Writing in plain language
This page provides tips and tools for writing in plain language
Plain language is a way of presenting information so that it makes sense and is easy to read for the intended audience. In the case of clinical research, the audience may be a specific patient population or the general public.
Documents for trial participants include: plain language summaries of trial or the trial’s results (also known as lay summaries), trial advertising material and Participant Information Sheets and Consent Forms (PICFs).
Readability tests, such as Flesch–Kincaid or SMOG readability formulae, are available online and are useful tools for identifying long words and sentences. They can be used to assess whether the reading level of documents such as PICFs, meet the Grade 8 reading level recommended by the NHMRC. However, readability scores cannot assess meaning or how ‘understandable’ the information will be.
Having consumers involved in your team will help to ensure that documents for participants have appropriate content, language style and formatting.
Plain Language Guidance
Use the active voice (or the imperative voice for instructions)
- Instead of: Automotive vehicles should not be operated
- Use: Do not drive
Keep paragraphs short and write directly to your reader
- Instead of: Participation in this study is entirely voluntary
- Use: You do not have to take part
Use short words (fewer syllables) and an appropriate tone (conversational)
- Instead of: Do not fail to inform your doctor if you experience any adverse reactions
- Use: Please tell your doctor if you have any side effects
Use positive phrasing (unless telling people not to do something) and ensure phrases are ‘person centred’
- Instead of: The disabled often…
- Use: People with a disability often…
Minimise jargon wherever possible
- Instead of: The drug will be given intravenously
- Use: We will give you the drug into a vein
Where technical terms have to be used, provide a lay description
- Instead of: This study will test a new treatment for Staph Aureus Bacteraemia
- Use: This study will test a new treatment for the blood infection called Staph Aureus Bacteraemia
Guidance from Melbourne Health provides a useful lists of useful examples.
Choose a font and font size that is clear and easy to read:
- Commonly used fonts include Times New Roman, Cambria, Arial and Calibri.
- The font size should be at least 12 point.
Consider how the text looks on the page:
- Choose left justification text (increases readability).
- Short paragraphs, with adequate white space make documents easier to read.
- For emphasis, use bold text to highlight important information rather than italicised or underlined text (which is thought to make reading harder).
- Avoid continuous upper-case writing.
- Bullet points reduce text density and help group related points.
- Illustrations and graphics may help make things clearer, but may not always prove useful.
The Study Plain Language Title
The scientific titles can often be strewn with complex trial jargon and words of four syllables or more. Registries, such as ClinicalTrials.gov and the Australian New Zealand Clinical Trials Registry (ANZCTR) require a plain language title. Carefully formulating your plain language will facilitate patient registry searches, and determine how likely your trial is found.
A plain language title is also recommended for all consumer-facing trial documentation. A well-constructed plain language title is critical as it is likely to be a consumer’s first point of contact with a trial, giving them their first impression of what the trial is about. Below is an example of how a Plain Language Study Title can be improved (Knapp et al 2009).
Plain Language (Lay) Summaries
Plain language summaries are required for funding applications and also to ensure that study results are widely disseminated.
Plain language summaries serve a number of other purposes including:
- explaining research to the someone who is not an expert in the health condition or field of research
- raising awareness of current studies,
- increasing health literacy (the ability to understand, and use healthcare information)
- demonstrating accountability to funders (and to medical research charity donors) for the use of funds.
A high-quality plain language summary provides an easy to read and balanced overview of your trial and answers to the following:
- What is the trial question?
- Why do you need to answer it (what don’t we know and why is that an issue)?
- How do you propose to find the answer (why did you choose the proposed study design and methods)?
- What is the timescale?
- Where will the project be conducted?
- Who will benefit (either directly or indirectly)?
- Who is funding the trial?
- Have consumers been involved during the planning stage and what difference did this make?
- How will consumers be involved as the trial progresses?
Plain language summaries are not only useful to consumers, but also make clinical research accessible to professionals working in similar fields.
The Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) provide guidance for writing an abstract for Aboriginal and Torres Strait Islander peoples and the Guidelines for Ethical Research in Australian Indigenous Studies 2012 provides information on disseminating results.
The European Union (EU) provides guidance on the content of the plain language summary that is mandatory for drug trials with investigator sites in the European Economic Area. The Food and Drugs Administration has also produced draft guidance. For commercial trials, TransCelerate Biopharma provides guidance on the drafting of non-promotional lay summaries.
Two versions of a Plain Language Summary Template are available for download:
Participant Information Sheets and Consent Forms
When it is designed well, the Participant Information Sheet and Consent Form (PICF) is a valuable tool which facilitates effective communication and supports shared decision making. However, information sheets are often lengthy and far more complex than the recommended reading level of Grade 8. Consumer involvement in the review of PICFs can also ensure the PICF is engaging, which is particularly important when conducting research with children.
The following Tool: Guide for Consumer Reviewers of the Participant Information Sheet is available to download. The guide provides ‘questions to consider’ when consumers undertake their review.
- The Australian Commission on Safety and Quality in Health Care: Fact Sheet 4: Writing health information for consumers (2017)
- The Australian Commission on Safety and Quality in Health Care: Tip Sheet 5: Preparing written information for consumers that is clear, understandable and easy to use (2015)
- McKenzie, A. ‘Consumer and Community Participation Fact Sheet M11: Plain Language Summaries’, Involving People in Research (2011)
- MRCT: Guidance on Provision of Plain Language Summaries (draft) (2017)
- Cancer Council: Writing ‘Plain Language’ Summaries v4 (2014)
- Knapp, P et al. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? -a randomized controlled trial. BMC medicine. (2011); 9: 89.
- INVOLVE: Plain English Summaries (2019)