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Validation of predictive models for disease outcomes in paediatric ulcerative colitis: A multicentre prospective
Ohad Atia1,2, Renz C W Klomberg3, Lissy de Ridder3
1Shaare Zedek Medical Centre, Jerusalem, Israel.
Insights
Existing models for predicting pediatric ulcerative colitis (UC) outcomes like PROTECT and Schechter showed limited accuracy in an external validation study. External validation is crucial before implementing predictive models in clinical practice for pediatric UC patients.
Area of Science:
- Pediatric Gastroenterology
- Inflammatory Bowel Disease Research
- Clinical Trial Methodology
Background:
- Several models, including PROTECT, Schechter, and PIBD-ahead, aim to predict outcomes in pediatric ulcerative colitis (UC).
- However, these models have lacked validation in external cohorts.
- This study addresses the need for external validation of existing predictive models.
Purpose of the Study:
- To externally validate established predictive models for pediatric ulcerative colitis (UC).
- To assess the accuracy of the PROTECT and Schechter models in predicting steroid-free remission (SFR) and acute severe colitis (ASC).
Main Methods:
- A prospective, multicenter inception cohort of newly diagnosed pediatric UC patients was established.
- Patients were followed at diagnosis, 3 months, 12 months, and last visit.
- Outcomes measured included steroid-free remission (SFR) and acute severe colitis (ASC).
Main Results:
- The PROTECT model demonstrated good predictive utility for SFR at 3 months (AUC 0.78) but not at 12 months (AUC 0.57).
- Schechter's criteria showed limited accuracy for predicting sustained SFR at 12 months (50% sensitivity, 60% specificity).
- Acute severe colitis (ASC) was best predicted by the Pediatric Ulcerative Colitis Activity Index (PUCAI) score at diagnosis and 3 months.
Conclusions:
- The PROTECT model's predictive value for pediatric UC outcomes diminishes significantly at 12 months.
- Existing predictive models like Schechter's did not achieve sufficient accuracy in this external cohort.
- External validation is essential for all predictive models before clinical application in pediatric ulcerative colitis.
Background:
Several studies have proposed models to predict disease outcomes in paediatric ulcerative colitis (UC), notably PROTECT, Schechter and PIBD-ahead, but none has been validated by external cohorts AIM: To explore these models in a prospective multicentre inception cohort METHODS: Children newly diagnosed with UC in 17 centres were followed at disease onset and 3 and 12 months thereafter, as well as at last visit. Outcomes included steroid-free remission (SFR) and acute severe colitis (ASC).
Results:
Of the 223 included children, 74 (34%), 97 (43%) and 52 (23%) presented with mild, moderate and severe disease, respectively. SFR rate was 35% at 3 months and 47% at 12 months (62% of those with mild disease at diagnosis vs. 41% in moderate-severe disease; p = 0.01). Thirty-six (16%) children developed ASC during the first month after diagnosis, and 53 (24%) during the first year. The AUC of the PROTECT model for predicting SFR at 3 and 12 months was 0.78 [95% CI 0.65-0.92] and 0.57 [95% CI 0.47-0.66], respectively. The sensitivity/specificity/PPV/NPV of Schechter's criteria to predict sustained SFR at 12 months was 50%/60%/35%/74%. ASC was predicted only by the PUCAI score at diagnosis and at 3 months.
Conclusions:
The PROTECT model had a good predictive utility for SFR at 3 months, but not at 12 months. The other predictive models did not achieve sufficient accuracy, which was far from that reported in the original studies. This highlights the necessity for external validation of any prediction model prior to its implementation into clinical practice.
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