The IeDEA harmonist data toolkit: A data quality and data sharing solution for a global HIV research consortium

Lewis, Judith T.; Stephens, Jeremy; Musick, Beverly; Brown, Steven A.; Malateste, Karen; Ostinelli, Cam Ha Dao; Maxwell, Nicola; Jayathilake, Karu; Shi, Qiuhu; Brazier, Ellen; Kariminia, Azar; Hogan, Brenna; Duda, Stephany N.

doi:10.1016/j.jbi.2022.104110

Cited by 5 publications

(4 citation statements)

References 24 publications

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“…All sites will use the secure, web-based REDCap data collection platform and/or the REDCap Mobile App for data collection 34 35. Common data management processes and procedures will be developed in collaboration with the Harmonist team at Vanderbilt University Medical Center, which provides informatics resources for IeDEA 36 37. For sites using film-based chest X-rays, films will be scanned and digitised using standard procedures defined by the NIH TB Portals platform 38…”

Section: Methods and Analysismentioning

confidence: 99%

“…Research staff will administer questionnaires using relevant local translations (in Bemba, French, Haitian Creole, Khmer, Lingala, Nyanja, Portuguese, Runyankole, Swahili and Thai) and adaptations as appropriate, implemented in paper CRFs and in the REDCap data collection platform. Regional data centres will conduct quality control or assurance activities for their sites based on guidance developed by the TB-SRN study team and the Harmonist team 36 37…”

Section: Methods and Analysismentioning

confidence: 99%

“…Regional data centres will conduct quality control or assurance activities for their sites based on guidance developed by the TB-SRN study team and the Harmonist team. 36 37 …”

Section: Methods and Analysismentioning

confidence: 99%

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The Tuberculosis Sentinel Research Network (TB-SRN) of the International epidemiology Databases to Evaluate AIDS (IeDEA): protocol for a prospective cohort study in Africa, Southeast Asia and Latin America

Enane,

Duda,

Chanyachukul

et al. 2024

BMJ Open

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IntroductionTuberculosis (TB) is a leading infectious cause of death globally. It is the most common opportunistic infection in people living with HIV, and the most common cause of their morbidity and mortality. Following TB treatment, surviving individuals may be at risk for post-TB lung disease. The TB Sentinel Research Network (TB-SRN) provides a platform for coordinated observational TB research within the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium.Methods and analysisThis prospective, observational cohort study will assess treatment and post-treatment outcomes of pulmonary TB (microbiologically confirmed or clinically diagnosed) among 2600 people aged ≥15 years, with and without HIV coinfection, consecutively enrolled at 16 sites in 11 countries, across 6 of IeDEA’s global regions. Data regarding clinical and sociodemographic factors, mental health, health-related quality of life, pulmonary function, and laboratory and radiographic findings will be collected using standardised questionnaires and data collection tools, beginning from the initiation of TB treatment and through 12 months after the end of treatment. Data will be aggregated for proposed analyses.Ethics and disseminationEthics approval was obtained at all implementing study sites, including the Vanderbilt University Medical Center Human Research Protections Programme. Participants will provide informed consent; for minors, this includes both adolescent assent and the consent of their parent or primary caregiver. Protections for vulnerable groups are included, in alignment with local standards and considerations at sites. Procedures for requesting use and analysis of TB-SRN data are publicly available. Findings from TB-SRN analyses will be shared with national TB programmes to inform TB programming and policy, and disseminated at regional and global conferences and other venues.

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Section: Methods and Analysismentioning

confidence: 99%

Section: Methods and Analysismentioning

confidence: 99%

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The Tuberculosis Sentinel Research Network (TB-SRN) of the International epidemiology Databases to Evaluate AIDS (IeDEA): protocol for a prospective cohort study in Africa, Southeast Asia and Latin America

Enane,

Duda,

Chanyachukul

et al. 2024

BMJ Open

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“…The process of data harmonisation and associated data quality checking can be extremely time and resource-consuming, and requires the development of common data models. For example, The International Epidemiology Databases to Evaluate AIDS consortium developed these tools, and used the OMOP common data model (https://ohdsi.github.io/CommonDataModel/index.html) in order to combine international datasets from studies of populations living with HIV/AIDS across multiple countries for meta-analysis and comparative studies 30. Large consortia such as the Global Genomic Medicine Collaboration31 (https://g2mc.org/), Global Alliance for Genomics and Health32 (https://www.ga4gh.org/) and International HundredK+Cohorts Consortium33 (https://ihccglobal.org/) now contribute significant resources into developing data standards for wider use, to enable such meta-analyses using health, epidemiological and genomic data without requiring retrofitting and retrospective harmonisation of data for meta-analysis.…”

Section: Modes Of Data Sharingmentioning

confidence: 99%

Multiple modes of data sharing can facilitate secondary use of sensitive health data for research

Tamuhla,

Lulamba,

Mutemaringa

et al. 2023

BMJ Glob Health

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Evidence-based healthcare relies on health data from diverse sources to inform decision-making across different domains, including disease prevention, aetiology, diagnostics, therapeutics and prognosis. Increasing volumes of highly granular data provide opportunities to leverage the evidence base, with growing recognition that health data are highly sensitive and onward research use may create privacy issues for individuals providing data. Concerns are heightened for data without explicit informed consent for secondary research use. Additionally, researchers—especially from under-resourced environments and the global South—may wish to participate in onward analysis of resources they collected or retain oversight of onward use to ensure ethical constraints are respected. Different data-sharing approaches may be adopted according to data sensitivity and secondary use restrictions, moving beyond the traditional Open Access model of unidirectional data transfer from generator to secondary user. We describe collaborative data sharing, facilitating research by combining datasets and undertaking meta-analysis involving collaborating partners; federated data analysis, where partners undertake synchronous, harmonised analyses on their independent datasets and then combine their results in a coauthored report, and trusted research environments where data are analysed in a controlled environment and only aggregate results are exported. We review how deidentification and anonymisation methods, including data perturbation, can reduce risks specifically associated with health data secondary use. In addition, we present an innovative modularised approach for building data sharing agreements incorporating a more nuanced approach to data sharing to protect privacy, and provide a framework for building the agreements for each of these data-sharing scenarios.

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High Prevalence of Unconfirmed Positive HIV Polymerase Chain Reaction Test Results Among African Infants With HIV Exposure in the International Epidemiology Databases to Evaluate AIDS Consortium

Carlucci,

Huntington,

Technau

et al. 2024

Clinical Infectious Diseases

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The IeDEA harmonist data toolkit: A data quality and data sharing solution for a global HIV research consortium

Cited by 5 publications

References 24 publications

The Tuberculosis Sentinel Research Network (TB-SRN) of the International epidemiology Databases to Evaluate AIDS (IeDEA): protocol for a prospective cohort study in Africa, Southeast Asia and Latin America

The Tuberculosis Sentinel Research Network (TB-SRN) of the International epidemiology Databases to Evaluate AIDS (IeDEA): protocol for a prospective cohort study in Africa, Southeast Asia and Latin America

Multiple modes of data sharing can facilitate secondary use of sensitive health data for research

High Prevalence of Unconfirmed Positive HIV Polymerase Chain Reaction Test Results Among African Infants With HIV Exposure in the International Epidemiology Databases to Evaluate AIDS Consortium

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