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Resumen Objetivo Evitar el deterioro de los pacientes con fibromialgia por actuaciones perjudiciales en la practica clinica potencialmente evitables. Metodos Un panel multidisciplinar de expertos identifico las areas clave, analizo la evidencia cientifica y formulo las recomendaciones a partir de esta evidencia y de tecnicas cualitativas de «evaluacion formal» o «juicio razonado». Resultados Se han elaborado 39 recomendaciones sobre diagnostico, tratamientos no eficaces ni seguros, educacion del paciente y formacion del profesional. En esta parte II se reflejan las 12 recomendaciones, referidas a las dos ultimas areas. Conclusiones Un buen conocimiento de la fibromialgia por el paciente mejora el afrontamiento y la aceptacion de la enfermedad reduciendo la gravedad de algunas manifestaciones clinicas. Los profesionales sanitarios que tratan a los pacientes con fibromialgia deben tener una buena formacion sobre esta enfermedad para mejorar los resultados del tratamiento y la relacion con el paciente.

Resumen Objetivo Evitar el deterioro de los pacientes con fibromialgia por actuaciones perjudiciales en la practica clinica potencialmente evitables. Metodos Un panel multidisciplinar de expertos identifico las areas claves, analizo la evidencia cientifica y formulo las recomendaciones a partir de esta evidencia y de tecnicas cualitativas de «evaluacion formal» o «juicio razonado». Resultados Se han elaborado 39 recomendaciones sobre diagnostico, tratamientos no eficaces ni seguros, educacion del paciente y formacion del profesional. En esta parte I se reflejan las 27 primeras, referidas a las 2 primeras areas. Conclusiones Establecer el diagnostico mejora el afrontamiento del paciente y reduce los costes sanitarios. Se deben evitar AINE, opioides mayores y benzodiacepinas por los efectos adversos. No existe una evidencia solida que justifique la asociacion de farmacos. Tampoco existe una buena evidencia para recomendar ningun tipo de terapia complementaria. Las cirugias muestran mas complicaciones y un grado de satisfaccion menor por el paciente por lo que deben evitarse si la indicacion no esta claramente establecida.

Objective To prevent the impairment of fibromyalgia patients due to harmful actions in daily clinical practice that are potentially avoidable. Methods A multidisciplinary team identified the main areas of interest and carried out an analysis of scientific evidence and established recommendations based on the evidence and “formal evaluation” or “reasoned judgment” qualitative analysis techniques. Results A total of 39 recommendations address diagnosis, unsafe or ineffective treatment interventions and patient and healthcare workers’ education. This part I shows the first 27 recommendations on the first 2 areas. Conclusions Establishing a diagnosis improves the patient's coping with the disease and reduces healthcare costs. NSAIDs, strong opioids and benzodiazepines should be avoided due to side effects. There is no good evidence to justify the association of several drugs. There is also no good evidence to recommend any complementary medicine. Surgeries show a greater number of complications and a lower degree of patient satisfaction and therefore should be avoided if the surgical indication is not clearly established.

Objective To prevent the deterioration of patients with fibromyalgia due to potentially avoidable harmful actions in clinical practice. Methods A multidisciplinary panel of experts identified key areas, analysed the scientific evidence and formulated recommendations based on this evidence and qualitative techniques of “formal assessment” or “reasoned judgement”. Results Thirty-nine recommendations were made on diagnosis, ineffective and unsafe treatments, patient education and practitioner training. This part II shows the 12 recommendations, referring to the latter two areas. Conclusions Good knowledge of fibromyalgia on the part of patients improves their coping and acceptance of the disease and reduces the severity of some clinical manifestations. Healthcare professionals treating patients with fibromyalgia should be well trained in this disease to improve treatment outcomes and patient relationships.

To assess the plasma apolipoprotein B/apolipoprotein A1 ratio and its potential association with cardiovascular events (CVE) in patients with rheumatoid arthritis (RA).A baseline analysis was made of the CARdiovascular in rheuMAtology Project (CARMA), a 10-year prospective study evaluating the presence of at least one CVE in 775 Spanish patients with RA. Of them, 29 had already experienced CVE prior to the inclusion in the study. We assessed the association between the elevation of the apoB/apoA1 ratio with the presence of CVE according to a logistic regression model for possible confounding factors. We also analysed the main parameters of activity of RA and parameters related to lipid metabolism. RA patients were classified according to treatment: patients treated with disease-modifying anti-rheumatic drugs without biologics and those undergoing biologic therapy (anti-TNF-α, anti-IL-6 receptor, and other biologic agents).The apoB/apoA1 ratio of patients who had experienced CVE was higher than that of patients without previous CVE (0.65 vs. 0.60). However, the difference between both subgroups did not reach statistical significance (p=0.197). It was also the case after the multivariate analysis [OR: 1.48 (95% CI: 0.15-14.4); p=0.735]. RA patients from the group with CVE were more commonly receiving lipid-lowering treatment with statins than those without CVE history (41.4% vs. 20%, p=0.005). High HAQ and high atherogenic index were significantly associated with the presence of CVE. There was no statistical association between the type of biologic therapy used in RA and the presence of CVE.No association between ApoB/apoA1 ratio and CVE was found at the baseline visit of patients with RA from the CARMA study.

Background Plasma concentrations of lipoprotein (a) (Lp(a)), a lipoprotein with atherogenic and thrombogenic properties, have a strong genetic basis, although high concentrations of Lp(a) have also been reported in the context of inflammation, as in rheumatoid arthritis (RA). Few studies evaluate the impact of biologic therapies (BT) on Lp(a) in RA, taking into account that with these new therapies a better control of inflammation is achieved. Objective The aim of the study was to evaluate the plasma concentrations of Lp(a) in Spanish RA patients on BT attending rheumatology outpatient clinics. Methods Baseline analysis of the CARdiovascular in rheuMAtology project, a 10-year prospective study, evaluating the risk of cardiovascular events in RA and other forms of inflammatory arthritis. RA patients were classified according to treatment: no biologic, anti-tumor necrosis factor, anti-interleukin-6 receptor tocilizumab (TCZ), and other biologic (rituximab or abatacept). A model of linear multivariate regression was built in which the dependent variable was Lp(a) concentration and the explanatory variable was BT. The model was adjusted for confounding factors. Results Seven hundred and seventy-five RA patients were analyzed. Plasma concentrations of total cholesterol and triglyceride were significantly higher in TCZ-treated patients. Nevertheless, no significant difference in the atherogenic index between TCZ-treated patients and patients without BT was found. After adjusting for confounding factors, patients with BT had lower concentrations of Lp(a) than those without BT; however, only TCZ-treated patients achieved statistically significant differences (?: ?0.303, 95% confidence interval: ?0.558 to ?0.047; P = .02). Conclusions RA patients treated with TCZ show lower plasma concentrations of Lp(a) compared with patients without BT. This project has been supported by an unrestricted grant from Abbvie, Spain. The design, analysis, interpretation of results, and preparation of the article have been done independently of Abbvie. Dr González-Gay's studies have been supported by grants from “Fondo de Investigaciones Sanitarias” PI06/0024, PS09/00748, and PI12/00060 and RD12/0009/0013 (RIER) from “Instituto de Salud Carlos III” (ISCIII) (Spain).

Resumen En el tratamiento farmacologico de la fibromialgia los antidepresivos triciclicos, como la amitriptilina y la ciclobenzaprina; los inhibidores selectivos de la recaptacion de serotonina, como la fluoxetina; los inhibidores de la recaptacion de serotonina y norepinefrina, como la duloxetina y el milnazipram; los analgesicos como el paracetamol, solo o asociado a tramadol, y algunos anticonvulsivantes del tipo de la pregabalina, son los farmacos que mejor han demostrado su eficacia en el control de los sintomas de la enfermedad. Otros farmacos, como los antiinflamatorios no esteroideos, los opioides mayores, los tratamientos hormonales y los productos de herbolario y parafarmacia, no han demostrado hasta la actualidad su eficacia en ensayos clinicos, por lo que tienen escasa utilidad en el tratamiento de la fibromialgia. Algunos antidepresivos, como la venlafaxina, la moclobemida, el pirlindol, la mirtazapina y el bupropion, han mostrado cierta eficacia en algunos estudios, pero se necesitan mas ensayos clinicos para recomendar su utilizacion en los pacientes con fibromialgia. Los farmacos agonistas de los receptores de dopamina pueden representar una buena opcion en el futuro del tratamiento de la fibromialgia si se confirman los resultados preliminares sobre la eficacia de este grupo de farmacos.

Resumen Objetivos Elaborar recomendaciones para el uso apropiado de AINE en reumatologia. Metodos Se utilizo una metodologia modificada de RAND/UCLA. Se seleccionaron dos grupos de panelistas, uno por el CMR y otro por la SER. A partir de grupos nominales, se obtuvieron propuestas de recomendaciones, que fueron sometidas a la prueba de acuerdo entre los reumatologos de ambas sociedades mediante encuesta Delphi a dos rondas. Del analisis de la segunda ronda Delphi, se extrajeron las recomendaciones finales y posteriormente se reviso el nivel de evidencia y el grado de acuerdo de la recomendacion segun el Centro de Medicina Basada en la Evidencia de Oxford. Finalmente, se efectuo revision sistematica de cinco recomendaciones sin acuerdo. Resultados Se presentan recomendaciones sobre el uso seguro de los AINE en las enfermedades reumaticas, con base en la mejor evidencia disponible, la opinion de expertos, el acuerdo entre reumatologos y la revision de la literatura. La tendencia es disminuir la frecuencia, la duracion y la dosis de AINE en favor de medidas no farmacologicas, analgesicos o farmacos modificadores de los sintomas o del curso de la enfermedad. Ademas, es obligado identificar perfiles de mayor riesgo de toxicidad, en especial gastrointestinal y cardiovascular. Se recomiendan pautas de actuacion y monitorizacion en los diferentes grupos de riesgo y en pacientes con empleo de antiagregantes plaquetarios, anticoagulacion o con terapias concomitantes. El porcentaje de acuerdo es elevado en la mayoria de los casos. Conclusiones Los AINE son medicamentos seguros y eficaces en el tratamiento de las afecciones reumaticas. No obstante, dado su perfil de riesgo, es necesario individualizar su uso.

Objetivo Lograr una version actualizada y de consenso del Fibromyalgia Impact Questionnaire (FIQ) para la poblacion espanola, el Cuestionario de Impacto de la Fibromialgia (CIF). Material y metodos La confeccion del CIF se llevo a cabo con participacion de todos los grupos de investigadores de las 4 versiones espanolas previas del FIQ y teniendo en consideracion la reciente version actualizada del original. Se aplico el CIF a una muestra de pacientes con fibromialgia para explorar la comprensibilidad de sus items y comparar las puntuaciones del cuestionario con 2 indices compuestos: “semiobjetivo” y “subjetivo” de gravedad de la fibromialgia. Se determinaron los correspondientes coeficientes de correlacion de Spearman. Resultados Se exponen las principales modificaciones introducidas en el cuestionario. Algunos pacientes confundieron las respuestas al subitem “j” y al item 3, los restantes items y subitems no plantearon problemas. Los coeficientes de correlacion entre las puntuaciones del CIF y los indices semiobjetivo y subjetivo fueron de 0,57 y 0,76, respectivamente (p Conclusion Se propone el CIF como version espanola actualizada y de consenso del FIQ.

Objective To obtain an updated FIQ consensus version for patients in Spain, the Cuestionario de Impacto de la Fibromialgia (CIF). Material and methods The CIF elaboration was carried out with the participation of all the groups of researchers in the 4 previous FIQ Spanish versions, and taking into account the recent updated version of the original FIQ. The CIF was completed by a sample of fibromialgia patients to explore how comprensible its items are and to compare its global score with 2 fibromialgia composite severity indexes, one semi-objective and one subjective. The corresponding Spearman correlation coefficients were determined. Results The main modifications introduced in the questionnaire are shown. Some patients were confused in their responses to subitem “j” and item 3, but not with regard to the remaining items or subitems. Correlation coeficients between the CIF and the semi-objective and subjective fibromialgia severity indexes were 0.57 and 0.76, respectively (P Conclusion The CIF is proposed as an updated Spanish version of the FIQ.

Objective To analyze the long-term efficacy of 2 interventions for female fibromyalgia (FM) patients: 1) cognitive-behavioral therapy (CBT), and 2) a physical exercise (PE)–based strategy. Methods We conducted a prospective, long-term, randomized, parallel clinical trial. The outcome variables are physical activity, aerobic capacity, and results of the Fibromyalgia Impact Questionnaire (FIQ), Short Form 36, Beck Anxiety and Depression Inventory, Chronic Pain Self-Efficacy Scale, and Chronic Pain Coping Inventory. All were measured at baseline, posttreatment, 6 months, and 1 year. The duration of both treatments was 8 weeks. Results Some items of the FIQ and some strategies to cope with pain improved significantly in both groups after treatment. All variables measuring functional capacity improved significantly in the PE group, whereas only physical activity of the vertebral column improved in the CBT group. There were no differences in anxiety, depression, and self efficacy after treatment in either group. After 1 year of followup, most of the parameters had returned to baseline values in both groups. However, in the PE group, functional capacity remained significantly better. Conclusions PE and CBT improve clinical manifestations in FM patients only for short periods of time. Improvement in self efficacy and physical fitness are not associated with improvement in clinical manifestations.

Objective To develop guidelines for the appropriate use of NSAIDs in rheumatology. Methods We used a methodology modified from the one developed by RAND/UCLA. Two groups of panellists were selected, one by the CMR and another by the SER. Recommendations were proposed from nominal groups and the agreement to them was tested among rheumatologists from both societies by a 2-round Delphi survey. The analysis of the second Delphi round supported the generation of the final set of recommendations and the assignment of a level of agreement to each of them. Systematic reviews of 5 recommendations in which the agreement was low or was divided were also carried out. Results Here we present recommendations for the safe use of NSAIDs in rheumatic diseases, based on the best available evidence, expert opinion, the agreement among rheumatologists, and literature review. The trend is to reduce the frequency, duration, and dose of NSAIDs in favour of non-pharmacological measures, analgesic drugs, or disease modifying drugs. In addition, the recommendations help to identify profiles for increased toxicity, with an emphasis on gastrointestinal and cardiovascular risks. The recommendations deal with the course of action and monitoring in different risk groups and in patients using antiplatelet or anticoagulant drugs. The overall level of agreement is high. Conclusions The NSAIDs are safe and effective drugs for the treatment of rheumatic diseases. However, it is necessary to individualize its use according to their risk profile.

To analyze the long-term efficacy of 2 interventions for female fibromyalgia (FM) patients: 1) cognitive-behavioral therapy (CBT), and 2) a physical exercise (PE)-based strategy.We conducted a prospective, long-term, randomized, parallel clinical trial. The outcome variables are physical activity, aerobic capacity, and results of the Fibromyalgia Impact Questionnaire (FIQ), Short Form 36, Beck Anxiety and Depression Inventory, Chronic Pain Self-Efficacy Scale, and Chronic Pain Coping Inventory. All were measured at baseline, posttreatment, 6 months, and 1 year. The duration of both treatments was 8 weeks.Some items of the FIQ and some strategies to cope with pain improved significantly in both groups after treatment. All variables measuring functional capacity improved significantly in the PE group, whereas only physical activity of the vertebral column improved in the CBT group. There were no differences in anxiety, depression, and self efficacy after treatment in either group. After 1 year of followup, most of the parameters had returned to baseline values in both groups. However, in the PE group, functional capacity remained significantly better.PE and CBT improve clinical manifestations in FM patients only for short periods of time. Improvement in self efficacy and physical fitness are not associated with improvement in clinical manifestations.

Chronic fatigue syndrome is characterised by intense fatigue, with duration of over six months and associated to other related symptoms. The latter include asthenia and easily induced tiredness that is not recovered after a night's sleep. The fatigue becomes so severe that it forces a 50% reduction in daily activities. Given its unknown aetiology, different hypotheses have been considered to explain the origin of the condition (from immunological disorders to the presence of post-traumatic oxidative stress), although there are no conclusive diagnostic tests. Diagnosis is established through the exclusion of other diseases causing fatigue. This syndrome is rare in childhood and adolescence, although the fatigue symptom per se is quite common in paediatric patients. Currently, no curative treatment exists for patients with chronic fatigue syndrome. The therapeutic approach to this syndrome requires a combination of different therapeutic modalities. The specific characteristics of the symptomatology of patients with chronic fatigue require a rapid adaptation of the educational, healthcare and social systems to prevent the problems derived from current systems. Such patients require multidisciplinary management due to the multiple and different issues affecting them. This document was realized by one of the Interdisciplinary Work Groups from the Institute for Rare Diseases, and its aim is to point out the main social and care needs for people affected with Chronic Fatigue Syndrome. For this, it includes not only the view of representatives for different scientific societies, but also the patient associations view, because they know the true history of their social and sanitary needs. In an interdisciplinary approach, this work also reviews the principal scientific, medical, socio-sanitary and psychological aspects of Chronic Fatigue Syndrome. We are also grateful to the Instituto de Salud Carlos III and the Public Health and Health Administration Chair of the Universidad Europea de Madrid for their sponsorship. Without each of their contributions, this publication would not have been possible. Sí