With the implementation of the Medical Device Regulation (2017/745) (MDR) in the EU, post-market clinical follow-up (PMCF) surveys have become a popular route to gather clinical data on your device. PMCF user surveys are a low-cost solution to the collection of clinical data to support a device’s performance and safety requirements. However, it is not an easy task to design and implement a high-quality survey. In this article, we provide some tips for a good PMCF survey design to obtain the desired information on the clinical use of your device.
There are two kinds of surveys for post-market surveillance (PMS) activities:
- General surveys: Intended to gather general data for proactive PMS activities. These are typically based on a clinician’s memory about a device. General surveys are considered evidence level 8, according to the MDCG 2020-6 guide.
- High-quality surveys: Intended to gather specific data to address a question or identified gap in the safety or performance of a device. These are based on the retrospective analysis of data from patients previously exposed to the device. High-quality user surveys are considered evidence level 4, according to the MDCG 2020-6 guide.
Many devices, such as Class III and implantable legacy devices are expected to have sufficient clinical evidence at a minimum of level 4 per MDCG guidance document 2020-6. Thus, high-quality surveys constitute a simple, low-cost solution to the collection of clinical data to support a device’s safety and performance requirements. However, it is not just a survey. Its purpose is to gather the information necessary to obtain sufficient clinical data, so it needs to have the right questions, prepared for the right users.
It must be considered that, depending on the device, the high-quality user survey may not necessarily be a simple solution. Since 2018, any organization that collects data related to people in the EU must follow the General Data Protection Regulation (2016/679) (GDPR), which imposes obligations regarding the collection and processing of data. A user survey must always meet the GDPR requirements and may additionally require Ethics Committee approval. In general, if a survey only intends to gather details about the device user (healthcare provider) but does not gather patient specific or patient identifying information, it can be justified that Ethics Committee approval is not required.
When designing a high-quality user survey, it is fundamental to consider the following aspects:
- Clinical gaps: Understanding the clinical gaps the survey will intend to close. Gaps are identified from the results of a clinical evaluation. For example, there might not be sufficient evidence of the performance and safety of the device for a particular indication, or for one or more device variants, or for a specific population (e.g. pediatric use).
- Device usage: Understanding how the device is used in the clinical practice, and who is the main user. The device should be used according to its instructions for use (IFU), and it is important to understand the steps of device usage to ask the right questions. Knowing the user of the device is also important. A survey intended for lay users should be written in lay user language, while a survey for healthcare professionals should be written in a medical or technical language. Other aspects to consider are the intended purpose and the claims of the device.
- Patient chart: Understanding what might be documented in the patient chart. It is essential to have a general idea of what information might be available. This information would depend on the intervention type and aim, and how the device is used. For example, for some interventions, the procedure time might be relevant (e.g. open surgeries), or the degree of patient improvement post-intervention (e.g. visual analogue scale (VAS) scores).
- Multidisciplinary team: Understanding that there are many professionals involved in the process of development and implementation of a high-quality user survey. Each role focuses on a specific aspect, therefore it is a team effort. The surveys typically involve a project manager, a clinical writer, a statistician, and other professionals to ensure coverage on regulatory aspects, survey design, data analysis and technical aspects of the device (for which the manufacturer’s expertise is very valuable). Input from a clinician on the use of the device is highly recommended.
- Protocol: All PMCF studies require a protocol. In this case, the survey requires a PMCF user survey plan, where all the relevant parameters are defined. This plan must cover endpoints and acceptance criteria, a sample size calculation based on statistics and a questionnaire. Furthermore, it must define how data are collected, monitored and analysed.
It is of note that the design of the questionnaire is an important factor in having a successful survey. A good, high-quality user survey questionnaire should aim to have the following characteristics:
- Short: Ideally no longer than 15 minutes, with questions that can be answered with Yes/No, scoring systems (e.g. rating on a scale of 1-5), or selection of checkboxes. Answers in open text fields are an alternative option but should be avoided when possible.
- Intuitive: Only ask questions applicable to the device and/or survey respondent. For example, if a device has certain indication only in a specific country, only ask about that indication if the respondent is from that country.
- Structured: A clear structure, which typically includes sections for: Screening, general user information, device information, procedure information, performance information, safety information, and other relevant information.
In addition to obtaining sufficient clinical data, high-quality user surveys are also a great way of confirming the safety and performance of the device, identifying previously unknown side-effects and emergent risks, and identifying possible systematic misuse or off-label use of the device.
At Qserve, we support our clients at diverse stages of their PMCF processes, including the development and execution of high-quality PMCF user surveys. From the PMCF user survey plan –including the questionnaire design, which is customized to the subject device– to the execution of the surveys and statistical analysis of the results.