"PepperPatch" Clinical Trial

Model Plain-Language Consent Form Published

Editor Goldfarb: keeping the readers engaged.

THE May 2006 edition of The Journal of Clinical Research Best Practices published a plain-language informed consent form (ICF) to be used as a model for clinical trials.

Called a "21st-century ICF," it was created by Journal Editor Norman Goldfarb and William DuBay of Impact Information. They were responding to reports that clinical-trial consent forms have rarely met legal requirements for readability.

As the article states, "The typical informed consent form (ICF) now consists of perhaps ten simplified and abbreviated form, it would look perfectly natural as the fine print on the back of an automobile loan contract."

The article includes a before-and-after ICF for a fictional clinical trial of a remedy for hair loss called the "PepperPatch." The purpose of an ICF is to ensure that the subjects understand the nature of the trial, the risks involved, and the rights of the subjects. The law requires the doctor to orally explain the clinical trial and to offer a written explanation—the ICF—which the subjects must read, understand, and sign.

The authors' main objective in doing the plain-language makeover was to maximize the reader's understanding of the experiment. In doing so, they emphasized:

  1. Simpler, more direct English.
  2. Better organization, with the critical points stated on the first page.
  3. Use of questions to emphasize critical points and to engage the reader.
  4. An attractive design using illustrations.

You can read the article, "Informed Consent Form Makeover" and the
before-and-after treatments of the ICF at: http://www.firstclinical.com/journal/2006/0605_Makeover.pdf

The Journal of Clinical Research Best Practices is an electronically distributed forum for sharing material of practical use in clinical research. With over 32,000 subscribers, it publishes "material that is too controversial, time-sensitive or non-traditional for other publications."

Readers of the article are invited to send comments and suggestions to Editor Goldfarb at: ngoldfarb@firstclinical.com.

Egocentric Email

Failing to Connect with the Reader

A study in the Journal of Personality and Social Psychology reported that a lack of writing skills greatly reduces the effectiveness of the most widely used communication channel in the world—email.

The study, "Egocentrism Over E-Mail: Can We Communicate as Well as We Think?" found email writers consistently misjudged the ability of their readers to find their humor funny or to distinguish sarcasm from seriousness.

The study included five experiments that showed that email writers tend to believe that they communicate better than they do. The studies suggested that this overconfidence is the result of not being able to evaluate the perspective of one's readers.

According to business-writing specialists, badly written emails are costing businesses millions of dollars in mistakes, damaged relationships, telephone calls to correct misunderstandings, and the time taken to read and write unnecessary messages. Email has enabled people to communicate badly in great volume.

You can read the study in Acrobat format at

For directions in improving the quality of email, go to:




Readability Calculations

Ed Frantz' Program Wins Again

Frantz: keeping his products on top.

EVER since it appeared in 1984, the Readability Calculations program from Micro Power and Light in Dallas has dominated the market for computerized readability formulas. It ran on both Windows and Apple computers. It displayed the difficulty levels of your texts as calculated by 8 of the most popular and reliable readability formulas including the Fry Graph.

Ed Frantz, the owner of the company, has recently released an updated version of the program with several significant improvements. For one price, you now get 9 formulas including the Fry Graph. The powerful Spache and the Dale-Chall formulas each have their own interface in which you can tag words like names and proper nouns for special treatment.

Frantz began his company in 1979 for developing educational software for schools and colleges. Currently, his products include Readability Calculations and the Vocabulary Assessor, which can identify words in texts which are beyond a targeted grade level. You can get more information at his Web site above or by calling Ed during business hours at his Dallas location: 214 553 0105.

Testing the Product

To test the relative validity of the formulas in Readability Calculations, we used the 53 normed passages in the book The Qualitative Assessment of Text Difficulty by Jeanne S. Chall and her colleagues (Brookline, 1996). The results listed here are the correlations of the general-purpose formulas (Grades 1 to 17) with all 53 of the normed passages:

FormulaCorrelationStandard Error
Flesch Reading Ease -.882.44
Fry Graph.862.31

The following two formulas were designed for children's texts. We tested them on passages only of the first four grades.

FormulaCorrelationStandard Error
Spache .870.56
Powers .600.89

Dealing with Correlations

In much of research, investigators look for correlations instead of causes. A correlation coefficient (r = ) is a descriptive statistic that can go from +1.00 to 0.0 or from 0.0 to -1.00. A correlation of 1.00 means a perfect one-to-one correspondence between two items going through a series of changes. Any correlation above .50 or -.50 is considered significant, that is, better than chance.

In testing readability formulas, investigators compare a number of passages of different grade levels with the formula scores for them. The resulting correlation shows how well the formula scores correspond to changes in text difficulty.

For example, if a formula gives a 9th-grade score for a 7th-grade text, and at other grade levels the difference is in the same direction and by a corresponding amount, the correlation could still be quite high.

The Standard Error is another indication of reliability. A Standard Error of 2.0 means we can expect less than a 2-grade error in 68% of the scores, or a less than a 4-grade error in 95% of the scores.

The correlations for the formulas shown above are quite good and compare well with the validity of other common psychological measures such as reading tests.

Caution: Don't write to the formula! When using the formulas to develop texts, just shortening words and sentences to get a better score will not work. You also have to adjust other features like purpose, organization, and approach to match the reading level of the audience.

Download It Now—Free!
The Principles of Readability
By William H. DuBay

A brief introduction to the research on the readability formulas.
70 pages, bibliography

"Thanks for the report on readability. It is really a very impressive work. You have pulled together a lot of information that ranges over a long period of time. A genuine work of classic scholarship—of which there is way too little that comes my way."
—Thomas Sticht, Ph.D., International Consultant on Adult Literacy

"I finally got around to reading your article. It is very good, scholarly, and complete. Even though readability formulas have been around for years, I think that the biggest current problem is that they are not widely used. Much education of writers, editors, and general population is needed."
—Edward Fry, Ph.D. Reading Consultant.

"I just wanted to tell you how much I appreciated the level of scholarship in your amazing work, The Principles of Readability.
—Eldon McMurray, Ph.D. Candidate, Utah Valley State College.

Plain Language in the News

Academic language not clear:

Crimes of academic language:

SEC seeks to simplify reports:

International plain-language auditing project:

Removing jargon from parental advice:

Professor banishes archaic legal waffle:

Wading through school jargon:

Combining privacy notices with consent forms:

Foreign accents at call centers a problem for Americans:

Office jargon hides inefficiency: