VALIDITY EVIDENCE FOR ERCP COMPETENCY ASSESSMENT TOOLS: A SYSTEMATIC REVIEW

INTRODUCTION:
Training in interventional endoscopy is offered by interventional endoscopy fellowship programs (IEFPs) not accredited by the ACGME. The number of these programs has increased exponentially with a concurrent increase in the breadth and complexity of these procedures. ACGME-accredited fellowships are governed by competency-based education, yet what constitutes a “high-quality” non-accredited IEFP has not been defined. Using an evidence-based consensus process, we aimed to establish minimum standards for IEFPs.

METHODS:
The RAND UCLA Appropriateness Method, a modified Delphi process to develop quality indicators (QIs), was utilized. A task force drafted potential QIs (structure, process and outcome) in 6 categories: a) activity preceding training, b) structure of IEFPs, c) training in ERCP, d) EUS, e) endoscopic mucosal resection (EMR) and f) luminal stenting. Three rounds of iterative feedback from 20 experts were conducted. Round 0 involved discussion of project details. In Round 1 experts independently ranked proposed QIs on a 9-point scale ranging from highly inappropriate (1) to highly appropriate (9). Next, proposed QIs were discussed and re-worded in a group meeting followed by Round 2 in which experts independently re-ranked proposed QIs and provided benchmarks (when applicable). The median score for each QI was calculated. Mean absolute deviation from the median was calculated and appropriateness of potential QIs was assessed using: (i) BIOMED Concerted Action on Appropriateness definition, (ii) P-value method and (iii) inter-percentile range adjusted for symmetry definition. A QI was deemed appropriate if median score was ≥7 and met criteria for appropriateness using all 3 defined statistical methods.

RESULTS:
Of 89 proposed QIs, 37 met criteria as appropriate for a QI (activity preceding training, 2; structure of IEFPs, 10; ERCP, 7; EUS, 8; EMR, 7; luminal stenting, 3) (Tables 1 & 2). Minimum thresholds were defined for 19 relevant QIs for number of trainers, procedures during fellowship and procedures prior to assessment of competence. Among the final appropriate QIs were that all trainees should undergo qualitative and quantitative competence assessments using validated tools at least quarterly with documented feedback throughout the training period and that trainees should track outcomes and relevant quality metrics for specific procedures.

CONCLUSION:
This ASGE-led initiative established minimum standards for training in interventional endoscopy. These may be assessed by all stakeholders and would ensure adequate training in interventional endoscopic procedures (ERCP, EUS, EMR, luminal stenting) during fellowship. This would also facilitate compliance with the ACGME/Next Accreditation System requirements of ensuring that trainees reach specific milestones in their progression to achieving cognitive and technical competency.

Background: Assessment of competence in endoscopic retrograde cholangiopancreatography (ERCP) is essential to ensure trainees possess the skills needed for independent practice. Traditionally, ERCP training has used the apprenticeship model, whereby novices learn skills under the supervision of an expert. A growing focus on procedural quality, however, has supported the implementation of competency-based medical education models which require documentation of a trainee’s competence for independent practice. Observational assessment tools with strong evidence of validity are critical to this process. Validity evidence supporting ERCP observational assessment tools has not been systematically evaluated.

Purpose: To conduct a systematic review of ERCP assessment tools and identify tools with strong evidence of validity using a unified validity evidence framework

Methods: We conducted a systematic search using electronic databases and hand-searching from inception until August 2021 for studies evaluating observational assessment tools of ERCP performance. We used a unified validity framework to characterize validity evidence from five sources: content, response process, internal structure, relations to other variables, and consequences. Each domain was assigned a score of 0-3 (maximum score 15). We assessed educational utility and methodological quality using the Accreditation Council for Graduate Medical Education framework and the Medical Education Research Quality Instrument, respectively.

Results: From 2769 records, we included 17 studies evaluating 7 assessment tools. Five tools were studied for clinical ERCP, one on simulated ERCP, and one on simulated and clinical ERCP. Validity evidence scores ranged from 2-12. The Bethesda ERCP Skills Assessment Tool (BESAT), ERCP Direct Observation of Procedural Skills Tool (ERCP DOPS), and The Endoscopic Ultrasound (EUS) and ERCP Skills Assessment Tool (TEESAT) had the strongest validity evidence with scores of 10, 12, and 11, respectively. Regarding educational utility, most tools were easy to use and interpret, and required minimal additional resources. Overall methodological quality was strong, with scores ranging from 10-12.5 (maximum 13.5).

Conclusions: The BESAT, ERCP DOPS, and TEESAT have strong validity evidence compared to other assessments. Integrating tools into training may help drive learners’ development and support competency decision-making.