RESUMEN
BACKGROUND: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a proinflammatory cytokine overproduced in several inflammatory and autoimmune diseases, including axial spondyloarthritis. Namilumab is a human IgG1 monoclonal anti-GM-CSF antibody that potently neutralises human GM-CSF. We aimed to assess the efficacy of namilumab in participants with moderate-to-severe active axial spondyloarthritis. METHODS: This proof-of-concept, randomised, double-blind, placebo-controlled, phase 2, Bayesian (NAMASTE) trial was done at nine hospitals in the UK. Participants aged 18-75 years with axial spondyloarthritis, meeting the Assessment in SpondyloArthritis international Society (ASAS) criteria and the ASAS-defined MRI criteria, with active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), were eligible. Those who had inadequately responded or had intolerance to previous treatment with an anti-TNF agent were included. Participants were randomly assigned (6:1) to receive subcutaneous namilumab 150 mg or placebo at weeks 0, 2, 6, and 10. Participants, site staff (except pharmacy staff), and central study staff were masked to treatment assignment. The primary endpoint was the proportion of participants who had an ASAS ≥20% improvement (ASAS20) clinical response at week 12 in the full analysis set (all randomly assigned participants). This trial is registered with ClinicalTrials.gov (NCT03622658). FINDINGS: From Sept 6, 2018, to July 25, 2019, 60 patients with moderate-to-severe active axial spondyloarthritis were assessed for eligibility and 42 were randomly assigned to receive namilumab (n=36) or placebo (n=six). The mean age of participants was 39·5 years (SD 13·3), 17 were women, 25 were men, 39 were White, and seven had previously received anti-TNF therapy. The primary endpoint was not met. At week 12, the proportion of patients who had an ASAS20 clinical response was lower in the namilumab group (14 of 36) than in the placebo group (three of six; estimated between-group difference 6·8%). The Bayesian posterior probability η was 0·72 (>0·927 suggests high clinical significance). The rates of any treatment-emergent adverse events in the namilumab group were similar to those in the placebo group (31 vs five). INTERPRETATION: Namilumab did not show efficacy compared with placebo in patients with active axial spondyloarthritis, but the treatment was generally well tolerated. FUNDING: Izana Bioscience, NIHR Oxford Biomedical Research Centre (BRC), NIHR Birmingham BRC, and Clinical Research Facility.
Asunto(s)
Espondiloartritis Axial , Factor Estimulante de Colonias de Granulocitos y Macrófagos , Humanos , Método Doble Ciego , Femenino , Masculino , Adulto , Persona de Mediana Edad , Factor Estimulante de Colonias de Granulocitos y Macrófagos/uso terapéutico , Factor Estimulante de Colonias de Granulocitos y Macrófagos/antagonistas & inhibidores , Factor Estimulante de Colonias de Granulocitos y Macrófagos/inmunología , Factor Estimulante de Colonias de Granulocitos y Macrófagos/administración & dosificación , Espondiloartritis Axial/tratamiento farmacológico , Reino Unido , Resultado del Tratamiento , Adulto Joven , Anciano , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/efectos adversos , Índice de Severidad de la Enfermedad , Adolescente , Prueba de Estudio ConceptualRESUMEN
BACKGROUND: Telerehabilitation is a term to describe rehabilitation services delivered via information and communication technology. Such services are an increasingly important component for the management of rheumatic and musculoskeletal diseases (RMDs). Telerehabilitation has the potential to expand the long-term self-management options for individuals with RMDs, improve symptoms, and relieve pressures on health care services. Yet, little is known about the variety of interventions implemented, and how they are being evaluated. Thus, this scoping review aims to identify and describe existing rehabilitation interventions delivered via telehealth for RMDs. Specifically, we aim to identify and summarize the key components of rehabilitation, the technology used, the level of health care professional interaction, and how the effectiveness of interventions is evaluated. METHODS: We will conduct this review following the latest JBI scoping review methodology and the PRISMA guidelines for Scoping Reviews (PRISMA-ScR). The 'Population-Concept-Context (PCC)' framework will be used, whereby the 'Population' is RMDs (≥18 years); the 'Concept' is rehabilitation; and the 'Context' is telehealth. Developed in collaboration with a subject Librarian, refined PCC key terms will be utilized to search (from 2011-2021) three electronic databases (i.e., Embase, Scopus, Web of Science) for articles published in English. Search results will be exported to the citation management software (EndNote), duplicates removed, and eligibility criteria applied to title/abstract and full-text review. Relevant information pertaining to the PCC framework will be extracted. Data will be summarized qualitatively, and if appropriate, quantitatively via frequency counts of the components comprising the 'Concept' and 'Context' categories of the PCC framework. DISCUSSION: Findings from the proposed scoping review will identify how telehealth is currently used in the delivery of rehabilitation interventions for RMDs. The findings will develop our understanding of such interventions and provide a platform from which to inform future research directions.
Asunto(s)
Enfermedades Musculoesqueléticas , Automanejo , Telemedicina , Telerrehabilitación , Humanos , Enfermedades Musculoesqueléticas/terapia , Revisiones Sistemáticas como Asunto , Literatura de Revisión como AsuntoRESUMEN
The objective of this study is to examine the contribution of pain catastrophising to Axial Spondyloarthritis (axSpA) patient's physical function and to test the mediating role of fear of movement, and uniquely, the contribution of competence frustration to the fear-avoidance model. Participants (N = 98, 70% female, M age = 45.62, SD 12.16) completed an online survey (December 2020-May 2021) distributed in the United Kingdom via the National Axial Spondyloarthritis Society (n ≈ 3500; NASS, 2019). The PROCESS SPSS macro was used to test three mediation models using percentile bootstrap 95% confidence intervals (PBCI). A significant indirect effect on the relationship between pain and physical function via fear of movement (ß = 0.10, 95% PBCI = 0.030-0.183) was observed (Model 1). Model 2 showed the relationship between pain catastrophising and physical function to be significantly mediated by fear of movement (ß = 0.16, 95% PBCI = 0.005-0.322). Finally, Model 3 showed a significant indirect effect on the relationship between pain catastrophising and physical function via competence frustration (ß = 0.15, 95% PBCI = 0.014-0.309) but not through fear of movement (ß = 0.062, 95% PBCI = - 0.134 to 0.248). To our knowledge, this is the first study to examine and demonstrate the unique contribution of competence need frustration to the Fear-avoidance model in people that live with axSpA. Identifying modifiable factors that contribute to disease outcomes such as physical function can improve the care and quality of life for people living with a disease currently without a cure.
Asunto(s)
Espondiloartritis Axial , Calidad de Vida , Humanos , Femenino , Persona de Mediana Edad , Masculino , Estudios Transversales , Frustación , Kinesiofobia , Dolor , MiedoRESUMEN
Objectives: The aim was to evaluate retention rates for secukinumab in patients with active PsA or radiographic axial spondyloarthritis (r-axSpA) treated in routine UK clinical practice. Methods: SERENA (CAIN457A3403) is an ongoing, non-interventional, international study of patients with moderate-to-severe chronic plaque psoriasis, active PsA or active r-axSpA, who had received secukinumab for ≥16 weeks before enrolment. The primary objective of this interim analysis was to assess treatment retention rates in patients with PsA or r-axSpA who were enrolled and followed for ≥2 years at centres in the UK. The safety analysis set includes all patients who received at least one dose of secukinumab. The target population set includes all patients who fulfilled the patient selection criteria. Results: The safety set comprised 189 patients (PsA, n = 81; r-axSpA, n = 108), and the target population set comprised 183 patients (PsA, n = 78; r-axSpA, n = 105). In the safety set, 107 patients (45 of 81 with PsA and 62 of 108 with r-axSpA) had previously received a biologic agent. Retention rates were similar between patients with PsA and r-axSpA after 1 year (PsA 91.0%, 95% CI: 84.0, 98.0; r-axSpA 89.2%, 95% CI: 82.7, 95.7) and 2 years (PsA 77.6%, 95% CI: 67.6, 87.7; r-axSpA 76.2%, 95% CI: 67.4, 85.0) of observation. Overall, 17.5% of patients (33 of 189) experienced at least one treatment-related adverse event, and 12.7% of patients (24 of 189) discontinued secukinumab because of adverse events. Conclusion: This analysis of real-world data from the UK demonstrates high retention rates for secukinumab over 2 years in patients with PsA or r-axSpA, with a favourable safety profile.
RESUMEN
Diagnostic delay in axial spondylarthritis (axSpA) remains an unacceptable worldwide problem; with evidence suggesting significant detrimental impact both clinically on the individual, and economically on society. There is therefore, a need for global action across various healthcare professions that come into contact with patients living, and suffering, with undiagnosed axSpA. Recent estimates of the median diagnostic delay suggest that globally, individuals with axSpA wait between 2 and 6 years for a diagnosis - revealing a clear benchmark for improvement. This timespan presents a window of opportunity for earlier diagnosis and intervention, which will likely improve patient outcomes. This review describes the current diagnostic delay as estimated across countries and over time, before presenting evidence from published strategies that may be implemented to improve this delay across primary and secondary care, including for specialties treating extra-musculoskeletal manifestations of axSpA (ophthalmology, gastroenterology, dermatology). Ongoing campaigns tackling delayed diagnosis in axSpA are also highlighted.
Asunto(s)
Espondiloartritis Axial , Espondiloartritis , Espondilitis Anquilosante , Humanos , Espondiloartritis/diagnóstico , Espondiloartritis/terapia , Espondiloartritis/complicaciones , Diagnóstico Tardío , Diagnóstico Precoz , Espondilitis Anquilosante/complicacionesRESUMEN
BACKGROUND: Rheumatic and musculoskeletal diseases (RMDs) cause significant burden to the individual and society, requiring lifelong management and specialist healthcare resource use. Costing over 200 billion euros per year in Europe, RMDs are the most expensive of all diseases for European healthcare systems. The incidence and burden of RMDs are projected to rise with the ageing global population and increase in sedentary, obesogenic lifestyles. In parallel, there is a global crisis in the rheumatology workforce, whereby capacity to deliver specialist care is being exceeded by demand. Pervasive, scalable mobile health technologies, such as apps, are being developed to support the self-management of RMDs and reduce pressure on healthcare services. However, it is unknown whether these apps are informed by theory or their use supported by an appropriate evidence base. The purpose of this review is therefore to provide a comprehensive overview of the development strategies, interventional components and theoretical underpinnings of existing smartphone apps, designed to support the self-management of RMDs. METHODS: Searches will be conducted within PubMed, Scopus, Web of Science, Embase, MEDLINE and PsycINFO. Reference lists and citing articles of the included studies will be searched. Identified publications will be screened for eligibility by two independent reviewers. Any discrepancies between reviewers will be resolved by consensus, with input from a third reviewer if required. Data will be extracted on study designs, methods, populations, setting, utilised theoretical frameworks, intervention components, behaviour change techniques, methods to evaluate effectiveness and barriers/facilitators to intervention engagement. Exploratory outcomes include reported effectiveness, acceptability and usability. A systematic, narrative synthesis of evidence will be presented. If appropriate (depending on quality and pool of evidence identified), qualitative meta-summary techniques will be used to combine and summarise qualitative findings regarding barriers/facilitators to intervention engagement. DISCUSSION: The results of this systematic literature review will provide insights for healthcare professionals, researchers, app designers and policy makers, to inform future development and implementation of smartphone apps to support self-management of RMDs. Evidence gaps for future research will be identified. Findings will be disseminated through a final manuscript/publication of results and via a conference abstract, patient organisations and social media. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022359704.
Asunto(s)
Aplicaciones Móviles , Enfermedades Musculoesqueléticas , Automanejo , Humanos , Enfermedades Musculoesqueléticas/terapia , Terapia Conductista , Revisiones Sistemáticas como AsuntoRESUMEN
OBJECTIVES: To develop a consensual definition for the term 'early axial spondyloarthritis-axSpA'-and 'early peripheral spondyloarthritis-pSpA'. METHODS: The ASAS (Assessment of SpondyloArthritis international Society-Spondyloarthritis EARly definition) steering committee convened an international working group (WG). Five consecutive steps were followed: (1) systematic literature review (SLR); (2) discussion of SLR results within the WG and ASAS community; (3) a three-round Delphi survey inviting all ASAS members to select the items that should be considered for the definition; (4) presentation of Delphi results to the WG and ASAS community and (5) ASAS voting and endorsement (2023 annual meeting). RESULTS: Following the SLR, consensus was to proceed with an expert-based definition for early axSpA (81% in favour) but not for pSpA (54% against). Importantly, early axSpA should be based on symptom duration taking solely axial symptoms into account. 151-164 ASAS members participated in the Delphi surveys. Consensus was achieved for considering the following items within early axSpA definition: duration of symptoms ≤2 years; axial symptoms defined as cervical/thoracic/back/buttock pain or morning stiffness; regardless of the presence/absence of radiographic damage. The WG agreed that in patients with a diagnosis of axSpA 'early axSpA' should be defined as a duration of ≤2 years of axial symptoms. Axial symptoms should include spinal/buttock pain or morning stiffness and should be considered by a rheumatologist as related to axSpA. The ASAS community endorsed this proposal (88% in favour). CONCLUSIONS: Early axSpA has newly been defined, based on expert consensus. This ASAS definition should be adopted in research studies addressing early axSpA.
RESUMEN
OBJECTIVE: Explore the experiences of patients and clinicians in rheumatology and cardiology outpatient clinics during the first year of the COVID-19 pandemic, focusing on the impact of remote consultations on interpersonal dynamics. DESIGN: Qualitative study using semistructured interviews, conducted between February and June 2021. SETTING: The rheumatology and cardiology departments of a general hospital in England, UK. PARTICIPANTS: All clinicians and a convenience sample of 100 patients in each department who had taken part in a remote consultation in the past month were invited to take part. Twenty-five interviews were conducted (13 with patients, 12 with clinicians). RESULTS: Three themes were developed through the analysis: adapting to the dynamics of remote consultations, impact on the patient's experience and impact on the clinician's experience. The majority of remote consultations experienced by both patients and clinicians had been via telephone. Both clinicians and patients found remote consultations to be more business-like and focused, with the absence of pauses restricting time for reflection. For patients with stable, well-managed conditions, remote consultations were felt to be appropriate and could be more convenient than in-person consultations. However, the loss of visual cues meant some patients felt they could not give a holistic view of their condition and limited clinicians' ability to gather and convey information. Clinicians adjusted their approach by asking more questions, checking understanding more frequently and expressing empathy verbally, but felt patients still shared fewer concerns remotely than in person; a perception with which patients concurred. CONCLUSIONS: These findings highlight the importance of ensuring, for each patient, that remote care is appropriate. Future research should focus on developing ways to support both clinicians and patients to gather and provide all information necessary during remote consultations, to enhance communication and trust.
Asunto(s)
COVID-19 , Cardiología , Consulta Remota , Reumatología , Humanos , Pandemias , Inglaterra , Instituciones de Atención AmbulatoriaRESUMEN
Pharmacological management has advanced considerably since the 2015 British Society for Rheumatology axial spondyloarthritis (axSpA) guideline to incorporate new classes of biologic DMARDs (bDMARDs, including biosimilars), targeted synthetic DMARDs (tsDMARDs) and treatment strategies such as drug tapering. The aim of this guideline is to provide an evidence-based update on pharmacological management of adults with axSpA (including AS and non-radiographic axSpA) using b/tsDMARDs. This guideline is aimed at health-care professionals in the UK who care directly for people with axSpA, including rheumatologists, rheumatology specialist nurses, allied health professionals, rheumatology specialty trainees and pharmacists; people living with axSpA; and other stakeholders, such as patient organizations and charities.
RESUMEN
OBJECTIVES: This study investigates longitudinal patterns, predictors and long-term impact of pain in axial spondyloarthritis (axSpA), using clinical and self-tracking data. METHODS: The presence of multisite pain (MSP), affecting at least six of nine body regions using a Margolis pain drawing, and subsequent chronic widespread pain (CWP), MSP at more than one timepoint, was assessed in a cohort of axSpA patients. Incident MSP (MSP at two consecutive visits or more), intermittent MSP (MSP at two or more non-consecutive visits) and persistent MSP (MSP at each visit) were described. Demographic, clinical and self-tracking measures were compared for the CWP vs non-CWP groups using Students t test, Wilcoxon-Mann-Whitney and χ2 test for normal, non-normal and categorical data, respectively. Predictors of CWP were evaluated using logistic regression modelling. RESULTS: A total of 136 patients, mean clinical study duration of 120 weeks (range 27-277 weeks) were included, with sufficient self-tracking data in 97 patients. Sixty-eight (50%) patients reported MSP during at least one clinical visit: eight (6%) incident MSP; 16 (12%) persistent MSP; and 44 (32%) intermittent MSP. Forty-six (34%) of the cohort had CWP. All baseline measures of disease activity, function, quality of life, sleep disturbance, fatigue and overall activity impairment were significant predictors of the development of CWP. BASDAI and BASFI scores were significantly higher in those with CWP and self-tracking data revealed significantly worse pain, fatigue, sleep quality and stress. CONCLUSIONS: The development of CWP is predicted by higher levels of disease activity and burden at baseline. It also impacts future disease activity and wellbeing.
Asunto(s)
Espondiloartritis Axial , Dolor Crónico , Humanos , Estudios de Cohortes , Calidad de Vida , Dolor Crónico/epidemiología , Dolor Crónico/etiología , Fatiga/epidemiología , Fatiga/etiologíaRESUMEN
Physical activity (PA) is a primary non-pharmacological treatment option for those living with rheumatoid arthritis (RA) and spondyloarthritis (SpA). The aim of this systematic literature review was to summarize and present an updated synthesis of the factors associated with PA in the RA and SpA populations. A tailored search of PubMed (inc. Medline), Web of Science, Embase, APA PsycNET, and Scopus was conducted for research published between 2004 and June 2019. Methodological quality was assessed using The National Institutes of Health (NIH) Quality Assessment Tools for Observational Cohort and Cross-sectional Studies, Case-Control Studies, and Controlled Intervention Studies. Forty RA and eleven SpA articles met the inclusion criteria. Methodological quality was generally fair to good, with two RA studies rated as poor. Correlates are discussed in the sociodemographic, physical, psychological, social, and environmental categories. Environmental factors were not measured in any RA study. In individuals living with RA, consistent positive associations were found between PA and high-density lipoprotein, self-efficacy, and motivation. Consistent negative associations were found for functional disability and fatigue. In individuals with SpA, consistent positive associations were found between PA and quality of life, and consistent negative associations with functional disability. Physical and psychological factors are most consistently related with PA parameters in those living with RA and SpA. Many variables were inconsistently studied and showed indeterminant associations. Studies with prospective designs are needed to further understand the factors associated with PA in these populations, especially in those living with SpA.
Asunto(s)
Artritis Reumatoide , Espondiloartritis , Adulto , Estudios Transversales , Ejercicio Físico , Humanos , Calidad de Vida , Espondiloartritis/psicología , Espondiloartritis/terapiaRESUMEN
OBJECTIVES: Updated guidelines for patients with axial SpA (axSpA) have sought to reduce diagnostic delay by raising awareness among clinicians. We used the National Early Inflammatory Arthritis Audit (NEIAA) to describe baseline characteristics and time to diagnosis for newly referred patients with axSpA in England and Wales. METHODS: Analyses were performed on sociodemographic and clinical metrics, including time to referral and assessment, for axSpA patients (n = 784) recruited to the NEIAA between May 2018 and March 2020. Comparators were patients recruited to the NEIAA with RA (n = 9270) or mechanical back pain (MBP; n = 370) in the same period. RESULTS: Symptom duration prior to initial rheumatology assessment was longer in axSpA than RA patients (P < 0.001) and non-significantly longer in axSpA than MBP patients (P = 0.062): 79.7% of axSpA patients had symptom durations of >6 months, compared with 33.7% of RA patients and 76.0% of MBP patients. Following referral, the median time to initial rheumatology assessment was longer for axSpA than RA patients (36 vs 24 days; P < 0.001) and similar to MBP patients (39 days; P = 0.30). Of the subset of patients deemed eligible for early inflammatory arthritis pathway follow-up, fewer axSpA than RA patients had disease education provided (77.5% vs 97.8%) and RA patients reported a better understanding of their condition and treatment. CONCLUSION: Diagnostic delay in axSpA remains a major challenge despite improved disease understanding and updated referral guidelines. Disease education is provided to fewer axSpA than RA patients, highlighting the need for specialist clinics and support programmes for axSpA patients.
Asunto(s)
Espondiloartritis Axial/diagnóstico , Adulto , Anciano , Artritis Reumatoide/diagnóstico , Dolor de Espalda/diagnóstico , Diagnóstico Tardío , Femenino , Humanos , Masculino , Persona de Mediana Edad , Derivación y Consulta/estadística & datos numéricos , Factores de Tiempo , Reino UnidoRESUMEN
Supervised physical therapy and rehabilitation are vital for effective long-term management of axial spondyloarthritis (SpA). However, the unprecedented year of 2020 and the COVID-19 pandemic has prompted a drastic change in health care provision across all disease areas. In this review, we summarize changes that have been introduced to support rehabilitation in axial SpA during the pandemic and considerations for the future of axial SpA rehabilitation in the wake of COVID-19. We have witnessed the launch of online virtual physical therapy and education, in addition to an emphasis on remote monitoring. We have been propelled into a new era of digital service provision; not only providing a temporary stop-gap in treatment for some patients, but in the future, potentially allowing for a wider reach and provision of care and resilience of vital services. Unique collaboration between patients, health care professionals, and researchers will be key to fostering relationships and trust and facilitating wider evaluation and implementation of digital services at each stage in a patient's journey, which is imperative for relieving pressure from health care providers. Despite the potential of such digital interventions, it is important to highlight the maintained critical need for face-to-face services, particularly for vulnerable patients or during diagnosis or a flare of symptoms. It is also vital that we remain vigilant regarding digital exclusion to avoid further widening of existing health inequalities. Optimization of digital infrastructure, staff skills, and digital education alongside promoting accessibility and engagement and building trust among communities will be vital as we enter this new age of blended in-person and digital service provision.
Asunto(s)
Espondiloartritis Axial/rehabilitación , COVID-19 , Telerrehabilitación , HumanosRESUMEN
OBJECTIVES: Our objective was to explore daily self-reported experiences of axial SpA (axSpA) flare based on data entered into the Project Nightingale smartphone app (www.projectnightingale.org), between 5 April 2018 and 1 April 2020. METHODS: Paired t-tests were conducted for mean_flare_on and mean_flare_off scores for each recorded variable. The mean estimated difference between flare and non-flare values for each variable was calculated with 95% CIs. Mean, S.d. and range were reported for flare duration and frequency. Participants with ≥10 days of data entry were included for affinity propagation cluster analysis. Baseline characteristics and mean flare on vs mean flare off values were reported for each cluster. Welch's t-test was used to assess differences between clusters. RESULTS: A total of 143/189 (75.7%) participants recorded at least one flare. Each flare lasted a mean of 4.30 days (S.d. 6.82, range 1-78), with a mean frequency of once every 35.32 days (S.d. 65.73, range 1-677). Significant relationships were identified between flare status and variable scores. Two clusters of participants were identified with distinct flare profiles. Group 1 experienced less severe worsening of symptoms during flare in comparison to group 2 (P < 0.01). However, they experienced significantly longer flare duration (7.2 vs 3.5 days; P < 0.01), perhaps indicating a prolonged, yet less intense flare experience. Groups were similar in terms of flare frequency and clinical characteristics. CONCLUSIONS: Two clusters of participants were identified with distinct flare experiences but similar baseline clinical characteristics. Smartphone technologies capture subtle changes in disease experience not currently considered in clinical practice.
RESUMEN
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.
Asunto(s)
Espondiloartritis Axial , Diagnóstico Tardío , Atención a la Salud , Calidad de Vida , Espondiloartritis Axial/diagnóstico , Espondiloartritis Axial/terapia , Barreras de Comunicación , Diagnóstico Tardío/efectos adversos , Diagnóstico Tardío/prevención & control , Diagnóstico Tardío/psicología , Atención a la Salud/organización & administración , Atención a la Salud/normas , Progresión de la Enfermedad , Humanos , Guías de Práctica Clínica como Asunto , Mejoramiento de la Calidad , Reumatología/métodos , Reumatología/normas , Tiempo de Tratamiento/organización & administración , Tiempo de Tratamiento/normasRESUMEN
Clinical assessment of spinal impairment in Axial Spondyloarthritis is currently performed using the Bath Ankylosing Spondylitis Metrological Index (BASMI). Despite being appreciated for its simplicity, the BASMI index lacks sensitivity and specificity of spinal changes, demonstrating poor association with radiographical range of motion (ROM). Inertial measurement units (IMUs) have shown promising results as a cost-effective method to quantitatively examine movement of the human body, however errors due to sensor angular drift have limited their application to a clinical space. Therefore, this article presents a wearable sensor protocol that facilitates unrestrained orientation measurements in space while limiting sensor angular drift through a novel constraint-based approach. Eleven healthy male participants performed five BASMI-inspired functional movements where spinal ROM and continuous kinematics were calculated for five spine segments and four spinal joint levels (lumbar, lower thoracic, upper thoracic and cervical). A Bland-Altman analysis was used to assess the level of agreement on range of motion measurements, whilst intraclass correlation coefficient (ICC), standardised error measurement, and minimum detectable change (MDC) to assess relative and absolute reliability. Continuous kinematics error was investigated through root mean square error (RMSE), maximum absolute error (MAE) and Spearman correlation coefficient (ρ). The overall error in the measurement of continuous kinematic measures was low in both the sagittal (RMSE = 2.1°), and frontal plane (RMSE = 2.3°). ROM limits of agreement (LoA) and minimum detectable change were excellent for the sagittal plane (maximum value LoA 1.9° and MDC 2.4°) and fair for lateral flexion (overall value LoA 4.8° and MDC 5.7°). The reliability analysis showed excellent level of agreement (ICC > 0.9) for both segment and joint ROM across all movements. The results from this study demonstrated better or equivalent accuracy than previous studies and were considered acceptable for application in a clinical setting. The protocol has shown to be a valuable tool for the assessment of spinal ROM and kinematics, but a clinical validation study on Axial Spondyloarthritis patients is required for the development and testing of a novel mobility index.
RESUMEN
BACKGROUND: Psoriasis is a chronic inflammatory disease of the skin affecting 2-3% of UK population. 30% of people affected by psoriasis will develop a distinct form of arthritis within 10 years of the skin condition onset. Although the pathogenesis of psoriatic arthritis is still unknown, there is a genetic predisposition triggered by environmental factors. Limited but convincing evidence link the gut microbiome to psoriatic arthritis. The Microbiome in Psoriatic ARThritis (Mi-PART) study propose is to characterise the microbiome-metabolic interface in patients affected by psoriatic arthritis to deepen our understanding of the pathogenesis of the disease. METHODS: This is a multicentre, prospective, observational study. Psoriatic arthritis (n = 65) and ankylosing spondylitis (n = 30) patients will be recruited in addition to a control group of healthy volunteers (n = 30). Patients eligibility will be evaluated against the Criteria for Psoriatic Arthritis (CASPAR), the Bath Ankylosing Spondylitis Activity Index (BASDAI) and the healthy volunteers who fulfil study inclusion and exclusion criteria. Information regarding their medical and medication history, demographics, diet and lifestyle will be collected. All the participants in the study will be asked to complete a 7-day food diary, to provide stool samples and to complete quality of life questionnaires. Routine clinical laboratory tests will be performed on blood and urine samples. Patients and healthy volunteers with gastrointestinal symptoms, previous history of cancer, gastrointestinal surgery in the previous 6 months or alcohol abuse will be excluded from the study. DISCUSSION: The aim of this trial is to characterise the microbiome of psoriatic arthritis patients and to compare it with microbiome of healthy volunteers and of patient with ankylosing spondylitis in order to define if different rheumatologic conditions are associated with characteristic microbiome profiles. Investigating the role of the microbiome in the development of psoriatic arthritis could deepen our understanding of the pathogenesis of the disease and potentially open the way to new therapies.