# Presentation: 300821

## Communicating Science Clearly: Making Your Writing Comprehensible to Your Reader

**Karen Lechter, J.D., Ph.D.**
**Office of Drug Safety**
**FDA**
**DIA**
**June 14, 2004**

## Disclaimer

**These comments are those of the presenter only and do not necessarily represent the positions or policies of the FDA**

## Overview

**Why is clear writing important?**
**Plain English at FDA**
**Phases of Writing:  The Ideal**
**Tips for Writing Clearly for All**
**Tips for Lay Audiences**
**Examples**
**Resources**

## Why Is Clear Writing Important?

- 1.  **For submissions to FDA and other technical audiences**
**want to be clear, concise, complete**
**want reviewers to understand data quickly**
- 2.  **For lay audiences, including patient labeling**
**health literacy is a national problem**

## Health Literacy is a Public Health Problem

**April 2004, IOM and AHRQ reports on health literacy**
**1/2 US adults have problems understanding medical information**
**Health literacy is a stronger predictor of health than age, income, education, employment, race**

## Health Literacy is a Public Health Problem

**Is a focus for US Surgeon General**
**AMA program to improve doctors’ communication with patients**
**Clear Health Communication Initiative**

## Plain English at FDA

**For documents generated **_**by**_** FDA**
**1993 Executive Order**
**1998 Presidential Memo**
**1999 began Commissioner memos****	**
**FDA activities**
***FDA Plain Language:  It’s the Write Idea***
**Award program**

**You Can Help**

## Phases of Writing: The Ideal

**Preparation before writing**
**Write draft**
**Revise and edit**
**Test with intended audience if appropriate****	****	**

## Phases of Writing: The Ideal

**Preparation before writing**
**Write draft**
**Revise and edit**
**Test with intended audience if appropriate****	****	**

## Phases of Writing: The Ideal

**Preparation before writing**
**Write draft**
**Revise and edit**
**Test with intended audience if appropriate****	****	**

## Phases of Writing: The Ideal

**Preparation before writing**
**Write draft**
**Revise and edit**
**Test with intended audience if appropriate****	****	**

## Tips for Writing Clearly for All Audiences

**Content follows purpose**
**Have communication objectives**
**Grouping and order direct the flow of ideas**
**“****Organizers” simplify cognitive load**
**Emphasis by word or formatting**
**Tables best for complex material**
**Appearance should invite reading**

## Tips: Organizers Simplify Cognitive Load

**Table of contents**** for long documents**** **
**Headings ****describe material that follows**
**Number**** ordered steps or counted items**
**Use ****flowchart**** for complicated instructions**
**Emphasize**** and ****summarize**** main points**
**Use ****boxes**** to separate key information**
**Use ****signal words**** for warnings**

## Tips: Emphasis by Word or Formatting

- Emphasize with
**bold**
- _underlining_
*Italics*
**color**
- background patterns
- white space surrounding

## Tips: Word Use Can Help or Hinder

**Define each abbreviation or acronym the first time you use it**
**Use specific adverbs**
**Use active voice, not passive**
**Place modifiers near words they modify**
**We can ****only**** hire graduate students**
**We can hire ****only**** graduate students**

## Tips: Word Use Can Help or Hinder

**Use pronouns that clearly refer to a specific noun**
**“****After the investigator assigns a subject to an arm, he or she must....”**
**“****After assigning a subject to an arm, the investigator must....”****	**
**Use everyday language, not jargon**
**Use the same term consistently****	**

## Tips: Word Use Can Help or Hinder

**Use pronouns that clearly refer to a specific noun**
**“****After the investigator assigns a subject to an arm, he or she must....”**
**“****After assigning a subject to an arm, the investigator must....”****	**
**Use everyday language, not jargon**
**Use the same term consistently****	**

## Tips: Appearance Should Invite Reading

**Ample use of white space**
**Ample space between lines**
**Clear short headings signal content**
**Font size **_**>**_**12 point**
**AVOID ALL CAPITAL LETTERS**
**Left justify margins, ragged right**

## Tips for Lay Audiences

**Repeat important points**
**Summarize important information**
**Personalize with “you” “your”**
**Use short **
**common words**
**sentences**
** ****paragraphs**
**Headings in question form**

## Tips for Lay Audiences

**Use graphics to illustrate instructions**
**Avoid unnecessary technical terms**
**Define terms when first appear**

## Tips for Lay Audiences

**Avoid abbreviations or uncommon or non-English words **
** ****etc., i.e., e.g., per **
**Use numerals instead of text for numbers**
**If possible, test materials with intended audience**

## Example: Unnecessary Words

**Simplify prepositional phrases**
**Poor: **Store the tablets in a dry area at all times.
**Better:** Always store the tablets in a dry area.

## Example: Technical Vocabulary

**Define terms the first time used; use examples**
**Poor: **You may need to take estrogens.
**Better:** You may need to take female hormones (estrogens).

## Examples:  Word Choice

**Put adjectives and adverbs near the words they modify**
**Poor:  **Use the wire that is covered with green plastic.
**Better:**  Use the green wire.

## Examples: Sentences

**Use as few words as possible to present an idea**
**Poor:**  Find the opaque plastic container that has a blue line on the upper half of it and fill it with any type of water until you reach the blue line.
**Better:  **Fill the plastic container to the blue line with water.

## Summary

**Write with your audience in mind**
**Follow the phases of writing**
**   ****to plan and perfect your product**
**Follow good writing practices**
**Invite reading through appearance**
**Test materials for lay audiences**
**	****	****	****	****	**

## Resources

**“****Write it Right: Recommendations for Writing User Instruction Manuals for Medical Devices Used in Home Health Care”**    --FDA/CDRH
-        **http://www.fda.gov/cdrh/dsma/897.pdf**
**“****Guidance on Medical Device Patient  **
**    ****Labeling”**    --FDA/CDRH
-         **http://www.fda.gov/cdrh/ohip/guidance/**
**          ****1128.pdf**

## Resources

**Website for government agencies**
** ****www.plainlanguage.gov****	**
**“****Clear and Simple: Developing Effective Print Materials for Low-Literate Readers”**   --NIH/NCI
-      **http://www.cancer.gov/cancerinformation/  **
**        ****clearandsimple**
**SEC website - helpful manual****   **
**      ****www.sec.gov/news/extra/handbook.htm****	**

## Final Thoughts

**Simplify the writing, don’t simplify the science***
***Julie Ann Miller, ed., *****Science News***