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

Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation.

OBJECTIVES: To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke and bleeding risks. DESIGN: The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA2DS2-VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). PARTICIPANTS: Data from 39 898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk. RESULTS: The discriminatory value of the GARFIELD-AF risk model was superior to CHA2DS2-VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76 to 0.78), 0.69 (0.67 to 0.71) and 0.66 (0.62 to 0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64-0.67), 0.64 (0.61-0.66) and 0.64 (0.61-0.68), respectively, for CHA2DS2-VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)), the CHA2DS2-VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64 to 0.75), 0.65 (0.56 to 0.73) and 0.60 (0.47 to 0.73) for each end point, respectively, versus 0.50 (0.45 to 0.55), 0.59 (0.50 to 0.67) and 0.55 (0.53 to 0.56) for CHA2DS2-VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C-statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-year all-cause mortality using the full and simplified model for all-cause mortality: C-statistics 0.75 (0.73 to 0.77) and 0.75 (0.73 to 0.77), respectively, and for predicting for any stroke or systemic embolism over 1 year, C-statistics 0.68 (0.62 to 0.74). CONCLUSIONS: Performance of the GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362) and for ORBIT-AF (NCT01165710)

Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF.

AIMS: The relationship between outcomes and time after diagnosis for patients with non-valvular atrial fibrillation (NVAF) is poorly defined, especially beyond the first year. METHODS AND RESULTS: GARFIELD-AF is an ongoing, global observational study of adults with newly diagnosed NVAF. Two-year outcomes of 17 162 patients prospectively enrolled in GARFIELD-AF were analysed in light of baseline characteristics, risk profiles for stroke/systemic embolism (SE), and antithrombotic therapy. The mean (standard deviation) age was 69.8 (11.4) years, 43.8% were women, and the mean CHA2DS2-VASc score was 3.3 (1.6); 60.8% of patients were prescribed anticoagulant therapy with/without antiplatelet (AP) therapy, 27.4% AP monotherapy, and 11.8% no antithrombotic therapy. At 2-year follow-up, all-cause mortality, stroke/SE, and major bleeding had occurred at a rate (95% confidence interval) of 3.83 (3.62; 4.05), 1.25 (1.13; 1.38), and 0.70 (0.62; 0.81) per 100 person-years, respectively. Rates for all three major events were highest during the first 4 months. Congestive heart failure, acute coronary syndromes, sudden/unwitnessed death, malignancy, respiratory failure, and infection/sepsis accounted for 65% of all known causes of death and strokes for <10%. Anticoagulant treatment was associated with a 35% lower risk of death. CONCLUSION: The most frequent of the three major outcome measures was death, whose most common causes are not known to be significantly influenced by anticoagulation. This suggests that a more comprehensive approach to the management of NVAF may be needed to improve outcome. This could include, in addition to anticoagulation, interventions targeting modifiable, cause-specific risk factors for death. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Aves de la cordillera del Kutukú, Morona Santiago, sureste de Ecuador

The cordillera del Kutukú is located in the southeastern Ecuador and is partially isolated from the Andes mountain range. We conducted five field expeditions to the region, where we directly obtained information regarding the richness of birds. In addition, we compile bird richness data from published records and Ecuadorian museum’s collections in order to provide an updated list. A total of 501 bird species were registered, in an elevation range from 500 to 2.300 m a.s.l. We found 13 species with new latitudinal and/or longitudinal distribution extensions. Twenty-six species (5.2%) are in an elevated risk category nationally or globally. The region’s limited roads, added to the Shuar ethnic group policies for entering to their territory has aided in the conservation of forests, especially those over 1800 m a.s.l. Thus, the biological knowledge of this area remains to be discovered. This remote area protects an important diversity, as well as threatened bird populations, water resources, territory and culture of the indigenous groups that inhabit it. However, unfortunately the entire mountain range is under concession for exploration of mining projects. Therefore, the attention of regional and national authorities is required to join efforts to ensure their conservation and biological exploration.La cordillera del Kutukú está ubicada al sureste de Ecuador y se encuentra parcialmente aislada de la cordillera de los Andes. Realizamos cinco expediciones a este macizo, donde obtuvimos de manera directa información referente a la riqueza de aves. Además, con el fin de generar un listado más completo, realizamos una recopilación de registros publicados y revisamos colecciones de museos ecuatorianos. En total registramos 501 especies de aves, en un rango entre 500 – 2300 m de altitud. Encontramos trece especies con nuevas ampliaciones de distribución altitudinal y/o latitudinal. Veintiséis especies de aves (5.2%) están en alguna categoría de amenaza a su conservación, a nivel mundial y nacional. Las escasas vías de acceso, sumadas a las políticas de ingreso al territorio, por parte de la etnia Shuar, han favorecido la preservación de los bosques, especialmente aquellos por encima de los 1800 m. Es así que, el conocimiento biológico de esta área queda aún por descubrir. Esta zona remota protege una importante diversidad, así como poblaciones de aves amenazadas, recursos hídricos, además del territorio y cultura de las comunidades que la habitan. Desafortunadamente la totalidad de la cordillera se encuentra concesionada para exploraciones de proyectos mineros. Por tanto, se requiere la atención de las autoridades regionales y nacionales para aunar esfuerzos que aseguren su conservación y exploración biológica

Relación de triglicéridos y estimación de riesgo cardiovasculares en mujeres posmenopáusicas

Objetivo: Determinar la relación de triglicéridos basales, con el riesgo a desarrollar enfermedades cardiovasculares en mujeres posmenopáusicas. Método: Estudio descriptivo, observacional y transversal, donde a 31 pacientes posmenopáusicas y sin antecedentes de enfermedades cardiometabólicas, se les determinó parámetros antropométricos (peso, talla, índice de masa corporal -IMC-); perfil lipídico en ayunas (colesterol total, triglicéridos o TG, lipoproteínas de baja y alta densidad -LDL, HDL-), por método enzimático colorimétrico, apolipoproteína B 100 (Apo B-100) por inmunodifusión radial, índices matemáticos LDL/Apo B-100 y TG/HDL y cálculo de colesterol no-HDL. Resultados: los promedio y desviación de las variables fueron: edad:59±5 años con tiempo de posmenopausia: 8,77±3,92 años; IMC: 27,6±4,4 kg/m.; colesterol total: 194±36 mg/dl; triglicéridos: 85±35 mg/dl; HDL: 33±8 mg/dl; LDL: 144±33 mg/dl; noHDL: 159±37 mg/dl; Apo B-100: 172±246 mg/dl; LDL/ Apo B-100: 1,15±0,03 y TG/HDL: 4,46±1,28. Discusión: Las pacientes se encontraron con sobrepeso, triglicéridos normales, colesterol total y LDL aumentado y las HDL bajas. El LDLC/Apo B-100-100, que se relaciona con el tamaño y densidad de LDL, estuvo por debajo de 1,3 indicando la presencia de partículas pequeñas-densas, mientras TG/HDL, que se usa para estimar riesgo cardiovascular, estuvo por encima del corte establecido de 3,5. Conclusiones: Al relacionar los triglicéridos basales con LDL/Apo B-100 y TG/HDL, se observa que a partir del valor de triglicéridos de 100 mg/dl, se observa la presencia de partículas de lipoproteínas pequeñas-densa

Impact of the International Nosocomial Infection Control Consortium (INICC) Multidimensional Hand Hygiene Approach During 3 Years in 6 Hospitals in 3 Mexican Cities

To evaluate the impact of the International Nosocomial Infection Control Consortium (INICC) multidimensional hand hygiene (HH) approach in Mexico, and analyze predictors of poor HH compliance. From June 2002 to April 2006, we conducted a prospective, observational, before-and-after study in 8 intensive care units (ICUs) from 6 hospitals in 3 cities of Mexico. The approach included administrative support, availability of supplies, education and training, reminders in the workplace, process surveillance, and performance feedback. A total of 13,201 observations for HH opportunities were done in each ICU, during randomly selected 30-minute periods. Overall, HH compliance increased from 45% to 79% (95% confidence interval [CI], 69.1-86.5; P = 0.01). Univariate and multivariate analyses showed that several variables were significantly associated with poor HH compliance: males versus females (61% versus 66%; 95% CI, 0.91-0.96; P = 0.0001), physicians versus nurses (62% versus 67%; 95% CI, 0.91-0.97; P = 0.0001), and adult versus neonatal ICUs (67% versus 54%; 95% CI, 0.79-0.84; P = 0.0001), among others. Hand hygiene programs should focus on variables found to be predictors of poor HH compliance

Findings of the International Nosocomial Infection Control Consortium (INICC), Part I: Effectiveness of a Multidimensional Infection Control Approach on Catheter-Associated Urinary Tract Infection Rates in Pediatric Intensive Care Units of 6 Developing Countries

DESIGN. A before-after prospective surveillance study to assess the impact of a multidimensional infection control approach for the reduction of catheter-associated urinary tract infection (CAUTI) rates. SETTING. Pediatric intensive care units (PICUs) of hospital members of the International Nosocomial Infection Control Consortium (INICC) from 10 cities of the following 6 developing countries: Colombia, El Salvador, India, Mexico, Philippines, and Turkey. PATIENTS. PICU inpatients. METHODS. We performed a prospective active surveillance to determine rates of CAUTI among 3,877 patients hospitalized in 10 PICUs for a total of 27,345 bed-days. The study was divided into a baseline period (phase 1) and an intervention period (phase 2). In phase 1, surveillance was performed without the implementation of the multidimensional approach. In phase 2, we implemented a multidimensional infection control approach that included outcome surveillance, process surveillance, feedback on CAUTI rates, feedback on performance, education, and a bundle of preventive measures. The rates of CAUTI obtained in phase 1 were compared with the rates obtained in phase 2, after interventions were implemented. RESULTS. During the study period, we recorded 8,513 urinary catheter (UC) days, including 1,513 UC-days in phase 1 and 7,000 UCdays in phase 2. In phase 1, the CAUTI rate was 5.9 cases per 1,000 UC-days, and in phase 2, after implementing the multidimensional infection control approach for CAUTI prevention, the rate of CAUTI decreased to 2.6 cases per 1,000 UC-days (relative risk, 0.43 [95% confidence interval, 0.21-1.0]), indicating a rate reduction of 57%. CONCLUSIONS. Our findings demonstrated that implementing a multidimensional infection control approach is associated with a significant reduction in the CAUTI rate of PICUs in developing countries. Infect Control Hosp Epidemiol 2012;33(7):696-70

Time-dependent analysis of extra length of stay and mortality due to ventilator-associated pneumonia in intensive-care units of ten limited-resources countries: findings of the International Nosocomial Infection Control Consortium (INICC)

Ventilator-associated pneumonias (VAPs) are a worldwide problem that significantly increases patient morbidity, mortality, and length of stay (LoS), and their effects should be estimated to account for the timing of infection. The purpose of the study was to estimate extra LoS and mortality in an intensive-care unit (ICU) due to a VAP in a cohort of 69 248 admissions followed for 283 069 days in ICUs from 10 countries. Data were arranged according to the multi-state format. Extra LoS and increased risk of death were estimated independently in each country, and their results were combined using a random-effects meta-analysis. VAP prolonged LoS by an average of 2.03 days (95% CI 1.52-2.54 days), and increased the risk of death by 14% (95% CI 2-27). The increased risk of death due to VAP was explained by confounding with patient morbidity