PMCF user surveys

This branch covers the user survey as a route to post-market clinical follow-up data, and divides it by the stage the survey is at: choosing the instrument and its evidence level, designing it before any response arrives, and running the collection. The other methods, studies, registries and real-world data, are left to the siblings in post-market clinical follow-up, as are the plan that names a survey among its methods and the evaluation report its findings go into.

• Choosing a PMCF user survey and its evidence level — what a survey offers, where it ranks in the hierarchy of clinical evidence, the general end-user and the case-specific instrument, when a clinical study suits a device better, and why surveys are hard to carry out
• Designing a PMCF survey — the stages and their timings, the feasibility check, the protocol, the endpoints and acceptance criteria, the sample size, and the rationale each question carries
• Running a PMCF survey — programming and testing, software that can show where the data came from, the case for doing without ethics committee approval, recruitment and fieldwork, analysis and deliverables, and carrying each round into the next