<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.136353.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>An epidemiological study of oral tobacco use amongst urban slum inhabitants in a town from central urban India</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: 2 not approved]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Kuruwanshi</surname>
                        <given-names>Sulochana</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0001-1767-9625</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Joshi</surname>
                        <given-names>Abhishek</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>School of Epidemiology in Public Health, Datta Meghe Institute of Higher Education &amp; Research, Wardha, Maharashtra, 442001, India</aff>
                <aff id="a2">
                    <label>2</label>Department of Community Medicine, Datta Meghe Institute of Higher Education &amp; Research, Wardha, Maharashtra, 442001, India</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:kuruwanshir@gmail.com">kuruwanshir@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>19</day>
                <month>7</month>
                <year>2023</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2023</year>
            </pub-date>
            <volume>12</volume>
            <elocation-id>847</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>6</day>
                    <month>7</month>
                    <year>2023</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Kuruwanshi S and Joshi A</copyright-statement>
                <copyright-year>2023</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/12-847/pdf"/>
            <abstract>
                <p>
                    <bold>Background:</bold> Smokeless tobacco users receive levels of nicotine known to be addictive, and clinical symptoms of dependency and withdrawal for smokeless tobacco are identical to those for cigarettes. Smokeless tobacco usage patterns share significant parallels with patterns of use of other addictive drugs. Because everyone spits after using oral tobacco, there are more persons who spit in public due toits use. Use of smokeless tobacco during pregnancy increases the chance of low-birth-weight babies by two to three times and is linked to stillbirths. Other negative health implications of smokeless tobacco use include dental decay, gum recession, high blood pressure, oral sub-mucous fibrosis (OSF), a crippling disorder, and mouth and food pipe malignancies. This warrants the study of patterns of oral tobacco use and its determinants in urban slum areas.</p>
                <p>
                    <bold>Objective:</bold> To estimate the prevalence and patterns of oral tobacco use and assess the motivating and demotivating factors associated with it amongst urban slum inhabitants.</p>
                <p>
                    <bold>Methods:</bold> A community-based cross-sectional study will be conducted in the urban field practice area of a tertiary care hospital. A semi-structured questionnaire assessing the socio-demographic profile, prevalence and pattern associated factors for oral tobacco use among the study participants will be implemented.</p>
                <p>
                    <bold>Study implications:</bold> This study will help to determine the prevalence and pattern of oral tobacco use, as well as the motivating and demotivating factors that contribute to oral tobacco use. Insights gained shall be useful to implement focussed prevention strategies.</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Tobacco use</kwd>
                <kwd>Oral tobacco</kwd>
                <kwd>Urban slum</kwd>
                <kwd>Epidemiological study.</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>
                <ext-link ext-link-type="uri" xlink:href="http://www.who.int/">The United Nations' World Health Organization (WHO)</ext-link> oversees global public health. The primary goal of the WHO, according to its constitution, is to ensure that everyone has the best possible level of health. Smokeless tobacco users receive levels of nicotine known to be addictive, and clinical symptoms of dependency and withdrawal for smokeless tobacco are identical to those for cigarettes. Smokeless tobacco usage patterns share significant parallels with patterns of use of other addictive drugs. The mandate of the WHO calls for global collaboration to enhance health, uphold world peace and harmony, and assist the vulnerable. It encourages a billion more people to participate in monitoring public health risks, coordinating emergency medical response efforts, promoting health and wellness, and implementing universal health care.</p>
            <p>Pan is frequently taken with chewed smokeless tobacco products like Mishri and Pan masala (a chewable tobacco made with areca nuts). Smokeless tobacco use, particularly in the eastern, northern, and north-eastern regions of the country, is a socially accepted addiction. Most prior studies on the prevalence of tobacco use were either based on small-scale research surveys with an urban bias, small sample numbers, and poorly known sociodemographic correlates of tobacco use. Additionally, earlier prevalence estimations made in India are still extremely speculative and non-representative.
                <sup>
                    <xref ref-type="bibr" rid="ref1">1</xref>
                </sup> Use of oral tobacco increases the frequency of people spitting in public because everyone spits after using it. In developing nations, it raises the risk of airborne infectious diseases, among which tuberculosis (TB) dissemination is one. Our primary goal in this study is to evaluate the pattern, prevalence, and sociodemographic characteristics associated with smokeless tobacco use in urban slum dwellers. To prepare tobacco for these uses, tobacco leaves are harvested when they turn yellow and brownish stains begin to develop. The leaves are then uniformly dried in the field, tied into bundles with water or molasses to keep them moist, and then stored for a few weeks to ferment. There are several issues with South Asians using smokeless tobacco. It is widely used and becoming more so, especially with the introduction of new smokeless tobacco varieties in recent years that have attracted more consumers.
                <sup>
                    <xref ref-type="bibr" rid="ref2">2</xref>
                </sup>
            </p>
            <p>Transport employees who are under stress are more likely to abuse alcohol and other drugs, with cigarettes being the most popular. There has been research on a connection between smoking and job stress. It is often believed that a substantial percentage of bus drivers and other employees smoke cigarettes. The second leading cause of death worldwide and the leading contributor to morbidity and mortality that may be prevented is tobacco smoking. Oral malignancies and possibly malignant lesions, the degree and depth of periodontal disease, and poor wound healing are the most harmful impacts of tobacco use on the oral cavity.
                <sup>
                    <xref ref-type="bibr" rid="ref3">3</xref>
                </sup> Although its use varies around the world, betel quid (pan), the most popular type of smokeless tobacco, quickly adopted tobacco as a new ingredient after its introduction. However, the legal gaps are being effectively used. For instance, replacements like &#x201c;supari mix&#x201d; packets are offered for sale with a free packet of Zarda or Khaini chewing tobacco. Except for a few limited geographic locations, both men and women regularly chew betel nut, but smoking tobacco is far more prevalent among men in Bangladesh, India, Pakistan, and Sri Lanka than among women.
                <sup>
                    <xref ref-type="bibr" rid="ref4">4</xref>
                </sup> To enable the creation and implementation of efficient intervention plans, this knowledge is necessary. The goal of the current report is to analyse in depth the smoking habits of a community in northern India and how they relate to the three different living strata, namely urban, urban-slum, and rural. However, the amount of substance being consumed, and the age of commencement are frequently not mentioned in these questionnaires. Studies on the epidemiology of coronary heart disease and its risk factors have either concentrated on urban or rural settings. studied the incidence of tobacco usage in northern Indian villages, towns, and cities.
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup> But it is crucial to emphasize a few points that are crucial for comprehending how addicted smokeless tobacco is. The use of smokeless tobacco rapidly increased, the products were found to be carcinogenic, and the demographics of users abruptly changed, all of which led to the development of smokeless tobacco addiction as a public health issue in the United States in the middle of the 1980s. Older folks were the main consumers of its products, and when they died off there were no new consumers to take their place. The smokeless tobacco business turned this trend around by creating new products, notably moist snuff products, and employing strong marketing techniques.
                <sup>
                    <xref ref-type="bibr" rid="ref6">6</xref>
                </sup>
            </p>
            <sec id="sec2">
                <title>Rationale</title>
                <p>India is a diverse nation that is home to numerous cultures, faiths, and languages in addition to various socioeconomic classes. Community health is a concern for all swaths of society, including the poor, the wealthy, children, adults, the elderly, men, and women. The Tobacco Control Team for the India Region works to reduce the burden of illness, mortality, and the financial costs associated with tobacco use and passive smoking. Tobacco use is currently the leading cause of death that may be prevented worldwide. Depending on the metastasis's location and features, other structures including the internal jugular vein, sternocleidomastoid muscle, or spinal auxiliary nerve may need to be sacrificed.
                    <sup>
                        <xref ref-type="bibr" rid="ref7">7</xref>
                    </sup>
                </p>
                <p>A significant portion of the nation's gross domestic product (GDP) and export earnings come from the production of tobacco, which is exported in 98 percent of cases. Typically, the crop accounts for roughly 10% of GDP, 30% of overall exports, and more than 50% of agricultural exports. The Tobacco Control team works to reduce the burden of illness, mortality, and the financial costs associated with tobacco use and exposure to passive smoking. Currently, smoking is the leading preventable cause of mortality in the world. For smokeless tobacco control, various strategies are required, including media campaigns and related programmes. Variable tobacco industry marketing tactics, lax enforcement of tobacco control laws, persistent affordability, and incomplete knowledge of the health hazards of tobacco use are all contributing reasons that are raising the use of smokeless tobacco.
                    <sup>
                        <xref ref-type="bibr" rid="ref8">8</xref>
                    </sup>
                </p>
            </sec>
            <sec id="sec3">
                <title>Objectives</title>
                <p>
                    <italic toggle="yes">Primary objective</italic>
                </p>
                <p>To study the prevalence of oral tobacco usage amongst residents from an urban slum in central urban India</p>
                <p>
                    <italic toggle="yes">Secondary objectives</italic>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>To study the pattern of oral tobacco usage amongst residents from an urban slum in central urban India.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>To assess the motivating and demotivating factors associated with usage of oral tobacco in our study settings.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
        </sec>
        <sec id="sec4">
            <title>Protocol</title>
            <sec id="sec5">
                <title>Study design and duration</title>
                <p>A cross-sectional study will be conducted in Wardha district from June 2023 to Nov 2023.</p>
            </sec>
            <sec id="sec6">
                <title>Setting</title>
                <p>The present study will be conducted in the urban slums of Wardha District.</p>
            </sec>
            <sec id="sec7">
                <title>Participants</title>
                <p>Both male and female adult inhabitants of urban slums from the field practice area of the urban health training center of institute will be approached by door-to-door household surveying using the systematic random sampling method.</p>
            </sec>
            <sec id="sec8">
                <title>Eligibility criteria</title>
                <p>Inclusion criteria: Study participants (&gt;18 years) who are willing to participate.</p>
                <p>Exclusion criteria: Study participants (&gt;18 years) who do not consent to take part in the research study.</p>
                <p>Sampling method: The personal interview method will be used to visit the households to reach the sample size.</p>
            </sec>
            <sec id="sec9">
                <title>Variables</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1)</label>
                            <p>Oral tobacco use</p>
                        </list-item>
                        <list-item>
                            <label>2)</label>
                            <p>Types of oral tobacco used</p>
                        </list-item>
                        <list-item>
                            <label>3)</label>
                            <p>Motivating &amp; demotivating factors</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec10">
                <title>Data sources</title>
                <p>Information on the participants' knowledge, attitudes, and perceptions of tobacco use gathered used a questionnaire that modified from the Global Youth Tobacco Survey and the Global Adults Tobacco Survey (
                    <xref ref-type="table" rid="T1">Table 1</xref>). This questionnaire is designed to obtain data on tobacco usage, including the type of tobacco used, how long used, when people first started chewing tobacco etc.</p>
                <table-wrap id="T1" orientation="portrait" position="float">
                    <label>Table 1. </label>
                    <caption>
                        <title>The study variables and questionnaire.</title>
                    </caption>
                    <table content-type="article-table" frame="hsides">
                        <thead>
                            <tr>
                                <th align="left" colspan="1" rowspan="1" valign="top">SN</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Key study parameters</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Variables</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Data Sources</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Data collection method</th>
                            </tr>
                        </thead>
                        <tbody>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">1.</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Socio-demographic profile</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">
                                    <p>
                                        <list list-type="bullet">
                                            <list-item>
                                                <label>&#x2022;</label>
                                                <p>Age</p>
                                            </list-item>
                                            <list-item>
                                                <label>&#x2022;</label>
                                                <p>Education</p>
                                            </list-item>
                                            <list-item>
                                                <label>&#x2022;</label>
                                                <p>Occupation</p>
                                            </list-item>
                                            <list-item>
                                                <label>&#x2022;</label>
                                                <p>Economic status</p>
                                            </list-item>
                                        </list>
                                    </p>
                                </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Households from field practice area from Urban Health Training Centre, Wardha</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Interview method using a Questionnaire</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">2.</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Assess the pattern of oral tobacco use</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">
                                    <p>
                                        <list list-type="bullet">
                                            <list-item>
                                                <label>&#x2022;</label>
                                                <p>Early initiation</p>
                                            </list-item>
                                            <list-item>
                                                <label>&#x2022;</label>
                                                <p>Oral tobacco duration</p>
                                            </list-item>
                                            <list-item>
                                                <label>&#x2022;</label>
                                                <p>First time chewing tobacco</p>
                                            </list-item>
                                        </list>
                                    </p>
                                </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Households from field practice area from Urban Health Training Centre, Wardha</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Interview method using a questionnaire</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">3.</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Assess the motivating and demotivating determinants</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Ever thought of quitting tobacco
                                    <break/>Have you ever stopped in the past
                                    <break/>What were the motivating factors for stopping the habit</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Participants who consume tobacco</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Interview method using a questionnaire</td>
                            </tr>
                        </tbody>
                    </table>
                </table-wrap>
            </sec>
            <sec id="sec11">
                <title>Data analysis plan</title>
                <p>The data collected will be entered into a Microsoft Excel spreadsheet.</p>
                <p>Descriptive statistics like mean, frequency and percentages of various parameters will calculated, the Open Epi version 3.01 Epi Info software (
                    <ext-link ext-link-type="uri" xlink:href="https://www.openepi.com/Menu/OE_Menu.htm">https://www.openepi.com/Menu/OE_Menu.htm</ext-link>) and data will be presented using tables and graphs.</p>
                <p>Bias: There may be information bias and selection bias and social desirability bias in this study.</p>
                <p>Selection bias will be addressed using systemic random sampling, and information and social disability bias will be minimizes as much as possible by building good rapport with study participants and making the beneficiaries understand the importance and objective of the study.</p>
                <p>Study size: The average population is around 28,000. Using formula n= pq/L2 and precision 10% sample size comes to be around 384 using prevalence 51% as per previous studies.</p>
                <p>
                    <italic toggle="yes">Quantitative variables</italic>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Data analysis on the quantitative variables</p>
                            <p>Descriptive Statistics like mean, frequency and percentages of various parameters will calculated, via the Open EPI Software and data will be presented using tables and graphs. Inferential statistics like chi square tests will be used.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>Different types of households in urban city areas use these tobacco products in different ways, so such households in field practice areas will be selected using systematic random sampling</p>
                            <p>Statistical method: Data will be entered using Microsoft Excel. All the responses will be tabulated, and graphical representation will be made wherever necessary. Data will be analysed by using the Open Epi Info software which is freely available in the public domain.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec12">
                <title>Expected outcomes/results</title>
                <p>Through our study we expect to assess the prevalence and pattern of oral tobacco use and its determinants in urban slum area and plan preventive strategies accordingly.</p>
            </sec>
            <sec id="sec13">
                <title>Ethical consideration</title>
                <p>Ethical approval for this study (DMIHER (DU) IEC/2023/643) was provided by the Ethical committee of Data Meghe Institute of Higher Education and Research (Deemed to be University) on 11/02/2023.</p>
            </sec>
        </sec>
        <sec id="sec14" sec-type="discussion">
            <title>Discussion</title>
            <p>Squamous cell carcinomas of the oral cavity (OSCC) make up a large percentage of cancer cases in India. The two most dangerous forms of oral cancer, with a higher incidence in India, are buccal mucosa and tongue OSCC.
                <sup>
                    <xref ref-type="bibr" rid="ref9">9</xref>
                </sup> Patients with oral cancer are always expected to require an intubation or a difficult airway. The safest way to perform nasotracheal intubation in these circumstances is with FOB assistance.
                <sup>
                    <xref ref-type="bibr" rid="ref10">10</xref>
                </sup> By autocrine and paracrine production of different growth factors, cytokines, and multiple proteolytic enzymes, the cancer-associated fibroblast would have the capacity to create an aggressive tumour phenotype. Invasive behaviour, local recurrence, and survival of carcinoma are all predicted by the expression of -SMA.
                <sup>
                    <xref ref-type="bibr" rid="ref11">11</xref>
                </sup> The main imaging modalities for loco-regional staging of head and neck squamous cell carcinoma continue to be CT and MRI. Both techniques aid in the evaluation of the primary tumour and the identification of non-palpable lymph nodes. Nevertheless, to distinguish between benign and malignant lymph nodes, both techniques rely on size-related and morphological parameters.
                <sup>
                    <xref ref-type="bibr" rid="ref12">12</xref>
                </sup> This choice justifies a trustworthy and economical strategy in patients with early-stage oral cancer. For minor to severe oral cavity deformities, inferiorly based islanded nasolabial flaps offer a one-stage procedure that is safer, quicker, and more dependable.
                <sup>
                    <xref ref-type="bibr" rid="ref13">13</xref>
                </sup>
            </p>
            <sec id="sec15">
                <title>Key results</title>
                <p>The study will provide knowledge and awareness regarding the initiation of oral tobacco use amongst urban slum inhabitants in both male and female.</p>
                <p>The information gathered in the study can further help decide what lifestyles and setting is responsible for oral tobacco problems in male and female. Moreover, the need to promote healthy lifestyle and proper assigning of lifestyles to avoid oral tobacco problems. Women with conditions where oral tobacco is contraindicated i.e., untreated active oral Cancer.</p>
            </sec>
            <sec id="sec16">
                <title>Limitations</title>
                <p>As the study is a cross sectional study being conducted at urban slums in catchment area of urban health training centre of a tertiary care hospital only so external validity of study shall be limited as prevalence and pattern and determinants of oral tobacco use may vary between geographical locations and prevailing socio-economic-cultural context.</p>
                <p>As the study relies on participant&#x2019;s response to oral tobacco use and perceptions, determinants there is chance of social desirability bias being introduced in the study.</p>
            </sec>
            <sec id="sec17">
                <title>Interpretation</title>
                <p>In this study, the early initiation of oral tobacco use amongst urban slum inhabitants, exclusive tobacco consumption, determine the knowledge, attitude, and practice of oral tobacco use amongst urban slum inhabitants. Study explains the importance of early initiation of tobacco cessation as a public health priority and it is an important intervention strategy in reducing the oral disease, Avoidance of tobacco consumption and ensuring early initiation of tobacco cessation.</p>
            </sec>
        </sec>
    </body>
    <back>
        <sec id="sec20" sec-type="data-availability">
            <title>Data availability</title>
            <p>No data is associated with this article.</p>
        </sec>
        <ack>
            <title>Acknowledgement</title>
            <p>I would like to thank Statisticians and Members of the Research Guidance Unit, Research &amp; Development Cell, DMIHER for their contribution in a part of sample size calculation to the completion of research manuscript.</p>
        </ack>
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    <sub-article article-type="reviewer-report" id="report208774">
        <front-stub>
            <article-id pub-id-type="doi">10.5256/f1000research.149492.r208774</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Thavarajah</surname>
                        <given-names>Rooban</given-names>
                    </name>
                    <xref ref-type="aff" rid="r208774a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-4159-4576</uri>
                </contrib>
                <aff id="r208774a1">
                    <label>1</label>Ragas Dental College and Hospital, Chennai, Tamil Nadu, India</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>25</day>
                <month>9</month>
                <year>2023</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Thavarajah R</copyright-statement>
                <copyright-year>2023</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport208774" related-article-type="peer-reviewed-article" xlink:href="10.12688/f1000research.136353.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>reject</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>It is universally agreed that tobacco in any form causes a myriad of health issues. In India, there is a notable shift of tobacco use from smoked forms to smokeless forms as revealed by several large scale studies. To formulate targeted or focussed policies &#x2013; there is a sub-par data with for smokeless forms as compared to the smoked forms. It is widely recognized that bio-psycho-economic-social constructs play a crucial role in tobacco usage. Hence the need for this study is justified. My comments are as follows:</p>
            <p> </p>
            <p> The sentence such as &#x201c;Because everyone spits after using oral tobacco, there are more persons who spit in public due toits use&#x201d; do not add meaningful contribution to the abstract or the protocol. Authors can remove such irrelevant, non-focussed sentence(s) to keep the focus of the article restricted to central theme. The abstract fails to justify the need for the study or the lacunae in the data to take policy based decisions.</p>
            <p> </p>
            <p> The first paragraph of the introduction is not focused and misleading from the central theme of the protocol and most importantly, unreferenced. In the second paragraph, authors use the term 
                <italic>Pan</italic> and 
                <italic>Pan masala</italic> without defining it properly. Government of India has clearly defined it and Pan masala is a no-tobacco containing entity &#x2013; but with areca nut &#x2013; requesting to visit the page:</p>
            <p> &#x00a0;
                <ext-link ext-link-type="uri" xlink:href="https://ntcp.mohfw.gov.in/surveys_reports_publications">https://ntcp.mohfw.gov.in/surveys_reports_publications</ext-link> and</p>
            <p> 
                <ext-link ext-link-type="uri" xlink:href="https://ntcp.mohfw.gov.in/assets/document/surveys-reports-publications/NIHFW-report-Evidence-assessment-Harmful-effects-of-consumption-of-gutkha-tobacco-pan-masala-and-similar-articles-manufactured-in-India.pdf">https://ntcp.mohfw.gov.in/assets/document/surveys-reports-publications/NIHFW-report-Evidence-assessment-Harmful-effects-of-consumption-of-gutkha-tobacco-pan-masala-and-similar-articles-manufactured-in-India.pdf</ext-link>
            </p>
            <p> Authors need to be careful in choice of term as such studies may form evidence for future actions and policies. Involving specific group such as transport employees or citing job stress to smokeless tobacco use is misleading and unwarranted for such study as the focus of study in urban slum &#x2013; hence such mis-construct may mislead and divert the intended goals of the study. Authors need to focus the words carefully. The introduction is superfluous and does not present a strong argument for the need of study, knowledge or data gap that exists. Authors claim the GTYS Indian data as &#x2013; &#x201c;India are still extremely speculative and non-representative&#x201d; but fail to establish the why these were speculative and non-representative &#x2013; hence their argument fails. Authors have preferred to write hundreds of words after stating primary goals of the study and that needs to be curtailed.</p>
            <p> </p>
            <p> The rationale part fails to say how this study would increase the knowledge on the subject matter and how it would help to frame better polices for combating smokeless tobacco usage. Instead it focusses on what is already known in the domain.</p>
            <p> </p>
            <p> For the methodology, operational definition of slum, tobacco (type/ frequency/ intensity/duration - pack years or equivalence), quantification of socio-economic factors, education etc., motivational and demotivational factors are missing. It is pertinent to note that authors prefer to use GYTS-GATS format, which they considered to be &#x201c;extremely speculative and non-representative&#x201d;.</p>
            <p> </p>
            <p> Better inferential statistics have to be planned to draw meaningful conclusions. Mere descriptive statistics would not be helpful to make recommendations.</p>
            <p>Is the study design appropriate for the research question?</p>
            <p>No</p>
            <p>Is the rationale for, and objectives of, the study clearly described?</p>
            <p>No</p>
            <p>Are sufficient details of the methods provided to allow replication by others?</p>
            <p>Partly</p>
            <p>Are the datasets clearly presented in a useable and accessible format?</p>
            <p>No</p>
            <p>Reviewer Expertise:</p>
            <p>Oral and Maxillofacial Pathology, Smokeless tobacco, Areca nut and products, NCD and Oral Health, Cystogenesis</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.</p>
        </body>
    </sub-article>
    <sub-article article-type="reviewer-report" id="report189370">
        <front-stub>
            <article-id pub-id-type="doi">10.5256/f1000research.149492.r189370</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Jayawardene</surname>
                        <given-names>Wasantha</given-names>
                    </name>
                    <xref ref-type="aff" rid="r189370a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-8798-0894</uri>
                </contrib>
                <aff id="r189370a1">
                    <label>1</label>School of Human Sciences, Southern Illinois University Carbondale, Carbondale, Illinois, USA</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>18</day>
                <month>8</month>
                <year>2023</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Jayawardene W</copyright-statement>
                <copyright-year>2023</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport189370" related-article-type="peer-reviewed-article" xlink:href="10.12688/f1000research.136353.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>reject</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>This cross-sectional study protocol intends to estimate the prevalence and patterns of oral tobacco use and assess the motivating and demotivating factors associated with it amongst urban slum inhabitants in India. Reporting of methodology is not up to standard and the writing of the manuscript needs to be substantially improved.</p>
            <p> </p>
            <p> 
                <bold>Abstract:</bold>
            </p>
            <p> </p>
            <p> Please check this sentence and correct any errors: &#x201c;Because everyone spits after using oral tobacco, there are more persons who spit in public due toits use&#x201d;</p>
            <p> </p>
            <p> Background is too long for an abstract. Please consider summarizing.</p>
            <p> </p>
            <p> In abstract, include the sample size and country.</p>
            <p> </p>
            <p> 
                <bold>Introduction</bold>
            </p>
            <p> </p>
            <p> These two sentences seem to be out of place or too general, and not relevant to the topic addressed in the article. Consider deleting: &#x201c;The United Nations&#x2019; World Health Organization (WHO) oversees global public health. The primary goal of the WHO, according to its constitution, is to ensure that everyone has the best possible level of health.&#x201d;</p>
            <p> </p>
            <p> There are no references for some statements. For example, &#x201c;Smokeless tobacco usage patterns share significant parallels with patterns of use of other addictive drugs.&#x201d; Please add them.</p>
            <p> </p>
            <p> Again, these statements are too general. Instead, consider adding a reference for a WHO initiative (if any) that targeted smokeless tobacco. Consider deleting: &#x201c;The mandate of the WHO calls for global collaboration to enhance health, uphold world peace and harmony, and assist the vulnerable. It encourages a billion more people to participate in monitoring public health risks, coordinating emergency medical response efforts, promoting health and wellness, and implementing universal health care.&#x201d;</p>
            <p> </p>
            <p> Please indicate the country in this sentence, because it hasn&#x2019;t been mentioned anywhere earlier in the manuscript: &#x201c;Smokeless tobacco use, particularly in the eastern, northern, and north-eastern regions of the country&#x2026;.&#x201d;</p>
            <p> </p>
            <p> What is Pan? &#x201c;Pan is frequently taken with chewed smokeless tobacco products&#x2026;&#x2026;&#x201d;</p>
            <p> </p>
            <p> Authors have not paid attention to the flow of information (poor transition from one point to another) and some sentences are out of place or irrelevant. For example, detailed description of tobacco processing is not necessary. I strongly suggest having this article edited by a professional English editor.</p>
            <p> Please replace &#x201c;Older folks&#x201d; with words that are more suitable for a scientific journal.</p>
            <p> </p>
            <p> 
                <bold>Rationale</bold>
            </p>
            <p> </p>
            <p> Stay focused on smokeless tobacco and reduce information about tobacco in general and it&#x2019;s health impacts.</p>
            <p> </p>
            <p> 
                <bold>Objectives</bold>
            </p>
            <p> </p>
            <p> Please do not use smokeless tobacco and oral tobacco interchangeable. Be consistent.</p>
            <p> </p>
            <p> Correct this. The word &#x201c;urban&#x201d; is redundant: &#x201c;&#x2026;&#x2026;.urban slum in central urban India&#x201d;</p>
            <p> </p>
            <p> 
                <bold>Setting</bold>
            </p>
            <p> </p>
            <p> Provide more details about the study setting and sampling population.</p>
            <p> </p>
            <p> 
                <bold>Eligibility Criteria</bold>
            </p>
            <p> </p>
            <p> Exclusion criteria are used for excluding ineligible participants (for example, based on a health condition) before they provide informed consent, and they are not invited to participate in the study. Therefore, not consenting to take part in the research study is not considered an exclusion criterion.</p>
            <p> </p>
            <p> Sampling method indicates that the personal interview method was used but data sources section indicates that a questionnaire was used. Did you use an oral interview or a paper-based questionnaire? Please provide your instrument or rubric as a supplementary material.</p>
            <p> </p>
            <p> 
                <bold>Data Analysis Plan</bold>
            </p>
            <p> </p>
            <p> Authors say that &#x201c;&#x2026;&#x2026;&#x2026;.. Selection bias will be addressed using systemic random sampling&#x201d;. I&#x2019;m curious if this is stratified random sampling, rather than systematic random sampling, and also, how you did it. Please provide more details of your sampling method.</p>
            <p> </p>
            <p> 
                <bold>Discussion</bold>
            </p>
            <p> </p>
            <p> Most of the information provided in discussion is not related to the topic and implications of the study.</p>
            <p> </p>
            <p> 
                <bold>Limitations</bold>
            </p>
            <p> </p>
            <p> This sentence needs to be corrected: &#x201c;In this study, the early initiation of oral tobacco use amongst urban slum inhabitants, exclusive tobacco consumption, determine the knowledge, attitude, and practice of oral tobacco use amongst urban slum inhabitants.&#x201d;</p>
            <p> </p>
            <p> Additional major comment: Methodology is not adequately reported, and a lot of information is missing. Please follow the STROBE checklist for reporting of cross-sectional studies.</p>
            <p>Is the study design appropriate for the research question?</p>
            <p>Partly</p>
            <p>Is the rationale for, and objectives of, the study clearly described?</p>
            <p>Partly</p>
            <p>Are sufficient details of the methods provided to allow replication by others?</p>
            <p>No</p>
            <p>Are the datasets clearly presented in a useable and accessible format?</p>
            <p>No</p>
            <p>Reviewer Expertise:</p>
            <p>Substance use</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.</p>
        </body>
    </sub-article>
</article>
