What is operational research and how can national tuberculosis programmes in low- and middle-income countries use it to end TB?

Highlights

• As a global community, we have pledged to end the tuberculosis epidemic by 2030.

• Ending TB will need a multi-sectoral response and new tools, but operational research is equally important.

• OR plays a crucial role in identifying implementation problems, their reasons and developing and testing solutions.

• OR thus optimizes implementation, improves programme performance and eventually contribute to ending tuberculosis.

• National tuberculosis programmes have to take a lead role in integrating and building a culture of OR in the country.

Abstract

Despite considerable progress over the years, tuberculosis (TB) still remains the top cause of death among the infectious diseases and has devastating socio-economic consequences for people in low- and middle-income countries. To add to this, the emergence of the COVID-19 pandemic has worsened delivery of TB care across the globe. As a global community, we have committed to end the TB epidemic by 2030. The World Health Organization has framed a strategy to achieve this goal which consists of three pillars namely i) integrated patient-centred care and prevention, ii) bold policies and systems and iii) intensified research and innovation. An analysis of the performance of national tuberculosis programmes (NTPs) across the globe against the ten priority indicators recommended for monitoring the end TB strategy show that there are huge gaps at every step in the cascade of care of TB patients. In our view, these gaps reflect suboptimal implementation of existing strategies known to be efficacious and operational research (OR) is one of the best available tools to plug the gaps.

In this paper, we define what operational research is and how it differs from other kinds of research. We also share our views and experiences about how operational research can be used by NTPs to identify implementation gaps and their reasons, and develop and test possible solutions – which are then integrated to make changes to policy and practice and eventually improve programme outcomes.

OR can be defined as research into interventions, strategies and tools which produces practical useable knowledge that can be used to enhance the quality, coverage, effectiveness and efficiency of disease control programmes, health services or health systems in which the research is conducted. The key steps in integrating operational research in the NTPs include: i) securing political commitment reflected by inclusion of OR in the national strategic plans of NTPs and earmarked funding, ii) having a critical mass of dedicated and trained human resources in OR within the NTP, iii) setting research priorities and steering the direction of research in the country, iv) using output-oriented models of capacity building such as the Structured Operational Research Training Initiative (SORT IT) model and building communities of practice, v) harnessing existing capacity in the country by forging partnerships with academia, vi) NTP-led nationwide, multicentre OR studies, vii) providing access to anonymized patient and programme surveillance data, vii) creating a forum for evidence dissemination and fostering policy change and ix) monitoring and accountability.

In conclusion, ending the TB epidemic will not be possible without new tools (diagnostics, drugs, vaccines) and a multi-sectoral response involving stakeholders beyond the health ministry, including private providers, patients and communities. However, timely conduct of operational research to fine-tune programme implementation and ensuring proper deployment of new tools will be equally crucial to maximize the effectiveness and efficiency of interventions and ultimately contribute towards ending TB.

Introduction

Tuberculosis (TB) is a preventable, treatable and curable infectious disease caused by a bacterium, named Mycobacterium tuberculosis, known to humankind since millennia. Despite this, TB remains one of the top ten causes of death and kills more people globally than any other single infectious agent. TB is also the most common cause of mortality among people living with human immunodeficiency virus (PLHIV) and a major cause of antimicrobial resistance.¹ In 2018, about 10 million people fell ill with TB (∼0.5 million of them due to rifampicin-resistant or multi-drug resistant strains) and 1.5 million died.¹ While these were people with active disease, there is a much larger reservoir of TB infections (estimated to be about 25% of the global population), in whom the disease agent remains dormant.¹ About 5–10% of such people progress to active disease during their lifetime when their immunity breaks down for any reason. Unless the reservoir of infections is also addressed, no real progress in TB care is possible. Most of the people with TB live in low- and middle-income countries (LMIC), reflecting the close association of TB with poverty and other socio-economic determinants such as homelessness, migration, malnutrition, indoor air pollution and tobacco and alcohol use. India, China, Indonesia, Philippines, Pakistan, Nigeria, Bangladesh and South Africa account for nearly half of the global burden of disease.¹

The emergence of the coronavirus disease 2019 (COVID-19) pandemic and the associated response (including lockdowns and other measures) has affected every aspect of human life globally. This includes a disruptive impact on the health services and continuity of care for other diseases including TB. A modelling study led by the STOP TB partnership estimated that there could be an additional 6.3 million new patients and 1.4 million additional deaths due to TB between 2020 and 2025 – implying a setback of at least 5–8 years in the fight against TB.² Similar estimates have also been made by individual countries.^3,4

As a global community, we envision a world free of TB (zero deaths, zero disease and zero suffering) and aim to eliminate TB as a public health problem by 2050 – defined as an incidence of less than one TB patient per million people globally. A more time-bound target of ‘ending the TB epidemic’ as enshrined in the Sustainable Development Goals of the United Nations consists of reducing the TB incidence rate by 80% and deaths by 90% by 2030 relative to 2015 levels, while ensuring all the time that no family is affected by catastrophic costs due to TB.⁵ There are ten global indicators recommended by the World Health Organization (WHO) to measure progress – which include achieving ≥90% targets for treatment coverage (for both TB disease and TB infection), TB treatment success rate, and uptake of new diagnostics and drugs by 2025 (Table 1).⁶ Similar interim targets are also recommended by other international agencies such as 90-(90)-90 diagnostic and treatment targets by the STOP TB partnership (diagnosing and treating 90% of all people with TB, including 90% among the key populations at risk, and achieving 90% treatment success for all people diagnosed with active TB and latent TB infection) and the UN High Level Meeting on TB that happened in 2018 (treat 40 million people for TB disease and 30 million people for TB infection between 2018 and 2022).7, 8, 9

The WHO's End TB Strategy provides a framework to end TB and consists of interventions that fall under three pillars: i) integrated, patient-centred care and prevention, ii) bold policies and supportive systems that aim to involve all stakeholders much beyond the public health sector including private providers and communities and iii) intensified research and innovation. The latter is critical if we want to bend the TB epidemic curve and reach the global targets and includes i) basic research to understand more about the bacterium and its interaction with the host, ii) research to develop new diagnostics (point-of-care and easy to deploy and use), new drugs (all-oral, shorter and safer regimens) and new vaccines (to prevent new infections and progression to disease among those who are infected) and iii) operational research (OR) to understand the best ways to implement interventions known to be efficacious.⁶

An analysis of the performance of National TB Programmes (NTPs) across the globe against the ten priority indicators recommended for monitoring show that there are huge gaps at every step in the cascade of care of tuberculosis patients (Table 2).¹ The extent of the gaps varies based on type of TB (drug-susceptible or drug-resistant or HIV-positive TB), type of care process involved (diagnosis, treatment or prevention) and from country to country. In our view, these gaps are mostly due to suboptimal implementation of existing tools and global recommendations which have already been proven to be effective. Further, we firmly believe that OR is one of the best available tools to fix the gaps in implementation and improve the performance of programmes. Even with new tools, OR will have an important role to identify the most effective and efficient ways to deploy them within countries.

In this paper, we define what is OR, how it is different from other kinds of research and how it forms an important component of the research landscape. We also share our views and experiences about how OR can be used by NTPs to identify implementation gaps and their reasons, develop and test possible solutions – which are then integrated to make changes to policy and practice and eventually improve programme outcomes and end TB.