Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements

Journal of Empirical Research on Human Research Ethics
Volume 16 Issue 5, December 2021
http://journals.sagepub.com/toc/jre/current

 

IRB/Performance and functioning
Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements
Min-Fu Tsan
First Published May 14, 2021; pp. 479–484

Invited Peer Commentary: Min-Fu Tsan: Improving the Quality and Performance of Institutional Review Boards in the U.S. Through Performance Measurement

Journal of Empirical Research on Human Research Ethics
Volume 16 Issue 5, December 2021
http://journals.sagepub.com/toc/jre/current

 

Invited Peer Commentary: Min-Fu Tsan: Improving the Quality and Performance of Institutional Review Boards in the U.S. Through Performance Measurement
Ryan Spellecy
First Published September 7, 2021; pp. 485–486

A Systematic Literature Review of Ethical Challenges Related to Medical and Public Health Data Sharing in China

Journal of Empirical Research on Human Research Ethics
Volume 16 Issue 5, December 2021
http://journals.sagepub.com/toc/jre/current

 

Ethical Issues in Data Sharing and Data Banks
A Systematic Literature Review of Ethical Challenges Related to Medical and Public Health Data Sharing in China
Xiaojie LI
First Published September 13, 2021; pp. 537–554

Unequal impact of the COVID-19 crisis on minority ethnic groups: a framework for understanding and addressing inequalities

Journal of Epidemiology & Community Health
October 2021 – Volume 75 – 10
https://jech.bmj.com/content/75/10

 

COVID-19
Unequal impact of the COVID-19 crisis on minority ethnic groups: a framework for understanding and addressing inequalities (21 April, 2021)
Srinivasa Vittal Katikireddi, Sham Lal, Enitan D Carrol, Claire L Niedzwiedz, Kamlesh Khunti, Ruth Dundas, Finn Diderichsen, Ben Barr

Restoring Immunization Services Provided by the Vaccines for Children Program in Puerto Rico After Hurricanes Irma and Maria, 2017-2019

Journal of Public Health Management & Practice
November/December 2021 – Volume 27 – Issue 6
https://journals.lww.com/jphmp/pages/currenttoc.aspx

 

Research Reports
Restoring Immunization Services Provided by the Vaccines for Children Program in Puerto Rico After Hurricanes Irma and Maria, 2017-2019
Luna-Pinto, S. Carolina; Rivera, Angel; Cardona, Iris; More
Journal of Public Health Management and Practice. 27(6):E228-E235, November/December 2021.

The Lancet and Financial Times Commission on governing health futures 2030: growing up in a digital world

The Lancet
Nov 06, 2021 Volume 398 Number 10312 p1663-1776
https://www.thelancet.com/journals/lancet/issue/current

 

The Lancet Commissions
The Lancet and Financial Times Commission on governing health futures 2030: growing up in a digital world
Ilona Kickbusch,et al. on behalf of the Secretariat of the Lancet and Financial Times Commission
Executive summary
From the short-term and long-term effects of the COVID-19 pandemic to the health insecurities brought about by climate change, health futures are unfolding in an era of accelerating economic, societal, technological, and environmental changes. Digital transformations, which we define as the multifaceted processes of integration of digital technologies and platforms into all areas of life, including health, are central to understanding—and shaping—many of these disruptive dynamics. Because large gaps remain in the current evidence base on the interface of digital technologies and health, taking a precautionary, mission-oriented, and value-based approach to its governance is crucial…

Digital technologies: a new determinant of health

Lancet Digital Health
Nov 2021 Volume 3 Number 11 e684-e750
https://www.thelancet.com/journals/landig/issue/current

 

Editorial
Digital technologies: a new determinant of health
The Lancet Digital Health
The Lancet and Financial Times have published a Commission with recommendations for successful integration of digital technologies in health. The bottom line of the Commission is that weak governance of digital technologies is causing health inequities and compromising human rights. This finding is compounded by the fact that many companies are expanding their reach into the health sector, collating and analysing health and personal data. The future governance of digital technologies in health care “must be driven by public purpose, not private profit”. But how can this be achieved when private corporations have such a large and vested interest in health data?
One of the key recommendations of the Commission is the need for data solidarity, an approach to the collection and use of health data with the aim of “building a culture of data justice and equity”…

The false hope of current approaches to explainable artificial intelligence in health care

Lancet Digital Health
Nov 2021 Volume 3 Number 11 e684-e750
https://www.thelancet.com/journals/landig/issue/current

 

Viewpoint
The false hope of current approaches to explainable artificial intelligence in health care
Marzyeh Ghassemi, Luke Oakden-Rayner, Andrew L Beam
Summary
The black-box nature of current artificial intelligence (AI) has caused some to question whether AI must be explainable to be used in high-stakes scenarios such as medicine. It has been argued that explainable AI will engender trust with the health-care workforce, provide transparency into the AI decision making process, and potentially mitigate various kinds of bias. In this Viewpoint, we argue that this argument represents a false hope for explainable AI and that current explainability methods are unlikely to achieve these goals for patient-level decision support. We provide an overview of current explainability techniques and highlight how various failure cases can cause problems for decision making for individual patients. In the absence of suitable explainability methods, we advocate for rigorous internal and external validation of AI models as a more direct means of achieving the goals often associated with explainability, and we caution against having explainability be a requirement for clinically deployed models.

High anti-SARS-CoV-2 antibody seroconversion rates before the second wave in Manaus, Brazil, and the protective effect of social behaviour measures: results from the prospective DETECTCoV-19 cohort

Lancet Global Health
Nov 2021 Volume 9 Number 11 e1474-e1622
https://www.thelancet.com/journals/langlo/issue/current

 

Articles
High anti-SARS-CoV-2 antibody seroconversion rates before the second wave in Manaus, Brazil, and the protective effect of social behaviour measures: results from the prospective DETECTCoV-19 cohort
Pritesh Lalwani, et al. and the DETECTCoV-19 Study Team

Vaccine effectiveness of the first dose of ChAdOx1 nCoV-19 and BNT162b2 against SARS-CoV-2 infection in residents of long-term care facilities in England (VIVALDI): a prospective cohort study

Lancet Infectious Diseases
Nov 2021 Volume 21 Number 11 p1471-1612, e341-e362
https://www.thelancet.com/journals/laninf/issue/current

 

Articles
Vaccine effectiveness of the first dose of ChAdOx1 nCoV-19 and BNT162b2 against SARS-CoV-2 infection in residents of long-term care facilities in England (VIVALDI): a prospective cohort study
Madhumita Shrotri, et al.
Open Access

Effectiveness of BNT162b2 and ChAdOx1 nCoV-19 COVID-19 vaccination at preventing hospitalisations in people aged at least 80 years: a test-negative, case-control study

Lancet Infectious Diseases
Nov 2021 Volume 21 Number 11 p1471-1612, e341-e362
https://www.thelancet.com/journals/laninf/issue/current

 

Effectiveness of BNT162b2 and ChAdOx1 nCoV-19 COVID-19 vaccination at preventing hospitalisations in people aged at least 80 years: a test-negative, case-control study
Catherine Hyams, et al.

The effect of BCG revaccination on all-cause mortality beyond infancy: 30-year follow-up of a population-based, double-blind, randomised placebo-controlled trial in Malawi

Lancet Infectious Diseases
Nov 2021 Volume 21 Number 11 p1471-1612, e341-e362
https://www.thelancet.com/journals/laninf/issue/current

 

The effect of BCG revaccination on all-cause mortality beyond infancy: 30-year follow-up of a population-based, double-blind, randomised placebo-controlled trial in Malawi
Judith R Glynn, et al.
Open Access

Optimal human papillomavirus vaccination strategies to prevent cervical cancer in low-income and middle-income countries in the context of limited resources: a mathematical modelling analysis

Lancet Infectious Diseases
Nov 2021 Volume 21 Number 11 p1471-1612, e341-e362
https://www.thelancet.com/journals/laninf/issue/current

 

Optimal human papillomavirus vaccination strategies to prevent cervical cancer in low-income and middle-income countries in the context of limited resources: a mathematical modelling analysis
Mélanie Drolet, et al.
Open Access

Safety, reactogenicity, and immunogenicity of homologous and heterologous prime-boost immunisation with ChAdOx1 nCoV-19 and BNT162b2: a prospective cohort study

Lancet Respiratory Medicine
Nov 2021 Volume 9 Number 11 p1203-1342, e104-e109
https://www.thelancet.com/journals/lanres/issue/current

 

Articles
Safety, reactogenicity, and immunogenicity of homologous and heterologous prime-boost immunisation with ChAdOx1 nCoV-19 and BNT162b2: a prospective cohort study
David Hillus, et al.

SARS-CoV-2 B.1.617.2 Delta variant replication and immune evasion

Nature
Volume 599 Issue 7883, 4 November 2021
https://www.nature.com/nature/volumes/599/issues/7883

 

Article | 06 September 2021 | Open Access
SARS-CoV-2 B.1.617.2 Delta variant replication and immune evasion
A study of SARS-CoV-2 variants examining their transmission, infectivity, and potential resistance to therapies provides insights into the biology of the Delta variant and its role in the global pandemic.
Petra Mlcochova, Steven A. Kemp, Ravindra K. Gupta

Misuse of the term ‘trans-ethnic’ in genomics research

Nature Genetics
Volume 53 Issue 11, November 2021
https://www.nature.com/ng/volumes/53/issues/11

 

Comment | 05 November 2021
Misuse of the term ‘trans-ethnic’ in genomics research
A concerning trend in genetics is the common use of the term ‘trans-ethnic’ to describe analyses that combine or compare several ancestrally diverse populations. In this commentary, we discuss how this term is inaccurate and alienating. We propose that geneticists avoid using the term trans-ethnic entirely and that researchers across disciplines reach a new consensus about the best terms to use to describe the populations we study.
Mireille Kamariza, Lorin Crawford, Hilary Finucane

Negative impact of the COVID-19 pandemic on routine childhood immunization: experience from Pakistan

Nature Reviews Immunology
Volume 21 Issue 11, November 2021
https://www.nature.com/nri/volumes/21/issues/11

 

Comment | 14 September 2021
Negative impact of the COVID-19 pandemic on routine childhood immunization: experience from Pakistan
Muhammad Suleman Rana and colleagues from the National Institute of Health in Pakistan discuss the urgent need to implement catch-up vaccination programmes for measles and polio to prevent resurgence of these deadly diseases.
Muhammad Suleman Rana, Aamer Ikram, Massab Umair

mRNA vaccines for infectious diseases: principles, delivery and clinical translation

Nature Reviews Drug Discovery
Volume 20 Issue 11, November 2021
https://www.nature.com/nrd/volumes/20/issues/11

 

Review Article | 25 August 2021
mRNA vaccines for infectious diseases: principles, delivery and clinical translation
The COVID-19 pandemic has established mRNA vaccines as a rapid, effective and safe approach for the protection of individuals from infectious disease. Here, Whitehead and colleagues review the principles of mRNA vaccine design, synthesis and delivery, assessing recent progress and key issues in the development of mRNA vaccines for a range of infectious diseases.
Namit Chaudhary, Drew Weissman, Kathryn A. Whitehead

SARS-CoV-2 Antibodies in Breast Milk After Vaccination

Pediatrics
Vol. 148, Issue 5 1 Nov 2021
https://pediatrics.aappublications.org/

 

Articles
SARS-CoV-2 Antibodies in Breast Milk After Vaccination
Dolores Sabina Romero Ramírez, María Magdalena Lara Pérez, Mercedes Carretero Pérez, María Isis Suárez Hernández, Saúl Martín Pulido, Lorena Pera Villacampa, Ana María Fernández Vilar, Mónica Rivero Falero, Paloma González Carretero, Beatriz Reyes Millán, Sabine Roper, Miguel Ángel García Bello
Pediatrics, Nov 2021, 148 (5) e2021052286

COVID-19 Vaccination–Associated Myocarditis in Adolescents

Pediatrics
Vol. 148, Issue 5 1 Nov 2021
https://pediatrics.aappublications.org/

 

COVID-19 Vaccination–Associated Myocarditis in Adolescents
Supriya S. Jain, Jeremy M. Steele, Brian Fonseca, Sihong Huang, Sanket Shah, Shiraz A. Maskatia, Sujatha Buddhe, Nilanjana Misra, Preeti Ramachandran, Lasya Gaur, Parham Eshtehardi, Shafkat Anwar, Neeru Kaushik, Frank Han, Nita Ray Chaudhuri, Lars Grosse-Wortmann
Pediatrics, Nov 2021, 148 (5) e2021053427

COVID-19 Vaccine Uptake Among US Child Care Providers

Pediatrics
Vol. 148, Issue 5 1 Nov 2021
https://pediatrics.aappublications.org/

 

Open Access
COVID-19 Vaccine Uptake Among US Child Care Providers
Kavin M. Patel, Amyn A. Malik, Aiden Lee, Madeline Klotz, John Eric Humphries, Thomas Murray, David Wilkinson, Mehr Shafiq, Inci Yildirim, Jad A. Elharake, Rachel Diaz, Chin Reyes, Saad B. Omer, Walter S. Gilliam
Pediatrics, Nov 2021, 148 (5) e2021053813

Is the BNT162b2 COVID-19 vaccine effective in elderly populations? Results from population data from Bavaria, Germany

PLoS One
http://www.plosone.org/
[Accessed 06 Nov 2021]

 

Research Article
Is the BNT162b2 COVID-19 vaccine effective in elderly populations? Results from population data from Bavaria, Germany
Delphina Gomes, Andreas Beyerlein, Katharina Katz, Gabriele Hoelscher, Uta Nennstiel, Bernhard Liebl, Klaus Überla, Rüdiger von Kries
Research Article | published 05 Nov 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0259370

National variability in Americans’ COVID-19 protective behaviors: Implications for vaccine roll-out

PLoS One
http://www.plosone.org/
[Accessed 06 Nov 2021]

 

National variability in Americans’ COVID-19 protective behaviors: Implications for vaccine roll-out
John A. Schneider, Bruce G. Taylor, Anna L. Hotton, Phoebe A. Lamuda, Jonathan Ozik, Qinyun Lin, Elizabeth Flanagan, Mai Tuyet Pho, Marynia Kolak, Russell Brewer, Jade Pagkas-Bather, Harold A. Pollack
Research Article | published 05 Nov 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0259257

Detecting and describing stability and change in COVID-19 vaccine receptibility in the United Kingdom and Ireland

PLoS One
http://www.plosone.org/
[Accessed 06 Nov 2021]

 

Detecting and describing stability and change in COVID-19 vaccine receptibility in the United Kingdom and Ireland
Philip Hyland, Frédérique Vallières, Todd K. Hartman, Ryan McKay, Sarah Butter, Richard P. Bentall, Orla McBride, Mark Shevlin, Kate Bennett, Liam Mason, Jilly Gibson-Miller, Liat Levita, Anton P. Martinez, Thomas V. A. Stocks, Thanos Karatzias, Jamie Murphy
Research Article | published 03 Nov 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0258871

COVID-19 vaccine hesitancy in underserved communities of North Carolina

PLoS One
http://www.plosone.org/
[Accessed 06 Nov 2021]

 

COVID-19 vaccine hesitancy in underserved communities of North Carolina
Irene A. Doherty, William Pilkington, Laurin Brown, Victoria Billings, Undi Hoffler, Lisa Paulin, K. Sean Kimbro, Brittany Baker, Tianduo Zhang, Tracie Locklear, Seronda Robinson, Deepak Kumar
Research Article | published 01 Nov 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0248542

Opinion: The importance of offering vaccine choice in the fight against COVID-19

PNAS – Proceedings of the National Academy of Sciences of the United States
October 26, 2021; vol. 118 no. 43
https://www.pnas.org/content/118/43

 

Front Matter
Opinion: The importance of offering vaccine choice in the fight against COVID-19
Mark T. Hughes, Paul G. Auwaerter, Michael R. Ehmann, Brian T. Garibaldi, Sherita H. Golden, Ting-Jia Lorigiano, Katie J. O’Conor, Allen Kachalia, and Jeffrey Kahn
PNAS October 26, 2021 118 (43) e2117185118;
https://doi.org/10.1073/pnas.2117185118

Disruption of health services for pregnant women, newborns, children, adolescents, and women during the COVID-19 pandemic: ISLAC 2020 Project

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

 

3 Nov 2021
Disruption of health services for pregnant women, newborns, children, adolescents, and women during the COVID-19 pandemic: ISLAC 2020 Project
Original research | Spanish |

Evidence Gaps and Challenges in the Fight Against COVID-19 in Africa: Scoping Review of the Ethiopian Experience

Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 06 Nov 2021]

 

Review
Evidence Gaps and Challenges in the Fight Against COVID-19 in Africa: Scoping Review of the Ethiopian Experience
Gudina EK, Siebeck M, Eshete MT
Risk Management and Healthcare Policy 2021, 14:4511-4521
Published Date: 4 November 2021

A new lane for science

Science
Volume 374| Issue 6568| 5 Nov 2021
https://www.science.org/toc/science/current

 

Editorial
A new lane for science
Enola K. Proctor and Elvin Geng
A recent Science editorial on the social and political headwinds that have blunted, obfuscated, and confused public behavior in the United States’ COVID-19 response cautioned both politicians who appoint themselves scientists and scientists—including virologists and epidemiologists—to stay in their lanes. The warning raises an important question: Should science add another lane?

Despite the remarkable development of safe and effective vaccines, only about two-thirds of Americans have received their first dose. Even nonmedical actions (social distancing and masking) supported by rigorous evidence are met with widespread indifference, resistance, and rage. Unfortunately, this number is the rule rather than the exception. Broadly, Americans receive about 55% of clinical interventions known to benefit their health.

To address this failing, science needs to add another lane—one called implementation research. Implementation scientists move beyond medication and device development and study how to facilitate their use by clinics, front-line health care providers, patients, communities, and policy- makers. Public health failures that could have been avoided, as well as successes attributable to this science, illustrate the importance of this work. The use of beta-blockers after myocardial infarction was proven to reduce mortality in a 1982 trial, but 15 years later, only 34% of Americans hospitalized with a heart attack were discharged with a prescription for these drugs, and the practice was not universally adopted until 2007. In HIV prevention research, numerous randomized trials in Africa found that adult male circumcision reduces HIV transmission. However, its use remained low despite the World Health

Organization’s endorsement and massive donor-funded work to scale up surgical capacity. A recent randomized trial in Tanzania showed that the engagement of pastors—who are influential community opinion leaders—boosted the acceptability and uptake of circumcision in men, demonstrating the value of social influence in implementation.

Similar research on how to expand the use of proven COVID-19 interventions is underway but must be scaled up substantially to address pressing questions: What strategies lead to vaccine acceptability, feasibility, fidelity, equity, scale-up, and spread? What social marketing messages are most effective? Who are the best opinion leaders? How can health systems overcome delays in identifying mildly ill outpatients eligible for monoclonal antibodies? Data are emerging about how to equip vaccine champions with the resources necessary to train others, build coalitions, and optimize organizations to administer vaccines as widely as possible. But more must be done, especially given the current politicized pandemic response and frayed social fabric.

Society needs a lane of science that studies rapid uptake of proven interventions. Questions pursued in implementation research require cross-disciplinary collaborations among scientists who understand communication, marketing, anthropology, economics, and social psychology—disciplines that have not historically interacted with one another.

Three steps would contribute to a better pandemic response now and in the years ahead. The US National Institutes of Health (NIH) should create an Office of Implementation Research with funding that institutes must compete for, modeled on the Office of AIDS Research. The office would study emerging interventions and address obstacles to their use. Insights would guide health delivery, making learning-while-doing a standard. The office should support innovations that track rates of intervention use (vaccination and effective therapeutics) and capture the strategies leading to their uptake. And the NIH should support networks for implementation research, similar to the AIDS Clinical Trials Group. At least 10% of the NIH budget should be dedicated to this work. If this seems expensive, consider the costs of not taking these steps: Effective interventions that are not used optimally will fail to reap value from existing investments.

COVID-19 has shown the world that “knowing what to do” does not ensure “doing what we know.” It demonstrates that intervention discovery is the start, not the end, of the scientific journey. There is no better time for science to establish a new lane, one devoted to ensuring that our nation’s health discoveries are used to improve population health. The headwinds demand nothing less.

Adolescent Health Series: HPV infection and vaccination in sub-Saharan Africa: 10 years of research in Tanzanian female adolescents – narrative review

Tropical Medicine & International Health
Volume 26, Issue 11 Pages: i-iv, 1325-1525 November 2021
https://onlinelibrary.wiley.com/toc/13653156/current

 

SERIES ON ADOLESCENT HEALTH
Adolescent Health Series: HPV infection and vaccination in sub-Saharan Africa: 10 years of research in Tanzanian female adolescents – narrative review
Hilary Whitworth, John Changalucha, Kathy Baisley, Deborah Watson-Jones
Pages: 1345-1355
First Published: 26 July 2021

Characteristics associated with COVID-19 vaccine hesitancy: A nationwide survey of 1000 patients with immune-mediated inflammatory diseases

Vaccine
Volume 39, Issue 44 Pages 6451-6564 (22 October 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/44

 

Short communication Full text access
Characteristics associated with COVID-19 vaccine hesitancy: A nationwide survey of 1000 patients with immune-mediated inflammatory diseases
Rodrigo Poubel Vieira Rezende, Alessandra S. Braz, Maria Fernanda B. Guimarães, Sandra Lúcia E. Ribeiro, … Marcelo M. Pinheiro
Pages 6454-6459