Is there a best way to visualize clinical trial PRO results to patients?
Findings from a literature search
Franziska Gross, MSc, and Lisa Wintner, PhD
University Hospital of Psychiatry II, Medical University of Innsbruck
Cancer patients are confronted with complex information when it comes to treatment decisions. They may get information from their doctor or patient organizations or educate themselves about different therapies. Such information can come from clinical trials, which investigate how well treatments work in patients. Their results not only influence which treatments are approved by regulatory authorities such as the EMA (European Medicines Agency) or FDA (U.S. Food and Drug Administration), but also which therapy is chosen to treat an individual patient in clinical care.
In order to give more weight to the patients’ perspective, clinical trials collect patient-reported outcomes, in short, PROs. PROs provide valuable information on how patients experience their own condition, treatment and quality of life. Therefore, presenting PRO data from clinical trials in an understandable and useful way is important to many users like patients, who need to decide which treatment may be right for them.
Graphs are one way to present PRO data. Making the graphical representation of PROs from clinical trials in oncology more consistent and comprehensible across different trials is one of the goals of the SISAQOL-IMI project (Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – Innovative Medicines Initiative). As one of the SISAQOL-IMI work packages (WP), WP4 is developing recommendations on how to graphically present PRO data from cancer clinical trials to different users. A big part of this work was searching through the literature and writing up what we found there. This way, we learnt what is already known and what is not yet known about graphical presentation of PRO data. At ISOQOL’s 29th Annual Conference, both an oral brief and a poster presentation provide the results of our literature search.
Here, we summarize our findings about how to present PRO trial results to patients. No clear preference for a particular type of graph can be seen from the literature. However, patients prefer simple graphs that are clear and easy to read. Patients like to see change over time by showing the results for several time points. Instructions on how to read a graph and explanations of what a graph is supposed to say can help patients understand its message. Labels, for example in the shape of arrows, can indicate whether numbers going upwards mean better or worse results. One should avoid showing statistical details, as most patients find these confusing. Patients like the use of colors in graphs, for example to distinguish the results of two treatment groups, but they should be easy to differentiate, including for color vision impaired people. In addition, the patients’ educational level can influence what they like and understand. This means, there is no “one-size-fits-all” solution.
SISAQOL-IMI WP4 not only searched the literature, but also interviewed patients, health professionals, PRO researchers and other experts. From this data, we found that these stakeholder groups are not as uniform as one might think. Within each stakeholder group, there are people who need explanations and basic graphs, as well as those who have more knowledge and therefore want complex graphs including detailed information. This is why our recommendations will address users with a lower and a higher level of knowledge on PROs, methods and graphics, no matter if they are patients, health professionals, researchers or other experts.
Adapting the level of complexity of PRO data representations to the target audience is also suggested by the PROTEUS Consortium, which includes members involved in the work of ISOQOL and/or SISAQOL-IMI (find an ISOQOL editorial on PROTEUS here). We will bring our recommendations in line with the work of PROTEUS in order to enhance available guidance and jointly support the use of PROs.
Long story short, patients and other users deserve informative and clear graphs. Our work will help to make things a bit less complicated by giving guidance on how to present PRO data from cancer clinical trials in an understandable and useful way to different viewers.
This publication reflects the views of the individual authors and should not be construed to represent official views or policies of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), US National Cancer Institute (NCI), Medicines and Healthcare products Regulatory Agency (MHRA), Institute for Quality and Efficiency in Health Care, Health Canada or the Norwegian Medicines Agency. This study received no funding from the US National Institutes of Health (NIH). No other authors were fully or partly NIH funded, employed by NIH, or are in receipt of an NIH grant for this work. Neither IMI nor the EU, nor EFPIA are responsible for any use that may be made of the information contained therein.
The SISAQOL-IMI project has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement No 945052. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Abstract will be presented in the Friday Afternoon Poster Presentations: Slot 8 on 21 October, 3:40 pm – 3:55 pm.
This newsletter editorial represents the views of the author and do not necessarily reflect the views of ISOQOL.
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