A Risk Sciences International Case Study

Evaluation of Health Product Risk Communication Tools

Health risk communication

Client: Health Canada

Listing of the client in no way affirms the client's support, sponsorship, or validation in any form of Risk Sciences International or the RSI staff member(s) who conducted this project during their stay with RSI or prior to joining the company. This case study is displayed for informative purposes only to demonstrate the capacity of RSI staff members. This case study reveals no proprietary information or information deemed sensitive.

Project description:

Evaluation of Health Product Risk Communication Tools

To enhance the effectiveness of health product risk communications, a systematic evaluation was requested to assess the performance of key instruments used to disseminate safety and efficacy information. The aim was to support efforts under the Evaluating the Effectiveness of Risk Communications (EERC) initiative by identifying methodologies and metrics that could measure how well these tools reach their intended audience, how clearly messages are conveyed, and what impact they have on knowledge, attitudes, and behaviours.

The scope of work focused on three principal communication tools: Dear Healthcare Professional Letters (DHPLs), Notices to Hospitals (NtoHs), and Public Communications (PCs). RSI was tasked with analyzing existing data provided by the client—such as website traffic, adverse event reports, and prescribing patterns—and generating new data through surveys and focus groups targeting both the public and healthcare professionals. The overall goal was to evaluate the utility of various methods and metrics, approximately 13 in total, that could support the measurement of dissemination reach, clarity of content, and impact on decision-making.

The work required the application of both qualitative and quantitative methods, including interrupted time-series analysis, suitability assessments of communication materials, usability testing, and comparisons with international regulatory counterparts. The resulting evaluation was intended to inform a long-term strategy for improving health product risk communication practices, establishing a validated and repeatable framework for performance measurement within the Canadian regulatory context.

Start: 2012

End: 2012

Experts related to this case study

Greg Paoli

CEO, Principal Risk Scientist

Greg Paoli is the CEO and Principal Risk Scientist at Risk Sciences International (RSI), a firm he co-founded in 2006 following the integration of his earlier consultancy, Decisionalysis Risk Consultants, with the consulting activities of the McLaughlin Centre for Population...
Read More about Greg Paoli

Donald Mattison (1944-2026)

Chief Medical Officer, Senior Vice-President

In Memoriam: Dr. Donald Mattison (1944-2026) Dr. Donald Mattison passed away at his home in Columbia, South Carolina on Sunday, March 22, with his family present. Don joined Risk Sciences International (RSI) in 2012 as Vice President and Chief Medical...
Read More about Donald Mattison (1944-2026)

Daniel Krewski

Chief Risk Scientist

Dr. Daniel Krewski is Chief Risk Scientist and co-founder of Risk Sciences International (RSI), a firm established in 2006 to bring evidence-based, multidisciplinary expertise to the challenge of understanding, managing, and communicating risk. As RSI’s inaugural CEO and long-time scientific...
Read More about Daniel Krewski

Anne Wiles

Senior Analyst

Dr. Anne Wiles joined Risk Sciences International (RSI) in 2008, where she currently serves as a Senior Analyst specializing in risk communication, perception, and governance. With a distinctive blend of expertise in language, regulation, and the use of science in...
Read More about Anne Wiles

More RSI Case Studies

RSI presents a very small selection of case studies to highlight some of its key work.

Developing a Risk-Based Compliance Framework for Digital Service Delivery

The Financial Consumer Agency of Canada (FCAC) engaged Risk Sciences International to provide strategic advisory services aimed at enhancing its regulatory compliance model through risk-based methodologies. FCAC’s objective was to explore new approaches that would integrate digital tools and data-driven...
Read More about Developing a Risk-Based Compliance Framework for Digital Service Delivery

Analysis in Support of Risk-Based Decision-Making for the Alberta Safety Codes Council

An independent regulatory organization responsible for oversight of Alberta’s safety codes system sought to strengthen its capacity for risk-based decision-making. The organization aimed to ensure that regulatory actions—particularly in the area of petroleum storage tanks—were guided by clear, evidence-based prioritization...
Read More about Analysis in Support of Risk-Based Decision-Making for the Alberta Safety Codes Council

Age-Related Cognitive Decline: Systematic Review and Meta-Analysis

The College of Physicians & Surgeons of Alberta (CPSA) commissioned a systematic review and meta-analysis to support evidence-informed decision-making around age-related cognitive decline among practicing physicians. The initiative was led by CPSA’s Physician Health Monitoring Program (PHMP), which sought to...
Read More about Age-Related Cognitive Decline: Systematic Review and Meta-Analysis

Update of WHO Guidance on Food Defense

To support international efforts in mitigating deliberate threats to the food system, the World Health Organization commissioned an update to its earlier guidance titled Terrorist Threats to Food. The revision aimed to broaden the original scope by addressing not only...
Read More about Update of WHO Guidance on Food Defense

Applying New Assessment Methods (NAMs) for Assessing Semi-Volatile Organic Compounds (SVOCs) in Indoor Residential Environments

Health Canada sought expert support in advancing its efforts to develop screening values for semi-volatile organic compounds (SVOCs) commonly found in residential indoor environments. Previous work on indoor air contaminants had focused on volatile organic compounds (VOCs), where screening values...
Read More about Applying New Assessment Methods (NAMs) for Assessing Semi-Volatile Organic Compounds (SVOCs) in Indoor Residential Environments

Institutional & communications assessment

In the mid-1990s the International Organization for Migration (IOM) faced one of the most pivotal moments in its history. Though it counted 76 member states, it remained outside the United Nations system, and its work was increasingly perceived to overlap...
Read More about Institutional & communications assessment

Finalization of Risk Assessment on Secure Opioid Dispensing Devices

To support decision-making around modifications to opioid agonist treatment delivery, a detailed risk assessment was requested to evaluate the integration of secure dispensing devices for direct patient access to hydromorphone. Building on a previously conducted preliminary assessment, the work required...
Read More about Finalization of Risk Assessment on Secure Opioid Dispensing Devices

Food safety risk analysis tools

The World Health Organization and the Food and Agriculture Organization of the United Nations asked RSI to develop a suite of online tools to support food regulators and the food industry in applying risk-based approaches to food safety. These organizations...
Read More about Food safety risk analysis tools

EFSA Framework for Problem Formulation

To enhance the methodological rigour of its scientific assessments, EFSA sought to develop a standardised framework for problem formulation (PF) within its non-application scientific assessment protocols. The goal was to support the planning phase of these assessments by establishing a...
Read More about EFSA Framework for Problem Formulation

Characterizing uncertainty in MAF values estimated using the KEMI MAF

The client sought to improve understanding of uncertainties surrounding the application of mixture assessment factors (MAFs) for aquatic receptors, specifically those estimated using the KEMI methodology. While the KEMI MAF approach is considered technically robust, its assumptions—particularly about chemical-specific controls,...
Read More about Characterizing uncertainty in MAF values estimated using the KEMI MAF

Measuring impact of zoonotic animal diseases in Canada

The Canadian Food Inspection Agency sought RSI’s support in exploring how human health impacts from zoonotic diseases could be compared consistently with other public health risks. Traditionally, animal disease control decisions relied on veterinary and economic measures, but there was...
Read More about Measuring impact of zoonotic animal diseases in Canada

Environmental Health Factors, Chronic Diseases, and Pandemic Resilience

To support more effective health policy and pandemic preparedness, this project examined how environmental health factors intersect with chronic disease and influence pandemic resilience. The client sought evidence to clarify how exposures to contaminants in air, water, and soil contribute...
Read More about Environmental Health Factors, Chronic Diseases, and Pandemic Resilience

Building an international alliance and campaign

UN-Habitat sought to establish a new global platform to bring coherence to international dialogue on sustainable urbanization. At the outset, this initiative had no name, no identity, and no governing structure, only the recognition that cities faced pressing challenges requiring...
Read More about Building an international alliance and campaign

Marine Planning and Conservation National Ecological Risk Guidance: Risk Communication Expertise

To support the refinement and implementation of its ecological risk guidance, a federal department responsible for marine conservation engaged expert assistance in risk communication. The primary objective was to ensure that the national guidance for ecological risk assessment—developed as part...
Read More about Marine Planning and Conservation National Ecological Risk Guidance: Risk Communication Expertise

Systematic Review of Artificial Sweeteners and Health Risks

A comprehensive systematic review was undertaken to assess experimental evidence regarding the potential health risks associated with artificial sweeteners, specifically focusing on cancer and pre-term delivery. The client sought a rigorous analysis of both in vivo and in vitro experimental...
Read More about Systematic Review of Artificial Sweeteners and Health Risks

Contraceptive recall review

Health Canada requested an external review following significant public criticism of its handling of a pharmaceutical recall. The case involved a contraceptive drug that was withdrawn due to packaging errors, and the department faced questions about whether it had acted...
Read More about Contraceptive recall review

Drinking Water Guidelines for Manganese

Establishing science-based drinking water guidelines for manganese requires integrating diverse regulatory approaches, emerging modeling tools, and evolving toxicological evidence. The client commissioned this project to systematically assess existing manganese drinking water guidelines and the scientific foundations upon which they are...
Read More about Drinking Water Guidelines for Manganese

Assessing the Impact of Interstudy Variation in LOAELs on Findings of Low-Dose Additivity in In Vivo Studies of Mixtures

Demonstrating the safe use of chemical mixtures remains a critical challenge in toxicological science. In recent years, studies have suggested that chemicals can exhibit dose additivity—causing a combined effect—even when each chemical individually is below its effect threshold. This project...
Read More about Assessing the Impact of Interstudy Variation in LOAELs on Findings of Low-Dose Additivity in In Vivo Studies of Mixtures