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BMC Medicine

Munyaradzi Dimairo, Elizabeth Coates, Philip Pallmann, Susan Todd, Steven A Julious, Thomas Jaki, James Wason, Adrian P Mander, Christopher J Weir, Franz Koenig, Marc K Walton, Katie Biggs, Jon Nicholl, Toshimitsu Hamasaki, Michael A Proschan, John A Scott, Yuki Ando, Daniel Hind, Douglas G Altman
BACKGROUND: Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline...
November 16, 2018: BMC Medicine
Marlies E Brouwer, Alishia D Williams, Sam E van Grinsven, Pim Cuijpers, Mijke P Lambregtse-van den Berg, Huibert Burger, Claudi L H Bockting
BACKGROUND: It is presumed that pharmacological and non-pharmacological treatment of prenatal common mental disorders can mitigate associated adverse effects in offspring, yet strong evidence for the prophylactic benefits of treatment is lacking. We therefore examined the effect of prenatal treatments for common mental disorders on offspring outcomes. METHODS: For this meta-analysis, articles published up to August 31, 2017, were obtained from PubMed, PsycInfo, Embase, and Cochrane databases...
November 15, 2018: BMC Medicine
Sarah E Jackson, Emma Beard, Susan Michie, Lion Shahab, Tobias Raupach, Robert West, Jamie Brown
BACKGROUND: Concerns have been raised that observing other people using e-cigarettes may undermine motivation to quit by renormalising smoking. This study aimed to explore associations between regular exposure to other people's e-cigarette use and motivation to stop smoking and quit attempts in smokers. METHODS: Data were from 12,787 smokers in England who participated in the Smoking Toolkit Study between November 2014 and May 2018. At baseline, respondents were asked whether anyone other than themselves regularly used an e-cigarette in their presence, whether they had made a quit attempt in the past year and how motivated they were to stop...
November 14, 2018: BMC Medicine
Andrew J Tatem
Spatial epidemiology is a rapidly advancing field, pushing our abilities to measure, monitor and map pathogens at increasingly finer spatiotemporal scales. However, these scales often do not align with the abilities of control programmes to act at them, building a disconnect between academia and implementation. Efforts are being made to feed innovations into government, build spatial data skills, and strengthen links between disease control programmes and universities, yet work remains to be done if goals for disease control, elimination and 'leaving no one behind' are to be met...
November 14, 2018: BMC Medicine
Alexandra L J Freeman, David J Spiegelhalter
Research that is poorly communicated or presented is as potentially damaging as research that is poorly conducted or fraudulent. Recent examples illustrate how the problem often lies with researchers, not press officers or journalists. The quest for publication and 'impact' must not outweigh the importance of accurate representation of science; herein, we suggest steps that researchers, journalists and press officers can take to help ensure this.
November 13, 2018: BMC Medicine
Shan-Yan Gao, Qi-Jun Wu, Ce Sun, Tie-Ning Zhang, Zi-Qi Shen, Cai-Xia Liu, Ting-Ting Gong, Xin Xu, Chao Ji, Dong-Hui Huang, Qing Chang, Yu-Hong Zhao
BACKGROUND: In 2005, the FDA cautioned that exposure to paroxetine, a selective serotonin reuptake inhibitor (SSRI), during the first trimester of pregnancy may increase the risk of cardiac malformations. Since then, the association between maternal use of SSRIs during pregnancy and congenital malformations in infants has been the subject of much discussion and controversy. The aim of this study is to systematically review the associations between SSRIs use during early pregnancy and the risk of congenital malformations, with particular attention to the potential confounding by indication...
November 12, 2018: BMC Medicine
James M Burns
Efforts to develop an effective malaria vaccine have encountered multiple challenges, and have had limited success to date. As the need remains urgent, novel approaches must be explored. One concept that has gained attention uses whole malaria parasites. Building on preclinical studies in animal models, Stanisic et al. describe the development of a vaccine based on chemically attenuated Plasmodium falciparum blood-stage parasites, with an evaluation of safety and immunogenicity in malaria-naïve human subjects...
November 9, 2018: BMC Medicine
Chung-Ho E Lau, Alexandros P Siskos, Léa Maitre, Oliver Robinson, Toby J Athersuch, Elizabeth J Want, Jose Urquiza, Maribel Casas, Marina Vafeiadi, Theano Roumeliotaki, Rosemary R C McEachan, Rafaq Azad, Line S Haug, Helle M Meltzer, Sandra Andrusaityte, Inga Petraviciene, Regina Grazuleviciene, Cathrine Thomsen, John Wright, Remy Slama, Leda Chatzi, Martine Vrijheid, Hector C Keun, Muireann Coen
BACKGROUND: Environment and diet in early life can affect development and health throughout the life course. Metabolic phenotyping of urine and serum represents a complementary systems-wide approach to elucidate environment-health interactions. However, large-scale metabolome studies in children combining analyses of these biological fluids are lacking. Here, we sought to characterise the major determinants of the child metabolome and to define metabolite associations with age, sex, BMI and dietary habits in European children, by exploiting a unique biobank established as part of the Human Early-Life Exposome project ( http://www...
November 8, 2018: BMC Medicine
Ilsa L Haeusler, Xin Hui S Chan, Philippe J Guérin, Nicholas J White
BACKGROUND: Several quinoline and structurally related antimalarial drugs are associated with cardiovascular side effects, particularly hypotension and electrocardiographic QT interval prolongation. A prolonged QT interval is a sensitive but not specific risk marker for the development of Torsade de Pointes-a potentially lethal polymorphic ventricular tachyarrhythmia. The increasing use of quinoline and structurally related antimalarials in mass treatments to eliminate malaria rapidly highlights the need to review their cardiovascular safety profiles...
November 7, 2018: BMC Medicine
Judith S Brand, Jane West, Derek Tuffnell, Philippa K Bird, John Wright, Kate Tilling, Debbie A Lawlor
BACKGROUND: Maternal gestational diabetes (GDM) is an established risk factor for large size at birth, but its influence on intrauterine fetal growth in different ethnic populations is less well understood. Here, we examine the joint associations of GDM and ethnicity with longitudinal fetal growth in South Asian and White European origin women. METHODS: This study included 10,705 singletons (4747 White European and 5958 South Asian) from a prospective cohort of women attending an antenatal clinic in Bradford, in the North of England...
November 6, 2018: BMC Medicine
Susana Santos, Iris Eekhout, Ellis Voerman, Romy Gaillard, Henrique Barros, Marie-Aline Charles, Leda Chatzi, Cécile Chevrier, George P Chrousos, Eva Corpeleijn, Nathalie Costet, Sarah Crozier, Myriam Doyon, Merete Eggesbø, Maria Pia Fantini, Sara Farchi, Francesco Forastiere, Luigi Gagliardi, Vagelis Georgiu, Keith M Godfrey, Davide Gori, Veit Grote, Wojciech Hanke, Irva Hertz-Picciotto, Barbara Heude, Marie-France Hivert, Daniel Hryhorczuk, Rae-Chi Huang, Hazel Inskip, Todd A Jusko, Anne M Karvonen, Berthold Koletzko, Leanne K Küpers, Hanna Lagström, Debbie A Lawlor, Irina Lehmann, Maria-Jose Lopez-Espinosa, Per Magnus, Renata Majewska, Johanna Mäkelä, Yannis Manios, Sheila W McDonald, Monique Mommers, Camilla S Morgen, George Moschonis, Ľubica Murínová, John Newnham, Ellen A Nohr, Anne-Marie Nybo Andersen, Emily Oken, Adriëtte J J M Oostvogels, Agnieszka Pac, Eleni Papadopoulou, Juha Pekkanen, Costanza Pizzi, Kinga Polanska, Daniela Porta, Lorenzo Richiardi, Sheryl L Rifas-Shiman, Nel Roeleveld, Loreto Santa-Marina, Ana C Santos, Henriette A Smit, Thorkild I A Sørensen, Marie Standl, Maggie Stanislawski, Camilla Stoltenberg, Elisabeth Thiering, Carel Thijs, Maties Torrent, Suzanne C Tough, Tomas Trnovec, Marleen M H J van Gelder, Lenie van Rossem, Andrea von Berg, Martine Vrijheid, Tanja G M Vrijkotte, Oleksandr Zvinchuk, Stef van Buuren, Vincent W V Jaddoe
BACKGROUND: Gestational weight gain differs according to pre-pregnancy body mass index and is related to the risks of adverse maternal and child health outcomes. Gestational weight gain charts for women in different pre-pregnancy body mass index groups enable identification of women and offspring at risk for adverse health outcomes. We aimed to construct gestational weight gain reference charts for underweight, normal weight, overweight, and grades 1, 2 and 3 obese women and to compare these charts with those obtained in women with uncomplicated term pregnancies...
November 5, 2018: BMC Medicine
Hamtandi Magloire Natama, Gemma Moncunill, Eduard Rovira-Vallbona, Héctor Sanz, Hermann Sorgho, Ruth Aguilar, Maminata Coulibaly-Traoré, M Athanase Somé, Susana Scott, Innocent Valéa, Petra F Mens, Henk D F H Schallig, Luc Kestens, Halidou Tinto, Carlota Dobaño, Anna Rosanas-Urgell
BACKGROUND: Factors driving inter-individual differences in immune responses upon different types of prenatal malaria exposure (PME) and subsequent risk of malaria in infancy remain poorly understood. In this study, we examined the impact of four types of PME (i.e., maternal peripheral infection and placental acute, chronic, and past infections) on both spontaneous and toll-like receptors (TLRs)-mediated cytokine production in cord blood and how these innate immune responses modulate the risk of malaria during the first year of life...
November 2, 2018: BMC Medicine
Mayya Husseini, Momodou K Darboe, Sophie E Moore, Helen M Nabwera, Andrew M Prentice
BACKGROUND: Childhood malnutrition remains highly prevalent in low-income countries, and a 40% reduction in under-5 year stunting is WHO's top Global Target 2025. Disappointingly, meta-analyses of intensive nutrition interventions reveal that they generally have low efficacy at improving growth. Unhygienic environments also contribute to growth failure, but large WASH Benefits and SHINE trials of improved water, sanitation and hygiene (WASH) recently reported no benefits to child growth...
November 1, 2018: BMC Medicine
Itziar Ubillos, Aintzane Ayestaran, Augusto J Nhabomba, David Dosoo, Marta Vidal, Alfons Jiménez, Chenjerai Jairoce, Hèctor Sanz, Ruth Aguilar, Nana Aba Williams, Núria Díez-Padrisa, Maximilian Mpina, Hermann Sorgho, Selidji Todagbe Agnandji, Simon Kariuki, Benjamin Mordmüller, Claudia Daubenberger, Kwaku Poku Asante, Seth Owusu-Agyei, Jahit Sacarlal, Pedro Aide, John J Aponte, Sheetij Dutta, Ben Gyan, Joseph J Campo, Clarissa Valim, Gemma Moncunill, Carlota Dobaño
BACKGROUND: The RTS,S/AS01E vaccine provides partial protection against malaria in African children, but immune responses have only been partially characterized and do not reliably predict protective efficacy. We aimed to evaluate comprehensively the immunogenicity of the vaccine at peak response, the factors affecting it, and the antibodies associated with protection against clinical malaria in young African children participating in the multicenter phase 3 trial for licensure. METHODS: We measured total IgM, IgG, and IgG1-4 subclass antibodies to three constructs of the Plasmodium falciparum circumsporozoite protein (CSP) and hepatitis B surface antigen (HBsAg) that are part of the RTS,S vaccine, by quantitative suspension array technology...
October 31, 2018: BMC Medicine
Kirsten E Wiens, Lauren P Woyczynski, Jorge R Ledesma, Jennifer M Ross, Roberto Zenteno-Cuevas, Amador Goodridge, Irfan Ullah, Barun Mathema, Joel Fleury Djoba Siawaya, Molly H Biehl, Sarah E Ray, Natalia V Bhattacharjee, Nathaniel J Henry, Robert C Reiner, Hmwe H Kyu, Christopher J L Murray, Simon I Hay
BACKGROUND: The host, microbial, and environmental factors that contribute to variation in tuberculosis (TB) disease are incompletely understood. Accumulating evidence suggests that one driver of geographic variation in TB disease is the local ecology of mycobacterial genotypes or strains, and there is a need for a comprehensive and systematic synthesis of these data. The objectives of this study were to (1) map the global distribution of genotypes that cause TB disease and (2) examine whether any epidemiologically relevant clinical characteristics were associated with those genotypes...
October 30, 2018: BMC Medicine
D Das, R F Grais, E A Okiro, K Stepniewska, R Mansoor, S van der Kam, D J Terlouw, J Tarning, K I Barnes, P J Guerin
BACKGROUND: Despite substantial improvement in the control of malaria and decreased prevalence of malnutrition over the past two decades, both conditions remain heavy burdens that cause hundreds of thousands of deaths in children in resource-poor countries every year. Better understanding of the complex interactions between malaria and malnutrition is crucial for optimally targeting interventions where both conditions co-exist. This systematic review aimed to assess the evidence of the interplay between malaria and malnutrition...
October 29, 2018: BMC Medicine
Kulapong Jayanama, Olga Theou, Joanna M Blodgett, Leah Cahill, Kenneth Rockwood
BACKGROUND: Nutritional status and individual nutrients have been associated with frailty in older adults. The extent to which these associations hold in younger people, by type of malnutrition or grades of frailty, is unclear. Our objectives were to (1) evaluate the relationship between individual nutrition-related parameters and frailty, (2) investigate the association between individual nutrition-related parameters and mortality across frailty levels, and (3) examine whether combining nutrition-related parameters in an index predicts mortality risk across frailty levels...
October 26, 2018: BMC Medicine
Florence Y Lai, Mintu Nath, Stephen E Hamby, John R Thompson, Christopher P Nelson, Nilesh J Samani
BACKGROUND: Adult height is associated with risk of several diseases, but the breadth of such associations and whether these associations are primary or due to confounding are unclear. We examined the association of adult height with 50 diseases spanning multiple body systems using both epidemiological and genetic approaches, the latter to identify un-confounded associations and possible underlying mechanisms. METHODS: We examined the associations for adult height (using logistic regression adjusted for potential confounders) and genetically determined height (using a two-sample Mendelian randomisation approach with height-associated genetic variants as instrumental variables) in 417,434 individuals of white ethnic background participating in the UK Biobank...
October 25, 2018: BMC Medicine
Zuyun Liu, Fang-Chi Hsu, Andrea Trombetti, Abby C King, Christine K Liu, Todd M Manini, Roger A Fielding, Marco Pahor, Anne B Newman, Stephen Kritchevsky, Thomas M Gill
BACKGROUND: Whether physical activity can reduce cognitive frailty-a relatively new "compound" phenotype proposed in 2013-and whether the effect of physical activity differs based on levels of inflammation are unknown. Therefore, this study aimed to evaluate the effect of physical activity on cognitive frailty and whether baseline interleukin-6 (IL-6) levels modified this effect. METHODS: We used data from the Lifestyle Interventions and Independence for Elders (LIFE) Study, a multicenter, single-blinded randomized trial conducted at eight US field centers between February 2010 and December 2013...
October 24, 2018: BMC Medicine
Panagiotis Filis, Sabine Hombach-Klonisch, Pierre Ayotte, Nalin Nagrath, Ugo Soffientini, Thomas Klonisch, Peter O'Shaughnessy, Paul A Fowler
BACKGROUND: Maternal lifestyle factors, including smoking and increased body weight, increase risks of adult diseases such as metabolic syndrome and infertility. The fetal thyroid gland is essential for the control of fetal metabolic rate, cardiac output, and brain development. Altered fetal thyroid function may contribute to increased disease onset later in life. Here, we investigated the impact of maternal smoking and high maternal weight on human fetal thyroid function during the second trimester...
October 23, 2018: BMC Medicine
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