Observational and cross-sectional study on clinical profile of nontuberculous mycobacterial (NTM) disease in patients at tertiary care hospital of central India

Jay Dinesh Bhanushali; Dr Babaji Ghewade; Dr Ulhas Jadhav

doi:10.12688/f1000research.144148.1

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Study Protocol

Observational and cross-sectional study on clinical profile of nontuberculous mycobacterial (NTM) disease in patients at tertiary care hospital of central India

[version 1; peer review: 2 approved with reservations]

Jay Dinesh Bhanushali ¹, Dr Babaji Ghewade¹, Dr Ulhas Jadhav¹

PUBLISHED 09 May 2024

Author details Author details

¹ Respiratory Medicine, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

Jay Dinesh Bhanushali
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Dr Babaji Ghewade
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Dr Ulhas Jadhav
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Nontuberculous Mycobacterial (NTM) diseases present unique clinical challenges and are increasingly recognised as significant contributors to respiratory and extrapulmonary morbidity. This study protocol outlines an observational and cross-sectional investigation aiming to comprehensively understand the clinical profile of NTM disease, including its prevalence, risk factors, and clinical features, in patients at a tertiary care hospital in central India.

Methods

Over two years, from July 2022 to June 2024, a convenience sample size will be recruited from TB suspects meeting inclusion criteria. Comprehensive data collection will be conducted, including demographic information, clinical history, radiological findings, microbiological test results, and risk factor assessments. Statistical methods will be applied to the collected data, including descriptive statistics, comparative analysis, risk factor assessments, and multivariate analyses.

Expected Results

The study aims to provide valuable insights into the prevalence and clinical manifestations of NTM disease, shedding light on the risk factors contributing to its occurrence. The statistical analyses will identify key factors associated with NTM disease and characterise its clinical and radiological features.

Keywords

Nontuberculous Mycobacterial (NTM) Disease, Clinical Profile, Prevalence, Risk Factors, Tertiary Care Hospital, Central India

Corresponding author: Jay Dinesh Bhanushali

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 Dinesh Bhanushali J et al. 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: Dinesh Bhanushali J, Ghewade DB and Jadhav DU. Observational and cross-sectional study on clinical profile of nontuberculous mycobacterial (NTM) disease in patients at tertiary care hospital of central India [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:463 (https://doi.org/10.12688/f1000research.144148.1) First published: 09 May 2024, 13:463 (https://doi.org/10.12688/f1000research.144148.1) Latest published: 09 May 2024, 13:463 (https://doi.org/10.12688/f1000research.144148.1)

Introduction

Nontuberculous Mycobacterial (NTM) diseases, caused by various species of mycobacteria other than Mycobacterium tuberculosis, have garnered increasing recognition for their clinical significance and impact on respiratory and extrapulmonary health. These infections present a complex clinical profile, often mimicking tuberculosis (TB) and posing diagnostic and therapeutic challenges.¹ In central India, a region with a diverse healthcare landscape, understanding the clinical characteristics, prevalence, and risk factors associated with NTM diseases is essential for improving patient care, diagnosis, and management.²

NTM diseases primarily affect individuals with underlying respiratory conditions, immunosuppression, or other risk factors. Moreover, their clinical presentation can range from mild respiratory symptoms to severe, life-threatening infections. As central India grapples with a high burden of TB and diverse environmental factors, differentiating NTM diseases from TB and elucidating their clinical features become paramount for precise diagnosis and appropriate management.³

This study protocol outlines an observational and cross-sectional research endeavour, with a primary objective to comprehensively investigate the clinical profile of NTM disease in patients at a tertiary care hospital in central India. The study seeks to determine the prevalence of NTM disease among TB suspects, examine various risk factors contributing to NTM infections, and elucidate the clinical and radiological features that distinguish NTM diseases from other respiratory conditions. In doing so, the study aims to provide valuable insights into the epidemiology and clinical characteristics of NTM diseases in the specific context of central India.

The research findings can inform healthcare professionals, public health initiatives, and policy-makers, ultimately leading to better diagnostic accuracy and tailored therapeutic strategies for NTM disease. Furthermore, this study contributes to a broader understanding of pulmonary and extrapulmonary diseases in the region, underscoring the growing importance of NTM diseases in the context of public health and patient care.

Aim

To study the Clinical profile of NTM disease.

Objectives

1. To determine the prevalence of NTM disease among TB suspects at Acharya Vinoba Bhave Rural Hospital
2. To study various risk factors of NTM disease
3. To study Clinical and radiological features of confirmed NTM disease patient

Methods

Study design

This study will adopt an observational and cross-sectional design to assess the clinical profile of Nontuberculous Mycobacterial (NTM) disease in patients at a tertiary care hospital in central India (Figure 1).

Figure 1. Diagnostic algorithm for detection of non-tuberculous mycobacteria.

Study population

The study will focus on individuals in central India who are TB suspects and fulfil the inclusion criteria for NTM disease. The study population includes pulmonary and extrapulmonary NTM disease patients, irrespective of gender, aged 12 years or older. These patients may have clinical symptoms, radiological findings, microbiological evidence suggestive of NTM disease, and those suspected of having drug-resistant TB (DR-TB).

Place of study

The study will be conducted at Acharya Vinoba Bhave Rural Hospital, a tertiary care hospital in central India.

Inclusion criteria: To be eligible for inclusion in the study, patients must meet the following criteria:

1. Age: Patients should be 12 years of age or older.
2. Gender: Inclusion is irrespective of gender.
3. Clinical criteria:
- • Pulmonary NTM disease: Patients should exhibit pulmonary symptoms or have nodular or cavitary opacities on chest radiograph or an HRCT scan showing multifocal bronchiectasis with multiple small nodules.
- • Extrapulmonary NTM disease: Patients with disseminated disease, including skin involvement, especially following organ transplantation.
4. Microbiological criteria: Patients should have positive culture results from at least two separate expectorated sputum samples.
5. DR-TB suspects: Patients suspected of having drug-resistant TB (DR-TB).

Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria:

1. Active Tuberculosis (TB) patients: Individuals with a confirmed diagnosis of active TB will not be included in this study, as the focus is on NTM disease.
2. Declining informed consent: Patients who must provide written informed consent for participation in the study will be excluded. Informed consent is essential to ensure voluntary participation and ethical considerations.

Bias

1. Selection bias: This type of bias occurs when the study sample does not represent the target population. To mitigate selection bias, ensure that study participant recruitment is done systematically and unbiasedly, adhering to the inclusion and exclusion criteria. Random sampling or stratified sampling methods can help minimise selection bias.
2. Information bias: Information bias arises from inaccuracies in data collection, either due to measurement error or misclassification of study variables. To reduce information bias, use standardised data collection tools, train data collectors, and establish quality control measures. Additionally, consider blinding data collectors to the research hypothesis to prevent measurement bias.
3. Confounding bias: Confounding bias occurs when a third variable influences the relationship between the exposure and the outcome. Conduct a multivariate analysis to control for potential confounding variables to address confounding. This may involve stratification, matching, or including confounders as covariates in statistical models.

Data collection process

The data collection process for this observational and cross-sectional study on the clinical profile of Nontuberculous Mycobacterial (NTM) disease involves several structured steps to ensure precise and comprehensive information acquisition. This organised approach meets the study’s objectives while maintaining patient confidentiality and ethical standards.

Patient identification and recruitment: Patients eligible for participation, as per the inclusion criteria outlined in the study protocol, will be identified through various channels, including referrals from healthcare providers, TB clinics, and other medical facilities. These patients, who provide voluntary written informed consent, will be recruited into the study.

Informed consent: Before commencing data collection, patients will be given a clear and detailed explanation of the study’s purpose, goals, and the procedures involved. Patients will be requested to provide written informed consent, signifying their willingness to participate in the research.

Data collection tools: Specialized data collection forms and questionnaires will be developed to capture relevant information systematically. These tools will encompass sections for demographic data, medical history, clinical symptoms, radiological findings, microbiological test results, and an assessment of potential risk factors.

Data collection: Highly trained healthcare professionals, including physicians, nurses, or research assistants, will conduct in-person interviews with the study participants. These interviews will delve into various topics, such as the patients’ medical histories, symptom profiles, potential risk factors, and medication histories. Additionally, clinical examinations will assess the patient’s physical conditions, with any relevant findings meticulously recorded. Radiological data will be gathered by reviewing chest radiographs and HRCT scans to document the presence of opacities, nodules, and bronchiectasis. Microbiological data will be collected by analysing sputum samples, including culture results from at least two samples.

Quality control: To ensure the precision and reliability of the collected data, regular training sessions will be conducted for data collectors, maintaining consistency in the data collection process. A thorough data review will be performed to confirm completeness and coherence, promptly addressing any discrepancies or missing information.

Data entry: All collected data will be securely entered into a dedicated database, prioritising data integrity and privacy.

Data analysis: After the data collection phase concludes, statistical and epidemiological analyses will be conducted to fulfil the study’s objectives. This may involve determining the prevalence of NTM disease, identifying associated risk factors, and characterising the clinical profiles of NTM disease patients.

Sample size

Formula

N = \frac{Z_{1 - α / 2}^{2} * p * (1 - p)}{D^{2}} .

$Z_{1 - α / 2} = 1.96, at 5% level of significance$

Prevalence of Annual prevalence of NTM infection = 0.5%.

p = 0.5% (As per reference article⁴)

D = estimated error (10%) = 3%

$= {(1.96)}^{2} * (0.05) * (1 - 0.5) / {(0.3)}^{2} = 22$

Minimum sample size required = 22

Statistical method

Descriptive statistics will offer an initial overview of the data by calculating mean, median, standard deviation, and percentages to characterise the study population. Secondly, the study will compute the prevalence of NTM disease among TB suspects, providing valuable insights into the scale of the issue. Comparative analyses will be crucial in assessing differences between groups within the study population, such as patients with pulmonary and extrapulmonary NTM disease. To explore the various risk factors associated with NTM disease, logistic regression will be used to identify significant associations. Multivariate analysis will help disentangle the simultaneous effects of multiple variables on the clinical profile of NTM disease patients. Moreover, statistical tests like Chi-Square or Fisher’s Exact Test will be employed to evaluate associations between categorical variables. T-tests or ANOVA will be used when comparing means of continuous variables. If relevant, survival analysis techniques like Kaplan-Meier curves and Cox regression will be applied to examine time-to-event data. Subgroup analyses will delve into specific characteristics within the study population. Statistical software such as R (RRID:SCR_001905), SPSS (RRID:SCR_014598), or SAS version 23 (RRID:SCR_004635) will be utilised for all these analyses and the copyright license have been obtained. Ethical considerations must be rigorously followed throughout these analyses to safeguard patient confidentiality and rights. The study’s findings will be reported comprehensively, presenting the results clearly and effectively, supporting the study’s objectives and conclusions.

Ethical considerations

The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIHER (DU)/IEC/2022/19. Date:15-07-2022). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives.

Dissemination

After the completion of the study, we will publish it in an indexed journal or conference.

Study status

The study has yet to start. After the publication of the protocol, we will start recruitment in the study.

Discussion

Nontuberculous mycobacterial (NTM) diseases have gained significant attention in recent years due to their impact on respiratory and extrapulmonary health. Numerous studies globally have reported an increasing prevalence of NTM diseases. The prevalence varies across regions, and India is no exception to this trend. Studies by Hoefsloot et al.⁵ and Prevots et al.⁶ have highlighted the rising prevalence of NTM diseases, particularly in areas with a high burden of TB.

One of the fundamental challenges in managing NTM diseases is their clinical resemblance to tuberculosis. This clinical mimicry often leads to misdiagnoses and delayed treatment initiation. Research by Prevots and Marras⁷ and Ringshausen et al.⁸ noted that differentiating NTM diseases from TB is vital for appropriate management.

NTM infections are not limited to a single risk factor or demographic group. The risk factors associated with NTM diseases are multifactorial and may include underlying respiratory conditions, immunosuppression, and environmental factors. Research by Kartalija et al.⁹ and Adjemian et al.¹⁰ has explored these risk factors and highlighted the complexity of NTM disease epidemiology.

The geographic distribution of NTM species and their clinical impact can vary widely. With its unique environmental and demographic characteristics, Central India presents a distinct context for studying NTM diseases. Research by Thomson et al.¹¹ has shown how environmental factors play a significant role in NTM epidemiology.

Accurate diagnosis is pivotal in managing NTM diseases effectively. Misdiagnoses lead to inappropriate treatment and contribute to antibiotic resistance and increased healthcare costs. Research by Griffith et al.¹² underscores the importance of accurate diagnosis in NTM disease management.

Understanding the clinical and radiological features specific to NTM diseases is crucial for distinguishing them from TB and other respiratory conditions. Research by Jeong et al.¹³ and Winthrop et al.¹⁴ has detailed the diverse clinical presentations and radiological findings associated with NTM infections.

Data availability

No data are associated with this article.

Extended data

Reporting guidelines

Zenodo: STROBE checklist for ‘Observational and cross-sectional study on clinical profile of nontuberculous mycobacterial (NTM) disease in patients at tertiary care hospital of central India’. https://zenodo.org/doi/10.5281/zenodo.10983365

Licence: CC BY 4.0 Deed|Attribution 4.0 International

References

1. Daniel-Wayman S, Abate G, Barber DL, et al.: Advancing Translational Science for Pulmonary Nontuberculous Mycobacterial Infections. A Road Map for Research. Am. J. Respir. Crit. Care Med. 2019; 199: 947–951. PubMed Abstract | Publisher Full Text | Free Full Text
2. Sharma SK, Sharma R, Singh BK, et al.: A prospective study of non-tuberculous mycobacterial disease among tuberculosis suspects at a tertiary care centre in north India. Indian J. Med. Res. 2019; 150: 458–467. PubMed Abstract | Publisher Full Text | Free Full Text
3. Sharma SK, Upadhyay V: Epidemiology, diagnosis & treatment of non-tuberculous mycobacterial diseases. Indian J. Med. Res. 2020; 152: 185–226. PubMed Abstract | Publisher Full Text | Free Full Text
4. Jani MN, Rodrigues CS, Mehta AP: The Neglected and Often Ignored: Nontuberculous Mycobacteria. J. Global Infect. Dis. 2011; 3: 94. PubMed Abstract | Publisher Full Text | Free Full Text
5. Hoefsloot W, van Ingen J , Andrejak C, et al.: The geographic diversity of nontuberculous mycobacteria isolated from pulmonary samples: an NTM-NET collaborative study. Eur. Respir. J. 2013; 42: 1604–1613. PubMed Abstract | Publisher Full Text
6. Prevots DR, Shaw PA, Strickland D, et al.: Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am. J. Respir. Crit. Care Med. 2010; 182: 970–976. PubMed Abstract | Publisher Full Text | Free Full Text
7. Prevots DR, Marras TK: Epidemiology of human pulmonary infection with nontuberculous mycobacteria: a review. Clin. Chest Med. 2015; 36: 13–34. PubMed Abstract | Publisher Full Text | Free Full Text
8. Ringshausen FC, Apel R-M, Bange F-C, et al.: Burden and trends of hospitalisations associated with pulmonary non-tuberculous mycobacterial infections in Germany, 2005–2011. BMC Infect. Dis. 2013; 13: 231. PubMed Abstract | Publisher Full Text | Free Full Text
9. Kartalija M, Ovrutsky AR, Bryan CL, et al.: Patients with nontuberculous mycobacterial lung disease exhibit unique body and immune phenotypes. Am. J. Respir. Crit. Care Med. 2013; 187: 197–205. PubMed Abstract | Publisher Full Text | Free Full Text
10. Adjemian J, Olivier KN, Seitz AE, et al.: Spatial clusters of nontuberculous mycobacterial lung disease in the United States. Am. J. Respir. Crit. Care Med. 2012; 186: 553–558. PubMed Abstract | Publisher Full Text | Free Full Text
11. Thomson R, Tolson C, Carter R, et al.: Isolation of nontuberculous mycobacteria (NTM) from household water and shower aerosols in patients with pulmonary disease caused by NTM. J. Clin. Microbiol. 2013; 51: 3006–3011. PubMed Abstract | Publisher Full Text | Free Full Text
12. Griffith DE, Aksamit T, Brown-Elliott BA, et al.: An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases. Am. J. Respir. Crit. Care Med. 2007; 175: 367–416. PubMed Abstract | Publisher Full Text
13. Jeong YJ, Lee KS, Koh W-J, et al.: Nontuberculous mycobacterial pulmonary infection in immunocompetent patients: comparison of thin-section CT and histopathologic findings. Radiology. 2004; 231: 880–886. PubMed Abstract | Publisher Full Text
14. Winthrop KL, McNelley E, Kendall B, et al.: Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am. J. Respir. Crit. Care Med. 2010; 182: 977–982. Publisher Full Text

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Version 1

VERSION 1 PUBLISHED 09 May 2024

Author details Author details

¹ Respiratory Medicine, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

Jay Dinesh Bhanushali
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Dr Babaji Ghewade
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Dr Ulhas Jadhav
Roles: Methodology, Project Administration, 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: 09 May 2024, 13:463

https://doi.org/10.12688/f1000research.144148.1

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© 2024 Dinesh Bhanushali J et al. 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.

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Dinesh Bhanushali J, Ghewade DB and Jadhav DU. Observational and cross-sectional study on clinical profile of nontuberculous mycobacterial (NTM) disease in patients at tertiary care hospital of central India [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:463 (https://doi.org/10.12688/f1000research.144148.1)

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PUBLISHED 09 May 2024

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Reviewer Report 25 Oct 2024

Ho Namkoong, Department of Infectious Diseases, Keio University School of Medicine, Tokyo, Japan

Approved with Reservations

https://doi.org/10.5256/f1000research.157902.r328378

The study protocol titled "Observational and Cross-sectional Study on Clinical Profile of Nontuberculous Mycobacterial (NTM) Disease" presents a relevant and timely investigation into an important public health issue, particularly in regions like central India where tuberculosis (TB) remains prevalent. By ... Continue reading

The study protocol titled "Observational and Cross-sectional Study on Clinical Profile of Nontuberculous Mycobacterial (NTM) Disease" presents a relevant and timely investigation into an important public health issue, particularly in regions like central India where tuberculosis (TB) remains prevalent. By focusing on distinguishing NTM from TB, this study has the potential to provide valuable insights for improving diagnostic and therapeutic strategies.

However, conducting the study at a single institution may introduce bias based on regional characteristics, and it may limit the generalizability of the results to other regions. Therefore, I strongly recommend expanding the study into a multi-center observational study. By collecting data from multiple healthcare institutions, the study can better capture the diverse clinical presentations of NTM disease, assess the influence of different regional and environmental factors, and significantly improve the reliability and generalizability of the findings.

The comprehensive data collection approach, covering demographic, clinical, radiological, and microbiological aspects, is commendable and will allow the study to capture the multifaceted nature of NTM diseases. The planned multivariate analysis is expected to identify key risk factors and clinical patterns that could guide future NTM management. Furthermore, the study's focus on a tertiary care hospital ensures the inclusion of diverse patient profiles, which enhances the comprehensiveness of the findings.

Additionally, the attention to ethical considerations, including patient consent and confidentiality, is well-handled, strengthening the study’s rigor. Despite the small sample size, this research could provide preliminary data that contribute to the understanding of NTM diseases in high-TB-burden regions. In order to overcome this issue, I recommend multi-center observational study.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: NTM

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.

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Reviewer Report 11 Jul 2024

Balaji Pathakumari, Mayo Clinic Rochester, Rochester, Minnesota, USA

Approved with Reservations

https://doi.org/10.5256/f1000research.157902.r296425

Bhanushali et al., proposed to conduct cross-sectional study to understand the clinical profile of NTM-LD. I think the study has the potential to find the various underlying clinical parameters to NTM-LD management. However, authors can consider the following potential comments ... Continue reading

Bhanushali et al., proposed to conduct cross-sectional study to understand the clinical profile of NTM-LD. I think the study has the potential to find the various underlying clinical parameters to NTM-LD management. However, authors can consider the following potential comments to improve the proposal quality.

I feel the objectives of this study are preliminary. I would ask authors to extend the aims and objectives by adding critical gaps in NTM research.
The sample size is too low. On what basis the sample size was fixed? Is there any power calculation carried-out to arrive this number? Does this give at least 80% power? Authors are kindly requested to explain this. And requested to give the power calculation. “In addition, powers of tests were calculated based on effect size and include the values of power calculation in statistics.
The authors used the broad term of NTM which includes different NTM species. Each NTM species has different clinical features including radiological findings and disease phenotypes. It would be needed to analyze and add data only on NTM patients caused by most prevalent species in Indian settings. Authors can consider this to add another objective to check the parameters in species level.
Authors should record the information on the etiological factors identified in the patients. Broader collection of clinical data to support the claim that the detected differences are each species specific. For data collection, authors can refer the following paper (see the table 1 and 2) (Marty PK, et al., 2024 [Ref 1])
Earlier reports showing the importance of effect of age and gender on the NTM risk of infection. I would strongly recommend analyzing the data based on age and gender matched healthy or other diseased controls.
Patient recruitment scheme is not in detail. Please describe in more detail the inclusion and exclusion criteria of the study. A chart explaining these criteria would be desirable.
There is a possibility to find mixed infection with other NTMs or M. tb. QuantiFERON has to be done for identifying Latent TB infection. What is the Authors comment on these subgroups. Species identification is important to assess the pathogenicity.
Methods: Check the Time period error for recruiting samples.
The conclusions are brief. It would be beneficial to provide a more detailed summary of the significance of the study and their implications for future research and clinical practice.
Finally, the authors should address how these findings would hold in a ‘real-life’ unselected group of patients.

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

References

1. Marty PK, Pathakumari B, Cox TM, Van Keulen VP, et al.: Multiparameter immunoprofiling for the diagnosis and differentiation of progressive versus nonprogressive nontuberculous mycobacterial lung disease-A pilot study.PLoS One. 2024; 19 (4): e0301659 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Expertise in infectious diseases that includes tuberculosis, non-tuberculosis mycobacterial diseases and Candida infections.

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.

CITE

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Version 1 09 May 24	read	read

Balaji Pathakumari, Mayo Clinic Rochester, Rochester, USA
Ho Namkoong, Keio University School of Medicine, Tokyo, Japan

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Reviewer Report

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25 Oct 2024 | for Version 1

Ho Namkoong, Department of Infectious Diseases, Keio University School of Medicine, Tokyo, Japan

1 Views Cite this report Responses(0)

Approved With Reservations

The study protocol titled "Observational and Cross-sectional Study on Clinical Profile of Nontuberculous Mycobacterial (NTM) Disease" presents a relevant and timely investigation into an important public health issue, particularly in regions like central India where tuberculosis (TB) remains prevalent. By focusing on distinguishing NTM from TB, this study has the potential to provide valuable insights for improving diagnostic and therapeutic strategies.

However, conducting the study at a single institution may introduce bias based on regional characteristics, and it may limit the generalizability of the results to other regions. Therefore, I strongly recommend expanding the study into a multi-center observational study. By collecting data from multiple healthcare institutions, the study can better capture the diverse clinical presentations of NTM disease, assess the influence of different regional and environmental factors, and significantly improve the reliability and generalizability of the findings.

The comprehensive data collection approach, covering demographic, clinical, radiological, and microbiological aspects, is commendable and will allow the study to capture the multifaceted nature of NTM diseases. The planned multivariate analysis is expected to identify key risk factors and clinical patterns that could guide future NTM management. Furthermore, the study's focus on a tertiary care hospital ensures the inclusion of diverse patient profiles, which enhances the comprehensiveness of the findings.

Additionally, the attention to ethical considerations, including patient consent and confidentiality, is well-handled, strengthening the study’s rigor. Despite the small sample size, this research could provide preliminary data that contribute to the understanding of NTM diseases in high-TB-burden regions. In order to overcome this issue, I recommend multi-center observational study.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

NTM

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.

Respond to this report

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Back to all reports

Reviewer Report

4 Views

11 Jul 2024 | for Version 1

Balaji Pathakumari, Mayo Clinic Rochester, Rochester, Minnesota, USA

4 Views Cite this report Responses(0)

Approved With Reservations

Bhanushali et al., proposed to conduct cross-sectional study to understand the clinical profile of NTM-LD. I think the study has the potential to find the various underlying clinical parameters to NTM-LD management. However, authors can consider the following potential comments to improve the proposal quality.

I feel the objectives of this study are preliminary. I would ask authors to extend the aims and objectives by adding critical gaps in NTM research.
The sample size is too low. On what basis the sample size was fixed? Is there any power calculation carried-out to arrive this number? Does this give at least 80% power? Authors are kindly requested to explain this. And requested to give the power calculation. “In addition, powers of tests were calculated based on effect size and include the values of power calculation in statistics.
The authors used the broad term of NTM which includes different NTM species. Each NTM species has different clinical features including radiological findings and disease phenotypes. It would be needed to analyze and add data only on NTM patients caused by most prevalent species in Indian settings. Authors can consider this to add another objective to check the parameters in species level.
Authors should record the information on the etiological factors identified in the patients. Broader collection of clinical data to support the claim that the detected differences are each species specific. For data collection, authors can refer the following paper (see the table 1 and 2) (Marty PK, et al., 2024 [Ref 1])
Earlier reports showing the importance of effect of age and gender on the NTM risk of infection. I would strongly recommend analyzing the data based on age and gender matched healthy or other diseased controls.
Patient recruitment scheme is not in detail. Please describe in more detail the inclusion and exclusion criteria of the study. A chart explaining these criteria would be desirable.
There is a possibility to find mixed infection with other NTMs or M. tb. QuantiFERON has to be done for identifying Latent TB infection. What is the Authors comment on these subgroups. Species identification is important to assess the pathogenicity.
Methods: Check the Time period error for recruiting samples.
The conclusions are brief. It would be beneficial to provide a more detailed summary of the significance of the study and their implications for future research and clinical practice.
Finally, the authors should address how these findings would hold in a ‘real-life’ unselected group of patients.

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

References

1. Marty PK, Pathakumari B, Cox TM, Van Keulen VP, et al.: Multiparameter immunoprofiling for the diagnosis and differentiation of progressive versus nonprogressive nontuberculous mycobacterial lung disease-A pilot study.PLoS One. 2024; 19 (4): e0301659 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Expertise in infectious diseases that includes tuberculosis, non-tuberculosis mycobacterial diseases and Candida infections.

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.

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Observational and cross-sectional study on clinical profile of nontuberculous mycobacterial (NTM) disease in patients at tertiary care hospital of central India

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Figure 1. Diagnostic algorithm for detection of non-tuberculous mycobacteria.

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