Adopting Patient Preference in Device Development
Overview
Established in tandem with the initial creation of MDIC itself, Patient Preferences have been a core pillar of MDIC’s and the leading part of SPI’s mission. Through producing multiple frameworks, guides, and use-case examples this project has shown the major impact PPI can have when collected by manufacturers.
Objective
To promote and stimulate industry wide accessibility, usability and widespread adoption of patient preference information (PPI) research across the Total Product Lifecycle (TPL)
Don't know where to start?
Learn more by visiting our Patient Preference Page to learn more about PPI and Patient Preference in Device Development:
Active Working Groups
Patient Preferences in Device Lifecycle (PDL)
The PDL Working Group was established, assembling a group of patient preference experts to help democratize the ability to conduct preference studies. The group seeks to make patient preference data not only widely accessible but more efficiently deployed.
Why it's important
There is a notable gap in the accessibility of PPI in the industry, often a major barrier to adoption of PPI is the cost and time associated with study development, implementation and analysis
FAQs about Conducting Patient Preference Studies
Preferences are qualitative or quantitative statements of the relative desirability or acceptability of attributes that differ among alternative health interventions (See MDIC Framework section II, p. 19-20). “Attributes” of a medical intervention or treatment are features of the treatment such as effectiveness, safety, tolerability, means of implantation/use, duration of the effect, duration of use, frequency of use, lifestyle aspects of use, and other characteristics that impact benefit-risk considerations. While “preference” in conventional use indicates desired features, in the patient preference context, preferences can be for benefits that are desired or harms that are accepted. Preferences can be qualitative (e.g. Migraine patients care more about being able to function than relieving pain) or quantitative (e.g. For migraine patients, the preference changes associated with completely restoring function from having to stay in bed all day to being able to work or go to school is three times as large as the preference change associated with complete removal of severe pain). Preferences may also be assessed of caretakers, physicians, or other stakeholders.
Patient preference studies are conducted to measure preferences. Typically, preference studies take place via facilitated small-group discussions or via on-line surveys.
Patient preference methodologies have been around for a long time. Different patient preference methods have evolved in different disciplines and have been used in different applications for decades. For example, health-state utility methods have been used in cost-utility analysis. Discrete-choice experiments have been used in transportation studies and environmental economics. Structured weighting methods have been used in multiple applications of decision analysis. The application of preference methods to heath, while not completely new, has begun to accelerate in recent years. These methods provide a means for engaging patients and providing systematic information from the patient perspective.
The MDIC Patient Centered Benefit-Risk Resources page has a number of useful resources for initiating a patient preference study. An MDICx webinar on practical considerations for measuring and integrating patient preference information into your regulatory submission offers useful information for sponsors looking to conduct a patient preference study.
Some key questions to consider when getting started:
- How much is currently known about the benefits and harms of the technology?
- Knowing these benefits and harms, is there preference-sensitive decision that patients face regarding the use of the technology?
- What type of patients should be surveyed?
- Have prior preference studies been done in the same or similar indication?
- How would the results of a patient preference study help better frame the benefit-risk assessment of the technology in a specific patient population?
- What are the budget and time available for the study?
Using Patient Preference Information in the Design of Clinical Trials Framework
The Medical Device Innovation Consortium (MDIC) has released a patient-centered framework developed to help researchers interested in conducting rigorous patient preference studies for medical device design, development, evaluation, and regulatory submissions.
Using Patient Preference Information in the Design of Clinical Trials outlines a systematic approach for patient-focused clinical trial design to better meet patient needs and priorities.
Patient Centered Benefit-Risk (PCBR) Framework
The PCBR Framework is intended to improve the understanding of the medical device community of how the patient’s perspective might be incorporated into the regulatory submission process.
This framework provides background on the concepts of benefit-risk and patient preference, discusses the potential value of including benefit-risk in a regulatory submission, discusses when in the product lifecycle such information might be collected, outlines factors to consider when selecting a patient preference method, and discusses considerations regarding the use of patient preference information in the regulatory submission process, reimbursement, marketing, and shared medical decision making.
Patient Centered Benefit-Risk (PCBR) Framework
Use of Patient Preference Information in Heart Failure: Executive Summary
Patient Engagement in Clinical Trials Survey Report
Science of Patient Input (SPI) Program
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