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Olaparib monotherapy in advanced triple-negative breast cancer patients with homologous recombination deficiency and without germline mutations in BRCA1/2: The NOBROLA phase 2 study.
No full text20.500.12530/87854To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut). NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1. Six of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8-88.2). The observed results could prompt further investigation. ClinicalTrials.gov identifier NCT03367689
Real-world evidence for vitiligo using an electronic medical records database in Spain: the REVEAL-ES study.
No full text20.500.12530/87870The European prevalence of vitiligo diagnosis is 0.2%-0.8%, with country-specific and methodological differences. Although vitiligo profoundly impacts quality of life, limited studies have evaluated disease burden and treatment patterns. This real-world study describes the prevalence, incidence, characteristics, and treatment patterns of vitiligo among patients in Spain during 2015-2021. This retrospective observational study using the IQVIA Electronic Medical Records database in Spain included patients with vitiligo (International Classification of Diseases, Ninth Revision codes 709.01/374.53). Incident and prevalent cohorts comprised registered patients with vitiligo diagnoses during and before 2015-2021, respectively. Patient characteristics and treatment data were extracted. Vitiligo incidence was 0.016 (95% CI: 0.014-0.018) per 100 person-years, and prevalence was 0.19% (95% CI: 0.18%-0.19%) in 2021. Females were more affected than males (0.16% vs 0.13%, respectively). Among 1,400 incident patients, mean (SD) age was 40.7 (19.7) years; most were female (53.9%). The most common comorbidities after vitiligo diagnosis were eczema (20.8%), hypercholesterolaemia/hypertriglyceridaemia (17.9%), anxiety (10.9%), thyroid disorders (9.1%), and diabetes (6.4%). In 2021, 78.6% of prevalent patients did not receive vitiligo-related treatments. The most prescribed vitiligo-related treatments were topical calcineurin inhibitors (13.9%) and topical corticosteroids (13.0%); 11.9% had a record of psychiatric medications. This study confirms the association between vitiligo and comorbidities (e.g., eczema, thyroid disorders) and high disease burden. The prevalence in Spain in 2021 (0.19%) was within the lower band of European estimates based on surveys/medical screenings. Most patients are not receiving vitiligo-related treatment and could benefit from new, effective treatments
Exercise in cancer patients: assistance levels and referral pathways-a position statement from the Spanish Society of Medical Oncology.
No full text20.500.12530/87858There is growing evidence about how physical activity can improve cancer care. Unfortunately, exercise is still not widely prescribed to oncology patients, despite the benefit it brings. For this to occur, it is necessary for a multidisciplinary approach involving different types of healthcare professionals, given that each treatment be tailored for each single case. Besides incorporating appropriate infrastructures and referral pathways, we need to integrate exercise into healthcare practice, which ameliorates patients' quality of life and treatment side effects. From the Spanish Society of Medical Oncology (SEOM), and through the Exercise and Cancer Working Group, we indicate considerations, analyze patient care scenarios, and propose a referral pathway algorithm for exercise prescription, taking in account the patient's needs. In later sections of this paper, we describe how this algorithm could be implemented, and how the exercise programs should be built, including the physical activity contents, the settings, and the delivery mode. We conclude that professionals, infrastructures, and organizations should be available at every assistance level to create programs providing adequate exercise training for cancer patients
Surgical vs Transcatheter Treatment in Patients With Coronary Artery Disease and Severe Aortic Stenosis.
No full textSevere aortic stenosis (AS) coexists with coronary artery disease (CAD) in approximately 50% of patients. The preferred treatment is combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG). However, transcatheter aortic valve replacement (TAVR) along with percutaneous coronary intervention (PCI) has emerged as a viable alternative. This study sought to compare the outcomes of PCI + TAVR vs CABG + SAVR. This national multicenter retrospective study in Spain involved patients with severe AS and CAD treated between 2018 and 2021. Patients underwent either PCI + TAVR or CABG + SAVR and were compared. The primary endpoint was all-cause mortality and stroke at 1 year. Propensity score analysis was performed to mitigate baseline differences. Of the 1,342 included patients, 625 (46.6%) underwent PCI + TAVR, and 713 (53.1%) underwent CABG + SAVR. Patients in the percutaneous arm were older (age 81.6 ± 5.8 years vs 72.1 ± 7 years; P Despite a lower baseline risk, CABG + SAVR in patients with severe AS and CAD was associated with a higher rate of death and stroke compared with PCI + TAVR, highlighting the necessity for a large, randomized analysis
The Dallas Donation after Circulatory Death Transplantation Summit: expanding donation after circulatory death procedures through process improvement, broader utilization, and innovation.
No full text20.500.12530/87913Despite a significant increase in utilization over the past decade, the number of donation after circulatory death (DCD) organs that are procured and transplanted in the United States (US) remains well below its potential. There is still room for expansion, as utilizing DCD organs to the fullest extent is currently the most viable solution to the persistent mismatch between supply and demand in transplantation. We convened a multidisciplinary transplantation summit to examine various aspects of DCD, with faculty members from around the world with clinical and academic interest in DCD donation and transplantation, including abdominal and cardiothoracic surgeons, organ procurement organization directors, hepatologists, and gastroenterologists. The conference focused on identifying barriers to DCD organ utilization and strategies to overcome these barriers. We divide the barriers to DCD utilization into three mains categories: (I) policy and process variation; (II) logistical and transportation challenges; and (III) higher risk perceptions related to DCD outcomes. For each barrier, we proposed a variety of solutions, providing an overview of the status of DCD donation in the US and suggestions on how to increase the use of DCD. There is a specific focus on ex situ machine perfusion, normothermic regional perfusion, and other opportunities to expand DCD utilization without negatively impacting recipient outcomes
Upper Eyelid Contour Changes After Müller's Muscle Conjunctiva Resection.
No full text20.500.12530/87908To analyze the upper eyelid contour after Müller's muscle conjunctiva resection (MMCR) performed by four different surgeons. Comparative cross-sectional analysis of the pre- and postoperative contours of a control group and four groups of upper lids (n = 88) of 65 patients who underwent MMCR at four international centers. The procedure employed was essentially the same as described by Putterman but performed with different instruments to entrap the posterior lamella. Multiple medial and lateral margin lid distances were measured on Bézier lines expressing the pre- and postoperative lid contours. Preoperatively, two groups had significant lateral and medial ptosis. After MMCR, the lateral segment of the lid's contour was corrected in all groups. In the two groups with more pronounced ptosis, the nasal lid contour was undercorrected. In MMCR, regardless of the instrument used to entrap the posterior lamella, the amount of medial tissue resection is essential to avoid postoperative nasal undercorrection. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266
Lack of awareness of systemic lupus erythematosus and its consequences in a cohort of moderate and severe patients in Spain: The LupusVoice study.
No full text20.500.12530/87858Systemic lupus erythematosus (SLE) is an autoimmune condition that can highly impact patients' quality of life (QoL). However, there is a lack of knowledge about SLE, affecting the general population and health care professionals (HCPs) alike. This lack of knowledge has negative implications for patients and the healthcare system, worsening prognosis, negatively impacting QoL, and increasing healthcare utilization. The aim of this paper is to draw attention, according to the perspective of the participants of this study, to the lack of awareness of SLE and its consequences in Spain, and to suggest improvements. This qualitative, descriptive, observational, multicenter, and cross-sectional study included 40 patients with moderate or severe SLE, recruited during their routine visits in six university hospitals in Spain. The study also included 11 caregivers and 9 HCPs. All participants were individually interviewed. Data from the interviews were coded and analyzed thematically by two anthropologists following a phenomenological perspective. Our study identified a lack of disease awareness among primary care physicians, emergency medicine doctors, and other specialists treating SLE symptomatology. This led to diagnostic delays, which had a clinical and emotional impact on patients. Furthermore, symptom awareness was found to be context dependent. Differences in symptom awareness between HCPs and patients led to a mismatch between the severity evaluation made by doctors and patients. Some HCPs did not consider the limitations of the current severity evaluation of SLE, and therefore attributed symptoms potentially caused by SLE to the unfavorable socioeconomic conditions patients lived in. Finally, a lack of social awareness among friends, family members, and romantic partners led to lower social support, increased isolation, and negative physical and emotional impact for patients. Gender differences in the provision of support were identified. This study highlights the need to increase SLE awareness among patients, HCPs, and the broader public in order to improve patient QoL. Being aware of the clinical and emotional impact of such lack of awareness, as well as the role played by context on the patient experience of SLE, is a crucial step towards achieving this goal
Follow-up of telemedicine mental health interventions amid COVID-19 pandemic.
No full text20.500.12530/87892The initiation of the program Mental Health Support Program for Coronavirus Infection addressed the increased demand for mental health services in the province of Salamanca, resulting from the COVID-19 pandemic. The psychiatry service provided care for COVID-19 patients, their families, and healthcare workers who treated them, as these groups were identified as being at risk. This study aims to describe the assistance provided, including personnel and resources utilized, types of interventions carried out, and to assess the demand for mental health care and predominant symptoms and emotions experienced by patients. Billboards and the complex's intranet publicized the program. Specific clinical approach using telemedicine were provide from March 2020 to December 2021 to COVID-19 patients, their relatives, and healthcare workers. 216 patients were included with a mean age of 53.2 years, with women comprising 77.3% of this group. All the groups received treatment in similar proportions. Over a period of 730 h, a total of 1376 interventions were performed, with an average duration of 31.8 min per intervention. The program could treat 79.6% of these patients without requiring referrals to other services. When the program concluded, only 21 participants (9.7%) were discharged to the local mental health network to continue their mental health treatment. The program effectively reduced the burden on regular mental health services due to its ability to treat most patients without requiring referrals. The program was able to attend to most mental health requests with minimal involvement of the regular mental health service
Soluble CD27 is an intrathecal biomarker of T-cell-mediated lesion activity in multiple sclerosis.
No full text20.500.12530/87854Soluble CD27 is a promising cerebrospinal fluid inflammatory biomarker in multiple sclerosis. In this study, we investigate relevant immune and neuro-pathological features of soluble CD27 in multiple sclerosis. Protein levels of soluble CD27 were correlated to inflammatory cell subpopulations and inflammatory cytokines and chemokines detected in cerebrospinal fluid of 137 patients with multiple sclerosis and 47 patients with inflammatory and non-inflammatory neurological disease from three independent cohorts. Production of soluble CD27 was investigated in cell cultures of activated T and B cells and CD27-knockout T cells. In a study including matched cerebrospinal fluid and post-mortem brain tissues of patients with multiple sclerosis and control cases, levels of soluble CD27 were correlated with perivascular and meningeal infiltrates and with neuropathological features. We demonstrate that soluble CD27 favours the differentiation of interferon-γ-producing T cells and is released through a secretory mechanism activated by TCR engagement and regulated by neutral sphingomyelinase. We also show that the levels of soluble CD27 correlate with the representation of inflammatory T cell subsets in the CSF of patients with relapsing-remitting multiple sclerosis and with the magnitude of perivascular and meningeal CD27 + CD4 + and CD8 + T cell infiltrates in post-mortem central nervous system tissue, defining a subgroup of patients with extensive active inflammatory lesions. Our results demonstrate that soluble CD27 is a biomarker of disease activity, potentially informative for personalized treatment and monitoring of treatment outcomes
Sex differences in patterns of potentially inappropriate prescribing and adverse drug reactions in hospitalized older people: Findings from the SENATOR trial.
No full text20.500.12530/87908Older women experience more adverse drug reactions (ADRs) than older men. However, the underlying basis for this sex difference is unclear. Sex (biological status) and/or gender (sociocultural constructs) influences on patterns of inappropriate prescribing in multimorbid older adults may be one reason for this ADR sex difference. In this secondary analysis, we examined whether incident ADR sex differences could be related to concurrent sex differences in potentially inappropriate prescribing. A retrospective secondary analysis of sex differences in the prevalence of potentially inappropriate medications (PIMs), potential prescribing omissions (PPOs), and ADRs among the 1537 participants (47.2% female, median [IQR] age 78 [72-84] years) was undertaken in the SENATOR clinical trial database, conducted in six large European medical centers. We looked specifically for male/female differences relating to PIMs and PPOs (defined by STOPP/START version 2 criteria) identified within 48 h of acute hospitalization. We also assessed sex differences for ADRs identified at 14 days from admission or discharge, whichever came first. ADRs were assessed by blinded endpoint adjudication panel consensus. During hospitalization, significantly more females experienced ≥1 ADR compared to males (28% and 21%, respectively; odds ratio 1.40, 95% CI 1.10-1.78, p We conclude that specific STOPP-criteria PIMs and START-criteria PPOs were identified more frequently in older women than older men during acute hospitalization, possibly contributing to higher ADR incidence in older women. Prescribers should appreciate sex differences in exposure to potentially inappropriate prescribing and ADR risk, given the preponderance of older women over older men in most clinical settings