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. Nonetheless, just lately Remiro‐Azócar (2024) proposed PICOSI framework. PICOSI stands for:
- Population
- Intervention
- Comparator(s)
- Outcomes
- Summary impact measure;
- Intercurrent occasions
The truth is, Canada’s Drug Company’s (CDA) latest 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 therapy has been initiated that will influence the interpretation of the tip level quantifying the therapy impact (e.g., the occasion modifies the therapy impact, equivalent to in using rescue drugs or different concomitant therapies, or has implications for adherence to the therapy routine, together with untimely therapy discontinuation)
The distinction is vital 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 selections usually contemplate 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.
Learn extra in regards to the CDA’s strategies information for know-how evaluation right here.
