Guidance on Medical Device Patient Labeling:- Appendix A

Readability:

Readability defined:

Readability is defined as the ease of understanding or comprehension achieved by the style of writing. Reading involves both decoding and comprehension. The reader must be able to recognize (decode) the words in the medical device patient labeling as well as comprehend the meaning of the text. We encourage you to follow the following guidance to assess and enhance readability.

Assessing readability:

To assess readability, analyze qualitative factors (e.g., explanation of jargon, careful organization) in combination with quantitative factors (results of readability formulas). You should test the medical device patient labeling with a sample of likely, representative users of the device.

A qualitative analysis:

Use these qualities in the text to enhance the reader’s comprehension of the medical device patient labeling:

• Define complex medical terminology and jargon when it first appears in the text.
• Carefully organize medical device patient labeling from a user’s perspective (organized in the way the user will use the information). Repeat important points and summarize important information, to increase the reader’s recall and reading comprehension. The reader will remember the message when key points are reinforced.
• Organize sections with headings and questions.

A quantitative analysis (readability formulas):

The reading level of the medical device patient labeling should be no higher than the eighth-grade level, the average reading level among adults. To predict the reading level of the medical device patient labeling, use the readability formulas (manual or software programs) available. (See References: Readability.)

Readability formulas use semantic (vocabulary difficulty) and syntactic (sentence length) factors to predict the readability of the medical device patient labeling. If the reading level is predicted to be above the eighth-grade level, the patient labeling should be rewritten by applying the principles of writing for increased comprehension (see Appendix B), and qualitative factors that can enhance reading comprehension. These formulas should be used to predict (not measure) the reading level of the text.

The formulas should not be used to write, rewrite, and revise medical device patient labeling to specific readability levels. While readability formulas can predict readability, the reader must actually read the text to determine if it is readable. To mechanically substitute easier for harder words does not necessarily make the text more readable. Such text could become harder to understand through loss of organization and cohesion and loss of clarity of concepts. As reading expert George Klare explains, merely shortening words and sentences to improve readability is like holding a lighted match under a thermometer when you want to make your house warmer. The thermometer certainly goes up, but the room does not get any warmer.

Testing:

Test the medical device patient labeling with a sample of appropriate users of the device. This is the only way to know if the medical device patient labeling is understandable and useful. User-oriented testing helps to find places where the medical device patient labeling may be inaccurate, incomprehensible, or poorly organized. Since reading is an interactive process between the reader and the text, testing the medical device patient labeling with the target audience is the best way to determine how well the audience understands the labeling.

A summary of readability:

Use qualitative factors in concert with readability formulas to assess the readability of medical device patient labeling. Reader background knowledge and interest, context clues (words that surround a particular word or passage and can throw light on its meaning), text organization, and opportunity for reinforcement are just a few factors other than formula-derived readability that should be used to predict the readability of medical device patient labeling. The best solution is to pretest the medical device patient labeling with the target audience to see if they comprehend it.