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. However, not too long ago Remiro‐Azócar (2024) proposed PICOSI framework. PICOSI stands for:
- Population
- Intervention
- Comparator(s)
- Outcomes
- Summary impact measure;
- Intercurrent occasions
In truth, Canada’s Drug Agency’s (CDA) latest draft strategies information recommends using PICOSI when defining a goal estimand. While the primary 5 parts many be acquainted, intercurrent occasions are much less well-known. CDA defines this as:
…intercurrent occasions consult with these occasions of curiosity that happen after remedy has been initiated which will affect the interpretation of the tip level quantifying the remedy impact (e.g., the occasion modifies the remedy impact, similar to in using rescue medicines or different concomitant therapies, or has implications for adherence to the remedy routine, together with untimely remedy discontinuation)
The distinction is necessary as a result of the views of regulators and payers differ.
The HTA paradigm locations emphasis on evaluating “real‐world” effectiveness, whereas regulators usually prioritize inside over exterior validity when assessing medical efficacy…HTA coverage selections usually take into account exterior validity, however exterior validity will depend on the inhabitants that’s focused by the payer
CDA describes the various kinds of proof that can be utilized inside an proof synthesis train for HTA functions within the determine under.
Read extra in regards to the CDA’s strategies information for know-how evaluation right here.