Optimizing Real World Data Collection: Monitoring Completion of Retrospective Records

Image credit: Wesley Tingey

Objectives for the Optimizing Real World Data Collection Tutorial Series

Overview

  • Real World Data (RWD) are patient-level data that originate from a variety of sources, including, but not limited to: Electronic health records (EHRs), billing claims, disease registries, and patient-generated data e.g. from mobile devices
  • RWD in the setting of a disease registry, is typicaly capture via either a retrospecture data collection or a prospective data collection

Monitoring Completion of Retrospective Records: Tutorial Overview

  • In this post we provide a workflow for monitoring completion of retrospective records containing RWD within a patient registry hosted on REDCap.
  • After this lesson, you will:
    • Understand the utility of a data metrics instrument in updating the completion progress of retrospective records.
    • Understand how to utilize reports to facilitate review of the status of retrospective records.
  • Skill Level: Intermediate

Overview of REDCap

  • REDCap is a user-friendly, web-based research electronic data capture platform utilized by researchers worldwide to collect structured data for statistical analysis.1,2
  • It is a powerful, secure, and HIPAA compliant database building solution created by Vanderbilt University in 2004 that allows development and deployment of subject facing surveys as well as forms for data capture by data entry personnel
  • Our lab has adopted REDCap as the data collection platform for our rare tumor patient registries. We have additionally deployed modules built in REDCap to streamline and analyze operations in the multidisciplinary clinic setting

Retrospective Versus Prospective Records

There are two types of records in a generic patient registry:

  • Retrospective Records: The patient’s documented clinical course has concluded prior to start of data collection due to patient expiry or other causes of loss to follow-up.
    • Data abstraction on the patient’s clinical course may be completed and the registry record can be validated by the Data Manager and sealed.
  • Prospective Records: The patient’s clinical course is ongoing during data collection.
    • Data abstraction can only bring the record up-to-date. After additional time has elapsed, the registry record will need to be be updated once again.

Monitoring Completion of Retrospective Records

Limitations in REDCap

  • REDCap does not have a built-in mechanism to designate whole instruments or forms as complete when the instrument, or form, is repeating, i.e. may contain multiple pages.

    • REDCap does feature the ability to designate individual pages, or instances, as “Incomplete,” “Unverified,” or “Complete.”
    • However, the status of individual pages, or instances, does not certify that the entire instrument is completed.
      • For example, there may be two instances already entered and validated in the “Pathology” Instrument for a given record. However, if there is a third pathology report in the patient’s chart that is yet to be entered, the instrument has not yet been completed.

Data Metrics Instrument

  • The Data Manager therefore needs a means to classify whole instruments as completed. To facilitate data management, we have designed a separate Data Metrics Instrument that provides fields for classifying the record type. tracking the data abstraction progress and completion status.
  • Within the Data Metrics Instrument, designating the record as retrospective opens up an instrument checklist field, retro_complete.

Custom Dashboards

  • We can then use REDCap’s Custom Record Dashboard feature to create a dashboard that displays only retrospective records that have been fully completed and validated, as well as a dashboard for retrospective records still in process.

    • The REDCap interface for creating and modifying record dashboards is illustrated below:

    • The filtering logic for the Retrospective Patients, Completed dashboard is:

      [retro_complete(1)] = 1 AND [retro_complete(2)] = 1 AND 
      [retro_complete(3)] = 1 AND [retro_complete(4)] = 1
    • The filtering logic for the Retrospective Patients, In Process dashboard is:

      [retro_complete(1)] <> 1 OR [retro_complete(2)] <> 1 OR 
      [retro_complete(3)] <> 1 OR [retro_complete(4)] <> 1

Takeaways

  • Monitoring completion of retrospective records may be accomplished with a checklist field in a dedicated data metrics instrument. Custom dashboards allow for easy review of records that have been fully completed, as well as those that are still in process.

Next in our series of tutorial posts on Optimizing Real World Data Collection: Routine Maintenance of Prospective Records within a Patient Registry in REDCap

Avatar
Farees Saqlain
Medical Student

My research interests include clinical and translational research in advanced skin cancers.

Related