Endoscopic Retrograde Cholangiopancreatography: Toward a Better Understanding of Competence

Most physicians, and probably all our patients, would like to know that when a medical procedure is performed, the individual who is carrying it out has been credentialed as competent. However, development of a meaningful definition of competence has become the Holy Grail of credentialing. The Oxford Dictionary definition of competence, “sufficiency of qualification; capacity to deal adequately with a subject”, provides little guidance to those in the profession who seek to quantify competence more precisely.

Is it practical, or even possible to always demonstrate competence before a technique or procedure is performed? Even the idealist appreciates that this is not realistic. For example, how do you demonstrate competence in carrying out a technique which is itself new? When endoscopic retrograde cholangiopancreatography (ERCP) was a fledgling procedure, many performed it after either reading about it or watching several ERCPs. In order to advance the technology and applications of ERCP, most physicians felt comfortable with that approach. Today, few gastroenterologists would support the idea of a physician carrying out unsupervised ERCP without any prior training or experience. At some point in the evolution of ERCP, it became unacceptable to train oneself. An important factor driving this change was that ERCP is an expensive, invasive procedure which carries a small but real risk of serious complications. As a comparison, readings of blood pressure would represent the other end of the spectrum of medical procedures. Most physicians would have no serious reservations about an unsupervised medical student practicing blood pressure readings. Now that there is a general consensus that physicians carrying out ERCP should have demonstrated competence in the procedure, it behooves us to establish a standard that defines such competence. Developing such a standard has proven an elusive goal.

The most difficult issue has been the meaningful definition of competence. The first attempt to define competence in ERCP was based, at least in part, on numbers of procedures performed [1] [2] . The American Society for Gastrointestinal Endoscopy (ASGE) recommended that at least 100 ERCPs (75 diagnostic and 25 therapeutic) were required for training in ERCP [1] [2] . Although these recommendations were intended as minimum numbers of procedures to be carried out before competence could be assessed, this approach seemed to generate controversy rather than being helpful [3].

There are several studies in the literature which provide insight into the assessment of competence in ERCP. Two studies from the United States prospectively evaluated physicians' performance of ERCP [4] [5] . Watkins et al. recorded the pancreatic and common bile duct cannulation rates in 21 trainees and nine proctors over 6 years [4]. They found that trainees selectively cannulated the pancreatic duct on 85 % of occasions after 70 procedures had been carried out; however, the 85 % cannulation rate for the common bile duct had not yet been reached after 100 procedures had been done. The present author and colleagues followed all trainees at a tertiary referral university center over a 2-year period [5]. Using successful achievement of the intended intervention on 80 % of occasions as a definition for technical competence, it was found that at least 180 procedures were required. Schlup et al., from New Zealand [6], reported the experience of a single gastroenterologist trained in upper and lower endoscopy who began to carry out ERCP after “assisting others with this examination over a 2-year period, but (for whom) previous practical experience in ERCP was limited to an introductory course.” This group used a target of 90% success rate in cannulation and intervention. The target was achieved after 120 procedures.

Therefore, data now exist regarding the number of procedures required to achieve competence. Can these data be used to guide the credentialing process? It seems clear that if there are continuing recommendations that performance of a minimum number of ERCPs is required before competence can be assessed, then the number should be higher than the current figure of 100, which was arrived at by an expert panel.

The task is to develop a standard which meaningfully addresses competence and which has not been watered down with generalities in order to satisfy all participants. This seems to be a Herculean task. Or is it? Clinicians in Australia are leading the way in this respect, and may have proven the nonbelievers wrong. The Conjoint Committee for the Recognition of Training in Gastrointestinal Endoscopy comprises representatives of the Gastroenterological Society of Australia, the Royal Australasian College of Physicians and the Royal Australasian College of Surgeons. The Conjoint Committee is responsible for maintaining a register of specialists who have completed a training program which meets guidelines set by the Committee. The guidelines encompass both numbers of procedures performed and cognitive aspects of endoscopy. Trainees are expected to complete at least 200 ERCPs including 80 sphincterotomies. The trainee's supervisor must attest to competence in procedures, as well as cognitive and interpretive skills, at the completion of the training program. Although this body does not have any power with regard to hospital credentialing committees, it is anticipated that most will only authorize physicians who are on the register of the Conjoint Committee (Speer, personal communication).

Whether the same arrangement can be achieved in the United States, Europe, or elsewhere remains to be seen. In the United States, there have been efforts to develop a consensus amongst some societies about guidelines for training and competence. An example is the Gastroenterology Core Curriculum, which addressed training in gastroenterology, including competence in ERCP [7]. The Gastroenterology Leadership Council developed this document; the Council had representation from the American Association for the Study of Liver Diseases, the American College of Gastroenterology (ACG), the American Gastroenterological Society, and the ASGE. This group essentially uses the ASGE's guidelines for minimal numbers of procedures required, with the recommendation that candidates should be able to selectively cannulate the desired duct with an 80 % success rate. Verification of overall competence, including the cognitive skills involved in endoscopy, is left to the program director's discretion.

The Core Curriculum did not address the concept of a register and the individual societies have likewise avoided this issue; competing interests make a register unlikely in the foreseeable future. Indeed many organizations may be concerned about appearing to restrict the ability of their (paying) members to be credentialed. However, the aim should not be for everyone to have the opportunity to carry out ERCP [8].

A joint committee of the ACG and the ASGE, the Committee on Credentialing, aimed at providing hospital credentialing bodies with established ASGE guidelines, has recently be formed (Baillie, personal communication). Whether this will change credentialing practices remains to be seen.

There is a relative paucity of data regarding competence and credentialing for ERCP in Europe. In Germany for example, trainees perform approximately 150 ERCP procedures over 2 years as part of standard training in gastroenterology. There is currently no formal credentialing for ERCP, although a certificate may soon be available which will be awarded after performance of an as yet unspecified number of ERCPs (Rösch, personal communication). In the United Kingdom, there are no formal guidelines for assessing competence in ERCP. Wicks et al. suggest the assessment of competence using objective criteria; physicians meeting these criteria would then be entered on a central register [9].

The ultimate decision on whether or not a physician can carry out ERCP usually rests with hospital credentialing committees. These committees set their own guidelines and standards for awarding privileges to perform the procedure. Unfortunately, such guidelines are often little more than arbitrary formalities. In a survey by Bhushan & Schmitt [10] of 59 hospitals in the United States, it was found that only ten hospitals had minimal requirements regarding number of procedures; the mean minimum for ERCP was 25. In the United States, there is no governing body that can enforce the same standards for all hospitals. Although there is merit in not having a mandatory standard, it would be ideal if all the relevant societies and physician groups could voluntarily agree on criteria for assessing competence to perform ERCP. While not strictly enforceable, such criteria could potentially become the de facto standard, especially if a register was part of the process. Hospital credentialing committees would likely be grateful to have such a well defined standard for competence. Such a standard might also provide some protection from malpractice suits which challenge physician competence.

Is there a way out of the current morass? Basing assessment of competence in procedures strictly on numbers performed has significant pitfalls and should be avoided. Once a minimum number of procedures is specified, it becomes, even if unintentionally, the standard for defining competence. A definition which measures the technical success of the individual physician seems more appropriate. For example, the criterion of an 80 % success rate for cannulating the desired duct in ERCP makes intuitive sense, and was the standard in the study by the present author and colleagues and is the standard suggested in the most recent set of guidelines from the ASGE [11]. Unfortunately, although this is an improvement over simple numbers of procedures performed, it does not address cognitive skills, such as judgment about when procedures are indicated, recognition of pathology, and the ability to diagnose and manage complications. In the United States and Australia, for example, the cognitive aspects are considered in the program director's recommendation that the applicant is competent at the completion of the training program. This approach is subjective but is the best we currently have. Pursuing consensus amongst the pertinent organizations, as has been done in Australia, seems to be the best option for developing a uniform standard that could be used by credentialing committees at hospitals. Prospective studies should be done to evaluate whether these credentialing criteria, if instituted, prove effective. Potential study end points would include complications and the number of repeat procedures performed. Such data may finally allow us to develop meaningful credentialing standards that reflect competence.

References

• 1 American Society for Gastrointestinal Endoscopy. Principles of training in gastrointestinal endoscopy.  Gastrointest Endosc. 1992;  38 743-746
• 2 American Society for Gastrointestinal Endoscopy. Methods of granting hospital privileges to perform gastrointestinal endoscopy.  Gastrointest Endosc. 1992;  38 765-767
• 3 Wigton R S. Measuring procedural skills (editoral; comment).  Ann Intern Med. 1996;  125 1003-1004
• 4 Watkins J L, Etzkorn K P, Wiley T E, DeGuzman L, Harig J M. Assessment of technical competence during ERCP training.  Gastrointest Endosc. 1996;  44 411-415
• 5 Jowell P S, Baillie J, Branch M S, Affronti J, Browning C L, Bute B P. Quantitative assessment of procedural competence. A prospective study of training in endoscopic retrograde cholangiopancreatography (see comments).  Ann Intern Med. 1996;  125 983-989
• 6 Schlup M M, Williams S M, Barbezat G O. ERCP: a review of technical competency and workload in a small unit.  Gastrointest Endosc. 1997;  46 48-52
• 7 The Gastroenterology Leadership Council. Training the gastroenterologist of the future: the gastroenterology core curriculum.  Gastroenterology. 1996;  110 1266-1300
• 8 Baillie J. ERCP for all? (editorial).  Gastrointest Endosc. 1995;  42 373-376
• 9 Wicks A CB, Robertson G SM, Veitch P S. Structured training and assessment in ERCP has become essential for the Calman era.  Gut. 1999;  45 154-156
• 10 Bhushan S, Schmitt C. Hospital privileges for gastrointestinal endoscopy: a pilot study of US hospitals.  Gastrointest Endosc. 1999;  49 338
• 11 American Society for Gastrointestinal Endoscopy. Guidelines for credentialing and granting of privileges for gastrointestinal endoscopy.  Gastrointest Endosc. 1998;  48 679-682