When conducting proof synthesis, many people use the PICO framework. PICO stands for inhabitants; intervention; comparator(s); and end result. This helps to explain the analysis query that the proof synthesis goals to reply. Nevertheless, not too long ago Remiro‐Azócar (2024) proposed PICOSI framework. PICOSI stands for:
PopulationInterventionComparator(s)OutcomesSummary impact measure; Intercurrent occasions
Actually, Canada’s Drug Company’s (CDA) current draft strategies information recommends the usage of 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 seek advice from these occasions of curiosity that happen after remedy has been initiated that will influence the interpretation of the top level quantifying the remedy impact (e.g., the occasion modifies the remedy impact, akin to in the usage of rescue drugs or different concomitant remedies, 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 “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 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 beneath.
Learn extra in regards to the CDA’s strategies information for expertise evaluation right here.
