BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 12 November 2016)

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Research article
Power, fairness and trust: understanding and engaging with vaccine trial participants and communities in the setting up the EBOVAC-Salone vaccine trial in Sierra Leone
Luisa Enria, Shelley Lees, Elizabeth Smout, Thomas Mooney, Angus F. Tengbeh, Bailah Leigh, Brian Greenwood, Deborah Watson-Jones and Heidi Larson
BMC Public Health 2016 16:1140
Published on: 8 November 2016
Abstract
Background
This paper discusses the establishment of a clinical trial of an Ebola vaccine candidate in Kambia District, Northern Sierra Leone during the epidemic, and analyses the role of social science research in ensuring that lessons from the socio-political context, the recent experience of the Ebola outbreak, and learning from previous clinical trials were incorporated in the development of community engagement strategies. The paper aims to provide a case study of an integrated social science and communications system in the start-up phase of the clinical trial.
Methods
The paper is based on qualitative research methods including ethnographic observation, interviews with trial participants and key stakeholder interviews.
Results
Through the case study of EBOVAC Salone, the paper suggests ways in which research can be used to inform communication strategies before and during the setting up of the trial. It explores notions of power, fairness and trust emerging from analysis of the Sierra Leonean context and through ethnographic research, to reflect on three situations in which social scientists and community liaison officers worked together to ensure successful community engagement. Firstly, a section on “power” considers the pitfalls of considering communities as homogeneous and shows the importance of understanding intra-community power dynamics when engaging communities. Secondly, a section on “fairness” shows how local understandings of what is fair can help inform the design of volunteer recruitment strategies. Finally, a section on “trust” highlights how historically rooted rumours can be effectively addressed through active dialogue rather than through an approach focused on correcting misinformation.
Conclusion
The paper firstly emphasises the value of social science in the setting up of clinical trials, in terms of providing an in depth understanding of context and social dynamics. Secondly, the paper suggests the importance of a close collaboration between research and community engagement to effectively confront political and social dynamics, especially in the context of an epidemic.

Developing World Bioethics
December 2016 Volume 16, Issue 3 Pages 121–180
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2016.16.issue-2/issuetoc
Special Issue: Ethics of Health Systems Research in Low and Middle Income Countries

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Editorial
Ethical Issues in Health Systems Research in Low and Middle-Income Countries (pages 122–123)
Paul Ndebele and Adnan A. Hyder
Version of Record online: 11 NOV 2016 | DOI: 10.1111/dewb.12126
[No abstract]

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Articles
A Scoping Study on the Ethics of Health Systems Research (pages 124–132)
Abdulgafoor M. Bachani, Abbas Rattani and Adnan A. Hyder
Version of Record online: 1 APR 2016 | DOI: 10.1111/dewb.12117
Abstract
Currently, health systems research (HSR) is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees (RECs), as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted (of the responses (n=29), no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step (to better understand the current status) towards a larger dialogue on the topic.

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Understanding Health Research Ethics in Nepal (pages 140–147)
Jeevan Raj Sharma, Rekha Khatri and Ian Harper
Version of Record online: 3 FEB 2016 | DOI: 10.1111/dewb.12109
Abstract
Unlike other countries in South Asia, in Nepal research in the health sector has a relatively recent history. Most health research activities in the country are sponsored by international collaborative assemblages of aid agencies and universities. Data from Nepal Health Research Council shows that, officially, 1,212 health research activities have been carried out between 1991 and 2014. These range from addressing immediate health problems at the country level through operational research, to evaluations and programmatic interventions that are aimed at generating evidence, to more systematic research activities that inform global scientific and policy debates. Established in 1991, the Ethical Review Board of the Nepal Health Research Council (NHRC) is the central body that has the formal regulating authority of all the health research activities in country, granted through an act of parliament. Based on research conducted between 2010 and 2013, and a workshop on research ethics that the authors conducted in July 2012 in Nepal as a part of the on-going research, this article highlights the emerging regulatory and ethical fields in this low-income country that has witnessed these increased health research activities. Issues arising reflect this particular political economy of research (what constitutes health research, where resources come from, who defines the research agenda, culture of contract research, costs of review, developing Nepal’s research capacity, through to the politics of publication of data/findings) and includes questions to emerging regulatory and ethical frameworks.

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Health Systems Research Consortia and the Promotion of Health Equity in Low and Middle-Income Countries (pages 148–157)
Bridget Pratt, Katharine A. Allen and Adnan A. Hyder
Version of Record online: 16 MAR 2016 | DOI: 10.1111/dewb.12116
Abstract
Health systems research is widely identified as an indispensable means to achieve the goal of health equity between and within countries. Numerous health systems research consortia comprised of institutions from high-income countries and low and middle-income countries (LMICs) are currently undertaking programs of research in LMICs. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Recent conceptual work has explored what features might be necessary for health systems research consortia and their research programs to promote health equity. Identified features include selecting research priorities that focus on improving access to high-quality health services and/or financial protection for disadvantaged populations in LMICs and conducting research capacity strengthening that promotes the independent conduct of health systems research in LMICs. Yet, there has been no attempt to investigate whether existing consortia have such characteristics. This paper describes the results of a survey undertaken with health systems research consortia leaders worldwide to assess how consistent current practice is with the proposed ethical guidance. The findings suggest that consortia may be fairly well organised to promote health equity, but have scope for improvement, particularly in terms of achieving inclusive priority-setting.

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Research Involving Health Providers and Managers: Ethical Issues Faced by Researchers Conducting Diverse Health Policy and Systems Research in Kenya (pages 168–177)
Sassy Molyneux, Benjamin Tsofa, Edwine Barasa, Mary Muyoka Nyikuri, Evelyn Wanjiku Waweru, Catherine Goodman and Lucy Gilson
Version of Record online: 4 OCT 2016 | DOI: 10.1111/dewb.12130

Health Affairs
November 2016; Volume 35, Issue 11
http://content.healthaffairs.org/content/current
Issue Focus: Culture Of Health
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Creating Healthier, More Equitable Communities By Improving Governance And Policy
Tamara Dubowitz, Tracy Orleans, Christopher Nelson, Linnea Warren May, Jennifer C. Sloan, and Anita Chandra
Abstract
How can healthier, more equitable communities be created? This is a key question for public health. Even though progress has been made in understanding the impact of social, physical, and policy factors on population health, there is much room for improvement. With this in mind, the Robert Wood Johnson Foundation made creating healthier, more equitable communities the third of four Action Areas in its Culture of Health Action Framework. This Action Area focuses on the interplay of three drivers—the physical environment, social and economic conditions, and policy and governance—in influencing health equity. In this article we review some of the policy and governance challenges confronting decisionmakers as they seek to create healthy communities on a broad scale. We use these challenges as a framework for understanding where the most critical gaps still exist, where the links could be exploited more effectively, and where there are opportunities for further research and policy development.
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A Culture Of Health And Human Rights
Wendy K. Mariner1,* and George J. Annas2
Abstract
A culture of health can be seen as a social norm that values health as the nation’s priority or as an appeal to improve the social determinants of health. Better population health will require changing social and economic policies. Effective changes are unlikely unless health advocates can leverage a framework broader than health to mobilize political action in collaboration with non–health sector advocates. We suggest that human rights—the dominant international source of norms for government responsibilities—provides this broader framework. Human rights, as expressed in the Universal Declaration of Human Rights and enforceable treaties, require governments to assure their populations nondiscriminatory access to food, water, education, work, social security, and a standard of living adequate for health and well-being. The policies needed to realize human rights also improve population health, well-being, and equity. Aspirations for human rights are strong enough to endure beyond inevitable setbacks to specific causes.
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Insights Into Collaborative Networks Of Nonprofit, Private, And Public Organizations That Address Complex Health Issues
Rachel A. Hogg1,* and Danielle Varda2
Abstract
Community networks that include nonprofit, public, and private organizations have formed around many health issues, such as chronic disease management and healthy living and eating. Despite the increases in the numbers of and funding for cross-sector networks, and the growing literature about them, there are limited data and methods that can be used to assess their effectiveness and analyze their designs. We addressed this gap in knowledge by analyzing the characteristics of 260 cross-sector community health networks that collectively consisted of 7,816 organizations during the period 2008–15. We found that nonprofit organizations were more prevalent than private firms or government agencies in these networks. Traditional types of partners in community health networks such as hospitals, community health centers, and public health agencies were the most trusted and valued by other members of their networks. However, nontraditional partners, such as employer or business groups and colleges or universities, reported contributing relatively high numbers of resources to their networks. Further evidence is needed to inform collaborative management processes and policies as a mechanism for building what the Robert Wood Johnson Foundation describes as a culture of health.
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Modeling The Economic Burden Of Adult Vaccine-Preventable Diseases In The United States
Sachiko Ozawa, Allison Portnoy, Hiwote Getaneh, Samantha Clark, Maria Knoll, David Bishai, H. Keri Yang, and Pallavi D. Patwardhan
Health Aff November 2016 35:2124-2132; published ahead of print October 12, 2016, doi:10.1377/hlthaff.2016.0462
Abstract
Vaccines save thousands of lives in the United States every year, but many adults remain unvaccinated. Low rates of vaccine uptake lead to costs to individuals and society in terms of deaths and disabilities, which are avoidable, and they create economic losses from doctor visits, hospitalizations, and lost income. To identify the magnitude of this problem, we calculated the current economic burden that is attributable to vaccine-preventable diseases among US adults. We estimated the total remaining economic burden at approximately $9 billion (plausibility range: $4.7–$15.2 billion) in a single year, 2015, from vaccine-preventable diseases related to ten vaccines recommended for adults ages nineteen and older. Unvaccinated individuals are responsible for almost 80 percent, or $7.1 billion, of the financial burden. These results not only indicate the potential economic benefit of increasing adult immunization uptake but also highlight the value of vaccines. Policies should focus on minimizing the negative externalities or spillover effects from the choice not to be vaccinated, while preserving patient autonomy.

International Journal of Epidemiology
Volume 45 Issue 5 October 2016
http://ije.oxfordjournals.org/content/current

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Photo Essays
Measles outbreak response vaccination in the Federated States of Micronesia
Sameer V Gopalani, Louisa Helgenberger, Carter Apaisam, Spencer Donre, Keyleen Takiri, Jocelyne Charley, Anamaria Yomai, Peter Judicpa, Naoki Nakazono, Eliaser Johnson, Eleanor Setik, Livinson Taulung, Augustus Elias, and Lisa Barrow-Kohler
Int. J. Epidemiol. (2016) 45 (5): 1394-1400 doi:10.1093/ije/dyw111
Extract
Measles is an acute, highly infectious, viral disease transmitted through respiratory droplets and aerosolized droplet nuclei.1 It is characterized by fever, cough, coryza, conjunctivitis and generalized maculopapular rash typical of the disease (Figure 1).
After 20 years with no reported measles cases, a widespread outbreak occurred in the Federated States of Micronesia (FSM), an Oceanic island nation just north of the Equator.2 From February to August 2014, a multi-state outbreak affected three of the four FSM states. As part of a systematic outbreak-response following the first laboratory-confirmed case of measles, an emergency mass vaccination campaign was launched successively in each FSM state, to interrupt transmission and contain the outbreak.
Vaccinating the target population of 82 472—80% of the national population—required concerted collaborative efforts of FSM state and national immunization programmes with support from all three levels of government and international …

JAMA Pediatrics
November 1, 2016, Vol 170, No. 11, Pages 1033-1124
http://archpedi.jamanetwork.com/issue.aspx

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Research Letter
Vaccination Coverage Rates and Factors Associated With Incomplete Vaccination or Exemption Among School-age Children Based in Public Schools in New York State
Jessica A. Nadeau, PhD; Louise-Anne McNutt, PhD; Jana Shaw, MD, MPH, MS
JAMA Pediatr. 2016;170(11):1104-1107. doi:10.1001/jamapediatrics.2016.1347
This study assesses vaccination coverage rates and factors associated with either incomplete vaccination or exemptions among school-age children in New York State public schools outside of New York City.

Journal of Global Infectious Diseases (JGID)
October-December 2016 Volume 8 | Issue 4 Page Nos. 127-162
http://www.jgid.org/currentissue.asp?sabs=n

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EXPERT RECOMMENDATIONS
Consensus recommendation for India and Bangladesh for the use of pneumococcal vaccine in mass gatherings with special reference to Hajj pilgrims

Dilip Mathai, Abul Khair Mohammad Shamsuzzaman, Ahrar Ahmed Feroz, Amin R Virani, Ashfaq Hasan, KL Ravi Kumar, Khalid Ansari, Khandaker ATM Forhad Hossain, Mahesh Marda, MA Wahab Zubair, Mohammed Mukarram Ali, N Ashraf, Riyaz Basha, Shaeq Mirza, Shafeeq Ahmed, Shamim Akhtar, Syed Mustafa Ashraf, Zahirul Haque
DOI:10.4103/0974-777X.193749
Abstract
Respiratory tract infections are prevalent among Hajj pilgrims with pneumonia being a leading cause of hospitalization. Streptococcus pneumoniae is a common pathogen isolated from patients with pneumonia and respiratory tract infections during Hajj. There is a significant burden of pneumococcal disease in India, which can be prevented. Guidelines for preventive measures and adult immunization have been published in India, but the implementation of the guidelines is low. Data from Bangladesh are available about significant mortality due to respiratory infections; however, literature regarding guidelines for adult immunization is limited. There is a need for extensive awareness programs across India and Bangladesh. Hence, there was a general consensus about the necessity for a rapid and urgent implementation of measures to prevent respiratory infections in pilgrims traveling to Hajj. About ten countries have developed recommendations for pneumococcal vaccination in Hajj pilgrims: France, the USA, Kuwait, Qatar, Bahrain, the UAE (Dubai Health Authority), Singapore, Malaysia, Egypt, and Indonesia. At any given point whether it is Hajj or Umrah, more than a million people are present in the holy places of Mecca and Madina. Therefore, the preventive measures taken for Hajj apply for Umrah as well. This document puts forward the consensus recommendations by a group of twenty doctors following a closed-door discussion based on the scientific evidence available for India and Bangladesh regarding the prevention of respiratory tract infections in Hajj pilgrims.

The Lancet
Nov 12, 2016 Volume 388 Number 10058 p2323-2448
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Brexit’s effect on access to new medicines
The Lancet

Articles
Dissonant health transition in the states of Mexico, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013
Héctor Gómez-Dantés, Nancy Fullman, Héctor Lamadrid-Figueroa, Lucero Cahuana-Hurtado, Blair Darney, Leticia Avila-Burgos, Ricardo Correa-Rotter, Juan A Rivera, Simon Barquera, Eduardo González-Pier, Tania Aburto-Soto, Elga Filipa Amorin de Castro, Tonatiuh Barrientos-Gutiérrez, Ana C Basto-Abreu, Carolina Batis, Guilherme Borges, Ismael Campos-Nonato, Julio C Campuzano-Rincón, Alejandra de Jesús Cantoral-Preciado, Alejandra G Contreras-Manzano, Lucia Cuevas-Nasu, Vanessa V de la Cruz-Gongora, Jose L Diaz-Ortega, María de Lourdes García-García, Armando Garcia-Guerra, Teresita González de Cossío, Luz D González-Castell, Ileana Heredia-Pi, Marta C Hijar-Medina, Alejandra Jauregui, Aida Jimenez-Corona, Nancy Lopez-Olmedo, Carlos Magis-Rodríguez, Catalina Medina-Garcia, Maria E Medina-Mora, Fabiola Mejia-Rodriguez, Julio C Montañez, Pablo Montero, Alejandra Montoya, Grea L Moreno-Banda, Andrea Pedroza-Tobías, Rogelio Pérez-Padilla, Amado D Quezada, Vesta L Richardson-López-Collada, Horacio Riojas-Rodríguez, Maria J Ríos Blancas, Christian Razo-Garcia, Martha P Romero Mendoza, Tania G Sánchez-Pimienta, Luz M Sánchez-Romero, Astrid Schilmann, Edson Servan-Mori, Teresa Shamah-Levy, Martha M Téllez-Rojo, José L Texcalac-Sangrador, Haidong Wang, Theo Vos, Mohammad H Forouzanfar, Mohsen Naghavi, Alan D Lopez, Christopher J L Murray, Rafael Lozano
Summary
Background
Child and maternal health outcomes have notably improved in Mexico since 1990, whereas rising adult mortality rates defy traditional epidemiological transition models in which decreased death rates occur across all ages. These trends suggest Mexico is experiencing a more complex, dissonant health transition than historically observed. Enduring inequalities between states further emphasise the need for more detailed health assessments over time. The Global Burden of Diseases, Injuries, and Risk Factors Study 2013 (GBD 2013) provides the comprehensive, comparable framework through which such national and subnational analyses can occur. This study offers a state-level quantification of disease burden and risk factor attribution in Mexico for the first time.
Methods
We extracted data from GBD 2013 to assess mortality, causes of death, years of life lost (YLLs), years lived with disability (YLDs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) in Mexico and its 32 states, along with eight comparator countries in the Americas. States were grouped by Marginalisation Index scores to compare subnational burden along a socioeconomic dimension. We split extracted data by state and applied GBD methods to generate estimates of burden, and attributable burden due to behavioural, metabolic, and environmental or occupational risks. We present results for 306 causes, 2337 sequelae, and 79 risk factors.
Findings
From 1990 to 2013, life expectancy from birth in Mexico increased by 3·4 years (95% uncertainty interval 3·1–3·8), from 72·1 years (71·8–72·3) to 75·5 years (75·3–75·7), and these gains were more pronounced in states with high marginalisation. Nationally, age-standardised death rates fell 13·3% (11·9–14·6%) since 1990, but state-level reductions for all-cause mortality varied and gaps between life expectancy and years lived in full health, as measured by HALE, widened in several states. Progress in women’s life expectancy exceeded that of men, in whom negligible improvements were observed since 2000. For many states, this trend corresponded with rising YLL rates from interpersonal violence and chronic kidney disease. Nationally, age-standardised YLL rates for diarrhoeal diseases and protein-energy malnutrition markedly decreased, ranking Mexico well above comparator countries. However, amid Mexico’s progress against communicable diseases, chronic kidney disease burden rapidly climbed, with age-standardised YLL and DALY rates increasing more than 130% by 2013. For women, DALY rates from breast cancer also increased since 1990, rising 12·1% (4·6–23·1%). In 2013, the leading five causes of DALYs were diabetes, ischaemic heart disease, chronic kidney disease, low back and neck pain, and depressive disorders; the latter three were not among the leading five causes in 1990, further underscoring Mexico’s rapid epidemiological transition. Leading risk factors for disease burden in 1990, such as undernutrition, were replaced by high fasting plasma glucose and high body-mass index by 2013. Attributable burden due to dietary risks also increased, accounting for more than 10% of DALYs in 2013.
Interpretation
Mexico achieved sizeable reductions in burden due to several causes, such as diarrhoeal diseases, and risks factors, such as undernutrition and poor sanitation, which were mainly associated with maternal and child health interventions. Yet rising adult mortality rates from chronic kidney disease, diabetes, cirrhosis, and, since 2000, interpersonal violence drove deteriorating health outcomes, particularly in men. Although state inequalities from communicable diseases narrowed over time, non-communicable diseases and injury burdens varied markedly at local levels. The dissonance with which Mexico and its 32 states are experiencing epidemiological transitions might strain health-system responsiveness and performance, which stresses the importance of timely, evidence-informed health policies and programmes linked to the health needs of each state.
Funding
Bill & Melinda Gates Foundation, Instituto Nacional de Salud Pública.

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Viewpoint
Assessment of economic vulnerability to infectious disease crisesAssessment of economic vulnerability to infectious disease crises
Peter Sands, Anas El Turabi, Philip A Saynisch, Victor J Dzau
Summary
Infectious disease crises have substantial economic impact. Yet mainstream macroeconomic forecasting rarely takes account of the risk of potential pandemics. This oversight contributes to persistent underestimation of infectious disease risk and consequent underinvestment in preparedness and response to infectious disease crises. One reason why economists fail to include economic vulnerability to infectious disease threats in their assessments is the absence of readily available and digestible input data to inform such analysis. In this Viewpoint we suggest an approach by which the global health community can help to generate such inputs, and a framework to use these inputs to assess the economic vulnerability to infectious disease crises of individual countries and regions. We argue that incorporation of these risks in influential macroeconomic analyses such as the reports from the International Monetary Fund’s Article IV consultations, rating agencies and risk consultancies would simultaneously improve the quality of economic risk forecasting and reinforce individual government and donor incentives to mitigate infectious disease risks.

Maternal and Child Health Journal
Volume 20, Issue 11, November 2016
http://link.springer.com/journal/10995/20/11/page/1

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From the Field
Improving Access to Child Health Care in Indonesia Through Community Case Management
Agus Setiawan, Denise Dignam, Cheryl Waters…
Abstract
Objectives In order to reduce infant mortality in Indonesia, community case management (CCM) was introduced. CCM is a community-based service delivery model to improve children’s wellness and longevity, involving the delivery of lifesaving, curative interventions to address common childhood illnesses, particularly where there are limited facility-based services. This paper reports the findings of a qualitative study that investigated the implementation of CCM in the Kutai Timur district, East Kalimantan Indonesia from the perspective of mothers who received care. Methods Seven mothers and health workers were observed during a consultation and these mothers were interviewed in their home weeks after delivery. Field notes and the interview transcriptions were analysed thematically. Findings Mothers reported that their access to care had improved, along with an increase in their knowledge of infant danger signs and when to seek care. Family compliance with care plans was also found to have improved. Mothers expressed satisfaction with the care provided under the CCM model. The mothers expressed a need for a nurse or midwife to be posted in each village, preferably someone from that village. However two mothers did not wish their children to receive health interventions as they did not believe these to be culturally appropriate. Conclusion CCM is seen by rural Indonesian mothers to be a helpful model of care in terms of increasing access to health care and the uptake of lifesaving interventions for sick children. However there is a need to modify the program to demonstrate cultural sensitivity and meet cultural needs of the target population. While CCM is a potentially effective model of care, further integrative strategies are required to embed this model into maternal and child health service delivery.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 12 November 2016)

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Perspective
Three Steps to Improve Management of Noncommunicable Diseases in Humanitarian Crises
Kiran Jobanputra, Philippa Boulle, Bayard Roberts, Pablo Perel
| published 08 Nov 2016 PLOS Medicine
http://dx.doi.org/10.1371/journal.pmed.1002180
Initial text
Treatment of noncommunicable diseases (NCDs) is particularly challenging in settings affected by humanitarian crises, where insecurity and damaged health systems reduce access to treatment. While a United Nations (UN) Political Declaration and a World Health Organization (WHO) Global Action Plan recognise the significant contribution of NCDs to global morbidity and mortality [1, 2], the problem of NCDs during emergencies and in humanitarian response has been underrecognised [3]. The evidence base is negligible: a systematic review on the effectiveness of interventions for NCDs in humanitarian settings found just eight studies published over the last 35 years, four of which came from the same refugee camp in Jordan [4]. Humanitarian guidelines (e.g., Sphere) provide scant information on NCDs [5], while leading international NCD guidelines are based on evidence from resource-rich settings and adapted to fit stable, resource-constrained settings [6].

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Research Article
Measures of Malaria Burden after Long-Lasting Insecticidal Net Distribution and Indoor Residual Spraying at Three Sites in Uganda: A Prospective Observational Study
Agaba Katureebe, Kate Zinszer, Emmanuel Arinaitwe, John Rek, Elijah Kakande, Katia Charland, Ruth Kigozi, Maxwell Kilama, Joaniter Nankabirwa, Adoke Yeka, Henry Mawejje, Arthur Mpimbaza, Henry Katamba, Martin J. Donnelly, Philip J. Rosenthal, Chris Drakeley, Steve W. Lindsay, Sarah G. Staedke, David L. Smith, Bryan Greenhouse, Moses R. Kamya, Grant Dorsey
| published 08 Nov 2016 PLOS Medicine
http://dx.doi.org/10.1371/journal.pmed.1002167

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 12 November 2016)

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Research Article
Use of the Health Belief Model for the Assessment of Public Knowledge and Household Preventive Practices in Karachi, Pakistan, a Dengue-Endemic City
Taranum Ruba Siddiqui, Saima Ghazal, Safia Bibi, Waquaruddin Ahmed, Shaimuna Fareeha Sajjad
Research Article | published 10 Nov 2016 PLOS Neglected Tropical Diseases
http://dx.doi.org/10.1371/journal.pntd.0005129

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Viewpoints
Zika Virus May Affect the Universal Two-Child Policy: A New Challenge for China
Pengcheng Zhou, Juan Wang, Yixiang Zheng, Rongrong Zhou, Xue-Gong Fan
| published 10 Nov 2016 PLOS Neglected Tropical Diseases
http://dx.doi.org/10.1371/journal.pntd.0004984

PLoS One
http://www.plosone.org/
[Accessed 12 November 2016]

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Research Article
Differences in Influenza Vaccination Coverage between Adult Immigrants and Italian Citizens at Risk for Influenza-Related Complications: A Cross-Sectional Study
Massimo Fabiani, Flavia Riccardo, Anteo Di Napoli, Lidia Gargiulo, Silvia Declich, Alessio Petrelli
Research Article | published 10 Nov 2016 PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0166517

Nationwide Trends in Bacterial Meningitis before the Introduction of 13-Valent Pneumococcal Conjugate Vaccine—Burkina Faso, 2011–2013
Dinanibè Kambiré, Heidi M. Soeters, Rasmata Ouédraogo-Traoré, Isaïe Medah, Lassana Sangare, Issaka Yaméogo, Guetawendé Sawadogo, Abdoul-Salam Ouédraogo, Soumeya Hema-Ouangraoua, Lesley McGee, Velusamy Srinivasan, Flavien Aké, Malika Congo-Ouédraogo, Soufian Sanou, Absatou Ky Ba, Ryan T. Novak, Chris Van Beneden, MenAfriNet Consortium
Research Article | published 10 Nov 2016 PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0166384

Pneumococcal Carriage in Children under Five Years in Uganda-Will Present Pneumococcal Conjugate Vaccines Be Appropriate?
Ann Lindstrand, Joan Kalyango, Tobias Alfvén, Jessica Darenberg, Daniel Kadobera, Freddie Bwanga, Stefan Peterson, Birgitta Henriques-Normark, Karin Källander
Research Article | published 09 Nov 2016 PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0166018

Research Article
A Platform for Designing Genome-Based Personalized Immunotherapy or Vaccine against Cancer
Sudheer Gupta, Kumardeep Chaudhary, Sandeep Kumar Dhanda, Rahul Kumar, Shailesh Kumar, Manika Sehgal, Gandharva Nagpal, Gajendra P. S. Raghava
Published: November 10, 2016
http://dx.doi.org/10.1371/journal.pone.0166372

Science
11 November 2016 Vol 354, Issue 6313
http://www.sciencemag.org/current.dtl

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Editorial
Who should direct WHO?
By David L. Heymann
Science11 Nov 2016 : 685
Summary
Last week, member states of the World Health Organization (WHO) advanced another step in the nearly 1-year rigorous process of selecting its next director-general. Candidates for the position presented their vision of international health work and the role of this global health body. Having worked at WHO in a number of capacities in the area of infectious diseases, I know well that international health covers a wide breadth of issues. Add to that noncommunicable diseases and matters such as intellectual property and universal health coverage, and it becomes clear that the next director-general must be a jack of all trades, but also a master of one—leadership in public health. Leadership in this role is about conceiving and articulating a vision, staying faithful to that vision in the face of undue influence, and effectively engaging with not only governments, but with all stakeholders to gain their support and enable the vision to be realized.

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Policy Forum
Precaution and governance of emerging technologies
By Gregory E. Kaebnick, Elizabeth Heitman, James P. Collins, Jason A. Delborne, Wayne G. Landis, Keegan Sawyer, Lisa A. Taneyhill, David E. Winickoff
Science11 Nov 2016 : 710-711 Restricted Access
Precaution can be consistent with support of science
Summary
Precautionary approaches to governance of emerging technology call for constraints on the use of technology whose outcomes include potential harms and are characterized by high levels of complexity and uncertainty. Although articulated in a variety of ways, proponents of precaution often argue that its essential feature is to require more evaluation of a technology before it is put to use, which increases the burden of proof that its overall effect is likely to be beneficial. Critics argue that precaution reflects irrational fears of unproven risks—“risk panics” (1)—and would paralyze development and use of beneficial new technologies (1, 2). Advocates give credence to this view when they suggest that precaution leads necessarily to moratoria (3). Progress in the debate over precaution is possible if we can reject the common assumption that precaution can be explained by a simple high-level principle and accept instead that what it requires must be worked out in particular contexts. The 2016 report from the U.S. National Academies of Science, Engineering, and Medicine (NASEM) on gene drive research (4) illustrates this position. The report shows both that precaution cannot be rejected out of hand as scaremongering and that meaningful precaution can be consistent with support for science.

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

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Forbes
http://www.forbes.com/
Accessed 12 November 2016
World Pneumonia Day: Progress But Also 5 Troubling Trends
Bruce Y. Lee, Contributor
Pneumonia is one of the top 5 causes of death worldwide among children under 5 years of age. In the U.S. next to giving birth, pneumonia is the most common reason why adults get admitted to the hospital. While the past decades have seen advances in preventing, controlling, and treating pneumonia, some troubling trends that threaten to reverse the gains.

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New York Times
http://www.nytimes.com/
Accessed 12 November 2016
Haiti Opens a Drive to Vaccinate 820,000 as Cholera Flares
November 10, 2016 – By REUTERS – World

J&J Vaccine Plus Gilead Immune Booster Shows Promise as HIV Fighter
CHICAGO — An experimental HIV vaccine from Johnson & Johnson combined with an immune system booster from Gilead Sciences Inc showed promise at keeping the virus at bay in monkeys even after treatments had stopped, marking yet..
November 09, 2016 – By REUTERS – Business Day

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 12 November 2016
Novavax to Cut 30% of Workforce
By Anne Steele
Nov. 9, 2016 5:55 pm ET

Washington Post
http://www.washingtonpost.com/
Accessed 12 November 2016
Parents are insisting on doctors who insist on vaccinations
The backlash against the anti-vaccine movement is gaining strength.
Lena H. Sun | Health-Environment-Science | Nov 12, 2016

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version:  A pdf of the current issue is available here: vaccines-and-global-health_the-week-in-review_5-november-2016

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Milestones :: Perspectives [to 5 November 2016]

Vaccine
In Press, Corrected Proof, Available online 28 October 2016
Funding gap for immunization across 94 low- and middle-income countries
Original Research Article
Sachiko Ozawa, Simrun Grewal, Allison Portnoy, Anushua Sinha, Richard Arilotta, Meghan L. Stack, Logan Brenzel
Highlights
:: Estimated financing and funding gap for vaccine, supply chain and service delivery.
:: Identified immunization funding gap: $7.6 billion over 2016–20 across 94 countries.
:: On average, the funding gap represents 2.3% of government health expenditures.
:: Largest funds needed for service delivery and supply chain to meet projected costs.

Abstract
Novel vaccine development and production has given rise to a growing number of vaccines that can prevent disease and save lives. In order to realize these health benefits, it is essential to ensure adequate immunization financing to enable equitable access to vaccines for people in all communities. This analysis estimates the full immunization program costs, projected available financing, and resulting funding gap for 94 low- and middle-income countries over five years (2016–2020). Vaccine program financing by country governments, Gavi, and other development partners was forecasted for vaccine, supply chain, and service delivery, based on an analysis of comprehensive multi-year plans together with a series of scenario and sensitivity analyses.

Findings indicate that delivery of full vaccination programs across 94 countries would result in a total funding gap of $7.6 billion (95% uncertainty range: $4.6–$11.8 billion) over 2016–2020, with the bulk (98%) of the resources required for routine immunization programs. More than half (65%) of the resources to meet this funding gap are required for service delivery at $5.0 billion ($2.7–$8.4 billion) with an additional $1.1 billion ($0.9–$2.7 billion) needed for vaccines and $1.5 billion ($1.1–$2.0 billion) for supply chain. When viewed as a percentage of total projected costs, the funding gap represents 66% of projected supply chain costs, 30% of service delivery costs, and 9% of vaccine costs. On average, this funding gap corresponds to 0.2% of general government expenditures and 2.3% of government health expenditures.

These results suggest greater need for country and donor resource mobilization and funding allocation for immunizations. Both service delivery and supply chain are important areas for further resource mobilization. Further research on the impact of advances in service delivery technology and reductions in vaccine prices beyond this decade would be important for efficient investment decisions for immunization.

::::::

Bulletin of the World Health Organization
Volume 94, Number 11, November 2016, 785-860
http://www.who.int/bulletin/volumes/94/11/en/

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RESEARCH
Inequalities in full immunization coverage: trends in low- and middle-income countries
María Clara Restrepo-Méndez, Aluísio JD Barros, Kerry LM Wong, Hope L Johnson, George Pariyo, Giovanny VA França, Fernando C Wehrmeister & Cesar G Victora
http://dx.doi.org/10.2471/BLT.15.162172
Abstract
Objective
To investigate disparities in full immunization coverage across and within 86 low- and middle-income countries.
Methods
In May 2015, using data from the most recent Demographic and Health Surveys and Multiple Indicator Cluster Surveys, we investigated inequalities in full immunization coverage – i.e. one dose of bacille Calmette-Guérin vaccine, one dose of measles vaccine, three doses of vaccine against diphtheria, pertussis and tetanus and three doses of polio vaccine – in 86 low- or middle-income countries. We then investigated temporal trends in the level and inequality of such coverage in eight of the countries.
Findings
In each of the World Health Organization’s regions, it appeared that about 56–69% of eligible children in the low- and middle-income countries had received full immunization. However, within each region, the mean recorded level of such coverage varied greatly. In the African Region, for example, it varied from 11.4% in Chad to 90.3% in Rwanda. We detected pro-rich inequality in such coverage in 45 of the 83 countries for which the relevant data were available and pro-urban inequality in 35 of the 86 study countries. Among the countries in which we investigated coverage trends, Madagascar and Mozambique appeared to have made the greatest progress in improving levels of full immunization coverage over the last two decades, particularly among the poorest quintiles of their populations.
Conclusion
Most low- and middle-income countries are affected by pro-rich and pro-urban inequalities in full immunization coverage that are not apparent when only national mean values of such coverage are reported.

Emergencies  [to 5 November 2016]

WHO Grade 3 Emergencies [to 5 November 2016]
Iraq – No new announcements identified.
Nigeria -No new announcements identified.
South Sudan – No new announcements identified.
The Syrian Arab Republic – No new announcements identified.
Yemen – No new announcements identified.

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WHO Grade 2 Emergencies [to 5 November 2016]
Cameroon –
:: Read the latest situation report in French pdf, 945kb 31 October 2015
Central African Republic – No new announcements identified.
Democratic Republic of the Congo – No new announcements identified.
Ethiopia – No new announcements identified.
Libya – No new announcements identified.
Myanmar – No new announcements identified.
Niger – No new announcements identified.
Ukraine – No new announcements identified.

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Editor’s Note:
While the WHO Emergency webpages above do not capture the announcements below, we add them here for continuity in understanding emergency contexts.

WHO Eastern Mediterranean Region EMRO
:: WHO reaches children and women in remote areas of Yemen
Sana’a, 3 November 2016 — WHO and partners have conducted the third round of integrated outreach activities in all remote and rural areas in Yemen’s 333 districts, providing more than 244,000 children with nutrition, immunization and integrated management of childhood illnesses (IMCI) services.

The activities, supported by WHO, have so far reached 17,000 villages. Almost 85,000 pregnant women and women of childbearing age were vaccinated against tetanus and received reproductive health, antenatal/postnatal care services. More than 7000 health workers took part in the outreach activities.
“Remote and rural areas in Yemen are deprived of essential health services. The health situation in these areas has been further worsened by the current conflict, which constrains health workers from reaching all areas in need. With health services reduced or halted in more than 1900 health facilities in 16 governorates, these integrated outreach activities serve as critical health support,” said Dr Ahmed Shadoul, WHO Representative to Yemen.

Currently, WHO is supporting 28 mobile health teams covering primary health care, including nutrition support, as well as 29 health facility-based teams and 12 therapeutic feeding centres in 10 governorates in Yemen.

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises.
Iraq –
:: Mosul Humanitarian Crisis, 1 November 2016
IN NUMBERS
1.2-1.5m – PEOPLE COULD BE AFFECTED OVERALL BY THE MILITARY OPERATIONS
1m – COULD BE DISPLACED IN A WORST-CASE SCENARIO
700,000 – PEOPLE MAY NEED TO BE ACCOMMODATED IN EMERGENCY SHELTERS
18,000 – PEOPLE ARE CURRENTLY DISPLACED
3,300 – DISPLACED PEOPLE HAVE ALREADY RETURNED TO THEIR HOMES
50% – OF THE DISPLACED PEOPLE ARE IN CAMPS
OVERVIEW
In a worst case scenario, the Mosul humanitarian response is likely to be the single largest and most complex in the world in 2016.

As many as 1.2-1.5 million people could be affected overall by the military operations.
In a worst-case scenario, up to 1 million girls, boys, women and men could be displaced and 700,000 may need to be accommodated in emergency shelters.

As military operations to retake Mosul from the Islamic State of Iraq and the Levant (ISIL) continue, civilians are at extreme risk of being caught up in cross-fire or targeted by snipers.
Tens of thousands of people may be forcibly expelled, trapped between fighting lines, besieged or held as human shields. Chemical weapons may be used.

Public facilities, thoroughfares and homes may be booby-trapped or contaminated by improvised mines and explosive hazards. Children, women, the elderly and disabled will be particularly vulnerable. Delays, abuses, and irregularities may occur during screening of displaced families.

DISPLACEMENT AND HUMANITARIAN NEEDS
According to the International Organization for Migration there are currently more than 17,900 people displaced. At least 3,300 additional people who fled during the first week of the military operations have returned to their homes following improved security conditions in the immediate area. The situation is fluid and the numbers and patterns of displacement are fluctuating as the front lines move. Overall displacement is expected to rise rapidly as the military operation moves closer to urban areas.

Just over 50 per cent of the people displaced so far are in camps: Qayyarah-Jadah, Zelikan and Hasansham camps in Ninewa Governorate; Debaga camp in Erbil Governorate; and Bzeibiz central camp in Fallujah district in Anbar Governorate.
Just under half of the displaced population are sheltering in private settings or critical shelters in host communities.

As humanitarian actors gain access to recently retaken areas, it is clear that humanitarian needs in vulnerable front line communities are significant. Further assessments are planned to better understand the needs of these vulnerable communities who have lived under the control of ISIL for more than two years.

UNHCR reports that 44 Iraqis from Mosul have crossed the border into Syria since 17 October.

:: Iraq: Mosul Humanitarian Response Situation Report #5 (29-31 October 2016) [EN/AR]

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Syria
:: Syria Crisis Bi-Weekly Situation Report No.16 (as of 31 October 2016) 4 Nov 2016
:: Statement by Mr. Al-Za’tari, the UN Resident/Humanitarian Coordinator for Syria and Mr. Kevin Kennedy, the Regional Humanitarian Coordinator for the Crisis in Syria, on Attack on UN Offices in Western Aleppo
Damascus and Amman, 31 October 2016
The United Nations strongly condemns an attack on the building where UN offices and staff are based in west Aleppo city. The UN presence in the building is long established and well known. On 30 October, the top floors of the building were damaged by a tank shell.

“It is appalling that the building that houses the UN offices was directly targeted,” said Ali Al-Za’tari, the UN Resident/Humanitarian Coordinator for Syria. “We strongly condemn the increased violence in all of Aleppo, east and west, which has resulted in the death and injury of scores of civilians, including children,” he stressed…

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Yemen
– No new announcements identified.

Zika virus [to 5 November 2016]
Public Health Emergency of International Concern (PHEIC)
http://www.who.int/emergencies/zika-virus/en/

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Zika situation report – 3 November 2016
Full report: http://apps.who.int/iris/bitstream/10665/250724/1/zikasitrep3Nov16-eng.pdf?ua=1
Key Updates
:: Countries and territories reporting mosquito-borne Zika virus infections for the first time in the past week:
… None
:: Countries and territories reporting microcephaly and other central nervous system (CNS) malformations potentially associated with Zika virus infection for the first time in the past week:
… Bolivia, Trinidad and Tobago, and Viet Nam
:: Countries and territories reporting Guillain-Barré syndrome (GBS) cases associated with Zika virus infection for the first time in the past week:
… None
:: The Ministry of Health and Sport of Myanmar reported a confirmed case of Zika virus. The case is under investigation as to determine if this is an autochthonous (locally-acquired) or imported case.
Analysis
:: Overall, the global risk assessment has not changed since last week.
:: Viet Nam is the second county in South-East Asia to report microcephaly cases potentially linked with Zika virus. This follows the 2 microcephaly cases reported in Thailand in the 6 October Zika situation report. Similar to the cases reported in Thailand, genetic sequencing of the virus was not possible therefore it is not known whether the mother was infected with a virus related to the same lineage as previously isolated in South-East Asia, or if there has instead been transmission of a virus imported from another location. The mother of the baby with microcephaly reported in Viet Nam had no history of travel outside of the country. To date, there have been no imported Zika virus cases reported in Viet Nam.

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Zika Open [to 5 November 2016]
[Bulletin of the World Health Organization]
:: All papers available here
No new papers identified.

POLIO [to 5 November 2016]
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 2 November 2016
:: The new Transition Independent Monitoring Board (Transition IMB) has now been established, to monitor and guide polio transition (previously referred to as ‘legacy’) planning. The Transition IMB is separate from the regular IMB which monitors and guides progress towards interrupt of transmission of polioviruses. The Transition IMB will hold its inaugural meeting next week in London, United Kingdom (UK). For more about the Transition IMB and transition planning.

:: In Nigeria this week, experts from the Government and international partners are convening a urgent meeting to assess the impact of outbreak response conducted thus far. The group will look at progress achieved in boosting immunity levels and strengthening surveillance, and review additional strategies and tactics to further intensify the outbreak response. A similar review will be conducted next week looking at the broader regional outbreak response across the entire Lake Chad basin.

:: A new field study conducted in Sri Lanka has concluded that fractional dose inactivated polio vaccine (fIPV) is as effective as full-dose IPV in boosting mucosal immunity in OPV-primed populations. Boosting mucosal immunity is critical to interrupting virus transmission in a community. Previous studies had already confirmed that fIPV was as effective at inferring humoral immunity as full-dose IPV. This latest evidence gives further weight to the recommendation of the Strategic Advisory Group of Experts on immunization (SAGE), for countries to consider adopting fIPV in both their supplementary and routine immunization activities. This approach could significantly improve the global IPV supply situation which is currently constrained, by reducing the volume of IPV needed to cover a population. Countries are increasingly using fIPV, both in routine and vaccination campaigns, including Pakistan which conducted a mass campaign using fIPV just last week.

:: News this week: continuing our focus on innovating strategies to facilitate eradication, an analysis reveals how new and strengthened surveillance in Nigeria helped detect the outbreak against the backdrop of insecurity and a humanitarian crisis. More.

Country Updates [Selected Excerpts]
Afghanistan
:: One new wild poliovirus type 1 (WPV1) case was reported in the past week, from Paktika province, with onset of paralysis on 28 September, bringing the total number of WPV1 cases for 2016 to nine. It is the most recent case in the country…
:: Paktika province is close to the border with Pakistan, and constitutes a common WPV transmission corridor posing a major risk to both national programmes. This corridor of transmission ranges from southern Khyber Pakhtunkhwa (KP)/Federally Administered Tribal Areas (FATA) in Pakistan through south-eastern Afghanistan in Paktika, Paktya and Khost provinces.
:: Both countries are continuing to strengthen coordination on supplementary immunization activities as well as surveillance, in order to maximise the impact of eradication efforts and address the common reservoir in a joint manner. This includes ensuring the vaccination of travellers associated with large-scale population movements between the two countries.
:: Elsewhere in the country, efforts continue to further strengthen immunization and surveillance activities. Again in close collaboration with Pakistan, attention is focusing on stopping the joint WPV transmission corridor in the east, ranging from greater Peshawar/Khyber on the Pakistan side to Nangarhar/Kunar/Laghman on the Afghanistan side; and in the south, from Quetta in Pakistan to Kandahar/Helmand in Afghanistan.

WHO & Regional Offices [to 5 November 2016]

Kyrgyzstan certified to be malaria-free
WHO
4 November 2016 – Today, Kyrgyzstan received the official WHO certification of malaria elimination. Countries that maintain zero locally-acquired malaria cases for at least 3 consecutive years are eligible to apply for this certification on a voluntary-basis. Globally, a total of 32 countries and territories have received the certification

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WHO recommends 29 ways to stop surgical infections and avoid superbugs
3 November 2016 | Geneva – People preparing for surgery should always have a bath or shower but not be shaved, and antibiotics should only be used to prevent infections before and during surgery, not afterwards, according to new guidelines from WHO that aim to save lives, cut costs and arrest the spread of superbugs

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Highlights
African leaders recognize importance of preventing and managing health emergencies on One Health Day
November 2016 – On the inaugural One Health Day, the World Health Organization (WHO) is calling attention to the importance of using the One Health approach in order to more successfully prevent and manage public health emergencies and threats. One Health is an approach to designing health systems and services in ways that account for the link between human, animal and environmental health.

New WHO/Europe report calls for urgent action to protect children from digital marketing of food
November 2016 – For the first time, researchers and health experts have undertaken a comprehensive analysis of the concerning situation in the WHO European Region of digital marketing to children of foods high in fats, salt and sugars.

.
GIN October 2016 pdf, 2.05Mb
2 November 2016

.
Weekly Epidemiological Record, 4 November 2016, vol. 91, 44 (pp. 517–524)
:: Progress towards poliomyelitis eradication: Afghanistan, January 2015–August 2016
:: Global RSV surveillance

.
:: WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: African leaders recognize importance of preventing and managing health emergencies on inaugural One Health Day
3 November 2016, Brazzaville – Today, on the inaugural One Health Day, the World Health Organization (WHO) is calling attention to the importance of using the One Health approach in order to more successfully prevent and manage public health emergencies and threats. One Health is an approach to designing health systems and services in ways that account for the link between human, animal and environmental health
:: West African Leaders to Commit to Combat Emerging Health Threats – 03 November 2016

WHO Region of the Americas PAHO
:: PAHO/WHO recognizes Costa Rica, El Salvador and Suriname for drastically reducing malaria cases and deaths in the last 15 years (11/03/2016)
:: Haiti needs support to restore, rebuild health services after Hurricane Matthew (11/03/2016)

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
:: Kyrgyzstan receives WHO certification for malaria elimination; Europe is the first WHO region to interrupt indigenous malaria transmission 04-11-2016
:: New WHO/Europe report calls for urgent action to protect children from digital marketing of food 04-11-2016
:: WHO report shows urban green spaces deliver multiple health benefits 02-11-2016
:: Communicating health and the Sustainable Development Goals: experiences from small countries of the WHO European Region 01-11-2016

WHO Eastern Mediterranean Region EMRO
:: WHO reaches children and women in remote areas of Yemen 3 November 2016
[See Yemen in Emergencies coverage above]

WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 5 November 2016]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/

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Press Release
FRIDAY, NOVEMBER 4, 2016
First cases of Candida auris reported in United States
Thirteen cases of Candida auris (C. auris), a serious and sometimes fatal fungal infection that is emerging globally, have been identified in the United States, according to the Centers for…

Media Advisory
WEDNESDAY, NOVEMBER 2, 2016
First annual One Health Day highlights link between people’s health and animals, environment
The first annual global One Health Day will be held Thursday, November 3, to raise awareness worldwide about the One Health concept, which recognizes that the health of people is…

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MMWR Weekly November 4, 2016 / No. 43
:: Recommendations for Use of Meningococcal Conjugate Vaccines in HIV-Infected Persons — Advisory Committee on Immunization Practices, 2016
At its June 2016 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of meningococcal conjugate vaccine (serogroups A, C, W, and Y; including MenACWY-D [Menactra, Sanofi Pasteur] or MenACWY-CRM [Menveo, GlaxoSmithKline]) for persons aged ≥2 months with human immunodeficiency virus (HIV) infection. ACIP has previously recommended routine vaccination of persons aged ≥2 months who have certain medical conditions that increase risk for meningococcal disease (1), including persons who have persistent (e.g., genetic) deficiencies in the complement pathway (e.g., C3, properdin, Factor D, Factor H, or C5–C9); persons receiving eculizumab (Soliris, Alexion Pharmaceuticals) for treatment of atypical hemolytic uremic syndrome or paroxysmal nocturnal hemoglobinuria (because the drug binds C5 and inhibits the terminal complement pathway); and persons with functional or anatomic asplenia (including persons with sickle cell disease). Routine vaccination with meningococcal conjugate vaccine is also recommended for all healthy adolescents in the United States (1). This report summarizes the evidence considered by ACIP in recommending vaccination for HIV-infected persons, and provides recommendations and guidance for use of meningococcal conjugate vaccines (serogroups A, C, W, and Y) among HIV-infected persons aged ≥2 months; the majority of meningococcal disease among HIV-infected persons is caused by these four serogroups…

:: Progress Toward Poliomyelitis Eradication — Afghanistan, January 2015–August 2016
:: Notes from the Field: Rift Valley Fever Response — Kabale District, Uganda, March 2016

Announcements/Perspectives
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Global Fund [to 5 November 2016]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
03 November 2016
Eastern European and Central Asian Countries Unite to Expand Access to Lifesaving HIV and TB Drugs
MINSK, Belarus – Health ministers from Eastern Europe and Central Asia adopted a Consensus Statement “HIV and TB treatment for all” on expanded and rapidly scaled-up access to affordable, quality-assured antiretroviral and TB drugs at the conclusion of the two-day Regional Consultation in Minsk, Belarus.
The countries committed to strengthen regional cooperation in order to advance access to affordable and quality medicines and deliver more cost-effective, equitable and sustainable solutions for common challenges by intensifying efforts through regional solidarity, shared responsibility and political leadership.
“Undoubtedly, the adoption of the Minsk Statement is a guarantee of our countries’ openness and readiness to share experience and work together in achieving sustainable development and commitments to the Political Declaration on HIV/AIDS and WHO TB Plan in Eastern Europe for 2016-2020,” said Vasiliy Zharko, Minister of Health of Belarus.
Representatives from 12 Eastern Europe and Central Asia (EECA) countries’ ministries of health – Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russian Federation, Tajikistan, Turkmenistan, Ukraine and Uzbekistan – endorsed the statement…
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European Vaccine Initiative [to 5 November 2016]
http://www.euvaccine.eu/news-events
02 November 2016
Zika research supported by the European Union
The European Union launched calls to support research on emerging diseases with a substantial investment from the Horizon2020…

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FDA [to 5 November 2016]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
:: Influenza Virus Vaccine for the 2016-2017 Season
Updated: 11/2/2016
:: Study of antibody responses to an investigative Ebola vaccine may guide development and evaluation of effective countermeasures
Posted: 11/2/2016

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PATH [to 5 November 2016]
http://www.path.org/news/index.php
Announcement | November 01, 2016
PATH announces leader for Reproductive Health Program
Martha Brady to lead PATH’s work in reproductive health
Martha Brady, MS, will join PATH as the new director of our Reproductive Health Program, beginning November 1, 2016. Based in our Washington, DC, office, she will lead our work to improve sexual and reproductive health by enhancing commitment and capacity to implement appropriate and effective interventions at scale. Her technical knowledge, experience, and track record in reproductive health will ensure continued robust and pioneering work in this area, and they will expand PATH’s work at this critical time in global health.

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EDCTP [to 5 November 2016]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials.
Eighth EDCTP Forum, from 6-9 November 2016 in Lusaka, Zambia.
Defeating poverty-related and neglected diseases in Africa: harnessing research for evidence-informed policies.
The symposium format allows groups of researchers or organisations to present an overview of a topic, including time for questions, discussion and exchange of views with Forum delegates.

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Fondation Merieux [to 5 November 2016]
http://www.fondation-merieux.org/news
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
4 November 2016, Les Pensières, Annecy (France)
Strategies to Increase Vaccine Acceptance and Uptake 2016
72 experts from 19 countries gathered at Les Pensières September 26-28 to discuss vaccine hesitancy and understand the drivers and barriers affecting vaccine acceptance.

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Coalition for Epidemic Preparedness Innovations (CEPI) [to 5 November 2016]
http://cepi.net/
Newsletter 4 November 2016 [Excerpts]
:: Message from the Interim CEPI CEO
“Over the last few weeks, CEPI has participated in several meetings, including in the IMI Stakeholder meeting in Brussels, the World Health Summit in Berlin, the Global Health Security Agenda in Rotterdam, the BARDA industry days in Washington DC as well as a workshop in Berlin on preparedness for health emergencies. The CEPI message has been well received during all briefings, and feedback from a broad group of stakeholders has contributed to further guiding CEPI in achieving our mission.”
John-Arne Røttingen, Interim CEPI CEO
:: Preliminary Business Plan
The Preliminary CEPI Business Plan for the period 2017-2021 is now available on the CEPI website. The plan outlines the strategic direction for CEPI’s work, and can be found here: http://cepi.net/approach.

Industry Watch [to 5 November 2016]
.
:: Pfizer’s Prevenar 13® Receives Approval For Use in Infants and Children in China
Prevenar 13® is Approved to Help Protect Infants and Children Aged Six Weeks to Fifteen Months from Invasive Pneumococcal Disease
November 02, 2016
NEW YORK–(BUSINESS WIRE)–Pfizer China announced today that it has received approval from the Chinese Food and Drug Administration (CFDA) to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13®, in China for active immunization for the prevention of invasive diseases (including bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused by Streptococcus pneumoniae (S. Pneumoniae) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children aged 6 weeks to 15 months. S. pneumoniae is the most common cause of invasive disease as well as pneumonia and upper respiratory tract infections…
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:: Takeda Donates 1 Billion Yen as an Exclusive Partner to the United Nations Foundation for “Global Measles Vaccination for Children” Program
– Aiming at vaccinating 5.4 million children in approximately 40 developing countries –
November 01, 2016
OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited today announced that Takeda will exclusively support “Global Measles Vaccination for Children” by the United Nations Foundation’s Shot@Life campaign. The initiative aims to provide measles vaccination to at least 5.4 million children in approximately 40 developing countries in Africa, Asia, and Latin America over 10 years. We have donated one billion yen to the United Nations Foundation to implement the program…
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:: 17th DCVMN Annual General Meeting – Corporate members elected the new members of the DCVMN Executive Committee and the new elected President is Ms. Mahima Datla, CEO of Biological E, from India.
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PhRMA [to 5 November 2016]
http://www.phrma.org/press-room
Report
New report highlights need to speed patent examination
Mark Grayson November 2, 2016
The Center for the Protection of Intellectual Property released a new report, “The Long Wait for Innovation: The Global Patent Pendency Problem,” documenting the growing global challenge of patent pendency – the length of time a patent application is left pending while under review.

The report found that while every country faces its own unique problems related to the backlog of patent applications, new trends and leaders in patent innovation have emerged. For example, countries such as Korea are strengthening commitments to patent processing and currently experiencing pendency of 2.8 years compared to 6.3 years in India.

Yet several countries are still falling behind the pendency curve. In countries such as Thailand and Brazil, the average time from patent application to approval is 10 years or more. This problem not only affects developing countries, but is a looming challenge in the United States and Europe, both of which are mature economies, governments and bureaucracies…

Introducing New Deliberative Scenario and Facilitator Guide from the Bioethics Commission: “MMR Vaccination in a Local Immigrant Community”
Presidential Commission for the Study of Bioethical Issues
Nov 02, 2016 by Ijeoma Egekeze

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released two new educational materials, Deliberative Scenario: MMR Vaccination in a Local Immigrant Community and Facilitator Guide for Deliberative Scenario: MMR Vaccination in a Local Immigrant Community. This new deliberative scenario and facilitator guide build on the work of two of the Bioethics Commission’s reports, Ethics and Ebola: Public Health Planning and Response (Ethics and Ebola) and Bioethics for Every Generation: Deliberation and Education in Health, Science, and Technology.

This deliberative scenario and facilitator guide draw from contemporary ethical questions and are designed to provide public health professionals with the means to integrate bioethics into public health practice. As outlined in Bioethics for Every Generation, democratic deliberation is a method of decision making that can help groups to identify reasonable options for action when faced with questions or complex topics without a clear consensus about the way forward.

Deliberative Scenario: MMR Vaccination in a Local Immigrant Community highlights contemporary ethical questions about the administration of measles, mumps, and rubella (MMR) vaccinations in immigrant communities, including challenges that might arise when MMR vaccination requirements are linked to access to community resources. This deliberative scenario presents an outline of ethically challenging situations that can be incorporated into deliberation process, providing public health professionals with the opportunity to practice the decision-making method.

The Facilitator Guide for Deliberative Scenario: MMR Vaccination in a Local Immigrant Community includes specific instructions for facilitating deliberations for the situations outlined in this deliberative scenario. This facilitator guide provides public health professionals with specific instructions for facilitating deliberations about the potential social, economic, and cultural effects of vaccination policies on an immigrant community. This guide also includes additional reading based on the roles played in the deliberation.

This new deliberative scenario and facilitator guide introduce public health professionals and public health ethics committees to the process of democratic deliberation. It highlights the benefits of democratic deliberation in developing and implementing public health policies and programs.

Journal Watch

   Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

American Journal of Infection Control
November 2016 Volume 44, Issue 11, p1197-1430, e183-e282
http://www.ajicjournal.org/current

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Major Articles
Social media as a tool for antimicrobial stewardship
Jennifer Pisano, Natasha Pettit, Allison Bartlett, Palak Bhagat, Zhe Han, Chuanhong Liao, Emily Landon
p1231–1236
Published in issue: November 01 2016

National surveillance of health care–associated infections in Egypt: Developing a sustainable program in a resource-limited country
Maha Talaat, Mona El-Shokry, Jehan El-Kholy, Ghada Ismail, Sara Kotb, Soad Hafez, Ehab Attia, Fernanda C. Lessa
p1296–1301
Published online: June 20, 2016
Open Access

Brief Reports
How will the MMR universal mass vaccination change the epidemiologic pattern of mumps? A 2012 Italian serosurvey
Silvio Tafuri, Maria Serena Gallone, Angela Maria Vittoria Larocca, Cinzia Germinario
p1420–1421
Published online: May 2, 2016

American Journal of Tropical Medicine and Hygiene
November 2016; 95 (5)
http://www.ajtmh.org/content/current

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An Outbreak of Fearsome Photos and Headlines: Ebola and Local Newspapers in West Africa
Eric S. Halsey Am J Trop Med Hyg 2016 95:988-992; Published online July 25, 2016, doi:10.4269/ajtmh.16-0245
OPEN ACCESS ARTICLE

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Dengue Dynamics and Vaccine Cost-Effectiveness Analysis in the Philippines
Eunha Shim
Am J Trop Med Hyg 2016 95:1137-1147; Published online September 6, 2016, doi:10.4269/ajtmh.16-0194
Abstract
Dengue is one of the most problematic vector-borne diseases in the Philippines, with an estimated 842,867 cases resulting in medical costs of $345 million U.S. dollars annually. In December 2015, the first dengue vaccine, known as chimeric yellow fever virus–dengue virus tetravalent dengue vaccine, was approved for use in the Philippines and is given to children 9 years of age. To estimate the cost-effectiveness of dengue vaccination in the Philippines, we developed an age-structured model of dengue transmission and vaccination. Using our model, we compared two vaccination scenarios entailing routine vaccination programs both with and without catch-up vaccination. Our results indicate that the higher the cost of vaccination, the less cost-effective the dengue vaccination program. With the current dengue vaccination program that vaccinates children 9 years of age, dengue vaccination is cost-effective for vaccination costs up to $70 from a health-care perspective and up to $75 from a societal perspective. Under a favorable scenario consisting of 1 year of catch-up vaccinations that target children 9–15 years of age, followed by regular vaccination of 9-year-old children, vaccination is cost-effective at costs up to $72 from a health-care perspective and up to $78 from a societal perspective. In general, dengue vaccination is expected to reduce the incidence of both dengue fever and dengue hemorrhagic fever /dengue shock syndrome. Our results demonstrate that even at relatively low vaccine efficacies, age-targeted vaccination may still be cost-effective provided the vaccination cost is sufficiently low.

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Herd Protection from Drinking Water, Sanitation, and Hygiene Interventions
James A. Fuller and
Joseph N. S. Eisenberg
Am J Trop Med Hyg 2016 95:1201-1210; Published online September 6, 2016, doi:10.4269/ajtmh.15-0677
Abstract
Herd immunity arises when a communicable disease is less able to propagate because a substantial portion of the population is immune. Nonimmunizing interventions, such as insecticide-treated bednets and deworming drugs, have shown similar herd-protective effects. Less is known about the herd protection from drinking water, sanitation, and hand hygiene (WASH) interventions. We first constructed a transmission model to illustrate mechanisms through which different WASH interventions may provide herd protection. We then conducted an extensive review of the literature to assess the validity of the model results and identify current gaps in research. The model suggests that herd protection accounts for a substantial portion of the total protection provided by WASH interventions. However, both the literature and the model suggest that sanitation interventions in particular are the most likely to provide herd protection, since they reduce environmental contamination. Many studies fail to account for these indirect effects and thus underestimate the total impact an intervention may have. Although cluster-randomized trials of WASH interventions have reported the total or overall efficacy of WASH interventions, they have not quantified the role of herd protection. Just as it does in immunization policy, understanding the role of herd protection from WASH interventions can help inform coverage targets and strategies that indirectly protect those that are unable to be reached by WASH campaigns. Toward this end, studies are needed to confirm the differential role that herd protection plays across the WASH interventions suggested by our transmission model.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 5 November 2016)

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Research article
Prevalence and epidemiology of meningococcal carriage in Southern Ethiopia prior to implementation of MenAfriVac, a conjugate vaccine
Neisseria meningitidis colonizes humans and transmits mainly by asymptomatic carriage. We sought to determine the prevalence and epidemiology of meningococcal carriage in Ethiopia prio…
Guro K. Bårnes, Paul A. Kristiansen, Demissew Beyene, Bereket Workalemahu, Paulos Fissiha, Behailu Merdekios, Jon Bohlin, Marie-Pierre Préziosi, Abraham Aseffa and Dominique A. Caugant
BMC Infectious Diseases 2016 16:639
Published on: 4 November 2016

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Review
Alternative pre-approved and novel therapies for the treatment of anthrax
Bacillus anthracis, the causative agent of anthrax, is a spore forming and toxin producing rod-shaped bacterium that is classified as a category A bioterror agent. This pathogenic micr...
Breanne M. Head, Ethan Rubinstein and Adrienne F. A. Meyers
BMC Infectious Diseases 2016 16:621
Published on: 3 November 2016

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Research article
Using the 4 pillars™ practice transformation program to increase adult influenza vaccination and reduce missed opportunities in a randomized cluster trial
An evidence-based, step-by-step guide, the 4 Pillars™ Practice Transformation Program, was the foundation of an intervention to increase adult immunizations in primary care and was tested in a randomized contr…
Chyongchiou J. Lin, Mary Patricia Nowalk, Valory N. Pavlik, Anthony E. Brown, Song Zhang, Jonathan M. Raviotta, Krissy K. Moehling, Mary Hawk, Edmund M. Ricci, Donald B. Middleton, Suchita Patel, Jeannette E. South-Paul and Richard K. Zimmerman
BMC Infectious Diseases 2016 16:623
Published on: 3 November 2016

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 5 November 2016)

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Debate
Autonomy of the child in the South African context: is a 12 year old of sufficient maturity to consent to medical treatment?
Wandile Ganya, Sharon Kling and Keymanthri Moodley
Published on: 2 November 2016
Abstract
Background
A child is a developing person with evolving capacities that include autonomy, mental (decisional) capacity and capacity to assume responsibility. Hence, children are entitled to participatory (autonomy) rights in South Africa as observed in the Children’s Act 38 of 2005. According to section 129 of the Act a child may consent to his or her own medical treatment provided that he or she is over the age of 12 years and is of sufficient maturity and decisional capacity to understand the various implications of the treatment including the risks and benefits thereof. However, the Act does not provide a definition for what qualifies as ‘sufficient maturity’ nor does it stipulate how health professionals ought to assess the decisional capacity of a child. In addition, South Africa is a culturally diverse country. The Western liberal notion of autonomy may not necessarily find equal prominence in the mores of people with a different worldview. Hence we demonstrate a few salient comparisons between legal liberal moral theory and African communitarianism as pertinent to the autonomy of the child.
Discussion
Children are rights-holders by virtue of their humanity. Their dignity as individual human persons affords them the entitlement to human rights as contemplated under the Constitution of the Republic of South Africa. However, contrary to the traditional Western notion of individual autonomous persons African societies hold a communalistic notion of person hence there is less regard for individual autonomy and rights with more emphasis on the communal good and maintaining the continuity of relationships and interdependencies shared within a community. A child considered in this view is not regarded as a full person. This implies that decisions concerning the child, including consent to medical treatment are discussed and determined by the community to which the child belongs. Lastly, in this article, we draw on the notion of capacity for responsibility to produce a pragmatic definition of sufficient maturity.
Conclusion
It seems reasonable to suggest a move away from a general legal age of consent for medical treatment toward more individualised, context-specific approaches in determining the maturity of a child patient to consent to medical treatment. Perhaps, decision-making with respect to consent to the medical treatment of a child belonging to a traditional African community where the notion of a person is embedded in communitarianism ought to involve the child’s parents/guardians/caregivers where possible provided that the best interests of the child are awarded priority.

BMC Medicine

(Accessed 5 November 2016)

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Research article
The emerging threat of pre-extensively drug-resistant tuberculosis in West Africa: preparing for large-scale tuberculosis research and drug resistance surveillance
Drug-resistant tuberculosis (TB) is a global public health problem. Adequate management requires baseline drug-resistance prevalence data. In West Africa, due to a poor laboratory infrastructure and inadequate…
Florian Gehre, Jacob Otu, Lindsay Kendall, Audrey Forson, Awewura Kwara, Samuel Kudzawu, Aderemi O. Kehinde, Oludele Adebiyi, Kayode Salako, Ignatius Baldeh, Aisha Jallow, Mamadou Jallow, Anoumou Dagnra, Kodjo Dissé, Essosimna A. Kadanga, Emmanuel Oni Idigbe…
BMC Medicine 2016 14:160
Published on: 3 November 2016

Bulletin of the World Health Organization
Volume 94, Number 11, November 2016, 785-860
http://www.who.int/bulletin/volumes/94/11/en/

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EDITORIALS
Research on community-based health workers is needed to achieve the sustainable development goals
Dermot Maher & Giorgio Cometto
http://dx.doi.org/10.2471/BLT.16.185918

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Elimination of mother-to-child transmission of HIV and syphilis in Cuba and Thailand
Naoko Ishikawa, Lori Newman, Melanie Taylor, Shaffiq Essajee, Razia Pendse & Massimo Ghidinelli
http://dx.doi.org/10.2471/BLT.16.185033

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RESEARCH
Inequalities in full immunization coverage: trends in low- and middle-income countries
María Clara Restrepo-Méndez, Aluísio JD Barros, Kerry LM Wong, Hope L Johnson, George Pariyo, Giovanny VA França, Fernando C Wehrmeister & Cesar G Victora
http://dx.doi.org/10.2471/BLT.15.162172
Abstract
Objective
To investigate disparities in full immunization coverage across and within 86 low- and middle-income countries.
Methods
In May 2015, using data from the most recent Demographic and Health Surveys and Multiple Indicator Cluster Surveys, we investigated inequalities in full immunization coverage – i.e. one dose of bacille Calmette-Guérin vaccine, one dose of measles vaccine, three doses of vaccine against diphtheria, pertussis and tetanus and three doses of polio vaccine – in 86 low- or middle-income countries. We then investigated temporal trends in the level and inequality of such coverage in eight of the countries.
Findings
In each of the World Health Organization’s regions, it appeared that about 56–69% of eligible children in the low- and middle-income countries had received full immunization. However, within each region, the mean recorded level of such coverage varied greatly. In the African Region, for example, it varied from 11.4% in Chad to 90.3% in Rwanda. We detected pro-rich inequality in such coverage in 45 of the 83 countries for which the relevant data were available and pro-urban inequality in 35 of the 86 study countries. Among the countries in which we investigated coverage trends, Madagascar and Mozambique appeared to have made the greatest progress in improving levels of full immunization coverage over the last two decades, particularly among the poorest quintiles of their populations.
Conclusion
Most low- and middle-income countries are affected by pro-rich and pro-urban inequalities in full immunization coverage that are not apparent when only national mean values of such coverage are reported.

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Research
Hepatitis B immunization for indigenous adults, Australia
Andre Louis Wattiaux, J Kevin Yin, Frank Beard, Steve Wesselingh, Benjamin Cowie, James Ward & Kristine Macartney
http://dx.doi.org/10.2471/BLT.16.169524
Abstract
Objective
To quantify the disparity in incidence of hepatitis B between indigenous and non-indigenous people in Australia, and to estimate the potential impact of a hepatitis B immunization programme targeting non-immune indigenous adults.
Methods
Using national data on persons with newly acquired hepatitis B disease notified between 2005 and 2012, we estimated incident infection rates and rate ratios comparing indigenous and non-indigenous people, with adjustments for underreporting. The potential impact of a hepatitis B immunization programme targeting non-immune indigenous adults was projected using a Markov chain Monte Carlo simulation model.
Findings
Of the 54 522 persons with hepatitis B disease notified between 1 January 2005 and 31 December 2012, 1953 infections were newly acquired. Acute hepatitis B infection notification rates were significantly higher for indigenous than non-indigenous Australians. The rates per 100 000 population for all ages were 3.6 (156/4 368 511) and 1.1 (1797/168 449 302) for indigenous and non-indigenous people respectively. The rate ratio of age-standardized notifications was 4.0 (95% confidence interval: 3.7–4.3). If 50% of non-immune indigenous adults (20% of all indigenous adults) were vaccinated over a 10-year programme a projected 527–549 new cases of acute hepatitis B would be prevented.
Conclusion
There continues to be significant health inequity between indigenous and non-indigenous Australians in relation to vaccine-preventable hepatitis B disease. An immunization programme targeting indigenous Australian adults could have considerable impact in terms of cases of acute hepatitis B prevented, with a relatively low number needed to vaccinate to prevent each case.

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POLICY & PRACTICE
Dengue vaccine: local decisions, global consequences
Hugo López-Gatell, Celia M Alpuche-Aranda, José I Santos-Preciado & Mauricio Hernández-Ávila
http://dx.doi.org/10.2471/BLT.15.168765
Abstract
As new vaccines against diseases that are prevalent in low- and middle-income countries gradually become available, national health authorities are presented with new regulatory and policy challenges. The use of CYD-TDV – a chimeric tetravalent, live-attenuated dengue vaccine – was recently approved in five countries. Although promising for public health, this vaccine has only partial and heterogeneous efficacy and may have substantial adverse effects. In trials, children who were aged 2–5 years when first given CYD-TDV were seven times more likely to be hospitalized for dengue, in the third year post-vaccination, than their counterparts in the control group. As it has not been clarified whether this adverse effect is only a function of age or is determined by dengue serostatus, doubts have been cast over the long-term safety of this vaccine in seronegative individuals of any age. Any deployment of the vaccine, which should be very cautious and only considered after a rigorous evaluation of the vaccine’s risk–benefit ratio in explicit national and subnational scenarios, needs to be followed by a long-term assessment of the vaccine’s effects. Furthermore, any implementation of dengue vaccines must not weaken the political and financial support of preventive measures that can simultaneously limit the impacts of dengue and several other mosquito-borne pathogens.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 5 November 2016]

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Research
Assessment of the scope and practice of evaluation among medical donation programs
Alisa M. Jenny, Meng Li, Elizabeth Ashbourne, Myron Aldrink, Christine Funk and Andy Stergachis
Globalization and Health 2016 12:69
Published on: 4 November 2016
Abstract
Background
Medical donation programs for drugs, other medical products, training and other supportive services can improve access to essential medicines in low- and middle-income countries (LMICs) and provide emergency and disaster relief. The scope and extent to which medical donation programs evaluate their impact on recipients and health systems is not well documented.
Methods
We conducted a survey of the member organizations of the Partnership for Quality Medical Donations (PQMD), a global alliance of non-profit and corporate organizations, to identify evaluations conducted in conjunction with donation programs.
Results
Twenty-five out of the 36 PQMD organizations that were members at the time of the survey participated in the study, for a response rate of 69 %. PQMD members provided information on 34 of their major medical donation programs. Half of the donation programs reported conducting trainings as a part of their donation program. Twenty-six (76 %) programs reported that they conduct routine monitoring of their donation programs. Less than 30 % of donation programs were evaluated for their impact on health. Lack of technical staff and lack of funding were reported as key barriers to conducting impact evaluations.
Conclusions
Member organizations of PQMD provide a broad range of medical donations, targeting a wide range of public health issues and events. While some level of monitoring and evaluation was conducted in nearly 80 % of the donation programs, a program’s impact was infrequently evaluated. Opportunities exist to develop consistent metrics for medical donation programs, develop a common framework for impact evaluations, and advocate for data collection and analysis plans that collect meaningful metrics.

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Research
The challenge of bridging the gap between researchers and policy makers: experiences of a Health Policy Research Group in engaging policy makers to support evidence informed policy making in Nigeria
Benjamin Uzochukwu, Obinna Onwujekwe, Chinyere Mbachu, Chinenye Okwuosa, Enyi Etiaba, Monica E. Nyström and Lucy Gilson
Globalization and Health 2016 12:67
Published on: 4 November 2016
Abstract
Background
Getting research into policy and practice (GRIPP) is a process of going from research evidence to decisions and action. To integrate research findings into the policy making process and to communicate research findings to policymakers is a key challenge world-wide. This paper reports the experiences of a research group in a Nigerian university when seeking to ‘do’ GRIPP, and the important features and challenges of this process within the African context.
Methods
In-depth interviews were conducted with nine purposively selected policy makers in various organizations and six researchers from the universities and research institute in a Nigerian who had been involved in 15 selected joint studies/projects with Health Policy Research Group (HPRG). The interviews explored their understanding and experience of the methods and processes used by the HPRG to generate research questions and research results; their involvement in the process and whether the methods were perceived as effective in relation to influencing policy and practice and factors that influenced the uptake of research results.
Results
The results are represented in a model with the four GRIPP strategies found: i) stakeholders’ request for evidence to support the use of certain strategies or to scale up health interventions; ii) policymakers and stakeholders seeking evidence from researchers; iii) involving stakeholders in designing research objectives and throughout the research process; and iv) facilitating policy maker-researcher engagement in finding best ways of using research findings to influence policy and practice and to actively disseminate research findings to relevant stakeholders and policymakers.
The challenges to research utilization in health policy found were to address the capacity of policy makers to demand and to uptake research, the communication gap between researchers, donors and policymakers, the management of the political process of GRIPP, the lack of willingness of some policy makers to use research, the limited research funding and the resistance to change.
Conclusions
Country based Health Policy and Systems Research groups can influence domestic policy makers if appropriate strategies are employed. The model presented gives some direction to potential strategies for getting research into policy and practice in the health care sector in Nigeria and elsewhere.

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 5 November 2016]
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Scoping Review
Alternatives to currently used antimalarial drugs: in search of a magic bullet
Malaria is a major cause of morbidity and mortality in many African countries and parts of Asia and South America. Novel approaches to combating the disease have emerged in recent years and several drug candid…
Akshaya Srikanth Bhagavathula, Asim Ahmed Elnour and Abdulla Shehab
Infectious Diseases of Poverty 2016 5:103
Published on: 4 November 2016

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Research Article
Assessment of the response to cholera outbreaks in two districts in Ghana
Despite recurring outbreaks of cholera in Ghana, very little has been reported on assessments of outbreak response activities undertaken in affected areas. This study assessed the response activities undertake...
Sally-Ann Ohene, Wisdom Klenyuie and Mark Sarpeh
Infectious Diseases of Poverty 2016 5:99
Published on: 2 November 2016

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Research Article
Tuberculosis care strategies and their economic consequences for patients: the missing link to end tuberculosis
While investment in the development of Tuberculosis (TB) treatment strategies is essential, it cannot be assumed that the strategies are affordable for TB patients living in countries with high economic constr…
Belete Getahun, Moges Wubie, Getiye Dejenu and Tsegahun Manyazewal
Infectious Diseases of Poverty 2016 5:93
Published on: 1 November 2016

JAMA
November 1, 2016, Vol 316, No. 17, Pages 1731-1838
http://jama.jamanetwork.com/issue.aspx

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Research Letter
Tdap Vaccination During Pregnancy and Microcephaly and Other Structural Birth Defects in Offspring
Malini DeSilva, MD, MPH; Gabriela Vazquez-Benitez, PhD; James D. Nordin, MD, MPH; et al.
JAMA. 2016;316(17):1823-1825. doi:10.1001/jama.2016.14432
This cohort study uses Vaccine Safety Datalink data to examine associations between maternal Tdap vaccination and structural birth defects in offspring.

Journal of Epidemiology & Community Health
November 2016, Volume 70, Issue 11
http://jech.bmj.com/content/current

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Research report
Factors associated with influenza vaccine uptake during a universal vaccination programme of preschool children in England and Wales: a cohort study
Pia Hardelid, Greta Rait, Ruth Gilbert, Irene Petersen
J Epidemiol Community Health 2016;70:1082-1087 Published Online First: 13 May 2016 doi:10.1136/jech-2015-207014

Journal of Health Care for the Poor and Underserved (JHCPU)
Volume 27, Number 4, November 2016
https://muse.jhu.edu/issue/35214

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Original Papers
How Should We Treat the Vulnerable?: Qualitative Study of Authoritative Ethics Documents
pp. 1656-1673
Ivana Zagorac
Abstract
The aim of this study is to explore what actual guidance is provided by authoritative ethics documents regarding the recognition and protection of the vulnerable. The documents included in this analysis are the Belmont Report, the Declaration of Helsinki, The Council for International Organizations of Medical Sciences (CIOMS) Guidelines, and the UNESCO Universal Declaration on Bioethics and Human Rights, including its supplementary report on vulnerability. A qualitative analysis of these documents was conducted in light of three questions: what is vulnerability, who are the vulnerable, and how should the vulnerable be protected? The results show significant differences among the documents regarding the first two questions. None of the documents provides any guidance on the third question (how to protect the vulnerable). These results suggest a great discrepancy between the acknowledged importance of the concept of vulnerability and a general understanding of the scope, content, and practical implications of vulnerability.

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Brief Communications
Pneumococcal Vaccination in Low-Income Latinos: An Unexpected Trend in Oregon Community Health Centers
pp. 1733-1744
John Heintzman, Steffani R. Bailey, Stuart Cowburn, Eve Dexter, Joseph Carroll, Miguel Marino
Abstract:
Background. In cross-sectional studies, Latino and Spanish-speaking U.S. residents age 65 and over are less likely to receive pneumococcal vaccination than non-Hispanic Whites.
Methods. We performed a time-to-event, cohort analysis, in 23 Oregon community health centers of low-income patients who turned 65 in the study period (2009–2013; n = 1,248). The outcome measure was receipt of PPSV-23 in the study period by race / ethnicity, preferred language, and insurance status.
Results. Insured Latino patients were more likely to receive PPSV-23 than insured non-Hispanic Whites (HR = 2.05, p < .001). Uninsured Latino seniors showed no difference from insured non-Hispanic Whites in PPSV-23 receipt (HR = 1.26, p = .381) unless they averaged fewer than one clinic visit yearly (HR = 1.80, p = .001).
Conclusions. Low-income Latino seniors in Oregon community health centers were immunized against pneumococcus more frequently than insured non-Hispanic Whites, although this finding was mitigated in Latinos without insurance. This finding needs further research in order to reduce adult immunization disparities in the society at large.

Journal of Infectious Diseases
Volume 214 Issue 10 November 15, 2016
http://jid.oxfordjournals.org/content/current

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EDITORIAL COMMENTARIES
Challenges Remain for Influenza Vaccination of Children
J Infect Dis. (2016) 214 (10): 1470-1472 doi:10.1093/infdis/jiw384
Kathryn M. Edwards and Wendy A. Keitel
Extract
Over the past decades, multiple active surveillance and observational studies have demonstrated the major impact of influenza on children and underscored the need for effective vaccines [1–4]. Since 2009, annual influenza vaccination has been recommended for all children ≥6 months of age in the United States [5]. Extensive studies in children have been conducted over the years with both inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIV). Influenza hemagglutination inhibition (HAI) antibody responses are considered to be the gold standard for assessing IIV immunogenicity and serve as the basis for their licensure. Although achievement of HAI antibody titers of ≥40 (putative protective titer) was associated with a 50% reduction in the occurrence of influenza [6, 7], others have proposed that the protective HAI titer is much higher [8]. Furthermore, there can be variability in HAI assay results among laboratories [9]. Cell-mediated immune (CMI) responses have been less well characterized, and no CMI correlate of protection (COP) has been proposed.’

In this issue of The Journal of Infectious Diseases, Reber et al report detailed humoral and CMI responses in 50 children ages 9–14 years after receipt of the 2010–2011 seasonal IIV [10]. In the previous year, 38% of the participants had received influenza vaccine (10% received LAIV and 28% received IIV), and 32% had been immunized with monovalent 2009 pandemic influenza A(H1N1) vaccine. Which vaccine(s) the children had received previously was not noted in the article, and their impact on subsequent immune responses was not assessed because of small sample size. HAI antibody responses were assayed against influenza virus antigens included in both the 2009–2010 and 2010–2011 vaccines, as well as the …

Journal of Medical Ethics
November 2016, Volume 42, Issue 11
http://jme.bmj.com/content/current

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Brief report
Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report
D Carrieri, C Bewshea, G Walker, T Ahmad, W Bowen, A Hall, S Kelly, on behalf of the 7th of October 2015 Exeter Stakeholders Meeting
J Med Ethics 2016;42:695-697 Published Online First: 27 September 2016 doi:10.1136/medethics-2016-103530
Abstract
Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research.

Journal of Medical Internet Research
Vol 18, No 11 (2016): November
http://www.jmir.org/2016/11

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Mobile Health (mhealth)
Can Mobile Phone Apps Influence People’s Health Behavior Change? An Evidence Review
J Med Internet Res 2016 (Nov 02); 18(11):e287
Jing Zhao, Becky Freeman, Mu Li
ABSTRACT
Background: Globally, mobile phones have achieved wide reach at an unprecedented rate, and mobile phone apps have become increasingly prevalent among users. The number of health-related apps that were published on the two leading platforms (iOS and Android) reached more than 100,000 in 2014. However, there is a lack of synthesized evidence regarding the effectiveness of mobile phone apps in changing people’s health-related behaviors. Objective: The aim was to examine the effectiveness of mobile phone apps in achieving health-related behavior change in a broader range of interventions and the quality of the reported studies. Methods: We conducted a comprehensive bibliographic search of articles on health behavior change using mobile phone apps in peer-reviewed journals published between January 1, 2010 and June 1, 2015. Databases searched included Medline, PreMedline, PsycINFO, Embase, Health Technology Assessment, Education Resource Information Center (ERIC), and Cumulative Index to Nursing and Allied Health Literature (CINAHL). Articles published in the Journal of Medical Internet Research during that same period were hand-searched on the journal’s website. Behavior change mechanisms were coded and analyzed. The quality of each included study was assessed by the Cochrane Risk of Bias Assessment Tool. Results: A total of 23 articles met the inclusion criteria, arranged under 11 themes according to their target behaviors. All studies were conducted in high-income countries. Of these, 17 studies reported statistically significant effects in the direction of targeted behavior change; 19 studies included in this analysis had a 65% or greater retention rate in the intervention group (range 60%-100%); 6 studies reported using behavior change theories with the theory of planned behavior being the most commonly used (in 3 studies). Self-monitoring was the most common behavior change technique applied (in 12 studies). The studies suggest that some features improve the effectiveness of apps, such as less time consumption, user-friendly design, real-time feedback, individualized elements, detailed information, and health professional involvement. All studies were assessed as having some risk of bias. Conclusions: Our results provide a snapshot of the current evidence of effectiveness for a range of health-related apps. Large sample, high-quality, adequately powered, randomized controlled trials are required. In light of the bias evident in the included studies, better reporting of health-related app interventions is also required. The widespread adoption of mobile phones highlights a significant opportunity to impact health behaviors globally, particularly in low- and middle-income countries.

Journal of Travel Medicine
Volume 24, Issue 1, July 2016
http://jtm.oxfordjournals.org/content/24/1

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Original Article
Pre-travel advice, attitudes and hepatitis A and B vaccination rates among travellers from seven countries
Anita E. Heywood, Hans Nothdurft, Dominique Tessier, Melissa Moodley, Lars Rombo, Cinzia Marano, Laurence De Moerlooze J Travel Med (2016) 24 (1): taw069 DOI: http://dx.doi.org/10.1093/jtm/taw069 First published online: 13 October 2016 (8 pages)
Abstract
Background: Knowledge about the travel-associated risks of hepatitis A and B, and the extent of pre-travel health-advice being sought may vary between countries.
Methods: An online survey was undertaken to assess the awareness, advice-seeking behaviour, rates of vaccination against hepatitis A and B and adherence rates in Australia, Finland, Germany, Norway, Sweden, the UK and Canada between August and October 2014. Individuals aged 18–65 years were screened for eligibility based on: travel to hepatitis A and B endemic countries within the past 3 years, awareness of hepatitis A, and/or combined hepatitis A&B vaccines; awareness of their self-reported vaccination status and if vaccinated, vaccination within the last 3 years. Awareness and receipt of the vaccines, sources of advice, reasons for non-vaccination, adherence to recommended doses and the value of immunization reminders were analysed.
Results: Of 27 386 screened travellers, 19 817 (72%) were aware of monovalent hepatitis A or combined A&B vaccines. Of these 13 857 (70%) had sought advice from a healthcare provider (HCP) regarding combined hepatitis A&B or monovalent hepatitis A vaccination, and 9328 (67%) were vaccinated. Of 5225 individuals eligible for the main survey (recently vaccinated = 3576; unvaccinated = 1649), 27% (841/3111) and 37% (174/465) of vaccinated travellers had adhered to the 3-dose combined hepatitis A&B or 2-dose monovalent hepatitis A vaccination schedules, respectively. Of travellers partially vaccinated against combined hepatitis A&B or hepatitis A, 84% and 61%, respectively, believed that they had received the recommended number of doses.
Conclusions: HCPs remain the main source of pre-travel health advice. The majority of travellers who received monovalent hepatitis A or combined hepatitis A&B vaccines did not complete the recommended course. These findings highlight the need for further training of HCPs and the provision of reminder services to improve traveller awareness and adherence to vaccination schedules

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Original Article
Refusal of recommended travel-related vaccines among U.S. international travellers in Global TravEpiNet
Sara M. Lammert, Sowmya R. Rao, Emily S. Jentes, Jessica K. Fairley, Stefanie Erskine, Allison T. Walker, Stefan H. Hagmann, Mark J. Sotir, Edward T. Ryan, Regina C. LaRocque J Travel Med (2016) 24 (1): taw075 DOI: http://dx.doi.org/10.1093/jtm/taw075 First published online: 30 October 2016 (7 pages)
Abstract
Background: International travellers are at risk of travel-related, vaccine-preventable diseases. More data are needed on the proportion of travellers who refuse vaccines during a pre-travel health consultation and their reasons for refusing vaccines.
Methods: We analyzed data on travellers seen for a pre-travel health consultation from July 2012 through June 2014 in the Global TravEpiNet (GTEN) consortium. Providers were required to indicate one of three reasons for a traveller refusing a recommended vaccine: (1) cost concerns, (2) safety concerns or (3) not concerned with the illness. We calculated refusal rates among travellers eligible for each vaccine based on CDC recommendations current at the time of travel. We used multivariable logistic regression models to examine the effect of individual variables on the likelihood of accepting all recommended vaccines.
Results: Of 24 478 travellers, 23 768 (97%) were eligible for at least one vaccine. Travellers were most frequently eligible for typhoid (N = 20 092), hepatitis A (N = 12 990) and influenza vaccines (N = 10 539). Of 23 768 eligible travellers, 6573 (25%) refused one or more recommended vaccine(s). Of those eligible, more than one-third refused the following vaccines: meningococcal: 2232 (44%) of 5029; rabies: 1155 (44%) of 2650; Japanese encephalitis: 761 (41%) of 1846; and influenza: 3527 (33%) of 10 539. The most common reason for declining vaccines was that the traveller was not concerned about the illness. In multivariable analysis, travellers visiting friends and relatives (VFR) in low or medium human development countries were less likely to accept all recommended vaccines, compared with non-VFR travellers (OR = 0.74 (0.59–0.95)).
Conclusions: Travellers who sought pre-travel health care refused recommended vaccines at varying rates. A lack of concern about the associated illness was the most commonly cited reason for all refused vaccines. Our data suggest more effective education about disease risk is needed for international travellers, even those who seek pre-travel advice.

The Lancet
Nov 05, 2016 Volume 388 Number 10057 p2209-2322 e12
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
After Bolam: what’s the future for patient consent?
The Lancet
Published: 05 November 2016
“Patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession”, declared the UK Supreme Court in the case of Montgomery vs Lanarkshire Health Board in 2015, affirming the patient as a subject and not simply the object of medical care. Before Montgomery, whether doctors reasonably communicated risks to patients about potential procedures was judged by reference to a responsible body of medical opinion (Bolam test), in line with the paternalistic model of medicine. Since Montgomery, what makes a risk material for a doctor to tell their patient about are the circumstances, views, and values of the individual patient, rather than the opinion of the medical profession.

In response to this renewed emphasis on patients’ rights to self-determination, the Royal College of Surgeons has released new guidance to help surgeons and other health-care professionals to obtain and document consent. Recognising that it is not enough to simply substitute expert opinion with an exhaustive list of potential risks and benefits, the guidance advocates for “supported decision-making”, with a focus on tailoring discussions to individual patients.

Considerable practical challenges loom large, not least of which is time. The guidance states that to determine the content of discussions around risk, doctors should take time to get to know their patients. These discussions need to take place long enough before planned interventions so patients have enough time to reflect, and in particularly complex or potentially life changing scenarios might need to take place over several sessions.

To deal with the new time pressures that this approach will involve, the guidance recommends surgeons raise the issue with their hospital management. But surely, to enable real patient-centred decision making to take root, we must do more than simply tell already time-pressed doctors to find yet more time. Such changes will require cultural and administrative reform at the institutional level. If we want to support patient choice and autonomy, then we must empower our medical professionals with the resources they need to make it happen.

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Series
Maternal Health
Drivers of maternity care in high-income countries: can health systems support woman-centred care?
Dorothy Shaw, Jeanne-Marie Guise, Neel Shah, Kristina Gemzell-Danielsson, KS Joseph, Barbara Levy, Fontayne Wong, Susannah Woodd, Elliott K Main

Maternal Health
Next generation maternal health: external shocks and health-system innovations
Margaret E Kruk, Stephanie Kujawski, Cheryl A Moyer, Richard M Adanu, Kaosar Afsana, Jessica Cohen, Amanda Glassman, Alain Labrique, K Srinath Reddy, Gavin Yamey

Maternal Health
Quality maternity care for every woman, everywhere: a call to action
Marjorie Koblinsky, Cheryl A Moyer, Clara Calvert, James Campbell, Oona M R Campbell, Andrea B Feigl, Wendy J Graham, Laurel Hatt, Steve Hodgins, Zoe Matthews, Lori McDougall, Allisyn C Moran, Allyala K Nandakumar, Ana Langer
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Lancet Global Health
Nov 2016 Volume 4 Number 11 e761-e871
http://www.thelancet.com/journals/langlo/issue/current
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Articles
Feasibility of achieving the 2025 WHO global tuberculosis targets in South Africa, China, and India: a combined analysis of 11 mathematical models
Rein M G J Houben, Nicolas A Menzies, Tom Sumner, Grace H Huynh, Nimalan Arinaminpathy, Jeremy D Goldhaber-Fiebert, Hsien-Ho Lin, Chieh-Yin Wu, Sandip Mandal, Surabhi Pandey, Sze-chuan Suen, Eran Bendavid, Andrew S Azman, David W Dowdy, Nicolas Bacaër, Allison S Rhines, Marcus W Feldman, Andreas Handel, Christopher C Whalen, Stewart T Chang, Bradley G Wagner, Philip A Eckhoff, James M Trauer, Justin T Denholm, Emma S McBryde, Ted Cohen, Joshua A Salomon, Carel Pretorius, Marek Lalli, Jeffrey W Eaton, Delia Boccia, Mehran Hosseini, Gabriela B Gomez, Suvanand Sahu, Colleen Daniels, Lucica Ditiu, Daniel P Chin, Lixia Wang, Vineet K Chadha, Kiran Rade, Puneet Dewan, Piotr Hippner, Salome Charalambous, Alison D Grant, Gavin Churchyard, Yogan Pillay, L David Mametja, Michael E Kimerling, Anna Vassall, Richard G White

Cost-effectiveness and resource implications of aggressive action on tuberculosis in China, India, and South Africa: a combined analysis of nine models
Nicolas A Menzies, Gabriela B Gomez, Fiammetta Bozzani, Susmita Chatterjee, Nicola Foster, Ines Garcia Baena, Yoko V Laurence, Sun Qiang, Andrew Siroka, Sedona Sweeney, Stéphane Verguet, Nimalan Arinaminpathy, Andrew S Azman, Eran Bendavid, Stewart T Chang, Ted Cohen, Justin T Denholm, David W Dowdy, Philip A Eckhoff, Jeremy D Goldhaber-Fiebert, Andreas Handel, Grace H Huynh, Marek Lalli, Hsien-Ho Lin, Sandip Mandal, Emma S McBryde, Surabhi Pandey, Joshua A Salomon, Sze-chuan Suen, Tom Sumner, James M Trauer, Bradley G Wagner, Christopher C Whalen, Chieh-Yin Wu, Delia Boccia, Vineet K Chadha, Salome Charalambous, Daniel P Chin, Gavin Churchyard, Colleen Daniels, Puneet Dewan, Lucica Ditiu, Jeffrey W Eaton, Alison D Grant, Piotr Hippner, Mehran Hosseini, David Mametja, Carel Pretorius, Yogan Pillay, Kiran Rade, Suvanand Sahu, Lixia Wang, Rein M G J Houben, Michael E Kimerling, Richard G White, Anna Vassall

Quality of basic maternal care functions in health facilities of five African countries: an analysis of national health system surveys
Margaret E Kruk, Hannah H Leslie, Stéphane Verguet, Godfrey M Mbaruku, Richard M K Adanu, Ana Langer

Lancet Global Health
Nov 2016 Volume 4 Number 11 e761-e871
http://www.thelancet.com/journals/langlo/issue/current
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Effectiveness of one dose of oral cholera vaccine in response to an outbreak: a case-cohort study
Andrew S Azman, Lucy A Parker, John Rumunu, Fisseha Tadesse, Francesco Grandesso, Lul L Deng, Richard Laku Lino, Bior K Bior, Michael Lasuba, Anne-Laure Page, Lameck Ontweka, Augusto E Llosa, Sandra Cohuet, Lorenzo Pezzoli, Dossou Vincent Sodjinou, Abdinasir Abubakar, Amanda K Debes, Allan M Mpairwe, Joseph F Wamala, Christine Jamet, Justin Lessler, David A Sack, Marie-Laure Quilici, Iza Ciglenecki, Francisco J Luquero
e856
Summary
Background
Oral cholera vaccines represent a new effective tool to fight cholera and are licensed as two-dose regimens with 2–4 weeks between doses. Evidence from previous studies suggests that a single dose of oral cholera vaccine might provide substantial direct protection against cholera. During a cholera outbreak in May, 2015, in Juba, South Sudan, the Ministry of Health, Médecins Sans Frontières, and partners engaged in the first field deployment of a single dose of oral cholera vaccine to enhance the outbreak response. We did a vaccine effectiveness study in conjunction with this large public health intervention.
Methods
We did a case-cohort study, combining information on the vaccination status and disease outcomes from a random cohort recruited from throughout the city of Juba with that from all the cases detected. Eligible cases were those aged 1 year or older on the first day of the vaccination campaign who sought care for diarrhoea at all three cholera treatment centres and seven rehydration posts throughout Juba. Confirmed cases were suspected cases who tested positive to PCR for Vibrio cholerae O1. We estimated the short-term protection (direct and indirect) conferred by one dose of cholera vaccine (Shanchol, Shantha Biotechnics, Hyderabad, India).
Findings
Between Aug 9, 2015, and Sept 29, 2015, we enrolled 87 individuals with suspected cholera, and an 898-person cohort from throughout Juba. Of the 87 individuals with suspected cholera, 34 were classified as cholera positive, 52 as cholera negative, and one had indeterminate results. Of the 858 cohort members who completed a follow-up visit, none developed clinical cholera during follow-up. The unadjusted single-dose vaccine effectiveness was 80·2% (95% CI 61·5–100·0) and after adjusting for potential confounders was 87·3% (70·2–100·0).
Interpretation
One dose of Shanchol was effective in preventing medically attended cholera in this study. These results support the use of a single-dose strategy in outbreaks in similar epidemiological settings.
Funding
Médecins Sans Frontières.

Lancet Global Health
Nov 2016 Volume 4 Number 11 e761-e871
http://www.thelancet.com/journals/langlo/issue/current
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Comment
2016: the beginning of the end of rabies?
Bernadette Abela-Ridder, Lea Knopf, Stephen Martin, Louise Taylor, Gregorio Torres, Katinka De BaloghPublished: 27 September 2016
Open Access
DOI: http://dx.doi.org/10.1016/S2214-109X(16)30245-5
Sept 28 is the tenth annual World Rabies Day. It is a date that commemorates the anniversary of the 1895 death of Louis Pasteur, who developed the first human rabies vaccine. Modern effective vaccines, combined with other interventions, the necessary political will, and community awareness make the disease 100% preventable. Yet, an estimated 59 000 people still die from the disease every year.1 World Rabies Day is thus an uncomfortable reminder for the global health community of the ongoing neglect of this disease. The theme for 2016 is “Educate. Vaccinate. Eliminate”, a slogan that emphasises the pillars of rabies prevention and the vision to end human rabies deaths.

Rabies has no cure, and by the time of clinical onset it is invariably fatal. More than 95% of deaths occur in Africa and Asia, 80% of which are in people living in rural, underserved populations, most of whom are children.2 Community awareness about the power of preventing dog bites and of life-saving human post-exposure prophylaxis is key. 95–99% of human rabies cases are from dog bites, meaning that canine vaccination programmes are crucial if the transmission cycle is to be broken.3 Cross-sectoral solutions from stakeholders in both human and animal health systems are essential for the greatest benefits to be realised.

In December, 2015, WHO, the World Organisation for Animal Health (OIE), the Food and Agriculture Organization (FAO), and the Global Alliance for Rabies Control (GARC) endorsed a global framework to eliminate human deaths from dog-mediated disease by 2030.4 The decision was reinforced by the OIE in May this year.5 A business plan by the key organisations to quantify the costs of reaching zero rabies deaths across the world is under development.
Under our One Health Initiative, WHO, OIE, FAO, and GARC are working on concurrent campaigns to eliminate canine rabies through the vaccination of dogs, the treatment of all potential human rabies exposures with wound washing and post-exposure prophylaxis, and the improvement of education about rabies prevention where it is needed most. By prioritising rabies, our partnership also intends to leverage the global political will needed to eliminate the disease. Reaching zero rabies deaths would contribute towards fulfilling the Sustainable Development Goals, particularly goal 3·3, which targets an end to epidemics of neglected tropical diseases. The goal is ambitious but possible, as evidenced by the progress made in rabies campaigns around the world.4, 6 Such examples of successful multisectoral approaches serve as both a reference and motivation for future campaigns.

Countries will need improved access to high quality and optimally priced dog and human vaccines, as well as to rabies immunoglobulins. Insufficient national forecasting at present means that vaccine requests from countries to manufacturers can be left unfulfilled because of long lead times in production. In such instances, countries are forced to turn to suppliers without quality-assured vaccine. Improvements in supply will help to overcome these difficulties. To match the OIE-led dog rabies vaccine bank,7 WHO is therefore creating a human rabies vaccine stockpile, planned to be operation by the end of next year.

The opportunity of a potential GAVI investment into human rabies vaccine in 2018 has rallied partners and countries to build the evidence base to help inform the investment decision process. Investment from GAVI would be a game changer and substantially increase awareness about this disease and stimulate the necessary political will. With dog vaccination campaigns increasing in reach, the possibility of interrupting rabies transmission will become more tangible. This goal is helped by the availability of online resources such as the Blueprint for Rabies Prevention and Control,8 which offers practical information, expert advice, and case studies to support countries that want to eliminate rabies. FAO and GARC are assisting countries with practical tools for developing their rabies control strategies.9

World Rabies Day increases the awareness about this neglected and horrific disease. It will also make people aware of the realistic ambition of interrupting transmission in dogs and, in turn, the reality of one day eliminating dog-mediated rabies in people. We have all the tools to end this neglected zoonotic disease—what is required is a coordinated effort from all stakeholders at local, national, regional, and global levels to realise the vision of zero human deaths from dog-mediated rabies by 2030.
We declare no competing interests.

Lancet Global Health
Nov 2016 Volume 4 Number 11 e761-e871
http://www.thelancet.com/journals/langlo/issue/current
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Comment
New strategies for cholera control
Louise C Ivers
Open Access
DOI: http://dx.doi.org/10.1016/S2214-109X(16)30257-1
Cholera remains a serious global public health problem, disproportionately affecting poor individuals, causing illness and death for thousands of people each year. Cholera cases are on the rise, with 47% more cases reported to WHO in 2014 than in 2013.1 Innovative approaches to control the disease are urgently needed, and the study by Andrew Azman and colleagues in The Lancet Global Health2 contributes to growing evidence of the important part that oral cholera vaccine strategies have to play in this regard.

Cholera can have devastating consequences, especially in epidemic settings. Azman and colleagues’ study assesses the effectiveness of a single dose of bivalent whole-cell oral cholera vaccine on epidemic cholera in Juba, South Sudan. Typically, this oral cholera vaccine is given in two doses 14 days apart, and studies have shown its efficacy and effectiveness with this dosing schedule.3, 4, 5 However, the use of one dose of vaccine for an outbreak response would reduce costs and double the number of people that could be served, which is especially important considering the global shortage of vaccine that is expected to last for the next few years. Faced with an emerging epidemic of cholera in South Sudan, limited vaccine supply, and some evidence that a single dose of vaccine might give sufficient protection to thwart an epidemic, local public health officials and the non-governmental organisation Médecins Sans Frontières decided to proceed with a single-dose public health oral cholera vaccine campaign in Juba. Public health activities and a research study took place hand in hand.

The study found that the adjusted single-dose vaccine effectiveness was 87·3% (70·2–100·0) for reducing medically attended cholera for up to 2 months. This adds to existing evidence including a randomised study of a single-dose regimen from Bangladesh that found 40% direct effectiveness for reducing all cholera, and 63% direct effectiveness for reducing severely dehydrating cholera at 6 months.6 By contrast, Azman and colleagues used a case-cohort study design in an effort to measure both the direct and indirect protection offered by the vaccine (ie, herd protection), and measured effectiveness in a shorter period. This design makes the study particularly interesting and pertinent to dilemmas in the approach to cholera outbreak control. Debate continues between water, sanitation, and hygiene (WASH) purists, who believe that investments in cholera vaccination campaigns are a distraction from the goal of universal access to water and sanitation, and a more progressive public health community that advocates for a combined approach to cholera control including vaccination and evidence-based WASH interventions. In this context, a study that helps us to measure the herd protection of an oral cholera vaccine strategy is key to understanding the population-level effect and therefore the public health usefulness of oral cholera vaccine (beyond individual protection).

This study is also an excellent example of research in action. Resolving, as the researchers did, to be scientific in the context of rapid decision making and the often chaotic environment of an epidemic response is not straightforward. The context of the study means that the results are particularly useful for understanding the intervention as it might happen in the real world, outside of a formal research setting. More studies like this are needed for us to understand the right approaches for use of cholera vaccine.

Armed with the results of this study, public health officials and implementing organisations in areas where cholera occurs with some frequency should consider the option of using a single-dose vaccination campaign as part of an emergency outbreak response. This should be coupled with good monitoring and evaluation activities to continue to add to our knowledge on the issue.

Importantly, the usefulness of single-dose oral cholera vaccine in cholera-naive populations cannot be presumed on the basis of this study, and the authors acknowledge this fact. The impetus now exists, though, to study the approach in cholera-naive populations. Further questions also emerge that remain to be answered. How long does the protective effect of a single dose of this oral cholera vaccine last in cholera-experienced populations such as Juba? Does a single-dose pre-emptive campaign prevent epidemic outbreaks in susceptible groups such as displaced people? How well protected are subgroups such as young children? What complementary emergency WASH activities at household or community level should be combined with the single-dose approach to ensure durable control of cholera? Would a booster dose sometime after the initial outbreak response contribute to longer-term cholera control? To answer these pragmatic questions, we require continued investment in the global stockpile of cholera vaccine, forward-thinking health officials, and continued assessment of the vaccine’s use.

When the right to universal access to safe water and sanitation is realised, the world will be a better, healthier place—this is not doubted. However, if Haiti is any example, the struggle to execute on water and sanitation ideals is real. Those challenges are related both to the availability of funding, and the ability to deliver WASH interventions in sufficient quantity and quality to interrupt transmission of cholera as a matter of urgency. While the 2016 rainy season brings a surge in cholera cases in Haiti, this study offers one potential vaccination strategy to consider in outbreak responses going forward. We can only wonder what might have happened in Haiti if Azman and colleagues’ research had pre-dated the Haitian cholera outbreak—the largest ongoing cholera outbreak in the world, with more than 10 000 deaths so far.7, 8 Perhaps officials, public health experts, and vaccine manufacturers would have done innovative work together in the early days, and helped to avert a disaster.
I declare no competing interests.

Lancet Global Health
Nov 2016 Volume 4 Number 11 e761-e871
http://www.thelancet.com/journals/langlo/issue/current
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Comment
Putting numbers on the End TB Strategy—an impossible dream?
Olivia Oxlade, Dick Menzies
In 2015, WHO announced a plan to end tuberculosis by 2035 (their End TB Strategy) and set ambitious intermediate targets to reduce tuberculosis incidence by 50% and mortality by 75% by 2025.1 In The Lancet Global Health, two related papers by Rein Houben2 and Nicolas Menzies3 and their colleagues describe the results of a unique international collaboration between 11 different tuberculosis modelling groups, and public health officials from national tuberculosis programmes. They assessed the feasibility, costs, and epidemiological outcomes of country-specific interventions in India, China, and South Africa, and determined that these 10-year targets could be achievable only in South Africa with a combination of continuous isoniazid preventive therapy for individuals on antiretroviral therapy, expanded facility-based screening for symptoms of tuberculosis at health centres, and improved tuberculosis care. In China and India, important reductions could be achieved, but they fell short of the WHO targets.2 All models that considered costs projected the need for massive and sustained increases in government health spending, to more than three times current levels, although most judged that these interventions could be considered cost-effective. Interestingly, all predicted that patients’ costs would be substantially reduced with most interventions.

This project showed the potential value of two innovative collaborations toward achieving global tuberculosis control. First, this investigation was accomplished simultaneously by several different modelling groups and investigators from a total of ten different countries—in itself a major achievement! The modelling groups worked independently, using their preferred modelling approaches, but with similar parameters and assumptions. Readers will usually want to know if the findings are unchanged when key assumptions are varied in sensitivity analyses, and if results are similar in studies published separately by different groups. We think readers should be sceptical, given the grand scale of assumptions made by the investigators of these two studies. In these Articles,2, 3 results from 11 models are presented together—a sort of uber-sensitivity analysis. The results are quite consistent and provide a coherent message, which we find reassuring. The second innovation was the partnership of these modelling teams with personnel from national tuberculosis programmes, who were responsible for the selection of interventions and helping to estimate their expected effects. This should make the results more applicable and realistic for the countries selected, while also enhancing knowledge translation.

For most health-care professionals, infectious-disease modelling is something of a black box. One can see the input assumptions (ie, what goes in) and the outputs (ie, what comes out), but what happens in between seems close to magic. Given their complexity, to understand any one of the models used in these studies is difficult; to understand the strengths and limitations of all 11 models might be beyond the capacity of most (if not all) readers. So, we must therefore accept a little magic, and rely on a careful review of what goes in, to decide if what comes out is credible. And the assumed inputs are a major limitation of these studies, for although the involvement of national tuberculosis programme officials in selecting interventions and targets was a strength, the actual population-level effect, and costs, of the interventions are unknown.
For example, active case finding through chest radiography was the cornerstone of tuberculosis control for decades in high-income countries,4 and interest in active case finding has been revived recently.5 However, scant published evidence of its effect on outcomes, transmission, or its cost-effectiveness is available,6 and therefore mass screening is not recommended by WHO.6 The true costs of these interventions, when applied at national scale, are also unknown.
Estimations of costs extrapolated from small projects might not be accurate for national-level interventions. For example, the finding that scaling up use of the Xpert RIF/MTB assay might simply reflect better information, since the actual costs for national expansion in South Africa have been carefully measured,7 by contrast with the estimated costs for the other interventions. Even feasibility is uncertain, particularly for population-level interventions such as mass chest radiography and isoniazid preventive therapy in South Africa, or partnerships with the rapidly evolving private sector in India.

Overall, however, we feel the investigators used all currently available information, and did a careful and thorough analysis of innovative approaches for global tuberculosis control. Although further research is required to better understand the epidemiological effects and the enormous health-system expenditures that will be needed to implement these interventions on a large scale, this requirement should not obscure two important messages from these studies. First, the consistent finding of substantial savings for patients is a reminder that reducing the tuberculosis burden is all about reducing the burden on patients. And second, that perhaps the goal of ending tuberculosis is not such an impossible dream.

We declare no competing interests.

Lancet Global Health
Nov 2016 Volume 4 Number 11 e761-e871
http://www.thelancet.com/journals/langlo/issue/current

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Editorial
Disease, conflict, and the challenge of elimination in the Americas
The Lancet Global Health
Good news from the Americas illuminated the global health scene in September. As the Ministers of Health from the western hemisphere gathered in Washington, DC, USA, for PAHO’s 55th Directing Council, a series of announcements confirmed the New World’s role as a pioneer of sorts in disease prevention and control. Repeating the pattern that began with smallpox in 1971, polio in 1994, and rubella in 2015, the region of the Americas was declared the first in the world to be free of endemic measles on Sept 27. This feat was achieved through 14 years of unrelenting efforts to reach the farthest pockets of unvaccinated populations and document the end of transmission of a virus that still caused over 110 000 deaths worldwide in 2014, mostly in children under 5 years of age. It is a laudable achievement and a testament to the success of yearly national immunisation campaigns and efforts to educate the populations of the region on the innocuity and efficacy of vaccines. The confidence in this essential global health tool in the countries of the Americas is highlighted in a recent article published in EBioMedicine, which shows that countries of the region reported low levels of scepticism on the dimensions surveyed, including the importance of vaccination and the safety and effectiveness of vaccines. The fact that other countries or regions do not show the same confidence, and the related impact on vaccination coverage, underscore the fragility of the elimination status and the importance of persistently promoting the value of vaccines at the global level.

Achievements such as these educate us on the feasibility of reaching elimination goals. They perhaps also provide additional thrust for efforts towards harder to reach, more uncertain milestones. The Ministers of Health concluded their gathering at PAHO with a set of agreements on the prevention, control, and elimination of diseases in the Americas, including a plan of action for malaria elimination with ambitious goals for the next 4 years. Elimination, if reached, would be a first step in a major global health quest: the eradication of malaria, a disease that currently threatens half of the world’s population, and in 2015 killed almost 500 000 people worldwide. Perhaps the Americas can show us once again how it is done.

While the region celebrated the elimination of one scourge, another—namely the devastating 52-year civil war in Colombia—was also on the brink of history. Over the years, and within the confines of Colombia’s borders, the conflict has touched on many issues that are now at the forefront of global health and development. Rapid urbanisation, fuelled in large part by the displacement of millions fleeing violence, led to the creation of slums and all their related health issues. Those who stayed in conflict zones, many of them of indigenous and African descent, were left in a health services vacuum and now suffer the consequences, on maternal and child health in particular, and in terms of inequalities. A historic peace agreement between the Colombian Government and the Revolutionary Armed Forces of Colombia (FARC) was signed in Cartagena on Sept 26. Yet on Oct 2, the Colombian people narrowly rejected this agreement in a national referendum, sending back to the negotiation table a document considered by some as too lenient towards the FARC.

So the promise of stronger social cohesion and human rights is not to be delivered just yet in Colombia, but the implications of the peace process and their potential impact on health must not be overlooked. Nobody denies the radical impact peace could have on these populations, and the now defunct agreement, negotiated with the active participation of women’s and minority groups in a process deemed by some as a model, had the consideration of health and inequalities threaded throughout its terms. So wherever the process goes in Colombia from this point forward, that experience and the point reached on the way to peace remain a much needed sign of hope in a world where violence is on the rise. War and violence, or the absence thereof, are now integral building blocks of the development agenda since their inclusion in SDG16. In Colombia and elsewhere, peace—just like health—is a delicate balancing act that requires constant work, but we must remain convinced that it is attainable.

The Lancet Infectious Diseases
Nov 2016 Volume 16 Number 11 p1203-1304 e241-e275
http://www.thelancet.com/journals/laninf/issue/current

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Articles
Potential for Zika virus introduction and transmission in resource-limited countries in Africa and the Asia-Pacific region: a modelling study
Isaac I Bogoch, Oliver J Brady, Moritz U G Kraemer, Matthew German, Maria I Creatore, Shannon Brent, Alexander G Watts, Simon I Hay, Manisha A Kulkarni, John S Brownstein, Kamran Khan

The number of privately treated tuberculosis cases in India: an estimation from drug sales data
Nimalan Arinaminpathy, Deepak Batra, Sunil Khaparde, Thongsuanmung Vualnam, Nilesh Maheshwari, Lokesh Sharma, Sreenivas A Nair, Puneet Dewan

Use of standardised patients to assess antibiotic dispensing for tuberculosis by pharmacies in urban India: a cross-sectional study
Srinath Satyanarayana, Ada Kwan, Benjamin Daniels, Ramnath Subbaraman, Andrew McDowell, Sofi Bergkvist, Ranendra K Das, Veena Das, Jishnu Das, Madhukar Pai
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The cascade of care in diagnosis and treatment of latent tuberculosis infection: a systematic review and meta-analysis
Hannah Alsdurf, Philip C Hill, Alberto Matteelli, Haileyesus Getahun, Dick Menzies

Personal View
Affordable HIV drug-resistance testing for monitoring of antiretroviral therapy in sub-Saharan Africa
Seth C Inzaule, Pascale Ondoa, Trevor Peter, Peter N Mugyenyi, Wendy S Stevens, Tobias F Rinke de Wit, Raph L Hamers

Medical Decision Making (MDM)
November 2016; 36 (8)
http://mdm.sagepub.com/content/current

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Original Articles
Quantitative Framework for Retrospective Assessment of Interim Decisions in Clinical Trials
Roger Stanev
Med Decis Making November 2016 36: 999-1010, first published on June 27, 2016 doi:10.1177/0272989X16655346
Abstract
This article presents a quantitative way of modeling the interim decisions of clinical trials. While statistical approaches tend to focus on the epistemic aspects of statistical monitoring rules, often overlooking ethical considerations, ethical approaches tend to neglect the key epistemic dimension. The proposal is a second-order decision-analytic framework. The framework provides means for retrospective assessment of interim decisions based on a clear and consistent set of criteria that combines both ethical and epistemic considerations. The framework is broadly Bayesian and addresses a fundamental question behind many concerns about clinical trials: What does it take for an interim decision (e.g., whether to stop the trial or continue) to be a good decision? Simulations illustrating the modeling of interim decisions counterfactually are provided.

New England Journal of Medicine
November 3, 2016 Vol. 375 No. 18
http://www.nejm.org/toc/nejm/medical-journal

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Original Article
Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention
Mary G. Fowler, M.D., M.P.H., Min Qin, Ph.D., Susan A. Fiscus, Ph.D., Judith S. Currier, M.D., Patricia M. Flynn, M.D., Tsungai Chipato, M.B., Ch.B., M.C.E., James McIntyre, F.R.C.O.G., Devasena Gnanashanmugam, M.D., George K. Siberry, M.D., M.P.H., Anne S. Coletti, M.S., Taha E. Taha, M.D., Ph.D., Karin L. Klingman, M.D., Francis E. Martinson, M.B., Ch.B., Ph.D., Maxensia Owor, M.B., Ch.B., M.P.H., Avy Violari, M.D., Dhayendre Moodley, Ph.D., Gerhard B. Theron, M.D., Ramesh Bhosale, M.D., Raziya Bobat, M.B., Ch.B., M.D., Benjamin H. Chi, M.D., Renate Strehlau, M.B., Ch.B., Pendo Mlay, M.D., Amy J. Loftis, B.S., Renee Browning, R.N., M.S.N., Terence Fenton, Ed.D., Lynette Purdue, Pharm.D., Michael Basar, B.A., David E. Shapiro, Ph.D., and Lynne M. Mofenson, M.D., for the IMPAACT 1077BF/1077FF PROMISE Study Team*
N Engl J Med 2016; 375:1726-1737 November 3, 2016 DOI: 10.1056/NEJMoa1511691
Abstract
Background
Randomized-trial data on the risks and benefits of antiretroviral therapy (ART) as compared with zidovudine and single-dose nevirapine to prevent transmission of the human immunodeficiency virus (HIV) in HIV-infected pregnant women with high CD4 counts are lacking.
Full Text of Background…
Methods
We randomly assigned HIV-infected women at 14 or more weeks of gestation with CD4 counts of at least 350 cells per cubic millimeter to zidovudine and single-dose nevirapine plus a 1-to-2-week postpartum “tail” of tenofovir and emtricitabine (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based ART); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). The primary outcomes were HIV transmission at 1 week of age in the infant and maternal and infant safety.
Full Text of Methods…
Results
The median CD4 count was 530 cells per cubic millimeter among 3490 primarily black African HIV-infected women enrolled at a median of 26 weeks of gestation (interquartile range, 21 to 30). The rate of transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8%; difference, −1.3 percentage points; repeated confidence interval, −2.1 to −0.4). However, the rate of maternal grade 2 to 4 adverse events was significantly higher with zidovudine-based ART than with zidovudine alone (21.1% vs. 17.3%, P=0.008), and the rate of grade 2 to 4 abnormal blood chemical values was higher with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%, P=0.03). Adverse events did not differ significantly between the ART groups (P>0.99). A birth weight of less than 2500 g was more frequent with zidovudine-based ART than with zidovudine alone (23.0% vs. 12.0%, P<0.001) and was more frequent with tenofovir-based ART than with zidovudine alone (16.9% vs. 8.9%, P=0.004); preterm delivery before 37 weeks was more frequent with zidovudine-based ART than with zidovudine alone (20.5% vs. 13.1%, P<0.001). Tenofovir-based ART was associated with higher rates than zidovudine-based ART of very preterm delivery before 34 weeks (6.0% vs. 2.6%, P=0.04) and early infant death (4.4% vs. 0.6%, P=0.001), but there were no significant differences between tenofovir-based ART and zidovudine alone (P=0.10 and P=0.43). The rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART.
Full Text of Results…
Conclusions
Antenatal ART resulted in significantly lower rates of early HIV transmission than zidovudine alone but a higher risk of adverse maternal and neonatal outcomes. (Funded by the National Institutes of Health; PROMISE ClinicalTrials.gov numbers, NCT01061151 and NCT01253538.)

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Editorial
First-in-Human Clinical Trials — What We Can Learn from Tragic Failures
Sergio Bonini, M.D., and Guido Rasi, M.D.
N Engl J Med 2016; 375:1788-1789 November 3, 2016 DOI: 10.1056/NEJMe1609006
This article has no abstract; the first 100 words appear below.
On January 10, 2016, a healthy volunteer who had received 50 mg per day of a fatty acid amide hydrolase (FAAH) inhibitor for 5 days as part of a first-in-human phase 1 clinical trial was admitted to Rennes University Hospital with neurologic and gait disturbances. After a dramatic worsening of neurologic symptoms, the participant died on January 17. Another 5 participants who received the same drug dose for 6 days were subsequently admitted to the hospital, 4 of them with similar neurologic symptoms. In this issue of the Journal, Kerbrat et al.1 report the clinical and imaging findings of the…

Pediatrics
November 2016, VOLUME 138 / ISSUE
http://pediatrics.aappublications.org/content/138/5?current-issue=y
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Articles
School-Located Influenza Vaccinations: A Randomized Trial
Peter G. Szilagyi, Stanley Schaffer, Cynthia M. Rand, Phyllis Vincelli, Ashley Eagan, Nicolas P.N. Goldstein, A. Dirk Hightower, Mary Younge, Aaron Blumkin, Christina S. Albertin, Byung-Kwang Yoo, Sharon G. Humiston
Pediatrics Nov 2016, 138 (5) e20161746; DOI: 10.1542/peds.2016-1746
Abstract
OBJECTIVE: Assess impact of offering school-located influenza vaccination (SLIV) clinics using both Web-based and paper consent upon overall influenza vaccination rates among elementary school children.
METHODS: We conducted a cluster-randomized trial (stratified by suburban/urban districts) in upstate New York in 2014–2015. We randomized 44 elementary schools, selected similar pairs of schools within districts, and allocated schools to SLIV versus usual care (control). Parents of children at SLIV schools were sent information and vaccination consent forms via e-mail, backpack fliers, or both (depending on school preferences) regarding school vaccine clinics. Health department nurses conducted vaccine clinics and billed insurers. For all children registered at SLIV/control schools, we compared receipt of influenza vaccination anywhere (primary outcome).
RESULTS: The 44 schools served 19 776 eligible children in 2014–2015. Children in SLIV schools had higher influenza vaccination rates than children in control schools county-wide (54.1% vs 47.4%, P < .001) and in suburban (61.9% vs 53.6%, P < .001) and urban schools (43.9% vs 39.2%; P < .001). Multivariate analyses (controlling for age, grade, vaccination in previous season) confirmed bivariate findings. Among parents who consented for SLIV, nearly half of those notified by backpack fliers and four-fifths of those notified by e-mail consented online. In suburban districts, SLIV did not substitute for primary care influenza vaccination. In urban schools, some substitution occurred. CONCLUSIONS: SLIV raised seasonal influenza vaccination rates county-wide and in both suburban and urban settings. SLIV did not substitute for primary care vaccinations in suburban settings where pediatricians often preorder influenza vaccine but did substitute somewhat in urban settings. Articles Complementary and Alternative Medicine and Influenza Vaccine Uptake in US Children William K. Bleser, Bilikisu Reni Elewonibi, Patricia Y. Miranda, Rhonda BeLue Pediatrics Nov 2016, 138 (5) e20154664; DOI: 10.1542/peds.2015-4664 Quality Reports Achieving High Adolescent HPV Vaccination Coverage Anna-Lisa M. Farmar, Kathryn Love-Osborne, Katherine Chichester, Kristin Breslin, Kristi Bronkan, Simon J. Hambidge Pediatrics Nov 2016, 138 (5) e20152653; DOI: 10.1542/peds.2015-2653 Abstract BACKGROUND AND OBJECTIVE: Despite national recommendations for adolescent human papillomavirus (HPV) vaccination, rates have lagged behind those of other adolescent vaccines. We implemented interventions and examined rates of vaccination coverage in a large, urban, safety net health care system to understand whether our tactics for achieving high rates of adolescent vaccination were successful. METHODS: Denver Health is an integrated urban safety net health system serving >17 000 adolescents annually. The process for achieving high vaccination rates in our health system includes “bundling” of vaccines, offering vaccines at every visit, and standard orders. Data from vaccine registry and utilization statistics were used to determine vaccination rates in adolescents aged 13 to 17 years from 2004 to 2014, and these findings were compared with state and national rates for 2013. Regression analysis was used to identify characteristics associated with vaccination.
RESULTS: In 2013 (N=11,463), HPV coverage of ≥1 dose was 89.8% (female subjects) and 89.3% (male subjects), compared with national rates of 57.3% and 34.6%. Rates of HPV coverage (≥3 doses) were 66.0% for female subjects and 52.5% for male subjects, versus 37.6% and 13.9% nationally. For both sexes, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, adsorbed, vaccine coverage was 95.9% (86.0% nationally), and meningococcal conjugate vaccine coverage was 93.5% (77.8% nationally). Female subjects, Hispanic subjects, non-English speakers, and teenagers <200% below the federal poverty level were more likely to have received 3 doses of HPV.
CONCLUSIONS: Through low-cost, system-wide standard procedures, Denver Health achieved adolescent vaccination rates well above national coverage rates. Avoiding missed opportunities for vaccination and normalizing the HPV vaccine were key procedures that contributed to high coverage rates.
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Articles
Complementary and Alternative Medicine and Influenza Vaccine Uptake in US Children
William K. Bleser, Bilikisu Reni Elewonibi, Patricia Y. Miranda, Rhonda BeLue
Pediatrics Nov 2016, 138 (5) e20154664; DOI: 10.1542/peds.2015-4664
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Quality Reports
Achieving High Adolescent HPV Vaccination Coverage
Anna-Lisa M. Farmar, Kathryn Love-Osborne, Katherine Chichester, Kristin Breslin, Kristi Bronkan, Simon J. Hambidge
Pediatrics Nov 2016, 138 (5) e20152653; DOI: 10.1542/peds.2015-2653
Abstract
BACKGROUND AND OBJECTIVE: Despite national recommendations for adolescent human papillomavirus (HPV) vaccination, rates have lagged behind those of other adolescent vaccines. We implemented interventions and examined rates of vaccination coverage in a large, urban, safety net health care system to understand whether our tactics for achieving high rates of adolescent vaccination were successful.
METHODS: Denver Health is an integrated urban safety net health system serving >17 000 adolescents annually. The process for achieving high vaccination rates in our health system includes “bundling” of vaccines, offering vaccines at every visit, and standard orders. Data from vaccine registry and utilization statistics were used to determine vaccination rates in adolescents aged 13 to 17 years from 2004 to 2014, and these findings were compared with state and national rates for 2013. Regression analysis was used to identify characteristics associated with vaccination.
RESULTS: In 2013 (N=11,463), HPV coverage of ≥1 dose was 89.8% (female subjects) and 89.3% (male subjects), compared with national rates of 57.3% and 34.6%. Rates of HPV coverage (≥3 doses) were 66.0% for female subjects and 52.5% for male subjects, versus 37.6% and 13.9% nationally. For both sexes, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, adsorbed, vaccine coverage was 95.9% (86.0% nationally), and meningococcal conjugate vaccine coverage was 93.5% (77.8% nationally). Female subjects, Hispanic subjects, non-English speakers, and teenagers <200% below the federal poverty level were more likely to have received 3 doses of HPV.
CONCLUSIONS: Through low-cost, system-wide standard procedures, Denver Health achieved adolescent vaccination rates well above national coverage rates. Avoiding missed opportunities for vaccination and normalizing the HPV vaccine were key procedures that contributed to high coverage rates.