Abstract
Background: Studies evaluating the impact of Xpert MTB/RIF testing for tuberculosis (TB) have demonstrated varied effects on health outcomes with many studies showing inconclusive results. We explored perceptions among diverse stakeholders about studies evaluating the impact of TB diagnostic tests, and identified suggestions for improving these studies. Methods: We used purposive sampling with consideration for differing expertise and geographical balance and conducted in depth semi-structured interviews. We interviewed English-speaking participants, including TB patients, and others involved in research, care or decision-making about TB diagnostics. We used the thematic approach to code and analyse the interview transcripts. Results: We interviewed 31 participants. Our study showed that stakeholders had different expectations with regard to test impact and how it is measured. TB test impact studies were perceived to be important for supporting implementation of tests but there were concerns about the unrealistic expectations placed on tests to improve outcomes in health systems with many influencing factors. To improve TB test impact studies, respondents suggested conducting health system assessments prior to the study; developing clear guidance on the study methodology and interpretation; improving study design by describing questions and interventions that consider the influences of the health-care ecosystem on the diagnostic test; selecting the target population at the health-care level most likely to benefit from the test; setting realistic targets for effect sizes in the sample size calculations; and interpreting study results carefully and avoiding categorisation and interpretation of results based on statistical significance alone. Researchers should involve multiple stakeholders in the design of studies. Advocating for more funding to support robust studies is essential. Conclusion: TB test impact studies were perceived to be important to support implementation of tests but there were concerns about their complexity. Process evaluations of their health system context and guidance for their design and interpretation are recommended.
Highlights
Tuberculosis (TB) continues to be a major public health burden
Interpretation; improving study design by describing questions and interpretation; improving study design by describing questions and interventions that consider the influences of the health-care ecosystem on the diagnostic test; selecting the target population at the health-care level most likely to benefit from the test; setting realistic targets for effect sizes in the sample size calculations; and interpreting study results carefully and avoiding categorisation and interpretation of results based on statistical significance alone
This response was confirmed by other respondents who stated that their understanding of the term impact of a test included improving health, improving detection of drug-resistant tuberculosis (DR-TB), improving timely treatment through high accuracy and rapid test results, improving access to diagnostic testing and reducing transmission of TB
Summary
Tuberculosis (TB) continues to be a major public health burden. In 2018 it was estimated that about 10 million people developed TB disease, there were about half a million new cases of rifampicin-resistant TB, and 1.5 million deaths due to TB1. In order to improve TB case detection and rapid initiation of treatment, new rapid molecular diagnostic tests with reported high sensitivity and specificity and/or short-turnaround times, such as Xpert MTB/RIF and Xpert Ultra (the newest version) continue to be introduced to the market[1,3]. It is expected that accurate diagnosis and rapid initiation of treatment would improve downstream health outcomes such as morbidity and mortality. Studies evaluating the impact of Xpert MTB/RIF testing for tuberculosis (TB) have demonstrated varied effects on health outcomes with many studies showing inconclusive results. We explored perceptions among diverse stakeholders about studies evaluating the impact of TB diagnostic tests, and identified suggestions for improving these studies. To improve TB test impact studies, respondents suggested conducting health system assessments prior to the study; developing clear guidance on the study methodology and version 1
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