An Inactivated Virus Candidate Vaccine to Prevent COVID-19

JAMA
September 8, 2020, Vol 324, No. 10, Pages 919-1016
https://jamanetwork.com/journals/jama/currentissue

 

Editorial
An Inactivated Virus Candidate Vaccine to Prevent COVID-19
Mark J. Mulligan, MD
… In summary, this preliminary report by Xia et al10 provides important interim safety, tolerability, and immune response results for a β-propiolactone–inactivated whole-virus vaccine against COVID-19. These interim data are of interest given the urgent global need for protective COVID-19 vaccines. With 7.8 billion individuals worldwide at risk for SARS-CoV-2 infection and COVID-19 morbidity and mortality, humanity needs as many safe and protective COVID-19 vaccines as possible.

Unwavering Regulatory Safeguards for COVID-19 Vaccines

JAMA
September 8, 2020, Vol 324, No. 10, Pages 919-1016
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Unwavering Regulatory Safeguards for COVID-19 Vaccines
Anand Shah, MD; Peter W. Marks, MD, PhD; Stephen M. Hahn, MD
free access has active quiz has multimedia has audio
JAMA. 2020;324(10):931-932. doi:10.1001/jama.2020.15725
This Viewpoint from the FDA reviews the minimum safety and efficacy standards COVID-19 vaccine candidates would need to meet to be considered for approval, and affirms its commitments to evaluating both in diverse populations and to postmarketing surveillance as means to ensure that approval will meet the highest safety and regulatory standards based on science and evidence, not politics.

Improving Physician Communication About Treatment Decisions – Reconsideration of “Risks vs Benefits”

JAMA
September 8, 2020, Vol 324, No. 10, Pages 919-1016
https://jamanetwork.com/journals/jama/currentissue

 

Improving Physician Communication About Treatment Decisions – Reconsideration of “Risks vs Benefits”
Daniel J. Morgan, MD; Laura D. Scherer, PhD; Deborah Korenstein, MD
has audio
JAMA. 2020;324(10):937-938. doi:10.1001/jama.2020.0354
This Viewpoint emphasizes the importance of precise language to help patients make evidence-informed decisions in shared decision-making, and argues that references to “chances of harms and benefits” will be more understandable to patients than discussions of “probabilities of risks and benefits.”
Conversations with Dr Bauchner: Changing Language to Improve Physician Communication About Treatment Decisions

Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19)

JAMA Pediatrics
September 2020, Vol 174, No. 9, Pages 815-916
http://archpedi.jamanetwork.com/issue.aspx

 

Viewpoint
Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19)
Thomas J. Hwang, AB; Adrienne G. Randolph, MD, MSc; Florence T. Bourgeois, MD, MPH
free access
JAMA Pediatr. 2020;174(9):825-826. doi:10.1001/jamapediatrics.2020.1888
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.

Incidence of Meningococcal Disease Before and After Implementation of Quadrivalent Meningococcal Conjugate Vaccine in the United States

JAMA Pediatrics
September 2020, Vol 174, No. 9, Pages 815-916
http://archpedi.jamanetwork.com/issue.aspx

 

Original Investigation
Incidence of Meningococcal Disease Before and After Implementation of Quadrivalent Meningococcal Conjugate Vaccine in the United States
Sarah Mbaeyi, MD, MPH; Tracy Pondo, MSPH; Amy Blain, MPH; et al.
JAMA Pediatr. 2020;174(9):843-851. doi:10.1001/jamapediatrics.2020.1990
This cohort study examines the association between quadrivalent meningococcal conjugate vaccination and the incidence of meningococcal disease in US adolescents.

Association Between Human Papillomavirus Vaccination School-Entry Requirements and Vaccination Initiation

JAMA Pediatrics
September 2020, Vol 174, No. 9, Pages 815-916
http://archpedi.jamanetwork.com/issue.aspx

 

Association Between Human Papillomavirus Vaccination School-Entry Requirements and Vaccination Initiation
Jamie S. Ko, MPH; Cameron S. Goldbeck, MS; Eleonore B. Baughan, BS; et al.
has active quiz
JAMA Pediatr. 2020;174(9):861-867. doi:10.1001/jamapediatrics.2020.1852
This cross-sectional study examines initiation of human papillomavirus vaccination in US jurisdictions with vs those without policies requiring vaccination for school entry.

A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing

Journal of Empirical Research on Human Research Ethics
Volume 15 Issue 4, October 2020
http://journals.sagepub.com/toc/jre/current

Empirical Studies on Research Integrity and Research Misconduct
A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing
Rebekah McWhirter, Lisa Eckstein, Don Chalmers, Christine Critchley, Jane Nielsen, Margaret Otlowski, Dianne Nicol
First Published May 19, 2020; pp. 355–364

The Urgent Need for Transparent and Accountable Procurement of Medicine and Medical Supplies in Times of COVID-19 Pandemic

Journal of Pharmaceutical Policy and Practice
https://joppp.biomedcentral.com/
[Accessed 12 Sep 2020]

 

Commentary
The Urgent Need for Transparent and Accountable Procurement of Medicine and Medical Supplies in Times of COVID-19 Pandemic
Authors: Jillian Clare Kohler and Tom Wright
11 September 2020
Abstract
The COVID-19 pandemic has unleashed unprecedented and complex public policy issues. One that has emerged as a challenge for many countries globally is how to ensure the efficient and effective procurement of quality medical supplies. Existing corruption pressures on procurement—everything from undue influence to the outright bribery of public officials—has been amplified by the pandemic, and thus demands commensurate policy responses. We argue that transparency and accountability in procurement are essential to preventing the corruption risks that threaten the health and well-being of populations.

Chronic comorbidities in children and adolescents with perinatally acquired HIV infection in sub-Saharan Africa in the era of antiretroviral therapy

The Lancet Child & Adolescent Health
Aug 2020 Volume 4 Number 8 p555-640, e26-e34
https://www.thelancet.com/journals/lanchi/issue/current

 

Review
Chronic comorbidities in children and adolescents with perinatally acquired HIV infection in sub-Saharan Africa in the era of antiretroviral therapy
Lisa J Frigati, et al

Potential impact of the COVID-19 pandemic on HIV, tuberculosis, and malaria in low-income and middle-income countries: a modelling study

Lancet Global Health
Sep 2020 Volume 8 Number 9 e1101-e1241
http://www.thelancet.com/journals/langlo/issue/current

 

Articles
Potential impact of the COVID-19 pandemic on HIV, tuberculosis, and malaria in low-income and middle-income countries: a modelling study
Alexandra B Hogan, et al
Summary
Background
COVID-19 has the potential to cause substantial disruptions to health services, due to cases overburdening the health system or response measures limiting usual programmatic activities. We aimed to quantify the extent to which disruptions to services for HIV, tuberculosis, and malaria in low-income and middle-income countries with high burdens of these diseases could lead to additional loss of life over the next 5 years.
Methods
Assuming a basic reproduction number of 3·0, we constructed four scenarios for possible responses to the COVID-19 pandemic: no action, mitigation for 6 months, suppression for 2 months, or suppression for 1 year. We used established transmission models of HIV, tuberculosis, and malaria to estimate the additional impact on health that could be caused in selected settings, either due to COVID-19 interventions limiting activities, or due to the high demand on the health system due to the COVID-19 pandemic.
Findings
In high-burden settings, deaths due to HIV, tuberculosis, and malaria over 5 years could increase by up to 10%, 20%, and 36%, respectively, compared with if there was no COVID-19 pandemic. The greatest impact on HIV was estimated to be from interruption to antiretroviral therapy, which could occur during a period of high health system demand. For tuberculosis, the greatest impact would be from reductions in timely diagnosis and treatment of new cases, which could result from any prolonged period of COVID-19 suppression interventions. The greatest impact on malaria burden could be as a result of interruption of planned net campaigns. These disruptions could lead to a loss of life-years over 5 years that is of the same order of magnitude as the direct impact from COVID-19 in places with a high burden of malaria and large HIV and tuberculosis epidemics.
Interpretation
Maintaining the most critical prevention activities and health-care services for HIV, tuberculosis, and malaria could substantially reduce the overall impact of the COVID-19 pandemic.
Funding
Bill & Melinda Gates Foundation, Wellcome Trust, UK Department for International Development, and Medical Research Council.

Mapping geographical inequalities in access to drinking water and sanitation facilities in low-income and middle-income countries, 2000–17

Lancet Global Health
Sep 2020 Volume 8 Number 9 e1101-e1241
http://www.thelancet.com/journals/langlo/issue/current

 

Mapping geographical inequalities in access to drinking water and sanitation facilities in low-income and middle-income countries, 2000–17
Local Burden of Disease WaSH Collaborators

Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial

Lancet Infectious Diseases
Sep 2020 Volume 20 Number 9 p993-1100, e215-e249
http://www.thelancet.com/journals/laninf/issue/current

 

Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial
Hanqing He, et al

Parental intent to initiate and complete the human papillomavirus vaccine series in the USA: a nationwide, cross-sectional survey

Lancet Public Health
Sep 2020 Volume 5 Number 9 e460-e511
https://www.thelancet.com/journals/lanpub/issue/current

 

Articles
Parental intent to initiate and complete the human papillomavirus vaccine series in the USA: a nationwide, cross-sectional survey
Kalyani Sonawane, Yenan Zhu, Jane R Montealegre, David R Lairson, Cici Bauer, Lindy U McGee, Anna R Giuliano, Ashish A Deshmukh

Population Health in the Time of COVID‐19: Confirmations and Revelations

The Milbank Quarterly
A Multidisciplinary Journal of Population Health and Health Policy

 

Volume 98, Issue 3 Pages: 619-1020 September 2020
https://onlinelibrary.wiley.com/toc/14680009/current
Perspectives Free Access
Population Health in the Time of COVID‐19: Confirmations and Revelations
ANA V. DIEZ ROUX
Pages: 629-640
First Published: 18 August 2020
Milbank Quarterly Classics

Don’t ignore genetic data from minority populations

Nature
Volume 585 Issue 7824, 10 September 2020
http://www.nature.com/nature/current_issue.html

 

Comment | 08 September 2020
Don’t ignore genetic data from minority populations
Efforts to build representative studies are defeated when scientists discard data from certain groups. Instead, researchers should work to balance statistical needs with fairness.
Chief Ben-Eghan, Rosie Sun[…] & Simon Gravel

Illuminating the dark spaces of healthcare with ambient intelligence

Nature
Volume 585 Issue 7824, 10 September 2020
http://www.nature.com/nature/current_issue.html

 

Review Article | 09 September 2020
Illuminating the dark spaces of healthcare with ambient intelligence
Albert Haque, Arnold Milstein & Li Fei-Fei
Abstract
Advances in machine learning and contactless sensors have given rise to ambient intelligence—physical spaces that are sensitive and responsive to the presence of humans. Here we review how this technology could improve our understanding of the metaphorically dark, unobserved spaces of healthcare. In hospital spaces, early applications could soon enable more efficient clinical workflows and improved patient safety in intensive care units and operating rooms. In daily living spaces, ambient intelligence could prolong the independence of older individuals and improve the management of individuals with a chronic disease by understanding everyday behaviour. Similar to other technologies, transformation into clinical applications at scale must overcome challenges such as rigorous clinical validation, appropriate data privacy and model transparency. Thoughtful use of this technology would enable us to understand the complex interplay between the physical environment and health-critical human behaviours.

Massive data initiatives and AI provide testbed for pandemic forecasting

Nature Biotechnology
Volume 38 Issue 9, 1 September 2020
https://www.nature.com/nbt/volumes/38/issues/9

 

News | 04 September 2020
Massive data initiatives and AI provide testbed for pandemic forecasting
Initiatives to gather massive epidemiological datasets aim to cut through national COVID-19 stats in a bid to understand the new coronavirus and aid public health policymakers.
Cormac Sheridan

Guidelines for AI in clinical trials

Nature Medicine
Volume 26 Issue 9, 1 September 2020
https://www.nature.com/nm/volumes/26/issues/9

 

Guidelines for AI in clinical trials
The image on the cover illustrates the potential of artificial intelligence (AI) to enhance healthcare delivery. In this issue, new extensions of SPIRIT and CONSORT guidelines dedicated to randomized clinical trials involving AI delineate the reporting standards for these interventions, and Nimri and colleagues report the results of a randomized clinical trial evaluating the performance of an AI for optimizing insulin dosing in patients with type 1 diabetes.

Welcoming new guidelines for AI clinical research

Nature Medicine
Volume 26 Issue 9, 1 September 2020
https://www.nature.com/nm/volumes/26/issues/9

 

Comment | 09 September 2020
Welcoming new guidelines for AI clinical research
With only a limited number of clinical trials of artificial intelligence in medicine thus far, the first guidelines for protocols and reporting arrive at an opportune time. Better protocol design, along with consistent and complete data presentation, will greatly facilitate interpretation and validation of these trials, and will help the field to move forward.
Eric J. Topol

Minimum information about clinical artificial intelligence modeling: the MI-CLAIM checklist

Nature Medicine
Volume 26 Issue 9, 1 September 2020
https://www.nature.com/nm/volumes/26/issues/9

 

Comment | 09 September 2020
Minimum information about clinical artificial intelligence modeling: the MI-CLAIM checklist
Here we present the MI-CLAIM checklist, a tool intended to improve transparent reporting of AI algorithms in medicine.
Beau Norgeot, Giorgio Quer[…] & Atul J. Butte

Clinical research underlies ethical integration of healthcare artificial intelligence

Nature Medicine
Volume 26 Issue 9, 1 September 2020
https://www.nature.com/nm/volumes/26/issues/9

 

Comment | 09 September 2020
Clinical research underlies ethical integration of healthcare artificial intelligence
Familiar concepts from research ethics can guide the meaningful and rigorous translation of artificial intelligence (AI) tools into clinical practice.
Melissa D. McCradden, Elizabeth A. Stephenson & James A. Anderson

Those designing healthcare algorithms must become actively anti-racist

Nature Medicine
Volume 26 Issue 9, 1 September 2020
https://www.nature.com/nm/volumes/26/issues/9

 

Comment | 09 September 2020
Those designing healthcare algorithms must become actively anti-racist
Many widely used health algorithms have been shown to encode and reinforce racial health inequities, prioritizing the needs of white patients over those of patients of color. Because automated systems are becoming so crucial to access to health, researchers in the field of artificial intelligence must become actively anti-racist. Here we list some concrete steps to enable anti-racist practices in medical research and practice.
Kellie Owens & Alexis Walker

The ethics of deferred consent in times of pandemics

Nature Medicine
Volume 26 Issue 9, 1 September 2020
https://www.nature.com/nm/volumes/26/issues/9

 

Comment | 10 July 2020
The ethics of deferred consent in times of pandemics
In the current COVID-19 pandemic, many researchers are applying to research ethics committees for deferred-consent procedures for protocols that aim either to test treatments or to obtain tissue or samples from research participants. However, the deferred-consent procedure has not been developed for pandemics. In this Comment, we interpret existing guidance documents and argue when and under which conditions deferred consent can be considered ethically acceptable in a pandemic.
Rieke van der Graaf, Marie-Astrid Hoogerwerf  & Martine C. de Vries

Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension

Nature Medicine
Volume 26 Issue 9, 1 September 2020
https://www.nature.com/nm/volumes/26/issues/9

 

Consensus Statements
Consensus Statement | 09 September 2020 | Open Access
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension
The CONSORT-AI and SPIRIT-AI extensions improve the transparency of clinical trial design and trial protocol reporting for artificial intelligence interventions.
Samantha Cruz Rivera, Xiaoxuan Liu[…] & Samuel Rowley

Consensus Statement | 09 September 2020 | Open Access
Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension
The CONSORT-AI and SPIRIT-AI extensions improve the transparency of clinical trial design and trial protocol reporting for artificial intelligence interventions.
Xiaoxuan Liu, Samantha Cruz Rivera[…] & Samuel Rowley

How digital tools can advance quality and equity in genomic medicine

Nature Reviews Genetics
Volume 21 Issue 9, 1 September 2020
https://www.nature.com/nrg/volumes/21/issues/9

 

Comment | 29 June 2020
How digital tools can advance quality and equity in genomic medicine
As highlighted by the COVID-19 pandemic, digital solutions are becoming essential for the provision of clinical genetics services. However, as this Comment emphasizes, the use of digital tools alone can exacerbate genomic and technological disparities and must be balanced with the merits of face-to-face interactions.
Yvonne Bombard & Robin Z. Hayeems

Antitumour dendritic cell vaccination in a priming and boosting approach

Nature Reviews Drug Discovery
Volume 19 Issue 9, 1 September 2020
https://www.nature.com/nrd/volumes/19/issues/9

 

Perspective | 06 August 2020
Antitumour dendritic cell vaccination in a priming and boosting approach
Dendritic cell vaccines have been widely investigated as a type of cancer immunotherapy, but their promise has not yet been realized. Kandalaft and colleagues propose that a prime and boost approach — primed with either standard therapies or dendritic cell vaccines and boosted with a personalized synthetic vaccine — could help fulfil the potential of such vaccines. They discuss improvements in dendritic cell vaccines that have enabled prime–boost approaches, as well as challenges for adoption.
Alexandre Harari, Michele Graciotti[…] & Lana E. Kandalaft

Changes in the HIV continuum of care following expanded access to HIV testing and treatment in Indonesia: A retrospective population-based cohort study

PLoS One
http://www.plosone.org/

 

Research Article
Changes in the HIV continuum of care following expanded access to HIV testing and treatment in Indonesia: A retrospective population-based cohort study
Yane N. Tarigan, Richard J. Woodman, Emma R. Miller, Rudi Wisaksana, F. Stephen Wignall, Paul R. Ward
Research Article | published 11 Sep 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0239041

Social media engagement association with human papillomavirus and vaccine awareness and perceptions: Results from the 2017 US Health Information National Trends Survey

Preventive Medicine
Volume 138 September 2020
https://www.sciencedirect.com/journal/preventive-medicine/vol/137/suppl/C

 

Research article Abstract only
Social media engagement association with human papillomavirus and vaccine awareness and perceptions: Results from the 2017 US Health Information National Trends Survey
Brittany L. Rosen, Christopher Wheldon, Erika L. Thompson, Sarah Maness, Philip M. Massey
Article 106151

Social media engagement association with human papillomavirus and vaccine awareness and perceptions: Results from the 2017 US Health Information National Trends Survey

Preventive Medicine
Volume 138 September 2020
https://www.sciencedirect.com/journal/preventive-medicine/vol/137/suppl/C

 

Research article Abstract only
Social media engagement association with human papillomavirus and vaccine awareness and perceptions: Results from the 2017 US Health Information National Trends Survey
Brittany L. Rosen, Christopher Wheldon, Erika L. Thompson, Sarah Maness, Philip M. Massey
Article 106151