Biostatistics and Data Management

The Biostatistics and Data Management Unit (UBIOES-DM) at ISGlobal began its activities in 1994 with the aim of providing data support to the research groups of the Hospital Clínic de Barcelona and their collaborators.

Currently, its mission is to provide advice, services and training to meet the data management and statistical analysis needs of biomedical, clinical or environmental research projects. This support covers the entire data lifecycle, from creation to preservation and sharing, with the aim of transforming information into knowledge.

To meet all these needs, the Biostatistics and Data Management Unit is composed of data managers and data analysts who provide the following specialised services.

Services

1. Data Management

• Design and organisation of data
  • Advice and support in implementing data collection andmanagement procedures for research projects, selecting the mostappropriate tools and systems for each case, and study design
  • We offer extensive knowledge of different data capture andmanagement tools and systems (EDC systems: Electronic DataCapture), including REDCap, LibreClinica, OpenClinica, KoboToolBox,ODK
  • Design of databases, applications, and/or adaptations needed tomeet specific data requirements for the project
  • Data import from other databases or migrations from other systems
  • Establishment of data collection tools and protocols (guided byGCDMP: Good Clinical Data Management Practices) and EDC systemsecurity
  • Support, documentation, and training for different user profiles ofdata
  • Creation, review, and refinement of data management plans (DMPs)

• Data Processing
  • Preparation of periodic reports on data entry progress
  • Data quality control and monitoring
  • Dashboards and summary data reports
  • Definition of data monitoring procedures and support in theirimplementation
  • Custom data exports Secure project and data closure

2. Data curation and publication

• Standardization and homogenization of data sets
• Adaptation of data to FAIR principles (Findable, Accessible,Interoperable, Reusable)
• Publication of data in the CORA repository or other Dataverse-basedrepositories

3. Data Analysis

• Advisory service
  • Sample size calculation
  • Statistical design of the research project
  • Statistical methodology drafting for grant applications
  • Drafting and revision of statistical methodology for journalpublications
  • Occasional statistical methodology advice
  • Drafting of the statistical analysis plan for a research project (SAP)
  • Randomization of participants in a clinical trial into study groups

• Statistical analysis
  • Descriptive data analysis
  • Statistical modeling of data
  • Machine learning techniques
  • Data visualization

• Data monitoring and safety (DSMB)
  • Generation of statistical assessment reports for clinical trials
  • Management of adverse event data collection
  • Independent statistical advice for the safety group (DSMB)
  • Blind or open statistical analysis by the safety group (DSMB)

4. Training

• Short courses (less than 4 hours):
  • Basic statistics with Stata
  • Linear regression with Stata
  • Logistic regression with Stata
  • Data management with Excel (Excel is not a data managementtool)
  • Basic concepts of data management in research and the datalifecycle

• Basic statistics course (part of the UB / ISGlobal Global HealthMaster’s programme)

Equipment 

• Data capture and management applications: REDCap,LibreClinica, OpenClinica, KoboToolBox, ODK 
• Dashboard and reporting applications: R Shiny, R Markdown,Google Data Studio 
• Statistical software: Stata, Stata MP, R, PASS 
• Application development: PHP, Python, Java, R Shiny 
• Databases: MySQL, Ms Access, Google Big Query, MongoDB 
• ETL (Extract, Transform, Load) procedures and design of otherdata extraction pipelines

This core facility is part of the CERCAGINYS platform.

Selected Projects

• CaDMIA and CaDMIA+
  Validation of the Minimally Invasive Autopsy (AMI) as a tool for investigating causes of death in developing countries
  Funding Body: Bill & Melinda Gates Foundation (2013-2015 and 2016-2018)
  Status: Completed
• The Mamah Project
  Funding Body: EU-European and Developing Countries Clinical Trials Partnership (EDCTP)
  Status: Ongoing
• BOHEMIA: Ivermectin for Malaria
  Funding Body: Unitaid (WHO)
  Status: Ongoing
• TIPTOP: Transforming Intermittent Preventive Treatment for Optimal Pregnancy
  Funding Body: Unitaid (WHO)
  Status: Ongoing
• ICARIA: Improving Care through Azithromycin Research for Infantsin Africa
  Funding Organism: Bill & Melinda Gates Foundation; "la Caixa" Foundation
  Status: Executing
• MULTIPLY: MULTIple doses of IPTi Proposal: a Lifesaving high Yield intervention
  Funding Organism: EU-European and Developing Countries Clinical TrialsPartnership (EDCTP)
  Status: Executing
• ChagasLAMP: Field validation of Trypanosoma cruzi-LAMP: a molecular point-of-care test for the control of congenital Chagas disease
  Funding Organism: Global Health Innovative Fund (GHIT)
  Status: Executing
• TESEO: New chemotherapy regimens and biomarkers for Chagas Disease
  Funding Organism: U.S. National Institutes of Health (NIH)
  Status: Executing
• MIBio: Identification of Prematurity and Pre-Eclampsia as Causes of Mortality
  Funding Organism: Bill & Melinda Gates Foundation
  Status: Finished
• MA-CoV: Maternal health and Covid-19 Reference
  Funding Organism: EU-European and Developing Countries Clinical Trials Partnership (EDCTP)
  Status: Finished
• SEROCOV: Seroprevalence of antibodies against SARS-CoV-2 among health care workers in a large Spanish reference hospital
  Funding Organism: Generalitat de Catalunya
  Status: Executing
• MESA-Track: A living database which captures research projects and institutions’ portfolios in malaria elimination and eradication
  Funding Organism: Bill & Melinda Gates Foundation
  Status: Executing

Selected Publications

• Khomenko S, Cirach M, Barrera-Gómez J, Pereira-Barboza E, Iungman T, Mueller N, Foraster M, Tonne C, Thondoo M, Jephcote C, Gulliver J, Woodcock J, Nieuwenhuijsen M. Impact of road traffic noise on annoyance and preventable mortality in European cities: a health impact assessment. Environ Int. 2022;162:107160. https://doi.org/10.1016/j.envint.2022.107160
• Koch S, Khomenko S, Cirach M, Ubalde-Lopez M, Baclet S, Daher C, Hidalgo L, Lõhmus M, Rizzuto D, Rumpler R, Susilo Y, Venkataraman S, Wegener S, Wellenius GA, Woodcock J, Nieuwenhuijsen M. Impacts of changes in environmental exposures and health behaviours due to the COVID-19 pandemic on cardiovascular and mental health: a comparison of Barcelona, Vienna, and Stockholm. Environ Pollut. 2022;119124. https://doi.org/10.1016/j.envpol.2022.119124
• Alemany S, Crous-Bou M, Vilor-Tejedor N, Milà-Alomà M, Suárez-Calvet M, Salvadó G, Cirach M, Arenaza-Urquijo EM, Sánchez-Benavides G, Grau-Rivera O, Minguillon C, Fauria K, Kollmorgen G, Domingo Gispert J, Gascon M, Nieuwenhuijsen M, Zetterberg H, Blennow K, Sunyer J, Molinuevo JL, ALFA Study. Associations between air pollution and biomarkers of Alzheimer’s disease in cognitively unimpaired individuals. Environ Int. 2021;157:106864. https://doi.org/10.1016/j.envint.2021.106864
• de Bont J, Hughes R, Tilling K, Díaz Y, de Castro M, Cirach M, Fossati S, Nieuwenhuijsen M, Duarte-Salles T, Vrijheid M. Early-life exposure to air pollution, green spaces and the built environment, and body mass index growth trajectories during the first 5 years of life: a large longitudinal study. Environ Pollut. 2020;266:115266. https://doi.org/10.1016/j.envpol.2020.115266
• Perelló J, Cigarini A, Vicens J, Bonhoure I, Rojas-Rueda D, Nieuwenhuijsen MJ, Cirach M, Daher C, Targa J, Ripoll A. Large-scale citizen science provides high-resolution nitrogen dioxide values and health impact while enhancing community knowledge and collective action. Sci Total Environ. 2021;789:147750. https://doi.org/10.1016/j.scitotenv.2021.147750
• Fernandez-Barres S, Robinson O, Fossati S, Márquez S, Basagaña X, de Bont J, de Castro M, Donaire-González D, Maitre L, Nieuwenhuijsen M, Romaguera D, Urquiza J, Chatzi L, Iakovides M, Vafeiadi M, Grazuleviciene R, Dedele A, Andrusaityte S, Aasvang GM, Evandt J, Hjertager Krog N, Lepeule J, Heude B, Wright J, McEachan RRC, Sassi F, Vineis P, Vrijheid M. Urban environment and health behaviours in children from six European countries. Environ Int. 2022;165:107319. https://doi.org/10.1016/j.envint.2022.107319
• de Bont J, Márquez S, Fernandez-Barres S, Warembourg C, Koch S, Persavento C, Fochs S, Pey N, de Castro M, Fossati S, Nieuwenhuijsen M, Basagaña X, Casas M, Duarte-Salles T, Vrijheid M. Urban environment and obesity and weight-related behaviours in primary school children. Environ Int. 2021;155:106700. https://doi.org/10.1016/j.envint.2021.106700
• Grazuleviciene R, Hernandez-Ferrer C, Heude B, McEachan R, Mon-Williams M, Nieuwenhuijsen M, Robinson O, Sakhi AK, Sebastián-Gallés N, Slama R, Sunyer J, Tamayo-Uria I, Thomsen C, Urquiza J, Vafeiadi M, Wright J, Basagaña X, Vrijheid M. Early-life multiple exposures and child cognitive function: a multicentric birth cohort study in six European countries. Environ Pollut. 2021;284:117404. https://doi.org/10.1016/j.envpol.2021.117404
• Maitre L, Julvez J, Lopez-Vicente M, Warembourg C, Tamayo-Uria I, Philippat C, Gutzkow KB, Guxens M, Andrusaityte S, Basagaña X, Casas M, de Castro M, Chatzi L, Evandt J, González JR, Grazuleviciene R, Småstuen Haug L, Heude B, Hernandez-Ferrer C, Kampouri M, Manson D, Márquez S, McEachan R, Nieuwenhuijsen M, Robinson O, Slama R, Thomsen C, Urquiza J, Vafeiadi M, Wright J, Vrijheid M. Early-life environmental exposure determinants of child behaviour in Europe: a longitudinal, population-based study. Environ Int. 2021;153:106523. https://doi.org/10.1016/j.envint.2021.106523
• Granum B, Oftedal B, Agier L, Siroux V, Bird P, Casas M, Warembourg C, Wright J, Chatzi L, de Castro M, Donaire D, Grazuleviciene R, Småstuen Haug L, Maitre L, Robinson O, Tamayo-Uria I, Urquiza J, Nieuwenhuijsen M, Slama R, Thomsen C, Vrijheid M. Multiple environmental exposures in early life and allergy-related outcomes in childhood. Environ Int. 2020;144:106038. https://doi.org/10.1016/j.envint.2020.106038
• Vrijheid M, Fossati S, Maitre L, Márquez S, Roumeliotaki T, Agier L, Andrusaityte S, Cadiou S, Casas M, de Castro M, Dedele A, Donaire-González D, Grazuleviciene R, Haug LS, McEachan R, Meltzer HM, Papadopoulou E, Robinson O, Sakhi AK, Siroux V, Sunyer J, Schwarze PE, Tamayo-Uria I, Urquiza J, Vafeiadi M, Valentin A, Warembourg C, Wright J, Nieuwenhuijsen MJ, Thomsen C, Basagaña X, Slama R, Chatzi L. Early-life environmental exposures and childhood obesity: an exposome-wide approach. Environ Health Perspect. 2020;128(6):67009. https://doi.org/10.1289/EHP5975
• Agier L, Basagaña X, Hernandez-Ferrer C, Maitre L, Tamayo-Uria I, Urquiza J, Andrusaityte S, Casas M, de Castro M, Cequier E, Chatzi L, Donaire-González D, Giorgis-Allemand L, González JR, Grazuleviciene R, Gutzkow KB, Haug LS, Sakhi AK, McEachan RRC, Meltzer HM, Nieuwenhuijsen M, Robinson O, Roumeliotaki T, Sunyer J, Thomsen C, Vafeiadi M, Valentin A, West J, Wright J, Siroux V, Vrijheid M, Slama R. Association between the pregnancy exposome and fetal growth. Int J Epidemiol. 2020;49(2):572–586. https://doi.org/10.1093/ije/dyaa017