Propuesta de actualización del Health Assessment Questionnaire / Proposal for updating the Health Assessment Questionnaire

Objetivo: Proponer una modificación consensuada del Health Assessment Questionnaire (HAQ) según los valores, idioma y cultura predominantes en la sociedad española actual. Métodos: En primer lugar, se realizó una revisión de alcance de la literatura y una encuesta a usuarios del HAQ para identificar las limitaciones de este cuestionario. En una segunda fase se celebró una reunión con profesionales expertos para discutir los resultados y diseñar propuestas de modificación. Resultados: La revisión de alcance permitió describir las principales versiones del HAQ, así como sus propiedades psicométricas. En la encuesta a usuarios del HAQ se valoraron el grado de comprensión, la utilidad, la actualidad y la universalidad de cada uno de los ítems y se admitieron sugerencias y opiniones sobre sus principales inconvenientes. Durante la reunión de discusión se propusieron modificaciones de los ítems en función de los resultados de la revisión de alcance y de la encuesta a usuarios. Además, se tuvieron en cuenta la dificultad de comprensión de los ítems, su dificultad para evaluar los movimientos previstos, el carácter redundante, su obsolescencia y el posible sesgo de género. Conclusiones: Se propone una actualización de la versión española del HAQ en base a la revisión de la literatura y a la opinión de expertos que pone de manifiesto el cambio de paradigma en los valores culturales y que pretende aumentar la validez de contenido y capacidad de discriminación de este cuestionario.(AU)

Objective: To propose a consensus modification of the HAQ according to the predominant values, language, and culture of the society. Methods: First, a scoping review of the literature and a survey of HAQ users were conducted to identify the problems of this questionnaire. In a second phase, a meeting was held with expert professionals to discuss the results and design proposals for modification. Results: The scoping review allowed us to describe the main versions of the HAQ, as well as their psychometric properties. The HAQ users survey assessed the degree of comprehension, usefulness, timeliness, and universality of each of the items, and suggestions and opinions on its main limitations were accepted. During the discussion meeting, modifications to the items were proposed based on the results of the scoping review and the users survey. In addition, the difficulty of understanding the items, their difficulty in assessing intended movements, redundancy, obsolescence, and possible gender bias were taken into account. Conclusions. An update of the Spanish version of the HAQ is proposed based on the literature review and expert opinion that highlights the paradigm shift in cultural values and aims to increase the content validity and discrimination capacity of this questionnaire.(AU)

Proposal for updating the Health Assessment Questionnaire.

OBJECTIVE: To propose a consensus modification of the HAQ according to the predominant values, language, and culture of the society. METHODS: First, a scoping review of the literature and a survey of HAQ users were conducted to identify the problems of this questionnaire. In a second phase, a meeting was held with expert professionals to discuss the results and design proposals for modification. RESULTS: The scoping review allowed us to describe the main versions of the HAQ, as well as their psychometric properties. The HAQ users survey assessed the degree of comprehension, usefulness, timeliness, and universality of each of the items, and suggestions and opinions on its main limitations were accepted. During the discussion meeting, modifications to the items were proposed based on the results of the scoping review and the users survey. In addition, the difficulty of understanding the items, their difficulty in assessing intended movements, redundancy, obsolescence, and possible gender bias were taken into account. CONCLUSIONS: An update of the Spanish version of the HAQ is proposed based on the literature review and expert opinion that highlights the paradigm shift in cultural values and aims to increase the content validity and discrimination capacity of this questionnaire.

Long-term follow-up of certolizumab pegol in uveitis due to immune-mediated inflammatory diseases: multicentre study of 80 patients.

OBJECTIVES: To evaluate effectiveness and safety of certolizumab pegol (CZP) in uveitis due to immune-mediated inflammatory diseases (IMID). METHODS: Multicentre study of CZP-treated patients with IMID uveitis refractory to conventional immunosuppressant. Effectiveness was assessed through the following ocular parameters: best-corrected visual acuity, anterior chamber cells, vitritis, macular thickness and retinal vasculitis. These variables were compared between the baseline, and first week, first, third, sixth months, first and second year. RESULTS: We studied 80 (33 men/47 women) patients (111 affected eyes) with a mean age of 41.6±11.7 years. The IMID included were: spondyloarthritis (n=43), Behçet's disease (n=10), psoriatic arthritis (n=8), Crohn's disease (n=4), sarcoidosis (n=2), juvenile idiopathic arthritis (n=1), reactive arthritis (n=1), rheumatoid arthritis (n=1), relapsing polychondritis (n=1), CONCLUSIONS: CZP seems to be effective and safe in uveitis related to different IMID, even in patients refractory to previous biological drugs.

Assessing treatment tolerability for rheumatoid arthritis. Validation and practical applications of the 'TOL-AR-18 questionnaire' / Evaluación de la tolerabilidad al tratamiento de la artritis reumatoide. Validación y aplicaciones prácticas del «cuestionario TOL-AR-18»

INTRODUCTION: Given the lack of standardized tools to assess tolerability from patient's perspective, we carried out the validation of a questionnaire to asses treatment tolerability for rheumatoid arthritis (RA): TOL-AR-18. METHODS: The TOL-AR-18 was validated in the cross-sectional observational study in adult patients with RA. Socio-demographic and clinical variables were collected. Patients completed the TOL-AR-18 and ARTS questionnaires and a question about their general health status. RESULTS: Data of 66 patients with a mean age (standard deviation; SD) of 56.71 (10.50) years were analyzed; 66.7% were women. Mean (SD) time to disease progression was 10.76 (8.23) years, and time from first treatment initiation was 9.24 (7.70) years. Patients did not report other adverse events rather than those included in the TOL-AR-18. The questionnaire was feasible with high internal consistency (Cronbach's Alpha >0.90). Discriminant validity was moderate, with significant differences between patients in remission and all other, and between patients who did not report adverse events and the rest (P<.05). Convergent validity was moderate-low when correlated with the ARTS questionnaire. CONCLUSION: The TOL-AR-18 is valid for use in a clinical setting and useful as an additional tool for all professionals to manage and assess tolerability in RA

INTRODUCCIÓN: La ausencia de herramientas estandarizadas para evaluar la tolerabilidad desde la perspectiva del paciente, planteó la posibilidad de validar el cuestionario TOL-AR-18 de tolerabilidad al tratamiento de la artritis reumatoide (AR) y evaluar su aplicación en la práctica clínica. MÉTODOS: El desarrollo del cuestionario se realizó siguiendo la metodología estandarizada y posteriormente se validó mediante un estudio observacional y transversal con pacientes >18 años diagnosticados de AR, en tratamiento durante al menos 3 meses. Se recogieron variables socio-demográficas y clínicas. Los pacientes completaron los cuestionarios TOL-AR-18, ARTS, y el cuestionario sobre el estado de salud percibida. RESULTADOS: Se analizaron datos de 66 pacientes de edad media (desviación estándar [DE]) de 56,71 (10,50) años; un 66,7% eran mujeres y el 65,1% presentaba remisión/baja actividad por DAS28. La media (DE) del tiempo de evolución y del inicio del primer tratamiento fue de 11,34 (9,41) y 9,24 (7,7) años, respectivamente. Los pacientes no reportaron reacciones adversas adicionales a las incluidas en el TOL-AR-18. El cuestionario resultó factible con una consistencia interna elevada (alfa de Cronbach>0,9). La validez discriminante fue moderada, con diferencias estadísticamente significativas entre pacientes en remisión y el resto, y entre quienes no reportaban reacciones adversas y el resto (p < 0,05). La validez convergente fue moderada-baja al correlacionarse con el cuestionario ARTS. CONCLUSIONES: El cuestionario TOLAR-18 es válido para su uso en la práctica clínica y útil como herramienta complementaria para el manejo y valoración de la tolerabilidad en la AR por parte de todos los profesionales implicados

Assessing treatment tolerability for rheumatoid arthritis. Validation and practical applications of the 'TOL-AR-18 questionnaire'.

INTRODUCTION: Given the lack of standardized tools to assess tolerability from patient's perspective, we carried out the validation of a questionnaire to asses treatment tolerability for rheumatoid arthritis (RA): TOL-AR-18. METHODS: The TOL-AR-18 was validated in the cross-sectional observational study in adult patients with RA. Socio-demographic and clinical variables were collected. Patients completed the TOL-AR-18 and ARTS questionnaires and a question about their general health status. RESULTS: Data of 66 patients with a mean age (standard deviation; SD) of 56.71 (10.50) years were analyzed; 66.7% were women. Mean (SD) time to disease progression was 10.76 (8.23) years, and time from first treatment initiation was 9.24 (7.70) years. Patients did not report other adverse events rather than those included in the TOL-AR-18. The questionnaire was feasible with high internal consistency (Cronbach's α >0.90). Discriminant validity was moderate, with significant differences between patients in remission and all other, and between patients who did not report adverse events and the rest (P<.05). Convergent validity was moderate-low when correlated with the ARTS questionnaire. CONCLUSION: The TOL-AR-18 is valid for use in a clinical setting and useful as an additional tool for all professionals to manage and assess tolerability in RA.

Abatacept in patients with rheumatoid arthritis and interstitial lung disease: A national multicenter study of 63 patients.

OBJECTIVE: Interstitial lung disease (ILD) is one of the most serious complications of rheumatoid arthritis (RA). In the present study, we aimed to assess the efficacy of abatacept (ABA) in patients with ILD associated to RA. METHODS: National multicenter, non-controlled, open-label registry study of RA patients with ILD treated with ABA. RESULTS: 63 patients (36 women) with RA-associated ILD undergoing ABA therapy were studied. The mean ± standard deviation age at the time of the study was 63.2 ± 9.8 years. The median duration of RA and ILD from diagnosis were 6.8 and 1 year, respectively. RA was seropositive in 55 patients (87.3%). In 15 (23.8%) of 63 patients the development of ILD was closely related to the administration of synthetic or biologic disease modifying anti-rheumatic drugs. After a follow-up of 9.4 ± 3.2 months, two-thirds of patients remained stable whereas one-quarter experienced improvement in the Modified Medical Research Council scale. At that time forced vital capacity remained stable in almost two-thirds of patents and improved in one out of five patients assessed. Also, diffusing capacity of the lung for carbon monoxide remained stable in almost two-thirds and showed improvement in a quarter of the patients assessed. At 12 months, 50% of the 22 patients in whom chest HRCT scan was performed due persistence of respiratory symptoms showed stabilization, 8 (36.4%) improvement and 3 worsening of the HRCT scan pattern. Eleven of 63 patients had to discontinue ABA, mainly due to adverse events. CONCLUSION: ABA appears to be an effective in RA-associated ILD.

Efficacy of tocilizumab in conventional treatment-refractory adult-onset Still's disease: multicenter retrospective open-label study of thirty-four patients.

OBJECTIVE: Adult-onset Still's disease (AOSD) is frequently refractory to standard therapy. Tocilizumab (TCZ) has demonstrated efficacy in single cases and in small series of patients with AOSD. The aim of this multicenter study was to assess the efficacy of TCZ in patients with AOSD refractory to conventional treatment. METHODS: This was a retrospective open-label study of TCZ treatment in 34 patients with AOSD who had experienced an inadequate response to corticosteroids and at least 1 standard synthetic immunosuppressive drug and also, in many cases, biologic agents. RESULTS: The mean ± SD age of the patients (8 men and 26 women) was 38.7 ± 16.1 years. The median duration of AOSD before TCZ was initiated was 4.2 years (interquartile range [IQR] 1-9 years). The initial dosages of intravenous TCZ were 8 mg/kg every 4 weeks in 22 patients, 4 mg/kg every 4 weeks in 2 patients, and 8 mg/kg every 2 weeks in 10 patients. TCZ treatment resulted in rapid and maintained improvement in both clinical and laboratory parameters. After 1 year of TCZ therapy, the incidence of joint manifestations had decreased from 97.1% at baseline to 32.4%, the incidence of both cutaneous manifestations and fever had decreased from 58.8% to 5.9%, and the incidence of lymphadenopathy had decreased from 29.4% to 0%. A dramatic reduction in laboratory markers of inflammation, including the C-reactive protein level, the erythrocyte sedimentation rate, and the ferritin level, was achieved. The median dosage of prednisone was also reduced, from 13.8 mg/day (IQR 5-45) at the initiation of TCZ to 2.5 mg/day (IQR 0-30) at 12 months. After a median followup of 19 months (IQR 12-31 months), only 2 patients required permanent discontinuation of TCZ therapy because of severe infections. CONCLUSION: TCZ treatment was associated with rapid and maintained clinical and laboratory improvement in patients with AOSD refractory to standard treatment. However, joint manifestations seem to be more refractory to treatment compared with systemic manifestations.

Development of leprosy in a patient with rheumatoid arthritis during treatment with etanercept: a case report.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder. There is a clear association between some disease-modifying drugs used to treat RA and infection. The introduction of the anti-tumor necrosis factor (TNF) therapies has improved the outcome of severe RA. The TNF-antagonism may increase susceptibility to granulomatous pathogens such as Mycobacterium tuberculosis, Listeria monocytogenes, and Histoplasma capsulatum. METHODS: We report the case of a 37-year-old woman with RA receiving an anti-TNF agent, who developed a rash on her back and both legs, which was finally diagnosed as tuberculoid leprosy. RESULTS: This is the first case of leprosy due to anti-TNF therapy reported in Europe. CONCLUSIONS: Clinicians should be aware of this and other types of atypical and serious infections that patients may suffer from when treated with anti-TNF agents.