Diagnosis

Diagnosis

Annex 1: Guideline development methods

Methods used to develop World Health Organization guidelines

To develop new or update existing guidelines for methods and tools to diagnose tuberculosis (TB), the World Health Organization (WHO) Global TB Programme commissions systematic reviews on the performance or use of the tool or method in question. A systematic review provides a summary of the current literature on diagnostic accuracy or user aspects, for the diagnosis of TB or the detection of anti-TB drug resistance in adults or children (or both) with signs and symptoms of TB.

Definitions

Advanced HIV disease: for adults, adolescents, and children aged 5 years or more, “advanced HIV disease” is defined as a CD4 cell count of less than 200 cells/mm³ or a WHO clinical stage 3 or 4 event at presentation for care. All children with HIV aged under 5 years should be considered as having advanced disease at presentation.

Age groups: the following definitions for adults and children are used in these guidelines for the purpose of implementing recommendations (countries may have other definitions under their national regulations)² :

Annex 2: Conflict of interest assessment for Guideline Development Group and External Review Group members

Before being considered for group membership, each Guideline Development Group (GDG) and External Review Group candidate was required to submit a completed declaration of interest (DOI) form. In addition, a preliminary internet search was performed to identify any obvious public controversies or interests that may lead to compromising situations for the World Health Organization (WHO) and the expert concerned.

Research gaps

Current recommendations on the various methods and tools should not prevent or restrict further research on new, rapid molecular drug-susceptibility tests, especially for assays that can be used as close as possible to where patients with a presumptive diagnosis of TB are identified and where treatment can be initiated. Priorities for further operational research on diagnostics are listed below, grouped for each technology.

Molecular assays intended as initial tests