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28 July 2014 
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Lay Summary Guidance
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Guidance Notes For Writing Lay Summaries

The lay summary of a trial is an important element of the record. Please read the recommendations below before proceeding with your application. A lay summary is an explanation of the trial in plain English. It is not the same as the patient information sheet. It is to give patients and the public something that they can understand the first time they read it.

The lay summary should be written in plain English. Ask yourself:
What do they need to know to have a basic understanding of the aim of your research?
What don’t they need to know?

ISRCTN recommends you use the following guidance developed and used by CancerHelp UK:

Layout:
Leave ‘white space’ – use short paragraphs with at least one line space in between
Use bullet points for lists
Style:
Order logically, to maximise natural flow
Don’t go into more detail than you need
Shorten your sentences
Take out unnecessary words and cut out repetition
Substitute simpler words and phrases: 'before' rather than 'prior to' , 'if' rather than 'in the event of', 'how well X works' rather than 'efficacy of X', 'treatment' rather than 'intervention', 'study' rather than 'randomised controlled trial', 'dummy' rather than 'placebo',
Active, not passive: ‘you will have chemotherapy’ rather than ‘the chemotherapy will be given to you’.
Phrase positively, not negatively where possible: You will come to the hospital every third week rather than ‘You will not need to come to the hospital for 2 weeks out of 3’
Use second person rather than third: ‘you’ rather than ‘they’ or ‘the patient’
Include medical terms after the plain English: ‘You will have an operation to remove your prostate (a radical prostatectomy)’
Include abbreviations after the full term: ‘chronic lymphocytic leukaemia (CLL)’
Use same tense throughout (present or future tense is best for ongoing studies, past is best for completed studies)
Evaluation:
Imagine you know nothing about the study. Is all the information you are providing clearly explained? Can you remove any unnecessary details?

What it means for the ISRCTN records:

For both ongoing/completed trials the lay summary is expected to be under or around 1000 words.

The lay summary should answer the following questions:

1. Background and study aims
Brief description of the disease or area of study
What are the objectives/aim of the study?
2. Who can participate?
What are the age range and gender of the participants?
Can they only participate if they have a certain condition or if they are healthy volunteers?
3.What does the study involve?
What interventions will be compared?
Will all participants receive the same treatment?
4. What are the possible benefits and risks of participating?
What can participants gain from enrolling?
Are there any side effects of the treatments and if so, what are the symptoms?
5. Where is the study run from?
What are the approximate number and names of centres taking part in this trial?
If there is a lead centre, which one is it?
6. When is study starting and how long is it expected to run for?
What is the anticipated start date and the approximate duration of the trial?
How long will the trial be recruiting participants for?
7. Who is funding the study?
Who will be paying the costs that the trial will incur during its lifecycle?
8. Who is the main contact?
If this is the same as the contact in the record, please provide the name and email address only
If different to the contact in the record, please provide the name, position they hold at the institution/organisation and their email address

The following ISRCTN records contain examples of what we would expect lay summaries to include:

http://www.controlled-trials.com/ISRCTN24760606/
http://www.controlled-trials.com/ISRCTN03408765/

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4 July 2012

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