Polycystic Kidney Disease Data Standard
Polycystic Kidney Disease (PKD) standard data elements and definitions are now posted for public review. Please send all comments to cdiscreviewcomments@cdisc.org by Friday, 1 October 2010.
The purpose of this project is to develop PKD clinical content data standards for regulated clinical research and clinical trials data. Expansion of total kidney volume (TKV) due to growth of multiple fluid filled cysts is the hallmark of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Yet, TKV is not yet recognized as a regulatory endpoint. Remapping of retrospective data and collecting prospective data in a common standard format will allow the creation of a new database of aggregated data from existing multiple, longitudinal and well-characterized research registries. This data will be used to develop a quantitative composite disease scale and disease progression model to examine the linkage between TKV and disease outcomes. These disease progression models will be utilized to generate scientific consensus on the utility and reliability of TKV as a biomarker and clinical endpoint for the progression of ADPKD.
This work is funded by the Polycystic Kidney Disease Foundation.
Over the past year, global stakeholders from the PKD clinical community, industry, government agencies, academia, the Polycystic Kidney Disease Foundation, and CDISC met regularly to develop standard data element names (or CRF questions), terminology and associated definitions. The data elements with their definitions and permissible value sets were developed from review of five sets of Case Report Forms from three longitudinal disease registries, one longitudinal observational study and one double blind controlled trial. The next step in the process is to obtain comments from the broader CDISC and PKD clinical communities on the materials produced. This review follows the CDISC public review process. Once all comments are addressed, the final standard / document will be posted on the CDISC website and made freely available. All permissible value sets and terms will be maintained for CDISC by National Cancer Institute Enterprise Vocabulary Services (NCI EVS) and published with other CDISC terminology sets.
For additional information, please contact Chris Tolk
Polycystic Kidney Disease Data Elements
PKD - Public Review Comment Form
Cardiovascular and Tuberculosis Data Standards
Package #1 for the Cardiovascular and Tuberculosis therapeutic specific data elements are now posted for public review.
The purpose of these projects is to develop clinical content data standards supporting both patient care and secondary data uses which include disease surveillance, quality improvement and clinical research. This work is funded through the NIH Re-Engineering the Clinical Research Enterprise Roadmap contracts. The resulting data elements and products were developed by a team from Industry; Standards Development Organizations, including CDISC and HL7; and Clinician and Government Stakeholders over the last 2.5 years.
The work focused on two separate clinical domains: Cardiovascular and Tuberculosis. Because these domains are large, they have been further broken down into packages. For the Cardiovascular domain, the Package 1 scope is Acute Coronary Syndrome and for Tuberculosis (TB), the focus is on Pulmonary TB.
The data elements with their definitions and permissible value sets were developed from Patient Use Case Scenarios and Activity Flow diagrams. These data elements were incorporated into class models, using Unified Modeling Language (UML), to illustrate the relationship of the data elements to each other. An example of how the data elements are produced in a form format is also included and the Tuberculosis data elements have been modeled in the SDTM format.
There are supporting documents to provide guidance on how to navigate through the products. There is an Index Document that provides a brief description of each document in the packet, and indicates which documents are for review and which are supporting documents. Hyperlinks are provided to help you navigate through each document.
The Project Document provides an overview of the project and a detailed explanation of the products in the packet. The Understanding Class Model Document gives an overview of the model and how to read it. The TB Implementation in SDTM provides guidance of how TB healthcare data standards could be implemented in clinical research using the CDISC Study Data Tabulation Model (SDTM) to aggregate data across research studies.
Through this work, we hope to provide and facilitate a path for others to follow as clinical content is defined with the semantic specificity necessary for interoperability.
