Do Clinical Trials Meet Current Care Needs? Views of Digestive Oncology Specialists in Galicia (Spain) Using the Delphi Method

Background: In recent years, abundant scientific evidence has been generated based on clinical trials (CT) in the field of oncology. The general objective of this paper is to find out the extent to which decision making is based on knowledge of the most recent CT. Its specific objectives are to pinpoint difficulties with decision making based on the CT performed and find out the motivations patients and clinicians have when taking part in a CT. Methodology: Combined, prospective study, based on the Delphi method. A lack of correspondence between the people who take part in CT and patients who come for consultation has been identified. A need for training in analysing and interpreting CT has also been identified and a lack of trust in the results of CT financed by the pharmaceutical industry itself has been perceived. Conclusions: There is a difficulty in selecting oncological treatment due to the lack of correspondence between the patients included in the CT and patients seen in consultation. In this process, real world data studies may be highly useful, as they may provide this group with greater training in interpreting CT and their results.S

CIBERER : Spanish national network for research on rare diseases: A highly productive collaborative initiative

Altres ajuts: Instituto de Salud Carlos III (ISCIII); Ministerio de Ciencia e Innovación.CIBER (Center for Biomedical Network Research; Centro de Investigación Biomédica En Red) is a public national consortium created in 2006 under the umbrella of the Spanish National Institute of Health Carlos III (ISCIII). This innovative research structure comprises 11 different specific areas dedicated to the main public health priorities in the National Health System. CIBERER, the thematic area of CIBER focused on rare diseases (RDs) currently consists of 75 research groups belonging to universities, research centers, and hospitals of the entire country. CIBERER's mission is to be a center prioritizing and favoring collaboration and cooperation between biomedical and clinical research groups, with special emphasis on the aspects of genetic, molecular, biochemical, and cellular research of RDs. This research is the basis for providing new tools for the diagnosis and therapy of low-prevalence diseases, in line with the International Rare Diseases Research Consortium (IRDiRC) objectives, thus favoring translational research between the scientific environment of the laboratory and the clinical setting of health centers. In this article, we intend to review CIBERER's 15-year journey and summarize the main results obtained in terms of internationalization, scientific production, contributions toward the discovery of new therapies and novel genes associated to diseases, cooperation with patients' associations and many other topics related to RD research

Vinculación entre los espacios de tipo hotelero y puntos de encuentro con el sector turístico a través de una identidad gráfica

“Este proyecto de investigación se basa en un estudio de casos de identidad desarrollados de forma internacional bajo la visión del diseño gráfico, el branding y los medios de difusión mismo que sirvieron de base para implementar un proyecto hotelero turístico de convenciones. Invitamos a todo lector de proyecto de investigación y diseño a analizar con detenimiento cada punto de este documento y su contenido el cual se presenta desde el marco teórico, que nos permite describir, comprender y mejorar cada parte de esta tesis, hasta lograr crear un proyecto viable para los desarrolladores del hotel, ya que de esta forma entenderán que cada aspecto antes mencionado tiene un porqué y un para qué (Capítulo I). A través de esta investigación recorreremos distintos aspectos de vital importancia, que invitan al lector a adentrarse cada vez más en su interesante contenido, ya que abordaremos aspectos de CUBA y la ciudad de Camagüey como sus aspectos culturales, geográficos, servicios y características hoteleras nacionales e internacionales, así como características del hotel que ha sido proyectado para ser centro de convenciones

Efficacy and safety of FOLFIRI/Aflibercept (FA) in an elderly population with metastatic colorectal cancer (mCRC) after the failure of an oxaliplatin-based regimen

Introduction: Aflibercept (ziv-aflibercept) significantly improves progression-free (PFS) and overall survival (OS) when added to FOLFIRI, compared with FOLFIRI alone, in the overall population of patients pretreated with oxaliplatin-based therapy. A subset analysis of elderly patients included in the registration VELOUR trial suggested that elderly (> 65 years) patients have a consistent, albeit small benefit in OS in PFS and a higher percentage of grade 3-4 toxicity. Our hypothesis was that selected patients with good PS could benefit from FOLFIRI-aflibercept (FA), provided they underwent careful monitoring of toxicity, and rapid intervention. Methods: We conducted a retrospective, multicentre, observational study of elderly patients (> 70 years) with mCRC treated with FOLFIRI-aflibercept after progression on an oxaliplatin-based regimen as part of routine clinical practice at seven hospitals from the Galician Research Group on Digestive Tumours (GITuD). Results: Of 315 patients treated with FA between June 2013 to November 2018, 71 elderly patients were recorded in this study. Median age was 72.7 years (range 70-84 years) and 33.4% were over 75 years (compared with only 14% in the VELOUR study subanalysis), 66.2 % were male, 83.1 % ECOG PS0-1, 43.7 % left-sided location, 76.1 % low grade, 63.4% RASmt and 2.8% BRAFmt, 66.2 % synchronous presentation and 77.5 % primary tumor resection. Prior therapy included bevacizumab (57.7%) and anti-EGFR agents (22.5%). Median of FA cycles was 9 (range 1-35 cycles). Overall Response Rate (ORR) and disease control rate (DCR) were 31.0 % and 63.4 %, respectively. With a median follow up of 27.1 months, median PFS was 6.6 months (95% CI, 5.0-8.3 months) and median OS was 15.1 months (95% CI, 12.1-18.1 months). The most common grade 3-4 toxicities were asthenia (18.3%), neutropenia (15.5%), diarrhoea (11.3%) and mucositis (9.9%). Aflibercept most common grade 3-4 related toxicities were hypertension (5.6%), dysphonia (5.6%), proteinuria (2.8%). Two patients experienced grade 5 toxicity (1 cerebrovascular event and 1 bowel perforation). This toxicity was managed with dose reduction of aflibercept in 39.4 % of cases, dose reduction of FOLFIRI on 57.7% and led to the discontinuation of aflibercept in 39.4%. Conclusion: Older patients with mCRC are underrepresented in clinical trials. The VELOUR study included only 6.4% patients over 65 years of age and only 14% of those over 65 were 75 years or older. Elderly patients treated with FA in the VELOUR trial experienced a higher rate of G3-4 adverse events (89.3% versus 80.5%) but this increase in toxicity was even more evident in the control arm (67.4% versus 59.4%). Our series confirms that with careful dose adjustment based on toxicity, including dose interruption if necessary elderly patients can be treated with FA with a 49.3% of grade 3-4 toxicity a PFS of 6.6 months and OS of 15.1 months, results that are comparable to those of younger patients

COVID-19 in hospitalized HIV-positive and HIV-negative patients : A matched study

CatedresObjectives: We compared the characteristics and clinical outcomes of hospitalized individuals with COVID-19 with [people with HIV (PWH)] and without (non-PWH) HIV co-infection in Spain during the first wave of the pandemic. Methods: This was a retrospective matched cohort study. People with HIV were identified by reviewing clinical records and laboratory registries of 10 922 patients in active-follow-up within the Spanish HIV Research Network (CoRIS) up to 30 June 2020. Each hospitalized PWH was matched with five non-PWH of the same age and sex randomly selected from COVID-19@Spain, a multicentre cohort of 4035 patients hospitalized with confirmed COVID-19. The main outcome was all-cause in-hospital mortality. Results: Forty-five PWH with PCR-confirmed COVID-19 were identified in CoRIS, 21 of whom were hospitalized. A total of 105 age/sex-matched controls were selected from the COVID-19@Spain cohort. The median age in both groups was 53 (Q1-Q3, 46-56) years, and 90.5% were men. In PWH, 19.1% were injecting drug users, 95.2% were on antiretroviral therapy, 94.4% had HIV-RNA < 50 copies/mL, and the median (Q1-Q3) CD4 count was 595 (349-798) cells/μL. No statistically significant differences were found between PWH and non-PWH in number of comorbidities, presenting signs and symptoms, laboratory parameters, radiology findings and severity scores on admission. Corticosteroids were administered to 33.3% and 27.4% of PWH and non-PWH, respectively (P = 0.580). Deaths during admission were documented in two (9.5%) PWH and 12 (11.4%) non-PWH (P = 0.800). Conclusions: Our findings suggest that well-controlled HIV infection does not modify the clinical presentation or worsen clinical outcomes of COVID-19 hospitalization

How do women living with HIV experience menopause? Menopausal symptoms, anxiety and depression according to reproductive age in a multicenter cohort

CatedresBackground: To estimate the prevalence and severity of menopausal symptoms and anxiety/depression and to assess the differences according to menopausal status among women living with HIV aged 45-60 years from the cohort of Spanish HIV/AIDS Research Network (CoRIS). Methods: Women were interviewed by phone between September 2017 and December 2018 to determine whether they had experienced menopausal symptoms and anxiety/depression. The Menopause Rating Scale was used to evaluate the prevalence and severity of symptoms related to menopause in three subscales: somatic, psychologic and urogenital; and the 4-item Patient Health Questionnaire was used for anxiety/depression. Logistic regression models were used to estimate odds ratios (ORs) of association between menopausal status, and other potential risk factors, the presence and severity of somatic, psychological and urogenital symptoms and of anxiety/depression. Results: Of 251 women included, 137 (54.6%) were post-, 70 (27.9%) peri- and 44 (17.5%) pre-menopausal, respectively. Median age of onset menopause was 48 years (IQR 45-50). The proportions of pre-, peri- and post-menopausal women who had experienced any menopausal symptoms were 45.5%, 60.0% and 66.4%, respectively. Both peri- and post-menopause were associated with a higher likelihood of having somatic symptoms (aOR 3.01; 95% CI 1.38-6.55 and 2.63; 1.44-4.81, respectively), while post-menopause increased the likelihood of having psychological (2.16; 1.13-4.14) and urogenital symptoms (2.54; 1.42-4.85). By other hand, post-menopausal women had a statistically significant five-fold increase in the likelihood of presenting severe urogenital symptoms than pre-menopausal women (4.90; 1.74-13.84). No significant differences by menopausal status were found for anxiety/depression. Joint/muscle problems, exhaustion and sleeping disorders were the most commonly reported symptoms among all women. Differences in the prevalences of vaginal dryness (p = 0.002), joint/muscle complaints (p = 0.032), and sweating/flush (p = 0.032) were found among the three groups. Conclusions: Women living with HIV experienced a wide variety of menopausal symptoms, some of them initiated before women had any menstrual irregularity. We found a higher likelihood of somatic symptoms in peri- and post-menopausal women, while a higher likelihood of psychological and urogenital symptoms was found in post-menopausal women. Most somatic symptoms were of low or moderate severity, probably due to the good clinical and immunological situation of these women