Objective: To estimate the Minimal Important Difference (MID) of the Comprehensive Complication Index® (CCI®) in patients undergoing abdominal surgery. Background: The CCI® is a validated metric that quantifies cumulative surgical morbidity. While the CCI® is a sensitive endpoint to detect treatment effects, a statistically significant effect does not necessarily translate into clinical relevance. Relevant differences from the patients' perspective are best captured by the MID. Methods: Individual patient data were extracted from surgical studies reporting CCI® at 30 days and using Patient Reported Outcome Measures (PROMs) with established MIDs at baseline and 30 days. To determine the MID for the CCI® we used an anchor-based approach as recommended by methods guidelines. A PROM was selected as an anchor only if the Spearman correlation coefficient between its change in score (baseline to 30 d postoperative) and the CCI® was ≥|0.30|. We used linear regression to estimate the MID of the CCI® across different anchors, and triangulation to determine a single MID. Results: Data were extracted from three published randomized controlled trials (RCTs) and one prospective observational study (n=1583 patients) in major abdominal surgery. In colorectal surgery cohorts, two sub-scores of the Short Form-36, two sub-scores of the Multidimensional Fatigue Inventory-20, the EuroQol-5-Dimension Index Score, and the EuroQol Visual Analog Scale showed a correlation with the CCI® of ≥|0.30|. This resulted in MID estimates for the CCI® ranging from 6.1 to 22.2. In hepato-pancreato-biliary surgery, one sub-score of the Short Form-36, and two sub-scores of the PROM Information System-29 questionnaire qualified as anchors providing MID estimates ranging from 6.2 to 13.8. Conclusion: We propose a mean difference of 12 points in the CCI® between treatment groups as a relevant difference in patients undergoing abdominal surgery. This MID provides an important foundation for sample size calculations and interpretation of RCTs and large real world observational studies.
Beyond P Values: Novel Minimal Important Difference of the Comprehensive Complication Index (CCI®) that reflects a Meaningful Outcome for Patients Undergoing Major Abdominal Surgery / Abbassi, F.; Pfister, M.; Braun, J.; Angenete, E.; Haglind, E.; Onerup, A.; Heijmans, M. H. M.; Slooter, G. D.; Molenaar, C. J. L.; Fiore, J. F.; Feldman, L. S.; Pecorelli, N.; Guarneri, G.; Falconi, M.; Drejian, S. K.; Fretland, A. A.; Edwin, B.; Ubels, S.; Hannink, G.; Puhan, M. A.; Clavien, P. -A.. - In: ANNALS OF SURGERY. - ISSN 0003-4932. - (2025). [Epub ahead of print] [10.1097/SLA.0000000000006877]
Beyond P Values: Novel Minimal Important Difference of the Comprehensive Complication Index (CCI®) that reflects a Meaningful Outcome for Patients Undergoing Major Abdominal Surgery
Pecorelli N.;Guarneri G.;Falconi M.;
2025-01-01
Abstract
Objective: To estimate the Minimal Important Difference (MID) of the Comprehensive Complication Index® (CCI®) in patients undergoing abdominal surgery. Background: The CCI® is a validated metric that quantifies cumulative surgical morbidity. While the CCI® is a sensitive endpoint to detect treatment effects, a statistically significant effect does not necessarily translate into clinical relevance. Relevant differences from the patients' perspective are best captured by the MID. Methods: Individual patient data were extracted from surgical studies reporting CCI® at 30 days and using Patient Reported Outcome Measures (PROMs) with established MIDs at baseline and 30 days. To determine the MID for the CCI® we used an anchor-based approach as recommended by methods guidelines. A PROM was selected as an anchor only if the Spearman correlation coefficient between its change in score (baseline to 30 d postoperative) and the CCI® was ≥|0.30|. We used linear regression to estimate the MID of the CCI® across different anchors, and triangulation to determine a single MID. Results: Data were extracted from three published randomized controlled trials (RCTs) and one prospective observational study (n=1583 patients) in major abdominal surgery. In colorectal surgery cohorts, two sub-scores of the Short Form-36, two sub-scores of the Multidimensional Fatigue Inventory-20, the EuroQol-5-Dimension Index Score, and the EuroQol Visual Analog Scale showed a correlation with the CCI® of ≥|0.30|. This resulted in MID estimates for the CCI® ranging from 6.1 to 22.2. In hepato-pancreato-biliary surgery, one sub-score of the Short Form-36, and two sub-scores of the PROM Information System-29 questionnaire qualified as anchors providing MID estimates ranging from 6.2 to 13.8. Conclusion: We propose a mean difference of 12 points in the CCI® between treatment groups as a relevant difference in patients undergoing abdominal surgery. This MID provides an important foundation for sample size calculations and interpretation of RCTs and large real world observational studies.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
