Development of Technologic Solutions to Address Complex Local Requirements of an International Prostate Cancer Clinical Quality Registry

Abstract

PURPOSE To detail the process for importing a defined data set into a centralized global registry via a secure file transfer platform and to understand the barriers to the establishment of a centralized global registry. RESULTS A bespoke solution was developed to allow transmission of data from international local data centers to a centralized repository. Data elements included in the import template were drawn from existing International Consortium for Health Outcome Measurement variables and refined to ensure accurate benchmarking as well as feasibility in data completeness. The data set was organized in accordance with the prostate cancer care trajectory. Key considerations in developing the data transfer platform included import file format, process of input validation, and technical provisions. Given the diversity in the legislation and ethical requirements with respect to consent, data handling, and cross-border data transfer across geographic locations, we encouraged each local data center to consult with its legal advisors and research ethics committee early on in the process. DISCUSSION A global collaboration, although highly valuable, posed many challenges because of inconsistent methods of data collection. User acceptance of a system is paramount to the success of establishing a metaregistry. Local information technology support and regular regression testing ensures quality and maintenance of the database. CONCLUSION We developed a Web-based system to facilitate the collection and secure storage of common data, which is scalable and secure. It is anticipated that through systematic recording of data, global standards of clinical practice and outcomes of care will see vast improvements.

Knowledge and insights from a maturing international clinical quality registry

“…Anonymity of registry participants is preserved with unique identifiers provided by each site. 8 This key identifier is held in their local registry and can be linked to the full patient data for error correction and follow-up, without fully identified information being released to TNGR.…”

“…Example 4(a) j Handling high missingness of data elements used in quality indicators Collection of data elements such as radiology imaging was optional in TNGR, because they were not part of the ICHOM Standard Set. 21 However, they are recognized as clinically relevant variables 6,8 and form part of some quality indicator calculations. 22 The magnitude of missing data impacted the number of cases that could be reasonably evaluated within a site.…”

“…LDCCode which distinguished sites within countries, and a unique identifier associated with individuals within a local center (LDCPatientID). 8 During the review process, sites were reporting more participants than was expected due to individuals being entered more than once into the TNGR but with unique identifiers.…”

Establishing a global quality of care benchmark report

“…Report deployment. A 'Report' page was added to the TrueNTH Global Registry data submission portal 3 which allowed authenticated users to download reports. Logics to manage access to files based upon LDC membership and email notification system to send emails to LDC users when a new report became available were created.…”

“…The governance structure of the TNGR, the role and responsibility of LDCs and participating sites have been previously reported. 3 A set of 33 evidence and consensus-based quality indicators has been selected through a Delphi process. 4 Currently, no universal design tool or guidelines exist for how quality of care should be benchmarked and reported.…”