ePRO and Parkinson's Disease Studies

July 6, 2011 Kai Langel

Kai Langel SmallerCRF Health has been very active recently by doing some usability research on our own. We have conducted workshops with patient focus groups as well as usability research and testing with different devices and indications. One of the most interesting and challenging groups we have worked with are patients with Parkinson’s Disease. We first did some PD studies a few years ago and got to understand some of the challenges these patients have to deal with as well as the research issues for clinical studies. The requirements for data collection in PD are the most demanding for the patients that I have seen in my 11 plus years of doing ePRO. This combined with the motor symptoms and the ON / OFF cycles the patients have to go through is not exactly an easy challenge for them. I took a bit of a personal interest to the matter after the FDA PRO guidance came out in 2009.  I realized that paper data collection is no longer going to be a very reliable option for collecting this data and that efficient and easy-to-use solutions are needed.  It wasn’t very clear in the beginning what those solutions might be and it took some Sponsor input, creative thinking and significant advances in device usability to come up with a new kind of user interface to collect this data.

interface for PD symptom status collection

The end result is quite interesting. Where previously it took several ‘clicks’ to enter symptom status data for a single 30-minute slot, the patients can now enter several time points at once, with just a single click each using a very visual and logical interface.  There is minimal amount of text on the screen as the visual, iPhone-inspired icons are quite self-explanatory.

Figure 1 - Improved and efficient interface for PD symptom status collection

We have also benefitted greatly through collaboration with Dr. Robert Hauser, who is the creator of the original paper version for the ON / OFF diary that is so typical in PD research. Dr. Hauser has given us great insight into current PR research and medical issues and has been instrumental throughout the process. We have also tested the design with some other investigators in Europe.  The feedback has been very positive and there have been great practical suggestions for improvement from the clinicians.

Most importantly, this design has been tested and well received by patients. Patients prefer the electronic version to paper, although some had initial reservations about their ability to use it. However, once they gave it a try, most found it easy to use. There were some patients who are simply in such an advanced stage of the disease that they commented they would not be able to use either method.  Many patients, though, especially liked the fact that with the electronic version, they can easily change their answers and can avoid having to do any handwriting at all. In fact, the electronic version can be used with just the patient’s finger, which is an advantage to many of them.

It has been very interesting to work with the challenge of ePRO for Parkinson’s Disease patients and I’m quite pleased with the results so far. We hosted a webinar on the topic a couple of weeks ago with Dr. Hauser as a guest speaker. It’s all recorded in case you’re interested in learning more of the details of our work so far. Click this button to request access to the recorded webinar.

Parkinson's Webinar

Best Regards,
Kai Langel
Senior Director, Technical Support, CRF Health


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