Transactions of the Royal Society of Tropical Medicine and Hygiene Advance Access published February 4, 2016

ORIGINAL ARTICLE

Trans R Soc Trop Med Hyg doi:10.1093/trstmh/trw001

Experience of implementing the integrated TB model in Zhejiang, China: a retrospective observational study Jieming Zhonga, Jia Yinb, Guanyang Zouc, Yanhong Hub, John Walleyd, Xiaomeng Wanga, Songhua Chena and Xiaolin Weib,e,* a

*Corresponding author: Present address: Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, M5T 3M7, Canada; Tel: +852 2252 8422; E-mail: [email protected]

Received 29 September 2015; revised 23 December 2015; accepted 23 December 2015 Background: This study aims to assess the implementation of the TB control program under the integrated model in China where TB diagnosis and treatment is provided in TB designated hospitals. Methods: Six counties under the integrated model in Zhejiang were randomly selected. TB referral and tracing was analyzed based on routine TB reporting data between January and December 2009 from county TB dispensaries. Regarding treatment and community management, we conducted face-to-face surveys with 50 new TB patients randomly selected from each county, and reviewed their medical charts. Results: A total of 7090 persons with presumptive TB were reported in 2009, of whom, 66.7% (4732/7090) were referred by other health facilities to TB designated hospitals, while 80.2% (3795/4732) were successfully referred. In total, 301 patients were surveyed and had a median medical expenditure of US$192. Ten percent (31/301) missed at least one dose during their treatment, and 64.5% (194/301) received direct observation, mostly by family members. Conclusions: The integrated model performed better on case referral and community management, but higher medical expenditures than those reported by studies under the dispensary model in China. Clear guidelines should be issued on supervising TB treatment in designated hospitals. Keywords: China, Implementation, Integrated model, Tuberculosis

Introduction China had the second highest TB burden in the world with one million new TB cases in 2012.1 In the 1990s, China introduced the WHO directly observed treatment, short-course (DOTS) strategy into the National TB Control Program (NTP). DOTS is an international TB control strategy which consists of five components: government commitment; case detection by predominantly passive case-finding; standardized short-course chemotherapy provided under proper case management conditions; a system of regular drug supply; and a monitoring system for program supervision and evaluation.2 China fully adopted the DOTS strategy in all provinces in 2002.3 In recent decades, China has made a remarkable achievement in TB control. From 1990 to 2010, the prevalence of smear-positive TB cases has been reduced by 65%.4 Since the 1990s, the dispensary model has been the most prevalent model implemented in China. In this model, a TB dispensary, often a department of the Centre for

Disease Control and Prevention (CDC), is responsible for providing a free package of clinical and public health TB services to persons with TB and presumptive TB. These services such as routine physical examinations and laboratory examinations, first-line anti-TB drugs, TB registering, tracing, supervising and patient supports, were fully funded by the Government.5 Persons with presumptive TB identified by the other health facilities should be reported and referred to TB dispensaries for further diagnosis and treatment. Since the end of the 1990s, TB dispensaries could not satisfy patients’ growing demand for high quality of health services due to their weak clinical capacity and limited medical resources. Patients who have persistent cough often prefer to visit general hospitals.3 In 2010, more than 50% of TB patients were diagnosed and treated in general hospitals, however, they could not receive standardized TB treatment there.4,6 In response to the challenges in the dispensary model, the integrated model was initiated in several counties in China since 2000. Under the new model, TB clinical service was integrated

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TB department, Zhejiang Centre for Disease Control and Prevention, Hangzhou, 310051, China; bThe Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, N.T., China; cChina Global Health Research and Development, Hong Kong SAR, and Shenzhen, 250012, China; dNuffield Centre for International Health and Development, University of Leeds, Leeds, LS2 9JT, UK; eDalla Lana School of Public Health, University of Toronto, Toronto, Ontario, M5T 3M7, Canada

J. Zhong et al.

Materials and methods Study setting

presumptive TB, patients with TB referred by the other health facilities, patients with TB who visited hospitals within 3 days of referral, patients with TB who were being traced and those who were successfully traced. Regarding patient treatment and community management, we randomly selected 50 new TB patients who were registered in 2008 and successfully finished their treatment by 31 May 2009 from a pool of 100–200 eligible patients with TB in each county. We excluded previously treated TB patients, extra-pulmonary patients, patients with severe complications such as cardiovascular diseases, cancers or severe respiratory symptoms and patients who were resistant to any first-line anti-TB drug, to avoid any potential casemix confounders as their regimens need to be adjusted and are more costly. We conducted a face-to-face survey with all sampled patients based on a questionnaire validated in a previous study,6 collecting information regarding patients’ socio-economic information, medication non-adherence, supervision and patient supports. We also reviewed the clinical charts of all the sampled patients regarding their treatment regimens, durations, medical examinations and expenditures. All data were collected from 1 May 2009 to 1 May 2010.

Data analysis Data were double entered into Epidata 3.1 (The EpiData Association, Odense, Denmark) and then statistically analyzed by SPSS 18.0 (IBM, Armonk, NY, USA). Missing values were less than 5% in all variables so they were not replaced. Continuous variables were calculated by median and IQR, while categorical variables were described by using frequencies and percentage. Proportion of persons with presumptive TB who were successfully referred was calculated as number who arrived at TB designated hospitals within 3 days after referral divided by number referred by other health facilities. Proportion of persons with presumptive TB who were successfully traced was calculated as number who visited TB designated hospitals after being traced divided by number who were traced after referral.

Validity and reliability of the data collected

This study was conducted in Zhejiang, a province with a population of 47 million and a gross domestic product (GDP) per capita of US$6536 in 2009.16 Since 2000, the province began to implement the integrated model in a few counties with the support of local health authorities. By the end of 2008, 44 out of the 90 counties in the province had implemented the integrated model. We employed a stratified sampling method to randomly select study sites from these 44 counties. They were divided into two strata: the relatively rich areas (≥US$5124) and the relatively poor areas (,US$5124), based on the median per capita GDP level in the province. Three counties were randomly selected from the rich areas, i.e., Haining, Tongxiang and Cixi, and three countries from the poor areas, i.e., Shengzhou, Longyou and Changshan.

Dedicated public health staff in county TB dispensaries checked the TB reporting system on a daily basis to ensure the accuracy and completeness of each case and provided the monthly report regarding case referral and treatment in the county. The prefectural and provincial CDCs would examine the quality of data via the TB reporting system on a daily basis. On a quarterly basis, the provincial CDC randomly selected 10 patients with TB in each county for interviews as a means of triangulation. To ensure the quality of medical records, a group of clinical, laboratory and public health experts in the higher levels of CDCs assessed the quality of TB records and medical diagnosis in the lower levels on a quarterly basis. In our survey, a team of postgraduate students was specifically trained for a half day, while each questionnaire was double checked by a team leader before data input.

Data collection

Results

Regarding case referral and tracing, we collected information from the internet-based TB reporting system between January and December 2009. We retrieved numbers of persons with

The population of study sites ranged from 329 000 to 1 035 000. Government in rich counties had a higher health input per capita than those in poor counties. TB notification rate ranged from 66.9

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into the general hospital in each county, while the general hospital was named as the designated hospital in the county. This model has been proved to reduce patient care pathways in TB diagnosis and their related costs compared with the traditional TB dispensary model.7 TB treatment, normally on an outpatient basis, remained the same as the TB DOTS program, while TB dispensaries provided public health services (e.g., health education, management of tracing and home visits) to patients.8 Primary care facilities including township hospitals and village clinics were responsible for providing community-based patient management. Township hospital doctors should visit patients’ homes at least four times during treatment, while village doctors should visit once a month. Directly observed therapy (DOT), which was defined as an appointed agent directly monitoring patients swallowing their anti-TB drugs,9 was supposed to be provided by village doctors to ensure treatment compliance. If village doctors were not available, volunteers and family members could be trained as substitutes.5 In addition, China set up an internet-based TB reporting system in 2004 to ensure timely reporting and referral.10 This system covered all the health institutions and enabled sharing of TB suspects and cases related information among them.10 The non-TB control institutions, i.e., other public or private hospitals and primary care facilities, are required to report persons with presumptive TB via the reporting system, and then refer them to the TB designated hospital.11 Persons with presumptive TB who did not visit the designated hospital within 3 days of referral, were supposed to be traced by TB dispensaries and primary care facilities through phone call or home visit.5 Previous studies mainly focused on the clinical aspects and impact, not on the programmatic and policy aspects such as case detection (reporting, referral) and community management.12–14 To fill this gap, we conducted this study in a pioneer province of the integrated model. As China is promoting health system reform which covers all the medical and health care institutions,15 this study will provide a comprehensive insight of TB control experience in the integrated model and give evidence for expanding this model to the other provinces.

Transactions of the Royal Society of Tropical Medicine and Hygiene

Table 1. Socio-economic information, TB reporting in the six counties of Zhejiang in 2009 Rich areas

Population (10 000) GDP per capita (US$) Per capital health input (US$) TB notification rate (per 100 000) Cure rate of sputum-positive cases (%)

Poor areas

Haining

Tongxiang

Cixi

Shengzhou

Longyou

Changshan

65.5 8414 40 66.9 87.6

67.1 7438 25 75.9 92.4

103.5 8874 61 101.6 90.4

73.4 4612 22 71.0 82.1

40.3 3555 19 107.7 92.0

32.9 2806 22 137.0 91.1

Table 2. Referral and tracing of TB suspects in the six counties of Zhejiang in 2009

No. TB suspects TB referral TB suspects who initially visited the TB designated hospitals, n (%) TB suspects who were referred by other health facilities, n (%) Referred by other hospitals Referred by township hospitals TB suspects who were successfully referred, n (%) TB tracing No. TB suspect who were traced after referral TB suspects who were successfully traced, n (%)

Haining

Tongxiang Cixi

Shengzhou Longyou

Changshan Total

1516

953

934

710

2415

482 (31.8) 155 (16.3)

562

7090

883 (36.6) 218 (23.3)

355 (63.2) 265 (37.3)

2358 (33.3)

1034 (68.2) 798 (83.7) 1532 (63.4) 716 (76.7)

207 (36.8) 445 (62.7)

4732 (66.7)

175 (16.9) 503 (63.0) 413 (27.0) 508 (70.9) 859 (83.1) 295 (37.0) 1119 (73.0) 198 (29.1) 770 (74.5) 709 (88.8) 1310 (85.5) 397 (55.4)

140 (67.6) 386 (86.7) 67 (32.4) 59 (13.3) 172 (83.1) 437 (98.2)

2125 (44.9) 2597 (55.1) 3795 (80.2)

264 201 (76.1)

89 77 (86.5)

222 319 148 (66.7) 239 (74.9)

35 31 (88.6)

8 6 (75.0)

937 702 (74.9)

Sources: Zhejiang TB routine report.

to 137.0 per 100 000 population. All counties except SZ had achieved over 85% cure rates in 2009 (Table 1).

Referral and tracing of persons with presumptive TB From January to December 2009, a total of 7090 persons with presumptive TB were reported in the six sites. One third (2358/ 7090) of the suspected patients initially visited designated hospitals after developing one or more TB symptoms. Of the remaining persons with presumptive TB, 44.9% (2125/4732) were referred to the designated hospitals by non-TB hospitals and the other 55.1% (2597/4732) were referred by primary healthcare facilities. Of all persons referred, 80.2% (3795/4732) successfully reached designated hospitals. The remainder were traced by healthcare workers, whereas 74.9% (702/937) of them were successfully reached within three days (Table 2).

Socio-economic information of the survey participants A total of 301 patients with TB participated in the survey, with a median age of 47 and 70.8% (213/301) males. The majority (247/

301, 82.1%) were married, while 50.8% (153/301) had been educated at the primary school level or were illiterate. Farmers accounted for 62.8% (189/301) of these cases. A small proportion of the patients were migrants (59/301, 19.6%). The median annual per capita income was US$915.

TB treatment in the TB designated hospital Charts of all 301 participants were reviewed. The median duration of treatment was 183 days. Each patient spent a median of US$192 in the designated hospital, ranging from US$144 in Haining to US$293 in Cixi. The total medical expenditure accounted for 5.9% of patient annual household income. Patients spent a median of US$42 and US$155 for medical examinations and drugs respectively, because these were not covered under free treatment policy. Drug expenditure accounted for 75.4% (159/211) of the total medical expenditure. The majority of patients (276/301, 91.7%) had been prescribed liver-protection drugs with a median expenditure of US$78. Second-line anti-TB drugs, mainly quinolones, were given to 73 patients (24.3% of 301) with a median cost of US$18. Although patients in

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Sources: Statistics Bureau of Zhejiang Province and Zhejiang TB routine report. According to China’s National Bureau of Statistics, US$1 ¼ 6.83 RMB on average discharge in 2009.

155 (90–212) 276 (91.7) 78 (46–162) 73 (24.3) 18 (9–111)

Community-based patient management In total, 31 (10.3% of 301) patients reported that they did not adhere to their regimens with a median of two missing doses. During TB treatment, approximately two-thirds of patients received direct observation. Among them, 75.8% (147/194) received DOT from family members. A total of 220 (73.1% of 301) patients received home visits from healthcare workers. Of the home visitors, doctors of township hospitals accounted for 67.8% (204/301). The lowest proportions for home visits were reported in Tongxiang. There were 254 patients who never received direct observation from village doctors. Of them, only 78 (30.7% of 254) were visited by village doctors. On average, one patient received four home visits from village doctors (Table 4).

111 (72–157) 48 (96.0) 46 (24–59) 32 (64.0) 9 (8–18)

Discussion

According to China’s National Bureau of Statistics, US$1 ¼ 6.83 RMB on average discharge in 2009.

191 (156–225) 170 (89–243) 167 (101–265) 129 (79–175) 46 (92.0) 39 (78.0) 49 (96.1) 47 (94.0) 193 (157–221) 64 (41–77) 145 (48–177) 83 (33–137) 3 (6.0) 20 (40.0) 4 (7.8) 10 (20.0) 80 (47–80) 148 (111–148) 14 (7–22) 18 (5–19) 122 (81–197) 47 (94.0) 118 (60–155) 4 (8.0) 17 (6–43)

42 (19–75) 26 (16–36) 12 (5–42) 19 (12–49)

123 (78–123)

42 (23–58) 71 (53–93)

5.9 (3.3–12.9) 8.7 (5.2–15.9) 5.7 (3.0–12.2) 10.3 (4.5–23.6) 8.1 (4.3–15.5) 4.5 (2.8–8.8) 3.0 (1.9–4.9)

181 (179–182) 182 (177–237) 182 (181–183) 213 (195–253) 182 (181–193) 194 (184–231) 183 (181–208) 144 (103–227) 213 (163–251) 293 (201–364) 237 (164–316) 169 (124–231) 152 (98–201) 192 (134–267)

Days of treatment, median (IQR) Total medical expenditures in TB designated hospitals, US$, median (IQR) Total medical expenditures as percentage of annual household income (%), median (IQR) Expenditures of self-supporting examinations and tests, US$, median (IQR) Expenditures of self-supporting drugs, US$, median (IQR) Liver-protection drugs, n (%) Expenditures of liver-protection drugs, US$, median (IQR) Second-line anti-TB drugs, n (%) Expenditures of second-line anti-TB drugs, US$, median (IQR)

Shengzhou n¼51 Cixi n¼50 Tongxiang n¼50 Haining n¼50

Table 3. TB treatment in the designated hospitals in the six counties of Zhejiang

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Changshan had the highest proportion of using the second-line anti-TB drugs, they incurred the lowest costs for these drugs (Table 3).

This study identified promising results of the integrated model. One-third of the patients initially visited TB designated hospitals, while over 80% of persons with presumptive TB who were referred by other hospitals arrived at the designated hospitals within 3 days. Only 10% did not adhere to their regimens. In addition, we observed a relatively high direct observation rate (64.5%) as well as home visit rate (73.1%) compared with studies conducted under the dispensary models (DOT: 48%; home visiting rate: 45%).17,18 The duration of treatment was in line with China’s national TB guidelines. However, expenditures for TB treatment were still high in designated hospitals. Adequate access to TB diagnosis and treatment is crucial to reduce TB transmission and increase treatment success.19 Previous studies in China have proved that the integrated model was effective in increasing the case detection rate and reducing treatment delays.7,20,21 However, there were concerns that the integrated model may increase treatment costs because public hospitals in China operate as for-profit organizations that maximize their revenue from medical services.13,14 In addition, patients may not be treated and managed according to the national TB control guidelines. Previous studies reported a proportion of non-adherence to medication ranging from 12 to 40%, and .50% of TB patients were not treated under DOT in provinces under the dispensary model in China.17,18,22,23 Our study reported a higher percentage of persons with presumptive TB who arrived at the TB designated hospitals within 3 days (80.2%) compared to that under the dispensary model (66%).8 TB symptoms are general, and patients prefer visiting general hospitals rather than TB dispensaries. Township hospitals are the major referral channels of TB cases, as well as of other severe clinical cases, to the county general hospital.24 Thus, moving clinical TB services to county hospitals would improve patient access to TB diagnosis and treatment. In addition, referring patients to TB designated hospitals would potentially reduce the workload of TB dispensaries and primary care facilities in terms of tracing.25 We discovered variations among the six research sites regarding TB referrals. Longyou reported the lowest proportion of referrals among six counties. In Longyou, the designated hospital is a general hospital and locally famous for treating infectious diseases;

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Longyou n¼50

Changshan n¼50

Total n¼301

J. Zhong et al.

Transactions of the Royal Society of Tropical Medicine and Hygiene

Table 4. Community-based patient management in the six counties of Zhejiang Haining n¼50

1 (2.0) 1

8 (15.7) 1 (1–2)

6 (12.0) 10 (20.0) 1 (1–3) 3 (3–4)

31 (10.3) 2 (1–4)

49 (98.0) 29 (58.0)

46 (92.0) 14 (27.5)

10 (20.0) 46 (92.0)

194 (64.5)

28 (57.1) 10 (34.5) 21 (42.9) 19 (65.5)

2 (4.3) 0 44 (95.7) 14 (100)

0 7 (15.2) 10 (100) 39 (84.8)

47 (24.2) 147 (75.8)

50 (100)

21 (42.0)

37 (74.0) 37 (72.6)

36 (72.0) 39 (78.0)

220 (73.1)

49 (98.0) 14 (28.0)

37 (74.0) 37 (72.6)

29 (58.0) 38 (76.0)

204 (67.8)

4 (2–7) 22

6 (12.0) 3 (2–6)

2 (1–4) 40

21 (95.5) 12 (30.0) 5 (4–10)

5 (2–12)

0 NC

Shengzhou Longyou Changshan Total n¼51 n¼50 n¼50 n¼301

4 (4–4) 48 2 (4.2) 1

3 (2–4) 51

3 (2–5) 50

4 (2–8) 43

4 (2–6) 254

0

34 (68.0)

9 (20.9)

78 (30.7)

NC

4 (3–6)

3 (3–4)

4 (3–6)

NC: not calculated.

thus, patients may prefer to visit it when they had persistent cough.26 Compared to other counties, a relatively low proportion of arrival within 3 days was observed in Shengzhou. It was possible that fewer patients in Shengzhou were aware of the TB designated hospital, free treatment policy, and location of the hospital.27 Thus, choosing a locally renowned hospital as the TB designated hospital would ease patient access to TB care. The integrated model reported lower medical costs compared with those reported under the dispensary model in previous studies.6,7,21 This may be due to the potentially shorter clinical pathways, as well as expenses, from symptom onset to TB diagnosis. In this study, we found higher medical expenditure for TB treatment than those in studies implemented the dispensary model.6,14 We only included uncomplicated TB patients, who should not receive second-line anti-TB drugs. The efficacy of liver protection drugs is questionable. However, we found that most patients received liver-protection drugs and a quarter received second-line anti-TB drugs, which in total accounted for 75.6% of their total medical expenditure. In Changshan, a large number of patients were given a short course of quinolones, which may increase the risk of developing drug resistance. Very likely, this was economically driven in China’s public hospitals.28 Previous studies of the integrated model reported that patients in poor counties spent more money on TB treatment than those in rich countries, indicating that TB designated hospitals in the poor counties, who may face higher financial pressure, were more likely to regard TB patients as a source of income.25 Therefore, health authorities need to supervise TB treatment in designated hospitals. Hence, there is an urgent need for national guidelines.

Community-based supervision and patient supports should be provided to improve patient medication adherence.5 The selfreported proportion of medication non-adherence in this study was much lower than that reported in previous studies.22,23 This may be related to the strengthened public health capacity of TB dispensaries in the integrated model.13 On the other hand, only a small proportion of patients received observation or home visits from village doctors, indicating that the village doctor DOT was not feasible, as demonstrated in a previous study.29 By managing a new TB patient for 6 months, a village doctor received an incentive of US$9,5 which was not sufficient to compensate them for time.30 Therefore, family members may be promoted as DOT providers after they received adequate training. This study has several limitations. First, selection bias may arise because we only studied uncomplicated TB patients to avoid any case-mix confounders. Second, recall bias may exist because of the nature of retrospective information. In addition, we did not collect information from comparable areas under the dispensary model as this information can be obtained from previous studies. Furthermore, results from the six sites cannot be extrapolated to other places in China, as poor provinces may not obtain the same level of government support. A prospective study of this model in poor provinces of China will present additional evidence to policy-makers.

Conclusions The integrated model performed better on case referral and community management, but with higher medical expenditures than

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Medication adherence Missed at least one dose of anti–TB drugs, n (%) Frequency of missing dose, median (IQR) Directly observed therapy (DOT) Patients who received DOT during TB treatment, n (%) Patients who received DOT from Village doctor, n (%) Family member, n (%) Home visits Home visits from health care worker, n (%) Family doctor of township hospital Patients who received home visits from family doctor of township hospital, n (%) Frequency of home visits, median (IQR) Village doctor Number of patients who did not receive DOT from village doctor Patients who were home visited by village doctors among the ones who did not received DOT from village doctor, n (%) Frequency of home visits, median (IQR)

Tongxiang Cixi n¼50 n¼50

J. Zhong et al.

those reported by studies under the dispensary model in China. Clear guidelines should be issued on supervising TB treatment in designated hospitals.

12 Jiang S, Zhang H, Liu X et al. The development and perspectives of TB designated hospitals in China. Chinese Journal of Antituberculosis 2013;35:765–7. 13 Zou G, Wei X, Walley JD et al. Factors influencing integration of TB services in general hospitals in two regions of China: a qualitative study. BMC Health Serv Res 2012;12:21.

Authors’ contributions: JZ and JY are co-first authors. JY, XLW, JZ and XMW designed the research and tools, oversaw the study, and analyzed data. JY, XLW wrote the manuscript. GZ, YH, JW, XMW and SHC provided critical comments and revised the manuscript. All authors read and approved the final manuscript. XLW is the guarantor of this paper.

Competing interests: None declared. Ethical approval: Ethical approval was obtained from the Ethics Committee of Zhejiang Centre for Disease Control and Prevention. All participants had signed the informed consents prior to the survey.

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Funding: This work was supported by the Communicable Disease and Health Service Delivery (Comdis-HSD) Research Consortium (http:// comdis-hsd.leeds.ac.uk/) funded by the Department of International Development of the UK Government [grant number: HRPC09].

14 Pan HQ, Bele S, Feng Y et al. Analysis of the economic burden of diagnosis and treatment of tuberculosis patients in rural China. Int J Tuberc Lung Dis 2013;17:1575–80.

Experience of implementing the integrated TB model in Zhejiang, China: a retrospective observational study.

This study aims to assess the implementation of the TB control program under the integrated model in China where TB diagnosis and treatment is provide...
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