To study the Clinical profile of NTM disease.

1.

To determine the prevalence of NTM disease among TB suspects at Acharya Vinoba Bhave Rural Hospital

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).

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).

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.

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.

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.

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.

Formula N = 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 article ⁴ )

D = estimated error (10%) = 3%

= ( 1.96 ) 2 ∗ ( 0.05 ) ∗ ( 1 − 0.5 ) / ( 0.3 ) 2 = 22

Minimum sample size required = 22

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.

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.

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

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