@ISPORorg @sillytenseldam 📍 Poster 2: PCR135 Improving Patient Involvement in Cancer Clinical Trials: Development of Plain Language Checklists Within the SISAQOL-IMI Initiative. 🔸️ @sillytense from @MyelomaEurope on behalf of @WECANadvocate

📍 Poster 1: MSR128 Implementing SISAQOL Recommendations: Insights From Cancer Clinical Trials 🔸️ Ahu Alanya from the @EORTC @eortc

SISAQOL-IMI is at @ISPORorg Europe 2025 presenting two posters in Glasgow, Scotland 🏴󠁧󠁢󠁳󠁣󠁴󠁿 #isporeurope #isporeurope2025 #sisaqol #qualityoflife #patientreportedoutcomes

We’re thrilled to announce that our consortium will be presenting the SISAQOL-IMI recommendations at the @RoyalStatSoc Conference 2025 in Edinburgh this September! We can't wait to share our insights and engage in thought-provoking discussions. Stay tuned for more details 📊📢

🚨 New Publication Alert! 🚨 Our latest publication in BMC Medical Research Methodology explores handling missing patient-reported outcome data in the presence of intercurrent events. Aligning analysis with the estimand framework is key! 📊 Read more:

Early this month, we presented key highlights from the final SISAQOL-IMI recommendations. We invite you to explore the executive summary about the public launch and the collaborative efforts that underpin this initiative https://t.co/EwWVTBlcMl

📢 Yesterday, SISAQOL-IMI officially launched its final recommendations for standardising patient-reported outcomes in cancer clinical trials! 🎉 A huge step toward better, more reliable data for patient-centered care. Learn more:

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

📢Today at the #SISAQOLIMI launch, MPE´s Silene ten Seldam will present on patient involvement and Plain Language Checklists for myeloma trial protocols. MPE board member, Vincent Claus also attended and joined a panel on implementing the recommendations.

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. https://t.co/Pck88hR4lu

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 this information 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…