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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. The working group reached consensus on a Core Outcome Domain Set in 2020. The next step is to develop a Core Outcome Measurement Set through the OMERACT Filter 2.2. METHODS: We conducted a scoping review (PRISMA-ScR) to identify candidate instruments for the OMERACT Filter 2.2 We systematically reviewed five databases (Ovid MEDLINE®, Embase, Cochrane Library, CINAHL and Web of Science). An information specialist designed search strategies to identify all measurement instruments used in SDM studies in adults or children living with rheumatic or musculoskeletal diseases or their important others. Paired reviewers independently screened titles, abstracts, and full text articles. We extracted characteristics of all candidate instruments (e.g., measured construct, measurement properties). We classified candidate instruments and summarized evidence gaps with an adapted version of the Summary of Measurement Properties (SOMP) table. RESULTS: We found 14,464 citations, read 239 full text articles, and included 99 eligible studies. We identified 220 potential candidate instruments. The five most used measurement instruments were the Decisional Conflict Scale (traditional and low literacy versions) (n=38), the Hip/Knee-Decision Quality Instrument (n=20), the Decision Regret Scale (n=9), the Preparation for Decision Making Scale (n=8), and the CollaboRATE (n=8). Only 44 candidate instruments (20%) had any measurement properties reported by the included studies. Of these instruments, only 57% matched with at least one of the 7-criteria adapted SOMP table. CONCLUSION: We identified 220 candidate instruments used in the SDM literature amongst people with rheumatic and musculoskeletal diseases. Our classification of instruments showed evidence gaps and inconsistent reporting of measurement properties. The next steps for the OMERACT SDM Working Group are to match candidate instruments with Core Domains, assess feasibility and review validation studies of measurement instruments in rheumatic diseases or other conditions. Development and validation of new instruments may be required for some Core Domains.
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Toma de Decisiones Conjunta , Enfermedades Musculoesqueléticas , Evaluación de Resultado en la Atención de Salud , Enfermedades Reumáticas , Humanos , Reumatología/normas , Participación del PacienteRESUMEN
OBJECTIVE: To describe the perspectives of patients with inflammatory arthritis (IA) on outcome domains of trials evaluating medication adherence interventions. METHODS: Adult patients (≥ 18 yrs) with IA taking disease-modifying antirheumatic drugs from centers across Australia, Canada, and the Netherlands participated in 6 focus groups to discuss outcome domains that they consider important when participating in medication adherence trials. We analyzed the transcripts using inductive thematic analysis. RESULTS: Of the 38 participants, 23 (61%) had rheumatoid arthritis and 21 (55%) were female. The mean age was 57.3 ± (SD 15.0) years. Improved outcome domains that patients wanted from participating in an adherence trial were categorized into 5 types: medication adherence, adherence-related factors (supporting adherence; e.g., medication knowledge), pathophysiology (e.g., physical functioning), life impact (e.g., ability to work), and economic impact (e.g., productivity loss). Three overarching themes reflecting why these outcome domains matter to patients were identified: how taking medications could improve patients' emotional and physical fitness to maintain their social function; how improving knowledge and confidence in self-management increases patients' trust and motivation to take medications as agreed with minimal risk of harms; and how respect and reassurance, reflecting health care that values patients' opinions and is sensitive to patients' individual goals, could improve medication-taking behavior. CONCLUSION: Patients value various outcome domains related to their overall well-being, confidence in medication use, and patient-healthcare provider relationships to be evaluated in future adherence trials.
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Antirreumáticos , Artritis Reumatoide , Cumplimiento de la Medicación , Adulto , Anciano , Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Femenino , Grupos Focales , Humanos , Masculino , Persona de Mediana Edad , MotivaciónRESUMEN
OBJECTIVE: Nonadherence to medications is common in rheumatic conditions and associated with increased morbidity. Heterogeneous outcome reporting by researchers compromises the synthesis of evidence of interventions targeting adherence. We aimed to assess the scope of outcomes in interventional studies of medication adherence. METHODS: We searched electronic databases to February 2019 for published randomized controlled trials and observational studies of interventions with the primary outcome of medication adherence including adults with any rheumatic condition, written in English. We extracted and analyzed all outcome domains and adherence measures with prespecified extraction and analysis protocols. RESULTS: Overall, 53 studies reported 71 outcome domains classified into adherence (1 domain), health outcomes (38 domains), and adherence-related factors (e.g., medication knowledge; 32 domains). We subdivided adherence into 3 phases: initiation (n = 13 studies, 25%), implementation (n = 32, 60%), persistence (n = 27, 51%), and phase unclear (n = 20, 38%). Thirty-seven different instruments reported adherence in 115 unique ways (this includes different adherence definitions and calculations, metric, and method of aggregation). Forty-one studies (77%) reported health outcomes. The most frequently reported were medication adverse events (n = 24, 45%), disease activity (n = 11, 21%), bone turnover markers/physical function/quality of life (each n = 10, 19%). Thirty-three studies (62%) reported adherence-related factors. The most frequently reported were medication beliefs (n = 8, 15%), illness perception/medication satisfaction/satisfaction with medication information (each n = 5, 9%), condition knowledge/medication knowledge/trust in doctor (each n = 3, 6%). CONCLUSION: The outcome domains and adherence measures in interventional studies targeting adherence are heterogeneous. Consensus on relevant outcomes will improve the comparison of different strategies to support medication adherence in rheumatology.
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Calidad de Vida , Enfermedades Reumáticas , Adulto , Humanos , Cumplimiento de la Medicación , Proyectos de Investigación , Enfermedades Reumáticas/tratamiento farmacológicoRESUMEN
OBJECTIVE: This study aimed to identify and prioritize factors important to patients and caregivers with regard to medication adherence in gout, osteoporosis (OP), and rheumatoid arthritis (RA) and to describe the reasons for their decisions. METHODS: Patients with gout, OP, and RA and their caregivers, purposively sampled from 5 rheumatology clinics in Australia, identified and ranked factors that they considered important for medication adherence using nominal group technique and discussed their decisions. An importance score (IS; scale 0-1) was calculated, and qualitative data were analyzed thematically. RESULTS: From 14 focus groups, 82 participants (67 patients and 15 caregivers) identified 49 factors. The top 5 factors based on the ranking of all participants were trust in doctor (IS 0.46), medication effectiveness (IS 0.31), doctor's knowledge (IS 0.25), side effects (IS 0.23), and medication-taking routine (IS 0.13). The order of the ranking varied by participant groupings, with patients ranking "trust in doctor" the highest, while caregivers ranked "side effects" the highest. The 5 themes reflecting the reasons for factors influencing adherence were as follows: motivation and certainty in supportive individualized care; living well and restoring function; fear of toxicity and cumulative harm; seeking control and involvement; and unnecessarily difficult and inaccessible. CONCLUSION: Factors related to the doctor, medication properties, and patients' medication knowledge and routine were important for adherence. Strengthening doctor-patient trust and partnership, managing side effects, and empowering patients with knowledge and skills for taking medication could enhance medication adherence in patients with rheumatic conditions.
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Artritis Reumatoide/tratamiento farmacológico , Gota/tratamiento farmacológico , Cumplimiento de la Medicación/psicología , Osteoporosis/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Cuidadores/psicología , Femenino , Humanos , Persona de Mediana Edad , ReumatologíaRESUMEN
There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients' needs. However, there is currently little guidance on how meaningful patient engagement may be achieved. An expert working group, representing a wide range of stakeholders and disciplines, was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO). Through a structured, collaborative process the group generated practical guidance to facilitate optimal patient engagement in clinical development and regulatory decisions. Patient engagement is a relational process. The principles outlined in this report were based on lessons learned through applied experience and on an extensive dialogue among the expert participants. This practice guidance forms a starting point from which tailoring of the approach to suit different chronic diseases may be undertaken.
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Osteoartritis , Osteoporosis , Participación del Paciente , Consenso , Investigación sobre Servicios de Salud/organización & administración , Humanos , Osteoartritis/tratamiento farmacológico , Osteoartritis/economía , Osteoporosis/tratamiento farmacológico , Osteoporosis/economía , Guías de Práctica Clínica como Asunto , Sociedades Médicas , Organización Mundial de la SaludRESUMEN
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Shared Decision Making (SDM) Working Group aims to determine the core outcome domain set for measuring the effectiveness of SDM interventions in rheumatology trials. METHODS: A white paper was developed to clarify the draft core domain set. It was then used to prepare for interviews to investigate reasons for lack of consensus on it and to suggest further improvements. RESULTS: OMERACT scientists/clinicians (n = 13) and patients (n = 10) suggested limiting the core domain set to outcome domains, removing process domains, and clarifying remaining domains. CONCLUSION: A revised core domain set will undergo further consensus-building.
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Toma de Decisiones Conjunta , Evaluación de Resultado en la Atención de Salud/métodos , Enfermedades Reumáticas , Reumatología/métodos , Consenso , Técnica Delphi , Humanos , Participación de los InteresadosRESUMEN
OBJECTIVE: The OMERACT-Adherence meeting was convened to discuss the conceptual and methodological challenges in developing a core domain set (Adherence-CDS) for trials of interventions for medication adherence in rheumatology. METHODS: Forty participants from nine countries participated. RESULTS: Four ideas emerged: for adherence trials, the Adherence-CDS could include adherence and the condition-specific CDS; many factors affect adherence and are intervention targets, contextual factors, or outcome domains; adherence is a critical factor in drug trials; and standardized adherence measures are needed. CONCLUSION: Despite the challenges, the meeting clarified an approach to developing an Adherence-CDS that complements existing OMERACT work and methodology.
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Antirreumáticos/uso terapéutico , Cumplimiento de la Medicación , Enfermedades Reumáticas/tratamiento farmacológico , Humanos , ReumatologíaRESUMEN
OBJECTIVE: The aim of this Outcome Measures in Rheumatology (OMERACT) Working Group was to determine the core set of outcome domains and subdomains for measuring the effectiveness of shared decision-making (SDM) interventions in rheumatology clinical trials. METHODS: Following the OMERACT Filter 2.0, and based on a previous literature review of SDM outcome domains and a nominal group process at OMERACT 2014, (1) an online Delphi survey was conducted to gather feedback on the draft core set and refine its domains and subdomains, and (2) a workshop was held at the OMERACT 2016 meeting to gain consensus on the draft core set. RESULTS: A total of 170 participants completed Round 1 of the Delphi survey, and 116 completed Round 2. Respondents came from 29 countries, with 49% being patients/caregivers. Results showed that 14 out of the 17 subdomains within the 7 domains exceeded the 70% criterion (endorsement ranged from 83% to 100% of respondents). At OMERACT 2016, only 8% of the 96 attendees were patients/caregivers. Despite initial votes of support in breakout groups, there was insufficient comfort about the conceptualization of these 7 domains and 17 subdomains for these to be endorsed at OMERACT 2016 (endorsement ranged from 17% to 68% of participants). CONCLUSION: Differences between the Delphi survey and consensus meeting may be explained by the manner in which the outcomes were presented, variations in participant characteristics, and the context of voting. Further efforts are needed to address the limited understanding of SDM and its outcomes among OMERACT participants.
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Toma de Decisiones , Enfermedades Reumáticas/terapia , Reumatología , Consenso , Manejo de la Enfermedad , HumanosRESUMEN
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop a reliable way to identify and measure RA flares in randomized controlled trials (RCT). Here, we summarized the development and field testing of the RA Flare Questionnaire (RA-FQ), and the voting results at OMERACT 2016. METHODS: Classic and modern psychometric methods were used to assess reliability, validity, sensitivity, factor structure, scoring, and thresholds. Interviews with patients and clinicians also assessed content validity, utility, and meaningfulness of RA-FQ scores. RESULTS: People with RA in observational trials in Canada (n = 896) and France (n = 138), and an RCT in the Netherlands (n = 178) completed 5 items (11-point numerical rating scale) representing RA Flare core domains. There was moderate to high evidence of reliability, content and construct validity, and responsiveness. Factor analysis supported unidimensionality. Rasch analysis showed acceptable fit to the Rasch model, with items and people covering a broad measurement continuum and evidence of appropriate targeting of items to people, ordered thresholds, minimal differential item functioning by language, sex, or age. A summative score across items is defensible, yielding an interval score (0-50) where higher scores reflect worsening flare. The RA-FQ received endorsement from 88% of attendees that it passed the OMERACT Filter 2.0 "Eyeball Test" for instrument selection. CONCLUSION: The RA-FQ has been developed to identify and measure RA flares. Its review through OMERACT Filter 2.0 shows evidence of reliability, content and construct validity, and responsiveness. These properties merit its further validation as an outcome for clinical trials.
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Artritis Reumatoide/diagnóstico , Dimensión del Dolor , Humanos , Psicometría , Reproducibilidad de los Resultados , Reumatología , Sensibilidad y Especificidad , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Evaluación de SíntomasRESUMEN
OBJECTIVE: The importance of contextual factors (CF) for appropriate patient-specific care is widely acknowledged. However, evidence in clinical trials on how CF influence outcomes remains sparse. The 2014 Outcome Measures in Rheumatology (OMERACT) Handbook introduced the role of CF in outcome assessment and defined them as "potential confounders and/or effect modifiers of outcomes in randomized controlled trials." Subsequently, the CF Methods Group (CFMG) was formed to develop guidance on how to address CF in clinical trials. METHODS: First, the CFMG conducted an e-mail survey of OMERACT working groups (WG) to analyze how they had addressed CF in outcome measurement so far. The results facilitated an informed discussion at the OMERACT 2016 CFMG Special Interest Group (SIG) session, with the aim of gaining preliminary consensus regarding an operational definition of CF and to make a first selection of potentially relevant CF. RESULTS: The survey revealed that the WG had mostly used the OMERACT Handbook and/or the International Classification of Functioning, Disability and Health (ICF) definition. However, significant heterogeneity was found in the methods used to identify, refine, and categorize CF candidates. The SIG participants agreed on using the ICF as a framework along with the OMERACT Handbook definition. A list with 28 variables was collected including person-related factors and physical and social environments. Recommendations from the SIG guided the CFMG to formulate 3 preliminary projects on how to identify and analyze CF. CONCLUSION: New methods are urgently needed to assist researchers to identify and characterize CF that significantly influence the interpretation of results in clinical trials. The CFMG defined first steps to develop further guidance.
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Medición de Resultados Informados por el Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Enfermedades Reumáticas/terapia , Reumatología/normas , Consenso , Interpretación Estadística de Datos , Humanos , Proyectos de InvestigaciónRESUMEN
OBJECTIVES: To update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform European League Against Rheumatism (EULAR) Task Force treatment recommendations. METHODS: MEDLINE, EMBASE and Cochrane databases were searched for phase III or IV (or phase II, if these studies were lacking) randomised controlled trials (RCTs) published between January 2013 and February 2016. Abstracts from the American College of Rheumatology and EULAR conferences were obtained. RESULTS: The RCTs confirmed greater efficacy with a bDMARD+conventional synthetic DMARD (csDMARD) versus a csDMARDs alone (level 1A evidence). Using a treat-to-target strategy approach, commencing and escalating csDMARD therapy and adding a bDMARD in cases of non-response, is an effective approach (1B). If a bDMARD had failed, improvements in clinical response were seen on switching to another bDMARD (1A), but no clear advantage was seen for switching to an agent with another mode of action. Maintenance of clinical response in patients in remission or low disease activity was best when continuing rather than stopping a bDMARD, but bDMARD dose reduction or 'spacing' was possible, with a substantial proportion of patients achieving bDMARD-free remission (2B). RCTs have also demonstrated efficacy of several new bDMARDs and biosimilar DMARDs (1B). CONCLUSIONS: This systematic literature review consistently confirmed the previously reported efficacy of bDMARDs in RA and provided additional information on bDMARD switching and dose reduction.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/uso terapéutico , Comités Consultivos , Antirreumáticos/administración & dosificación , Productos Biológicos/administración & dosificación , Biosimilares Farmacéuticos/uso terapéutico , Sustitución de Medicamentos , Quimioterapia Combinada , Humanos , Guías de Práctica Clínica como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
OBJECTIVES: To assess the safety of synthetic (s) and biological (b) disease-modifying antirheumatic drugs (DMARDs) for the management of rheumatoid arthritis (RA) to inform the European League Against Rheumatism recommendations for the management of RA. METHODS: Systematic literature review (SLR) of observational studies comparing any DMARD with another intervention for the management of patients with RA. All safety outcomes were included. A comparator group was required for the study to be included. Risk of bias was assessed with the Hayden's tool. RESULTS: Twenty-six observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria (15 on serious infections, 4 on malignancies). Substantial heterogeneity precluded meta-analysis. Together with the evidence from the 2013 SLR, based on 15 studies, 7 at low risk of bias, patients on bDMARDs compared with patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1 to 1.8)-without differences across bDMARDs-a higher risk of tuberculosis (aHR 2.7 to 12.5), but no increased risk of infection by herpes zoster. Patients on bDMARDs did not have an increased risk of malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5). CONCLUSIONS: These findings confirm the known safety pattern of bDMARDs, including both tumour necrosis factor-α inhibitor (TNFi) and non-TNFi, for the treatment of RA.
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Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/efectos adversos , Infecciones/epidemiología , Neoplasias/epidemiología , Humanos , Estudios Observacionales como Asunto , Guías de Práctica Clínica como Asunto , Inhibidores de Proteínas Quinasas/efectos adversos , Factores de Riesgo , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
OBJECTIVE: Discussion and endorsement of the OMERACT total joint replacement (TJR) core domain set for total hip replacement (THR) and total knee replacement (TKR) for endstage arthritis; and next steps for selection of instruments. METHODS: The OMERACT TJR working group met at the 2016 meeting at Whistler, British Columbia, Canada. We summarized the previous systematic reviews, the preliminary OMERACT TJR core domain set and results from previous surveys. We discussed preliminary core domains for TJR clinical trials, made modifications, and identified challenges with domain measurement. RESULTS: Working group participants (n = 26) reviewed, clarified, and endorsed each of the inner and middle circle domains and added a range of motion domain to the research agenda. TJR were limited to THR and TKR but included all endstage hip and knee arthritis refractory to medical treatment. Participants overwhelmingly endorsed identification and evaluation of top instruments mapping to the core domains (100%) and use of subscales of validated multidimensional instruments to measure core domains for the TJR clinical trial core measurement set (92%). CONCLUSION: An OMERACT core domain set for hip/knee TJR trials has been defined and we are selecting instruments to develop the TJR clinical trial core measurement set to serve as a common foundation for harmonizing measures in TJR clinical trials.
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Artritis/cirugía , Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Consenso , Humanos , Evaluación de Resultado en la Atención de Salud , Resultado del TratamientoRESUMEN
OBJECTIVE: Patient participation in research is increasing; however, practical guidelines to enhance this participation are lacking. Specifically within the Outcome Measures in Rheumatology (OMERACT) organization, although patients have participated in OMERACT meetings since 2002, consensus about the procedures for involving patients in working groups has not been formalized. The objective is to develop a set of recommendations regarding patient research partner (PRP) involvement in research working groups. METHODS: We conducted a systematic literature review on recommendations/guidelines of PRP involvement in research; elaborated a structured consensus process involving multiple participants to develop a set of recommendations; and sought endorsement of recommendations by OMERACT. RESULTS: In the 18 articles included in the literature review, there was general agreement on the broad concepts for recommendations covering PRP involvement in research although they were heterogeneous in detail. Most considered PRP involvement in all phases of research with early engagement, training, and support important, but details on the content were scarce. This review informed a larger consensus-building process regarding PRP inclusion in OMERACT research. Three overarching principles and 8 recommendations were developed, discussed, and refined at OMERACT 2014. The guiding principles were endorsed during the OMERACT plenary session. CONCLUSION: These recommendations for PRP involvement in OMERACT research reinforce the importance of patient participation throughout the research process as integral members. Although the applicability of the recommendations in other research contexts should be assessed, the generalizability is expected to be high. Future research should evaluate their implementation and their effect on outcome development.
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Conferencias de Consenso como Asunto , Evaluación de Resultado en la Atención de Salud , Participación del Paciente/estadística & datos numéricos , Guías de Práctica Clínica como Asunto , Reumatología/normas , Femenino , Humanos , Masculino , Investigación , Enfermedades Reumáticas/diagnóstico , Enfermedades Reumáticas/tratamiento farmacológicoRESUMEN
OBJECTIVE: The treatment of rheumatoid arthritis (RA) should target patient-relevant outcomes, making patient perspective on remission essential. In 2010, patients, physicians, health professionals, and researchers at the Outcome Measures in Rheumatology (OMERACT) conference developed an ambitious research agenda to study the concept of remission. Qualitative research has since helped us understand the concept of remission from the patient perspective. METHODS: During OMERACT 12, the OMERACT working group on patient perspective on remission in RA elaborated on data generated to date and discussed the methodological challenges ahead. Challenges included (1) selection of domains, (2) choice of a patient remission definition or a single domain to add to the current remission definition, and (3) the importance of pain in defining remission from a patient perspective. RESULTS: Focus in the coming years will be on increasing our understanding by identifying the most important domains from the patient perspective regarding remission and investigating how these domains can be measured. Investigation into the Rheumatoid Arthritis Impact of Disease questionnaire, disease flare, as well as the concordance of domains from our ongoing remission survey is appropriate. More data and further discussions are needed to decide on the next steps. CONCLUSION: Progress summarized over 4 years highlights the main methodological challenges discussed within the working group on patient perspective on remission in RA during OMERACT 12.
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Artritis Reumatoide/terapia , Conferencias de Consenso como Asunto , Evaluación del Resultado de la Atención al Paciente , Participación del Paciente/estadística & datos numéricos , Artritis Reumatoide/diagnóstico , Progresión de la Enfermedad , Femenino , Humanos , Masculino , Investigación Cualitativa , Inducción de Remisión , Medición de Riesgo , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: Reaching the therapeutic target of remission or low-disease activity has improved outcomes in patients with rheumatoid arthritis (RA) significantly. The treat-to-target recommendations, formulated in 2010, have provided a basis for implementation of a strategic approach towards this therapeutic goal in routine clinical practice, but these recommendations need to be re-evaluated for appropriateness and practicability in the light of new insights. OBJECTIVE: To update the 2010 treat-to-target recommendations based on systematic literature reviews (SLR) and expert opinion. METHODS: A task force of rheumatologists, patients and a nurse specialist assessed the SLR results and evaluated the individual items of the 2010 recommendations accordingly, reformulating many of the items. These were subsequently discussed, amended and voted upon by >40 experts, including 5 patients, from various regions of the world. Levels of evidence, strengths of recommendations and levels of agreement were derived. RESULTS: The update resulted in 4 overarching principles and 10 recommendations. The previous recommendations were partly adapted and their order changed as deemed appropriate in terms of importance in the view of the experts. The SLR had now provided also data for the effectiveness of targeting low-disease activity or remission in established rather than only early disease. The role of comorbidities, including their potential to preclude treatment intensification, was highlighted more strongly than before. The treatment aim was again defined as remission with low-disease activity being an alternative goal especially in patients with long-standing disease. Regular follow-up (every 1-3 months during active disease) with according therapeutic adaptations to reach the desired state was recommended. Follow-up examinations ought to employ composite measures of disease activity that include joint counts. Additional items provide further details for particular aspects of the disease, especially comorbidity and shared decision-making with the patient. Levels of evidence had increased for many items compared with the 2010 recommendations, and levels of agreement were very high for most of the individual recommendations (≥9/10). CONCLUSIONS: The 4 overarching principles and 10 recommendations are based on stronger evidence than before and are supposed to inform patients, rheumatologists and other stakeholders about strategies to reach optimal outcomes of RA.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Planificación de Atención al Paciente , Índice de Severidad de la Enfermedad , Artritis Reumatoide/patología , Artritis Reumatoide/fisiopatología , Comorbilidad , Medicina Basada en la Evidencia , Humanos , Quimioterapia de Mantención , Participación del Paciente , Inducción de Remisión , Terminología como AsuntoRESUMEN
OBJECTIVE: A systematic literature review (SLR; 2009-2014) to compare a target-oriented approach with routine management in the treatment of rheumatoid arthritis (RA) to allow an update of the treat-to-target recommendations. METHODS: Two SLRs focused on clinical trials employing a treatment approach targeting a specific clinical outcome were performed. In addition to testing clinical, functional and/or structural changes as endpoints, comorbidities, cardiovascular risk, work productivity and education as well as patient self-assessment were investigated. The searches covered MEDLINE, EMBASE, Cochrane databases and Clinicaltrial.gov for the period between 2009 and 2012 and separately for the period of 2012 to May of 2014. RESULTS: Of 8442 citations retrieved in the two SLRs, 176 articles underwent full-text review. According to predefined inclusion/exclusion criteria, six articles were included of which five showed superiority of a targeted treatment approach aiming at least at low-disease activity versus routine care; in addition, publications providing supportive evidence were also incorporated that aside from expanding the evidence provided by the above six publications allowed concluding that a target-oriented approach leads to less comorbidities and cardiovascular risk and better work productivity than conventional care. CONCLUSIONS: The current study expands the evidence that targeting low-disease activity or remission in the management of RA conveys better outcomes than routine care.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Planificación de Atención al Paciente , Índice de Severidad de la Enfermedad , Artritis Reumatoide/diagnóstico por imagen , Artritis Reumatoide/fisiopatología , Ensayos Clínicos como Asunto , Comorbilidad , Medicina Basada en la Evidencia , Humanos , Radiografía , Resultado del TratamientoRESUMEN
OBJECTIVE: Despite the importance of shared decision making for delivering patient-centered care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this Outcome Measures in Rheumatology (OMERACT) working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspectives of patients, health professionals, and researchers. METHODS: We followed the OMERACT Filter 2.0 method to develop a draft core domain set by (1) forming an OMERACT working group; (2) conducting a review of domains of shared decision making; and (3) obtaining opinions of all those involved using a modified nominal group process held at a session activity at the OMERACT 12 meeting. RESULTS: In all, 26 people from Europe, North America, and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the draft core set: (1) identifying the decision, (2) exchanging information, (3) clarifying views, (4) deliberating, (5) making the decision, (6) putting the decision into practice, and (7) assessing the effect of the decision. Contextual factors were also suggested. CONCLUSION: We proposed a draft core set of shared decision-making domains for OA intervention research studies. Next steps include a workshop at OMERACT 13 to reach consensus on these proposed domains in the wider OMERACT group, as well as to detail subdomains and assess instruments to develop a core outcome measurement set.
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Conferencias de Consenso como Asunto , Toma de Decisiones , Osteoartritis/diagnóstico , Osteoartritis/terapia , Evaluación de Resultado en la Atención de Salud , Anciano , Australia , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , América del Norte , Guías de Práctica Clínica como Asunto , Reumatología/normas , Medición de RiesgoRESUMEN
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 9â 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.
Asunto(s)
Artritis Reumatoide/psicología , Actitud Frente a la Salud , Actividades Cotidianas/psicología , Adaptación Psicológica , Adulto , Anciano , Femenino , Grupos Focales , Humanos , Masculino , Persona de Mediana Edad , Investigación Cualitativa , Inducción de Remisión , Reinserción al Trabajo , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVES: The aims of this study were to disseminate, assess agreement with, assess the application of and identify potential barriers for implementation of the European League Against Rheumatism (EULAR) recommendations for the role of nurses in the management of chronic inflammatory arthritis (CIA) using a survey of nurses, rheumatologists and patients. METHODS: A Web-based survey was distributed across Europe and the USA using snowball sampling. Levels of agreement and application were assessed using a 0-10 rating scale (0 = none, 10 = full agreement/application). Reasons for disagreement and potential barriers to application of each recommendation were sought. Regional differences with respect to agreement and application were explored. RESULTS: In total, 967 nurses, 548 rheumatologists and 2034 patients from 23 countries participated in the survey. Median level of agreement was high in all three groups, ranging from 8 to 10 per recommendation. Median level of application was substantially lower, ranging from 0 to 8 per recommendation. Agreement and application were lowest in Eastern and Central Europe. The most commonly reported reasons for incomplete agreement were too many other responsibilities (nurses), doubts about knowledge of the nurse (rheumatologists) and fear of losing contact with the rheumatologist (patients). The most commonly reported barriers to the application were time constraints and unavailability of service. Rheumatologists responses suggested that nurses had insufficient knowledge to provide the recommended care. CONCLUSION: The EULAR recommendations for the role of nurses in the management of CIA have been disseminated among nurses, rheumatologists and patients across Europe and the USA. Agreement with these recommendations is high, but application is lower and differed across regions.