Patient reported outcomes (PRO) are becoming increasingly important to medical device clinical trials. Your regulatory strategy, reimbursement strategy, marketing, and more will all be affected to some degree by the data you collect from patients.
The data that sponsors collect from physicians is important, but it’s only part of the story. To understand how devices are used in the field if they’re helping patients, you need to collect accurate and complete data from those patients.
And that means the way you collect PRO data is of the utmost importance. Decades ago, most patient reported outcomes were collected on physical paper. But today, electronic patient reported outcomes (ePRO) have overtaken paper as the preferred form of data capture for patients, investigators, and sponsors alike.
In fact, an article published in the the National Institute of Health, summarizing the research on ePRO vs paper, called ePRO “the gold standard for PRO data capture in clinical trials.”
That’s strong language, but the truth is that the results from ePRO in clinical trials back it up. So, let’s dig into those results and why they point to such a clear advantage for ePRO over paper PRO.
NOTE: There are several types of patient reported outcomes, but in this article, I’m focusing on self-reported PRO, rather than those based on interviews with a clinician.
Handing someone a piece of paper and tasking them with filling it out and bringing it back is not as simple as it sounds—just ask any teacher. And while paper PRO forms are not quite the same thing as homework, clinical investigators face the same struggles as teachers when they use them.
Sometimes the patient loses the questionnaire. Sometimes the patient simply forgets to fill it out. Sometimes the dog eats it.
Whatever the case, the consequence is a loss of critical data. As one study quoted in the NIH article concluded, paper-based PRO could “result in untimely, unreadable, missing, illogical, or otherwise faulty data.”
The problem is, MedTech companies need strong PRO data from their clinical trials. It’s crucial they have accurate and complete data to assess the safety and efficacy of their device. But paper PRO forms continue to be completed at exceedingly low rates and are often back- or front-filled by patients.
ePRO resolves these issues by offering patients easier, more intuitive options for self-reporting:
At Greenlight Guru, we’ve found that users of SMART-TRIAL by Greenlight Guru often experience huge surges in the percentages of PRO that are successfully completed, in some cases nearly doubling their rate of completion.
These results track with the studies cited in the NIH article, which found that “ePRO systems can lead to more accurate and complete data, improved protocol compliance, (and) avoidance of secondary data entry errors.”
Now, it’s true that making a paper form electronic doesn’t automatically make it easier for patients to use. As the NIH article states:
The advantages of electronic data capture are well documented, but those advantages mean little if measurement error is introduced by poor implementation of a PRO instrument on an ePRO platform. This is a particularly important consideration when, as is often the case, the PRO instrument being used was initially developed as a paper-based questionnaire.
It’s not just the electronic aspect of ePRO that matters; the software must be user-friendly and intuitive. At Greenlight Guru, we’ve worked hard to ensure that both sponsors and patients have everything they need to collect the most accurate clinical data with our ePRO tool.
For instance, based on feedback from clients and the MedTech industry, we’ve developed a new best-in-class slider for graded questions.
This type of intuitive and customizable user interface heavily reduces the number of misleading or inaccurate responses patients tend to make with a paper form.
On top of that, SMART-TRIAL by Greenlight Guru offers our ePRO in 40+ languages. When you’re working with a diverse patient population, giving patients the ability to answer questions in the language they’re most comfortable with is invaluable. Not only can it lead to increased rates of completion, but more accurate data entry, as well.
More accurate data on the front end means less work trying to clean up data later on, when the errors are discovered.
The NIH article also notes an important fact for study sponsors: regulatory bodies have taken note of the advantages of ePRO.
For example, in the US, the FDA’s Patient-Reported Outcome Measures Guidance states that:
If a patient diary or some other form of unsupervised data entry is used, we plan to review the clinical trial protocol to determine what steps are taken to ensure that patients make entries according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected.
The NIH article calls that an implicit endorsement of ePRO, and I don’t disagree with that assessment. The use of paper makes it extremely difficult to ensure data entry is occurring “according to the clinical trial design.”
At the end of the day, clinical trials must be able to collect accurate and comprehensive data from patients to determine the safety and efficacy of the medical device in question. We have ample evidence that this is far more likely to occur with ePRO than with paper.
As the NIH article puts it,
“It’s (ePRO’s) numerous advantages over paper-based data collection result in more complete and accurate PRO datasets, which could be the difference between a failed and successful clinical trial.”
The verdict here is clear—if you’re still using paper, it’s time to switch.
The ePRO vs paper debate may be over, but that doesn’t mean all ePRO solutions are created equally. SMART-TRIAL by Greenlight Guru is an electronic data capture (EDC) platform built specifically for the medical device industry. All our releases are thoroughly validated to ensure compliance with MedTech industry standards.
If you’re ready to get the most accurate and complete data from your clinical studies, then get your free demo of SMART-TRIAL by Greenlight Guru today.