How much is too much?

As a software company, we continually look for ways to improve the experience for our end users, including research coordinators and the patients who participate in clinical trials. As part of that process, we meet with these people to better understand their lives.

Recently, I spoke with a participant in a Phase 2 trial for a bladder condition. Although thankful for the opportunity to take part in the study, she was a bit overwhelmed by the expectations.  At the onset, she had to compile historical medical records from various urologists, PTs, OB/Gyn, and pain specialists. As one might imagine requesting all of this data, organizing it and sharing it with the research coordinator was no insignificant task, (not to mention the coordinator’s job of sifting through it) but she persevered.

Beyond the initial stress of aggregating the record, the ongoing task of juggling a variety of data collection tools frustrated her the most. To participate, she had to complete the following:

  • Pain Dairy: Provisioned, single purpose Android device; filled out daily pain dairy each evening
  • Bladder Diary: Carbonless copy paper; filled out remotely at various times throughout the study
  • Adverse Event Recording: non-structured data collection; led to issues of non-reporting or mis-reporting date/time of AEs
  • Quality of Life Questionnaires: Carbonless copy paper; filled during specific study visits

There is no reason that these four tasks of data collection couldn’t be in one single electronic platform. This would streamline data collection for the patient (as well as the coordinator / sponsor) and let her feel more at ease. As you can see from the email excerpt below, having to juggle multiple mediums led to a bad experience. 

I already have a migraine diary to keep on top of (which is paper again after the Google form died), a Fitbit, these other diaries, so honestly I have been feeling out of control with my patient data and things to carry around. 

I’m very optimistic about digital platforms, but also scared of them. I have a neurostimulator for my pain in my bladder and my first months of data were lost when it froze up when the [nurse] went to print out how long I used each frequency using the computer. There’s no back-up somehow? My TI-83 plus is more advanced than my InterStim or my EMPI Tens Unit.

As product developers who invest significant time and energy in what we build, it is easy to assume our designs are intuitive to our customers. However, remaining in our own bubble can lead to building siloed tools that fail to appreciate the context in which they are used. Taking time to listen to the stories of the people who commit to participating in medical research and use our solutions is a critical important part of our process.

I am incredibly thankful for individuals who are willing to share their perspective and help contribute to better user experience. Technology provides exciting opportunities for putting the patient first and making the clinical trials process more patient friendly, however it is clear that there is low-hanging fruit in the sheer number and format of tools used to collect patient data.

By Matt Cantor, VP of Business Operations at Koneksa Health