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2.
Semin Arthritis Rheum ; 67: 152476, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38851171

RESUMEN

BACKGROUND: International focus groups with patients with idiopathic inflammatory myopathies (IIM) conducted by the OMERACT Myositis Working Group over the years demonstrated the pain as an important symptom experienced by these patients. In this study, we aimed to examine the frequency and degree of pain interference, the aspects of daily life impacted by pain, and the factors associated with pain interference in adults with IIM. METHODS: This was a prospective observational study with two visits. The patients who fulfilled the probable/definite IIM (ACR/EULAR Myositis Classification Criteria) were enrolled. Pain interference was assessed with PROMIS pain interference form (6a). Myositis core set measures and PROMIS fatigue (7a) and physical function (8b) were obtained at both visits. Logistic regression and linear mixed models were performed to assess the association between pain interference and other parameters. RESULTS: A total of 129 patients with IIM (60 % females) were recruited from U.S., South Korea, Netherlands, Sweden, and Australia. Approximately 71 % reported pain interference. The patients in the greater pain interference group were more likely to be female, had significantly worse patient/physician global disease activity, fatigue, and physical function than those in the lower pain interference group. The most commonly impacted life aspect was household chores. Manual muscle testing, patient/physician global disease activity, fatigue, and physical function were all significantly associated with pain interference score >60. CONCLUSION: The majority of the patients with IIM experience the impact of pain on their daily activities, particularly household chores. Myositis disease activity, duration, and subtype could be associated with greater pain interference.


Asunto(s)
Actividades Cotidianas , Miositis , Humanos , Miositis/fisiopatología , Miositis/complicaciones , Miositis/diagnóstico , Femenino , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Adulto , Dolor/etiología , Dolor/fisiopatología , Anciano , Dimensión del Dolor
3.
Semin Arthritis Rheum ; 67: 152473, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38805898

RESUMEN

OBJECTIVES: To assess whether addition of the salivary gland ultrasonography (SGUS) OMERACT score influences the performance of the 2016 ACR/EULAR classification criteria for Sjögren's disease (SjD) in daily clinical practice. METHODS: Patients visiting the Sjögren Expertise centre in the University Medical Center Groningen for a diagnostic trajectory because of a suspicion of SjD were included. SGUS was performed of both parotid and submandibular glands. ROC analysis was used to assess the accuracy to predict clinical diagnosis of SjD with the SGUS OMERACT score, and by adding the SGUS OMERACT score to the ACR/EULAR criteria. Furthermore, the performance of the SGUS OMERACT and total SGUS Hocevar score were compared. RESULTS: In total, 419 consecutive patients were included. ROC analysis of the highest SGUS OMERACT score out of all four salivary glands (range 0-3) showed good accuracy (AUC 0.849) to predict clinical diagnosis of SjD, comparable to the accuracy of the total SGUS OMERACT score (range 0-12; AUC 0.868) and total Hocevar score (range 0-48; AUC 0.864). When incorporating the highest SGUS OMERACT score (cut-off score of ≥2) as additional item in the ACR/EULAR criteria, accuracy remained excellent (AUC 0.974), and clinical diagnosis could be predicted with a sensitivity of 96.4% and specificity of 86.5%. CONCLUSION: The accuracy of the ACR/EULAR classification criteria for predicting the clinical diagnosis of SjD remained excellent after incorporating the SGUS OMERACT score and extends the diagnostic options in patients suspected with SjD.


Asunto(s)
Glándulas Salivales , Síndrome de Sjögren , Ultrasonografía , Humanos , Ultrasonografía/métodos , Femenino , Persona de Mediana Edad , Masculino , Glándulas Salivales/diagnóstico por imagen , Síndrome de Sjögren/diagnóstico por imagen , Síndrome de Sjögren/clasificación , Síndrome de Sjögren/diagnóstico , Anciano , Adulto , Índice de Severidad de la Enfermedad
4.
J Arthroplasty ; 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38697320

RESUMEN

BACKGROUND: Remaining pain and functional limitations may cause dissatisfaction in patients after total knee arthroplasty (TKA). Furthermore, anxiety and depression are associated with remaining postoperative symptoms and dissatisfaction. We investigated if patient-reported anxiety or depression increased the risk of dissatisfaction 1 year after TKA in patients who improved in pain or function. METHODS: Data on primary TKAs due to osteoarthritis between 2017 and 2019 were obtained from the Swedish Knee Arthroplasty Register. Out of 14,120 patients, 9,911 completed the Knee injury and Osteoarthritis Outcome Score and satisfaction rate with the result of the surgery. According to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria patients were classified as responders (improved in pain or function) or nonresponders. Anxiety and depression were assessed through EuroQol-5 Dimension 3 levels. Log-linear regression models estimated the risk ratios (RRs) for dissatisfaction in all patients and stratified by age groups (< 65, 65 to 74, and > 74 years). There were 8,745 patients who were classified as responders whereas 11% were defined as dissatisfied. The proportion of patients who reported anxiety or depression was 35% preoperatively and 17% postoperatively. RESULTS: Anxiety or depression increased the risk of dissatisfaction preoperatively (RR 1.23, 95% confidence interval = 1.09 to 1.40) and postoperatively (RR 2.65, confidence interval 2.33 to 3.00). Patients younger than 65 years reported preoperative anxiety or depression to a greater extent but did not have an increased risk of dissatisfaction. CONCLUSIONS: Patient-reported anxiety or depression preoperatively and postoperatively are important and potentially treatable factors to consider, as they were found to increase the risk of dissatisfaction after TKA despite improvements in pain or function.

5.
Artículo en Inglés | MEDLINE | ID: mdl-38613847

RESUMEN

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.

6.
Semin Arthritis Rheum ; 66: 152437, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38564998

RESUMEN

Inter-reader reliability of a new scoring system for evaluating joint inflammation and enthesitis in whole body MRI (WBMRI) in juvenile idiopathic arthritis was tested. The scoring system grades 732 item-region combinations of bone marrow and soft tissue changes for commonly involved joints and entheseal sites. Five radiologists rated 17 WBMRI scans through an online rating platform. Item-wise reliability was calculated for 117 items with non-zero scores in >10 % of readings. Interquartile ranges of the five-reader Kappa reliability coefficients were 0.58-0.73 (range: 0.36-0.88) for the joints, 0.65-0.81 (range: 0.39-0.95) for the entheses, and 0.62-0.75 (range: 0.60-0.76) for chronic nonbacterial osteomyelitis-like lesions.


Asunto(s)
Artritis Juvenil , Imagen por Resonancia Magnética , Imagen de Cuerpo Entero , Humanos , Artritis Juvenil/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Reproducibilidad de los Resultados , Niño , Imagen de Cuerpo Entero/métodos , Masculino , Índice de Severidad de la Enfermedad , Femenino , Adolescente , Articulaciones/diagnóstico por imagen , Preescolar
7.
Semin Arthritis Rheum ; 66: 152411, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38537323

RESUMEN

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. CONCLUSION: Ongoing collaboration with individuals and organisations within and beyond rheumatology ensures broader applicability of OMERACT-Adherence COS.


Asunto(s)
Antirreumáticos , Cumplimiento de la Medicación , Enfermedades Reumáticas , Reumatología , Humanos , Enfermedades Reumáticas/tratamiento farmacológico , Antirreumáticos/uso terapéutico , Técnica Delphi , Ensayos Clínicos como Asunto , Evaluación de Resultado en la Atención de Salud
8.
Semin Arthritis Rheum ; 66: 152414, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38447468

RESUMEN

OBJECTIVES: The Outcome Measures in Rheumatology Clinical Trials (OMERACT) Emerging Leaders Program (ELP) aims to cultivate a cohort of skilled leaders within the OMERACT community empowering them with expertise and knowledge to help shape and steer the organization into the future. This publication highlights the significance of the ELP in driving leadership excellence, its impact on OMERACT's evolution, and the outcomes and learnings from the OMERACT 2023 ELP. METHODS: Insights from the 2018 ELP report informed 2023 program improvements. Engagement was measured by attendance and WhatsApp interactions. Positive program aspects, areas for improvement and ideas for enhancing future ELPs were captured via anonymous survey and participant focus groups. RESULTS: Engagement with the ELP was high with 9 participants, 96 % attendance at all workshops, 154 WhatsApp interactions. All program components were highly rated, with the highest being the 'Psychological Safety' and 'Methodology/Process/Politics' workshops. Future enhancements included creating further networking, connection and support activities, practical leadership and methodological skill development opportunities, and a new stream focussing on organisational advancement. CONCLUSIONS: The 2023 OMERACT ELP was well received and successfully addressed areas previously identified as requiring improvement. New educational enhancements were valued, and the importance of fostering psychological safety at all levels was highlighted. The ELP fortifies OMERACT by nurturing a diverse array of skilled leaders who embody OMERACTs core values. Continuing to refine and evolve the ELP over time will help OMERACT sustain its global influence in patient-centered outcome research.


Asunto(s)
Liderazgo , Reumatología , Humanos , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos como Asunto
9.
Semin Arthritis Rheum ; 66: 152423, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38460282

RESUMEN

OBJECTIVE: To develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets. METHODS: We identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions. RESULTS: One-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains. CONCLUSION: Using a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.


Asunto(s)
Consenso , Evaluación de Resultado en la Atención de Salud , Calidad de Vida , Reumatología , Humanos , Reumatología/normas , Enfermedades Reumáticas
10.
Semin Arthritis Rheum ; 66: 152422, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38461757

RESUMEN

OBJECTIVE: To increase awareness and understanding of the principles of Equity, Diversity, and Inclusivity (EDI) within Outcome Measures in Rheumatology's (OMERACT) members. For this, we aimed to obtain ideas on how to promote and foster these principles within the organization and determine the diversity of the current membership in order to focus future efforts. METHODS: We held a plenary workshop session at OMERACT 2023 with roundtable discussions on barriers and solutions to increased diversity within OMERACT. We conducted an anonymous, web-based survey of members to record characteristics including population group, gender identity, education level, age, and ability. RESULTS: The workshop generated ideas to increase diversity of participants across the themes of building relationships [12 topics], materials and methods [5 topics], and conference-specific [6 topics]. Four hundred and seven people responded to the survey (25 % response rate). The majority of respondents were White (75 %), female (61 %), university-educated (94 %), Christian (42 %), spoke English at home (60 %), aged 35 to 55 years (50 %), and did not report a disability (64 %). CONCLUSION: OMERACT is committed to improving its diversity. Next steps include strategic recruitment of members to the EDI working group, drafting an EDI mission statement centering equity and inclusivity in the organization, and developing guidance for the OMERACT Handbook to help all working groups create actionable plans for promoting EDI principles.


Asunto(s)
Diversidad Cultural , Reumatología , Humanos , Femenino , Masculino , Sociedades Médicas , Adulto , Persona de Mediana Edad , Encuestas y Cuestionarios
11.
Semin Arthritis Rheum ; 66: 152438, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38555726

RESUMEN

OBJECTIVE: This manuscript highlights the importance of enhancing the uptake of Core Outcome Sets (COS) by building partnerships with Collaborators and addressing their needs in COS development. METHODS AND SETTING: This session was structured as a simulation, resembling a format akin to a classic television game show. The moderator posed a series of questions to eight different Collaborator groups who briefly described the importance of COS within their areas of interest. Previous studies examining the uptake of individual core outcomes revealed disparities in uptake rates. The Identified barriers to the uptake of COS include the lack of recommendations for validated instruments for each domain, insufficient involvement of patients and key Collaborator groups in COS development, and a lack of awareness regarding the existence of COS. CONCLUSIONS: This analysis underscores the need for COS development approaches that prioritize the inclusion of patients and diverse Collaborator groups at every stage. While current studies on COS uptake are limited, future research should explore the broader implementation of COS across diverse disease categories and delve into the factors that hinder or facilitate their uptake such as, the importance of COS developers extending their work to recommending domains with well validated instruments. Embracing patient leadership and multifaceted engagement is essential for advancing the relevance and impact of COS in clinical research.


Asunto(s)
Evaluación de Resultado en la Atención de Salud , Humanos , Conducta Cooperativa , Reumatología , Congresos como Asunto
12.
Semin Arthritis Rheum ; 65: 152406, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38401294

RESUMEN

OBJECTIVES: Over the last years ultrasound has shown to be an important tool for evaluating lung involvement, including interstitial lung disease (ILD) a potentially severe systemic involvement in many rheumatic and musculoskeletal diseases (RMD). Despite the potential sensitivity of the technique the actual use is hampered by the lack of consensual definitions of elementary lesions to be assessed and of the scanning protocol to apply. Within the Outcome Measures in Rheumatology (OMERACT) Ultrasound Working Group we aimed at developing consensus-based definitions for ultrasound detected ILD findings in RMDs and assessing their reliability in dynamic images. METHODS: Based on the results from a systematic literature review, several findings were identified for defining the presence of ILD by ultrasound (i.e., Am-lines, B-lines, pleural cysts and pleural line irregularity). Therefore, a Delphi survey was conducted among 23 experts in sonography to agree on which findings should be included and on their definitions. Subsequently, a web-reliability exercise was performed to test the reliability of the agreed definitions on video-clips, by using kappa statistics. RESULTS: After three rounds of Delphi an agreement >75 % was obtained to include and define B-lines and pleural line irregularity as elementary lesions to assess. The reliability in the web-based exercise, consisting of 80 video-clips (30 for pleural line irregularity, 50 for B-lines), showed moderate inter-reader reliability for both B-lines (kappa = 0.51) and pleural line irregularity (kappa = 0.58), while intra-reader reliability was good for both B-lines (kappa = 0.72) and pleural line irregularity (kappa = 0.75). CONCLUSION: Consensus-based ultrasound definitions for B-lines and pleural line irregularity were obtained, with moderate to good reliability to detect these lesions using video-clips. The next step will be testing the reliability in patients with ILD linked to RMDs and to propose a consensual and standardized protocol to scan such patients.

13.
Semin Arthritis Rheum ; 67: 152418, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38422901

RESUMEN

OBJECTIVES: To evaluate whether ultrasound findings of monosodium urate (MSU) crystal deposition predict frequent gout flares in index joints over 12 months. METHODS: This single-center study enrolled people with at least one gout flare involving the MTP1, ankle or knee joint. The most painful or most frequently joint was identified as index joint for analysis. All participants were started on urate-lowering therapy and had an ultrasound scan of the index joints at the baseline visit. OMERACT scores (for tophus, double contour sign and aggregates) were used to analyze whether ultrasound scores predicted frequent (≥2) gout flares in the index joint over 12 months. RESULTS: Frequent flares were significantly higher in those with ultrasound findings in all index joints (MTP1: tophus: 85.0% vs 46.0%, P < 0.001, aggregates: 78.8% vs 59.0%, P < 0.01; ankle: tophus: 54.6% vs 20.8%, P < 0.001; aggregates: 60.0% vs 35.9%, P < 0.05; knee: tophus: 68.4% vs 28.6%, P < 0.05). For the MTP1, for each 1-point increase in tophus score, the odds of frequent gout flares increased by 5.19 [(95%CI: 1.26-21.41), 7.91 [(95%CI: 2.23-28.14), and 13.79 [(95%CI: 3.79-50.20)] fold respectively. For the ankle, a tophus score of 3 markedly improved the prediction of the frequent flares [OR= 9.24 (95%CI=2.85-29.91)]. Semi-quantitative sum scores were associated with frequent flares with an OR (95%CI) of 13.66 (3.44-54.18), P < 0.001 at the MTP1, 7.05 (1.98-25.12), P < 0.001 at the ankle. CONCLUSION: Ultrasound features of MSU crystal deposition at the MTP1 and knee predict subsequent risk of frequent gout flares in the same joints following initiation of urate-lowering therapy, with the highest risk in those with high tophus scores.


Asunto(s)
Supresores de la Gota , Gota , Ultrasonografía , Ácido Úrico , Humanos , Masculino , Gota/diagnóstico por imagen , Gota/tratamiento farmacológico , Gota/sangre , Femenino , Persona de Mediana Edad , Estudios Prospectivos , Supresores de la Gota/uso terapéutico , Ácido Úrico/sangre , Brote de los Síntomas , Anciano , Articulación de la Rodilla/diagnóstico por imagen , Adulto , Articulación del Tobillo/diagnóstico por imagen , Valor Predictivo de las Pruebas
14.
Semin Arthritis Rheum ; 65: 152385, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38340608

RESUMEN

OBJECTIVES: Sjögren's disease (SjD) is a heterogenous disease with a wide range of manifestations, ranging from symptoms of dryness, fatigue, and pain, to systemic involvement. Considerable advances have been made to evaluate systemic activity or patient-reported outcomes, but most of the instruments were not able to assess all domains of this multifaceted disease. The aim of this scoping review was to generate domains that have been assessed in randomized controlled trials, as the first phase of the Outcome Measures in Rheumatology (OMERACT) process of core domain set development. METHODS: We systematically searched Medline (Pubmed) and EMBASE between 2002 and March 2023 to identify all randomized controlled trials assessing relevant domains, using both a manual approach and an artificial intelligence software (BIBOT) that applies natural language processing to automatically identify relevant abstracts. Domains were mapped to core areas, as suggested by the OMERACT 2.1 Filter. RESULTS: Among the 5,420 references, we included 60 randomized controlled trials, focusing either on overall disease manifestations (53%) or on a single organ/symptom: dry eyes (17%), xerostomia (15%), fatigue (12%), or pulmonary function (3%). The most frequently assessed domains were perceived dryness (52% for overall dryness), fatigue (57%), pain (52%), systemic disease activity (45%), lacrimal gland function (47%) and salivary function (55%), B-cell activation (60%), and health-related quality of life (40%). CONCLUSION: Our scoping review highlighted the heterogeneity of SjD, in the study designs and domains. This will inform the OMERACT SjD working group to select the most appropriate core domains to be used in SjD clinical trials and to guide the future agenda for outcome measure research in SjD.


Asunto(s)
Calidad de Vida , Síndrome de Sjögren , Humanos , Inteligencia Artificial , Fatiga/etiología , Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto
15.
Semin Arthritis Rheum ; 66: 152420, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38422727

RESUMEN

OBJECTIVE: To begin evaluating deep learning (DL)-automated quantification of knee joint effusion-synovitis via the OMERACT filter. METHODS: A DL algorithm previously trained on Osteoarthritis Initiative (OAI) knee MRI automatically quantified effusion volume in MRI of 53 OAI subjects, which were also scored semi-quantitatively via KIMRISS and MOAKS by 2-6 readers. RESULTS: DL-measured knee effusion correlated significantly with experts' assessments (Kendall's tau 0.34-0.43) CONCLUSION: The close correlation of automated DL knee joint effusion quantification to KIMRISS manual semi-quantitative scoring demonstrated its criterion validity. Further assessments of discrimination and truth vs. clinical outcomes are still needed to fully satisfy OMERACT filter requirements.


Asunto(s)
Aprendizaje Profundo , Articulación de la Rodilla , Imagen por Resonancia Magnética , Osteoartritis de la Rodilla , Humanos , Articulación de la Rodilla/diagnóstico por imagen , Articulación de la Rodilla/patología , Imagen por Resonancia Magnética/métodos , Osteoartritis de la Rodilla/diagnóstico por imagen , Algoritmos , Masculino , Femenino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Anciano
16.
Semin Arthritis Rheum ; 65: 152381, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38306813

RESUMEN

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. Finally, the WG members had virtual meetings and e-mail exchanges to review survey results and finalize names, definitions and descriptions of the domains. RESULTS: WG members contributed to developing the definitions. Fifty-two members representing four continents and 13 countries completed the survey, including 15 PRPs, 33 clinicians and 37 researchers. PRPs and clinicians/researchers agreed with all definitions and descriptions with agreements ranging from 87% to 100%. Respondents suggested wording changes to the names, definitions and descriptions to better reflect the domains. Discussions led to further simplification and clarification to address common questions/concerns about the domains. CONCLUSION: Our WG reached consensus on the definitions and descriptions of the domains of the core domain set for rheumatology trials of SDM interventions. This step is crucial to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set. CLINICAL SIGNIFICANCE: The current study provides consensus-based definitions and descriptions for the domains of the OMERACT core domain set for shared decision making interventions from patients/caregivers, clinicians and researchers. This is a crucial step to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set for trials of SDM interventions.


Asunto(s)
Reumatología , Humanos , Consenso , Toma de Decisiones Conjunta , Evaluación de Resultado en la Atención de Salud
17.
Semin Arthritis Rheum ; 65: 152378, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38310657

RESUMEN

Sjögren's disease (SjD) is a systemic autoimmune exocrinopathy with key features of dryness, pain, and fatigue. SjD can affect any organ system with a variety of presentations across individuals. This heterogeneity is one of the major barriers for developing effective disease modifying treatments. Defining core disease domains comprising both specific clinical features and incorporating the patient experience is a critical first step to define this complex disease. The OMERACT SjD Working Group held its first international collaborative hybrid meeting in 2023, applying the OMERACT 2.2 filter toward identification of core domains. We accomplished our first goal, a scoping literature review that was presented at the Special Interest Group held in May 2023. Building on the domains identified in the scoping review, we uniquely deployed multidisciplinary experts as part of our collaborative team to generate a provisional domain list that captures SjD heterogeneity.


Asunto(s)
Síndrome de Sjögren , Humanos , Resultado del Tratamiento , Síndrome de Sjögren/terapia , Dolor , Fatiga
18.
Semin Arthritis Rheum ; 65: 152384, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38325053

RESUMEN

OBJECTIVE: To develop a reference image atlas for the Outcome Measures in Rheumatology whole-body MRI scoring system for inflammation in peripheral joints and entheses (OMERACT MRI-WIPE) of the knee region. METHODS: Image examples of each pathology, location and grade, were collected and discussed at web-based, interactive meetings within the OMERACT MRI in Arthritis Working Group. Subsequently, reference images were selected by consensus. RESULTS: Reference images for each grade, pathology and location are depicted, along with definitions, reader rules and recommended MRI-sequences. CONCLUSION: The atlas guides scoring whole-body MRIs for inflammation in joints and entheses of the knee region according to MRI-WIPE methodology in clinical trials and cohorts.


Asunto(s)
Inflamación , Espondiloartritis , Humanos , Inflamación/diagnóstico por imagen , Espondiloartritis/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Imagen de Cuerpo Entero/métodos , Índice de Severidad de la Enfermedad , Reproducibilidad de los Resultados
19.
Semin Arthritis Rheum ; 65: 152372, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38325052

RESUMEN

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.


Asunto(s)
Enfermedad de Raynaud , Esclerodermia Sistémica , Humanos , Femenino , Tobillo , Esclerodermia Sistémica/complicaciones , Investigación Cualitativa , Dolor/complicaciones , Enfermedad de Raynaud/etiología
20.
Semin Arthritis Rheum ; 65: 152383, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38325055

RESUMEN

OBJECTIVE: To develop a reference image atlas for scoring the hip/pelvis region according to the OMERACT whole-body MRI scoring system for inflammation in peripheral joints and entheses (MRI-WIPE). METHODS: We collected image examples of each pathology, location and grade, discussed them at web-based, interactive meetings and, finally, selected reference images by consensus. RESULTS: Reference images for each grade and location of osteitis, synovitis and soft tissue inflammation are provided, as are definitions, reader rules and recommended MRI-sequences. CONCLUSION: A reference image atlas was created to guide scoring whole-body MRIs for arthritis and enthesitis in the hip/pelvis region in spondyloarthritis/psoriatic arthritis clinical trials and cohorts.


Asunto(s)
Espondiloartritis , Sinovitis , Humanos , Inflamación/diagnóstico por imagen , Espondiloartritis/diagnóstico por imagen , Sinovitis/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Pelvis/diagnóstico por imagen , Reproducibilidad de los Resultados
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