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🌟 Discover the Results of SISAQOL-IMI: Advancing Patient-Reported Outcomes Research 🌟 We’re excited to announce the public launch of the SISAQOL-IMI project results! 📢 Visit our project website to register for online or limited in-person attendance: lnkd.in/eFX6BsWf.

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

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…

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.

After years of dedicated research, we are excited to officially launch the results of SISAQOL-IMI! 🔬 This milestone marks a significant step toward improving patient-centred research and ensuring high-quality PRO data in clinical studies. Subscribe: sisaqol-imi.org

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.

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.

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.

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.

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).

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

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.

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

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!

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

📢 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: sisaqol-imi.org/2025/02/05/sis…

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 lnkd.in/eQqWB2Pv

🚨 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: bmcmedresmethodol.biomedcentral.com/articles/10.11…

We’re thrilled to announce that our consortium will be presenting the SISAQOL-IMI recommendations at the Royal Statistical Society 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 📊📢