Anything you put in your body — whether it’s a prescription drug, a vaccine, implant, or a natural health product — carries some degree of risk. But in an age when both information and misinformation are readily available online, communicating that risk has become very complex.
To respond to this challenge, Health Canada asked the Council of Canadian Academies to assess the ways in which the effectiveness of health product risk communications can be measured and evaluated. The resulting report RISK: Is the Message Getting Through? was released June 9, 2015.
Annette O’Connor, Distinguished Emeritus Professor from the University of Ottawa’s School of Nursing is Chair of the expert panel that produced the report. She discusses the Panel’s findings in the Q and A below.
What is a “health product risk communication”?
Health products, such as drugs, vaccines, implants, or vitamin supplements, may have side effects or product defects that need to be communicated. There are a range of tools to do this, such as package inserts that describe known risks of prescription drugs. New risks are communicated by Health Canada in what are called “Dear Doctor” letters or public advisories to describe potential harms or warn about the recall of a specific product.
In the report, you talk about a paradigm shift in health risk communication; what has changed?
Traditionally, the focus was on getting the science right and understanding the risk. Communication was typically one-way: from the government to doctors and the public.
Today, we’ve moved to a multi-way communication model between governments and other communicators, health professionals, and the public. The aim is to create ongoing relationships, so that everyone involved can take ownership of the information.
There are also advances in the science of risk communication and best practices for communicating those risks. They take into account who’s involved, what their needs are, and how they learn about risk to make informed decisions.
Can you give examples of best practices for risk communication?
Use plain language rather than jargon. Describe risks with numbers rather than words. . For example, if you use words to convey that a given drug is “associated with weight gain” people often assume that the risk is much greater than it actually is.
Another finding from risk communication science is that you should use numbers that explain absolute risk, not relative risk. For example, taking a certain drug might “double the risk” of a certain side effect. But doubling the chances from two to four out of 100 is very different from doubling them from 20 to 40 out of 100. It’s also important to put the risk in context with the benefit, so that both the prescriber and the person receiving the medication can make the most informed decision.
In the report, you discuss new tools for health product risk communication. Can you give some examples?
The most promising innovation is called a drug fact box. The concept is similar to a nutrition label that you would find on your breakfast cereal. The drug fact box standardizes the presentation of the chances of risks and benefits across many different products. It makes it easier to scan information about a drug and to compare benefits versus risks.
Academic researchers who have tested drug fact boxes in focus groups and trials have shown that they are understood by most people. What’s needed now is for a regulator to evaluate their real-world applicability.
The Panel also identified several other tools that use new technologies and different media to expand the reach of communications or to support informed decision-making and behaviour change. Online and social media are very important as they are able to reach many people very quickly and efficiently. They also provide an opportunity to respond back and engage with the people providing the messages.
What about ways to evaluate how effectively the messages are getting through?
Unfortunately, we didn’t find a lot of publicly-available evaluations of risk communication tools that examined their reach, use, and impact. This is true across all the jurisdictions we looked at, not just Canada. So it’s challenging to establish best practices for evaluations.
That doesn’t necessarily mean that the tools that regulators use are never evaluated; the information may be in internal documents. In the published studies there have been evaluations of literacy levels required to make use of certain communication tools, and how communication tool affect the overall use of certain drugs. But there isn’t a lot of published, publicly-available evidence for most risk communication tools.
How should risk communication tools be evaluated?
There isn’t one perfect way to evaluate a communication; the methods need to be tailored to the situation. However, we do think that evaluation should be integrated throughout the communication process, from the development of the risk communication tool to understanding its reach, how people use it, and what impact it’s having on behavior and other outcomes.
For example, in the early stages of crafting the message you can conduct a focus group to evaluate information needs and then compare your message to a checklist of best practices, followed by a pre-test to make sure people understand it and find it meaningful.
When the message is ready to go, you can monitor downloads to evaluate reach, and examine behavior changes such as prescription rates or use of a product. In cases where you expect to detect changes in the population’s health, you can evaluate changes using health outcomes databases.
Ultimately, the best approach is tailored to needs of the people involved as well as the type, goal, and stage of the communication.
All this evaluation could become expensive. How much is enough?
Even minimal evaluation of a communication can have benefits. You could make a difference even if you can only use a checklist to determine whether your message uses science-based practices or conduct focus groups to make sure it meets people’s needs, or download data to determine whether they are being received.
What we’ve done in this report is to update the evidence and to provide a toolkit of methods that regulators can use. There’s an opportunity for regulators and government institutions around the world to become leaders in this area, and to conduct relevant well-planned and comprehensive evaluations.