Annex PICO Info
A key element of this step is defining the research questions that could form the scope of a future HTA. These types of questions are commonly referred to as PICO questions.
At this stage, patients can capture patient relevant issues as well as variations across countries. Patients who contribute to the JCA scoping can offer advice on comparators that could be considered and outcomes and share their national needs.
Patients can ensure the selected definition is clear, specific and reflects the relevant target group, not mixing patients’ subgroups. It is important to identify different subgroups as different patients may respond differently to the same health technology.
Patients are not involved when it comes to developing the description of the technology. However, patient feedback on the information that is provided by the health technology developer can be valuable to both health technology developer and assessors.
When it comes to intervention, Patients can suggest critical questions to the health technology developer relating to e.g., the mode of action, formulation, dosing regimen, administration of medicinal products, or to functionality, risks and/or adverse events, and usage of medical devices. They can ask questions based on their experiences with existing technologies and practical considerations on the expected use. This kind of feedback helps ensuring that the information about the technology is patient relevant.
Comparator:
Comparator(s) that is/are selected for the Joint Clinical Assessment must meet regulatory requirements, for the approval of a marketing authorisation by the European Commission. Patients and Patient Organisations can benefit from also knowing the regulatory requirements that drive the selection of comparators in clinical trials, for them to provide the best comparator questions or recommendations. This should always be balanced with knowledge about the current standard of care in the specific member state that the patient group represents.
Input on which comparators are relevant are collected from every Member State. This may result in several comparators because of variation in standard of care across the EU, i.e., health systems do not offer the same treatments/medicines/medical devices for the same disease or patient group. In this way the ’best available alternative’ may vary very much.
For the clinical evaluation of a new technology in the context of HTA it is necessary to understand how well it performs when compared to an existing technology. Therefore, a comparator – or comparators – must be defined as part of the Joint Clinical Assessment.
Outcomes:
Patients can help identify outcomes that are relevant and important to them. For example, if a study is investigating a new medication for high blood pressure, patients might provide input on outcomes such as quality of life, ability to perform daily activities, and side effects of the medication.
Patients can provide relevant input on outcomes by sharing their experiences and perspectives on the health issue being studied, and they can contribute to the discussion on which outcomes matter to them.