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Background: In China, an indigenously developed electronic medication monitor (EMM) was designed and used in 138 counties from three provinces. Previous studies showed positive results on accuracy, effectiveness, acceptability, and feasibility, but also found some ineffective implementations. In this paper, we assessed the effect of implementation of EMMs on treatment outcomes. Methods: The longitudinal ecological method was used at the county level with aggregate secondary programmatic data. All the notified TB cases in 138 counties were involved in this study from April 2017 to June 2019, and rifampicin-resistant cases were excluded. We fitted a multilevel model to assess the relative change in the quarterly treatment success rate with increasing quarterly EMM coverage rate, in which a mixed effects maximum likelihood regression using random intercept model was applied, by adjusting for seasonal trends, population size, sociodemographic and clinical characteristics, and clustering within counties. Results: Among all 69 678 notified TB cases, the treatment success rate was slightly increased from 93.5% [95% confidence interval (CI): 93.0–94.0] in second quarter of 2018 to 94.9% (95% CI: 94.4–95.4) in second quarter of 2019 after implementing EMMs. There was a statistically significant effect between quarterly EMM coverage and treatment success rate after adjusting for potential confounders (P = 0.0036), increasing 10% of EMM coverage rate will lead to 0.2% treatment success rate augment. Besides, an increase of 10% of elderly or bacteriologically confirmed TB will lead to a decrease of 0.4% and 0.9% of the treatment success rate. Conclusions: Under programmatic settings, we found a statistically significant effect between increasing coverage of EMM and treatment success rate at the county level. More prospective studies are needed to confirm the effect of using EMM on TB treatment outcomes. We suggest performing operational research on EMMs that provides real-time data under programmatic conditions in the future. [ABSTRACT FROM AUTHOR]

Background: In China, an indigenously developed electronic medication monitor (EMM) was used. EMM recorded each time the device was opened (no real time data), offering an indirect measure of tuberculosis treatment adherence. Previous study in China showed that the EMM uptake was satisfactory, missing adherence data were common in the information management system (25%) and shift to directly observed therapy (DOT) based on poor adherence documented by EMMs were seldom. Objectives: Among people with tuberculosis notified in 30 counties (July-December 2018) where EMM supported self-administered therapy (SAT) was suggested to all eligible (no communication impairment, ambulatory), we assessed the relative differences in unfavourable outcomes and deaths among those started on EMM at baseline (within first month of diagnosis) when compared to SAT alone. Methods: This was a cohort study using secondary data. We employed an intention to treat analysis, and used modified Poisson regression with robust variance estimates to assess the association. Results: Of 1810 eligible people, 1047 used EMM at baseline and of them, 216 (20.1%) stopped using EMM midway. Of 763 people who did not use EMM at baseline, 267 (35.0%) started using EMM later during the treatment. Among those who started using EMM at baseline, 6.3% [95% CI: 4.9, 8.0] had unfavourable outcomes compared to 6.7% [95% CI: 5.1, 8.8] among those who did not (p = 0.746). Lesser deaths were observed in people who started EMM at baseline when compared to those who did not: 2.5% [95% CI: 1.7, 3.7] versus 3.5% [95% CI: 2.4, 5.2], p = 0.191. The lack of association remained after adjusting for potential confounders (occupation, TB classification and TB category). Conclusion: Under programmatic settings, we did not find significant differences in the outcomes. Optimization of EMMs by shifting to DOT when indicated, addressing the issue of missing data and ensuring continuous use is required. [ABSTRACT FROM AUTHOR]

Background: China piloted a digital adherence technology called electronic medication monitor (EMM) to support self-administered treatment for tuberculosis. EMM is a portable plastic box that records each time the device is opened, offering an indirect measure of treatment adherence. During the monthly patient visits to tuberculosis designated hospitals, the doctors access the data from the EMM. Objectives: Among people with tuberculosis notified in 30 counties in China (July-December 2018) where EMM supported self-administered treatment was suggested to all those eligible (no communication impairment, ambulatory care), we assessed the i) proportion eligible for using EMM ii) uptake of EMM and factors associated and iii) treatment adherence, including the proportion shifted to DOT. Methods: This was an observational study using secondary programme data. Single instance of ≥50% or continued instance of 20–49% monthly missed doses was the eligibility criteria to shift to DOT. We used log binomial regression to identify factors associated with not using EMM within first month. Results: Of 2227 with EMM eligibility data, 1810 (81%) were eligible for EMM. Of 1810 people, 1314 (73%) ever used EMM anytime during treatment, among them, 134 (10%) were eligible for shift to DOT (based on EMM data), and 29 (22%) were shifted. In addition, 70 were shifted while the EMM data was missing. Of 1047 people who started using EMM within first month, we observed 6381 person-months of follow up and there were 1526(25%) instances of missing EMM data. Children (<15 years), elderly (≥65 years), semi-skilled or unemployed people, people with tuberculosis pleurisy and previous tuberculosis treatment were less likely to use EMM within first month. Conclusion: The EMM uptake was satisfactory but shift to DOT has to be ensured based on adherence data from EMM. The subsequent follow-up action when EMM data is missing has to be clarified in the guidelines. [ABSTRACT FROM AUTHOR]

Background: In settings such as China, where universal implementation of directly observed therapy (DOT) is not feasible, innovative approaches are needed to support patient adherence to TB treatment. The electronic medication monitor (EMM) is one of the digital technologies recommended by the World Health Organization (WHO), but evidence from implementation studies remains sparse. In this study, we evaluated acceptance of the EMM among health care workers and patients while implementing the device for differential TB patient management at the community level.Methods: Zhenjiang City in Jiangsu Province was purposively selected for the study. All participating patients were allowed to select their preferred management approach. If patients declined to use the EMM, DOT was offered. The EMM was designed to hold 1 month of anti-TB drugs for once-daily dosing of fixed-dose combination (FDC) tablets. Patient EMM records were monitored monthly by a physician; if 20 to 50% of doses were missed twice, or more than 50% of doses were missed once, the patient was switched to DOT. The four physicians and five nurses involved in the study at four designated hospitals were surveyed using a structured questionnaire to assess their acceptance of the EMM.Results: From October 2017 through January 2018, 316 pulmonary TB patients were notified in the TB information management system, and 231 (73.1%) met the study enrollment criteria. Although 186 patients (80.5%) initially consented to use the EMM, 17 later refused to use it. Among the 169 patients who used the EMM, 15 (8.9%) were switched to DOT due to poor adherence, and the other 154 completed the treatment course. The median adherence rate was 99.3%. Surveyed health care workers from designated hospitals found the EMM acceptable, although eight of nine felt use of the device moderately increased their workload. However, the EMM program significantly reduced the workload of community physicians by reducing patient visits by 87.9%.Conclusions: This study demonstrated the acceptability of using an indigenously developed EMM for differential management of TB patients at the community level. However, more operational research should be conducted before introducing and scaling the technology throughout China. [ABSTRACT FROM AUTHOR]

• The extrapulmonary tuberculosis (EPTB) epidemic situation in China was systematically revealed. • One-fourth of tuberculosis patients had EPTB, and the proportion of EPTB solo was 21.3%. • The proportion of EPTB in children was significantly higher, reaching 50.5%. • EPTB occurs mostly in respiratory, musculoskeletal, and peripheral lymphatic systems. • EPTB should be added to the National Tuberculosis Program as a notifiable disease. Extrapulmonary tuberculosis (EPTB) is not a notifiable infectious disease in China but is a heavy burden on public health. However, the epidemic situation of EPTB nationwide is unclear. This study aimed to investigate the magnitude and main subtypes of EPTB in China. We conducted a national cross-sectional study with multistage, stratified cluster random sampling during 2020-2021. We calculated proportions of EPTB in all patients with TB by organs. Logistic regression models were used to estimate odds ratios by characteristics. A total of 6843 patients with TB were included. Of them, 24.6% were patients with EPTB, and the proportion of EPTB solo was 21.3%. Higher EPTB burden was observed in children, female patients, clinically diagnosed patients, provincial-level and prefectural-level health facilities, and Central and West China. EPTB occurred most frequently in respiratory (35.5%), musculoskeletal (15.8%), and peripheral lymphatic (15.8%) systems with top three subtypes, including tuberculous pleurisy (35.0%), spinal TB (9.8%) and cervical tuberculous lymphadenopathy (7.9%). With the increase of age, proportion of peripheral lymphatic TB decreased, and proportion rank of genitourinary TB rose. It is essential to strengthen the diagnosis and treatment capacity for EPTB in primary medical facilities. EPTB should be added to the National Tuberculosis Program as a notifiable disease. [ABSTRACT FROM AUTHOR]

Background: The China National Health Commission-Gates TB Project Phase III implemented a comprehensive TB control model including multiple interventions to address the burden of drug-resistant TB (DRTB). This study aims to evaluate the quality of DRTB clinical services and assess the financial burden of DRTB patients during the intervention period. Methods: A mixed-methods approach was used to evaluate the effectiveness of interventions in the three project provinces: Zhejiang, Jilin and Ningxia Hui Autonomous Region. The quantitative data included de-identified DRTB registry data during 2015–2018 in project provinces from China CDC, medical records of DRTB patients registered in 2018 (n = 106) from designated hospitals, and a structured DRTB patient survey in six sample prefectures in 2019. The quality of clinical services was evaluated using seven indicators across patient screening, diagnosis and treatment. Logistic regression was conducted to explore factors associated with the extremely high financial burden. Semi-structured in-depth interviews with policymakers and focus group discussions with physicians and DRTB patients were conducted to understand the interventions implemented and their impacts. Results: The percentage of bacterially confirmed patients taking a drug susceptibility test (DST) increased significantly between 2015 and 2018: from 57.4 to 93.6% in Zhejiang, 12.5 to 86.5% in Jilin, and 29.7 to 91.4% in Ningxia. The treatment enrollment rate among diagnosed DRTB patients also increased significantly and varied from 73 to 82% in the three provinces in 2018. Over 90% of patients in Zhejiang and Jilin and 75% in Ningxia remained in treatment by the end of the first six months' treatment. Among all survey respondents 77.5% incurred extremely high financial burden of treatment. Qualitative results showed that interventions on promoting rapid DST technologies and patient referral were successfully implemented, but the new financing policies for reducing patients' financial burden were not implemented as planned. Conclusions: The quality of DRTB related clinical services has been significantly improved following the comprehensive interventions, while the financial burden of DRTB patients remains high due to the delay in implementing financing policies. Stronger political commitment and leadership are required for multi-channel financing to provide additional financial support to DRTB patients. [ABSTRACT FROM AUTHOR]

Background: China is still faced with the public health challenge of tuberculosis (TB), and a robust surveillance system is critical for developing evidence-based TB control policies. The Tuberculosis Information Management System (TBIMS), an independent system launched in 2005, has encountered several challenges in meeting the current needs of TB control. The Chinese government also planned to establish the National Health Information System (NHIS) aggregating data in different areas. The China National Health Commission-Gates TB Project Phase III launched a new TB surveillance system to address these challenges and also as a pilot for the countrywide implementation of the NHIS. This commentary highlights the improvements and challenges in implementing the new TB system and also discusses the implications for the roll-out of the NHIS. Main text: The new TB surveillance system piloted in each prefecture of the project provinces was designed based on the local information system under the unified principle of organizing patient information under a unique ID and realizing the function of data exchange. Upon mid-2019, the data exchange successful rate reached almost 100%, and the system showed good performance in data completeness. Major improvements of the new system included achieving automatic data extraction instead of manual entry, assisting clinical service provision, and the augmented statistical functions. The major challenges in the implementation and scale-up of the new system were the licensing issue and the diversities of infrastructures that hinder the promotion of the new system at a low cost. This pilot also accumulated experiences for the roll-out of the NHIS regarding the technical solutions of reforming current information systems as well as effective training approaches for the developers and users of the new system. Conclusions: The successful implementation of the new TB surveillance system in the three TB designated medical institutions demonstrated how the diverse infrastructures of the information system could be reformed to achieve the functions of automatic data extraction and data exchange and better cater to the needs of healthcare workers. This pilot also accumulated rich experiences and lessons learnt for developing technical solutions and personnel training for the scale-up of the NHIS. [ABSTRACT FROM AUTHOR]