When conducting proof synthesis, many people use the PICO framework. PICO stands for
population; intervention; comparator(s); and outcome. This helps to explain the analysis query that the proof synthesis goals to reply. Nevertheless, lately Remiro‐Azócar (2024) proposed PICOSI framework. PICOSI stands for:
- Population
- Intervention
- Comparator(s)
- Outcomes
- Summary impact measure;
- Intercurrent occasions
In truth, Canada’s Drug Company’s (CDA) current draft strategies information recommends using PICOSI when defining a goal estimand. Whereas the primary 5 elements many be acquainted, intercurrent occasions are much less well-known. CDA defines this as:
…intercurrent occasions seek advice from these occasions of curiosity that happen after therapy has been initiated that will impression the interpretation of the top level quantifying the therapy impact (e.g., the occasion modifies the therapy impact, akin to in using rescue medicines or different concomitant remedies, or has implications for adherence to the therapy routine, together with untimely therapy discontinuation)
The distinction is essential as a result of the views of regulators and payers differ.
The HTA paradigm locations emphasis on evaluating “actual‐world” effectiveness, whereas regulators sometimes prioritize inside over exterior validity when assessing medical efficacy…HTA coverage choices sometimes think about exterior validity, however exterior validity depends upon the inhabitants that’s focused by the payer
CDA describes the several types of proof that can be utilized inside an proof synthesis train for HTA functions within the determine beneath.
Learn extra in regards to the CDA’s strategies information for know-how evaluation right here.
