Reports

As a few years have passed since patient engagement in rheumatology began, guidance and recommendations are developed based on lessons learned.

• 2010: Patient Research Partner (PRP): As a result of patient-researcher collaboration with Outcome Measures in Rheumatology  (OMERACT) OMERACT is a global community for the development of Core Outcome Sets in the field of rheumatology. Patients participate as research partners in all phases of the research and are equal members in any OMERACT working group.
  omeract.org; omeractprpnetwork.orgin 2002, Eueropean Alliance of Associations for Rheumatology European Alliance of Associations for Rheumatology (EULAR) European Alliance of Associations for Rheumatology (EULAR) is the organization which represents the people with arthritis/rheumatism, health professionals (HPR), and scientific societies of rheumatology of all the European nations. The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention, and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe.
  eular.org publishes recommendations for patient-researcher collaboration and defines the role of Patient Research Partner (PRP)Patient Research Partner (PRP) is defined as a person with a relevant disease who participates or has participated as an active research team member on an equal basis with professional researchers, thus adding the value of experiential knowledge to a research project.
  De Wit M, et al. European League Against Rheumatism recommendations for the inclusion of patient representatives in scientific projects. Annals of the rheumatic diseases 2011;70(5):722-6.
  eular.org Europe
• 2010: The University of the West of England (UWE)The University of the West of England (UWE) rheumatology group is involved in projects of regional, national, and global significance.www.uwe.ac.uk rheumatology group publishes a dedicated paper Patient collaboration in the design of Patient-Reported Outcome Measures: Capturing the Experience of Fatigue in Rheumatoid Arthritis
  Nicklin J, et al. Collaboration with patients in the design of patient-reported outcome measures: Capturing the experience of fatigue in rheumatoid arthritis. Arthritis Care & Research 2010;62(11):1552-8. on patient-researcher collaboration in the development of a new patient-reported outcome (PRO) for fatigue in rheumatoid arthritis (BRAF). United Kingdom. Measures were updated in 2017.Bristol rheumatoid arthritis fatigue scales (BRAFS) are free to use for clinical or academic reasons.
  www1.uwe.ac.uk/
• 2011: European Alliance of Associations for Rheumatology (EULAR) EULAR is the organization that represents the people with arthritis/rheumatism, health professionals (HPR), and scientific societies of rheumatology of all the European nations. The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention, and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe.
  www.eular.org establishes the network of Patient Research Partners and develops patient engagement Reference Cards and Background document . Europe
• 2012: INVOLVEINVOLVE, Establishment 1996 and funded by the National Institute for Health Research (NIHR) to support active public involvement in National Health Services (NHS) public health and social care research. As a national advisory group, the role of INVOLVE is to bring together expertise, insight, and experience in the field of public involvement in research (PIR), with the aim of advancing it as an essential part of the process by which research is identified, prioritized, designed, conducted and disseminated.
  www.invo.org.uk publishes updated briefing notes for researchers . INVOLVE notes some of the content is drawn from earlier editions is substantially different in its content, reflecting the changing environment since the original briefing notes were written in 2004. United Kingdom

CoPI: Patient Research Partners (PRPs), Public Involvement in Research (PIR)/Patient and Public Involvement in Research (PPI)

Tools: Recommendations – patient-researcher engagement; Reports – patient researcher engagement; Guidance documents – patient researcher engagement and briefing notes

Context: Guideline development, Patient-reported outcomes (PROs) 

As the decade progresses, international efforts to expand the patient voice in rheumatology research continues. As a result, more programs that focus on patient-reported needs, guidance for involving patients in research, and reports that assess patient involvement emerge.

• 2013: Patient-Centered Outcomes Research Institute (PCORI)PCORI is an independent nonprofit, nongovernmental organization and was authorized by Congress in 2010. PCORI is the largest funder of comparative effectiveness research (CER) in the United States with the mandate to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policymakers make better-informed health decisions. In addition to requiring patient and stakeholder engagement in PCORI funded research, PCORI also engages the public through its own institutional activities, such as Merit Review, which includes patients and stakeholders as reviewers of research applications, ensuring dollars spent are aligned with research outcomes that are meaningful to the patient population. www.pcori.org began the novel funding opportunity, Eugene Washington Engagement Awards ProgramThe Eugene Washington PCORI Engagement Award program, named in honor of the first chair of PCORI’s Board of Governors, is intended to bring more patients, caregivers, clinicians, and other healthcare stakeholders into the research process. The goal is to support projects that will build a community better able to participate in patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) and serve as channels to disseminate study results. www.pcori.org/engagement , which supports projects that will build a community better able to participate in patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) and serve as channels to disseminate study results. Example of award: Matching Actions to Needs: What Matters Most to the Arthritis Community? – Arthritis Foundation, United States
• 2014: Canada’s Strategy for Patient-Oriented Research (SPOR)Endorses the active partnership of patients, researchers, health professionals and decision-makers in research so as to build a sustainable and accessible health care system that optimizes the health of Canadian citizens. cihr-irsc.gc.ca publishes A Resource Guide for Research Teams and Networks , a living guide to support researchers, decision-makers and other relevant stakeholders involved in a wide range of SPOR-related activitiesThis resource aims to:
  1) Clarify key concepts and terms relevant to involving patients in health research such as what we mean by patients, the public and stakeholders, and the different levels and types of involvement, and the rationales and perceived benefits of patient involvement
  2) Describe, at a very high level, the current state of the evidence about patient engagement with respect to the effectiveness of different methods in relation
  to process and outcome measures
  3) Assemble in one place, a selection of resource documents collected from leading patient engagement organizations around the world to provide basic guidance for researchers about principles and methods for involving patients
  in health research. 
• 2014: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) is organized exclusively for non-profit, educational, and scientific purposes, specifically to facilitate the sharing of information related to psoriasis and psoriatic arthritis, networking among different medical disciplines that see psoriasis and psoriatic arthritis patients, and to enhance research, diagnosis, and treatment of psoriasis and psoriatic arthritis.
  www.grappanetwork.org publishes Patient Participation in Psoriasis and Psoriatic Arthritis Outcome Research report , co-authored by Patient Research Partners (PRPs)Patient Research Partner (PRP) is defined as a person with a relevant disease who participates or has participated as an active research team member on an equal basis with professional researchers, thus adding the value of experiential knowledge to a research project. After this publication, GRAPPA publishes annual patient reports through 2018.
• 2014: Cochrane Musculoskeletal Consumer Group (CMSG)Formed in 1993, enlisting patient systematic reviewers to join health care professionals and researchers belonging to Cochrane. “The feedback provides a layperson’s perspective to complement the feedback provided by our clinical experts.” musculoskeletal.cochrane.org updates recommendations to aid knowledge translation and exchange between clinicians and consumers .

CoPI: Patient Research Partners (PRPs), Patient-Oriented Research (POR), Patient-Centered Outcomes Research (PCOR)

Tools: Guidance – patient-researcher engagement;  Reports – patient researcher engagement, patient engagement, and dissemination; Instruments – patient engagement

Context: Patient-reported outcomes (PROs), Clinical Effectiveness Research (CER)/decision science, dissemination/knowledge translation

Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. The primary goal of patient-focused drug development is to better incorporate the patient’s voice in drug development and evaluation

• 2012: The Food and Drug Administration (FDA)Food and Drug Administration’s (FDA) evaluation of new medicines (United States). During clinical trials, researchers study whether new medicines are safe and effective for patients and whether the medicine’s benefits outweigh the risks.
  www.fda.gov/ established the PFDD initiative under the Prescription Drug User Fee Act (PDUFA V)2012, the US President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) to include the reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.
  www.fda.gov.
•  2016: The National Psoriasis FoundationNational Psoriasis Foundation (NPF) drives efforts to cure psoriatic disease and to improve the lives of those affected.
  www.psoriasis.org a public meeting to hear perspectives from psoriasis patients, caregivers, and other patient representatives on the most significant dermal or skin-related effects of the disease. Publishes Voice of the Patient report . While attendees were not asked to focus on the arthritic component, a large percentage of comments and concerns included those with Psoriatic Arthritis.
•  2017: The Arthritis Foundation
  The Arthritis Foundation boldly pursues a cure for America’s #1 cause of disability while championing the fight against arthritis with life-changing resources, science, advocacy, and community connections. www.arthritis.org hosts the first externally ledExternally-led means it was not commissioned by the FDA so nonprofit organization(s) raise funds to host a meeting offsite. Patient-Focused Drug Development (PFDD) meeting for Osteoarthritis and, as a result, publishes OA Voice of the Patient ReportVisit www.arthritis.org to view videos and more information about this PFDD. You can also download the Report HERE .
•  2017: Lupus and Allied Diseases AssociationThe Lupus and Allied Diseases Association, Inc., is an all-volunteer national non-profit dedicated to enhancing quality of life for those impacted by lupus and allied diseases and other conditions of unmet needs by fostering collaboration among stakeholders, promoting unity in the community, and participating in innovative advocacy, awareness and biomedical research initiatives www.ladainc.org , the Lupus Research AllianceThe Lupus Research Alliance is the largest nongovernmental, nonprofit funder of lupus research worldwide. The organization aims to transform treatment while advancing toward a cure by funding the most innovative lupus research; fostering diverse scientific talent; stimulating collaborations; and driving discovery toward better diagnostics, improved treatments and, ultimately, a cure for lupus. www.lupusresearch.org , and the Lupus Foundation of America unite to host an externally-led PFDD meeting for lupus. Publishes Lupus: Patient Voices reportVisit www.lupuspfdd.org to learn more about this PFDD. The full report can be downloaded HERE .
• 2018 – 2019: FDA develops PFDD guidance materialsInformation and documents related to FDA’s development of the methodological PFDD guidance, including public workshops, draft guidance, and hypothetical scenarios, which are all intended to serve as a basis for dialogue.
  View guidance materials at:
  www.fda.gov to improve efforts to gain patient input and assessing outcomes in regulatory engagement.
• 2019: FasterCuresFasterCures, a center of the Milken Institute works to build a system that is effective, efficient, and driven by a clear vision: working with our partners to build a patient-centric system where science is accelerated, unnecessary barriers are overcome, and lifesaving and life-enhancing treatments get to those who need them as rapidly as possible.
  https://milkeninstitute.org publishes a guide for patient advocacy organizations interested in hosting, or are currently planning, an externally led PFDD meeting. The guide includes links to other tools for planning PFDD meetings, including the PFDD Meeting Tracker, the PFDD Readiness Assessment, and the PFDD Community Toolbox.

CoPI: Patient-Focused Drug Development (PFDD), regulatory reviewers

Tools: Guidance Documents – patient-focused drug development (PFDD); Reports – patient-focused drug development (PFDD)

Context: Regulatory process, clinical trials, Research & Development, guideline development

While the European League Against Rheumatism (EULAR)EULAR is the organization that represents people with arthritis/rheumatism, health professionals (HPR), and scientific societies of rheumatology of all the European nations. The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention, and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe. As such, they have always had their own educational program at the annual EULAR Congress meeting, but in the earlier years, the symposia they organized was mostly independent of the other congress sessions. eular.org has always involved patients at their annual Congress, the American College of Rheumatology (ACR)American College of Rheumatology (ACR) is a professional membership organization whose mission is to empower rheumatology professionals to excel in their specialty. They are committed to improving the care of patients with rheumatic disease and advancing the rheumatology subspecialty.
www.rheumatology.org had a slower start.

• 2016: 1st patient-centered research study group is held at the American College of Rheumatology (ACR) annual meeting.
• 2017: EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE)(EULAR PARE) is the Committee within EULAR comprised of representatives and musculoskeletal user groups around Europe to work together towards improving the quality of life for people in Europe living with these conditions, with the vision to empower and help them lead full and independent lives.
  www.eular.org/pare initiate the EULAR study group for collaborative research. The EULAR study group meets annually during the EULAR congress and reports progress and activities through an electronic poster. The study group for collaborative research is meant to bring together physicians/researchers and PRPs. It provides a great opportunity to exchange new experiences and developments and discuss trendy topics. View meeting overview .
• 2017: The ACR invites patients, for the first time, to present research posters.

CoPI: Patient-Centered Outcomes Research (PCOR), Patient Research Partners (PRP), conference participant

Tools: Report – patient engagement

Context: Poster presentations, study groups

• 2020: COVID-19 brought to light many inequalities in healthcare, including disparities based on socioeconomic factors and societal structure. In the United States, the realities of systemic bias and structural racism emerged, presenting the opportunity to increase efforts to advance health equity – and work to eliminate health inequities nationwide.
• 2020: In November, for the first time at a scientific conference, the American College of Rheumatology (ACR) American College of Rheumatology (ACR) is a professional membership organization whose mission is to empower rheumatology professionals to excel in their specialty. They are committed to improving the care of patients with rheumatic disease and advancing the rheumatology subspecialty.
  www.rheumatology.org/ Convergence virtual meeting included a track dedicated to diversity, inclusion, and racial disparities. Session topics and abstracts focused on unconscious bias, racial barriers to care, and LGBTQ+ community education. Persons living with rheumatic diseases were included in many presentations and actively participated in coordinating online chats.

Abstract: Impact of the COVID-19 Pandemic on Racial and Ethnic Minority Groups Diagnosed with Rheumatic Disease – Presented by the COVID-19 Global Rheumatology AllianceCOVID-19 Global Rheumatology Alliance (GRA) aims to collect, analyze and disseminate information about COVID-19 and rheumatology to patients, physicians and other relevant groups to improve the care of patients with rheumatic disease. Their vision is to bring together the global rheumatology community to curate and disseminate accurate and comprehensive knowledge to advance rheumatology care in the COVID-19 pandemic.https://rheum-covid.org/

CoPI: Conference participant

Tools: Report – health equity

Contexts: Registries