Understanding Randomized Trials and Cohort Studies
Randomized trials involve choosing a population to receive an intervention and a control group at random, while cohort studies observe associations between exposures and risk factors. Cohort studies are often retrospective, meaning you can get all the data for all the patients you need at once, as long as you know how to identify the patients and exposures. Epic Cosmos is a great resource for these kinds of studies since it contains billions of clinical data points from millions of patients, far more than a randomized trial could ever hope to have. However, cohort studies have limitations, as Dr. Qian explains in the video below, including confounders and indication bias. Randomized controlled trials may be more work, but the advantages they offer are significant.
Randomized Trial and EHR Integration
Integrating a randomized trial into the Electronic Health Record (EHR) offers many advantages. As Dr. Qian explains in the video linked below, the first step is to have clearly defined inclusion and exclusion criteria, specifically chart-based criteria for inclusion and clinician-based criteria for exclusion. The video also demonstrates how to use a Best Practice Advisory (BPA) to implement the trial criteria in the EHR and addresses the challenge of tracking patient enrollment in the study as well as creative solutions.
Video only available on Confluence on the VUMC network: https://confluence.app.vumc.org/display/VCLIC/Using+Epic+to+Support+Clinical+Research
How to Randomize Patients for Enrollment in a Study
In the video linked below, Dr. Qian guides you through the process of using a BPA extension to perform a coin flip and assign a randomization number for each patient. He also discusses the importance of the smart data element and the context in which you want to randomize patients. Additionally, he also addresses the timing of the randomization process and potential issues that may arise.
Video only available on Confluence on the VUMC network: https://confluence.app.vumc.org/display/VCLIC/Using+Epic+to+Support+Clinical+Research
Understanding Randomization in Smart Data Elements
In the video linked below, Dr. Qian provides a comprehensive overview of the steps involved in assigning and utilizing randomization in smart data elements. He demonstrates how to assign a randomization number using the coin flip extension and how it can be applied to a smart set, as well as how to create smart groups for ordering specific medications based on the randomization number.
Video only available on Confluence on the VUMC network: https://confluence.app.vumc.org/display/VCLIC/Using+Epic+to+Support+Clinical+Research
Understanding Trial Monitoring and Data Extraction
In the video linked below, Dr. Qian discusses the importance of trial monitoring and data extraction in clinical trials. He explains the two different aspects of trial monitoring, provider compliance with the trial protocol and patient safety, and highlights the significance of obtaining up-to-date data through reports in Chronicles. Additionally, using simulated data in a non-production environment, Dr. Qian demonstrates how to run a report to evaluate patient issues and adherence to the trial protocol, emphasizing the need for involvement in the planning stages of a trial to ensure that outcome measures can be easily extracted from the electronic health record (EHR).
Video only available on Confluence on the VUMC network: https://confluence.app.vumc.org/display/VCLIC/Using+Epic+to+Support+Clinical+Research