Date: November 13, 2018
Contributed by: Abigail Isaacson, Data Manager at DF/Net
Over the past several months, DF/Net Research has been embracing its first opportunity to pilot ePRO (electronic patient-reported outcome) services for clients. Syntrix Biosystems Omni-Pain-201, a Phase II drug treatment trial for patients with diabetic neuropathy, is the first study to test this process. With the moving pieces of a Google Forms daily survey, a generic text messaging system, and our talented IT and Data Analytics groups, DF/Net has successfully imported ePRO test data from Google into our newest software version, DFdiscover 2018.
How does it work? Imagine you are an adult suffering from medium to high levels of pain associated with diabetic neuropathy. You are recruited into a new study and have confirmed you have access to a smartphone for the duration of the study. You come in to the clinic for your first Screening visit, and the Study Coordinator explains the importance of completing a daily electronic survey about your medication intake and side effects. Together, you open a specialized webpage, using a platform that will send you a text message reminder and Google survey link nightly before you go to bed. The Coordinator enters your phone number and an ePRO ID to the webpage, and your phone is immediately sent a welcome email to verify you accept text messages for the study. You type Verify and are in the ePRO system! You return home with instructions on how to respond to the next text message, which you will receive a within a few days and will contain a link to a brief Google survey (created by DF/Net and approved by Syntrix). You will continue receiving a daily message to complete the survey daily until the end of the study.
Behind the scenes, the site staff opens a Google Sheet provided by DF/Net and enters that subject’s ePRO ID and date they were enrolled. The DF/Net Data Coordinator, who checks this sheet daily, will see that a new subject has been enrolled for ePRO text messaging. The Data Coordinator can open the matching ePRO ID and date link to locate the phone number. He has already created enough unique copies of the Google Survey to match each possible ePRO ID, so he copies the Google Survey link matching the ePRO ID assigned at the site and links it to the phone number entered. He schedules a recurring time for the daily text messages to arrive, enters approved language instructions, and sends the subject’s first survey link. S/he can “OPT OUT” at the end of the study to stop receiving messages.
Each day the subject submits a new survey, the Google csv file will populate a new row of data. A Daily Survey CRF log is waiting in DFdiscover to receive daily data for each enrolled subject. IT and DA wrote programming to move that csv data into the database, similar to how a lab import would take place. Study staff who have access to the study’s database can view and run reports on this data to determine the drug’s effect on each subject’s pain level. Just. Like. That….
Lessons learned, and considerations for the future:
- We used an affordable business platform but it lacks flexibility to adapt certain language and templates preferable to the clinical research world. Working with another platform in the future with enhanced security and lower risk of personally identifying subjects would be ideal.
- This process feels at high risk of human error, with lots of moving steps in the background. We had to create a Google Sheet to link the ePRO and SUBJ IDs. Sites must be carefully trained not to enter subject names. Mis-assignment of an ePRO ID or a break in any of the Google processes would be detrimental to the study.
- Setting up import plates in the development database was simplified to string fields only, although there is talk that number fields would work as well. Plate key fields should be setup like a log page.
- For very long studies, having one log page per day per subject could set database records!