Impact of an innovative bundled payment to TB health care providers in China: an economic simulation analysis.

BACKGROUND: Tuberculosis is the second most deadly infectious disease after COVID-19 and the 13th leading cause of death worldwide. Among the 30 countries with a high burden of TB, China ranks third in the estimated number of TB cases. China is in the top four of 75 countries with a deficit in funding for TB strategic plans. To reduce costs and improve the effectiveness of TB treatment in China, the NHSA developed an innovative BP method. This study aimed to simulate the effects of this payment approach on different stakeholders, reduce the economic burden on TB patients, improve the quality of medical services, facilitate policy optimization, and offer a model for health care payment reforms that can be referenced by other regions throughout the world. METHODS: We developed a simulation model based on a decision tree analysis to project the expected effects of the payment method on the potential financial impacts on different stakeholders. Our analysis mainly focused on comparing changes in health care costs before and after receiving BPs for TB patients with Medicare in the pilot areas. The data that were used for the analysis included the TB service claim records for 2019-2021 from the health insurance agency, TB prevalence data from the local Centre for Disease Control, and health care facilities' revenue and expenditure data from the Statistic Yearbook. A Monte Carlo randomized simulation model was used to estimate the results. RESULTS: After adopting the innovative BP method, for each TB patient per year, the total annual expenditure was estimated to decrease from $2,523.28 to $2,088.89, which is a reduction of $434.39 (17.22%). The TB patient out-of-pocket expenditure was expected to decrease from $1,249.02 to $1,034.00, which is a reduction of $215.02 (17.22%). The health care provider's revenue decreased from $2,523.28 to $2,308.26, but the health care provider/institution's revenue-expenditure ratio increased from -6.09% to 9.50%. CONCLUSIONS: This study highlights the potential of BPs to improve medical outcomes and control the costs associated with TB treatment. It demonstrates its feasibility and advantages in enhancing the coordination and sustainability of medical services, thus offering valuable insights for global health care payment reform.

Added Value of Comprehensive Program to Provide Universal Access to Care for Sputum Smear-Negative Drug-Resistant Tuberculosis, China.

The increase in drug-resistant tuberculosis in China calls for scaling up rapid diagnosis. We evaluated introduction of rapid resistance testing by line-probe assay for all patients with a diagnosis of pulmonary tuberculosis in 2 prefectures in middle and eastern China. We analyzed sputum samples for smear-positive patients and cultures for smear-negative patients. We used a before-after comparison of baseline and intervention periods (12 months each) and analyzed data for 5,222 baseline period patients and 4,364 intervention period patients. The number of patients with rifampin resistance increased from 30 in the baseline period to 97 in the intervention period for smear-positive patients and from 0 to 13 for smear-negative patients, reflecting a low proportion of positive cultures (410/2,844, 14.4%). Expanding rapid testing for drug resistance for smear-positive patients resulted in a 3-fold increase in patients with diagnoses of rifampin-resistant tuberculosis. However, testing smear-negative patients had limited added value because of a low culture-positive rate.

Over- and under-treatment of TB patients in Eastern China: an analysis based on health insurance claims data.

OBJECTIVE: Poor compliance with existing guidelines for tuberculosis (TB) care and treatment is an issue of concern in China. We assessed health service use by TB patients over the entire treatment process and compared it to the recommended guidelines. METHODS: We collected insurance claims data in three counties of one province of Eastern China. Patient records with a diagnosis of 'pulmonary TB' in 2015 and 2016 were extracted. Treatment duration, number of outpatient (OP) visits and hospital admissions, as well as total cost, out-of-pocket (OOP) payments and effective reimbursement rates were analysed. RESULTS: A total of 1394 patients were included in the analysis. More than 48% received over the 8 months of treatment that TB guidelines recommend, and over 28% received less. 49% of Urban and Rural Resident Basic Medical Insurance (URRBMI) TB patients were hospitalised while 30% of those with Urban Employee Basic Medical Insurance (UEBMI) had at least one admission. Median total cost for patients with hospital admission was almost 10 times that of patients without. By comparison, the average OOP was 5 times higher. UEBMI patients had a shorter treatment period, more outpatient visits but considerably fewer hospital admissions than URRBMI patients. CONCLUSIONS: We found an alarming extent of TB over- and under-treatment in our study population. There is an urgent need to improve compliance with treatment guidelines in China and to better understand the drivers of divergence. Extending the coverage of health insurance schemes and increasing reimbursement rates for TB outpatient services would seem to be key factors in reducing both the overall cost and financial burden on patients.

OBJECTIF: Le mauvais respect des directives existantes en matière de soins et de traitement de la tuberculose (TB) est un sujet préoccupant en Chine. Nous avons évalué l'utilisation des services de santé par les patients TB tout au long du processus de traitement et l'avons comparée aux directives recommandées. MÉTHODES: Nous avons collecté des données sur les réclamations d'assurance dans trois comtés d'une province de l'est de la Chine. Les dossiers de patients avec un diagnostic de «TB pulmonaire¼ en 2015 et 2016 ont été extraits. La durée du traitement, le nombre de visites ambulatoires et d'hospitalisations, ainsi que le coût total, les paiements directs et les taux de remboursement effectifs ont été analysés. RÉSULTATS: 1.394 patients ont été inclus dans l'analyse. Plus de 48% ont reçu plus de 8 mois du traitement recommandé par les directives TB et plus de 28% en ont reçu moins. 49% des patients TB résidents urbains et ruraux de l'assurance médicale de base (URRBMI) ont été hospitalisés, tandis que 30% de ceux avec une assurance médicale de base des employés urbains (UEBMI) ont eu au moins une admission. Le coût total moyen pour les patients hospitalisés était près de 10 fois plus élevé que celui des patients non hospitalisés. En comparaison, le payement direct moyen était 5 fois plus élevé. Les patients UEBMI ont eu une période de traitement plus courte, plus de visites ambulatoires mais beaucoup moins d'hospitalisations que les patients URRBMI. CONCLUSIONS: Nous avons trouvé une étendue alarmante de sur- et sous-traitement de la TB dans notre population d'étude. Il est urgent d'améliorer le respect des directives de traitement en Chine et de mieux comprendre les facteurs de divergence. L'extension de la couverture des schémas d'assurance santé et l'augmentation des taux de remboursement des services ambulatoires pour la TB sembleraient être des facteurs essentiels pour réduire à la fois le coût global et la charge financière pour les patients.

The effect of NCMS on catastrophic health expenditure and impoverishment from tuberculosis care in China.

BACKGROUND: Health expenditure for tuberculosis (TB) care often pushes households into catastrophe and poverty. New Cooperative Medical Scheme (NCMS) aims to protect households from catastrophic health expenditure (CHE) and impoverishment in rural China. This article assesses the effect of NCMS on relieving CHE and impoverishment from TB care in rural China. METHODS: Three hundred fourty-seven TB cases are included in the analysis. We analyze the incidence and intensity of CHE and poverty, and assess the protective effect of NCMS by comparing the CHE and impoverishment before and after reimbursement. RESULTS: After out-of-pocket (OOP) payment for TB care, 16.1 % of non-poor fall below poverty line. The NCMS reduces the incidence of CHE and impoverishment by 11.5 % and 7.3 %. After reimbursement, 46.7 % of the households still experience CHE and 35.4 % are below the poverty line. The NCMS relieves the mean gap, mean positive gap, poverty gap and normalized positive gap by 44.5 %, 51.0 %, US$115.8 and 31.6 % respectively. CONCLUSIONS: The NCMS has partial effect on protecting households from CHE and impoverishment from TB care. The limited protection could be enhanced by redesigning benefit coverage to improve the "height" of the NCMS and representing fee-for-service with alternative payment mechanisms.

Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial.

BACKGROUND: Mobile text messaging and medication monitors (medication monitor boxes) have the potential to improve adherence to tuberculosis (TB) treatment and reduce the need for directly observed treatment (DOT), but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients. METHODS AND FINDINGS: In a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control). Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined) withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients) or were switched to a different treatment model because of hospitalisation or travel (58 patients), leaving 4,173 TB patients (by arm: 1,104 control, 1,008 text messaging, 997 medication monitor, 1,064 combined). The cluster geometric mean of the percentage of patient-months on TB treatment where at least 20% of doses were missed was 29.9% in the control arm; in comparison, this percentage was 27.3% in the text messaging arm (adjusted mean ratio [aMR] 0.94, 95% CI 0.71, 1.24), 17.0% in the medication monitor arm (aMR 0.58, 95% CI 0.42, 0.79), and 13.9% in the combined arm (aMR 0.49, 95% CI 0.27, 0.88). Patient loss to follow-up was lower in the text messaging arm than the control arm (aMR 0.42, 95% CI 0.18-0.98). Equipment malfunction or operation error was reported in all study arms. Analyses separating patients with and without medication monitor problems did not change the results. Initiation of intensive management was underutilised. CONCLUSIONS: This study is the first to our knowledge to utilise a randomised trial design to demonstrate the effectiveness of a medication monitor to improve medication adherence in TB patients. Reminders from medication monitors improved medication adherence in TB patients, but text messaging reminders did not. In a setting such as China where universal use of DOT is not feasible, innovative approaches to support patients in adhering to TB treatment, such as this, are needed. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN46846388.

Multicenter evaluation of genechip for detection of multidrug-resistant Mycobacterium tuberculosis.

Drug-resistant tuberculosis (TB), especially multidrug-resistant TB (MDR-TB), is still one of the most serious threats to TB control worldwide. Early diagnosis of MDR-TB is important for effectively blocking transmission and establishing an effective protocol for chemotherapy. Genechip is a rapid diagnostic method based on molecular biology that overcomes the poor biosafety, time consumption, and other drawbacks of traditional drug sensitivity testing (DST) that can detect MDR-TB. However, the Genechip approach has not been effectively evaluated, especially in limited-resource laboratories. In this study, we evaluated the performance of Genechip for MDR-TB in 1,814 patients in four prefectural or municipal laboratories and compared its performance with that of traditional DST. The results showed that the sensitivity and specificity of Genechip were 87.56% and 97.95% for rifampin resistance and 80.34% and 95.82% for isoniazid resistance, respectively. In addition, we found that the positive grade of the sputum smears influenced the judgment of results by Genechip. The test judged only 75% of the specimens of "scanty" positive grade. However, the positive grade of the specimens showed no influence on the accuracy of Genechip. Overall, the study suggests that, in limited-resource laboratories, Genechip showed high sensitivity and specificity for rifampin and isoniazid resistance, making it a more effective, rapid, safe, and cost-beneficial method worthy of broader use in limited-resource laboratories in China.

Novel Influenza Vaccines: From Research and Development (R&D) Challenges to Regulatory Responses.

Influenza vaccines faced significant challenges in achieving sufficient protective efficacy and production efficiency in the past. In recent decades, novel influenza vaccines, characterized by efficient and scalable production, advanced platforms, and new adjuvant technologies, have overcome some of these weaknesses and have been widely licensed. Furthermore, researchers are actively pursuing the development of next-generation and universal influenza vaccines to provide comprehensive protection against potential pandemic subtypes or strains. However, new challenges have emerged as these novel vaccines undergo evaluation and authorization. In this review, we primarily outline the critical challenges and advancements in research and development (R&D) and highlight the improvements in regulatory responses for influenza vaccines.

Digital adherence technologies to improve tuberculosis treatment outcomes in China: a cluster-randomised superiority trial.

BACKGROUND: Drug-sensitive tuberculosis treatment requires 6 months of therapy, so adherence problems are common. Digital adherence technologies might improve tuberculosis treatment outcomes. We aimed to evaluate the effect of a daily reminder medication monitor, monthly review of adherence data by the health-care provider, and differentiated care for patients with adherence issues, on tuberculosis treatment adherence and outcomes. METHODS: We did a cluster-randomised superiority trial across four prefectures in China. 24 counties or districts (clusters) were randomly assigned (1:1) to intervention or control groups. We enrolled patients aged 18 years or older with GeneXpert-positive, rifampicin-sensitive pulmonary tuberculosis, who were receiving daily fixed-dose combination treatment. Patients in the intervention group received a medication monitor for daily drug-dosing reminders, monthly review of adherence data by health-care provider, and management of poor adherence; and patients in the control group received routine care (silent-mode monitor-measured adherence). Only the independent endpoints review committee who assessed endpoint data for some participants were masked to study group assignment. Patients were followed up (with sputum solid culture) at 12 and 18 months. The primary outcome was a composite of death, loss to follow-up, treatment failure, switch to multidrug-resistant tuberculosis treatment, or tuberculosis recurrence by 18 months from treatment start, analysed in the intention-to-treat population. Analysis accounted for study design with multiple imputation for the primary outcome. This trial is now complete and is registered with ISRCTN, 35812455. FINDINGS: Between Jan 26, 2017, and April 3, 2019, 15 257 patients were assessed for eligibility and 3074 were enrolled, 2686 (87%) of whom were included in the intention-to-treat population. 1909 (71%) of 2686 patients were male, 777 (29%) were female, and the median age was 44 years (IQR 29-58). By 18 months from treatment start, using multiple imputation for missing outcomes, 239 (16% [geometric mean of cluster-level proportion]) of 1388 patients in the control group and 224 (16%) of 1298 in the intervention group had a primary composite outcome event (289 [62%] of 463 events were loss to follow-up during treatment and 42 [9%] were tuberculosis recurrence). The intervention had no effect on risk of the primary composite outcome (adjusted risk ratio 1·01, 95% CI 0·73-1·40). INTERPRETATION: Our digital medication monitor intervention had no effect on unfavourable outcomes, which included loss to follow-up during treatment, tuberculosis recurrence, death, and treatment failure. There was a failure to change patient management following identification of treatment non-adherence at monthly reviews. A better understanding of adherence patterns and how they relate to poor outcomes, coupled with a more timely review of adherence data and improved implementation of differentiated care, may be required. FUNDING: Bill & Melinda Gates Foundation.

Ending tuberculosis in China: health system challenges.

China has made remarkable progress in reducing tuberculosis cases and deaths during the past three decades; however, it is still far from achieving the targets set out in the WHO End TB Strategy. Since the 2000s, China has tried to transform its vertical tuberculosis control programme led by the Chinese Center for Disease Control and Prevention (CDC) into an integrated system under the collaboration of CDC, tuberculosis-designated hospitals, and primary health centres. Such a transition has faced many challenges. Profit-driven practices in hospitals designated to tuberculosis and an absence of adequate tuberculosis-related training for health professionals are partially jeopardising the quality of tuberculosis care. In addition, primary health-care providers are not incentivised to make referrals and manage cases effectively. The CDC does not have the administrative power to influence hospital practices or deploy resources to support community-based tuberculosis control activities. Furthermore, an absence of policy coherence and effective coordination causes challenges for quality tuberculosis care that is affordable and accessible. Improving policy dialogues and multi-level coordination within the government is fundamental to successfully ending tuberculosis in China and other countries facing similar challenges.

The Impact of COVID-19 on Tuberculosis Patients' Behavior of Seeking Medical Care - China, 2020.

What is already known on this topic? The coronavirus disease 2019 (COVID-19) pandemic has disrupted the tuberculosis (TB) service system. However, the impact on TB patients in China remains unknown. What is added by this report? This report firstly addressed the impact of COVID-19 on TB patients in China. About half of TB patients did not revisit the hospital due to personal reasons. The reasons for irregular medication and postponing or cancelling examination after full treatment course were different. What are the implications for public health practice? Health education and risk communication should be strengthened for better TB patient management and treatment adherence, especially in light of the COVID-19 pandemic.

Temporal Factors and Missed Doses of Tuberculosis Treatment. A Causal Associations Approach to Analyses of Digital Adherence Data.

Rationale: Tuberculosis treatment lasts for 6 months or more. Treatment adherence is critical; regimen length, among other factors, makes this challenging. Globally, analyses mapping common types of nonadherence are lacking. For example, is there a greater challenge resulting from early treatment cessation (discontinuation) or intermittent missed doses (suboptimal dosing implementation)? This is essential knowledge for the development of effective interventions and more "forgiving" regimens, as well as to direct national tuberculosis programs.Objectives: To granularly describe how patients take their tuberculosis medication and the temporal factors associated with missed doses.Methods: The present study included patients with pulmonary tuberculosis enrolled in the control arm of a pragmatic, cluster-randomized trial in China of electronic reminders to improve treatment adherence. Treatment was the standard 6-month course (180 d), dosed every other day (90 doses). Medication monitor boxes recorded adherence (box opening) without prompting reminders. Patterns of adherence were visualized and described. Mixed-effects logistic regression models examined the temporal factors associated with per-dose suboptimal dosing implementation, adjusting for clustering within a participant. Cox regression models were used to examine the association between early suboptimal dosing implementation and permanent discontinuation.Results: Across 780 patients, 16,794 (23.9%) of 70,200 doses were missed, 9,487 of which were from suboptimal dosing implementation (56.5%). By 60 days, 5.1% of participants had discontinued, and 14.4% had discontinued by 120 days. Most participants (95.9%) missed at least one dose. The majority of gaps were of a single dose (71.4%), although 22.6% of participants had at least one gap of 2 weeks or more. In adjusted models, the initiation-continuation phase transition (odds ratio, 3.07 [95% confidence interval, 2.68-3.51]) and national holidays (1.52 [1.39-1.65]) were associated with increased odds of suboptimal dosing implementation. Early-stage suboptimal dosing implementation was associated with increased discontinuation rates.Conclusions: Digital tools provide an unprecedented step change in describing and addressing nonadherence. In our setting, nonadherence was common; patients displayed a complex range of patterns. Dividing nonadherence into suboptimal dosing implementation and discontinuation, we found that both increased over time. Discontinuation was associated with early suboptimal dosing implementation. These apparent causal associations between temporal factors and nonadherence present opportunities for targeted interventions.Clinical trial registered with the ISRCTN Registry (ISRCTN46846388).

Effectiveness of the Integrated TB Surveillance System - China, 2018-2019.

What is already known about this topic? China's national health information system provides important support and means for deepening the country's medical and health reform, for improving relevant delivery services, for enhancing the level of scientific management of health, and for promoting the goal of basic medical and health services for everyone in China. What is added by this report? To further the construction of the national health information system, the National Center for Tuberculosis Control and Prevention of China CDC, started a pilot project for a new tuberculosis (TB) integrated health (iHealth) surveillance system, which was integrated with regional health information platforms. The goal was to explore automatic data exchange between hospitals and disease control facilities to reduce the workload of data-entry. What are the implications for public health practice? This pilot proved that data sharing and automatic exchanges between different information systems can be achieved through a unified surveillance dataset, which could provide a reference point for the construction of surveillance systems for other infectious diseases or for the entire public health information system.

Accuracy of Commercial Molecular Diagnostics for the Detection of Pulmonary Tuberculosis in China: A Systematic Review.

This systematic review assesses the accuracy of molecular diagnostic methods for the detection of pulmonary tuberculosis in studies performed in China, published in Chinese and English. We searched for studies that assessed the accuracy of molecular diagnostics for pulmonary TB in China in the China National Knowledge Infrastructure, the Wanfang Database, SinoMed, VIP Information, Pubmed, Embase, and the Cochrane Library. For each index test, a summary estimation for sensitivity and specificity was calculated using the bivariate random-effects model. A total of 59 studies were included in our analysis. Loop-mediated isothermal amplifcation (LAMP) assay (six studies; pooled sensitivity 90%, 95% CI 78-95%; specificity 93%, 85-97%), line probe assay (LPA) (one study; 87%, 84-90%; 94%, 92-95%) and polymerase chain reaction (PCR) (FQ-PCR and RT-PCR) (four studies; 90%, 55-99%; 93%, 71-99%) showed good diagnostic performance in the meta-analysis. The highest pooled sensitivity was from Xpert MTB/RIF (20 studies; pooled sensitivity 91%, 95% CI 87-94%). The highest pooled specificity was from cross-priming amplification (CPA) (six studies; pooled specificity 97%, 95-99%). The lowest pooled sensitivity and specificity were from simultaneous amplification and testing (SAT)-TB (three studies; 79%, 66-88%; 72%, 48-88%). In subgroup analysis, molecular diagnostics demonstrated higher sensitivity for pulmonary TB detection in smear-positive specimens. Xpert MTB/RIF, LAMP, LPA, CPA and PCR demonstrated high accuracy overall for pulmonary tuberculosis detection, while SAT-TB had poor performance.

Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial.

BACKGROUND: Treatment for drug-sensitive tuberculosis (TB) is taken for at least 6 months and problems with adherence are common. Therefore, there is substantial interest in the possible use of eHealth interventions to support patients to take their treatment. Electronic medication monitors have been shown to improve adherence to TB medication, but the impact on clinical outcomes is unknown. We aim to evaluate the impact of a medication monitor-based treatment strategy for drug-sensitive TB patients on a composite poor outcome measured over 18 months from start of TB treatment. METHODS/DESIGN: We will conduct an open, pragmatic, cluster randomised superiority trial, with 24 counties/districts in three provinces in China, randomised 1:1 to implement the intervention or standard of care. Adults (aged ≥ 18 years) with a new episode of GeneXpert-positive and rifampicin-sensitive pulmonary TB, who plan to be in the study area for the next 18 months, and will receive daily fixed-dose combination tablets for 6 months of treatment are eligible. The intervention is centred around a medication monitor that holds a 1-month supply of medication and has three key functions: as an audio and visual reminder for patients to take their daily medication; reminds patients of upcoming monthly visit; and records date and time whenever the box is opened. At the monthly follow-up visit, the doctor downloads these data to generate a graphical display of the last month's adherence record for discussion with the patient and potentially to switch the patient to more intensive management. The primary outcome is a composite poor outcome measured over 18 months from start of TB treatment, defined as either of poor outcome at the end of treatment (death, treatment failure, or loss to follow-up) or subsequent recurrence (culture positive for TB at 12 or 18 months or re-starting TB treatment in the follow-up period). An economic evaluation will also be conducted as part of this study. DISCUSSION: This trial will assess whether a medication monitor-based treatment strategy can improve clinical outcomes for TB patients. Several trials of other eHealth interventions for TB treatment are ongoing and are summarised in this paper. This trial will provide an important part of the emerging evidence base for the potential of eHealth to improve TB treatment outcomes. TRIAL REGISTRATION: This trial was registered with Current Controlled Trials (identifier: ISRCTN35812455 ). Registered on May 19, 2016.

Usability of a Medication Event Reminder Monitor System (MERM) by Providers and Patients to Improve Adherence in the Management of Tuberculosis.

Poor initiation and implementation and premature discontinuation of anti-tuberculous therapy, all forms of nonadherence, are major reasons for treatment failure, the development of drug-resistant tuberculosis, and transmission to other non-infected individuals. Directly Observed Therapy (DOT) has been the worldwide standard, but implementation of DOT is burdensome for providers and patients, especially in resource-limited settings, where most of the burden of active TB is located. Among the alternatives to DOT is electronic monitoring (EM) of drug dosing histories. Here we report a usability study of a newly-designed, modular electronic monitor product, called the MERM (Medication Event and Reminder Monitor), that is compatible with TB medication formats and supply chains in resource-limited settings. This study, done in a rural setting in China, showed that the use of the MERM for EM of TB medications was associated with a high degree of user performance, acceptability, and satisfaction among both TB patients and medical staff. Based on these data, EM is becoming the standard of care for drug-susceptible TB patients in China and scaled implementations in several other countries with high TB burden have begun. In addition, the MERM is being used in MDR-TB patients and in clinical trials involving patients with TB/HIV and latent TB.

Multicenter evaluation of a real-time loop-mediated isothermal amplification (RealAmp) test for rapid diagnosis of Mycobacterium tuberculosis.

The real-time loop-mediated isothermal amplification (RealAmp) test is a novel technology for rapid diagnosis of Mycobacterium tuberculosis (MTB) from sputum samples. This test has not previously been effectively evaluated. In this study, we assessed the performance of the RealAmp test for tuberculosis (TB) detection among TB suspected patients from three provincial hospitals in China. Each eligible TB suspected patients in Shanghai, Guangzhou, and Shandong provided one sputum specimen each, smear microscopy, liquid culture, and the RealAmp test were performed per patient. A total of 1583 TB suspected patients were enrolled in the study, and 1519 were used for the performance analysis. The sensitivity and specificity of the RealAmp test for MTB detection were calculated using liquid culture as reference method. The sensitivity of RealAmp test in smear-negative and culture-positive patients was 60.08%; the sensitivity in smear-positive and culture-positive patients was 97.09%; and the overall sensitivity in culture-positive patients was 74.88%. The specificity of RealAmp test for MTB detection was 86.50%.

Use of anti-tuberculosis drugs among newly diagnosed pulmonary tuberculosis inpatients in China: a retrospective study.

BACKGROUND: China's national tuberculosis control program (NTP) provides free, first-line anti-tuberculosis (TB) drugs to pulmonary TB patients. This treatment regimen follows the World Health Organization's (WHO) guideline. The objective of this paper is to evaluate the current status of anti-TB drug use for newly diagnosed pulmonary TB inpatients treated in prefecture- and county-level designated hospitals. METHODS: Three prefecture-level hospitals and nine county-level hospitals were selected for the study. All newly diagnosed pulmonary TB inpatient medical records from 2012 were reviewed and doubly examined by two national senior physicians. The rational use of anti-TB drugs was evaluated based on criteria in line with WHO's guideline. RESULTS: Of the 2,060 total treatment regimens for TB, 53.1 % were found to be rational (1093/2060). The percentages in prefecture-level and county-level hospitals were 50.3 % (761/1513) and 60.7 % (332/547), respectively. The difference between the two levels of hospitals was statistically significant (Chi-square value = 17.44, P < 0.01). The percentages of rational treatment regimens for first-time hospitalizations and for two or more hospitalizations were 59.5 % (983/1653) and 27.0 % (110/407), respectively, with a statistically significant difference (Chi-square value = 138.00, P < 0.01). The overall use of second-line drugs (SLD) was 54.9 % (1131/2060). The percentages for prefecture-level and county-level hospitals were 50.6 % (766/1513) and 66.7 % (365/547), respectively. A statistically significant difference was found (Chi-square value = 42.06, P < 0.01). The use of SLD for inpatients hospitalized once and inpatients hospitalized twice or more was 58.4 % (966/1653) and 40.5 % (165/407), respectively, with a statistically significant difference (Chi-square value = 42.26, P < 0.01). CONCLUSIONS: Half of inpatients might be treated with irrational regimens, and the use of SLD was more appropriately dispensed in city-level hospitals than in county-level hospitals. Trainings and guidelines for health personnel, supervision led by health authorities and increased investment to designated hospitals may help to improve the rational use of anti-TB drugs.

Rapid diagnosis of MDR and XDR tuberculosis with the MeltPro TB assay in China.

New diagnostic methods have provided a promising solution for rapid and reliable detection of drug-resistant TB strains. The aim of this study was to evaluate the performance of the MeltPro TB assay in identifying multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) patients from sputum samples. The MeltPro TB assay was evaluated using sputum samples from 2057 smear-positive TB patients. Phenotypic Mycobacterial Growth Indicator Tube (MGIT) 960 drug susceptibility testing served as a reference standard. The sensitivity of the MeltPro TB assay was 94.2% for detecting resistance to rifampicin and 84.9% for detecting resistance to isoniazid. For second-line drugs, the assay showed a sensitivity of 83.3% for ofloxacin resistance, 75.0% for amikacin resistance, and 63.5% for kanamycin resistance. However, there was a significant difference for detecting kanamycin resistance between the two pilot sites in sensitivity, which was 53.2% in Guangdong and 81.5% in Shandong (P = 0.015). Overall, the MeltPro TB assay demonstrated good performance for the detection of MDR- and XDR-TB, with a sensitivity of 86.7% and 71.4%, respectively. The MeltPro TB assay is an excellent alternative for the detection of MDR- and XDR-TB cases in China, with high accuracy, short testing turn-around time, and low unit price compared with other tests.