Keywords
Leptospirosis, Sri Lanka, Outpatient department, Ambulatory care, OPD, burden, underestimation
This article is included in the Neglected Tropical Diseases collection.
Leptospirosis, Sri Lanka, Outpatient department, Ambulatory care, OPD, burden, underestimation
After submitting the first version of the manuscript, we received comments from two reviewers. Both reviewers did an excellent job, and the comments helped to improve the quality of the paper. We made the following major changes to the manuscript. The spelling, grammar, and formatting of the text are revised and corrected. We have added an additional file as extended data for the list of serovars used in the MAT panel to diagnose leptospirosis. Some of the misleading parts of the questionnaire were explained, and the corrected questionnaire is uploaded. There was a mismatch between the abstract and the main text. The abstract mentioned “antibiotics” while it was “treatment” in the main text. We have changed the treatment to “antibiotic treatment” in the results section of the main text. All changes are mentioned as track changes in the manuscript.
See the authors' detailed response to the review by Chinthika P. Gunasekara
See the authors' detailed response to the review by Georgies F Mgode
Assessing the true burden of disease is required for proper health planning and resource allocation, including the control of transmissible diseases such as leptospirosis. Sri Lankan communicable disease burden estimates are usually done using routinely reported data in the surveillance system1. Lack of actionable diagnostic tests and the diversity of clinical features leading to under-notification of leptospirosis are the major reasons for poor estimation of this disease, a leading cause of acute febrile illness in Sri Lanka2,3. A recently published systematic review has suggested a correction factor for hospitalized leptospirosis cases to estimate the burden of this disease more accurately. This study estimated the incidence of leptospirosis in Sri Lanka as 52.1 per 100,000 population3. However, these estimations and corrections are made for hospitalized patients without considering outpatient departments (OPDs). It is estimated that approximately 5–15% of outpatients with undifferentiated febrile cases could be due to leptospirosis4,5, and undifferentiated febrile patients usually present to OPDs. Finally, these estimates have not been applied to assessing disability-adjusted life years, which is always a challenge for acute febrile illnesses. Therefore, prospective studies in the outpatient setting are essential for estimating the burden of disease due to leptospirosis, which in turn is needed to justify investment in diagnostics and vaccine development.
Few studies have assessed leptospirosis in non-hospitalized patients with acute febrile illness. Biggs et al. highlighted the underestimation of leptospirosis due to the non-inclusion of ambulatory patients for disease estimates in Tanzania6. A study conducted in Vanuatu showed the importance of screening for leptospirosis among acute febrile illness patients presenting to OPDs during outbreaks, highlighting the need for improved awareness and diagnostic capacity, which are interrelated7. In the Vanuatu study, 12 of 161 (7.4%) suspected patients were confirmed as having leptospirosis. However, only 2 of 12 confirmed patients had criteria fulfilling the surveillance case definition, showing the inadequacy of the case definitions used7. Another study conducted in Guadeloupe, Martinique (French territories in the Caribbean) suggested that the actual burden of leptospirosis could be 3 to 4 times higher than reported cases8. A study conducted in Mozambique also provided supportive evidence for the importance of outpatient leptospirosis by estimating that as much as 10% of febrile patients attending ambulatory care could be attributed to leptospirosis9. The purpose of the present study was to determine the prevalence of leptospirosis in an OPD setting in a regional public hospital in Sri Lanka to provide further estimation of disease burden estimations.
The study was conducted from August 2017 to September 2017 in the OPD of Rathnapura Provincial General Hospital (RPGH) as a part of a larger clinico-epidemiological study. Previous data suggested that the Rathnapura district is one of four major districts affected by leptospirosis10. At the time of the present study, the OPD had a separate desk for patients presenting with acute febrile illness. This was partly due to the massive epidemic of dengue ongoing during that period.
Once the medical officer screened the patients for obvious foci of infection, and after sending probable dengue patients for further investigation, a medical graduate awaiting an internship appointment screened the remaining acute undifferentiated fever patients. Clinically suspected patients were recruited as “possible” cases of leptospirosis using a standardized, written surveillance case definition for Sri Lanka11. In the meantime, a survey was conducted among inward clinically confirmed leptospirosis patients of RPGH to assess the past treatment history.
Recruited patients were interviewed using a standardized, written clinical data checklist and a questionnaire (Extended data). A blood sample of 4ml was taken, and 2ml was transferred to a plain tube and 2ml to an EDTA tube and stored in the microbiology laboratory of RPGH.
Samples were transported to the public health research laboratory of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka. Testing for leptospirosis was done using the microscopic agglutination test (MAT) and quantitative polymerase chain reaction, as previously published in the study protocol12.
Hospital notification data were obtained from the infection control unit at RPGH. The number of confirmed OPD patients was compared with the number of leptospirosis-confirmed hospitalized patients during the same period and normalized to total patient populations. Care-seeking was compared with a sample of hospitalized patients treated as leptospirosis by attending physicians.
A total of 2,960 febrile patients were screened in the fever section of the OPD during the study period. Of these, 33 (1.1%) were clinically suspected leptospirosis patients and all were recruited for the present study (Figure 1). These included 23 (69.7%) men and 10 (30.3%) women. The mean age was 46.5 years (SD 17.1). During the same period, RPGH made 82 notifications of possible cases of leptospirosis from hospitalized patients. The missing OPD patients from the notification accounted for 28.6% (95% CI 19.4-40.4) (Table 1).
Of 33 possible cases, 8 (24.2%) were laboratory-confirmed as leptospirosis. One patient was categorized as “probable” with a single MAT titre of 1/20012. Of the 33 cases selected, 12 (36.4%) had received antibiotic treatment from a primary care centre before coming to the RPGH OPD. During the same period, we interviewed 29 hospitalized patients who were treated presumptively for leptospirosis. Of these, 19 (66.5%) reported that they were given treatment for fever from a primary care provider prior to hospital admission. However, none of these 19 visited the OPD of RPGH, confirming that the cases presented to OPD are really “missing” from the system.
In this preliminary study to evaluate the missing leptospirosis patient load in the surveillance system, we made three important observations: (1) almost one-third of the patients presenting to the OPD of RPGH were missing from the notification system; (2) most of the patients (although we could say none, there might be admissions after the study period) presenting to the OPD were not hospitalized; (3) most of the hospitalized patients sought healthcare from primary care centres rather than from a tertiary care centre. The OPD data clearly shows that 28.6% (95% CI 19.4-40.4) of leptospirosis patients presenting to this tertiary centre were not included in the system. Nevertheless, statistical assumptions cannot be made for the primary care institution without proper studies conducted in local hospitals and private healthcare institutions. This study mainly focused on the cases presenting in an endemic setting and during an outbreak period. The missing numbers can neither be generalized to all areas of Sri Lanka nor for all the months of the year in the same area. Establishing a well-functioning disease surveillance system in OPDs and primary care institutions is essential for proper disease burden estimates, not only for leptospirosis, but also for other notifiable diseases. Various small-scale studies have been conducted to identify feasible methods for disease surveillance, such as incorporating smartphone technology, which is being carried by hand by the treating physician13. These feasibility studies need to be upscaled to identify the barriers and feasible methods to implement the system. Well-planned studies covering outpatient, inpatient, and private sectors should be initiated to estimate the actual burden of diseases.
Zenodo: OPD Lepto Database - Clinical check List, http://doi.org/10.5281/zenodo.401324814.
Zenodo: OPD Lepto Database - Clinical check List, http://doi.org/10.5281/zenodo.401324814.
This project contains the following extended data:
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
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Competing Interests: No competing interests were disclosed.
Is the work clearly and accurately presented and does it cite the current literature?
Partly
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Partly
If applicable, is the statistical analysis and its interpretation appropriate?
Yes
Are all the source data underlying the results available to ensure full reproducibility?
No
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Leptospirosis, immune response
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Partly
If applicable, is the statistical analysis and its interpretation appropriate?
Yes
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Rodent borne zoonotic diseases - leptospirosis and plague disease, tuberculosis and taxonomy
Alongside their report, reviewers assign a status to the article:
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Version 1 14 Sep 20 |
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