🔧 PART 15: The “O” in PICO, how outcomes shape the JCA evidence requirements
Series: monthly news from the EU HTA workshop

 

How are outcomes defined within the JCA framework❓

 

🔎 Based on several ongoing JCA procedures we are supporting, the level of detail and scope of requested outcomes varies across assessments.

 

While core outcome domains are consistently addressed, important nuances emerge in how they are specified and operationalized.

 

💡 We have received the respective assessment scopes and share our early learnings focusing on the “O” in PICO:

🔹 Outcomes are generally requested across all PICOs, rather than being defined separately per PICO.
🔹 The level of detail varies, some outcomes are precisely defined, while others remain broad, such as general disease symptoms.
🔹 A clear influence of national HTA bodies, such as the G-BA, is visible, with both generic and disease-specific quality of life measures requested, for example generic HRQoL, preferably via SF-36.
🔹 In some cases, outcomes are requested that go beyond those assessed in the clinical trials.
🔹 Adverse events of special interest (AESI) are not consistently requested, and when included, not always in a comprehensive manner.
🔹 No specific analytical requirements are typically defined, for example regarding time-to-event analyses or minimal important differences.
🔹 Overall, the list of requested outcomes remains relatively focused, covering symptoms, quality of life, safety, and key indication-specific outcomes.

 

👉 From a strategic perspective, early validation of outcome availability against anticipated JCA requirements is critical to avoid evidence gaps and ensure alignment with HTA expectations.

 

👉 In the next part of this series, we will take a closer look at requested subgroup analyses within the JCA framework.

 

We are providing you with insights from our current work on EU HTA.