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Journal Cover The Lancet
  [SJR: 11.563]   [H-I: 514]   [1609 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 0140-6736 - ISSN (Online) 1474-547X
   Published by Elsevier Homepage  [2969 journals]
  • Congenital Zika virus syndrome in Brazil: a case series of the first 1501
           livebirths with complete investigation
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Giovanny V A França, Lavinia Schuler-Faccini, Wanderson K Oliveira, Claudio M P Henriques, Eduardo H Carmo, Vaneide D Pedi, Marília L Nunes, Marcia C Castro, Suzanne Serruya, Mariângela F Silveira, Fernando C Barros, Cesar G Victora
      Background In November, 2015, an epidemic of microcephaly was reported in Brazil, which was later attributed to congenital Zika virus infection. 7830 suspected cases had been reported to the Brazilian Ministry of Health by June 4, 2016, but little is known about their characteristics. We aimed to describe these newborn babies in terms of clinical findings, anthropometry, and survival. Methods We reviewed all 1501 liveborn infants for whom investigation by medical teams at State level had been completed as of Feb 27, 2016, and classified suspected cases into five categories based on neuroimaging and laboratory results for Zika virus and other relevant infections. Definite cases had laboratory evidence of Zika virus infection; highly probable cases presented specific neuroimaging findings, and negative laboratory results for other congenital infections; moderately probable cases had specific imaging findings but other infections could not be ruled out; somewhat probable cases had imaging findings, but these were not reported in detail by the local teams; all other newborn babies were classified as discarded cases. Head circumference by gestational age was assessed with InterGrowth standards. First week mortality and history of rash were provided by the State medical teams. Findings Between Nov 19, 2015, and Feb 27, 2015, investigations were completed for 1501 suspected cases reported to the Brazilian Ministry of Health, of whom 899 were discarded. Of the remainder 602 cases, 76 were definite, 54 highly probable, 181 moderately probable, and 291 somewhat probable of congenital Zika virus syndrome. Clinical, anthropometric, and survival differences were small among the four groups. Compared with these four groups, the 899 discarded cases had larger head circumferences (mean Z scores −1·54 vs −3·13, difference 1·58 [95% CI 1·45–1·72]); lower first-week mortality (14 per 1000 vs 51 per 1000; rate ratio 0·28 [95% CI 0·14–0·56]); and were less likely to have a history of rash during pregnancy (20·7% vs 61·4%, ratio 0·34 [95% CI 0·27–0·42]). Rashes in the third trimester of pregnancy were associated with brain abnormalities despite normal sized heads. One in five definite or probable cases presented head circumferences in the normal range (above −2 SD below the median of the InterGrowth standard) and for one third of definite and probable cases there was no history of a rash during pregnancy. The peak of the epidemic occurred in late November, 2015. Interpretation Zika virus congenital syndrome is a new teratogenic disease. Because many definite or probable cases present normal head circumference values and their mothers do not report having a rash, screening criteria must be revised in order to detect all affected newborn babies. Funding Brazilian Ministry of Health, Pan American Health Organization, and Wellcome Trust.


      PubDate: 2016-08-28T02:56:11Z
       
  • Comparative efficacy and tolerability of antidepressants for major
           depressive disorder in children and adolescents: a network meta-analysis
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Andrea Cipriani, Xinyu Zhou, Cinzia Del Giovane, Sarah E Hetrick, Bin Qin, Craig Whittington, David Coghill, Yuqing Zhang, Philip Hazell, Stefan Leucht, Pim Cuijpers, Juncai Pu, David Cohen, Arun V Ravindran, Yiyun Liu, Kurt D Michael, Lining Yang, Lanxiang Liu, Peng Xie
      Background Major depressive disorder is one of the most common mental disorders in children and adolescents. However, whether to use pharmacological interventions in this population and which drug should be preferred are still matters of controversy. Consequently, we aimed to compare and rank antidepressants and placebo for major depressive disorder in young people. Methods We did a network meta-analysis to identify both direct and indirect evidence from relevant trials. We searched PubMed, the Cochrane Library, Web of Science, Embase, CINAHL, PsycINFO, LiLACS, regulatory agencies' websites, and international registers for published and unpublished, double-blind randomised controlled trials up to May 31, 2015, for the acute treatment of major depressive disorder in children and adolescents. We included trials of amitriptyline, citalopram, clomipramine, desipramine, duloxetine, escitalopram, fluoxetine, imipramine, mirtazapine, nefazodone, nortriptyline, paroxetine, sertraline, and venlafaxine. Trials recruiting participants with treatment-resistant depression, treatment duration of less than 4 weeks, or an overall sample size of less than ten patients were excluded. We extracted the relevant information from the published reports with a predefined data extraction sheet, and assessed the risk of bias with the Cochrane risk of bias tool. The primary outcomes were efficacy (change in depressive symptoms) and tolerability (discontinuations due to adverse events). We did pair-wise meta-analyses using the random-effects model and then did a random-effects network meta-analysis within a Bayesian framework. We assessed the quality of evidence contributing to each network estimate using the GRADE framework. This study is registered with PROSPERO, number CRD42015016023. Findings We deemed 34 trials eligible, including 5260 participants and 14 antidepressant treatments. The quality of evidence was rated as very low in most comparisons. For efficacy, only fluoxetine was statistically significantly more effective than placebo (standardised mean difference −0·51, 95% credible interval [CrI] −0·99 to −0·03). In terms of tolerability, fluoxetine was also better than duloxetine (odds ratio [OR] 0·31, 95% CrI 0·13 to 0·95) and imipramine (0·23, 0·04 to 0·78). Patients given imipramine, venlafaxine, and duloxetine had more discontinuations due to adverse events than did those given placebo (5·49, 1·96 to 20·86; 3·19, 1·01 to 18·70; and 2·80, 1·20 to 9·42, respectively). In terms of heterogeneity, the global I 2 values were 33·21% for efficacy and 0% for tolerability. Interpretation When considering the risk–benefit profile of antidepressants in the acute treatment of major depressive disorder, these drugs do not seem to offer a clear advantage for children and adolescents. Fluoxetine is probably the best option to consider when a pharmacological treatment is indicated. Funding National Basic Research Program of China (973 Program).


      PubDate: 2016-08-28T02:56:11Z
       
  • Department of Error
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047




      PubDate: 2016-08-28T02:56:11Z
       
  • Cost and Outcome of Behavioural Activation versus Cognitive Behavioural
           Therapy for Depression (COBRA): a randomised, controlled, non-inferiority
           trial
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): David A Richards, David Ekers, Dean McMillan, Rod S Taylor, Sarah Byford, Fiona C Warren, Barbara Barrett, Paul A Farrand, Simon Gilbody, Willem Kuyken, Heather O'Mahen, Ed R Watkins, Kim A Wright, Steven D Hollon, Nigel Reed, Shelley Rhodes, Emily Fletcher, Katie Finning
      Background Depression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy—cognitive behavioural therapy (CBT)—is complex and costly. A simpler therapy—behavioural activation (BA)—might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. Methods In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954. Findings Between Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI −1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [–1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed). Interpretation We found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals. Funding National Institute for Health Research.


      PubDate: 2016-08-28T02:56:11Z
       
  • Bipolar disorder: defining symptoms and comorbidities – Authors'
           reply
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Eduard Vieta, Michael Berk, Boris Birmaher, Iria Grande



      PubDate: 2016-08-28T02:56:11Z
       
  • Bipolar disorder: defining symptoms and comorbidities
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Philip B Mitchell



      PubDate: 2016-08-28T02:56:11Z
       
  • Bipolar disorder: defining symptoms and comorbidities
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Alain Dervaux, Xavier Laqueille



      PubDate: 2016-08-28T02:56:11Z
       
  • Austerity threatens universal health coverage in Brazil
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Katarzyna Doniec, Rafael Dall'Alba, Lawrence King



      PubDate: 2016-08-28T02:56:11Z
       
  • Prospective Zika virus disease cohort: systematic screening
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Franck de Laval, Séverine Matheus, Marianne Maquart, Emmanuel Yvrard, Nicolas Barthes, Cédric Combes, Dominique Rousset, Isabelle Leparc-Goffart, Sébastien Briolant



      PubDate: 2016-08-28T02:56:11Z
       
  • Scientific Panel for Health: better research for better health
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Karin Sipido, Laurent Degos, Richard Frackowiak, Detlev Ganten, Hans Hofstraat, Ildiko Horvath, Frank Luyten, Michael Manns, Wolfgang Oertel, Tomáš Zima



      PubDate: 2016-08-28T02:56:11Z
       
  • Transparency and availability of data for cancer research
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Joseph R A Fitchett, Nour Sharara, Michael G Head, Franklin Huang, Rifat Atun



      PubDate: 2016-08-28T02:56:11Z
       
  • A medical emergency in Pukapuka
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Robert Beaglehole



      PubDate: 2016-08-28T02:56:11Z
       
  • Alfred George Knudson
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Geoff Watts



      PubDate: 2016-08-28T02:56:11Z
       
  • Increased momentum in antimicrobial resistance research
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Line Matthiessen, Richard Bergström, Shiva Dustdar, Pierre Meulien, Ruxandra Draghia-Akli



      PubDate: 2016-08-28T02:56:11Z
       
  • Voices of invisible women
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Marco De Ambrogi



      PubDate: 2016-08-28T02:56:11Z
       
  • Joanne Liu, MSF International President: a need for greater humanity
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Sarah Boseley



      PubDate: 2016-08-28T02:56:11Z
       
  • Gaps remain in Russia's response to HIV/AIDS
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Fiona Clark



      PubDate: 2016-08-28T02:56:11Z
       
  • Robert Koch's culture tubes
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Bill Bynum, Helen Bynum



      PubDate: 2016-08-28T02:56:11Z
       
  • Nothing new in UK's strategy on childhood obesity
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Tim Lobstein, Klim McPherson



      PubDate: 2016-08-28T02:56:11Z
       
  • US presidential candidates' proposals to reduce drug prices
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Susan Jaffe



      PubDate: 2016-08-28T02:56:11Z
       
  • Dietary guidelines on trial: the charges are not evidence based
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Jim Mann, Lisa Te Morenga, Rachael McLean, Boyd Swinburn, Cliona Ni Mhurchu, Rod Jackson, Jonathan Kennedy, Robert Beaglehole



      PubDate: 2016-08-28T02:56:11Z
       
  • Zika and histopathology in first trimester infections
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Drucilla J Roberts, Matthew P Frosch



      PubDate: 2016-08-28T02:56:11Z
       
  • Weight loss diet studies: we need help not hype
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Yoni Freedhoff, Kevin D Hall



      PubDate: 2016-08-28T02:56:11Z
       
  • Antidepressants fail, but no cause for therapeutic gloom
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Jon Jureidini



      PubDate: 2016-08-28T02:56:11Z
       
  • Surveillance of Zika virus infection and microcephaly in Brazil
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Jörg Heukelbach, Guilherme Loureiro Werneck



      PubDate: 2016-08-28T02:56:11Z
       
  • Global dissemination and implementation of behavioural activation
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Jonathan W Kanter, Ajeng J Puspitasari



      PubDate: 2016-08-28T02:56:11Z
       
  • Unfinished business: women's health inequality in the USA
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): The Lancet



      PubDate: 2016-08-28T02:56:11Z
       
  • Torture and ill treatment in Syria's prisons
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): The Lancet



      PubDate: 2016-08-28T02:56:11Z
       
  • UK Government won't step up to the plate on childhood obesity
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): The Lancet



      PubDate: 2016-08-28T02:56:11Z
       
  • Pathology of congenital Zika syndrome in Brazil: a case series
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Roosecelis Brasil Martines, Julu Bhatnagar, Ana Maria de Oliveira Ramos, Helaine Pompeia Freire Davi, Silvia D'Andretta Iglezias, Cristina Takami Kanamura, M Kelly Keating, Gillian Hale, Luciana Silva-Flannery, Atis Muehlenbachs, Jana Ritter, Joy Gary, Dominique Rollin, Cynthia S Goldsmith, Sarah Reagan-Steiner, Yokabed Ermias, Tadaki Suzuki, Kleber G Luz, Wanderson Kleber de Oliveira, Robert Lanciotti, Amy Lambert, Wun-Ju Shieh, Sherif R Zaki
      Background Zika virus is an arthropod-borne virus that is a member of the family Flaviviridae transmitted mainly by mosquitoes of the genus Aedes. Although usually asymptomatic, infection can result in a mild and self-limiting illness characterised by fever, rash, arthralgia, and conjunctivitis. An increase in the number of children born with microcephaly was noted in 2015 in regions of Brazil with high transmission of Zika virus. More recently, evidence has been accumulating supporting a link between Zika virus and microcephaly. Here, we describe findings from three fatal cases and two spontaneous abortions associated with Zika virus infection. Methods In this case series, formalin-fixed paraffin-embedded tissue samples from five cases, including two newborn babies with microcephaly and severe arthrogryposis who died shortly after birth, one 2-month-old baby, and two placentas from spontaneous abortions, from Brazil were submitted to the Infectious Diseases Pathology Branch at the US Centers for Disease Control and Prevention (Atlanta, GA, USA) between December, 2015, and March, 2016. Specimens were assessed by histopathological examination, immunohistochemical assays using a mouse anti-Zika virus antibody, and RT-PCR assays targeting the NS5 and envelope genes. Amplicons of RT-PCR positive cases were sequenced for characterisation of strains. Findings Viral antigens were localised to glial cells and neurons and associated with microcalcifications in all three fatal cases with microcephaly. Antigens were also seen in chorionic villi of one of the first trimester placentas. Tissues from all five cases were positive for Zika virus RNA by RT-PCR, and sequence analyses showed highest identities with Zika virus strains isolated from Brazil during 2015. Interpretation These findings provide strong evidence of a link between Zika virus infection and different congenital central nervous system malformations, including microcephaly as well as arthrogryposis and spontaneous abortions. Funding None.


      PubDate: 2016-08-28T02:56:11Z
       
  • Multiple enchondromas and skin angiomas: Maffucci syndrome
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Vincenzo Maione, Giuseppe Stinco, Enzo Errichetti



      PubDate: 2016-08-28T02:56:11Z
       
  • Hyperthyroidism
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Simone De Leo, Sun Y Lee, Lewis E Braverman
      Hyperthyroidism is characterised by increased thyroid hormone synthesis and secretion from the thyroid gland, whereas thyrotoxicosis refers to the clinical syndrome of excess circulating thyroid hormones, irrespective of the source. The most common cause of hyperthyroidism is Graves' disease, followed by toxic nodular goitre. Other important causes of thyrotoxicosis include thyroiditis, iodine-induced and drug-induced thyroid dysfunction, and factitious ingestion of excess thyroid hormones. Treatment options for Graves' disease include antithyroid drugs, radioactive iodine therapy, and surgery, whereas antithyroid drugs are not generally used long term in toxic nodular goitre, because of the high relapse rate of thyrotoxicosis after discontinuation. β blockers are used in symptomatic thyrotoxicosis, and might be the only treatment needed for thyrotoxicosis not caused by excessive production and release of the thyroid hormones. Thyroid storm and hyperthyroidism in pregnancy and during the post-partum period are special circumstances that need careful assessment and treatment.


      PubDate: 2016-08-28T02:56:11Z
       
  • The frontotemporal dementia-motor neuron disease continuum
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): James R Burrell, Glenda M Halliday, Jillian J Kril, Lars M Ittner, Jürgen Götz, Matthew C Kiernan, John R Hodges
      Early reports of cognitive and behavioural deficits in motor neuron disease might have been overlooked initially, but the concept of a frontotemporal dementia-motor neuron disease continuum has emerged during the past decade. Frontotemporal dementia-motor neuron disease is now recognised as an important dementia syndrome, which presents substantial challenges for diagnosis and management. Frontotemporal dementia, motor neuron disease, and frontotemporal dementia-motor neuron disease are characterised by overlapping patterns of TAR DNA binding protein (TDP-43) pathology, while the chromosome 9 open reading frame 72 (C9orf72) repeat expansion is common across the disease spectrum. Indeed, the C9orf72 repeat expansion provides important clues to disease pathogenesis and suggests potential therapeutic targets. Variable diagnostic criteria identify motor, cognitive, and behavioural deficits, but further refinement is needed to define the clinical syndromes encountered in frontotemporal dementia-motor neuron disease.


      PubDate: 2016-08-28T02:56:11Z
       
  • The ethics of expanding access to cheaper, less effective treatments
    • Abstract: Publication date: 27 August–2 September 2016
      Source:The Lancet, Volume 388, Issue 10047
      Author(s): Govind C Persad, Ezekiel J Emanuel



      PubDate: 2016-08-28T02:56:11Z
       
  • Lung cancer: current therapies and new targeted treatments
    • Abstract: Publication date: Available online 27 August 2016
      Source:The Lancet
      Author(s): Fred R Hirsch, Giorgio V Scagliotti, James L Mulshine, Regina Kwon, Walter J Curran, Yi-Long Wu, Luis Paz-Ares
      Lung cancer is the most frequent cause of cancer-related deaths worldwide. Every year, 1·8 million people are diagnosed with lung cancer, and 1·6 million people die as a result of the disease. 5-year survival rates vary from 4–17% depending on stage and regional differences. In this Seminar, we discuss existing treatment for patients with lung cancer and the promise of precision medicine, with special emphasis on new targeted therapies. Some subgroups, eg—patients with poor performance status and elderly patients—are not specifically addressed, because these groups require special treatment considerations and no frameworks have been established in terms of new targeted therapies. We discuss prevention and early detection of lung cancer with an emphasis on lung cancer screening. Although we acknowledge the importance of smoking prevention and cessation, this is a large topic beyond the scope of this Seminar.


      PubDate: 2016-08-28T02:56:11Z
       
  • Face transplant: long-term follow-up and results of a prospective open
           study
    • Abstract: Publication date: Available online 25 August 2016
      Source:The Lancet
      Author(s): Laurent Lantieri, Philippe Grimbert, Nicolas Ortonne, Caroline Suberbielle, Dominique Bories, Salvador Gil-Vernet Cebrián, Cédric Lemogne, Frank Bellivier, Jean Pascal Lefaucheur, Nathaniel Schaffer, Fréderic Martin, Jean Paul Meningaud, Pierre Wolkenstein, Mikael Hivelin
      Background More than 30 face transplantations have been done worldwide since 2005 but no documented long-term follow-up has been reported in the literature. We aimed to answer remaining question about the long-term risks and benefits of face transplant. Methods In this single-centre, prospective, open study, we assessed 20 patients presenting with facial defects. Ten patients were selected, and, after three were secondarily excluded, seven were transplanted: two with neurofibromatosis 1, one with a burn, and four with self-inflicted facial gunshot injuries. We report the long-term outcomes of six face allotransplant recipients at an average of 6 years (range 3·4–9 years) after the transplantation. All admissions to hospital except for planned revisions and immunosuppressive follow-up therapy were reported as adverse events (safety endpoint). Predefined immunological, metabolic, surgical, and social integration endpoints were collected prospectively. Patients underwent quantitative health-related quality of life assessments through Short Form 36 health questionnaires. This study was registered with ClinicalTrials.gov, number NCT00527280. Findings Two of seven patients died: one at 65 days due to transplant destruction with concomitant pseudomonas infection and the second at 3·4 years after transplantation by suicide. The six patients alive at long-term follow-up presented with functional transplants. Safety endpoints were related to infection in the first month, acute rejection from 1 day to 7 years after transplantation, or side-effects of immunosuppressive therapy. Recurrent rejection episodes justified maintenance therapy with high-dose steroids at high levels in all patients at last follow-up, yet none of the patients developed diabetes. Three patients were found to have hypertension with one requiring therapy. All patients had a noticeable reduction in glomerular filtration rate. All recipients and their families accepted their transplant. Improvements in social integration and quality of life were highly variable among the patients and depended on baseline levels and psychiatric comorbidities. Interpretation These long-term results show the crucial effect of patients' social support and pre-existing psychiatric conditions on the risk–benefit ratio of facial transplantation. Careful preoperative patient selection and long-term postoperative follow-up programmes under strict institutional review board controls should be used for any future grafts of this type. Funding Protocole Hospitalier de Recherche Clinique (PHRC) National.


      PubDate: 2016-08-28T02:56:11Z
       
  • Facial transplantation: knowledge arrives, questions remain
    • Abstract: Publication date: Available online 25 August 2016
      Source:The Lancet
      Author(s): J Rodrigo Diaz-Siso, Eduardo D Rodriguez



      PubDate: 2016-08-28T02:56:11Z
       
  • Department of Error
    • Abstract: Publication date: Available online 25 August 2016
      Source:The Lancet




      PubDate: 2016-08-28T02:56:11Z
       
  • Efficacy of infant simulator programmes to prevent teenage pregnancy: a
           school-based cluster randomised controlled trial in Western Australia
    • Abstract: Publication date: Available online 25 August 2016
      Source:The Lancet
      Author(s): Sally A Brinkman, Sarah E Johnson, James P Codde, Michael B Hart, Judith A Straton, Murthy N Mittinty, Sven R Silburn
      Background Infant simulator-based programmes, which aim to prevent teenage pregnancy, are used in high-income as well as low-income and middle-income countries but, despite growing popularity, no published evidence exists of their long-term effect. The aim of this trial was to investigate the effect of such a programme, the Virtual Infant Parenting (VIP) programme, on pregnancy outcomes of birth and induced abortion in Australia. Methods In this school-based pragmatic cluster randomised controlled trial, eligible schools in Perth, Western Australia, were enrolled and randomised 1:1 to the intervention and control groups. Randomisation using a table of random numbers without blocking, stratification, or matching was done by a researcher who was masked to the identity of the schools. Between 2003 and 2006, the VIP programme was administered to girls aged 13–15 years in the intervention schools, while girls of the same age in the control schools received the standard health education curriculum. Participants were followed until they reached 20 years of age via data linkage to hospital medical and abortion clinic records. The primary endpoint was the occurrence of pregnancy during the teenage years. Binomial and Cox proportional hazards regression was used to test for differences in pregnancy rates between study groups. This study is registered as an international randomised controlled trial, number ISRCTN24952438. Findings 57 (86%) of 66 eligible schools were enrolled into the trial and randomly assigned 1:1 to the intervention (28 schools) or the control group (29 schools). Then, between Feb 1, 2003, and May 31, 2006, 1267 girls in the intervention schools received the VIP programme while 1567 girls in the control schools received the standard health education curriculum. Compared with girls in the control group, a higher proportion of girls in the intervention group recorded at least one birth (97 [8%] of 1267 in the intervention group vs 67 [4%] of 1567 in the control group) or at least one abortion as the first pregnancy event (113 [9%] vs 101 [6%]). After adjustment for potential confounders, the intervention group had a higher overall pregnancy risk than the control group (relative risk 1·36 [95% CI 1·10–1·67], p=0·003). Similar results were obtained with the use of proportional hazard models (hazard ratio 1·35 [95% CI 1·10–1·67], p=0·016). Interpretation The infant simulator-based VIP programme did not achieve its aim of reducing teenage pregnancy. Girls in the intervention group were more likely to experience a birth or an induced abortion than those in the control group before they reached 20 years of age. Funding The Health Promotion Research Foundation of Western Australia (Healthway), Lotteries WA, the Western Australian Department of Education and Training, and the Western Australian Department of Health.


      PubDate: 2016-08-28T02:56:11Z
       
  • Spontaneous bacterial peritonitis
    • Abstract: Publication date: Available online 25 August 2016
      Source:The Lancet
      Author(s): Burcin Ekser, Richard S Mangus



      PubDate: 2016-08-28T02:56:11Z
       
  • Magic dolls: no quick fix for teenage pregnancy
    • Abstract: Publication date: Available online 25 August 2016
      Source:The Lancet
      Author(s): Julie A Quinlivan



      PubDate: 2016-08-28T02:56:11Z
       
  • Gemcitabine: a game changer in nasopharyngeal carcinoma
    • Abstract: Publication date: Available online 23 August 2016
      Source:The Lancet
      Author(s): Melvin L K Chua, Anthony T C Chan



      PubDate: 2016-08-28T02:56:11Z
       
  • Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent
           or metastatic nasopharyngeal carcinoma: a multicentre, randomised,
           open-label, phase 3 trial
    • Abstract: Publication date: Available online 23 August 2016
      Source:The Lancet
      Author(s): Li Zhang, Yan Huang, Shaodong Hong, Yunpeng Yang, Gengsheng Yu, Jun Jia, Peijian Peng, Xuan Wu, Qing Lin, Xuping Xi, Jiewen Peng, Mingjun Xu, Dongping Chen, Xiaojun Lu, Rensheng Wang, Xiaolong Cao, Xiaozhong Chen, Zhixiong Lin, Jianping Xiong, Qin Lin, Conghua Xie, Zhihua Li, Jianji Pan, Jingao Li, Shixiu Wu, Yingni Lian, Quanlie Yang, Chong Zhao
      Background Outcomes are poor for patients with recurrent or metastatic nasopharyngeal carcinoma and no well established first-line chemotherapy is available for the disease. We compared the efficacy and safety of gemcitabine plus cisplatin versus fluorouracil plus cisplatin in patients with recurrent or metastatic nasopharyngeal carcinoma. Methods In this multicentre, randomised, open-label, phase 3 trial, patients with recurrent or metastatic nasopharyngeal carcinoma were recruited from 22 hospitals in China. Key inclusion criteria were Eastern Cooperative Oncology Group performance status of 0 or 1, adequate organ function, and measurable lesions according to Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned in a 1:1 ratio to receive either gemcitabine (1 g/m2 intravenously on days 1 and 8) and cisplatin (80 mg/m2 intravenously on day 1), or fluorouracil (4 g/m2 in continuous intravenous infusion over 96 h) and cisplatin (80 mg/m2 on day 1 given intravenously) once every 3 weeks for a maximum of six cycles. The randomisation was done centrally via an interactive phone response system using block randomisation with a size of six. The primary endpoint was progression-free survival assessed by the independent image committee in the intention-to-treat population. Safety analyses were done in patients who received at least one cycle of study drug. This study is ongoing and is registered with ClinicalTrials.gov, number NCT01528618. Findings Between Feb 20, 2012, and Oct 30, 2015, 362 patients were randomly assigned to a group (181 to the gemcitabine [plus cisplatin] group and 181 to the fluorouracil [plus cisplatin] group). Median follow-up time for progression-free survival was 19·4 months (IQR 12·1–35·6). The median progression-free survival was 7·0 months (4·4–10·9) in the gemcitabine group and 5·6 months (3·0–7·0) in the fluorouracil group (hazard ratio [HR] 0·55 [95% CI 0·44–0·68]; p<0·0001). A total of 180 patients in the gemcitabine group and 173 patients in the fluorouracil group were included in the safety analysis. Significantly different treatment-related grade 3 or 4 adverse events between the gemcitabine and fluorouracil groups were leucopenia (52 [29%] vs 15 [9%]; <0·0001), neutropenia (41 [23%] vs 23 [13%]; p=0·0251), thrombocytopenia (24 [13%] vs three [2%]; p=0·0007), and mucosal inflammation (0 vs 25 [14%]; <0·0001). Serious treatment-related adverse events occurred in seven (4%) patients in the gemcitabine group and ten (6%) in the fluorouracil group. Six (3%) patients in the gemcitabine group and 14 (8%) patients in the fluorouracil group discontinued treatment because of drug-related adverse events. No treatment-related deaths occurred in either group. Interpretation Gemcitabine plus cisplatin prolongs progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma. The results establish gemcitabine plus cisplatin as the standard first-line treatment option for this population. Funding The 5010 Clinical Research Foundation of Sun Yat-sen University.


      PubDate: 2016-08-28T02:56:11Z
       
  • Department of Error
    • Abstract: Publication date: Available online 23 August 2016
      Source:The Lancet




      PubDate: 2016-08-28T02:56:11Z
       
  • BMI and mortality: the limits of epidemiological evidence
    • Abstract: Publication date: 20–26 August 2016
      Source:The Lancet, Volume 388, Issue 10046
      Author(s): David Berrigan, Richard P Troiano, Barry I Graubard



      PubDate: 2016-08-22T17:23:58Z
       
  • Age of PISCES: stem-cell clinical trials in stroke
    • Abstract: Publication date: 20–26 August 2016
      Source:The Lancet, Volume 388, Issue 10046
      Author(s): Cesar V Borlongan



      PubDate: 2016-08-22T17:23:58Z
       
  • Stroke is largely preventable across the globe: where to next'
    • Abstract: Publication date: 20–26 August 2016
      Source:The Lancet, Volume 388, Issue 10046
      Author(s): Valery L Feigin, Rita Krishnamurthi



      PubDate: 2016-08-22T17:23:58Z
       
  • Atrial fibrillation and stroke: unrecognised and undertreated
    • Abstract: Publication date: 20–26 August 2016
      Source:The Lancet, Volume 388, Issue 10046
      Author(s): The Lancet



      PubDate: 2016-08-22T17:23:58Z
       
  • Canada's inquiry into violence toward Indigenous women
    • Abstract: Publication date: 20–26 August 2016
      Source:The Lancet, Volume 388, Issue 10046
      Author(s): The Lancet



      PubDate: 2016-08-22T17:23:58Z
       
  • Health-care crisis in Turkey: urgent actions needed
    • Abstract: Publication date: 20–26 August 2016
      Source:The Lancet, Volume 388, Issue 10046
      Author(s): The Lancet



      PubDate: 2016-08-22T17:23:58Z
       
 
 
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