Journal Watch

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.

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Human Papillomavirus Vaccine Uptake: Increase for American Indian Adolescents, 2013–2015

American Journal of Preventive Medicine
August 2017 Volume 53, Issue 2, p139-274, e35-e78

Research Articles
Human Papillomavirus Vaccine Uptake: Increase for American Indian Adolescents, 2013–2015
Jasmine L. Jacobs-Wingo, Cheyenne C. Jim, Amy V. Groom
Published online: February 28, 2017
Although Indian Health Service, tribally-operated, and urban Indian (I/T/U) healthcare facilities have higher human papillomavirus (HPV) vaccine series initiation and completion rates among adolescent patients aged 13–17 years than the general U.S. population, challenges remain. I/T/U facilities have lower coverage for HPV vaccine first dose compared with coverage for other adolescent vaccines, and HPV vaccine series completion rates are lower than initiation rates. Researchers aimed to assist I/T/U facilities in identifying interventions to increase HPV vaccination series initiation and completion rates.
Study design
Best practice and intervention I/T/U healthcare facilities were identified based on baseline adolescent HPV vaccine coverage data. Healthcare professionals were interviewed about barriers and facilitators to HPV vaccination. Researchers used responses and evidence-based practices to identify and assist facilities in implementing interventions to increase adolescent HPV vaccine series initiation and completion. Coverage and interview data were collected from June 2013 to June 2015; data were analyzed in 2015.
I/T/U healthcare facilities located within five Indian Health Service regions.
Interventions included analyzing and providing feedback on facility vaccine coverage data, educating providers about HPV vaccine, expanding access to HPV vaccine, and establishing or expanding reminder recall and education efforts.
Main outcome measures
Impact of evidence-based strategies and best practices to support HPV vaccination.
Mean baseline first dose coverage with HPV vaccine at best practice facilities was 78% compared with 46% at intervention facilities. Mean third dose coverage was 48% at best practice facilities versus 19% at intervention facilities. Intervention facilities implemented multiple low-cost, evidence-based strategies and best practices to increase vaccine coverage. At baseline, most facilities used electronic provider reminders, had standing orders in place for administering HPV vaccine, and administered tetanus, diphtheria, and acellular pertussis and HPV vaccines during the same visit. At intervention sites, mean coverage for HPV initiation and completion increased by 24% and 22%, respectively.
A tailored multifaceted approach addressing vaccine delivery processes and patient and provider education may increase HPV vaccine coverage.

The End of Written Informed Consent for HIV Testing: Not With a Bang but a Whimper

American Journal of Public Health
August 2017  107(8)

The End of Written Informed Consent for HIV Testing: Not With a Bang but a Whimper
Ronald Bayer, Morgan Philbin and Robert H. Remien
107(8), pp. 1259–1265
In 2014, only two states in the United States still mandated specific written informed consent for HIV testing and, after years of controversy, New York ended this requirement, leaving only Nebraska. New York’s shift to opt-out testing meant that a singular feature of what had characterized the exceptionalism surrounding HIV testing was eliminated. We trace the history of debates on written informed consent nationally and in New York State. Over the years of dispute from when HIV testing was initiated in 1985 to 2014, the evidence about the benefits and burdens of written informed consent changed. Just as important was the transformation of the political configuration of HIV advocacy and funding, both nationwide and in New York State. What had for years been the subject of furious debate over what a rational and ethical screening policy required came to an end without the slightest public protest. (Am J Public Health. 2017;107:1259–1265. doi:10.2105/AJPH.2017.303819)

BMC Infectious Diseases (Accessed 29 July 2017)

BMC Infectious Diseases
(Accessed 29 July 2017)

Research article
Knowledge and perceptions about Zika virus in a Middle East country
Zika virus, an emerging serious infectious disease, is a threat to persons living or travelling to regions where it is currently endemic, and also to contacts of infected individuals. The aim of this study was…
Sohaila Cheema, Patrick Maisonneuve, Ingmar Weber, Luis Fernandez-Luque, Amit Abraham, Hekmat Alrouh, Javaid Sheikh, Albert B. Lowenfels and Ravinder Mamtani
BMC Infectious Diseases 2017 17:524
Published on: 26 July 2017

Research article
A cross-sectional sero-survey on preoperative HBV vaccination policy in Poland
A two-dose preoperative vaccination schedule against HBV has been the widely accepted policy in Poland. However, its effectiveness has not yet been assessed.
Maria Ganczak, Marcin Korzen, Alina Jurewicz and Zbigniew Szych
BMC Infectious Diseases 2017 17:515
Published on: 25 July 2017

The public health value of vaccines beyond efficacy: methods, measures and outcomes

BMC Medicine
(Accessed 29 July 2017)

The public health value of vaccines beyond efficacy: methods, measures and outcomes
Wilder-Smith, I. Longini, P. L. Zuber, T. Bärnighausen, W. J. Edmunds, N. Dean, V. Masserey Spicher, M. R. Benissa and B. D. Gessner
BMC Medicine 2017 15:138
Published on: 26 July 2017
Assessments of vaccine efficacy and safety capture only the minimum information needed for regulatory approval, rather than the full public health value of vaccines. Vaccine efficacy provides a measure of proportionate disease reduction, is usually limited to etiologically confirmed disease, and focuses on the direct protection of the vaccinated individual. Herein, we propose a broader scope of methods, measures and outcomes to evaluate the effectiveness and public health impact to be considered for evidence-informed policymaking in both pre- and post-licensure stages.
Pre-licensure: Regulatory concerns dictate an individually randomised clinical trial. However, some circumstances (such as the West African Ebola epidemic) may require novel designs that could be considered valid for licensure by regulatory agencies. In addition, protocol-defined analytic plans for these studies should include clinical as well as etiologically confirmed endpoints (e.g. all cause hospitalisations, pneumonias, acute gastroenteritis and others as appropriate to the vaccine target), and should include vaccine-preventable disease incidence and ‘number needed to vaccinate’ as outcomes.
Post-licensure: There is a central role for phase IV cluster randomised clinical trials that allows for estimation of population-level vaccine impact, including indirect, total and overall effects. Dynamic models should be prioritised over static models as the constant force of infection assumed in static models will usually underestimate the effectiveness and cost-effectiveness of the immunisation programme by underestimating indirect effects. The economic impact of vaccinations should incorporate health and non-health benefits of vaccination in both the vaccinated and unvaccinated populations, thus allowing for estimation of the net social value of vaccination.
The full benefits of vaccination reach beyond direct prevention of etiologically confirmed disease and often extend across the life course of a vaccinated person, prevent outcomes in the wider community, stabilise health systems, promote health equity, and benefit local and national economies. The degree to which vaccinations provide broad public health benefits is stronger than for other preventive and curative interventions.

Ethics review in compassionate use

BMC Medicine
(Accessed 29 July 2017)

Ethics review in compassionate use
Jan Borysowski, Hans-Jörg Ehni and Andrzej Górski
BMC Medicine 2017 15:136
Published on: 24 July 2017
Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particularly that approval by a research ethics committee (institutional review board) is a requirement for compassionate use in some countries (e.g. the US, Spain, and Italy), but not in others (e.g. Canada, the UK, France, and Germany).
The main objective of this article is to present aspects of compassionate use that are important for the discussion of the role of research ethics committees in the review of compassionate use. These aspects include the nature of compassionate use, potential risks to patients associated with the use of drugs with unproven safety and efficacy, informed consent, physicians’ qualifications, and patient selection criteria. Our analysis indicates that the arguments for mandatory review substantially outweigh the arguments to the contrary.
Approval by a research ethics committee should be obligatory for compassionate use. The principal argument against mandatory ethical review of compassionate use is that it is primarily a kind of treatment rather than biomedical research. Nonetheless, compassionate use is different from standard clinical care and should be subject to review by research ethics committees. First, in practice, compassionate use often involves significant research aspects. Second, it is based on unapproved drugs with unproven safety and efficacy. Obtaining informed consent from patients seeking access to unapproved drugs on a compassionate use basis may also be difficult. Other important problems include the qualifications of the physician who is to perform treatment, and patient selection criteria.

Characterizing expanded access and compassionate use programs for experimental drugs

BMC Research Notes
(Accessed 29 July 2017)

Research note
Characterizing expanded access and compassionate use programs for experimental drugs
We sought to determine the characteristics of “expanded access” and “compassionate use” programs registered in and to determine the percentage of drugs provided through these programs that u…
Jennifer E. Miller, Joseph S. Ross, Kenneth I. Moch and Arthur L. Caplan
BMC Research Notes 2017 10:350
Published on: 28 July 2017