Cost-effectiveness analysis of levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg versus other long-acting reversible contraceptives for contraception in Spain.

INTRODUCTION: Condoms and combined oral contraceptive pills are widely used in Spain with high failure rates. Long-Acting Reversible Contraceptive (LARC) methods offer better efficacy and adherence and reduce unintended pregnancies (UP) compared with short-acting reversible contraceptive (SARC) methods. OBJECTIVE: To assess the cost-effectiveness of LNG-IUS 52 mg (Mirena®) versus other LARC for contraception in Spain. MATERIALS AND METHODS: A Markov model with annual cycles and an eight-year time horizon was developed from the Spanish national healthcare system (NHS) perspective, considering costs for contraceptive method acquisition, health care resources (HCR) and UP. Effectiveness was based on failure and discontinuation rates. Sensitivity analyses were performed to test the model's robustness. RESULTS: LNG-IUS 52 mg (Mirena®) resulted in lower costs and fewer UP versus LNG-IUS 13.5 mg (Jaydess®), Implant (Implanon®) and Copper IUD. LNG-IUS 52 mg (Levosert®) prevented the same UP events at a higher cost. LNG-IUS 19.5 mg (Kyleena®) was the most effective option, due to a lower discontinuation rate. CONCLUSIONS: LNG-IUS 52 mg (Mirena®) is the least costly LARC, driven by lower acquisition costs and reduced HCR utilisation. Increasing LNG-IUS 52 mg (Mirena®) uptake in contraception could generate further cost savings for the Spanish NHS and reduce economic burden of UP.

Levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena^®) is an effective and cost-saving long-acting reversible contraceptive (LARC) method compared with other similar methods in Spain over an eight-year time horizon, and Kyleena^® was the most effective option.

Severe infections in systemic necrotizing vasculitis.

Infections in patients with systemic vasculitis represent one of the main causes of mortality. Corticosteroid use, immunosuppressive therapy, age, associated organic involvement and dialysis dependence are risk factors of infection. OBJECTIVES: To determine the prevalence of severe infection and associated factors in patients diagnosed with ANCA-associated vasculitis (AAV) and Polyarteritis Nodosa (PAN). METHODS: retrospective study was conduced in a single rheumatology center (2000-2018). We included patients diagnosed with AAV (Granulomatosis with Polyangiitis (GPA), Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Microscopic Polyangiitis (PAM) and Polyarteritis nodosa (PAN). Serious infectious events requiring hospitalisation or prolonged antibiotic/antiviral treatment, recurrent infection of Herpes Zoster Virus or opportunistic infections were evaluated. Sites of infection, isolated microorganisms and mortality related were analyzed. RESULTS: 105 patients were analyzed, follow-up time median 18 m, 58.7% were women and median age was 52 years. Types of vasculitis: 41.9% PAM, 16.2% EPGA, 40% GPA, 1.9% PAN. Constitutional, pulmonary, renal and otorhinolaryngology manifestations were the most frequent. PREVALENCE OF INFECTION: 34.2%, with a median of 3 months from diagnosis of vasculitis to the infectious event. Low respiratory tract (42.8%), sepsis (31.4%), and urinary tract (14.3%) were the most common sites of infections. Bacterial aetiology was the most prevalent (67.7%). Mortality at the first event was 14.3% and a 72.2% of patients were in the induction phase of treatment. Infectious events were significantly associated with age > 65 years (p = 0.030), presence of lung (p = 0.016) and renal involvement (p = 0.001), BVASv3 > 15, mortality (p = 0.0002). CONCLUSIONS: The prevalence of infection was 34.2%. Lower airway infections, septicemia and urinary tract infections were the most prevalent. Infections were associated with renal and pulmonary involvement, age older than 65 years and score BVAS > 15. Severe infections were associated with mortality, especially in elderly patients.

Results and prognosis of kidney transplantation in lupus nephritis: Experience of an Argentine center.

INTRODUCTION: Although RT has improved the survival of the population with ESRD due to all causes, renal outcomes in SLE are controversial. The objective of this study is to describe the characteristics and evolution of the patients and the kidney transplant in LN, and compare it with patients transplanted for other causes. MATERIALS AND METHODS: Retrospective, observational, analytical, single-center study in which records of patients undergoing nephrotransplantation for LN were analyzed. They were compared with a group of patients transplanted at the same center for other causes of ESRD. RESULTS: 41 patients with kidney transplant due to SLE and 89 transplanted due to other causes of ESRD were registered. Graft loss occurred in 12 (29.26%) patients with LN and 34 (38.2%) patients in the comparison group (p = .428). Only one case (4.8%) presented reactivation of the LN in the graft, without graft loss. Median graft survival was 73.1 months in the LN group and 66.3 months in the comparison group (p = .221). A total of 8 (19.5%) patients with LN and 11 (12.4%) without LN died (p = .42), with infections being the main cause in both groups. There were no statistically significant differences between groups in graft and patient survival. In a sub-analysis of 28 patients with LN with aPL study, 4 thrombotic events were observed, in 3 different patients, in the aPL-positive group. There were no statistically significant differences in terms of causes of graft loss and graft survival (positive aFL 75.7 months vs negative aFL 72.7 months, p= .96). There were also no differences in mortality between the groups (p = .61). CONCLUSION: Patients transplanted for LN did not differ from the control population in terms of graft and patient survival. Infections were the main cause of death, so prophylaxis and vaccination continue to be a fundamental pillar in the prevention of infections in immunocompromised patients.

[Advance care planning in nursing homes: scoping review]. / Planificación anticipada de cuidados en residencias de mayores: revisión narrativa.

Advance care planning is a deliberative process that aims to help patients define goals and preferences for future care and treatment at a times when they have limited decision-making capacity. This study aims to analyze models of advance care planning in elderly individuals living in nursing homes. We reviewed papers published in Cochrane, PubMed and Embase. A total of 26 studies were selected, including a total of 44,131 people over 65 years of age. We analyzed the types of intervention (interviews, videos, workshops, documentation, etc.) and their results derived from the application. We conclude that no study implements a standardized intervention model. These interventions include decision-making (transfers to hospital, resucitation orders) and the adequacy of therapeutic effort (antibiotherapy, nutrition, serotherapy, etc.). Other outcomes are implementation barriers (time and training).

Time to diagnosis in systemic lupus erythematosus: Associated factors and its impact on damage accrual and mortality. Data from a multi-ethnic, multinational Latin American lupus cohort.

BACKGROUND: Systemic lupus erythematosus (SLE) often mimics symptoms of other diseases, and the interval between symptom onset and diagnosis may be long in some of these patients. Aims: To describe the characteristics associated with the time to SLE diagnosis and its impact on damage accrual and mortality in patients with SLE from a Latin American inception cohort. METHODS: Patients were from a multi-ethnic, multi-national Latin-American SLE inception cohort. All participating centers had specialized lupus clinics. Socio-demographic, clinical/laboratory, disease activity, damage, and mortality between those with a longer and a shorter time to diagnosis were compared using descriptive statistical tests. Multivariable Cox regression models with damage accrual and mortality as the end points were performed, adjusting for age at SLE diagnosis, gender, ethnicity, level of education, and highest dose of prednisone for damage accrual, plus highest dose of prednisone, baseline SLEDAI, and baseline SDI for mortality. RESULTS: Of the 1437 included in these analyses, the median time to diagnosis was 6.0 months (Q1-Q3 2.4-16.2); in 721 (50.2%) the time to diagnosis was longer than 6 months. Patients whose diagnosis took longer than 6 months were more frequently female, older at diagnosis, of Mestizo ethnicity, not having medical insurance, and having "non-classic" SLE symptoms. Longer time to diagnosis had no impact on either damage accrual (HR 1.09, 95% CI 0.93-1.28, p = 0.300) or mortality (HR 1.37, 95% CI 0.88-2.12, p = 0.200). CONCLUSIONS: In this inception cohort, a maximum time of 24 months with a median of 6 months to SLE diagnosis had no apparent negative impact on disease outcomes (damage accrual and mortality).

Active lupus in Argentina: Results of a multicenter and national registry.

OBJECTIVE: To evaluate the association between patients' characteristics and disease activity in an Argentine lupus registry. METHODS: Cross-sectional study. Disease activity was stratified into: Remission off-treatment: SLEDAI = 0, without prednisone and immunosuppressive drugs. Low disease activity Toronto Cohort (LDA-TC): SLEDAI ≤2, without prednisone or immunosuppressive drugs. Modified lupus low disease activity (mLLDAS): SLEDAI score of ≤4, with no activity in major organ systems and no new features, prednisone of ≤10 mg/day and/or immunosuppressive drugs (maintenance dose) and Active disease: SLEDAI score of >4 and prednisone >10 mg/day and immunosuppressive drugs. A descriptive analysis and logistic regression model were performed. RESULTS: A total of 1346 patients were included. Of them, 1.6% achieved remission off steroids, 0.8% LDA-TC, 12.1% mLLDAS and the remaining 85.4% had active disease. Active disease was associated with younger age (p ≤ 0.001), a shorter time to diagnosis (p ≤ 0.001), higher frequency of hospitalizations (p ≤ 0.001), seizures (p = 0.022), serosal disease (p ≤ 0.001), nephritis (p ≤ 0.001), higher SDI (p ≤ 0.001), greater use of immunosuppressive therapies and higher doses of prednisone compared to those on mLLDAS. In the multivariable analysis, the variables associated with active disease were the presence of pleuritis (OR 2.1, 95% CI 1.2-3.9; p = 0.007), persistent proteinuria (OR 2.5, 95% CI 1.2-5.5; p ≤ 0.011), nephritis (OR 2.5, 95% CI 1.2-5.6; p = .018) and hospitalizations (OR 8.9, 95% CI 5.3-16.0; p ≤ 0.001) whereas age at entry into the registry was negatively associated with it (OR 0.9, 95% CI 0.9-1.0; p = 0.029). CONCLUSION: Active disease was associated with shorter time to diagnosis, worse outcomes (SDI and hospitalizations) and renal, neurological and serosal disease.

Use of Contraceptive Methods Among Women in the General Population and Female Gynecologists in Spain: the ELEGIAN Survey.

Background: The contraceptive preferences of obstetricians and gynecologists (OB/GYNs) are thought to influence the contraceptive counseling they provide. The purpose of this study was to assess contraceptive preferences of OB/GYNs and women in the general population (WGP) in the current Spanish contraceptive scenario. Materials and Methods: Anonymous online survey of 100 OB/GYNs and 1,217 WGP aged 23-49 years. Results: WGP were younger (35.3 ± 7.3 vs. 37.9 ± 6.2 years, respectively) and less likely to have stable partners (64.7% vs. 84.0%) and children (49.1% vs. 62.0%) (all p < 0.05 vs. OB/GYNs). Seventy-nine percent versus 82%, respectively, used contraceptive methods, with condoms used most frequently by WGP (37% vs. 22% by OB/GYNs; p < 0.05) and pills by OB/GYNs (26% vs. 21% by WGP; p > 0.05). Intrauterine devices (IUDs) were more frequently used by OB/GYNs (20% vs. 5%; p < 0.05), especially the levonorgestrel-releasing intrauterine devices (LNG-IUDs) (18% vs. 2.6%; p < 0.05). The highest-rated methods were condoms among WGP and LNG-IUDs among OB/GYNs. Effectiveness was the most valued attribute of contraceptive methods for both. Reasons related to convenience were the main reason for choosing IUDs. OB/GYNs prescribed the contraceptive method in 40% of cases. Conclusions: Our study reveals differences between female OB/GYNs and WGP in contraceptive methods use and rating. The use of LNG-IUDs was much higher among OB/GYNs.

Frecuencia de eventos cardiovasculares en pacientes con lupus eritematoso sistémico / Frequency of cardiovascular events in patients with systemic lupus erythematosus

Resumen Introducción: el progreso en los tratamientos para el lupus eritematoso sistémico (LES) resultó en una disminución de la mortalidad; sin embargo, la enfermedad cardiovascular y las complicaciones infecciosas aún son las principales causas de muerte. La evidencia apoya la participación del sistema inmunológico en la generación de la placa aterosclerótica, así como su conexión con las enfermedades autoinmunes. Objetivos: describir la frecuencia de eventos cardiovasculares (ECV) en el Registro de Lupus Eritematoso Sistémico de la Sociedad Argentina de Reumatología (RELESSAR) transversal, así como sus principales factores de riesgo asociados. Materiales y métodos: estudio descriptivo y transversal para el cual se tomaron los pacientes ingresados en el registro RELESSAR transversal. Se describieron las variables sociodemográficas y clínicas, las comorbilidades, score de actividad y daño. ECV se definió como la presencia de al menos una de las siguientes patologías: enfermedad arterial periférica, cardiopatía isquémica o accidente cerebrovascular. El evento clasificado para el análisis fue aquel posterior al diagnóstico del LES. Se conformaron dos grupos macheados por edad y sexo 1:2. Resultados: 1515 pacientes mayores de 18 años participaron del registro. Se describieron 80 pacientes con ECV (5,3%). En este análisis se incluyeron 240 pacientes conformando dos grupos. La edad media fue de 47,8 (14,4) y 47,6 (14,2) en el grupo con y sin ECV respectivamente. Los pacientes con ECV tuvieron mayor duración del LES en meses, mayor índice de Charlson, mayor SLICC (Systemic Lupus International Collaborating Clinics/American College of Rheumatology), mayor frecuencia de manifestaciones neurológicas, síndrome antifosfolípido, hospitalizaciones y uso de ciclofosfamida. Las únicas variables asociadas en el análisis multivariado fueron el índice de Charlson (p=0,004) y el SLICC (p<0,001). Conclusiones: los ECV influyen significativamente en nuestros pacientes, y se asocian a mayor posibilidad de daño irreversible y comorbilidades.

Abstract Introduction: progress in treatments for systemic lupus erythematosus (SLE) has resulted in a decrease in mortality; however, cardiovascular and infectious diseases remain the leading causes of death. Evidence supports the involvement of the immune system in the generation of atherosclerotic plaque, as well as its connection to autoimmune diseases. Objectives: to describe the frequency of cardiovascular disease (CVD) in the cross-sectional RELESSAR registry, as well as its associated variables. Materials and methods: a descriptive and cross-sectional study was performed using patients admitted to the cross-sectional RELESSAR registry. Sociodemographic variables, clinical variables, comorbidities, activity and damage scores were described. CVD was defined as at least one of the following: peripheral arterial disease, ischemic heart disease, or cerebrovascular accident. All patients with at least one CVD were included in our analysis (heart attack, central nervous system vascular disease, and peripheral arteries atherosclerotic disease). The event classified for the analysis was that after the diagnosis of SLE. SLE diagnosis was previous to CVD. Two groups matched by age and sex, 1:2 were formed. Results: a total of 1515 patients older than 18 years participated in the registry. Eighty patients with CVD (5.3%) were described in the registry. Two-hundred and forty patients were included, according to two groups. The mean age was 47.8 (SD 14.4) and 47.6 (SD 14.2) in patients with and without CVD, respectively. Patients with CVD had a longer duration of SLE in months, a higher Charlson index, a higher SLICC, increased frequency of neurological manifestations, antiphospholipid syndrome, hospitalizations, and use of cyclophosphamide. The associated variables in the multivariate were the Charlson Index (p=0.004) and the SLICC (p<0.001). Conclusions: CVDs have a significant influence on our patients, being associated with a greater possibility of damage and comorbidities.

Manifestaciones cutáneas en pacientes con lupus eritematoso sistémico: formas al inicio de la enfermedad y durante el seguimiento. Análisis retrospectivo / Cutaneous manifestations in patients with systemic lupus erythematosus: Forms at the beginning of the disease and during follow-up. Retrospective analysis

Objetivo: Describir el compromiso cutáneo (CC) en pacientes con lupus eritematoso sistémico (LES) al inicio de la enfermedad y durante el seguimiento. Determinar factores asociados a dicho compromiso al comienzo de la enfermedad. Materiales y métodos: Estudio retrospectivo, observacional y descriptivo, de centro único, en pacientes con diagnóstico de LES (ACR97 o SLICC2012). Se utilizó la clasificación de Gilliam modificada para el CC. Se realizó estadística descriptiva y análisis bivariado y multivariado para evaluar los factores asociados al compromiso cutáneo. Resultados: Se incluyeron 149 pacientes (91,3% mujeres) con una mediana de edad al diagnóstico de 33años. El CC al inicio de la enfermedad ocurrió en 125 pacientes (83,9%), seguido por compromiso articular en 120 (80,5%). Las lesiones no específicas fueron más frecuentes que las específicas: 92,8% versus 66,4%, respectivamente. En el análisis bivariado, la mayor demora al diagnóstico, la presencia de compromiso articular, la menor presencia de trombocitopenia y la mayor puntuación de SLEDAI-2K se asociaron con la presencia de CC al inicio de la enfermedad. En el análisis multivariado, la variable que se mantuvo asociada de manera independiente fue el compromiso articular (OR: 2,8; IC95%: 1,1-7,5; p=0,04). Durante el seguimiento, 4/24 pacientes que no habían presentado CC al diagnóstico y 51/125 pacientes que sí lo presentaron tuvieron al menos un nuevo episodio cutáneo (rango: 1-5 brotes). Conclusiones: Nuestro estudio demuestra la alta frecuencia de pacientes que presentan compromiso cutáneo en el LES, tanto en el diagnóstico como evolutivamente, y confirma los datos reportados previamente en cuanto a la existencia de un fenotipo cutáneo-articular.(AU)

Objectives: To describe skin involvement (SI) in patients with systemic lupus erythematosus (SLE) at onset and during follow-up of the disease and to determine factors associated with SI at lupus diagnosis. Materials and methods: Retrospective, observational, and descriptive study, from a single centre in patients diagnosed with SLE (ACR1982-97 or SLICC2012 criteria). The modified Gilliam classification for SI was used. Descriptive statistics and bivariate and multivariate analysis were performed to evaluate the factors associated with SI at diagnosis of the disease. Results: A total of 149 patients were included, 91.3% women, with a median age at diagnosis of 33years. SI at onset of the disease occurred in 125 patients (83.9%), followed by joint involvement in 120 cases (80.5%). Non-specific skin lesions were more frequent than specific lesions, 92.8% versus 66.4%, respectively. In the bivariate analysis, a longer delay to diagnosis, the presence of joint involvement, a lower presence of thrombocytopenia, and a higher SLEDAI-2K score were associated with the presence of SI at onset of the disease. In the multivariate analysis, the variable that remained independently associated was joint involvement (OR: 2.8: 95%CI: 1.1-7.5; P=.04). During follow-up, 4/24 patients who had not presented SI at diagnosis and 51/125 patients who had, had at least one new skin flare (range: 1-5 outbreaks). Conclusions: Our study demonstrates the high frequency of skin involvement in SLE, both diagnostically and evolutionarily, and confirms previously reported data regarding the existence of a skin-articular phenotype.(AU)

Psychological impact of the COVID-19 pandemic and lockdown in a Spanish sample with anxiety disorder: sex differences.

The early psychological impact of the COVID-19 pandemic and lockdown is greater in people with mental disorders. This study explored the differences in the psychological impact on people with an anxiety disorder by sex in Spain.

Cutaneous manifestations in patients with systemic lupus erythematosus: Forms at the beginning of the disease and during follow-up. Retrospective analysis.

OBJECTIVES: To describe skin involvement (SI) in patients with systemic lupus erythematosus (SLE) at onset and during follow-up of the disease and to determine factors associated with SI at lupus diagnosis. MATERIALS AND METHODS: Retrospective, observational, and descriptive study, from a single centre in patients diagnosed with SLE (ACR 1982-97 or SLICC 2012 criteria). The modified Gilliam classification for SI was used. Descriptive statistics and bivariate and multivariate analysis were performed to evaluate the factors associated with SI at diagnosis of the disease. RESULTS: 149 patients were included, 91.3% women with a median age at diagnosis of 33 years. SI at onset of the disease occurred in 125 patients (83.9%), followed by joint involvement in 120 cases (80.5%). Non-specific skin lesions were more frequent than specific lesions, 92.8% versus 66.4%, respectively. In the bivariate analysis, a longer delay to diagnosis, the presence of joint involvement, a lower presence of thrombocytopenia, and a higher SLEDAI-2K score were associated with the presence of SI at onset of the disease. In the multivariate analysis, the variable that remained independently associated was joint involvement (OR 2.8%-95% CI 1.1-7.5, p: .04). During follow-up, 4/24 patients who had not presented SI at diagnosis and 51/125 patients who had, had at least one new skin flare (range: 1-5 outbreaks). CONCLUSIONS: Our study demonstrates the high frequency of skin involvement in SLE, both diagnostically and evolutionarily, and confirms previously reported data regarding the existence of a skin-articular phenotype.

Study of the Chemical Composition and Biological Activity of the Essential Oil from Congona (Peperomia inaequalifolia Ruiz and Pav.).

The species Peperomia inaequalifolia, commonly known as congona, is a succulent herbaceous plant belonging to the Piperaceae family, which is used for different purposes in traditional medicine. In this study, the chemical composition, enantiomeric distribution, and biological activity of essential oil isolated from the leaves of this species was determined. Hydrodistillation was used to isolate the essential oil. Gas chromatography coupled to mass spectrometry was used to determine the qualitative composition, a gas chromatograph equipped with a flame ionization detector was used to determine quantitative composition, and gas chromatography on an enantioselective column was used to determine enantiomeric distribution. Antibacterial activity was determined using the broth microdilution method, for which we used three Gram-positive cocci bacteria, a Gram-positive bacilli bacterium, and three Gram-negative bacilli bacteria. 2,2'-azinobis-3-ethylbenzothiazoline-6-sulfonic acid (ABTS) radical cations and 2,2-diphenyl-1-picrylhydryl (DPPH) radicals were used as reagents for determining the antioxidant activity of the essential oil. The spectrophotometric method was used to analyze the acetylcholinesterase inhibitory effect of the essential oil. The yield of leaves in essential oil was 0.16 ± 0.01% (v/w). Forty-three chemical compounds were identified in the essential oil, which represent 97.46% of the total composition. Sesquiterpene hydrocarbons were the most representative group, with 24 compounds (21.63%). The principal constituents were found to be elemicin (27.44 ± 1.35%), bisabolol <α-> (17.76 ± 1.38), myristicin (15.45 ± 0.86), methyl eugenol (6.22 ± 0.24), viridiflorene (6.81 ± 0.10), and safrole (6.68 ± 0.23). Three pairs of enantiomers were identified in the essential oil of Peperomia inaequalifolia. Essential oil presented a minimum inhibitory concentration (MIC) of 4000 µg/mL against Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Listeria monocytogenes, and Escherichia coli. The antioxidant activity of the essential oil was strong according to the DPPH and ABTS methods, with a half radical scavenging capacity (SC50) of 293.76 ± 3.12 µg/mL and 226.86 ± 0.05 µg/mL, respectively. Additionally, the essential oil reported moderate anticholinesterase activity, with an IC50 of 43.93 ± 1.05 µg/mL.

Postnatal catch-up growth in term newborns with altered fetal weight patterns. The GROWIN study.

BACKGROUND: Small for gestational age (SGA) perform a postnatal catch-up growth to recover their genetic trajectory. We studied the postnatal catch-up growth pattern of fetuses born with an appropriate-for-gestational-age (AGA) weight but with fetal growth deceleration (FGD) to explore whether they catch up. METHODS: Nine hundred and sixty-six newborns at Villalba University General Hospital (HUGV), were followed from 34 to 37 weeks to birth. Z-scores, adjusted for sex and age, of weight, length, and BMI at 3, 6, 9, and 12 months were calculated. We define catch-up as an increase in z-score greater than 0.67 SD in the growth curves. RESULTS: AGA FGD had lower mean weight and length than AGA non-FGD at all time points; BMI was lower until 3 months. AGA FGD had a lower weight, length, and BMI z-score (until 9, 6 months, and at birth, respectively) than AGA non-FGD. AGA FGD newborns had a significantly increased likelihood of weight catch-up at 3 months (OR 1.79; 95% CI: 1.16, 2.78; p = 0.009) and BMI in all investigated periods (OR 1.90; 95% CI 1.30, 2.78; p < 0.001 at 3 months), compared to AGA non-FGD newborns. CONCLUSIONS: AGA FGD newborns perform catch-up growth, especially in weight and BMI, in the first year of life, compared to AGA non-FGD. IMPACT: Appropriate-for-gestational-age (AGA) newborns with fetal growth deceleration (FGD), between the third trimester of pregnancy and delivery, present a lower weight and height, during the first year of life, compared to AGA non-FGD. Appropriate-for-gestational-age (AGA) newborns with fetal growth deceleration (FGD), between the third trimester of pregnancy and delivery, present a higher likelihood of weight catch-up in the first 3 months of life and of BMI in the first year compared to AGA non-FGD. AGA FGD experienced early weight and BMI catch-up, especially in the first 3 months of life, like SGA. This finding should be considered in the future follow-up.

Impacto psicológico de la pandemia de COVID-19 y el confinamiento en una muestra española con trastorno de ansiedad: diferencias entre sexos / Psychological impact of the covid-19 pandemic and lockdown in a spanish sample with anxiety disorder: sex differences

Introducción. El impacto psicológico en las etapas iniciales de la pandemia por COVID-19 y el confinamiento fue mayor en personas con trastornos mentales. En este estudio se exploraron las diferencias en el impacto psicológico según el sexo en personas con trastorno de ansiedad en España. Metodología. Estudio transversal, descriptivo y comparativo de los datos aportados por los participantes en una encuesta online anónima realizada entre el 19 y el 26 de marzo de 2020. El cuestionario ad hoc incluyó datos sociodemográficos, clínicos y variables relacionadas con COVID-19,junto con preguntas sobre estrategias de afrontamiento y las versiones en español de la Escala de Escalas de Depresión Ansiedad Estrés (DASS-21) y la Escala de Impacto del Estresor(IES). Se utilizaron análisis descriptivos bivariados y modelos de regresión logística. Resultados. De los 21.207 participantes, se analizaron1617 (7,6%) personas con trastorno de ansiedad autoinformado [1347 (83,3%) mujeres; 270 (16,7%) varones]. El impacto psicológico fue mayor en las mujeres que en los hombres con diferencias estadísticamente significativas en cada subescala del DASS-21 y subescalas del IES. Después de ajustar por posibles variables de confusión, se observó que ser mujer se asoció con puntuaciones más altas en las subescalas de pensamientos intrusivos y evitativos. Conclusiones. Nuestro estudio sugiere que las mujeres con trastorno de ansiedad son un grupo vulnerable a un mayor impacto negativo en la salud mental y, especialmente, en los síntomas relacionados con el trastorno de estrés postraumático. (AU)

Background. The early psychological impact of the COVID-19 pandemic and lockdown is greater in peoplewith mental disorders. This study explored the differences in the psychological impact on people with an anxiety disorder by sex in Spain. Methods. Cross-sectional, descriptive, comparative study of the data provided by participants in an anonymous online survey between March 19 and 26, 2020. Thead hoc questionnaire included sociodemographic, clinical,and variable data related to COVID-19, along with questions about coping strategies, and the Spanish versions ofthe Depression, Anxiety, and Stress Scale (DASS-21) andImpact of Event Scale (IES). Descriptive bivariate analyses and logistic regression models were used. Results. Of the 21,207 participants, 1617 (7.6%) people with self-reported anxiety disorder were analyzed [1347(83.3%) females; 270 (16.7%) males]. The psychological impact was greater on women than men with statistically significant differences in each subscale of the DASS-21and subscales of the IES. After adjusting for potential confounding variables, it was observed that being awoman was associated with higher scores on the intrusiveand avoidant thoughts subscales. Conclusions. Our study suggests that women with ananxiety disorder are a group vulnerable to a greater negative impact on mental health and, especially, symptomsr elated to post-traumatic stress disorder. (AU)

Predictors of severe hemolytic anemia and its impact on major outcomes in systemic lupus erythematosus: Data from a multiethnic Latin American cohort.

OBJECTIVE: To determine the predictors of the occurrence of severe autoimmune hemolytic anemia (AIHA) and its impact on damage accrual and mortality in SLE patients. METHODS: Factors associated with time to severe AIHA (hemoglobin level ≤7 g/dL) occurring from the onset of SLE symptoms were examined by Cox proportional hazards regressions. The association of severe AIHA with mortality was examined by logistic regression analyses while its impact on damage was by negative binomial regression. RESULTS: Of 1,349 patients, 49 (3.6%) developed severe AIHA over a mean (SD) follow-up time of 5.4 (3.8) years. The median time from the first clinical manifestation to severe AIHA was 111 days (IQR 43-450). By multivariable analysis, male sex (HR 2.26, 95% CI 1.02-4.75, p = 0.044), and higher disease activity at diagnosis (HR 1.04, 95% CI 1.01-1.08, p = 0.025) were associated with a shorter time to severe AIHA occurrence. Of the SLEDAI descriptors, only hematologic (leukopenia and/or thrombocytopenia) showed a certain trend toward significance in the multivariable analysis (HR 2.36, 95% CI 0.91-6.13, p = 0.0772). Severe AIHA contributed neither to damage nor to mortality. CONCLUSIONS: Severe AIHA occurs during the early course of SLE. Male sex and higher disease activity at diagnosis emerged as independent predictors of a shorter time to severe AIHA occurrence. Although not statistically significant, hematological abnormalities at SLE diagnosis could predict the occurrence of severe AIHA in a shorter time. Damage and mortality did not seem to be impacted by the occurrence of severe AIHA.

Potentially inappropriate medications according to Marc, STOPP and PRISCUS criteria in a cohort of elderly HIV+ patients. The COMMPI project / Prevalencia de medicamentos potencialmente inapropiados según criterios Marc, STOPP y PRISCUS en una cohorte de pacientes VIH+ de edad avanzada. Proyecto COMMPI

Introduction: The objective is to determine the prevalence of potentially inappropriate drugs according to the Marc, STOPP, and PRISCUS lists in elderly HIV patients. Patients and methods: It was an observational, retrospective, and multicenter study. People living with HIV 65 years or older who underwent chronic concomitant treatment were included. Descriptive and multivariate analyzes were performed to study the association between polypharmacy and potentially inappropriate medication compliance. Results: A total of 55 patients were included, 81.8% men and a median age of 69 years (IQR: 67-73). The median number of comorbidities was 3 (IQR: 2-5) and the most frequent pattern of multimorbidity was cardiometabolic (62.9%). The predominant antiretroviral treatment was triple therapy (65.5%). Polypharmacy was present in 70.9% of the patients and 25.5% had major polypharmacy. The most frequent polypharmacy pattern was cardiovascular (69.2%). The percentage of potentially inappropriate medications according to the Marc, STOPP and PRISCUS lists was 65.5%, 30.9% and 14.5%, respectively (p<0.001). Adjusted for age and sex, polypharmacy was not independently associated with potentially inappropriate medication compliance in any of the lists. Conclusion: Polypharmacy and potentially inappropriate medications have a high prevalence. There is great variability in the percentage according to the list applied. Age, sex, and presence of polypharmacy are not predisposing factors to the presence of potentially inappropriate medications. (AU)

Introducción: El objetivo de este estudio es determinar la prevalencia de medicamentos potencialmente inapropiados según los listados Marc, STOPP y Priscus en pacientes VIH+ de edad avanzada. Pacientes y métodos: Estudio observacional, transversal y multicéntrico. Se incluyeron aquellos pacientes VIH+ mayores de 65 años en tratamiento antirretroviral y tratamiento concomitante crónico. Para conocer la asociación entre polifarmacia y presencia de medicación potencialmente inapropiada se llevaron a cabo análisis descriptivos y multivariante.Resultados: Se incluyeron 55 pacientes (81.8% hombres); mediana de edad 69 años (RIQ 67-73). Todos presentaban alguna comorbilidad (mediana 3, RIQ 2-5). El patrón de multimorbilidad más frecuente fue cardio-metabólico (62.9%). La triple terapia fue el esquema de tratamiento antiretroviral predominante (65.5%) y el patrón de polifarmacia más frecuente fue el cardiovascular (69.2%). Se identificó presencia de polifarmacia en un 70,9% y un 25,5% polifarmacia mayor. El cumplimiento de algún criterio según el listado Marc, STOPP y PRISCUS observó en 65,5%, 30,9% y 14,5% de los pacientes (p<0.001). Según análisis multivariante se observa que la edad, sexo o presencia de polifarmacia no son factores determinantes de presencia de medicamentos inapropiados en los listados. Conclusión. La prevalencia de medicación potencialmente inapropiada según los listados utilizados fue alta, existiendo una gran variabilidad en la identificación entre las diferentes herramientas. Edad, sexo y polifarmacia no son factores predictivosde presencia de medicamentos potencialmente inapropiados. (AU)

Seguridad de las drogas biológicas y sintéticas dirigidas utilizadas en pacientes con enfermedades reumáticas inmunomediadas. Datos del registro BIOBADASAR 3.0 / Safety of biological and targeted synthetic drugs in patients with immune-mediated rheumatic diseases. Data from the BIOBADASAR 3.0 registry

Introducción: conocer la seguridad de las drogas actualmente disponibles para el tratamiento de las enfermedades reumáticas es muy importante al momento de tomar decisiones terapéuticas objetivas e individualizadas en la consulta médica diaria. Asimismo, datos de la vida real amplían el conocimiento revelado por los ensayos clínicos. Objetivos: describir los eventos adversos (EA) reportados, estimar su frecuencia e identificar los factores relacionados con su desarrollo. Materiales y métodos: se utilizaron datos BIOBADASAR, un registro voluntario y prospectivo de seguimiento de EA de tratamientos biológicos y sintéticos dirigidos en pacientes con enfermedades reumáticas inmunomediadas. Los pacientes son seguidos hasta la muerte, pérdida de seguimiento o retiro del consentimiento informado. Para este análisis se extrajeron datos recopilados hasta el 31 de enero de 2023. Resultados: se incluyó un total de 6253 pacientes, los cuales aportaron 9533 ciclos de tratamiento, incluyendo 3647 (38,3%) ciclos sin drogas modificadoras de la enfermedad biológicas y sintéticas dirigidas (DME-b/sd) y 5886 (61,7%) con DME-b/sd. Dentro de estos últimos, los más utilizados fueron los inhibidores de TNF y abatacept. Se reportaron 5890 EA en un total de 2701 tratamientos (844 y 1857 sin y con DME-b/sd, respectivamente), con una incidencia de 53,9 eventos cada 1000 pacientes/año (IC 95% 51,9-55,9). La misma fue mayor en los ciclos con DME-b/sd (71,1 eventos cada 1000 pacientes/año, IC 95% 70,7-77,5 versus 33,7, IC 95% 31,5-36,1; p<0,001). Las infecciones, particularmente las de la vía aérea superior, fueron los EA más frecuentes en ambos grupos. El 10,9% fue serio y el 1,1% provocó la muerte del paciente. El 18,7% de los ciclos con DME-b/sd fue discontinuado a causa de un EA significativamente mayor a lo reportado en el otro grupo (11,5%; p<0,001). En el análisis ajustado, las DME-b/sd se asociaron a mayor riesgo de presentar al menos un EA (HR 1,82, IC 95% 1,64-1,96). De igual manera, la mayor edad, el mayor tiempo de evolución, el antecedente de enfermedad pulmonar obstructiva crónica, el diagnóstico de lupus eritematoso sistémico y el uso de corticoides se asociaron a mayor riesgo de EA. Conclusiones: la incidencia de EA fue significativamente superior durante los ciclos de tratamientos que incluían DME-b/sd.

Introduction: knowing the efficacy and safety of the drugs currently available for the treatment of rheumatic diseases is very important when making objective and individualized therapeutic decisions in daily medical consultation. Likewise, real-life data extends the knowledge revealed by clinical trials. Objectives: to describe the reported adverse events (AEs), estimate their frequency and identify factors associated to them. Materials and methods: BIOBADASAR data were used, which is a voluntary, prospective follow-up registry of AEs of biological and synthetic treatments in patients with immune-mediated rheumatic diseases. Patients are followed until death, loss of followup, or withdrawal of informed consent. To carry out this analysis, the data collected up to January 31, 2023 was extracted. Results: a total of 6253 patients were included, who contributed with 9533 treatment periods, including 3647 (38.3%) periods without b/ts-DMARDs and 5886 (61.7%) with b/ts-DMARDs. Among the latter, the most used were TNF inhibitors and abatacept. A total of 5890 AEs were reported in a total of 2701 treatments (844 and 1857 without and with b/ts-DMARDs, respectively), with an incidence of 53.9 events per 1000 patients/ year (95% CI 51.9-55.9). It was higher during the periods with b/ts-DMARDs (71.1 events per 1000 patients/year, 95% CI 70.7-77.5 vs 33.7, 95% CI 31.5-36.1, p<0.001). Infections, particularly those of the upper respiratory tract, were the most frequent AEs in both groups. 10.9% were severe and 1.1% were associated with the death of the patient. 18.7% of the periods with b/ts-DMARDs were discontinued due to an AE, significantly higher than that reported in the other group (11.5%; p<0.001). In the adjusted analysis, b/ts-DMARDs were associated with a higher risk of presenting at least one AE (HR 1.82, 95% CI 1.64-1.96). Similarly, older age, longer evolution time, history of chronic obstructive pulmonary disease, diagnosis of systemic lupus erythematosus, and use of corticosteroids were associated with a higher risk of AE. Conclusions: the incidence of AEs was significantly higher during those treatment periods that included DME-b/sd.

Sensitivity to Change of the SAMANTA Questionnaire, a Heavy Menstrual Bleeding Diagnostic Tool, After 1 Year of Hormonal Treatment.

Background: The validated SAMANTA questionnaire allows identification of women with heavy menstrual bleeding (HMB); that is, with excessive menstrual bleeding that interferes with quality of life (QoL). We assessed its value for monitoring HMB treatment in clinical practice. Material and Methods: This is a prospective observational study conducted between December 2018 and March 2021 in consecutively recruited women with HMB attending gynecologists' offices who started a hormonal treatment. Sociodemographic characteristics were recorded at enrollment. At baseline and month 12, we assessed the HMB (SAMANTA questionnaire), the global impression of menstrual bleeding severity in patients (PGI-S) and clinicians (CGI-S), and the QoL (SF36). At month 12, we assessed the global impression of menstrual bleeding change in patients (PGI-C) and clinicians (CGI-C). Changes in SAMANTA questionnaire score at month 12 were compared with the presence of amenorrhea and changes in blood loss, menstrual period duration, and PGI-S, PGI-C, CGI-S, and CGI-C. Results: The study included 371 women aged 41.2 ± 6.5 years, 87% of whom were using the levonorgestrel intrauterine system. The SAMANTA questionnaire score significantly decreased in 97.3% of women. The decrease was greater in women reporting a reduction in blood loss, shorter menstrual bleeding duration, or a strong improvement in menstrual bleeding severity (PGI-S and CGI-S) or amount (PGI-C and CGI-C) (p < 0.001 for all), but not amenorrhea. SF-36 domains improved significantly; changes being inversely associated with changes in the SAMANTA questionnaire score. Conclusions: The SAMANTA questionnaire seems a valuable tool for monitoring hormonal treatment for HMB. ClinicalTrials.gov identifier NCT03751800.

Características de los pacientes con artritis reumatoidea que impactan en la satisfacción y la adherencia al tratamiento: subanálisis de los datos de Argentina, Chile y Uruguay del estudio SENSE / Characteristics of patients with rheumatoid arthritis that impact treatment satisfaction and adherence: subanalysis of data from Argentina, Chile and Uruguay from the SENSE study

Introducción: las necesidades y perspectivas de los pacientes son determinantes para tratar la artritis reumatoidea (AR). Objetivos: evaluar el impacto de la respuesta inadecuada a los fármacos antirreumáticos modificadores de la enfermedad (DMARD) sobre la satisfacción con el tratamiento, los resultados y las perspectivas de pacientes adultos con control inadecuado de la AR de actividad moderada/alta. Materiales y métodos: se evaluó la satisfacción mediante el cuestionario Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4. Se recolectaron datos sobre la calidad de vida, la adherencia y las estrategias de manejo. Se presentan los resultados para Argentina, Chile y Uruguay (n=202). Resultados: el promedio de la escala de satisfacción global TSQM fue de 62,3±21,8. El 83% informó buena adherencia. Las principales expectativas del tratamiento fueron "alivio duradero de los síntomas" y "menos dolor articular". El 53,47% prefirió tratamiento oral y el 75,74% eligió un rápido inicio de acción. El efecto secundario menos aceptado fue "mayor riesgo de neoplasias". Se planificó rotar el DMARD en el 55% de los casos. De estos, el 84,7% se consideraron terapias avanzadas. La mayoría estaba abierto a un esquema combinado, pero el 25,2% prefirió no utilizarlo. Conclusiones: los resultados reafirman el compromiso con las estrategias treat-to-target, considerando la individualización de las decisiones terapéuticas en el contexto regional.

Introduction: patients' needs and perspectives are determinants for the treatment of rheumatoid arthritis (RA). Objectives: to evaluate the impact of inadequate response to disease-modifying antirheumatic drugs (DMARDs) on treatment satisfaction, outcomes and perspectives of adult patients with inadequate control of moderate/high activity RA. Materials and methods: satisfaction was assessed using the TSQM v1.4 questionnaire. Data on quality of life, adherence and management strategies were collected. Results are presented for Argentina, Chile and Uruguay (n=202). Results: the mean of the TSQM global satisfaction score was 62.3±21.8. Eighty-three percent reported good adherence. The main expectations of treatment were "lasting relief of symptoms" and "less joint pain". The 53.47% of patients preferred an oral treatment; 75.74% chose a rapid onset of action. The least accepted side effect was "increased risk of malignant neoplasms". Fifty-five percent planned to rotate DMARD. Of these, advanced therapies were considered in only 84.7%. Most were open to a combination treatment, but 25.2% preferred not to use it. Conclusions: the results reaffirm the commitment to treat-to-target strategies, considering the individualization of therapeutic decisions in the regional context.