Developing a core outcome set for future infertility research : An international consensus development study

STUDY QUESTION: Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form

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

Bem-estar na produção de frango de corte em diferentes sistemas de criação Animal welfare in different housing systems of broiler production

Esta pesquisa foi conduzida com o objetivo de avaliar diferentes sistemas de criação para frangos de corte, caracterizando o ambiente térmico, os parâmetros fisiológicos e o comportamento animal. O experimento foi realizado no decorrer de um ciclo produtivo de 42 dias, no município de Carpina, Estado de Pernambuco, na Estação Experimental de Pequenos Animais da Universidade Federal Rural de Pernambuco (UFRPE). A pesquisa foi desenvolvida em um módulo de produção dividido em 15 boxes, com 10 aves por Box, e densidade de 10 aves por m², totalizando 150 aves, submetidas a três sistemas de criação: semiconfinado com 3 m² por ave de área de piquete (SC 3), semiconfinado com 6 m² por ave de área de piquete (SC 6) e confinamento total (CONF). O delineamento experimental para análise geral dos dados foi inteiramente casualizado (DIC) em parcelas subdivididas, sendo as semanas alocadas nas parcelas, e os sistemas de criação (SC 3, SC 6, CONF e EXT), nas subparcelas, com as médias comparadas pelo teste de Tukey. As variáveis meteorológicas, índices de conforto e os parâmetros fisiológicos apontam o sistema de criação SC 3 como aquele que permitiu melhor acondicionamento térmico natural às aves, apresentando valores médios da ordem de 25,4 ºC; 69,9 kJ kg-1; 75,7; 65,12 movimentos min-1 e 41,92 ºC para temperatura de bulbo seco, entalpia, índice de temperatura de globo e umidade, frequência respiratória e temperatura cloacal, respectivamente. As aves submetidas ao sistema de criação SC 3 foram as que tiveram melhor oportunidade de expressar seus comportamentos naturais e de explorar o ambiente externo ao módulo de criação, potencializando o bem-estar animal.<br>This research was carried out to evaluate different housing systems for broiler chickens production, characterizing the thermal environment, physiological parameters and animal behavior. The experiment was conducted in a production cycle of 42 days, in the city of Carpina, state of Pernambuco, Brazil, at the Experimental Station for Small Animals of the Federal Rural University of Pernambuco (UFRPE). The survey was developed in production module divided into 15 boxes with 10 birds per box and density of the 10 birds per m², totaling 150 birds, submitted to the three housing systems: semi-confined with 3m² per broiler of paddock area (SC 3), semi-confined with 6m² per broiler of paddock area (SC 6) and total confinement (CONF). The experimental design for data general analysis was completely randomized (CRD), in split plots, being the weeks allocated in the plots and the accommodation systems (SC 3, SC 6, CONF and EXT) in the sub-plots with the averages compared through the Tukey test. The meteorological variables, comfort indexes and physiological parameters indicated the semi-confined system of accommodation SC 3 as one that allowed better natural conditioning heat to the birds, presenting the average values of 25.4ºC, 69.9 kJ kg-1, 75.7, 65.12 movements min-1 and 41.92ºC for dry bulb temperature, enthalpy, black globe humidity index, respiratory rate and cloacal temperature, respectively. The birds subjected to the semi-confined system SC 3 were those that had better opportunity to express their natural behavior and explore the external environment to the module of production, leveraging the animal welfare

Qualidade da Dieta Selecionada por Bovinos na Sub-Região da Nhecolândia, Pantanal Quality of the Diet Selected by Cattle in the Nhecolândia Sub-Region, Pantanal

Objetivou-se com o estudo determinar o valor nutritivo da dieta selecionada por vacas de cria, numa área característica da sub-região da Nhecolândia, Pantanal, durante dois anos hidrológicos (outubro de 1997 a setembro de 1999). Mensalmente foram colhidas manualmente amostras das partes das principais forrageiras selecionadas por bovinos, identificadas por meio de observação direta, para análise de proteína bruta (PB), fibra em detergente neutro (FDN), fibra em detergente ácido (FDA) e lignina (LIG). A digestibilidade da matéria orgânica (DMO) da dieta foi avaliada em amostras fecais com o uso da espectrofotometria de reflectância no infravermelho proximal (NIRS). Houve efeito interativo de ano e época para todos os constituintes químicos analisados na dieta. O valor nutritivo da dieta selecionada por bovinos diminuiu no período de abril a junho, em ambos os anos estudados. As vacas apresentaram uma melhor condição corporal de setembro a março do ano hidrológico 1998/99, no qual a dieta apresentou valores médios de 60,4% de digestibilidade, 10% de PB; 40,20% de FDA; 71% de FDN e 6,0% de lignina, considerada adequada para obtenção de um desempenho reprodutivo satisfatório. Portanto, o valor nutritivo da dieta selecionada por bovinos na sub-região da Nhecolândia depende especialmente da intensidade e distribuição das chuvas, responsáveis pela maior ou menor presença de água nas unidades mais baixas, que possuem forrageiras de melhor qualidade.<br>The objective of this study was to evaluate the nutritive value of the diet by cows grazing in natural pastures, in a typical area of Nhecolândia sub-region, Pantanal, during two hydrological years: from October 1997 to September 1999. Grazed forage species samples, representative of the animals' diet, were collected manually in each month. All forage samples were analyzed for crude protein (CP), acid detergent fiber (ADF), neutral detergent fiber (NDF), and lignin (LIG). Near infrared spectrofotometry (NIRS) was used to estimate the organic matter digestibility (%) indirectly from fecal samples collected monthly. There was year vs season interaction for all chemical constituents. Cows showed better body score condition from September to March of 1998/99, when the diet had average levels of 60,4%, 10%, 40.20%, 71%, and 6% for digestibility, CP, ADF, NDF and LIG, respectively. These levels appeared appropriate for meeting cow reproductive demands in the conditions of the studied area. Thus, the diet nutritive value selected by cattle is dependent on annual climatic conditions, especially the rainfall intensity and distribuiton, that cause more or less presence of water on the lowland, areas with more nutritive forage species