How appropriate is treating patients diagnosed with advanced esophageal cancer with anticancer drugs? A multicenter retrospective cohort Spanish study.

AIM: To assess the appropriateness of systemic oncological treatments (SOT) provided to patients diagnosed with advanced esophageal cancer (EC) across a group of participating hospitals. METHODS: Multicenter, retrospective cohort study in five Spanish hospitals including newly confirmed advanced EC cases between July 1, 2014, and June 30, 2016, with a 5-year follow-up. RESULTS: We identified 157 patients fulfilling the inclusion criteria (median age: 65 years, 85.9% males). Most patients, 125 (79.6%) were treated at least with one active treatment, and 33% received two or more lines of SOT. The 1-, 2- and 5-year overall survival rates were 30.3% [95%CI: 23.8, 38.7], 14.0% [95%CI: 9.3, 21.0], and 7.1% [95% CI: 3.8, 13.1] respectively, and the median survival time 8 months (95% CI: 6, 19) for stages IIIb IIIc and 7 months (95% CI: 5, 9) for stage IV. Clinical stage, receiving more than one line of SOT, and treatment with radiotherapy accelerated the time to death (0.4, 0.9-, and 0.8-times shorter survival respectively, p < 0.05). Better performance status (ECOG < 2) extended survival time by 2.2 times (p = 0.04). Age < 65 years (OR 9.4, 95% CI 3.2, 31.4, p < 0.001), and being treated in one particular hospital (OR 0.2, 95% CI 0.0, 0.8, p < 0.01) were associated with the administration of two or more lines of SOT. Altogether, 18.9% and 9.0% of patients received chemotherapy in the last four and two weeks of life, respectively. Moreover, 2.5% of patients were prescribed a new line of chemotherapy during the last month of life. The proportion of all patients who did not have access to palliative care reached 29.3%, and among those who had access to it, 34.2% initiated it in the last month of life. CONCLUSION: A high proportion of advanced EC patients receive many treatments not based on sound evidence and they do not benefit enough from palliative care services. The most accepted appropriateness indicators point out that some of the analyzed patients could have been overtreated. This study provides important insights into the quality of care provided to advanced EC, and furthermore, for giving valuable insight and opportunities for improvement.

Health service and psychotropic medication use for mental health conditions among healthcare workers active during the Spain Covid-19 Pandemic - A prospective cohort study using web-based surveys.

Little is known about healthcare workers' (HCW) use of healthcare services for mental disorders. This study presents data from a 16-month prospective cohort study of Spanish HCW (n = 4,809), recruited shortly after the COVID-19 pandemic onset, and assessed at four timepoints using web-based surveys. Use of health services among HCW with mental health conditions (i.e., those having a positive screen for mental disorders and/or suicidal thoughts and behaviours [STB]) was initially low (i.e., 18.2 %) but increased to 29.6 % at 16-month follow-up. Service use was positively associated with pre-pandemic mental health treatment (OR=1.99), a positive screen for major depressive disorder (OR=1.50), panic attacks (OR=1.74), suicidal thoughts and behaviours (OR=1.22), and experiencing severe role impairment (OR=1.33), and negatively associated with being female (OR = 0.69) and a higher daily number of work hours (OR=0.95). Around 30 % of HCW with mental health conditions used anxiolytics (benzodiazepines), especially medical doctors. Four out of ten HCW (39.0 %) with mental health conditions indicated a need for (additional) help, with most important barriers for service use being too ashamed, long waiting lists, and professional treatment not being available. Our findings delineate a clear mental health treatment gap among Spanish HCW.

Assessment of liver fibrosis in patients with rheumatoid arthritis treated with methotrexate: Utility of fibroscan and biochemical markers in routine clinical practice.

OBJECTIVES: To study the prevalence of liver fibrosis (LF) measured by FibroScan and APRI index in patients with rheumatoid arthritis (AR) undergoing treatment with methotrexate (MTX). METHODS: We included 59 patients with RA on MTX. Medical records, FibroScan measures and serological markers of liver damage were compared on the basis of cumulative methotrexate dose. RESULTS: Mean treatment duration was 82.4±65.1 months and mean cumulative dose was 5214.5±4031.9mg. Five patients met LF criteria by fibroscan, while only one patient had a suggestive APRI score. No statistically significant differences were found in terms of LF measured by both APRI and fibroScan between patients with cumulative doses above and below 4000mg. There was also no relationship between LF and treatment duration. CONCLUSIONS: The occurrence of LF in patients with RA on MTX is a multifactorial process that does not seem directly related to its cumulative dose. FibroScan may be a useful technique in clinical practice to screen for this complication.

Assessment of liver fibrosis in patients with rheumatoid arthritis treated with methotrexate: Utility of fibroscan and biochemical markers in routine clinical practice / Evaluación de la fibrosis hepática en pacientes con artritis reumatoide en tratamiento con metotrexato: utilidad en la práctica clínica habitual del FibroScan y marcadores bioquímicos

Objectives: To study the prevalence of liver fibrosis (LF) measured by FibroScan and APRI index in patients with rheumatoid arthritis (AR) undergoing treatment with methotrexate (MTX). Methods: We included 59 patients with RA on MTX. Medical records, FibroScan measures and serological markers of liver damage were compared on the basis of cumulative methotrexate dose. Results: Mean treatment duration was 82.4±65.1 months and mean cumulative dose was 5214.5±4031.9mg. Five patients met LF criteria by fibroscan, while only one patient had a suggestive APRI score. No statistically significant differences were found in terms of LF measured by both APRI and fibroScan between patients with cumulative doses above and below 4000mg. There was also no relationship between LF and treatment duration. Conclusions: The occurrence of LF in patients with RA on MTX is a multifactorial process that does not seem directly related to its cumulative dose. FibroScan may be a useful technique in clinical practice to screen for this complication. (AU)

Objetivos: Estudiar la prevalencia de la fibrosis hepática (FH) medida por FibroScan e índice APRI en pacientes con artritis reumatoide (AR) en tratamiento con metotrexato (MTX). Métodos: Se incluyeron 59 pacientes con AR en tratamiento con MTX. Se compararon las historias clínicas, las mediciones de FibroScan y los marcadores serológicos de daño hepático en función de la dosis acumulada de MTX. Resultados: La duración media del tratamiento fue de 82,4±65,1 meses y la dosis media acumulada de 5214,5±4031,9mg. Cinco pacientes cumplían criterios de FH por FibroScan y un solo paciente por APRI. No se encontraron diferencias estadísticamente significativas en cuanto a FH tanto por APRI como por FibroScan en base a dosis acumuladas superiores o inferiores a 4000mg. Tampoco hubo relación entre FH y duración del tratamiento. Conclusiones: La FH en pacientes con AR tratados con MTX es un proceso multifactorial sin aparente relación directa con la dosis acumulada. El FibroScan puede ser una técnica útil en la práctica clínica para detectar esta complicación. (AU)

Traumatic stress symptoms among Spanish healthcare workers during the COVID-19 pandemic: a prospective study.

AIM: To investigate the occurrence of traumatic stress symptoms (TSS) among healthcare workers active during the COVID-19 pandemic and to obtain insight as to which pandemic-related stressful experiences are associated with onset and persistence of traumatic stress. METHODS: This is a multicenter prospective cohort study. Spanish healthcare workers (N = 4,809) participated at an initial assessment (i.e., just after the first wave of the Spain COVID-19 pandemic) and at a 4-month follow-up assessment using web-based surveys. Logistic regression investigated associations of 19 pandemic-related stressful experiences across four domains (infection-related, work-related, health-related and financial) with TSS prevalence, incidence and persistence, including simulations of population attributable risk proportions (PARP). RESULTS: Thirty-day TSS prevalence at T1 was 22.1%. Four-month incidence and persistence were 11.6% and 54.2%, respectively. Auxiliary nurses had highest rates of TSS prevalence (35.1%) and incidence (16.1%). All 19 pandemic-related stressful experiences under study were associated with TSS prevalence or incidence, especially experiences from the domains of health-related (PARP range 88.4-95.6%) and work-related stressful experiences (PARP range 76.8-86.5%). Nine stressful experiences were also associated with TSS persistence, of which having patient(s) in care who died from COVID-19 had the strongest association. This association remained significant after adjusting for co-occurring depression and anxiety. CONCLUSIONS: TSSs among Spanish healthcare workers active during the COVID-19 pandemic are common and associated with various pandemic-related stressful experiences. Future research should investigate if these stressful experiences represent truly traumatic experiences and carry risk for the development of post-traumatic stress disorder.

Piloting the informed health choices resources in Barcelona primary schools: A mixed methods study.

INTRODUCTION: The main objective of the Informed Health Choices (IHC) project is to teach people to assess treatment claims and make informed health choices. For this purpose, the IHC learning resources were developed for primary school children. The aim of this study is to explore students' and teachers' experience when using the IHC resources in primary schools in Barcelona (Spain). METHODS: We conducted a mixed methods study for piloting the IHC resources in a convenience sample of primary schools in Barcelona. The intervention included a workshop with teachers, and nine lessons with students. We collected data using multiple approaches. We performed quantitative and qualitative analyses, and integrated the findings in a joint display. Finally, we formulated recommendations for using the IHC resources in this setting. RESULTS: Two schools, with a total of 143 students in 4th and 5th grade and six teachers, participated in the study. One school followed the suggested IHC teaching plan and competed all the lessons; the other school modified the plan substantially and did not complete all the lessons. Overall, students and teachers from both schools understood, were interested in, and were able to apply the content of the lessons. During the lessons, the textbook was useful for students; nevertheless, for the teachers, the usefulness of the IHC resources was variable. Teachers adapted the IHC resources to increase student participation and used Information and Communications Technologies tools. We observed more facilitators than barriers to teach the lessons. The teachers suggested some ideas to improve the lessons based on activities they developed and implemented. The integration analysis showed great convergence of the quantitative and qualitative findings. We propose seven recommendations for using the IHC resources in this setting. CONCLUSIONS: Students and teachers from primary schools in Barcelona showed a positive experience when using IHC resources; however, these resources should be adapted to promote classroom participation.

Development and Validation of a Prediction Model and Score for Transthyretin Cardiac Amyloidosis Diagnosis: T-Amylo.

BACKGROUND: Although transthyretin cardiac amyloidosis (ATTR-CA) is often underdiagnosed, clinical suspicion is essential for early diagnosis. OBJECTIVES: The aim of this study was to develop and validate a feasible prediction model and score to facilitate the diagnosis of ATTR-CA. METHODS: This retrospective multicenter study enrolled consecutive patients who underwent 99mTc-DPD scintigraphy for suspected ATTR-CA. ATTR-CA was diagnosed if Grade 2 or 3 cardiac uptake was evidenced on 99mTc-DPD scintigraphy in the absence of a detectable monoclonal component or by demonstration of amyloid by biopsy. A prediction model for ATTR-CA diagnosis was developed in a derivation sample of 227 patients from 2 centers using multivariable logistic regression with clinical, electrocardiography, analytical, and transthoracic echocardiography variables. A simplified score was also created. Both of them were validated in an external cohort (n = 895) from 11 centers. RESULTS: The obtained prediction model combined age, gender, carpal tunnel syndrome, interventricular septum in diastole thickness, and low QRS interval voltages, with an area under the curve (AUC) of 0.92. The score had an AUC of 0.86. Both the T-Amylo prediction model and the score showed a good performance in the validation sample (ie, AUC: 0.84 and 0.82, respectively). They were tested in 3 clinical scenarios of the validation cohort: 1) hypertensive cardiomyopathy (n = 327); 2) severe aortic stenosis (n = 105); and 3) heart failure with preserved ejection fraction (n = 604), all with good diagnostic accuracy. CONCLUSIONS: The T-Amylo is a simple prediction model that improves the prediction of ATTR-CA diagnosis in patients with suspected ATTR-CA.

Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights.

BACKGROUND: The real impact of the degree of association (DoA) between endpoint components of a composite endpoint (CE) on sample size requirement (SSR) has not been explored. We estimate the impact of the DoA between death and acute myocardial infarction (AMI) on SSR of trials using use the CE of major adverse cardiac events (MACE). METHODS: A systematic review and quantitative synthesis of trials that include MACE as the primary outcome through search strategies in MEDLINE and EMBASE electronic databases. We limited to articles published in journals indexed in the first quartile of the Cardiac & Cardiovascular Systems category (Journal Citation Reports, 2015-2020). The authors were contacted to estimate the DoA between death and AMI using joint probability and correlation. We analyzed the SSR variation using the DoA estimated from RCTs. RESULTS: Sixty-three of 134 publications that reported event rates and the therapy effect in all component endpoints were included in the quantitative synthesis. The most frequent combination was death, AMI, and revascularization (n = 20; 31.8%). The correlation between death and AMI, estimated from 5 trials¸ oscillated between - 0.02 and 0.31. SSR varied from 14,602 in the scenario with the strongest correlation to 12,259 in the scenario with the weakest correlation; the relative impact was 16%. CONCLUSIONS: The DoA between death and AMI is highly variable and may lead to a considerable SSR variation in a trial including MACE.

Validation of the Modified Determinant-Based Classification for Patients With Acute Pancreatitis in Intensive Care Medicine.

OBJECTIVES: To validate the Modified Determinant-Based Classification (MDBC) system, and compare it with the Revised Atlanta Classification (RAC) and the Determinant-Based Classification (DBC). METHODS: Prospective observational research was conducted in 35 international intensive care units, on patients with acute pancreatitis, and at least 1 organ failure (OF). Patient classification according to the MDBC was as follows: group 1 (transient OF, without local complications [LCs]), group 2 (transient OF and LC), group 3 (persistent OF, without LC), and group 4 (persistent OF and LC). RESULTS: A total of 316 patients were enrolled (mortality of 25.6%). In group 1, patients presented with low mortality (3.31%) and low morbidity (13.68%); in group 2, low mortality (5.26%) and moderate morbidity (55.56%); in group 3, high mortality (32.18%) and moderate morbidity (54.24%); and in group 4, high mortality (53.93%) and high morbidity (97.56%). The area under the receiver operator characteristic curve for mortality was 0.80 (95% confidence interval [CI], 0.75-0.84), with significant differences in comparison to RAC (0.76; 95% CI, 0.70-0.80) and DBC (0.79; 95% CI, 0.74-0.83) (P < 0.01). CONCLUSIONS: The MDBC identified 4 groups with differentiated clinical evolutions. Its tiered mortality rating provided it with better discriminatory power than the DBC and the RAC.

Development and validation of a multivariate prediction model for patients with acute pancreatitis in Intensive Care Medicine.

BACKGROUND/OBJECTIVES: Development and validation of a multivariate prediction model for patients with acute pancreatitis (AP) admitted in Intensive Care Units (ICU). METHODS: A prospective multicenter observational study, in 1 year period, in 46 international ICUs (EPAMI study). PATIENTS: adults admitted to an ICU with AP and at least one organ failure. INTERVENTIONS: Development of a multivariate prediction model, using the worst data of the stay in ICU, based in multivariate analysis, simple imputation in a development cohort. The model was validated in another cohort. RESULTS: 374 patients were included (mortality of 28.9%). Variables with statistical significance in multivariate analysis were age, no alcoholic and no biliary etiology, development of shock, development of respiratory failure, need of continuous renal replacement therapy, and intra-abdominal pressure. The model created with these variables presented an AUC of ROC curve of 0.90 (CI 95% 0.81-0.94) in the validation cohort. We developed a multivariable prediction model, and AP cases could be classified as low mortality risk (between 2 and 9.5 points, mortality of 1.35%), moderate mortality risk (between 10 and 12.5 points, 28.92% of mortality), and high mortality risk (13 points of more, mortality of 88.37%). Our model presented better AUC of ROC curve than APACHE II (0.91 vs 0.80) and SOFA in the first 24 h (0.91 vs 0.79). CONCLUSIONS: We developed and validated a multivariate prediction model, which can be applied in any moment of the stay in ICU, with better discriminatory power than APACHE II and SOFA in the first 24 h.

Estudio prospectivo de la evolución del acúfeno tras exéresis por vía translaberíntica del neurinoma del acústico / Change in tinnitus after acoustic neuroma removal using a translabyrinthine approach. A Prospective study

Introducción: El acúfeno es uno de los síntomas más prevalentes entre los pacientes afectos de neurinoma del acústico y su evolución tras cirugía es difícilmente predecible. Material y métodos: Se realiza un estudio prospectivo de los pacientes intervenidos por vía translaberíntica en nuestro centro en un período de 4 años (2009-2013). Los pacientes contestan al cuestionario de incapacidad del tinnitus (THI). Se recogen de la historia clínica la edad, sexo, tamaño tumoral, audiometría prequirúrgica y función facial postoperatoria. Resultados: Participaron en el estudio 39 pacientes. El 71,8% de pacientes padecían acúfeno. El 50% de los pacientes presentaban un deterioro muy leve, el 17,9% leve, el 10,7% moderado, el 21,4% severo y el 0% muy severo. No encontramos asociación estadísticamente significativa entre ninguna de las variables estudiadas y el acúfeno preoperatorio. El porcentaje total de pacientes con acúfeno postoperatorio fue del 48,7%. El 31,6% presentaron un deterioro muy leve, el 36,8% leve, el 10,5% moderado, el 15,8% severo y el 5,3% muy severo. La diferencia de medias entre el THI pre y postoperatorio resultó estadísticamente significativa (p = 0,011), siendo esta diferencia de mayor magnitud en pacientes jóvenes. Asimismo, existió una correlación negativa y significativa (r = ---0,335; p = 0,037) entre la audición preoperatoria y el THI postoperatorio. Conclusiones: No encontramos asociación significativa entre el tinnitus y la edad, sexo, tamaño tumoral y función facial postoperatoria. La exéresis del neurinoma del acústico por vía translaberíntica disminuye la percepción del acúfeno en esta serie, siendo los pacientes que mejoran más jóvenes. Los mejores resultados del THI posquirúrgico los encontramos entre pacientes con peor audición prequirúrgica (AU)

Introduction: Tinnitus is one of the primary symptoms of vestibular schwannoma (VS) and the effect of surgery is unpredictable. Materials and methods: We conducted a prospective study of the patients who underwent a translabyrinthine approach for the treatment of their VS (2009-2013) at our Hospital. Patients answered the Tinnitus Handicap Inventory (THI) questionnaire pre- and postoperatively. The clinical charts provided data such as age, gender, tumour size, preoperative audiometry and postoperative facial function. Results: The study included 39 patients. Of these, 71.8% suffered from tinnitus: 50% grade I, 17.9% grade II, 10.7% grade III, 21.4% grade IV and 0% grade V. We found no statistical association between tinnitus and the different variables measured preoperatively. Postoperatively, 48.7% of the patients suffered from tinnitus: 31.6% grade I, 36.8% grade II, 10.5% grade III, 15.8% grade IV and 5.3% grade V. The difference between mean pre- and postoperative THI was statistically significant (P = .011); this difference was greater in younger patients. We have found a significant negative correlation (r = ---0.335; P = .037) between preoperative audiometry and postoperative THI. Conclusions: We did not find any significant association between tinnitus and age, gender, tumour size and postoperative facial function. Translabyrinthine surgical removal of VS in these patients led to better THI results, with the younger patients having better outcomes. The patients with poorest preoperative audition were the ones that had the best results in the postoperative THI questionnaire (AU)

Change in tinnitus after acoustic neuroma removal using a translabyrinthine approach. A Prospective study. / Estudio prospectivo de la evolución del acúfeno tras exéresis por vía translaberíntica del neurinoma del acústico.

INTRODUCTION: Tinnitus is one of the primary symptoms of vestibular schwannoma (VS) and the effect of surgery is unpredictable. MATERIALS AND METHODS: We conducted a prospective study of the patients who underwent a translabyrinthine approach for the treatment of their VS (2009-2013) at our Hospital. Patients answered the Tinnitus Handicap Inventory (THI) questionnaire pre- and postoperatively. The clinical charts provided data such as age, gender, tumour size, preoperative audiometry and postoperative facial function. RESULTS: The study included 39 patients. Of these, 71.8% suffered from tinnitus: 50% grade I, 17.9% grade II, 10.7% grade III, 21.4% grade IV and 0% grade V. We found no statistical association between tinnitus and the different variables measured preoperatively. Postoperatively, 48.7% of the patients suffered from tinnitus: 31.6% grade I, 36.8% grade II, 10.5% grade III, 15.8% grade IV and 5.3% grade V. The difference between mean pre- and postoperative THI was statistically significant (P=.011); this difference was greater in younger patients. We have found a significant negative correlation (r=-0.335; P=.037) between preoperative audiometry and postoperative THI. CONCLUSIONS: We did not find any significant association between tinnitus and age, gender, tumour size and postoperative facial function. Translabyrinthine surgical removal of VS in these patients led to better THI results, with the younger patients having better outcomes. The patients with poorest preoperative audition were the ones that had the best results in the postoperative THI questionnaire.

Comparison Between Revised Atlanta Classification and Determinant-Based Classification for Acute Pancreatitis in Intensive Care Medicine. Why Do Not Use a Modified Determinant-Based Classification?

OBJECTIVE: To compare the classification performance of the Revised Atlanta Classification, the Determinant-Based Classification, and a new modified Determinant-Based Classification according to observed mortality and morbidity. DESIGN: A prospective multicenter observational study conducted in 1-year period. SETTING: Forty-six international ICUs (Epidemiology of Acute Pancreatitis in Intensive Care Medicine study). PATIENTS: Admitted to an ICU with acute pancreatitis and at least one organ failure. INTERVENTIONS: Modified Determinant-Based Classification included four categories: In group 1, patients with transient organ failure and without local complications; in group 2, patients with transient organ failure and local complications; in group 3, patients with persistent organ failure and without local complications; and in group 4, patients with persistent organ failure and local complications. MEASUREMENTS AND MAIN RESULTS: A total of 374 patients were included (mortality rate of 28.9%). When modified Determinant-Based Classification was applied, patients in group 1 presented low mortality (2.26%) and morbidity (5.38%), patients in group 2 presented low mortality (6.67%) and high morbidity (60.71%), patients in group 3 presented high mortality (41.46%) and low morbidity (8.33%), and patients in group 4 presented high mortality (59.09%) and morbidity (88.89%). The area under the receiver operator characteristics curve of modified Determinant-Based Classification for mortality was 0.81 (95% CI, 0.77-0.85), with significant differences in comparison to Revised Atlanta Classification (0.77; 95% CI, 0.73-0.81; p < 0.01), and Determinant-Based Classification (0.77; 95% CI, 0.72-0.81; p < 0.01). For morbidity, the area under the curve of modified Determinant-Based Classification was 0.80 (95% CI, 0.73-0.86), with significant differences in comparison to Revised Atlanta Classification (0.63, 95% CI, 0.57-0.70; p < 0.01), but not in comparison to Determinant-Based Classification (0.81, 95% CI, 0.74-0.88; nonsignificant). CONCLUSION: Modified Determinant-Based Classification identified four groups with different clinical presentation in patients with acute pancreatitis in ICU, with better discriminatory power in comparison to Determinant-Based Classification and Revised Atlanta Classification.