Tigran examines the idea of using EDC edit checks to assure patient compliance to the protocol.
How should I assure patient compliance to the protocol in a medical device trial?
I get asked sometimes whether automated patient compliance deviation detection and response is not overkill.
After all, all EDC systems allow comparing input to preset ranges and data types (edit checks). Why not use this, already available off the shelf functionality, to catch non-compliance? As Phileas Fogg put it: “Learn to use what you have got, and you won’t need what you have not”.
Why edit checks are not enough
There are 4 issues with using EDC edit checks to enforce patient compliance:
The original purpose of edit checks is to catch data entry mistakes. As they are generated automatically, they need to be robust enough not to fire indiscriminately. The effect non-compliance has on clinical data can be far less clearcut. This is especially true when taking individual variation between patients into account.
Even if we were able to reliably catch non-compliance through clinical data alone, there’s the issue of timing.
Each hour of delay between non-compliance event and a prompt to return to compliance devalues the prompt. Delays could come from a) manually entering source data into EDC, b) edit check firing in batch mode rather than during data entry, c) the time needed to process the edit checks. What’s the benefit of being told you were not compliant one week ago?
Talk of closing the stable door after the horse has bolted…
By the time the nurse contacts the patient, the damage has already been done. No reinforcement is possible, as a patient could (theoretically) be reminded about the need to be compliant with the interval of several weeks – in which case this will serve as a token reminder, nothing more.
The study nurse may not have spare time on her hands
Let’s assume we live in an ideal world, where the study nurse isn’t overwhelmed by thousands of edit checks firing for no reason, and where data flows into EDC with no delay.
Even if this is true, there’s still the small matter of actually reaching out to the patient. When compliance reaches 90% that’s considered a good result – so in the best case scenario, the nurse would need to reach out to patients in 10% of cases. Edit checks are meant to be resolved immediately. If the EDC used fires edit checks during data entry, then the data entry process will be paralyzed. If edit checks are fired in the background, then the whole data cleaning/query resolution process would stall.
Edit checks are not an operational tool
What would happen in reality, though, is that any edit checks introduced to monitor patient compliance would be overridden by site staff. Together with any legitimate edit checks designed to keep the errors out. Resulting in the same level of compliance and much dirtier database. And that’s best case scenario, if otherwise no data would be entered at all.
Tigran Arzumanov is an experienced business development/sales consultant running BD as a service, a Contract Sales Organization for Healthcare IT and Clinical development.