
the methodological process utilized [1 ] and reports the agreed list of key performance measures for pancreatobiliary endoscopy.
Methodology
The multistep process of the methodology for developing performance measures has been
described previously [1 ]. During initial meetings of the working group, a PICO approach (where P stands for
Population/Patient; I for Intervention/Indicator; C for Comparator/Control; and O
for Outcome) was used to define clinically relevant questions. Systematic literature
searches were then performed by an expert team of methodologists. This in turn led
to the development of performance measures in a consensus process.
The PICOs and the clinical statements derived from these were modified or excluded
during iterative rounds of discussion of the working group members during a Delphi
process [4 ]
In total, working group members participated in two rounds of voting to agree on performance
measures in predefined domains and on their respective thresholds, discussed below.
Statements were modified during the process and ultimately discarded if agreement
was not reached after two voting rounds. The agreement that is given for the different
statements refers to the last voting round in the Delphi process. The threshold for
agreement was set at 80 % throughout the process. The key performance measures were
distinguished from minor performance measures on the basis of the ISFU criteria [1 ] (Importance, Scientific acceptability, Feasibility, Usability, and comparison with
competing measures), and expressed by mean voting scores. We used the Grading of Recommendations
Assessment, Development and Evaluation (GRADE) system to assess the quality of the
available evidence [5 ].
Performance measures for pancreatobiliary endoscopy
Performance measures for pancreatobiliary endoscopy
Using the evidence derived by the literature search group and input from the working
group members, a total of 10 clinical statements addressing 8 potential performance
measures grouped into five of the seven predefined quality domains were formulated.
Over the course of two voting rounds, a consensus agreement was reached for 8 statements
regarding 8 performance measures; 7 are considered to be key performance measures
and one a minor performance measure. The development process for performance measures
can be reviewed in the Supporting information (available online).
We used the highest mean voting scores to identify 7 key performance measures for
five of the seven quality domains ([Fig. 1 ]). As mentioned above, the remaining performance measure was considered to be a minor
performance measure. The pre-procedure domain and management of pathology domain each
had 2 performance measures. All performance measures were deemed valuable by the working
group members and were obtained after a rigorous process as described above. The use
of appropriate endoscopy reporting systems is crucial for facilitating data retrieval
on identified performance measures [6 ].
Fig. 1 The domains and performance measures chosen by the pancreatobiliary working group. EUS-FNA,
endoscopic ultrasound-fine needle aspiration; ERCP, endoscopic retrograde cholangiopancreatography;
PEP, post-ERCP pancreatitis; N/A, not available.
All the performance measures are presented below, according to domain, using the descriptive
framework developed by the quality improvement committee (QIC) and with a short summary
of evidence for the ISFU criteria. Each table describes a performance measure, the
level of agreement during the modified Delphi process (scores), how the performance
measure should be calculated, and recommendations supporting its adoption. The tables
also note the desired thresholds.
The minimum number needed to assess whether the threshold for a certain performance
measure has been reached can be calculated by estimating the 95 % confidence intervals
(CI) around the predefined threshold for different sample sizes [3 ]
[7 ]. As with previous ESGE performance measures, for issues of practicality and to simplify
implementation and auditing, we suggest that at least 100 consecutive procedures (or
all of them if fewer than 100 procedures are performed) should be measured to assess
a performance measure. Continuous monitoring is however the preferred method of measurement.
1 Domain: Pre-procedure
Key performance measure
Adequate antibiotic prophylaxis before ERCP
Description
The percentage of patients with adequate administration of prophylactic antibiotics
before ERCP.
Domain
Pre-procedure
Category
Process
Rationale
Reduction of infection, prevention of inappropriate antibiotic use
Construct
Denominator: Patients with indication for antibiotic prophylaxis
Numerator: Patients receiving antibiotics
Exclusions: Patients who are on ongoing antibiotic treatment
Calculation: Proportion (%) Level of analysis: Service and endoscopist level Frequency: Yearly audit of a sample of 100 consecutive cases
Standards
Minimum standard: 90 % Target standard: 95 %
Consensus agreement for performance measure
100 %
PICO number (see Supporting information)
3.1
Evidence grading
Low quality evidence
The acceptance of this performance measure is based on agreement with the following
statement:
Routine antibiotic prophylaxis is not recommended for ERCP in unselected patients.
Antibiotic prophylaxis should be given before ERCP for the subgroup of patients with
predicted incomplete biliary drainage, e. g. those with primary sclerosing cholangitis
(PSC) and hilar tumors; to immunocompromised individuals and to patients with pancreatic
pseudocysts communicating with the pancreatic duct. (Statement number 7.2)
Adherence to recommendations on prophylactic antibiotics before ERCP [8 ] should be monitored and reasons for deviation documented. The indication for antibiotic
prophylaxis should be recorded in the endoscopy report.
Routine antibiotic prophylaxis is not recommended for ERCP in unselected patients
as prophylactic antibiotics do not significantly reduce cholangitis in this setting.
A systematic review of RCTs [9 ] reported that antibiotics did not significantly prevent cholangitis in unselected
patients.
A Cochrane systematic review of RCTs [10 ] concluded that prophylactic antibiotics reduced cholangitis; however, in patients
in whom biliary obstruction was relieved there was no benefit in using prophylactic
antibiotics.
Key performance measure
Antibiotic prophylaxis before EUS-guided puncture of cystic lesions
Description
The percentage of patients with prophylactic antibiotics before EUS-guided puncture
of cystic lesions
Domain
Pre-procedure
Category
Process
Rationale
Patient safety, reduction of infection following EUS-fine needle aspiration (EUS-FNA)
Construct
Denominator: Patients undergoing EUS-FNA in cystic lesions
Numerator: Patients in denominator receiving antibiotics
Exclusions: Patients who are on ongoing antibiotic treatment
Calculation: Proportion (%) Level of analysis: Service and, if necessary, endoscopist level Frequency: Yearly, for a sample of 50 consecutive EUS-FNAs. If the minimum standard
is not reached, analysis on an individual level should be performed.
Standards
Minimum standard: 95 % Target standard: 95 %
Consensus agreement for performance measure
90 %
PICO number (see Supporting information)
3.2
Evidence grading
Very low quality of evidence
The acceptance of this performance measure is based on agreement with the following
statement:
The percentage of patients with administration of prophylactic antibiotics before
EUS-guided puncture of cystic lesions should be at least 95 % (minimum standard).
In general, antibiotic prophylaxis should be used; the reason for any deviation (patient
intolerance, patient preference etc.) should be reported.
The rate of infectious complications following EUS-guided puncture of cystic lesions
is low [11 ]
[12 ]. There are no systematic reviews or RCTs comparing antibiotics with no antibiotics
before EUS-guided puncture of cystic lesions although one study compared two regimens
of antibiotics [13 ], and two retrospective cohort studies [14 ]
[15 ] focused exclusively on pancreatic cystic lesions. The study by Kwok and colleagues
[13 ], in which 117 patients were screened over an 11-month period, lacked statistical
significance however, since only 22 % of screened patients could be enrolled. The
observed rate of cyst infection was zero. An adequately powered study to test noninferiority
of withholding antibiotics in this setting would likely be logistically challenging
since the authors calculated that inclusion of between 614 and 2450 patients would
be needed. Current ESGE [16 ] and American Society for Gastrointestinal Endoscopy (ASGE) [8 ] guidelines recommend the use of prophylactic antibiotics for the EUS-guided puncture
of cystic lesions although data are equivocal [14 ]. In addition, the use of prophylactic antibiotics might not be free of adverse events.
2 Domain: Completeness of procedure
2 Domain: Completeness of procedure
Key performance measure
Bile duct cannulation rate
Description
The percentage of successful bile duct cannulations in patients with normal anatomy
(and native papilla)
Domain
Completeness of procedure
Category
Process
Rationale
Successful biliary ERCP requires deep cannulation of the common bile duct via the
major duodenal papilla. A low bile duct cannulation rate is associated with a delay
in definitive therapy and increased risk of adverse events, and leads to increased
costs and inconvenience as the examination has to be repeated or recourse made to
alternative therapeutic techniques
Construct
Denominator: All procedures in patients with normal anatomy
Numerator: Procedures that document successful biliary cannulation (report and fluoroscopy)
Exclusions: Procedures with no indication for biliary cannulation. Previous biliary sphincterotomy
Calculation: Proportion (%)
Level of analysis: Service and endoscopist level
Frequency: Yearly audit of a sample of 100 consecutive cases Successful bile duct cannulation, meaning deep cannulation of the common bile duct
via the major duodenal papilla, should be documented in a written report as well as
in fluoroscopy documentation
Standards
Minimum standard: 90 % Target standard: 95 % (in expert centers)
Consensus agreement for performance measure
100 %
PICO number (see Supporting Information)
1.17
Evidence grading
Low quality evidence
The acceptance of this performance measure is based on agreement with the following
statement:
Technical success at biliary ERCP is predicated on successful deep cannulation of
the desired duct. Success or failure of cannulation should be documented in the post-procedure
report for all cases. In certain clinical scenarios, e. g. pyloric or duodenal stenosis
and post-surgical altered anatomy, conventional ERCP may be impossible and such cases
are not included in this performance measure. In addition, patients with prior sphincterotomy
should not be included in the calculation of cannulation rate. There are a number
of potential determinants of successful cannulation of a native papilla, including
endoscopist experience and case mix. The literature predominantly reports outcomes
from academic centers, where case mix and experience may differ from other settings.
The included studies reported cannulation rates from 70.5 % to 100 % [17 ]
[18 ]
[19 ]
[20 ]
[21 ]
[22 ]
[23 ]
[24 ]
[25 ]
[26 ]
[27 ]
[28 ]
[29 ]
[30 ]
[31 ]
[32 ]
[33 ]
[34 ]
[35 ]
[36 ]
[37 ]
[38 ]
[39 ]
[40 ]
[41 ]
[42 ]
[43 ] with a median of 96 % and mean of 91.4 %. The consensus of the working party was
that a competent ERCP practitioner should achieve a cannulation rate in excess of
90 % with a target standard of 95 % at expert centers. ESGE guidance on different
techniques is available [44 ].
During the voting process (second voting round), members of the pancreatobiliary working
group discussed whether this performance measure (bile duct cannulation rate) should
be extended and be adopted to both duct systems in the pancreatobiliary system – the
common bile duct and the pancreatic duct – by stating “cannulation rate of desired
duct.” However, to our knowledge, there are no data which would support adopting such
a performance measure.
3 Domain: Identification of pathology
3 Domain: Identification of pathology
Key performance measure
Tissue sampling during EUS
Description
Frequency of obtaining a diagnostic tissue sample in EUS-FNA or EUS-fine needle biopsy
(FNB) of solid lesions
Domain
Procedure
Category
Process
Rationale
Improve technical success of EUS-FNA/FNB of solid lesions
Construct
Denominator: All EUS-FNAs of solid lesions performed
Numerator: Successful acquisition of diagnostic tissue of solid lesions during EUS
Exclusions: Patients with post-surgery altered anatomy
Calculation: Proportion (%) Level of analysis: Service and endoscopist level Frequency: Yearly, for a sample of 50 consecutive EUS-FNAs. If the minimum standard
is not reached, analysis on an individual level should be performed
Standards
Minimum standard: 85 % Target standard: 90 %
Consensus agreement for performance measure
90 %
PICO number (see Supporting Information)
1.21
Evidence grading
Very low quality of evidence
The acceptance of this performance measure is based on agreement with the following
statement:
The percentage of patients in which a full diagnostic tissue sample, meaning a tissue
sample allowing an accurate diagnosis, is obtained in EUS-FNA of solid lesions should
be documented. The frequency of successful EUS-FNA of a solid lesion should be at
least 85 % (minimum standard); ESGE proposes a target standard of 90 %.
Since the evidence is of very low quality, this recommendation is to be considered
as expert opinion. Although the evidence is scarce as regards the available literature
[45 ]
[46 ]
[47 ]
[48 ]
[49 ]
[50 ]
[51 ]
[52 ]
[53 ]
[54 ]
[55 ]
[56 ], we consider the clinical issue of successful tissue sampling to be a major element
in EUS. Based on the impact of EUS-fine needle puncture, whether performed as aspiration
(FNA) or biopsy (FNB), we feel that this clinical quality indicator must be used as
a key performance measure.
Minor performance measure
Adequate documentation of EUS landmarks
Description
Percentage of EUS reports that contain appropriate documentation of relevant landmarks
Domain
Identification of pathology
Category
Process
Rationale
Ensure comprehensive identification of pathology
Construct
Denominator: All EUS procedures
Numerator: EUS procedures where the landmark documentation is adequate
Exclusions: EUS-guided therapy. Sampling of well-defined lesions where further anatomical overview
is irrelevant Calculation: Proportion (%) Level of analysis: Service and, if necessary, individual Frequency: Yearly, for a sample of 50 consecutive EUS procedures. If the minimum standard
is not reached, analysis on an individual level should be performed
Standards
Minimum standard: 90 % Target standard: 90 %
Consensus agreement for performance measure
100 %
PICO numbers (see Supporting Information)
2.1 – 2.4
Evidence grading
Very low quality of evidence (expert opinion)
The acceptance of this performance measure is based on agreement with the following
statement:
The components of a complete EUS investigation will vary depending on the indications
for the procedure. In many cases, however, the visualization and documentation of
standardized landmarks give a measure of the quality of the procedure. Documentation
of the appropriate landmarks includes detailed description in the patient record of
the endosonographic findings of the EUS procedure, and ideally, procedure quality
will be enhanced by image documentation of normal or diseased landmarks. Such reporting
forms the basis of the quality indicator. Although EUS is not indicated for staging
of metastatic tumors, which might have been previously documented by other imaging
modalities, there are clinical settings in which EUS may be indicated nevertheless,
for example if therapeutic decision making is based on EUS findings, or if EUS-FNA
is used to obtain a full diagnostic tissue sample (see domain above, Identification
of pathology) which may change the further management of the patient.
There are few data supporting the specification of the landmarks required for a high
quality report, but the selection of landmarks surely relates to the indication for
the procedure. The QIC working group agreed that, depending on the indication for
EUS, the landmarks shown in [Table 1 ] should be evaluated during the EUS procedure and the assessment recorded afterwards.
This includes a written report and documentation of the relevant images.
Table 1
Landmarks to be assessed at endoscopic ultrasound (EUS) according to the indication
for the procedure.
Indication for EUS
Relevant landmarks for visualization and documentation
Mediastinal lesion/Esophageal cancer
Mass/tumor Mediastinum (lymph nodes) Gastroesophageal junction Celiac axis (lymph nodes) Left lobe of the liver (to rule out metastatic disease)
Subepithelial tumor
Subepithelial mass including the affected wall layers Regional lymph nodes Vascular infiltration Infiltration of surrounding organs (e. g. liver, pancreas)
Pancreatobiliary cancer
Entire pancreas including pancreatic mass (tumor, cancer) Biliary tract (common bile duct, cystic duct, gallbladder) Local lymph nodes (peripancreatic) Celiac axis (lymph nodes) Left lobe of the liver and visible parts of the right lobe (to rule out metastatic
disease) Vascular infiltration: superior mesenteric artery, superior mesenteric vein, portal
vein Infiltration of other peripancreatic organs
Rectal cancer
Tumor including its location, expansion, infiltration of surrounding structures Surrounding structures: genitourinary structures, iliac vessels, sphincter apparatus,
lymph nodes
In 2015, an ASGE – American College of Gastroenterology (ACG) task force published
a work on quality indicators for EUS [58 ]. The authors stated that inclusion of the indication for EUS in the procedural documentation
for all cases is a useful quality measure for two reasons. First, it may provide a
justification for the procedure, serving as a means of tracking compliance with accepted
indications. Second, the indication puts the procedure report into a context wherein
reporting of certain EUS landmarks and finding characteristics should logically follow.
For example, a detailed description of the pancreatobiliary system may not be necessary
when the indication for EUS is staging of esophageal cancer. If the indication for
the EUS examination is staging of esophageal cancer, certain landmarks should be included
(uT-stage and uN-stage, including celiac axis visualization). The exception to this
is in the case of failed passage of a stenosed stricture when the tumor cannot be
safely passed.
4 Domain: Management of pathology
4 Domain: Management of pathology
Key performance measure
Appropriate stent placement in patients with biliary obstruction below the hilum
Description
Percentage of successful stent placements in cases of strictures located below the
liver hilum, after successful cannulation
Domain
Completeness of procedure
Category
Process
Rationale
Unsuccessful stent placement is associated with an increased risk of cholangitis and
entails further health care costs and potential hospitalization.
Construct
Denominator: All ERCPs in patients with subhilar biliary strictures requiring stent placement,
after successful cannulation
Numerator: Successful stent placement
Calculation: Proportion (%) Level of analysis: Service and endoscopist level Frequency: Yearly audit
Standards
Minimum standard: 95 % Target standard: 95 %
Consensus agreement for performance measure
90 %
PICO number (see Supporting Information)
1.19
Evidence grading
Low quality evidence
The acceptance of this performance measure is based on agreement with the following
statement:
This statement refers to placement of plastic or metal stents. Subhilar strictures
are the type most commonly encountered in daily practice. Stent placement in patients
with obstruction below the hilum is technically less challenging than placement for
obstruction at or above the hilum, with high success rates reported [59 ]
[60 ].
Indications include failure to clear bile duct stones, and the presence of biliary
strictures of benign or malignant origin. Competent ERCP practitioners should achieve
successful subhilar stent placement in at least 95 % of cases.
Key performance measure
Bile duct stone extraction
Description
Adequate removal of bile duct stones (< 10 mm) utilizing a retrieval balloon or basket
Domain
Management of pathology
Category
Process
Rationale
Incomplete stone extraction increases the risk of cholangitis and entails further
health care costs and potential hospitalization.
Construct
Denominator: All ERCPs for patients with bile duct stones of < 10 mm in diameter (after successful
cannulation of the common bile duct)
Numerator: Successful stones removal
Calculation: Proportion (%) Level of analysis: Service and endoscopist level Frequency: Yearly audit of a sample of 100 consecutive cases
Standards
Minimum standard: 90 % Target standard: 95 % (in expert centers)
Consensus agreement for performance measure
90 %
PICO number (see Supporting Information)
1.18
Evidence grading
Low quality evidence
The acceptance of this performance measure is based on agreement with the following
statement:
The endoscopy report should provide details about size, number, and position of stones
in the bile duct, and whether they were successfully cleared from the duct. All relevant
findings, such as the presence of a stricture, should also be recorded.
A range of techniques and devices, including balloon/basket extraction, balloon dilation
of the ampulla, and mechanical lithotripsy, are available for clearance of stones
from the bile duct with high success rates reported for stones smaller than 10 mm
in size [61 ]
[62 ]. Competent ERCP practitioners should be able to achieve a duct clearance rate in
excess of 90 %.
5 Domain: Adverse events and harms
5 Domain: Adverse events and harms
Key performance measure
Post-ERCP pancreatitis (PEP)
Description
Rate of PEP diagnosed according to consensus definition [63 ]
Domain
Procedure
Category
Process
Rationale
Pancreatitis is the most frequent complication of ERCP and potentially life-threatening.
The rate of PEP is a surrogate quality indicator for performance of ERCP
Construct
Denominator: All procedures
Numerator: Cases in which acute pancreatitis develops
Exclusions: Patients with post-surgical altered anatomy
Calculation: Proportion (%) Level of analysis: Service and endoscopist level Frequency: Yearly audit of a sample of 100 consecutive cases. Rate of pancreatitis
should be evaluated according to the case mix
Standards
Minimum standard: < 10 % Target standard: < 5 %
Consensus agreement for performance measure
100 %
PICO number (see Supporting Information)
1.7
Evidence grading
Low quality evidence
The acceptance of this performance measure is based on agreement with the following
statement:
Post-ERCP pancreatitis (PEP) is the most common adverse event following ERCP and is
therefore the most appropriate indicator of adverse event rate. There are a number
of well-recognized risk factors, including female sex, normal bilirubin, and previous
PEP. A recent systematic review of randomized controlled trials documented an overall
PEP rate of 9.7 % with a rate of 14.7 % in high risk patients [64 ]. Large observational studies have reported rates of between 2.7 % and 5.1 % [65 ]
[66 ]
[67 ]
[68 ]. A minimum standard of < 10 % adverse event rate (pancreatitis) is therefore recommended,
with a target standard of 5 %. At audit, the rate of pancreatitis should be evaluated
in terms of case mix. ESGE recommends PEP prophylaxis using rectal nonsteroidal anti-inflammatory
drug (NSAID) administration for all patients in whom a contraindication does not exist,
and consideration of placement of pancreatic duct stents in high risk cases [69 ]. The working group suggests the documentation of use of rectal NSAIDs and prophylactic
pancreatic duct stenting, to facilitate root cause analysis in severe cases of pancreatitis
and to investigate reasons why this performance measure might not be reached.
General conclusions, research priorities, and future prospects
General conclusions, research priorities, and future prospects
These performance measures, generated by evidence-based consensus, can be used for
pancreatobiliary endoscopy, including ERCP and EUS (in general, as applied for large
parts of the GI tract). We used a systematic and scientifically based methodology
to substantiate the proposed measures with available evidence where possible. As this
is a largely unexplored field, most of the evidence found was, as expected, graded
as low quality. This generated important research priorities, primarily to audit the
proposed performance measures and to evaluate whether they do in fact influence health
outcome. Service providers would then be responsive to the findings and change practice.
Furthermore, the working group identified several additional research priorities;
these are listed in [Table 2 ] (ERCP) and [Table 3 ] (EUS) and will be addressed in a paper from the ESGE Research Committee.
Table 2
Research priorities identified by the pancreatobiliary working group for quality improvement
performance measures: endoscopic retrograde cholangiopancreatography (ERCP).
Prophylaxis of post-ERCP pancreatitis: Value of pancreatic duct stenting vs. NSAIDs?
Where and when (early/late) is precut indicated and safe?
How to manage benign pancreatic strictures?
Is ERCP-radiofrequency ablation (RFA) safe and effective for palliative cancer treatment?
What is the optimal endoscopic approach to access the biliary tree in in patients
with altered anatomy?
Table 3
Research priorities identified by the pancreatobiliary working group for quality improvement
performance measures: endoscopic ultrasonography (EUS).
What are the thresholds for accurate T and N staging of GI malignancies?
How does the accurate description of landmarks influence quality of EUS staging?
How can the results of EUS-fine needle aspiration (FNA) (tissue sampling) and fine
needle biopsy (FNB) be improved?
Value of rapid on-site cytological evaluation (ROSE)
Formal EUS-FNA teaching classes/curriculum
Clinical cytology for endoscopists
Therapeutic EUS
Management (ablation) of cystic neoplasias of the pancreas
Endosonography-guided ablation therapy and implantation of diagnostic material (fiducial
placement)
Interventional endosonographic drainage procedures (e. g., randomized controlled trial
on EUS-biliary drainage vs. percutaneous transhepatic choledochal drainage [PTCD])
Endosonography-guided therapy of acute cholecystitis
How do we improve noninvasive diagnostic methods (e. g. contrast-enhanced EUS, 3D-reconstruction)
for differential diagnosis of pancreatic cancer and non-neoplastic diseases?
What is the optimal endoscopic approach to access the biliary tree in in patients
with altered anatomy?
What are the roles of MRCP, ERCP, and EUS in purely diagnostic clinical questions?
MRCP, magnetic resonance cholangiopancreatography.
This manuscript, like the other ESGE quality improvement papers, is a working document
that will be used, it is hoped, by national member societies to determine which performance
measures can feasibly be monitored in the setting of their countries and which measures
are relevant. The first task now is to implement these new performance measures into
endoscopy practice throughout Europe on a national basis. This is in order to determine
the value of setting performance measures, to allow audit against such measures, and,
in the light of audit findings, to permit responsive adaptation of performance measures
in the future.
The implementation of performance measures is important to identify services and individual
endoscopists with lower performance levels. Obviously, there are no legal implications
associated with the ESGE QIC Initiative since these documents are not guidelines but
are rather guidance on how quality can be monitored for all aspects of GI endoscopy.
The aim of setting performance measures is to improve the quality of endoscopy, and
we encourage individual endoscopists, as well as heads of endoscopy units, to implement
these performance measures without delay. Since the techniques of ERCP and EUS, belong
to the most sophisticated endoscopic examinations, with a flat learning curve, performance
measures should be put in place as soon as possible to monitor endoscopist and endoscopy
unit performance. At a unit level, this may mean investing in hardware to accommodate
a more efficient auditing process.
Through such feedback, measures can be taken to improve quality, to rise above the
proposed minimum thresholds. This should not be considered as a “1984”-like scenario
with the goal of penalizing specific endoscopists, but rather as a tool to improve
patient outcomes, and provide training and assistance to endoscopists where needed.
A second barrier may be the perceived financial implications of establishing a quality
control system. The aim is to encourage hospital management to support the implementation
of these performance measures in endoscopy services. We think that in an era where
hospital accreditation is becoming more important, hospital administrations will be
more inclined to support such actions.
Moreover, we owe it to our patients to overcome individual or financial barriers to
ensure that endoscopy services are of the highest quality, and to set research priorities
to gather data that will inform the next generation of performance measures ([Table 4 ]).
Table 4
Performance measures to be included in the future for quality improvement in endoscopic
retrograde cholangiopancreatography (ERCP) and endoscopic ultrasonography (EUS).
Application of NSAIDs for prevention of post-ERCP pancreatitis
Documentation of relevant structures specific to the indication for EUS examination
Completeness of ERCP documentation (endoscopic and radiological images)
Radiation exposure and protection (staff and patient)
Accuracy of T and N staging for cancer
Cost – effectiveness of diagnostic and therapeutic cholangioscopy (is there an overuse
of cholangioscopy?)
Patient involvement in discussing performance measures
NSAIDs, nonsteroidal anti-inflammatory drugs
Supporting information
The detailed literature searches performed by an expert team of methodologists, as
well as evolution and adaptation of the different PICOs and clinical statements during
the Delphi voting process can be viewed in Supporting Information on the ESGE website.
online content viewable at: https://www.esge.com/performance-measures-for-ercp-and-eus.html