A New Tool “Counts” of Potential Study Participants who Meet Specific Study Criteria
A new tool to help you plan clinical studies and develop a participant recruitment strategy.
An early challenge in designing clinical studies is estimating your sample size. Statistical approaches help you estimate the power of various sample sizes, but you also need to know the feasibility of recruiting a cohort that will provide solid statistical power. SC CTSI is introducing a new online tool that can help. It is called Informatics Integrating Biology & the Bedside (i2b2 for short). I2b2 was developed by members of the national Clinical and Translational Science Award (CTSA) consortium to get “counts” of potential study participants who meet specific inclusion and exclusion criteria.
I2b2 is now live at USC and CHLA, where you can use it to help refine your target study cohort. Using a self-service interface, researchers can drag-and-drop various study entry criteria (e.g., age, diagnosis, medications, recent lab results) and – through the magic of informatics – find out how many patients in the Keck and/or CHLA electronic health record(s) meet the criteria. Change the entry criteria and see how a slightly different study design will affect the pool of potential participants. No protected health information is provided by i2b2, so there is no risk to patient privacy. All you get is counts. But fear not – that is not where this resources stops. Once you finalize your study design and get IRB approval to open enrollment, you can submit the results of your i2b2 query to request contact information for the potential participants. In my mind, this is a major advance in our ability to support study design and recruitment at USC and CHLA. Thanks to The Health Information Technology teams at CHLA and Keck and the SC CTSI Clinical Research Informatics team for implementing i2b2 here at USC and CHLA!
You can use i2b2 if you are an investigator or research team member at USC or CHLA. All you need is an i2b2 account, which you can request by emailing the i2b2 support team at firstname.lastname@example.org.
More information about i2b2 at USC and CHLA, including upcoming training events for using i2b2, is available on the SC CTSI website: http://sc-ctsi.org/new-resources/access-to-clinical-data-with-i2b2. Give it a try!