Harmonisation of Zika virus research protocols to address key public health concerns

Kerkhove, Maria D. Van; Revéiz, Ludovic; Souza, João Paulo; Jaenisch, Thomas; Carson, Gail; Broutet, Nathalie

doi:10.1016/s2214-109x(16)30255-8

Cited by 20 publications

(24 citation statements)

References 3 publications

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“…Further, all of the protocols include a standardized questionnaire [36] to ensure standardization of collection of information on symptoms and other relevant information. Questionnaires were specifically developed for each of the six zika standardized research protocols based on existing case report forms [16, 36]. …”

Section: Findings and Discussionmentioning

confidence: 99%

“…Additionally, relevant stakeholders attempted to minimize the potential biases found in observational studies through the development of the six standardized research protocols that were created during the ZIKV research consultation in May 2016 and face-to-face meeting in Mexico City, Mexico in June 2016 [16]. These meetings permitted discussions on how to best manage common biases in observational epidemiological studies of ZIKV and allowed authors to consider the potential bias found in observational research.…”

Section: Methodsmentioning

confidence: 99%

“…Given the severity of the current outbreak, numerous countries have quickly developed epidemiological studies to assess ZIKV and its potential health consequences [16]. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization (WHO), Pan American Health Organization (PAHO), Institut Pasteur, the Consortium for the Standardization of Influenza Seroepidemiology (CONSISE), Fiocruz, the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) and others joined efforts to harmonize current research through discussions on ongoing research on ZIKV and associated complications.…”

Section: Introductionmentioning

confidence: 99%

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Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols

et al. 2017

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IntroductionGiven the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV.MethodsWe conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols.ResultsObservational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design.ConclusionObservational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at different stages of the study. Biases need to be considered by researchers implementing the standardized protocols as well as by users of observational epidemiological studies of ZIKV.

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Section: Findings and Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols

et al. 2017

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“…Since establishment of sylvatic cycles would change the fate of ZIKV and CHIKV in the Americas, samples that are geographically representative and cover the large genetic diversity of Neotropical NHP are urgently needed. Because sampling of NHP in the wild is restricted for ethical and financial reasons ( 51 ), multicenter studies joining groups and animal samples in analogy to prospective cohort studies investigating congenital Zika disease in humans ( 52 ) would be highly desirable. If indeed NHP were not involved in sylvatic transmission cycles in Latin America, other wildlife or peri-domestic animals might fill this ecological niche, highlighting the relevance of targeted epidemiological investigations of Neotropical animals for infection with ZIKV and CHIKV.…”

Section: Discussionmentioning

confidence: 99%

Limited Evidence for Infection of Urban and Peri-urban Nonhuman Primates with Zika and Chikungunya Viruses in Brazil

Moreira-Soto

Carneiro

Fischer

et al. 2018

mSphere

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Since 2013, Zika virus (ZIKV) and chikungunya virus (CHIKV) have infected millions of people in the Americas via urban transmission cycles. Nonhuman primates (NHP) are involved in sylvatic transmission cycles maintaining ZIKV and CHIKV in the Old World. We tested NHP sampled during 2012 to 2017 in urban and peri-urban areas severely affected by ZIKV and CHIKV in Brazil. Seroprevalence and antibody titers were low for both viruses. Additionally, we found evidence for infection by heterologous viruses eliciting cross-reactive antibodies. Our data suggest that urban or peri-urban NHP are not easily infected by ZIKV and CHIKV despite intense local transmission. These data may imply that the ZIKV and CHIKV outbreaks in the Americas cannot be sustained in urban or peri-urban NHP once human population immunity limits urban transmission cycles. Investigation of diverse animals is urgently required to determine the fate of the ZIKV and CHIKV outbreaks in the Americas.

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“…Table 2 defines the key clinical research questions identified from each theme. This table was modelled after a publication describing harmonisation of Zika virus protocols [6]. Themes appear in order based on how many SARS and MERS articles attempted to address a question within that theme.…”

Section: Sars-cov and Mers-cov Systematic Reviewmentioning

confidence: 99%

An evidence-based framework for priority clinical research questions for COVID-19

Harris¹,

Carson²,

Baillie³

et al. 2020

Journal of Global Health

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Background On 31 December, 2019, the World Health Organization China Country Office was informed of cases of pneumonia of unknown aetiology. Since then, there have been over 75 000 cases globally of the 2019 novel coronavirus (COVID-19), 2000 deaths, and over 14 000 cases recovered. Outbreaks of novel agents represent opportunities for clinical research to inform real-time public health action. In 2018, we conducted a systematic review to identify priority research questions for Severe Acute Respiratory Syndrome-related coronavirus (SARS-CoV) and Middle East Respiratory Syndrome-related coronavirus (MERS-CoV). Here, we review information available on COVID-19 and provide an evidenced-based framework for priority clinical research in the current outbreak. Methods Three bibliographic databases were searched to identify clinical studies published on SARS-CoV and MERS-CoV in the outbreak setting. Studies were grouped thematically according to clinical research questions addressed. In February 2020, available information on COVID19 was reviewed and compared to the results of the SARS-CoV and MERS-CoV systematic review. Results From the research objectives for SARS-CoV and MERS-CoV, ten themes in the literature were identified: Clinical characterisation, prognosis, diagnosis, clinical management, viral pathogenesis, epidemiological characterisation, infection prevention and control/transmission, susceptibility, psychosocial, and aetiology. For COVID19, some information on clinical presentation, diagnostic testing, and aetiology is available but many clinical research gaps have yet to be filled. Conclusions Based on a systematic review of other severe coronaviruses, we summarise the state of clinical research for COVID-19, highlight the research gaps, and provide recommendations for the implementation of standardised protocols. Databased on internationally standardised protocols will inform clinical practice real-time.

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Harmonisation of Zika virus research protocols to address key public health concerns

Cited by 20 publications

References 3 publications

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols

Limited Evidence for Infection of Urban and Peri-urban Nonhuman Primates with Zika and Chikungunya Viruses in Brazil

An evidence-based framework for priority clinical research questions for COVID-19

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