It was wonderful to see such a great turnout at the CRI Working Group Meeting last week. At the meeting, there was some interest in having a space and coordinator for discussions related to Eligibility Criteria.
As you know, several CRI-WG members presented a panel on the topic at the 2007 AMIA Symposium. (attached). After that panel, there was a great deal of discussion around a variety of topics, including: ethical, workflow, representation, systems and technical issues.
I do think that it would be a useful activity for the CRI group to address some facet of the topic. I know that some of us have a paper in the works summarizing some of the formal represenation aspects of eligibility criteria, but there certaily are many un-addressed areas that someone from our group might want to take a lead on.
Eligibility criteria are the 'rules' that define the sample in clinical research studies, and are relevant to applications in a number of areas, including:
sample size estimation (study planning), protocol applicability determination and screening, application of clinical practice guidelines, protocol authoring, trial registries, data registries, and data analysis/meta-analysis. Defining the workflow and systems requirements & implications for each of these application areas is an important and unaddressed area. There are several groups working on the issue of standardizing / utlilizing eligibility criteria (HL7, CDISC, NCI/caBIG, W3C), but there is probably a role for the AMIA CRI-WG to provide some guidance.
Please reply to this post with your interest. If there is enough discussion and some volunteers, then I will try to get something started
Thanks, Rachel Richesson (Univ. of South Florida)
