Patient-Centered Core Impact Sets: What They are and Why We Need Them

A Foundation for Patient-Centered Core Impact Sets: Key Learnings from Past and Existing Approaches

EveryLife Foundation Guide to Patient Involvement in Rare Disease Therapy Development

Patient-Centered Outcomes Research Institute (PCORI) Patient and Family Engagement Rubric

Patient-Focused Medicines Development’s (PFMD) Patient Engagement Management Suite includes several resources including these How-To Guides and guidance on high-quality engagement

The Patient-Led Research Collaborative, a “self-organized group of Long COVID patients working on patient-led research around the Long COVID experience”

The National Health Council Rubric to Capture the Patient Voice

The National Health Council Representativeness Rubric and Roadmap

The Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Handbook Principles, Chapter 3, Section C engagement

Patient-Important Outcomes in the Long-Term Treatment of Bipolar Disorder Case Example

The Harmonizing Outcome Measures for Eczema (HOME) Roadmap for C0re Outcome Sets (COS) Development

Patient and family engagement in the development of two rare disease COS

Parent Project Muscular Dystrophy (PPMD) repository of activities

Juvenile Idiopathic Arthritis Patient-Focused Drug Development (PFDD) Meeting Voice of the Patient Report

Lupus Collaborative Voice of the Patient Report 

Patient-Centered Outcomes Research Institute (PCORI)-funded Patient-Powered Research Network (PPRN), iConquerMS

Improve Care Now, an Inflammatory Bowel Disease (IBD) research platform

The Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Principles on patient engagement, Chapter 3, Section C

The Patient-Centered Outcomes Research Institute (PCORI) guidance for building and maintaining multi-stakeholder collaborations. 

Stakeholder Engagement in Research Studies Toolkit

TOPPER/HIPXChange Toolkit

Partnership and Infrastructure to Support Patient & Stakeholder Engagement: A Scan of PCORnet Practices

Patient-Focused Medicines Development’s (PFMD) Patient Engagement Management (PEM) Suite includes several resources including these How-To Guides

HIPxChange Deeply Engaging Patients with a Mix & Match of Methods

The National Health Council Rubric to Capture the Patient Voice and Representativeness Rubric and Roadmap

Stakeholder mapping tool ensure the full complement of inputs are being leveraged

OMERACT Handbook for patient engagement in outcome measure efforts

Stakeholder Engagement in Research Studies Toolkit

TOPPER/HIPXChange Toolkit

Partnership and Infrastructure to Support Patient & Stakeholder Engagement: A Scan of PCORnet Practices

PRISMA tool for stakeholder mapping

Center for Medical Technology Policy (CMTP) coreHEM final report (consult page 6) provides guidance on ensuring patient-prioritized items are appropriately retained

University of Maryland’s Patient-Driven Value in Healthcare Evaluation (PAVE) Center’s  framework for prioritization

De-identified Budget from a U.S Food & Drug Administration (FDA) Patient-Focused Drug Development Meeting

De-identified Budget from a Patient-Centered Outcomes Research Institute (PCORI) Engagement Award

The Improve Care Now sponsorship page reflects the wide array of potential funders for such work including individual donors, banks, foundations, and federal partners.

The National Health Council Fair-Market Value calculator

Patient-Centered Outcomes Research Institute (PCORI) Framework for Compensation

The NHC’s Standards of Excellence Certification Program for Voluntary Health Agencies Guidance

PCORI Engagement Award Funding Opportunities

Grantmakers in Health

U.S Food & Drug Administration (FDA)-Led Patient-Focused Drug Development (PFDD) Public Meetings website

RARE-X Patient-Powered registry

Duchenne Data registry

FDA Voice of the Patient Reports (pediatric asthma (VOP pending),JIA, UMDF

Patient-group led Voice-of-the-Patient Report, National Kidney Foundation

Patient-group led Voice-of-the-Patient Report, Arthritis Foundation.

RARE-X Patient-Powered registry

Duchenne Data registry

Juvenile Idiopathic Arthritis (JIA) PFDD Voice of the Patient Report

Lupus Collaborative Voice of the Patient Report 

PCORI-funded Patient-Powered Research Network (PPRN), iConquerMS

Improve Care Now, an IBD research platform

The Patient-Led Research Collaborative, a “self-organized group of Long COVID patients working on patient-led research around the Long COVID experience”

Patient and family engagement in the development of two rare disease Core Outcome Sets (COS)

Patient-Centered Outcomes Research Institute (PCORI) Research Fundamentals Training

Multi-Method Patient-Engagement Approach: A case example from a PCORI-Funded Training Project.

The Kaiser Foundation Patient Engagement Toolkit and Guidance for training and engaging patients in data analysis

HIPxChange Deeply Engaging Patients with a Mix & Match of Methods

Patient-Focused Medicines Development’s (PFMD) Patient Engagement Management Engagement Training

The Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Handbook for patient engagement in outcome measure efforts

U.S. Food & Drug Administration’s (FDA’s) Patient-Focused Drug Development (PFDD) Guidance 1, Focus Group guidance

NHC Patient Experience Mapping Toolbox (PEMT) Interviewer Training Guide and Project Coordinator Guide pages 4-7

FDA’s PFDD Guidance 1, Focus Group guidance

Patient-Centered Outcomes Research Institute (PCORI) Methodology Standards for Patient-Centeredness

FDA PFDD data collection guidance

University of Maryland PCORI project methods guidance

FDA Patient-Focused Drug Development Guidance 1

FDA Patient-Focused Drug Development Guidance 2

Innovative Medicines Initiative Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) Patient Preference Methodology

A resource on understanding Triangulation

The Core Outcome Measures in Effectiveness Trials (COMET) plain-language summaries of methods for nominal group technique and Delphi process

Medical Device Innovation Consortium (MDIC)’s catalog of methods

RAND Guidance

INVOLVE UK Delphi Methods Description

Systematic Review of Patient participation in Delphi surveys to develop core outcome sets

PATHWAY Programme Stated Preference Case Example

Arthritis Foundation Live Yes! INSIGHTS Methodology Description

Cystic Fibrosis Foundation Discrete Choice Analysis Case Example

Co-creation and prioritization guidance from Patient Focused Medicines Development project

European Union’s Responsible Research & Innovation guidance

The Center for Medical Technology (CMTP) and Policy Core Outcome Sets (COS) Projects and methodology

CMTP coreHEM final report

NHC Patient Experience Mapping Toolbox (PEMT) Interviewer Training Guide and Project Coordinator Guide pages 4-7

University of Maryland’s Patient-Driven Value in Healthcare Evaluation (PAVE) Center’s framework for prioritization

University of Maryland “What Works When” methods guidance

National Health Council and Duke University Real-World Evidence training webinar series

The National Health Council’s Developing Patient-Centered Real-World Evidence manuscript and White Paper and Real World Evidence classroom

PFMD Book of Good Practices

Patient-Focused Medicines Development’s (PFMD) Synapse

The Core Outcome Measures in Effectiveness Trials (COMET) database

Parent Project Muscular Dystrophy repository of activities

The Core Outcome Set- STAndards for Reporting (COS-STAR) Guidelines for reporting resource

The Core Outcome Set-STAdards for Development (COS-STAD) standards for developing a Core Outcome Set (COS)

COS-STAR guidance to describe geographic diversity of stakeholders.

The Center for Medical Technology and Policy COS Projects and methodology

Innovation and Value Initiative’s Open Source principles on how to transparently and accessibly communicate

The International Society for Pharmacoeconomics and Outcomes Research (PCORI)  Open Source Models Special Interest Group (SIG) publications and convening on barriers and facilitators to most transparently sharing methods and processes