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There have been few independent evaluations of computer-aided detection (CAD) software for tuberculosis (TB) screening, despite the rapidly expanding array of available CAD solutions. We developed a test library of chest X-ray (CXR) images which was blindly re-read by two TB clinicians with different levels of experience and then processed by 12 CAD software solutions. Using Xpert MTB/RIF results as the reference standard, we compared the performance characteristics of each CAD software against both an Expert and Intermediate Reader, using cut-off thresholds which were selected to match the sensitivity of each human reader. Six CAD systems performed on par with the Expert Reader (Qure.ai, DeepTek, Delft Imaging, JF Healthcare, OXIPIT, and Lunit) and one additional software (Infervision) performed on par with the Intermediate Reader only. Qure.ai, Delft Imaging and Lunit were the only software to perform significantly better than the Intermediate Reader. The majority of these CAD software showed significantly lower performance among participants with a past history of TB. The radiography equipment used to capture the CXR image was also shown to affect performance for some CAD software. TB program implementers now have a wide selection of quality CAD software solutions to utilize in their CXR screening initiatives.

Recent technological and radiological advances have renewed interest in using X-rays to screen and triage people with tuberculosis (TB). The miniaturization of digital X-ray (DXR), combined with automatic interpretation using computer-aided detection (CAD) software can extend the reach of DXR screening interventions for TB. This qualitative study assessed early implementers' experiences and lessons learned when using ultra-portable (UP) DXR systems integrated with CAD software to screen and triage TB. Semi-structured interviews were conducted with project staff and healthcare workers at six pilot sites. Transcripts were coded and analyzed using a framework approach. The themes that emerged were subsequently organized and presented using the Consolidated Framework for Implementation Research (CFIR). There were 26 interviewees with varying roles: supervisory, clinicians, radiographers, and radiologists. Participants recognized the portability as the main advantage, but criticize that it involves several compromises on throughput, internet dependence, manoeuvrability, and stability, as well as suitability for patients with larger body sizes. Furthermore, compared to using hardware and software from the same supplier and without digital health information systems, complexity increases with interoperability between hardware and software, and between different electronic health information systems. Currently, there is a limited capacity to implement these technologies, especially due to the need for threshold selection, and lack of guidance on radiation protection suitable for UP DXR machines. Finally, the respondents stressed the importance of having protected means of sharing patient medical data, as well as comprehensive support and warranty plans. Study findings suggest that UP DXR with CAD was overall well received to decentralize radiological assessment for TB, however, the improved portability involved programmatic compromises. The main barriers to uptake included insufficient capacity and lack of guidance on radiation protection suitable for UP DXR.

Background A population-wide, systematic screening initiative for tuberculosis (TB) was implemented on Daru island in the Western Province of Papua New Guinea, where TB is known to be highly prevalent. The initiative used a mobile van equipped with a digital X-ray device, computer-aided detection (CAD) software to identify TB-related abnormalities on chest radiographs, and GeneXpert machines for follow-on diagnostic testing. We describe the results of the TB screening initiative, evaluate its population-level impact and examine risk factors associated with TB detection. Methods Through a retrospective review of screening data, we assessed the effectiveness of the screening by examining the enrolment coverage and the proportion of people with TB among screened subjects. A cascade analysis was performed to illustrate the flow of participants in the screening algorithm. We conducted univariate and multivariate analyses to identify factors associated with TB. Furthermore, we estimated the number of additional cases detected by the project by examining the trend of routine TB case notifications during the intervention period, compared to the historical baseline cases and trend-adjusted expected cases. Results Of the island’s 18,854 residents, 8,085 (42.9%) were enrolled and 7,970 (98.6%) had chest X-ray interpreted by the CAD4TB software. A total of 1,116 (14.0%) participants were considered to have abnormal CXR. A total of 69 Xpert-positive cases were diagnosed, resulting in a detection rate of 853 per 100 000 population screened. 19.4% of people with TB had resistance to rifampicin. People who were in older age groups (aOR 6.6, 95%CI: 1.5–29.1 for the 45–59 age group), were severely underweight (aOR 2.5, 95%CI:1.0-6.1) or underweight (aOR 2.1, 95%CI: 1.1–3.8), lived in households < 5 people (aOR 3.4, 95%CI:1.8–6.6) and had a past history of TB (aOR 2.1, 95%CI: 1.2–3.6) were more likely to have TB. The number of bacteriologically confirmed TB notified during the intervention period was 79.3% and 90.8% higher than baseline notifications and forecasted notifications, respectively. Conclusion The screening project demonstrated its effectiveness with the high Xpert-positive TB prevalence among the participants and by successfully yielding additional cases of bacteriologically confirmed TB including rifampicin-resistant TB. The results and lessons learnt from the project should inform future TB screening initiatives in Papua New Guinea.

Background The Xpert MTB/RIF assay has garnered significant interest as a sensitive and rapid diagnostic tool to improve detection of sensitive and drug resistant tuberculosis. However, most existing literature has described the performance of MTB/RIF testing only in study conditions; little information is available on its use in routine case finding. TB REACH is a multi-country initiative focusing on innovative ways to improve case notification. Methods We selected a convenience sample of nine TB REACH projects for inclusion to cover a range of implementers, regions and approaches. Standard quarterly reports and machine data from the first 12 months of MTB/RIF implementation in each project were utilized to analyze patient yields, rifampicin resistance, and failed tests. Data was collected from September 2011 to March 2013. A questionnaire was implemented and semi-structured interviews with project staff were conducted to gather information on user experiences and challenges. Results All projects used MTB/RIF testing for people with suspected TB, as opposed to testing for drug resistance among already diagnosed patients. The projects placed 65 machines (196 modules) in a variety of facilities and employed numerous case-finding strategies and testing algorithms. The projects consumed 47,973 MTB/RIF tests. Of valid tests, 7,195 (16.8%) were positive for MTB. A total of 982 rifampicin resistant results were found (13.6% of positive tests). Of all tests conducted, 10.6% failed. The need for continuous power supply was noted by all projects and most used locally procured solutions. There was considerable heterogeneity in how results were reported and recorded, reflecting the lack of standardized guidance in some countries. Conclusions The findings of this study begin to fill the gaps among guidelines, research findings, and real-world implementation of MTB/RIF testing. Testing with Xpert MTB/RIF detected a large number of people with TB that routine services failed to detect. The study demonstrates the versatility and impact of the technology, but also outlines various surmountable barriers to implementation. The study is not representative of all early implementer experiences with MTB/RIF testing but rather provides an overview of the shared issues as well as the many different approaches to programmatic MTB/RIF implementation.

Background Globally, most people with multidrug-resistant tuberculosis (MDR-TB) and their households experience catastrophic costs of illness, diagnosis, and care. However, the factors associated with experiencing catastrophic costs are poorly understood. This study aimed to identify risk factors associated with catastrophic costs incurrence among MDR-TB-affected households in Ho Chi Minh City (HCMC), Viet Nam. Methods Between October 2020 and April 2022, data were collected using a locally-adapted, longitudinal WHO TB Patient Cost Survey in ten districts of HCMC. Ninety-four people with MDR-TB being treated with a nine-month TB regimen were surveyed at three time points: after two weeks of treatment initiation, completion of the intensive phase and the end of the treatment (approximately five and 10 months post-treatment initiation respectively). The catastrophic costs threshold was defined as total TB-related costs exceeding 20% of annual pre-TB household income. Logistic regression was used to identify variables associated with experiencing catastrophic costs. A sensitivity analysis examined the prevalence of catastrophic costs using alternative thresholds and cost estimation approaches. Results Most participants (81/93 [87%]) experienced catastrophic costs despite the majority 86/93 (93%) receiving economic support through existing social protection schemes. Among participant households experiencing and not experiencing catastrophic costs, median household income was similar before MDR-TB treatment. However, by the end of MDR-TB treatment, median household income was lower (258 [IQR: 0–516] USD vs. 656 [IQR: 462–989] USD; p  = 0.003), and median income loss was higher (2838 [IQR: 1548–5418] USD vs. 301 [IQR: 0–824] USD; p  < 0.001) amongst the participant households who experienced catastrophic costs. Being the household’s primary income earner before MDR-TB treatment (aOR = 11.2 [95% CI: 1.6–80.5]), having a lower educational level (aOR = 22.3 [95% CI: 1.5–344.1]) and becoming unemployed at the beginning of MDR-TB treatment (aOR = 35.6 [95% CI: 2.7–470.3]) were associated with experiencing catastrophic costs. Conclusion Despite good social protection coverage, most people with MDR-TB in HCMC experienced catastrophic costs. Incurrence of catastrophic costs was independently associated with being the household’s primary income earner or being unemployed. Revision and expansion of strategies to mitigate TB-related catastrophic costs, in particular avoiding unemployment and income loss, are urgently required.

Background In the field of tuberculosis (TB), Community Healthcare Workers (CHWs) have been engaged for advocacy, case detection, and patient support in a wide range of settings. Estimates predict large-scale shortfalls of healthcare workers in low- and middle-income settings by 2030 and strategies are needed to optimize the health workforce to achieve universal availability and accessibility of healthcare. In 2018, the World Health Organization (WHO) published guidelines on best practices for CHW engagement, and identified remaining knowledge gaps. Stop TB Partnership’s TB REACH initiative has supported interventions using CHWs to deliver TB care in over 30 countries, and utilized the same primary indicator to measure project impact at the population-level for all TB active case finding projects, which makes the results comparable across multiple settings. This study compiled 10 years of implementation data from the initiative’s grantee network to begin to address key knowledge gaps in CHW networks. Methods We conducted a cross-sectional study analyzing the TB REACH data repository ( n  = 123) and primary survey responses ( n  = 50) of project implementers. We designed a survey based on WHO guidelines to understand projects’ practices on CHW recruitment, training, activities, supervision, compensation, and sustainability. We segmented projects by TB notification impact and fitted linear random-effect regression models to identify practices associated with higher changes in notifications. Results Most projects employed CHWs for advocacy alongside case finding and holding activities. Model characteristics associated with higher project impact included incorporating e-learning in training and having the prospect of CHWs continuing their responsibilities at the close of a project. Factors that trended towards being associated with higher impact were community-based training, differentiated contracts, and non-monetary incentives. Conclusion In line with WHO guidelines, our findings emphasize that successful implementation approaches provide CHWs with comprehensive training, continuous supervision, fair compensation, and are integrated within the existing primary healthcare system. However, we encountered a great degree of heterogeneity in CHW engagement models, resulting in few practices clearly associated with higher notifications.

Background Vietnam’s primary mechanism of achieving sustainable funding for universal health coverage (UHC) and financial protection has been through its social health insurance (SHI) scheme. Steady progress towards access has been made and by 2020, over 90% of the population were enrolled in SHI. In 2022, as part of a larger transition towards the increased domestic financing of healthcare, tuberculosis (TB) services were integrated into SHI. This change required people with TB to use SHI for treatment at district-level facilities or to pay out of pocket for services. This study was conducted in preparation for this transition. It aimed to understand more about uninsured people with TB, assess the feasibility of enrolling them into SHI, and identify the barriers they faced in this process. Methods A mixed-method case study was conducted using a convergent parallel design between November 2018 and January 2022 in ten districts of Hanoi and Ho Chi Minh City, Vietnam. Quantitative data were collected through a pilot intervention that aimed to facilitate SHI enrollment for uninsured individuals with TB. Descriptive statistics were calculated. Qualitative interviews were conducted with 34 participants, who were purposively sampled for maximum variation. Qualitative data were analyzed through an inductive approach and themes were identified through framework analysis. Quantitative and qualitative data sources were triangulated. Results We attempted to enroll 115 uninsured people with TB into SHI; 76.5% were able to enroll. On average, it took 34.5 days to obtain a SHI card and it cost USD 66 per household. The themes indicated that a lack of knowledge, high costs for annual premiums, and the household-based registration requirement were barriers to SHI enrollment. Participants indicated that alternative enrolment mechanisms and greater procedural flexibility, particularly for undocumented people, is required to achieve full population coverage with SHI in urban centers. Conclusions Significant addressable barriers to SHI enrolment for people affected by TB were identified. A quarter of individuals remained unable to enroll after receiving enhanced support due to lack of required documentation. The experience gained during this health financing transition is relevant for other middle-income countries as they address the provision of financial protection for the treatment of infectious diseases.

Background Computer-aided detection (CAD) software provides scalable, standardized chest X-ray (CXR) interpretation, helping address the global shortage of radiologists and inter-reader variability. Printed X-ray films remain common in many low-resource settings, yet most CAD software can only process Digital Imaging and Communications in Medicine (DICOM) files. Genki software (DeepTek, India) is one of the few World Health Organization (WHO)–recommended CAD software capable of interpreting both DICOM files and photographs of printed X-ray films (Joint Photographic Experts Group [JPEG] files), but its performance using JPEG files has not been independently evaluated. Methods We evaluated Genki software using a test library of 1466 CXR images from adults screened for tuberculosis (TB) in Ho Chi Minh City, Viet Nam. Each participant’s TB status was determined using a composite reference standard, based on radiological findings and Xpert MTB/RIF Ultra testing. Each CXR image was blindly re-read by 10 human readers and processed by Genki software using both DICOM and JPEG files. Genki software performance was evaluated using median abnormality scores, area under the receiver operating characteristic curves (AUC), and sensitivity/specificity comparisons at different abnormality score thresholds. Results Genki software abnormality scores were significantly higher when using JPEG files, but this did not translate into significant differences in AUCs between the file types (DICOM AUC = 0.94 vs JPEG AUC = 0.92, p  = 0.190). When abnormality score thresholds were calibrated to match average human reader sensitivity (79.0%), Genki achieved significantly higher specificity with both DICOM (95.2% vs 84.8%, p  < 0.001) and JPEG (92.1% vs 84.8%, p  < 0.001) files. When the software’s abnormality score thresholds were calibrated to achieve 90% sensitivity, Genki maintained high specificity with both DICOM (89.3%) and JPEG (81.1%) file types, meeting the minimum Target Product Profile (TPP) criteria for a high-sensitivity, high-specificity screening test. Conclusions Genki software performs comparably when interpreting DICOM and JPEG files, outperforming human readers and meeting TPP criteria with both file types. This capability enhances its usability in resource-limited settings where digital infrastructure is lacking, supporting its broader deployment for TB screening. Further research is needed to assess real-world implementation feasibility and performance in diverse populations and clinical environments.

Deep learning (DL) neural networks have only recently been employed to interpret chest radiography (CXR) to screen and triage people for pulmonary tuberculosis (TB). No published studies have compared multiple DL systems and populations. We conducted a retrospective evaluation of three DL systems (CAD4TB, Lunit INSIGHT, and qXR) for detecting TB-associated abnormalities in chest radiographs from outpatients in Nepal and Cameroon. All 1196 individuals received a Xpert MTB/RIF assay and a CXR read by two groups of radiologists and the DL systems. Xpert was used as the reference standard. The area under the curve of the three systems was similar: Lunit (0.94, 95% CI: 0.93–0.96), qXR (0.94, 95% CI: 0.92–0.97) and CAD4TB (0.92, 95% CI: 0.90–0.95). When matching the sensitivity of the radiologists, the specificities of the DL systems were significantly higher except for one. Using DL systems to read CXRs could reduce the number of Xpert MTB/RIF tests needed by 66% while maintaining sensitivity at 95% or better. Using a universal cutoff score resulted different performance in each site, highlighting the need to select scores based on the population screened. These DL systems should be considered by TB programs where human resources are constrained, and automated technology is available.

New versions of computer-aided detection (CAD) software for chest X-ray (CXR) interpretation during tuberculosis (TB) screening are regularly released which purport to have incremental performance gains. No studies have independently assessed differences in software performance between the World Health Organization recommended INSIGHT CXR software (Lunit, South Korea). A well-characterized Digital Imaging and Communications in Medicine (DICOM) test library was compiled using data from a community-based TB screening initiative in Ho Chi Minh City, Viet Nam. The performance of Lunit CAD software versions 3.1.0.0 and 3.9.0.1 (newer version) were compared by measuring the area under the receiver operating characteristic curve (AUC), stratified by key clinical and demographic variables and using Xpert MTB/RIF Ultra (Ultra) test results as the reference standard. Median abnormality scores were compared using the Wilcoxon signed-rank test and performance characteristics were compared at clinically-relevant cut-off thresholds (e.g., 90% sensitivity) between the versions. The DICOM test library contained 2,708 participants, of whom 10.3% had a Mycobacterium tuberculosis (MTB) positive Ultra test result. The newer software version had a significantly higher AUC than its predecessor (AUC 0.76 vs 0.78, p = 0.029), and performed significantly better among people with a past history of TB (AUC 0.67 vs 0.73, p = 0.003), older individuals (0.75 vs 0.77, p = 0.040) and males (0.73 vs 0.76, p = 0.008). When using an cut-off threshold optimized for the older software version, the newer software was significantly less accurate than its predecessors. However, when the cut-off threshold was re-calibrated, there were no significant differences in sensitivity and specificity between the software versions. Although INSIGHT CXR v3.9.0.1 has some significantly improved performance characteristics compared to its predecessor, further studies should assess how these performance differences translate into real-world improvements during TB screening. As new CAD software versions are rolled out, cut-off thresholds must be re-calibrated to ensure the continued accuracy of CXR interpretation.