Exploring preferences of at-risk individuals for preventive treatments for rheumatoid arthritis

Simons, Gwenda; Bywall, Karin Schölin; Englbrecht, Matthias; Johansson, Eva C.; DiSantostefano, Rachael L.; Radawski, Christine; Veldwijk, Jorien; Raza, Karim; Falahee, Marie

doi:10.1080/03009742.2022.2116805

Cited by 2 publications

(1 citation statement)

References 38 publications

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“…Many individuals at risk of RA have expressed reluctance to take preventive medications, especially when asymptomatic, while making lifestyle changes is perceived to be more acceptable 14 15. Periodontal treatment and advice could be considered a non-invasive, low-risk intervention that may provide similar systemic benefits to drug therapy, but without the risk of drug side effects, and has the additional benefit of treating a coexisting disease with its own complications such as pain and tooth loss.…”

Section: Introductionmentioning

confidence: 99%

‘It surprised me a lot that there is a link’: a qualitative study of the acceptability of periodontal treatment for individuals at risk of rheumatoid arthritis

et al. 2023

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ObjectivesCurrent evidence suggests that periodontal disease could be a causal risk factor for rheumatoid arthritis (RA) onset and progression. Earlier periodontal intervention in individuals at risk of RA could provide a unique opportunity to prevent or delay the onset of RA. This study aimed to explore the acceptability of periodontal treatment as a measure to potentially prevent RA among at-risk individuals and healthcare professionals.MethodsSemistructured interviews were conducted with anti-CCP positive at-risk individuals (CCP+ at risk) and a range of healthcare professionals. At-risk participant data were analysed using reflexive thematic analysis; subsequent coding of healthcare professional data was deductive, based on a preidentified set of constructs.ResultsNineteen CCP+ at-risk and 11 healthcare professionals participated. Three themes (six subthemes) were identified: (1) understanding risk (knowledge of shared at-risk factors; information and communication); (2) oral health perceptions and experiences (personal challenges and opportunities for dental intervention and oral health maintenance; external barriers) and (3) oral health treatment and maintenance (making oral health changes with the aim of preventing RA; acceptability of participation in periodontal research).ConclusionsPeriodontal disease is common in individuals at risk of RA, but the impact of poor oral health may not be well understood. Oral health information should be tailored to the individual. CCP+ at-risk participants and healthcare professionals identified seeking dental treatment can be hindered by dental phobia, treatment costs or inability to access dentists. While CCP+ at-risk individuals may be reluctant to take preventive medications, a clinical trial involving preventive periodontal treatment is potentially acceptable.

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Section: Introductionmentioning

confidence: 99%

‘It surprised me a lot that there is a link’: a qualitative study of the acceptability of periodontal treatment for individuals at risk of rheumatoid arthritis

et al. 2023

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How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action

Janssens,

Barbier,

Muller

et al. 2023

Front. Pharmacol.

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Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what trade-offs patients are willing to make. IMI PREFER was a six-year European public-private partnership under the Innovative Medicines Initiative that developed recommendations on how to assess and use PPS in medical product decision-making, including in the regulatory evaluation of medicinal products. This paper aims to summarize findings and recommendations from IMI PREFER regarding i) PPS applications in regulatory evaluation, ii) when and how to consult with regulators on PPS, iii) how to reflect PPS in regulatory communication and iv) barriers and open questions for PPS in regulatory decision-making.Methods: PREFER performed six literature reviews, 143 interviews and eight focus group discussions with regulators, patient representatives, industry representatives, Health Technology Assessment bodies, payers, academics, and clincians between October 2016 and May 2022.Results: i) With respect to PPS applications, prior to the conduct of clinical trials of medicinal products, PPS could inform regulators’ understanding of patients’ unmet needs and relevant endpoints during horizon scanning activities and scientific advice. During the evaluation of a marketing authorization application, PPS could inform: a) the assessment of whether a product meets an unmet need, b) whether patient-relevant clinical trial endpoints and outcomes were studied, c) the understanding of patient-relevant effect sizes and acceptable trade-offs, and d) the identification of key (un-)favorable effects and uncertainties. ii) With respect to consulting with regulators on PPS, PPS researchers should ideally have early discussions with regulators (e.g., during scientific advice) on the PPS design and research questions. iii) Regarding external PPS communication, PPS could be reflected in the assessment report and product information (e.g., the European Public Assessment Report and the Summary of Product Characteristics). iv) Barriers relevant to the use of PPS in regulatory evaluation include a lack of PPS use cases and demonstrated impact on regulatory decision-making, and need for (financial) incentives, guidance and quality criteria for implementing PPS results in regulatory decision-making. Open questions concerning regulatory PPS use include: a) should a product independent broad approach to the design of PPS be taken and/or a product-specific one, b) who should optimally be financing, designing, conducting, and coordinating PPS, c) when (within and/or outside clinical trials) to perform PPS, and d) how can PPS use best be operationalized in regulatory decisions.Conclusion: PPS have high potential to inform regulators on key unmet needs, endpoints, benefits, and risks that matter most to patients and their acceptable trade-offs. Regulatory guidelines, templates and checklists, together with incentives are needed to foster structural and transparent PPS submission and evaluation in regulatory decision-making. More PPS case studies should be conducted and submitted for regulatory assessment to enable regulatory discussion and increase regulators’ experience with PPS implementation and communication in regulatory evaluations.

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Exploring preferences of at-risk individuals for preventive treatments for rheumatoid arthritis

Cited by 2 publications

References 38 publications

‘It surprised me a lot that there is a link’: a qualitative study of the acceptability of periodontal treatment for individuals at risk of rheumatoid arthritis

‘It surprised me a lot that there is a link’: a qualitative study of the acceptability of periodontal treatment for individuals at risk of rheumatoid arthritis

How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action

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