What is the aim of this review?
We aimed to understand the experiences and opinions of people using rapid automated tests that identify tuberculosis and resistance to tuberculosis drugs (molecular diagnostic tests). Users include people who might have tuberculosis and their families or caregivers, doctors, nurses, laboratory staff, and managers of services or programmes.
What was studied in this review?
Rapid molecular diagnostic tests were designed to make diagnosis easier and faster for people with signs and symptoms of tuberculosis, because they do not require a well-equipped laboratory, but can be done in clinics closer to where people live. Since these tests can also suggest whether an individual suffers from drug-resistant tuberculosis (including multidrug-resistant tuberculosis (MDR-TB)), the right treatment can be started earlier. We collected and analysed all relevant studies and found 32 studies conducted in areas where tuberculosis is common in low- and middle-income countries.
MDR-TB is tuberculosis caused by resistance to at least rifampicin and isoniazid, the two most effective first-line drugs used to treat tuberculosis.
This qualitative evidence synthesis links to another Cochrane Review that examines the diagnostic accuracy of a rapid molecular test for tuberculosis drug resistance. Yet, diagnostic tests only have an impact on health if they are put to use in a correct and timely manner. Accuracy studies do not reveal what users think of or how they experience the test in question. We need to understand the perspectives and experiences of all users. Otherwise, we risk these tests not fitting settings where they are to be used or not being accessible for those in need.
What are the main findings?
People with tuberculosis value knowing what is wrong with them. People valued having an accurate diagnosis, avoiding delays in being diagnosed, having accessible testing facilities, and keeping cost low. Similarly, healthcare providers value having accurate tests that give them confidence in the diagnosis, rapid results, and keeping cost low, being able to use different specimens (such as sputum and stool) and receiving information about drug resistance as part of the test results. Laboratory personnel appreciated that laboratory work was made easier and that staff was more satisfied thanks to rapid molecular diagnostic tests.
Our review also identified several challenges to realizing these values. Some people with tuberculosis and some healthcare providers were reluctant to use rapid molecular diagnostic tests because of fears of testing positive, concerns of stigma or discredit in the community, or expenses related to the testing. Additional support is required to overcome these barriers that are common to other approaches to testing for tuberculosis. Other challenges that led to delays and underuse of rapid molecular diagnostic tests were health system inefficiencies; poor quality of specimens; difficulty in transporting specimens; lack of sufficient resources such as staff or equipment; increased workload for providers; inefficiencies in integrating the test into routines at clinics; the complicated or lengthy steps involved in obtaining a tuberculosis diagnosis; clinicians relying too much on the test result while neglecting their own experience with diagnosing tuberculosis; and processes of implementing the test in national programmes that lacked data about real-life situations and did not include all relevant stakeholders such as local decision-makers, providers or people seeking a diagnosis.
Lastly, people expressed concerns about unsustainable funding, maintenance requirements of the tests, lengthy delays in diagnosis, underuse of rapid molecular diagnostic tests, lack of tuberculosis diagnostic facilities in local communities, conflicts of interest between donors and people who utilize the tests, and too many restrictions on who was allowed to access the test. These concerns hampered access to prompt and accurate testing and treatment. This was particularly the case for vulnerable people, such as children, people with MDR-TB, or those with limited ability to pay.
Overall, these challenges risk undoing the added value of rapid molecular diagnostic tests. They risk leading to less frequent use of these tests. Implementation of new diagnostic tests, like those considered in this review, will need to tackle the challenges identified in this review including weak infrastructure and systems, as well as insufficient data about real-life situations before and during implementation in order to ensure the tests are accessible for those in need.
How up to date is this review?
We included studies published between 1 January 2007 and 20 October 2021. We limited all searches to 2007 onward because the development of Xpert MTB/RIF, the first rapid molecular diagnostic test in this review, was completed in 2009.