This study examined the whole-course quality of TB care in rural China using the chart abstraction method. To our knowledge, this is the first study that assessed the TB care quality of the whole course in rural China. This study confirmed the achievements in the quality of TB care after the new reform on the designated hospital service delivery model: the diagnosis of TB was based on adequate evidence of appropriate tests and examination, the treatment for outpatients complied with standards, with more than 90% outpatients taking the standard regimen, and 87% of patients completed treatment. However, challenges remain in quality, especially for whole-course management and inpatient treatment. Only 47.9% of patients received midterm assessments, and the recommended examinations and tests declined along the treatment course. Inpatient doctors overused irrational second-line drugs, with 53.2% of inpatients prescribed second-line drugs, of which 85.1% were inappropriate.
Achievements in the quality of TB care
Our observations of the achievements in quality TB care align with previous studies. 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.
The achievements in the quality of TB diagnosis, treatment, and treatment completion reflect China’s substantial efforts in TB combat. The Chinese government has injected massive funding into TB control, increasing from 2.5 million CNY before 2000 to 1.1 billion CNY in 202021. In 2016, the national health blueprint, Healthy China 2030, highlighted the need to “build integrated TB control system, enhance detection and surveillance of MDR-TB and standardize the treatment and management of TB”22. In 2019, the China National Health Commission issued End TB Action Plan (2019–2022), further outlining the process of enacting the goal23. Since 2011, the new designated hospital-led TB control model was launched to improve integration, patient-centeredness, and quality of care. New information technology and equipment, such as artificial intelligence (AI)-based microscopic examination, have been introduced to TB care to increase diagnostic accuracy24. New technology, such as electronic pillbox and WeChat group (a widely used instant messaging app in China), has also been introduced to improve adherence and treatment completion21.
Challenges to the quality of TB care
The first challenge in quality is insufficient whole-course management. The sputum tests, chest radiographs, liver and renal function tests, and complete blood counts all decreased in the whole course, especially the sputum tests. However, it should be noted that the two project counties had large differences in sputum tests, suggesting a substantial regional variation in China. The standard 6-month treatment regimen for drug-susceptible patients is a long course, and even longer for drug-resistant patients. Ensuring patient adherence to the whole-course treatment was the primary challenge for such a prolonged regimen25. Our results suggested that patients were able to complete the treatment, indicating that they were able to take drugs regularly from the dispensary, but they had low adherence to the tests and examinations during the whole course. Sputum tests and chest radiographs at the second month and the end of treatment are important for determining whether adjusting future therapy and achieving a good clinical outcome, for example, emerging drug resistance26, 27. Low adherence to tests and examinations in the whole course undermines the opportunity to detect treatment failure and drug resistance, which will lead to a substantial failure in controlling the TB epidemic at both household and community levels because a person with active TB can infect 5–15 persons per year on average28.
The reasons for the gap in whole-course management are complex. Some patients do not have bacilli in sputum that can be cultured after two months of therapy, but it’s recommended to continue therapy for additional 4 months to avoid relapse25. DOTS strategy is useful in improving adherence but faces many challenges in implementation, for example, village doctors are the main providers to implement direct observation but are not incentivized enough for this time-consuming work12. Care in county-level hospitals is mainly episodic. Doctors have no incentives to urge patients to finish whole-course management.
The fragmentation between CDC and hospitals also contributes to unsatisfactory whole-course management. In the traditional CDC-led TB control model, diagnosis/treatment and management of TB patients were both delivered by CDC. CDC may have a stronger incentive to remind and urge TB patient to have sputum tests and chest radiographs in order to improve TB control performance. In the new designated hospital model, diagnosis/treatment was assigned to hospitals. CDC mainly supervise and monitor hospital and also supervise patient management. However, CDC, especially at the county level, often has a weak position to supervise hospitals. They have less authority over pneumology departments in hospitals. As most CDC health workers are not licensed doctors, they are not in a powerful position to monitor and supervise the quality issues of hospital doctors29.
The second challenge in quality is the high irrationality of second-line drugs prescribed by inpatient doctors. The rampant use of second-line drugs in inpatients has been documented. Lin et al. also found a substantial proportion of patients using second-line drugs (24.4%) in Yunnan province, a resource-poor area in China30. Huang et al. reported 54.9% of the inpatients used second-line drugs in hospitals in 201229.
The reasons for using unnecessary second-line drugs by inpatient doctors are two-fold. First, outpatient and inpatient TB care in designated hospitals is usually provided by different teams. There are no designated TB departments in inpatient settings, so inpatients are primarily admitted to pneumology departments. Outpatient doctors receive TB patients all the time and are better trained in TB knowledge and practice than those in pneumology departments. Many doctors from pneumology departments do not receive sufficient training on TB treatments and do not know how to manage complex TB inpatients13, 29. Second, first-line drugs, smear tests, and chest radiographs are fully subsidized in China and are provided to patients for free. County-level public hospitals largely depend on service revenues, and TB departments are unable to generate large revenues. Second-line drugs can generate profits, and doctors’ incomes are closely associated with hospitals’ revenue, so inpatient doctors may have incentives to prescribe second-line drugs29, 31.
Patients with TB symptoms have higher treatment completion while those with previous inpatient admission have lower treatment completion. The degree of receiving services during the whole course did not have a significant impact on treatment completion. In China, completing treatment only requires patients to receive drugs from a dispensary for the whole course of treatment18, and this indicator is on the watchlist to evaluate local governments’ progress in combating TB. However, receiving sufficient services requires patients to receive all the recommended examinations and tests during the whole course, and this indicator is only “recommended” to local governments but not on the watchlist.
Comparison of methodologies
Chart abstraction was criticized for its recording bias - not everything that happens in a clinical encounter was recorded, and medical records are not stored sufficiently in health organizations14, 32, 33. Medical records that were written by hand face recording bias. However, the materials used in this study were primarily records in the electronic health information system, which could minimize recording bias and inaccuracy in abstraction. The Chinese government issued strict policies on filing and preserving the records of TB patients, and stipulated that a specific officer in CDC and hospitals is responsible to file and preserve all the records of each TB patient 18.
Results measured by chart abstraction underestimate the quality of care and can serve as a lower-bound estimate32. Chart abstraction has advantages over other methods – lower cost, more convenient access to a large sample of data, and sometimes being the only data source for measurement34.
Standardized patient is another method to measure quality 35. Although it has been considered as the “golden standard” to assess quality, it’s limited to a single or few clinical encounters35, 36. Besides, standardized patient has the highest costs compared with other methods, and also causes high intrusion to doctors’ practice when time could be provided to patients with real needs15.
Limitations
This study was subject to several limitations. First, the finding of this study should not be generalized to represent China because the two counties from the two provinces are both resource-poor areas. Second, because only diagnosed TB cases were included in the study, we are unable to assess the quality of TB detection and the delay between symptoms onset and diagnosis. The quality of TB detection can be evaluated by standardized patients10, 11. The methods of chart abstraction and standardized patients could be combined in the future to assess different aspects of quality. Third, other significant populations of TB such as drug-resistant TB were not included because they were admitted by prefecture-level or provincial hospitals.