W-09: Data Quality in a Longitudinal, Observational Registry Without On-site Monitoring: Findings From the ORBIT AF II Registry
Clinical Research Associate II
Duke Clinical Research Institute United States
The objective of this study was to describe remote project oversight procedures, rather than on-site monitoring visits, that led to high levels of follow up data completeness and data quality in ORBIT-AF II, a multicenter, longitudinal, observational registry.
ORAL PRESENTATION: 1:50PM
We reviewed the remote project oversight procedures conducted by the registry coordinating center from February 2013-July 2017, including incorporating edit checks in the EDC system, query monitoring, data quality reports, and regular communication with sites via newsletters and team calls.
The ORBIT-AF II coordinating center was able to maintain high follow-up data completeness and overall data quality. Of the 13,394 patients consented to participate, 12,365 (92.3%) patients had relevant clinical data 6 months after the time of consent and 11,344 (84.7%) patients had relevant clinical data 12 months after the time of consent. The completion benchmarks for 18 and 24 months follow up reflect a change in the initial registry design; in April 2016 the follow-up period was decreased from 24 to 12 months from the time of consent; for the purposes of reporting registry completion, the 24 month benchmark was used for patients prior to April 2016 and the 12 month benchmark was used for patients after April 2016. End of registry patient status rates are included in Table 2. 13,040 (97.3%) patients completed the registry or died during their participation. 354 (2.7%) patients did not complete the registry due to becoming lost to follow-up, withdrawing consent, registry site closure, or patient preference. The high percentages of data completeness and data quality were accomplished by establishing regular communication with registry site staff and providing frequent data quality updates.
Table 1. Follow-up Completion
Patient has 6 month record
No 1029 7.68
Yes 12365 92.32
Patient has 12 month record
No 2050 15.31
Yes 11344 84.69
Patient has 18 month record
No 8631 64.44
Yes 4763 35.56
Patient has 24 month record
No 10472 78.18
Yes 2922 21.82
Table 2. End of Participation Subject Status
Completed registry period 12,394 (92.5%)
Death 646 (4.8%)
Lost to Follow-up 149 (1.1%)
Withdrawal of Consent 77 (0.6%)
Investigator Left Practice or Practice Closed 83 (0.6%)
Other 42 (0.3%)
Missing 3 (0.0%)
97.3% of consented patients completed the expected follow-up period or reached a registry endpoint in this multicenter, observational registry. The remote project oversight procedures conducted by the coordinating center played a significant role in ensuring a high completion rate. Regular communication between the registry sites and the coordinating center, such as site-specific phone calls, creative and unique newsletters and prezi presentations, and registry team update calls open to all principal investigators and site coordinators, provided the guidance and training for registry sites to understand the participation requirements and follow-up expectations needed to provide complete data on participating subjects. The overall quality of ORBIT-AF II data was also maintained through the use of various reporting tools. Monthly site data entry status reports detailing patients due for data entry were sent to sites as part of the routine, ongoing communication with site coordinators and annual feedback reports that illustrated individual site performance as compared to other similar registry sites benchmarks provided timely data to help sites assess their performance. Problems identified by the coordinating center team at a particular site or across sites were addressed in a timely manner with site training and remote monitoring to avoid re-occurrence. Finally, the EDC system was programmed with numerous edit checks to instantly alert sites to incomplete or out-of-range data points that helped streamline the remote monitoring process. These system-generated queries along with additional targeted off-site, remote monitoring practices by the coordinating center served to keep the data clean and complete, which expedited ongoing analyses and resulted in numerous manuscript publications utilizing ORBIT-AF II data. The ORBIT-AF registry was sponsored by Janssen Scientific Affairs, LLC, Raritan, NJ.