"I couldn't carry on taking a drug like that": A qualitative study of patient perspectives on side effects from rheumatology drugs.

OBJECTIVES: There is growing interest in collecting outcome information directly from patients in clinical trials. This study evaluates what patients with rheumatic and musculoskeletal diseases (RMDs) consider important to know about symptomatic side effects they may experience from a new prescription drug. METHODS: Patients with inflammatory arthritis, who had one or more prescribed drugs for their disease for at least 12 months, participated in focus groups and individual interviews. Discussions were analysed using reflexive thematic analysis. RESULTS: We conducted seven focus groups with 34 participants across three continents. We found four overarching and two underpinning themes. The 'impact on life' was connected to participants 'daily life', 'family life', 'work life', and 'social life'. In 'psychological and physical aspects' participants described 'limitation to physical function', 'emotional dysregulation' and 'an overall mental state'. Extra tests, hospital visits and payment for medication were considered a 'time, energy and financial burden' of side effects. Participants explained important measurement issues to be 'severity', 'frequency', and 'duration'. Underpinning these issues, participants evaluated the 'benefit-harm-balance' which includes 'the cumulative burden' of having several side effects and the persistence of side effects over time. CONCLUSIONS: In treatment for RMDs, there seems to be an urgent need for feasible measures of patient-reported bother (impact on life and cumulative burden) from side effects and the benefit-harm-balance. These findings contribute new evidence in support of a target domain-an outcome that represents the patient voice evaluating the symptomatic treatment-related side effects for people with RMDs enrolled in clinical trials.

Associations of gender with sexual functioning, loneliness, depression, fatigue and physical function amongst patients suffering from rheumatoid arthritis with a particular focus on methotrexate usage.

There is a lack of knowledge regarding methotrexate (MTX) usage in patients with rheumatoid arthritis (RA) and its possible links with gender, disease characterization and sexual functioning, loneliness, fatigue and depression. We, therefore, investigated the associations of gender with physical function, fatigue, depression, loneliness and sexual functioning with a particular focus on MTX usage. A cross-sectional study design was used. Inclusion criteria were RA diagnosis, age above 18 years and available data on MTX treatment 1 year after diagnosis. Data consisted of responses from validated questionnaires regarding physical function, fatigue, depression, loneliness and sexual functioning combined with evaluations from medical records. Data were analysed with linear regression models comparing numerical outcome measures between male and female patients and between MTX users and MTX non-users. Amongst 286 patients with RA (69 men and 217 women), 67.8% were MTX users 1 year after diagnosis. Comparing women and men, both overall and within subgroups of MTX usage, we found significantly more adverse outcomes for women than men in physical functioning at diagnosis and in sexual function, depression, fatigue and physical functioning at enrolment in the study. Gender differences were also present when comparing MTX users with MTX non-users divided by gender. There were only significant differences in the HAQ and loneliness scores when comparing MTX users with MTX non-users. Women with RA had more negative outcomes measured by the selected PROMs compared to men with RA, both overall and in subgroups of users and non-users of MTX. These findings call for sharpened attention to the importance of gender in the treatment and care of patients with RA, as well as in future clinical research.

'I turned in my man card': a qualitative study of the experiences, coping styles and support needs of men with systemic sclerosis.

OBJECTIVES: Men with SSc have a more severe clinical phenotype and reduced survival compared with women. No previous psychosocial studies have focused solely on men with SSc. This study aimed to explore experiences, coping strategies and support preferences of men with SSc. MATERIAL AND METHODS: An international qualitative research study comprising seven focus groups (three USA, four UK) of 25 men with SSc. Transcripts were analysed using reflexive thematic analysis. RESULTS: Three overarching themes and one underpinning theme were identified. In 'impact of SSc on masculinity', the men described an 'impact on roles and activities', reported 'sex, intimacy, and erectile dysfunction' as a salient issue that may be overlooked by clinicians, and experienced challenges to 'masculine self-image'. 'Dealing with SSc' meant 'always being prepared', 'becoming an expert' and 'balancing priorities' in responsibilities, activities and symptom management. In 'support for living with SSc' men were selective in '(Not) talking about SSc', would '(reluctantly) accept help' and described 'preferences for support'. Underpinning these experiences was 'facing an uncertain future' with some participants preferring not to focus on an unpredictable future, and others worrying about disease progression. CONCLUSION: These novel data suggest SSc impacts male patients' masculine identity and roles, and although they will accept practical help, they may mask the full emotional impact. Sex and intimacy are important overlooked issues with erectile dysfunction often not discussed at diagnosis. Further research should develop a self-management intervention for men with rheumatic diseases with a combination of disease-specific and common core components.

Towards consensus in defining and handling contextual factors within rheumatology trials: an initial qualitative study from an OMERACT working group.

OBJECTIVES: The Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term 'contextual factors' exist. This study explores the perspectives of researchers (including clinicians) and patients in defining 'contextual factor' and its related terminology, identifying such factors and accounting for them in trials across rheumatology. METHODS: We conducted individual semistructured interviews with researchers (including clinicians) who have experience within the field of contextual factors in clinical trials or other potentially relevant areas, and small focus group interviews with patients with rheumatic conditions. We transcribed the interviews and applied qualitative content analysis. RESULTS: We interviewed 12 researchers and 7 patients. Researcher's and patient's descriptions of contextual factors were categorised into two broad themes, each comprising two contextual factors types. The 'treatment effect' theme focused on factors explaining variations in treatment effects (A) among patients and (B) among studies. The 'outcome measurement' theme focused on factors that explain (C) variations in the measurement result itself (apart from actual changes/differences in the outcome) and (D) variations in the outcome itself (beside treatment of interest). Methods for identifying and handling contextual factors differed among these themes and types. CONCLUSIONS: Two main themes for contextual factors with four types of contextual factors were identified based on input from researchers and patients. This will guide operationalisation of contextual factors. Further research should refine our findings and establish consensus among relevant stakeholders.

The patient perspective of nurse-led care in early rheumatoid arthritis: A systematic review of qualitative studies with thematic analysis.

INTRODUCTION: Management of rheumatoid arthritis has changed dramatically over the last decade and is characterised by early start of intensive treatment and tight monitoring of disease activity until remission. The role of nurse-led care at early stage of disease is not well understood. AIMS: To develop an understanding of rheumatology nurse-led care from the perspective of patients with early rheumatoid arthritis. METHODS: A systematic review of qualitative studies, reported in line with PRISMA checklist. In March 2019, the following databases were searched: MEDLINE, EMBASE, CINAHL, PsycINFO and OpenGrey. Studies were included if they: included adults with rheumatoid arthritis; were qualitative studies with data on patients' perspectives of nurse-led care; and published in peer-reviewed journals, in English, between 2010-2019. Due to few studies in early rheumatoid arthritis, inclusion was extended to adults with established rheumatoid arthritis. Two reviewers screened abstracts and full texts. Joanna Briggs Institute Critical Appraisal Tool was used for quality assessment. Thematic synthesis was conducted according to the framework of Thomas and Harden (2008). RESULTS: The search identified 1034 records. After screening and assessing for eligibility, eight qualitative studies were included in the review (133 patients). Three themes were identified from the synthesis. Nurse-led care was seen to provide professional expertise in planning and delivery of care. A person-centred approach was used combined with good communication skills, thus creating a positive therapeutic environment. Nurse-led care was described as providing a sense of empowerment and psychological support. CONCLUSION: Patients with rheumatoid arthritis are supportive of nurse-led care. They value its professionalism and person-centred approach which provide a sense of security and confidence. RELEVANCE TO CLINICAL PRACTICE: The findings outline ingredients of nurse-led care that are important to patients. These can inform nurses' professional development plans, service improvement and the competence framework for rheumatology nursing.

'Everyone assumes a man to be quite strong': Men, masculinity and rheumatoid arthritis: A case-study approach.

Current literature has overlooked the impact of chronic illness on masculine identity. We therefore aimed to investigate the impact of rheumatoid arthritis (a long term condition, affecting more women than men) on masculine identity. Six focus groups with 22 men with rheumatoid arthritis (RA) (data reported elsewhere) followed by five one-to-one interviews with men (English, mean age: 59 years) sampled to reflect a heterogeneous experience of life with RA based on knowledge gained from the focus groups. Transcripts were analysed using thematic analysis and are presented as individual case studies. Whilst the case studies provide five distinct experiences, common themes can be drawn across them, such as the importance of paid work. The men needed to renegotiate their masculine identity to deal with their RA. Two dealt with this by pushing through pain to retain masculine activities, two replaced masculine roles they could no longer do with other roles, and one rejected masculinity completely. Men with long term conditions may need to re-write their masculinity scripts to enable them to accept and adapt to their condition. However, some men struggle with this, which should be taken into consideration when designing self-management services for men with long term conditions.

The patient perspective on absence of disease activity in rheumatoid arthritis: a survey to identify key domains of patient-perceived remission.

BACKGROUND: Guidelines suggest treatment in rheumatoid arthritis (RA) to target remission, in close consultation with the patient. Our recent qualitative study of the patients' perspective on remission in RA identified 26 domains. The current study aimed to identify a short list of the most important aspects to inform future research. METHODS: Patients with RA from the Netherlands, the UK, Austria, Denmark, France and the USA completed a survey that contained all domains identified in our qualitative study. They rated domains for importance ('not important', 'important' or 'essential' to characterise a period of remission) and if important or essential, whether this domain needs to be 'less', 'almost gone' or 'gone' to reflect remission. Respondents were also asked to determine their personal top 3 most important/essential domains. Frequency of specific domains in the top 3 was calculated, and domains were sorted on the percentage of patients that evaluated a particular domain as 'essential'. RESULTS: Of 274 respondents, 75% were female, mean (SD) age 57(13) years, disease duration 12(9) years. The top 3 were as follows: pain (67%), fatigue (33%) and independence (19%); domains most frequently rated as 'essential' were as follows: pain (60%), being mobile (52%), physical function (51%), being independent (47%) and fatigue (41%). Pain needed to be less (13%), almost gone (42%) or gone (45%) to reflect remission. Similar patterns were seen for fatigue, independence, mobility and physical functioning. CONCLUSION: Patients identified pain, fatigue and independence as the most important domains of RA disease activity that need to be improved to reflect remission.

The patient perspective on remission in rheumatoid arthritis: 'You've got limits, but you're back to being you again'.

OBJECTIVES: The aim of rheumatoid arthritis (RA) treatment is remission. As treatment should be targeted at outcomes relevant to patients, it is important to understand how patients perceive remission, and to assess whether the current definition of remission adequately reflects these perceptions. The objective of this study is to explore the patient perspective on remission in RA. METHODS: Nine focus-group discussions in Austria, The Netherlands and UK were conducted, including patients in American College of Rheumatology (ACR)/ European League of Rheumatology (EULAR) remission, self-declared remission and in moderate/high disease activity. Moderators employed a prespecified interview guide helped to engage patients in a discussion on their experience with remission. Inductive thematic analysis was performed within each country, and identified themes were discussed across countries. RESULTS: 47 RA patients (66% women, disease duration 9 years) participated. Three major themes of patient-perceived remission emerged: (1) symptoms would either be absent or strongly reduced, (2) impact of the disease on daily life would diminish by increased independence, ability to do valued activities, improved mood and ability to cope; (3) leading to a return to normality, including work, family role and perception of others. Patients felt the concept of remission was influenced by ageing, side effects of medication, comorbidities, accrued damage to joints and disease duration. Opinions on duration of state, the role of medication and measurement instruments varied widely. CONCLUSIONS: Patients characterise remission by the absence or reduction of symptoms, but more directly by decreased daily impact of their condition and the feeling of a return to normality. The next step is to study whether an additional patient-perceived measure of remission may add value to the ACR/EULAR definition of remission.

It's like a juggling act: rheumatoid arthritis patient perspectives on daily life and flare while on current treatment regimes.

OBJECTIVE: The objective of this study was to explore patients' experiences of RA daily life while on modern treatments. METHODS: The methods of this study comprised semi-structured interviews with 15 RA patients, analysed using inductive thematic analysis. RESULTS: Four themes suggest patients experience life with RA along a continuum from RA in the background to the foreground of their lives, underpinned by constant actions to maintain balance. Living with RA in the background shows patients experience continuous, daily symptoms, which they mediate through micromanagement (mediating the impact of RA on daily life), while learning to incorporate RA into their identity (redefining me). RA moving into the foreground shows patients experience fluctuating symptoms (unwelcome reminders) that may or may not lead to a flare (trying to make sense of fluctuation). Dealing with RA in the foreground shows how patients attempt to manage RA flares (trying to regain control) and decide to seek medical help only after feeling they are losing control. Patients employ a stepped approach to self-management (mediation ladder) as symptoms increase, with seeking medical help often seen as the last resort. Patients seek to find a balance between managing their fluctuating RA and living their daily lives. CONCLUSION: Patients move back and forth along a continuum of RA in the background vs the foreground by balancing self-management of symptoms and everyday life. Clinicians need to appreciate that daily micromanagement is needed, even on current treatment regimes. Further research is needed to quantify the level and impact of daily symptoms and identify barriers and facilitators to seeking help.

A Q-methodology study of flare help-seeking behaviours and different experiences of daily life in rheumatoid arthritis.

BACKGROUND: Previous studies have not addressed rheumatoid arthritis (RA) patients' help-seeking behaviours for RA flares, and only one small qualitative study has addressed how patients experience daily life on current treatment regimes. Thus, this study aims to identify clusters of opinion related to RA patients' experiences of daily life on current treatments, and their help-seeking behaviours for RA flares. METHODS: Using Q-methodology (a methodology using qualitative and quantitative methods to sort people according to subjective experience), two separate studies were conducted with the same sample of RA patients (mean age 55, 73% female). Thirty participants sorted 39 statements about daily life (Q-study 1) and 29 participants separately sorted 23 statements about flare help-seeking (Q-study 2). Data were examined using Q-factor analysis. RESULTS: Daily life with RA (Q-study 1): Three factors relating to the experience of living with RA were extracted and explained. Patients belonging to Factor A (mean age 62, 86% female) use effective self-management techniques to control the daily impact of RA. Those in Factor B (mean age 55, 75% male) struggle to self-manage and cope. Whilst patients in Factor C (mean age 42, 100% female) prioritise life responsibilities over their RA, reporting less impact.Flare help-seeking (Q-study 2): Two factors explaining the experience of flare help-seeking (unrelated to the factors from Q-study 1) were extracted and explained. Factor X (68.8% on biologics) reported seeking help quickly, believing the medical team is there to help. Factor Y (0% on biologics) delay help-seeking, concerned about wasting the rheumatologist's time, believing they should manage alone. All participants agreed they sought help due to intense pain and persistent, unmanageable symptoms. CONCLUSIONS: Patients with different characteristics appear to manage RA life in different ways and men may struggle more than women. Whilst all patients are prompted to seek help by persistent, unmanageable symptoms, some delay help-seeking. Further research is needed to quantify the severity of daily symptoms, the level of symptoms needed for patients to define themselves as in flare and to understand the support needs of RA men.

'Do I cry or just carry on': A story completion study of healthcare professionals' anticipated responses to experiencing chest pain.

Healthcare professionals may experience barriers to seeking healthcare that differ from the general population. We explored healthcare professionals' anticipated responses to experiencing chest pain following a period of stress using qualitative story completion method with healthcare professionals (n = 44). Data were analysed using reflexive thematic analysis, which identified three themes: '"Do I cry or just carry on?": A Culture of Suffering in Silence' identified worries that expressing health concerns would be perceived as weakness, with potential impact on career opportunities. Participants also described self-diagnosis and self-medication rather than help-seeking. '"Me? Have a panic attack?": Psychosomatic Shame' suggested mental health issues may be ignored due to stigma. '"We definitely don't take care of ourselves": Prioritising Pressures of Multiple Responsibilities over Self-care' identified real or perceived pressures to de-prioritise their health. Future research should explore the design of confidential, time efficient support for healthcare professionals that tackle cultural norms and barriers to self-care.

Patients' perspectives on systemic sclerosis-related Raynaud's phenomenon in the feet: A qualitative study from the OMERACT Foot and Ankle Working Group.

OBJECTIVE: To explore, from patients' perspectives, the symptoms and impact of Raynaud's phenomenon (RP) on the feet of patients with systemic sclerosis (SSc-RP), and to identify which foot-related domains are important to patients. METHODS: Forty participants (34 women) with SSc-RP took part in one of six focus groups held in the United Kingdom or United States. Participants were purposively sampled to ensure diversity in disease type, duration, and ethnicity. The topic guide included questions on RP impact, self-management, and treatment expectations. Qualitative content analysis was employed to identify key concepts in the data relating to foot-specific symptoms and their impact. Themes were organized by corresponding domains of potential importance. RESULTS: Twenty-eight participants (70 %) reported experiencing RP in their feet. Five themes were identified corresponding to domains of potential importance: temperature changes, pain, cramping and stiffness, numbness, and color changes. These issues negatively affected participants' lives, impairing walking, driving, and socializing, and causing issues with footwear and hosiery. CONCLUSIONS: This large qualitative study exploring the experiences of patients with SSc-RP in the feet identified several key domains of high importance to patients. SSc-RP is common in the feet, presents in several patterns, and impacts multiple aspects of patients' lives. These findings indicate where future foot-specific interventions for RP could be targeted. Findings from this study improve understanding of what domains are important to patients with SSc-RP affecting the feet and will contribute to the development of a core outcome set for foot and ankle disorders in rheumatic and musculoskeletal diseases.

Nurse-led care for people with early rheumatoid arthritis: Interview study with thematic analysis.

AIMS: To develop an understanding of what comprises nurse-led care in early rheumatoid arthritis from the perspective of rheumatology nurse specialists in England. DESIGN: Qualitative study. METHODS: Semi-structured telephone interviews with rheumatology nurse specialists in England were conducted in Summer 2020. Interviews were audio-recorded, transcribed verbatim and analysed using reflexive thematic analysis. Reporting follows the appropriate elements of consolidated criteria for reporting qualitative research. RESULTS: Sixteen nurses were recruited and interviews lasted 30-60 min. Four themes with 14 subthemes were identified. A SPECIALIST SERVICE DELIVERED BY EXPERIENCED RHEUMATOLOGY NURSES: Specialist care is provided by experienced nurse specialists with a high degree of autonomy in the rheumatology multidisciplinary team context. ADDRESSING PATIENTS' COMPLEX CARE NEEDS: Care is evidence-based and aims to start treatment, keep in treatment, educate and support. Access to psychology expertise is needed. CARE WITH COMPASSION USING PERSON-CENTRED, HOLISTIC AND EMPATHETIC APPROACHES: Nurses create patient relationships and a positive therapeutic environment. Nurse-led telephone advice lines are essential for treatment adjustment, patient support and empowerment. CONTINUED EVALUATION AND DEVELOPMENT OF THE SERVICE: Consultations are reviewed, and patients are asked for feedback. The COVID-19 pandemic caused disruption, but changes streamlined procedures and improved documentation and communication. CONCLUSION: Nurse-led care in early rheumatoid arthritis is a specialist service delivered with compassion, addressing complex care needs and using person-centred approaches. This study identifies key aspects of care in early disease from the nurse perspective.

Defining independence: A scoping review by the OMERACT patient perspective of remission in rheumatoid arthritis group.

AIMS: The Outcome Measures in Rheumatology Trials (OMERACT) Remission in Rheumatoid Arthritis (RA) patient perspective working group has previously found that patients prioritised independence, pain, and fatigue as key domains of remission in RA. However, there is currently no clear definition of independence. Consequently, this scoping review aimed to explore how independence is represented in the RA literature. METHODS: A comprehensive search of the EMBASE, Medline, and PsycInfo databases was performed for publications that used independence or autonomy as a disease activity measure, description of disease in remission or treatment outcome. Papers were included if they involved adult participants and were written in English, with no restrictions on study design or publication year. Two reviewers (TK and AC, AT or BJ) independently screened the abstracts. A thematic approach was applied to derive common definitions and descriptions of independence. RESULTS: 660 articles were identified, of which 58 (25 qualitative, 28 quantitative, one mixed, and four reviews) met the inclusion criteria. 86% of total participants were female. Ten publications referenced remission. Independence took many forms; in addition to physical and functional capability, it was described in relation to work, social activities, autonomy in healthcare, and household activities. Four common themes describing independence were identified: 1. A return to a state before arthritis. 2. Being physically and functionally able. 3. A sense of freedom without needing to rely on others. 4. Having control over the organisation of one's life. CONCLUSION: Although independence is frequently mentioned in the RA literature, it has various meanings, lacks a consistent definition, and is a concept rarely applied to remission. It is multi-factorial, exceeding functional ability alone, and contextualised within sociodemographic and disease factors. This scoping review provides common descriptions of independence to inform future qualitative work towards the development of an outcome measure of independence for the assessment of RA in remission.

Living with foot and ankle disorders in rheumatic and musculoskeletal diseases: A systematic review of qualitative studies to inform the work of the OMERACT Foot and Ankle Working Group.

OBJECTIVES: This study aimed to determine outcome domains of importance to patients living with foot and ankle disorders in rheumatic and musculoskeletal diseases (RMDs), by exploring the symptoms and impact of these disorders reported in existing qualitative studies. METHODS: Six databases were searched from inception to March 2022. Studies were included if they used qualitative interview or focus group methods, were published in English, and involved participants living with RMDs (inflammatory arthritis, osteoarthritis, crystal arthropathies, connective tissue diseases, and musculoskeletal conditions in the absence of systemic disease) who had experienced foot and ankle problems. Quality was assessed using the Critical Appraisal Skills Programme qualitative tool and confidence in the findings was assessed using the Grading of Recommendations Assessment, Development and Evaluation Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) approach. All data from the results section of included studies were extracted, coded and synthesised to develop themes. RESULTS: Of 1,443 records screened, 34 studies were included, with a total of 503 participants. Studies included participants with rheumatoid arthritis (n = 18), osteoarthritis (n = 5), gout (n = 3), psoriatic arthritis (n = 1), lupus (n = 1), posterior tibial tendon dysfunction (n = 1), plantar heel pain (n = 1), Achilles tendonitis (n = 1), and a mixed population (n = 3), who live with foot and ankle disorders. Seven descriptive themes were generated from the thematic synthesis: pain, change in appearance, activity limitations, social isolation, work disruption, financial burden and emotional impact. Descriptive themes were inductively analysed further to construct analytical themes relating to potential outcome domains of importance to patients. Foot or ankle pain was the predominant symptom experienced by patients across all RMDs explored in this review. Based on grading of the evidence, we had moderate confidence that most of the review findings represented the experiences of patients with foot and ankle disorders in RMDs. CONCLUSIONS: Findings indicate that foot and ankle disorders impact on multiple areas of patients' lives, and patients' experiences are similar regardless of the RMD. This study will inform the development of a core domain set for future foot and ankle research and are also useful for clinicians, helping to focus clinical appointments and measurement of outcomes within clinical practice.

Developing an Outcome Measures in Rheumatology (OMERACT) Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT): core domain set study protocol.

BACKGROUND: Foot and ankle involvement is common in rheumatic and musculoskeletal diseases (RMDs). High-quality evidence is lacking to determine the effectiveness of treatments for these disorders. Heterogeneity in the outcomes used across clinical trials and observational studies hinders the ability to compare findings, and some outcomes are not always meaningful to patients and end-users. The Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT) study aims to develop a core outcome set (COS) for use in all trials of interventions for foot and ankle disorders in RMDs. This protocol addresses core outcome domains (what to measure) only. Future work will focus on core outcome measurement instruments (how to measure). METHODS: COMFORT: Core Domain Set is a mixed-methods study involving the following: (i) identification of important outcome domains through literature reviews, qualitative interviews and focus groups with patients and (ii) prioritisation of domains through an online, modified Delphi consensus study and subsequent consensus meeting with representation from all stakeholder groups. Findings will be disseminated widely to enhance uptake. CONCLUSIONS: This protocol details the development process and methodology to identify and prioritise domains for a COS in the novel area of foot and ankle disorders in RMDs. Future use of this standardised set of outcome domains, developed with all key stakeholders, will help address issues with outcome variability. This will facilitate comparing and combining study findings, thus improving the evidence base for treatments of these conditions. Future work will identify suitable outcome measurement instruments for each of the core domains. TRIAL REGISTRATION: This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, as of June 2022: https://www.comet-initiative.org/Studies/Details/2081.

Developing a core outcome set for foot and ankle disorders in rheumatic and musculoskeletal diseases: A scoping review and report from the OMERACT 2022 foot and ankle special interest group session.

OBJECTIVES: Foot and ankle involvement is common in rheumatic and musculoskeletal diseases, yet high-quality evidence assessing the effectiveness of treatments for these disorders is lacking. The Outcome Measures in Rheumatology (OMERACT) Foot and Ankle Working Group is developing a core outcome set for use in clinical trials and longitudinal observational studies in this area. METHODS: A scoping review was performed to identify outcome domains in the existing literature. Clinical trials and observational studies comparing pharmacological, conservative or surgical interventions involving adult participants with any foot or ankle disorder in the following rheumatic and musculoskeletal diseases (RMDs) were eligible for inclusion: rheumatoid arthritis (RA), osteoarthritis (OA), spondyloarthropathies, crystal arthropathies and connective tissue diseases. Outcome domains were categorised according to the OMERACT Filter 2.1. RESULTS: Outcome domains were extracted from 150 eligible studies. Most studies included participants with foot/ankle OA (63% of studies) or foot/ankle involvement in RA (29% of studies). Foot/ankle pain was the outcome domain most commonly measured (78% of studies), being the most frequently specified outcome domain across all RMDs. There was considerable heterogeneity in the other outcome domains measured, across core areas of manifestations (signs, symptoms, biomarkers), life impact, and societal/resource use. The group's progress to date, including findings from the scoping review, was presented and discussed during a virtual OMERACT Special Interest Group (SIG) in October 2022. During this meeting, feedback was sought amongst delegates regarding the scope of the core outcome set, and feedback was received on the next steps of the project, including focus group and Delphi methods. CONCLUSION: Findings from the scoping review and feedback from the SIG will contribute to the development of a core outcome set for foot and ankle disorders in RMDs. The next steps are to determine which outcome domains are important to patients, followed by a Delphi exercise with key stakeholders to prioritise outcome domains.

Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group.

OBJECTIVES: To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to developing or selecting an outcome measurement instrument. METHODS: OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients' harm-reporting. RESULTS: Domain was defined in detail and supported by qualitative work. Participants in the Special-Interest-Group endorsed (96 %) that enough qualitative data are available to start Delphi survey(s). CONCLUSION: We present a definition of safety/harms that represents the patient voice (i.e., patients' perception of safety) evaluating the symptomatic treatment-related adverse events for people with RMDs enrolled in clinical trials.

Preferences for Self-Management and Support Services in Patients With Inflammatory Joint Disease: A Danish Nationwide Cross-Sectional Study.

OBJECTIVE: To explore preferences for self-management and support services in patients with inflammatory joint disease (IJD) and to investigate whether these preferences differ by age, sex, diagnosis, and disease duration. METHODS: We used a nationwide cross-sectional online survey for patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Descriptive statistics were applied to explore preferences and to test for differences according to the different subgroups of patients. RESULTS: The questionnaire was completed by 664 patients. Younger patients indicated greater interest in 1-to-1 discussions with psychologists or another patient, educational sessions, events, and online services, and older patients indicated greater interest in talks by researchers. More women than men indicated interest in health professionals' 1-to-1 discussions, occupational therapists' question-and-answer (Q and A) sessions, physical activity, and informational websites. Patients with axial spondyloarthritis tended to indicate the most interest in the different services, and patients with rheumatoid arthritis the least interest, reaching statistical significance regarding discussion groups about IJD experiences, 1-to-1 discussions with psychologists or another patient, Q and A with another patient, stress/anger management, and online patient communication. More patients with short rather than long disease duration indicated interest in 1-to-1 discussions with rheumatologists or nurses, organized talks with experienced patients, and online services for patient communication and stories. CONCLUSION: Patients with IJD report various needs regarding self-management and support services, including 1-to-1 services traditionally delivered as part of usual care, but also talks, physical activity, and educational and online services. Although preferences differed across age, sex, diagnosis, and disease duration, all subgroups indicated great need for support, with only small differences in their top preferences.

Considerations and priorities for incorporating the patient perspective on remission in rheumatoid arthritis: An OMERACT 2020 special interest group report.

OBJECTIVE: To determine how best to incorporate the patient perspective into rheumatoid arthritis remission criteria. METHODS: At OMERACT 2020, several studies, including a longitudinal multi-centre study testing the validity of adding patient-valued domains to the ACR/EULAR criteria, were presented and discussed by the virtual Special Interest Group. RESULTS: Overall consensus was that there is insufficient evidence to change the remission criteria at this point. Future work should focus on measurement of the new domain of independence, clarifying the value of the patient global assessment, and optimizing the input of domains that patients value in the criteria. CONCLUSION: Incorporating the patient perspective into remission criteria should be further explored.