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OBJECTIVES: To investigate sex differences in patient-reported outcome measures (PROMs) among axSpA patients initiating their first TNFi and identify factors contributing to these disparities over the follow-up. METHODS: Data were included from 15 EuroSpA registries and consisted of axSpA patients initiating their first TNFi, with ≥2 measurements for each analysed PROM (BASDAI and BASFI, scale 0-100) taken at any time point. Linear mixed models were employed to analyse sex differences in PROMs over 24 months and to evaluate how baseline characteristics were related to the observed sex differences. RESULTS: We analysed 13 102 (38% women) in the BASDAI analyses and 10 623 (38% women) in the BASFI analyses. At follow-up, mean sex differences in BASDAI increased from 4.3 units at baseline (95% CI, 3.5-5.1)-8.0 (7.2-8.8) at 6 months, and in BASFI from 2.2 (1.4-3.1)-4.6 (3.6-5.5), with consistently worse scores in women. Baseline characteristics could not substantially account for the observed sex differences over time; however, the magnitude of the sex differences was reduced by HLA-B27 positivity, longer disease duration, and increased CRP levels, but increased by TNFi initiation in later years and peripheral arthritis. CONCLUSION: In axSpA patients initiating their first TNFi, baseline sex differences in BASDAI and BASFI increased two-fold after 6 months of treatment and persisted thereafter, with worse scores in women. Several baseline characteristics moderated the sex differences, though none could fully account for them. These findings improve our understanding of sex differences and underscore their importance in axSpA.
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The relationship between self-reported falls and fracture risk was estimated in an international meta-analysis of individual-level data from 46 prospective cohorts. Previous falls were associated with an increased fracture risk in women and men and should be considered as an additional risk factor in the FRAX® algorithm. INTRODUCTION: Previous falls are a well-documented risk factor for subsequent fracture but have not yet been incorporated into the FRAX algorithm. The aim of this study was to evaluate, in an international meta-analysis, the association between previous falls and subsequent fracture risk and its relation to sex, age, duration of follow-up, and bone mineral density (BMD). METHODS: The resource comprised 906,359 women and men (66.9% female) from 46 prospective cohorts. Previous falls were uniformly defined as any fall occurring during the previous year in 43 cohorts; the remaining three cohorts had a different question construct. The association between previous falls and fracture risk (any clinical fracture, osteoporotic fracture, major osteoporotic fracture, and hip fracture) was examined using an extension of the Poisson regression model in each cohort and each sex, followed by random-effects meta-analyses of the weighted beta coefficients. RESULTS: Falls in the past year were reported in 21.4% of individuals. During a follow-up of 9,102,207 person-years, 87,352 fractures occurred of which 19,509 were hip fractures. A previous fall was associated with a significantly increased risk of any clinical fracture both in women (hazard ratio (HR) 1.42, 95% confidence interval (CI) 1.33-1.51) and men (HR 1.53, 95% CI 1.41-1.67). The HRs were of similar magnitude for osteoporotic, major osteoporotic fracture, and hip fracture. Sex significantly modified the association between previous fall and fracture risk, with predictive values being higher in men than in women (e.g., for major osteoporotic fracture, HR 1.53 (95% CI 1.27-1.84) in men vs. HR 1.32 (95% CI 1.20-1.45) in women, P for interaction = 0.013). The HRs associated with previous falls decreased with age in women and with duration of follow-up in men and women for most fracture outcomes. There was no evidence of an interaction between falls and BMD for fracture risk. Subsequent risk for a major osteoporotic fracture increased with each additional previous fall in women and men. CONCLUSIONS: A previous self-reported fall confers an increased risk of fracture that is largely independent of BMD. Previous falls should be considered as an additional risk factor in future iterations of FRAX to improve fracture risk prediction.
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Fracturas de Cadera , Fracturas Osteoporóticas , Masculino , Humanos , Femenino , Fracturas Osteoporóticas/epidemiología , Fracturas Osteoporóticas/etiología , Estudios Prospectivos , Medición de Riesgo , Estudios de Cohortes , Factores de Riesgo , Densidad Ósea , Fracturas de Cadera/etiología , Fracturas de Cadera/complicacionesRESUMEN
BACKGROUND: The UK's "Getting It Right First Time" programme recommends that management of people with fibromyalgia should centre on primary care. However, it remains unclear as to how best to organise health systems to deliver services to optimise patient outcomes. AIM: To profile UK healthcare services for people with fibromyalgia: provision of National Health Services (NHS) and use of non-NHS services by people with fibromyalgia. METHODS: Two online open surveys (A and B) incorporating questions about diagnosis, treatment and management of fibromyalgia and gaps in healthcare services were conducted between 11th September 2019 and 3rd February 2020. These were targeted to NHS healthcare professionals consulting with people with fibromyalgia (Survey A) and people ≥16 years diagnosed with fibromyalgia using non-NHS services to manage their condition (Survey B). Descriptive statistics were used to report quantitative data. Thematic analysis was undertaken for qualitative data. RESULTS: Survey A received 1701 responses from NHS healthcare professionals across the UK. Survey B received 549 responses from people with fibromyalgia. The results show that NHS services for people with fibromyalgia are highly disparate, with few professionals reporting care pathways in their localities. Diagnosing fibromyalgia is variable among NHS healthcare professionals and education and pharmacotherapy are mainstays of NHS treatment and management. The greatest perceived unmet need in healthcare for people with fibromyalgia is a lack of available services. From the pooled qualitative data, three themes were developed: 'a troublesome label', 'a heavy burden' and 'a low priority'. Through the concept of candidacy, these themes provide insight into limited access to healthcare for people with fibromyalgia in the UK. CONCLUSION: This study highlights problems across the NHS in service provision and access for people with fibromyalgia, including several issues less commonly discussed; potential bias towards people with self-diagnosed fibromyalgia, challenges facing general practitioners seeking involvement of secondary care services for people with fibromyalgia, and a lack of mental health and multidisciplinary holistic services to support those affected. The need for new models of primary and community care that offer timely diagnosis, interventions to support self-management with access to specialist services if needed, is paramount.
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Fibromialgia , Médicos Generales , Fibromialgia/diagnóstico , Fibromialgia/terapia , Accesibilidad a los Servicios de Salud , Humanos , Internet , Reino UnidoRESUMEN
OBJECTIVE: To quantify the change in quality of life, disease-specific indicators, health and lifestyle before and during the COVID-19 pandemic among people with musculoskeletal diagnoses and symptoms. METHODS: We undertook an additional follow-up of two existing UK registers involving people with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) and participants in a trial in the UK who had regional pain and were identified at high risk of developing chronic widespread pain. Participants completed the study questionnaire between July and December 2020, throughout which time there were public health restrictions in place. RESULTS: The number of people taking part in the study was 1054 (596 axSpA, 162 PsA, 296 regional pain). In comparison with their previous (pre-pandemic) assessment, there was an age-adjusted significant, small decrease in quality of life measured by EQ-5D [-0.020 (95% CI -0.030, -0.009)] overall and across all population groups examined. This was primarily related to poorer mental health and pain. There was a small increase in fibromyalgia symptoms, but a small decrease in sleep problems. There was a small deterioration in axSpA disease activity, and disease-specific quality of life and anxiety in PsA participants. Predictors of poor quality of life were similar pre- and during the pandemic. The effect of lockdown on activity differed according to age, gender and deprivation. CONCLUSION: Important lessons include focusing on addressing anxiety and providing enhanced support for self-management in the absence of normal health care being available, and awareness that all population groups are likely to be affected.
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COVID-19 , Dolor Crónico/psicología , Control de Enfermedades Transmisibles , Enfermedades Musculoesqueléticas/psicología , Calidad de Vida , Adulto , Anciano , Ansiedad/epidemiología , Ansiedad/etiología , Femenino , Estudios de Seguimiento , Accesibilidad a los Servicios de Salud , Humanos , Masculino , Persona de Mediana Edad , Aceptación de la Atención de Salud/psicología , Sistema de Registros , SARS-CoV-2 , Reino Unido/epidemiologíaRESUMEN
Management guidelines assume that results from clinical trials can be generalised, although seldom is data available to test this assumption. We aimed to determine the proportion of patients commencing tumour necrosis factor inhibition (TNFi) who would have been eligible for relevant clinical trials, and whether treatment response differs between these groups and the trials themselves. The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) recruited a real-world cohort of TNFi-naïve spondyloarthritis patients with data collection from clinical records and patient questionnaires. Participant characteristics were extracted from trials identified from a recent Health Technology Assessment of TNFi for ankylosing spondylitis/non-radiographic axial spondyloarthritis. Descriptive statistics were used to determine the differences, including treatment response, between BSRBR-AS participants who would/would not have been eligible for the clinical trials and with trial participants. Among 2420 BSRBR-AS participants, those commencing TNFi (34%) had shorter symptom duration (15 vs 22 years) but more active disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 6.4 vs 4.0; Bath Ankylosing Spondylitis Disease Functional Index (BASFI) 6.2 vs 3.8). Of those commencing TNFi, 41% met eligibility criteria for ≥1 of fourteen relevant trials; they reported higher disease activity (BASDAI 6.9 vs 6.1) and poorer function (BASFI 6.6 vs 6.0). 61.7% of trial participants reported a positive treatment response, vs 51.3% of BSRBR-AS patients (difference: 10.4%; 95% CI 4.4% to 16.5%). Potential eligibility for trials did not influence treatment response (difference 2.0%; -9.4% to 13.4%). Fewer patients in the real world respond to TNFi than is reported in the trial literature. This has important implications for the generalisability of trial results, and the cost-effectiveness of TNFi agents.
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Antirreumáticos/uso terapéutico , Ensayos Clínicos como Asunto/estadística & datos numéricos , Determinación de la Elegibilidad/estadística & datos numéricos , Espondiloartritis/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Adulto , Productos Biológicos/uso terapéutico , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
OBJECTIVE: To examine differences in clinical and patient-reported outcomes, including work, in individuals with axial spondyloarthritis (axSpA) living in rural and urban settings. METHODS: Using a sequential, explanatory mixed-method design, data from the British Society for Rheumatology Biologics Register for Ankylosing Spondylitis were used to (1) characterise participants with axSpA living in rural and urban areas and (b) assess any differences in outcome after commencement of biologic therapy (phase 1). Semistructured interviews (phase 2) further explored the results from phase 1. RESULTS: Patients with axSpA living in rural areas were older and more likely to work in a physical job. Among patients prescribed biologics, there were no differences in response to biologics, but after adjustment for age, sex and local area deprivation rural dwellers reported more presenteeism and overall work impairment. Work effects could be explained by accounting for individual differences in disease activity, fatigue, physical function and job type. Interviews highlighted the complex relationship between clinical factors, contextual factors (work environment, job demands) and work disability. The ability to work and flexibility in terms of what, when and how tasks are undertaken were important. Support from employers was variable and healthcare professionals were often perceived as unsupportive. CONCLUSIONS: Patients with axSpA living in rural areas report a greater impact of their disease on work productivity. New measures are needed to capture important contextual factors and comprehensively determine the impact of long-term conditions on work. Future European League Against Rheumatism axSpA recommendations should include support to work as a target to optimise quality of life in patients with axSpA.
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Antirreumáticos/uso terapéutico , Eficiencia/efectos de los fármacos , Espondiloartritis/complicaciones , Espondiloartritis/tratamiento farmacológico , Absentismo , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Presentismo/estadística & datos numéricos , Sistema de Registros , Población Rural , Resultado del Tratamiento , Reino Unido , Población UrbanaRESUMEN
BACKGROUND: Adults with rare autoimmune rheumatic diseases face unique challenges and struggles to navigate health-care systems designed to manage common conditions. Evidence to inform an optimal service framework for their care is scarce. Using systemic vasculitis as an exemplar, we aimed to identify and explain the key service components underpinning effective care for rare diseases. METHODS: In this mixed-methods study, data were collected as part of a survey of vasculitis service providers across the UK and Ireland, interviews with patients, and from organisational case studies to identify key service components that enable good care. The association between these components and patient outcomes (eg, serious infections, mortality) and provider outcomes (eg, emergency hospital admissions) were examined in a population-based data linkage study using routine health-care data obtained from patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis from national health datasets in Scotland. We did univariable and multivariable analyses using Bayesian poisson and negative binomial regression to estimate incident rate ratios (IRRs), and Cox proportional hazards models to estimate hazard ratios (HRs). People with lived experiences were involved in the research and writing process. FINDINGS: Good care was characterised by service components that supported timely access to services, integrated care, and expertise. In 1420 patients with ANCA-associated vasculitis identified from national health datasets, service-reported average waiting times for new patients of less than 1 week were associated with fewer serious infections (IRR 0·70 [95% credibility interval 0·55-0·88]) and fewer emergency hospital admissions (0·78 [0·68-0·92]). Nurse-led advice lines were associated with fewer serious infections (0·76 [0·58-0·93]) and fewer emergency hospital admissions (0·85 [0·74-0·96]). Average waiting times for new patients of less than 1 week were also associated with reduced mortality (HR 0·59 [95% credibility interval 0·37-0·93]). Cohorted clinics, nurse-led clinics, and specialist vasculitis multi-disciplinary team meetings were associated with fewer serious infections (IRR 0·75 [0·59-0·96] for cohorted clinics; 0·65 [0·39-0·84] for nurse-led clinics; 0·72 [0·57-0·90] for specialist vasculitis multi-disciplinary team meetings) and emergency hospital admissions (0·81 [0·71-0·91]; 0·75 [0·65-0·94]; 0·86 [0·75-0·96]). Key components were characterised by their ability to overcome professional tensions between specialties. INTERPRETATION: Key service components associated with important health outcomes and underpinning factors were identified to inform initiatives to improve the design, delivery, and effectiveness of health-care models for rare autoimmune rheumatic diseases. FUNDING: Versus Arthritis.
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Enfermedades Reumáticas , Humanos , Femenino , Masculino , Adulto , Persona de Mediana Edad , Enfermedades Reumáticas/terapia , Irlanda/epidemiología , Enfermedades Autoinmunes/terapia , Reino Unido/epidemiología , Enfermedades Raras/terapia , Anciano , Vasculitis Asociada a Anticuerpos Citoplasmáticos Antineutrófilos/terapia , Atención a la Salud/organización & administraciónRESUMEN
Patient and public involvement (PPI) in research has evolved over recent years, yet it often remains an 'optional extra' and, in some cases, tokenistic. Discussions are often focused on processes and methods, and are yet to make PPI the norm; we argue that the conversation needs to change to one of 'value': a culture of common values and principles across all types of research. Taking a reflexive, personalised approach, we reflect on how our team's experiences as patients, healthcare professionals and academics have changed over time and shaped what we value, our involvement in research and the way we involve people in research. We illustrate, through our work together, the productive tensions we experience, our efforts to resolve these through analytic conversations and our ethic of responsibility to each other. Moving forward, embracing reflexivity and supporting relationships can help PPI to become integral to research; a value as opposed to a method.
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OBJECTIVE: To compare the impact of symptoms and health care utilization of people diagnosed with fibromyalgia, people who fulfill the criteria but are not diagnosed, and people with chronic pain. METHODS: We recruited people who had participated in a previous population survey across Scotland and who reported some typical fibromyalgia symptoms or had received a diagnosis of fibromyalgia. Responses to a postal questionnaire were used to define mutually exclusive groups: people who had a fibromyalgia diagnosis, who met criteria for fibromyalgia, and who had chronic pain. RESULTS: Participants included 85 people with a diagnosis of fibromyalgia, 110 who met criteria for fibromyalgia, and 133 with chronic pain. The mean age across groups ranged 57-59 years, but the percentage female varied markedly: 86%, 64%, and 67%, respectively. Compared to those with chronic pain, participants with a fibromyalgia diagnosis were more likely to be out of employment due to health. An average of 3 years was needed to receive a fibromyalgia diagnosis, and more than half were diagnosed in secondary care (most commonly rheumatology). The fibromyalgia diagnosis and criteria groups were similar in terms of symptom impact, quality of life, and life satisfaction but were worse than the chronic pain group. Participants who had received a diagnosis of fibromyalgia reported the poorest health care experiences. CONCLUSION: An urgent need exists for a model of care for fibromyalgia to ensure prompt diagnosis, access to evidence-based care, and long-term support, with the aim of improving function. The data suggest that diagnosis in men may be overlooked, and this finding warrants further study.
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Dolor Crónico , Fibromialgia , Masculino , Femenino , Humanos , Persona de Mediana Edad , Fibromialgia/diagnóstico , Fibromialgia/terapia , Fibromialgia/complicaciones , Estudios Transversales , Calidad de Vida , Dolor Crónico/diagnóstico , Dolor Crónico/terapia , Aceptación de la Atención de SaludRESUMEN
OBJECTIVES: To understand what we can learn from the impact of the COVID-19 pandemic and lockdown about what enables work participation for people with inflammatory arthritis and chronic pain conditions. DESIGN: Qualitative interviews embedded within an observational questionnaire study of individuals with musculoskeletal (MSK) conditions. SETTING: UK primary care (general practices), and secondary care-based rheumatology services. PARTICIPANTS: Individuals with axial spondyloarthritis, psoriatic arthritis and MSK pain from three established cohorts completed an online/paper-based questionnaire (July-December 2020). A subset of respondents were selected for semistructured interviews. PRIMARY AND SECONDARY OUTCOME MEASURES: The survey quantified the effects of lockdown on work circumstances. Qualitative interviews explored the impacts of these changes and the advantages and disadvantages of changes in work circumstances. RESULTS: 491 people (52% female, median age 49 years) who were employed at the time of lockdown responded to the questionnaire. The qualitative analysis included 157 free-text comments on work from the questionnaire and data collected within 18 interviews.Participants reported impacts on mental and physical health, and significant financial anxieties. The impact of work changes varied depending on individual and home circumstances. Some felt forced to ignore advice to shield and continue working. The flexibility offered by home working and changes in commuting enabled greater physical activity for some, while others missed the exercise normally undertaken as part of their commute. Others reported a constant need to be 'present' online, which heightened anxiety and worsened MSK symptoms. CONCLUSION: Lockdown showed that flexible working arrangements, which consider the positive and negative aspects of commuting, posture, movement, and work environment matter for work participation, and can have wider benefits in terms of health and well-being for those with long-term MSK conditions. Incorporating these into new models of work will help make the workplace more equitable and inclusive for people with long-term MSK conditions.
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COVID-19 , Dolor Musculoesquelético , Ansiedad , Control de Enfermedades Transmisibles , Femenino , Humanos , Masculino , Persona de Mediana Edad , PandemiasRESUMEN
OBJECTIVE: To assess whether clinical and patient-reported outcomes are poorer for individuals with inflammatory and noninflammatory rheumatic diseases living in rural locations. METHODS: We searched 6 databases for articles that reported on primary peer-reviewed research, published in English between 1990 and 2019, that focused on selected rheumatic diseases (rheumatoid arthritis [RA], psoriatic arthritis, axial spondyloarthritis, or osteoarthritis [OA]) and quantified either patient-reported or clinically measured outcomes by a measure of rurality or remoteness. Selected articles were synthesized narratively. RESULTS: Eight eligible publications, including 753 rural and 929 urban patients, evaluated outcomes in RA (5 studies) and OA (3 studies). Studies were small, single center, and rarely provided a definition of rurality. Aspects relating to rurality, such as access to services, were not measured. In RA, some studies suggested greater functional disability and disease activity in rural dwellers. In OA, there was some evidence to suggest that rural dwellers presented with more advanced degenerative hip changes, and that illness perceptions and coping differed between rural and urban dwellers. No studies examined work outcomes. Potentially important confounding factors such as socioeconomic status were rarely considered. CONCLUSION: There remains considerable uncertainty whether outcomes differ for patients with rheumatic disease in rural settings. There is a need for larger scale studies characterizing participants in relation to place of residence in order to determine whether rurality is an independent predictor of outcome or a surrogate marker for socioeconomic factors.
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Medición de Resultados Informados por el Paciente , Enfermedades Reumáticas/terapia , Salud Rural , Salud Urbana , Adaptación Psicológica , Costo de Enfermedad , Evaluación de la Discapacidad , Progresión de la Enfermedad , Estado Funcional , Humanos , Enfermedades Reumáticas/diagnóstico , Enfermedades Reumáticas/epidemiología , Clase Social , Determinantes Sociales de la Salud , Resultado del TratamientoRESUMEN
OBJECTIVE: The aim was to assess the feasibility and acceptability of a telephone-based cognitive behaviour therapy (tCBT) intervention for individuals with axial SpA (axSpA), with and without co-morbid FM, and to measure the change in patient-reported health outcomes. METHODS: A convenience sample of individuals recruited from British Society for Rheumatology Biologics Registry for AS (BSRBR-AS) sites were offered a course of tCBT (framed as coaching). Patient-reported outcomes were measured at baseline and on course completion. Semi-structured qualitative interviews assessed intervention acceptability. Thematic analysis was informed by the theoretical framework of acceptability. RESULTS: Forty-two participants attended for initial assessment. Those completing at least one tCBT session (n = 28) were younger, more likely to meet classification criteria for FM (57 vs 29%) and reported higher disease activity. Modest improvements were reported across a range of disease activity and wider health measures, with 62% of patients self-rating their health as improved (median 13 weeks post-intervention). Twenty-six participants were interviewed (including six who discontinued after initial assessment). tCBT was widely acceptable, offering a personalized approach. Despite low or unclear expectations, participants described improved sleep and psychological well-being and gained new skills to support self-management. Reasons for non-uptake of tCBT centred on lack of perceived need and fit with individual value systems. Many felt that tCBT would be most useful closer to diagnosis. CONCLUSION: Higher uptake among axSpA patients with co-morbid FM suggests that these individuals have additional needs. The findings are helpful in identifying patients most likely to engage with and benefit from tCBT and to maximize participation.
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Fibromyalgia is a common and complex long-term pain condition. Despite advancements in our understanding and treatment of fibromyalgia, patients report patchy health care provision and frustrating journeys through the health care system. To inform how best to deliver care, we undertook 2 narrative reviews examining existing evidence on (1) models of care for fibromyalgia and (2) patients' experiences, preferences, and unmet needs regarding their health care. Seven databases were systematically searched. Quantitative data was narratively synthesised and qualitative data thematically analysed. No evidence-based model of care covering the patient journey through the entire health care system was identified. Limited evidence suggests no clear benefit for ongoing care in secondary care settings. Patients with fibromyalgia report difficult interactions with the health care system that might equally be expressed by those with other long-term conditions, such as inconsistent and poorly coordinated care. However, they also face unique problems; fibromyalgia was often not viewed as a real condition, resulting in difficult encounters with health care staff, in particular not feeling believed or listened to. Significant delays in diagnosis were commonplace. Positive care experiences such as being listened to and shared decision-making made patients feeling better informed, well supported, and more satisfied. There is little evidence to inform how best to organise health care for patients with fibromyalgia and ensure care is delivered in a coordinated and consistent way. These findings provide a strong rationale for developing a new model of care for fibromyalgia.
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Fibromialgia , Atención a la Salud , Fibromialgia/terapia , HumanosRESUMEN
OBJECTIVES: GCA patients with large vessel involvement (LV-GCA) experience greater CS requirements and higher relapse rates compared with classical cranial GCA. Despite the distinct disease course, interventions in LV-GCA have yet to be investigated specifically. This study aimed to evaluate the CS-sparing effect and tolerability of first-line mycophenolate in LV-GCA. METHODS: A retrospective cohort study was conducted in patients with LV-GCA identified from a regional clinical database between 2005 and 2019. All cases were prescribed mycophenolate derivatives (MYC; MMF or mycophenolic acid) at diagnosis and were followed up for ≥2 years. The primary outcome was the cumulative CS dose at 1 year. Secondary outcomes included MYC tolerance, relapse rates and CRP levels at 1 and 2 years. RESULTS: A total of 37 patients (65% female; mean age 69.4 years, SD 7.9 years) were identified. All cases demonstrated large vessel involvement via CT/PET (n = 34), CT angiography (n = 5) or magnetic resonance angiography (n = 2). After 2 years, 31 patients remained on MYC, whereas 6 had switched to MTX or tocilizumab owing to significant disease relapse. The mean (±SD) cumulative prednisolone dose at 1 year was 4960 (±1621) mg. Relapse rates at 1 and 2 years were 16.2 and 27%, respectively, and CRP levels at 1 and 2 years were 4 [interquartile range (IQR) 4-6] and 4 (IQR 4-4) mg/l, respectively. CONCLUSION: To our knowledge, this is the first attempt to assess the effectiveness of any specific agent in LV-GCA. MYC might be both effective in reducing CS exposure and well tolerated in this subpopulation. A future randomized controlled trial is warranted.
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BACKGROUND: Pain after breast cancer surgery remains largely unexplained and inconsistently quantified. This study aims to describe the perioperative pain patterns in patients with breast cancer, up to two years after surgery. METHODS: This is a pre-planned sub-study of the Ketorolac in Breast Cancer (KBC) trial. The KBC trial was a multicentre, prospective, double-blind, placebo-controlled, randomised trial of a single dose of 30 mg of ketorolac just before breast cancer surgery, aiming to test its effect on recurrences. This sub-study focuses only on pain outcomes. From 2013 to 2015, 203 patients were randomised to ketorolac (n = 96) or placebo (n = 107). Structured questionnaires were delivered by telephone after one and two years, exploring the presence, location, permanence, and frequency of pain. Patients' perceptions of pain were captured by an open-ended question, the responses to which were coded and classified using hierarchical clustering. RESULTS: There was no difference in pain between the ketorolac and the placebo group. The reported incidence of permanent pain was 67% and 45% at one and two years, respectively. The largest category was musculoskeletal pain. Permanent pain was mainly described in patients with musculoskeletal pain. The description of pain changed in most patients during the second postoperative year, i.e., moved from one category to another (no pain, permanent, or non-permanent pain, but also, the localisation). This phenomenon includes patients without pain at one year. CONCLUSIONS: Pain is a complex phenomenon, but also a fragile and unstable endpoint. Pain after breast cancer surgery does not necessarily mean breast pain but also musculoskeletal and other pains. The permanence of pain and the pain phenotype can change over time.
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Following their introduction in the 1990s, bisphosphonates have become the mainstay of treatment in the management of postmenopausal osteoporosis, and their use continues to rise. Commonly noted adverse effects in clinical practice include gastrointestinal side-effects, acute phase reactions (predominately seen with intravenous preparations) cutaneous reactions and more rarely, ocular side-effects. However, recent reports of potentially serious adverse effects of bisphosphonate therapy, including atypical subtrochanteric and femoral shaft fractures, atrial fibrillation, oesophageal carcinoma and osteonecrosis of the jaw, have prompted concerns regarding the long-term safety of this class of drugs. This review summarizes the benefits and potential adverse effects of bisphosphonates used in the treatment of postmenopausal osteoporosis. Although evidence of a definitive casual relationship between bisphosphonate therapy and serious adverse effects is lacking, concern remains particularly in relation to atypical subtrochanteric and femoral shaft fractures. This has important consequences in terms of determining optimum duration of therapy and how best to target therapy at those most at risk. Recently, attention has focused on individual fracture risk assessment in order to optimize the risk-benefit ratio of treatment for individual patients. A review of the role of hormone replacement therapy in younger women with significant risk of osteoporotic fractures may be timely in these circumstances.