As a follow up to its 2020 Patient Engagement Forum, MDIC published a “Lessons Learned Report” to highlight key takeaways from the day-long virtual meeting. This report highlights opportunities to support and enhance communication with patients about medical device...
Project: Communicating Benefit, Risk and Uncertainty
Appropriate communication of benefits, risks, and uncertainty is essential at every stage of the medical device life cycle. Products can be designed, and studies conducted, based on the risk, benefit, and uncertainty preferences of the target patient population. During review, authoriziation, and subsequent use of a device, sponsors and regulators have an obligation to ensure that benefits, risks, and uncertainty associated with the device are communicated in an understandable way. Similarly, patient-centered care requires effective communication of benefits, risks, and uncertainty among patients and providers. The intent of the Communication Report, developed by MDIC’s Science of Patient Input Communication Working Group, is to familiarize all medical device stakeholders with evidence-based practices for communicating the benefits, risks, and uncertainty of medical technology to patients and healthcare providers. In addition to developing the report, MDIC used the content as a basis for its Patient Engagement Forum in 2020 and the subsequent report.
As the art and science of patient engagement continues to advance within regulatory science, it is increasingly important to ensure that all stakeholders communicate benefits, risks, and uncertainties of medical devices in a way that maximizes each patient’s understanding and ability to make informed treatment decisions. There is a significant need to identify and promote best practices resources for medical device developers as they communicate with providers and patients about the benefits, risks, and uncertainty associated with use of medical devices.
The Communications Report is designed to be a practical resource for professionals across the medical device community, including:
- Investigators who want to make sure trial subjects are fully informed;
- Regulators who consider content for device communications, including device labels;
- Clinicians who want to make sure that patients understand the risk, benefits, and uncertainty of a therapy at the point of care delivery;
- Industry professionals who want to support their companies in developing appropriate materials and messaging about their products;
- Patient advocacy organizations who want to educate their constituency about treatment options that include the use of medical devices; and
- Payers who are evaluating evidence, data, and claims and communicating with patients.
Although there are unique considerations in the field of medical device development, it is possible to borrow (and, where necessary, adapt) approaches and tools for communicating benefit, risk, and uncertainty information from other medical product disciplines, especially in drug development. As a basis for development of this report, a broad literature search was conducted to understand and leverage existing information about the most effective methods for communicating information related to benefits, risks, and uncertainty. Relevant methods and tools stemming from that review are incorporated into recommended best practices within this report. Throughout this report there is discussion about identified gaps, challenges, and opportunities within existing literature and standard practice that may benefit from further research, stakeholder discussion, and development of best practice approaches.
These topics were the basis for MDIC’s Patient Engagement Forum held in 2020, during which a diverse group of medical device stakeholders discussed key concepts and considerations for successful communication with patients about benefits, risks, and uncertainty associated with the use of medical devices. Forum participants had the opportunity to learn directly from individual patients with diabetes, arthritis, chronic pain, and cardiovascular disease about their experiences with medical devices and the quest for information about how these products would impact their health and their overall lives. This event offered the medical device community a platform from which to evaluate current communications efforts, identify gaps, and prioritize additional needs for advancing progress on this topic. Key learnings and themes emerging from the Forum were summarized in an ensuing report.
Communicating Benefit, Risk and Uncertainty
The goal of the Forum was to familiarize a diverse group of medical device stakeholders with key concepts and considerations for successful communication with patients about benefits, risks, and uncertainty associated with the use of medical devices. Additionally,...
MDICx SPI: Science of Patient Input Report: Communicating Benefit/Risk for Medical Devices Presentation
This slide deck is presented in the webinar video “MDICx: Science of Patient Input Report: Communicating Benefit/Risk for Medical Devices.” Patients that are planning to watch the video may find it useful to review the presentation slides as they provide an overview...
MDIC designed this report to be a practical resource to help professionals across the medical device community discuss medical device benefits, risks, and uncertainty in easy-to-understand language. While investigators, physicians, regulators, and others involved in...