Co-RESPOND: a federated network of cohorts on mental health and adversity during the COVID-19 pandemic. Challenges, solutions and recommendations for retrospective data harmonization

Background: The SARS-Cov-2 pandemic was associated with a substantial rise in trauma and stressor exposure. The Co-RESPOND consortium (part of the EU horizon 2020-funded RESPOND project) has been initiated to study the impact on mental health, using longitudinal data of separate international cohorts. Aims: The Co-RESPOND initiative aims to retrospectively harmonize mental health and resilience data of ongoing longitudinal cohort studies at the individual participant level; to create an interoperable network of cohorts within a secure environment; to manage these data along with harmonization products (e.g. transformation procedures and variable dictionaries) according to the FAIR principles; and to keep this network live in order to add new data waves or to be joined by new cohorts. Methods: Data were harmonized retrospectively according to the Maelstrom guidance. A federated data network (FDN) was created using the OBiBa software suite. Results: To date, Co-RESPOND consists of nine European cohorts and one global cohort, including 50,885 individual participants. This paper presents Co-RESPOND as a case study for retrospective harmonization of decentralized data where teams collected and transformed data without prior coordination, facing methodological as well as regulatory challenges. The process of this project is outlined in detail, so it could be applied by other researchers for future projects. Its outcomes and the resulting data harmonization products are presented. Conclusions and outlook: The harmonized data are now ready to be shared with external partners for analyses, and Co-RESPOND is open for more partners to join. Lessons learned throughout the project will be reported, and established classification standards will be recommended for use to generate data sets that are available for joint analyses from the start. Trial registration:ClinicalTrials.gov identifier: NCT04556565. Longitudinal cohort data collected during the COVID-19 pandemic hold an extraordinary opportunity to study the impact of elevated trauma and stressor prevalence on trauma and mental health.This project aims to retrospectively harmonize, i.e. transform, already collected data of originally separate cohorts in a way that it can be analysed jointly on the individual-participant level, and to manage data sustainably in a fair (findable, accessible, interoperable, and reusable) way.Ten cohort studies covering mental health outcomes of more than 50.000 individuals have been harmonized so far. The data sets are available within a federated data network and can be accessed upon request for further analyses. Longitudinal cohort data collected during the COVID-19 pandemic hold an extraordinary opportunity to study the impact of elevated trauma and stressor prevalence on trauma and mental health. This project aims to retrospectively harmonize, i.e. transform, already collected data of originally separate cohorts in a way that it can be analysed jointly on the individual-participant level, and to manage data sustainably in a fair (findable, accessible, interoperable, and reusable) way. Ten cohort studies covering mental health outcomes of more than 50.000 individuals have been harmonized so far. The data sets are available within a federated data network and can be accessed upon request for further analyses.背景：新型冠状病毒（SARS-CoV-2）大流行与创伤及应激暴露的大幅增加密切相关。Co-RESPOND联盟（隶属于欧盟地平线2020计划资助的RESPOND项目）已启动，旨在利用多个独立国际队列的纵向数据，研究疫情对心理健康的影响。 目标：Co-RESPOND项目旨在于个体参与者层面，对正在开展的多项纵向队列研究的心理健康与心理韧性数据进行回顾性标准化；在安全环境中构建队列互操作网络；依据FAIR原则（可发现、可访问、可互操作、可复用）对数据及标准化产物（如数据转换流程、变量词典）进行管理；维持该网络的动态更新，以便接入新的数据波次或吸纳新的队列加入。 方法：依据Maelstrom指南对数据进行回顾性标准化。采用OBiBa软件套件构建了联邦数据网络（Federated Data Network, FDN）。 结果：截至目前，Co-RESPOND已纳入9个欧洲队列与1个全球队列，共计50885名个体参与者。本文将Co-RESPOND作为去中心化数据回顾性标准化的案例研究进行展示：各团队在未预先协调的前提下完成数据收集与转换，同时面临方法论与监管层面的双重挑战。本文详细阐述了该项目的实施流程，以供其他研究人员在未来项目中参考复用，并展示了项目成果与最终的数据标准化产物。 结论与展望：标准化后的数据集现已可与外部合作伙伴共享以开展分析工作，Co-RESPOND也面向更多合作伙伴开放加入通道。本文将汇报项目实施过程中总结的经验教训，并推荐已确立的分类标准，以便从项目初始阶段即可生成可用于联合分析的数据集。 临床试验注册：ClinicalTrials.gov标识符：NCT04556565。 新冠疫情期间收集的纵向队列数据为研究创伤与应激暴露发生率升高对创伤及心理健康的影响提供了绝佳契机。本项目旨在对原本独立的多个队列已收集的数据进行回顾性标准化（即数据转换），使其可在个体参与者层面开展联合分析，并以FAIR原则（可发现、可访问、可互操作、可复用）的方式对数据进行可持续管理。截至目前，共完成10项覆盖5万余名个体心理健康结局的队列研究的数据标准化工作。相关数据集已部署于联邦数据网络中，经申请即可访问以开展进一步分析。 新冠疫情期间收集的纵向队列数据为研究创伤与应激暴露发生率升高对创伤及心理健康的影响提供了绝佳契机。本项目旨在对原本独立的多个队列已收集的数据进行回顾性标准化（即数据转换），使其可在个体参与者层面开展联合分析，并以FAIR原则（可发现、可访问、可互操作、可复用）的方式对数据进行可持续管理。截至目前，共完成10项覆盖5万余名个体心理健康结局的队列研究的数据标准化工作。相关数据集已部署于联邦数据网络中，经申请即可访问以开展进一步分析。