EDITORIALS Quality Tuberculosis Care All Should Adopt the New International Standards for Tuberculosis Care Jeremiah Chakaya1 and Mario Raviglione2 1
Centre for Respiratory Diseases Research, Kenya Medical Research Institute, Nairobi, Kenya; 2Global Tuberculosis Program, World Health Organization, Geneva, Switzerland
Tuberculosis (TB) remains a major global health problem. In 2012 an estimated 8.6 million people developed the disease, and 1.3 million people died (1). Great progress has been made in combating TB: the 2015 Millennium Development Goal of halting and beginning to reverse the incidence of TB has been achieved, and a target of 50% reduction in mortality compared with 1990 is on track. However, in some parts of the world, like Africa, this target may not be reached, and the global elimination target set for 2050 does not currently seem within reach because TB incidence is declining far too slowly. Current TB control strategies are crucially dependent on care that is provided to persons who have symptoms of TB and those who have the disease. When TB is not considered and appropriately evaluated in persons with compatible symptoms, the resulting delay promotes further transmission of infection and more severe disease (2, 3). The inappropriate use of the few anti-TB medicines that are currently available is the major driver for the development of drug-resistant TB, including of forms that are virtually untreatable (4, 5). Thus, individual care of people with TB symptoms or disease is the key and, at the same time, the vulnerable point of current public health actions for TB control. Substantial variations in the clinical approach to persons with TB symptoms or disease have been observed within and among countries, in the public and private
health care sector, and among clinicians in the same health facility (6, 7). These variations can have important implications for TB control. While many national TB control programs have progressively adopted the recommendations for TB care of the World Health Organization (WHO), private practitioners, nongovernmental caregivers, and academicians often have perceived national tuberculosis control program guidelines as inferior or not applicable to their settings, thus creating a public– private schism. This is particularly problematic in countries with a large private health sector (8, 9). Also in the past, a major criticism of national tuberculosis control program interventions and even of some elements of WHO guidelines, such as directly observed therapy (DOT), was that they were not evidence-based (10, 11). To address these concerns and ensure maximum adherence to scientific evidence, an international coalition of organizations led by the World Health Organization and the American Thoracic Society published the first edition of the International Standards for Tuberculosis Care (ISTC) in 2006. The ISTC aimed to unify approaches to clinical care of persons with TB symptoms or disease, irrespective of the country or setting in which care is taking place (12). ISTC was conceived as a critical bridge between public health officials and clinicians, especially those in the private health care setting who often are “Doubting Thomases”
concerning the utility of any public health approach to direct patient care. By compiling a list of key care standards backed by scientific evidence and written in a language that academicians, private doctors, and other care providers understand, the ISTC authors and sponsoring organizations hoped to loop these caregivers more effectively into the overall network of TB service providers. An important concept was to ensure that the DOTS strategy— and later, the Stop TB strategy—were interpreted properly by those not subject to influence by national TB control programs. This would facilitate the provision of a high standard of care to patients with TB in a manner that satisfies both individual needs and the public health obligations linked to managing TB. The first version of the ISTC set forth 17 standards: 6 on TB diagnosis, 9 on treatment, and 2 for the public health responsibilities that every health provider undertaking the care of persons with TB should carry out. At the time the first edition was published, a commitment was made to ensure that the ISTC became a living document that would be updated as new information emerged. Accordingly, a second updated and expanded version of the ISTC was published in 2009. This second edition incorporated 21 standards, which included revisions and expansion of some of the original standards and 4 completely new standards addressing
(Received in original form January 10, 2014; accepted in final form January 13, 2014 ) Author disclaimer: M.R. is a staff member of the World Health Organization; the views expressed in this article are his own and do not necessarily represent WHO policies. Correspondence and requests for reprints should be addressed to Jeremiah Chakaya, Centre for Respiratory Diseases Research, Kenya Medical Research Institute, P.O Box 47855 – 00202 Nairobi, Kenya. E-mail: [email protected] Ann Am Thorac Soc Vol 11, No 3, pp 397–398, Mar 2014 Copyright © 2014 by the American Thoracic Society DOI: 10.1513/AnnalsATS.201401-014ED Internet address: www.atsjournals.org
Editorials
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EDITORIALS comorbid conditions, isoniazid preventive therapy in children and HIV-infected persons, and prevention of infection transmission in health care facilities. While retaining the same number of standards as the second version, the current third edition of the ISTC, discussed in this issue of AnnalsATS (pp. 277–285), aims to make the standards more concise and includes, among other important updates (13): 1. diagnostic, treatment, and public health recommendations made by WHO resulting from recent advances in rapid diagnosis of TB, and in particular the use of rapid molecular tests; 2. the increasing need to pay special attention to individuals and populations at an increased risk of TB so as to reduce diagnostic delays; and 3. new recommendations for the treatment of multidrug-resistant TB (MDR-TB), including the proper use of bedaquiline, the first new drug in more than 40 years to be approved for the TB treatment. These innovations fully justify the need to revise the ISTC in keeping with the concept of a “living document.” In addition to technical updating, the ISTC needed to be aligned with the new post-2015 global TB strategy (14). One basic principle and call is that of “knowing your epidemic”; this demands a careful epidemiological assessment to identify persons at high risk and vulnerable
populations, leading to the adaptation of approaches to different country settings and according to well-understood priorities. The current version of the ISTC has captured this strategy nicely in the new Diagnostic Standard #1: “To ensure early diagnosis, providers must be aware of individual and group risk factors for tuberculosis and perform prompt clinical evaluations and appropriate diagnostic testing for persons with symptoms and findings consistent with tuberculosis.” In our view, the entire package of 21 standards should now be applicable everywhere, befitting the label of “international standards.” To disseminate the ISTC and ensure the widest implementation and use, endorsements have been obtained from a wide range of organizations with a special focus on professional associations. Professional associations are to exert peer pressure on the members of these associations to adopt the promoted care standards. If used appropriately by all practitioners, the new standards can greatly enhance the care of persons with TB and hold promise to reduce both short- and long-term morbidity and mortality at the individual and population level (15). The measure of success of the ISTC should be the quality of care that is provided to persons with TB symptoms and disease. However, while ISTC has been
References 1 World Health Organization. Global Tuberculosis Report 2013 [accessed 15 Feb 2014]. Available from: http://apps.who.int/iris/ bitstream/10665/91355/1/9789241564656_eng.pdf?ua=1 2 Greenaway C, Menzies D, Fanning A, Grewal R, Yuan L, FitzGerald JM; Canadian Collaborative Group in nosocomial Transmission of Tuberculosis. Delays in diagnosis among hospitalized patients with active tuberculosis: predictors and outcomes. Am J Respir Crit Care Med 2002;165:927–933. 3 Lee CH, Lee MC, Lin HH, Shu CC, Wang JY, Lee LN, Chao KM. Pulmonary tuberculosis and delay in anti-tuberculous treatment are important risk factors for chronic obstructive pulmonary disease. PLosOne 2012;7(5):e37978. 4 Udwadia ZF, Amale RA, Ajbani KK, Rodrigues C. Totally drug-resistant tuberculosis in India. Clin Infect Dis 2012;54:579–581. 5 van der Werf MJ, Langendam MW, Huitric E, Manissero D. Multidrug resistance after inappropriate tuberculosis treatment: a metaanalysis. Eur Respir J 2012;39:1511–1519. 6 Uplekar M, Juvekar S, Morankar S, Rangan S, Nunn P. Tuberculosis patients and practitioners in private clinics in India. Int J Tuberc Lung Dis 1998;2:324–329.
398
accepted and adopted in a variety of settings, there is still a lack of evidence that they have led to improvement in the quality of care. This clearly requires operational research and better evaluation of the metrics that should routinely be used to monitor quality of care. National TB control programs in highly endemic countries for the most part do not routinely carry out quality checks on the care that persons with TB receive, primarily because quality of care is not expected to be reported at the national level and to WHO. This is a challenge that needs to be addressed as the third edition of the ISTC rolls off the ramp. There are additional challenges regarding dissemination and promotion of use that have persisted since the initiation of ISTC 13 years ago. These challenges may be overcome by effective application of mobile electronic communications media and tools—referred to collectively as e/mHealth—to enable the ISTC to be rapidly and effectively disseminated to a wide range of health care providers. The ISTC offers the best benchmark upon which care for persons with TB symptoms and disease should be measured. We call on all practitioners, public and private, to adopt the new ISTC in their practice. n Author disclosures are available with the text of this article at www.atsjournals.org.
7 Chung WS, Chang RE, Guo HR. Variations of care quality for infectious pulmonary tuberculosis in Taiwan: a population based cohort study. BMC Public Health 2007;7:107. 8 Vyas RM, Small PM, DeRiemer K. The private-public divide: impact of conflicting perceptions between the private and public health care sectors in India. Int J Tuberc Lung Dis 2003;7:543–549. 9 Singh AA, Frieden TR, Khatri GR, Garg R. A survey of tuberculosis hospitals in India. Int J Tuberc Lung Dis 2004;8:1255–1259. 10 Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev 2003;1:CD003343. 11 Garner P, Volmink J. Directly observed treatment for tuberculosis. BMJ 2003;327:823–824. 12 Hopewell PC, Pai M, Maher D, Uplekar M, Raviglione MC. International standards for tuberculosis care. Lancet Infect Dis 2006;6:710–725. 13 Hopewell PC, Fair EL, Uplekar M. Updating the international standards for tuberculosis care: entering the era of molecular diagnostics. Ann Am Thorac Soc 2014;11:277–285. 14 World Health Organization. Global Strategy and Targets for tuberculosis prevention, care and control after 2015. Report by Secretariat [accessed 15 Feb 2014]. Available from: http://apps. who.int/gb/ebwha/pdf files/EB134/b134 12-en.pdf 15 Dye C, Glaziou P, Floyd K, Raviglione M. Prospects for tuberculosis elimination. Annu Rev Public Health 2013;34:271–286.
AnnalsATS Volume 11 Number 3 | March 2014
Centre for Respiratory Diseases Research, Kenya Medical Research Institute, Nairobi, Kenya; 2Global Tuberculosis Program, World Health Organization, Geneva, Switzerland
Tuberculosis (TB) remains a major global health problem. In 2012 an estimated 8.6 million people developed the disease, and 1.3 million people died (1). Great progress has been made in combating TB: the 2015 Millennium Development Goal of halting and beginning to reverse the incidence of TB has been achieved, and a target of 50% reduction in mortality compared with 1990 is on track. However, in some parts of the world, like Africa, this target may not be reached, and the global elimination target set for 2050 does not currently seem within reach because TB incidence is declining far too slowly. Current TB control strategies are crucially dependent on care that is provided to persons who have symptoms of TB and those who have the disease. When TB is not considered and appropriately evaluated in persons with compatible symptoms, the resulting delay promotes further transmission of infection and more severe disease (2, 3). The inappropriate use of the few anti-TB medicines that are currently available is the major driver for the development of drug-resistant TB, including of forms that are virtually untreatable (4, 5). Thus, individual care of people with TB symptoms or disease is the key and, at the same time, the vulnerable point of current public health actions for TB control. Substantial variations in the clinical approach to persons with TB symptoms or disease have been observed within and among countries, in the public and private
health care sector, and among clinicians in the same health facility (6, 7). These variations can have important implications for TB control. While many national TB control programs have progressively adopted the recommendations for TB care of the World Health Organization (WHO), private practitioners, nongovernmental caregivers, and academicians often have perceived national tuberculosis control program guidelines as inferior or not applicable to their settings, thus creating a public– private schism. This is particularly problematic in countries with a large private health sector (8, 9). Also in the past, a major criticism of national tuberculosis control program interventions and even of some elements of WHO guidelines, such as directly observed therapy (DOT), was that they were not evidence-based (10, 11). To address these concerns and ensure maximum adherence to scientific evidence, an international coalition of organizations led by the World Health Organization and the American Thoracic Society published the first edition of the International Standards for Tuberculosis Care (ISTC) in 2006. The ISTC aimed to unify approaches to clinical care of persons with TB symptoms or disease, irrespective of the country or setting in which care is taking place (12). ISTC was conceived as a critical bridge between public health officials and clinicians, especially those in the private health care setting who often are “Doubting Thomases”
concerning the utility of any public health approach to direct patient care. By compiling a list of key care standards backed by scientific evidence and written in a language that academicians, private doctors, and other care providers understand, the ISTC authors and sponsoring organizations hoped to loop these caregivers more effectively into the overall network of TB service providers. An important concept was to ensure that the DOTS strategy— and later, the Stop TB strategy—were interpreted properly by those not subject to influence by national TB control programs. This would facilitate the provision of a high standard of care to patients with TB in a manner that satisfies both individual needs and the public health obligations linked to managing TB. The first version of the ISTC set forth 17 standards: 6 on TB diagnosis, 9 on treatment, and 2 for the public health responsibilities that every health provider undertaking the care of persons with TB should carry out. At the time the first edition was published, a commitment was made to ensure that the ISTC became a living document that would be updated as new information emerged. Accordingly, a second updated and expanded version of the ISTC was published in 2009. This second edition incorporated 21 standards, which included revisions and expansion of some of the original standards and 4 completely new standards addressing
(Received in original form January 10, 2014; accepted in final form January 13, 2014 ) Author disclaimer: M.R. is a staff member of the World Health Organization; the views expressed in this article are his own and do not necessarily represent WHO policies. Correspondence and requests for reprints should be addressed to Jeremiah Chakaya, Centre for Respiratory Diseases Research, Kenya Medical Research Institute, P.O Box 47855 – 00202 Nairobi, Kenya. E-mail: [email protected] Ann Am Thorac Soc Vol 11, No 3, pp 397–398, Mar 2014 Copyright © 2014 by the American Thoracic Society DOI: 10.1513/AnnalsATS.201401-014ED Internet address: www.atsjournals.org
Editorials
397
EDITORIALS comorbid conditions, isoniazid preventive therapy in children and HIV-infected persons, and prevention of infection transmission in health care facilities. While retaining the same number of standards as the second version, the current third edition of the ISTC, discussed in this issue of AnnalsATS (pp. 277–285), aims to make the standards more concise and includes, among other important updates (13): 1. diagnostic, treatment, and public health recommendations made by WHO resulting from recent advances in rapid diagnosis of TB, and in particular the use of rapid molecular tests; 2. the increasing need to pay special attention to individuals and populations at an increased risk of TB so as to reduce diagnostic delays; and 3. new recommendations for the treatment of multidrug-resistant TB (MDR-TB), including the proper use of bedaquiline, the first new drug in more than 40 years to be approved for the TB treatment. These innovations fully justify the need to revise the ISTC in keeping with the concept of a “living document.” In addition to technical updating, the ISTC needed to be aligned with the new post-2015 global TB strategy (14). One basic principle and call is that of “knowing your epidemic”; this demands a careful epidemiological assessment to identify persons at high risk and vulnerable
populations, leading to the adaptation of approaches to different country settings and according to well-understood priorities. The current version of the ISTC has captured this strategy nicely in the new Diagnostic Standard #1: “To ensure early diagnosis, providers must be aware of individual and group risk factors for tuberculosis and perform prompt clinical evaluations and appropriate diagnostic testing for persons with symptoms and findings consistent with tuberculosis.” In our view, the entire package of 21 standards should now be applicable everywhere, befitting the label of “international standards.” To disseminate the ISTC and ensure the widest implementation and use, endorsements have been obtained from a wide range of organizations with a special focus on professional associations. Professional associations are to exert peer pressure on the members of these associations to adopt the promoted care standards. If used appropriately by all practitioners, the new standards can greatly enhance the care of persons with TB and hold promise to reduce both short- and long-term morbidity and mortality at the individual and population level (15). The measure of success of the ISTC should be the quality of care that is provided to persons with TB symptoms and disease. However, while ISTC has been
References 1 World Health Organization. Global Tuberculosis Report 2013 [accessed 15 Feb 2014]. Available from: http://apps.who.int/iris/ bitstream/10665/91355/1/9789241564656_eng.pdf?ua=1 2 Greenaway C, Menzies D, Fanning A, Grewal R, Yuan L, FitzGerald JM; Canadian Collaborative Group in nosocomial Transmission of Tuberculosis. Delays in diagnosis among hospitalized patients with active tuberculosis: predictors and outcomes. Am J Respir Crit Care Med 2002;165:927–933. 3 Lee CH, Lee MC, Lin HH, Shu CC, Wang JY, Lee LN, Chao KM. Pulmonary tuberculosis and delay in anti-tuberculous treatment are important risk factors for chronic obstructive pulmonary disease. PLosOne 2012;7(5):e37978. 4 Udwadia ZF, Amale RA, Ajbani KK, Rodrigues C. Totally drug-resistant tuberculosis in India. Clin Infect Dis 2012;54:579–581. 5 van der Werf MJ, Langendam MW, Huitric E, Manissero D. Multidrug resistance after inappropriate tuberculosis treatment: a metaanalysis. Eur Respir J 2012;39:1511–1519. 6 Uplekar M, Juvekar S, Morankar S, Rangan S, Nunn P. Tuberculosis patients and practitioners in private clinics in India. Int J Tuberc Lung Dis 1998;2:324–329.
398
accepted and adopted in a variety of settings, there is still a lack of evidence that they have led to improvement in the quality of care. This clearly requires operational research and better evaluation of the metrics that should routinely be used to monitor quality of care. National TB control programs in highly endemic countries for the most part do not routinely carry out quality checks on the care that persons with TB receive, primarily because quality of care is not expected to be reported at the national level and to WHO. This is a challenge that needs to be addressed as the third edition of the ISTC rolls off the ramp. There are additional challenges regarding dissemination and promotion of use that have persisted since the initiation of ISTC 13 years ago. These challenges may be overcome by effective application of mobile electronic communications media and tools—referred to collectively as e/mHealth—to enable the ISTC to be rapidly and effectively disseminated to a wide range of health care providers. The ISTC offers the best benchmark upon which care for persons with TB symptoms and disease should be measured. We call on all practitioners, public and private, to adopt the new ISTC in their practice. n Author disclosures are available with the text of this article at www.atsjournals.org.
7 Chung WS, Chang RE, Guo HR. Variations of care quality for infectious pulmonary tuberculosis in Taiwan: a population based cohort study. BMC Public Health 2007;7:107. 8 Vyas RM, Small PM, DeRiemer K. The private-public divide: impact of conflicting perceptions between the private and public health care sectors in India. Int J Tuberc Lung Dis 2003;7:543–549. 9 Singh AA, Frieden TR, Khatri GR, Garg R. A survey of tuberculosis hospitals in India. Int J Tuberc Lung Dis 2004;8:1255–1259. 10 Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev 2003;1:CD003343. 11 Garner P, Volmink J. Directly observed treatment for tuberculosis. BMJ 2003;327:823–824. 12 Hopewell PC, Pai M, Maher D, Uplekar M, Raviglione MC. International standards for tuberculosis care. Lancet Infect Dis 2006;6:710–725. 13 Hopewell PC, Fair EL, Uplekar M. Updating the international standards for tuberculosis care: entering the era of molecular diagnostics. Ann Am Thorac Soc 2014;11:277–285. 14 World Health Organization. Global Strategy and Targets for tuberculosis prevention, care and control after 2015. Report by Secretariat [accessed 15 Feb 2014]. Available from: http://apps. who.int/gb/ebwha/pdf files/EB134/b134 12-en.pdf 15 Dye C, Glaziou P, Floyd K, Raviglione M. Prospects for tuberculosis elimination. Annu Rev Public Health 2013;34:271–286.
AnnalsATS Volume 11 Number 3 | March 2014
