Patient and public involvement in the design of an international clinical trial: real world experience.

Background: The value of patient and public involvement (PPI) during the earliest stages of clinical trial development, and prior to the award of substantive funding, is widely recognised. However, it is often under-resourced and PPI processes during this phase are rarely reported in detail. Having benefitted from seed funding to develop an international clinical trial proposal, we sought to describe and appraise PPI activities and processes that support pre-award co-development.

GRAPPA 2023 Patient Research Partner (PRP) Network Update: Enhancing PRP Involvement Within GRAPPA.

Nine patient research partners (PRPs) attended the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 annual meeting in person in Dublin, Ireland. The importance of close relations between researchers, clinicians, and PRPs was highlighted at the PRP premeeting, with discussion regarding PRP engagement within GRAPPA with the GRAPPA leadership team. A presentation was given by PRPs at the plenary session, and there was continued active engagement of PRPs in breakout sessions, workshops, and plenary sessions compared to previous annual meetings.

How to Involve Patients in GRAPPA Research as Partners.

Patient research partners (PRPs) have been actively participating in the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meetings, working groups, and research activities since 2013. As they have evolved, the PRPs operate as a cohesive group supported by their GRAPPA-approved handbook and policy documents. The number of involved PRPs has increased, allowing more opportunity for the incorporation of the patient voice and experience in GRAPPA activities.

EULAR recommendations for the involvement of patient research partners in rheumatology research: 2023 update.

Background: Since the publication of the 2011 European Alliance of Associations for Rheumatology (EULAR) recommendations for patient research partner (PRP) involvement in rheumatology research, the role of PRPs has evolved considerably. Therefore, an update of the 2011 recommendations was deemed necessary.

Methods: In accordance with the EULAR Standardised Operational Procedures, a task force comprising 13 researchers, 2 health professionals and 10 PRPs was convened.

Exploring the effect on primary endpoints in trials testing targeted therapy interventions for rheumatoid arthritis: a meta-epidemiological study on the appropriate use of a core outcome set.

Objectives: To explore which core domain is best associated with the American College of Rheumatology (ACR) 20% response in trials assessing the effect of targeted interventions in rheumatoid arthritis (RA).

Methods: A meta-epidemiological study was performed on randomised trials investigating biologics and targeted agents compared with placebo or conventional disease-modifying antirheumatic drugs in patients with RA. The main outcome measures were ORs for the ACR 20% response and at least one of the eight core domains according to the existing RA core outcome set (COS) analysed based on standardised mean differences.

Patient research partner involvement in rheumatology research: a systematic literature review informing the 2023 updated EULAR recommendations for the involvement of patient research partners.

Background: Patient research partners (PRPs) are people with a disease who collaborate in a research team as partners. The aim of this systematic literature review (SLR) was to assess barriers and facilitators to PRP involvement in rheumatology research.

Methods: The SLR was conducted in PubMed/Medline for articles on PRP involvement in rheumatology research, published between 2017 and 2023; websites were also searched in rheumatology and other specialties.

Strategies to promote implementation of core outcomes for medication adherence trials in rheumatology: A report from the OMERACT-Adherence Group.

Objectives: To identify barriers, facilitators, and strategies for future implementation of the OMERACT-Adherence Core Outcome Set (COS) in medication adherence trials for rheumatic conditions.

Methods: Preliminary Delphi survey findings were discussed at OMERACT 2023, utilising the Consolidated Framework for Implementation Research 2 to identify implementation barriers, facilitators, and solutions.

Results: Implementation strategies included simplifying the COS definitions, making it adaptabile for clinical practice and drug trials, adherence trial training workshops, and collaborating with key stakeholders such as payers and other COS developers.

Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials.

Objective: To gain consensus on the definitions and descriptions of the domains of the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials evaluating shared decision making (SDM) interventions.

Methods: Following the OMERACT Handbook methods, our Working Group (WG), comprised of 90 members, including 17 patient research partners (PRPs) and 73 clinicians and researchers, had six virtual meetings in addition to email exchanges to develop draft definitions and descriptions. The WG then conducted an international survey of its members to gain consensus on the definitions and descriptions.

OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments.

Objectives: Shared decision making (SDM) is a central tenet in rheumatic and musculoskeletal care. The lack of standardization regarding SDM instruments and outcomes in clinical trials threatens the comparative effectiveness of interventions. The Outcome Measures in Rheumatology (OMERACT) SDM Working Group is developing a Core Outcome Set for trials of SDM interventions in rheumatology and musculoskeletal health.

Patient outcomes in longitudinal observational studies (POLOS) of rheumatoid arthritis: Determining the OMERACT core domain set.

Objective: To define and select rheumatoid arthritis (RA)-specific core domain set for Longitudinal Observational Studies (LOS) within the Outcome Measures in Rheumatology (OMERACT) framework.

Methods: A three-round online Delphi exercise, including patient research partners (PRPs) and other community partners in healthcare, was conducted. Domains scored 7-9 (i.

Involving patients as research partners in research in rheumatology: a literature review in 2023.

Objective: The inclusion of patient research partners (PRPs) in research projects is increasingly recognised and recommended in rheumatology. The level of involvement of PRPs in translational research in rheumatology remains unknown, while in randomised clinical trials (RCTs), it has been reported to be 2% in 2020. Therefore, we aimed to assess the involvement of PRPs in recent translational studies and RCTs in rheumatology.

Distinction and prognosis of early arthritis phenotypes: an analysis in three European cohorts.

Objectives: The objective of this study is to evaluate whether there are differences in the long-term prognosis across various phenotypes of early arthritis (EA).

Methods: Three EA cohorts (Reade, Etude et Suivi des Polyarthrites Indifférenciées Récentes (ESPOIR) and Early Arthritis Clinic (EAC)) were analysed. Clinical data were collected up to 24 years.

Tolerability and comparative effectiveness of TNF, IL-17 and IL-23(p19) inhibitors in psoriatic arthritis: a target trial emulation study.

Objectives: To compare the tolerability and effectiveness of two different classes of biological DMARDs [IL-17 and IL-23(p19) inhibitors, IL-17i and IL-23(p19)i] relative to TNF inhibitors (TNFi) regarding the drug survival rates and treatment outcomes in patients with PsA.

Methods: We emulated a target trial on comparative effectiveness using observational data from a prospective cohort study based on the Parker Institute's PsA cohort (the PIPA cohort). All patients underwent interview and a clinical examination programme at baseline and at follow-up visits at 4 and 12 months.

Association between obesity and likelihood of remission or low disease activity status in psoriatic arthritis applying index-based and patient-based definitions of remission: a cross-sectional study.

Objectives: We aimed to evaluate whether obese patients with psoriatic arthritis (PsA) were less likely to be in remission/low disease activity (LDA).

Methods: We used data from the ReFlaP, an international multi-centre cohort study (NCT03119805), which recruited consecutive adults with definite PsA (disease duration ≥ 2 years) from 14 countries. Demographics, clinical data, comorbidities, and patient-reported outcomes were collected.

Application of clinical and molecular profiling data to improve patient outcomes in psoriatic arthritis.

Achieving a good outcome for a person with Psoriatic Arthritis (PsA) is made difficult by late diagnosis, heterogenous clinical disease expression and in many cases, failure to adequately suppress inflammatory disease features. Single-centre studies have certainly contributed to our understanding of disease pathogenesis, but to adequately address the major areas of unmet need, multi-partner, collaborative research programmes are now required. HIPPOCRATES is a 5-year, Innovative Medicines Initiative (IMI) programme which includes 17 European academic centres experienced in PsA research, 5 pharmaceutical industry partners, 3 small-/medium-sized industry partners and 2 patient-representative organizations.

Series: Public engagement with research. Part 4: Maximising the benefits of involving the public in research implementation.

This final article in the four-part series focuses on the often neglected yet important role of the public in implementing research in General Practice and Primary Care more broadly. Experience in implementation of findings from research with public engagement in Primary Care has highlighted how partnership working with patients and the public is important in transitioning from 'what we know' from the evidence-base to 'what we do' in practice. Factors related to Primary Care research that make public engagement important are highlighted e.

Series: Public engagement with research. Part 1: The fundamentals of public engagement with research.

Background: In the first of a four-part series, we describe the fundamentals of public engagement in primary care research.

Objectives: The article's purpose is to encourage, inform and improve the researcher's awareness about public engagement in research. For a growing number of researchers, funders and patient organisations in Europe, public engagement is a moral and ethical imperative for conducting high-quality research.

Proceedings of the Collaborative Research Network Meeting at the GRAPPA 2022 Annual Meeting.

At the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2022 annual meeting, the Collaborative Research Network (CRN) met to present updates on several projects. These included the GRAPPA-Industry biomarker projects, Axial Psoriatic Arthritis Molecular and Clinical Characterisation Study, Axial Involvement in Psoriatic Arthritis Cohort (AXIS) study, and the Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States (HIPPOCRATES). The meeting concluded with a discussion on pathways to further academia-industry collaboration.

Initiating Evaluation of Composite Outcome Measures for Psoriatic Arthritis: 2022 Updates From the GRAPPA-OMERACT Working Group.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) working group-comprising rheumatologists, dermatologists, methodologists, and patient research partners-provided updates at the GRAPPA 2022 annual meeting on its work to evaluate composite outcome measures for PsA. Ten composite outcome measures were considered. Initial steps were to define the population, the purpose of use, and the proposed pros and cons of the 10 candidate composite instruments for PsA.

EULAR points to consider for the definition of clinical and imaging features suspicious for progression from psoriasis to psoriatic arthritis.

Background: The transition from psoriasis (PsO) to psoriatic arthritis (PsA) and the early diagnosis of PsA is of considerable scientific and clinical interest for the prevention and interception of PsA.

Objective: To formulate EULAR points to consider (PtC) for the development of data-driven guidance and consensus for clinical trials and clinical practice in the field of prevention or interception of PsA and for clinical management of people with PsO at risk for PsA development.

Methods: A multidisciplinary EULAR task force of 30 members from 13 European countries was established, and the EULAR standardised operating procedures for development for PtC were followed.