Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. Methods/design: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP.Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term. Assessment of outcomes will be blinded and will follow the intention-to-treat principle. Discussion: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. Trial registration: ISRCTN: ISRCTN5871969

Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population : cluster randomised trial

Background: Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. Methods/Design: A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm) and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox regression. Discussion: We hope to provide evidence of the effectiveness of the proposed biopsychosocial multidisciplinary intervention in avoiding the chronification of low back pain, and to reduce the duration of non-specific low back pain episodes. If the intervention is effective, it could be applied to Primary Health Care Centres

Interleukin 15 Levels in Serum May Predict a Severe Disease Course in Patients with Early Arthritis

Background: Interleukin-15 (IL-15) is thought to be involved in the physiopathological mechanisms of RA and it can be detected in the serum and the synovial fluid of inflamed joints in patients with RA but not in patients with osteoarthritis or other inflammatory joint diseases. Therefore, the objective of this work is to analyse whether serum IL-15 (sIL-15) levels serve as a biomarker of disease severity in patients with early arthritis (EA). Methodology and Results: Data from 190 patients in an EA register were analysed (77.2% female; median age 53 years; 6-month median disease duration at entry). Clinical and treatment information was recorded systematically, especially the prescription of disease modifying anti-rheumatic drugs. Two multivariate longitudinal analyses were performed with different dependent variables: 1) DAS28 and 2) a variable reflecting intensive treatment. Both included sIL-15 as predictive variable and other variables associated with disease severity, including rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (ACPA). Of the 171 patients (638 visits analysed) completing the follow-up, 71% suffered rheumatoid arthritis and 29% were considered as undifferentiated arthritis. Elevated sIL-15 was detected in 29% of this population and this biomarker did not overlap extensively with RF or ACPA. High sIL-15 levels (β Coefficient [95% confidence interval]: 0.12 [0.06-0.18]; p&0.001) or ACPA (0.34 [0.01-0.67]; p = 0.044) were significantly and independently associated with a higher DAS28 during follow-up, after adjusting for confounding variables such as gender, age and treatment. In addition, those patients with elevated sIL-15 had a significantly higher risk of receiving intensive treatment (RR 1.78, 95% confidence interval 1.18-2.7; p = 0.007). Conclusions: Patients with EA displaying high baseline sIL-15 suffered a more severe disease and received more intensive treatment. Thus, sIL-15 may be a biomarker for patients that are candidates for early and more intensive treatmentThe work of Belen Díaz-Sánchez was supported by the RETICS Programme (Programa de Redes Temáticas de Investigación Colaborativa [Colaborative Research Thematic Network Programme]; RD08/0075 - RIER [Red de Inflamación y Enfermedades Reumáticas; Inflammation and Rheumatic Diseases Network]) from the Instituto de Salud Carlos III, Spain (URL: www.isciii.es) within the VI National Plan for I+D+I 2008–2011 (FEDER). The work of Isidoro González-Álvaro was in part supported by a grant for the Intensification of the Research Tasks in the National Health Care System from Instituto de Salud Carlos III, Spain. The consumables for measurements and data analysis were supported by a Fondo de Investigación Sanitaria grant (08/0754) from the Instituto de Salud Carlos II

Variabilidad fitoquímica y repercusión antinutricional potencial en especies del género Albizia Phytochemical variability and potential antinutritional repercussion in species of the Albizia genus

Mediante los análisis de componentes principales (ACP), clasificación automática (ACA) y varianza simple (ANOVA), se estudió el espectro de variaciones de la composición química de once especies del género Albizia (A. berteriana, A. caribaea, A. cubana, A. falcata, A. kalkora, A. lebbeck, A. lucida, A. procera, A. saman, A. semani y A. odoratissima), establecidas en el arboretum de la EEPF "Indio Hatuey" en Matanzas, Cuba. Los indicadores bromatológicos evaluados fueron: PB, FDN, P, K, Na, Ca, Mg, ceniza y carbohidratos solubles (CHS); mientras que las concentraciones de los polifenoles totales (FT), los taninos que precipitan las proteínas (TPP), los taninos condensados (TC), los alcaloides (Alc), las saponinas (Sap) y las sales nitrogenadas de naturaleza no alcaloidal (SNNA) describieron las particularidades fitoquímicas. Se detectó una alta variabilidad para las primeras tres componentes en los indicadores bromatológicos y fitoquímicos (71,19 y 81,95%, respectivamente). Los ACA permitieron identificar cuatro grupos en ambos casos. Las variables que explicaron mejor la varianza fueron los contenidos de K, Ca, ceniza, CHS, FT, TPP y TC. Se concluye que, independientemente que las especies mostraron características particulares en su composición proximal, todas presentaron una aceptable composición bromatológica. Las arbóreas pueden ser divididas por sus características esencialmente polifenólicas (A. berteriana, A. cubana, A. falcata, A. kalkora y A. lucida) o saponínicas (A. caribaea, A. procera y A. saman), con elevadas concentraciones de fenoles y Sap (A. odoratissima), o por presentar bajos contenidos de estos últimos metabolitos secundarios (A. lebbeck y A. semani). Desde el punto de vista nutricional A. lebbeck, A. semani, A. caribaea, A. procera y A. saman constituyen las mejores opciones para la alimentación de los rumiantes, y solamente A. lebbeck y A. semani presentan potencialidades para los monogástricos.<br>By means of the analyses of main components (MCA), automatic classification (ACA) and simple variance (ANOVA), the spectrum of variations of the chemical composition of eleven species of the Albizia genus (A. berteriana, A. caribaea, A. cubana, A. falcata, A. kalkora, A. lebbeck, A. lucida, A. procera, A. saman, A. semani and A. odoratissima), established in the arboretum of the EEPF &#8220;Indio Hatuey&#8221; in Matanzas, Cuba, was studied. The bromatological indicators evaluated were: CP, NDF, P, K, Na, Ca, Mg, ash and soluble carbohydrates (SCH); while the concentrations of total polyphenols TP, protein precipitable tannins (PPT), condensed tannins (CT), alkaloids (Alk), saponins (Sap) and non-alkaloidal nitrogen salts (NANS) described the phytochemical particularities. A high variability was detected for the first three components in the bromatological and phytochemical indicators (71,19 and 81,95%, respectively). The ACA allowed to identify four groups in both cases. The variables that better accounted for the variance were the contents of K, Ca, ash, SCH, TP, PPT and CT. It is concluded that, independently from the fact that the species showed particular characteristics in their proximal composition, all of them presented an acceptable bromatological composition. The trees may be divided according to their essentially polyphenolic (A. berteriana, A. cubana, A. falcata, A. kalkora and A. lucida) or saponinic characteristics (A. caribaea, A. procera and A. saman), with high concentrations of phenols and Sap (A. odoratissima), or the presence of low contents of these latter metabolites (A. lebbeck and A. semani). From the nutritional point of view A. lebbeck, A. semani, A. caribaea, A. procera and A. saman constitute the best choices for feeding ruminants, and only A. lebbeck and A. semani show potentialities for monogastric animals