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Table of Contents
RESEARCH ARTICLE
Year : 2019  |  Volume : 56  |  Issue : 4  |  Page : 315-322

Magnitude of unreported kala-azar cases in a highly endemic district of Bihar, India: A positive impact of Indian elimination programme


ICMR-Rajendra Memorial Research Institute of Medical Sciences, Patna, Bihar, India

Date of Submission15-May-2018
Date of Acceptance19-Jul-2019
Date of Web Publication30-Nov-2020

Correspondence Address:
Dr. N A Siddiqui
Scientist D, Department of Epidemiology & Biostatistics, ICMR Rajendra Memorial Research Institute of Medical Sciences, Agamkuan, Patna– 800 007, Bihar
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-9062.302034

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  Abstract 

Background & objectives: In India, kala-azar surveillance is weak and no public-private partnership exists for disease containment. Estimate of disease burden is not reliably available and still cases are going to private providers for the treatment. The present study aimed to assess the magnitude of kala-azar cases actually detected and managed at private set-up and unreported to existing health management information system.
Methods: Institution based cross-sectional prospective pilot study was conducted. List of facilities was created with the help of key informants. The information about incidence of kala-azar cases were captured on monthly basis from July 2010 to June 2011. Rapid diagnostic strip test (rk-39) or bone marrow/splenic puncture were applied as laboratory methods for the diagnosis of kala-azar. Descriptive statistics as well as chi-square test for comparison between proportions was conducted.
Results: Overall availability of private practitioners (PPs) was 4.59/1,00,000 population and maximum PPs (46; 93.9%) were from qualified category. The median years of medical practice was 25 yr (inter quartile-range [18, 28]). Interestingly, only a small proportion (240; 19%) of cases was managed by PPs. Amongst the PPs, only low proportion (32; 18.2%) managed >2 cases per month. The mean number of kala-azar suspects and cases identified varied significantly between different PPs’ professions with p <0.048 and p <0.032, respectively. A highly significant difference (p <0.0001) was observed for kala-azar case load between qualified and unqualified practitioners. A small proportion (38; 15.8%) of kala-azar cases was not present in the public health system record.
Interpretation & conclusion: Still sizeable proportions of cases are going to PPs and unrecorded into government surveillance system. A mechanism need to be devised to involve at least qualified PPs in order to reduce treatment delay and increase case detection in the region.

Keywords: Dermal leishmaniasis; elimination programme; kala-azar; private practitioners; public health system; visceral leishmaniasis


How to cite this article:
Siddiqui N A, Pandey K, Das V, Sinha S K, Verma R B, Lal C S, Ali V, Topno R K, Dikhit M R, Das P. Magnitude of unreported kala-azar cases in a highly endemic district of Bihar, India: A positive impact of Indian elimination programme. J Vector Borne Dis 2019;56:315-22

How to cite this URL:
Siddiqui N A, Pandey K, Das V, Sinha S K, Verma R B, Lal C S, Ali V, Topno R K, Dikhit M R, Das P. Magnitude of unreported kala-azar cases in a highly endemic district of Bihar, India: A positive impact of Indian elimination programme. J Vector Borne Dis [serial online] 2019 [cited 2021 Jan 21];56:315-22. Available from: https://www.jvbd.org/text.asp?2019/56/4/315/302034


  Introduction Top


Visceral leishmaniasis (VL), commonly known as kala-azar is a major cause of morbidity and mortality and of tremendous public health importance in India. Bangladesh and Nepal, affecting the poorest population groups, primarily in rural areas. With an estimated 200 million people at risk, India, Nepal and Bangladesh harbour an estimated 67% of the global VL disease burden[1]. In this region, Leishmania donovani is the only species causing VL, the female sand fly Phlebotomus argentipes is the only vector and humans are the only known reservoir[2],[3]. Recent advances in rapid field based diagnostics and availability of effective and safe drugs make the disease a target for elimination[4]. National programme for kala-azar elimination (NPKE) was launched in 2005 by Bangladesh, India and Nepal. One of the main strategies is early case detection and management of VL and post kala-azar dermal leishmaniasis (PKDL). Further, it has been coupled with integrated vector management strategies including indoor residual spraying, promotion of use of insecticide treated bed nets which aim to reduce VL transmission and disease bur- den[5]. Despite these efforts, disease transmission continues. The health information system is a key component for any disease control programs and its accuracy is necessary for the assessment of actual disease burden. But unfortunately in India, kala-azar surveillance is weak and no public-private partnership exists for the disease containment in the affected areas. The estimate of disease burden in endemic areas is not reliably available, and is suspected to be underestimated by service statistics in the absence of a robust surveillance mechanism[6],[7],[8]. An important cause for this may be treatment seeking behavior of endemic population. Early detection is hindered by a current surveillance system which is primarily dependent on passive reporting of patients to a public health facility. Recent studies showed that active case detection strategies increases kala-azar case detection in Indian subcontinent[9-10. Other studies documented that even after various interventions initiated under kala-azar elimination programme since 2006-07; cases are going to private practitioners (PPs) for treatment in India[11]. Recently, the WHO recognized that the global target of detecting all new kala- azar cases is not likely to be met unless current efforts are strengthened by including important stakeholders in kala-azar elimination program[12].

Private practitioner’s involvement in tuberculosis control has shown significant results[13],[14]. Earlier PPs managed a substantial number of kala-azar cases in Bihar state of India which does not exist in the public health system record [government surveillance system (GSS)][15]. The unreported cases would affect the assessment of current kala-azar elimination program of the country. Keeping that in mind, national government has declared kala-azar as notifiable disease in the endemic states. However, after elimination initiatives, there has been no systematic study on proportion of unreported kala-azar cases in Bihar. Such study is much needed to document and estimate the current situation. The objective of the present study was to assess the extent of unreported cases of kala-azar in the public health system records and kala-azar case load amongst PPs. The study may act as lead for the national programme for further policy discussions to establish means of collaboration between the private and public sector, if necessary. It may also be helpful in assessing the progress of kala-azar elimination, specifically for Bihar.


  Methods Top


Study design and duration

The study was designed as a pilot cross-sectional study. The study was for a period of 18 months. However, the information about incident kala-azar cases was captured on monthly basis from July, 2010 to June 2011 for one year period.

Study area/setting

The present study was conducted in Saran district of Bihar, India, on the basis of their consistent higher ende- micity. There are 15 primary health centres (PHCs) with total population of ~3.5 million. In Bihar, generally seriously ill people used to go either to public set-up at district level (district hospital/medical college) or to ‘well-renowned’ private qualified doctor clinics for their treatment. With the intention to have adequate number of kala-azar cases, study was conducted in the four PHC areas (Parsa, Mashrakh, Baniyapur and Mahrowra) based on incidence ranking from 1-4. In addition, the private clinics involved in the treatment of kala-azar at district head quarter (Chapra) level were also included in the study.

Study subject

The study subjects were included on the basis of WHO case definition of VL/kala-azar. A patient from the endemic area with fever of more than 2-weeks, splenomegaly, not responding to anti-malarial and antibiotic treatment and positive by rapid diagnostic strip test (rk-39) for kala-azar or a case with a laboratory-confirmed diagnosis (splenic puncture or bone marrow puncture/biopsy) is a case of kala-azar. The rapid diagnostic strip test (rk-39) used, for diagnosis of kala-azar is an immunochromato graphic test (Kala-azar Detect Rapid Test; Inbios International Inc, Seattle, WA, USA; Lot No WD 1295) that was designed for qualitative detection of antibodies against L. donovani. It is specific for antibodies in patients with VL caused by L. donovani complex. It is an easy and reliable serological tool for field based diagnosis of VL using peripheral blood samples. A trained field technician performed the rK-39 strip test as per the manufacturer’s instructions. The sensitivity of the rK-39 test is about 95-96% in India. Any individual attending facility confirmed for kala-azar was the inclusion criteria for study subjects.

Sample size

Being a pilot study, appropriate sample size was not attempted. However, the required sample size was the private clinics involved in the treatment of kala-azar in four PHCs and one district headquarter, with the intention to capture adequate number of kala-azar cases.

Sampling technique

Service statistics data of kala-azar is suspected to be underestimated in the absence of a robust surveillance mechanism. Keeping kala-azar elimination in mind (goal of reducing its incidence to <1/10,000 populations at block level), a lowest administrative unit within the district which contains mostly rural population with small proportion of urban population and that of such information is of vital importance for the programme managers, a non probability sampling techniques was utilized for selection of private clinics. The purposive or judgment sampling technique was adopted for deliberate selection of sample that conforms to some predetermined criteria.

Study procedure

Prior to listing of study clinics, few visits of the district head quarter and PHCs were performed to find the private clinics involved in treatment of kala-azar. Initially, a list of such clinics was prepared with the help of public health system (District Health Authorities), key political and other relevant informants (Block pramukh, mukhiya, surpanch, teachers, NGOs, social activists, local leaders etc.). They are the local influential persons in the society and considered as the main gate keepers. The information about case detection and management was captured on monthly basis from July 2010 to June 2011 for each unit available in the list of clinics.

The participating clinics personnel were instructed about the needed information and methods of data collection. They were told to record confirmed kala-azar cases in a record register designed for the purpose of the study. The record register contained the details of kala- azar patients such as name, alias name if any, father/ husband name, complete address, age, sex, contact number if any, date of arrival to the facility, inclusion criteria of subjects, date and type of diagnostic tests and their results, name of drug and date of start of treatment, etc. The training was imparted with the help of standard operating procedure, specially designed for recording and documentation. The questionnaire was presented and the staffs were imparted training about how to gather information from the patients coming to the clinic prior to start of survey. Each clinic was visited fortnightly to observe the documentation and to obtain recorded data. If any deviation from the project procedure observed during the visit, it was corrected on the spot and clinic personnel were told to ensure the procedure in future. All kala-azar cases registered at clinics were matched with the public health system records for the specific period of the district.

Thus all such cases treated in the private clinics and missed from the health system record were assessed. Standardized data collection forms were developed and pre-tested. Data collection was conducted by the researchers working in the institute. Technical assistance and specific training was imparted to them to handle the project activities correctly and efficiently.

Data entry and statistical analysis

The entire questionnaire was scrutinized for accuracy and consistency by putting distribution checks and range values. Cleaned data were entered and analyzed through computer using Epi Info version 3.3.2 (CDC, Atlanta). Proportion, mean and standard deviation were calculated using descriptive statistics. Group differences were analyzed using independent unpaired t-test. The population of respective blocks was used as denominator for estimation of availability of PPs. A p-value <0.05 was considered statistically significant.

Ethical statement

The study was duly approved by the Ethics Committee and the Scientific Advisory Committee of the Rajendra Memorial Research Institute of Medical Sciences, vide No. RMRI/ICMR/Ext/06/EPI dated 14th January, 2010. A written informed consent was obtained from all the institutions participating in the study. Confidentiality of institutions was maintained as per the ethical norm.


  Results Top


Profile of study district

Saran is located 70 km away from state capital (Patna) and stretches in 2641 km[2] area with latitude 25.36’-26.13’ N and longitude 84.24’- 85.15’ E. The soil of the district is alluvial. The climate of the district is generally tropical in nature with hot summer and cold winter. Overall, literacy rate was 69% with 949 females per 1000 males. Public health facility is provided through PHCs (primary level care), district hospital (secondary level hospital), and referral hospital (secondary level hospital) in the study district. Map of the study district, locating study areas is shown in [Figure 1].
Figure 1: Map of the study district (Saran), showing study areas (marked as circles) in Bihar state, India.

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Baseline profile of private practitioners (PPs) involved in kala-azar care delivery services

Altogether 49 PPs were involved in the treatment of kala-azar in the study area and all were male. Further, the availability of PP was found 2.62/1,00,000 population at PHC level (rural) while much higher (11.82/1,00,000) at district level (urban). However, overall availability of PP was 4.59/1,00,000 population for the study area. Amongst the available PPs, majority (40; 82%) belonged to clinician category and rest (9; 18%) were pathologists. Clinician category was higher at both levels as compared to pathologist category. As regard to treatment, PPs were further classified on the basis of their professional expertise, which revealed that maximum (46; 93.9%) were from qualified category, followed by 6.1% (3) from unqualified category. Qualified category of clinician was comparatively much higher at both levels when compared to unqualified category of clinician. Out of the clinician category, only 22% (9) were providing treatment of kala- azar in their clinic and rest (31; 78%) referring the patients to government health facilities for the treatment of kala-azar. Clinicians providing the treatment of kala-azar in own clinic was much lower at both levels when compared to referral for treatment. The mean age of PPs was 52 yr. The median years of medical practice was 25 yr (inter quartile-range [IQR; 18, 28] . In this study, few PP’s had seen a significant number of kala-azar patients and suspects in their respective clinics. The median number of kala-azar cases detected per month was 1.3 (IQR; 0.8, 1.8). About 18% (7) of the PPs diagnosed >2 cases per month. The median number of kala-azar suspects detected per month was 3.7 [(IQR; 2.8, 5]. In a period of one year, a total of 1279 kala-azar patients were reported for the study areas and out of that maj ority (1039; 81%) were captured by government health facilities. Out of these, 1163 (90.9%) of kala-azar cases were diagnosed by rapid diagnostic strip test (rk-39) and rest 116 (9.1%) by bone marrow/splenic puncture. Interestingly, only a small proportion (240; 19%) of cases was managed by PPs, which was comparatively higher (144; 23%) at district level when compared to PHC level (96; 15%).

The PHC-wise distribution of kala-azar cases detected by public health system and PPs are presented in [Table 1]. It was observed that kala-azar case detection through PPs was maximum (24; 22%) in Parsa PHC and minimum (12; 7%) in Mahraura PHC.
Table 1: PHC-wise distribution of kala-azar cases detected by public health system (PHS) and private practitioners (PPs)

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Out of the 240 cases detected by PPs, only 38 (15.8%) cases were not in the GSS which was slightly higher (28; 19.4%) at district level [Table 2].
Table 2: Kala-azar cases detected by PPs and not existing in government surveillance system (GSS) during the study period

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The mean number of kala-azar suspects and cases identified varied significantly between the different PPs’ professions with p <0.048 and p <0.032, respectively [Table 3]. A highly significant difference (p <0.001) was observed for kala-azar case load between qualified and unqualified practitioners. Majority of the kala-azar cases were seen and treated by the very confined practitioners, known for their practice of kala-azar in the endemic areas by the endemic community (well renowned/known doctor for kala-azar).
Table 3: Kala-azar cases and suspects identified by qualified and unqualified category of private practitioners (PPs)

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Management of kala-azar patients and broad reasons for going to PPs

A key tool for kala-azar diagnosis in their patients was mainly based on rk-39 (90.9%) strip test, done at different laboratories available in the area along with clinical signs and symptoms of the patients and to a lesser extent (116; 9.1%), on bone marrow/splenic puncture. About three fourth (30; 75%) of PPs prescribed Fungizone (Amphoterecin-B), freely available in the open market. Only 17.5% (7) kept a standardized clinical history oftheir kala-azar patients in their clinics. The broad reasons for going to private practitioners for kala-azar treatment were their non-awareness (72%) about the public health facility of kala-azar in their area followed by lack of faith (49%), willingness for superior treatment (44%), role of broker (32%), advice of fellow villagers, friends, local doctors & others (28%). In addition to above, untimely payment of incentive to the patients was also playing role (25 %) in this. These findings were of multiple response type.


  Discussion Top


Recently, the WHO recognized that the global target of detecting all new kala-azar cases is not likely to be met unless current efforts are strengthened by including important stakeholders in kala-azar elimination programme. Earlier conducted studies in the region reported that in India, a large proportion of kala-azar cases are managed by PPs, which lead to increased risk of drug resistance and continued transmission[16]. The trends of kala-azar incidence in different PHCs of study district are consistently high (1.7/10,000) for the 2016, 2017 and 2018) i.e. much above the elimination target (< 1 case per 10,000 population at block level), as compared to (0.9 and 0.8 per 10,000) surrounding districts (Gopalganj and Siwan respectively). There were 20 PHCs in the study district (Saran). Out of them 14 PHCs were above the elimination target (>1 case/10,000), which includes Parsa, Baniyapu, Mashrakh and Marhaura.

However, a study conducted by Thakur[17] documented a declining trend in India as well as in Bihar and stated further that kala-azar may be eliminated if we take up elimination programme with renewed vigour, effective drugs, better insecticides and strict supervision. The study suggested the government of India to provide supervisory support to local doctors and PPs for kala-azar case management in the endemic areas[17]. A recent study concluded that the distribution of VL in Bihar is highly heterogeneous, and reported caseloads and associated mortality vary significantly across different districts, posing different challenges to the elimination campaign[18].

The overall availability of PPs was 4.59/1,00,000 population for the study area. Amongst the available PPs, majority (40; 82%) belonged to clinician category and out of that maximum. In the study majority of PPs (46; 93.9%) were from qualified category of physicians, which contradict an earlier study finding where 81% patients first presented to unqualified practitioners[19]. It is self evident from the finding that kala-azar case management is being provided mainly by qualified categories of PPs which contradict the earlier perception that good proportion of kala-azar cases have been managed by unqualified categories of private practitioners. The results further showed that sizeable proportions (9; 22%) of PPs were providing treatment of kala-azar in their own clinic. It was not consistent with earlier study finding as PPs were the first choice for seeking care for kala-azar and people prefer PPs (50%) for kala-azar treatment.[9],[11] Whereas, a study conducted by Kumar et al[15] revealed the presence of private practitioners only for kala-azar case management in Indian subcontinent[15]. This study for the first time reports in-depth scenario of PPs in highly endemic area of Bihar, India.

The median number of kala-azar suspects and cases detected per month were low (3.7, 1.3), indicating that PP’s were not much potential sources of health care for kala-azar patients in the study region. Low proportion (2; 18.2%) of the PPs managed more than 2 cases per month. Present study finding is identical with that reported in Indonesia and Pakistan in case of TB[9],[20],[21]. The results further revealed that PPs in Bihar do see presumptive kala-azar cases, although the number per PP was notably low. Not all, PPs involved in the kala-azar care delivery have seen presumptive kala-azar; rather only few PPs had seen a significant number of kala-azar patients and suspects in their respective clinics. Alternatively, kala- azar treatment was available in very few PPs clinics, and such PPs might be familiar for delivering kala-azar treatment in their own clinic to the endemic population. However, this is in line with findings from a previous survey on TB conducted among PPs in Jogjakarta, Indonesia[20].

Interestingly, in this study only a small proportion (240, 19%) of cases were managed by PPs, and out of that only 15% (36) of kala-azar cases were not present in the public health system record (GSS). It means that PPs are providing the kala-azar treatment in their clinics but not reporting to public surveillance system, in spite the disease is notifiable in the state. Notifiable disease means every physician providing the treatment of kala-azar must report to government. This requires coordination between the government and PPs treating the kala-azar in their clinics. It may be strengthen with the help of regular monitoring and evaluation or by limited logistics support.

On the other hand, Singh et al[6] had documented that overall magnitude of VL cases not reporting to the GSS was higher by a factor of 4.17 and in other study annual incidence was found 21.9 per 10,000, which was much higher in comparison to public health system records and these cases were taking kala-azar care delivery services from private practitioners[8].

Therefore, the findings of earlier conducted studies in Indian sub-continent did not coincide with our results. The possible explanations of our result may be that a good number of interventions already took place at the grass root level under the elimination programme. Specifically, interventions, viz incentive based kala-azar case detection through accredited social health activist (ASHA), wage loss payment to kala-azar patients, awareness of endemic population about kala-azar through IEC campaign possibly may be diverted the kala-azar patients to public health system than private practitioners clinic as reported by earlier conducted studies. This means that, the region may achieve a 15% increase in the kala-azar cases missing from the GSS by involving at least PPs dealing with kala-azar. These unreported cases would affect kala-azar elimination programme in the state as well as in the country. However in case oftuberculosis electronic reporting systems, in which case reports are sent electronically from PPs to government databases, have been implemented successfully in other countries[22],[23].

Therefore, the existing surveillance system of kala- azar need to be strengthened in such a way that every case of kala-azar must be recorded in the surveillance system. It has been done successfully for VL in Meshkin- Shahr district of Ardebil province, north-western Islamic Republic of Iran. It revealed that the mean annual incidence of VL decreased significantly from 1.88 before (19852000) to 0.77 per 1000 child population after the intervention (2001-2007). The findings further suggested that timely treatment of cases could decrease the mortality and morbidity rates of VL in endemic areas[24].

The mean number of kala-azar suspects and cases identified varied significantly between the different PPs professions with p <0.048 and p <0.032 respectively. More cases were seen by qualified practitioners, which was identical with other study, medical specialists were also found to have seen more cases compared to other PPs[20]. A considerable proportion of PP’s indicated that few kala-azar patients visited unqualified practitioners also. A highly significant difference (p <0.0001) was also observed for kala-azar case load between qualified and unqualified practitioners.

We do not have any information about asymptomatic individuals, because it was not the primary objective of this study. Commonly, asymptomatic individuals do not visit to health facilities until symptoms appear in India. Long mean delay (90 days) between onset of symptoms and getting a proper diagnosis and treatment which support the above argument[25].

The broad reasons for going to PPs for kala-azar treatment were non-awareness about the public health facility, faith, willingness for superior treatment and untimely payment of incentive to the patients, against the provision of incentive under the national elimination programme. If government ensures timely payment of incentives to the patients and volunteers as per the laid down provision, it may further reduce the proportion of kala-azar cases going to private practitioners for kala-azar treatment. Thus, it has been said that the new interventions (diagnostic, drug, incentive, etc.) have already took place at the grass root level and working under the existing system. Therefore, majority of the cases were managed by public health system of kala-azar programme of the country. The results of this study are encouraging and supporting the elimination programme of the country.

It has been further noted from the outcome of the present study that still sizeable proportion of cases was going to private practitioners and not reported to GSS. This drawback may affect the current kala-azar elimination programme. But still measuring actual disease burden is a challenge in the endemic areas of Bihar, India for the national programme. Keeping the kala-azar elimination in mind by 2020 there is an urgent need of involvement of PPs in the kala-azar elimination programme by way of periodic training and retraining with limited logistics support. A mechanism need to be evolved to engage at least qualified PPs delivering kala-azar care services in their own clinic. Reporting of such kala-azar cases has to be made compulsory for the treating PPs in district surveillance system. It may be helpful in capturing every kala- azar case in the system and thus can reduce transmission of the disease in endemic population.

Overall, trend analysis confirmed the declining trend of kala-azar in India as well as in Bihar. Currently, elimination target has been achieved in 423 PHCs (92%) of Bihar. However, in 35 PHCs (8%) elimination target could not be achieved. The incidence of kala-azar is well under control in Bihar with the existing interventions. The existing interventions under the elimination programme and new intervention need to be implanted rigorously and effectively in those PHCs where the elimination target is not met.

Limitation

The major limitation of this study was the sampling technique which might be responsible for some selection bias. Being a prospective study, we believe that the possibility of recall bias could be reduced. The other possible limitation could be the sample size of the study.


  Conclusion Top


Still sizeable proportions of kala-azar cases are going to PPs and go on unrecorded into GSS. There is a need for innovative measures (training/re-training/logistics support/etc.) to increase participation of the private sector in the national kala-azar elimination programme and to improve the quality of services in government facilities. A mechanism should be devised to involve at least qualified PPs who are engaged in the treatment of kala-azar in order to reduce treatment delay and increase case detection of kala-azar in the region. However, involvement of unqualified practitioners needs to be assessed further at an appropriate level and with a clearly defined role in kala-azar control efforts. Additional studies investigating the role of PPs in the management of kala-azar in the region are warranted.

Conflict of interest

The authors declare that they have no conflict of interests.


  Acknowledgements Top


The study received the financial support from WHO/ TDR under small grant scheme for SEARO region (No. SEA-2010-C8-TSA-0008).

 
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    Figures

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    Tables

  [Table 1], [Table 2], [Table 3]



 

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Abstract
Introduction
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