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INTRODUCTION: To assess differences in the diagnosis journey and access to care in a large sample of patients with axial spondyloarthritis (axSpA) from around the world, included in the International Map of Axial Spondyloarthritis (IMAS). METHODS: IMAS was a cross-sectional online survey (2017-2022) of 5557 unselected patients with axSpA from 27 countries. Across five worldwide geographic regions, the patient journey until diagnosis and healthcare utilization in the last 12 months prior to survey were evaluated. Univariable and multivariable linear regression was used to analyze factors associated with higher healthcare utilization. RESULTS: Of 5557 participants in IMAS, the diagnosis took an average of 7.4 years, requiring more than two visits to HCPs (77.7% general practitioner and 51.3% rheumatologist), and more than two diagnostic tests [67.5% performed human leukocyte antigen B27 (HLA-B27), 64.2% x-ray, and 59.1% magnetic resonance imaging (MRI) scans]. North America and Europe were the regions with the highest number of healthcare professional (HCP) visits for diagnosis, while the lowest number of visits was in the Asian region. In the previous 12 months, 94.9% (n = 5272) used at least one healthcare resource, with an average of 29 uses per year. The regions with the highest healthcare utilization were Latin America, Europe, and North America. In the multiple linear regression, factors associated with higher number of healthcare utilization were younger age (b = - 0.311), female gender (b = 7.736), higher disease activity (b = 1.461), poorer mental health (b = 0.624), greater functional limitation (b = 0.300), greater spinal stiffness (b = 1.527), and longer diagnostic delay (b = 0.104). CONCLUSION: The diagnosis of axSpA usually takes more than two visits to HCPs and at least 7 years. After diagnosis, axSpA is associated with frequent healthcare resource use. Younger age, female gender, higher disease activity, poorer mental health, greater functional limitation, greater spinal stiffness, and longer diagnostic delay are associated with higher healthcare utilization. Europe and North America use more HCP visits and diagnostic tests before and after diagnosis than the other regions.
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OBJECTIVE: European Alliance of Associations for Rheumatology (EULAR) task forces (TF) requires participation of ≥2 junior members, a health professional in rheumatology (HPR) and two patient research partners for the development of recommendations or points to consider. In this study, participation of these junior and representative members was compared with the one of traditional TF members (convenor, methodologist, fellow and expert TF members). METHODS: An online survey was developed and emailed to previous EULAR TF members. The survey comprised multiple-choice, open-ended and 0-100 rating scale (fully disagree to fully agree) questions. RESULTS: In total, 77 responded, 48 (62%) women. In total, 46 (60%) had participated as a junior or representative TF member. Most junior/representative members reported they felt unprepared for their first TF (10/14, 71%). Compared with traditional members, junior/representative members expressed a significantly higher level of uncertainty about their roles within the TF (median score 23 (IQR 7.0-52.0) vs 7 (IQR 0.0-21.0)), and junior/representative members felt less engaged by the convenor (54% vs 71%). Primary factors that facilitated interaction within a TF were experience, expertise and preparation (54%), a supportive atmosphere (42%) and a clear role (12%). CONCLUSION: Juniors, patients and HPR experience various challenges when participating in a EULAR TF. These challenges differ from and are generally less pronounced than those experienced by traditional TF members. The convenor should introduce the participants to the tasks, emphasise the value of their contributions and how to prepare accordingly for the TF meeting.
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Comités Consultivos , Personal de Salud , Reumatología , Humanos , Femenino , Encuestas y Cuestionarios , Masculino , Personal de Salud/psicología , Adulto , Europa (Continente) , Persona de Mediana EdadRESUMEN
BACKGROUND: This study aims to assess the prevalence of poor mental health in axial spondyloarthritis (axSpA) and its associated factors in a large sample of patients from the International Map of Axial Spondyloarthritis (IMAS) study from around the globe. METHODS: IMAS is a cross-sectional online survey (2017-2022) that includes 5557 unselected patients with axSpA worldwide. Mental health was evaluated by the 12-item General Health Questionnaire (GHQ-12) and the cut-off point for poor mental health was set at 3. Logistic regression analysis was used to evaluate relationships between the investigated factors and poor mental health (GHQ-12≥3) in patients with axSpA (n=4335). RESULTS: Of 5351 patients, the mean of GHQ-12 was 4.7 and 59.4% were having poor mental health, being 69.9% in South Africa, 63.7% in Latin America, 60.8% in Europe, 54.3% in North America and 51.8% in Asia. Overall, 40.5% and 37.2% of patients experienced anxiety and depression. The factors associated with poor mental health were younger age (OR=0.99), female gender (OR=1.16), being on sick leave or unemployed (OR=1.63), non-physical activity (OR=1.22), smoking (OR=1.20), higher Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] (OR=1.42), functional limitation (OR=1.02) and shorter symptoms duration (OR=0.98). CONCLUSIONS: Globally, 6 in 10 patients with axSpA had poor mental health, with a higher proportion in South Africa and lower in Asia. The factors associated with poor mental health include domains such as younger age, female gender, employment difficulties, harmful habits, disease burden and symptom duration. A holistic management approach to axSpA should encompass both physical and mental health.
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Espondiloartritis Axial , Salud Mental , Humanos , Masculino , Femenino , Adulto , Estudios Transversales , Espondiloartritis Axial/epidemiología , Espondiloartritis Axial/etiología , Persona de Mediana Edad , Prevalencia , Depresión/epidemiología , Depresión/etiología , Encuestas y Cuestionarios , Factores de Riesgo , Ansiedad/epidemiología , Ansiedad/etiologíaRESUMEN
BACKGROUND: The International Map of Axial Spondyloarthritis (IMAS) is a global initiative aimed to assess the impact and burden of axial spondyloarthritis (axSpA) and identify the unmet needs from the patient's perspective. METHOD: IMAS is a collaboration between the Axial Spondyloarthritis International Federation (ASIF), the University of Seville, Novartis Pharma AG and steered by a scientific committee. IMAS collected information through an online cross-sectional survey (2017-2022) from unselected patients with axSpA from Europe, Asia, North America, Latin America and Africa who completed a comprehensive questionnaire containing over 120 items. RESULTS: 5557 patients with axSpA participated in IMAS. Mean age was 43.9 ±12.8 years, 55.4% were female, 46.2% had a university education and 51.0% were employed. The mean diagnostic delay was 7.4 ±9.0 years (median: 4.0), and the mean symptom duration was 17.1 ±13.3 years. 75.0% of patients had active disease (Bath Ankylosing Spondylitis Disease Activity Index ≥4), and 59.4% reported poor mental health (12-item General Health Questionnaire ≥3). In the year before the survey, patients had visited primary care physicians 4.6 times and the rheumatologist 3.6 times. 78.6% had taken non-steroidal anti-inflammatory drug ever, 48.8% biological disease-modifying antirheumatic drugs and 43.6% conventional synthetic disease-modifying antirheumatic drugs. Patients's greatest fear was disease progression (55.9%), while the greatest hope was to be able to relieve pain (54.2%). CONCLUSIONS: IMAS shows the global profile of patients with axSpA, highlighting unmet needs, lengthy delays in diagnosis and high burden of disease in patients with axSpA worldwide. This global information will enable more detailed investigations to obtain evidence on the critical issues that matter to patients around the world to improve their care and quality of life.
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Espondiloartritis Axial , Calidad de Vida , Humanos , Masculino , Femenino , Adulto , Estudios Transversales , Persona de Mediana Edad , Espondiloartritis Axial/diagnóstico , Espondiloartritis Axial/epidemiología , Encuestas y Cuestionarios , Costo de Enfermedad , Salud Global , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: Intra-articular hyaluronic acid (IAHA) products are often used in the treatment of adults with mild-to-moderate knee osteoarthritis (KOA). The International Symposium on Intra-Articular Treatment (ISIAT) convened a multidisciplinary technical expert panel to define characteristics for an innovative IAHA product that should answer unmet needs in the clinical management of adults with mild-to-moderate KOA. METHODS: An initial set of evidence-based statements was developed based on data extracted from articles identified through a comprehensive literature search. A Delphi panel comprising 19 experts in KOA voted in 3 rounds to rate their degree of agreement with accepted statements. RESULTS: The final set of 13 accepted statements focus on the effect of an innovative IAHA across 5 key domains of nociceptive pain, joint function, quality of life, joint structure and integrity, and adverse effects. The statements set thresholds for clinically meaningful improvements that exceed those generally achievable by currently available IAHA products. CONCLUSION: The characteristics described by these statements from the ISIAT set new standards for what should be expected from an innovative IAHA. These statements should serve as a framework for driving the development of innovative IAHA products that will surpass the actual outcomes achieved by current viscosupplements in patients with mild-to-moderate KOA.
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OBJECTIVES: To explore differences in axial spondyloarthritis (axSpA) clinical phenotype around the world in a large sample of patients included in the International Map of Axial Spondyloarthritis (IMAS). METHOD: IMAS was a cross-sectional online survey (2017-2022) of 5,557 unselected axSpA patients from 27 countries. We analysed across five geographic regions the age at symptom onset, diagnostic delay, gender, HLA-B27, family history, extra-musculoskeletal manifestations, presence of comorbidities, disease activity (BASDAI), level of spinal stiffness, and treatments. RESULTS: Of 5,557 IMAS participants, 3,493 were from Europe, 770 from North America, 600 from Asia, 548 from Latin America, and 146 from South Africa. Age at symptom onset ranged between 25-30 years and was higher in Latin America. Diagnostic delay was longest in South Africa and lowest in Asia. The lowest HLA-B27 positivity was observed in Latin America and the highest in Asia. Extra-musculoskeletal manifestations were the lowest in Europe. Mean disease activity (BASDAI) was 5.4, with highest values in South Africa and lowest in Asia. Most of the patients had used NSAIDs for their condition and less than half had ever taken csDMARDS; both were more frequent in Latin America and South Africa. Almost half of the patients had ever taken bDMARDs, more frequent being in the Americas. CONCLUSIONS: There is great heterogeneity of axSpA clinical phenotype presentation around the world. AxSpA manifests differently in different regions, so further understanding of these differences of phenotypes is needed to achieve early diagnosis and initiation of optimal disease treatment in axSpA in the different regions.
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BACKGROUND: Qualitative data on how the COVID-19 pandemic has affected the lives of people with rheumatic and musculoskeletal diseases (RMDs) in different European countries are lacking. OBJECTIVES: To describe the impact of the first two waves of the COVID-19 pandemic on people with inflammatory RMDs concerning (self)management of their disease, interaction with the health care team, emotional well-being and overall health. METHODS: A mixed-methods study of adults (>18 years) with RMDs on immunosuppression from Cyprus, England, Greece, and Portugal took part on online focus groups (FG) after the first wave (July-August, 2020). The data was transcribed verbatim and thematically analyzed. Informed by the qualitative findings, a follow-up survey was developed for the same participants after the second wave, allowing to compare the perceived impact. RESULTS: Twenty-four patients (6 from each country; 21 women; 33-74 years range) participated. Three key themes were identified (with 3-7 subthemes each), focusing on the impact of COVID-19 on the: (i) individual, (ii) health settings, and (iii) work and community. Overall, qualitative results were similar across countries. The follow-up survey during the second wave highlighted a worsening of psychosocial aspects, e.g. sleep problems, stress, and isolation. CONCLUSIONS: People with RMDs felt vulnerable and anxious, specifically about how to cope with isolation and difficulties in communicating with healthcare providers. The second wave had a more significant impact on patients. Healthcare providers and policymakers need to consider measures to ameliorate the longer-term impact that many may still face.
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COVID-19 , Enfermedades Musculoesqueléticas , Adulto , Humanos , Femenino , COVID-19/epidemiología , Pandemias , Enfermedades Musculoesqueléticas/epidemiología , Portugal , ChipreRESUMEN
BACKGROUND: Fibromyalgia syndrome (FMS) is defined as chronic widespread pain associated with sleep disorders, cognitive dysfunction, and somatic symptoms present for at least three months and cannot be better explained by another diagnosis. OBJECTIVES: To examine efficacy and safety of non-pharmacological interventions for FMS in adults reported in Cochrane Reviews, and reporting quality of reviews. METHODS: Systematic reviews of randomised controlled trials (RCTs) of non-pharmacological interventions for FMS were identified from the Cochrane Database of Systematic Reviews (CDSR 2022, Issue 3 and CDSR 2023 Issue 6). Methodological quality was assessed using the AMSTAR-2 tool and a set of methodological criteria critical for analgesic effects. The primary efficacy outcomes of interest were clinically relevant pain relief, improvement in health-related quality of life (HRQoL), acceptability, safety, and reduction of mobility difficulties as reported by study participants. No pooled analyses were planned. We assumed a clinically relevant improvement was a minimal clinically important difference (MCID) between interventions and controls of 15%, or a SMD of more than 0.2, or a MD of more than 0.5, on a 0 to 10 scale. RESULTS: Ten Cochrane reviews were eligible, reporting 181 randomized or quasi- randomized trials (11,917 participants, average trial size 66 participants). The reviews examined exercise training, acupuncture, transcutaneous electrical nerve stimulation, and psychological therapies. One review was rated moderate according to AMSTAR 2, seven were rated low and two were rated critically low. All reviews met most of the additional methodological quality criteria. All reviews included studies with patient-reported outcomes for pain. We found low certainty evidence of clinically relevant positive effects of aerobic and mixed exercise training and for cognitive behavioural therapies (CBTs) at reducing mobility difficulties and for mixed exercise training and CBTs for improving HRQoL at the end of the intervention. Number needed to treat for an additional beneficial outcome (NNTB) values for a MCID of 15% ranged between 4 and 9. We found low certainty evidence that was clinically relevant for mixed exercise and CBTs for reducing mobility difficulties at an average follow up of 24 weeks. We found low certainty evidence of clinically relevant positive effects of mixed exercise on HRQoL at an average follow up of 24 weeks. NNTB values for a MCID of 15% ranged from 5 to 11. The certainty of evidence of the acceptability (measured by dropouts) of the different non-pharmacological interventions ranged from very low to moderate and the dropout rate for any reason did not differ across the interventions or the controls, except for biofeedback and movement therapies. All the systematic reviews stated that the reporting of adverse events was inconsistent in the studies analysed (very low certainty evidence). AUTHORS' CONCLUSIONS: There is low certainty evidence of clinically relevant reduction of mobility difficulties and of improvement of HRQoL among individuals with FMS by aerobic and mixed exercise training and by CBTs at the end of the intervention. There is low certainty evidence that CBTs and mixed exercise training reduces mobility difficulties post-treatment and that mixed exercise training improves HRQoL at follow-up by clinically meaningful scores.
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Dolor Crónico , Fibromialgia , Adulto , Humanos , Fibromialgia/terapia , Revisiones Sistemáticas como Asunto , Dolor Crónico/psicología , Ejercicio Físico , Terapia por Ejercicio , Calidad de VidaRESUMEN
OBJECTIVE: To identify the parameters associated with self-reported diagnostic delay (DD) in axial spondyloarthritis (axSpA) patients across Europe. METHODS: Data from 2652 patients from 13 countries who participated in the European Map of Axial Spondyloarthritis (EMAS) were collected through an online survey (2017-2018). DD was calculated as the difference between age at diagnosis and age at symptom onset reported by participants. Associations between DD and sociodemographic characteristics, as well as disease-related factors were explored through univariable and multivariable linear regression analysis. RESULTS: Average DD was 7.4 (8.4) years with a variation between countries. The variables associated with longer DD in the final multivariable regression model were: younger age at symptom onset (b = -0.26; 95% CI: -0.28, -0.23), female gender (b = 1.34; 95% CI: 0.73, 1.96) and higher number of health-care professionals (HCPs) seen before diagnosis (b = 1.19; 95% CI: 0.95, 1.43). There was a significant interaction between the female gender and the number of HCPs seen before diagnosis. A substantial variation of the DD across European countries was observed. CONCLUSION: In this sample of axSpA patients, average DD was greater than 7 years. Younger age at symptom onset, female gender, higher number of HCPs seen before diagnosis, and being diagnosed by rheumatologist were the parameters associated with a longer DD in axSpA. These findings indicate a need for continuing efforts dedicated to recognition of patients with a high probability of axSpA on the level of non-rheumatology specialists and facilitating referral to a rheumatologist for timely diagnosis.
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Espondiloartritis Axial/diagnóstico , Adulto , Edad de Inicio , Espondiloartritis Axial/patología , Estudios Transversales , Diagnóstico Tardío , Europa (Continente) , Femenino , Humanos , Masculino , Factores de Riesgo , Factores Sexuales , Encuestas y Cuestionarios , Factores de TiempoRESUMEN
OBJECTIVE: To determine the presence of mental disorder risk and associated factors in European patients with axial spondyloarthritis (axSpA). METHODS: Data from 2,166 patients with axSpA in 12 European countries were collected from 2017 to 2018 through the European Map of Axial Spondyloarthritis online survey. Risk of mental disorders was assessed using the 12-item General Health Questionnaire. Possible predictors included age, gender, relationship status, patient organisation membership, job status, educational level, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), functional limitation (0-54) and self-reported depression or anxiety. Bivariate analyses were conducted to determine predictors of risk of mental disorders (Mann-Whitney and χ2) and multivariable analysis identified factors associated with risk of mental disorders. RESULTS: 60.7% of patients reported risk of mental disorders: they were younger (41.7 vs 46.0 years), more likely female (68.2% vs 57.9%), unemployed (7.5% vs 2.7%), on temporary (15.9% vs 5.4%) or permanent sick leave (13.2% vs 8.0%), reported depression (45.2% vs 14.2%) or anxiety (41.3% vs 12.5%), higher disease activity (BASDAI ≥4; 87.6% vs 62.3%) and functional limitation (16.5 vs 10.8). The factors most associated with risk of mental disorders were disease activity (OR=2.80), reported depression (OR=2.42), anxiety (OR=2.39), being unemployed or on sick leave (OR=1.98), functional limitation (OR=1.02) and younger age (OR=0.97). CONCLUSIONS: Compared with the general population, patients with axSpA show disproportionately worse mental health associated mainly with disease activity and employment status. Healthcare professionals should pay close attention to patients with high disease activity and address internally or refer to specialist services, where appropriate to ensure optimal patient outcomes.
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Espondiloartritis Axial , Espondilitis Anquilosante , Ansiedad/epidemiología , Europa (Continente)/epidemiología , Femenino , Humanos , Salud MentalRESUMEN
AIM: To assess the impact of the COVID-19 pandemic on patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: REUMAVID is a cross-sectional study using an online survey developed by an international multidisciplinary patient-led collaboration across seven European countries targeting unselected patients with RMDs. Healthcare access, daily activities, disease activity and function, well-being (WHO Five Well-Being Index (WHO-5)), health status, anxiety/depression (Hospital Anxiety and Depression Scale (HADS)) and access to information were evaluated. Data were collected in April-July 2020 (first phase). RESULTS: Data from the first phase included 1800 patients with 15 different RMDs (37.2% axial spondyloarthritis, 29.2% rheumatoid arthritis, 17.2% osteoarthritis and others). Mean age was 53, 80% female and 49% had undertaken university studies. During the beginning of the pandemic, 58.4% had their rheumatology appointment cancelled and 45.6% reported not having received any information relating to the possible impact of SARS-CoV-2 infection in their RMDs, with the main source being patient organisations (27.6%).Regarding habits, 24.6% increased smoking, 18.2% raised their alcohol consumption, and 45.6% were unable to continue exercising. Self-reported disease activity was high (5.3±2.7) and 75.6% reported elevated pain. Half the patients (49.0%) reported poor well-being (WHO-5) and 46.6% that their health had changed for the worse during lockdown. According to HADS, 57.3% were at risk of anxiety and 45.9% of depression. CONCLUSION: Throughout the first wave of the COVID-19 pandemic, patients with RMDs have experienced disruption in access to healthcare services, poor lifestyle habits and negative effects on their overall health, well-being and mental health. Furthermore, information on COVID-19 has not reached patients appropriately.
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Ansiedad , COVID-19 , Depresión , Ejercicio Físico , Salud Mental/estadística & datos numéricos , Enfermedades Musculoesqueléticas , Aceptación de la Atención de Salud/estadística & datos numéricos , Enfermedades Reumáticas , Ansiedad/diagnóstico , Ansiedad/epidemiología , COVID-19/epidemiología , COVID-19/psicología , Estudios Transversales , Depresión/diagnóstico , Depresión/epidemiología , Europa (Continente)/epidemiología , Femenino , Estado Funcional , Humanos , Estilo de Vida , Masculino , Persona de Mediana Edad , Enfermedades Musculoesqueléticas/diagnóstico , Enfermedades Musculoesqueléticas/epidemiología , Enfermedades Musculoesqueléticas/psicología , Gravedad del Paciente , Medición de Resultados Informados por el Paciente , Enfermedades Reumáticas/diagnóstico , Enfermedades Reumáticas/epidemiología , Enfermedades Reumáticas/psicología , SARS-CoV-2RESUMEN
OBJECTIVES: The number of published clinical practice guidelines related to COVID-19 has rapidly increased. This study explored if basic methodological standards of guideline development have been met in the published clinical practice guidelines related to COVID-19. STUDY DESIGN AND SETTING: Rapid systematic review from February 1 until April 27, 2020 using MEDLINE [PubMed], CINAHL [Ebsco], Trip and manual search, including all types of healthcare workers providing any kind of healthcare to any patient population in any setting. RESULTS: There were 1342 titles screened and 188 guidelines included. The highest average AGREE II domain score was 89% for scope and purpose, the lowest for rigor of development (25%). Only eight guidelines (4%) were based on a systematic literature search and a structured consensus process by representative experts (classified as the highest methodological quality). The majority (156; 83%) was solely built on an informal expert consensus. A process for regular updates was described in 27 guidelines (14%). Patients were included in the development of only one guideline. CONCLUSION: Despite clear scope, most publications fell short of basic methodological standards of guideline development. Clinicians should use guidelines that include up-to-date information, were informed by stakeholder involvement, and employed rigorous methodologies.
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COVID-19/terapia , Guías de Práctica Clínica como Asunto/normas , Humanos , SARS-CoV-2RESUMEN
OBJECTIVES: During the COVID-19 pandemic, much communication occurred online, through social media. This study aimed to provide patient perspective data on how the COVID-19 pandemic impacted people with rheumatic and musculoskeletal diseases (RMDs), using Twitter-based patient-generated health data (PGHD). METHODS: A convenience sample of Twitter messages in English posted by people with RMDs was extracted between 1 March and 12 July 2020 and examined using thematic analysis. Included were Twitter messages that mentioned keywords and hashtags related to both COVID-19 (or SARS-CoV-2) and select RMDs. The RMDs monitored included inflammatory-driven (joint) conditions (ankylosing spondylitis, RA, PsA, lupus/SLE and gout). RESULTS: The analysis included 569 tweets by 375 Twitter users with RMDs across several countries. Eight themes emerged regarding the impact of the COVID-19 pandemic on people with RMDs: (i) lack of understanding of SARS-CoV-2/COVID-19; (ii) critical changes in health behaviour; (iii) challenges in healthcare practice and communication with healthcare professionals; (iv) difficulties with access to medical care; (v) negative impact on physical and mental health, coping strategies; (vi) issues around work participation; (vii) negative effects of the media; and (viii) awareness-raising. CONCLUSION: The findings show that Twitter serves as a real-time data source to understand the impact of the COVID-19 pandemic on people with RMDs. The platform provided 'early signals' of potentially critical health behaviour changes. Future epidemics might benefit from the real-time use of Twitter-based PGHD to identify emerging health needs, facilitate communication and inform clinical practice decisions.
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COVID-19/prevención & control , Enfermedades Musculoesqueléticas/psicología , Cuarentena/psicología , Enfermedades Reumáticas/psicología , Medios de Comunicación Sociales , Adaptación Psicológica , Comunicación , Conductas Relacionadas con la Salud , Accesibilidad a los Servicios de Salud , Humanos , SARS-CoV-2RESUMEN
INTRODUCTION/OBJECTIVES: To evaluate the journey to diagnosis, disease characteristics and burden of disease in male and female patients with axial spondyloarthritis (axSpA) across Europe. METHOD: Data from 2846 unselected patients participating in the European Map of Axial Spondyloarthritis (EMAS) study through an online survey (2017-2018) across 13 countries were analysed. Sociodemographic characteristics, lifestyle, diagnosis, disease characteristics and patient-reported outcomes (PROs) [disease activity -BASDAI (0-10), spinal stiffness (3-12), functional limitations (0-54) and psychological distress (GHQ-12)] were compared between males and females using chi-square (for categorical variables) and student t (for continuous variables) tests. RESULTS: In total, 1100 (38.7%) males and 1746 (61.3%) females participated in the EMAS. Compared with males, females reported considerable longer diagnostic delay (6.1 ± 7.4 vs 8.2 ± 8.9 years; p < 0.001), higher number of visits to physiotherapists (34.5% vs 49.5%; p < 0.001) and to osteopaths (13.3% vs 24.4%; p < 0.001) before being diagnosed and lower frequency of HLA-B27 carriership (80.2% vs 66.7%; p < 0.001). In addition, females reported higher degree of disease activity in all BASDAI aspects and greater psychological distress through GHQ-12 (4.4 ± 4.2 vs 5.3 ± 4.1; p < 0.001), as well as a greater use of alternative therapies. CONCLUSION: The patient journey to diagnosis of axSpA is much longer and arduous in females, which may be related to physician bias and lower frequency of HLA-B27 carriership. Regarding PROs, females experience higher disease activity and poorer psychological health compared with males. These results reflect specific unmet needs in females with axSpA needing particular attention. Key Points ⢠Healthcare professionals' perception of axSpA as a predominantly male disease may introduce some bias during the diagnosis and management of the disease. However, evidence about male-female differences in axSpA is scarce. ⢠EMAS results highlight how female axSpA patients report longer diagnostic delay and higher burden of the disease in a large sample of 2846 participants of 13 European countries. ⢠Results reflect unmet needs of European female patients. Healthcare professionals should pay close attention in order to accurately diagnose and efficiently manage axSpA cases while further research should be developed on the cause of reported gender differences.
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Factores Sexuales , Espondiloartritis , Diagnóstico Tardío , Europa (Continente) , Femenino , Antígeno HLA-B27/genética , Humanos , Masculino , Espondiloartritis/diagnósticoRESUMEN
OBJECTIVE: To evaluate work-related issues (WRIs) and their determinants in patients with axial spondyloarthritis (SpA) across Europe. METHODS: The European Map of Axial Spondyloarthritis is a cross-sectional online survey (2017-2018) of unselected patients with self-reported axial SpA from 13 European countries. Participants were classified as active or inactive members of the labor force according to the International Labor Organization standards. Those employed reported WRIs due to axial SpA in the past 12 months. Sociodemographic characteristics and patient-reported outcomes were compared between patients with and without WRIs. Stepwise regression analysis was conducted to identify independent determinants of WRIs. RESULTS: The sample comprised 2,846 patients with axial SpA, 1,653 were active members of the labor force, 1,450 were employed, and of those employed, 67.7% reported at least 1 WRI. The most frequently reported WRIs were taking sick leave (56.3%), difficulty fulfilling working hours (44.6%), and missing work for doctor's appointments (34.6%). Of the total sample, 74.1% declared that they had faced or would face difficulties finding a job due to axial SpA. Patients with WRIs were more often female, were less likely to be married or in a relationship, and had a higher educational level, poorer patient-reported outcomes, and a greater prevalence of anxiety and depression. Multivariable regression showed that WRIs were associated with a higher Bath Ankylosing Spondylitis Disease Activity Index score (odds ratio [OR] 1.30 [95% confidence interval (95% CI) 1.16-1.45]) and the 12-item General Health Questionnaire score (OR 1.15 [95% CI 1.09-1.22]), and were negatively associated with inflammatory bowel disease (OR 0.58 [95% CI 0.36-0.91]). CONCLUSION: Approximately two-thirds of employed patients experienced WRIs due to axial SpA. Association between disease activity and psychological distress with WRIs suggests the need to ensure that axial SpA patients receive the required support to cope with their working life.
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Espondiloartritis Axial , Empleo/estadística & datos numéricos , Trabajo/estadística & datos numéricos , Adulto , Anciano , Estudios Transversales , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Autoinforme , Ausencia por Enfermedad/estadística & datos numéricos , Encuestas y CuestionariosRESUMEN
The key question addressed in this Chapter is "What do people need?", with "people" here meaning those who live with a rheumatic or musculoskeletal disease. The word "patient" is avoided at this point as not all of the problems or solutions identified are medical in nature. Many are personal, societal and/or environmental. The lead authors are all people who not only live with a rheumatic or musculoskeletal disease, but who are experienced "patient representatives". Therefore, their insights here stem from a combination of personal and collective experiences and views. Although from different continents, the authors identify a range of common barriers to social participation and optimum management of these conditions, such as late diagnosis, stigma and access to care. However, several solutions are common across these regions too, such as the need for supported self-management and greater public awareness of the impact of these diseases.
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Enfermedades Musculoesqueléticas , Automanejo , Humanos , Evaluación de NecesidadesRESUMEN
The affiliation of the corresponding author Silvio Danese, which currently reads.
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Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.
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Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/inmunología , Biosimilares Farmacéuticos/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/inmunología , Biosimilares Farmacéuticos/efectos adversos , HumanosRESUMEN
PURPOSE OF REVIEW: Scientific research in axial spondyloarthritis (axSpA) has grown significantly. Nevertheless, the patient perspective remains insufficiently explored. Using a cross-sectional survey, the European Map of Axial Spondyloarthritis (EMAS) describes how patients living with self-reported axSpA experience their disease physically, psychologically, and socially. RECENT FINDINGS: 2846 patients participated: mean age 43.9 ± 12.3 years, 61.3% female, mean disease duration was 17.2 ± 12.4 years, and 71.3% were HLA-B27 positive. Mean diagnostic delay was 7.4 ± 8.4 years. Mean BASDAI score was 5.5 ± 2.0 and 75.7% reported moderate/severe spinal stiffness throughout the day. Daily life was substantially impaired: 74.1% reported difficulties finding a job due to the disease, and 61.5% reported psychological distress. EMAS results showed long diagnostic delay and substantial physical and psychological burden, indicating important unmet needs for patients. Furthermore, axSpA restricted patients' ability to participate in their daily routine and lead a productive work life. Understanding the patient's perspective can improve both health outcomes and shared decision-making between patient and rheumatologist.
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Costo de Enfermedad , Calidad de Vida/psicología , Espondiloartritis/diagnóstico , Adulto , Diagnóstico Tardío , Femenino , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Espondiloartritis/psicologíaRESUMEN
BACKGROUND: In this work, we aimed to establish a clinical target in the management of knee osteoarthritis (KOA) and to propose good clinical practice (GCP) statements for carrying out a treat-to-target strategy. METHODS: A steering committee of seven experts had formulated a provisional set of recommendations that were exposed for discussion and modification to a technical expert panel (TEP) of 25 multidisciplinary experts from Europe, North America, South America and Asia. The level of evidence and strength of each recommendation was discussed. The TEP formulated overarching principles and GCP statements based on the level of agreement for each item with a vote using a 10-point numerical scale. RESULTS: Two overarching principles and 10 GCP statements were formulated by the TEP. These GCP statements suggest: treatment should achieve clinical improvement bringing the patient to the Patient Acceptable Symptom State (PASS); pharmacological and nonpharmacological treatment should begin as early as possible, with an early diagnosis of symptomatic KOA; the patient should be evaluated every 3-6 months; risk factors of KOA progression should be identified and managed with patients at the beginning of the treatment and monitored regularly; treatment should be adapted according to patient phenotype and disease severity; healthy lifestyle must be promoted and monitored. The level of agreement average ranged from 8.7 to 9.6 on scale. CONCLUSIONS: The proposed overarching principles and GCP statements have the aim of involving patients, general practitioners and multidisciplinary specialists in sharing a therapeutic treat-to-target strategy for KOA management based on the best evidence and expert opinions.