Development and validation of a performance assessment checklist for insertion of an intra-uterine device (IUD).

Abstract

The World Health Organization (WHO) supports increasing the availability and acceptability of long-acting reversible contraception including intra-uterine device (IUD), but its insertion includes certain risks (uterine perforation). The objective was to develop and validate an IUD insertion performance assessment checklist. This prospective study took place in hospitals and simulation center of the Poitou-Charentes region, France. The checklist content reached consensus among 10 experts solicited by a Delphi method. A modified gynecologic mannequin Zoe (Gaumard®) was used for simulations. Psychometric testing included 30 multi-professional participants for internal consistency and reliability between two independent observers, and 27 residents for assessment of score evolution over time and reliability. Cronbach alpha (CA) and intraclass coefficient (ICC) were used. Progression of performance was carried out using ANOVA for repeated measures. The data collected were used to plot receiver operating characteristic (ROC) curves for the score values and the area under the curve (AUC) was determined. The checklist included 27 items (2 sections, total score = 27). Psychometric testing showed CA = 0.79, ICC = 0.99, and good clinical relevance. The checklist is discriminative, showing a significant increase in performance scores when the simulations were repeated (F = 77.6, p < 0.0001). ROC curve [AUC: 0.792 (95% CI: 0.71-0.89); p < 0.0001] revealed the best score cutoff predictive of 100% sensitivity, i.e., true positive rate or success rate. Performance score was highly correlated to success rate. The cut-off score guaranteeing successful IUD insertion was 22/27. This coherent and reproducible checklist for IUD insertion provide an objective assessment of the procedure during SBT, with the aim of obtaining a score ≥ 22/27.