On the 4th of February the international SISAQOL-IMI guidelines were launged in Ghent/Belgium. ESD is provided software for interactive tables, glossary and guidebook.
#SISAQOL #IMI #EORTC #ESD #CHES

SISAQOL – Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life endpoints Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Outputs COMING SOON INTERACTIVE TABLE COMING SOON GUIDEBOOK COMING SOON GLOSSAR...

Congratulations to @madelinepe.bsky.social + the whole #SISAQOL group. Years ago, had coffee with Madeline and heard the vision. She, Monika, Ahu, Corneel, plus many others made a reality. Thank you for positive work during hard times. A bright part of World Cancer Day www.sisaqol-imi.org

The fearless leaders of #SISAQOL: Anders Ingelgaard & Madeline Pe — thank you for your vision and work to enhance PRO statistical analysis for everyone!

Stakeholder panel at #SISAQOL. Interesting discussion about whether collection of PROs post-progression is feasible, how to make PROs less burdensome, & where to place PROs in the hierarchy of clinical trial endpoints. Universal agreement that SISAQOL moves the field forward!

Coming soon from #SISAQOL: guidebook, interactive table, glossary, patient material, and more! Will be posted on the SISAQOL website. www.sisaqol-imi.org

Coming soon from #SISAQOL for patient advocates & patient research partners: checklist for reviewing PRO measures in protocols, and checklist for reviewing visualizations in cancer clinical trials.

#SISAQOL developed recommendations on how to select a threshold for interpreting PROs and how to report that threshold.

Harmonized terms to replace the vague term “MID” from #SISAQOL! Need to be clear about whether you are talking about within-patient change (eg, responder analysis) or three group-level options (mean comparisons within or between groups - see slides).

Last two #SISAQOL #datadiz recommendations: indicate the directionality of PRO scores (what is good/bad, or what is improved/worsened) and use asterisks instead of p-values in graphs for audiences outside of the scientific community.

This #SISAQOL #dataviz recommendation gets a dedicated post. While I agree in general with including sample size, missing data, & incurrent event information on all graphs for clarity, three lines of text per arm may be infeasible for multi-arm trials and may be more readable in a standalone table.

Excited that #SISAQOL included recommendations about #dataviz for #patientreportedoutcomes! Graphs vary by audience consistent with prior literature. Include p-values for preplanned tests only, and use consistent y-axis scaling throughout your paper.

Next #SISAQOL turns to #patientreportedoutcomes in single-arm trials. PRO objectives should be clearly defined & can be descriptive (more common) or comparative to historical control data. Important to consider missing data & incurrent events as in randomized trials.

Next #SISAQOL highlights involve missing data. Need to separate missing data from intercurrent events, and recommendations reinforce using “completion rate” & “available data rate” - quit using “compliance rate” in your papers! Finally, avoid biased missing data approaches.

Diving into #SISAQOL recommendations. First highlights involve handling death or other intercurrent events. Basically there is no standard approach but need to be clear in the approach that you are using. Some new language here that many folks might not be familiar with…

Excited for a full day of new #SISAQOL recommendations for the statistical analysis of #patientreportedoutcomes in cancer clinical trials!