SISAQOL-IMI

For a person with cancer, daily life presents challenges that can be just as debilitating as the disease itself. Quality of life is continually highlighted by cancer patients as being a key concern, yet it is measured in an inconsistent way. Often, different methods are used to measure quality of life, and this has led to confusing and conflicting results.  As a result, it is difficult to compare from one study to another, making it almost impossible for researchers to translate quality of life findings into real-world results, and studies involving patient-reported outcome measures (PROMs) have not always been taken seriously by the scientific community.

SISAQOL sought to change this, and the project developed a suite of tools and systems to ensure that quality of life can now be measured in a meaningful, standardised way during clinical trials for cancer. 

The project delivered a toolkit including resources for both researchers and patients, so that researchers can refine how they measure quality of life to better answer their research questions, and so that patient advocates have a framework to better evaluate whether clinical trials are measuring quality of life endpoints in a meaningful way, and whether scientific visualisations are accurately demonstrating quality of life results to specific target audiences.

In the beginning, a large part of SISAQOL’s work involved sifting through scientific literature and finding all the different ways that cancer researchers were evaluating patient-reported outcome measures. Often, they found commonalities which could form part of an established standard. Where they found differences, they tried to identify why those differences were happening and what was the reasoning behind the differing approaches. In some cases, the project found that researchers were not using the right endpoint to answer the question that they were asking.

Patient-reported outcome measures come with their own unique complications which makes them different from other kinds of clinical endpoints. For instance, collecting PROMs often involves patients filling out questionnaires, but the questionnaires are not always completed, resulting in missing data. There were other hurdles too, like the fact that many studies considered "we will measure quality of life" as an appropriate way to define an endpoint, which it is not.

SISAQOL developed an interactive table designed to make researchers running clinical trials reflect more on the research questions that they are asking to understand exactly which endpoints related to quality of life they should be considering.

The researcher inputs information relating to the question that they want to ask and the interactive table indicates what’s needed in terms of statistical analysis. It guides researchers to be more specific in regards to what it is about the patient’s quality of life that they want to assess and indicates the most relevant endpoints. The interactive table was developed with input from all of SISAQOL’s partners, including patient representatives, cancer researchers, industry partners, research organisations, regulators and health technology assessment (HTA) bodies.

SISAQOL also built graphical templates into the interactive table so that researchers have a blueprint to help them to design scientific visualisations that are easily understandable and communicate the quality-of-life findings from cancer clinical trials properly.

Patient advocates are increasingly called on to check clinical trial protocols to ensure that they are addressing the needs of patients. However, there can be a knowledge gap – sometimes advocates don’t necessarily know how to ensure that clinical trials are addressing quality of life concerns properly. SISAQOL has developed a checklist to help with that. Thanks to the checklist, patient advocates have a tool to evaluate whether a trial is evaluating quality of life in a meaningful way.

SISAQOL also developed checklists for patient advocates, healthcare practitioners and other interested stakeholders to assess visualisations, both scientific and plain-language. Scientific visualisations are used in peer-reviewed papers and reports that are written up after trials take place, containing the findings. Where they cover quality of life aspects, SISAQOL has written a set of recommendations on how they should be presented. Similarly, the plain-language visualisation checklist enables patients and interested stakeholders to evaluate whether a visualisation depicting quality of life results that is targeting a general audience is fit-for-purpose. 

In addition to the checklists, SISAQOL has developed a series of videos for patients providing explanations for some of the key terms and important definitions that they should know about if examining whether quality of life measures have been properly measured in a cancer clinical trial.  

To help interested parties to navigate through the suite of tools, SISAQOL developed a guidebook which is available on their website. The guidebook also outlines how the recommendations were developed and is available in HTML or PDF.  

SISAQOL also developed a glossary of 227 terms between scientific language and plain language. The goal of the glossary is to ensure that everyone can understand the scientific terminology and to enhance the clarity of the recommendations.

In 2024, SISAQOL won the American Statistical Award (ASA) for Collaboration between Academia, Industry and Government: 2024 SPAIG Award Honors Collaboration Between 41 Organizations. The project is delivering an in-person training workshop on how to use the materials in September 2026, and an e-learning training will also be available online on the website.