Non-comprehensive list of aspects for patient involvement in HTA of Medical Devices

Key questions:

      • To what extent does the technology produce the intended outcomes in real world settings?
      • To what extent does the technology produce the intended outcomes in experimental or ideal settings?
      • How should comparison between efficacy and effectiveness be integrated in the overall assessment of the technology?

Aspects to address:

  • Prioritisation of which medical technologies should obtain evidence via RCTs based on which benefit the technology is expected to provide.
  • The relative safety profile (including human factor implications) and novelty of the technology.
  • The evaluation of risks associated with the use of a medical technology, which should feed into the clinical evaluation.
  • The prioritisation of characteristics and features of the device to be measured.
  • The co-development of decision tree tools based on outcomes, acceptability, tolerance and convenience measures.
  • Introduce a continuum of operational aspects and point to challenges that should be assessed (patients who provide this kind of input should know their community well, and be familiar which alternative devices are being used and how the community values benefits, functionalities and other characteristics), see also page on Setting. 
  • Point to relevant post-market time points when an assessment would be appropriate.
  • Discussions on ethical aspects, placebos and tolerance levels, including the time period for possible use of placebo if an RCT is deemed necessary. See also page on Patient and social aspects. 

Patients should play an important role in pointing out these aspects and making sure they are integrated in the HTA under the domain Patient and social aspects.