Recommendations by the Spanish Society of Rheumatology on risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis.

OBJECTIVE: To present recommendations based on the available evidence and the consensus of experts, for risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis. METHODS: Clinical research questions relevant to the purpose of the document were identified. These questions were reformulated in PICO format (patient, intervention, comparison, outcome or outcome) by a panel of experts, selected based on their experience in the area. A systematic review of the evidence was carried out, grading according to the GRADE criteria (Grading of Recommendations Assessment, Development, and Evaluation). Specific recommendations were then formulated. RESULTS: 6 PICO questions were proposed by the panel of experts based on their clinical relevance and the existence of recent information regarding the risk of occurrence of serious infections, the risk of reactivation of the hepatitis B virus, the risk of reactivation of the virus varicella-zoster, the risk of appearance of skin (melanoma and non-melanoma) or haematological cancer, the risk of appearance of thromboembolic disease and the risk of progression of the human papilloma virus. A total of 28 recommendations were formulated, structured by question, based on the evidence found and the consensus of the experts. CONCLUSIONS: The SER recommendations on risk management of treatment with biologic therapies and JAK inhibitors in rheumatoid arthritis are presented.

Exploring Disparities in Self-Reported Mental Health Symptoms Across Professional Categories in Spain's Emergency Medical Services: A Nationwide Cross-Sectional Study.

OBJECTIVE: This study aimed to analyze stress, anxiety, depression, and self-efficacy levels among Spanish out-of-hospital emergency medical professionals from February 1, 2021, to April 30, 2021. METHODS: A nationwide survey was completed by 1666 Emergency Medical Services (EMS) workers. The Depression, Anxiety, and Stress Scale (DASS-21) and the General Self-Efficacy Scale (GSE) were used. Data analysis used chi-squared, análisis of variance (ANOVA), and logistic regressions. RESULTS: The sample comprised 833 (50%) men, with an average age of 44.3 ± 9.9 y (range: 19-67 y). Occupational distribution included 453 (27.2%) physicians, 474 (28.4%) nurses, and 739 (44.4%) emergency medical technicians (EMTs). EMTs exhibited higher odds of severe or extremely severe depression compared with physicians (odds ratio [OR]: 1.569; 95% confidenceinterval [95% CI]: 1.213-2.030) and nurses (OR: 1.561; 95% CI: 1.211-2.012). EMTs also displayed higher probabilities of severe or extremely severe anxiety compared with nurses (OR: 1.944; 95% CI: 1.529-2.701). Furthermore, EMTs demonstrated elevated probabilities of severe or extremely severe stress compared with physicians (OR: 1.387; 95% CI: 1.088-1.770). However, no significant differences were found in self-efficacy, with a median value of 73 [20]. CONCLUSIONS: Out-of-hospital EMS workers experienced mental health challenges, showing varying levels of depression, stress, and anxiety across different occupational groups. EMTs were particularly affected.

Secondary School Athletic Trainers' Clinical Management Decisions of Low Socioeconomic Status Patients.

CONTEXT: Evidence suggests that negative social determinants of health (SDOH) and lower socioeconomic status (SES) contribute to health care disparities. Due to their accessibility in the high school setting, secondary school athletic trainers (SSATs) may encounter patients that are historically underserved in health care such as low SES patients. However, there is a significant gap in knowledge regarding how SES and SDOH may influence SSATs' clinical management decisions. OBJECTIVE: The purpose of this study was to describe SSATs' perceptions of how patient SDOH and SES influence clinical management decisions and to identify barriers to athletic healthcare. DESIGN: Cross-sectional study. SETTING: Online survey. PARTICIPANTS: NATA SSATs (6.7% response rate). MAIN OUTCOME MEASURE(S): SSATs were asked about their perceptions of patient SES and the SDOH (CVI = 0.83 for relevancy). Questions were ranked on a 4-point Liker scale on level of relevance and agreement. Data were summarized by means and standard deviations (SD), frequencies and proportions (%), and median scores. RESULTS: A total of 380 SSATs participated (years of experience mean=14.9±11.7 years). When providing care, most (71.3%) SSATs believed that their patient's health/health care access SDOH to be the most relevant of the 5 SDOH whereas the other 4 SDOH were less than 60% relevant. Most SSATs agreed/strongly agreed that patient SES impacts referral (67.4%) and the reliance on conservative treatment before referral (71.2%). SSATs identified patient/guardian compliance (70.2%) and type of health insurance (61.5%) as barriers to providing care to low SES patients. CONCLUSIONS: SSATs perceived health/health care access as the most relevant SDOH when providing care to low SES patients. When SSATs further considered the SES of patients, they identified all SDOHs as barriers to providing health care they were ill equipped to navigate as they delivered care and engaged in patient referral.

[What about the weekend effect? Impact of the day of admission on in-hospital mortality, length of stay and cost of hospitalization]. / ¿Qué hay del efecto fin de semana? Impacto del día de ingreso sobre la mortalidad intrahospitalaria, la duración de la estancia y el coste de la hospitalización.

INTRODUCTION: There is no agreement on the existence of the weekend effect in healthcare or, if it exists, on its possible causes. The objective of the study was to evaluate the differences in healthcare outcomes between patients admitted on weekdays or weekends in a high-complexity hospital. METHODS: Observational and retrospective study of patients admitted between 2016 and 2019 in a public hospital with more than 1300 beds. Hospitalization episodes were classified according to whether admission took place between Friday at 3:00 p.m. and the following Monday at 8:00 a.m. (weekend admission) or not (admission on weekdays). Mortality, length of stay and associated costs were compared, applying their respective risk-adjustment models. RESULTS: Of the total 169,495 hospitalization episodes analyzed, 48,201 (28.44%) corresponded to the weekend, presenting an older age (54.9 years vs. 53.9; P<.001), a higher crude mortality rate (5.22% vs. 4.59%; P<0.001), and a longer average length of stay (7.42 days vs. 6.74; P<.001), than those admitted on weekdays. The median crude cost of stay was lower (€731.25 vs. €850.88; P<0.001). No significant differences were found when applying the adjustment models, with a risk-adjusted mortality ratio of 1.03 (0.99-1.08) vs. 0.98 (0.95-1.01), risk-adjusted length of stay of 1.002 (0.98-1.005) vs. 0.999 (0.997-1.002) and risk-adjusted cost of stay of 0.928 (0.865-0.994) vs. 0.901 (0.843-0.962). CONCLUSION: The results of the study reveal that the assistance provided during the weekends does not imply worse health outcomes or increased costs. Comparing the impact between hospitals will require a future homogenization of temporal criteria and risk adjustment models.

Economic burden of recurrent Clostridioides difficile infection in adults admitted to Spanish hospitals. A multicentre retrospective observational study.

OBJECTIVE: Clostridioides difficile infection (CDI) is associated with increased hospital stays and mortality and a high likelihood of rehospitalization, leading to increased health resource use and costs. The objective was to estimate the economic burden of recurrent CDI (rCDI). METHODS: Observational, retrospective study carried out in six hospitals. Adults aged ≥18 years with ≥1 confirmed diagnosis (primary or secondary) of rCDI between January 2010 and May 2018 were included. rCDI-related resource use included days of hospital stay (emergency room, ward, isolation and ICU), tests and treatments. For patients with primary diagnosis of rCDI, the complete hospital stay was attributed to rCDI. When diagnosis of rCDI was secondary, hospital stay attributed to rCDI was estimated using 1:1 propensity score matching as the difference in hospital stay compared to controls. Controls were hospitalizations without CDI recorded in the Spanish National Hospital Discharge Database. The cost was calculated by multiplying the natural resource units by the unit cost. Costs (euros) were updated to 2019. RESULTS: We included 282 rCDI episodes (188 as primary diagnosis): 66.31% of patients were aged ≥65 years and 57.80% were female. The mean hospital stay (SD) was 17.18 (23.27) days: 86.17% of rCDI episodes were isolated for a mean (SD) of 10.30 (9.97) days. The total mean cost (95%-CI) per episode was €10,877 (9,499-12,777), of which the hospital stay accounted for 92.56. CONCLUSIONS: There is high cost and resource use associated with rCDI, highlighting the importance of preventing rCDI to the Spanish National Health System.

Assessment of nutrient contamination in the waters of the El Fuerte River, southern Gulf of California, Mexico.

This study assessed the spatial and temporal nutrient variability in the El Fuerte River basin in northwestern Mexico, considering its effects on the water trophic status as well as the nutrient loading to the Gulf of California. Physicochemical parameters, inorganic species of nitrogen, phosphate, total nitrogen, total phosphorus, and chlorophyll-a (chl-a) were quantified at 16 selected sites along the river in April (dry season) and October (rainy season) 2017. Mean concentrations of nutrients during dry and rainy seasons were 36.3 ± 24.1 and 55.1 ± 74.6 µg L-1 of total ammonia nitrogen, 3.4 ± 3.6 and 4.5 ± 3.5 µg L-1 of NO2--N, 190.8 ± 256.0 and 163.6 ± 261.0 µg L-1 of NO3--N, 42.4 ± 44.2 and 104.9 ± 76.2 µg L-1 of PO43--P, 1.0 ± 1.3 and 691 ± 2242 mg L-1 of TN, 0.06 ± 0.06 and 0.08 ± 0.09 mg L-1 of TP, and 0.9 ± 0.6 and 2.0 ± 0.9 µg L-1 of chl-a with significant differences (p < 0.05) between sites and seasons. When waters are transported downstream, nutrient levels are enriched by 4 to 35 times compared to those upstream due to increased population and agriculture downstream, confirming the hypothesis of the study. The calculated TN and TP fluxes were 1.23 × 104 and 3.57 × 101 ton year-1, respectively. Factor analysis indicated that inorganic nitrogen species and phosphorus are the main factors affecting the river water quality. Despite N excess during the rainy season, the river reached mesotrophic waters due to phosphorus limitation. This suggests the need to establish a water quality monitoring program to understand the vulnerability of the river course to changes in its trophic state.

Long-term assessment of nano and bulk copper compound exposure in sugarcane (Saccharum officinarum).

As interest in the use of copper-based nanomaterials in agriculture continue to increase, research into their exposure effects must expand from short-term, high exposure studies to long-term studies at realistic concentrations. Long-term studies can better elucidate the implications of copper nanomaterial exposure by allowing plants to mature and adapt to higher copper concentrations. In this study, sugarcane plants were grown to maturity in large nursery pots using soils amended with one of the following treatments: Kocide 3000 (Cu(OH)2), a nano-sized CuO (nCuO), a bulk-sized CuO (bCuO), copper metal nanoparticles (Cu NP), or CuCl2 at 20, 40, and 60 mg kg-1. After tissue harvesting, copper content in plant tissues, including pressed cane juice, were determined. Chlorophyll content and the activity of reactive oxygen species (ROS) related enzymes, in root tissues, were measured as an indicator of plant health. Elemental analysis revealed significant changes in root copper concentrations only upon application of the highest levels of Kocide 3000, nCuO, and Cu NP. However, translocation of copper to leaf tissues displayed consistent increases with added copper over controls. Plants treated with Kocide 3000 at 60 mg kg-1 experienced a significant 31% decrease in cane juice yield; copper concentrations in the pressed juice of plants treated with: Kocide 3000 at 20 and 60 mg kg-1, nCuO at 20 and 60 mg kg-1, bCuO at 20 mg kg-1, CuCl2 at 40 mg kg-1, and Cu NP increased by at least 58%. Chlorophyll content remained comparable to controls, and there was a significant 50 to 68% decrease in superoxide dismutase (SOD) activity in plants treated with nCuO, bCuO, Cu NP, and CuCl2. The results indicate that sugarcane plants exposed to the selected copper-based treatments were not adversely affected.

Clinical assessment of tolerability, immunological and cutaneous reactivity effects of an abbreviated schedule with Olea europaeanative extract of subcutaneous immunotherapy.

Summary: Objectives. To evaluate the tolerability and efficacy of Olea europaea subcutaneous immunotherapy (SCIT) on patients with rhinoconjunctivitis. Methods. In this open clinical trial patients were assigned to an abbreviated build-up scheme. The outcomes were: number, percentage, and severity of adverse reactions. Secondary outcomes included: changes in immunoglobulin titers and changes in dose-response skin prick tests. Results. Only 8 systemic reactions were registered, which represented 7/47 (14.9%) of patients and 8/429 (1.9%) of administered doses. Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system. Cutaneous reactivity decreased significantly. Conclusions. Olea europaea SCIT (Allergovac® depot ROXALL Medicina España S.A.) showed a good safety and tolerability profile. Immunological changes with induction of blocking IgG and decreases in cutaneous reactivity were detected in the patients.

External photon radiation treatment for prostate cancer: Uncomplicated and cancer-free control probability assessment of 36 plans.

PURPOSE: To perform a systematic and thorough assessment, using the Uncomplicated and Cancer-Free Control Probability (UCFCP) function, of a broad range of photon prostate cancer RT treatments, on the same scenario (a unique pelvic CT set). UCFCP considers, together with the probabilities of local tumour control (TCP) and deterministic (late) sequelae (NTCP), the second primary cancer risk (SPCR) due to photon and neutron peripheral doses. METHODS AND MATERIALS: Thirty-six radiotherapy plans were produced for the same CT. 6, 10, 15 and 18 MV 3DCRT, IMRT and VMAT (77.4 Gy in 43 fractions) and 6 and 10 MV SBRT (36.25 Gy in 5 fractions with flattened and FFF beams) for Elekta, Siemens and Varian Linacs plans were included. DVH and peripheral organ dosimetry were used to compute TCP, NTCP, and SPCR (the competition and LNT models) for further plan ranking. RESULTS: Biological models (and parameters) used predicted an outcome which is in agreement with epidemiological findings. SBRT plans showed the lowest SPCR and a below average NTCPrectal. High energy plans did not rank worse than the low energy ones. Intensity modulated plans were ranked above the 3D conformal techniques. CONCLUSIONS: According to UCFCP, the best plans were the10 MV SBRTs. SPCR rates were low and did not show a substantial impact on plan ranking. High energy intensity-modulated plans did not increase in excess the average of SPCR. Even more, they ranked among the best, provided that MU were efficiently managed.

In Favour of Regional Diabetes Day Hospitals.

Diabetes mellitus is considered a public health issue worldwide, with a high prevalence. It is a direct cause of death, disability, and high health costs. In addition, it generates a series of complications of variable types and degrees that have frequent negative effects on the quality of life of the people who suffer from it. Efficiency in public health implies a reduction in costs and improvements in citizens' quality of life. With the twofold aim of rationalizing costs and promoting an improvement in the care of people with diabetes, we propose a project: a Diabetes Day Hospital (DDH) in Extremadura (Spain). This involves a new organizational model which has already been implemented in other European regions, generating satisfactory results. This study includes details on the structure and operation of the DDH, as well as the expected costs. The DDH allows for a proper coordination among the parties involved in the monitoring and treatment of the disease, and reduces the costs derived from unnecessary admissions and chronic complications. Results show that efficiency in the regional health system could be improved and a significant amount of money could be saved.

Review of the novelties presented at the 2018 ECTRIMS Congress: 11th Post-ECTRIMS Meeting (II). / Revision de las novedades presentadas en el Congreso ECTRIMS 2018: XI Reunion Post-ECTRIMS (II).

The Post-ECTRIMS Meeting was held for the eleventh consecutive year in October 2018 in Madrid, with the aim of analysing the advances made in multiple sclerosis that were highlighted at the latest ECTRIMS annual congress. Based on the issues discussed at this meeting, attended by the nation's foremost opinion leaders on multiple sclerosis, two review articles are presented. This second part includes the growing body of evidence confirming the safety of exposure to disease-modifying treatments in women planning a pregnancy, and the beneficial effect of breastfeeding, provided that the disease is not very active. It addresses data showing how the application of the 2017 McDonald criteria in the paediatric population has significantly improved diagnosis compared to the previous criteria. With regard to progressive multiple sclerosis, the results of neuroprotective drugs are inconclusive, but biomarkers are proposed to improve the evaluation of the therapeutic response. Studies on myelin repair treatments suggest that remyelination in multiple sclerosis is possible. Likewise, there are favourable indications for haematopoietic stem cell transplantation, provided that patients are selected appropriately. On the other hand, we also conduct a review of the similarities and differences of the recommendations in the new clinical practice guidelines. Finally, the positive results of cognitive and motor rehabilitation with the use of new technologies point to the systematic incorporation of these tools in the treatment of the disease in the near future.

TITLE: Revision de las novedades presentadas en el Congreso ECTRIMS 2018: XI Reunion Post-ECTRIMS (II).La reunion Post-ECTRIMS se celebro por undecimo año consecutivo el pasado octubre de 2018 en Madrid, con el objetivo de analizar los avances en esclerosis multiple destacados en el ultimo congreso anual ECTRIMS. Fruto de esta reunion, formada por los lideres de opinion en esclerosis multiple de ambito nacional, se presentan dos articulos de revision. En esta segunda parte, se incluye el creciente numero de evidencias que confirman la seguridad de la exposicion a los tratamientos modificadores de la enfermedad en mujeres que planifican un embarazo, y el efecto beneficioso de la lactancia, siempre y cuando la enfermedad no este muy activa. Se abordan los datos que muestran como la aplicacion de los criterios de McDonald de 2017 en poblacion pediatrica ha mejorado considerablemente el diagnostico en comparacion con los criterios anteriores. En cuanto a la esclerosis multiple progresiva, los resultados de los farmacos neuroprotectores son poco concluyentes, pero se proponen biomarcadores para mejorar la evaluacion de la respuesta terapeutica. Los estudios sobre tratamientos de reparacion de la mielina sugieren que la remielinizacion en la esclerosis multiple es posible. De igual manera, se exponen indicios favorables sobre el trasplante de celulas madre hematopoyeticas, siempre que se seleccione adecuadamente a los pacientes. Por otro lado, se revisan las similitudes y diferencias de las recomendaciones de las nuevas guias de practica clinica publicadas. Por ultimo, los resultados positivos de la rehabilitacion cognitiva y motora con el uso de las nuevas tecnologias vaticinan la incorporacion sistematica de estas herramientas en el tratamiento de la enfermedad en un futuro proximo.

Medical versus surgical treatment of first trimester spontaneous abortion: A cost-minimization analysis.

BACKGROUND: Traditionally the gold-standard technique for the treatment of spontaneous abortion has been uterine evacuation by aspiration curettage. However, many studies have proposed medical treatment with misoprostol as an alternative to the conventional surgical treatment. The aim of this study was to apply cost minimization methods to compare the cost and effectiveness of the use of vaginal misoprostol as a medical treatment for first trimester spontaneous abortion with those of evacuation curettage as a surgical treatment. METHODOLOGY/PRINCIPAL FINDINGS: We present a longitudinal, prospective and quasi-experimental research study including a total of 547 patients diagnosed with first-trimester spontaneous abortion, in the period from January 2013 to December 2015. Patients were offered medical treatment with 800 mg vaginal misoprostol or evacuation curettage. Patients treated with misoprostol were followed-up at 7 days and a transvaginal ultrasound was performed to confirm the success of the treatment. If it failed, a second dose of 800 mg of vaginal misoprostol was prescribed and a new control ultrasound was performed. In case of failure of medical treatment after the second dose of misoprostol, evacuation curettage was indicated. The effectiveness of each of the treatment options was calculated using a decision tree. The cost minimization study was carried out by weighting each cost according to the effectiveness of each branch of the treatment. Of the 547 patients who participated in the study, 348 (64%) chose medical treatment and 199 (36%) chose surgical treatment. The overall effectiveness of medical treatment was 81% (283/348) and surgical treatment of 100%. The estimated final cost for medical treatment was € 461.92 compared to € 2038.72 for surgical treatment, which represents an estimated average saving per patient of € 1576.8. CONCLUSIONS/SIGNIFICANCE: Medical treatment with misoprostol is a cheaper alternative to surgery: in the Spanish Public Healthcare System, it is five times more inexpensive than curettage. Given its success rates higher than 80%, mild side effects, controllable with additional medication and the high degree of overall satisfaction, it should be prioritized over the evacuation curettage in patients who meet the treatment criteria.

[Work-related violence among public health professionals (2008-2012)]. / Agresiones externas al personal sanitario de un servicio público de salud (2008-2012).

OBJECTIVE: To describe the types of work-related violence and associated factors among professionals of the Navarra Health Service-Osasunbidea from August 2008 to December 2012. METHOD: This was a descriptive study of reported work-related violence incidents. The outcome variable was the type of violence (physical and/or verbal assault). The characteristics of the victims and the aggression were described using frequencies and percentages. Associations between the type of violence and the independent variables were evaluated using chi-square statistics. Work-related violence incidence rates per 100 worker-years were estimated and rates compared using the rate ratio. RESULTS: 684 attacks were reported (45.4%were verbal).Mental health was the service where most attacks were recorded (51.9%), predominantly physical. Verbal aggression were most common in primary and specialty care. The incidence of aggressions were highest among orderlies (4.5 per 100 worker-years), mental health (5,5 per 100 worker-years) and professionals under 35 years of age (5.9 per 100 worker-years). Rates were similar in men and women (1.6 per 100 workeryears). However, when stratified by professional category, women at the greatest risk were female physicians and administrative assistants; among the men, risk was greatest among male nurses and orderlies. CONCLUSIONS: Factors associated with work-related violence, such as location and professional category, should be considered when designing preventive measures.

OBJETIVO: Describir los tipos y factores asociados a las agresiones de usuarios o acompañantes a los profesionales en el Servicio Navarro de Salud-Osasunbidea, desde agosto del 2008 a diciembre del 2012. MÉTODO: Estudio descriptivo de las agresiones externas registradas. La variable resultado fue el tipo de agresión (agresión física y/o verbal). Las características del personal agredido y de la agresión se describieron mediante frecuencias y porcentajes. La asociación entre el tipo de agresión y las variables estudiadas se valoró mediante el Chi-cuadrado. Se estimaron tasas de incidencias de agresiones por 100 trabajadores-año y se compararon mediante la razón de tasas. RESULTADOS: Se notificaron 684 agresiones (45,4% fueron verbales). Salud Mental fue el servicio donde más agresiones se registraron (51,9%) predominando las físicas. Las verbales destacaron en Atención Primaria y Especializada. Se determinó una mayor tasa de incidencia de agresiones en celadores (4,5 por 100 trabajadores-año), Salud Mental (5,5 por 100 trabajadores-año) y menores de 35 años (5,9 por 100 trabajadores-año). La tasa fue la misma en hombres y mujeres (1,6 por 100 trabajadores-año) aunque estratificando por categoría profesional las mujeres que presentaron mayor riesgo fueron facultativas y administrativas y los hombres, enfermeros y celadores. CONCLUSIONES: Los factores asociados a los episodios de violencia externa en trabajadores como tipo de servicio y categorías profesionales deben considerarse en el diseño de medidas preventivas.

[Assessment of control of cardiovascular risk factors in obese posmenopausal women after monitoring a structured dietary education and exercise program. (SÍSIFO Program)]. / Valoración del control de los factores de riesgo cardiovascular en mujeres menopáusicas obesas tras el seguimiento de un programa estructurado de educación dietética y ejercicio físico. (Programa SÍSIFO).

OBJECTIVE: Evaluate the influence of a specific program of physical exercise on cardiovascular risk, quality of life and eating habits of menopausal women. METHOD: Prospective, intervention study previous-after without control group for three months. 66 menopausal women were included. The intervention consisted of a structured diet and exercise program. Biochemical, anthropometric, dietary and life quality parameters were determined before and three months after surgery. RESULTS: After the intervention a decrease in weight (4.4±2,3kg) and BMI (1.83±0.84kg/m(2)) (p<.05) occurs. A decrease in SBP (p<.05) was also observed. The fasting glucose went down 13.75±11.11mg/dl and HbA1c fell by 0.19±0,12%, both with p<.05. The lipid profile follows a similar behavior, highlighting a decline of 8± 6.2mg/dl in LDL cholesterol values (p<.05). The score on the measured cardiovascular risk by the Framingham tables decreases by 3% postoperatively (p<.05). Regarding the quality of life, it is significantly improved in all analyzed areas. CONCLUSIONS: The application of a structured exercise and diet program improves close monitoring parameters associated with cardiovascular risk of the women studied. It also improves the quality of life and dietary habits.

[Therapeutic equivalence of the new oral anticoagulants]. / Sobre la equivalencia terapéutica y los nuevos anticoagulantes orales.

In an attempt to minimize the economic impact due to the incorporation of innovative drugs, health authorities have promoted and supported the evaluation and market positioning of drugs, as equivalent therapeutic alternatives. This issue has recently gained importance, possibly due to the current economic crisis. The equivalent therapeutic alternatives are justified by the need to compete on price, and by the authorities recommendation to establish therapeutic equivalence, price and financing of medicinal products at the same time. The establishment of the new oral anticoagulants and the equivalent therapeutic alternatives is a problematic issue if it is based on the absence of direct comparisons between different drugs and the questionable methodology used in the current indirect comparisons. Currently, it is difficult to determine when a new oral anticoagulant is more recommendable than others, but efforts are being made in order to propose alternatives for the decision based on patient characteristics.

Development and psychometric validation of a brief comprehensive health status assessment scale in older patients with hematological malignancies: The GAH Scale.

OBJECTIVES: The purpose of this study was to develop a new brief, comprehensive geriatric assessment scale for older patients diagnosed with different hematological malignancies, the Geriatric Assessment in Hematology (GAH scale), and to determine its psychometric properties. MATERIALS AND METHODS: The 30-item GAH scale was designed through a multi-step process to cover 8 relevant dimensions. This is an observational study conducted in 363 patients aged≥65years, newly diagnosed with different hematological malignancies (myelodysplasic syndrome/acute myeloblastic leukemia, multiple myeloma, or chronic lymphocytic leukemia), and treatment-naïve. The scale psychometric validation process included the analyses of feasibility, floor and ceiling effect, validity and reliability criteria. RESULTS: Mean time taken to complete the GAH scale was 11.9±4.7min that improved through a learning-curve effect. Almost 90% of patients completed all items, and no floor or ceiling effects were identified. Criterion validity was supported by reasonable correlations between the GAH scale dimensions and three contrast variables (global health visual analogue scale, ECOG and Karnofsky), except for comorbidities. Factor analysis (supported by the scree plot) revealed nine factors that explained almost 60% of the total variance. Moderate internal consistency reliability was found (Cronbach's α: 0.610), and test-retest was excellent (ICC coefficients, 0.695-0.928). CONCLUSION: Our study suggests that the GAH scale is a valid, internally reliable and a consistent tool to assess health status in older patients with different hematological malignancies. Future large studies should confirm whether the GAH scale may be a tool to improve clinical decision-making in older patients with hematological malignancies.