How to communicate scientific and medical information to patients, advocates and caregivers, presented by Jan Geissler at the European Medical Writer's Symposium (EMWA) on 12 May 2016

1. How to communicate scientific and
medical information to patients,
caregivers and patient advocates
Jan Geissler
Director, European Patients’ Academy (EUPATI)
CML Advocates Network

2. CML Advocates Network
107 patient organisations, 82 countries
http://www.cmladvocates.net/members
About 1/3 of members
serve different leukemias, not only CML

3. European Patients’ Academy (EUPATI)
@ www.eupati.eu
1. Discovery of
Medicines
2. Pre-clinical
development
3. Clinical Development
4. Clinical Trials
5. Regulatory Affairs,
Drug Safety,
Pharmacovigilance
6. Health Technology
Assessment
English
French
German
Spanish
Polish
Italian
Russian

4. Patient advocacy groups have a key role to play in
patient support, advocacy and research
Support & inform patients
• Support the individual
• Provide patient information
Advocate (in health policy)
• for better/patient-centric regulation and laws
• for better access to treatment
• for public awareness
Enhance Research
• Collaborate internationally with clinicians & industry
• Help defining research priorities and conduct

5. Patients are not just patients:
Distinct lay audiences!
• Patients and carers (in their own disease interest)
• Patient advocates (supporters of patients, insights into larger
number of patients, representing a larger group)
• Patient experts (well-trained advocates, working with medical
experts and societies)

6. Patients are managers of their own health
1. Understand the disease
2. Find the right doctor
3. Find other patients
4. Understand & consider trial participation
5. Decide on therapy based on best quality care
6. Know about interactions, adherence,
CAM use, Quality of Life

7. Why are patients interested in trial information?
As participants of trials
• Understand the trial!
• Hear how others are doing
• Receive feedback on the research to which they have contributed
As patients or relatives
• Interpret symptoms
• Identify or decide on a new/alternative/continued treatment
• find out if a trial exists in which they could participate

8. §+ +
The doctor should be the primary source for
information. But what is the reality?
• Healthcare systems do not incentivise detailed consultation:
8-12 minutes from door to door!
• Non-medical/legal language barrier in patient-physician
communication
• Lack of information about best treatment and care for
patients, especially in rare diseases

9. There is an information disconnect
(results, harms and benefits) about study information
„Had I only known about this study / had I understood“
• Most patients are not even informed about the existence of studies,
or there is no time for consultation. Patient organisations often act as navigators.
„What was the result of ‚my‘ study?“
• 90% of study participants want to know results of the study1
• 93% never receive study results from doctors or sponsors2
• 98% of study doctors would like to share results3
1. Shalowitz, D. and Miller, F. 2008. PLoS Medicine. 5: 714-720. 2. Sood, A. et al. 2009. Mayo Clinic Proceedings. 84(3): 243-247.
3. Dixon-Woods, M. et al. 2006. BMJ. 332: 206-210.

10. Informed consent today:
extensive and complex

11. Verbal improvement of Informed Consent
(Readability)
• Clear structure of the document
• Classification of major topics: trial-related information,
organisational information, consent and data confidentiality
• Improvement of readability (e.g. Hamburger Verständlichkeitsmodell)
– Simplicity (short sentences w/ 9-13 words, short words, familiar wording)
– Classification (only one thought per sentence, contextual paragraphs)
– Conciseness (verb instead of substantive, figurative language)
– Stimulation (explanatory pictures and illustration)
• Implementation of a glossary (lay term first, reduce use of medical terms)
• Avoid duplications
• 1-page overview of relevant study information

12. Visual improvement of Informed Consent
(Presentation)
• Visually attractive overall layout
• Well-structured layout with side notes and consistent formatting
(headlines, paragraphs etc.)
• Simple and comfortable text font (Serif font)
• Clustering of information (listing)
• Accentuation of selected relevant information
• Use of icons
(“important information” / “definition” / “background information”)
• Illustrations
• Visual representation of the study process

13. Would Ethics Committees ever agree to this?
Some already do!
Table of contents
“TIGER-Study” (CML-V)
EudraCT 2010-024262-22
in use in >100 trial centers in Germany, CH, CZ
Clear separation of study design,
diagnostics, tissue/blood samples,
monitoring, biology, data
protection, patient rights

14. Visualisation
• Accentuation
• Icons („Important!
Definition!)
• Colour coding
• Flow charts and
illustrations

15. Language and Glossary
• Language of a „12 year old“:
• Short and concise sentences
• Avoidance / description of
medical terms, LAY TERMS first

16. One-page summary
• One-page summary of the core
aspects of the informed consent
document

17. Example: CML Trial Register
@ cmladvocates.net/cmltrials
• Currently 29 CML trials listed
• Title, intervention, type, recruitment status in
lay-friendly language
• List of trial centers, link to informed consent
• Basics: “What are clinical trials”
• Run by medical writer, managing also
information gathering and rewriting

18. New Clinical Trial Regulation 536/2014:
Lay-friendly summary will be mandatory – and good?
• Unless patients are informed about results they may not participate in1, and that at the
end of a trial they no longer feel valued2
• CTR stipulates that a layperson summary with 10 items must be provided within 1 year
from end of a CT in all MS3
 It’s on you and us whether this will just be a tick-box exercise or something really useful
1 Sood et al, Mayo Clin Proc. (2009);84(3):243–7;
2 Getz K. ACRP Monitor. (2008):17-21
3 Regulation 536/2014, Paragraphs 39, 67, Art 29.6, 37.4, 39, Annex IV and V

19. New Clinical Trial Regulation 536/2014:
Elements of the lay-friendly summary (Annex V)
1. Clinical trial identification (including title of the trial, protocol number, EU trial number and other
identifiers);
2. Name and contact details of the sponsor;
3. General information about the clinical trial (including where and when the trial was conducted, the main
objectives of the trial and an explanation of the reasons for conducting it);
4. Population of subjects (including information on the number of subjects included in the trial in the
Member State concerned, in the Union and in third countries; age group breakdown and gender break-down;
inclusion and exclusion criteria);
5. Investigational medicinal products used;
6. Description of adverse reactions and their frequency;
7. Overall results of the clinical trial;
8. Comments on the outcome of the clinical trial;
9. Indication if follow up clinical trials are foreseen;
10. Indication where additional information could be found

20. Patient-friendly summary of official
European LeukemiaNET therapy recommendations
@ cmladvocates.net/cmlsummary
• English lay-friendly
summary authored by
patient advocates and
medical writer, supported
by hematologists
• Community-based
translation into 20
languages

21. Our hunger for scientific news:
Reports for patient experts from medical conferences
• Screening of abstracts and slides at
conferences, and accessing journals
• Unofficial advice and
review by medical experts
• Provision of lay summaries
• Translations

22. Some suggestions on written
communication to patients
1. Short, simple sentences. Split them
2. Write as you would speak. Speak it out loud. If it still seems like it doesn’t
make sense, then it probably doesn’t
3. Avoid relative clauses
4. Avoid use of double negatives (cell biologists absolutely adore double
negatives)
5. Avoid compound nouns (ditto)
6. Avoid neologisms (very popular in the USA)
7. Avoid creative-writing classes
8. Reduce technicalities (If your audience doesn’t understand P-values, does
your patient summary need to state them?)
9. Make it nice!
(#1-8 courtesy Henry Gee, Nature editor, and Bettina Ryll, myeloma advocate)

23. Thank you!
Jan Geissler
jan@cmladvocates.net
Twitter @jangeissler