ICMR-Rajendra Memorial Research Institute of Medical Sciences, Patna, India.
Randstad India Private Limited, New Delhi, Delhi, India.
PLoS Negl Trop Dis. 2021 Aug 24;15(8):e0009598. doi: 10.1371/journal.pntd.0009598. eCollection 2021 Aug.
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.
内脏利什曼病(VL),又称黑热病(KA),是一种被忽视的媒介传播疾病,目标是消除该病,但比哈尔邦的几个受影响地区由于高发病率病例而面临挑战,此外,该疾病正在新的地区传播。印度高质量的黑热病监测一直令人非常关注。当前黑热病管理信息系统(KMIS)需要完整和准确的患者水平数据。另一方面,当前的监测系统无法提供关于皮肤利什曼病(PKDL)和合并感染后负担的准确数据,这可能会成为一个严重的问题。此外,在病例较少的情况下,哨点监测可能有助于开展消除活动后阶段的工作,并维持黑热病(KA)的消除。首次提出了基于卫生机构的哨点监测系统,以便恰当地计算 KA、PKDL 和合并感染的发病率、死亡率、诊断、病例管理、热点识别和消除干预措施的影响。
方法/主要发现:在印度比哈尔邦的 13 个卫生机构中建立并启动了黑热病哨点监测系统,使用分层抽样技术,于 2011 年至 2014 年期间进行了监测。通过专门设计的表格从哨点机构的所有门诊患者中收集数据。在 20968 例有症状的病例中,从 889 个流行村登记了 2996 例 KA 和 53 例 PKDL。有症状的病例是指发热超过 15 天、体重减轻、疲劳、贫血以及肝脾肿大(脾肿大和肝肿大)的患者。新病例和旧病例的比例分别为 86.1%和 13.9%。从 2011 年的 4.13/10000 到 2014 年的 1.75/10000,KA 的发病率呈显著下降(p<0.001)。与 2011 年相比(0.03/10000 人口,0.06/10000 人口),2014 年 PKDL 和合并感染的发病率分别显著增加(0.08 人和 0.10 人/10000 人口)。HIV-VL 合并感染的比例明显更高(1.6%,p<0.05),而其他合并感染的比例则较低。所有年龄组的男性比例均较高,且差异具有统计学意义(卡方检验=7.6,P=0.026)。实验室服务的利用率得到了极大的提高。弗里德曼检验显示,不同抗黑热病药物的反应存在统计学差异(F=25.0,P=0.004)。两性霉素 B 脂质体的初始和最终治愈率均非常高(100%)。符号秩和检验显示,无反应率的对称性具有统计学意义(P=0.03)。同样,戊烷脒的复发率也明显高于其他药物(95%CI 0.2165 至 19.7035;P=0.03)。发病率为 1-2 例的村庄(74%)与发病率为 3-5 例的村庄(15%)之间存在显著差异(p<0.001)。现有的政府监测系统(KMIS)(p<0.001)有效地捕获了更高比例(95%)的病例,而私人提供者仅捕获了 5%的病例。
结论/意义:在印度比哈尔邦建立基于哨点的黑热病监测系统有效地检测到了 PKDL 和合并感染的上升趋势,并获得了完整和准确的患者水平数据。此外,该系统可能为改善其他比哈尔邦卫生机构的实验室服务、KA、PKDL 和合并感染的病例管理提供模式,而无需进一步转诊。项目管理者可以使用这些结果评估项目的效果。它可以为改变比哈尔邦卫生保健工作者的实践提供范例,并在资源有限的情况下树立高质量监测数据的基准。然而,这种哨点监测发现的推广性仍然是该研究的一个主要限制。这一限制的原因是:哨点是在传统的高流行区的 PHC 建立的。其他条件包括诊断(rk-39)和一线抗黑热病药物米替福新的计划承诺,整个研究期间在哨点都得到了实施。此外,每个哨点都有满足准备标准的条款(在第 8 页的第 171 行到第 180 行、第 9 页的第 181 行到第 189 行和第 10 页的第 192 行到第 212 行已经描述了这些条款)。为了满足准备标准,我们付出了艰苦的努力来改善所有的哨点,并在满足准备标准后才开始研究活动。因此,本研究中描述的哨点监测不能与其他设置(中低流行区)整合。然而,它可以与有计划承诺和满足准备标准的高度流行区整合。