One (incomplete) view of Electronic Data Capture is that it’s a way of building validation checks into your Case Report Forms. A paper form can’t tell you that you missed a question or that you’ve confused today’s date and the subjects date of birth but the validation checks built into the EDC system can.
But when you look at the ways that those validation checks are programmed in EDC systems it’s easy to see that they are a kind of add-on to the data collection forms. EDC systems are providing us with better paper, not a system that has any designed-in understanding of the data collected.
Take a Body Mass Index calculation:
I don’t know how many times I’ve written that calculation in different systems over the years. Whether I pull it from a standard library or program it new for each study, the EDC system doesn’t inherently know that a patient has a height or a weight or that the two are related through the BMI calculation. It only knows what we program it to know. For BMI I have to create height and weight fields and convert these entries from whatever units they are entered in into their SI equivalent so that the calculation can be run.
But what if we started to add some decision-support type functionality into our eClinical systems? What if instead of having to create a field called “weight” and schedule it into a form and an event, I could just tell the EDC system “collect weight here” and the same for the patients height, pulse, blood pressure, gender and other universal elements.
The user would see a slight difference in the EDC system. Based on their preferences for input units they would see a question “Weight” in the collection form with their preferred unit input. The system would automatically convert to the SI unit and show that on the screen too (if different). If we collect a height at the same event we can automatically generate the BMI value and in validation checks we can ask the system “if patient is obese…” without having to program all the rules because the system knows how to calculate if the patient is obese from the BMI.
This imaginary system would have knowledge of what weight and height are and would supply BMI charts and graphs of change across visits as standard without having to write a custom report. Hey, you’re collecting data on human beings! Would you like to see a chart of your patients ages / heights / BMI’s / Gender?
Most EDC systems are not that different from business applications that allow you to create forms and collect data. They have no built-in assumptions, no knowledge that the subject of the data collection is a human being (or maybe a horse, cat or dog in a veterinary study).
Isn’t it time we found a way to give our EDC systems better understanding of our patients? If I define a CRF with patient age, sex, height collected at Screening and then weight and blood pressure collected at Visits 1, 2 and 3 then I should be able to ask my EDC system “Give me a list of underweight patients with apparent hypertension” with no need to write any validations or calculations because the system has a built-in understanding of these concepts.
Maybe our eClinical systems of the future will exhibit a little more expertise on our study subjects.