Missing data and missed opportunities: Inability to perform secondary analysis of prospective randomized control trials due to missing general anesthesia data.

Abstract

e23012 Background: Medications given to facilitate general anesthesia are known to impact recovery and may impact cancer outcomes after surgery. Most general anesthesia is facilitated with inhalational anesthesia (IA) while recent data suggests propofol-based total intravenous anesthesia (TIVA) results in improved patient recovery, lower rates of tumor recurrence, and improved overall survival in several solid tumors. We attempted to analyze the impact that anesthetic approach (TIVA vs IA) had on the outcome of several recent landmark RCTs where surgery requiring general anesthesia was central to the oncologic intervention. Methods: We proposed a secondary analysis of six RCTs whose primary outcome was published between 2019 and 2024 where surgery requiring general anesthesia was central to the oncologic intervention. Trial data was requested through correspondence with the authors or official data requests as appropriate. Results: Two of the six studies do not share data, prohibiting secondary analysis. In the other four trials, none captured anesthetic data. We then queried the case report forms for two ongoing international RCTs we are currently participating in. Of these, neither collect medications delivered during surgery. In total, of the eight RCTs queried (six published, two enrolling), we were unable to perform secondary analysis of the impact anesthetic approach has on cancer outcomes in all eight. Conclusions: We were not able to use secondary analysis of RCT data to investigate the impact that anesthetic approach (TIVA vs IA) has on cancer recurrence and overall survival. Currently, the choice between delivering TIVA and IA is made largely by anesthesiologist preference without prospectively collected data to validate the retrospective observation that TIVA results in lower recurrence and improved overall survival. Electronic medical records capture anesthetic data, but if it is not included within the case report forms on prospective RCTs, secondary analysis is impossible. Collection of anesthetic data during RCTs would allow the study of the impact anesthesia has on cancer outcomes and should be a common part of data collection on surgically focused cancer trials. NCT Pub Date Method of Request Data Availability NCT01216644 5/11/19 Data sharing statement Data not shared NCT02562716 1/21/21 Email with NCTN Data Archive Administrator Anesthesia data not captured NCT01804790 5/5/21 Email with corresponding author Anesthesia data not captured NCT02998528 4/11/22 Data sharing statement Data not shared NCT03698019 3/1/23 Email with NCTN Data Archive Administrator Anesthesia data not captured NCT04949113 6/2/24 Email with PI Anesthesia data not captured NCT03860883 Not yet published Query of case request form Anesthesia data not captured NCT04031677 Not yet published Query of case request form Anesthesia data not captured