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Volume 26, Number 3—March 2020
Online Report

Improving Quality of Patient Data for Treatment of Multidrug- or Rifampin-Resistant Tuberculosis

Jonathon R. Campbell, Dennis Falzon, Fuad Mirzayev, Ernesto Jaramillo, Giovanni Battista Migliori, Carole D. Mitnick, Norbert Ndjeka, and Dick MenziesComments to Author 
Author affiliations: McGill University, Montreal, Québec, Canada (J.R. Campbell, D. Menzies); Research Institute of the McGill University Health Centre, Montreal (J.R. Campbell, D. Menzies); World Health Organization, Geneva, Switzerland (D. Falzon, F. Mirzayev, E. Jaramillo); World Health Organization Collaborating Centre for Tuberculosis and Lung Diseases, Tradate, Italy (G.B. Migliori); Harvard Medical School, Boston, Massachusetts, USA (C.D. Mitnick); South African National Department of Health, Pretoria, South Africa (N. Ndjeka); Montréal Chest Institute, Montreal (D. Menzies)

Main Article

Table 1

Data-sharing principles for contributors of individual patient data for multidrug-/rifampin-resistant tuberculosis

Principle Additional notes
Data contributed to the IPD should be coded to remove identifying information.
 • All names, the date of birth, address, telephone number, and other easily identifying personal information must be removed (e.g., national identification or health insurance numbers).
• Each participant contributed should be re-coded with a new IPD identification number that is mapped to the original identification number retained by the contributing investigator, group, and/or program.
• Dates of events (e.g., treatment start, cultures, medication changes) should be retained in the sent participant data file.
• Other local rules for encoding and other data protection measures should be followed.
The contributing investigator, group, and/or program retains ownership of the data and should have permission to share them.
 • The transfer of data for use in guideline development or other projects does not constitute transfer of ownership.
• Data contributors are free to withdraw their data at any time.
• Data must be contributed only if they are permitted by programs or donor agencies.
• A data sharing agreement will specify the details of the transfer of data (an example of a “starting point” for these data sharing agreements is contained in the Appendix).
All transfers of data must clear ethics review
 • The institutional review board responsible for the bioethics of each contributed dataset should approve that the data can be shared.
• All anticipated uses of the data should be reviewed and approved by the institutional review board.
All uses of data are subject to oversight by the collaborative group.
 • Ideally 1 individual is designated to liaise with the rest of the contributors of IPD to approve or deny use of their data for current or future analyses and be part of the oversight committee.
• The oversight committee reviews proposals for data use and sharing of data.
All data are held centrally in a secure data repository. • The IPD used for the development of MDR/RR-TB treatment guidelines for the WHO and other entities has been held securely by the McGill University Health Centre (MUHC) under Dick Menzies since 2010.
• The MUHC (now a WHO collaborating center) is expected to retain these responsibilities, pending approval of the oversight committee.
• Use of data held in this repository follows these principles, with bioethics approval and conforming to the current data sharing agreements signed.

Main Article

Page created: January 09, 2020
Page updated: January 09, 2020
Page reviewed: January 09, 2020
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.
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