Background

The World Health Organization (WHO) is bringing together evidence on radiofrequency electromagnetic field (RF-EMF) exposure in relation to health outcomes, previously identified as priorities for evaluation by experts in the field, to inform exposure guidelines. A suite of systematic reviews are being undertaken by a network of topic experts and methodologists in order to collect, assess and synthesise data relevant to these guidelines. Here, we present the protocol for the systematic review on the effect of exposure to RF on adverse reproductive outcomes (human observational studies), also referred to as Systematic Review (SR) 3 within the series of systematic reviews currently being commissioned.

Objectives

Following the WHO handbook for guideline development and the COSTER conduct guidelines, we will systematically review the effect of RF-EMF exposure on both male fertility (SR3A) and adverse pregnancy outcomes (SR3B) in human observational studies. Herein we adhere to the PRISMA-P reporting guidelines.

Data sources

We will conduct a broad search for potentially relevant records relevant for both reviews within the following bibliographic databases: MEDLINE; Embase; and EMF Portal. We will also conduct searches of grey literature through relevant databases and organisational websites. RF-EMF experts will also be consulted. We will hand search citation and reference lists of included study records.

Study eligibility criteria

We will include quantitative human observational studies on the effect of RF-EMF exposure: (in SR3A) in adult male participants on infertility, sperm morphology, concentration or total sperm count or motility; and (in SR3B) in preconception adults or pregnant women on preterm birth, small for gestational age (associated with intrauterine growth restriction), miscarriage, stillbirth and congenital anomalies.

Study appraisal and synthesis methods

Titles, abstracts and then full texts will be screened in blinded duplicate against eligibility criteria with input from a third reviewer as required. Data extraction from included studies will be completed by two reviewers as will risk of bias assessment using the Office of Health Assessment and Translation (OHAT) tool. If appropriate we will undertake meta-analysis to pool effect measures and explore heterogeneity using sub-group analyses or meta-regression as feasible. We will conduct sensitivity analysis to assess the impact of any assumptions made throughout the review process. The OHAT methodology, based on the GRADE guidelines for evidence assessment, will be used to evaluate the certainty of evidence per outcome and to conclude the level of evidence of a health effect.

Conclusion

This manuscript details the protocols for two systematic reviews. The aims of publishing details of both protocols are to: pre-specify their scope and methods; reduce the impact of reviewer bias; promote transparency and replicability; and improve the review process.

Prospero registration

CRD42021265401 (SR3A), CRD42021266268 (SR3B).

中文翻译：

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射频暴露对男性生育能力和不良生殖结果的影响：对人类观察性研究进行两项系统评价并进行荟萃分析的方案

背景

世界卫生组织 (WHO) 正在收集与健康结果相关的射频电磁场 (RF-EMF) 暴露的证据，这些证据以前被该领域的专家确定为优先评估，以告知暴露指南。主题专家和方法学家网络正在开展一套系统评价，以收集、评估和综合与这些指南相关的数据。在这里，我们提出了关于暴露于 RF 对不良生殖结果的影响的系统审查协议（人类观察性研究），在目前正在委托的一系列系统审查中也称为系统审查 (SR) 3。

目标

根据 WHO 指南制定手册和 COSTER 实施指南，我们将在人类观察性研究中系统地回顾 RF-EMF 暴露对男性生育力 (SR3A) 和不良妊娠结局 (SR3B) 的影响。在此，我们遵守 PRISMA-P 报告指南。

数据源

我们将在以下书目数据库中广泛搜索与这两个评论相关的潜在相关记录：MEDLINE；驻扎; 和 EMF 门户。我们还将通过相关数据库和组织网站进行灰色文献检索。还将咨询 RF-EMF 专家。我们将手动搜索包含研究记录的引文和参考列表。

研究资格标准

我们将包括关于 RF-EMF 暴露影响的定量人类观察研究：（在 SR3A 中）成年男性参与者对不孕症、精子形态、浓度或总精子数量或运动能力的影响；和（在 SR3B 中）在早产、小于胎龄（与宫内生长受限相关）、流产、死产和先天性异常的孕前成人或孕妇中。

研究评价与综合方法

标题、摘要和全文将根据资格标准进行盲选，并根据需要由第三位评审员提供输入。纳入研究的数据提取将由两名审查员完成，偏倚风险评估也将由健康评估和翻译办公室 (OHAT) 工具完成。如果合适，我们将进行荟萃分析以汇集效应措施，并在可行的情况下使用亚组分析或荟萃回归探索异质性。我们将进行敏感性分析，以评估在整个审查过程中所做的任何假设的影响。OHAT 方法基于证据评估的 GRADE 指南，将用于评估每个结果的证据确定性，并得出健康影响的证据级别。

结论

这份手稿详细介绍了两个系统评价的协议。发布这两个协议的细节的目的是： 预先指定它们的范围和方法；减少审稿人偏见的影响；提高透明度和可复制性；并改进审查过程。

Prospero 注册

CRD42021265401 (SR3A)、CRD42021266268 (SR3B)。