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 datamanagers 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

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

Publicaciones seleccionadas

• Quintó L, Sanz S, De Lazzari E, Aponte JJ. HTML output in Stata. The Stata Journal. 2012;12(4):702–717. doi: https://doi.org/10.1177/1536867X1201200409
• Quintó L, Aponte JJ, Menéndez C, Sacarlal J, Aide P, Espasa M, Mandomando I, Guinovart C, Macete E, Hirt R, Urassa H, Navia MM, Thompson R, Alonso PL. Relationship between haemoglobin and haematocrit in the definition of anaemia. Trop Med Int Health. 2006 Aug;11(8):1295–1302. doi: https://doi.org/10.1111/j.1365-3156.2006.01679.x. PMID: 16903892.
• Menéndez C, Quintó L, Castillo P, Fernandes F, Carrilho C, Ismail MR, Lorenzoni C, Hurtado JC, Rakislova N, Munguambe K, Moraleda C, Maixenchs M, Macete E, Mandomando I, Martínez MJ, Alonso PL, Bassat Q, Ordi J. Quality of care and maternal mortality in a tertiary-level hospital in Mozambique: a retrospective study of clinicopathological discrepancies. Lancet Glob Health. 2020 Jul;8(7):e965–e972. doi: https://doi.org/10.1016/S2214-109X(20)30236-9. PMID: 32562652; PMCID: PMC7303952.
• Chaccour C, Zulliger R, Wagman J, Casellas A, Nacima A, Elobolobo E, Savaio B, Saifodine A, Fornadel C, Richardson J, Candrinho B, Robertson M, Saute F. Incremental impact on malaria incidence following indoor residual spraying in a highly endemic area with high standard ITN access in Mozambique: results from a cluster-randomized study. Malar J. 2021 Feb 10;20(1):84. doi: https://doi.org/10.1186/s12936-021-03611-7. PMID: 33568137; PMCID: PMC7877039.
• Aldasoro E, Posada E, Requena-Méndez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060–1067. doi: https://doi.org/10.1093/jac/dkx516. PMID: 29351667.
• Mitjà O, Houinei W, Moses P, Kapa A, Paru R, Hays R, Lukehart S, Godornes C, Bieb SV, Grice T, Siba P, Mabey D, Sanz S, Alonso PL, Asiedu K, Bassat Q. Mass treatment with single-dose azithromycin for yaws. N Engl J Med. 2015 Feb 19;372(8):703–710. doi: https://doi.org/10.1056/NEJMoa1408586. PMID: 25693010.
• Aponte JJ, Schellenberg D, Egan A, Breckenridge A, Carneiro I, Critchley J, Danquah I, Dodoo A, Kobbe R, Lell B, May J, Premji Z, Sanz S, Sevene E, Soulaymani-Becheikh R, Winstanley P, Adjei S, Anemana S, Chandramohan D, Issifou S, Mockenhaupt F, Owusu-Agyei S, Greenwood B, Grobusch MP, Kremsner PG, Macete E, Mshinda H, Newman RD, Slutsker L, Tanner M, Alonso P, Menendez C. Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials. Lancet. 2009 Oct 31;374(9700):1533–1542. doi: https://doi.org/10.1016/S0140-6736(09)61258-7. Epub 2009 Sep 16. PMID: 19765816.