To conduct the research reviews, the scientists will use a “tailored version” of the National Toxicology Program’s OHAT risk of bias rating tool “for evaluating individual study risk of bias or internal validity – the assessment of whether the design and conduct of a study compromised the credibility of the link between exposure and outcome” (1-3). This tool has been recommended for assessing risk of bias in human environmental epidemiology studies (Eick et al., 2021; see abstract below).
“The extent to which particular scientific results constitute progress in knowledge or contribute to societal well-being is often contested. This is especially the case when scientific findings are uncertain or controversial and when they can be interpreted to support controversial policy choices….Assessing science, no matter how rigorous the methods that may be used, is ultimately a matter of interpretation. The possibility of competing interpretations of evidence is ever-present when using science indicators or applying any other analytic method for measuring the progress and impact of science.” (4)
(1) National Toxicology Program. Handbook for Conducting Systematic Reviews for Health Effects Evaluations. https://ntp.niehs.nih.gov/
(2) National Toxicology Program. Handbook for Conducting a Literature-Based Health Assessment Using OHAT Approach for Systematic Review and Evidence Integration (March 4, 2019): https://ntp.niehs.nih.gov/ntp/
(3) National Toxicology Program. 2019 OHAT Handbook Update and Clarification Summary Document (March 4, 2019). https://ntp.niehs.nih.gov/ntp/
Research Protocols for Radiofrequency EHC Reviews
Susanna Lagorio, Maria Blettner, Dan Baaken, Maria Feychting, Ken Karipidis, Tom Loney, Nicola Orsini, Martin Röösli, Marilia Silva Paulo, Mark Elwood. The effect of exposure to radiofrequency fields on cancer risk in the general and working population: A protocol for a systematic review of human observational studies. Environ Int. 2021 Aug 22;157:106828. doi: 10.1016/j.envint.2021.106828.
• A systematic review of all subject-relevant epidemiological studies is now needed.
• A detailed protocol ensures the review’s transparency, utility and credibility.
• Original study validity will be evaluated with a customized OHAT risk of bias tool.
• Internal coherence and external plausibility will inform conclusions.
Abstract
Background: The World Health Organization (WHO) has an ongoing project to assess potential health effects of exposure to radiofrequency electromagnetic fields (RF-EMF) in the general and working population. Here we present the protocol for a systematic review of the scientific literature on cancer hazards from exposure to RF-EMF in humans, commissioned by the WHO as part of that project.
Objective: To assess the quality and strength of the evidence provided by human observational studies for a causal association between exposure to RF-EMF and risk of neoplastic diseases.
Eligibility criteria: We will include cohort and case-control studies investigating neoplasia risks in relation to three types of exposure to RF-EMF: near-field, head-localized, exposure from wireless phone use (SR-A); far-field, whole body, environmental exposure from fixed-site transmitters (SR-B); near/far-field occupational exposures from use of handheld transceivers or RF-emitting equipment in the workplace (SR-C). While no restriction on tumour type will be applied, we will focus on selected neoplasms of the central nervous system (brain, meninges, pituitary gland, acoustic nerve) and salivary gland tumours (SR-A); brain tumours and leukaemias (SR-B, SR-C).
Information sources: Eligible studies will be identified through Medline, Embase, and EMF-Portal.
Risk-of-bias assessment: We will use a tailored version of the OHAT’s tool to evaluate the study’s internal validity.
Data synthesis: We will consider separately studies on different tumours, neoplasm-specific risks from different exposure sources, and a given exposure-outcome pair in adults and children. When a quantitative synthesis of findings can be envisaged, the main aims of the meta-analysis will be to assess the strength of association and the shape of the exposure-response relationship; to quantify the degree of heterogeneity across studies; and explore the sources of inconsistency (if any). When a meta-analysis is judged inappropriate, we will perform a narrative synthesis, complemented by a structured tabulation of results and appropriate visual displays.
Evidence assessment: Confidence in evidence will be assessed in line with the GRADE approach.
Funding: This project is supported by the World Health Organization. Co-financing was provided by the New Zealand Ministry of Health; the Istituto Superiore di Sanità in its capacity as a WHO Collaborating Centre for Radiation and Health; ARPANSA as a WHO Collaborating Centre for Radiation Protection.
Registration: PROSPERO CRD42021236798.
• Male infertility and adverse pregnancy outcomes are relevant human health problems.
• Radiofrequency electromagnetic fields are widespread in the human environment.
• A link between radiofrequency and adverse reproductive outcomes is controversial.
• This is the protocol of WHO-funded systematic review and meta-analysis on this issue.
Abstract
Background Radiofrequency Electromagnetic Fields (RF-EMF) at environmental level have been reported to induce adverse effects on the male reproductive system and developing embryos. However, despite the number of experiments conducted since the 1970s, the diversity of testing approaches and exposure conditions, inconsistencies among results, and dosimetric flaws have not yet permitted a solid assessment of the relationship between RF-EMF exposure and such effects, warranting a more systematic and methodologically rigorous approach to the evaluation of available data.
Objectives This study aims at evaluating the effects of RF-EMF exposure on male fertility and pregnancy outcomes by a systematic review (SR) of experimental studies, conducted in compliance with international guidelines. The evidence will be organized into three streams: 1) Studies evaluating the impact of RF-EMF on the male reproductive system of experimental mammals; 2) studies evaluating the impact of RF-EMF on human sperm exposed in vitro; 3) studies evaluating the impact of RF-EMF on adverse pregnancy, birth outcomes and delayed effects in experimental mammals exposed in utero.
Study eligibility and criteria Eligible studies will include peer-reviewed articles reporting of original results about effects of controlled exposures to RF-EMF in the frequency range 100 kHz–300 GHz on the selected outcomes without any language or year-of-publication restrictions. Eligible studies will be retrieved by calibrated search strings applied to three electronic databases, PubMed, Scopus and EMF Portal and by manual search of the list of references of included papers and published reviews.
Study appraisal and synthesis method The internal validity of the studies will be evaluated using the Risk of Bias (RoB) Rating Tool developed by National Toxicology Program/Office of Health Assessment and Translation (NTP/OHAT) integrated with input from the SYRCLE RoB tool. Given sufficient commensurate data, meta-analyses will be performed, otherwise narrative syntheses will be produced. Finally, the certainty of the effects of RF-EMF exposure on male fertility and pregnancy and birth outcomes will be established following GRADE.
Funding The study is financially supported by the World Health Organization.
Registration OSF Registration DOI https://doi.org/10.17605/OSF.
This project is partially funded by the World Health Organization (contract 2020/1026306-0). Additional in-kind funds are provided by ENEA, Health Canada and Swinburne University of Technology.
Blanka Pophof, Jacob Burns, Heidi Danker-Hopfe, Hans Dorn, Cornelia Egblomassé-Roidl, Torsten Eggert, Kateryna Fuks, Bernd Henschenmacher, Jens Kuhne, Cornelia Sauter, Gernot Schmid. The effect of exposure to radiofrequency electromagnetic fields on cognitive performance in human experimental studies: A protocol for a systematic review. Environ Int. 2021 Jul 29;157:106783. doi: 10.1016/j.envint.2021.106783.
Abstract
Background: The World Health Organization (WHO) is currently assessing the potential health effects of exposure to radiofrequency electromagnetic fields (RF-EMFs) in the general and working population. Related to one such health effect, there is a concern that RF-EMFs may affect cognitive performance in humans. The systematic review (SR) aims to identify, summarize and synthesize the evidence base related to this question. Here, we present the protocol for the planned SR.
Objectives: The main objective is to present a protocol for a SR which will evaluate the associations between short-term exposure to RF-EMFs and cognitive performance in human experimental studies.
Data sources: We will search the following databases: PubMed, Embase, Web of Science, Scopus, and the EMF-Portal. The reference lists of included studies and retrieved review articles will be manually searched.
Study eligibility and criteria: We will include randomized human experimental studies that assess the effects of RF-EMFs on cognitive performance compared to no exposure or lower exposure. We will include peer-reviewed articles of any publication date in any language that report primary data.
Data extraction and analysis: Data will be extracted according to a pre-defined set of forms developed and piloted by the review author team. To assess the risk of bias, we will apply the Rating Tool for Human and Animal Studies developed by NTP/OHAT, supplemented with additional questions relevant for cross-over studies. Where sufficiently similar studies are identified (e.g. the heterogeneity concerning population, exposure and outcome is low and the studies can be combined), we will conduct random-effects meta-analysis; otherwise, we will conduct a narrative synthesis.
Assessment of certainty of evidence: The certainty of evidence for each identified outcome will be assessed according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Performing the review according to this protocol will allow the identification of possible effects of RF-EMFs on cognitive performance in humans. The protocol has been registered in PROSPERO, an open-source protocol registration system, to foster transparency.
This project is funded by the World Health Organization.
Registration
PROSPERO CRD42021236168.
Stephanie M. Eick, Dana E. Goin, Nicholas Chartres, Juleen Lam, Tracey J. Woodruff. Assessing risk of bias in human environmental epidemiology studies using three tools: different conclusions from different tools. Syst Rev 9, 249 (2020). https://doi.org/10.1186/
Abstract
Background Systematic reviews are increasingly prevalent in environmental health due to their ability to synthesize evidence while reducing bias. Different systematic review methods have been developed by the US National Toxicology Program’s Office of Health Assessment and Translation (OHAT), the US Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS), and by the US EPA under the Toxic Substances Control Act (TSCA), including the approach to assess risk of bias (ROB), one of the most vital steps which is used to evaluate internal validity of the studies. Our objective was to compare the performance of three tools (OHAT, IRIS, TSCA) in assessing ROB.
Methods We selected a systematic review on polybrominated diphenyl ethers and intelligence quotient and/or attention deficit hyperactivity disorder because it had been endorsed by the National Academy of Sciences. Two reviewers followed verbatim instructions from the tools and independently applied each tool to assess ROB in 15 studies previously identified. We documented the time to apply each tool and the impact the ROB ratings for each tool had on the final rating of the quality of the overall body of evidence.
Results The time to complete the ROB assessments varied widely (mean = 20, 32, and 40 min per study for the OHAT, IRIS, and TSCA tools, respectively). All studies were rated overall “low” or “uninformative” using IRIS, due to “deficient” or “critically deficient” ratings in one or two domains. Similarly, all studies were rated “unacceptable” using the TSCA tool because of one “unacceptable” rating in a metric related to statistical power. Approximately half of the studies had “low” or “probably low ROB” ratings across all domains with the OHAT and Navigation Guide tools.
Conclusions Tools that use overall ROB or study quality ratings, such as IRIS and TSCA, may reduce the available evidence to assess the harms of environmental exposures by erroneously excluding studies, which leads to inaccurate conclusions about the quality of the body of evidence. We recommend using ROB tools that circumvent these issues, such as OHAT and Navigation Guide.
https://www.saferemr.com/2021/09/who-radiofrequency-emf-health-risk.html