TPT 6.12 From Procedure Metrics to Pathway Governance: Construct Validity of “Documented Discussion of Management Options Prior to Index ERCP” As a Quality Indicator in Bile Duct Stone Disease

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2026
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Abstract
Abstract Background ERCP quality assurance is moving from procedure metrics to pathway governance. For choledocholithiasis, ERCP and single-stage laparoscopic common bile duct exploration (LCBDE) are both accepted duct-clearance strategies where expertise exists; governance depends on a retrievable record that options were considered before the index procedure. We aimed to develop and evaluate the construct validity of a pragmatic indicator for documented discussion of duct-clearance options before index ERCP and to benchmark performance against contemporaneous LCBDE. Methods Retrospective cohort of all index ERCPs for choledocholithiasis (2023–2024) across two acute hospitals in a UK health board, plus contemporaneous LCBDEs. Indicator: explicit pre-procedure documentation that management options were discussed. Construct validity was assessed using a prespecified argument with hypothesis tests for feasibility, response process, convergent comparator association, and negative controls. Results 356 ERCPs and 38 LCBDEs were included; the indicator was auditable in 100%. ERCP attainment was 20.5% (73/356; 95% CI 16.6% to 25.0). Documentation co-occurred with a specific recorded rationale for not offering LCBDE (100% vs 11.3%; p<0.001) and differed in known-groups comparison (LCBDE 100% vs ERCP 20.5%; p<0.001). Negative controls showed no material associations, supporting bounded interpretation as documentation reliability. Conclusion A feasible indicator with construct validity signals consistent with an auditable documentation bundle at the ERCP decision point. Low attainment for index ERCPs identifies a target for measurement-for-improvement and supports quarterly run-chart monitoring, without conflating documentation with consent quality or clinical outcomes.
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Authors Makthum Muwafikha Ismail, Charlotte Smith, Khurram Shahzad Khan
Journal the british journal of surgery
Year 2026
DOI
10.1093/bjs/znag087.235
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