Plain-language and health literacy guides, toolkits and training

Guides and training can support plain-language writing, document design and communication with patients. Glossaries offer help with terminology, while toolkits also address organisation, presentation and reader feedback. Selecting a resource requires attention to its intended audience, scope, definitions, maintenance and accessibility.

Writing guides and training

The CDC's Simply Put guide helps turn complicated scientific and technical information into materials general audiences can understand. ¹ The National Institutes of Health offers introductory online plain-language training. ² The Plain English Campaign and Plain Language Association International also provide guidance and training for public-facing writing. ³

Employer-sponsored plain-language and health literacy training can help regulatory writing teams produce accessible clinical trial summaries for participants. ³ The EMWA and AMWA directories can help locate plain-language and patient-education specialists to edit drafts for readability. ⁴

The Federal Plain Language Guidelines provide tips and examples on active voice, jargon, short sentences and writing for the web, with additional guidance on letters and headings. ⁵ Plain English Campaign's How to write medical information in plain English combines alternatives to medical terms with advice on information accompanying over-the-counter medicines and letters to patients. ⁶

The Program for Readability In Science and Medicine (PRISM) toolkit contains plain-English substitutes for scientific and medical terms, a participant-materials checklist, standard wording for consent forms, and worked examples of readability and formatting improvements. ⁶ Its free one-hour tutorial concerns consent forms and other participant-facing information. ⁶

The CMS writing and design toolkit

The Centers for Medicare and Medicaid Services' Toolkit for Making Written Material Clear and Effective takes a reader-centred approach to developing and testing print materials. ⁷ Its scope includes brochures, booklets, flyers, fact sheets, posters, bookmarks, application forms, comparison charts, postcards, instruction sheets and questionnaires. ⁷ Its eleven parts cover the following areas. ⁷

1. The toolkit and how it can help.
2. A reader-centred approach to developing and testing material.
3. A summary of writing and design guidelines.
4. Detailed writing guidelines.
5. Detailed graphic design guidelines.
6. Collecting and using reader feedback.
7. A caution about readability formulas.
8. Material intended for a website.
9. Material for older adults.
10. A before-and-after brochure revision using the guidelines.
11. Culturally appropriate translation.

⁷

The writing guidance addresses content, organisation, style, and engaging, motivating and supporting readers. ⁷ The graphic design guidance covers working with design professionals, overall design and layout, fonts, print size and contrast, headings, lists and emphasis, colour, photographs and illustrations, tables, charts and diagrams, and forms and questionnaires. ⁷

The toolkit files can be downloaded, saved, printed and distributed; permission is needed to use material that is not in the public domain. ⁷ Although developed for CMS recipients, its suggestions were judged by one medical writer to suit consumer audiences more broadly. ⁷

A handbook for communicating with patients

The second edition of Helen Osborne's Health Literacy From A to Z: Practical Ways to Communicate Your Health Message has 42 alphabetically arranged chapters. ⁸ Each chapter contains context-setting starting points, strategies and suggestions, stories from practice, citations and sources for further learning. ⁸

Its coverage includes the business side of health literacy; patients who feel scared, sick or overwhelmed; what patients learn from the media; community, state and national efforts; regulatory and legal language; writing for the web; audience knowledge; and technology. ⁸ Two chapters address checking understanding, including teach-back. ^{8, 9} Seven chapters concern children and young people, different cultures and languages, differing emotions and cognition, hearing loss, different literacy levels, older adults and visual problems. ⁹ Four technology chapters cover podcasts, blogs, social media, email and text messaging, and interactive multimedia. ⁹

The book offers an introduction to communicating clearly with patients and ideas for writers new to that work, rather than all the information needed to write a lay summary. ⁹

Choosing and checking a glossary

Lay glossaries can help translate medical terms into familiar language and support consistency and transparency in public trial communications. ^{10, 11} Organisations should cooperate to standardise glossaries, avoid contradictory information, facilitate sharing and improve usability. ¹² A common lexicon can reduce confusion caused by different wording for the same disease or procedure, and making it freely available serves writers and the public. ¹³

The audience determines how technical a glossary can be. ¹⁴ The CDISC glossary draws on authoritative technical sources for researchers, developers and regulators, whereas the Multi-Regional Clinical Trials (MRCT) Center's plain-language glossary addresses the public. ^{15, 14} Therapy-area glossaries may fill gaps in a general research glossary, but their definitions should still be checked for genuinely plain language. ¹⁶

A 2015 assessment illustrated how uneven suggested alternatives can be: pyrexia became fever, but vomit became emesis, hazard was left unchanged, and serology was rendered as “study of blood strength”. ⁶ Other circular explanations included lymphocytes as “lymph cells” and virus as “virus”. ⁶ Resources need correction, completion and continued management. ¹⁷

EMA's medical terms simplifier supplies public-friendly descriptions of side effects, mechanisms of action and other terms used in medicines information and assessments. ^{18, 19} It does not cover rarely used terms, most disease states, very specialised areas or medical science generally. ¹⁸

Simple English Wikipedia, or a disease article using the medical term, may help locate a simpler expression or lay term; this is help with wording rather than a translation resource. ^{20, 21}

The MRCT clinical research glossary

The MRCT Center's Clinical Research Glossary supplies plain-language definitions for common research terms and is maintained with CDISC as a clinical research standard. ^{11, 16} Its task force deliberately aimed at common terms rather than a comprehensive dictionary. ¹⁶ Defining what counts as plain required extended discussion because wording plain to one person may not be plain to another. ¹¹

Consensus and governance

The glossary grew out of work on communicating research results: patient feedback on prototype summaries showed that creating understandable materials required specific skills even when writers attended to health literacy principles. ²² Health Literacy in Clinical Research, launched in autumn 2019, extended this work to participant materials throughout clinical development and exposed the need for a fuller shared glossary. ²²

The 2020 pilot involved 27 people from patient and advocacy groups, non-profit and academic organisations, life sciences companies, medical writing and independent consultancy. ^{22, 23} It planned rapid, iterative drafting and critical review towards consensus. ²³ Its four planned stages were as follows. ²⁴

1. Build multistakeholder consensus on terms, definitions and procedure descriptions, including how to resolve disagreement and distinguish technical differences that matter to participants.
2. Establish governance for project resources, review and adaptation of existing terms and graphics, creation and evaluation of definitions, ongoing curation and maintenance, attribution, and copyright and licensing.
3. Assess potential adoption through organisational use cases, possible endorsement, outreach, formats and dissemination.
4. Determine whether and how to expand to more terms, procedures, images and audiovisual formats, using the pilot's lessons and external review.

^{22, 24, 25, 26, 27}

A later task-force account described consensus as the most time-consuming step: complete agreement was rare, and a good-enough definition went forward for review. ¹⁶ In a 2023 contributor's account, most task-force members were patients, advocates or carers, with about three from industry. ¹⁴ These members acted as surrogates for the audience. ¹⁴ A contributor from industry described having to resist the instinct that everyone understood the terminology. ²⁸

Entries can combine a definition with context and an image. ^{28, 29} The double-blind example explained that the participant, investigator, clinician and study nurse did not know which treatment the participant received. ^{28, 29} A picture of identically appearing investigational and comparator products may illustrate how the assignment stays concealed. ²⁹

Expected benefits of harmonisation

The pilot team proposed seven benefits for a shared glossary. ²⁶

Benefit	Proposed contribution
Consistency	Use the same explanations within and across organisations, including for participants comparing sponsors' trials.
Accuracy	Co-create, review and user-test precise, understandable definitions with different stakeholders, including patients.
Efficiency	Avoid independently defining the same concepts for communications from before enrolment to study completion and after commercialisation.
Ease of translation	Reduce problems caused by multiple terms for one concept, for human and machine translation in international studies and multilingual populations.
Electronic interoperability	Retain technical meaning and context in a curated, coded, machine-readable glossary.
Transparency	Help participants access complete, truthful information.
Trustworthiness	Support confidence in research through clear communication and co-creation with patients and participants.

^{22, 26, 30}

A later task-force account also identified easier adoption of machine-learning technologies as a benefit. ¹⁶ The pilot team hoped that better understanding could reduce prolonged recruitment and participant attrition, and that prioritising comprehension could improve research trustworthiness, access and eventually health outcomes. ^{22, 30}

Maintaining a sponsor glossary

A sponsor's lay glossary, described in January 2024, grew from translating the unwanted-effects section of lay summaries and aimed to improve consistency, accuracy and patient understanding, including safety and contraception information. ³¹ It was developed with patients and patient expert panels where possible and made accessible across the company. ^{32, 31} Its hundreds of terms had been translated into 26 European languages, Chinese and Japanese. ^{31, 33}

Anyone in the company could submit terms or modifications for review and validation, with weekly updates and patient-expert review where possible. ³³ Exemplar glossaries and resources informed the definitions. ³³ Digital access was relatively new and internal at that time. ^{34, 35}

Access to resources and continuing learning

The ISO plain-language standard is sold rather than freely available. ³⁶ A member of its drafting committee defended charging as a means of keeping ISO independent of economic and political influence and supporting impartial standards that meet stakeholders' needs. ^{37, 36} A health literacy commentary took the opposing position: restricting a plain-language standard behind a paywall contradicts its accessibility aims, and writers and organisations should advocate for open access to supporting resources. ^{38, 39}

Helen Osborne's Health Literacy Out Loud podcast offers free interviews with health literacy experts, many with transcripts, on practice, research and further learning in health communication and patient education. ⁴⁰ The series began in 2008. ⁴⁰