Public call for individual patient data on treatment of drug-resistant tuberculosis

WHO is initiating the development of new guidelines on the treatment of drug-resistant tuberculosis (TB) to support countries in the programmatic management of drug-resistant TB. The latest evidence-based consolidated guidelines on the treatment of drug-resistant TB were published by WHO in June 2020 in accordance with the requirements of the WHO Guidelines Review Committee, using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE). However, over the past year new evidence has become available which requires a new assessment.

To prepare for the guideline development group meeting, WHO will commission reviews of relevant evidence on the effect of different treatment regimens on patient important outcomes. To enable this process and to ensure inclusion of all data available by mid-2021, WHO is issuing a public call, appealing to industry, researchers, national TB programmes and other agencies to provide suitable datasets.

The request is for individual patients’ data on bacteriologically-confirmed MDR/RR-TB patients (including MDR/RR-TB, MDR/RR-TB with additional resistance to second-line drugs or pre-XDR-TB, XDR-TB[1]) with the following specifics:

1.     use of modified shorter (less than 12 months) all-oral regimens using at least bedaquiline and linezolid.

2.     use of WHO recommended shorter bedaquiline-containing all-oral regimen (9-11 months) in the following combination 4–6 Bdq(6 m)-Lfx/Mfx-Cfz-Z-E-Hh-Eto / 5 Lfx/Mfx-Cfz-Z-E

3.     use of WHO recommended longer all oral treatment regimen containing at least bedaquiline and linezolid.   

The following essential criteria will have to be fulfilled for inclusion:

• Individual datasets of at least 25 patients who completed treatment and in whom an end-of-treatment outcome was assigned. Outcomes should be reported as per WHO definitions (Definitions and reporting framework for tuberculosis. 2013 revision preferred) 

• Baseline drug susceptibility results for rifampicin, isoniazid and fluoroquinolone are strongly preferred (+/- resistance to other group A drugs) using a WHO-recommended phenotypic or molecular test

• Data should be organized in anonymized, individual records (i.e. one row per treatment episode) for the minimum set of variables, preferably coded in a standard way (see Annex 1)

• Datasets are available in a digital format with essential variables as per attached data dictionary and can be shared within the requested period of time (please see below timeline)

Eligible data, in agreement with data owners, will be appended to an individual patient data platform on DR-TB treatment.

Please let us know by 30 July 2021 if you have data to contribute, by sending email at GTBPCI@who.int with a subject line ‘’individual patient data set’’.

The completed datasets in the requested format should be available, agreed to be shared with WHO by the data contributor (with a data sharing agreement if necessary) and submitted by 30 August 2021.

More information on the requirements of the datasets, variables, the process, deadlines and contacts is available here.