[version 1; peer review: 2 approved with reservations]
No competing interests were disclosed.
Non-communicable diseases (NCDs) are chronic in nature (
The prevalence of CVDs was estimated to be 271 million worldwide in 1990, and this value doubled to 523 million in 2019. During the same period, the number of CVD-related deaths due to CVD increased from 12.1 million to 18.6 million (
WHO's action plan aspires to counter the CVD epidemic by encouraging research work, reducing, monitoring and modifying determinants and risk factors and integrating disease prevention programs and controlling local policies under global strategy for the prevention and control of NCDs (
In 2016, the estimated prevalence of CVDs in India was 54.5 million cases. One in four deaths in India is attributed to CVDs, especially coronary artery disease and stroke, which accounts for greater than 80% of the burden of CVDs in India (
Every year, approximately 150 million people face financial emergencies owing to healthcare payments. Developing countries have meagre budgets for healthcare and are overly reliant on out-of-pocket health spending when compared to developed countries, which have a tax-funded health system or social health insurance schemes (
The estimated hospitalization cost for CVDs was INR 94 billion in 2004 and it is expected to project at INR 152 billion by 2021 (
To reduce the total economic burden, the Government of India (GOI) introduced Ayushman Bharat Yojana (ABY), a national health protection mission, in early 2018. This health insurance program is expected to benefit around half a billion poor and vulnerable families
Thus, there is a need to synthesize evidence on this subject. To address this, a scoping review of peer-reviewed, non-peer-reviewed, and grey literature articles indicating the cost of CVDs is planned.
The objective of this review is to summarize the estimated costs associated with CVD care management in India with the available evidence and identify gaps in the literature. This study also aims to report the predominance of out-of-pocket spending and the economic burden of managing CVDs in India. This may aid policymakers in framing appropriate schemes to reduce OOPE and to encourage UHC. This study indirectly projects the potential impacts on inequalities in healthcare and strengthens the knowledge base for UHC in India.
Methods for this scoping review will follow the updated JBI methodology for scoping reviews (
Identification of the research question Identifying relevant studies Selection of eligible studies Data extraction and charting Collating, summarizing, and reporting the results
The broad question that directs this review is: what are the costs incurred for the diagnosis and treatment of CVDs in India? This review will elucidate relevant concepts by delineating and clarifying them, identifying research gaps, and reporting the most important evidence available to address and inform practice.
The literature published in English language from 2000 onwards will be considered in the scoping review. The population, concept, and context (PCC) frameworks will guide the inclusion and exclusion criteria for this review.
| Criteria | Determinants |
|---|---|
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Participants with borderline or established CVDs |
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Cost associated with CVD management |
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India |
PCC, population, concept, and context; CVD, cardiovascular disease.
Studies that include participants/patients/individuals with borderline or established CVDs of any age in India will be included. As per the types given by WHO, the CVDs include cerebrovascular disease, coronary heart disease (CHD), congenital heart disease, peripheral vascular disease, deep vein thrombosis and pulmonary disease, rheumatic heart disease, their synonyms and commonly used terms will be included for the review
The main concept of this review includes the direct and indirect costs incurred in the management of CVDs in India. This includes direct medical and non-medical costs, along with indirect costs. Direct medical costs include physician visits, emergency room services, and medications, while direct non-medical costs involve food, accommodation, and travel. Indirect costs include the loss of earnings, time, and productivity loss of both patients and their caregivers while seeking medical care (
This scoping review aims to determine the economic burden of CVDs in India. Therefore, studies on all types of CVDs in India will be considered. This review will consider studies conducted in any clinical setting (
The eligible studies include case-control studies, cohort studies, cross-sectional studies, randomized control trials (RCTs), non-RCTs, before-and-after studies, qualitative and quantitative studies, conference papers, and peer and non-peer review studies. Letters to the editor, editorials, commentary perspectives, and reviews will be excluded. Studies on co-occurring diseases and CVDs will also be included. Studies on CVD prevention costs will get excluded, based on the initial scoping process.
A comprehensive search strategy was developed to retrieve both published and unpublished studies. A primary search of
| Search string | Hits | |
|---|---|---|
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1,514,590 |
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554,864 |
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146,151 |
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478 |
After completion of the searches, all identified citations will be collated and transferred to
| Criteria | Inclusion criteria | Exclusion criteria |
|---|---|---|
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Participants of any age with borderline or established CVDs. | None. |
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All the studies involving cost associated with CVD management that includes direct or indirect costs and OOPE. | Prevention cost of CVDs. |
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India | Studies outside India or studies with a focus on LMICs or South Asia, where the costs are not provided separately for India. |
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Quantitative and qualitative study designs. | Reviews, letters to the editor, editorials, perspective papers, and commentaries. |
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Studies in English language published from January 2000 onwards. | Non-English articles published before 2000. |
CVD, cardiovascular disease; OOPE, out-of-pocket expenditure; LMIC, low- and middle-income countries.
Data from these studies will be independently extracted. A custom data extraction form developed by the research team, using Microsoft Excel as an abetting platform, will be used. The data extracted will capture study components such as author names, publication year, publication title, type of CVDs, intervention, target population, population excluded, study setting, study design, sample size, and diagnostic and treatment costs. The data extraction form will be pretested before implementation to ensure that it accurately captures imperative information. The necessary modifications will be made as required during the pilot process. A detailed explanation of all modifications will be provided in the scoping review. The resolution of the differences between the reviewers’ decisions will be discussed with a subject expert or a senior reviewer.
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| Title of the study |
| Authors |
| Year of publication |
| Type and source of publication |
| Author affiliation |
| Contact information |
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| Aim/Objectives of the study |
| Study period |
| Location (State where the study was conducted) |
| Type of CVDs |
| Type of economic evaluation |
| Years of data collection |
| Study design |
| Target population |
| Sample size |
| Sampling method |
| Study perspective |
| Setting |
| Data sources |
| Cost/economic outcomes measured |
| Currency of cost |
| Key findings |
CVD, cardiovascular disease.
A PRISMA flow diagram will be used to report the screening process (
Currently the authors are performing searches on all the electronic databases mentioned.
This scoping review will provide a comprehensive rundown of cost induction for CVD care management in India and raise awareness among patients, clinicians, decision makers, and third-party payers about the economic burden of such chronic diseases. Along with this, one suggestion is to grasp health inequalities and the high priority of UHC for the Indian population.
This is the first scoping evaluation of the costs associated with managing CVDs in India. The current scoping study will employ eight electronic databases and tailored search terms that will be iteratively optimized to obtain as many relevant articles as possible. Grey literature will also be identified and synthesized. An assessment of the quality of the articles included in the scoping review will not be performed because it is beyond the scope of the scoping review. A scoping review was undertaken because the topic has not been extensively reviewed and the scope has a broader agreement.
This study does not require ethical approval because the information and data collected will be obtained from publicly available sources. Regarding dissemination activities, the full review will be presented at a relevant conference and submitted to a peer-reviewed scientific journal for publication to report the outcomes of the scoping review.
No data are associated with this article.
All the authors have proofread the protocol and given their final approval of the version to be published. Authors would like to acknowledge and extend their gratitude to Dr. Bhumika TV, Assistant Professor and Coordinator, PHESA, PSPH, and MAHE for her support with the development of this protocol.
This protocol sets the groundwork for a useful study to quantify costs associated with CVDs. The protocol will benefit with further tightening of definitions, particularly the population, costs and perspectives, and what the term CVD covers.
Define CVDs (perhaps when the term is introduced in the first paragraph), as it comes as a bit of a surprise in the methods that the scoping review will also cover CVDs such as rheumatic heart disease, congenital heart disease etc. Is all the data mentioned in the introduction including these conditions as well? 1st sentence: 55 million - specify the country This sentence could be reworded: Low- and middle-income countries (LMICs) contributes to more than three-quarter of the world’s fatalities due to CVDs, which is attributed to insufficiency in primary healthcare services and the absence of robust universal health coverage (UHC) systems. Reason: LMICs account for 84% of the world’s population, but 75% of CVD deaths. The citation makes a slightly different point: that people in LMICs are less likely to benefit from early detection and treatment, and they die at a younger age. This could be linked with the next sentence as well. CVDs was INR 94 billion in 2004 and it is expected to project at INR 152 billion by 2021: it would be useful to give the USD amount in brackets Over the past few decades, CVDs have become a leading cause of mortality, causing a huge social and economic menace. - this sentence is out of place here In the sentence before the objective, it is mentioned that a review is planned of articles “indicating the cost of CVDs”. However the objective says “costs of care management”. “Cost of CVD” could include societal costs as well, so should maintain consistency as to what costs you are focusing on.
Table 1 population: make the terms used in the table and text consistent. Suggest using “individuals” instead of participants/patients What does “borderline CVD” mean? Is it risk of CVD? From the search terms, it looks like risk of CVD is not being looked at, and it would be good to mention if you are or are not looking at CVD risk screening costs (primary prevention of CVD), and if not, why not. Table 4: Data extraction would benefit in capturing the perspective of the costs (individual / healthcare / societal costs) - you allude to it with “study perspective”. Please clarify if you are collecting the perspective of the costs as well. Stage 3 - The two stages followed.. should it be “will follow”? Is there a process to ensure harmonization between the teams? Is it the same for title/abstract and full text screening? How many teams are there?
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
Yes
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Reviewer Expertise:
Public health, policy policy and health economics with a focus on non-communicable diseases, particularly CVD.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
The authors have developed a well-documented and thorough scoping review protocol. The authors aim to document and determine any gaps in the literature on the direct and indirect healthcare costs of cardiovascular disease in India. The scope and aim of this study are well defined and the study design is appropriate for the research proposed.
Study Identification
The authors would benefit from providing a rationale for why a date limit, articles from January 2000 onwards, was used for the review. The authors list a number of cardiovascular diseases to be included in the scoping review but did not include heart attacks or stroke within the list of eligible CVDs though they are listed in the search terms. Authors should include the concept of heart attacks/stroke as an included CVD or exclude the concept from the search strategy. The authors state indirect healthcare costs as a main concept in addition to direct healthcare costs, but definitions for the types of indirect costs are not stated. The authors should provide information as to the types of indirect healthcare costs that will be considered for inclusion. The authors should include MeSH and Emtree controlled vocabulary terms for the searches conducted in PubMed and Embase. The authors should consider expanding terminology for direct/indirect healthcare costs. Terminology regarding economic evaluations, expenditure, etc. would be beneficial for expanding the search on direct healthcare costs. Further terminology related to indirect healthcare costs should be considered for the search as well. The authors should include what database(s) within the ProQuest platform was searched. The authors provide a sound methodology for studying selection. The inclusion/exclusion criteria would be aided by the addition of the items suggested in the above points. The authors provide a detailed methodology for data extraction. Authors would benefit from stating the number of reviewers extracting data and if a reviewer(s) will resolve any data conflicts and/or review the accuracy of extracted data. The authors should consider extracting data on any related comorbidities as this could be helpful for future analysis, policy development, etc. The authors provide a sound proposal for how the anticipated data will be analyzed and reported.
Selection of Eligible Studies
Data Extraction and Charting
Data Analysis and Reporting
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
Yes
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Yes
Reviewer Expertise:
Health Sciences librarian with extensive knowledge and training in evidence synthesis methodology and searching.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.