Europe Pathway
1991

EULAR Congress Inclusion of Patients

EULAR Congress Inclusion of Patients
  • 1973: In 1973, "Social Leagues" - which were the patient organizations - officially joined the European Alliance of Associations for Rheumatology (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 which is now the European League Against Rheumatism.
  • 1991: The EULAR Congress in Budapest marks a change in the goal to implement more comprehensive programs organized by the Social Leagues, including more collaboration with health professionals.
It was not until 2008, after the EULAR Congress in Paris, where patient organizations merged into EULAR, becoming EULAR PARE (People with Arthritis/Rheumatism in Europe)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.cfm For decades, EULAR PARE has featured patient posters dedicated to education and advocacy, and later an increasing number of abstracts and program sessions on collaborative research.   CoPI: Conference participant Context: Poster presentation
1996

INVOLVE is established to support public involvement in research

INVOLVE is established to support public involvement in research
  • 1996: INVOLVEINVOLVE was established 1996 and is 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 was established as part of the National Institute for Health Research (NIHR) NIHR was established in 2006 under the government’s health research strategy Best Research for Best Health to “create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public”. Since that time, we have transformed research in and for the NHS and helped to shape the health research landscape more broadly. Our mission is unchanged: to improve the health and wealth of the nation through research. We deliver against this mission through five core workstreams. www.nihr.ac.uk, 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 has been to bring together expertise, insight, and experience in the field of public involvement in research (PIR) Patient Involvement in Research is defined as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them, with the aim of advancing it as an essential part of the process by which research is identified, prioritized, designed, conducted, and disseminated. United Kingdom
NOTE: "PIR" is also referred to as Patient and Public Involvement (PPI) or Consumer Involvement. INVOLVE later incorporated into the new NIHR Centre for Engagement and Dissemination, 2020.   CoPI: Public Involvement in Research (PIR)/Patient and Public Involvement (PPI), advisory panels Context: Dissemination/knowledge translation
2000

Patients included in the regulatory process

Patients included in the regulatory process
While not specific to rheumatology, including patients in the regulatory process paves the way for advances in therapeutic outcomes.
  • 2000: The European Medicines Agency (EMA) EMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU www.ema.europa.eu invites patients as committee members and 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 expands the Patient Representative role to serve as consultants to scientific and regulatory reviewers.
  • 2003: EMA expands to patient inclusion in working groups.
  • 2005: EMA establishes their first collaboration framework for regulatory practices between EMA and patients and consumers and their organizations, which was revised in 2014
  • 2006: The EMA establishes the Patients' and Consumers' Working Party (PCWP) EMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The Patients' and Consumers' Working Party (PCWP) provides a platform for exchange of information and discussion of issues of common interest between EMA and patients and consumers. www.ema.europa.eu, which provides a platform for the exchange of information and discussion of issues of common interest between EMA and patients and consumers. The PCWP provides recommendations to EMA and its human scientific committees on all matters of interest in relation to medicines.
CoPI: Working groups, regulatory reviewers, consumer reviewers Context: Regulatory process
2002

Young people and families are included in research

Young people and families are included in research
 
  • 2002: The Childhood Arthritis and Rheumatology Research Alliance (CARRA) Founded by a small group of pediatric rheumatologists who aimed to create an investigator-led collaborative research network by establishing a registry. The information is provided by the medical team and by patients and their families. The registry was created to monitor the long-term safety of the medications used to treat pediatric rheumatic diseases. https://carragroup.org pediatric registry is established.  The founding members quickly realized that one of the best ways to achieve its primary focus was to begin a registry project. The CARRA Registry was later founded as a means to collect information about how childhood-onset rheumatic diseases are treated and how they affect patients by collecting information from the medical team, patients, and their families. United States
  • 2006: The National Institute for Health Research (NIHR) (NIHR) was established in 2006 under the government’s health research strategy Best Research for Best Health to “create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public”. Since that time, we have transformed research in and for the NHS and helped to shape the health research landscape more broadly. Our mission is unchanged: to improve the health and wealth of the nation through research. We deliver against this mission through five core workstreams. www.nihr.ac.uk establishes the ‘Patient Research Ambassadors’ network and supporting GenerationRGenerationR is a National Network (GenerationR Alliance) of Young People’s Advisory Group’s (YPAGs) based across the United Kingdom to support the design and delivery of paediatric research. GenerationR Alliance YPAGs are a resource available to any health researcher (both academic and life science industries) who seek the input of children, young people, and families in their research projects www.invo.org.uk , a series of young people’s advisory groups across the country enabling children and young people under 25 to be involved in research. United Kingdom
CoPI: Advisory panels Context: Research & Development, dissemination (knowledge translation), children, registries, young adults
2005

Rheumatology guidance begins

Rheumatology guidance begins
  • 2005: Cochrane Musculoskeletal (CM)Cochrane Musculoskeletal (CM) is made up of health care professionals, researchers and consumer representatives that belong to Cochrane, an international, non-profit organization that aims to help people make well-informed decisions about health care by preparing, maintaining and promoting reviews on the effects of health care treatments. They produce reliable, up-to-date reviews of interventions for the prevention, treatment or rehabilitation of musculoskeletal disorders in the form of systematic reviews. CM is also dedicated to making our systematic reviews available to those interested in treatments for musculoskeletal diseases (dissemination). In 1993, they formed a Consumer Group (CMSG), enlisting patient systematic reviewers to join health care professionals and researchers belonging to Cochrane. Canada musculoskeletal.cochrane.org develops guidance for systemic review authors and for building partnerships in research.Consumer‐driven health care: Building partnerships in research, 2005. Shea B, Santesso N, Qualman A, Heiberg T, Leong A, Judd M, et al. Consumer-driven health care: building partnerships in research. Health Expectations 2005;8(4):352-9. musculoskeletal.cochrane.org Download PDF (download pdf)
  • 2006: Cochrane Musculoskeletal Consumer Group (CMSG)The 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 develops initial recommendations to aid knowledge translation and exchange between clinicians and consumersSantesso N, Maxwell L, Tugwell PS, Wells GA, O'connor AM, Judd M, Buchbinder R. Knowledge transfer to clinicians and consumers by the Cochrane Musculoskeletal Group. J Rheumatol. 2006 Nov;33(11):2312-8. PMID: 17086612.. These were updated in 2014.
  • 2008: Assessment of SpondyloArthritis International SocietyAssessment of SpondyloArthritis International Society is an international group of experts in the field of spondyloarthritis. asas-group.org/European Alliance of Associations for Rheumatology European League Against Rheumatism (EULAR) aims to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention, and rehabilitation of musculoskeletal diseases. eular.org (ASAS/EULAR) collaborated with patients to translate recommendations for the management of ankylosing spondylitis for the first time into a language easily understood by patients. (download pdf)
  CoPI: Advisory panels, consumer reviewers Tools: Guidance documents - patient-researcher engagement; Recommendations - dissemination Context: Systemic literature reviews, lay summaries, guideline development, dissemination (knowledge translation)
2007

EULAR PARE Established

EULAR PARE Established
In 2007, the patient initiative of 'PARE manifesto' (which started in 1989) and 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 Social Leagues officially merged, becoming the standing committee of EULAR PARE (People with Arthritis/Rheumatism in Europe)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.cfm. In this year it was also decided that PARE members should be user-led organizations. This was put in writing through a the publication of PARE Value Principles. At this time, health professionals also became their own Standing Committee. This was the beginning of the three pillars of EULAR, which still exist today.
  Since this time, EULAR PARE has featured patient posters dedicated to education and advocacy, and later an increasing number of abstracts and program sessions on collaborative research.   CoPI: Conference participant Context: Poster presentation  
2010

Experience working with patients in research leads to guidance for best practices

Experience working with patients in research leads to guidance for best practices
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 (download pdf) 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 (download pdf). 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 (download pdf). 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) 

Concepts of Patient Involvement (CoPI) change the paradigm for patient engagement in research

Concepts of Patient Involvement (CoPI) change the paradigm for patient engagement in research
 
  • 2011: Strategy for Patient Oriented Research (SPOR): Canadian Institutes of Health Research (CIHR) Canadian Institutes of Health Research played a prominent role in the launch, implementation, and oversight of SPOR, but represents only one in a multitude of partners.cihr-irsc.gc.ca.html establishes a Strategy for Patient-Oriented Research SPOR is a collaboration of researchers, patients, provinces and territories, health care professionals, and others – all working in partnership to integrate research into patient care, ultimately improving the health of Canadians. cihr-irsc.gc.ca (SPOR) to integrate evidence in all levels of the health care system.
  • 2012: Patient Research Partner (PRP): Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 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. grappanetwork.org invites Patient Research Partners for the first time. In 2015, a team of Patient Research Partners was permanently added to round out their perspective first report from Patient Research Partner perspective: De Wit M, Campbell W, FitzGerald O, Gladman DD, Helliwell PS, James J, et al. Patient Participation in Psoriasis and Psoriatic Arthritis Outcome Research: A Report from the GRAPPA 2013 Annual Meeting. The Journal of Rheumatology 2014;41(6):1206-11.
  • 2013: Core Outcome Measures in Effectiveness Trials (COMET)COMET brings together people interested in the development and application of agreed standardized sets of outcomes, known as ‘Core Outcome Sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, but COS are also suitable for use in routine care, clinical audit, and research other than randomized trials. comet-initiative.org & the International Dermatology Outcome Measures (IDEOM)(IDEOM) is a non-profit organization seeking to develop and validate measures throughout dermatology with an initial focus on psoriatic disease. They strive for the establishment of patient-centric outcomes to enhance the research and treatment of dermatological conditions. Launched in 2013, IDEOM seeks to bring together physicians, researchers, government agencies, pharmaceutical companies, payers, and patients from around the globe to develop and validate measures throughout the field of dermatology with an initial focus on psoriasis. dermoutcomes.org collaborate with Outcome Measures in Rheumatology OMERACTOMERACT 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 to adopt the patient-centered approach of developing core outcome sets with full involvement of patients.
  CoPI: Patient Research Partner (PRP), Patient-Centered Outcomes Research (PCOR), Strategy for Patient-Oriented Research (SPOR), conference participant Context: Clinical trials, assessing grant applications, Core Outcome Set (COS)

Opportunities for patient involvement in advisory panels expands

Opportunities for patient involvement in advisory panels expands
  • 2011: PCOR - Patient-Centered Research Outcomes (PCOR)Established by PCORI, this research approach is a new form of comparative effectiveness research (CER) that considers the needs and perspectives of patients and stakeholders by engaging them throughout the entire research process. www.pcori.org is established by the Patient-Centered Outcomes Research Institute (PCORI)The Patient-Centered Outcomes Research Institute (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. www.pcori.org and enlists patients to participate in clinical research grant evaluationsPCORI also engage 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. United States View other PCORI projects that included rheumatology patients in research. (download pdf)
  • 2012: National Institute for Arthritis and Musculoskeletal and Skin diseases (NIAMS)The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. www.niams.nih.gov adds one patient to the grant application review team. 
  • 2012: The US Department of Defense (DoD) The Department of Defense is America's largest government agency. With our military tracing its roots back to pre-Revolutionary times, the department has grown and evolved with our nation. Our mission is to provide the military forces needed to deter war and ensure our nation's security. www.defense.gov created the Peer Reviewed Medical Research Program (PRMRP)PRMRP is one of 35 research programs managed by the Congressionally Directed Medical Research Programs (CDMRP). Patients/survivors/individuals living with the diseases and conditions with research programs managed by the CDMRP were incorporated into all aspects of the program cycle with equal voice to include research focus, investment strategy, and programmatic review in 1993, and into peer review in 1995. cdmrp.army.mil adds patients/individuals living with rheumatoid arthritis and osteoarthritis as peer reviewers starting in 2012 and lupus was added in 2015. In 2017, lupus became its own research program within the Congressionally Directed Medical Research Programs (CDMRP). The CDMRP is a Department of Defense (DOD) program. that receives congressional appropriations explicitly for. biomedical research in specific, congressionally identified. health matters. cdmrp.army.mil However, patients/individuals living with lupus originally participated in peer review starting in 2005 and continue doing so in the Lupus Research Program.
  • 2013: Establishment of Foundation for Research in Rheumatology (FOREUM)FOREUM Foundation for Research in Rheumatology is devoted to promote research in rheumatic and musculoskeletal diseases (RMDs) as an independent research funding body in rheumatology research. Basic and applied research of highest quality is supported to reduce the burden of disease for people with RMDs. www.foreum.org, supported by 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, involves patients in the government of the foundation as well as in the review of research grant applications.
  • 2013: The Patient-Centered Outcomes Research Institute (PCORI)The Patient-Centered Outcomes Research Institute (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 policy makers make better-informed health decisions. www.pcori.org established the Advisory Panel for Patient EngagementBy inviting the patient and caregiver community to help generate research questions, review research proposals, assist in the conduct of research, help disseminate information and evaluate impact, patient engagement ensures authentic patient-centeredness in the research process. www.pcori.org which is an advisory body that provides input and recommendations to PCORI Board of Governors, Methodology Committee, and staff to help plan, develop, implement, improve, and refine efforts toward meaningful patient-centered research. Panel members assure the highest patient engagement standards and a culture of patient-centeredness in all aspects of its work.
  • Most pharmaceutical companies realize the need for an internal patient engagement department. The use of Patient Advisors becomes common.
CoPI: Advisory panels , consumer reviewers, Patient-Centered Outcomes Research (PCOR) Context: Assessing grant applications, Research & Development, Patient-Reported Outcomes (PROs)

As the value of patient engagement evolves, so does guidance and outcome focus

As the value of patient engagement evolves, so does guidance and outcome focus
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? (download pdf) – 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 (download pdf), 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 (download pdf), 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 (download pdf).
  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

Formal training of patients to be more active in research begins with EUPATI

Formal training of patients to be more active in research begins with EUPATI
● 2012: The European Patients’ Academy (EUPATI)The European Patients’ Academy (EUPATI) was formed as a pan-European project implemented as a public-private partnership by a collaborative multi-stakeholder consortium from the pharmaceutical industry, academia, not-for-profit, and patient organizations. The Academy was started, developed, and implemented as a flagship project of the Innovative Medicines Initiative and continues to be led by the European Patients’ Forum (EPF) www.eupati.eu was established. They focus is on education and training to increase the capacity and capability of patients to understand and contribute to medical research and development and also improve the availability of objective, reliable, patient-friendly information for the public. Europe ● 2014: EUPATI Launches Patient Expert Training CoursesLearn more about the Patient Expert Training Courses at www.eupati.eu, as a result, as of 2019 has trained 96 patient experts on medicines development, clinical trials, medicines regulations, health technology assessment. ● Ongoing projects of EUPATI include rigorous content development for patient education, the furthering of advocacy skills of patient experts, and the strengthening of a European patient movement, and a continuously updated inventory of possibilities for patients to get involved in biomedical research and development.   CoPI: Patient Research Partner (PRP) Tools: Instruments - patient engagement Context: Clinical trials, regulatory process, health technology assessment, Research & Development

Young People Help Shape Rheumatology Research

Young People Help Shape Rheumatology Research
Young people need a voice too! The evolution of patient engagement in rheumatology research expands to ensure the voice of the younger patients is counted.
  • 2014: EULAR Young PAREYoung PARE aims to improve the quality of life of young people (18 to 35 years old) with rheumatic and musculoskeletal diseases (RMDs) by raising the profile of these conditions, and by creating a network of individuals who work in European countries on behalf of young people with RMDs. eular.org/pare_young_pare was established as the first youth committee (ages 18-35) established within an international umbrella organization, with a remit for embedding the youth perspective into EULAR’s activities, as well as in shaping clinical and research activities of relevance to young people. The founding of Young PARE was based on a collaborative and co-produced youth research project, funded by EULAR, in collaboration with young people, adult patients, health professionals and researchers in rheumatology across Europe.
  • 2016: Your RheumYour Rheum is a group of people in the UK aged 11-24 years who have a diagnosed rheumatic condition. Your Rheum provides an easy way for young people to understand and get involved in rheumatology research that is relevant to them. https://yourrheum.org/ was established to provide young people aged 11 to 24 with the opportunity to shape pediatric and adolescent rheumatology research. United Kingdom
  CoPI: Advisory panels, co-production of stakeholder groups Context: Children, Research & Development, young adults  

Patient engagement in research is here to stay – the growth of patient-centered research conferences

Patient engagement in research is here to stay – the growth of patient-centered research conferences
Blended Engagement Conferences
  • 2014: Since the launch and success of patient-engagement conferences in the United States and Europe in 2014, stakeholders in search of information to help improve collaboration efforts has surged. However, most include sessions that merge various disease groups, who utilize different Concepts of Patient Involvement (CoPI) Concepts of Patient Involvement (CoPI) define methods of engagement that involve patients in the research process. Some CoPIs have published guidance associated with them, which is recommended to follow by others planning to use the same term. and whose communities have disease-specific engagement barriers that are not considered. For those new to the patient engagement in the research space, this can cause confusion and the adaptation of terms and processes that were established in one community may not translate to the next. This can lead to issues with value measurements, particularly if the same term is used with different collaborative methods.
  •  This problem was demonstrated in 2014, during a US Patients as Partners meeting, when audience members requested clarification of the term 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., which was used by several presenters but the method of engagement varied. This moment contributed to the realization that a rheumatology-specific Council may be necessary (See ACTion Council, 2018). 
"Patients Included" Events
  • 2015: PCORI's first Annual Meeting in 2015 brought together more than 1,100 members of the 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. www.pcori.org community, including patients, researchers, and other health care stakeholders. PCORI has had meetings every year since 2015 and all have been designated as a “Patients Included” event, meaning, patients and caregivers are involved as full participants in the event's planning and delivery, and necessary accommodations are provided for patients and caregivers to facilitate their participation.
CoPI: Patient Research Partner (PRP), Patient-Centered Outcomes Research (PCOR), conference participant
2015

Patient Engagement in the Regulatory Process – Tools Emerge

Patient Engagement in the Regulatory Process – Tools Emerge
Patient testimony in the regulatory process expands in the second half of this decade and 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 and the European Medicines Agency (EMA) EMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU www.ema.europa.eu join forces! In addition to the European Medicines Agency EMA recently revising their original framework for interaction between the agency and patients and consumers and their organizations (2014) (download pdf):
  • 2015: The FDA launches the Patient Engagement Advisory Committee (PEAC)Patient Engagement Advisory Committee (PEAC) - Food and Drug Administration (FDA) committee providing advice to the Commissioner or designee on complex issues relating to medical devices, the regulation of devices, and their use by patients. www.fda.gov/patients to provide advice relating to medical devices (download pdf). CoPI: Patient Preference Information (PPI)PPI: Qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions. is established to describe this patient engagement. PPI framework and guidance released for the Center for Devices and Radiological Health (CDRH)(CDRH) recognizes that scientists, clinicians, device developers, and regulators play critical roles in evaluating and communicating the benefits and risks of medical devices. However, only patients live with their medical conditions and make daily choices regarding their health care. Their voice and perspective are critical to understanding the impact of medical devices. www.fda.gov/about-fda/fda-organization medical device decision-making.
  • 2016: FDA and the EMA create a new workgroup on patient engagement called the FDA/EMA Patient Engagement ClusterWork group that allows FDA and EMA to share best practices involving patients along drug and biologic regulatory lifecycles. Information that is discussed is covered by confidentiality agreements signed by the FDA and EMA. www.fda.gov/patients to share best practices involving patients along with drug and biologic regulatory lifecycles.
  • 2017: FDA launches Patient Engagement Collaborative The Patient Engagement Collaborative (PEC) is a group of patient organizations and individual representatives who discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions at the FDA. The PEC was established by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership that brings together organizations and individuals representing academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups and others to develop evidence-based solutions to clinical research challenges. www.fda.gov/patients with the Clinical Trials Transformation Initiative (CTTI)The FDA, together with the Clinical Trials Transformation Initiative, established a group of patient organization and individual representatives to discuss topics focusing on enhancing patient engagement in medical product development and regulatory discussions at FDA. www.ctti-clinicaltrials.org/ to develop guidance materials (download pdf) for including patients in the R & D continuum. This collaborative was modeled after the European Medicines Agency (EMA)’s Patients’ and Consumers’ Working PartyEMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The Patients' and Consumers' Working Party (PCWP) provides a platform for exchange of information and discussion of issues of common interest between EMA and patients and consumers. www.ema.europa.eu/en/committees.
  • 2017: EMA involves young people in their activities and establishes the principles for the involvement of young patients, consumers, and their carers, in the Agency’s scientific committees and working parties in a consistent and efficient manner (download pdf).
  • 2017: EMA begins holding public hearings to give European citizens a voice in the evaluation of the safety of medicines and empower them to express their views on issues related to the safety of certain medicines and the management of risks.
  • 2017: EMA expands opportunities to acquire patients’ perspectives on benefit/risk considerations within the Committee for Medicinal Products for Human Use (CHMP)(CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.www.ema.europa.eu/en/committees meetings.
CoPI: Regulatory reviewers, working groups, advisory panels, Patient Preference Information (PPI) Tools: Frameworks - regulatory; Guidance Documents - patient engagement Context: Regulatory process, clinical trials, Research & Development, health technology assessment (HTA), decision aids, young adults

Rheumatology Scientific Meetings Continue to Unite Researchers, Rheumatologists, and Patients

Rheumatology Scientific Meetings Continue to Unite Researchers, Rheumatologists, and Patients
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 (download pdf).
  • 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

Additional frameworks and recommendations for including patients in research

Additional frameworks and recommendations for including patients in research
  • 2018: INVOLVEINVOLVE was established in 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 produces a set of six draft Standards for Patient Engagement (download pdf) that are currently piloted and evaluated in different areas of health research. United Kingdom
  • 2018: Canadian Institute of Health Research (CIHR)The Canadian Institutes of Health Research (CIHR) is Canada's federal funding agency for health research. Composed of 13 Institutes. It collaborates with partners and researchers to support the discoveries and innovations that improve our health and strengthen our health care system.https://cihr-irsc.gc.ca publishes draft Ethics Guidance for Developing Research Partnerships with PatientsThe proposed ethics guidance builds on the SPOR Patient Engagement Framework and, once finalized, could be adapted in various formats by SPOR leads and other initiatives, organizations, and institutions to serve as an educational resource for all those involved in research partnerships with patients. http://www.cihr-irsc.gc.ca, in support of 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.https:cihr-irsc.gc.ca. The project is a response to ethical issues that were initially identified by the SPOR SUPPORT Unit Patient Engagement Working GroupPatient engagement means fostering a climate in which researchers, health care providers, decision-makers and policy-makers understand the value of patient involvement and patients see the value of these interactions.Engaging patients is an integral component in the development and implementation of all elements of SPOR https://cihr-irsc.gc.ca and reiterated at various conferences and workshops.
  • 2019: ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases)ESCEO is a not-for-profit organization, dedicated to a close interaction between clinical scientists dealing with bone, joint, and muscle disorder, pharmaceutical industry developing new compounds in this field, regulators responsible for the registration of such drugs and health policymakers, to integrate the management of Osteoporosis and Osteoarthritis within the comprehensive perspective of health resources utilization. The objective of ESCEO is to provide practitioners with the latest clinical and economic information, allowing them to organize their daily practice, in an evidence-based medicine perspective, with a cost-conscious perception. www.esceo.org & World Health Organisation (WHO) publish (download pdf)Best practice principles for engaging patients in health research, treatment guidelines, and regulatory processesM. de Wit e.a., Principles for engaging with patients in health research, treatment guidelines and regulatory processes: Results of an expert group meeting organized by the World Health Organization (WHO)WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health.www.who.int and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases (ESCEO), Lancet, April 2019”.
CoPI: Strategy for Patient-Oriented Research (SPOR), Patient Involvement in Research (PIR)/Patient and Public Involvement (PPI), working groups Tools:  Guidance documents - ethics Context: Ethical review, regulatory process, clinical research, guideline development

Additional frameworks, recommendations, and reviews

Additional frameworks, recommendations, and reviews
 
  • 2015: 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.https://omeract.org publishes recommendations for collaborative research Cheung PP, et al. Recommendations for the Involvement of Patient Research Partners (PRP) in OMERACT Working Groups. A Report from the OMERACT 2014 Working Group on PRP. The Journal of rheumatology 2016;43(1):187-932015 https://omeractprpnetwork.org.
  • 2015: With funding from 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, a mixed task force of researchers and patient research partners from over ten European countries develops a new patient derived Health Related Quality of Life instrumentde Wit MPT, Kvien TK, Gossec L. Patient participation as an integral part of patient-reported outcomes development ensures the representation of the patient voice: a case study from the field of rheumatology. RMD Open 2015;1:e000129. doi:10.1136/rmdopen-2015-000129 www.eular.org for rheumatoid arthritis (RAID) and psoriatic arthritis (PsAID) (download pdf).
  • 2016: European Patients’ Academy (EUPATI)EUPATI is a pan-European project implemented as a public-private partnership by a collaborative multi-stakeholder consortium from the pharmaceutical industry, academia, not-for-profit, and patient organizations. The Academy was started, developed and implemented as a flagship project of the Innovative Medicines Initiative and continues to be led by the European Patients’ Forum (EPF). EUPATI has already trained 96 patient experts on medicines development, clinical trials, medicines regulations, health technology assessment. Additionally, EUPATI offers and maintains the Toolbox on Medicine Development, and coordinates a network of national platforms for patient advocates.https://eupati.eu offers and maintains the Toolbox on Medicine Research & Development and Patient EngagementLearn more about this tool at https://toolbox.eupati.eu/.
  • EUPATI coordinates the network of national platforms for patient advocates National Platforms bring patient, academic, and industry partners together to discuss patient education and patient involvement in medicines research and development (R&D). Working together, National Platforms raise awareness about the important role of patients, and members identify challenges and opportunities for joint action. https://www.eupati.eu/.
CoPI: Patient Research Partner (PRP) Tools: Recommendations - patient researcher engagement; Instruments - patient-researcher engagement Context: Patient-reported outcomes (PROs), Research & Development