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
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 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 remedy has been initiated that will affect the interpretation of the top level quantifying the remedy impact (e.g., the occasion modifies the remedy impact, akin to in using rescue drugs or different concomitant therapies, or has implications for adherence to the remedy routine, together with untimely remedy 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 sometimes prioritize inner over exterior validity when assessing medical efficacy…HTA coverage choices sometimes take into account exterior validity, however exterior validity is determined by 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 expertise evaluation right here.