Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Elective cancer surgery in COVID-19-free surgical pathways during the SARS-CoV-2 pandemic: An international, multicenter, comparative cohort study

PURPOSE As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19–free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19–free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19–free surgical pathways. Patients who underwent surgery within COVID-19–free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19–free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score–matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19–free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION Within available resources, dedicated COVID-19–free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study.

PURPOSE: As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19-free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS: This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19-free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS: Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19-free surgical pathways. Patients who underwent surgery within COVID-19-free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19-free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score-matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19-free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION: Within available resources, dedicated COVID-19-free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Intra- and interspecific performance in growth and reproduction increase with altitude : a case study with two Saxifraga species from northern Spain

Summary: 1.Improving our knowledge on plant functions underlying shifts in species ranges along altitudinal and latitudinal gradients is a research priority to understand biotic responses to climate change. Although much is known about biological responses to elevation, coupled observations of ecophysiological and reproductive traits with whole-plant performance metrics are rare, and thus our understanding disjunct rather than holistic. 2.We expected growth and reproductive performance to decrease with elevation, irrespective of adjustments in traits, modifications in allocation, or congeneric shifts in populations. To test this hypothesis we assessed growth, reproductive investments and traits related to resource use efficiency and reproductive success in populations of two vicariant species growing along an elevation gradient: Saxifraga trifurcata (lowland species) and S. canaliculata (highland species). 3.For most metrics, a relationship with elevation arose, mostly related to the replacement of species, but also to within-species variation in S. trifurcata. Leaves of S. canaliculata, and of the higher populations of S. trifurcata, were denser, had lower specific leaf area (SLA) and lower N concentration but higher N resorption efficiency. Collectively, these trends indicate a more conservative resource use pattern at the highlands as compared to the lowlands. Despite this, vegetative growth per unit canopy area was higher in S. canaliculata than in S. trifurcata, and in the highland than lowland populations of S. trifurcata. Reproductive investments, measured as the reproductive mass per unit canopy area, were lower, and reproductive maturity was reached later, in S. canaliculata, but reproductive success (fruit set and seed germination) increased at the high altitude limit of each species’ range. 4.Performance did not uniformly decrease with altitude. Growth was higher in the uplands possibly because preferential biomass and meristem allocation to the vegetative function compensated for the decrease in growth season length. Similarly, the decrease in reproductive investments in the highland populations was partially compensated for, since fruit set was higher and more viable seeds (per gram invested in reproduction) were produced in the highland limit of each species. 5.This suggests that populations growing in increasingly limiting environments can partially compensate by modifications in allocation and morpho-functional traits

Precipitation-dependent Flowering of Globularia alypum and Erica multiflora in Mediterranean Shrubland Under Experimental Drought and Warming, and its Inter-annual Variability

11 páginas,7 figuras, 2 tablas, i apéndice.† Background and Aims Relationships between autumn flowering, precipitation and temperature of plant species of Mediterranean coastal shrublands have been described, but not analysed experimentally. These relationships were analysed for two species of co-occurring, dominant, autumn-flowering shrubs, Globularia alypum and Erica multi- flora, over 4 years and in experimentally generated drought and warming conditions. The aim was to improve predictions about the responses and adaptations of flowering of Mediterranean vegetation to climate change. †Methods Beginning of anthesis and date of maximum flowering intensity (‘peak date’) were monitored over 4 years (2001–2004) on a garrigue land type in the noth-east of the Iberian Peninsula. Two experimental treatments were applied, increased temperature (þ0.738C) and reduced soil moisture (–17%) relative to untreated plots. †Key Results Flowering of Globularia alypum and Erica multiflora differed greatly between years depending on the precipitation of the previous months and the date of the last substantial rainfall (.10 mm). Globularia alypum flowered once or twice (unimodal or bimodal) as the result of differences in the distribution and magnitude of precipitation in late-spring and summer (when floral buds develop). The drought treatment delayed and decreased flowering of Globularia alypum in 2001 and delayed flowering in 2002. Warming extended the period between the beginning of flowering and the end of the second peak for autumn flowering in 2001 and also increased peak intensity in 2002. Flowering of Erica multiflora was unaffected by either treatment. †Conclusions Autumn flowering of Globularia alypum and Erica multiflora is more dependent on water availability than on temperature. Considerable inter-annual plasticity in the beginning of anthesis and peak date and on unimodal or bimodal flowering constitutes a ‘safe strategy’ for both species in relation to varying precipitation and temperature. However, severe changes in precipitation in spring and summer may severely affect flowering of Globularia alypum but not Erica multiflora, thus affecting development/structure of the ecosystem if such conditions persist.This research was funded by the EU under the projects CLIMOOR (Contract ENV4-CT97-0694) and VULCAN (Contract EVK2-CT-2000–00094), and we also received financial help from the Spanish Government (grants CGL2004–1402/BOS and CGL2006–04025/ BOS), the Catalan Government (SGR2005–00312), the European project ALARM (Contract 506675), and the Fundacio´n Banco Bilbao Vizcaya 2004 grant.Peer reviewe

COVID-19 dynamics in Madrid (Spain): A new convolutional model to find out the missing information during the first three waves.

This article presents a novel mathematical model to describe the spread of an infectious disease in the presence of social and health events: it uses 15 compartments, 7 convolution integrals and 4 types of infected individuals, asymptomatic, mild, moderate and severe. A unique feature of this work is that the convolutions and the compartments have been selected to maximize the number of independent input parameters, leading to a 56-parameter model where only one had to evolve over time. The results show that 1) the proposed mathematical model is flexible and robust enough to describe the complex dynamic of the pandemic during the first three waves of the COVID-19 spread in the region of Madrid (Spain) and 2) the proposed model allows us to calculate the number of asymptomatic individuals and the number of persons who presented antibodies during the first waves. The study shows that the following results are compatible with the reported data: close to 28% of the infected individuals were asymptomatic during the three waves, close to 29% of asymptomatic individuals were detected during the subsequent waves and close to 26% of the Madrid population had antibodies at the end of the third wave. This calculated number of persons with antibodies is in great agreement with four direct measurements obtained from an independent sero-epidemiological research. In addition, six calculated curves (total number of confirmed cases, asymptomatic who are confirmed as positive, hospital admissions and discharges and intensive care units admissions) show good agreement with data from an epidemiological surveillance database