How ePRO can help comply with EU MDR Post-Market Surveillance

May 14, 2019
.  written by 
Jón I.

The EU MDR places more focus on Post-Market Surveillance (PMS) and clinical data collection. From next year, Medical Device manufacturers need to keep better track of device efficacy and safety. In this post, you'll learn how you can use ePRO to simplify data collection for PMS reporting.

What is ePRO?

One of the issues with paper-based data collection is the high risk of missing and erroneous data. This is especially of concern when collecting patient-reported outcomes (PROs) in clinical studies. Paper-based questionnaires have been used to collect PROs for years. But as IT evolved, organizations have moved towards digital solutions.

ePRO stands for electronic Patient Reported Outcomes, and it's used to describe e-clinical solutions that can support a digital collection of PROs. ePRO is often mentioned in relation to eCOA (electronic Clinical Outcomes Assessment) and might at times be confused with eCOA. Although it is true that ePRO is a part of a clinical outcome assessment (COA), COA also includes the collection of data directly from healthcare professionals and healthcare systems.

When ePRO was first introduced in clinical studies (before the era of the smartphone) participants would use PDAs to complete questionnaires.
Today ePRO has evolved to different platforms, such as smartphone apps and web-apps. But, bring your own device ePRO is becoming increasingly more popular, because of its potential to future-proof data collection in clinical studies.

Even though ePRO was initially created to support data collection from patients. Its potential to support other kinds of data collection, such as that for PMS, has been overseen.

Before we look at how ePRO can be used for PMS, let's clarify what PMS is under the EU MDR.

What is Post-Market Surveillance according to the MDR?

The EU MDR lays out requirements for a new kind of PMS system. Manufacturers now have to proactively gather input and data about their device safety and clinical efficacy.

A PMS system like this must be incorporated into the ongoing risk management and clinical evaluation processes throughout the device life cycle. Depending on the device classification and type, this can be achieved in different ways.

A PMS plan will define what data needs to be collected, how it should be analyzed, and which actions to take. In addition, it establishes whether a Post-Market Clinical Follow-Up (PMCF) is needed or not. Thus, PMS covers a variety of different activities. Some require information gathering (data collection), others not.

In the following section, we will learn how ePRO can be applied for collecting data; on safety (vigilance), in a Post-Market Clinical-Follow up, and clinical market feedback.

3 ways to use SMART-TRIAL ePRO for PMS

Even though ePRO stands for electronic Patient Reported Outcomes, SMART-TRIAL ePRO is not only used to send questions to patients.

SMART-TRIAL is centered around subjects, and a subject can be a patient, clinician, or any other participant. Thus, the SMART-TRIAL ePRO can and has been utilized, for much broader data collection than just PROs.

Here are three ways you can use SMART-TRIAL ePRO for PMS.

For clinical follow up and patient feedback

Together with Electronic Data Capture (EDC), ePRO can be a very powerful tool for PMCF studies.

Use the SMART-TRIAL ePRO together with EDC to build a registry of clinical follow-ups. Combine clinical information with patient-reported outcomes, to build a solid registry around the usage and efficacy of your device.

Depending on the type of device, the process is designed differently. But an example of a PMCF study is:

  • A subject answers a survey/questionnaire via SMART-TRIAL ePRO before the medical device is introduced to the care pathway. This will act as the patient's baseline data.
  • Gather relevant clinical and device information from healthcare professionals via SMART-TRIAL EDC, before and after application of the medical device in the care pathway. This could also be achieved with SMART-TRIAL ePRO - all depending on your focus.
  • Use SMART-TRIAL ePRO to collect post-treatment information and feedback from the patient. This can be done once or multiple times (automatically) over the course of a couple of months or years - depending on the device type.

PMCF should be conducted with key opinion leaders (KOL) and clinical sites interested in research within the area. Make sure to have appropriate contracts in place which govern data ownership and the general collaboration.

Migrating operational device data via the SMART-TRIAL API, together with PMCF data, can also be valuable for R&D purposes. This eliminates the need to migrate data afterwards.

Proactive collection of safety and vigilance information

One of the ways you can proactively collect information about safety issues and Adverse Events (AEs) is to conduct customer surveys. Because SMART-TRIAL ePRO is not solely used for time-based questionnaires, it can also be used in a survey-based manner.

Depending on the PMS plan, surveys can be conducted with distributors, customers, and other actors that might have knowledge about safety issues or AEs. Surveys can e.g. be performed every X months, to identify any new events that originate in the market.

  • Create a Form in SMART-TRIAL to classify safety events with a set of simple questions.
  • Send this survey to distributors and/or customers on a regular basis, according to the PMS plan. Use SMART-TRIAL ePRO with e.g. public sign-up, or normal subject events.
  • If survey results indicate serious safety issues, send a follow-up questionnaire to gather more information about the issue/event. Use SMART-TRIAL ePRO with subject events for this purpose.

Depending on the type of device, serious safety issues require additional device information to be collected. For this purpose,  SMART-TRIAL dynamic Forms can be used to hide/show questions accordingly.

Collect data on device's usability, design, and off-label use

Similar to surveys for collecting information on a device vigilance. A manufacturer can use SMART-TRIAL ePRO for validating the device's usability, design, and general application in clinical practice.

The optimal way to do this is to gather a group of KOL or other customers who are interested in sharing their opinion. Such a survey can be conducted e.g. once every 2 or 3 years.

  • Create Forms in SMART-TRIAL that gather information about general usability, design, and clinical application (depending on device).
  • Usability and design related questions shall e.g. use the Likert scale as a standard. Try to minimize the use of open-ended questions - leave these for off-label use enquiries by asking about the clinical application.
  • Send this survey to KOL and selected customers. Use SMART-TRIAL ePRO with e.g. public sign-up, or normal subject events.
  • If survey responses indicate unexpected results, send a follow-up questionnaire to gather more information about the subject of interest. Use SMART-TRIAL ePRO with subject events for this purpose.

The data on the customer's experience with the device can be used by regulatory, clinical, and R&D teams. This information can prove vital to improving the customer's experience and satisfaction with the device. And if used correctly, have a great impact on the device success in the market.

How to use SMART-TRIAL ePRO for your PMS

In this post, you've learned the basics of ePRO and how the SMART-TRIAL ePRO can be used for Medical Device Post-Market Surveillance.

Because the SMART-TRIAL ePRO is not solely fixed on patients, one can use ePRO for data-collection on a much wider level.
The examples covered in this post were:

  • Clinical follow-up and patient feedback
  • Proactive collection of safety and vigilance information
  • Collecting data on the device's usability, design, and off-label use

By using ePRO for these activities, you can increase the quality of data available for regulatory affairs, improve the customer experience with your device, and improve the overview of the device performance in the market.

PMS is device specific and requires thorough planning before diving into data collection design. But if your PMS plan is well underway, you can take a look at the feature highlight article on SMART-TRIAL ePRO and see how easy it is to set up.

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