Harmonizing Emerging Risk Documents: MedSun Small Sample Survey Summary
MedSun: Newsletter #66, November 2011

Survey Topic: Harmonizing Emerging Risk Documents - Summary of Responses
Year Conducted: 2011

FDA currently uses multiple communication vehicles with different formats to convey new and emerging risk information to the public about drugs, devices and biologics that are regulated by the FDA. These Web-based documents have the common goal of providing important safety information to healthcare professionals in a variety of settings, caregivers, patients, and consumers.

However, recent feedback from the general public indicates that having multiple FDA risk communication vehicles with each using different formats can be confusing. To address these concerns, a survey was conducted with nine healthcare professionals, most of whom are Risk Managers, from nine MedSun hospitals. The purpose of the survey was to obtain feedback on the format and design of two sample risk documents and to learn about their experiences with reviewing and sharing safety information within their hospitals.

The information that follows is a summary of responses. The two sample formats used during the survey interviews are referred to as “Example A” and “Example B.”

Overall, eight out of nine respondents prefer Example B over Example A. Respondents report that the information in both examples is clear and complete but Example B is more user friendly and appealing. This is due mostly to section headings that are phrased as questions. Also, several think Example B may be more effective at encouraging readers to seek more information and also view it as an educational resource. There are no major changes or suggestions for either example. However, respondents suggest some minor changes such as re-ordering section headings, including a statement that directs individuals to contact their physician if they have additional questions, and adding some information to the shaded box (or blue box) that appears at the beginning of the document.

Document Title and Audience
Respondents think the main message of both communications is the same and is evident in the title and summary in the blue shaded box. Most prefer the title format on Example B and think it is more impactful and direct. They also think it is more important to lead with the issue instead of indicating that it is an FDA communication since the information appears on the FDA Web site. The title of Example B attracts their attention right away than the title in Example A.

In terms of perceived audience, more than half of the respondents think that Example A is written more for healthcare professionals and Example B is written for the general public. The less formal language and question format in Example B seems friendlier and is written more for a broader audience. The other respondents think that both formats would be appropriate for all audiences including healthcare professionals, caregivers, and the public. One respondent suggests including the term, “caregivers” because of the increasing numbers of people who are not healthcare professionals but provide care to patients.

Blue (or shaded) Summary Box
When asked to respond to the information in the blue shaded box that appears in the beginning of the communication, all think it is very important. Most respondents think the information included in both boxes is attention-getting and easy to read. Healthcare professionals may not have time to read the entire document so the shaded box briefly summarizes the most important information. Many believe it allows them to easily determine if the message applies to them. Respondents also like that the particular audience for the communication is identified in both boxes.

The response varies on which example of the shaded box was better, however, a majority prefer the section headings that appear in a question format in Example B. Also, Example B provides more clarification and can help anticipate questions they may receive from patients. One hospital Risk Manager who prefers Example A thinks it is shorter and more succinct, and probably more appealing to healthcare professionals.

When commenting on whether reading either example of the shaded box would make them want to continue reading the entire document, one person would continue reading more regardless of which box she’s looking at particularly if the affected product is used in her facility. Another believes it’s dependent on who needs to be involved, what day it is, and how pertinent the information is at the time. Some others also think the boxes have enough information that they don’t need to read any further. Of those who will read further, they prefer Example B because Example A doesn’t hold their attention the same way.

There is also a comment on the placement of the heading, “Communication Type – Take Immediate Action.” Most respondents think that this information should be above the blue box, as in Example B, instead of inside of it. This allows the reader to prioritize the urgency of the message quickly. In addition, the phrase “Take Immediate Action” is viewed as significant and indicates a priority level that would provoke action. Another comment is that instead of “Communication Type,” use the word “Urgency” because “Communication Type” isn’t very descriptive.

Terminology for Communicating Levels of Alerts and Actions
In response to a question about terminology or a framework that FDA could use to help recipients prioritize safety information and respond accordingly, respondents suggest using larger fonts, bold type, or all uppercase letters for information requiring an urgent response. Another suggestion is to use different colors for different levels of urgency. However, if colors are used FDA would need to assure compliance with Section 508 of the Rehabilitation Act; 29 U.S.C. § 794d.

The terms, “High, Urgent, and Take Immediate Action” are suggestions from respondents to indicate high priority FDA messages. Words such as, “Moderate” and “Warning” could be terms for the next level. Using “Information Only,” “No Action Required,” General Information,” and “Low,” are suggestions for lower risk issues. One Risk Manager states that maybe a third or lowest level isn’t needed. Other respondents also agree that it may not be necessary to send out a message that says “For Information Only.”

Section Headings
All respondents prefer section headings worded as questions instead of statements as in Example A. Example A’s headings may be too clinical and boring. One person believes the questions in Example B make you think more and are less overwhelming than the section headings in A.

Upon review of the section headings, respondents suggest “Products Affected” appear as the 2nd or 3rd heading in the list. When facilities receive communications they want to know quickly what products are affected after they read about the problem. Also, they want to determine whether their facility has the affected products without having to read through the entire document. Additional comments involve the section heading entitled, “Reporting Problems to FDA.” Respondents believe it may be confusing to the public and suggest wording such as, “What Sort of problems is FDA interested in” or “What kinds of problems does FDA want to know about?”

Responses vary about the section entitled, “Review of Data” and whether it should appear in the body of the document or on a separate page with a link to it. Some think having the link to additional information saves time. Those who prefer the section left in the document say they probably won’t read it right away but would like it there so they could come back to it if needed. One respondent thinks the information is good so it should be left in the document. Another respondent likes having a link to the “Review of Data” but notes that it could be a problem for those in rural areas where internet access may be intermittent or for individuals who may use mobile communication devices such as a BlackBerry.

Additionally, some miscellaneous comments include: keeping the section entitled, “Contact Us” because it’s very helpful, keep messages clear, simple and at an appropriate reading level to reach all audiences, and include pictures of the affected products on all FDA communications, when possible.

In conclusion, there are many common themes in the respondents’ feedback about both examples but overall, the preference for design and format is Example B.

Special Studies and Surveys are two of many tools the Agency is using to evaluate the public health impact of the potential problems associated with the use of medical products. Additionally, FDA continues to receive adverse event reports from its Reporting Programs. FDA will also continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes there is a significant risk of adverse events as noted from the survey, it will combine those results with data gained from the other sources. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, FDA continues to work with manufacturers to ensure the development, testing and promulgation of methods for reducing the risk associated with these products and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these products, FDA may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

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