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Plain Language Guide to Write a Brief Summary

Introduction

Plain language is communication that the intended audience can understand the first time they read or hear it. ClinicalTrials.gov study records include a Brief Summary of the clinical trial. A Brief Summary written in plain language helps the general public more easily understand a study’s goal, research questions, and design.

Data providers can:

  • Review these evidence-based plain language best practices for writing a Brief Summary
  • Use the template for writing a Brief Summary in plain language
  • View examples of Brief Summaries

Plan language best practices

Focus on your intended audience and what they want to know

The intended audience for the Brief Summary is the general public, who may have limited health and science knowledge. Specifically, each study’s Brief Summary is intended for people who have the health condition being studied and those who care for them. To focus on your intended audience and make the purpose of your research clear:

  • Think about the questions that your specific audience may have about the study and aim to answer them in the brief summary. Explain the purpose, or why, of the research, including possible benefits.
  • Include the information that is most important to help the intended audience understand the study, such aswho can take part and how the research will happen. Omit details that are not vital to understand the study, such as background information or descriptions of previous research.

Choose your words carefully

Make your words easy to understand:

  • Replace complex terms with common, everyday words. For example:
    • If it is effective = if it works to treat
    • Utilize = use
  • Define essential jargon using common words. For example, a placebo is a look-alike substance that contains no drug.
  • Write out the full name for acronyms on first use and give the acronym in parentheses. For example, adverse event (AE). After giving the full name, use the acronym on future uses.
  • Use consistent terms rather than varying them. If you choose “researchers”, stick with that throughout the summary, instead of using both “researchers” and “investigators”.
  • Use inclusive and person-centered language:
    • Use the word “participants” instead of “subjects” or “patients”. For example, participants will answer survey questions.
    • Don’t define people by their health conditions or demographic characteristics. For example:
      • Use “people with diabetes” instead of “diabetes patient”
      • Use “older adults” instead of “the elderly”

Write short, conversational sentences and paragraphs

Make sentences and paragraphs easier to read and understand:

  • Write sentences in active voice, in which the subject performs the action:
    • Use active voice: The researcher read the chart.
    • Avoid passive voice: The chart was read.
  • Keep sentences and paragraphs short. Aim for sentences of 15 words or less, and paragraphs of 3-5 sentences or less.
  • Delete extra words that muddy sentences, such as “in order to”.
  • Aim for a 6th to 8th grade reading level.
  • Check for spelling and grammar errors.

Make numbers clear

Make numbers easier to understand:

  • Include only essential numbers that are clearly related to the purpose or that will help readers take action. Eliminate background information, such as prevalence data.
  • If you must include numbers, frame numbers by giving them context, such as a familiar comparison. Give numbers meaning by using words such as “high” or “low” and “better” or “worse”.
  • Use words and numbers to give a complete understanding. For example, pair “about half” with “17 out of 40”.
  • Give both percentages and natural frequencies: 7 out of 10 participants (70%).
  • Use words instead of numerical symbols. For example:
    • Use more than instead of >
    • Use number instead of instead of #
  • Avoid qualitative terms such as reduce or increase. Use simpler terms such as lower or raise.

Structure or organize the summary

Structure your summary so readers can easily find what they need:

  • Place the content in this order:
    1. Most important information – the core message or what readers need to know to take action
    2. Supporting information
    3. Background information, if required to understand the research, such as history or data. Remove background information if not required.
  • Stick to 1 main message supported by 3 to 5 points that tie directly to the purpose.
  • Use bullets for lists of items. Limit bulleted lists to 2-7 items.

Test the summary

The best practice is to test the summary with people from your intended audience to ensure it is easy to understand. When that isn’t possible, ask a peer in another field, a family member, or a friend to read and share feedback. This can help identify jargon and content that may be misinterpreted.

Learn more about plain language

Template for writing a brief summary for the study overview

Use the template below as a guide to write a Brief Summary of a study in plain language. Tailor the text that appears in brackets to your research study. To finalize, delete the text in italics if it doesn’t apply to your study.

Brief summary template

The goal of this [study type: observational study or clinical trial] is to [primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.] in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]:

  • [primary hypothesis or outcome measure 1]?
  • [primary hypothesis or outcome measure 2]?

If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].

Participants will [describe the main tasks participants will be asked to do, interventions they’ll be given and use bullets if it is more than 2 items].

Examples of brief summaries

Example 1: clinical trial

The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are:

  • Does drug ABC lower the number of times participants need to use a rescue inhaler?
  • What medical problems do participants have when taking drug ABC?

Researchers will compare drug ABC to a placebo (a look-alike substance that contains no drug) to see if drug ABC works to treat severe asthma.

Participants will:

  • Take drug ABC or a placebo every day for 4 months
  • Visit the clinic once every 2 weeks for checkups and tests
  • Keep a diary of their symptoms and the number of times they use a rescue inhaler

Example 2: observational study

The goal of this observational study is to learn about the long-term effects of intervention A in women over the age of 60 who take intervention A to treat their rheumatoid arthritis (RA). The main question it aims to answer is:

  • Does intervention A lower joint pain in women over age 60 when taken long-term to treat RA?

Participants already taking intervention A as part of their regular medical care for RA will answer online survey questions about their joint pain for 5 years.

Last updated on March 19, 2024