frontline gastroenterology 2014 ekkelenkamp

RESEARCH

Quality evaluation throughself-assessment: a novel method togain insight into ERCP performance

Vivian E Ekkelenkamp, Arjun D Koch, Jelle Haringsma, Jan-Werner Poley,Henk R van Buuren, Ernst J Kuipers, Robert A de Man

Department of Gastroenterologyand Hepatology, Erasmus MC,University Medical CenterRotterdam, Rotterdam,The Netherlands

Correspondence toDr Vivian E Ekkelenkamp,Department of Gastroenterologyand Hepatology, Erasmus MC,University Medical Center,room Ca-415, P.O. Box 2040,Rotterdam 3000 CA,The Netherlands;[email protected]

Received 3 April 2013Revised 21 June 2013Accepted 2 July 2013Published Online First18 July 2013

To cite: Ekkelenkamp VE,Koch AD, Haringsma J, et al.Frontline Gastroenterology2014;5:10–16.

ABSTRACTBackground The American Society forGastrointestinal Endoscopy Committee onOutcomes Research has recommendedmonitoring nine endoscopic retrogradecholangiopancreatography (ERCP)-specific qualityindicators for quality assurance in ERCP. With thedevelopment of a self-assessment tool for ERCP(Rotterdam Assessment Form for ERCP—RAF-E),key indicators can easily be assessed.Objective The aim of this study was to test indaily practice an easy-to-use form for assessmentof procedural quality in ERCP and to determineERCP quality outcomes in a tertiary referralhospital.Design This was a prospective study carried outin a tertiary referral hospital. In January 2008, aquality self-assessment programme was started.Five qualified endoscopists participated in thisstudy. All ERCPs were appraised using RAF-E.Primary parameters were common bile duct(CBD) cannulation rate and procedural success.The indication was classified and proceduraldifficulty was graded; success rates oftherapeutic interventions were measured for alldifferent difficulty degrees.Results A total number of 1691 ERCPs wereperformed. 1515 (89.6%) of these wereappraised using RAF-E. Median CBD cannulationsuccess rate was 94.1%. Successfulsphincterotomy was accomplished in almost allpatients (median 100%; range 98.2–100%).Stent placement was successful in 97.8% andcomplete stone extraction, if indicated, wasachieved in 86.8%.Conclusions Quality indicators for ERCP can bemeasured using the Rotterdam self-assessmentprogramme for ERCP. Outcome data in ERCPsobtained with this RAF-E provide insight into thequality of individual as well as groupperformance and can be used to assess and setstandards for quality control in ERCP.

BACKGROUNDIn endoscopic procedures, the awareness onquality has increased over the last decade.Important landmarks are documentingwhether the intended outcome of the pro-cedure was achieved under the restriction ofacceptable side effects, patient comfort andcosts. Endoscopic retrograde cholangiopan-creatography (ERCP) is a complex and chal-lenging procedure for diagnosis andtreatment of biliary and pancreatic disor-ders. It carries a relatively high risk of com-plications, and thus, assurance of quality ispivotal.1–3

However, monitoring and enhancing thequality of endoscopic procedures is impos-sible without methods to register specificparameters. Therefore, the AmericanSociety for Gastrointestinal Endoscopy(ASGE) Committee on Outcomes Researchhas defined a set of quality indicators forERCP.4 These quality indicators roughlyfall in three separate domains: pre-procedural quality indicators (appropriate-ness of indication), procedural quality indi-cators (ie, common bile duct (CBD)cannulation rates and therapeutic success)and post-procedural outcomes (ie, docu-mentation and complications). There havebeen several publications on complicationsas a marker of quality,5–9 but proceduralsuccess or patient-related outcomes are lessoften described.10

In addition, self-assessment of proced-ural performance in ERCP might enhancequality by stimulating active reflection onone’s actions. Questions on topics such asindividual versus group performance,personal performance level comparedwith that of colleagues and how tolearn from mistakes made can beanswered through proper self-assessment.

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Furthermore, specific objective outcomes such as CBDcannulation rate can easily be calculated. In order togain insight into quality of ERCPs, especially focusingon endoscopists’ performance, we developed a self-assessment programme for ERCP. A similar method hasproven its value for colonoscopy.11 Based on this study,as well as on previously validated assessment tools, theRotterdam Assessment Form for ERCP (RAF-E) wasdeveloped (figure 1).12–14

The aim of this study was to test in daily practice aneasy-to-use form for assessment of procedural qualityin ERCP. A major drawback of an easy-to-use form tobe completed after every procedure without taking uptoo much time is the number of parameters that canbe measured. Second, we aimed to determine ERCPquality outcomes in a tertiary referral centre.

METHODSFrom January 2008 to December 2011, a prospective,single centre evaluation of ERCP performance wascarried out in the Erasmus MC, University MedicalCenter in Rotterdam, the Netherlands. A qualityassessment programme was carried out through the

use of self-assessment. All staff members of thedepartment performing ERCP participated. All ERCPprocedures performed by these five qualified endosco-pists were included in the analysis. Both scheduledand emergency procedures were included.Participants completed RAF-E after each ERCP. The

form, as shown in figure 1, contains an objective partand a subjective part. Objective parameters includeindication, difficulty degree adapted from Schutz’sclassification (table 1),15 previous failed attempts atcannulation in a different centre and the presence of a‘virgin’ papilla or previous sphincterotomy, as well asCBD cannulation success and success of various thera-peutic procedures. In the subjective section, endosco-pists are asked to grade their performance on a VisualAnalogue Scale. After each completion of a set of 10assessment forms, an improvement plan can be formu-lated based on the Osborn–Parnes Creative ProblemSolving Process as used in other fields.16 The subject-ive scores are not taken into account in the statisticalanalysis, nor the outcome of the improvementplan. The value of the subjective assessment lies increating self-awareness to enable self-reflection on

Figure 1 The Rotterdam Assessment Form for endoscopic retrograde cholangiopancreatography (ERCP). PSC, primary sclerosingcholangitis.

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performance rather than in providing evidence forquality measurements. To exclude registration bias, allnon-self-assessed cases were evaluated as well. Thenumber and outcome of these were studied by check-ing reports from the endoscopy database and assessedaccording to the same RAF-E criteria.A questionnaire with questions on the endoscopists’

experience with the form, why some forms were notcompleted and suggestions for improvement was filledout by all participating endoscopists to gain insightinto their opinion on the added value of this qualitymeasurement programme.

STATISTICAL ANALYSISData were analysed using the statistical softwarepackage PASW V.17. Descriptive statistics and graphswere used to characterise the data. χ2 tests were usedin order to test for differences between two groups.Regarding all results, a two-sided p-value <0.05 wasconsidered statistically significant. Performance dataon cannulation rate are expressed as group mediansplus ranges unless stated otherwise.

RESULTSFrom January 2008 to December 2011, the five quali-fied endoscopists performing ERCP in our depart-ment participated in this study. A total number of1691 ERCPs was performed by these endoscopists inthis period. Fifteen hundred fifteen procedures wereappraised using RAF-E. Adherence to completion ofthe self-assessment forms was 89.6%. All 176 non-assessed ERCPs were checked manually by derivingreports from our electronic endoscopy reportingsystem that captures all procedures. The CBD cannu-lation success rate of non-assessed procedures was notsignificantly different from self-assessed ERCPs(95.3% vs 94.1%; χ²=0.774, p=0.379).The appraised procedures were further analysed.

The average number of ERCPs per endoscopist peryear was 116 (range 56–184). Table 2 presents anoverview of indications and complexity for ERCP inthis hospital. The distribution of difficulty degrees isshown in table 3. Figure 2 shows the ERCP difficulty

degree distribution per endoscopist. Table 4 shows theresults of performance data of all endoscopists whoparticipated in this study (total procedural outcomesas well as separate per difficulty degree).

Indications per difficulty levelThe most frequent indications in level 1 ERCPs wereCBD stones (n=251; 27.6%), benign strictures(n=216; 23.7%) or malignant strictures (n=240;26.4%). Malignant stricture was in the level 2 group,the most frequent indication for ERCP; this accountedfor 41.7% of the total number (n=96). The majorpart of level 3 ERCPs was performed for pancreaticindications, such as endoscopic therapy in chronicpancreatitis (47.2% of all level 3 ERCPs).

Success of proceduresProcedural success was calculated for the mostcommon indications: stone extraction and benign ormalignant strictures. In 148 patients with stones, bothsphincterotomy and stone extraction were attemptedafter cannulation of CBD. In these cases, sphincterot-omy was successfully performed in all cases as welland complete stone extraction was successful in92.3%. Procedural success in cases in which ERCPwas indicated for suspicion of CBD stones was there-fore 92.3% (range 84.2–94.4%). In patients withstrictures (either benign or malignant; n=482), CBD

Table 1 Degrees of difficulty based on Schutz’s classification15

Difficultydegree Biliary procedures Pancreatic procedures

Grade 1 ▸ Diagnostic cholangiography▸ Biliary cytology▸ Stone extraction ≤10 mm▸ Dilatation of stenosis/stent placement/nasobiliary drain in extrahepatic

strictures

▸ Diagnostic pancreatography▸ Pancreatic cytology

Grade 2 ▸ Stone extraction >10 mm▸ Dilatation of stenosis/stent placement/nasobiliary drain in hilar tumours or

benign intrahepatic strictures

▸ Cannulation of papilla minor

Grade 3 ▸ BII anatomy▸ Intrahepatic stone extraction▸ Stone extraction with lithotrypsy

▸ Therapeutic pancreatic procedures, includingpseudocyst drainage

Table 2 Overview of indications for ERCP

IndicationNumber of procedures(total n=1515) (%)

Stones 346 (22.8)

Malignant stenosis 359 (23.7)

Benign stenosis 272 (18.0)

Chronic pancreatitis 190 (12.5)

PSC 90 (5.9)

Biliary leakage or trauma 79 (5.2)

Endoprosthesis change 41 (2.7)

Other 138 (9.1)

ERCP, endoscopic retrograde cholangiopancreatography; PSC, primarysclerosing cholangitis.

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cannulation success rate was 98.4% and stent place-ment was successful in 96.8% of the cases, resultingin an overall 95.3% (range 82.4–100%) proceduralsuccess rate.The CBD cannulation success rate in patients with a

virgin papilla compared with patients who had under-gone a previous sphincterotomy was significantlydifferent (87.0 (range 79.2–95.5) vs 98.4% (range90.5–100); χ²=36.66, p<0.01). Analysing CBD can-nulation success rate in previous ERCP failure versusno failed procedure before (86.7 vs 96.2%) showed asignificant difference as well (χ²=13.88, p<0.01).

QuestionnaireThe participating endoscopists were asked to givetheir opinion about the self-assessment programmethrough a short questionnaire. The common opinionwas that this programme was valuable and useful togain insight into performance. The form was found tobe easy to fill out with clear questions. It took the par-ticipating endoscopists approximately 1 min to fill outthe form. The endoscopists were also asked forreasons why some procedures were not assessed. Themain reason for this was that they forgot to fill out

RAF-E due to time pressure or busy programmes.Receiving feedback on performance was stated asimportant in order to achieve and maintain goodadherence.

DISCUSSIONIn this study, we prospectively evaluated the perform-ance of endoscopists with respect to ERCPs in a ter-tiary referral hospital using a self-assessment method.With a simple form, we were able to present a descrip-tive analysis of indications, difficulty degrees, cannula-tion success rates and therapeutic success. This qualityassessment of 1515 procedures gave insight into per-formance of individual endoscopists as well as groupperformance. The self-assessment programme seems areliable method to monitor quality and performance.With the rising attention for quality assurance and theexpectancy that healthcare inspection will take mea-sures within the near future in order to assess andassure endoscopic quality, this method of self-assessment seems a useful instrument to register per-formance. In addition to complication registration,which is already compulsory for all endoscopy depart-ments in our country, this procedural registration willaddress a different and valuable aspect of proceduralquality.

Development of the formThe demand for quality assessment in endoscopic pro-cedures is increasing, but up until now, there is still nogold standard to assess the quality of ERCPs. Dutchguidelines state that an endoscopist is certified for

Figure 2 Endoscopic retrograde cholangiopancreatography (ERCP) difficulty degree distribution per endoscopist.

Table 3 Distribution of difficulty degrees

Difficulty degree n (%)

1 910 (60.1)

2 230 (15.2)

3 375 (24.8)

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ERCP when he has performed 100 procedures (DutchAssociation of Gastroenterologists). Obviously, there isno scientific basis for this threshold number and thequality of these procedures remains unknown. ASGEguidelines state that a CBD cannulation success rate of≥90% is an overall appropriate target, includingexperts, and that most endoscopists should be able toachieve a success rate of 85%.4 In general, gastroen-terologists in smaller regional hospitals usuallyperform ERCPs with a level 1 difficulty degree.Technically more challenging procedures with diffi-culty level 2 or 3 are more often performed in tertiaryreferral centres. Questions regarding quality are beingraised, such as the number of successful CBD cannula-tions and whether there was a difference in successbetween virgin papillas and patients with previoussphincterotomy. Numbers on the most frequently per-formed types of procedures are interesting as well.Another matter might be about a case with successfulCBD cannulation, but failed stone extraction. On topof these questions, we wanted to encourage criticallyreflecting on one’s performance. Our aim was todevelop a self-assessment form that was easy to fillout and addressed the problems raised. A major draw-back of too extensive evaluation forms is the inverselycorrelated drop in adherence to filling them out as weexperienced in a pilot study. As reported by the parti-cipants, the most common reason not to fill out the

form was lack of time during a busy programme. Itwas thus necessary to find a balance between thenumber of questions asked in the form and ease ofcompleting it. Unfortunately, this implies an inevitabletrade-off for a number of parameters that would havebeen interesting to monitor as well. In order toachieve compliance as high as possible and to developa practical assessment tool for future, the mostimportant outcome parameters were determinedthrough expert opinion and this process resulted inthe development of the RAF-E form used in thisstudy. The final version of the form combines registra-tion of procedural intention and outcome; we haveused parts of previously validated assessment toolsand metrics as described by Peter Cotton.17 18

Parameters that were scored as ‘partially successful’were considered to be failures in the analysis in orderto avoid any discussions on definitions of partialsuccess. The results have shown that RAF-E is aneasy-to-use device that provides insight into perform-ance of individual endoscopists as well as largergroups. Unfortunately, the improvement plan wassparsely filled out by the experts, so it is difficult tomake a statement on whether performance hasimproved afterwards. However, it might be worthconsidering linking RAF-E to the electronic endos-copy reporting system. This is a desirable step to takewithin the near future, which ensures the reliability of

Table 4 Performance data

ERCP difficulty Intent Papilla (n) Success (%) Partial success* (%) Failure (%)

All CBD cannulation All (1317) 94.1 (84.2–97.2) 0.6 (0–1.8) 5.6 (2.3–15.5)

Virgin (602) 87.0 (79.2–95.5) 1.4 (0–4.0) 10.7 (3.2–20.2)

Sphincterotomy (713) 98.4 (90.5–100) 0 1.6 (0–9.5)

Previous failure (266) 86.7 (65.4–96.2) 0 (0–3.4) 13.3 (3.2–34.6)

No previous failure (733) 96.2 (89.8–99.2) 0 (0–1.0) 3.6 (0.8–10.2)

Sphincterotomy n=377 100 (98.2–100) 0 0 (0–1.8)

Stenting n=808 97.8 (90.2–98.5) 1.0 (0–4.6) 2.1 (0–5.2)

Stone extraction n=296 86.8 (74.1–89.6) 6.6 (0–14.8) 8.3 (6.3–11.1)

1 CBD cannulation n=892 91.9 (85.0–96.0) 0.7 (0–1.8) 7.0 (3.2–14.7)

Sphincterotomy n=254 100 0 0

Stenting n=498 97.4 (91.2–100) 0 (0–5.4) 2.6 (0–4.9)

Stone extraction n=201 91.3 (83.9–100) 0 (0–8.9) 5.7 (0–13.3)

2 CBD cannulation n=229 100 (90.0–100) 0 (0–3.2) 0 (0–10.0)

Sphincterotomy n=46 100 0 0

Stenting n=163 97.0 (90.0–100) 0 (0–4.8) 0 (0–10.0)

Stone extraction n=53 75.0 (50.0–100) 16.7 (0–37.5) 0 (0–13.3)

3 CBD cannulation n=196 85.7 (62.5–96.7) 0 (0–0.8) 14.3 (2.5–37.5)

PD cannulation n=266 85.7 (65.7–91.7) 0 (0–2.7) 14.3 (8.1–34.3)

Spincterotomy n=76 100 (83.3–100) 0 0 (0–16.7)

Stenting n=147 95.7 (81.3–100) 0 (0–4.5) 1.3 (0–18.8)

Stone extraction n=42 75.0 (50.0–100) 12.5 (0–25.0) 4.5 (0–25.0)

*Partial success regarding cannulation was defined as passage of contrast fluid or successful cannulation with a guidewire, but cannulation with thecatheter was not achieved.CBD, common bile duct; ERCP, endoscopic retrograde cholangiopancreatography; PD, pancreatic duct.

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this method and provides easy accessible data for ana-lysis. Since too much registration seems to be aburden for doctors in general, as well as for endosco-pists, we believe that this linking of systems will resultin even more reliable data.

What is known in the literaturePrevious studies on ERCP quality focused mainly oncomplications, an accepted outcome parameter toassess quality.19–21 However, next to complicationregistration, we believe that the procedural quality isof equal importance as stated above. Some studygroups have published their performance data on, thatis, cannulation success with numbers similar to ourcentre (92% to 94%).6 7 22 Since performing ERCPonly for diagnostic purposes, for example, in sus-pected CBD stones23 24 is considered obsolete andrisky, less invasive methods such as magnetic reson-ance cholangiopancreatography (MRCP) or endo-scopic ultrasound (EUS) are recommended fordiagnostics. ERCP should thus be limited to thera-peutic interventions. Taking this into account, thera-peutic or procedural success is an important outcomeparameter as well. ASGE states that clearance of CBDstones should be achieved in >85% of the cases. Inour centre the overall success rate was 86.8%, whichis adequate. Stent placement was successful in 97.8%of patients, which is in line with the ASGE recommen-dations as well (>90% success rate). These data showthat our RAF-E provides insight into performance cri-teria such as those formulated by ASGE. We used amodified version of the Schutz’s classification in thisstudy. An ASGE working party has proposed a revisedcomplexity score with four difficulty categories. Thisscore was not yet available at the start of this study.25

The results of our study are in line with the findingsof the ERCP Quality Network,26 which is an elec-tronic system where endoscopists can enter their dataanonymously. As a result of this anonymity, no dataverification can be performed and data are thussubject to bias. Moreover, one cannot recollectwhether the ERCPs entered in the database are theonly procedures performed by the participatingendoscopists (registration bias). On the other hand,since the ERCP Quality Network is anonymous, thereis less incentive to leave out failed cases. Our studywas single centre; the ERCP Quality Network enablesendoscopists from different centres to enter their pro-cedures in the database.

Strengths and limitationsThis is the first study to show the rationale for using aself-assessment programme in order to assess thequality of ERCPs and the prospective design is one ofthe strengths. In the Netherlands, no methods areavailable to gain insight into quality and performanceof ERCP apart from retrospective database research.This results in the unique character of our data.

There are some limitations to this study. One pos-sible source of bias is registration bias. The endosco-pists themselves are responsible for filling out theassessment forms correctly. One might state that theforms are sensitive for falsification since they are notlinked to an endoscopy report database. An endosco-pist could just leave out the procedures that failed.Therefore, reports of all ERCPs performed in thetime frame were extracted to quantify and evaluatenon-assessed procedures. These non-assessed proce-dures were checked manually on procedural outcomessuch as CBD cannulation success. There were no sig-nificant differences in outcome between assessed andnon-assessed procedures, which makes it unlikely thatprocedures were left out on purpose. Another limita-tion of this study is that it was performed in a singletertiary referral centre. The performance numberscannot be extrapolated to general endoscopists insmaller hospitals with a different workload and casemix. Moreover, there were quite some variations innumbers and case mix between the endoscopists inthis study alone. This might have had some influenceon the results, but this is a reflection of the workloadand caseload in our endoscopy unit and probablymany other endoscopy units across the world.However, a clear relation between numbers of ERCPsperformed and outcome has not been establishedyet.27 The numbers in this study are too small for aclear point of view on this topic, but when lookingcloser at our analysis, there was no correlationbetween volume and performance of the participatingendoscopists. The one with the lowest volume was notthe worst performer and vice versa. Finally, theimpact of trainees on procedural outcome or successwas not established in this study. Since this study wasperformed in a teaching hospital, trainees wereinvolved in most ERCPs. It would be interesting toanalyse their contribution in a new prospective study.

ImplicationsThis study shows that a simple self-assessment form isa successful device to provide insight into quality ofERCPs on an individual basis as well as group per-formance. However, we experienced that in order toachieve and maintain a good adherence, reportingdata to the participants on an individual basis waseminent, but this required time and dedication as wellas one of the endoscopists stimulating the others tofill out the RAF-E forms. The next step is to roll outthis self-assessment programme nationwide in theNetherlands, which will provide insight into qualityand performance regarding ERCPs across the country.Next to investigating quality of ERCPs performed byexperienced endoscopists, including trainees, in thisself-assessment programme will provide additionalinformation on learning curves on top of qualityassessment.

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What is already known on this subject

▸ Although quality monitoring of ERCPs is extremelyimportant, useful assessment tools are lacking.

What this study adds

▸ Self-assessment is a valuable method to gain insightin ERCP performance.

▸ The RAF-E captures the most important proceduralquality parameters and is easy to incorporate in dailypractice.

Contributors VEE: conception and design; analysis andinterpretation of the data; drafting of the article; final approvalof the article. ADK, JH, EJK and RAdM: conception anddesign; critical revision of the article for important intellectualcontent; final approval of the article. J-WP and HRvB: criticalrevision of the article for important intellectual content; finalapproval of the article.

Competing interests None.

Ethics approval Institutional Review Board.

Provenance and peer review Not commissioned; externallypeer reviewed.

Open Access This is an Open Access article distributed inaccordance with the Creative Commons Attribution NonCommercial (CC BY-NC 3.0) license, which permits others todistribute, remix, adapt, build upon this work non-commercially, and license their derivative works on differentterms, provided the original work is properly cited and the useis non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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performancea novel method to gain insight into ERCP Quality evaluation through self-assessment:

Poley, Henk R van Buuren, Ernst J Kuipers and Robert A de ManVivian E Ekkelenkamp, Arjun D Koch, Jelle Haringsma, Jan-Werner

doi: 10.1136/flgastro-2013-1003342013

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frontline gastroenterology 2014 ekkelenkamp

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