Annals of surgery · 2025
Construct Validity and Reliability of the Comprehensive Complication Index as a Morbidity Outcome Measure in Pancreatic Surgery.
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Pecorelli Nicolò, Fermi Francesca, Abbassi Fariba, Bannone Elisa, Capretti Giovanni, Desiato Elena, Di Lucca Gabriele, Donisi Greta, Fogliati Alessandro, Frigerio Isabella, Guarneri Giovanni, Gronchi Federico, Lucas Katharina L, Paiella Salvatore, Ramser Michaela, Sandini Marta, Vallorani Alessia, Butturini Giovanni, Gianotti Luca, Salvia Roberto, Zerbi Alessandro, Fiore Julio F, Clavien Pierre-Alain, Falconi Massimo
Аннотация
OBJECTIVE: To assess the reliability and construct validity of the CCI®️ following pancreatic surgery.
SUMMARY BACKGROUND DATA: The Comprehensive Complication Index (CCI®️) is the only validated metric that quantifies cumulative morbidity, with a continuous score ranging from 0 (no complications) to 100 (death).
METHODS: To address construct validity, we assessed patients undergoing elective pancreatic surgery for any disease at five Italian centers enrolled in a randomized controlled trial (NCT04438447) and a prospective cohort study (NCT04431076). The severity of 90-day complications was assessed using the CCI®️. We tested 10 a priori construct validity hypotheses through linear regression. Regression coefficients represented the between-group mean difference in CCI®️, with an effect size ≥0.2 considered potentially meaningful. Validity was deemed adequate if >75% of the hypotheses were supported. To address reliability, three independent raters among six centers assessed the CCI®️ from 100 anonymous case vignettes to evaluate inter-rater and inter-center reliability through intraclass correlation coefficient (ICC) and standard error of measurement (SEM).
RESULTS: 797 patients were included (66±11 y, 50% female, 60% malignancy). The construct validity was supported by data, with 9/10 a priori hypotheses confirmed (90%). The CCI®️ showed excellent inter-rater (ICC=0.96, 95%CI: 0.95-0.97), high inter-center reliability (ICC >0.75 in each center), with a SEM ranging from 2.73 to 6.38.
CONCLUSIONS: This study supports CCI®️as a valid and reliable measure of morbidity after pancreatic surgery, supporting its use in both clinical practice and comparative effectiveness research.
SUMMARY BACKGROUND DATA: The Comprehensive Complication Index (CCI®️) is the only validated metric that quantifies cumulative morbidity, with a continuous score ranging from 0 (no complications) to 100 (death).
METHODS: To address construct validity, we assessed patients undergoing elective pancreatic surgery for any disease at five Italian centers enrolled in a randomized controlled trial (NCT04438447) and a prospective cohort study (NCT04431076). The severity of 90-day complications was assessed using the CCI®️. We tested 10 a priori construct validity hypotheses through linear regression. Regression coefficients represented the between-group mean difference in CCI®️, with an effect size ≥0.2 considered potentially meaningful. Validity was deemed adequate if >75% of the hypotheses were supported. To address reliability, three independent raters among six centers assessed the CCI®️ from 100 anonymous case vignettes to evaluate inter-rater and inter-center reliability through intraclass correlation coefficient (ICC) and standard error of measurement (SEM).
RESULTS: 797 patients were included (66±11 y, 50% female, 60% malignancy). The construct validity was supported by data, with 9/10 a priori hypotheses confirmed (90%). The CCI®️ showed excellent inter-rater (ICC=0.96, 95%CI: 0.95-0.97), high inter-center reliability (ICC >0.75 in each center), with a SEM ranging from 2.73 to 6.38.
CONCLUSIONS: This study supports CCI®️as a valid and reliable measure of morbidity after pancreatic surgery, supporting its use in both clinical practice and comparative effectiveness research.