In this article, we discuss why you should use validated patient reported outcomes (PROs) in your PMCF survey. Under EU Medical Device Directive (MDD), the use of the validated questionnaires in the post-market survey had not been so rigidly required. However, under MDR, this has not been the case. Notified Bodies are now expecting all studies with patient reported outcomes to generate clinical evidence to use validated questionnaires. This is also true with FDA as well.
Real-World Evidence and the role of PROs
Both FDA and competent authorities in EU are putting more importance on Real-World Evidence (RWE) since normal investigational studies are not sufficient to provide assurance of efficacy and safety of medical treatment using medical devices throughout their lifetime. One of the tools to obtain Real-World Data (RWD) is the patient-reported outcome (PRO). In order to generate reliable and accurate clinical data, many researchers and institutions have developed PRO questionnaires to collect consistent, reliable and accurate data from patients and validated them through extensive testing. There are a number of these validated PROs available in many of therapeutic arenas.
What are validated PROs and non-validated PROs?
The validated PROs are the ones that have been rigorously tested for their validity in measuring psychometrics with consistency across different demographics, linguistics and cultures. On the other hand, non-validated PROs are the ones that are developed in-house but never been rigorously tested for its validity in delivering consistent measurement.
The rise of patient-centric research
Due to moving to emphasis on patient centric clinical research and studies, the patient-reported outcomes (PROs) are becoming more used than ever. In fact, FDA is recommending to use clinical outcome assessment (COA) including PROs in a way reducing burdens on patients who participate in the studies as substitute to traditional way of studies. The quality of data cannot be traded off by using the PROs. To ensure to deliver high quality reliable data, a number of researchers and clinicians in many therapeutic domains have developed the PROs through rigorous testing and review.
Examples of validated PROs
Here are some of examples of PROs: the Kansas City Cardiomyopathy Questionnaire (KCCQ), which provides a measure of disease specific health-status in patients with heart failure; the Breast Evaluation Questionnaire (BEQ), which assesses patients’ satisfaction with their breasts before and after surgery; FACE-Q, which assesses aesthetic devices using for different subsets of scales for appearance appraisal scales, adverse effect checklist, process of cares scales, and quality of life scales. There are a number of these readily available validated PROs in most of therapeutic areas.
Since it takes significant time and cost to develop validated PROs or validate your own PRO, it is recommended to use readily-available PROs whenever suitable ones are available for your clinical studies including PMCF surveys.
Why you need to use validated PROs for your PMCF surveys?
The purpose of PMCF is to collect clinical data to generate clinical evidence to fill the gap of data deficiency and to update the devices’ clinical safety and performance. Therefore, the high quality of evidence is required. From our experience, in fact, the NBs will no longer accept non-validated PROs for your PMCF plan. Even if they accept the PMCF plan, it would be extremely difficult to convince the data generated by such a non-validated PRO as sufficient clinical evidence.
In order to use ready-available validated PROs, for most of cases, you will need to pay license fee to obtain permission for use from the author of the PRO as it is copy-righted. If certain PROs are not required to pay license fees, you will still need to obtain permission from the author as they are copy-righted.
Cost vs efficiency
You may think it expensive to pay the license fee as you probably have never done it before. However, it is the most efficient way to use the validated PRO for your PMCF survey. If you cannot find any ready-available validated PRO for your PMCF survey, it would not be a good idea to conduct the PMCF survey but it would be better to look for other alternatives such as PMCF studies instead.
Regulatory and financial considerations
Thus, complying with EU MDR poses financial challenges on medtech manufacturers comparing to MDD. It is, therefore, crucial to choose the optimal PMCF activities not only from regulatory compliance aspect but also from corporate financial aspect. The PMCF survey is one of the efficient options for PMCF activities. Therefore, if it is applicable to fill the data gap for your CER, the PMCF survey is a highly recommended option.
The PMCF survey can be efficiently implemented if using electronic patient-reported outcomes (ePROs). There are a number of digital platform providers who offer ePROs and some other modules such as eConsent, etc. We will discuss the ePROs and digital platform in other blogs.
Contact us
If you want to learn more about validated PROs or PMCF surveys, please feel free to contact us at clientcare@eclevar.com.
