Impact of the COVID-19 pandemic on cervical cancer screening participation, abnormal cytology prevalence and screening interval in Catalonia.

Background: The COVID-19 pandemic led to a national lockdown and the interruption of all cancer preventive services, including cervical cancer screening. We aimed to assess the COVID-19 pandemic impact on opportunistic screening participation, abnormal cytology (ASCUS+) prevalence and screening interval in 2020 and 2021 within the Public Health System of Catalonia, Spain. Methods: Individual data on cytology and HPV testing of women aged 25-65 from 2014 to 2021 were retrieved from the Information System for Primary Care Services (SISAP). Time-series regression models were used to estimate expected screening participation and abnormal cytology prevalence in 2020 and 2021. The impact was determined by comparing observed and expected values (ratios). Additionally, changes in screening interval trends between 2014 and 2021 were assessed by fitting a Piecewise linear regression model. Results: Cervical cancer screening participation decreased by 38.8% and 2.2% in 2020 and 2021, respectively, with the most significant impact on participation (-96.1%) occurring in April 2020. Among older women, participation was lower, and it took longer to recover. Abnormal cytology prevalence was 1.4 times higher than expected in 2020 and 2021, with variations by age (range=1.1-1.5). From June 2020 onwards, the screening interval trend significantly changed from an increase of 0.59 to 3.57 months per year, resulting in a median time of 48 months by December 2021. Conclusions: During the pandemic, fewer women have participated in cervical cancer screening, abnormal cytology prevalence has increased, and the screening interval is more prolonged than before. The potential cervical cancer lifetime risk implications highlight the need for organized HPV-based screening.

Long-term use of clomiphene in male macroprolactinomas with persistent hypogonadism.

BACKGROUND: Men with macroprolactinoma can present persistent hypogonadism despite normoprolactinemia achieved with clinical and/or neurosurgical treatment. Usually, testosterone replacement therapy is indicated. Nevertheless, although off-label, clomiphene citrate (CC), a selective estrogen receptor modulator, has also been used, mainly when fertility is an issue. The aim of this study is to evaluate the effectiveness of CC in recovering the gonadal axis in men with macroprolactinoma, with or without hyperprolactinemia, and evaluate its safety as a long-term therapy. METHODS: This is a retrospective study including 10 men with macroprolactinoma on cabergoline treatment and persistent hypogonadism. All patients received initially 50 mg/d of CC. RESULTS: The median age at diagnosis of prolactinomas was 34 (range, 26-60) years old. All patients were treated with cabergoline at a median maximum dose of 2 (1-7) mg/week, with a median time of treatment of 8.5 (2-15) years. Prolactin was still above the normal range when CC was introduced only in two patients. The mean duration of CC therapy was 3.2 (±2.8) years. Prolactin levels maintained stable (p = 0.252) and testosterone increased (p = 0.027) significantly on CC therapy. Tumor size remained stable. Eight patients (80%) maintained testosterone above 300 ng/dL and were classified as responders. Three responders succeeded in using a lower dose of CC and one of them completed withdrawal CC and maintained eugonadism. There were no side effects or safety concerns reported. CONCLUSION: CC should be seen as a safe treatment option for men with macroprolactinoma and persistent hypogonadism.

Menstrual characteristics and associations with sociodemographic factors and self-rated health in Spain: a cross-sectional study.

BACKGROUND: Evidence on how menstrual characteristics may differ based on socioeconomic factors and self-rated health is significantly scarce. The main aim of this study was to investigate the associations between menstrual characteristics, sociodemographic factors and self-rated health among women and people who menstruate (PWM) aged 18-55 in Spain. METHODS: This cross-sectional study includes data from an online survey collected in March-July 2021 across Spain. Descriptive statistical analyses and multivariate logistic regression models were performed. RESULTS: The analyses included a total of 19,358 women and PWM. Mean age at menarche was 12.4 (SD = 1.5). While 20.3% of our participants experienced a menstrual abundance over 80 ml, 64.1% reported having menstrual blood clots; 6.4% menstruated for longer than 7 days. 17.0% had menstrual cycles that were shorter than 21 days or longer than 35 days. Reports of moderate (46.3%) and high (22.7%) intensity menstrual pain were common. 68.2% of our participants experienced premenstrual symptoms in all or most cycles. The odds for lighter menstrual flow, shorter bleeding days and menstrual cycles were higher as age increased, and amongst participants with less educational attainment. Caregivers presented higher odds for abundant menstrual flow and longer menstruations. Reporting financial constraints and a poorer self-rated health were risk factors for abundant menstrual flow, menstrual blood clots, shorter/longer menstruations and menstrual cycles, premenstrual symptoms, moderate and intense menstrual pain. CONCLUSIONS: This study suggests that age, educational attainment, caregiving, experiencing financial hardship and a poorer self-rated health may shape or mediate menstrual characteristics. It thus highlights the need to investigate and address social inequities of health in menstrual research.

Perspectives on menstrual policymaking and community-based actions in Catalonia (Spain): a qualitative study.

BACKGROUND: Menstrual research and policymaking have become imperative worldwide. It is necessary that these are informed by women and people who menstruate (PWM) alongside expert professionals and activists. METHODS: The main aim of this study was to identify and propose policies and community-based actions to address menstrual inequity and promote menstrual health in Catalonia (Spain). This study consisted of two qualitative studies: (a) 34 individual photoelicitation interviews with women and PWM, (b) a World Café study with 22 professionals and activists. Sampling for both studies was purposive and selective. Recruitment was conducted through healthcare centres, social media, key contacts, and snowball sampling techniques. Data were collected in December 2020-September 2022, and analysed using Framework Analysis. RESULTS: Participants considered the implementation of menstrual policies that address the taboo and stigma of menstruation to be crucial. They stressed the need for menstrual education, which should be integrated into formal education curricula. Participants, and especially women and PWM, highlighted the need to improve the access and quality of healthcare services, so that the menstrual cycle and menstruation are seen as health indicators. Health professionals should encourage agentic informed decisions, hence why both participant groups considered menstrual health education amongst health professionals to be pivotal. Taking action to improve the access and affordability of menstrual products was also imperative for participants, especially for socioeconomically vulnerable populations. Participants agreed on guaranteeing fully equipped menstrual management facilities, and and professionals discussed gender-neutral and sex-segregated bathrooms. Workplace menstrual policies to accommodate and ensure menstrual self-care were also suggested. CONCLUSIONS: Our study highlights the need for multi-dimensional menstrual policies. These should include actions to address menstrual taboo and stigma, to promote menstrual education that goes beyond the hegemonic biomedical prism, to improve the access and quality of menstrual health services, along with policies ensuring adequate menstrual management facilities in public spaces and the access to menstrual products. Policymaking should also focus on how to ensure menstrual management and care in workplaces. Menstrual policies and community-based actions should be framed within intersectionality, to consider how societal structures of power and oppression influence menstrual experiences.

RESUMEN: INTRODUCCIóN: Siendo la investigación y la implementación de políticas menstruales imprescindibles, es necesario que estos procesos estén informados por mujeres y personas que menstrúan (PM), así como por profesionales expertas y activistas. MéTODOS: El objetivo principal de este estudio fue identificar y proponer políticas y acciones comunitarias para abordar la inequidad menstrual y promover la salud menstrual en Cataluña (España). Este estudio consistió en dos estudios cualitativos: (a) 34 entrevistas individuales de fotoelicitación con mujeres y PM, (b) un World Café con 22 profesionales y activistas. El muestreo para ambos estudios fue intencional y selectivo. El reclutamiento se realizó a través de centros de salud, redes sociales, contactos clave y técnicas de bola de nieve. Los datos se recogieron entre diciembre de 2020 y septiembre de 2022 y se analizaron mediante Framework Analysis. RESULTADOS: Las participantes consideraron crucial la implementación de políticas menstruales para abordar el tabú y el estigma menstrual. Destacaron la necesidad de una educación menstrual, que debería integrarse en los currículums escolares. Las participantes, y especialmente las mujeres y PM, resaltaron la necesidad de mejorar el acceso y la calidad de los servicios de salud, de manera que el ciclo menstrual y la menstruación sean consideradas indicadores de salud. Mencionaron que el personal sanitario debe fomentar las decisiones informadas, de ahí que ambos grupos de participantes consideraran fundamental la educación sobre la salud menstrual entre los profesionales de la salud. También, para las participantes fue imperativo asegurar el acceso y asequibilidad de productos menstruales, especialmente para las poblaciones socioeconómicamente vulnerabilizadas. Las participantes estuvieron de acuerdo en la necesidad de garantizar espacios equipadas para el manejo menstrual, y se llevaron a cabo debates entre las profesionales sobre los baños inclusivos y segregados por sexo. También se sugirieron y debatieron políticas menstruales en entornos laborales, para adaptar y garantizar el autocuidado menstrual. CONCLUSIONES: Nuestro estudio destaca la necesidad de políticas menstruales multidimensionales. Estas deberían incluir acciones para abordar el tabú y el estigma menstrual, promover una educación menstrual que vaya más allá de la perspectiva biomédica hegemónica, mejorar el acceso y la calidad de los servicios de salud menstrual, junto con políticas para garantizar la disponibilidad de instalaciones adecuadas para el manejo menstrual en espacios públicos, así como el acceso a productos menstruales. La creación de políticas también debería centrarse en cómo garantizar el manejo y los cuidados menstruales en entornos laborales. Finalmente, estas políticas menstruales y acciones comunitarias deben enmarcarse desde la interseccionalidad, para considerar cómo las estructuras y poderes sociales operan e influyen en las experiencias menstruales.

Medication guide for dose adjustment and management of cardiotoxicity and lipid metabolic adverse events of oral antineoplastic therapy.

Objective: The management of cardiotoxicity concerning the use of oral antineoplastic agents (OAAs) is a challenge for healthcare professionals. Our objective was to create a comprehensive medication management guide with dose adjustment recommendations on OAAs concerning cardiotoxic and lipid metabolic adverse events (AEs) to assist healthcare professionals when prescribing OAAs. Materials and methods: A review of the available information on all dose adjustments necessary to safely prescribe and dispense OAAs concerning cardiotoxicity was conducted. In January 2023, we identified all OAAs authorized by the European Medicines Agency (EMA). For each drug, the latest summary of product characteristics (SPC) approved by the EMA and the tertiary data source Lexicomp® were reviewed. Cardiotoxic AEs were recorded, namely, QT interval prolongation, decrease in left ventricular ejection fraction (LVEF), imbalances in blood pressure (hypertension and hypotension), alterations in heart rate (tachycardia and bradycardia), and thrombosis. Any available dose adjustment recommendations in case of an occurrence of these adverse events were collected. Results: In all, 93 different OAAs had been approved by the EMA and were reviewed. Among them, 51.6% have recognized cardiotoxic AEs and 10.8% can cause alterations in lipid metabolism. A total of 27 (29.0%) OAAs had specific recommendations regarding QT prolongation; 88.9% were listed in the SPC and 59.3% in Lexicomp®. Eight OAAs (9.68%) have reported a decrease in LVEF, and four of these drugs, namely, encorafenib, lorlatinib, ripretinib, and sunitinib, have specific management recommendations. Almost half (49.5%) of currently approved OAAs can potentially alter blood pressure; 34 (36.6%) of them have been reported to cause hypertension and 12 (12.9%) are related to hypotension. Tachycardia and/or bradycardia are associated with 22.6% and 8.6% of the evaluated drugs, respectively. Regarding thrombosis, 30 (32.3%) of the drugs analyzed included the appearance of a thrombus as a possible AE. Conclusions: More than half of the OAAs can produce cardiotoxic effects, with the most frequent being blood pressure alteration and QT interval prolongation with a non-depreciable incidence of LV dysfunction or thrombosis. Before starting the treatment, it is necessary to stratify baseline cardiovascular risk, plan a surveillance schedule, and consider referral to cardio-oncology units.

Menstruation and social inequities in Spain: a cross-sectional online survey-based study.

BACKGROUND: Available research suggests that menstrual inequity has an impact on (menstrual) health outcomes and emotional wellbeing. It is also a significant barrier to achieve social and gender equity and compromises human rights and social justice. The aim of this study was to describe menstrual inequities and their associations with sociodemographic factors, among women and people who menstruate (PWM) aged 18-55 in Spain. METHODS: A cross-sectional survey-based study was conducted in Spain between March and July 2021. Descriptive statistical analyses and multivariate logistic regression models were performed. RESULTS: A total of 22,823 women and PWM were included in the analyses (Mean age = 33.2, SD = 8.7). Over half of the participants had accessed healthcare services for menstruation (61.9%). The odds for accessing menstrual-related services were significantly higher among participants with university education (aOR: 1.48, 95% CI, 1.13-1.95). Also, 57.8% reported having had partial or no menstrual education pre-menarche, with odds being higher among participants born in non-European or Latin American countries (aOR: 0.58, 95% CI, 0.36-0.93). Lifetime self-reported menstrual poverty was between 22.2-39.9%. Main risk factors for menstrual poverty were identifying as non-binary (aOR: 1.67, 95% CI, 1.32-2.11), being born in non-European or Latin American countries (aOR: 2.74, 95% CI, 1.77-4.24), and not having a permit to reside in Spain (aOR: 4.27, 95% CI, 1.94-9.38). Completed university education (aOR: 0.61, 95% CI, 0.44-0.84) and no financial hardship < 12 months (aOR: 0.06, 95% CI, 0.06-0.07) were protective factors for menstrual poverty. Besides, 75.2% reported having overused menstrual products due to lack of access to adequate menstrual management facilities. Menstrual-related discrimination was reported by 44.5% of the participants. Non-binary participants (aOR: 1.88, 95% CI, 1.52-2.33) and those who did not have a permit to reside in Spain (aOR: 2.11, 95% CI, 1.10-4.03) had higher odds of reporting menstrual-related discrimination. Work and education absenteeism were reported by 20.3% and 62.7% of the participants, respectively. CONCLUSIONS: Our study suggests that menstrual inequities affect a high number of women and PWM in Spain, especially those more socioeconomically deprived, vulnerabilised migrant populations and non-binary and trans menstruators. Findings from this study can be valuable to inform future research and menstrual inequity policies.

RESUMEN: INTRODUCCIóN: Investigación previa disponible indica que la inequidad menstrual tiene un impacto en los resultados de salud (menstrual) y en el bienestar emocional. Es también una barrera para la equidad social y de género. El objetivo de este estudio es evaluar la inequidad menstrual y las asociaciones con factores sociodemográficos, en mujeres y personas que menstrúan entre 18-55 años en España. MéTODOS: Este es un estudio transversal, basado en una encuesta, llevado a cabo en España entre marzo y julio de 2021. Se realizaron análisis descriptivos y modelos de regresión logística multivariados.  RESULTADOS: Los análisis se realizaron con los datos de 22,823 mujeres y personas que menstrúan. Más de la mitad de las participantes habían accedido a servicios sanitarios para la menstruación (60.5%). La probabilidad de acceder a servicios sanitarios para la menstruación fue significativamente más alta en participantes con educación universitaria (aOR: 1.48, 95% CI, 1.13-1.95). El 57.8% informó no haber tenido educación menstrual o que ésta fuera parcial, pre-menarquia; la probabilidad fue más alta en participantes que no habían nacido en países europeos o latinoamericanos (aOR: 0.58, 95% CI, 0.36-0.93). La pobreza menstrual durante el ciclo vital se reportó en el 22.2-39.9% de las participantes. Los principales factores de riesgo fueron identificarse como persona no binaria (aOR: 1.67, 95% CI, 1.32-2.11), nacer en países fuera de Europa o Latinoamérica (aOR: 2.74, 95% CI, 1.77-4.24), y no tener papeles para residir en España (aOR: 4.27, 95% CI, 1.94-9.38). Tener estudios universitarios (aOR: 0.61, 95% CI, 0.44-0.84) y no haber reportado problemas económicos en los últimos 12 meses (aOR: 0.06, 95% CI, 0.06-0.07) fueron factores protectores para la pobreza menstrual. Además, el 74.6% indicó haber sobreutilizado productos menstruales por no haber tenido acceso a espacios adecuados para el manejo menstrual. El 42.6% de las participantes comunicaron experiencias de discriminación menstrual. Participantes no binarios (aOR: 1.88, 95% CI, 1.52-2.33) y aquellas que no tenían papeles (aOR: 2.11, 95% CI, 1.10-4.03) presentaron una mayor probabilidad de indicar discriminación menstrual. El absentismo laboral y escolar fue indicado por el 18.3% y el 56.6% de las participantes respectivamente. CONCLUSIONES: Nuestro estudio sugiere que la inequidad menstrual afecta a un número significativo de mujeres y personas que menstrúan en España y, especialmente, a aquellas en situaciones de mayor deprivación socioeconómica, algunos colectivos vulnerabilizados de personas migradas, y a personas no binarias y trans que menstrúan. Los resultados de este estudio pueden ser útiles para investigación futura, así como para el desarrollo de políticas públicas de equidad menstrual.

Menstrual health and management during the COVID-19 syndemic in the Barcelona area (Spain): A qualitative study.

BACKGROUND: Available evidence suggests that menstrual health and management have been impaired during the COVID-19 syndemic. However, research in this area is scarce, and it is failing to voice the experiences of women and people who menstruate regarding their menstrual experiences. OBJECTIVES: This study aimed to explore the experiences of menstrual health and menstrual management among women and people who menstruate in the Barcelona area (Spain) during the COVID-19 syndemic. DESIGN: This is a qualitative study, conducted taking a critical feminist approach, is embedded in the 'Equity and Menstrual Health in Spain' project. METHODS: It includes photo-elicitation individual interviews with 34 women and people who menstruate in the area of Barcelona (Spain). Data were collected in person and through telephone calls between December 2020 and February 2021. Analyses were performed using Thematic Analysis. RESULTS: Main findings navigated through the menstrual changes experienced by some participants, especially women living with long COVID-19, and the barriers to access healthcare and menstrual products during COVID-19. While some participants experienced menstrual poverty, this did not appear to be exacerbated during COVID-19. Instead, access to menstrual products was compromised based on products' availability and mobility restrictions. Menstrual management and self-care were generally easier, given that menstrual experiences were almost exclusively relegated to private spaces during lockdown periods. CONCLUSIONS: Our findings highlight the need to further research and policy efforts towards promoting menstrual health and equity, considering social determinants of health, and taking intersectional and gender-based approaches. These strategies should be further encouraged in social and health crises such as the COVID-19 syndemic.

[Characteristics of the migrant women attended by the Reproductive Health Care Services of the Catalan Health Institute.] / Características de las mujeres migradas atendidas por los Servicios de Salud Reproductiva del Institut Català de la Salut.

OBJECTIVE: The feminization of migration, the need to provide health care to an increasingly diverse population, seeking optimal health data led to considering this research. The objective was to determine the characteristics (socio-demographic profile, obstetric and gynecological record, and monitoring) of migrated pregnant women with a pregnancy process completed in 2019 in Catalonia compared to native women, in public centers (ASSIR-ICS). METHODS: This descriptive study was based on computerized clinical records of women in the 28 centers dependent on the ICS. A descriptive analysis of the variables was carried out to compare the origin of the pregnant women. The Pearson Chi-Square test at 5% and the corrected standardized residual was used to compare the groups and an analysis of variance for the comparison of means also at 5%. RESULTS: 36.315 women were analyzed and the resulting mean age was 31.1 years. The BMI at the beginning of pregnancy was 25.4 on average. Smoking habit was 18.1% among Spanish 17.3% among European. Sexist violence was 4% in Latin American women, being statistically higher than the rest. The risk of preeclampsia was 23.4% in sub-Saharan women. Gestational diabetes was diagnosed mainly among Pakistanis (18.5%). The prevalence of Sexually Transmitted Infections (STIs) was detected in Latin Americans (8.6%), Spanish (5.8%) and Europeans (4.5%). Sub-Saharan women performed insufficient ultrasound control (58.2%) and had the lowest percentage of visits with 49.5%. Pregnancy monitoring was insufficient in 79.9% of all rural pregnant women. CONCLUSIONS: There are differences derived from the geographical origins of pregnant women that condition access to health services.

OBJETIVO: La feminización de la migración y la necesidad de dar asistencia sanitaria a una población cada vez más diversa, buscando unos datos óptimos de salud, llevó a plantearse esta investigación. El objetivo fue determinar las características (perfil socio-demográfico, antecedentes obstétricos-ginecológicos y el seguimiento) de gestantes migradas con un proceso de embarazo finalizado en 2019 en Cataluña frente a las autóctonas, en centros públicos (ASSIR-ICS). METODOS: Este estudio descriptivo se basó en los registros de historia clínica informatizada de mujeres en veintiocho centros dependientes del ICS. Se analizaron las variables según la procedencia de las gestantes y se utilizó la prueba de Ji Cuadrado de Pearson al 5% acompañada del residuo estandarizado corregido para compararlas, así como el análisis de la varianza para la comparación de medias también al 5%. RESULTADOS: Se analizaron 36.315 registros con edad media de 31,1 años. El IMC al inicio de gestación fue de 25,4. El consumo de tabaco fue del 18,1% entre españolas y del 17,3% en el resto de las europeas. El cribado de violencia machista llegó al 4% en latinoamericanas, siendo estadísticamente superior al resto. El riesgo de preeclampsia fue del 23,4% en subsaharianas. La diabetes gestacional fue diagnosticada principalmente entre paquistaníes (18,5%). La prevalencia de Infecciones de Transmisión Sexual (ITS) fue del 8,6% en latinoamericanas, del 5,8% en españolas y del 4,5% en europeas. Las subsaharianas (58,2%) realizaron un control insuficiente de ecografías y un menor porcentaje de visitas con un 49,5%. El seguimiento del embarazo fue insuficiente en el 79,9% del total de las gestantes rurales. CONCLUSIONES: Existen diferencias derivadas del origen geográfico de las gestantes que condicionan el acceso a los servicios sanitarios.

Antimicrobial Defined Daily Dose in Neonatal Population: Validation in the Clinical Practice.

BACKGROUND: Currently, there is no validated method for estimating antimicrobial consumption in the neonatal population, as it exists for adults using Defined Daily Doses (DDD). In neonatology, although there are different methods, each one with advantages and disadvantages, there is no unified criterion for use. The aim of this study is to validate the neonatal DDD designed as a new standardised form of antimicrobial consumption over this population. METHODS: The validation of the neonatal DDD, Phase II of the research project, was carried out through a descriptive observational study. Periodic cut-offs were performed to collect antimicrobial prescriptions of neonates admitted to the neonatology and intensive care units of nine Spanish hospitals. The data collected included demographic variables (gestational age, postnatal age, weight and sex), antimicrobial dose, frequency and route of administration. The selection of the optimal DDD value takes into account power value, magnitude obtained from the differences in the DDD, statistical significance obtained by the Wilcoxon test and degree of agreement in the stipulated doses. RESULTS: Set of 904 prescriptions were collected and finally 860 were analysed based on the established criteria. The antimicrobials were mostly prescribed in the intensive care unit (63.1%). 32 different antimicrobials were collected, and intravenous administration was the most commonly used route. Neonatal DDD were defined for 11 different antimicrobials. A potency > 80% was obtained in 7 antibiotics. The 57.1% of the selected DDD correspond to phase I and 21.4% from phase II. CONCLUSION: DDD validation has been achieved for the majority of intravenously administered antimicrobials used in clinical practice in the neonatal population. This will make it possible to have an indicator that will be used globally to estimate the consumption of antimicrobials in this population, thus confirming its usefulness and applicability.

PRL-R Variants Are Not Only Associated With Prolactinomas But Also With Dopamine Agonist Resistance.

CONTEXT: Knockout prolactin receptor gene (PRL-R) mice are animal models for prolactinomas and PRL acts via autocrine/paracrine inhibiting lactotroph proliferation. Recently, variants of the PRL-R were identified in prolactinoma patients and their frequency was higher compared to individuals from the genomic database. OBJECTIVE: We analyzed PRL-R variants frequency in an extensive cohort of prolactinoma patients and evaluated their association with clinical, laboratorial, and imaging characteristics and hormonal response to cabergoline. DESIGN: Observational, retrospective, and cross-sectional study. SETTING: This study took place at the Neuroendocrinology Unit of Clinics Hospital, Medical School of University of São Paulo, Brazil, a tertiary referral center. PATIENTS AND METHODS: Study participants included adults with sporadic prolactinomas treated with cabergoline, where response to therapy was defined by prolactin normalization with up to 3 mg/week doses. DNA was extracted from blood samples and the PRL-R was analyzed by polymerase chain reaction techniques and automatic sequencing. The association of PRL-R variants with serum prolactin levels, maximal tumor diameter, tumor parasellar invasiveness, and response to cabergoline was analyzed. RESULTS: We found 6 PRL-R variants: p.Ile100(76)Val, p.Ile170(146)Leu, p.Glu400(376)Gln/p.Asn516(492)Ile, p.Glu470Asp e p.Ala591Pro; the last 2 are newly described in prolactinomas' patients. The variants p.Glu400(376)Gln/p.Asn516(492)Ile and p.Ala591Pro were more frequent amongst patients compared to genomic databases, and the p.Asn516(492)Ile showed pathogenic potential using in silico analysis as previously described. PRL-R variants were associated with male sex (P = 0.015), higher serum PRL levels (P = 0.007), larger tumors (P = 0.001), and cabergoline resistance (P < 0.001). CONCLUSIONS: The prolactin/prolactin receptor system seems to be related to prolactinoma tumorigenesis and cabergoline resistance. Additional studies are needed to better understand the PRL-R variants' role and their potential as therapeutic targets.

Complementary and alternative medicine in cancer patients: characteristics of use and interactions with antineoplastic agents.

PURPOSE: Our objectives were to analyze the use of complementary and alternative medicine (CAM) in cancer patients and to describe the incidence and characteristics of interactions between CAM and antineoplastic agents. METHODS: We performed an observational study in cancer outpatients at a university hospital. Variables were collected through a 22-item questionnaire. Potential interactions between CAM and antineoplastic agents were analyzed using the Lexicomp®, the About Herbs®, and the summary of product characteristics. Mechanism of action, reliability, and the potential clinical effect of interactions were analyzed. RESULTS: The study population comprised 937 patients, of whom 65% used CAM (70.6% herbal products, 25.8% dietary supplements, and 3.6% homeopathy). Female sex, younger age, and breast cancer were associated with more frequent use of CAM. The primary source of information about CAM was friends and family (43.5%). A total of 335 (57.1%) patients did not tell their doctor that they took CAM. The five most common CAM were chamomile, green tea, pennyroyal mint, linden, and rooibos. At least one interaction between CAM and antineoplastic agents was reported by 65.0% of CAM users (33.9% of all patients). Depending on the mechanism of action, 80% of CAM diminished the metabolism of the antineoplastic agents. CONCLUSION: Our results reveal a high incidence of interactions between CAM and antineoplastic agents. The most frequent CAM were herbal products. Family and friends were the primary sources of information that led patients to start taking CAM, and more than half of the patients did not tell their doctor that they were taking CAM.

Possible heart failure caused by osimertinib in a lung cancer patient.

INTRODUCTION: Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) indicated for the treatment of epidermal growth factor receptor mutated non-small cell lung cancer (NSCLC). It has demonstrated better results concerning effectiveness than other TKIs for the same indication. However, despite a good safety profile, it could produce some cardiotoxicity that does not occur with other drugs of the same group. CASE REPORT: We report the evolution and management of a female patient diagnosed with NSCLC who developed a grade 3 cardiotoxicity due to treatment with osimertinib. This patient suffered from a left bundle branch block, dyslipidemia, and hypertension as cardiovascular risk factors. After a long period of treatment with osimertinib, she developed a severe heart failure (HF) with an important decrease in left ventricular ejection fraction (LVEF), which triggered an admission to the oncology unit for eight days. MANAGEMENT AND OUTCOMES: Treatment with osimertinib was first suspended and then resumed after stabilization of the HF. She also developed atrial fibrillation during admission and has required narrow cardiac monitoring and management since the debut of the HF. After evaluating the benefit-risk balance, osimertinib was reintroduced and the patient continues in treatment at the moment, although the baseline LVEF is not recovered. DISCUSSION: There is scarce evidence in the literature concerning HF and important LVEF decrease due to osimertinib. However, its severity and repercussion for the patient justify the thorough screening of cardiovascular risk factors before starting the therapy.

First PCR-free electrochemical bioplatform for the detection of mustard Sin a 1 protein as a potential "hidden" food allergen.

A disposable electrochemical PCR-free biosensor for the selective detection of a fragment encoding the protein Sin a 1, a 2S albumin considered a diagnostic marker for sensitization to mustard, is reported. The methodology is based on the formation of DNA/RNA heterohybrids by sandwich hybridization of a specific fragment of the Sin a 1 allergen coding sequence with appropriately designed RNA probes. Labeling with commercial antibodies specific to the heteroduplexes and secondary antibodies conjugated with horseradish peroxidase (HRP) was carried out onto the surface of magnetic beads (MBs). Amperometric transduction was undertaken on screen-printed electrodes using H2O2 as enzyme substrate and hydroquinone (HQ) a redox mediator. The electrochemical biosensor allows the simple and fast detection (75 min) of Sin a 1 reaching a limit of detection of 3 pM. The bioplatform was successfully applied to the analysis of the targeted Sin a 1 gene specific region using just 50 ng of non-fragmented denatured genomic DNA extracted from yellow mustard seeds.

Implementation and evaluation of a home pharmaceutical care model through Telepharmacy.

OBJECTIVE: To describe the impact of a Specialized Pharmaceutical Care model  that includes pharmacotherapeutic monitoring of patients through an  Telepharmacy platform and home medication dispensing. METHOD: A descriptive and retrospective study conducted in the Pharmacy Service of a tertiary hospital, between 23 March 2020 and 31  December 2021. A new pharmaceutical care model for chronic ambulatory  patients was developed, including: (i) definition of criteria for selecting  Telepharmacy candidate patients; (ii) stratification of patients by risk level; (iii)  definition of individualized pharmacotherapeutic monitoring; (iv)  adaptation of the Pharmacy Service app platform to ensure continuous pharmacotherapeutic monitoring and patient monitoring (e- Oncohealth, e-Midcare and farMcuida), (v) implementation of an appointment  system; and (vi) development of a software module for the management of  home medication delivery. The impact of this pharmaceutical care model was assessed by analyzing indicators of activity, safety, adherence and  perceived quality. Moreover, an additional study on the impact of COVID­19 was developed in order to assess the accessibility of medical care  and continuity of treatment through a survey conducted on a random sample of 100 patients. RESULTS: During the study period, 2,737 patients benefited from the new  remote pharmaceutical care model. A total of 7,758 Telepharmacy consultations were performed. Pharmacotherapeutic monitoring  prevented 1,043 adverse drug reactions, which affected 10.4% of patients  (3.6 adverse drug reactions/patient). Mean adherence to treatment  was 95.2%. Overall satisfaction with the new model was 9.8/10. All patients would recommend this model to other patients. CONCLUSIONS: The new Pharmaceutical care model increases patient safety and  improves treatment adherence, with a high perceived quality. Patient  stratification and individualized follow-up via an Telepharmacy platform were  crucial to the development of this model.

OBJETIVO: Describir el impacto de un modelo de atención farmacéutica especializada que incluye el seguimiento farmacoterapéutico de  los pacientes mediante una plataforma de Telefarmacia y la dispensación de  la medicación en el domicilio.Método: Estudio descriptivo, retrospectivo, llevado a cabo en un servicio de  farmacia de un hospital terciario entre el 23 marzo de 2020 y el 31 de  diciembre de 2021. Se desarrolló un nuevo modelo de atención farmacéutica para la atención de los pacientes crónicos ambulatorios, que incluye: i) definición de los criterios de selección de los pacientes  candidatos a Telefarmacia, ii) estratificación de los pacientes según el nivel de riesgo, iii) definición del seguimiento farmacoterapéutico individualizado, iv)  adaptación de la plataforma de apps del servicio de  farmacia para garantizar el seguimiento farmacoterapéutico continuo y la  monitorización de los pacientes (e-Oncosalud, e-Midcare y farMcuida), v)  implantación de un sistema de citación, y vi) el desarrollo de un módulo  informático para la gestión de la dispensación y entrega de la medicación en el  domicilio. El impacto de este modelo de atención se evaluó mediante el análisis  de indicadores de actividad, seguridad, adherencia y calidad percibida.  Asimismo, se incluyó un estudio adicional sobre el impacto de la  COVID­19 en  la accesibilidad de la atención médica y la continuidad de los  tratamientos, mediante una encuesta a una muestra aleatoria de 100  pacientes. RESULTADOS: Durante el periodo de estudio, 2.737 pacientes se han beneficiado del nuevo modelo de atención farmacéutica a distancia. El número de consultas de Telefarmacia realizadas fue 7.758. El seguimiento  farmacoterapéutico evitó 1.043 eventos adversos asociados a la  medicación, que afectaron al 10,4% de los pacientes atendidos (3,6 eventos  adversos asociados a la medicación/paciente). La adherencia media al  tratamiento de los pacientes fue del 95,2%. La satisfacción global con el nuevo  modelo de atención farmacéutica fue de 9,8/10. El 100% de los  pacientes lo recomendaría a otros pacientes. CONCLUSIONES: Este nuevo modelo de atención farmacéutica aumenta la  seguridad del paciente y mejora su adherencia al tratamiento, con unos índices  de calidad percibida elevados. La estratificación de pacientes y el  seguimiento personalizado mediante la plataforma Telefarmacia resultaron clave en su desarrollo.

"Maternal Vaccination Greatly Depends on Your Trust in the Healthcare System": A Qualitative Study on the Acceptability of Maternal Vaccines among Pregnant Women and Healthcare Workers in Barcelona, Spain.

The World Health Organization (WHO) identified vaccine hesitancy as one of the top 10 threats to global health in 2019. Health promotion and education have been seen to improve knowledge and uptake of vaccinations in pregnancy. This qualitative study was conducted based on phenomenology, a methodological approach to understand first-hand experiences, and grounded theory, an inductive approach to analyse data, where theoretical generalisations emerge. Data were collected through semi-structured interviews with pregnant women attending antenatal care services and healthcare workers (HCWs) in Barcelona, Spain. Interviews were audio-recorded, transcribed, and coded, and notes were taken. Inductive thematic analysis was performed, and data were manually coded. Pertussis was reported as the most trusted vaccine among pregnant women due to its long-standing background as a recommended vaccine in pregnancy. The influenza vaccine was regarded as less important since it was perceived to cause mild disease. The COVID-19 vaccine was the least trustworthy for pregnant women due to uncertainties about effectiveness, health effects in the mid- and long-term, the fast development of the vaccine mRNA technology, and the perceptions of limited data on vaccine safety. However, the necessity to be vaccinated was justified by pregnant women due to the exceptional circumstances of the COVID-19 pandemic. The recommendations provided by HCW and the established relationship between the HCW, particularly midwives, and pregnant women were the main factors affecting decision-making. The role of mass media was perceived as key to helping provide reliable messages about the need for vaccines during pregnancy. Overall, vaccines administered during pregnancy were perceived as great tools associated with better health and improved quality of life. Pregnancy was envisioned as a vulnerable period in women's lives that required risk-benefits assessments for decision-making about maternal vaccinations. A holistic approach involving the community and society was considered crucial for health education regarding maternal vaccines in support of the work conducted by HCWs.

A smartphone app to improve the safety of patients undergoing treatment with oral antineoplastic agents: 4 years of experience in a university hospital.

Objective: This study aims to analyze the impact of the eOncosalud app on the management and follow-up of adverse effects (AE) in patients receiving oral antineoplastic agents. Material and methods: We performed an observational, prospective study of cancer outpatients treated with oral antineoplastic agents (OAA), monitored by the eOncosalud app between August 2017 and October 2021. Safety variables were collected from eOncosalud: the number of AE; severity of the AE according to CTCAE, version 4.03; timelapse from app installation to first recorded AE; automatic recommendations issued; and the patient's acceptance of the recommendations made. To assess the impact of the recommendations generated by the algorithm, we calculated the positive predictive value (PPV) as the number of recommendations accepted out of the total number of recommendations generated. Safety-related patient messages were also analyzed (AE, drug-drug interactions, drug administration). Result: The app was downloaded and used by 186 patients (58.0% women), with a mean age of 59.0 years. A total of 1,368 AE were recorded, the most frequent being fatigue (19.37%), diarrhea (18.20%), and skin changes (9.21%). Regarding the recommendations issued by the app algorithm, 102 patients received 344 information brochures, 39 patients received 51 recommendations for supportive care to control AE, 60 patients received 240 recommendations to visit their primary care doctor, 14 patients received 16 recommendations to contact their specialist pharmacist or oncologist-hematologist, and 34 patients received 73 recommendations to go to the emergency room. The suggestion to go to the emergency room and contact the specialist pharmacist or oncologist-hematologist had a PPV of 0.51 and 0.35, respectively. Half of the patients (50.4%) used the messaging module. A total of 1,668 messages were sent. Of these, 47.8% were related to treatment safety: AE, 22.7%; drug-drug interactions, 20.6%; drug administration, 3.6%; and missing a dose, 1.0%. Conclusions: The eOncosalud app enables close, real-time monitoring of patients treated with OAA. The automatic recommendations through the app's algorithm have optimized available healthcare resources. The app facilitated early detection of AE, thus enabling patients themselves to improve the safety of their treatment.

Perceptions of COVID-19 Maternal Vaccination among Pregnant Women and Healthcare Workers and Factors That Influence Vaccine Acceptance: A Cross-Sectional Study in Barcelona, Spain.

COVID-19 is associated with poor maternal and pregnancy outcomes. COVID-19 vaccination is recommended in Spain, yet vaccination rates in pregnancy are suboptimal. This study investigates the perceptions of pregnant women and healthcare workers (HCW) regarding COVID-19 vaccination. A web-based cross-sectional quantitative study was conducted in 2021-2022 among 302 pregnant women and 309 HCWs in the Catalan public health system. Most pregnant women (83%) and HCWs (86%) were aware of COVID-19 maternal vaccines. The recommendation of the COVID-19 vaccination by an HCW was identified as the greatest facilitator for maternal vaccine uptake, while the fear of harming the foetus was the most significant barrier reported for rejecting vaccination. HCWs recognised they received limited information and training about COVID-19 vaccination in pregnancy, which hindered them from providing informed recommendations. This study highlights that information and education on COVID-19 vaccines to pregnant women and health professionals are pivotal to ensuring informed decision-making and increasing vaccine uptake.

Patient-reported outcomes and mobile applications. A review of their impact on patients' health outcomes.

OBJECTIVE: To review the evidence of the mobile apps in collection patient- reported outcomes and their impact on health outcomes. Method: A review was conducted of the literature on apps aimed at collecting  patient-reported outcomes. Selected articles were required to consider the  apps' impact on patients' health outcomes. The search was carried out during  April 2021 in Pubmed and Embase using the search terms "app", "mobile  applications" , "patient-reported outcomes", "outcome assessment, health  care", and "quality of life", To be included articles had to be written in English  or Spanish and they were required to dwell on apps used by patients, family  members and/or caregivers that measured at least one health outcome. No  time restrictions were applied. RESULTS: Of the 26 articles reviewed, 19 (73.1%) were clinical trials, 4  (15.4%) were quasi-experimental studies, and 3 (11.5%) were observational studies. A pharmacy department was involved in 4 studies  (15.4%), and 3 (11.5%), were carried out in Spain. The sample size ranged  from 14 to 411. Depending on the study population, the most frequent studies included cancer patients (42.3%) and patients with cardiovascular  diseases (26.9%). Most of the studies focused on measuring the impact of the app on the patients' quality of life (50.0%), control of clinical parameters  (46.2%), adherence (38.5%), and management of symptoms and/or reduction  of complications (26.9%). Overall efficacy in terms of the  percentage of studies where apps were found to result in a significant  improvement was 73.1%. The most heavily impacted patient-reported  outcomes were adherence, health-related quality of life and satisfaction. CONCLUSIONS: There is emerging evidence that apps have a positive impact on  patients' health outcomes. These tools have shown to lead to an improvement  in the management of different conditions, with results showing a reduction in  complications rates and in the consumption of resources as well as better  adherence to medication and enhanced patient quality of life.

OBJETIVO: Realizar una revisión sobre la evidencia de las aplicaciones móviles  en el registro de los patient-reported outcomes y su impacto en los resultados  en salud.Método: Revisión de la literatura sobre los estudios de aplicaciones orientadas  al registro de patient-reported outcomes y que analizaran su impacto en los  resultados en salud de los pacientes. La búsqueda se realizó en abril de 2021  en Pubmed y Embase con los términos "App", "Mobile Applications"; "Patient  Reported Outcomes"; "Outcome Assessment, Health Care"; "Quality of Life". Se  incluyeron artículos publicados en inglés o español sin límite de tiempo y  que incluyeran aplicaciones cuyos participantes fueran pacientes, familiares y/o  cuidadores y que midieran algún tipo de resultado en salud. RESULTADOS: De los 26 artículos revisados, 19 (73,1%) fueron ensayos clínicos, 4 (15,4%) estudios cuasiexperimentales y 3 (11,5%) estudios  observacionales. En 4 estudios (15,4%) estaba implicado un servicio  de farmacia y en 3 (11,5%) el estudio fue realizado en España. El tamaño  muestral varió de 14 a 411. En función de la población de estudio, los más  frecuentes incluyeron pacientes oncológicos (11 [42,3%] estudios) y pacientes  con patologías cardiovasculares (7 [26,9%] estudios). La mayoría de los  estudios se centraron en la medición del impacto de las aplicaciones en  términos de calidad de vida (50,0%), control de parámetros clínicos (46,2%),  adherencia (38,5%) y manejo de los síntomas y/o reducción de complicaciones (26,9%). La eficacia global en términos del porcentaje en los que se observó una mejoría significativa con el uso de las aplicaciones fue del 73,1%. Los patient-reported outcomes en los que se observó un mayor impacto fueron la adherencia, la calidad de vida relacionada con la salud y la satisfacción. CONCLUSIONES: Existe evidencia emergente de que las aplicaciones tienen un  impacto positivo en los resultados en salud de los pacientes. Estas herramientas están demostrando una mejora en el manejo de diferentes patologías, con resultados que muestran una reducción de  complicaciones y consumo de recursos y mejoras en la adherencia y calidad de  vida de los pacientes.

Implementation of a methodology to assess patient reported outcomes in lung cancer patients: The PeOpLe (Patient-reported Outcomes in Lung cancer ) study protocol.

OBJECTIVE: The purpose of this article is to describe the PeOpLe study protocol, developed to assess patient-reported health outcomes in  advanced or metastatic non-small-cell lung cancer in routine clinical practice using the methodology provided by the International Consortium for Health Outcomes Measurement tool. METHOD: The study envisaged will be multicenter, longitudinal, ambispective and observational. Two groups will be compared: a control group (followed up according to standard clinical practice) and an experimental group (followed up using the International Consortium for Health  Outcomes Measurement methodology adapted to the Spanish setting for 6  months). The variables collected will be related to demography (age, sex,  degree of family support), clinical factors (smoking, comorbidities, lung  capacity), the neoplasm (histology, staging, mutations), pharmacotherapy  (treatment schedule, modifications, and complications), health status  (functional status, quality of life, satisfaction and overall survival) and resource consumption (emergency visits, hospital admissions and time spent by health providers). The PeOpLe study protocol has been approved by the Ethics Committee for Research into Medicinal Products of the Gregorio Marañón General University Hospital and will be conducted in compliance with prevailing ethical principles and standards. CONCLUSIONS: The PeOpLe study will explore how patient-reported outcomes collection can be developed and integrated with the clinical processes used in  the management of patients with locally advanced or metastatic nonsmall cell  lung cancer what patient-reported outcomes can be measured with systems  that can conveniently be used both by patients and by healthcare providers.  Systematic evaluation of patient-reported outcomes will help determine their  impact in terms of effectiveness (survival), safety (complications of systemic  therapy), and quality of life and patient satisfaction. The multidisciplinary and  multicenter nature of the study will facilitate a comprehensive view of the  subject analyzed and allow external reproducibility.

OBJETIVO: El objetivo es describir el protocolo del estudio PeOpLe, cuyo fin es  evaluar los resultados en salud centrados en el paciente con cáncer de pulmón  no microcítico avanzado o metastásico en la práctica clínica habitual mediante  una metodología adaptada de la herramienta del International Consortium for  Health Outcomes Measurement.Método: Estudio observacional, ambispectivo, longitudinal y multicéntrico. Se  compararán dos grupos: grupo control (seguimiento según práctica clínica  habitual) frente a un grupo intervención (seguimiento mediante la metodología  del International Consortium for Health Outcomes Measurement adaptada al entorno español) durante un período de 6 meses.  Las variables recogidas incluirán aspectos demográficos (edad, sexo, apoyo familiar), clínicos (hábito tabáquico, comorbilidades, capacidad   pulmonar), del tumor (histología, estadiaje, mutaciones), farmacoterapéutico (esquema de tratamiento, modificaciones y  complicaciones), grado de salud (estado funcional, calidad de vida, satisfacción y supervivencia global) y consumo de recursos (visitas a urgencias, ingresos  hospitalarios y tiempo dedicado por los profesionales sanitarios). El protocolo  del estudio PeOpLe ha sido aprobado por el Comité de Ética de la Investigación con medicamentos y se realizará respetando los principios y las normas éticas  básicas. CONCLUSIONES: El estudio PeOpLe explorará cómo se pueden desarrollar e  integrar los procesos de medición de resultados en salud centrados en los  pacientes, especialmente los patient-reported outcomes, en pacientes con  cáncer de pulmón no microcítico localmente avanzado o metastásico en la  práctica clínica. La evaluación sistemática de estos patient-reported outcomes  permitirá conocer su impacto en términos de efectividad (supervivencia),  seguridad (complicaciones de la terapia sistémica) y calidad de vida y  satisfacción. El carácter multidisciplinar y multicéntrico facilitará una visión  integral y su reproducibilidad externa.

Endometriosis prevalence and incidence trends in a large population-based study in Catalonia (Spain) from 2009 to 2018.

OBJECTIVE: Endometriosis greatly impacts women's health and quality of life. However, research on the prevalence and incidence of endometriosis remains inconclusive. This study assesses time trends in the prevalence and incidence of endometriosis diagnoses in Catalonia (Spain) from 2009 to 2018, considering differences by age and socioeconomic status. METHODS: Population-based cohort study using data from the Information System for Research in Primary Care (SIDIAP) database. Data were included from over 2.4 million women aged 15-55 years between 1 January 2006 and 31 December 2018. RESULTS: A total of 2,337,717 women were selected as the incident population; 0.7% had an endometriosis diagnosis. Median (interquartile range) age at diagnosis was 37 (32-43) years. Most women were European (92.3%) and lived in urban areas (73.6%). Overall prevalence of endometriosis consistently increased during the 2009-2018 period, and it was 1.24% in 2018. Trends were the highest for women with less socioeconomic deprivation and for the 35-44 years age group. Median incidence rates were 94.9 (92.6-102.9) per 100,000 women-years, being the highest in women aged 35-44 years throughout the whole study period. Overall, incidence increased between 2015 and 2017, and plateaued or decreased in 2018. Incidence rates in women from the most deprived and rural areas were lower, although incidence time trends by socioeconomic status were unclear. CONCLUSION: Healthcare services and public health strategies need to be strengthened to ensure timely endometriosis diagnosis and treatment. Special attention should be given to the most affected populations and the social inequities of health.