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

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

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.