VI. Adverse Events and Success of ERCPIncome and outcome metrics for the objective evaluation of ERCP and alternative methods☆
Section snippets
Mixing diagnosis and therapy
The fact that ERCP can contribute both diagnostically and therapeutically is certainly useful clinically but adds considerable complexity to the process of evaluation. From a scientific standpoint, diagnostic and therapeutic aspects must be considered separately, because the goals (and their determinants) are quite different. Yet they are not separate in practice, because the therapeutic procedure may be dependent on the ERCP diagnosis. ERCP treatment may not be initiated or may be targeted
Context-specific evaluation
Clinicians have to deal with a spectrum of situations. Sometimes the intention of ERCP is clearly and solely therapeutic (e.g., known bile duct stone). More often the intent is initially diagnostic (e.g., obstructive jaundice), with the possibility of instituting therapy if ERCP shows a treatable lesion, and if treatment is judged to be technically possible. Thus, head-to-head comparisons between ERCP and a purely diagnostic technique (e.g., CT) and comparisons between therapeutic ERCP and
Diagnostic ERCP
There are published figures for the sensitivity and specificity of ERCP in various diseases, many of which are referenced in this supplement. Some of these data are difficult to interpret. The results of ERCP (and other tests to a lesser extent) are operator-dependent, and evaluations are often undertaken and reported by involved enthusiasts. Referral bias may also have a big impact. There is sometimes a problem in defining an independent reference standard, e.g., in the early stages of chronic
Therapeutic ERCP
The goal of therapeutic ERCP is to make patients better at acceptable cost. Outcome studies attempt to document that intervention process. To do so, it is necessary to dissect and to define exactly what is meant by “patients,” “better,” “cost,” and even “ERCP.” Outcomes cannot be understood or predicted for an individual patient without all of those details.
Patients vary in many ways: by their demographics (age, gender, and geography); their presenting symptoms and disease; the resulting burden
The intervention equation
All of the elements discussed above can be incorporated into a comprehensive intervention equation (Fig. 3). This article has concentrated on the difficulties of reaching consensus in defining these elements and instruments, even within the endoscopic community. Answering questions about the value (and relative value) of ERCP demands that the difficulties are overcome. This involves a series of steps, listed below.
Recommendations
- 1.
Charge a small multidisciplinary group (sanctioned by their relevant professional bodies) to refine and to define all the listed metrics that are needed for the assessment of all types of pancreatic and biliary interventions.
- 2.
Incorporate these data fields in endoscopy reporting databases.
- 3.
Develop prospective multicenter, context-specific cohort studies using these databases. Incorporate “disinterested” referees in their planning and analysis.21
- 4.
Encourage surgical and radiologic groups to do
Acknowledgements
Delegates to the ASGE Workshop on Outcomes of ERCP (Atlanta, Georgia, January 2001) were James Frakes, David Carr-Locke, Glen Eisen, John Johansen, Paul Jowell, Richard Kozarek, Glen Lehman, David Lieberman, Bret Petersen, Stephen Schutz, Martin Freeman, Sven Adamsen, John Hunter, Bayne Selby, and Peter Cotton.
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Reprint requests: Peter B. Cotton, MD, Medical University of South Carolina, Digestive Disease Center, PO Box 250327, 96 Jonathan Lucas Street, Charleston, SC 29425.