Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About New Medicines: a Randomized Controlled Trial
Phase: NA
Conditions: Cancer
Sponsor: London School of Economics and Political Science

 
Study Protocol 
 
 
Effect of communicating structured benefit and harm information in European 
patient leaflets on expectations about new medicines: a randomized controlled 
trial  
 
 
Avi Cherla,1,2 Huseyin Naci,1,2.3 Steven Woloshin,3,4 Anita K Wagner,2,3 Barbara Mintzes,5 
Julian Treadwell,6 Courtney Davis 3,7 
 
 
1. Department of Health Policy, London School of Economics and Political Science, 
London, United Kingdom 
2. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim 
Health Care Institute, Boston, Massachusetts 
3. Lisa Schwartz Foundation for Truth in Medicine, Norwich, Vermont 
4. Center for Medicine in the Media, Dartmouth Institute for Health Policy and Clinical 
Practice, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire 
5. School of Pharmacy, University of Sydney, Sydney, New South Wales, Australia 
6. Centre for Academic Primary Care, University of Bristol, Bristol, United Kingdom 
7. Department of Global Health and Social Medicine, King’s College London, London, 
United Kingdom 
 
 
 
 
 
Funding: King’s College London. 
 
 
 
 
 
 
 
 
 
 
Final version date: July 2, 2025 
 
 
 
 
 
 
 
 
 
 

Introduction 
 
The patient information leaflet, also known as the package leaflet, is a written summary of 
the information available on medicines designed to help patients use their medications 
safety and appropriately. It is the primary tool through which regulatory agencies 
communicate essential information to patients, and it is included with every prescription 
medicine in Europe. Patient information leaflets are the most widely distributed source of 
printed medicine information in Europe, and are also available electronically via the 
electronic Medicines Compendium and the websites of the European Medicines Agency 
(EMA).  
 
Although widely available, many people find regulated patient information leaflets unhelpful 
because they do not meet people’s information needs – particularly their need to understand 
how well a medicine works.1–3 In order to make informed, evidence-based decisions aligned 
with their preferences, patients need clear information about the potential benefits, harms, 
and uncertainties of drugs, including treatment alternatives.3,4 However, much of this 
information is either inadequately communicated or entirely absent from current patient 
leaflets. Leaflets often omit the goal of treatment (e.g., whether the treatment is palliative or 
curative) and provide no data on the magnitude and relevance of expected benefits.5 While 
side effects are listed, they are rarely accompanied by data on frequency, severity,6–8 or how 
these risks compare to other treatments.  
 
Patients consistently express interest in receiving written information about prescription 
drugs at the point of care that more effectively addresses their informational needs.1,2 The 
European Medicines Agency (EMA) recently proposed a series of reforms aimed at 
improving the clarity and usefulness of patient information leaflets. One key proposal is the 
introduction of a ‘key information section’; a concise summary at the beginning of the leaflet 
that includes qualitative statements about the goal of treatment, main benefits, 
contraindications, and the most serious side effects.9  
 
To inform the EMA’s consultation on improving patient information leaflets, we developed a 
key information section that summarizes the main benefits and harms of a medicine. Its 
design was informed by evidence on effective health communication. Recognising that 
qualitative statements alone could be misinterpreted by patients,4,8,10 we incorporated a 
structured summary table presenting quantitative information on treatment effects and side 
effects. Previous research shows that patients not only want this type of information,1,2 but 
they also understand it, and can use it to make more informed decisions.4,11–13  
 
To evaluate the impact of structured benefit-harm information in patient leaflets, we will 
conduct a randomized controlled trial with a nationally representative sample of adults in the 
United Kingdom (UK). The trial will evaluate whether including qualitative or quantitative 
information about drug benefits and harms improves individuals’ expectations and 
understanding of a newly approved drug. Participants will be randomly assigned to one of 
three groups: (1) the standard patient information leaflet (control), (2) a leaflet incorporating 
the EMA’s proposed key information section with qualitative statements, or (3) a leaflet with 
a key information section that includes both qualitative and quantitative information on the 
drug’s benefits and harms.  
 
Methods 
 
This study received ethics approval from the London School of Economics and Political 
Science. The protocol was registered prior to recruiting participants (ClinicalTrials.gov) and 
the study will be reported in accordance with the CONSORT guidelines for randomized 
controlled trials.  

 
Randomization 
Participants will be individually randomized with equal allocation to 1 of 3 versions of a 
patient information leaflet: (1) the standard patient information leaflet (control), (2) a leaflet 
incorporating the EMA’s proposed key information section with qualitative statements, or (3) 
a leaflet featuring a key information section that summarises quantitative data on the drug’s 
main benefits and harms in addition to qualitative statements. We will use Qualtrics to 
randomize participants and to administer the survey.  
 
Participants 
Adults 18 years and older, fluent in English, and residing in the UK will be invited to 
participate in this survey. Participants will be recruited by Cint, a market research company 
that identifies participants from hundreds of research panel providers that use different 
methods for recruitment. We plan to recruit a nationally representative census-matched 
sample of adults according to age, sex, and education. Informed consent will be obtained 
from participants before initiating the survey; participants will be directly compensated by the 
survey company after completion. No identifying information about participants will be 
recorded.  
 
Interventions 
Participants in the control group will receive the standard patient information leaflet for a 
recently approved cancer drug, obtained electronically from the EMA website. There are 2 
experimental conditions.  
 
For participants randomized to receive the EMA’s proposed key information section with 
qualitative statements, we developed a version based on the draft proposal published by the 
EMA.9 The proposed key information section summarizes the goal of treatment, main 
benefits, contraindications, and most serious side effects. To ensure accuracy of our 
interpretation, we sought feedback from the EMA. The final version tested in the trial 
incorporated their suggestions. 
 
Next, we developed a key information section that includes quantitative data on the drug’s 
main benefits and side effects, modeled on the Drug Facts Box – a tabular summary format 
for prescription drugs, designed to resemble a nutrition label.13 The key information section 
presents qualitative information about the drug (including its indication and treatment goal), 
and how it was studied (the comparator treatment and number of patients enrolled in the 
clinical trial that supported the drug’s approval). It supplements this with quantitative data the 
drug’s benefits and side effects. Data on the drug’s benefits and side effects were sourced 
from European Public Assessment Reports (EPARs). Further details are provided in the 
appendix. 
 
Procedure 
Upon entering the study, participants will be randomized to 1 of 3 versions of a patient 
leaflet. The patient leaflet is for tivozanib (Fotivda), a cancer drug approved by the EMA for 
the treatment of advanced kidney cancer. An electronic version of the patient leaflet along 
with a download link will be displayed alongside each multiple-choice question. Participants 
will first complete a practice question designed to test their ability to scroll through and 
navigate the leaflet. Participants who answer the practice question incorrectly will be 
excluded from the study at this stage.  
 
The first set of questions is designed to evaluate participants’ expectations, perceived 
magnitude, and understanding of the drug’s benefits and side effects based on the 
information provided in the patient leaflet. To assess expectations, we will ask participants 
about the likelihood that patients with advanced kidney cancer would be cured, live longer, or 

feel better if they were treated with tivozanib. They will also be asked about the perceived 
magnitude of the tivozanib’s benefits and side effects.13–15  
 
To assess understanding, we will ask participants 3 questions: (1) the approved indication of 
tivozanib, (2) the most common serious side effect associated with treatment, and (3) the 
recommended dose of treatment. Answers to all 3 questions can be found in the standard 
patient leaflet. Information about the drug’s indication is also included in both key information 
sections; information about the most common serious side effect is presented in the EMA’s 
proposed key information section with qualitative statements. Participants randomized to the 
key information section with both qualitative statements and quantitative data will receive 2 
additional questions: one asking them to identify the difference in overall survival between 
tivozanib and standard treatment, and another asking about the difference in serious side 
effects.  
 
Next, all participants will be asked a series of questions to assess their satisfaction with the 
information presented in the version of the patient leaflet they were assigned. Before ending 
the survey, we will ask participants for information about their demographics: their age, sex, 
highest level of educational attainment, and personal experience with cancer (whether 
themselves, an immediate family member or close friend had been diagnosed with cancer). 
 
Primary outcome 
The primary outcome of the study is participants’ expectations about the drug’s benefits and 
side effects. We selected tivozanib as the test treatment because it is representative of many 
recently approved cancer drugs. Tivozanib is not curative for advanced kidney cancer and, 
at the time of approval, it demonstrated no additional overall survival or quality of life benefit 
relative to standard treatment (sorafenib). Owing to the lack of information about drug 
benefits in the standard patient leaflet and the limited information quantifying side effects, we 
hypothesized that participants would overestimate the benefits and underestimate the side 
effects of tivozanib.14  
 
We assessed 3 questions related to participants’ expectations about treatment outcomes: 
whether participants expected that tivozanib was curative, extended overall survival, or 
improved quality of life. We selected these 3 outcomes because research shows that 
patients undergoing cancer treatment value these outcomes the most.15,16 For the primary 
analysis, we will compare the proportion of participants in each group who had accurate 
expectations for at least 2 of the 3 treatment outcomes with tivozanib (defined as responding 
“definitely no” or “probably no” to these questions).  
 
Secondary outcomes 
Participants’ understanding of the information presented in the patient leaflet, their perceived 
magnitude of the drug’s benefits and harms, and their satisfaction with the information are 
secondary outcomes of the trial. To assess understanding, we will compare the proportion of 
correct responses to each comprehension question across the randomized groups. To 
assess participants’ perceived magnitude of the drug’s benefits and harms, we will compare 
the proportion of participants in each group who responded that (1) the benefits of tivozanib 
were large, (2) the side effects were not concerning, and (3) the benefits of tivozanib 
outweighed the side effects. To assess satisfaction, we will compare the proportion of 
participants in each group who provided positive ratings about the leaflet (e.g., reporting that 
the leaflet was helpful and easy to understand). 
 
Quality control 
We will use several strategies to enhance the reliability and validity of the survey response 
data. First, we have included 2 attention check questions at different points throughout the 
survey. The first question will validate that participants can navigate the online survey and 
scroll through the patient leaflet; the second question will ask participants to select a specific 

answer to ensure that they are paying attention. Participants that answer either question 
incorrectly will be excluded from the study at that stage. We will also exclude participants 
that (1) do not complete the survey, (2) complete the survey but straight-line their responses, 
and (3) participants that complete the survey in under 180 seconds.  
 
Statistical analysis 
The sample size and power calculations for this trial were informed by previous studies.13 
This trial is powered to detect an absolute difference of 10% between groups (60% vs 50%) 
with 90% power and a two-sided alpha of 0.05. We plan to adjust for 3 pairwise comparisons 
for the primary outcome, comparing each of the intervention arms with one another. 
Therefore, we aimed to recruit 700 participants per group and considered Bonferroni-
corrected p values <0.0167 to be statistically significant. 
 
We will use X2 tests to compare the difference in proportions between groups. Logistic 
regression models will be used for adjusted analyses, controlling for participant 
demographics. We will conduct additional subgroup analyses to explore heterogeneity of 
treatment effects based on participants’ sex, age, education level, and personal experience 
with cancer. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Appendix 
 
eMethods 
 
Development of the EMA’s proposed key information section with qualitative statements 
The EMA published its proposal for a key information section in patient leaflets in July 2024.9 
The content of this proposed section was based on surveys conducted with patients, 
members of the public, and healthcare professionals, focusing on what they considered to 
be ‘key information’ about a medicine. According to the EMA’s draft, the key information 
section should include: the indication and goal of treatment / main benefits (with cross 
reference to section 1 of the current patient leaflet), contraindications and important 
precautions (section 2), and most serious side effects / main risks (section 4). 
 
Since the guidance and template for the EMA’s proposed key information section had not 
been finalized by the time of the trial, we developed a version for testing based on the 
content of the EMA’s draft proposal. Statements about the goal of treatment, benefits, 
contraindications, and side effects were sourced from the EMA’s medicines overview and 
patient information leaflet. To ensure the accuracy of the version used in the trial, we shared 
our draft with the EMA and incorporated their feedback into the final version tested. 
 
Development of the key information section with qualitative and quantitative information 
We designed the key information section that includes both qualitative and quantitative 
information based on evidence-based principles for communicating health information to 
patients and members of the public. Patients need information about the benefits, harms, 
and uncertainties of drugs in order to make informed decisions consistent with their 
preferences. This includes qualitative descriptions of the intention of treatment (e.g., whether 
it is palliative or curative),17 and quantitative data on the effect of treatment on clinically 
meaningful outcomes.15 Presenting this information in a structured format helps support 
better comprehension.10,13  
 
We based the design of the key information section on the Drug Facts Box – a tabular 
summary format developed to communicate drug benefits and harms to the public.13 We 
adapted the design considerably to align with the EMA’s consultation on the proposed key 
information section and to address gaps in the presentation of prescription drug information 
in current European patient leaflets. 
 
The key information section that includes both qualitative and quantitative information on 
drug benefits and harms is divided into 2 parts: general information about the drug, and data 
on treatment outcomes. The general information section begins with a header describing the 
drug name and approved indication (“Key information about…”), followed by 2 subheadings. 
The first subheading (“What is Fotivda and what is it used for”) includes 3 bullet points.  
 
The first bullet point describes the indication of the drug as approved by the EMA. The 
second describes the intention of treatment, indicating whether treatment is curative or is 
intended to delay disease progression and extend survival. The third bullet summarizes the 
main benefits demonstrated in clinical trials, including whether the drug was associated with 
clinically relevant outcomes for patients. This section concludes with another subheading 
which summarizes the key features of the clinical trial which supported the drug’s approval 
(“Benefits and side effects of Fotivda”). A brief sentence provides information about the 
comparator treatment used in the clinical trial and the number of participants enrolled. 
 
Next, the key information section presents data on treatment outcomes in a tabular format. 
The columns correspond to the treatments administered in the clinical trial and the rows 
correspond to the outcomes measured. For each outcome, the table displays the absolute 

difference between the two treatments; the results for the new drug; and results for the 
comparator treatment. 
 
To present information on drug benefits, we included data on outcomes that are clinically 
meaningful for patients with the condition, as well as the primary outcome of the clinical trial 
that supported the drug’s approval. In oncology trials, clinical outcomes typically include 
overall survival and quality of life. Therefore, if the trial’s primary outcome was a surrogate 
endpoint (e.g., progression-free survival), the included 3 rows of benefit information: overall 
survival, quality of life, and the surrogate endpoint. If the primary outcome was overall 
survival, only 2 rows were included: overall survival and quality of life. 
 
For tivozanib, the primary endpoint of the pivotal study was progression-free survival. To 
reduce confusion with overall survival, we described progression-free survival in plain 
language as “how long did people have before the cancer grew or spread”, while overall 
survival was described as “how long did people live?”.18 Because the improvement in overall 
survival was not statistically significant between tivozanib and sorafenib at the time of 
approval, we reported the absolute difference between the two treatment in the 
corresponding column of the table but noted that the observed difference may be due to 
chance.  
 
For data on quality of life, we used any measure of global health-related quality of life 
reported in the EPAR, given that quality of life outcomes are inconsistently measured and 
reported in cancer drug trials.19 In the case of tivozanib, quality of life was measured using a 
108-point scale. Because the difference in quality of life between tivozanib and sorafenib 
was not statistically significant, we reported the absolute difference in the table but noted 
that the observed difference may be due to chance. 
 
The final outcome reported in the table is the percentage of patients who experienced 
severe side effects. Severe side effects were defined as grade 3 (severe events requiring 
hospitalization or prolongation of hospitalization) and grade 4 (life threatening) adverse 
events, according to the common terminology criteria for adverse events (CTCAE). We 
reported the overall proportion of patients who experienced these adverse events rather than 
the proportion determined to be treatment related by trial investigators. We excluded grade 5 
adverse events (death) since these were relatively rare and could be misinterpreted.  
 
Drug information 
Tivozanib (Fotivda) was approved by the EMA in 2017 for the treatment of advanced kidney 
cancer. The primary outcome of the clinical trial that supported tivozanib’s approval showed 
an additional benefit in progression-free survival of 2.8 months compared to sorafenib (11.8 
months vs 9.1 months). Overall survival and overall health related quality of life were 
secondary outcomes in the trial but neither showed a statistically significant difference 
between the two treatments. Severe harms (defined as life threatening or requiring 
hospitalization [grade 3 and 4]) were more common with tivozanib (70%) than with sorafenib 
(64%). 
 
 
 
 
 
 
 
 
 

References 
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research on the role and effectiveness of written information available to patients about 
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information on new drugs. BMJ. 2024;387:e081720. doi:10.1136/bmj-2024-081720 
4. Stacey D, Lewis KB, Smith M, et al. Decision aids for people facing health treatment or 
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decision outcomes: A risk communication primer for patient decision aid developers. BMC 
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13. Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits 
and harms: Two randomized trials. Ann Intern Med. 2009;150(8):516-527. doi:10.7326/0003-
4819-150-8-200904210-00106 
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Published online 2023. doi:10.1093/jnci/djad138 
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prognosis and their treatment preferences. JAMA. 1998;279(21):1709-1714. 
doi:10.1001/jama.279.21.1709 
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endpoints: A literature review. Patient Educ Couns. 2020;103(9):1724-1735. 
doi:10.1016/j.pec.2020.03.018 
19. Davis C, Naci H, Gurpinar E, Poplavska E, Pinto A, Aggarwal A. Availability of evidence of 
benefits on overall survival and quality of life of cancer drugs approved by European 
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2017;359:j4530-j4530. doi:10.1136/bmj.j4530 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Figure 1: Patient leaflet for tivozanib and key information sections tested in the trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Left panel shows the standard patient leaflet for tivozanib (control); upper right panel shows the 
EMA’s proposed key information section with qualitative statements; lower right panel shows the key 
information section containing both qualitative and quantitative information. 
 
 
 
 
 
 
 
 
 
 

EMA patient leaflet survey 
 
 
About this study 
Every prescription medicine comes with written information for patients about the medicine 
and how to use it. It is called the patient information leaflet. This is what the patient leaflet 
looks like.  
 
[leaflet image] 
 
----- end of page---- 
 
 
About this study 
Researchers in the UK, US, and Australia are interested in what people think about the 
patient leaflet and how it could be improved. This study is funded by King’s College London 
in the United Kingdom. 
 
The survey takes about 15 minutes to complete. 
 
Consent 
Participation in this survey is voluntary. The survey is anonymous – that means we will not 
record your name or any information that could connect you to your answers.  
 
If you have any questions regarding this study, please contact the researcher, Avi Cherla, at 
a.j.cherla@lse.ac.uk. If you have any concerns regarding the conduct of this research, 
please contact the LSE research ethics managers via research.ethics@lse.ac.uk.  
 
Instructions 
Please try to answer all the questions even if you are not completely sure about an answer. 
Once you complete a question, you will not be able to go back and change your answer.  
 
By selecting next, you agree that you: 
• 
Are 18 years or older 
• 
Live in the United Kingdom 
• 
Are fluent in reading, writing and speaking in English 
• 
Have read and understand the instructions 
• 
Consent to participating in the survey 
 
 
----- end of page---- 
 
 
 
 
 
 
 

 
Section A: Previous experience using the patient leaflet 
 
1. If you are currently prescribed or have ever been prescribed a medicine, how often do 
you read the patient leaflet? 
• 
Often 
• 
Sometimes 
• 
Rarely 
• 
Never  
 
2. If you are currently prescribed or have ever been prescribed a medicine, how often do 
you talk to your doctor about the information you see in the patient leaflet? 
• 
Often 
• 
Sometimes 
• 
Rarely 
• 
Never 
 
 
----- end of page---- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Section B: Participants’ expectations and understanding of treatment using the 
patient leaflet 
 
 
Imagine that your doctor prescribes you a new medicine. When you pick up the medicine 
from the pharmacy, you read the patient leaflet included in the box. 
 
 
This patient leaflet is for a medicine called Fotivda. You can zoom in and scroll through 
every page of the leaflet. You can also download it here: Fotivda.pdf  
 
You will be shown the patient leaflet for Fotivda on every page for the next few questions, 
along with an option to download the leaflet. Please use the information in the leaflet to 
answer the questions. 
 
----- end of page---- 
 
 
3. This first question is practice. Scroll to section 3 of the leaflet and find the first word. 
• 
Always [correct] 
• 
Serious 
• 
Patient 
• 
Chance 
----- end of page---- 
 
4. What is Fotivda used for?  
• 
To treat adults with breast cancer 
• 
To treat adults with heart failure 
• 
To treat adults with advanced kidney cancer [correct] 
• 
To treat adults with advanced lung cancer 
• 
Not sure 
----- end of page---- 
 
5. Does Fotivda cure advanced kidney cancer?  
• 
Definitely yes 
• 
Probably yes 
• 
Probably no 
• 
Definitely no 
----- end of page---- 
 
6. Do people with advanced kidney cancer live longer when treated with Fotivda? 
• 
Definitely yes 
• 
Probably yes 
• 
Probably no 
• 
Definitely no 
----- end of page---- 
 
7. Do people with advanced kidney cancer feel better when treated with Fotivda? 

• 
Definitely yes 
• 
Probably yes 
• 
Probably no 
• 
Definitely no 
----- end of page---- 
 
8. Compared to standard treatment, how long did people given Fotivda live? [Key 
information table group]  
• 
6 months less than people given standard treatment  
• 
2.6 months less than people given standard treatment [correct] 
• 
About the same as people given standard treatment 
• 
2.6 months longer than people given standard treatment 
• 
6 months longer than people given standard treatment 
• 
Not sure 
----- end of page---- 
 
9. Overall, how large are the benefits of Fotivda? 
• 
Very large  
• 
Large 
• 
Moderate 
• 
Small 
• 
Very small to none 
----- end of page---- 
 
10. To confirm that the survey is functioning correctly, please select ‘Standard treatment’, 
below. 
• 
Fotivda 
• 
Advanced kidney cancer 
• 
Standard treatment [correct] 
• 
Neither Fotivda or standard treatment 
 
----- end of page---- 
 
11. Compared to standard treatment, how common were serious side effects with 
Fotivda? [Key information table group]  
• 
22% less common than with standard treatment 
• 
6% less common than with standard treatment [correct] 
• 
About the same as standard treatment 
• 
6% more common than with standard treatment 
• 
22% more common than with standard treatment 
• 
Not sure 
----- end of page---- 
 
12. What is the most common serious side effect of Fotivda?  
• 
Rapid or irregular heart beat 
• 
High blood pressure [correct] 

• 
Diarrhoea 
• 
Muscle spasms 
• 
Not sure 
----- end of page---- 
 
13. How concerning are the side effects of Fotivda? 
• 
Extremely concerning 
• 
Very concerning 
• 
Somewhat concerning 
• 
Not at all concerning 
 
----- end of page---- 
 
14. Do you think the benefits of Fotivda outweigh the side effects? 
• 
Definitely yes 
• 
Probably yes 
• 
Probably no 
• 
Definitely no 
----- end of page---- 
 
15. What is the recommended dose of Fotivda during the first 3 weeks of treatment? [All 
groups] 
• 
One 890 microgram capsule daily 
• 
One 1340 microgram capsule daily [correct; answer in section 3 of PIL] 
• 
Two 1340 microgram capsules daily 
• 
Two 890 microgram capsules daily 
• 
Not sure 
----- end of page---- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Section C: Participants’ satisfaction with the patient leaflet 
 
 
You’re almost done. What was your experience of using the patient leaflet for 
Fotivda?  
 
16. Was it easy to find information about Fotivda using the leaflet? 
• 
Very easy 
• 
Easy 
• 
Difficult 
• 
Very difficult 
 
17. Was it easy to understand the information? 
• 
Very easy 
• 
Easy 
• 
Difficult 
• 
Very difficult 
 
 
Please rate your agreement with the following statements. 
 
18. The leaflet helped me think about the benefits of Fotivda. 
• 
Strongly agree 
• 
Agree 
• 
Disagree 
• 
Strongly disagree 
 
19. The leaflet helped me think about the side effects of Fotivda 
• 
Strongly agree 
• 
Agree 
• 
Disagree 
• 
Strongly disagree 
 
20. The leaflet helped me think of questions I would like to ask my doctor 
• 
Strongly agree 
• 
Agree 
• 
Disagree 
• 
Strongly disagree 
 
21. Overall, did you find the patient leaflet for Fotivda: 
• 
Very helpful 
• 
Helpful 
• 
Unhelpful 
• 
Very unhelpful 
 
----- end of page---- 

Section D: Demographics 
 
Thank you for taking the time to respond to this survey. These last 5 questions are to 
help us better understand you. 
 
22. How old are you? 
• 
18 to 24 
• 
25 to 44 
• 
45 to 64 
• 
65 and older 
 
23. What is your sex? 
• 
Male 
• 
Female 
• 
Other 
 
24. What is the highest level of education that you have completed? 
• 
Less than 5 GCSE’s A* to C (or equivalent i.e., level 1 diploma/ certificate 
/BTEC /NVQ) 
• 
5 or more GCSE’s A* to C (or equivalent i.e., level 2 diploma/ certificate/ 
BTEC/ NVQ, O-Levels) 
• 
2 or more A-Levels (or equivalent I.e., level 3 diploma/ certificate/ BTEC) 
• 
Undergraduate degree or higher 
 
25. What is your approximate yearly income? 
• 
Less than £20,000 
• 
£20,000 to £34,999 
• 
£35,000 to £44,999 
• 
£45,000 and above 
 
26. Have you, a close friend, or immediate family member (i.e. your partner, parents, 
siblings, or children) ever been diagnosed with cancer? (Select as many that apply) 
• 
I have been diagnosed (currently, or in the past) 
• 
An immediate family member has been diagnosed with cancer 
• 
A close friend has been diagnosed with cancer 
• 
To my knowledge, none of my close friends or family, or myself, has been 
diagnosed with cancer 
 
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