In the world of presenting and understanding information, there is no doubt that smartphones and the iPad have given us a fresh take on how information can be presented to the user. It’s under this notion that a challenge was recently run to help re-design and re-imagine the Electronic Medical Record (EMR).
For those who have never seen an EMR file, they are filled with text and are heavy in data but lack any sort of design to make them usable to a wide audience. See Exhibit A below. Edward Tufte would be appalled.
The Health Design Challenge, run in cooperation with the US Department of Health and Human Services, prompted over 230 submissions to modernize the Electronic Medical Record. The winning submission is called Nightingale and was designed by Gravity Tank. According to those behind the submission, the web and mobile app make EMRs:
- and holistic
The presentation is much clearer and actionable, for both the physician and the patient. Patients, or their caregivers, can track their health progress and have a much better understanding and ownership of their health data.
To visualize how Nightingdale helps make EMR information be useful and meaningful to a wider audience, click the screenshot below for a full PDF overview of their approach and design.
Applying these learnings to clinical trials
Just as EMR information presentation has much room for improvement, so do clinical trial protocols. Taking the learnings from the Health Data Challenge and applying them to clinical trials, what can we learn?
In a clinical trial, the protocol is carefully designed to safeguard the health of the participants as well as answer specific research questions.
The protocol document answers many questions for potential trial participants including:
- Objective(s) of the trial
- Risk/Benefits of participation in the trial
- Who can participate in the trial (inclusion and exclusion criteria)
- What the screening process looks like
- Study duration and participant interaction (schedule of events)
- How data will be collected and what it will be used for
- How outcomes will be measured and analyzed (statistic analysis plan)
The protocol is the heart of clinical research – it defines the what and the how of the study. But it is lengthy (often 50-80 pages), full of dense text, and rife with scientific terminology and subject matter that can be disconnecting to the patient. For a picture of the length and complexity of a protocol document, see this sample template. Here is an actual protocol available through PLOS.
The protocol represents the controlled scientific method for the clinical trial. This is important and critical. However, it (nor it’s companion Informed Consent Document) doesn’t do a good job of conveying the study in a patient-friendly form. If we evaluate it from a patient user-friendly lens, there are many ways to make the protocol document can be re-imagined. Much like Nightingale and others are doing for EMRs, we believe if protocol representation were re-built from a participant (patient) point-of-view, we could all benefit.
How protocols might be re-invented
Let’s start with taking off our scientific hats and listening to questions patients have about clinical trials. There are many that come to mind, some of which we’ve heard through our guest bloggers:
- What are the risks and benefits of my participation?
- How will my doctor play into the study?
- What/when do you need me to do if I participate?
- Does this study have placebos or parts of its design that won’t lead to my improved health? Then why would I participate?
- How do logistics and reimbursement for my costs happen?
- Many more…
Reinventing the study design representation would greatly improve understanding and answers the key questions of patients. For example, imagine a ‘study timeline map’ that would lay out the patient journey on the study: screening procedures, patient visits with interventions and procedures, follow-up care and results sharing, etc…
By visualizing the clinical trial protocol in a mobile and web-friendly manner, we also enable the use of related data sources. For example – the logisitcs of traveling to the site. It is easy to imagine the use of a map mashup that would allow the patient to see – both before and during the study – what logistics options are available to them, from directions to public transit to hotel accommodations.
We’ve already explored ideas that could make trials more engaging and rebooting the clinical trial protocol design document for patients would be a great start. We’ll be exploring with some sample web and eventually mobile apps over the months ahead. We welcome your ideas and feedback on our prototypes (watch for release soon). We even hope to challenge the external community, much like the Health Design Challenge, to innovate on study representation for patients.
So, with a patient in mind, how would you visualize a clinical trial protocol?