EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis

Mankia, Kulveer; Siddle, Heidi J.; Kerschbaumer, Andreas; Rodriguez, Deshire Alpizar; Catrina, Anca I.; Cañete, Juan D.; Cope, Andrew; Daïen, C.; Deane, Kevin D.; Gabalawy, Hani El; Finckh, Axel; Holers, V. Michael; Koloumas, Marios; Ometto, Francesca; Raza, Karim; Zabalan, C.; Mil, Annette H M van der Helm-van; Schaardenburg, Dirkjan van; Aletaha, Daniel; Emery, Paul

doi:10.1136/annrheumdis-2021-220884

Cited by 47 publications

(42 citation statements)

References 128 publications

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“…Third, the participants included within our review were either individuals with musculoskeletal symptoms but without clinical arthritis or FDRs of individuals with RA recruited through secondary care; therefore, our findings provide limited insights into the perceptions and experiences of other individuals at-risk of developing the condition, such as other asymptomatic at-risk individuals (eg, indigenous North Americans who are at increased genetic risk) and at-risk individuals with early clinical arthritis, including patients with palindromic rheumatism and undifferentiated arthritis. 18 We acknowledge that the themes we have identified might potentially differ between the different groups of individuals at-risk included within this review (eg, in terms of their knowledge of RA), as well as groups of at-risk individuals not represented in study samples. Additionally, while our search strategy included the term ‘inflammatory arthritis’, no qualitative studies relating to patients at-risk of inflammatory arthritides other than RA were found.…”

Section: Discussionmentioning

confidence: 99%

“…At-risk populations eligible for inclusion were (1) asymptomatic at-risk individuals, which includes first-degree relatives (FDRs) of people with RA and indigenous North Americans; (2) at-risk individuals with musculoskeletal symptoms without clinical arthritis; and (3) at-risk individuals with early clinical arthritis, which includes patients with palindromic rheumatism and undifferentiated arthritis. 18 We included full articles in the English language that were published in peer-reviewed journals. Conference abstracts were excluded.…”

Section: Methodsmentioning

confidence: 99%

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Perceptions and experiences of individuals at-risk of rheumatoid arthritis (RA) knowing about their risk of developing RA and being offered preventive treatment: systematic review and thematic synthesis of qualitative studies

et al. 2021

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ObjectivesThere is increasing interest in identifying individuals at-risk of rheumatoid arthritis (RA) and initiating early treatment to prevent or delay the onset of arthritis. We aimed to describe the perceptions and experiences of at-risk individuals and to inform the conduct of clinical trials and studies, and clinical practice.MethodsA systematic review and thematic synthesis of qualitative studies was conducted. Two review authors independently screened studies for inclusion, appraised their methodological quality using the Critical Appraisal Skills Programme checklist and assessed confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation–Confidence in Evidence from Reviews of Qualitative Research approach.ResultsSeven studies involving 115 individuals at-risk of developing RA were included. Three major themes (seven subthemes) were identified: understanding the risk of developing RA (knowledge of RA and identification of potential risk factors); preventive interventions to reduce the risk of developing RA (understanding the value and role of preventive interventions, and engagement with preventive interventions); and perceptions of predictive testing for RA (benefits of predictive testing, decision to undertake predictive testing and concerns about predictive testing). Moderate confidence in most review findings was evident.ConclusionWhile there are clear benefits in informing individuals at-risk of RA about their risk following predictive testing and offering preventive treatment, there are potential barriers to engagement, intensified by the burden of uncertainty. Identification of the optimum approaches for presenting risk information, including the risks and benefits of engaging with preventive interventions, is urgently needed to support individuals at-risk of RA in their decision making.PROSPERO registration numberCRD42021236034.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Perceptions and experiences of individuals at-risk of rheumatoid arthritis (RA) knowing about their risk of developing RA and being offered preventive treatment: systematic review and thematic synthesis of qualitative studies

et al. 2021

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“…Only recently, the European Alliance of Rheumatology (EULAR) has published points to consider for conducting clinical trials and observational studies in at-risk individuals ( 46 ). The different outcomes for assessment agreed on within our consortium are also named in this recommendation paper, which also reflects the different phases in the development of arthritis, and the foci that are set in the contributing individual registries.…”

Section: Discussionmentioning

confidence: 99%

Prospective Studies on the Risk of Rheumatoid Arthritis: The European Risk RA Registry

Studenic¹,

Hensvold²,

Kleyer³

et al. 2022

Front. Med.

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BackgroundThe accumulation of risk for the development of rheumatoid arthritis (RA) is regarded as a continuum that may start with interacting environmental and genetic factors, proceed with the initiation of autoimmunity, and result in the formation of autoantibodies such as anti-citrullinated peptide antibodies (ACPA). In parallel, at-risk individuals may be asymptomatic or experience joint pain (arthralgia) that is itself non-specific or clinically suspicious for evolving RA, even in the absence of overt arthritis. Optimal strategies for the management of people at-risk of RA, both for symptom control and to delay or prevent progression to classifiable disease, remain poorly understood.MethodsTo help address this, groups of stakeholders from academia, clinical rheumatology, industry and patient research partners have collaborated to advance understanding, define and study different phases of the at-risk state. In this current report we describe different European initiatives in the field and the successful effort to build a European Registry of at-risk people to facilitate observational and interventional research.ResultsWe outline similarities and differences between cohorts of at-risk individuals at institutions spanning several countries, and how to best combine them within the new database. Over the past 2 years, besides building the technical infrastructure, we have agreed on a core set of variables that all partners should strive to collect for harmonization purposes.ConclusionWe emphasize to address this process from different angles and touch on the biologic, epidemiologic, analytic, and regulatory aspects of collaborative studies within a meta-database of people at-risk of RA.

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“…These are individuals without a diagnosis of RA who have either (i) genetic risk factors for RA, (ii) environmental risk factors for RA, (iii) systemic autoimmunity associated with RA, (iv) symptoms without clinical arthritis or (v) unclassified arthritis [ 7 ]. Core risk factors for RA have now been defined [ 8 ], and EULAR guidelines for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis have been published [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

“…Given the increasing focus on prevention of RA [ 8 , 9 ], the present systematic review of studies to elicit preferences for RA treatments updates and extends the previous review [ 6 ] by including studies of the preferences of individuals who do not have RA, and those of ‘at risk’ populations for RA prevention [ 17 ]. This inquiry will explore differences between preference studies for RA treatment and prevention, and across different populations (patients, general public, at risk groups).…”

Section: Introductionmentioning

confidence: 99%

Systematic review of quantitative preference studies of treatments for rheumatoid arthritis among patients and at-risk populations

et al. 2022

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Treatments used for rheumatoid arthritis (RA) are under investigation for their efficacy to prevent RA in at risk groups. It is therefore important to understand treatment preferences of those at risk. We systematically reviewed quantitative preference studies of drugs to treat, or prevent RA, to inform the design of further studies and trials of RA prevention. Stated preference studies for RA treatment or prevention were identified through a search of five databases. Study characteristics and results were extracted, and the relative importance of different types of treatment attributes was compared across populations. Twenty three studies were included 20 of RA treatments (18 of patients; 2 of the general public) and 3 prevention studies with first-degree relatives (FDRs). Benefits, risks, administration method and cost (when included) were important determinants of treatment choice. A benefit was more important than a risk attribute in half of the studies of RA treatment that included a benefit attribute and 2/3 studies of RA prevention. There was variability in the relative importance of attributes across the few prevention studies. In studies with non-patient participants, attributes describing confidence in treatment effectiveness/safety were more important determinants of choice than in studies with patients. Most preference studies relating to RA are of treatments for established RA. Few studies examine preferences for treatments to prevent RA. Given intense research focus on RA prevention, additional preference studies in this context are needed. Variation in treatment preferences across different populations is not well understood and direct comparisons are needed.

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EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis

Cited by 47 publications

References 128 publications

Perceptions and experiences of individuals at-risk of rheumatoid arthritis (RA) knowing about their risk of developing RA and being offered preventive treatment: systematic review and thematic synthesis of qualitative studies

Perceptions and experiences of individuals at-risk of rheumatoid arthritis (RA) knowing about their risk of developing RA and being offered preventive treatment: systematic review and thematic synthesis of qualitative studies

Prospective Studies on the Risk of Rheumatoid Arthritis: The European Risk RA Registry

Systematic review of quantitative preference studies of treatments for rheumatoid arthritis among patients and at-risk populations

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