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 parts 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 remedy has been initiated that will impression the interpretation of the top level quantifying the remedy impact (e.g., the occasion modifies the remedy impact, corresponding 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 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 inside over exterior validity when assessing medical efficacy…HTA coverage choices usually contemplate exterior validity, however exterior validity will depend 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 in regards to the CDA’s strategies information for expertise evaluation right here.
