The vision of the ACT project is to create a CTSA federated network to increase accrual to clinical trials.
1.) What kinds of data are available through SHRINE? Total numbers of patients at each participating SHRINE hospital meeting your inclusion or exclusion criteria for demographics (age, gender, race, etc), diagnoses (ICD9/Billing Codes), labs, and most frequently prescribed medications. Not all data points will be available on all patients.
2.) I ran the same query several times. Why are the results different each time? As an additional way to protect patient privacy, we blur the aggregate patient counts so they are an estimate of the actual number. If you run the same query more than once, you will receive slightly different results each time. The system is designed to lock out users who run the exact same query too many times. If you would like to find out more about the obfuscation process please see "A Security Architecture for Query Tools used to Access Large Biomedical Databases" (Murphy, SN and Chueh, HC, Proc AMIA Symp. 2002:552-6).
3.) I get a result of “No Results Available” from my query. What does that mean? If the user experiences issues with queries where one or more institutions never returns a result, or returns “no results available,” it may be a result of a query that is linked to an extremely high number of codes at local institutions. Such issues are most likely to appear when several commonly used medications are queried together. While queries of individual terms should never lead to this issue, querying more than 5 common medications may cause this result.
4.) Is my query activity monitored? Each of your individual queries is logged and will be reviewed by the Data Steward for compliance with your approved query topic. Violation of the Terms of Access Agreement will result in a misconduct review by your institution and, if appropriate, by Harvard Medical School.
5.) What is i2b2? i2b2 (Informatics for Integrating Biology and the Bedside) is an NIH-funded National Center for Biomedical Computing based at Partners Healthcare. i2b2 has developed a software suite (typically shorthanded to "i2b2") that can be installed "on top of" an existing research patient data repository to enable easy and logical manipulation of the data contained within that repository. Each of the Harvard SHRINE hospitals has installed a version of that software suite and thus can be easily linked by a web-based query (SHRINE).
6.) Can I get patient samples? No, not directly through SHRINE.
7.) Can I search directly through the text of medical records? SHRINE does not allow direct access to patient records.
8.) We have not implemented modifiers as a general rule. Is having modifiers fully implemented a requirement for participation or could we add them later? No, modifiers are not required. But eventual participation in the full network will require them.
9.) We have installed PCORI.SHRINE not i2b2.SHRINE. We can easily install i2b2.SHRINE and could spin up a VM to show this but have not yet had the need to. Should we do this or can we just demonstrate that we have PCORI SHRINE up and running? PCORI/SCILHS and ACT programs have similar requirements. Demonstration with PCORI SHRINE is acceptable.
10.) Who should I contact for more information? Vincent D’Itri, firstname.lastname@example.org.
11.) What does the acronym “ACT” represent? ACT is an acronym for: The Accrual of patients to Clinical Trials.
12.) Where does funding come from? Initial funding for the ACT project was provided by NCATS.