Access to quality diagnosis and rational treatment for tuberculosis: real-world evidence from China–Gates Tuberculosis Control Project Phase III

Abstract

Background China has successfully reduced tuberculosis (TB) incidence rate over the past three decades, however, challenges remain in improving the quality of TB diagnosis and treatment. In this paper, we assess the effects of the implementation of “China National Health Commission (NHC) and Gates Foundation TB Prevention and Control Project” on the quality of TB care in the three provinces. Methods We conducted the baseline study in 2016 and the final evaluations in 2019 in the 12 selected project counties. We obtained TB patients’ information from the TB Information Management System and reviewed medical records of TB cases in the TB designated hospitals. We compared TB diagnosis and treatment services with the national practice guideline and used Student’s t-test and Pearson χ2 tests or Fisher’s exact tests to compare the difference before and after the project implementation. Results The percentage of sputum smear-negative (SS–) patients taking culture or rapid molecular test (RMT) doubled between 2015 and 2018 (from 35% to 87%), and the percentage of bacteriologically confirmed pulmonary TB cases increased from 36% to 52%. RMT has been widely used and contributed an additional 20% of bacteriologically confirmed TB cases in 2018. The percentage of TB patients taking drug susceptibility tests (DST) also doubled (from 40% in 2015 to 82% in 2018), and the proportion of TB patients receiving adequate diagnosis services increased from 85% to 96%. Among all SS– TB patients, over 86% received the recommended diagnostic services at the end of the study period, an improvement from 75% prior to the project implementation. However, the proportion of TB patients treated irrationally using second-line anti-TB drugs (SLDs) increased from 12.6% in 2015 to 19.9% in 2018. The regional disparities remained within the project provinces, albeit the gaps between them narrowed down for almost all indicators. Conclusions The quality of TB diagnosis services has been improved substantially, which is attributable to the coverage of new diagnosis technology. However, irrational use of SLDs remains a concern after the project implementation. Graphic abstract

Whole course quality of tuberculosis care in rural China: challenges in diagnosis, treatment, and management

“…In 2015, a study using standardized patients found that 90% ordered a chest radiograph, sputum test, or referral to the standardized patients for diagnosis 10 . Another study in 2016 that used chart abstraction found that 85.3% of TB patients received adequate diagnostic services (including three sputum smears, chest X-ray or CT examinations, TB symptoms, tuberculosis skin tests, interferon-gamma release assays, and differential diagnosis) 9 . For treatment completion, compared with other high-burden countries, most TB patients were able to complete the treatment in our study, which was higher than that in India (45%) 19 , and South Africa (53%) 20 .…”

“…Inappropriate treatments or treatment interruption expose patients to a high risk of relapse or deterioration into drug-resistant TB/multidrug-resistant TB 7 . Previous studies have mainly focused on a single-doctor-patient interaction and overlooked the quality of the whole course [8][9][10][11] .…”

Distribution of bacteriologically positive and bacteriologically negative pulmonary tuberculosis in Northwest China: spatiotemporal analysis

“…Notified BN-PTB cases refer to clinically diagnosed patients whose sputum smear and culture were both negative. According to the National TB Diagnosis and Treatment Guidelines of China, a case is diagnosed as BN-PTB after other lung diseases have been excluded by differential diagnosis and one of the following criterion is met: (1) abnormalities consistent with active PTB on chest radiography and clinical features of PTB; (2) abnormalities consistent with active PTB on chest radiography and moderately positive or strongly positive tuberculin test; (3) abnormalities consistent with active PTB on chest radiography and positive interferon-gamma release; (4) abnormalities consistent with active PTB on chest radiography and a positive Mycobacterium tuberculosis antibody test; or (5) abnormalities consistent with active PTB on chest radiography and TB lesions confirmed by extra-pulmonary histopathological examination 20 .…”

Baseline Assessments of TB Detection Centres in Selected Public and Private Laboratories in India and Need for Introducing Quality Management Systems

“…Smear microscopy for TB case detection is plagued with poor sensitivity that may miss TB case diagnosis and, does not ascertain drug resistance (Chopra & Singh, 2020). Rapid molecular TB diagnostics like GeneXpert MTB/Rif and Truenat MTB have made inroads in National TB Control Programs across the globe even in peripheral laboratories (Li et al, 2021). A strong laboratory quality management system (QMS) is critical to ensuring the quality of testing and, for better health system outcomes (Centres for Disease Control and Prevention, n.d.).…”