Validation of a New Web-Based System for Point-of-Care Implant Documentation in Total Knee Arthroplasty

Abstract

Implant documentation in total knee arthroplasty (TKA) must be both accurate and comprehensive. A new system enables surgeons to complete a secure, web-based operative report for each surgery. This study evaluated implant documentation using this system and hypothesized that it would be as reliable as the current standard. This was a retrospective study of all primary and revision TKA performed at a single academic institution from January 1, 2015 to March 31, 2015, by eight adult reconstruction surgeons who used the web-based system. Electronic medical records and implant logbooks were chosen as a composite standard reference for implant documentation. Cohen's kappa statistic and Pearson's correlation coefficients were used to determine agreement between the system and the standard reference. Mean kappa value for entire system was 0.916 ± 0.152 ( = 0.015) indicating "almost perfect" agreement (as per Landis and Koch's method) with standard reference. Pearson's correlation coefficient was 0.926 ± 0.147 ( = 0.021) further corroborating this excellent agreement. There was "substantial" or "fair" agreement for items pertaining to cement and augments. Overall, sensitivity was 0.98 (95% confidence interval: 0.71-0.98) and specificity 0.93 (95% confidence interval: 0.53-0.98) indicating that the system was very effective at documenting whether or not an implant was placed. The system exhibited significantly greater sensitivity than specificity ( = 0.027). This study demonstrated excellent performance of this novel system in point-of-care TKA implant documentation. Further research is needed to validate its use in arthroplasty of other joints and its potential for documentation of biomedical device implantation in other fields such as cardiothoracic surgery and gastroenterology.

Validity and efficiency of a smartphone-based electronic data collection tool for operative data in rotator cuff repair

“…2;4;21 As of February, 2018, OME is used by 57 surgeons at 10 sites within the Cleveland Clinic Health System to document surgical details and PROMs on 97% of 21,500 elective knee, shoulder, and hip surgeries. Validation studies for OME in total knee arthroplasty, 21 total hip arthroplasty, 4 ACL and meniscus repair have demonstrated excellent performance of this new system in point-of-care implant documentation. Having developed and now validated the OME system for data collection, one of our future objectives is to use the OME system to create a standardized operative report and integrate with EMR systems to replace the existing methods of creating operative reports.…”

Validation of a Novel Smartphone-Based Electronic Data Capture System Following Surgical Fixation of Distal Radial Fractures

“…However, the OME data collection tool and resultant datasets have been previously validated for multiple surgical interventions and used in a growing number of contemporary studies. 7-12,15-17 Curtis et al 8 investigated the completion rates and agreement measures between OME- and EMR-based control datasets capturing peri/intraoperative details of primary total hip arthroplasty. The authors reported that the OME dataset demonstrated significantly higher completion rates in 41% of the evaluated variables.…”

“…Previous studies have established its effectiveness in hip, knee, and shoulder surgeries, but it has yet to be proven in hand surgery. 7-12…”

Should an Age Cutoff Be Considered for Elective Total Knee Arthroplasty Patients? An Analysis of Operative Success Based on Patient-Reported Outcomes

“…10 The OME system is a prospectively collected patient-reported outcomes database that leverages the Research Electronic Data Capture software (REDCap, Nashville, Tennessee) 11 and has been previously established as a reliable tool for capturing patient-reported data, including assessments of joint-specific pain function, and knee-related and general health-related QOL; general demographic characteristics; and surgeon-collected data, including patient demographic characteristics, surgical history, and surgical procedure details. [12][13][14] The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement recommendations were followed. 13,15…”

“…[12][13][14] The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement recommendations were followed. 13,15…”