The Case for an Open Patient Preference Attribute Library

Authored by members of the MDIC Patient Preferences in Device Product Lifecycle Project Team | July 2026

Health preference research is a well-established scientific discipline that systematically examines how patients (and other stakeholders) value different features of health interventions and the tradeoffs they are willing to make among benefits, risks, and other outcomes. In the context of medical product development, preference research provides structured evidence on what matters most to patients and how those preferences and priorities vary across contexts and populations. 

The U.S. Food and Drug Administration (FDA) refers to this body of evidence as Patient Preference Information (PPI). The FDA defines PPI as qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ across health interventions. Well-designed PPI studies elicit which attributes are important to patients, how important they are relative to each other, and the tradeoffs patients are willing to accept when evaluating medical devices and other therapies. In the most recent 2026 PPI guidance from FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics and Evaluation and Research (CBER), emphasizes that PPI can inform decision-making across the total product life cycle, including early development, clinical trial design, premarket benefit–risk assessment, and post-market usage, and coverage decisions. 

As the regulatory and payer relevance of PPI has increased, so too has the volume of published patient preference studies. However, the field continues to face a critical methodological barrier: the attributes used to describe health outcomes, risks, and treatment experiences are defined and operationalized differently across studies, disease areas, and research teams. These attributes are the core building blocks of preference studies, and variations in their descriptions leads to various interpretation and application challenges.  

Researchers often reinvent variations of descriptions for the same attribute. Study sponsors internally debate alternative attribute descriptions, repeatedly, often without reference to prior work. Regulators and payers see variations of attribute descriptions without knowing how consequential they may be to a study’s findings. 

The cost of this fragmentation shows up in many ways. It results in slower study design, higher development costs, internal debate that delays progress, and difficulty comparing findings across the literature. The preference field needs an organized, accessible, trustworthy infrastructure for generating this patient-first evidence. 

To address these challenges, the Medical Device Innovation Consortium (MDIC), convened the Patient Preferences in the Device Product Lifecycle Working Group in 2022, through its Science of Patient Input (SPI) program. Since its formation, the working group has collaborated across industry, academia, patient organizations, and regulatory experts to develop a shared, non‑prescriptive infrastructure that supports accessible and efficient preference research. A central output of this effort is the MDIC Patient Preference Attribute Library.

The MDIC Patient Preference Attribute Library is a publicly accessible, searchable database of attributes drawn from published preference studies. It is not a standard, and it does not prescribe which attributes sponsors should use. It is a reference database, meant to facilitate identification of previously used attributes, increase consistency, reduce time for study design, improve transparency, and improve the usefulness of future studies.

In its current form, the Attribute Library enables researchers, sponsors, regulators, and patient advocates to:

• Search for attributes by disease area, study type, patient population, and therapeutic context
• Compare how the same health concept has been defined and framed across different studies (Ex: stroke severity, fatigue, treatment burden)
• Identify where definitions converge and where variability exists in attribute context
• Access source publications and aspects of study context to evaluate attributes in their original setting
• Contribute new attributes from emerging studies through a structured upload process

As of April 2025, the Attribute Library contains data from 171 published preference studies, comprising 1,181 distinct attributes across four major disease areas: cardiology, neurology, oncology, and diabetes. This corpus reflects several years of systematic data extraction, curation, and quality review conducted by the MDIC project team and its collaborators. The initiative has advanced through multiple development phases, with foundational data collection and infrastructure development completed between 2022 and 2024, pilot testing initiated in 2025, and staged public releases planned beginning in late 2025 and continuing through 2026.

• A shared, vetted Attribute Library is a public good that benefits sponsors, researchers, regulators, and patients. 

• Transparency about what attributes have been used and how they have been described could improve the quality and credibility of new preference studies. 

• This resource should be openly accessible, non-prescriptive, and maintained with clear documentation of its scope and limitations. 

• The value of this infrastructure will increase as the Attribute Library grows. 

• Using the Attribute Library as a reference resource in preference study design where relevant, and documenting our use to build the Library’s evidence of impact 

• Contributing learnings from our own research to support the Library’s growth and coverage 

• Engaging with MDIC’s project team to provide feedback that improves the Library’s functionality, data completeness, and user experience 

• Sharing this resource within our networks to accelerate adoption (sponsors, colleagues, students, and collaborators) 
• Advocating for the Library’s long-term sustainability through funding support, institutional partnerships, and ongoing participation in its development 

We support this Library because we understand both its promise and its current boundaries. The following limitations reflect the Library’s current state and will evolve with ongoing development: 

• The Attribute Library captures attribute definitions when available and study-level metadata from published preference studies. It does not currently capture full patient population characteristics, recruitment context, or study results —information that is important for making contextually appropriate comparisons. 

• The Attribute Library is a resource. It is not meant to serve as a regulatory standard. Attribute selection and development remains the responsibility of the research team, informed by clinical context, patient engagement, and methodological judgment. 

• Data completeness will improve over time. Early users should treat the Library as a starting point for attribute exploration and literature review. Though it aims to become a comprehensive catalog, this will take time. 

• Patient preference research is growing in regulatory and payer importance, and the infrastructure to support it has not kept pace. 

• The burden of attribute selection and development falls disproportionately on individual research teams, creating unnecessary duplication and variability. 

• There are few neutral, openly accessible references for cross-comparing published patient preference attributes at scale. (Ex: HPSTR) 

• Inconsistent attribute definitions make cross-study comparison difficult, limiting the field’s ability to build cumulative evidence. 

• The FDA’s updated 2026 Patient Preference Information (PPI) guidance explicitly encourages more rigorous, comparable, patient-centered preference research. The Attribute Library and similar infrastructure support this goal. 

This Group Statement of Support reflects the shared position of members of the MDIC Patient Preferences in Device Product Lifecycle Working Group and affiliated stakeholders. It articulates the rationale for an open, reference based Attribute Library; the value such infrastructure provides to sponsors, researchers, regulators, and patients; and a collective commitment to its responsible use, ongoing contribution, and long‑term sustainability.  

Collectively, the undersigned view the Attribute Library as a necessary public good for advancing rigorous, comparable, and patient‑centered preference research that aligns with FDA’s evolving expectations for PPI and supports better‑informed medical device decision‑making.   

We believe the infrastructure for patient preference research deserves the same investment and rigor we apply to the research itself.