INT J TUBERC LUNG DIS 7(9):837–841 © 2003 IUATLD Impact of national consultants on successful expansion of effective tuberculosis control in India T. R. Frieden,*†‡ G. R. Khatri§¶ * Regional Office for Southeast Asia, World Health Organization, New Delhi, New Delhi, India; † NYC Department of Health and Mental Hygiene, New York, New York, ‡ National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA; § Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, New Delhi, India; ¶ FIDELIS, International Union Against Tuberculosis and Lung Disease (IUATLD), Paris, France SUMMARY S E T T I N G : India, during a period of rapid expansion of DOTS services. DOTS expansion has been slow in many countries. O B J E C T I V E : To document use of consultants to expand DOTS effectively. D E S I G N : Staff were contracted to monitor DOTS expansion and implementation. To estimate the impact of these staff, we compared areas with and without consultants, and individual areas before and after consultants were assigned. Consultants were preferentially assigned to the more difficult areas; the temporary absence of consultants reflected non-availability of candidates. R E S U L T S : Areas with consultants met pre-defined criteria and began DOTS service delivery faster (median 9 vs. 18 months of preparation) than areas without consul- tants. Rates of sputum conversion (87% vs. 83%, P 0.001) and treatment success (83% vs. 78%, P 0.001) were significantly higher in areas with consultants present. C O N C L U S I O N : Assignment of consultants resulted in much more rapid implementation of the DOTS strategy, and better quality performance. Continued effective performance in these areas will rely on many factors, but the need for consultants appears to be decreasing, suggesting that they have provided sustainable improvements. The effectiveness of local consultants may have important implications for efforts to scale up public health interventions for tuberculosis, malaria, AIDS and other diseases in developing countries. K E Y W O R D S : tuberculosis; DOTS; WHO; supervision THE DOTS (directly observed treatment, short-course) strategy has been the World Health Organization (WHO) recommended strategy for tuberculosis control since 1994.1 However, by 1999 less than one out of four patients in the world were being treated under this strategy.2 In India, progress in expansion of DOTS, known as the Revised National Tuberculosis Control Programme (RNTCP), was slow from 1993–1998, then rapid from late 1998 to the present.3,4 Many factors have contributed to the rapid and successful expansion of DOTS in India.5 One important factor has been the use of WHO-contracted local consultants. This article reviews the methods by which these staff were recruited, trained and supervised, and provides minimum estimates of their effectiveness and impact based on an ecological correlation between the presence of consultants and the pace and quality of expansion. among patients self-reporting to health services, regular supply of anti-tuberculosis drugs, standardized short-course treatment given by directly observed treatment, and systematic monitoring and accountability for treatment results.1 In India, the RNTCP is implemented by districts (average population, 2 million), with central and state government support. Prior to initiation of service delivery, districts must meet pre-defined appraisal criteria including the hiring of a small number of local staff to help run the programme and training of large numbers of health workers. After the beginning of service delivery, each district submits quarterly reports on case detection, patient progress (conversion of sputum smears for acid-fast bacilli from positive to negative), outcomes of every patient started on treatment, and programme management. The programme is funded by the central and state governments of India, the World Bank, and bilateral donors. WHO-contracted staff have been funded by the WHO and the Canadian International Development Agency. From August 1999, WHO-contracted staff, known METHODS The DOTS strategy consists of political commitment, case detection using smear microscopy primarily Correspondence to: Dr Thomas R Frieden, Commissioner, Department of Health and Mental Hygiene, 125 Worth Street, CN28, Room 331, New York, NY 10013, USA. Tel: (1) 212-295-5427 or 295-5341. Fax: (1) 212-295-5426. e-mail: [email protected] Article submitted 5 September 2002. Final version accepted 18 March 2003. [A version in French of this article is available from the Editorial Office in Paris and from the IUATLD Website www.iuatld.org] 838 The International Journal of Tuberculosis and Lung Disease as RNTCP Medical Consultants (RMCs), were assigned to assist the State and district governments in supervision of the programme. RMCs are required to have a medical degree and at least 2 years of experience. The positions are advertised in national newspapers, and short-listing is by a professional firm. Between 1% and 5% of applicants were offered positions, more than 80% of those offered positions accepted, and retention has been more than 90%. Selection is by a joint committee of WHO, the Government of India, and a State government. Consultants are trained for 2–3 weeks initially, including technical, administrative and operational aspects of the RNTCP, use of computers, data analysis, writing, presentation skills and 5 days of field supervision with an experienced supervisor. RMCs are generally provided with a jeep and laptop computer, and are reimbursed for work-related cell phone and internet use. A per diem for overnight visits is provided. Salaries are equivalent to government compensation for doctors with a similar level of responsibility. RMCs report to State and Central governments of India and to WHO on a monthly basis, and are provided with technical supervision and advice from WHO. Approximately twice a year there are meetings of all RMCs; WHO staff visit RMCs once or twice a year for hands-on training and supervision. Consultants are charged with the following duties: to provide technical support and assistance for training, supervision, implementation, monitoring and appraisal of the RNTCP according to Central governmental policy; investigate cases of treatment failure, default, death and relapse to determine causes and implications for programme improvement; visit all tuberculosis units and other peripheral institutions within assigned districts on a regular schedule, identifying problems in logistics and proposing solutions; assist in coordination among governmental and nongovernmental organizations and private physicians; and communicate information on programme and policy implementation, including programme status and financial reporting. The policy was to provide one consultant to oversee RNTCP preparation or implementation for districts with a total population of approximately 10 million. However, due to a scarcity of suitable candidates, the failure of several applicants to begin work as scheduled, delays, and unexpected departures, some areas were without RMC coverage for one or more quarters. Areas without RMC coverage were generally those expected to be better-performing; available consultants were preferentially sent to the more difficult areas (i.e., those areas with lower socio-economic development, weaker state tuberculosis control programmes, and/or weaker health systems). To estimate the effectiveness of consultants, areas with and without RMC coverage were compared. We analysed data from all 160 implementing districts over 10 quarters, representing an evaluation of more than 200 000 patients from the beginning of 1999 to mid2001. Areas whose implementation was supported by bilateral donors (5% of total implementing districts during this period), which utilised different supervisory mechanisms, were excluded from analysis. Four separate impact indicators were assessed: pace of expansion, sputum conversion rate, cure rate and treatment success rate. Pace of expansion was defined as the number of months between approval and start of DOTS provision. DOTS can only begin in India after predetermined appraisal criteria relating to hiring and training of staff have been met. Cure and treatment success rates were defined as per WHO guidelines.6 To estimate the impact of consultants, average case detection and cure rates were compared based on published and locally available data, as follows: total case detection rate under DOTS: 126 per 100 000 population;4 cure rate under DOTS of 82% and less than 40% under non-DOTS treatment;2 case fatality rate in smear-positive patients treated under DOTS: 5%;2 case fatality rate in smear-positive patients treated under non-DOTS: 29%;7 overall difference in case fatality rate between DOTS and non-DOTS (all patients): 18%.* RESULTS In the 2.5 years of data analysed, consultants were provided for 74% of the population covered, leaving 26% of the population without consultants. Prior to consultants being in place, it took a median of 18 months to begin service delivery in a small number of districts. A much larger number of districts have taken a median of 9 months to start service delivery since consultants have been in place. A similar difference has been seen in districts with and without consultants present during the preparatory phase. Sputum conversion, cure and treatment success rates are significantly higher in districts with RMCs in place (Figure 1). Rates of sputum conversion, reflecting effective treatment, were higher in areas with local supervisors (87% vs. 83%, P 0.001). Similarly, the treatment success rate was higher in areas with local supervisors: (83% vs. 78%, P 0.001). These differences were quite consistent over time, as shown for the success rates in Figure 2. Another way to evaluate effectiveness is against minimum performance standards: 79% of districts covered by an RMC had success rates 80%, compared with only 53% of districts without a consultant; sputum conversion was 80% in 87% of districts with a consultant compared with 72% of districts with no RMC (P 0.001 for both comparisons). * See www.tbcindia.org/method.asp for details of calculation. Impact of national consultants on TB control in India 839 Figure 1 Sputum smear conversion, cure and success rates in districts with and without medical consultants, Revised National Tuberculosis Control Programme, India, August 1999–June 2001. Based on these data it is possible to estimate the public health impact of RMCs. By expediting service delivery by 9 months, the average RMC, covering a population of 10 million, resulted in treatment of an additional 10 000 patients under the DOTS strategy, of whom at least 4000 would not otherwise have been cured (9/12ths of a year 126 cases/100 000 10 million population; cure rate 82% vs. 40%), and averted nearly 2000 deaths among these patients. By increasing the treatment success rate in areas under DOTS implementation, each RMC resulted in 1000 additional patients being successfully treated (126 cases/100 000 0.08% increase in treatment success) in each year of programme implementation. Figure 2 Treatment success rates in districts with and without medical consultants, Revised National Tuberculosis Control Programme, India, August 1999–June 2001. DISCUSSION Contracting of consultants by WHO in conjunction with the Government of India and state governments appears to have resulted in much more rapid implementation of the DOTS strategy and better quality of performance. The total annual cost of each consultant, including salary, benefits, travel, equipment and administration, has been less than $20 000 per year (WHO, unpublished data). This is in addition to the costs of implementation of DOTS (drugs, microscopy, training, local staff, etc.). In the first year of DOTS implementation, a group of less than two dozen consultants each resulted in an average of 4000 additional patients cured and 2000 deaths averted. Consultant impact is much greater in the first year of implementation than in subsequent years. This is because DOTS implementation results in a dramatic improvement in performance; expediting this implementation has substantial benefits. In subsequent years, consultants significantly improve performance, but from an already high level. Hence, from both programmatic and cost-effectiveness perspectives, use of RMCs in the early stages of expansion and implementation is of greatest importance. The relative merits of vertical versus horizontal implementation of public health programmes have long been debated.8,9 Consultants in the tuberculosis control programme were hired in an analogous fashion to consultants hired earlier for the polio eradication programme.10,11 Consultants have been used in various public health programmes, but there is a surprising lack of description and analysis of the methods used and of the results of assignment of national consultants in the medical and public health literature. The DOTS programme in India is implemented by the general health staff in rural areas and specialised staff 840 The International Journal of Tuberculosis and Lung Disease in some urban areas. In urban areas, high caseloads make the use of specialised staff more efficient. In addition to the consultants described in this article, for each 1 million population covered, two full-time treatment supervisors and two full-time laboratory supervisors are provided. Treatment and laboratory supervisors in the health system are a critical first line of supervision. Consultants contracted by WHO were able to strengthen state and district tuberculosis control officers’ ability to implement the programme, largely by increasing the effectiveness of the health system’s treatment and laboratory performance and supervision. The existence of specialised, full-time supervisory staff both within and outside the regular health care delivery system has been essential. We believe this type of specialised supervision is likely to be essential for successful implementation of many public health programmes in developing countries. Some of the most important functions of the consultants have been to ensure ongoing progress with preparation for service delivery, ensure accurate and timely reporting, and address problems or poor performance in specific geographic areas as they arise. The estimates presented here are likely to be robust for several reasons. First, they are consistent among indicators. Cure rates, success rates and sputum conversion rates all vary at around the same rate. Second, the analysis is consistent for results analysed crosssectionally—comparing all districts in each quarter with and without consultants—as well as longitudinally, comparing districts that lacked consultants for the quarters in which they were with and without a consultant. Third, these represent conservative estimates, as districts lacking a consultant sometimes did have partial services of a consultant from a neighbouring district. Fourth, we have included as ‘consultant’ quarters even those rare cases in which a poorly performing consultant was posted; this would tend to make the results under-estimate the actual impact. It is unlikely that the superior performance of districts with consultants is due to the characteristics of the districts themselves, because consultants were preferentially assigned to districts that were considered more likely to have difficulties in effectively implementing the RNTCP (e.g., because these areas had lower socioeconomic status, no full-time state tuberculosis control officer, or a relatively weak health system). There are important limitations to this analysis. Many variables affect performance, relatively few areas have been without a consultant for significant periods of time, some poorly performing districts did not report accurately (particularly when no RMC was present), performance may take 2–3 quarters to improve after an RMC was posted, the presence of an RMC earlier can make a difference much later, and if an RMC joins later, she or he can sometimes significantly improve performance from periods when there was no consultant. All of these limitations would tend to reduce the measured impact of RMCs, hence the differences documented in this study are most likely a minimal estimate of the impact of supervisors on performance. There is also a possibility of unrecognised selection and information bias. A further limitation of this analysis is that RMC effectiveness relies on a large range of input, including technical and logistic support from the Government of India, World Bank funds, State and District government staff, etc. However, RMCs provide a critical leverage input to make all of these resources more effective in programme implementation. Continued effective performance in these areas will rely on many factors, but the need for local consultants appears to be decreasing, suggesting that these staff provide sustainable improvements. Consultants focus on establishing patterns of effective functioning; these patterns are much easier to sustain than they are to establish. The plan is to provide consultants for 3–4 years after full implementation of DOTS, then to reduce the number to no more than one per state in most areas. The effectiveness of local consultants may have important implications for efforts to scale up public health interventions for tuberculosis, malaria, AIDS and other diseases in developing countries. Acknowledgements We thank the RNTCP Medical Consultants for their hard work and dedication to tuberculosis control in India, the Canadian International Development Agency for financial support of this project, Mr Santhosh Kumar for expert assistance with data management and manuscript preparation, and Mr Drew Blakeman for assistance with manuscript preparation. References 1 World Health Organization. Framework for effective tuberculosis control. WHO/TB/94.179. Geneva: WHO, 1994. 2 World Health Organization. Global tuberculosis control. WHO Report 2001 WHO/CDS/TB/2001.287. Geneva: WHO, 2001. 3 Khatri G R, Frieden T R. The status and prospects of tuberculosis control in India. Int J Tuberc Lung Dis 2000; 4: 193–200. 4 Ministry of Health and Family Welfare. TB India 2001: RNTCP status report. New Delhi: Government of India, 2001, 44 pp. 5 Khatri G R, Frieden T R. Rapid DOTS expansion in India— lessons for the world. Bull World Health Organ 2002;80:457–463. 6 Revised international definitions in tuberculosis control. Int J Tuberc Lung Dis 2001; 5: 213–215. 7 Datta M, Radhmani M P, Selvaraj R, et al. Critical assessment of smear-positive pulmonary tuberculosis patients after chemotherapy under the district tuberculosis programme. Tubercle Lung Dis 1993; 74: 180–186. 8 Hellberg H. Tuberculosis programmes: Fragmentation or integration? Tubercle Lung Dis, 1995; 76: 1–3. 9 Raviglione M C, Pio A. Evolution of WHO policies for tuberculosis control, 1948–2001. Lancet 2002; 359: 775–780. 10 Banerjee K, Hlady W G, Andrus J K, Sarkar S, Fitzsimmons J, Abeykoon P. Poliomyelitis surveillance: the model used in India for polio eradication. Bull World Health Organ 2000; 78: 321–329. 11 Andrus J K, Thapa A B, Withana N, Fitzsimmons J W, Abeykoon P, Aylward B. A new paradigm for international disease control: lessons learned from polio eradication in Southeast Asia. Am J Public Health 2001; 91: 146–150. Impact of national consultants on TB control in India 841 RÉSUMÉ L’Inde, au cours du développement rapide des services de DOTS. Le développement du DOTS s’est avéré lent dans beaucoup de pays. O B J E C T I F : Documenter les méthodes utilisées pour le développement du DOTS de façon efficiente. S C H É M A : Des consultants ont été engagés pour superviser le développement et la mise en œuvre du DOTS. Pour estimer l’impact de ces superviseurs, nous avons comparé les zones avec ou sans superviseurs ainsi que des zones individuelles avant et après la désignation des superviseurs. Les consultants ont été désignés de façon préférentielle dans les zones les plus difficiles : l’absence temporaire de consultants a résulté de l’absence de candidats. R É S U L T A T S : Les zones où des consultants avaient été désignés ont été capables de répondre aux critères prédéfinis et de commencer la fourniture de services DOTS plus CONTEXTE : rapidement (une préparation médiane de 9 mois vs. 18 mois) que les zones sans superviseurs. Les taux de négativation des expectorations (87% vs. 83%, P 0,001) et du succès du traitement (83% vs 78%), P 0,001) ont été plus élevés dans les zones avec consultants. C O N C L U S I O N : La désignation de consultants a entraîné une mise en œuvre beaucoup plus rapide de la stratégie DOTS et une meilleure qualité des performances. La poursuite d’une performance efficiente dans ces zones dépendra de nombreux facteurs, mais le besoin de consultants semble décroissant, ce qui suggère qu’ils ont fourni des améliorations de longue haleine. L’efficience des consultants locaux pourra avoir des implications importantes pour les efforts visant à améliorer les interventions de santé publique en matière de tuberculose, malaria, SIDA et autres maladies dans les pays en développement. RESUMEN C O N T E X T O : La India, durante el desarrollo rápido de los servicios de DOTS. La expansión del DOTS ha sido lenta en muchos países. O B J E T I V O : Documentar los métodos utilizados para la expansión del DOTS de manera eficaz. D I S E Ñ O : Consultantes fueron contratados para supervisar la expansión y la implementación del DOTS. Para estimar el impacto de estos supervisores se compararon áreas con y sin consultantes asignados, así como áreas individuales antes y después de la designación de supervisores. Los consultores fueron asignados preferentemente a las áreas más difíciles ; la ausencia temporal de consultores resultaba en una indisponibilidad de candidatos. R E S U L T A D O S : Las áreas con consultores asignados fueron capaces de lograr los criterios predefinidos y de comenzar a prestar servicios más rapidamente (una mediana de 9 meses de preparación contra 18 meses), que las áreas sin supervisores. Las tasas de negativización de la expectoración (87% contra 83%, P 0,001) y de éxito del tratamiento (83% contra 78%, P 0,001) fue más elevada en las áreas con consultores. C O N C L U S I Ó N : La designación de consultores tuvo como resultado una implementación mucho más rápida de la estrategia DOTS y un rendimiento de mejor calidad. La continuidad de un rendimiento eficaz en estas áreas dependerá de muchos factores, pero la necesidad de consultores parece disminuir, lo que sugiere que estos consultores han aportado mejoramientos durables. La eficacia de los consultores locales puede tener implicaciones importantes para los esfuerzos dirigidos a perfeccionar las intervenciones en tuberculosis, malaria, SIDA y otras enfermedades, en los países en desarrollo.
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