| ObjectiveTo evaluate the diagnostic efficiency of interferon-gamma release assay(IGRA)for active tuberculosis(ATB)in patients with rheumatic diseases,and to evaluate the value of IGRA for screening latent tuberculosis infection(LTBI)in this population from a health economics perspective,and to provide scientific evidence for health decision-makers to choose screening strategies.MethodsPart I:The accuracy of interferon-gamma release assays and tuberculin skin tests for the diagnosis of active tuberculosis in rheumatic diseases patients:systematic review and meta-analysisWe searched the PubMed,Embase,Cochrane Library,CNKI,and WanFang Data databases for studies that assessed the diagnostic accuracy of T-SPOT.TB,QFT-GIT or TST in diagnosing ATB in rheumatic disease patients.Two researchers independently conducted literature screening,data extraction,and bias assessment.Meta-analysis was performed using Stata 16.0 software,and the quality of evidence was evaluated using the GRADE grading system for systematic reviews.Part II:Health Economics Evaluation of Interferon Gamma Release Assays for Screening Tuberculosis Infection in Patients with Rheumatic DiseasesA decision tree-Markov model was constructed using TreeAge Pro 2022 software based on the natural history of tuberculosis and the clinical pathway of screening and diagnosis.Model parameters,including rate parameters,cost parameters,and discount rates,were obtained through secondary research of relevant literature,retrieval of published textbooks or papers,and expert consultations,building upon previous research conducted by our team.Cost,utility,and incremental cost-effectiveness ratio(ICER)of various screening strategies were compared,and deterministic sensitivity analysis and probability density sensitivity analysis were conducted.ResultsPart I:The accuracy of interferon-gamma release assays and tuberculin skin tests for the diagnosis of active tuberculosis in rheumatic diseases patients:systematic review and meta-analysisA total of 15 studies that evaluated the diagnostic accuracy of TST,T-SPOT.TB,and QFT-GIT in diagnosing ATB in rheumatic disease patients were included in the metaanalysis.Among them,there were 12 studies assessing the diagnostic accuracy of TSPOT.TB,one study on QFT-GIT,and 11 studies on TST.The meta-analysis results showed that in rheumatic disease patients,the combined sensitivity(SEN),specificity(SPE),and area under the curve(AUC)of T-SPOT.TB for diagnosing ATB were 0.82(95%CI:0.73,0.88),0.84(95%CI:0.71,0.92),and 0.88(95%CI:0.88,0.92),respectively.The SEN,SPE,and AUC of TST for diagnosing ATB were 0.42(95%CI:0.32,0.53),0.84(95%CI:0.77,0.89),and 0.69(95%CI:0.63,0.75),respectively.Meta-analysis for QFTGIT was not performed due to the insufficient number of studies available.The quality of evidence for the combined SEN and SPE of T-SPOT.TB and TST in diagnosing ATB in rheumatic disease patients was assessed as low-level evidence.Part Ⅱ:Health Economics Evaluation of Interferon Gamma Release Assays for Screening Tuberculosis Infection in Patients with Rheumatic DiseasesCost parameter study found that the average screening costs for TST,T-SPOT.TB,and QFT-GIT were 73.6 Yuan/time,524.2 Yuan/time,and 544.5 Yuan/time,respectively.The average diagnosis cost for ATB was 835 Yuan/time,and the average treatment cost and preventive anti-tuberculosis treatment cost for ATB were 2738.59 Yuan/time and 1555.15 Yuan/time,respectively.Compared to the no screening strategy,the ICER for TST,T-SPOT.TB,QFT-GIT,TST/QFT-GIT,and TST/T-SPOT.TB were 3973.237 Yuan/Quality Adjusted Life Years(QALY),8955.593 Yuan/QALY,9513.658 Yuan/QALY,10915.929 Yuan/QALY,and 10401.950 Yuan/QALY,respectively.When TST was used as the reference strategy,the ICER for T-SPOT.TB,QFT-GIT,TST/QFT-GIT,and TST/TSPOT.TB were 31881.153 Yuan/QALY,40329.112 Yuan/QALY,44333.829 Yuan/QALY,and 33477.392 Yuan/QALY,respectively.Compared to the previous dominant strategy,the ICER for TST relative to the no screening strategy was 3973.237 Yuan/QALY,while the ICER for T-SPOT.TB relative to the TST strategy was 31881.153 Yuan/QALY,and the ICER for TST/T-SPOT.TB relative to the T-SPOT.TB strategy was 39702.781 Yuan/QALY.The costs of QFT-GIT and TST/QFT-GIT screening strategies were higher than the TSPOT.TB strategy,while the utility values obtained were lower,indicating that they were dominated strategies.deterministic sensitivity analysis identified the top 5 parameters that had the greatest impact on the model were the health utility value of LTBI,the health utility value of cured tuberculosis,mortality rate of ATB after treatment,the incidence rate of LTBI in non-MTB infected patients,and the incidence rate of ATB in LTBI.Probabilistic sensitivity analysis showed that as the willingness-to-pay threshold increased,the dominant screening strategy shifted from TST to T-SPOT.TB and ultimately to TST/TSPOT.TB strategy.Conclusion(1)In rheumatic disease patients,the sensitivity of T-SPOT.TB for diagnosing ATB is higher than that of TST,while the specificity difference is not significant.(2)There are relatively few studies on the diagnostic accuracy of QFT-GIT in diagnosing ATB and the occurrence of indeterminate results with IGRA in rheumatic disease patients,and further research is needed to validate these findings.(3)Screening for tuberculosis infection using TST,IGRA,or TST combined with IGRA,and providing LTBI preventive anti-tuberculosis treatment to patients with rheumatic diseases is cost-effective.(4)When screening for LTBI in rheumatic diseases patients,TST or T-SPOT.TB alone can be preferred,and TST/T-SPOT.TB screening can be preferred if economically feasible. |
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