Response to Novel Drugs before and after Allogeneic Stem Cell Transplantation in Patients with Relapsed Multiple Myeloma.

Multiple myeloma (MM) remains as an incurable disease and, although allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative approach, most patients ultimately relapse, and their treatment remains challenging. Because allo-HSCT can modify not only the biology of the disease, but also the immune system and the microenvironment, it can potentially enhance the response to rescue therapies. Information on the efficacy and safety of novel drugs in patients relapsing after allo-HSCT is lacking, however. The objectives of this study were to evaluate the efficacy and toxicity of rescue therapies in patients with MM who relapsed after allo-HSCT, as well as to compare their efficacy before and after allo-HSCT. This retrospective multicenter study included 126 consecutive patients with MM who underwent allo-HSCT between 2000 and 2013 at 8 Spanish centers. All patients engrafted. The incidence of grade II-IV acute graft-versus-host disease (GVHD) was 47%, and nonrelapse mortality within the first 100 days post-transplantation was 13%. After a median follow-up of 92 months, overall survival (OS) was 51% at 2 years and 43% at 5 years. The median progression-free survival after allo-HSCT was 7 months, whereas the median OS after relapse was 33 months. Patients relapsing in the first 6 months after transplantation had a dismal prognosis compared with those who relapsed later (median OS, 11 months versus 120 months; P < .001). The absence of chronic GVHD was associated with reduced OS after relapse (hazard ratio, 3.44; P < .001). Most patients responded to rescue therapies, including proteasome inhibitors (PIs; 62%) and immunomodulatory drugs (IMiDs; 77%), with a good toxicity profile. An in-depth evaluation, including the type and intensity of PI- and IMiD-based combinations used before and after allo-HSCT, showed that the overall response rate and duration of response after allo-HSCT were similar to those seen in the pretransplantation period. Patients with MM who relapse after allo-HSCT should be considered candidates for therapy with new drugs, which can achieve similar response rates with similar durability as seen in the pretransplantation period. This pattern does not follow the usual course of the disease outside the transplantation setting, where response rates and time to progression decreases with each consecutive line of treatment.

Incidence, associated factors and clinical impact of severe infections in a large, multicentric cohort of patients with systemic lupus erythematosus.

OBJECTIVES: To estimate the incidence of severe infection and investigate the associated factors and clinical impact in a large systemic lupus erythematosus (SLE) retrospective cohort. METHODS: All patients in the Spanish Rheumatology Society Lupus Registry (RELESSER) who meet ≥4 ACR-97 SLE criteria were retrospectively investigated for severe infections. Patients with and without infections were compared in terms of SLE severity, damage, comorbidities, and demographic characteristics. A multivariable Cox regression model was built to calculate hazard ratios (HRs) for the first infection. RESULTS: A total of 3658 SLE patients were included: 90% female, median age 32.9 years (DQ 9.7), and mean follow-up (months) 120.2 (±87.6). A total of 705 (19.3%) patients suffered ≥1 severe infection. Total severe infections recorded in these patients numbered 1227. The incidence rate was 29.2 (95% CI: 27.6-30.9) infections per 1000 patient years. Time from first infection to second infection was significantly shorter than time from diagnosis to first infection (p < 0.000). Although respiratory infections were the most common (35.5%), bloodstream infections were the most frequent cause of mortality by infection (42.0%). In the Cox regression analysis, the following were all associated with infection: age at diagnosis (HR = 1.016, 95% CI: 1.009-1.023), Latin-American (Amerindian-Mestizo) ethnicity (HR = 2.151, 95% CI: 1.539-3.005), corticosteroids (≥10mg/day) (HR = 1.271, 95% CI: 1.034-1.561), immunosuppressors (HR = 1.348, 95% CI: 1.079-1.684), hospitalization by SLE (HR = 2.567, 95% CI: 1.905-3.459), Katz severity index (HR = 1.160, 95% CI: 1.105-1.217), SLICC/ACR damage index (HR = 1.069, 95% CI: 1.031-1.108), and smoking (HR = 1.332, 95% CI: 1.121-1.583). Duration of antimalarial use (months) proved protective (HR = 0.998, 95% CI: 0.997-0.999). CONCLUSIONS: Severe infection constitutes a predictor of poor prognosis in SLE patients, is more common in Latin-Americans and is associated with age, previous infection, and smoking. Antimalarials exerted a protective effect.

Centre characteristics determine ambulatory care and referrals in patients with spondyloarthritis.

OBJECTIVE: To describe the variability in rheumatology visits and referrals to other medical specialties of patients with spondyloarthritis (SpA) and to explore factors that may influence such variability. METHODS: Nation-wide cross-sectional study performed in 2009-2010. Randomly selected records of patients with a diagnosis of SpA and at least one visit to a rheumatology unit within the previous 2 years were audited. The rates of rheumatology visits and of referrals to other medical specialties were estimated-total and between centres-in the study period. Multilevel regression was used to analyse factors associated with variability and to adjust for clinical and patient characteristics. RESULTS: 1168 patients' records (45 centres) were reviewed, mainly ankylosing spondylitis (55.2 %) and psoriatic arthritis (22.2 %). The patients had incurred in 5908 visits to rheumatology clinics (rate 254 per 100 patient-years), 4307 visits to other medical specialties (19.6 % were referrals from rheumatology), and 775 visits to specialised nurse clinics. An adjusted variability in frequenting rheumatology clinics of 15.7 % between centres was observed. This was partially explained by the number of faculties and trainees. The adjusted intercentre variability for referrals to other specialties was 12.3 %, and it was associated with urban settings, number of procedures, and existence of SpA dedicated clinics; the probability of a patient with SpA of being referred to other specialist may increase up to 25 % depending on the treating centre. CONCLUSION: Frequenting rheumatology clinics and referrals to other specialists significantly varies between centres, after adjustment by patient characteristics.

Centre-related variability in hospital admissions of patients with spondyloarthritis.

The aim of this study was to explore the variability in hospital admissions of patients with spondyloarthritis (SpA) in Spain, and the centre factors that may influence that variability. Descriptive cross-sectional study, part of the emAR II study, performed in Spain (2009-2010). Health records of patients with a diagnosis of SpA and at least one visit to the rheumatology units within the previous 2 years were reviewed. Variables related to hospital admissions, to the SpA, and to the patient and centre were collected. A multilevel logistic regression analysis of random intercept with non-random slopes was performed to assess variability between centres. From 45 centres, 1168 patients' health records were reviewed. Main SpA forms were ankylosing spondylitis (55.2 %) and psoriatic arthritis (22.2 %). A total of 248 admissions were registered for 196 patients (19.2 %, n = 1020). An adjusted variability of 17.6 % in hospitalizations between centres was noted. The following hospital-related factors showed a significant association with admissions: the total number of admissions of the centre, the existence of electronic admission, and the availability of ultrasound in rheumatology. However, these factors only explained 42.9 % of the inter-centre variability. The risk of a patient with SpA of being admitted could double (median OR 2.09), depending on the hospital where the patient was being managed. Hospital admissions of patients with SpA varied between hospitals due to centre characteristics. Further studies are needed to ascertain which specific factors may be causing the variation, as studied variables explained less than half of the variability.

Fibromyalgia prevalence and related factors in a large registry of patients with systemic lupus erythematosus.

OBJECTIVES: The objective of this study is to determine the prevalence of fibromyalgia (FM) in systemic lupus erythematosus (SLE) patients and to study its relationship to depression and other SLE-related factors. METHODS: A cross-sectional data analysis from the RELESSER-Transversal Spanish Registry, which includes SLE patients in a national multicentre retrospective charts review, was performed. INCLUSION CRITERIA: patients who fulfilled ≥4 ACR 1997 SLE criteria. Main variables were disease duration, depression, sociodemographics, comorbidities, SLE activity symptoms, serological findings, therapies and different disease status indices. Statistical analyses included a descriptive, associative and logistic regression analyses. A literature review was performed. RESULTS: 3,591 SLE patients were included, 90.1% women, 34.6 years of age at diagnosis (SD 14.6 years) and 93.1% Caucasians. FM prevalence was 6.2%. SLE patients with disease duration >5 years showed more FM than those with duration <5 years: 6.9% vs. 4.0%, respectively (p<0.05). SLE-FM patients showed higher prevalence of depression compared to non-FM-SLE patients: 53.1% vs. 14.6%, respectively (p<0.001). After adjusting by risk factors, the OR (CI) of suffering depression in FM-SLE patients was 6.779 (4.770-9.636), p<0.001. The OR of having secondary Sjögren's 2.447 (1.662-3.604), p<0.001, photosensitivity 2.184 (1.431-3.334), p<0.001, and oral ulcers 1.436 (1.005-2.051), p=0.047. CONCLUSIONS: Prevalence of FM in Caucasian SLE patients was high compared to the general population, and was significantly higher in those in later stages of disease. SLE patients with depression showed a strong risk of developing FM. Photosensitivity, oral ulcers and secondary Sjögren's were the only SLE-related factors associated with FM.

Cardiovascular morbidity and associated risk factors in Spanish patients with chronic inflammatory rheumatic diseases attending rheumatology clinics: Baseline data of the CARMA Project.

OBJECTIVE: To establish the cardiovascular (CV) morbidity and associated risk factors for CV disease (CVD) in Spanish patients with chronic inflammatory rheumatic diseases (CIRD) and unexposed individuals attending rheumatology clinics. METHODS: Analysis of data from the baseline visit of a 10-year prospective study [CARdiovascular in rheuMAtology (CARMA) project] that includes a cohort of patients with CIRD [rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)] and another cohort of matched individuals without CIRD attending outpatient rheumatology clinics from 67 hospitals in Spain. Prevalence of CV morbidity, CV risk factors, and systematic coronary risk evaluation (SCORE) assessment were analyzed. RESULTS: A total of 2234 patients (775 RA, 738 AS, and 721 PsA) and 677 unexposed subjects were included. Patients had low disease activity at the time of recruitment. PsA patients had more commonly classic CV risk factors and metabolic syndrome features than did the remaining individuals. The prevalence of CVD was higher in RA (10.5%) than in AS (7.6%), PsA (7.2%), and unexposed individuals (6.4%). A multivariate analysis adjusted for the presence of classic CV risk factors and disease duration revealed a positive trend for CVD in RA (OR = 1.58; 95% CI: 0.90-2.76; p = 0.10) and AS (OR = 1.77; 95% CI: 0.96-3.27; p = 0.07). Disease duration in all CIRD groups and functional capacity (HAQ) in RA were associated with an increased risk of CVD (OR = 2.15; 95% CI: 1.29-3.56; p = 0.003). Most patients had a moderate CV risk according to the SCORE charts. CONCLUSIONS: Despite recent advances in the management of CIRD, incidence of CVD remains increased in Spanish subjects with CIRD attending outpatient rheumatology clinics.

Drug survival of anti-tumour necrosis factor α therapy in spondyloarthropathies: results from the Spanish emAR II Study.

OBJECTIVE: To assess drug survival and the reasons for switching anti-TNF-α therapy in SpA patients in a Spanish nationwide study. METHODS: A cross-sectional study was performed. Sample size was calculated to represent all regions and hospitals throughout the country. Demographic data, patient characteristics and disease activity parameters were obtained. Drug survival and reasons for switching anti-TNF therapy were also recorded. RESULTS: A total of 467 SpA patients receiving at least one anti-TNF agent were identified. Among patients who received a first, second and third anti-TNF course, 39.4%, 37.4% and 23.1% discontinued treatment, respectively. The main reasons for switching anti-TNF agents in the first course were lack or loss of efficacy (LOE) and adverse events (AEs) in 40% and 30% of switchers, respectively. Similarly, reasons for switching during the second anti-TNF course were LOE in 48% and AEs in 28% of switchers. Of the 467 SpA patients starting anti-TNF therapy, 28% switched to a second and 8% switched to a third therapy. Mean drug survival for the first, second and third anti-TNF courses were 84.4 (95% CI 78.4, 90.5), 70.2 (95% CI 61.6, 78.9) and 64.8 (95% CI 51.1, 78.5) months, respectively (P = 0.315). CONCLUSION: Twenty-eight per cent of SpA patients starting anti-TNF therapy switched to a second anti-TNF agent. Drug survival did not differ among anti-TNF courses. The main reason for switching anti-TNF therapy was LOE. Switchers were more frequently women and had higher disease activity parameters at the time of the study than non-switchers.

Pharmaceutical care in smoking cessation.

As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation.

Variability in the prescription of non-biologic disease-modifying antirheumatic drugs for the treatment of spondyloarthritis in Spain.

OBJECTIVE: To describe the variability in the prescription of non-biologic disease-modifying antirheumatic drugs (nbDMARDs) for the treatment of spondyloarthritis (SpA) in Spain and to explore which factors relating to the disease, patient, physician, and/or center contribute to these variations. METHODS: A retrospective medical record review was performed using a probabilistic sample of 1168 patients with SpA from 45 centers distributed in 15/19 regions in Spain. The sociodemographic and clinical features and the use of drugs were recorded following a standardized protocol. Logistic regression, with nbDMARDs prescriptions as the dependent variable, was used for bivariable analysis. A multilevel logistic regression model was used to study variability. RESULTS: The probability of receiving an nbDMARD was higher in female patients [OR = 1.548; 95% confidence interval (CI): 1.208-1.984], in those with elevated C-reactive protein (OR = 1.039; 95% CI: 1.012-1.066) and erythrocyte sedimentation rate (OR = 1.012; 95% CI: 1.003-1.021), in those with a higher number of affected peripheral joints (OR = 12.921; 95% CI: 2.911-57.347), and in patients with extra-articular manifestations like dactylitis (OR = 2.997; 95% CI: 1.868-4.809), psoriasis (OR = 2.601; 95% CI: 1.870-3.617), and enthesitis (OR = 1.717; 95% CI: 1.224-2.410). There was a marked variability in the prescription of nbDMARDs for SpA patients, depending on the center (14.3%; variance 0.549; standard error 0.161; median odds ratio 2.366; p < 0.001). After adjusting for patient and center variables, this variability fell to 3.8%. CONCLUSION: A number of factors affecting variability in clinical practice, and which are independent of disease characteristics, are associated with the probability of SpA patients receiving nbDMARDs in Spain.

Supervivencia en cáncer de mama tras 10 años de seguimiento en las provincias de Granada y Almería / Breast cancer survival after 10 years of follow up, in Granada and Almeria spanish provinces

Fundamento: Describir la supervivencia global y libre de enfermedad a los cinco y diez años del diagnóstico de cáncer de mama en mujeres participantes un estudio caso control previo, y establecer las variables pronóstico relacionadas. Métodos: Se realizó el seguimiento de 202 mujeres diagnosticadas en tres hospitales públicos de Granada y Almería entre 19961998. La supervivencia se evaluó mediante el método de Kaplan-Meier, y la identificación de factores relacionados mediante el análisis de regresión de Cox. Resultados: La edad media al diagnóstico fue de 54,27±10,4 años. La supervivencia global a los 5 años fue del 83,9% (IC 95%: 78,13-89,66) y a los 10 años del 71% (IC 95%: 63,25-78,74) con un tiempo medio de seguimiento de 119,91 meses (IC 95% 113,65126,17). La supervivencia libre de enfermedad a los 5 años fue del 81% (IC 95%: 74,52-87,47) y a los 10 años del 71,3% (IC 95%: 63,33-79,26) con un tiempo medio de seguimiento de 118,75 meses (IC 95% 111,86-125,65). La mortalidad de la serie fue del 33’17%. Conclusiones: Las características de la enfermedad en las mujeres de la muestra estudiada son similares a las de otras regiones de España y Europa, con una supervivencia global superior a la descrita en Europa y y comparable a la de España amba referidas para el mismo periodo(AU)

Background: To describe the overall and disease-free survival at five and ten years after breast cancer diagnosis in women from a previous case-control study, and establish related prognostic factors. Methods: We followed up 202 patients diagnosed between 1996 and 1998 in three public hospitals in Granada and Almeria provinces in Spain. Survival rates were calculated using the Kaplan and Meier method, and the Cox proportional hazards model was applied to identify the most significant variables contributing to survival. Results: Mean age at diagnosis was 54.27±10.4 years. Mean follow-up for overall survival was 119.91 months (95%CI 113.65126.17); the five-year survival rate was 83.9% (95%CI: 78.13-89.66) and the ten-year rate was 71% (95%CI: 63.25-78.74). Mean followup for disease-free survival was 118.75 months (95%CI 111.86125.65); the five-year disease-free survival rate was 81% (95%CI: 74.52-87.47) and the ten-year rate was 71.3% (95%CI: 63.33-79.26). The mortality rate of the study population was 33.17%. Conclusions: Disease characteristics are similar in our population to those in other Spanish and European regions, while the overall survival is higher than the mean rate during the same period in Europe (5-yr rate of 79%) and similar to that in Spain (83%)(AU)

[Breast cancer survival after 10 years of follow up, in Granada and Almeria Spanish Provinces]. / Supervivencia en cáncer de mama tras 10 años de seguimiento en las provincias de Granada y Almería.

BACKGROUND: To describe the overall and disease-free survival at five and ten years after breast cancer diagnosis in women from a previous case-control study, and establish related prognostic factors. METHODS: We followed up 202 patients diagnosed between 1996 and 1998 in three public hospitals in Granada and Almeria provinces in Spain. Survival rates were calculated using the Kaplan and Meier method, and the Cox proportional hazards model was applied to identify the most significant variables contributing to survival. RESULTS: Mean age at diagnosis was 54.27 ± 10.4 years. Mean follow-up for overall survival was 119.91 months (95%CI 113.65-126.17); the five-year survival rate was 83.9% (95%CI: 78.13-89.66) and the ten-year rate was 71% (95% CI: 63.25-78.74). Mean follow-up for disease-free survival was 118.75 months (95%CI 111.86-125.65); the five-year disease-free survival rate was 81% (95% CI: 74.52-87.47) and the ten-year rate was 71.3% (95% CI: 63.33-79.26). The mortality rate of the study population was 33.17%. CONCLUSIONS: Disease characteristics are similar in our population to those in other Spanish and European regions, while the overall survival is higher than the mean rate during the same period in Europe (5-yr rate of 79%) and similar to that in Spain (83%).

Cómo redactar un resumen para una publicación comunicación científica / No disponible

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Cómo elaborar un protocolo de investigación en salud / How to elaborate a protocol on health research

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Dificultades en la comunicación con el paciente de cáncer y su familia: la perspectiva de los profesionales / Communication difficulties with cancer patients and their families from the perspective of healthcare professionals

Objetivos: Conocer cómo los profesionales de los servicios de oncología perciben la comunicación con los pacientes de cáncer y sus familiares. Detectar las necesidades de formación en habilidades de comunicación de estos profesionales. Material y método: El estudio se realizó mediante un proceso de obtención de consensos y discrepancias, utilizando un método Delphi, con 2 rondas de consultas a un grupo de expertos seleccionado entre el personal médico y de enfermería de los servicios de oncología médica y radioterápica de los hospitales del sistema sanitario público de Andalucía. Resultados: Los profesionales reconocen como elementos favorecedores de la comunicación con el paciente/familia aspectos que dependen del profesional sanitario, como pueden ser el tipo de acogida, el tiempo dedicado y la importancia que se da a la comunicación dentro de la labor asistencial. Las dificultades detectadas van desde elementos relacionados con el profesional sanitario (la falta de adiestramiento en materia de comunicación), hasta dificultades que dependen del medio y del entorno (esperas inadecuadas, espacios inapropiados) y aspectos relacionados con el paciente y las características de la enfermedad. Destaca el consenso en la valoración de la importancia que dan los profesionales a la formación en habilidades emocionales y de comunicación. Conclusiones: Dado que los profesionales reconocen las dificultades de la comunicación con los pacientes y familiares y la carencia de formación adecuada para resolverlas, consideramos que se debe impulsar la formación en habilidades emocionales y de comunicación

Objectives: To determine how difficulties in communicating with cancer patients and their relatives are perceived by staff in oncology departments and to detect training needs in communication skills among these professionals. Material and method: The study was performed through a process of obtaining consensus and discrepancies, using a Delphi method, with two rounds of consultations with a group of experts selected from the medical and nursing staff of the medical oncology and radiotherapy departments of the hospitals of the Andalusian health system. Results: The health professionals identified some staff-related elements favoring communication with patients and their families, such as the type of welcome and the time and importance given to communication within medical care. The difficulties detected ranged from staff-related elements (lack of training in communication skills), to resource­ and environment-related difficulties (excessive delays, unsuitable spaces) and patient­ and disease-related elements. There was notable consensus on the importance given by health professionals to training in emotional and communication skills. Conclusions: Because the health professionals in this study acknowledged difficulties in communicating with patients and their families, as well as lack of adequate training in these skills, we believe that training in emotional and communication skills should be provided