Evaluation of Research Accessibility and Data Elements of HIV Registries

Abstract

Background:: Patient registries represent a long-term data collection system that is a platform for performing multiple research studies to generate real-world evidence. Many of these registries use common data elements (CDEs) and link data from Electronic Health Records. Objective:: This study evaluated HIV registry features that contribute to the registry’s usability for retrospective analysis of existing registry data or new prospective interventional studies. Methods:: We searched PubMed and ClinicalTrials.gov (CTG) to generate a list of HIV registries. We used the framework developed by the European Medical Agency (EMA) to evaluate the registries by determining the presence of key research features. These features included information about the registry, request and collaboration processes, and available data. We acquired data dictionaries and identified CDEs. Results: We found 13 HIV registries that met our criteria, 11 through PubMed and 2 through CTG. The prevalence of the evaluated features ranged from all 13 (100%) having published key registry information to 0 having a research contract template. We analyzed 6 data dictionaries and identified 14 CDEs that were present in at least 4 of 6 (66.7%) registry data dictionaries. Conclusion:: The importance of registries as platforms for research data is growing and the presence of certain features, including data dictionaries, contributes to the reuse and secondary research capabilities of a registry. We found some features such as collaboration policies were in the majority of registries while others such as, ethical support, were in a few and are more for future development.

The use of electronic PROMs provides same outcomes as paper version in a spine surgery registry. Results from a prospective cohort study

“…Having assessed the absence of significant differences between the two methods, the authors believe that the electronic will over time substitute the paper form. It is possible to make this prediction since the distribution, collection and compilation of PROMs within electronic registers entails obvious advantages regarding logistics and data usability [26]. Several advantages can be obtained with the systematic use of electronic formats.…”

Colombian HIV/AIDS registry and health risk management

“…Mayer et al 4 , in a systematic review of the literature, identified 13 HIV registries, of which 61.5% are the product of a collaboration policy and 53.8% have a management process for requesting data collaboration, although there are shortcomings related to ethical support and research data 5 . In comparison, our registry contains all the key features for data collection like criteria for inclusion of participants (case definitions, data elements collected, etc.)…”

“…A review by Craig et al aimed to assess the elements that make up a registry and whether they contain research data. This identified 13 HIV registries that include specific-registry information, collaboration processes and research data 5 . Examples of these registries or observational cohorts were EMBRACE (USA) 6 , CFAR Registry (USA) 7 , CCR/HIV of the VA Department (USA) 8 , San Francisco HIV/AIDS Surveillance Registry 9 , New York City HIV/AIDS Surveillance Registry 10 , Stiching HIV Monitoring in Netherlands 11 , HARS in Missouri 12 , Australian National HIV Registry 13 , InfCare HIV (Sweden) 14 , Minnesota HIV Surveillance Registry 15 , IeDEA (Rwanda) 16 and others 5,17,18 .…”

Analysis of data dictionary formats of HIV clinical trials

“…CDISC HIV therapeutic area user guide, published in January 2019, is the only relevant HIV-specific data element effort [3] (in addition to base SDTM elements, it highlights lab codes for CD4 count, LOINC codes for HIV viral load testing and mother-infant data linking among many other things). A study focused on data elements and data sharing for HIV registries was published by our team in 2019 [27]. There are, however, prior studies that are not specific to HIV and cover data elements and dictionaries for medicine in general.…”