Обратная связьAdverse event: Any untoward medical occurrence that may present in a person with tuberculosis (TB) during treatment with a pharmaceutical product but that does not necessarily have a causal relationship with the treatment.
Bacteriologically confirmed TB case: A case from whom a biological specimen is positive by smear microscopy, culture or a World Health Organization (WHO) recommended rapid diagnostic (e.g. Xpert® MTB/RIF).
Bacteriologically confirmed: when a biological specimen is positive by smear microscopy, culture or a rapid diagnostic test for TB recommended by WHO.
Clinically diagnosed: when a person who does not fulfil the criteria for bacteriological confirmation has been diagnosed with TB disease by a medical practitioner who has decided to give the person a full course of TB treatment.
Drug-resistant TB (DR-TB): TB disease caused by a strain of Mycobacterium tuberculosis complex that is resistant to any TB medicines.
Drug susceptibility testing (DST): In vitro testing using either molecular, genotypic techniques to detect resistance-conferring mutations, or phenotypic methods to determine susceptibility to a medicine.¹
Drug-susceptible TB (DS-TB): A bacteriologically confirmed or clinically diagnosed case of TB, without evidence of infection with strains resistant to isoniazid and rifampicin.
Extensive (or advanced) pulmonary TB disease: The presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography (CXR). In children aged under 15 years, advanced disease is usually defined by the presence of cavities or bilateral disease on CXR.
Extensively drug-resistant TB (XDR-TB): TB disease caused by a strain of M. tuberculosis complex that is resistant to rifampicin (and may also be resistant to isoniazid), and that is also resistant to at least one fluoroquinolone (levofloxacin or moxifloxacin) and to at least one other “Group A” drug (bedaquiline or linezolid).
Multidrug-resistant TB (MDR-TB): TB caused by Mycobacterium tuberculosis strains that are resistant to at least both isoniazid and rifampicin.
Multidrug- or rifampicin-resistant TB (MDR/RR-TB): The term used in this handbook and elsewhere to group MDR-TB and RR-TB cases; both MDR-TB and RR-TB cases are eligible for treatment with MDR-TB regimens. MDR/RR-TB usually refers to all patients affected by either MDR-TB or RR-TB.
New case: a person with TB disease who has never been treated for TB or has only previously ever taken TB drugs for less than 1 month.
Non-severe pulmonary TB: A form of TB defined as intrathoracic lymph node TB without airway obstruction; uncomplicated TB pleural effusion; or paucibacillary, non-cavitary disease confined to one lobe of the lungs and without a miliary pattern.
Operational research or implementation research: “the use of systematic research techniques for programme decision-making to achieve a specific outcome”.² In the context of this document, these terms are also applied to research that aims to develop the critical evidence base that informs the effective, sustained and embedded adoption of interventions within a health system, to improve health or patient outcomes. Such research deals with the knowledge gap between efficacy, effectiveness and current practice to produce the greatest gains in disease control.³ Operational research also provides decision-makers with information to enable them to improve the performance of their health programmes.⁴
People-centred (or person-centred) care is defined as “providing care that is respectful of, and responsive to, individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions”.
Pre-extensively drug-resistant TB (pre-XDR-TB): TB disease caused by a strain of M. tuberculosis complex that is resistant to rifampicin (and may also be resistant to isoniazid), and that is also resistant to at least one fluoroquinolone (either levofloxacin or moxifloxacin).
Rifampicin-resistant TB (RR-TB): TB caused by M. tuberculosis strains that are resistant to rifampicin. RR-TB strains may be susceptible to isoniazid or resistant to it (i.e. multidrug-resistant TB), or resistant to other first-line or second-line TB medicines.
Rifampicin-susceptible, isoniazid-resistant TB (Hr-TB): TB disease caused by a strain of M. tuberculosis complex that is resistant to isoniazid but susceptible to rifampicin.
Serious adverse event: An adverse event that leads to death or a life-threatening experience, to hospitalization or prolongation of hospitalization, to persistent or significant disability, or to a congenital anomaly. Includes adverse events that do not immediately result in one of these outcomes but that require an intervention to prevent such an outcome from happening.
Severe extrapulmonary TB: presence of miliary TB, TB meningitis, osteoarticular or pericardial TB. In children aged below 15 years, extrapulmonary forms of disease other than lymphadenopathy (peripheral nodes or isolated mediastinal mass without compression) are considered severe.
Social support in this document is defined as support to TB patients that includes informational and educational support (health education and counselling), psychological or emotional support, material support and companion support.
TB case: the occurrence of TB disease in a person.
TB disease: a disease in humans caused by the M. tuberculosis complex, which comprises eight distinct but closely related organisms – M. bovis, M. caprae, M. africanum, M. microti, M. pinnipedii, M. mungi, M. orygis and M. canetti. The most common and important agent of human disease is M. tuberculosis.
TB patient: a person who is in care for TB disease.
Treatment adherence interventions include social support such as: patient education or information support and counselling; material support (e.g. food, financial enablers, transport fees); psychological support; tracers such as home visits or digital health communications (e.g. short message service [SMS], telephone calls); medication monitors; and staff education. The interventions should be selected on the basis of the assessment of the individual patient’s needs, values and beliefs, and the provider’s resources and conditions for implementation.
Treatment administration options include: various suitable forms of treatment support, such as regular community- or home-based treatment support and video-supported treatment; and less preferable forms of treatment administration such as health facility-based treatment support and self-administered or unsupervised treatment.
Treatment support: Used here to describe an approach to supporting patients who are taking prescribed doses of TB medicines, to help ensure adherence to treatment and maximize its efficacy. Treatment support needs to be provided in the context of people-centred care and should be based on the individual patient’s needs, acceptance and preferences. It includes aspects of support, motivation and understanding of patients without coercion. Historically, this group of interventions were labelled as “directly observed treatment”.
1 Implementing tuberculosis diagnostics: a policy framework. Geneva: World Health Organization; 2015 (https://apps.who.int/iris/bitstream/10665/162712/1/9789241508612_eng.pdf)
2 Allotey P, Reidpath DD, Ghalib H, Pagnoni F, Skelly WC. Efficacious, effective, and embedded interventions: implementation research in infectious disease control. BMC Public Health. 2008;8:1–6. doi: https://doi.org/10.1186/1471-2458-8-343.
3 Guide to operational research in programmes supported by the Global Fund. Geneva: The Global Fund & World Health Organization; 2007 (https://medbox.org/document/guide-to-operational-research-in-programs-supported-by-the-global-fund#GO).
4 Expanding capacity for operations research in reproductive health: summary report of a consultative meeting, World Health Organization, Geneva, Switzerland, December 10–12. Geneva: World Health Organization; 2003 (https://apps.who.int/iris/handle/10665/67936).