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OBJECTIVES: There are few papers concerning ethnic differences in disease expression in PsA, which may be influenced by a number of genetic, lifestyle and cultural factors. This article aims to compare clinical and radiographic phenotypes in people of South Asian (SA) and North European (NE) origin with a diagnosis of PsA. METHODS: This was a cross-sectional observational study recruiting patients of SA and NE origin from two hospitals in a well-defined area in the North of England. RESULTS: A total of 58 SA and 48 NE patients were recruited. SA patients had a more severe clinical phenotype with more tender (median 5 vs 2) and swollen (median 1 vs 0) joints, more severe enthesitis (median 3 vs 1.5), more patients with dactylitis (24% vs 8%), more severe skin disease (median PASI 2.2 vs 1) and worse disease activity as measured by the composite Psoriatic Arthritis Disease Activity Score (mean 4.5 vs 3.6). With regards to patient-completed measures, SA patients had worse impact with poorer quality of life and function (mean HAQ 0.9 vs 0.6; mean PsAQoL 10.8 vs 6.2; mean 36-item short form physical component score 33.5 vs 38.9). No significant differences in current MTX and biologics use were found. CONCLUSIONS: SA patients had a worse clinical phenotype and worse impact of disease than NE patients. Further studies are needed to confirm and explore the reasons behind these differences.
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Artritis Psoriásica/diagnóstico , Entesopatía/diagnóstico , Inflamación/diagnóstico , Calidad de Vida , Adulto , Artritis Psoriásica/diagnóstico por imagen , Artritis Psoriásica/etnología , Estudios Transversales , Progresión de la Enfermedad , Inglaterra , Entesopatía/diagnóstico por imagen , Entesopatía/etnología , Femenino , Humanos , Inflamación/diagnóstico por imagen , Inflamación/etnología , Masculino , Persona de Mediana Edad , Radiografía , Índice de Severidad de la EnfermedadRESUMEN
At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Collaborative Research Network (CRN) annual meeting, the GRAPPA-CRN group presented a pilot investigator-initiated study protocol to test electronic case report forms (eCRFs) and proposed Standardized Operating Procedures (SOPs) to evaluate biomarkers of psoriatic arthritis (PsA) associated with axial disease. The progress on 3 studies was also presented: BioDAM PsA (Biomarkers as Predictors of structural DAMage in PsA; to validate soluble biomarkers as predictors of structural damage in PsA), PreventPsA (examining the development of PsA and risk factors among patients with psoriasis and no arthritis), and PredictORPsA (Predicting Treatment respOnse in patients with eaRly PsA; in collaboration with Pfizer using samples from the Oral Psoriatic Arthritis TriaL [OPAL], to identify biomarkers of treatment response). GRAPPA-CRN funding partnerships and applications are also underway with both the Innovative Medicines Initiative (IMI) in Europe and Accelerating Medicines Partnerships (AMP) 2.0 in the USA, and the progress of these applications and associated objectives were presented.
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Artritis Psoriásica , Psoriasis , Artritis Psoriásica/diagnóstico , Artritis Psoriásica/tratamiento farmacológico , Biomarcadores , Europa (Continente) , Humanos , InvestigadoresRESUMEN
At the 2019 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis-Collaborative Research Network annual meeting, the group presented its progress in selecting a database platform; items to include in an electronic case report form (eCRF); and standardized operating procedures (SOP) for the collection, processing, storage, and transport of biomaterial. A pilot investigator-initiated study was also proposed that, in addition to addressing an area of unmet need, would allow for the testing of both the eCRF and SOP.
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Artritis Psoriásica , Psoriasis , Materiales Biocompatibles , Manejo de Datos , Bases de Datos Factuales , Humanos , Estándares de Referencia , InvestigadoresRESUMEN
OBJECTIVE: To develop new composite disease activity indices for psoriatic arthritis (PsA). METHODS: Data from routine clinic visits at multiple centres were collected in a systematic manner. Data included all domains identified as important in randomised controlled trials in PsA. Decisions to change treatment were used as surrogates for high disease activity. New indices were developed by multiple linear regression (psoriatic arthritis disease activity score: PASDAS) and empirically, utilising physician-defined cut-offs for disease activity (arithmetic mean of desirability functions: AMDF). These were compared with existing composite measures: Composite Psoriatic arthritis Disease Activity Index (CPDAI), Disease Activity for PSoriatic Arthritis (DAPSA), and Disease Activity Score for rheumatoid arthritis (DAS28). RESULTS: 161/503 (32%) subjects had treatment changes. Although all measures performed well, compared with existing indices, PASDAS was better able to discriminate between high and low disease activity (area under receiver operating curves (ROC)) curve with 95% CI: PASDAS 0.773 (0.723, 0.822); AMDF 0.730 (0.680, 0.780); CPDAI 0.719 (0.668, 0.770); DAPSA 0.710 (0.654, 0.766); DAS28 0.736 (0.680, 0.792). All measures were able to discriminate between disease activity states in patients with oligoarthritis, although area under the receiver operating curves (AUC) were generally smaller. In patients with severe skin disease (psoriasis area and severity index>10) both nonparametric and AUC curve statistics were nonsignificant for all measures. CONCLUSIONS: Two new composite measures to assess disease activity in PsA have been developed. Further testing in other datasets, including comparison with existing measures, is required to validate these instruments.
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Artritis Psoriásica/diagnóstico , Índice de Severidad de la Enfermedad , Adulto , Femenino , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Curva ROCRESUMEN
OBJECTIVES: To develop a preliminary composite psoriatic disease activity index (CPDAI) for psoriasis and psoriatic arthritis. METHODS: Five domains were assessed and specific instruments were employed for each domain to determine the extent of domain involvement and the effect of that involvement on quality of life/function. Disease activity for each domain was then graded from 0 to 3 giving a CPDAI range of 0-15. Patient and physician global disease activity measures were also recorded and an independent physician was asked to indicate if treatment change was required. Bivariate correlation analysis was performed. Factor, tree analysis and standardised response means were also calculated. RESULTS: Significant correlation was seen between CPDAI and both patient (r = 0.834) and physician (r = 0.825) global disease activity assessments (p = 0.01). Tree analysis revealed that 96.3% of patients had their treatment changed when CPDAI values were greater than 6; no patient had their treatment changed when CPDAI values were less than 5. CONCLUSION: CPDAI correlates well with patient and physician global disease activity assessments and is an effective tool that clearly distinguishes those who require a treatment change from those who do not.
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Artritis Psoriásica/diagnóstico , Índice de Severidad de la Enfermedad , Adulto , Anciano , Antirreumáticos/uso terapéutico , Artritis Psoriásica/tratamiento farmacológico , Monitoreo de Drogas/métodos , Métodos Epidemiológicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Calidad de Vida , Resultado del TratamientoRESUMEN
OBJECTIVE: Due to the recent pandemic caused by the coronavirus disease 2019 (COVID-19), in-person scheduled rheumatology appointments in many countries have been reserved for urgent cases only. Here we report the development of a multidimensional, patient-completed disease assessment tool for use in psoriatic arthritis (PsA). METHODS: A focus group development and education method was used, followed by a paired observation design to assess feasibility and validity. The Psoriatic Arthritis Disease Activity Score (PASDAS) was used as the basis for the clinical assessments, but elements of this tool were modified during the focus group sessions. RESULTS: A preliminary tool assessed tender and swollen joint counts, enthesitis, dactylitis, area of skin involved by psoriasis, and scores for global disease activity, fatigue, and spinal pain. In parallel assessments, good agreement was found between subject and healthcare professional (HCP) assessors, although overall disease activity was low. CONCLUSION: A self-assessment tool for disease activity in PsA has been developed in conjunction with patients, demonstrating generally good agreement between patients and HCPs; however, further validation is needed before it can be recommended for clinical practice.
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Artritis Psoriásica , COVID-19 , Artritis Psoriásica/diagnóstico , Humanos , SARS-CoV-2 , Autoevaluación (Psicología) , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: Evaluation of a psoriatic arthritis (PsA), multidimensional, patient-completed disease flare questionnaire (FLARE). METHODS: The FLARE questionnaire was administered to 139 patients in a prospective observational study. The "gold standard" of flare was based on patient opinion. Test-retest reliability was evaluated by intraclass correlation coefficient (ICC). Disease activity was measured by the Psoriatic Arthritis Disease Activity Score (PASDAS), Group for Research and Assessment of Psoriasis and PsA (GRAPPA) Composite Exercise (GRACE), Composite Psoriatic Disease Activity Index (CPDAI), and Disease Activity Index for Psoriatic Arthritis (DAPSA). RESULTS: The most common symptoms of a PsA flare were musculoskeletal, followed by fatigue, frustration, loss of function, and an increase in cutaneous symptoms. The test-retest ICC for the FLARE questionnaire was 0.87 (95% CI 0.72-0.94). The optimum cut-off to identify a flare of disease was 4/10 (sensitivity 0.82, specificity 0.76; area under the curve 0.85). For those patients scoring ≥ 4, the mean score for the composite measures was as follows (score for those not reporting a flare in parentheses): PASDAS 5.3 ± 1.3 (3.1 ± 1.6); GRACE 4.5 ± 1.2 (2.2 ± 1.4); CPDAI 8.9 ± 2.5 (4.7 ± 3.1); and DAPSA 38.2 ± 20.3 (16.8 ± 14.9). In a new flare, the increase in composite measure score was calculated as follows: 1 for PASDAS and GRACE, 2 for CPDAI, and 7 for DAPSA. Agreement between the definition of flare using the cut-off of 4 from the questionnaire, and that indicated by the subject in a separate, standalone question was 0.57 (Cohen κ). CONCLUSION: A PsA flare displays escalation of symptoms and signs across multiple domains. The FLARE questionnaire has external validity in terms of both composite disease activity and overall patient opinion about the state of their condition.
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Artritis Psoriásica , Psoriasis , Artritis Psoriásica/diagnóstico , Humanos , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Encuestas y CuestionariosRESUMEN
At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)- Collaborative Research Network (CRN) annual meeting, the GRAPPA-CRN group presented a pilot investigator-initiated study protocol to test electronic case report forms (eCRFs) and proposed Standardized Operating Procedures (SOPs) to evaluate biomarkers of psoriatic arthritis (PsA) associated with axial disease. The progress on 3 studies was also presented: BioDAM PsA (Biomarkers as Predictors of structural DAMage in PsA; to validate soluble biomarkers as predictors of structural damage in PsA), PreventPsA (examining the development of PsA and risk factors among patients with psoriasis and no arthritis), and PredictORPsA (Predicting Treatment respOnse in patients with eaRly PsA; in collaboration with Pfizer using samples from the Oral Psoriatic Arthritis TriaL [OPAL], to identify biomarkers of treatment response). GRAPPA-CRN funding partnerships and applications are also underway with both the Innovative Medicines Initiative (IMI) in Europe and Accelerating Medicines Partnerships (AMP) 2.0 in the USA, and the progress of these applications and associated objectives were presented.
RESUMEN
Objective Thrombolysis decreases the chance of post-stroke dependence, although its use carries significant risk, notably of intra-cerebral haemorrhage. Patients (and families) face an important risk/benefit decision before consenting. We drafted a patient information booklet for this purpose, and applied performance-based readability testing with the aim that the most important information in the booklet could be found and understood. Methods The booklet was developed with reference to best practice in information writing and design. We User-Tested its performance on 56 people without prior experience of stroke. After reading the booklet they were asked to find and explain 15 pieces of information. The booklet was revised according to its performance and re-tested, until each item was found and understood by at least 80% of participants. Key findings The four-page information booklet contained approximately 900 words, organised into six sections. A risk-palette graphic showed the chance of positive and negative outcomes. The booklet was tested on four participant cohorts and revised, including more bold text, re-wording, changing the title and changing the graphic to a coloured bar chart. Testing the final version on the fourth cohort of 20 people showed that each of the 15 tested items of information met the target of at least 80% participants being able to find and understand it. Conclusions The use of information design and User Testing produced a booklet that is understandable by people with no prior experience of stroke. User Testing is an inexpensive and quick method to ensure that information intended for patients is usable.
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Folletos , Educación del Paciente como Asunto/métodos , Accidente Cerebrovascular/tratamiento farmacológico , Terapia Trombolítica/métodos , Enfermedad Aguda , Adulto , Anciano , Anciano de 80 o más Años , Hemorragia Cerebral/inducido químicamente , Comprensión , Femenino , Fibrinolíticos/efectos adversos , Fibrinolíticos/uso terapéutico , Humanos , Consentimiento Informado , Masculino , Persona de Mediana Edad , Proyectos Piloto , Terapia Trombolítica/efectos adversos , Activador de Tejido Plasminógeno/efectos adversos , Activador de Tejido Plasminógeno/uso terapéuticoRESUMEN
OBJECTIVE: The Tight Control of inflammation in Psoriatic arthritis (TICOPA; isrctn.com: ISRCTN30147736) trial compared standard care (StdC) and tight control (TC) in early psoriatic arthritis (PsA), demonstrating better outcomes for TC. This substudy evaluated the performance metrics of modern imaging outcomes and compared them to the clinical data. METHODS: Non-contrast 0.2T magnetic resonance imaging (MRI; single hand) was assessed using the Outcomes in Rheumatology (OMERACT) PsA MRI Scoring System (PsAMRIS) with an additional global inflammation score. Ultrasound (US; same hand) was scored for greyscale, power Doppler, and erosions at the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints and scores summated. RESULTS: Seventy-eight patients had paired (baseline and 48 weeks) US data and 61 paired MRI data; 50 had matched clinical, MR, and US data. Significant within-group changes were seen for the inflammatory PsAMRIS components at MCP level: MRI global inflammation [median difference (range), standardized response mean (SRM)]: 3.25 (-5.0 to 12.0), 0.68; 1.0 (-4.5 to 17.5), 0.45 for TC and StdC, respectively. Similar within-group differences were obtained for US: 1.0 (-13.0 to 23.0), 0.45; 3.0 (-6.0 to 21.0), 0.77 for TC and StdC, respectively. No differences were seen between treatment groups. Significant correlations were found between baseline and change MRI and US scores. A significant correlation was found between baseline PsA disease activity scores and MRI global inflammation scores (Spearman ρ for MCP, PIP: 0.46, 0.63, respectively). No differences in erosion progression were observed. CONCLUSION: The PsAMRIS and US inflammation scores demonstrated good responsiveness. No between-group differences were demonstrated, but this substudy was likely underpowered to determine differences between the 2 treatment strategies.
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Artritis Psoriásica , Artritis Psoriásica/diagnóstico por imagen , Artritis Psoriásica/tratamiento farmacológico , Mano , Humanos , Inflamación , Imagen por Resonancia Magnética , UltrasonografíaRESUMEN
BACKGROUND: Guidelines recommend foot orthoses for people with both early (< 2 years) and established rheumatoid arthritis (RA). While prefabricated foot orthoses are cheaper and can exhibit comparable effects to customised devices, the available evidence for their effectiveness is inconsistent. Little is known about what types of foot orthoses clinicians prescribe. This study describes the foot orthoses prescription habits of podiatrists for people with rheumatoid arthritis. METHODS: One hundred and eighty-three podiatrists from the United Kingdom (UK) (n = 88), Australia (n = 68) and New Zealand (n = 27) completed a self-administered, online survey regarding the types of foot orthoses prescribed in clinical practice for people with RA. This study forms part of a wider international survey exploring foot orthosis prescription habits. RESULTS: UK respondents were more likely to prescribe prefabricated orthoses for early RA (n = 47, 53%) and customised orthoses for established RA (n = 47, 53%). Respondents in Australia were more likely to prescribe customised orthoses for both early (n = 32, 47%) and established (n = 46, 68%) RA, whilst respondents in New Zealand were more likely to prescribe prefabricated orthoses for both early (n = 16, 59%) and established (n = 10, 37%) disease.Irrespective of disease stage, the use of foam impression boxes was more prevalent in the UK and New Zealand when capturing a model of the feet prior to manufacturing customised orthoses. In contrast, electronic scanning and plaster of Paris were more common in Australia. Computer aided manufacture was utilised more frequently among respondents in Australia than in the UK and New Zealand. Respondents in all three countries specified more flexible shell materials for established RA, compared to early disease. Cushioning top covers (e.g. PORON® or polyurethane) were most frequently specified in all countries for both disease stages. CONCLUSIONS: Considerable variation was seen in the self-reported foot orthoses prescription habits of respondents for people with RA. Variation between countries and disease stage was seen in type of orthoses, specific brands, manufacturing methods, and materials prescribed. The results allow podiatrists and broader health service providers to compare their practice against reported national and international patterns.
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Artritis Reumatoide/rehabilitación , Ortesis del Pié/estadística & datos numéricos , Prescripciones/estadística & datos numéricos , Práctica Profesional/estadística & datos numéricos , Australia , Estudios Transversales , Femenino , Hábitos , Encuestas de Atención de la Salud , Humanos , Masculino , Nueva Zelanda , Podiatría/estadística & datos numéricos , Diseño de Prótesis , Reino UnidoRESUMEN
BACKGROUND: Foot orthoses are frequently used but little is known about which types are used in contemporary practice. This study aimed to explore the types of foot orthoses currently used by podiatrists and the prescription variations in a range of conditions. METHODS: A web-based, cross-sectional survey was distributed through professional bodies in the United Kingdom (UK), Australia, and New Zealand. Questions focussed on foot orthosis prescription habits in relation to 26 conditions affecting the back and lower limb. RESULTS: Two hundred and sixty-four podiatrists practising in 19 different countries completed the survey; the majority practised in the UK (47%, n = 124), Australia (30%, n = 79) and New Zealand (12%, n = 32). Respondents qualified between 1968 and 2016, and 147 (56%) were female. Respondents worked in different healthcare sectors and this varied between countries: 42 (34%) respondents in the UK worked solely in the public sector, compared to 3 (4%) in Australia and 2 (6%) in New Zealand. Forty-four (35%) respondents in the UK worked solely in private practice, compared to 64 (81%) in Australia and 14 (44%) in New Zealand.UK respondents prescribed more prefabricated orthoses per week (mean 5.5 pairs) than simple insole-type devices (±2.7) and customised devices (±2.9). Similarly, respondents in New Zealand prescribed more prefabricated orthoses per week (±7.7) than simple (±1.4) and customised (±2.8) devices. In contrast, those in Australia prescribed more customised orthoses per week (±4.4) than simple (±0.8) and prefabricated (±1.9) orthoses. Differences in the types of orthoses prescribed were observed between country of practice, working sector, and the condition targeted. Generally, prefabricated orthoses were commonly prescribed for the 26 highlighted conditions in the UK and New Zealand. Australian podiatrists prescribed far fewer devices overall, but when they did prescribe, they were more likely to prescribe custom devices. Respondents in all three countries were more likely to prescribe customised orthoses for people with diabetes complicated by peripheral neuropathy than for diabetes without this complication. CONCLUSIONS: Foot orthosis prescription habits vary between countries. Prefabricated orthoses were frequently prescribed in the UK and New Zealand, and customised orthoses in Australia. Prescriptions for people with diabetes differed depending on the presence of neuropathy, despite a lack of robust evidence supporting these decisions. This study provides new insight into contemporary practice.
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Diseño de Equipo/tendencias , Ortesis del Pié/efectos adversos , Podiatría/estadística & datos numéricos , Prescripciones/estadística & datos numéricos , Australia/epidemiología , Estudios Transversales , Femenino , Ortesis del Pié/estadística & datos numéricos , Hábitos , Humanos , Masculino , Nueva Zelanda/epidemiología , Encuestas y Cuestionarios/estadística & datos numéricos , Reino Unido/epidemiologíaRESUMEN
This study hypothesises that an educational leaflet about psoriatic arthritis (PsA) will improve psoriasis patients' attendance for screening for PsA. A random sample of patients ≥18 years old with a coded diagnosis of psoriasis and no diagnosis of PsA, rheumatoid arthritis or ankylosing spondylitis were identified from five GP surgeries in Yorkshire, UK. Patients were randomised 1:1 to receive study information alone or with the educational leaflet, with an invitation to attend for a screening examination by a dermatologist and rheumatologist. Nine hundred thirty-two invitation packs were sent to recruit 191 (20.5%) participants. One hundred sixty-nine (88.5%) had current or previous psoriasis and 17 (10.1%) had previously undiagnosed PsA. The estimated prevalence of PsA was 18.1% (95% CI: 16.2, 20.1%).The response rate was lower than expected and was not significantly higher when patients received the educational leaflet (22.8 vs 18.3%, p = 0.08). Response rates varied by practice (14.7 to 30.6%). However, deprivation scores for each practice revealed a significant increase in response with the leaflet for deprivation decile of 3 (p < 0.001) but no significant differences in the other practices. An educational leaflet about PsA improves attendance for screening in primary care, but only in those practices with higher levels of socioeconomic deprivation.
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Artritis Psoriásica/diagnóstico , Artritis Psoriásica/etiología , Folletos , Educación del Paciente como Asunto , Atención Primaria de Salud , Psoriasis/complicaciones , Femenino , Humanos , Masculino , Tamizaje Masivo , Persona de Mediana Edad , Clase Social , Factores SocioeconómicosRESUMEN
OBJECTIVE: The objective of this Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) initiative is to develop a questionnaire to determine the presence of a flare of disease activity in psoriatic disease (PsD), for use in clinical care and research settings. METHODS: In 2014 and 2015, 2 online Delphi surveys of patients and physicians attempted to achieve consensus about items that might discriminate a flare of disease. In the first round, items were derived from previous qualitative studies with patients; in the second round, new items, suggested by both patients and physicians, were added. Survey results were discussed at the 2015 GRAPPA annual meeting, and 8 breakout groups discussed specific aspects of PsD flares. RESULTS: Survey participants were patients (n = 103 and n = 57 in rounds 1 and 2) and physicians (n = 125 and n = 81). Items for flare covered 6 domains (joints, skin, emotion, participation, fatigue, and unclassified). Patients agreed that 20 items were important (10 joints, 1 participation, 8 fatigue, 1 unclassified), and physicians agreed on 23 items (5 skin, 11 joints, 4 participation, 3 unclassified). Eight items were selected as important by both groups: 7 joint items and 1 unclassified. Patients emphasized fatigue and physicians emphasized skin and participation. Breakout groups concluded that the components of a flare instrument should be derived from patients. A flare should be defined as a change in disease state requiring intervention. CONCLUSION: The concept of flare in PsD covers articular, skin, emotional, participation, and fatigue domains. Further work is required to specify items that represent these domains.
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Artritis Psoriásica/diagnóstico , Psoriasis/diagnóstico , Encuestas y Cuestionarios , Humanos , Evaluación de SíntomasRESUMEN
The objective of this study is to assess patient preferences for treatment-related benefits and risk of disease relapse in the management of low disease states of psoriatic arthritis (PsA). Focus groups with patients and a literature review were undertaken to determine the characteristics of treatment and symptoms of PsA important to patients. Patient preferences were assessed using a discrete choice experiment which compared hypothetical treatment profiles of the risk and benefits of treatment withdrawal. The risk outcome included increased risk of disease relapse, while benefit outcomes included reduced sickness/nausea from medication and changes in health-related quality of life. Each patient completed 12 choice sets comparing treatment profiles. Preference weights were estimated using a logic regression model, and the maximum acceptable risk in disease relapse for a given improvement in benefit outcomes was elicited. Final sample included 136 patients. Respondents attached the greatest importance to eliminating severe side effects of sickness/nausea and the least importance to a change in risk of relapse. Respondents were willing to accept an increase in the risk of relapse of 32.6 % in order to eliminate the side effects of sickness/nausea. For improvements in health status, the maximum acceptable risk in relapse was comparable to a movement from some to no sickness/nausea. The study suggests that patients in low disease states of PsA are willing to accept greater risks of relapse for improvements in side effects of sickness/nausea and overall health status, with the most important benefit attribute being the elimination of severe sickness or nausea.
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Artritis Psoriásica/psicología , Artritis Psoriásica/terapia , Prioridad del Paciente , Privación de Tratamiento , Adulto , Conducta de Elección , Femenino , Grupos Focales , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Recurrencia , Análisis de Regresión , Reumatología/métodos , Riesgo , Resultado del TratamientoRESUMEN
TNF therapy is effective for all aspects of psoriatic disease, but these drugs are costly and the long-term effects are unknown. Further, methotrexate causes concern with long-term adverse events. The purpose of this pilot study was to test the feasibility of drug withdrawal from patients with psoriatic arthritis, in stable low disease state. We examined the availability of patients, their willingness to participate, study procedures, and the proportion of patients in the withdrawal arm who relapsed during the study. Low disease state was defined by minimal disease activity criteria (MDA), and relapse by failure to achieve these criteria. Patients in the withdrawal group underwent a phased withdrawal of medication where the last treatment added was the first withdrawn. Assessments were monthly for 3 months before study exit. Seventy-two patients were invited to participate, of which 57 were found to be eligible. Twenty-six (36.1 %) subsequently attended the screening visit but 9 failed eligibility criteria so that 17 patients (29.8 % of the 57 eligible patients, 95 % confidence interval (CI) 18.4, 43.4 %) were randomised at a ratio of 2:1 in favour of the withdrawal arm (11 withdrawals, 6 standard care). Six patients experienced a flare, all of whom were in the withdrawal arm (relapse rate 54.6 %, 95 % CI 23.4, 83.3 %). Four of the flares were apparent from visit 3 (8 weeks after starting withdrawal). Given the high relapse rate, an alternative trial design of partial treatment withdrawal, possibly including a patient preference arm, is recommended.
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Antirreumáticos/uso terapéutico , Artritis Psoriásica/tratamiento farmacológico , Inmunosupresores/uso terapéutico , Privación de Tratamiento , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , RecurrenciaRESUMEN
BACKGROUND AND OBJECTIVES: Podiatry (chiropody) services are one of the most frequently requested services in primary care. The elderly are given priority access to podiatry services in the UK blocking access for other priority groups. To evaluate the clinical and cost-effectiveness of a self-management program as a means of managing nonurgent demands for podiatry services by the elderly without compromising foot-related disability. METHOD: Randomized clinical trial with blinded 6-month follow-up and economic evaluation. People aged 60+ seeking self-initiated or primary referred podiatric consultation were screened. Five hundred ninety-nine were excluded on the basis of health status, and 259 refused to participate or did not attend initially. Seventy-eight were randomized to receive a self-management program, and 75 usual care. The main outcome measure was foot disability, as measured by the Manchester Foot Disability Questionnaire. RESULTS: At 6 months, self-management program participants had lower foot disability scores than the usual care group (difference between scores -1, 95% C.I. -2, 0), and returned for fewer treatments within the 6-month study period (39 vs. 92 treatments). The cost per patient for the self-management program (pound sterling 10.92) was found to be the same as for usual care (pound sterling 10.71), but this included the cost of nail care packs. CONCLUSION: In this group a self-care program for routine foot care did not compromise therapeutic outcomes, and may be more cost effective in the long term. Further work is required to extend self-management programs to other target groups, such as people with diabetes at low risk for foot problems.
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Podiatría , Autocuidado/métodos , Anciano , Análisis Costo-Beneficio , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Educación del Paciente como Asunto , Podiatría/economía , Autocuidado/economía , Método Simple Ciego , Resultado del TratamientoRESUMEN
This study was conducted to determine the predictors of foot ulceration occurring in patients with rheumatoid arthritis (RA) without diabetes. A multi-centre case control study was undertaken; participants were recruited from eight sites (UK). Cases were adults diagnosed with RA (without diabetes) and the presence of a validated foot ulcer, defined as a full thickness skin defect occurring in isolation on / below the midline of the malleoli and requiring > 14 days to heal. Controls met the same criteria but were ulcer naive. Clinical examination included loss of sensation (10g monofilament); ankle-brachial pressure index (ABPI); forefoot deformity (Platto); plantar pressures (PressureStat); RA disease activity (36 swollen/tender joint counts) and the presence of vasculitis. History taking included past ulceration/foot surgery; current medication and smoking status. Participants completed the Health Assessment Questionnaire (HAQ) and Foot Impact Scale. A total of 83 cases with 112 current ulcers and 190 ulcer naïve controls participated. Cases were significantly older (mean age 71 years; 95 % confidence interval [CI], 69-73 vs. 62 years, 60-64) and had longer RA disease duration (mean 22 years; 19-25 vs. 15, 13-17). Univariate analysis showed that risk of ulceration increases with loss of sensation; abnormality of ABPI and foot deformity. Plantar pressures and joint counts were not significant predictors. HAQ score and history of foot surgery were strongly associated with ulceration (odds ratio [OR] = 1.704, 95 % CI 1.274-2.280 and OR = 2.256, 95 % CI 1.294-3.932). Three cases and two controls presented with suspected cutaneous vasculitis. In logistic regression modelling, ABPI (OR = 0.04; 95 % CI, 0.01-0.28) forefoot deformity (OR = 1.14; 95 % CI, 1.08-1.21) and loss of sensation (OR = 1.22; 95 % CI, 1.10-1.36) predicted risk of ulceration. In patients with RA, ABPI, forefoot deformity and loss of sensation predict risk of ulceration but, in contrast with diabetes, raised plantar pressures do not predict risk.