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BMC Medicine

Joshua D Wallach, Oriana Ciani, Alison M Pease, Gregg S Gonsalves, Harlan M Krumholz, Rod S Taylor, Joseph S Ross
BACKGROUND: The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product's actual clinical effect. This study aims to compare the treatment effects among pivotal trials supporting FDA approval of novel therapeutics based on surrogate markers of disease with those observed among postapproval trials for the same indication...
March 21, 2018: BMC Medicine
Daniel J Gottlieb, Jeffrey M Ellenbogen, Matt T Bianchi, Charles A Czeisler
BACKGROUND: Insufficient sleep duration and obstructive sleep apnea, two common causes of sleep deficiency in adults, can result in excessive sleepiness, a well-recognized cause of motor vehicle crashes, although their contribution to crash risk in the general population remains uncertain. The objective of this study was to evaluate the relation of sleep apnea, sleep duration, and excessive sleepiness to crash risk in a community-dwelling population. METHODS: This was a prospective observational cohort study nested within the Sleep Heart Health Study, a community-based study of the health consequences of sleep apnea...
March 20, 2018: BMC Medicine
Amanda M Rojek, Kassiani Gkolfinopoulou, Apostolos Veizis, Angeliki Lambrou, Lyndsey Castle, Theano Georgakopoulou, Karl Blanchet, Takis Panagiotopoulos, Peter W Horby
BACKGROUND: Refugees may have an increased vulnerability to infectious diseases, and the consequences of an outbreak are more severe in a refugee camp. When an outbreak is suspected, access to clinical information is critical for investigators to verify that an outbreak is occurring, to determine the cause and to select interventions to control it. Experience from previous outbreaks suggests that the accuracy and completeness of this information is poor. This study is the first to assess the adequacy of clinical characterisation of acute medical illnesses in refugee camps...
March 19, 2018: BMC Medicine
Linden Disney-Hogg, Alex J Cornish, Amit Sud, Philip J Law, Ben Kinnersley, Daniel I Jacobs, Quinn T Ostrom, Karim Labreche, Jeanette E Eckel-Passow, Georgina N Armstrong, Elizabeth B Claus, Dora Il'yasova, Joellen Schildkraut, Jill S Barnholtz-Sloan, Sara H Olson, Jonine L Bernstein, Rose K Lai, Minouk J Schoemaker, Matthias Simon, Per Hoffmann, Markus M Nöthen, Karl-Heinz Jöckel, Stephen Chanock, Preetha Rajaraman, Christoffer Johansen, Robert B Jenkins, Beatrice S Melin, Margaret R Wrensch, Marc Sanson, Melissa L Bondy, Richard S Houlston
BACKGROUND: An inverse relationship between allergies with glioma risk has been reported in several but not all epidemiological observational studies. We performed an analysis of genetic variants associated with atopy to assess the relationship with glioma risk using Mendelian randomisation (MR), an approach unaffected by biases from temporal variability and reverse causation that might have affected earlier investigations. METHODS: Two-sample MR was undertaken using genome-wide association study data...
March 15, 2018: BMC Medicine
Liv Tybjærg Nordestgaard, Anne Tybjærg-Hansen, Katrine Laura Rasmussen, Børge G Nordestgaard, Ruth Frikke-Schmidt
BACKGROUND: Clusterin, also known as apolipoprotein J (apoJ), is one of the most abundantly expressed apolipoproteins in the brain after apolipoprotein E (apoE). Like the ε4 allele of the apolipoprotein E gene (APOE), the clusterin gene (CLU) is a risk locus for Alzheimer's disease, and may play additional roles in atherosclerosis pathogenesis. We tested whether genetic variation in CLU was associated with either Alzheimer's disease or atherosclerosis-related diseases. METHODS: We studied individual data on 103,987 participants from the Copenhagen General Population Study (CGPS) and the Copenhagen City Heart Study (CCHS)...
March 14, 2018: BMC Medicine
Jihane Ben Farhat, Karl Blanchet, Pia Juul Bjertrup, Apostolos Veizis, Clément Perrin, Rebecca M Coulborn, Philippe Mayaud, Sandra Cohuet
BACKGROUND: Since 2015, Europe has been facing an unprecedented arrival of refugees and migrants: more than one million people entered via land and sea routes. During their travels, refugees and migrants often face harsh conditions, forced detention, and violence in transit countries. However, there is a lack of epidemiological quantitative evidence on their experiences and the mental health problems they face during their displacement. We aimed to document the types of violence experienced by migrants and refugees during their journey and while settled in Greece, and to measure the prevalence of anxiety disorders and access to legal information and procedures...
March 13, 2018: BMC Medicine
Jannike Øyen, Ingrid Kvestad, Lisa Kolden Midtbø, Ingvild Eide Graff, Mari Hysing, Kjell Morten Stormark, Maria Wik Markhus, Valborg Baste, Livar Frøyland, Berthold Koletzko, Hans Demmelmair, Lisbeth Dahl, Øyvind Lie, Marian Kjellevold
BACKGROUND: Marine resources including fatty fish are important sources of n-3 long chain polyunsaturated fatty acids (n-3 LC-PUFAs), which are important for brain development. To our knowledge, this is the first randomized controlled trial (RCT) investigating the impact of fatty fish on cognition in preschool children. The purpose of the trial was to investigate whether an increased intake of fatty fish compared to meat improves cognitive function in children 4-6 years old. METHODS: The children (n = 232) in this two-armed RCT, Fish Intervention Studies-KIDS (FINS-KIDS) were recruited from 13 kindergartens in Bergen, Norway...
March 12, 2018: BMC Medicine
A Aramburo, Jim Todd, Elizabeth C George, Sarah Kiguli, Peter Olupot-Olupot, Robert O Opoka, Charles Engoru, Samuel O Akech, Richard Nyeko, George Mtove, Diana M Gibb, Abdel G Babiker, Kathryn Maitland
BACKGROUND: Hyperlactataemia (HL) is a biomarker of disease severity that predicts mortality in patients with sepsis and malaria. Lactate clearance (LC) during resuscitation has been shown to be a prognostic factor of survival in critically ill adults, but little data exist for African children living in malaria-endemic areas. METHODS: In a secondary data analysis of severely ill febrile children included in the Fluid Expansion as Supportive Therapy (FEAST) resuscitation trial, we assessed the association between lactate levels at admission and LC at 8 h with all-cause mortality at 72 h (d72)...
March 9, 2018: BMC Medicine
Carol Coupland, Trevor Hill, Richard Morriss, Michael Moore, Antony Arthur, Julia Hippisley-Cox
BACKGROUND: Antidepressants are one of the most commonly prescribed medications in young and middle-aged adults, but there is relatively little information on their safety across a range of adverse outcomes in this age group. This study aimed to assess associations between antidepressant treatment and several adverse outcomes in people aged 20-64 years diagnosed with depression. METHODS: We conducted a cohort study in 238,963 patients aged 20-64 years registered with practices across the UK contributing to the QResearch primary care database...
March 8, 2018: BMC Medicine
Matthew J Spittal, David M Studdert, Ron Paterson, Marie M Bismark
The original article [1] contains a major error whereby all rates in Table 2 are mistakenly presented as 50% of their true values; this error was caused by a miscalculation in annualising the original values that represented the rates.
March 7, 2018: BMC Medicine
Symon M Kariuki, Amina Abubakar, Martha Kombe, Michael Kazungu, Rachael Odhiambo, Alan Stein, Charles R J C Newton
BACKGROUND: Acute symptomatic seizures and febrile seizures are common in children admitted to hospitals in Africa and may be markers of brain dysfunction. They may be associated with behavioural and emotional problems, but there are no published community-based studies in Africa. METHODS: We screened 7047 children aged 1-6 years (randomly sampled from 50,000 in the community) for seizures (using seven questions) and invited those who screened positive and a proportion of negatives for a clinical assessment...
March 7, 2018: BMC Medicine
Kurt A Jellinger, Amos D Korczyn
BACKGROUND: Dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD), which share many clinical, neurochemical, and morphological features, have been incorporated into DSM-5 as two separate entities of major neurocognitive disorders with Lewy bodies. Despite clinical overlap, their diagnosis is based on an arbitrary distinction concerning the time of onset of motor and cognitive symptoms, namely as early cognitive impairment in DLB and later onset following that of motor symptoms in PDD...
March 6, 2018: BMC Medicine
Beniamino Guerra, Sarah R Haile, Bernd Lamprecht, Ana S Ramírez, Pablo Martinez-Camblor, Bernhard Kaiser, Inmaculada Alfageme, Pere Almagro, Ciro Casanova, Cristóbal Esteban-González, Juan J Soler-Cataluña, Juan P de-Torres, Marc Miravitlles, Bartolome R Celli, Jose M Marin, Gerben Ter Riet, Patricia Sobradillo, Peter Lange, Judith Garcia-Aymerich, Josep M Antó, Alice M Turner, Meilan K Han, Arnulf Langhammer, Linda Leivseth, Per Bakke, Ane Johannessen, Toru Oga, Borja Cosio, Julio Ancochea-Bermúdez, Andres Echazarreta, Nicolas Roche, Pierre-Régis Burgel, Don D Sin, Joan B Soriano, Milo A Puhan
BACKGROUND: External validations and comparisons of prognostic models or scores are a prerequisite for their use in routine clinical care but are lacking in most medical fields including chronic obstructive pulmonary disease (COPD). Our aim was to externally validate and concurrently compare prognostic scores for 3-year all-cause mortality in mostly multimorbid patients with COPD. METHODS: We relied on 24 cohort studies of the COPD Cohorts Collaborative International Assessment consortium, corresponding to primary, secondary, and tertiary care in Europe, the Americas, and Japan...
March 2, 2018: BMC Medicine
Mike English, Paul Mwaniki, Thomas Julius, Mercy Chepkirui, David Gathara, Paul O Ouma, Peter Cherutich, Emelda A Okiro, Robert W Snow
BACKGROUND: There is increasing focus on the strength of primary health care systems in low and middle-income countries (LMIC). There are important roles for higher quality district hospital care within these systems. These hospitals are also sources of information of considerable importance to health systems, but this role, as with the wider roles of district hospitals, has been neglected. KEY MESSAGES: As we make efforts to develop higher quality health systems in LMIC we highlight the critical importance of district hospitals focusing here on how data on hospital mortality offers value: i) in understanding disease burden; ii) as part of surveillance and impact monitoring; iii) as an entry point to exploring system failures; and iv) as a lens to examine variability in health system performance and possibly as a measure of health system quality in its own right...
March 1, 2018: BMC Medicine
José M Benito, María C Ortiz, Agathe León, Luis A Sarabia, José M Ligos, María Montoya, Marcial Garcia, Ezequiel Ruiz-Mateos, Rosario Palacios, Alfonso Cabello, Clara Restrepo, Carmen Rodriguez, Jorge Del Romero, Manuel Leal, María A Muñoz-Fernández, José Alcamí, Felipe García, Miguel Górgolas, Norma Rallón
BACKGROUND: Despite long-lasting HIV replication control, a significant proportion of elite controller (EC) patients may experience CD4 T-cell loss. Discovering perturbations in immunological parameters could help our understanding of the mechanisms that may be operating in those patients experiencing loss of immunological control. METHODS: A case-control study was performed to evaluate if alterations in different T-cell homeostatic parameters can predict CD4 T-cell loss in ECs by comparing data from EC patients showing significant CD4 decline (cases) and EC patients showing stable CD4 counts (controls)...
February 28, 2018: BMC Medicine
V J Gnanapragasam, O Bratt, K Muir, L S Lee, H H Huang, P Stattin, A Lophatananon
BACKGROUND: The purpose of this study is to validate a new five-tiered prognostic classification system to better discriminate cancer-specific mortality in men diagnosed with primary non-metastatic prostate cancer. METHODS: We applied a recently described five-strata model, the Cambridge Prognostic Groups (CPGs 1-5), in two international cohorts and tested prognostic performance against the current standard three-strata classification of low-, intermediate- or high-risk disease...
February 28, 2018: BMC Medicine
Philip Pallmann, Alun W Bedding, Babak Choodari-Oskooei, Munyaradzi Dimairo, Laura Flight, Lisa V Hampson, Jane Holmes, Adrian P Mander, Lang'o Odondi, Matthew R Sydes, Sofía S Villar, James M S Wason, Christopher J Weir, Graham M Wheeler, Christina Yap, Thomas Jaki
Adaptive designs can make clinical trials more flexible by utilising results accumulating in the trial to modify the trial's course in accordance with pre-specified rules. Trials with an adaptive design are often more efficient, informative and ethical than trials with a traditional fixed design since they often make better use of resources such as time and money, and might require fewer participants. Adaptive designs can be applied across all phases of clinical research, from early-phase dose escalation to confirmatory trials...
February 28, 2018: BMC Medicine
Anna Fernández, Juan M Mendive, Sonia Conejo-Cerón, Patricia Moreno-Peral, Michael King, Irwin Nazareth, Carlos Martín-Pérez, Carmen Fernández-Alonso, Antonina Rodríguez-Bayón, Jose Maria Aiarzaguena, Carmen Montón-Franco, Antoni Serrano-Blanco, Inmaculada Ibañez-Casas, Emiliano Rodríguez-Sánchez, Luis Salvador-Carulla, Paola Bully Garay, María Isabel Ballesta-Rodríguez, Pilar LaFuente, María Del Mar Muñoz-García, Pilar Mínguez-Gonzalo, Luz Araujo, Diego Palao, María Cruz Gómez, Fernando Zubiaga, Desirée Navas-Campaña, Jose Manuel Aranda-Regules, Alberto Rodriguez-Morejón, Juan de Dios Luna, Juan Ángel Bellón
BACKGROUND: Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care...
February 23, 2018: BMC Medicine
Laura B Nellums, Kieran Rustage, Sally Hargreaves, Jon S Friedland
BACKGROUND: Multidrug-resistant tuberculosis (MDR-TB) is a growing concern in meeting global targets for TB control. In high-income low-TB-incidence countries, a disproportionate number of MDR-TB cases occur in migrant (foreign-born) populations, with concerns about low adherence rates in these patients compared to the host non-migrant population. Tackling MDR-TB in this context may, therefore, require unique approaches. We conducted a systematic review and meta-analysis to identify and synthesise data on MDR-TB treatment adherence in migrant patients to inform evidence-based strategies to improve care pathways and health outcomes in this group...
February 22, 2018: BMC Medicine
Daniel J Niven, T Jared McCormick, Sharon E Straus, Brenda R Hemmelgarn, Lianne Jeffs, Tavish R M Barnes, Henry T Stelfox
BACKGROUND: The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies. METHODS: We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals...
February 21, 2018: BMC Medicine
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