WHO Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis: 2011 Update
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Eur Respir J 2011; 38: 516–528 DOI: 10.1183/09031936.00073611 WHO GUIDELINES WHO guidelines for the programmatic management of drug-resistant tuberculosis: 2011 update D. Falzon, E. Jaramillo, H.J. Schu¨nemann, M. Arentz, M. Bauer, J. Bayona, L. Blanc, J.A. Caminero, C.L. Daley, C. Duncombe, C. Fitzpatrick, A. Gebhard, H. Getahun, M. Henkens, T.H. Holtz, J. Keravec, S. Keshavjee, A.J. Khan, R. Kulier, V. Leimane, C. Lienhardt, C. Lu, A. Mariandyshev, G.B. Migliori, F. Mirzayev, C.D. Mitnick, P. Nunn, G. Nwagboniwe, O. Oxlade, D. Palmero, P. Pavlinac, M.I. Quelapio, M.C. Raviglione, M.L. Rich, S. Royce, S. Ru¨sch-Gerdes, A. Salakaia, R. Sarin, D. Sculier, F. Varaine, M. Vitoria, J.L. Walson, F. Wares, K. Weyer, R.A. White and M. Zignol ABSTRACT: The production of guidelines for the management of drug-resistant tuberculosis (TB) AFFILIATIONS fits the mandate of the World Health Organization (WHO) to support countries in the For author affiliation details, please refer to the Acknowledgements reinforcement of patient care. section. WHO commissioned external reviews to summarise evidence on priority questions regarding case- finding, treatment regimens for multidrug-resistant TB (MDR-TB), monitoring the response to MDR-TB CORRESPONDENCE treatment, and models of care. A multidisciplinary expert panel used the Grading of Recommendations D. Falzon Stop TB Dept Assessment, Development and Evaluation (GRADE) approach to develop recommendations. World Health Organization The recommendations support the wider use of rapid drug susceptibility testing for isoniazid and 20 rifampicin or rifampicin alone using molecular techniques. Monitoring by sputum culture is important Av. Appia for early detection of failure during treatment. Regimens lasting o20 months and containing CH-1211 Geneva 27 Switzerland pyrazinamide, a fluoroquinolone, a second-line injectable drug, ethionamide (or prothionamide), and E-mail: [email protected] either cycloserine or p-aminosalicylic acid are recommended. The guidelines promote the early use of antiretroviral agents for TB patients with HIV on second-line drug regimens. Systems that primarily Received: employ ambulatory models of care are recommended over others based mainly on hospitalisation. May 01 2011 Accepted after revision: Scientific and medical associations should promote the recommendations among practitioners June 11 2011 and public health decision makers involved in MDR-TB care. Controlled trials are needed to improve the quality of existing evidence, particularly on the optimal composition and duration of MDR-TB treatment regimens. KEYWORDS: Ambulatory care facilities, diagnosis, drug therapy, guideline, multidrug-resistant tuberculosis his article reproduces the recommenda- tables presented in this article are reproduced from tions of the update of the World Health the guidelines [1] and are presented with the T Organization (WHO) Guidelines for the pro- permission of WHO. grammatic management of drug-resistant tuberculosis [1] released in June 2011. The guidelines were Tuberculosis (TB) control in the world today must developed in compliance with the requirements of face the challenge posed by the global spread of the WHO Guidelines Review Committee for Mycobacterium tuberculosis strains that are resistant evidence gathering, assessment and formulation to standard anti-TB drugs [2, 3]. It is estimated that of recommendations. Some of the text and the ,3% of incident new TB cases in the world have European Respiratory Journal Print ISSN 0903-1936 A press release for this article is available from www.erj.ersjournals.com/site/misc/presspack.xhtml Online ISSN 1399-3003 516 VOLUME 38 NUMBER 3 EUROPEAN RESPIRATORY JOURNAL D. FALZON ET AL. WHO GUIDELINES multidrug-resistant TB (MDR-TB), defined as resistance to at resistance to rifampicin and isoniazid or rifampicin alone on least isoniazid and rifampicin, the two most effective anti-TB all patients in the group at the time of TB diagnosis, in order to drugs [4]. Around 440,000 MDR-TB cases (95% CI 390,000– prescribe appropriate treatment at the outset? 510,000) are estimated to emerge annually among new and 2) Among patients with MDR-TB receiving appropriate retreated TB patients. The frequency of MDR-TB varies treatment in settings with reliable direct microscopy, is according to region and is much higher among previously monitoring using sputum smear microscopy alone, rather than treated patients. Amongst the vast majority of MDR-TB patients, sputum smear and culture, more or less likely to lead to the very little is known about their access to quality care. Treatment relevant outcomes listed in table 1? of MDR-TB is complex and uses toxic drugs that must be administered for a longer duration than for drug-susceptible TB 3) When designing regimens for patients with MDR-TB, is the patients, with a lower likelihood of treatment success [5]. inclusion of specific drugs (with or without documented susceptibility) more or less likely to lead to the relevant In 2009, in recognition of the threat posed by drug-resistant TB outcomes listed in table 1? to global public health security, the World Health Assembly urged Member States to achieve universal access to diagnosis 4) When designing regimens for patients with MDR-TB, is the and treatment of patients with this form of disease [6]. The inclusion of fewer drugs in the regimen (depending on the WHO was mandated to provide technical support to countries drug used, the patient’s history of using the drug and isolate for the development and implementation of national frame- susceptibility) more or less likely to lead to the relevant works of care for drug-resistant TB patients. The production of outcomes listed in table 1? guidelines for the programmatic management of drug-resistant TB is part of this role. WHO has previously developed guidelines 5) In patients with MDR-TB, is shorter treatment, compared on this subject, which were based on an assessment of available with the duration currently recommended by WHO, more or evidence and best practice by a large group of TB specialists [7, less likely to lead to the relevant outcomes listed in table 1? 8]. In 2008, an Emergency Update of the guidelines was 6) In patients with HIV infection and drug-resistant TB who published, which expired in 2010. Here, we report on the 2011 are receiving antiretroviral therapy (ART), is the use of drugs update of the guidelines [1], which was developed through a with overlapping and potentially additive toxicities, compared coordinated process that began in 2009. The guidelines target with their avoidance, more or less likely to lead to the relevant priority areas in drug-resistant TB care. They followed a careful outcomes listed in table 1? process of systematic retrieval and synthesis of evidence in preparation for the formulation of recommendations by a 7) Among patients with MDR-TB, is ambulatory therapy multidisciplinary expert panel (Guideline Development Group, compared with in-patient treatment more or less likely to lead see Acknowledgements). The panel included TB practitioners, to the relevant outcomes listed in table 1? public health professionals, representatives of professional The External Review Group also provided input into the design societies, National TB Control Programme staff and guideline and content of the questions. The Guideline Development methodologists, as well as members of civil society and Group then selected and scored outcomes to determine those nongovernmental organisations who provided technical sup- which were critical or important for making decisions on port, and WHO staff. A second group composed of National TB recommendations and on which data were to be sought during Control Programme staff, WHO regional advisers, clinicians and evidence retrieval and synthesis (table 1). public health experts was appointed to serve in a peer-review capacity as an External Review Group (see Acknowledgements). Reviewing the evidence Data sources MATERIAL AND METHODS Between October 2009 and May 2010, WHO commissioned teams Defining the scope of the updated guidelines (‘‘scoping’’) from leading academic centres (see Acknowledgements) to review The 2008 Emergency Update [8] of the guidelines identified areas and compile evidence for each of the questions through a series of of controversy in which guidance in policy and practice was to be systematic reviews of the literature using methods suggested by prioritised in future editions of the guidelines. In early 2009, an the Cochrane Collaboration [11]. The teams screened the titles, evaluation of the first two versions of the guidelines was conducted abstracts and full text of potentially relevant papers using key via a user questionnaire [9]. The members of the Guideline subject words and text words. The search was not limited by study Development Group discussed the findings of these two versions type or by a time period. In addition, the teams contacted article and decided to limit the scope of the guidelines to: 1) case-finding authors and consulted the Guideline Development Group (rapid molecular tests for drug resistance, and the investigation of members to identify studies that were missing or in progress. contacts and other high-risk groups); 2) MDR-TB treatment Individual patient data were collected from authors of published regimens and duration in HIV-positive and HIV-negative patients; studies to address questions dealing with bacteriology and 3) monitoring during treatment; and 4) models of care. treatment regimen (questions 2–6). Modelling