Interactive table

How to navigate the SISAQOL-IMI webtool

The instructional video on the left demonstrates how to navigate the webtool’s interface, explore tailored recommendations by study type and PRO endpoint, and access detailed guidance on key topics such as the estimands framework, PRO score interpretation thresholds, study design and analysis considerations, as well as results communication and visualisation.

The online interactive table presents international multi-stakeholder consensus recommendations on the on design, analysis, presentation, and interpretation for PROs and HRQOL data in cancer clinical trials.  

This table assumes that researchers have considered all relevant aspects related to the development of these endpoints before consulting the recommendations. For example, the rationale for assessing PROs in the clinical trial is clearly stated, a validated questionnaire is used, appropriate time points or timeframes for assessment are identified, and, if available, the scoring algorithm and an interpretation guide for the chosen PRO measure is followed. The recommendations are instrument-agnostic, meaning they are designed to apply to any validated PRO measure. It is also worth noting that if the PRO concept is used for confirmatory PRO objectives, it is critical to ensure that the trial has an adequate sample size.  

The SISAQOL-IMI interactive tables provide recommendations for randomised clinical trials (RCT) or single arm trials (SAT) separately. Use the interactive table to find statements applicable to your study.

Selecting the PRO objective (column)

Confirmatory objective: Evaluate clinical benefit. Formal comparison to demonstrate that a treatment group is superior (superiority) or similar/not worse (equivalence/non-inferior) than a reference group.

Descriptive objective: Describe patient perspective.

PRO objective - Illustration
PRO variable of interest - Illustration

Select the PRO variable of interest (row)

Recommendations for the following six PRO variables of interest are presented:

  1. Magnitude of PRO (change) score at time t: the actual value or change from baseline value for a PRO domain at predefined time points.
  2. Proportion of responders with improvement at time t: whether the value (or change from baseline value) from a PRO domain at a specific time point reaches a predefined improvement threshold or not.
  3. Proportion of responders with worsening at time t: whether the value (or change from baseline value) from a PRO domain at a specific time point reaches a pre-specified worsening threshold or not.
  4. Time to PRO improvement: the time taken for a clinically relevant improvement from a PRO domain to be observed within a pre-specified time frame.
  5. Time to PRO worsening: the time taken for a clinically relevant worsening from a PRO domain to be observed within a pre-specified time frame.
  6. Overall mean or median scores over a specified time frame: the starting point for the PRO variable of interest is the mean or median score of all available scores from a PRO domain for an individual patient over a pre-specified timeframe.