In this installment, we will focus on Preparatory to Research Activities.
Dr. Lydia’s first goal is to determine if it is feasible to conduct her study at UW. In other words, can she access the research subjects needed to power her pilot study of chronic diabetes? She requires 47 patients who meet her inclusion/exclusion criteria. She can determine the number of potential subjects treated in the UW Health clinic system by using tools that query HealthLink and return de-identified counts—an activity called cohort discovery or feasibility counts. How should she start?
Dr. Lydia can use two complementary methods at UW to proceed: Informatics for Integrating Biology and the Bedside tool (i2b2) and the ICTR Clinical Research Data Service (CRDS).
i2b2 is a self-service tool developed at Harvard that uses a drag-and-drop web interface. The UW i2b2 installation provides counts of de-identified patient data from HealthLink including patient demographics, diagnoses, medications, procedures, laboratory results, surgeries, clinic visits, and vital signs. The UW i2b2 can also query the North American Association of Central Cancer Registries, aka the Cancer Registry, which houses a nationwide database of oncology patients. As no protected health information is released, IRB approval is not necessary for i2b2 queries.
Investigators most often choose i2b2 if they understand the characteristics of HealthLink data, are knowledgeable about data query logic, and want the convenience of working at their own pace to acquire feasibility counts. An i2b2 query returns the number of patients with specific demographic and clinical criteria seen in a given time period at clinical sites included in HealthLink. Observational or retrospective cohort studies that use data collected during routine clinical care can also benefit from using i2b2 de-identified data prior to a full dataset query.
In contrast, CRDS is an assisted service for investigators. The CRDS team operates within the ICTR Biomedical Informatics (BMI) office and works collaboratively with SMPH information technology professionals to provide UW investigators with free support in extracting data from HealthLink.
The CRDS team can assist investigators with developing and running data queries, provide guidance about study design, and can deliver both de-identified data or patient-specific data using secure and compliant methods. Researchers are more likely to opt for CRDS services if their feasibility counts require complex data queries (for example multi-term or conditional queries), or if they want to access data that is not available in i2b2, or if the patient data contains protected health information (PHI).
Eneida Mendonça, faculty lead for the CRDS team, notes,
We don’t like to frame the choice of i2b2 or CRDS as an either/or situation. The two approaches are complementary to each other and form part of a continuum that addresses data needs of investigators beginning with de-identified numbers and ranging to IRB-regulated extraction of patient data containing PHI. We always suggest investigators start with a basic consultation to assess which approach best suits their needs.
With the exception of de-identified feasibility count requests, a data request through CRDS is typically a multi-step process that starts with a consult request and encompasses compliance review, followed by advanced query design and development. There are also internal quality assurance measures and data delivery though secure systems. The BMI team builds technically intricate queries that are compliant with federal privacy and human subjects protection regulations.
CRDS has served approximately 250 investigators since it was first formed in late 2015. UW also has 115 registered i2b2 users. We’re here to help research teams and investigators, whether via analyst assistance through CRDS or custom training classes on how to use i2b2.
For i2b2 training, register for one of the training sessions scheduled for fall 2017 or complete the BMI Consult form on the ICTR website and check “I would like to request i2b2 custom training” under the Preparatory to Research Activities category.
What did Dr. Lydia do? Because she needed an immediate number for a pilot award application, she elected to submit a request to CRDS through the BMI consult form. The request form allowed her to share her inclusion and exclusion criteria. As she was only requesting a feasibility count of de-identified data, the CRDS team could process the request and quickly email her the number she needed. Success! There are 102 local patients fitting her inclusion criteria, so her study can proceed to the next stage. However, after submitting her grant, Dr. Lydia also scheduled a custom i2b2 training session for her and her research team, using the BMI consult form. She selected one of her fellows to take an in-depth training session planned for fall 2017. The ample feasibility count returned from her initial query gave her ideas for additional queries to refine her hypothesis and it was hard to beat the convenience of the self-service web-based interface.
In the next installment of this series, follow Dr. Lydia as she develops her recruitment and enrollment plan and discovers how the BMI group can help her contact patients.
Missed the beginning of the series? Read the introduction.