Abstract
BACKGROUND: The purpose of this study was to demonstrate the validity and efficiency of the Outcomes Management and Evaluation (OME) system, a prospectively designed electronic data collection tool, for collecting comprehensive and standardized surgical data in shoulder arthroplasty. METHODS: Surgical data from the first 100 cases of shoulder arthroplasty that were collected into the OME database were analyzed. Surgeons completed a traditional narrative operative note and also an OME case report using an encrypted smartphone. A blinded reviewer extracted data from the operative notes and implant logs in the electronic medical records (EMR) by manual chart review. OME and EMR data were compared with regard to data counts and agreement between 39 variables related to preoperative pathology, including rotator cuff status and glenoid wear, and surgical procedures. Data counts were assessed using both raw percentages and with McNemar's test (with continuity correction). Agreement of nominal variables was analyzed using Cohen's unweighted kappa (κ) and of ordinal variables using the linearly weighted Cohen's test. Efficiency was assessed by calculating the median time needed to complete OME. RESULTS: Compared to the EMR, the OME database had significantly higher data counts for 56% (22 of 39) of the variables assessed. A high level of proportional and statistical agreement was demonstrated between the data in the two datasets. 10 of 39 variables had 100% agreement but could not be statistically compared because both datasets had the same single response under those variables. Among the 29 variables that were compared, 79% (23 of 29) of variables had >80% raw proportional agreement, and 69% (20 of 29) of variables showed at least substantial agreement (κ > 0.6). The median time for completing OME surgery data entry was 92 seconds (IQR 70 - 126). CONCLUSION: The prospectively designed, electronic data entry system (OME) is an efficient and valid tool for collecting comprehensive and standardized surgical data on shoulder arthroplasty. LEVEL OF EVIDENCE: Level IV.