2. Setting



When planning the HTA questions and methodologies, patients can describe the most probable setting for the use of the device. Traditionally, devices have gone through many iterations, and some devices that are intended for use by the patient at home still look like laboratory equipment. Likewise, instructions and manuals also reflect the thinking that the device will be used in an almost sterile environment, whereas the reality may be that the patient needs to operate the device while standing in line at the supermarket or sitting in the bus. These everyday settings are very relevant to consider when planning what to assess and with which methodologies, as settings may have an impact on the convenience and usefulness of the device, and hence also on the clinical effectiveness.