Shared Decision-making in Breast Cancer Reconstructive Surgery: Experience in a Leading Hospital.

Background: The paradigm of healthcare has evolved toward patient-centered approaches, where shared decision-making (SDM) plays a pivotal role. This study aimed to explore the implementation of SDM during breast cancer reconstruction consultations and assess its impact on patient satisfaction and the decision-making process as a whole. Methods: A total of 102 female patients undergoing breast reconstruction were included in a multidisciplinary breast pathology unit. A streamlined SDM model involving choice introduction, option description, and preference exploration was implemented. A validated Spanish version of the nine-item Shared Decision Making Questionnaire was used alongside a complementary questionnaire. Data analysis was carried out using electronic data capture software. Results: The nine-item Shared Decision Making Questionnaire results indicate strong agreement in presenting various options and explaining their advantages and disadvantages. Patients were less confident about their participation in decision-making. The Complementary Shared Decision Making Questionnaire highlighted high satisfaction with interview times and language clarity but areas for improvement in consultation space and therapeutic choice participation. Conclusions: Integrating SDM into breast reconstruction consultations empowers patients in the decision-making process and enhances satisfaction. Decision aids prove effective in this context, facilitating patients' comprehension and reducing decisional conflict. There are areas for improvement within the SDM strategy, and they are detectable through scales. Although challenges in information transmission and patient involvement persist, adopting an SDM model has potential benefits that warrant further investigation.

Health equity in urban and rural settings: implementation of the place standard tool in Spain.

The physical, social, and economic characteristics of neighborhoods and municipalities determine the health of their residents, shaping their behaviors and choices regarding health and well-being. Addressing local environmental inequalities requires an intersectoral, participatory, and equity-focused approach. Community participation plays a vital role by providing deeper insights into local contexts, integrating community knowledge and values into processes, and promoting healthier, fairer, and more equitable actions. In recent years, various tools have been developed to assess places and transform them into health-promoting settings. One such tool, the Place Standard Tool (PST), facilitates discussions on Social Determinants of Health grouped into 14 themes, serving as a starting point for local health interventions. In this study, that took place between August 2019 and February 2020, we described the resident's perceptions of two municipalities in the Valencian Community, Spain, using the validated Spanish version of the PST. A mixed-method convergent-parallel design was used to gain a holistic insight into residents' experiences concerning their physical, economic, and social environment. A total of 356 individuals from both municipalities participated in the study through discussion groups, structured interviews, and online survey. Descriptive analysis of the individual questionnaire answers was conducted, and differences between municipalities were explored. Qualitative thematic analysis was conducted on structured interviews and discussion groups. Quantitative and qualitative data were integrated to facilitate their comparison and identify areas of convergence or divergence in the findings. Overall, rural areas received more favorable evaluations compared to urban ones. Public Transport as well as Work and Local Economy were consistently rated the lowest across all groups and contexts, while Identity and Belonging received the highest ratings. In the urban area, additional negative ratings were observed for Traffic and Parking, Housing and Community, and Care and Maintenance. Conversely, Identity and Belonging, Natural Spaces, Streets and Spaces, Social Interaction, and Services emerged as the highest-rated themes overall. In the rural context, positive evaluations were given to Walking or Cycling, Traffic and Parking, Housing and Community, and Influence and Sense of Control. Significant differences (p < 0.01) between urban and rural settings were observed in dimensions related to mobility, spaces, housing, social interaction, and identity and belonging. Our study illustrated the capacity of the PST to identifying aspects within local settings that influence health, revealing both positive and challenging factors. Successful implementation requires appropriate territorial delineation, support from local authorities, and effective management of expectations. Furthermore, the tool facilitated community participation in decision-making about local environments, promoting equity by connecting institutional processes with citizen needs.

Treatment Interruptions and Mortality among Puerto Rican Women with Gynecologic Cancers in Puerto Rico after Hurricanes Irma and María: A Retrospective Cohort Study.

OBJECTIVE: Cancer patients are among the most vulnerable populations during and after a disaster. We evaluated the impact of treatment interruption on the survival of women with gynecologic cancer in Puerto Rico following hurricanes Irma and María. METHODS: Retrospective cohort study among a clinic-based sample of women diagnosed between January 2016-September 2017 (n=112). Women were followed up from their diagnosis until December 2019, to assess vital status. Kaplan-Meier survival curves and Cox proportional hazards models were performed. RESULTS: Mean age was 56 (±12.3) years; corpus uteri (58.9%) was the most common gynecologic cancer. Predominant treatments were surgery (91.1%) and chemotherapy (44.6%). Overall, 75.9% were receiving treatment before the hurricanes, 16.1% experienced treatment interruptions and 8.9% died during the follow-up period. Factors associated with treatment interruption in bivariate analysis included younger age (≤55 years), having regional/distant disease, and receiving >1 cancer treatment (p<0.05). Crude analysis revealed an increased risk of death among women with treatment interruption (HR: 3.88, 95% CI=1.09-13.77), persisting after adjusting for age and cancer stage (HR: 2.49, 95% CI= 0.69-9.01). CONCLUSIONS: Findings underscore the detrimental impact of treatment interruption on cancer survival in the aftermath of hurricanes, emphasizing the need for emergency response plans for this vulnerable population.

Protecting Caribbean patients diagnosed with cancer from compounding disasters.

Caribbean small island developing states are becoming increasingly vulnerable to compounding disasters, prominently featuring climate-related hazards and pandemic diseases, which exacerbate existing barriers to cancer control in the region. We describe the complexities of cancer prevention and control efforts throughout the Caribbean small island developing states, including the unique challenges of people diagnosed with cancer in the region. We highlight potential solutions and strategies that concurrently address disaster adaptation and cancer control. Because Caribbean small island developing states are affected first and worst by the hazards of compounding disasters, the innovative solutions developed in the region are relevant for climate mitigation, disaster adaptation, and cancer control efforts globally. In the age of complex and cascading disaster scenarios, developing strategies to mitigate their effect on the cancer control continuum, and protecting the health and safety of people diagnosed with cancer from extreme events become increasingly urgent. The equitable development of such strategies relies on collaborative efforts among professionals whose diverse expertise from complementary fields infuses the local community perspective while focusing on implementing solutions.

Increased blood draws for ultrasensitive ctDNA and CTCs detection in early breast cancer patients.

Early breast cancer patients often experience relapse due to residual disease after treatment. Liquid biopsy is a methodology capable of detecting tumor components in blood, but low concentrations at early stages pose challenges. To detect them, next-generation sequencing has promise but entails complex processes. Exploring larger blood volumes could overcome detection limitations. Herein, a total of 282 high-volume plasma and blood-cell samples were collected for dual ctDNA/CTCs detection using a single droplet-digital PCR assay per patient. ctDNA and/or CTCs were detected in 100% of pre-treatment samples. On the other hand, post-treatment positive samples exhibited a minimum variant allele frequency of 0.003% for ctDNA and minimum cell number of 0.069 CTCs/mL of blood, surpassing previous investigations. Accurate prediction of residual disease before surgery was achieved in patients without a complete pathological response. A model utilizing ctDNA dynamics achieved an area under the ROC curve of 0.92 for predicting response. We detected disease recurrence in blood in the three patients who experienced a relapse, anticipating clinical relapse by 34.61, 9.10, and 7.59 months. This methodology provides an easily implemented alternative for ultrasensitive residual disease detection in early breast cancer patients.

Presymptomatic Testing for Huntington's Disease in Mexico: 28 Years of Experience.

INTRODUCTION: Huntington's disease (HD) is a genetic neurodegenerative disorder with dominant inheritance. Our center in Mexico City has offered presymptomatic testing (PT) since 1995. OBJECTIVE: To describe the main clinical and demographic characteristics of at-risk HD individuals who applied to the PT program, the reasons for seeking it, and the molecular results. METHODS: A cross-sectional study was conducted with sociodemographic and clinical data of all PT applicants from 1995-2023. Reasons for seeking PT were assessed using a modified questionnaire. In addition, anxiety, and depressive symptoms before and after PT were evaluated with Beck's instruments; cognitive impairment (CI) was assessed with the Mini-Mental State Examination (MMSE) and molecular results. RESULTS: 214 people applied for PT (2.1% of the at-risk population identified in our center); 63% were women (mean age of 37.11 years). 204 (95.3%) were accepted and 190 received results. 70% indicated that the main reason for applying for PT was to inform their offspring about the risk of inheriting HD. Significant differences were observed in the reasons for seeking PT by age group. Although some subjects received treatment, Beck's instrument scores did not indicate special attention or pharmacological treatment. The MMSE showed probable CI in 20 subjects. Of those who received results, 37% were carriers of a full penetrance allele. CONCLUSION: Our center has the only formal PT program for HD in Mexico. The reasons for seeking PT are varied and age-related. Although PT is offered to all subjects at risk for HD, uptake remains low.

Comparing niraparib versus platinum-taxane doublet chemotherapy as neoadjuvant treatment in patients with newly diagnosed homologous recombination-deficient stage III/IV ovarian cancer: study protocol for cohort C of the open-label, phase 2, randomized controlled multicenter OPAL trial.

BACKGROUND: Maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, has been shown to extend progression-free survival in patients with newly diagnosed advanced ovarian cancer who responded to first-line platinum-based chemotherapy, regardless of biomarker status. However, there are limited data on niraparib's efficacy and safety in the neoadjuvant setting. The objective of Cohort C of the OPAL trial (OPAL-C) is to evaluate the efficacy, safety, and tolerability of neoadjuvant niraparib treatment compared with neoadjuvant platinum-taxane doublet chemotherapy in patients with newly diagnosed stage III/IV ovarian cancer with confirmed homologous recombination-deficient tumors. METHODS: OPAL is an ongoing global, multicenter, randomized, open-label, phase 2 trial. In OPAL-C, patients will be randomized 1:1 to receive three 21-day cycles of either neoadjuvant niraparib or platinum-taxane doublet neoadjuvant chemotherapy per standard of care. Patients with a complete or partial response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) will then undergo interval debulking surgery; patients with stable disease may proceed to interval debulking surgery or alternative therapy at the investigator's discretion. Patients with disease progression will exit the study treatment and proceed to alternative therapy at the investigator's discretion. After interval debulking surgery, all patients will receive up to three 21-day cycles of platinum-taxane doublet chemotherapy followed by niraparib maintenance therapy for up to 36 months. Adult patients with newly diagnosed stage III/IV ovarian cancer eligible to receive neoadjuvant platinum-taxane doublet chemotherapy followed by interval debulking surgery may be enrolled. Patients must have tumors that are homologous recombination-deficient. The primary endpoint is the pre-interval debulking surgery unconfirmed overall response rate, defined as the investigator-assessed percentage of patients with unconfirmed complete or partial response on study treatment before interval debulking surgery per RECIST v1.1. DISCUSSION: OPAL-C explores the use of niraparib in the neoadjuvant setting as an alternative to neoadjuvant platinum-taxane doublet chemotherapy to improve postsurgical residual disease outcomes for patients with ovarian cancer with homologous recombination-deficient tumors. Positive findings from this approach could significantly impact preoperative ovarian cancer therapy, particularly for patients who are ineligible for primary debulking surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT03574779. Registered on February 28, 2022.

Antifibrotic treatment adherence, efficacy and outcomes for patients with idiopathic pulmonary fibrosis in Spain: a real-world evidence study.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a rare disorder associated with increased mortality and morbidity. There are currently two drugs approved for IPF but their safety and efficacy profile in real-world settings in Spain is not well understood. METHODS: An observational, multicentre, prospective study was carried out among patients with IPF who started treatment with pirfenidone or nintedanib from 2015 to 2021. Data regarding clinical characteristics, drug adherence, safety profiles and clinical outcomes between these two drugs were collected. RESULTS: 232 patients were included in the analysis. There were no meaningful differences between both groups at baseline. Patients who started pirfenidone showed a decreased risk for treatment withdrawal compared with those starting nintedanib (HR 0.65 (95% CI 0.46 to 0.94; p=0.002)). Time to first adverse event and all-cause mortality was similar between study groups. Risk factors for withdrawal were female sex, diarrhoea and photosensitivity. CONCLUSIONS: in this real-world study, both pirfenidone and nintedanib showed similar efficacy profiles. Pirfenidone was associated with less treatment discontinuations due to side effects.

Screening for Delirium During Pediatric Brain Injury Rehabilitation.

OBJECTIVE: To assess feasibility of routine delirium screening using the Cornell Assessment of Pediatric Delirium (CAPD) in children admitted for rehabilitation with acquired brain injury (ABI), report on the prevalence of positive delirium screens in this population, and explore longitudinal trends in CAPD scores and their association with rehabilitation outcomes. DESIGN: Retrospective study. SETTING: Pediatric inpatient rehabilitation unit. PARTICIPANTS: 144 children (median 10.8 years) with ABI (N=144). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Percent compliance with twice daily delirium screening; prevalence of positive delirium screens; trajectories in CAPD scores and their relation with FIM for Children (WeeFIM) scores. RESULTS: Screening was feasible (mean 75% compliance for each of 144 children). Of 16,136 delirium screens, 29% were positive. 62% of children had ≥1 positive screen. Four primary patterns of CAPD trajectories were identified: Static Encephalopathy (10%), Episodic Delirium (10%), Improving (32%), and No Delirium (48%). Validity of these trajectories was demonstrated through association with WeeFIM and CALS outcomes. Younger age at admission was associated with positive delirium screens, and rehabilitation length of stay was significantly longer for the Improving group. CONCLUSIONS: Delirium occurs frequently in children with ABI during inpatient rehabilitation. Routine delirium screening provides clinically relevant information including the potential to facilitate early detection and intervention for medical complications. Longitudinal ratings of delirium symptoms may also have a role in developing a standardized definition for Post Traumatic Confusional State (PTCS) stage of recovery in children.

Ecological and Syntaxonomic Analysis of the Communities of Glebionis coronaria and G. discolor (Malvion neglectae) in the European Mediterranean Area.

Nitrophilous communities dominated by Glebionis coronaria and Glebionis discolor in the European Mediterranean area were studied. The nomenclature was corrected according to the current taxonomy, following the International Code of Phytosociological Nomenclature (ICPN). The statistical analysis revealed six new associations and one subassociation, with four in Spain, one in Greece, and one in Italy. Additionally, a subassociation of high relevance due to its endemic character was identified. These grasslands exhibit requirements for organic matter and other edaphic nutrients that are closer to those of Malva neglecta communities than to those of Hordeum murinum subsp. leporinum. We confirmed the published syntaxon with the rank of Resedo albae-Glebionenion coronariae suballiance and its subordination to the Malvion neglectae alliance, and we established the type association for this suballiance. Sisimbrietalia officinalis J. Tüxen in Lohmeyer et al. 1962 em. Rivas-Martínez, Báscones, T. E. Díaz, Fernández-González & Loidi 1991. Stellarietea mediae Tüxen, Lohmeyer & Preising ex von Rochow 1951.

Seven-chain adaptive immune receptor repertoire analysis in rheumatoid arthritis reveals novel features associated with disease and clinically relevant phenotypes.

BACKGROUND: In rheumatoid arthritis (RA), the activation of T and B cell clones specific for self-antigens leads to the chronic inflammation of the synovium. Here, we perform an in-depth quantitative analysis of the seven chains that comprise the adaptive immune receptor repertoire (AIRR) in RA. RESULTS: In comparison to controls, we show that RA patients have multiple and strong differences in the B cell receptor repertoire including reduced diversity as well as altered isotype, chain, and segment frequencies. We demonstrate that therapeutic tumor necrosis factor inhibition partially restores this alteration but find a profound difference in the underlying biochemical reactivities between responders and non-responders. Combining the AIRR with HLA typing, we identify the specific T cell receptor repertoire associated with disease risk variants. Integrating these features, we further develop a molecular classifier that shows the utility of the AIRR as a diagnostic tool. CONCLUSIONS: Simultaneous sequencing of the seven chains of the human AIRR reveals novel features associated with the disease and clinically relevant phenotypes, including response to therapy. These findings show the unique potential of AIRR to address precision medicine in immune-related diseases.

Ecological competition in the oral mycobiome of Hispanic adults living in Puerto Rico associates with periodontitis.

Background: Fungi are a major component of the human microbiome that only recently received attention. The imbalance of indigenous fungal communities and environmental fungi present in the oral cavity may have a role in oral dysbiosis, which could exacerbate oral inflammatory diseases. Methods: We performed a cross-sectional study and recruited 88 participants aged 21 to 49 from sexually transmitted infection clinics in Puerto Rico. A full-mouth periodontal examination following the NHANES protocol defined periodontal severity (CDC/AAP). ITS2 (fungal) genes were amplified and sequenced for mycobiota characterization of yeast and environmental fungi. Environmental outdoor spore levels were measured daily by the American Academy of Allergy Asthma and Immunology San Juan station and defined by quartiles as spore scores. Results: Our data indicate polymicrobial colonization of yeast and environmental fungi in the oral cavity. Dominant taxa associated with periodontal disease included Saccharomyces cerevisiae, Rigidoporus vinctus, and Aspergillus penicilloides, while Candida albicans were found to be ubiquitous. Fungal aerosols were found to impact the oral cavity biofilm, likely due to competition and neutralization by inhaled outdoor and indoor fungal spores. Conclusion: To our knowledge, this is the first report showcasing the ecological competition of measured outdoor environmental fungi with the human oral mycobiota.

Population-based Influenza and Respiratory Syncytial Virus Hospitalizations and In-hospital Mortality Rates Among Mexican Children Less Than Five Years of Age.

BACKGROUND: Population-based information regarding the impact of respiratory syncytial virus (RSV) and influenza on hospital admissions and mortality is scant for many countries. METHODS: Prospective testing of RSV and influenza virus was undertaken in patients <5 years old admitted to hospital with acute respiratory infection (ARI) between July, 2014 and June, 2015, and mortality rates for children living in 3 municipalities in the state of San Luis Potosí were calculated. RESULTS: During the 12-month study period, 790 children living in these municipalities were admitted with ARI. RSV was detected in 245 (31%) and influenza in 47 (5.9%). History of preterm birth was recorded for 112 children on admission. For children <5 years old, ARI-, RSV- and influenza-associated admission rates were 23.2, 7.2 and 1.4 (per 1000 population), respectively. The corresponding admission rates per 1000 infants <1 year old were 78, 25.2 and 4.4. Preterm infant admission rates were 2 times higher than those of term infants. Six children died; RSV was detected in 4 (66.6%) of the deceased, while no deaths were associated with influenza. ARI and RSV in-hospital mortality rates for children <5 years were 0.18 and 0.12 per 1000 population. ARI and RSV mortality rates in preterm infants were 7 and 14 times higher than in term infants, respectively. CONCLUSIONS: RSV was associated with both high admission and in-hospital mortality rates in children <5 years old. Specific interventions, such as active or passive immunization, to prevent RSV infections are required to reduce ARI-associated infant mortality.

Association of tobacco use and the presence of anal warts in people who attend the anal Neoplasia clinic in Puerto Rico.

Background: Limited research exists regarding the association between smoking and anal warts. In this study, we evaluated this association among a clinic-based Hispanic population in Puerto Rico. Methods: Cross-sectional study among eligible patients seen at the Anal Neoplasia Clinic of the University of Puerto Rico Comprehensive Cancer Center (2016-2023) (n = 920). Sociodemographic and clinical variables were collected from medical records. Patients underwent a high-resolution anoscopy (HRA) during the clinical visit; physicians assessed anal condylomas on HRA. Poisson regression models with robust standard errors were used to evaluate the association between smoking and anal warts. Demographic and clinical factors were also assessed. Results: The mean age of participants was 45.8 ± 13.1 years, 66.4 % were men, and 21.6 % were current smokers. While 10.8 % self-reported a history of anogenital condylomas, 18.9 % had anal condylomas on clinical evaluation. A higher prevalence of anal condylomas was observed among current smokers (PR = 1.28, 95 % CI: 0.94-1.75) in comparison to non-smokers in adjusted analysis, but this was not statistically significant. However, a higher prevalence of anal condylomas was observed among younger individuals (PR = 0.96, 95 % CI: 0.96-0.98) and individuals with anal high-grade squamous intraepithelial lesions (HSIL) as compared to those with benign histology (PR = 1.74. 95 % CI: 1.09-2.77). Conclusions: Although current smoking seemed to be positively associated with anal condylomas in this high-risk Hispanic population, this finding was not statistically significant as the power to detect an association was limited. However, younger age and HSIL diagnosis were associated with a higher prevalence of anal condylomas.

Impact of the implementation of a telemedicine program on patients diagnosed with asthma.

BACKGROUND: Asthma is one of the most common respiratory ailments worldwide. Despite broad understanding of the illness and of the available therapeutic options for it, patients with serious asthma suffer poor monitoring of their illness in 50% of cases. AIM: To assess the impact of the implementation of a mobile application (ESTOI) to control asthma in patients diagnosed with the illness, their adherence to treatment, and their perceived quality of life. METHODOLOGY: Randomized clinical trial with 52 weeks' follow-up of patients with asthma seen in a specialized hospital for their treatment in Spain. Some 108 included patients will be divided into two groups. The intervention group will undergo more exhaustive follow-up than normal, including access to the ESTOI application, which will have various categories of attention: control of symptoms, health recommendations, current treatment and personalized action plan, PEF record, nutritional plan, and chat access with a medical team. The asthma control questionnaire ACT is the main assessment variable. Other variables to be studied include an adherence test for the use of inhalers (TAI), the number of exacerbations, maximum exhalation flow, exhaled nitric oxide test, hospital anxiety and depression scale, asthma quality-of-life questionnaire, forced spirometry parameters (FVC, FEV1, and PBD), and analytic parameters (eosinophilia and IGE). The data will be collected during outpatient visits. TRIAL REGISTRATION: This trial has registered at ClinicalTrials.gov (Identifier: NCT06116292).

Comparative study of droplet-digital PCR and absolute Q digital PCR for ctDNA detection in early-stage breast cancer patients.

BACKGROUND: Analysis of circulating tumor DNA (ctDNA) is increasingly used for clinical decision-making in oncology. However, ctDNA could represent ≤ 0.1 % of cell-free DNA in early-stage tumors and its detection requires high-sensitive techniques such as digital PCR (dPCR). METHODS: In 46 samples from patients with early-stage breast cancer, we compared two leading dPCR assays for ctDNA analysis: QX200 droplet digital PCR (ddPCR) system from Bio-Rad which is the gold-standard in the field, and Absolute Q plate-based digital PCR (pdPCR) system from Thermo Fisher Scientific which has not been reported before. We analyzed 5 mL of baseline plasma samples prior to any treatment. RESULTS: Both systems displayed a comparable sensitivity with no significant differences observed in mutant allele frequency. In fact, ddPCR and pdPCR possessed a concordance > 90 % in ctDNA positivity. Nevertheless, ddPCR exhibited higher variability and a longer workflow. Finally, we explored the association between ctDNA levels and clinicopathological features. Significantly higher ctDNA levels were present in patients with a Ki67 score > 20 % or with estrogen receptor-negative or triple-negative breast cancer subtypes. CONCLUSION: Both ddPCR and pdPCR may constitute sensitive and reliable tools for ctDNA analysis with an adequate agreement in early-stage breast cancer patients.

Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial.

BACKGROUND: The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone. METHODS: In this investigator-initiated, randomised, open-label, phase 3 trial, patients from 92 sites in Europe, Japan, and the USA with metastatic (stage IVB), persistent, or recurrent cervical cancer that was measurable, previously untreated, and not amenable to curative surgery or radiation were randomly assigned 1:1 to receive standard therapy (cisplatin 50 mg/m2 or carboplatin area under the curve of 5, paclitaxel 175 mg/m2, and bevacizumab 15 mg/kg, all on day 1 of every 3-week cycle) with or without atezolizumab 1200 mg. Treatment was continued until disease progression, unacceptable toxicity, patient withdrawal, or death. Stratification factors were previous concomitant chemoradiation (yes vs no), histology (squamous cell carcinoma vs adenocarcinoma including adenosquamous carcinoma), and platinum backbone (cisplatin vs carboplatin). Dual primary endpoints were investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumours version 1.1 and overall survival analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03556839, and is ongoing. FINDINGS: Between Oct 8, 2018, and Aug 20, 2021, 410 of 519 patients assessed for eligibility were enrolled. Median progression-free survival was 13·7 months (95% CI 12·3-16·6) with atezolizumab and 10·4 months (9·7-11·7) with standard therapy (hazard ratio [HR]=0·62 [95% CI 0·49-0·78]; p<0·0001); at the interim overall survival analysis, median overall survival was 32·1 months (95% CI 25·3-36·8) versus 22·8 months (20·3-28·0), respectively (HR 0·68 [95% CI 0·52-0·88]; p=0·0046). Grade 3 or worse adverse events occurred in 79% of patients in the experimental group and in 75% of patients in the standard group. Grade 1-2 diarrhoea, arthralgia, pyrexia, and rash were increased with atezolizumab. INTERPRETATION: Adding atezolizumab to a standard bevacizumab plus platinum regimen for metastatic, persistent, or recurrent cervical cancer significantly improves progression-free and overall survival and should be considered as a new first-line therapy option. FUNDING: F Hoffmann-La Roche.

Construcciones sociales de la salud sexual en mujeres adolescentes de una comunidad rural / Social constructions of sexual health in adolescent women from a rural community / Construções sociais da saúde sexual em mulheres adolescentes de uma comunidade rural

Objetivo: Descubrir cuáles son las construcciones sociales en la salud sexual de las mujeres adolescentes de una comunidad rural. Material y Métodos: Estudio cualitativo fenomenológico hermenéutico, donde participaron mujeres adolescentes de 14 a 19 años, pertenecientes a la comunidad, El Molino, Ojuelos Jalisco, México. A través de un muestreo por cadena de referencia, se realizaron entrevistas fenomenológicas, transcritas de manera artesanal y anal-izadas mediante el "círculo hermenéutico Heiderggeriano". Se obtuvo la autorización mediante el consentimiento informado, así como el asentimiento por parte de los tutores. Se cumple un rigor metodológico a través de la trasparencia, transferibilidad, credibilidad y autenticidad. Resultados: Se realizaron 10 entrevistas afines a 10 adolescentes y se determinaron 6 unidades de significado a partir del análisis hermenéutico, de los cuales tres son ónticas; una realidad palpable a la desinformación sobre vida sexual, ideologías paternales adiestradas y falo centrismo como base central en la dinámica social. Y tres son ontológicas; Sesgo educativo, Discurso del lenguaje culturizado, finalmente tabúes y estigmas familiares. Conclusión: Las mujeres adolescentes de una comunidad rural viven una doble moral social. Así se demuestra un ineficiente conocimiento sobre salud sexual hasta ser un tema intrascendente, los padres son quienes influyen y toman decisiones sobre la educación, autonomía y forma de pensar.

Objective: Discover what the social constructions in the sexual health of adolescent women in a rural community. Material and Methods: A qualitative hermeneutic phenomenological study, involving adolescent women from 14 to 19 years old, belonging to the community, El Molino Ojuelos Jalisco, México. Through a reference chain sampling, phenomenological inter-views were carried out, transcribed by hand and analyzed through the "Heiderggerian herme-neutic circle". Authorization was obtained through informed consent, as well as the assent of the tutors. Complying with methodological rigor through transparency, transferability, credibility and authenticity. Results: 10 related interviews were carried out with 10 adolescents, and 6 units of meaning were determined from the hermeneutic analysis, of which three are ontic; a palpable reality to the ignorance of contraceptive methods, trained paternal ideologies and phallocentrism as a central basis in social dynamics. And three are ontological; Educational bias, cultured language discourse, finally taboos and family stigmas. Conclusion: Adolescent women from a rural community experience a double social standard. Thus, demonstrating an inefficient knowledge about sexual health until it is an insignificant issue, parents are the ones who influence and make decisions about education, autonomy and way of thinking

Objetivo: Descubra quais são as construções sociais na saúde sexual de mulheres adolescentes de uma comunidade rural. Material e Métodos: Estudo hermenêutico fenomenológico quali-tativo, onde participaram mulheres adolescentes de 14 a 19 anos, pertencentes à comunidade El Molino, Ojuelos Jalisco, México. Por meio de amostragem por cadeia de referência, foram realizadas entrevistas fenomenológicas, transcritas à mão e analisadas por meio do "círculo her-menêutico heideggeriano". A autorização foi obtida mediante consentimento informado, bem como assentimento dos responsáveis. Cumprir o rigor metodológico através da transparência, transferibilidade, credibilidade e autenticidade. Resultados: foram realizadas 10 entrevistas relacionadas com 10 adolescentes e foram determinadas 6 unidades de significado a partir da análise hermenêutica, das quais três são ônticas; uma realidade palpável do desconhecimento dos métodos contraceptivos, das ideologias paternas treinadas e do falocentrismo como base central na dinâmica social. E três são ontológicos; Viés educacional, discurso de linguagem cul-turalizado, finalmente tabus e estigmas familiares. Conclusão: As mulheres adolescentes de uma comunidade rural vivenciam um duplo padrão social. Demonstrando assim um conhecimento ineficiente sobre saúde sexual a ponto de ser uma questão inconsequente, são os pais que influ-enciam e tomam decisões sobre educação, autonomia e modo de pensar

Humoral Response to SARS-COV-2 Vaccination in Patients with Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder: A Real-World Study.

INTRODUCTION: The risk of SARS-CoV-2 infection or severe coronavirus disease 2019 (COVID-19) has been shown to increase in patients with multiple sclerosis (MS). Vaccination is recommended in this patient population, and the effect of disease-modifying treatments (DMTs) on response to vaccination should be considered. METHODS: This prospective, observational, cross-sectional study investigated humoral response after COVID-19 vaccination as well as possible predictors for response in patients with MS and other neuroinflammatory diseases who received DMTs in routine clinical practice in Spain. Responses were compared versus those seen in healthy controls. RESULTS: After vaccination against COVID-19, most patients with MS developed an immune response comparable to that of healthy individuals. However, approximately half of patients receiving a sphingosine-1-phosphate modulator (SP1-M, fingolimod or siponimod) or a B-cell-depleting agent (aCD20, ocrelizumab or rituximab) did not develop protective antibodies, although patients receiving other DMTs had humoral immune responses comparable to healthy controls. Lymphocyte count was not associated with reduced humoral response in patients receiving an SP1-M or aCD20, whereas, in patients receiving an aCD20 or SP1-M, older age was associated with lower anti-SARS-CoV-2 spike protein immunoglobulin G antibody levels. CONCLUSIONS: Treatment with aCD20 or SP1-M therapies appears to be associated with a lower humoral response to vaccines against SARS-CoV-2. Vaccination prior to initiation of these DMTs should be recommended whenever possible.