Improved kala-azar case management through implementation of health facility-based sentinel sites surveillance system in Bihar, India

Background Visceral leishmaniasis (VL), also known as kala-azar (KA), is a neglected vector-borne disease, targeted for elimination, but several affected blocks of Bihar are posing challenges with the high incidence of cases, and moreover, the disease is spreading in newer areas. High-quality kala-azar surveillance in India, always pose great concern. The complete and accurate patient level data is critical for the current kala-azar management information system (KMIS). On the other side, no accurate data on the burden of post kala-azar dermal leishmaniasis (PKDL) and co-infections are available under the current surveillance system, which might emerge as a serious concern. Additionally, in low case scenario, sentinel surveillance may be useful in addressing post-elimination activities and sustaining kala-azar (KA) elimination. Health facility-based sentinel site surveillance system has been proposed, first time to do a proper accounting of KA, PKDL and co-infection morbidity, mortality, diagnosis, case management, hotspot identification and monitoring the impact of elimination interventions. Methodology/principal findings Kala-azar sentinel site surveillance was established and activated in thirteen health facilities of Bihar, India, using stratified sampling technique during 2011 to 2014. Data were collected through specially designed performa from all patients attending the outpatient departments of sentinel sites. Among 20968 symptomatic cases attended sentinel sites, 2996 cases of KA and 53 cases of PKDL were registered from 889 endemic villages. Symptomatic cases meant a person with fever of more than 15 days, weight loss, fatigue, anemia, and substantial swelling of the liver and spleen (enlargement of spleen and liver).The proportion of new and old cases was 86.1% and 13.9% respectively. A statistically significant difference was observed for reduction in KA incidence from 4.13/10000 in 2011 to 1.75/10000 in 2014 (p<0.001). There were significant increase (0.08, 0.10 per 10 000 population) in the incidences of PKDL and co-infection respectively in the year 2014 as compared to that of 2011 (0.03, 0.06 per 10 000 population). The proportion of HIV-VL co-infection was significantly higher (1.6%; p<0.05) as compared to other co-infections. Proportions of male in all age groups were higher and found statistically significant (Chi-square test = 7.6; P = 0.026). Utilization of laboratory services was greatly improved. Friedman test showed statistically significant difference between response of different anti kala-azar drugs (F = 25.0, P = 0.004).The initial and final cure rate of AmBisome was found excellent (100%). The results of the signed rank sum test showed significant symmetry of unresponsiveness rate (P = 0.03). Similarly, relapse rate of sodium antimony gluconate (SAG) was also found significantly higher as compared to other drugs (95%CI 0.2165 to 19.7035; P = 0.03). A statistically significant difference was found (p<0.001) between villages having 1-2 cases (74%) and villages with 3-5 cases (15%). Significantly higher proportion (95%) of cases were captured by existing Govt. surveillance system (KMIS) (p<0.001), as compared to private providers (5%). Conclusions/significance Establishment of a sentinel site based kala-azar surveillance system in Bihar, India effectively detected the rising trend of PKDL and co-infections and captured complete and accurate patient level data. Further, this system may provide a model for improving laboratory services, KA, PKDL and co-infection case management in other health facilities of Bihar without further referral. Program managers may use these results for evaluating program's effectiveness. It may provide an example for changing the practices of health care workers in Bihar and set a benchmark of high quality surveillance data in a resource limited setting. However, the generalizability of this sentinel surveillance finding to other context remains a major limitation of this study. The justifications for this; the sentinel sites were made in the traditionally high endemic PHC's. The other conditions were Program commitment for diagnostic (rk-39) and the first line anti kala-azar drug i.e. miltefosine throughout the study period in the sentinel sites. In addition, there were clause of fulfillment of readiness criteria at each sentinel site (already described in the line no 171 to 180 at page no-8, 181-189 at page no-9 and 192-212 at page no-10). Rigorous efforts were taken to improve all the sentinel sites to meet the readiness criteria and research activities started only after meeting readiness criteria at the site. Therefore sentinel site surveillance described under the present study cannot be integrated into other set up (medium and low endemic areas). However, it can be integrated into highly endemic areas with program commitment and fulfillment of readiness criteria. Author summary Visceral leishmaniasis is a neglected vector-borne disease, and one of the major public health problems of Bihar. The disease has been targeted for elimination by 2020. Bihar still posing challenge i.e. incidence is much high in a number of affected blocks, and even the disease is spreading in newer areas. None availability of an accurate data on the burden of post kala-azar dermal leishmaniasis (PKDL) and co-infections under the current surveillance system may emerge as a serious concern. Therefore, health facility-based sentinel site surveillance system has been attempted for the first time in Bihar for proper accounting of KA, PKDL and co-infection morbidity, mortality, diagnosis, case management, hotspot identification and monitoring the impact of elimination interventions. A system for capturing regional transmission is essential that can target focal areas of infection to monitor progress towards kala-azar elimination. Kala-azar sentinel site surveillance was established and activated in thirteen health facilities of Bihar during 2011 to 2014. The results showed a significant increase in PKDL and co-infection in 2014 when compared to 2011. Findings further revealed that utilization of laboratory services and case management were greatly improved, as majority of patients with KA, PKDL & co-infections were managed by the sentinel sites itself. The final cure rate of AmBisome was found excellent (100%). These observations may be useful to provide the basis for the design, refinement and resource allocation of the kala-azar control program. This system may also be useful in measuring impact of elimination interventions, their effectiveness and finally help in improving program management. It may further be used as an example for changing the practices of health care workers in Bihar and a lesson how to achieve high quality surveillance data in a resource limited setting. Standardization of sentinel site surveillance in terms of improved procedure, training, logistics, etc may further increase the effectiveness of this system. It may possibly be used as a cost-effective approach for capturing real-time kala-azar data under national kala-azar elimination programme.

Automated summary

The establishment and activation of kala-azar sentinel site surveillance in thirteen health facilities of Bihar from 2011 to 2014 detected a rise in PKDL and co-infections. The results showed significant improvement in utilization of laboratory services and case management, with most patients being managed by the sentinel sites. The system may provide a model for improving elimination interventions and program management.