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, just lately Remiro‐Azócar (2024) proposed PICOSI framework. PICOSI stands for:
- Population
- Intervention
- Comparator(s)
- Outcomes
- Summary impact measure;
- Intercurrent occasions
In reality, Canada’s Drug Company’s (CDA) latest draft strategies information recommends the usage of 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 confer with these occasions of curiosity that happen after therapy has been initiated that will impression the interpretation of the tip level quantifying the therapy impact (e.g., the occasion modifies the therapy impact, akin to in the usage of rescue drugs 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 usually prioritize inner over exterior validity when assessing scientific efficacy…HTA coverage choices usually take into account exterior validity, however exterior validity relies on 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 under.
Learn extra concerning the CDA’s strategies information for expertise evaluation right here.