Guidebook
Coming soon
This Guidebook provides information about the background, methods and lessons learned for the development of the recommendations, including a sustainability plan. The recommendations are presented as statements with accompanying explanations and examples, organised according to the SISAQOL-IMI analytical framework.
The Guidebook provides recommendations for the use of the SISAQOL-IMI outputs including the interactive table, the glossary, and the plain language checklist. It is intended for a broad audience, e.g. statisticians, PhD students, clinicians, regulatory and health technology assessment bodies, industry and academics, patient advocates.
The Guidebook is available as both an HTML and a PDF version. To facilitate interpretation, the interactive glossary is available in the HTML version.


Glossary
Coming soon
The comprehensive SISAQOL-IMI Glossary comprises 227 terms with acronyms/abbreviations and definitions.
The user may switch between reading the scientific or plain language definitions. It is integrated into the Guidebook and Interactive table to provide easy access to standardised terminology and enhanced clarity of the recommendations.
The Glossary is also available as a stand- alone tool.
Patient material
SISAQOL-IMI is good news for patients taking part in cancer clinical trials as the impact that treatment has on their quality of life will be better captured, understood, and presented. This project and its generated standards are also of importance to organizations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), as PRO data presented in the same way across trials and cancers will help support fair and informed decision making.
The plain language materials are the recommendations adapted for an audience without scientific PROM knowledge, such as checklists for patient representatives and other user/stakeholder groups and tutorial videos.

Educational material
Coming soon
SISAQOL-IMI developed recommendations on the design, analysis, presentation, and interpretation of health-related quality of life (HRQoL) and patient-reported outcome (PRO) data, which considered the estimand framework throughout the development process. To support this initiative, a range of educational materials is being created.
These materials include, among others: video recordings with presentations from various stakeholders and experts with interest in PROs, PDF of the slide decks used in the presentations, a brief 3-minute lay summary of the highlights of these presentations, example protocols and statistical analysis plans that incorporate the recommendations; and in the future, targeted e-learning modules aimed towards the needs of the users of the SISAQOL-IMI recommendations.
The guides will outline best practices for using the SISAQOL-IMI tools, ensuring accurate data collection and interpretation. These materials are designed to empower users, facilitating better health outcomes and informed decision-making in patient care.
