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Journal Cover The Lancet
  [SJR: 14.638]   [H-I: 600]   [2204 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 0140-6736 - ISSN (Online) 1474-547X
   Published by Elsevier Homepage  [3049 journals]
  • Millions in need of humanitarian assistance in Yemen
    • Authors: Sharmila Devi
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Sharmila Devi


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33250-6
       
  • Hypertension in China: the gap between policy and practice
    • Authors: Therese Hesketh; Xudong Zhou
      Pages: 2529 - 2530
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Therese Hesketh, Xudong Zhou


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32743-5
       
  • Childhood cancer: the long-term costs of cure
    • Authors: Miranda M Fidler; Michael M Hawkins
      Pages: 2530 - 2531
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Miranda M Fidler, Michael M Hawkins


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)31755-5
       
  • A new vision for global health leadership
    • Authors: Michele Barry; Zohray Talib; Ashley Jowell; Kelly Thompson; Cheryl Moyer; Heidi Larson; Katherine Burke
      Pages: 2536 - 2537
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Michele Barry, Zohray Talib, Ashley Jowell, Kelly Thompson, Cheryl Moyer, Heidi Larson, Katherine Burke


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33101-x
       
  • Offline: The tasks facing Dr Tedros
    • Authors: Richard Horton
      First page: 2538
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Richard Horton


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33137-9
       
  • Phage therapy: revival of the bygone antimicrobial
    • Authors: Geoff Watts
      Pages: 2539 - 2540
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Geoff Watts


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33249-x
       
  • Qimin Zhan: driving medical research for better health in China
    • Authors: Rachael Davies
      First page: 2541
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Rachael Davies


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33090-8
       
  • Hospital histories
    • Authors: Margaret McCartney
      First page: 2542
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Margaret McCartney


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33091-x
       
  • Health-care delivery for long-term survivors of childhood cancer
    • Authors: Gregory J Aune
      First page: 2545
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Gregory J Aune


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33081-7
       
  • Political determinants of Sustainable Development Goals
    • Authors: Camila Gianella; Marta Rodriguez de Assis Machado; Siri Gloppen
      Pages: 2545 - 2546
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Camila Gianella, Marta Rodriguez de Assis Machado, Siri Gloppen


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33082-9
       
  • Anonymity in HIV testing: implications for public health
    • Authors: Edson Luis Bernardo; Laura Fuente-Soro; Elisa Lopez-Varela; Denise Naniche
      First page: 2546
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Edson Luis Bernardo, Laura Fuente-Soro, Elisa Lopez-Varela, Denise Naniche


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33083-0
       
  • Overestimation of cardiovascular outcome incidence
    • Authors: Yuanzi Ye; Ricardo Fonseca
      Pages: 2546 - 2547
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Yuanzi Ye, Ricardo Fonseca


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33084-2
       
  • Overestimation of cardiovascular outcome incidence – Authors' reply
    • Authors: Helmut Schumacher; Felix Mahfoud; Michael Böhm
      First page: 2547
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Helmut Schumacher, Felix Mahfoud, Michael Böhm


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33085-4
       
  • Antiplatelet cessation to manage bleeding events in elderly people
    • Authors: Cody Magnusson
      Pages: 2547 - 2548
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Cody Magnusson


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33086-6
       
  • Antiplatelet cessation to manage bleeding events in elderly people –
           Authors' reply
    • Authors: Linxin Li; Peter M Rothwell
      First page: 2548
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Linxin Li, Peter M Rothwell


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33087-8
       
  • Prevalence, awareness, treatment, and control of hypertension in China:
           data from 1·7 million adults in a population-based screening study (China
           PEACE Million Persons Project)
    • Authors: Jiapeng Lu; Yuan Lu; Xiaochen Wang; Xinyue Li; George C Linderman; Chaoqun Wu; Xiuyuan Cheng; Lin Mu; Haibo Zhang; Jiamin Liu; Meng Su; Hongyu Zhao; Erica S Spatz; John A Spertus; Frederick A Masoudi; Harlan M Krumholz; Lixin Jiang
      Pages: 2549 - 2558
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Jiapeng Lu, Yuan Lu, Xiaochen Wang, Xinyue Li, George C Linderman, Chaoqun Wu, Xiuyuan Cheng, Lin Mu, Haibo Zhang, Jiamin Liu, Meng Su, Hongyu Zhao, Erica S Spatz, John A Spertus, Frederick A Masoudi, Harlan M Krumholz, Lixin Jiang
      Background Hypertension is common in China and its prevalence is rising, yet it remains inadequately controlled. Few studies have the capacity to characterise the epidemiology and management of hypertension across many heterogeneous subgroups. We did a study of the prevalence, awareness, treatment, and control of hypertension in China and assessed their variations across many subpopulations. Methods We made use of data generated in the China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Million Persons Project from Sept 15, 2014, to June 20, 2017, a population-based screening project that enrolled around 1·7 million community-dwelling adults aged 35–75 years from all 31 provinces in mainland China. In this population, we defined hypertension as systolic blood pressure of at least 140 mm Hg, or diastolic blood pressure of at least 90 mm Hg, or self-reported antihypertensive medication use in the previous 2 weeks. Hypertension awareness, treatment, and control were defined, respectively, among hypertensive adults as a self-reported diagnosis of hypertension, current use of antihypertensive medication, and blood pressure of less than 140/90 mm Hg. We assessed awareness, treatment, and control in 264 475 population subgroups—defined a priori by all possible combinations of 11 demographic and clinical factors (age [35–44, 45–54, 55–64, and 65–75 years], sex [men and women], geographical region [western, central, and eastern China], urbanity [urban vs rural], ethnic origin [Han and non-Han], occupation [farmer and non-farmer], annual household income [< ¥10 000, ¥10 000–50 000, and ≥¥50 000], education [primary school and below, middle school, high school, and college and above], previous cardiovascular events [yes or no], current smoker [yes or no], and diabetes [yes or no]), and their associations with individual and primary health-care site characteristics, using mixed models. Findings The sample contained 1 738 886 participants with a mean age of 55·6 years (SD 9·7), 59·5% of whom were women. 44·7% (95% CI 44·6–44·8) of the sample had hypertension, of whom 44·7% (44·6–44·8) were aware of their diagnosis, 30·1% (30·0–30·2) were taking prescribed antihypertensive medications, and 7·2% (7·1–7·2) had achieved control. The age-standardised and sex-standardised rates of hypertension prevalence, awareness, treatment, and control were 37·2% (37·1–37·3), 36·0% (35·8–36·2), 22·9% (22·7–23·0), and 5·7% (5·6–5·7), respectively. The most commonly used medication class was calcium-channel blockers (55·2%, 55·0–55·4). Among individuals whose hypertension was treated but not controlled, 81·5% (81·3–81·6) were using only one medication. The proportion of participants who were aware of their hypertension and were receiving treatment varied significantly across subpopulations; lower likelihoods of awareness and treatment were associated with male sex, younger age, lower income, and an absence of previous cardiovascular events, diabetes, obesity, or alcohol use (all p<0·01). By contrast, control rate was universally low across all subgroups (<30·0%). Interpretation Among Chinese adults aged 35–75 years, nearly half have hypertension, fewer than a third are being treated, and fewer than one in twelve are in control of their blood pressure. The low number of people in control is ubiquitous in all subgroups of the Chinese population and warrants broad-based, global strategy, such as greater efforts in prevention, as well as better screening and more effective and affordable treatment. Funding Ministry of Finance and National Health and Family Planning Commission, China.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32478-9
       
  • Availability, cost, and prescription patterns of antihypertensive
           medications in primary health care in China: a nationwide cross-sectional
           survey
    • Authors: Meng Su; Qiuli Zhang; Xueke Bai; Chaoqun Wu; Yetong Li; Elias Mossialos; George A Mensah; Frederick A Masoudi; Jiapeng Lu; Xi Li; Sebastian Salas-Vega; Anwen Zhang; Yuan Lu; Khurram Nasir; Harlan M Krumholz; Lixin Jiang
      Pages: 2559 - 2568
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Meng Su, Qiuli Zhang, Xueke Bai, Chaoqun Wu, Yetong Li, Elias Mossialos, George A Mensah, Frederick A Masoudi, Jiapeng Lu, Xi Li, Sebastian Salas-Vega, Anwen Zhang, Yuan Lu, Khurram Nasir, Harlan M Krumholz, Lixin Jiang
      Background Around 200 million adults in China have hypertension, but few are treated or achieve adequate control of their blood pressure. Available and affordable medications are important for successfully controlling hypertension, but little is known about current patterns of access to, and use of, antihypertensive medications in Chinese primary health care. Methods We used data from a nationwide cross-sectional survey (the China Patient-Centered Evaluative Assessment of Cardiac Events Million Persons Project primary health care survey), which was undertaken between November, 2016 and May, 2017, to assess the availability, cost, and prescription patterns of 62 antihypertensive medications at primary health-care sites across 31 Chinese provinces. We surveyed 203 community health centres, 401 community health stations, 284 township health centres, and 2474 village clinics to assess variation in availability, cost, and prescription by economic region and type of site. We also assessed the use of high-value medications, defined as guideline-recommended and low-cost. We also examined the association of medication cost with availability and prescription patterns. Findings Our study sample included 3362 primary health-care sites and around 1 million people (613 638 people at 2758 rural sites and 478 393 people at 604 urban sites). Of the 3362 sites, 8·1% (95% CI 7·2–9·1) stocked no antihypertensive medications and 33·8% (32·2–35·4) stocked all four classes that were routinely used. Village clinics and sites in the western region of China had the lowest availability. Only 32·7% (32·2–33·3) of all sites stocked high-value medications, and few high-value medications were prescribed (11·2% [10·9–11·6] of all prescription records). High-cost medications were more likely to be prescribed than low-cost alternatives. Interpretation China has marked deficiencies in the availability, cost, and prescription of antihypertensive medications. High-value medications are not preferentially used. Future efforts to reduce the burden of hypertension, particularly through the work of primary health-care providers, will need to improve access to, and use of, antihypertensive medications, paying particular attention to those with high value. Funding CAMS Innovation Fund for Medical Science, the Entrusted Project from the China National Development and Reform Commission, and the Major Public Health Service Project from the Ministry of Finance of China and National Health and Family Planning Commission of China.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32476-5
       
  • The cumulative burden of surviving childhood cancer: an initial report
           from the St Jude Lifetime Cohort Study (SJLIFE)
    • Authors: Nickhill Bhakta; Qi Liu; Kirsten K Ness; Malek Baassiri; Hesham Eissa; Frederick Yeo; Wassim Chemaitilly; Matthew J Ehrhardt; Johnnie Bass; Michael W Bishop; Kyla Shelton; Lu Lu; Sujuan Huang; Zhenghong Li; Eric Caron; Jennifer Lanctot; Carrie Howell; Timothy Folse; Vijaya Joshi; Daniel M Green; Daniel A Mulrooney; Gregory T Armstrong; Kevin R Krull; Tara M Brinkman; Raja B Khan; Deo K Srivastava; Melissa M Hudson; Yutaka Yasui; Leslie L Robison
      Pages: 2569 - 2582
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Nickhill Bhakta, Qi Liu, Kirsten K Ness, Malek Baassiri, Hesham Eissa, Frederick Yeo, Wassim Chemaitilly, Matthew J Ehrhardt, Johnnie Bass, Michael W Bishop, Kyla Shelton, Lu Lu, Sujuan Huang, Zhenghong Li, Eric Caron, Jennifer Lanctot, Carrie Howell, Timothy Folse, Vijaya Joshi, Daniel M Green, Daniel A Mulrooney, Gregory T Armstrong, Kevin R Krull, Tara M Brinkman, Raja B Khan, Deo K Srivastava, Melissa M Hudson, Yutaka Yasui, Leslie L Robison
      Background Survivors of childhood cancer develop early and severe chronic health conditions (CHCs). A quantitative landscape of morbidity of survivors, however, has not been described. We aimed to describe the cumulative burden of curative cancer therapy in a clinically assessed ageing population of long-term survivors of childhood cancer. Methods The St Jude Lifetime Cohort Study (SJLIFE) retrospectively collected data on CHCs in all patients treated for childhood cancer at the St Jude Children's Research Hospital who survived 10 years or longer from initial diagnosis and were 18 years or older as of June 30, 2015. Age-matched and sex-frequency-matched community controls were used for comparison. 21 treatment exposure variables were included in the analysis, with data abstracted from medical records. 168 CHCs for all participants were graded for severity using a modified Common Terminology Criteria of Adverse Events. Multiple imputation with predictive mean matching was used for missing occurrences and grades of CHCs in the survivors who were not clinically evaluable. Mean cumulative count was used for descriptive cumulative burden analysis and marked-point-process regression was used for inferential cumulative burden analysis. Findings Of 5522 patients treated for childhood cancer at St Jude Children's Research Hospital who had complete records, survived 10 years or longer, and were 18 years or older at time of study, 3010 (54·5%) were alive, had enrolled, and had had prospective clinical assessment. 2512 (45·5%) of the 5522 patients were not clinically evaluable. The cumulative incidence of CHCs at age 50 years was 99·9% (95% CI 99·9–99·9) for grade 1–5 CHCs and 96·0% (95% CI 95·3–96·8%) for grade 3–5 CHCs. By age 50 years, a survivor had experienced, on average, 17·1 (95% CI 16·2–18·1) CHCs of any grade, of which 4·7 (4·6–4·9) were CHCs of grade 3–5. The cumulative burden in matched community controls of grade 1–5 CHCs was 9·2 (95% CI 7·9–10·6; p<0·0001 vs total study population) and of grade 3–5 CHCs was 2·3 (1·9–2·7, p<0·0001 vs total study population). Second neoplasms, spinal disorders, and pulmonary disease were major contributors to the excess total cumulative burden. Notable heterogeneity in the distribution of CHC burden in survivors with differing primary cancer diagnoses was observed. The cumulative burden of grade 1–5 CHCs at age 50 years was highest in survivors of CNS malignancies (24·2 [95% CI 20·9–27·5]) and lowest in survivors of germ cell tumours (14·0 [11·5–16·6]). Multivariable analyses showed that older age at diagnosis, treatment era, and higher doses of brain and chest radiation are significantly associated with a greater cumulative burden and severity of CHCs. Interpretation The burden of CHCs in survivors of childhood cancer is substantial and highly variable. Our assessment of total cumulative burden in survivors of paediatric cancer, with detailed characterisation of long-term CHCs, provide data to better inform future clinical guidelines, research investigations, and health services planning for this vulnerable, medically complex population. Funding The US National Cancer Institute, St Baldrick's Foundation, and the American Lebanese Syrian Associated Charities.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)31610-0
       
  • Vanishing lung syndrome: giant bullous emphysema
    • Authors: Peter Davies; Christine Bradley
      First page: 2583
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Peter Davies, Christine Bradley


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32246-8
       
  • The primary health-care system in China
    • Authors: Xi Li; Jiapeng Lu; Shuang Hu; KK Cheng; Jan De Maeseneer; Qingyue Meng; Elias Mossialos; Dong Roman Xu; Winnie Yip; Hongzhao Zhang; Harlan M Krumholz; Lixin Jiang; Shengshou Hu
      Pages: 2584 - 2594
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Xi Li, Jiapeng Lu, Shuang Hu, KK Cheng, Jan De Maeseneer, Qingyue Meng, Elias Mossialos, Dong Roman Xu, Winnie Yip, Hongzhao Zhang, Harlan M Krumholz, Lixin Jiang, Shengshou Hu
      China has made remarkable progress in strengthening its primary health-care system. Nevertheless, the system still faces challenges in structural characteristics, incentives and policies, and quality of care, all of which diminish its preparedness to care for a fifth of the world's population, which is ageing and which has a growing prevalence of chronic non-communicable disease. These challenges include inadequate education and qualifications of its workforce, ageing and turnover of village doctors, fragmented health information technology systems, a paucity of digital data on everyday clinical practice, financial subsidies and incentives that do not encourage cost savings and good performance, insurance policies that hamper the efficiency of care delivery, an insufficient quality measurement and improvement system, and poor performance in the control of risk factors (such as hypertension and diabetes). As China deepens its health-care reform, it has the opportunity to build an integrated, cooperative primary health-care system, generating knowledge from practice that can support improvements, and bolstered by evidence-based performance indicators and incentives.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33109-4
       
  • China's Silk Road and global health
    • Authors: Kun Tang; Zhihui Li; Wenkai Li; Lincoln Chen
      Pages: 2595 - 2601
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Kun Tang, Zhihui Li, Wenkai Li, Lincoln Chen
      In 2013, China proposed its Belt and Road Initiative to promote trade, infrastructure, and commercial associations with 65 countries in Asia, Africa, and Europe. This initiative contains important health components. Simultaneously, China launched an unprecedented overseas intervention against Ebola virus in west Africa, dispatching 1200 workers, including Chinese military personnel. The overseas development assistance provided by China has been increasing by 25% annually, reaching US$7 billion in 2013. Development assistance for health from China has particularly been used to develop infrastructure and provide medical supplies to Africa and Asia. China's contributions to multilateral organisations are increasing but are unlikely to bridge substantial gaps, if any, vacated by other donors; China is creating its own multilateral funds and banks and challenging the existing global architecture. These new investment vehicles are more aligned with the geography and type of support of the Belt and Road Initiative. Our analysis concludes that China's Belt and Road Initiative, Ebola response, development assistance for health, and new investment funds are complementary and reinforcing, with China shaping a unique global engagement impacting powerfully on the contours of global health.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32898-2
       
  • The need for a complex systems model of evidence for public health
    • Authors: Harry Rutter; Natalie Savona; Ketevan Glonti; Jo Bibby; Steven Cummins; Diane T Finegood; Felix Greaves; Laura Harper; Penelope Hawe; Laurence Moore; Mark Petticrew; Eva Rehfuess; Alan Shiell; James Thomas; Martin White
      Pages: 2602 - 2604
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Harry Rutter, Natalie Savona, Ketevan Glonti, Jo Bibby, Steven Cummins, Diane T Finegood, Felix Greaves, Laura Harper, Penelope Hawe, Laurence Moore, Mark Petticrew, Eva Rehfuess, Alan Shiell, James Thomas, Martin White


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)31267-9
       
  • Family planning: accelerating the way ahead
    • Authors: Lancet
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): The Lancet


      PubDate: 2017-12-11T07:10:35Z
       
  • Putting research evidence at the heart of policy making
    • Authors: Lancet
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): The Lancet


      PubDate: 2017-12-11T07:10:35Z
       
  • When a hospital becomes a prison
    • Authors: Lancet
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): The Lancet


      PubDate: 2017-12-11T07:10:35Z
       
  • Icarus
    • Authors: Athar Yawar
      Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112
      Author(s): Athar Yawar


      PubDate: 2017-12-11T07:10:35Z
       
  • Department of Error
    • Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112


      PubDate: 2017-12-11T07:10:35Z
       
  • Department of Error
    • Abstract: Publication date: 9–15 December 2017
      Source:The Lancet, Volume 390, Issue 10112


      PubDate: 2017-12-11T07:10:35Z
       
  • Osman Sankoh: better data for better health
    • Authors: Geoff Watts
      Abstract: Publication date: Available online 8 December 2017
      Source:The Lancet
      Author(s): Geoff Watts


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33252-x
       
  • Department of Error
    • Abstract: Publication date: Available online 7 December 2017
      Source:The Lancet


      PubDate: 2017-12-11T07:10:35Z
       
  • Improving access to psychological therapies in England
    • Authors: Graham Thornicroft
      Abstract: Publication date: Available online 7 December 2017
      Source:The Lancet
      Author(s): Graham Thornicroft


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32158-x
       
  • Transparency about the outcomes of mental health services (IAPT approach):
           an analysis of public data
    • Authors: David M Clark; Lauren Canvin; John Green; Richard Layard; Stephen Pilling; Magdalena Janecka
      Abstract: Publication date: Available online 7 December 2017
      Source:The Lancet
      Author(s): David M Clark, Lauren Canvin, John Green, Richard Layard, Stephen Pilling, Magdalena Janecka
      Background Internationally, the clinical outcomes of routine mental health services are rarely recorded or reported; however, an exception is the English Improving Access to Psychological Therapies (IAPT) service, which delivers psychological therapies recommended by the National Institute for Health and Care Excellence for depression and anxiety disorders to more than 537 000 patients in the UK each year. A session-by-session outcome monitoring system ensures that IAPT obtains symptom scores before and after treatment for 98% of patients. Service outcomes can then be reported, along with contextual information, on public websites. Methods We used publicly available data to identify predictors of variability in clinical performance. Using β regression models, we analysed the outcome data released by National Health Service Digital and Public Health England for the 2014–15 financial year (April 1, 2014, to March 31, 2015) and developed a predictive model of reliable improvement and reliable recovery. We then tested whether these predictors were also associated with changes in service outcome between 2014–15 and 2015–16. Findings Five service organisation features predicted clinical outcomes in 2014–15. Percentage of cases with a problem descriptor, number of treatment sessions, and percentage of referrals treated were positively associated with outcome. The time waited to start treatment and percentage of appointments missed were negatively associated with outcome. Additive odd ratios suggest that moving from the lowest to highest level on an organisational factor could improve service outcomes by 11–42%, dependent on the factor. Consistent with a causal model, most organisational factors also predicted between-year changes in outcome, together accounting for 33% of variance in reliable improvement and 22% for reliable recovery. Social deprivation was negatively associated with some outcomes, but the effect was partly mitigated by the organisational factors. Interpretation Traditionally, efforts to improve mental health outcomes have largely focused on the development of new and more effective treatments. Our analyses show that the way psychological therapy services are implemented could be similarly important. Mental health services elsewhere in the UK and in other countries might benefit from adopting IAPT's approach to recording and publicly reporting clinical outcomes. Funding Wellcome Trust.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32133-5
       
  • Department of Error
    • Abstract: Publication date: Available online 7 December 2017
      Source:The Lancet


      PubDate: 2017-12-11T07:10:35Z
       
  • Atraumatic versus conventional lumbar puncture needles: a systematic
           review and meta-analysis
    • Authors: Siddharth Nath; Alex Koziarz; Jetan H Badhiwala; Waleed Alhazzani; Roman Jaeschke; Sunjay Sharma; Laura Banfield; Ashkan Shoamanesh; Sheila Singh; Farshad Nassiri; Wieslaw Oczkowski; Emilie Belley-Côté; Ray Truant; Kesava Reddy; Maureen O Meade; Forough Farrokhyar; Malgorzata M Bala; Fayez Alshamsi; Mette Krag; Itziar Etxeandia-Ikobaltzeta; Regina Kunz; Osamu Nishida; Charles Matouk; Magdy Selim; Andrew Rhodes; Gregory Hawryluk; Saleh A Almenawer
      Abstract: Publication date: Available online 7 December 2017
      Source:The Lancet
      Author(s): Siddharth Nath, Alex Koziarz, Jetan H Badhiwala, Waleed Alhazzani, Roman Jaeschke, Sunjay Sharma, Laura Banfield, Ashkan Shoamanesh, Sheila Singh, Farshad Nassiri, Wieslaw Oczkowski, Emilie Belley-Côté, Ray Truant, Kesava Reddy, Maureen O Meade, Forough Farrokhyar, Malgorzata M Bala, Fayez Alshamsi, Mette Krag, Itziar Etxeandia-Ikobaltzeta, Regina Kunz, Osamu Nishida, Charles Matouk, Magdy Selim, Andrew Rhodes, Gregory Hawryluk, Saleh A Almenawer
      Background Atraumatic needles have been proposed to lower complication rates after lumbar puncture. However, several surveys indicate that clinical adoption of these needles remains poor. We did a systematic review and meta-analysis to compare patient outcomes after lumbar puncture with atraumatic needles and conventional needles. Methods In this systematic review and meta-analysis, we independently searched 13 databases with no language restrictions from inception to Aug 15, 2017, for randomised controlled trials comparing the use of atraumatic needles and conventional needles for any lumbar puncture indication. Randomised trials comparing atraumatic and conventional needles in which no dural puncture was done (epidural injections) or without a conventional needle control group were excluded. We screened studies and extracted data from published reports independently. The primary outcome of postdural-puncture headache incidence and additional safety and efficacy outcomes were assessed by random-effects and fixed-effects meta-analysis. This study is registered with the International Prospective Register of Systematic Reviews, number CRD42016047546. Findings We identified 20 241 reports; after exclusions, 110 trials done between 1989 and 2017 from 29 countries, including a total of 31 412 participants, were eligible for analysis. The incidence of postdural-puncture headache was significantly reduced from 11·0% (95% CI 9·1–13·3) in the conventional needle group to 4·2% (3·3–5·2) in the atraumatic group (relative risk 0·40, 95% CI 0·34–0·47, p<0·0001; I 2=45·4%). Atraumatic needles were also associated with significant reductions in the need for intravenous fluid or controlled analgesia (0·44, 95% CI 0·29–0·64; p<0·0001), need for epidural blood patch (0·50, 0·33–0·75; p=0·001), any headache (0·50, 0·43–0·57; p<0·0001), mild headache (0·52, 0·38–0·70; p<0·0001), severe headache (0·41, 0·28–0·59; p<0·0001), nerve root irritation (0·71, 0·54–0·92; p=0·011), and hearing disturbance (0·25, 0·11–0·60; p=0·002). Success of lumbar puncture on first attempt, failure rate, mean number of attempts, and the incidence of traumatic tap and backache did not differ significantly between the two needle groups. Prespecified subgroup analyses of postdural-puncture headache revealed no interactions between needle type and patient age, sex, use of prophylactic intravenous fluid, needle gauge, patient position, indication for lumbar puncture, bed rest after puncture, or clinician specialty. These results were rated high-quality evidence as examined using the grading of recommendations assessment, development, and evaluation. Interpretation Among patients who had lumbar puncture, atraumatic needles were associated with a decrease in the incidence of postdural-puncture headache and in the need for patients to return to hospital for additional therapy, and had similar efficacy to conventional needles. These findings offer clinicians and stakeholders a comprehensive assessment and high-quality evidence for the safety and efficacy of atraumatic needles as a superior option for patients who require lumbar puncture. Funding None.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32451-0
       
  • Atraumatic lumbar puncture needles: practice needs to change
    • Authors: Diederik van de Beek; Matthijs C Brouwer
      Abstract: Publication date: Available online 7 December 2017
      Source:The Lancet
      Author(s): Diederik van de Beek, Matthijs C Brouwer


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32480-7
       
  • Department of Error
    • Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet


      PubDate: 2017-12-11T07:10:35Z
       
  • Walking to a pathway for cardiovascular effects of air pollution
    • Authors: George D Thurston; Jonathan D Newman
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): George D Thurston, Jonathan D Newman


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33078-7
       
  • Respiratory and cardiovascular responses to walking down a
           traffic-polluted road compared with walking in a traffic-free area in
           participants aged 60 years and older with chronic lung or heart disease
           and age-matched healthy controls: a randomised, crossover study
    • Authors: Rudy Sinharay; Jicheng Gong; Benjamin Barratt; Pamela Ohman-Strickland; Sabine Ernst; Frank Kelly; Junfeng (Jim) Zhang; Peter Collins; Paul Cullinan; Kian Fan Chung
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Rudy Sinharay, Jicheng Gong, Benjamin Barratt, Pamela Ohman-Strickland, Sabine Ernst, Frank Kelly, Junfeng (Jim) Zhang, Peter Collins, Paul Cullinan, Kian Fan Chung
      Background Long-term exposure to pollution can lead to an increase in the rate of decline of lung function, especially in older individuals and in those with chronic obstructive pulmonary disease (COPD), whereas shorter-term exposure at higher pollution levels has been implicated in causing excess deaths from ischaemic heart disease and exacerbations of COPD. We aimed to assess the effects on respiratory and cardiovascular responses of walking down a busy street with high levels of pollution compared with walking in a traffic-free area with lower pollution levels in older adults. Methods In this randomised, crossover study, we recruited men and women aged 60 years and older with angiographically proven stable ischaemic heart disease or stage 2 Global initiative for Obstructive Lung Disease (GOLD) COPD who had been clinically stable for 6 months, and age-matched healthy volunteers. Individuals with ischaemic heart disease or COPD were recruited from existing databases or outpatient respiratory and cardiology clinics at the Royal Brompton & Harefield NHS Foundation Trust and age-matched healthy volunteers using advertising and existing databases. All participants had abstained from smoking for at least 12 months and medications were taken as recommended by participants' doctors during the study. Participants were randomly assigned by drawing numbered disks at random from a bag to do a 2 h walk either along a commercial street in London (Oxford Street) or in an urban park (Hyde Park). Baseline measurements of participants were taken before the walk in the hospital laboratory. During each walk session, black carbon, particulate matter (PM) concentrations, ultrafine particles, and nitrogen dioxide (NO2) concentrations were measured. Findings Between October, 2012, and June, 2014, we screened 135 participants, of whom 40 healthy volunteers, 40 individuals with COPD, and 39 with ischaemic heart disease were recruited. Concentrations of black carbon, NO2, PM10, PM2.5, and ultrafine particles were higher on Oxford Street than in Hyde Park. Participants with COPD reported more cough (odds ratio [OR] 1·95, 95% CI 0·96–3·95; p<0·1), sputum (3·15, 1·39–7·13; p<0·05), shortness of breath (1·86, 0·97–3·57; p<0·1), and wheeze (4·00, 1·52–10·50; p<0·05) after walking down Oxford Street compared with Hyde Park. In all participants, irrespective of their disease status, walking in Hyde Park led to an increase in lung function (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]) and a decrease in pulse wave velocity (PWV) and augmentation index up to 26 h after the walk. By contrast, these beneficial responses were attenuated after walking on Oxford Street. In participants with COPD, a reduction in FEV1 and FVC, and an increase in R5–20 were associated with an increase in during-walk exposure to NO2, ultrafine particles and PM2.5, and an increase in PWV and augmentation index with NO2 and ultrafine particles. In healthy volunteers, PWV and augmentation index were associated both with black carbon and ultrafine particles. Interpretation Short-term exposure to traffic pollution prevents the beneficial cardiopulmonary effects of walking in people with COPD, ischaemic heart disease, and those free from chronic cardiopulmonary diseases. Medication use might reduce the adverse effects of air pollution in individuals with ischaemic heart disease. Policies should aim to control ambient levels of air pollution along busy streets in view of these negative health effects. Funding British Heart Foundation.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32643-0
       
  • A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an
           everolimus-eluting durable polymer stent (Xience) after percutaneous
           coronary intervention (DESSOLVE III): a randomised, single-blind,
           multicentre, non-inferiority, phase 3 trial
    • Authors: Robbert J de Winter; Yuki Katagiri; Taku Asano; Krzysztof P Milewski; Philipp Lurz; Pawel Buszman; Gillian A J Jessurun; Karel T Koch; Roland P T Troquay; Bas J B Hamer; Ton Oude Ophuis; Jochen Wöhrle; Rafał Wyderka; Guillaume Cayla; Sjoerd H Hofma; Sébastien Levesque; Aleksander Żurakowski; Dieter Fischer; Maciej Kośmider; Pascal Goube; E Karin Arkenbout; Michel Noutsias; Markus W Ferrari; Yoshinobu Onuma; William Wijns; Patrick W Serruys
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Robbert J de Winter, Yuki Katagiri, Taku Asano, Krzysztof P Milewski, Philipp Lurz, Pawel Buszman, Gillian A J Jessurun, Karel T Koch, Roland P T Troquay, Bas J B Hamer, Ton Oude Ophuis, Jochen Wöhrle, Rafał Wyderka, Guillaume Cayla, Sjoerd H Hofma, Sébastien Levesque, Aleksander Żurakowski, Dieter Fischer, Maciej Kośmider, Pascal Goube, E Karin Arkenbout, Michel Noutsias, Markus W Ferrari, Yoshinobu Onuma, William Wijns, Patrick W Serruys
      Background MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. Methods We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50–3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)—cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation—between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Findings Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference −0·8% [95% CI −3·3 to 1·8], pnon-inferiority=0·0001). Procedural complications occurred in 12 patients (1·7%) in the sirolimus-eluting stent group and ten patients (1·4%) in the everolimus-eluting stent group; no clinical adverse events could be attributed to these dislodgements through a minimum of 12 months of follow-up. The rate of stent thrombosis, a safety indicator, did not differ between groups and was low in both treatment groups. Interpretation The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice. Funding The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33103-3
       
  • Primary care-led weight management for remission of type 2 diabetes
           (DiRECT): an open-label, cluster-randomised trial
    • Authors: Michael EJ Lean; Wilma S Leslie; Alison C Barnes; Naomi Brosnahan; George Thom; Louise McCombie; Carl Peters; Sviatlana Zhyzhneuskaya; Ahmad Al-Mrabeh; Kieren G Hollingsworth; Angela M Rodrigues; Lucia Rehackova; Ashley J Adamson; Falko F Sniehotta; John C Mathers; Hazel M Ross; Yvonne McIlvenna; Renae Stefanetti; Michael Trenell; Paul Welsh; Sharon Kean; Ian Ford; Alex McConnachie; Naveed Sattar; Roy Taylor
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Michael EJ Lean, Wilma S Leslie, Alison C Barnes, Naomi Brosnahan, George Thom, Louise McCombie, Carl Peters, Sviatlana Zhyzhneuskaya, Ahmad Al-Mrabeh, Kieren G Hollingsworth, Angela M Rodrigues, Lucia Rehackova, Ashley J Adamson, Falko F Sniehotta, John C Mathers, Hazel M Ross, Yvonne McIlvenna, Renae Stefanetti, Michael Trenell, Paul Welsh, Sharon Kean, Ian Ford, Alex McConnachie, Naveed Sattar, Roy Taylor
      Background Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. Methods We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20–65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27–45 kg/m2, and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825–853 kcal/day formula diet for 3–5 months), stepped food reintroduction (2–8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA1c) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. Findings Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8–49·8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0–5 kg weight loss, 19 (34%) of 56 participants with 5–10 kg loss, 16 (57%) of 28 participants with 10–15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10·0 kg (SD 8·0) in the intervention group and 1·0 kg (3·7) in the control group (adjusted difference −8·8 kg, 95% CI −10·3 to −7·3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5–10·3; p=0·0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study. Interpretation Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care. Funding Diabetes UK.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33102-1
       
  • Tradition and innovation in development of a Zika vaccine
    • Authors: Ernesto T A Marques; Donald S Burke
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Ernesto T A Marques, Donald S Burke


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33107-0
       
  • Remission of type 2 diabetes: mission not impossible
    • Authors: Matti Uusitupa
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Matti Uusitupa


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33100-8
       
  • Modern contraceptive use, unmet need, and demand satisfied among women of
           reproductive age who are married or in a union in the focus countries of
           the Family Planning 2020 initiative: a systematic analysis using the
           Family Planning Estimation Tool
    • Authors: Niamh Cahill; Emily Sonneveldt; John Stover; Michelle Weinberger; Jessica Williamson; Chuchu Wei; Win Brown; Leontine Alkema
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Niamh Cahill, Emily Sonneveldt, John Stover, Michelle Weinberger, Jessica Williamson, Chuchu Wei, Win Brown, Leontine Alkema
      Background The London Summit on Family Planning in 2012 inspired the Family Planning 2020 (FP2020) initiative and the 120×20 goal of having an additional 120 million women and adolescent girls become users of modern contraceptives in 69 of the world's poorest countries by the year 2020. Working towards achieving 120 × 20 is crucial for ultimately achieving the Sustainable Development Goals of universal access and satisfying demand for reproductive health. Thus, a performance assessment is required to determine countries' progress. Methods An updated version of the Family Planning Estimation Tool (FPET) was used to construct estimates and projections of the modern contraceptive prevalence rate (mCPR), unmet need for, and demand satisfied with modern methods of contraception among women of reproductive age who are married or in a union in the focus countries of the FP2020 initiative. We assessed current levels of family planning indicators and changes between 2012 and 2017. A counterfactual analysis was used to assess if recent levels of mCPR exceeded pre-FP2020 expectations. Findings In 2017, the mCPR among women of reproductive age who are married or in a union in the FP2020 focus countries was 45·7% (95% uncertainty interval [UI] 42·4–49·1), unmet need for modern methods was 21·6% (19·7–23·9), and the demand satisfied with modern methods was 67·9% (64·4–71·1). Between 2012 and 2017 the number of women of reproductive age who are married or in a union who use modern methods increased by 28·8 million (95% UI 5·8–52·5). At the regional level, Asia has seen the mCPR among women of reproductive age who are married or in a union grow from 51·0% (95% UI 48·5–53·4) to 51·8% (47·3–56·5) between 2012 and 2017, which is slow growth, particularly when compared with a change from 23·9% (22·9–25·0) to 28·5% (26·8–30·2) across Africa. At the country level, based on a counterfactual analysis, we found that 61% of the countries that have made a commitment to FP2020 exceeded pre-FP2020 expectations for modern contraceptive use. Country success stories include rapid increases in Kenya, Mozambique, Malawi, Lesotho, Sierra Leone, Liberia, and Chad relative to what was expected in 2012. Interpretation Whereas the estimate of additional users up to 2017 for women of reproductive age who are married or in a union would suggest that the 120 × 20 goal for all women is overly ambitious, the aggregate outcomes mask the diversity in progress at the country level. We identified countries with accelerated progress, that provide inspiration and guidance on how to increase the use of family planning and inform future efforts, especially in countries where progress has been poor. Funding The Bill & Melinda Gates Foundation, through grant support to the University of Massachusetts Amherst and Avenir Health.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33104-5
       
  • MiStent: just another example of non-inferiority'
    • Authors: Takeshi Kimura
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Takeshi Kimura


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33079-9
       
  • Disease Control Priorities, 3rd edition—from theory to practice
    • Authors: Pamela Das; Richard Horton
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Pamela Das, Richard Horton


      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)32905-7
       
  • Preliminary aggregate safety and immunogenicity results from three trials
           of a purified inactivated Zika virus vaccine candidate: phase 1,
           randomised, double-blind, placebo-controlled clinical trials
    • Authors: Kayvon Modjarrad; Leyi Lin; Sarah L George; Kathryn E Stephenson; Kenneth H Eckels; Rafael A De La Barrera; Richard G Jarman; Erica Sondergaard; Janice Tennant; Jessica L Ansel; Kristin Mills; Michael Koren; Merlin L Robb; Jill Barrett; Jason Thompson; Alison E Kosel; Peter Dawson; Andrew Hale; C Sabrina Tan; Stephen R Walsh; Keith E Meyer; James Brien; Trevor A Crowell; Azra Blazevic; Karla Mosby; Rafael A Larocca; Peter Abbink; Michael Boyd; Christine A Bricault; Michael S Seaman; Anne Basil; Melissa Walsh; Veronica Tonwe; Daniel F Hoft; Stephen J Thomas; Dan H Barouch; Nelson L Michael
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Kayvon Modjarrad, Leyi Lin, Sarah L George, Kathryn E Stephenson, Kenneth H Eckels, Rafael A De La Barrera, Richard G Jarman, Erica Sondergaard, Janice Tennant, Jessica L Ansel, Kristin Mills, Michael Koren, Merlin L Robb, Jill Barrett, Jason Thompson, Alison E Kosel, Peter Dawson, Andrew Hale, C Sabrina Tan, Stephen R Walsh, Keith E Meyer, James Brien, Trevor A Crowell, Azra Blazevic, Karla Mosby, Rafael A Larocca, Peter Abbink, Michael Boyd, Christine A Bricault, Michael S Seaman, Anne Basil, Melissa Walsh, Veronica Tonwe, Daniel F Hoft, Stephen J Thomas, Dan H Barouch, Nelson L Michael
      Background A safe, effective, and rapidly scalable vaccine against Zika virus infection is needed. We developed a purified formalin-inactivated Zika virus vaccine (ZPIV) candidate that showed protection in mice and non-human primates against viraemia after Zika virus challenge. Here we present the preliminary results in human beings. Methods We did three phase 1, placebo-controlled, double-blind trials of ZPIV with aluminium hydroxide adjuvant. In all three studies, healthy adults were randomly assigned by a computer-generated list to receive 5 μg ZPIV or saline placebo, in a ratio of 4:1 at Walter Reed Army Institute of Research, Silver Spring, MD, USA, or of 5:1 at Saint Louis University, Saint Louis, MO, USA, and Beth Israel Deaconess Medical Center, Boston, MA, USA. Vaccinations were given intramuscularly on days 1 and 29. The primary objective was safety and immunogenicity of the ZPIV candidate. We recorded adverse events and Zika virus envelope microneutralisation titres up to day 57. These trials are registered at ClinicalTrials.gov, numbers NCT02963909, NCT02952833, and NCT02937233. Findings We enrolled 68 participants between Nov 7, 2016, and Jan 25, 2017. One was excluded and 67 participants received two injections of Zika vaccine (n=55) or placebo (n=12). The vaccine caused only mild to moderate adverse events. The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]). By day 57, 52 (92%) of vaccine recipients had seroconverted (microneutralisation titre ≥1:10), with peak geometric mean titres seen at day 43 and exceeding protective thresholds seen in animal studies. Interpretation The ZPIV candidate was well tolerated and elicited robust neutralising antibody titres in healthy adults. Funding Departments of the Army and Defense and National Institute of Allergy and Infectious Diseases.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33106-9
       
  • Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine
           candidates in healthy adults: randomised, open-label, phase 1 clinical
           trials
    • Authors: Martin R Gaudinski; Katherine V Houser; Kaitlyn M Morabito; Zonghui Hu; Galina Yamshchikov; Ro Shauna Rothwell; Nina Berkowitz; Floreliz Mendoza; Jamie G Saunders; Laura Novik; Cynthia S Hendel; LaSonji A Holman; Ingelise J Gordon; Josephine H Cox; Srilatha Edupuganti; Monica A McArthur; Nadine G Rouphael; Kirsten E Lyke; Ginny E Cummings; Sandra Sitar; Robert T Bailer; Bryant M Foreman; Katherine Burgomaster; Rebecca S Pelc; David N Gordon; Christina R DeMaso; Kimberly A Dowd; Carolyn Laurencot; Richard M Schwartz; John R Mascola; Barney S Graham; Theodore C Pierson; Julie E Ledgerwood; Grace L Chen; Sarah Plummer; Pamela Costner; Kathryn Zephir; Joseph Casazza; Abidemi Ola; Milalynn Victorino; Carol Levinson; William Whalen; Xiaolin Wang; Jennifer Cunningham; Olga Vasilenko; Maria Burgos Florez; Somia Hickman; Iris Pittman; Lam Le; Brenda Larkin; Charla Andrews; Preeti Apte; Renunda Hicks; Cora Trelles Cartagena; Pernell Williams; Catina R Boyd; Michelle Conan-Cibotti; Judy Stein; Florence Kaltovich; Hope DeCederfelt; Stacey McAdams; Phyllis Renehan; Wilbur Chen; Nancy Greenberg; Nancy Wymer; Linda Wadsworth; Melissa Billington; Toni Robinson; Colleen Boyce; Faith Pa'ahana Brown; Lisa Chrisley; Alyson Kwon; Prashant Patel; Panagoita Kominou; Brenda Dorsey; Staci Eddington; Shinyi Telscher; Myoughee Lee; Regina Mosely; April Ross; Geoffrey Ford; Briyana Domjahn; Jianguo Xu; Allison Beck; Rebecca Fineman; Shiela Heeke; Jean Winter; Shashi Nagar; Colleen Kelley; Mark Mulligan; Sarah Plummer; Pamela Costner; Kathryn Zephir; Joseph Casazza; Abidemi Ola; Milalynn Victorino; Carol Levinson; William Whalen; Xiaolin Wang; Jennifer Cunningham; Olga Vasilenko; Maria Burgos Florez; Somia Hickman; Iris Pittman; Lam Le; Brenda Larkin; Charla Andrews; Preeti Apte; Renunda Hicks; Cora Trelles Cartagena; Pernell Williams; Catina R Boyd; Michelle Conan-Cibotti; Judy Stein; Florence Kaltovich; Hope DeCederfelt; Stacey McAdams; Phyllis Renehan
      Abstract: Publication date: Available online 5 December 2017
      Source:The Lancet
      Author(s): Martin R Gaudinski, Katherine V Houser, Kaitlyn M Morabito, Zonghui Hu, Galina Yamshchikov, Ro Shauna Rothwell, Nina Berkowitz, Floreliz Mendoza, Jamie G Saunders, Laura Novik, Cynthia S Hendel, LaSonji A Holman, Ingelise J Gordon, Josephine H Cox, Srilatha Edupuganti, Monica A McArthur, Nadine G Rouphael, Kirsten E Lyke, Ginny E Cummings, Sandra Sitar, Robert T Bailer, Bryant M Foreman, Katherine Burgomaster, Rebecca S Pelc, David N Gordon, Christina R DeMaso, Kimberly A Dowd, Carolyn Laurencot, Richard M Schwartz, John R Mascola, Barney S Graham, Theodore C Pierson, Julie E Ledgerwood, Grace L Chen
      Background The Zika virus epidemic and associated congenital infections have prompted rapid vaccine development. We assessed two new DNA vaccines expressing premembrane and envelope Zika virus structural proteins. Methods We did two phase 1, randomised, open-label trials involving healthy adult volunteers. The VRC 319 trial, done in three centres, assessed plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera), and the VRC 320, done in one centre, assessed plasmid VRC5283 (wild-type Zika virus). Eligible participants were aged 18–35 years in VRC19 and 18–50 years in VRC 320. Participants were randomly assigned 1:1 by a computer-generated randomisation schedule prepared by the study statistician. All participants received intramuscular injection of 4 mg vaccine. In VRC 319 participants were assigned to receive vaccinations via needle and syringe at 0 and 8 weeks, 0 and 12 weeks, 0, 4, and 8 weeks, or 0, 4, and 20 weeks. In VRC 320 participants were assigned to receive vaccinations at 0, 4, and 8 weeks via single-dose needle and syringe injection in one deltoid or split-dose needle and syringe or needle-free injection with the Stratis device (Pharmajet, Golden, CO, USA) in each deltoid. Both trials followed up volunteers for 24 months for the primary endpoint of safety, assessed as local and systemic reactogenicity in the 7 days after each vaccination and all adverse events in the 28 days after each vaccination. The secondary endpoint in both trials was immunogenicity 4 weeks after last vaccination. These trials are registered with ClinicalTrials.gov, numbers NCT02840487 and NCT02996461. Findings VRC 319 enrolled 80 participants (20 in each group), and VRC 320 enrolled 45 participants (15 in each group). One participant in VRC 319 and two in VRC 320 withdrew after one dose of vaccine, but were included in the safety analyses. Both vaccines were safe and well tolerated. All local and systemic symptoms were mild to moderate. In both studies, pain and tenderness at the injection site was the most frequent local symptoms (37 [46%] of 80 participants in VRC 319 and 36 [80%] of 45 in VRC 320) and malaise and headache were the most frequent systemic symptoms (22 [27%] and 18 [22%], respectively, in VRC 319 and 17 [38%] and 15 [33%], respectively, in VRC 320). For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials. Interpretation VRC5283 was well tolerated and has advanced to phase 2 efficacy testing. Funding Intramural Research Program of the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health.

      PubDate: 2017-12-11T07:10:35Z
      DOI: 10.1016/s0140-6736(17)33105-7
       
  • India—a tale of one country, but stories of many states
    • Authors: Lancet
      Abstract: Publication date: 2–8 December 2017
      Source:The Lancet, Volume 390, Issue 10111
      Author(s): The Lancet


      PubDate: 2017-12-11T07:10:35Z
       
  • The global fight against malaria is at crossroads
    • Authors: Pedro Alonso; Abdisalan M Noor
      Abstract: Publication date: Available online 29 November 2017
      Source:The Lancet
      Author(s): Pedro Alonso, Abdisalan M Noor


      PubDate: 2017-11-29T10:56:59Z
      DOI: 10.1016/s0140-6736(17)33080-5
       
  • The mental health of refugees and asylum seekers on Manus Island
    • Authors: Suresh Sundram; Peter Ventevogel
      Abstract: Publication date: Available online 27 November 2017
      Source:The Lancet
      Author(s): Suresh Sundram, Peter Ventevogel


      PubDate: 2017-11-29T10:56:59Z
      DOI: 10.1016/s0140-6736(17)33051-9
       
 
 
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