Abbreviations
ASHA; Accredited Social Health Activist
CMO: Chief Medical Officer
DALY: Disability-adjusted life years
DW: Disability Weights
DMO: District Medical Officer
DPM: District Programme Management
EQ-5D: EuroQoL5 Dimension
GBD: Global Burden of Disease
NHM: National Health Mission
VAS: Visual Analogue Scale
YLD: Years lived with disability
YLL: Years of lives lost
Introduction
Snakebite is a major public health problem in the rural communities of Asia, Africa, and Latin America, and most neglected among all the neglected tropical diseases. Many studies on the bio-medical perspectives of snakebite exist but very few studies have been conducted from a socio-economic viewpoint 1 . Global estimates of snakebite range from 4.5 million to 5.4 million annually with an estimated 2 million of them in India, with tremendous socioeconomic consequences 2 . As per the Registrar General of India-Million Death Study (RGI-MDS), the number of deaths due to venomous snakebite in India is 46,900 per year 3 . Reports suggest that only 20–30% victims of snakebite in rural India seek treatment in hospitals 4 . A recent update of the MDS suggests that the number of deaths are higher still at 58,000 per year 5 .
The geographical variation, lack of data and underreporting on cases of snakebites and deaths make it difficult to estimate socio-economic burden of snakebite in India. Few studies have provided data on mortality, cause of death , hospital based case series (in Maharashtra, West Bengal, Kerala and Andhra Pradesh states), compensations paid to snakebite victims and socio-economic impact 6– 14 .
Along with mortality, snakebite may lead to physical and psychological impairment, scarring, permanent residual disability, blindness, malignant ulcers, pregnancy loss and of productivity following hospitalisation and incapacitation 15 . The Disability Adjusted-Life Years (DALYs) is a widely used metric for quantifying disease burden 16 . One DALY is equal to one lost year of healthy life. The sum of the DALYs for all diseases, across all age groups and either gender is a measure of the gap between current health status and an ideal health situation where the entire population lives to an advanced age, free of disease and disability.
Previous studies measuring economic burden of snakebites in low and middle income countries have used different approaches for estimating DALYs for snakebites. Kasturiratne
This proposed study aims to address some of these issues by conducting a retrospective incidence study to provide evidence on disability weights, epidemiological and socio-economic burden due to snakebites in Kerala state, India. The study will be conducted in Ernakulam district of Kerala to provide a state specific estimate on incidence, mortality, pattern of injuries, treatment seeking behaviour and cost of illness among snakebite victims. Additionally, the study will conduct a health state valuation to account for community perspectives in estimating disability weights for snakebites.
Rationale for the study
There is lack of data and underreporting on cases of snakebites and deaths that makes it difficult to estimate socio-economic burden of snakebite in India. Disability-weights (DWs) are values obtained from an individual’s perception of health states. It is to be noted that Global Burden of Disease (GBD) disability weights are not universal in nature as social and cultural contexts of health states were not accounted for in the GBD process 20 . This is mainly because the GBD valuers generally, were educated professionals either from medical or health fields and could easily participate in the cognitively demanding valuation methods 20– 25 . Although of late GBD and numerous other studies started including the general population along with professionals as participants, these studies were unable to capture the community-level perception of individual health states thus eliciting over-or-under-estimation of health states 20, 26– 31 .
It is envisaged that the derived DWs from this proposed study along with the epidemiological and economic burden estimations, would be useful for future researchers and policymakers in the country to guide further research and policy in management of snakebites in the country.
Aim and objectives
The aim of this study is to estimate the epidemiological and socio-economic burden and community-derived disability weights due to snakebites in Kerala state, India.
1. To determine the prevalence, morbidity and mortality due to snakebite in Ernakulam district of Kerala state, India.
2. To determine the economic burden due to snakebites in the community.
3. To determine the community-derived disability weights for snakebites.
Methods
Study design
A cross-sectional study involving adult populations for estimating epidemiological and economic burden of snakebite will be conducted. These adults will be recruited over a total period of 12 months, prior to start of study across various Gram Panchayats in Ernakulam district, Kerala state. For the community-derived disability weights, 70 adult patients admitted in the three months prior to start of data collection at either of Amrita Institute of Medical Sciences (AIMS), Kochi Hospital or Little Flowers Hospital (LF), Angamaly would be interviewed. ( Figure 1) The study will be started in March 2021 and is expected to be completed by June 2021.
Figure 1.
Patient inclusion flow chart for the epidemiologic and disability weight sub-sets of the study.
Study geography
Ernakulam district, with an area of 3063 sq. km, has a population of 3.47 million. Industry and service sectors are the main sources of occupation in the urban areas with agriculture being so in the eastern part of the district. Export oriented fishing industry is also a major source of revenue and occupation towards the coast.
Study participants
Table 1.
6D-3L description system.
Dimension | Dimension description | Severity level |
---|---|---|
Mobility | Getting around in the community, walking, climbing
| 1- No problems walking about
|
Self-care | Bathing, cleaning, washing, toileting et. | 1- No problems with self-care
|
Usual activity | Performance of usual role activities such as working at
| 1- No problems with performing usual activities
|
Pain/Discomfort | Subjective feeling of bodily distress of discomfort | 1- No pain or discomfort
|
Anxiety/depression | Negative psychological states including anxiety,
| 1- Not anxious or depressed
|
Cognition | Cognitive problems, such as forgetfulness, difficulty in
| 1- No problems in cognition
|
The application of EQ-6D-3L will be conducted using a modified card sort (CS) method rather than the cognitively demanding techniques such as standard gamble (SG), time trade-off (TTO), and patient trade-off (PTO) that required certain level of education to comprehend and use for estimating disability weights 34 . Any process of eliciting valuation of health states irrespective of the technique used requires valuers (i.e. the patient or care-giver) to visualize the entire description of health states. The modified CS process used prior to VAS will not only be a validation tool but also a “warm up” for the entire valuation process.
We will be using a set of pictorial narrations describing the three severity levels under each of the six dimensions, i.e., 18 pictures will be prepared. The local social context relevant to the geographical and cultural settings are depicted through the pictures. Several drafts of pictures were drawn by a commercial artist and shared with the study team for final set of 18 pictures to be used (Figure available in
To overcome the issue of ranking and assigning scores, the study team decided to divide the rank order into two parts for ease of understanding. Thus, during CS, the description of each health state was read out to the valuers in random order by the interviewer, who would then be instructed to rank their preference between 1 and 5 for less severe health states (according to their choice) and 6–11 for more severe.
For our study we will be using the Visual Analogue Scale (VAS) to valuate health states on a continuous graduated line segment, one end labelled as ‘death’ and the other labelled as ‘perfect health’ ranging from 0 to 100. The VAS allows the user to rate a particular health state between the mentioned anchor points, i.e. death and perfect health. A picture of a happy face near “100” on one side and a picture of a sad face near “0” will further help the valuer to the direction of severity (Extended data: Annexure 3 35 ).
At the end of both exercises, the CS rank and VAS scores will be checked for concordance, by the investigator. In instances where the values and ranks did not correspond, the valuer will be requested to review his/her responses through iterations by the investigator. Multiple iterations would be conducted until the valuer’s response for each health state was final.
The interview schedule will have four sections: (1) socio-demographic profile of valuer; (2) “own health state” valuation using VAS; (3) Hospitalisation details, (4) EQ-6D-3L scores, and (5) VAS scores.
So as to account for victims with different degrees of severity of envenoming we shall interview twenty each victims of mild, moderate and severe envenoming and ten of non-venomous / dry bites. We shall go by the classification; mild envenoming as victims who had symptoms limited to local reaction at the bite site without signs and symptoms of systemic envenoming and or a hospital stay of < 3 days, moderate qualified as presence of signs and symptoms and laboratory parameters suggestive of systemic envenoming and or a hospital stay of 3–5 days and severe being qualified by any one of life threatening, hospital stay > 7 days, need for a surgical procedure, ventilation support, dialysis or requirement of blood products. Non-venomous/ dry bites are characterised by absence of signs and symptoms of either local or systemic envenoming.
For the study component related to disability weights, victims admitted and treated for snakebite at AIMS, Kochi or Little Flower Hospital, Angamaly 3 months prior to the start of study would be interviewed. The main reason to choose admitted patients over the community based individuals is that the VAS and EQ-6D-3L being complex to administer will be conducted by JCM.
For the epidemiological and economic burden components of the study, victims with a history of snakebite in the preceding 12 months would be interviewed.
Symptoms related to poisoning other than due to snakebite or non-ophid bites and those not willing to provide consent will be excluded.
Sample size calculation
For our study, the annual mortality of snakebites is estimated at 6/100,000 3, 5 , and the sample size to estimate a mortality of 0.006 percent will be 92,190 persons. Assuming a 15 % loss of information the actual sample size to determine the mortality rate is 108,458 persons in Ernakulam (representing 3.18% of total population (3.4 million as per Census of India 2011 estimates) of Ernakalum district.
The following formula is used to estimate sample size for our study:
Z
1-a/2 = Is standard normal variate [at 5% type 1 error (
d = Absolute error or precision
Outcomes
The study will measure annual incidence, mortality, and treatment costs of snakebites in Ernakulam district of Kerala state, India. Additionally, the study will also calculate community-derived disability weights for snakebites in the district.
Statistical analysis
YLDs will be calculated using the incidence approach where YLD=I × DW × L, where I = number of incident cases, DW= disability weight, L= average duration of the case until recovery or death (years).
Data collection, quality checks and monitoring
The study would be facilitated through the offices of the District Program Manager, National Health Mission and the Chief/District Medical Officer of Ernakulam district.
Trained ASHAs attached to each Gram Panchayat will inform 2 Field Officers specially recruited for the study of the families reporting snakebite episodes 365 days prior in a particular village. The field officers will then be responsible to administer the informed consent and study questionnaire (
From the hospital register of AIMS and LF contact details of patients admitted and discharged 3 months to survey period will be identified. These patients and/or care-givers (if patient had died post discharge) will be invited to visit AIMS and will be interviewed by JCM. JCM will also be responsible for extracting hospitalisation information from medical records from AIMS or LF of each interviewed patient/care-giver.
Data gathered at the Panchayat (village) level would be collated on a Tab PC by the field officers from where it would be synced on to the server at Amrita Institute of Medical Sciences, accessible only to JCM,DJ and GRM. De-identified details would be used for statistical analysis and reporting. Details gathered would not be shared on any public domain and would be kept confidential. Any data queries will be handled using a data access committee 39 .
Informed consent from all participants will be conducted prior to administration of any data collection questionnaire (
However, for information related to any family member whose age is below 18 years, the mother or the father shall be interviewed. Information about the victim, profile of envenomation and complications thereof, other related characteristics, treatment outcome and any other related details will be noted but kept coded and confidential.
Data entry and storage
Data entry will be conducted by a single data entry operator at the research unit of AIMS. One of the co-authors will review the data entry to check for any discrepancies including any data entry errors from the data entry form. The data will be stored in a desktop computer with access to the data entry operator, and Principal Investigator (JCM). Once the data entry is completed and cleaned, the data sheet will be transferred to the laptops of the co-authors (JCM, GRM & DJ) for further analysis. After analysis these data sheets will be destroyed in these laptops and the data sheet would be available only with the desktop present at research unit of AIMS.
Data gathered at the Panchayat (village) level would be collated on a Tab PC by the field officers from where it would be synced on to the server at AIMS, accessible only to JCM,DJ and GRM. De-identified details would be used for statistical analysis and reporting. Details gathered would not be shared on any public domain and would be kept confidential.
Ethical approval
Participants will be informed about the nature of the study and will be assured that privacy will be maintained, and information provided by the respondent will be held confidentially and only be used for research purposes. Their willingness to participate will be sought and informed written consent in a language understood by the respondent (English or Malayalam) will be taken before including them in the study. For children an assent form will be used. Social and cultural values of the participants will be respected and considered as needed. Information obtained during research will not be used for any other purpose except research and research findings will be disseminated as per research dissemination ethics.
The study received ethics approval from the Institutional Ethics Committee of Amrita Institute of Medical Sciences, Kochi (study reference number IRB-AIMS-2020-1 01) on 13/03/2020.
Study challenges
Snakebite is generally a disease of the working community, being most common among farmers, rubber tappers, tea/coffee estate pickers, brick kiln workers, and plywood industry workers. The majority of bites are accidents, which occur at the workplace or at home with the lower socio-economic groups being most affected. The degree of education and comprehension of the CS and VAS could be a challenge in this group of individuals. There could be a recall bias in victims bitten close to a year back on degree of disability and other disease details as well. Additionally, the community responses for healthcare expenditure could also be subject to overestimation due to self-reported recall bias.
Distribution of study results
The study results will be submitted to a suitable peer-review publication within 6#six months of study completion. Additionally, the results will also be presented in suitable national/international conferences based on resources available for participation. The study results for epidemiology will be presented using STROBE guidelines for cross-sectional studies 40 and cost of illness checklist adapted from Larg and Moss (2011) 41 .
Study status
The study protocol was discussed and agreed by Steering Group members (clinicians from Amrita Institute of Medical Sciences (AIMS), Kochi Hospital or Little Flowers Hospital (LF), Angamaly handling patients affected with snakebite) prior to start of data collection.
Training session of staff who would be administering the VAS score has been completed and the necessary permission for using frontline health workers in identifying victims of snakebite in the community has been secured from the District Program Manager of the National Health Mission’s office, and we expect to start the field work form the 1 st April 2021.
Discussion
Our study uses a community survey to estimate incidence of mortality, morbidity and disability and economic burden of snakebites in Ernakulam district along with use of Visual Analogue Scale (VAS) as the tool for obtaining values required for computing community-derived disability weights. We have used sample size as per standard calculations to estimate epidemiological and economic burden at district level. For the community-derived disability weights we will be using VAS which is a tested and validated method since the early 1990s. We have deliberately combined VAS with card sort method rather than the alternate PTO, TTO or SG, or recent paired comparisons (PC) or discrete choice experiments (DCE) to order to ensure easier comprehension by community members across different sections of society and location. Our method follows the standard protocol that has been tested previously in Indian settings 34, 42, 43 . We also believe that this pilot initiative for estimating community derived disability weights for snakebite using cognitively less demanding tools on the values would be an appropriate choice for rural and less educated populations for understanding their health preferences in India and similar settings in other developing countries.
As per our knowledge, this is the first methodological protocol developed for estimating epidemiological and economic burden along with community derived disability weights on snakebites in a LMIC setting. Our approaches described for each of the study components, i.e. epidemiology, economic, and health state valuation has been described in meticulous detail. We are hopeful that this well-designed, systematic protocol can be used across various locations, cultures and even countries to explore health state values for other diseases as well. Our method describing the community-derived disability weights will be useful to guide researchers to implement such studies at community level in the future.
Conclusion
This paper constitutes the first published protocol for estimating epidemiological and economic burden as also community derived disability weights for snakebite in LMICs. The protocol has been developed using guidelines for cross-sectional studies, and international guidelines for conducting community-derived disability weights. The findings of the study will be useful to inform researchers for a proposed extension of the study in other states as part of ICMR-funded study to be initiated in 2021(five of the authors are also investigators on this study). The evidence generated by this study will contribute significantly to knowledge regarding the epidemiology, economic burden and community-derived disability weights for snakebite in India and other countries where incidence of snakebite is high, thus playing a significant role in policy decision making for resource allocation in snakebite prevention and healthcare provision.
Data availability
Underlying data
No underlying data is associated with this article.
Extended data
Figshare: Estimating epidemiological and economic burden and community derived disability weights for snakebite in Kerala: A study protocol, https://doi.org/10.6084/m9.figshare.14061215.v3 35
This project contains the following extended data:
Annexure 1. Consent Form.docx
Annexure 2. Questionnaire.docx
Annexure 3. VAS tool.docx
Vignettes for EQ-6D-3L.zip
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
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Abstract
Background: In India, lack of data and underreporting of cases and deaths due to snakebite makes it difficult to estimate its socio-economic burden. Previous studies measuring economic burden of snakebite in low-and-middle-income countries (LMICs) using different approaches have been conducted, but none in India. The proposed study aims to provide evidence on disability weights, epidemiological and economic burden due to snakebites in Kerala state, India.
Protocol: The study is a community based cross-sectional study recruiting victims of snakebite occurring over a 12 month period prior to start of the study , across Ernakulam district, Kerala state, India. For the community-derived disability weights,70 adult patients who were treated within a 3 month period prior to commencement of the study at Amrita Institute of Medical Sciences, Kochi or Little Flower Hospital, Angamaly would be interviewed. The study will measure annual incidence, mortality, treatment cost of snakebites along with community-derived disability weights for snakebites in Ernakulam district.. Standard methods for analysis and reporting of mortality, morbidity, Years of Lives Lost (YLL), Years lived with disability (YLD), disability weights, and costs of treatment will be calculated. The study will be started in April 2021 and is expected to be completed by July2021..
Discussion: This protocol is the first published for estimating epidemiological, economic burden and community derived disability weights for snakebites in India. Besides, the Global Burden of Disease has not attached a particular disability weight to snakebite and this would be an attempt to do so. The protocol has been developed using guidelines for cross-sectional studies, cost of illness studies and international guidelines for conducting community derived disability weights. The evidence generated by this study will contribute significantly to knowledge regarding the epidemiology, economic burden and community-derived disability weights for snakebites in India and other countries where incidence of snakebite is high.
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