Assessment of the status of presentation and management of tuberculosis patients in central India

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Analyzing the causes of presentation, management, and treatment delays of tuberculosis can offer valuable understanding into local trends and aid in crafting specific approaches for the successful management of TB. This research involves a cross-sectional examination conducted among TB patients residing in the regions served by the District Tuberculosis Centre, Wardha, and the directly observed treatment short course center in Sawangi. Information will be collected using a standardized questionnaire endorsed by the World Health Organization." } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/13-101/v1", "name": "Assessment of the status of presentation and management of tuberculosis..." } } ] } Home Browse Assessment of the status of presentation and management of tuberculosis... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Saha M and Chakole S. Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.12688/f1000research.141720.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] Mitul Saha https://orcid.org/0000-0002-6338-5070 1 , Swarupa Chakole 1 Mitul Saha https://orcid.org/0000-0002-6338-5070 1 , Swarupa Chakole 1 PUBLISHED 16 Feb 2024 Author details Author details 1 Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India Mitul Saha Roles: Conceptualization, Resources, Writing – Review & Editing Swarupa Chakole Roles: Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Tuberculosis (TB) continues to pose a notable public health issue not just within India but on a worldwide scale. Analyzing the causes of presentation, management, and treatment delays of tuberculosis can offer valuable understanding into local trends and aid in crafting specific approaches for the successful management of TB. This research involves a cross-sectional examination conducted among TB patients residing in the regions served by the District Tuberculosis Centre, Wardha, and the directly observed treatment short course center in Sawangi. Information will be collected using a standardized questionnaire endorsed by the World Health Organization. READ ALL READ LESS Keywords tuberculosis, National Tuberculosis Elimination Programme, directly observed therapy short course, presentation delay, diagnosis delay, treatment delay Corresponding Author(s) Mitul Saha ( [email protected] ) Close Corresponding author: Mitul Saha Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Saha M and Chakole S. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Saha M and Chakole S. Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.12688/f1000research.141720.1 ) First published: 16 Feb 2024, 13 :101 ( https://doi.org/10.12688/f1000research.141720.1 ) Latest published: 16 Feb 2024, 13 :101 ( https://doi.org/10.12688/f1000research.141720.1 ) Introduction In 2021, approximately 10.6 million individuals globally received a tuberculosis (TB) diagnosis, with a 95% confidence interval ranging from 9.9 to 11 million. This count comprised 6.0 million males, 3.4 million females, and 1.2 million children. Among the total cases, 6.7% were individuals coexisting with HIV. Over the same year, TB claimed the lives of 1.6 million people, with 187,000 of these fatalities occurring in individuals with HIV. More than two-thirds of the total worldwide TB cases were attributed to eight countries: India, Indonesia, China, Philippines, Pakistan, Nigeria, Bangladesh, and the Democratic Republic of the Congo. From 2000 to 2021, TB treatment has led to the preservation of 74 million lives. On a global scale, the count of individuals who received new TB diagnoses and those reported to their respective national authorities declined from 7.1 million in 2019 to 5.8 million in 2020, with a partial rebound to 6.4 million in 2021. TB continues to be a significant public health issue in India. The difficulty lies not only in delivering successful treatment but also in minimizing the gap between identifying TB symptoms and promptly commencing treatment. Prompt and effective identification and treatment of TB cases play a pivotal role in managing the disease. If TB diagnosis is delayed, it can amplify the spread of infection, exacerbate illness severity, elevate mortality rates, and might be a factor contributing to the limited reduction in TB incidence, despite the worldwide expansion of the directly observed treatment, short course (DOTS). 1 Identifying the reasons behind delays can contribute to achieving India’s goal of eliminating tuberculosis by 2025. Hence, a primary area of emphasis within India’s National Tuberculosis Elimination Programme (NTEP) is rapid diagnosis and timely treatment. 2 Having information about the diagnostic routes is crucial for devising strategies to minimize the delays in diagnosis or treatment. 1 India possesses a multifaceted and diverse healthcare delivery structure, encompassing public and various forms of private healthcare providers, including both formal and informal sectors. Private and informal healthcare providers frequently serve as the initial point of contact for addressing illnesses, including tuberculosis. 3 The time taken for diagnosis and treatment delay, along with the factors contributing to these delays, vary among different communities, types of healthcare facilities visited, and geographical regions. This variation holds true even within population groups within the same local context and disease category. 3 Research indicates that elements leading to patient delay encompass aspects such as family size, employment, household income, social stigma, awareness about TB, proximity to healthcare facilities, and the practice of self-medication. 3 The increasing volume of research on delays in diagnosis and treatment underscores the need for conducting studies tailored to specific populations. This is crucial for identifying factors unique to each population that contribute to delays in diagnosing and treating TB. As per the 2014 guidelines from the World Health Organization (WHO), individuals displaying indicative symptoms and signs of TB, which encompass a cough lasting more than two weeks, fever persisting for over two weeks, considerable weight loss, coughing up blood, and any irregularities detected in a chest X-ray, as well as children experiencing continuous fever and/or a cough lasting more than two weeks, failure to gain weight or losing weight, and/or having been in contact with individuals diagnosed with pulmonary TB, should undergo an assessment to ascertain the presence of TB. Multiple diagnostic tests are accessible for pulmonary TB, including confirming the presence of the bacteria through sputum analysis, examining chest X-rays, conducting serological assessments, employing tests like tuberculin skin test and interferon gamma release assay. In the case of children and individuals living with HIV (PLHIV), the preferred initial diagnostic method is the cartridge-based nucleic-acid amplification test. Existing TB diagnostic methods like culture, sputum smear examination, tuberculin skin tests, and molecular assays, entail lengthy processing times, and certain methods are financially inaccessible for countries with limited economic resources. 4 Ensuring widespread availability for prompt and precise TB diagnosis and improving the efficiency of identifying potential TB cases right at the initial care encounter, followed by connecting them with optimal diagnostic assessments, holds immense significance. Swift identification of potential cases during the early stages is critical for halting the spread of TB infection. Every new tuberculosis patient in India should be provided with a globally recognized initial standard treatment plan (referring to the prescribed treatment course, which includes the TB medications) for newly diagnosed patients. The beginning intensive phase incorporate the medications Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), and Ethambutol (E). Subsequently, the follow-up phase, with the administration of the trio of medications Isoniazid, Rifampicin, and Ethambutol. This regimen is also expressed as 2HREZ/4HRE. There is no requirement for prolonging the follow-up phase. Patients’ medication dosages must correspond to their body weight and fall within one of four specified weight ranges. All patients are required to take their daily tuberculosis medications while being directly observed by a designated DOTS provider. DOTS mandates that patients ingest their TB drugs in the presence of a DOTS agent. This agent is typically a volunteer from the patient’s local community and could potentially be a family member. DOTS doesn’t specify the particular medications to be taken; rather, it applies whenever a DOTS volunteer oversees the patient taking any TB medications. While there might be existing studies on TB delays, an updated study in 2023 can provide insights into the evolving healthcare landscape. Factors such as the COVID-19 pandemic’s impact on healthcare seeking behaviour and service delivery could influence TB-related delays differently, making up-to-date research essential. This study on assessing delay in presentation, diagnosis, and treatment of TB patients in central India in 2023 is important for understanding the specific challenges in this region, improving patient outcomes, reducing disease transmission, and contributing to effective TB control strategies. The aim of this study is to assess the status of presentation and management of tuberculosis patients in central India. We used the STROBE reporting guidelines to aid our reporting of this protocol. 2 Protocol Ethical considerations Ethical approval was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Medical Science, DMIMS (DU), Sawangi, Wardha with reference no. DMIMS (DU)/IEC/2022/213 on 30 th August 2022. Written informed consent for participation and publication of this study will be obtained from the study participants and from the parents of children below 18 years of age. Study design This will be a hospital based, observational cross-sectional study. Study settings The study will be carried out in the area covered under the District Tuberculosis Centre, Wardha and the DOTS centre, Sawangi. Eligibility criteria Inclusion criteria 1. Newly diagnosed TB patients registered under National Tuberculosis Elimination Programme. 2. Tuberculosis patients of age seven years or older. Exclusion critera 1. Multidrug resistant TB (MDR TB) patients 2. Extensively drug-resistant TB (XDR TB) patients 3. TB patients registered under NTEP in Wardha but migrated or planning to transfer to another city or state. Study participants The study will be conducted on TB patients registered in DTC Wardha and the DOTS centre under the NTEP. Sampling procedure A detailed list of all the sputum positive TB individuals for the period of 1 st July 2022 to 30 th December 2023 will be obtained from Nikshay, the web enabled patient management system for TB control under the National Tuberculosis Elimination Programme (NTEP). with prior permission from the DTO Wardha. This list will be used as a sampling framework to select a simple random sample of 377 individuals who are registered under the NTEP and attending the outpatient department (OPD) or admitted at DTC, Wardha and DOTS centre, Sawangi. The Random Number Generator app, version 1.0.11, will be used on the Samsung A34 mobile will be used to carry out the selection of individuals. Further data collection will be carried out at the OPD from patients attending OPD and from patients admitted at tuberculosis wards. Data sources/measurements Data will be gathered through the utilization of a structured questionnaire, Diagnostic and treatment delay in tuberculosis , created by the World Health Organization (WHO). The questionnaire has been translated into the Marathi and Hindi language. Subsequently, direct interviews will be conducted with patients, following the acquisition of written informed consent from the patients. No pretesting phase will be conducted. Sample size The sample size was calculated using Open Source Epidemiologic Statistics for Public Health ( OpenEpi ), Version 5.5.11. For this study delay in presentation, diagnosis and treatment were included as outcome variables. The hypothesized frequency of outcome variables (p) were taken to be 56.9%, 38% and 8% respectively. The Confidence Interval (CI) was kept at 95%, with an absolute error of 5% for all variables and design effect (DEFF) was 1.0. The sample size was calculated to be 377, 362 and 114. The sample size was calculated using the formula: n = DEFF ∗ Np 1 − p / [ ( d 2 / Z 21 − α / 2 ∗ N − 1 + p ∗ 1 − p ] and then the sample size was taken as 377. Key results Key results of this study will be the current status of presentation, diagnosis and treatment of tuberculosis cases in recent times. In case we find any delay, we will calculate the mean duration for the total pathway including presentation delay, diagnostic delay and treatment delay. Statistical analysis Regarding the scoring methodology, the scores will be initially reversed before their integration into the relevant domains. This reversal will be executed to accurately reflect the positive trajectory of the studied variable. The mean percentage score for socioeconomic status, stigma, satisfaction with care, and knowledge will be ascertained using the following formula: (Sum of attained scores/Maximum attainable scores) × 100. Following this, the mean percentage scores will be computed to establish the variables’ scaling ranging from 0 to 100%. The highest percentage value will signify the most significant improvement in that particular characteristic or variable. Instances that exhibit prolonged delays will be categorized as “cases,” whereas those with shorter delays will be denoted as “controls.” The threshold for defining “extended” delays will be established by considering the median value achieved for each respective cases. This median value will also serve as the criterion for classifying other variables such as stigma, knowledge, and satisfaction with care into categories of satisfactory and unsatisfactory. Data analysis will be executed utilizing the statistical software package, R ,Version -4.3.1. Descriptive statistics including measures like frequency, mean, standard deviation, median, minimum, and maximum will be employed. For qualitative/categorical variables, group comparisons will be conducted using the Chi-square test or Fischer’s exact test as suitable. Similarly, quantitative variables will be compared using the t-test or Mann-Whitney test. To account for the influence of various identified factors affecting diagnostic and treatment delays in TB patients, a multivariate regression analysis will be carried out. The significance level will be set at 95% (with a P value <0.05 considered significant), and all tests will be two-sided. Dissemination Articles arising from this study will be published in indexed journals of public health. Study status The study is yet to be started. We envisage it will start by November 2023. Discussion In a study carried out in Mumbai, India, by Mistry and colleagues, it was found that the average duration for the entire pathway of uncomplicated pulmonary TB patients was 65 days, and approximately 29% of patients fell outside this average duration. Notably, the average time taken for initial care seeking was consistent for both new patients (24 days) and retreatment patients (25 days). 5 According to Mundra and colleagues, the midpoint duration for seeking initial care and diagnosis was 10 days each, while treatment initiation had a median delay of two days. The areas recognized as causes for delay in care seeking encompassed disregard for health, health-related factors, facility-associated challenges, as well as domestic and societal considerations. For delays in diagnosis, the factors identified were linked to the system and the patients, with each having two distinct subcategories. 6 The research of Paramasivam and colleagues showed that the average age of participants was 48.6 years with a standard deviation of 14.5 years. Among the study population, males comprised 76.5%. The average time of diagnostic delay was approximately 43.5 days, with a standard deviation of 29.1 days (median: 37 days). The median durations for patient delay and health system delay were 16 days and 15 days, respectively. Patient delay was more predominant, accounting for 55.6% compared to the 44.4% attributed to health system delay. Notably, poor understanding of TB, initial consultation with a private physician, and a higher number of medical visits were significantly linked to diagnostic delay. 7 According to Sreeramareddy and co-authors, the median estimates (with interquartile ranges) for patient, diagnostic, and treatment delay were found to be 18.4 days (with a range of 14.3 to 27.0 days), 31.0 days (with a range of 24.5 to 35.4 days), and 2.5 days (with a range of 1.9 to 3.6 days), respectively, when considering both TB and chest symptomatic patients together. The total median delay encompassing all these factors was approximately 55.3 days (with a range of 46.5 to 61.5 days). Notably, about 48% of all patients initially sought care from private healthcare providers, and an average of 2.7 healthcare providers were consulted before a diagnosis was established. 3 Patki and colleagues found that the median duration of delay was 35.5 days, with diagnostic delay constituting 84% of this duration. Male patients and those from families falling below the poverty line exhibited notably shorter median delay, and these differences were statistically significant (P < 0.05). Notably, a distinct delay was observed in the initiation of TB treatment, with diagnostic delay being the primary contributor to the overall delay. Limitations There are several possible limitations to this study: Cultural differences : The WHO questionnaire may have been developed with a global perspective, which might not fully account for cultural nuances and variations specific to central India. Questionnaire validity : While the WHO questionnaire is widely used, its applicability and validity in the context of central India may not have been thoroughly assessed. Certain questions might not accurately capture the region-specific factors contributing to delays. Response bias : Participants’ responses can be influenced by social desirability bias or recall bias. This could affect the accuracy and reliability of the collected data, particularly when reporting sensitive information or events related to delays. Generalisability When complete this study in central India can be generalised to over the whole of India due to similarity in cultural believes and practices. Data availability Underlying data No data are associated with this article. Reporting guidelines Zenodo: STROBE checklist for ‘Assessment of the status of presentation and management of tuberculosis patients in central India’, https://www.doi.org/10.5281/zenodo.8285467 . 4 Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Acknowledgements I would like to thank the District Tuberculosis Officer, Wardha for permitting data collection. References 1. Chandra A, Kumar R, Kant S, et al. : Diagnostic Pathways and Delays in Initiation of Treatment among Newly Diagnosed Tuberculosis Patients in Ballabgarh, India. Am J Trop Med Hyg. 2021 Feb 1; 104 (4): 1321–1325. PubMed Abstract | Publisher Full Text | Free Full Text 2. Saha M: Assessment of the status of presentation and management of tuberculosis patients in Central India (version v1). [Data]. Zenodo. 2023. Publisher Full Text 3. Sreeramareddy CT, Qin ZZ, Satyanarayana S, et al. : Delays in diagnosis and treatment of pulmonary tuberculosis in India: a systematic review. Int J Tuberc Lung Dis Off J Int Union Tuberc Lung Dis. 2014 Mar; 18 (3): 255–266. PubMed Abstract | Publisher Full Text | Free Full Text 4. Martin DR, Sibuyi NR, Dube P, et al. : Aptamer-Based Diagnostic Systems for the Rapid Screening of TB at the Point-of-Care. Diagnostics. 2021 Jul 28; 11 (8): 1352. PubMed Abstract | Publisher Full Text | Free Full Text 5. Mistry N, Rangan S, Dholakia Y, et al. : Durations and Delays in Care Seeking, Diagnosis and Treatment Initiation in Uncomplicated Pulmonary Tuberculosis Patients in Mumbai, India. PLoS One. 2016; 11 (3): e0152287. PubMed Abstract | Publisher Full Text | Free Full Text 6. Mundra A, Kothekar P, Deshmukh P, et al. : Why tuberculosis patients under revised national tuberculosis control programme delay in health-care seeking? A mixed-methods research from Wardha District, Maharashtra. Indian J Public Health. 2019; 63 (2): 94. 7. Paramasivam S, Thomas B, Chandran P, et al. : Diagnostic delay and associated factors among patients with pulmonary tuberculosis in Kerala. J Fam Med Prim Care. 2017; 6 (3): 643–648. PubMed Abstract | Publisher Full Text | Free Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 16 Feb 2024 ADD YOUR COMMENT Comment Author details Author details 1 Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India Mitul Saha Roles: Conceptualization, Resources, Writing – Review & Editing Swarupa Chakole Roles: Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 16 Feb 2024, 13:101 https://doi.org/10.12688/f1000research.141720.1 Copyright © 2024 Saha M and Chakole S. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Saha M and Chakole S. Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.12688/f1000research.141720.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 16 Feb 2024 Views 0 Cite How to cite this report: Burhan E and Rakasiwi MID. Reviewer Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r269584 ) The direct URL for this report is: https://f1000research.com/articles/13-101/v1#referee-response-269584 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 26 Sep 2024 Erlina Burhan , Department of Pulmonology and Respiratory Medicine, Universitas Indonesia and Persahabatan Hospital, Jakarta, Indonesia Muhammad Ilham Dhiya Rakasiwi , Respiratory & Tuberculosis Research & Training Center, Jakarta, Indonesia Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.155189.r269584 Summary of Manuscript The protocol outlines a study aimed at assessing the presentation and management of tuberculosis (TB) cases in central India. It encompasses a hospital-based observational cross-sectional design, targeting newly diagnosed TB patients registered under the National Tuberculosis ... Continue reading READ ALL Summary of Manuscript The protocol outlines a study aimed at assessing the presentation and management of tuberculosis (TB) cases in central India. It encompasses a hospital-based observational cross-sectional design, targeting newly diagnosed TB patients registered under the National Tuberculosis Elimination Programme (NTEP). The study will investigate the status of presentation, diagnosis, and treatment of TB cases, with data collection conducted through structured interviews using a translated questionnaire. A sample size of 377 individuals will be selected using a random sampling method. Statistical analysis will involve descriptive statistics, group comparisons, and multivariate regression analysis. The study aims to provide insights into the specific challenges in TB management in central India, contributing to effective TB control strategies and patient outcomes. Overall Assessment: This manuscript provides a concise overview of the research design to be conducted by the researchers. Although the researchers have developed a structured protocol, there are several major sections that can be improved to enhance clarity and comprehensiveness. The reproducibility of this study is relatively low and improvements are needed to enhance the quality of the protocol. Specific Comments: Introduction/Aims: Be more concise, avoid verbosity. No need to explain the theoretical basis of diagnosis or therapy. Paragraphs should be constructed instead of sentence-by-sentence. Ensure accurate citations, as there are no citations from WHO guidelines. Pay attention to the risk of self-citation. Highlight the novelty of the research. Clearly explain the aim of the study. Is it to assess delays or to evaluate the factors causing delays? There is inconsistency between the manuscript and the abstract. Keywords: Determine the most appropriate and representative ones, align with MeSH terms. Methods: The research design needs to be elaborated in more detail and consistency is required, as there is a statement of a cross-sectional study design but the data analysis is grouped based on cases and controls. Informed consent needs to be detailed, specifying who is eligible to provide consent (adult, parent, adolescent, child). Detailed timeline of the research plan is required. Elaborate on the subject recruitment process to enhance clarity in data collection. Eligibility criteria need to be more detailed, including whether extrapulmonary TB is included, whether relapsed TB is included, and combining MDR and XDR into DR TB. Detailed explanation of the research location is needed, including the context and rationale for selecting the location (readers are confused whether Wardha and Sawangi are cities, districts, or other administrative regions) Explain which variables are collected and provide the intended questionnaire. The sample size calculation results in 3 digits, but it is not explained why the authors wrote the number of samples to be taken in the protocol. Dissemination plan should be more detailed, indexed where. Significance: Provide a more comprehensive discussion, comparing the potential results of the current study with previous studies. Make implementation recommendations based on the results of this study in the real world. Recommendations: Improvements are needed in every section of the protocol to enhance clarity, relevance, and comprehensibility. Conclusion: The authors have provided a structured outline of the research plan in the field of TB and addressed the issue of delayed TB services for patients. Although some sections need major improvement and further elaboration, this manuscript has the potential to be a reference for addressing TB service delays, particularly in the Indian context. Therefore, I recommend returning this manuscript to the authors and rejecting it for its current state of quality. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? No Competing Interests: No competing interests were disclosed. Reviewer Expertise: Tuberculosis, COVID-19, Pulmonary infection We confirm that we have read this submission and believe that we have an appropriate level of expertise to state that we do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Burhan E and Rakasiwi MID. Reviewer Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r269584 ) The direct URL for this report is: https://f1000research.com/articles/13-101/v1#referee-response-269584 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Shah HD. Reviewer Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r304072 ) The direct URL for this report is: https://f1000research.com/articles/13-101/v1#referee-response-304072 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 22 Aug 2024 Harsh D Shah , Indian Institute of Public Health (IIPH), Gandhinagar, Gujarat, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.155189.r304072 The authors are encouraged to carefully review the following comments: Introduction: The authors may refer Global TB report 2023 for latest data counts on TB. Please ensure that the Tuberculin Skin ... Continue reading READ ALL The authors are encouraged to carefully review the following comments: Introduction: The authors may refer Global TB report 2023 for latest data counts on TB. Please ensure that the Tuberculin Skin Test (TST) and Interferon-Gamma Release Assays (IGRA) are correctly referenced as tools for identifying TB infection rather than diagnosing TB. The authors should adhere to the diagnostic algorithms outlined by the National Tuberculosis Elimination Program (NTEP). Study Objectives: Several studies in India have already identified delays in TB care and proposed public health actions. This study could provide valuable additional insights specific to particular geographies, such as specific districts or states. Study Method: The study focuses exclusively on drug-sensitive TB patients within a specific age range. There is a risk of overlooking drug-resistant cases and pediatric patients under seven years old, who may be more susceptible to delays. Clarification is needed on whether the study includes both pulmonary and extrapulmonary TB, public and private sector patients, seriously ill or hospitalized individuals, etc. The suggested tools for the questionnaires require updating in accordance with the latest NTEP guidelines. Notably, changes related to the oral daily dose and weight-band drug regimen should be reflected. Discussion: The discussion section references studies on overall delays in TB care, rather than focusing solely on drug-sensitive TB as per the study design. Please revise this section to align with the study's scope. You may refer following studies: 1. Shah HD,.et.al., 2022 (Ref1) 2. Yasobant S,. et.al., 2023 (Ref 2) 3. Subbaraman R,.et.al.2019 (Ref 3) Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Partly References 1. Shah HD, Nazli Khatib M, Syed ZQ, Gaidhane AM, et al.: Gaps and Interventions across the Diagnostic Care Cascade of TB Patients at the Level of Patient, Community and Health System: A Qualitative Review of the Literature. Trop Med Infect Dis . 2022; 7 (7). PubMed Abstract | Publisher Full Text 2. Yasobant S, Shah H, Bhavsar P, Patel J, et al.: Why and where?-Delay in Tuberculosis care cascade: A cross-sectional assessment in two Indian states, Jharkhand, Gujarat. Front Public Health . 2023; 11 : 1015024 PubMed Abstract | Publisher Full Text 3. Subbaraman R, Nathavitharana RR, Mayer KH, Satyanarayana S, et al.: Constructing care cascades for active tuberculosis: A strategy for program monitoring and identifying gaps in quality of care. PLoS Med . 2019; 16 (2): e1002754 PubMed Abstract | Publisher Full Text Competing Interests: No competing interests were disclosed. 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. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Shah HD. Reviewer Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r304072 ) The direct URL for this report is: https://f1000research.com/articles/13-101/v1#referee-response-304072 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Shah Y. Reviewer Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r253402 ) The direct URL for this report is: https://f1000research.com/articles/13-101/v1#referee-response-253402 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 28 Mar 2024 Yogendra Shah , Province Public Health Laboratory, Rajpur, Nepal Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.155189.r253402 Title: Assessment of the status of presentation and management of tuberculosis patients in central India Reviewer: I respectfully suggest the following improvements to enhance the manuscript's format : Abstract: Emphasize the significant findings ... Continue reading READ ALL Title: Assessment of the status of presentation and management of tuberculosis patients in central India Reviewer: I respectfully suggest the following improvements to enhance the manuscript's format : Abstract: Emphasize the significant findings of the manuscript, including background, rationale, study objectives, methods, results, conclusions, and recommendations. Select only the most essential keywords from the abstract for better searchability. Introduction: Begin by providing a concise overview of global tuberculosis statistics, with a specific focus on India, highlighting drug resistance issues including multi-drug resistant (MDR) and extensively drug-resistant (XDR) strains. Clearly state the rationale and justification for the study, emphasizing any existing gaps in knowledge or clinical management of pulmonary tuberculosis patients in central India. Discuss the rationale behind employing genotypic and phenotypic diagnosis methods, as well as the Directly Observed Treatment, Short-course (DOTS) treatment strategy. Justify the objectives of the current study in an easily understandable manner to capture the reader's interest and demonstrate their relevance. Methods: Clearly describe the study design, including inclusion and exclusion criteria, determination of sample size, collection of clinical data, laboratory tests performed, and statistical analysis methods, ensuring simplicity for better comprehension. Present a flow chart illustrating the procedure employed in the current study. Results: Discuss the significant findings of the study in a straightforward manner, avoiding complex formats to enhance clarity. Discussion: Revisit the discussion to include a comparison of the current study's findings with previously published literature, offering logical explanations for better comprehension. Address any limitations of the research, acknowledging potential constraints or biases that could impact result interpretation. Conclude with practical recommendations for implementing the study findings in clinical practice, emphasizing real-world applications and strategies to enhance pulmonary tuberculosis management, while also considering potential barriers to implementation. By incorporating these suggestions, the manuscript can be improved in terms of format, clarity, and relevance. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Infectious Diseases 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. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Shah Y. Reviewer Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r253402 ) The direct URL for this report is: https://f1000research.com/articles/13-101/v1#referee-response-253402 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 16 Feb 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 Version 1 16 Feb 24 read read read Yogendra Shah , Province Public Health Laboratory, Rajpur, Nepal Harsh D Shah , Indian Institute of Public Health (IIPH), Gandhinagar, India Erlina Burhan , Universitas Indonesia and Persahabatan Hospital, Jakarta, Indonesia Muhammad Ilham Dhiya Rakasiwi , Respiratory & Tuberculosis Research & Training Center, Jakarta, Indonesia Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Burhan E et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 26 Sep 2024 | for Version 1 Erlina Burhan , Department of Pulmonology and Respiratory Medicine, Universitas Indonesia and Persahabatan Hospital, Jakarta, Indonesia Muhammad Ilham Dhiya Rakasiwi , Respiratory & Tuberculosis Research & Training Center, Jakarta, Indonesia 0 Views copyright © 2024 Burhan E et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Summary of Manuscript The protocol outlines a study aimed at assessing the presentation and management of tuberculosis (TB) cases in central India. It encompasses a hospital-based observational cross-sectional design, targeting newly diagnosed TB patients registered under the National Tuberculosis Elimination Programme (NTEP). The study will investigate the status of presentation, diagnosis, and treatment of TB cases, with data collection conducted through structured interviews using a translated questionnaire. A sample size of 377 individuals will be selected using a random sampling method. Statistical analysis will involve descriptive statistics, group comparisons, and multivariate regression analysis. The study aims to provide insights into the specific challenges in TB management in central India, contributing to effective TB control strategies and patient outcomes. Overall Assessment: This manuscript provides a concise overview of the research design to be conducted by the researchers. Although the researchers have developed a structured protocol, there are several major sections that can be improved to enhance clarity and comprehensiveness. The reproducibility of this study is relatively low and improvements are needed to enhance the quality of the protocol. Specific Comments: Introduction/Aims: Be more concise, avoid verbosity. No need to explain the theoretical basis of diagnosis or therapy. Paragraphs should be constructed instead of sentence-by-sentence. Ensure accurate citations, as there are no citations from WHO guidelines. Pay attention to the risk of self-citation. Highlight the novelty of the research. Clearly explain the aim of the study. Is it to assess delays or to evaluate the factors causing delays? There is inconsistency between the manuscript and the abstract. Keywords: Determine the most appropriate and representative ones, align with MeSH terms. Methods: The research design needs to be elaborated in more detail and consistency is required, as there is a statement of a cross-sectional study design but the data analysis is grouped based on cases and controls. Informed consent needs to be detailed, specifying who is eligible to provide consent (adult, parent, adolescent, child). Detailed timeline of the research plan is required. Elaborate on the subject recruitment process to enhance clarity in data collection. Eligibility criteria need to be more detailed, including whether extrapulmonary TB is included, whether relapsed TB is included, and combining MDR and XDR into DR TB. Detailed explanation of the research location is needed, including the context and rationale for selecting the location (readers are confused whether Wardha and Sawangi are cities, districts, or other administrative regions) Explain which variables are collected and provide the intended questionnaire. The sample size calculation results in 3 digits, but it is not explained why the authors wrote the number of samples to be taken in the protocol. Dissemination plan should be more detailed, indexed where. Significance: Provide a more comprehensive discussion, comparing the potential results of the current study with previous studies. Make implementation recommendations based on the results of this study in the real world. Recommendations: Improvements are needed in every section of the protocol to enhance clarity, relevance, and comprehensibility. Conclusion: The authors have provided a structured outline of the research plan in the field of TB and addressed the issue of delayed TB services for patients. Although some sections need major improvement and further elaboration, this manuscript has the potential to be a reference for addressing TB service delays, particularly in the Indian context. Therefore, I recommend returning this manuscript to the authors and rejecting it for its current state of quality. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? No Competing Interests No competing interests were disclosed. Reviewer Expertise Tuberculosis, COVID-19, Pulmonary infection We confirm that we have read this submission and believe that we have an appropriate level of expertise to state that we do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Burhan E and Rakasiwi MID. Peer Review Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r269584) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-101/v1#referee-response-269584 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Shah H. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 22 Aug 2024 | for Version 1 Harsh D Shah , Indian Institute of Public Health (IIPH), Gandhinagar, Gujarat, India 0 Views copyright © 2024 Shah H. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The authors are encouraged to carefully review the following comments: Introduction: The authors may refer Global TB report 2023 for latest data counts on TB. Please ensure that the Tuberculin Skin Test (TST) and Interferon-Gamma Release Assays (IGRA) are correctly referenced as tools for identifying TB infection rather than diagnosing TB. The authors should adhere to the diagnostic algorithms outlined by the National Tuberculosis Elimination Program (NTEP). Study Objectives: Several studies in India have already identified delays in TB care and proposed public health actions. This study could provide valuable additional insights specific to particular geographies, such as specific districts or states. Study Method: The study focuses exclusively on drug-sensitive TB patients within a specific age range. There is a risk of overlooking drug-resistant cases and pediatric patients under seven years old, who may be more susceptible to delays. Clarification is needed on whether the study includes both pulmonary and extrapulmonary TB, public and private sector patients, seriously ill or hospitalized individuals, etc. The suggested tools for the questionnaires require updating in accordance with the latest NTEP guidelines. Notably, changes related to the oral daily dose and weight-band drug regimen should be reflected. Discussion: The discussion section references studies on overall delays in TB care, rather than focusing solely on drug-sensitive TB as per the study design. Please revise this section to align with the study's scope. You may refer following studies: 1. Shah HD,.et.al., 2022 (Ref1) 2. Yasobant S,. et.al., 2023 (Ref 2) 3. Subbaraman R,.et.al.2019 (Ref 3) Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Partly References 1. Shah HD, Nazli Khatib M, Syed ZQ, Gaidhane AM, et al.: Gaps and Interventions across the Diagnostic Care Cascade of TB Patients at the Level of Patient, Community and Health System: A Qualitative Review of the Literature. Trop Med Infect Dis . 2022; 7 (7). PubMed Abstract | Publisher Full Text 2. Yasobant S, Shah H, Bhavsar P, Patel J, et al.: Why and where?-Delay in Tuberculosis care cascade: A cross-sectional assessment in two Indian states, Jharkhand, Gujarat. Front Public Health . 2023; 11 : 1015024 PubMed Abstract | Publisher Full Text 3. Subbaraman R, Nathavitharana RR, Mayer KH, Satyanarayana S, et al.: Constructing care cascades for active tuberculosis: A strategy for program monitoring and identifying gaps in quality of care. PLoS Med . 2019; 16 (2): e1002754 PubMed Abstract | Publisher Full Text Competing Interests No competing interests were disclosed. 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. reply Respond to this report Responses (0) Shah HD. Peer Review Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r304072) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-101/v1#referee-response-304072 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Shah Y. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 28 Mar 2024 | for Version 1 Yogendra Shah , Province Public Health Laboratory, Rajpur, Nepal 0 Views copyright © 2024 Shah Y. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Title: Assessment of the status of presentation and management of tuberculosis patients in central India Reviewer: I respectfully suggest the following improvements to enhance the manuscript's format : Abstract: Emphasize the significant findings of the manuscript, including background, rationale, study objectives, methods, results, conclusions, and recommendations. Select only the most essential keywords from the abstract for better searchability. Introduction: Begin by providing a concise overview of global tuberculosis statistics, with a specific focus on India, highlighting drug resistance issues including multi-drug resistant (MDR) and extensively drug-resistant (XDR) strains. Clearly state the rationale and justification for the study, emphasizing any existing gaps in knowledge or clinical management of pulmonary tuberculosis patients in central India. Discuss the rationale behind employing genotypic and phenotypic diagnosis methods, as well as the Directly Observed Treatment, Short-course (DOTS) treatment strategy. Justify the objectives of the current study in an easily understandable manner to capture the reader's interest and demonstrate their relevance. Methods: Clearly describe the study design, including inclusion and exclusion criteria, determination of sample size, collection of clinical data, laboratory tests performed, and statistical analysis methods, ensuring simplicity for better comprehension. Present a flow chart illustrating the procedure employed in the current study. Results: Discuss the significant findings of the study in a straightforward manner, avoiding complex formats to enhance clarity. Discussion: Revisit the discussion to include a comparison of the current study's findings with previously published literature, offering logical explanations for better comprehension. Address any limitations of the research, acknowledging potential constraints or biases that could impact result interpretation. Conclude with practical recommendations for implementing the study findings in clinical practice, emphasizing real-world applications and strategies to enhance pulmonary tuberculosis management, while also considering potential barriers to implementation. By incorporating these suggestions, the manuscript can be improved in terms of format, clarity, and relevance. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Infectious Diseases 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. reply Respond to this report Responses (0) Shah Y. Peer Review Report For: Assessment of the status of presentation and management of tuberculosis patients in central India [version 1; peer review: 2 approved with reservations, 1 not approved] . F1000Research 2024, 13 :101 ( https://doi.org/10.5256/f1000research.155189.r253402) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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