forthcoming Call for patient advisors for the CORE-MD project: Evaluation of high-risk medical devices

November 2021

* This call was originally intended for early 2022, but had to be delayed due to external circumstances

The European Patients' Forum (EPF) is pleased to announce a call for patient advisors for CORE-MD, a project focusing on translating expert evidence on high-risk medical devices into advice for EU policy makers. The call is expected to launch in March/April 2022. 

The patient advisors will inform the work of the project by participating in two to three rounds of surveys and a focus group meeting that will aim to capture patients’ experiences and reports on measures that matter to them in their specific situation (PROMs*). These experiences and preferences will be taken into account when formulating the advice for EU policy makers, and ensures that patient experiences and priorities are integrated into the project from the start.

Who are we looking for?

  • Ten People living with high-risk medical devices, particularly, but not limited to:
    • Cardiovascular devices (Drug eluting stents, Bioresorbable vascular scaffolds, Surgical heart valves, Transcatheter aortic valve replacement, Transcatheter mitral valve repair, Left atrial appendage occlude, Leadless pacemaker, Subcutaneous implantable cardioverter, defibrillator)
    • Orthopaedic devices (Hip joint replacement [total hip cups, heads, liners, and stems], Knee joint replacement [total knee systems, unicompartmental knee systems])
    • Diabetic medical devices (implantable continuous glucose monitoring system, implantable insulin pumps, automated insulin delivery devices)
  • People with a condition that will require them to have a high-risk medical device inserted
  • Carers of people in the above situations
  • Fluent English required, min. 18 years of age

What does the work entail?

  • Participation in a Group Interview/Discussion (online, ~4 hours, incl. breaks) in late April/May 2022 (dates tbc, pending participant availability)
  • Participation in surveys for consensus building (2-3 rounds)
  • Preparation call (~ one hour)
  • Availability via email in April/May 2022
  • Potentially the need to familiarise with short pre-reads

Timeline and selection process

The call is expected to launch in March/April 2022, and will last one month. 

Applications will be evaluated by an EPF member of staff. 

Compensation

Your input will be renumerated with a fixed amount of € 500.

Application form and questions

The application form will consist of questions about your personal details (name, country of residence, experience), short questions about your motivation for applying, a declaration of interest, and information on how EPF will process your personal information.

Should you have any questions, or should you already wish to express your interest, please feel free to contact Hannes Jarke at hannes.jarke@eu-patient.eu

Background:

Evaluating high-risk medical devices includes many aspects. While clearly such an evaluation needs to account for economic aspects, longevity, and how much it pro-longs the life of a patient, it is also crucial to see the impact such devices have on the quality of life (QoL) of patients. QoL is often measured through surveying patients, but it is not one-dimensional. While someone with a heart stencil might report they are content with life in general and would rate their well-being as adequate or good after the operation, a person with a new hip will likely have very different priorities. Such a patient will clearly not be happy simply to survive their operation, but value very different outcomes, such as being able to take longer walks, or easily climb a set of stairs in their house.

Patient-reported outcome measures (PROMs*) are frequently used in assessing such aspects and should feed back into the evaluation of high-risk medical devices. Based on a literature review of such measures, EPF aims to conduct a DELPHI (a method consisting of surveys to find consensus and a focus group session) with patients, or carers of patients, who live with high-risk medical devices or are planning to have one inserted.

The goal is to identify outcomes beyond economic and biological markers that are most important to patients living with different devices, how to measure them, how frequently, and how long they should be checked. This would provide input to create a more holistic evaluation of different high-risk medical devices. This work will inform the work of CORE-MD. You can also find a detailed plan and description of the project in this paper.