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Background Primary prevention of cardiovascular disease (CVD) requires adequate control of hypertension and diabetes. We designed and implemented pharmaceutical and healthy lifestyle interventions for patients with diabetes and/or hypertension in rural primary care, and assessed their effectiveness at reducing severe CVD events. Methods and findings We used a pragmatic, parallel group, 2-arm, controlled, superiority, cluster trial design. We randomised 67 township hospitals in Zhejiang Province, China, to intervention (34) or control (33). A total of 31,326 participants were recruited, with 15,380 in the intervention arm and 15,946 in the control arm. Participants had no known CVD and were either patients with hypertension and a 10-year CVD risk of 20% or higher, or patients with type 2 diabetes regardless of their CVD risk. The intervention included prescription of a standardised package of medicines, individual advice on lifestyle change, and adherence support. Control was usual hypertension and diabetes care. In both arms, as usual in China, most outpatient drug costs were out of pocket. The primary outcome was severe CVD events, including coronary heart disease and stroke, during 36 months of follow-up, as recorded by the CVD surveillance system. The study was implemented between December 2013 and May 2017. A total of 13,385 (87%) and 14,745 (92%) participated in the intervention and control arms, respectively. Their mean age was 64 years, 51% were women, and 90% were farmers. Of all participants, 64% were diagnosed with hypertension with or without diabetes, and 36% were diagnosed with diabetes only. All township hospitals and participants completed the 36-month follow-up. At 36 months, there were 762 and 874 severe CVD events in the intervention and control arms, respectively, yielding a non-significant effect on CVD incidence rate (1.92 and 2.01 per 100 person-years, respectively; crude incidence rate ratio = 0.90 [95% CI: 0.74, 1.08; P = 0.259]). We observed significant, but small, differences in the change from baseline to follow-up for systolic blood pressure (-1.44 mm Hg [95% CI: -2.26, -0.62; P < 0.001]) and diastolic blood pressure (-1.29 mm Hg [95% CI: -1.77, -0.80; P < 0.001]) in the intervention arm compared to the control arm. Self-reported adherence to recommended medicines was significantly higher in the intervention arm compared with the control arm at 36 months. No safety concerns were identified. Main study limitations include all participants being informed about their high CVD risk at baseline, non-blinding of participants, and the relatively short follow-up period available for judging potential changes in rates of CVD events. Conclusions The comprehensive package of pharmaceutical and healthy lifestyle interventions did not reduce severe CVD events over 36 months. Improving health system factors such as universal coverage for the cost of essential medicines is required for successful risk-based CVD prevention programmes. Trial registration ISRCTN registry ISRCTN58988083., Author(s): Xiaolin Wei 1, Zhitong Zhang 1, Marc K. C. Chong 2, Joseph P. Hicks 3, Weiwei Gong 4, Guanyang Zou 5, Jieming Zhong 4, John D. Walley 3, Ross [...]

Background Inappropriate antibiotic prescribing causes widespread serious health problems. To reduce prescribing of antibiotics in Chinese primary care to children with upper respiratory tract infections (URTIs), we developed an intervention comprising clinical guidelines, monthly prescribing review meetings, doctor-patient communication skills training, and education materials for caregivers. We previously evaluated our intervention using an unblinded cluster-randomised controlled trial (cRCT) in 25 primary care facilities across two rural counties. When our trial ended at the 6-month follow-up period, we found that the intervention had reduced antibiotic prescribing for childhood URTIs by 29 percentage points (pp) (95% CI -42 to -16). Methods and findings In this long-term follow-up study, we collected our trial outcomes from the one county (14 facilities and 1:1 cluster randomisation ratio) that had electronic records available 12 months after the trial ended, at the 18-month follow-up period. Our primary outcome was the antibiotic prescription rate (APR)-the percentage of outpatient prescriptions containing any antibiotic(s) for children aged 2 to 14 years who had a primary diagnosis of a URTI and had no other illness requiring antibiotics. We also conducted 15 in-depth interviews to understand how interventions were sustained. In intervention facilities, the APR was 84% (1,171 out of 1,400) at baseline, 37% (515 out of 1,380) at 6 months, and 54% (2,748 out of 5,084) at 18 months, and in control facilities, it was 76% (1,063 out of 1,400), 77% (1,084 out of 1,400), and 75% (2,772 out of 3,685), respectively. After adjusting for patient and prescribing doctor covariates, compared to the baseline intervention-control difference, the difference at 6 months represented a 6-month intervention-arm reduction in the APR of -49 pp (95% CI -63 to -35; P < 0.0001), and compared to the baseline difference, the difference at 18 months represented an 18-month intervention-arm reduction in the APR of -36 pp (95% CI -55 to -17; P < 0.0001). Compared to the 6-month intervention-control difference, the difference at 18 months represented no change in the APR: 13 pp (95% CI -7 to 33; P = 0.21). Factors reported to sustain reductions in antibiotic prescribing included doctors' improved knowledge and communication skills and focused prescription review meetings, whereas lack of supervision and monitoring may be associated with relapse. Key limitations were not including all clusters from the trial and not collecting returned visits or sepsis cases. Conclusions Our intervention was associated with sustained and substantial reductions in antibiotic prescribing at the end of the intervention period and 12 months later. Our intervention may be adapted to similar resource-poor settings. Trial registration ISRCTN registry ISRCTN14340536., Author(s): Xiaolin Wei 1, Zhitong Zhang 2, Joseph P. Hicks 3, John D. Walley 3, Rebecca King 3, James N. Newell 3, Jia Yin 4,5, Jun Zeng 6, Yan Guo [...]

Abstract Background In the majority of China, the Centre for Disease Control (CDC) at the county level provides both clinical and public health care for TB cases, with hospitals and other health facilities referring suspected TB cases to the CDC. In recent years, an integrated model has emerged, where the CDC remains the basic management unit for TB control, while a general hospital is designated to provide clinical care for TB patients. This study aims to explore the factors that influence the integration of TB services in general hospitals and generate knowledge to aid the scale-up of integration of TB services in China. Methods This study adopted a qualitative approach using interviews from sites in East and West China. Analysis was conducted using a thematic framework approach. Results The more prosperous site in East China was more coordinated and thus had a better method of resource allocation and more patient-orientated service, compared with the poorer site in the West. The development of public health organizations appeared to influence how effectively integration occurred. An understanding from staff that hospitals had better capacity to treat TB patients than CDCs was a strong rationale for integration. However, the economic and political interests might act as a barrier to effective integration. Both sites shared the same challenges of attracting and retaining a skilled workforce for the TB services. The role of the health bureau was more directive in the Western site, while a more participatory and collaborative approach was adopted in the Eastern site. Conclusion The process of integration identifies similarities and differences between sites in more affluent East China and poorer West China. Integration of TB services in the hospitals needs to address the challenges of stakeholder motivations and resource allocation. Effective inter-organizational collaboration could help to improve the efficiency and quality of TB service. Key words: TB control, service delivery, integration, hospitals, China.

Abstract Background In 2004, the Ministry of Health issued the policy of decentralising microscopy services (MCs) to one third of all township hospitals in China. The study was conducted in Gansu Province, a poor western one in China. Ganzhou was one county in Gansu Province. Ganzhou County was identified as a unique case of further decentralisation of tuberculosis (TB) treatment services in township hospitals. The study evaluated the impact of the MC policy on providers and patients in Gansu Province. The second objective was to assess the unique case of Ganzhou County compared with other counties in the province. Methods Both quantitative and qualitative methods were used. All 523 MCs in the province completed an institutional survey regarding their performance. Four counties were selected for in-depth investigation, where 169 TB suspects were randomly selected from the MC and county TB dispensary registers for questionnaire surveys. Informant interviews were conducted with 38 health staff at the township and county levels in the four counties. Results Gansu established MCs in 39% of its township hospitals. From January 2006 to June 2007, 8% of MCs identified more than 10 TB sputum smear positive patients while 54% did not find any. MCs identified 1546 TB sputum smear positive patients, accounting for 9% of the total in the province. The throughputs of MCs in Ganzhou County were eight times of those in other counties. Interviews identified several barriers to implement the MC policy, such as inadequate health financing, low laboratory capacity, lack of human resources, poor treatment and management capacities, and lack of supervisions from county TB dispensaries. Conclusion Microscopy centre throughputs were generally low in Gansu Province, and the contribution of MCs to TB case detection was insignificant taking account the number of MCs established. As a unique case of full decentralisation of TB service, Ganzhou County presented better results. However, standards and quality of TB care needed to be improved. The MC policy needs to be reviewed in light of evidence from this study.

Abstract Background Prompt, quality assured laboratory diagnosis is key to effective malaria case management and control, especially since the introduction of the more expensive artemisinin combination therapy (ACT). The malaria programme and its non-government partners, on the basis of WHO recommended Lot Quality Assurance methods, have developed a district level external quality assurance (EQA) system. This study was designed to assess the feasibility, under programme conditions, of an integrated district level external quality assurance and supervision approach for malaria microscopy. Design and Methods A prospective study conducted over seven months period (May-November 2007). In addition to the standard WHO EQA elements, three operational innovations were introduced, with the a district laboratory supervisor: a) onsite re-checking of slides, b) in ensuring uninterrupted availability of laboratory reagents and supplies at diagnostic centers, and c) supervision of administrative and technical components. The quantitative data for the study came from the service records/documents, whereas the qualitative data came from the key informant interviews. Results During the seven month period in four districts, a total of 8,118 slides were examined of which 209 (2.6%) were found positive for malaria parasites (slide positivity range between1.6% to 6.0%). The District Laboratory Supervisors in four districts reexamined a total of 1,770 slides (22%). The proportion of slides found discordant ranged from 0.5% to 1%. The quality of smear preparation was found acceptable in 73% slides. Conclusions A district-based EQA, based on lot quality assurance methods was implemented, using context-specific operational guidelines, tools and training modules, and other inputs from the malaria control programme and partners. This EQA and supervision approach was found to be feasible and acceptable to those involved. Further study is required on the microscopy quality and cost-effectiveness of adding external quality assurance and supervision to district malaria microscopy services.

Abstract Background Delays seeking care worsen the burden of tuberculosis and cost of care for patients, families and the public health system. This study investigates costs of tuberculosis diagnosis incurred by patients, escorts and the public health system in 10 districts of Ethiopia. Methods New pulmonary tuberculosis patients ≥ 15 years old were interviewed regarding their health care seeking behaviour at the time of diagnosis. Using a structured questionnaire patients were interviewed about the duration of delay at alternative care providers and the public health system prior to diagnosis. Costs incurred by patients, escorts and the public health system were quantified through patient interview and review of medical records. Results Interviews were held with 537 (58%) smear positive patients and 387 (42%) smear negative pulmonary patients. Of these, 413 (45%) were female; 451 (49%) were rural residents; and the median age was 34 years. The mean (median) days elapsed for consultation at alternative care providers and public health facilities prior to tuberculosis diagnosis was 5 days (0 days) and 3 (3 days) respectively. The total median cost incurred from first consultation to diagnosis was $27 per patient (mean = $59). The median costs per patient incurred by patient, escort and the public health system were $16 (mean = $29), $3 (mean = $23) and $3 (mean = $7) respectively. The total cost per patient diagnosed was higher for women, rural residents; those who received government food for work support, patients with smear negative pulmonary tuberculosis and patients who were not screened for TB in at least one district diagnostic centers. Conclusions The costs of tuberculosis diagnosis incurred by patients and escorts represent a significant portion of their monthly income. The costs arising from time lost in seeking care comprised a major portion of the total cost of diagnosis, and may worsen the economic position of patients and their families. Getting treatment from alternative sources and low index of suspicion public health providers were key problems contributing to increased cost of tuberculosis diagnosis. Thus, the institution of effective systems of referral, ensuring screening of suspects across the district public health system and the involvement of alternative care providers in district tuberculosis control can reduce delays and the financial burden to patients and escorts.

Abstract Background Southern Africa is disproportionately affected by the HIV/AIDS epidemic. In Lesotho 23% of adults are HIV-positive, and only 26% of those in need are accessing antiretroviral treatment (ART). Consequently, about 18,000 people die from AIDS each year. In this situation, palliative care is needed towards the end of life, but is also recommended throughout the HIV disease trajectory. The World Health Organisation (WHO) has produced the Integrated Management of Adolescent and Adult Illness (IMAI) guidelines, which includes a palliative care guidebook (as well as acute and chronic ART guidebooks). IMAI aims to facilitate the implementation of integrated HIV/AIDS care in resource-poor areas. The opinions of health workers towards this integrated approach to care and the use of IMAI has not been considered in previous research studies. This paper therefore aims to address some of these issues. Methods Semi-structured interviews were conducted with six key informants and ten nurses in Lesotho. The interviews were transcribed verbatim and analysed using content thematic analysis. Results Many nurses described palliative care as synonymous with chronic care and felt that palliative care is necessary for HIV-positive patients despite the introduction of ART. It was thought that the approach taken should be holistic and integrated throughout the disease trajectory. Pain management was noted to be a particular area of need for palliative care, and it was suggested that this could be improved in Lesotho. The IMAI guidelines were thought to be useful, but knowledge of the palliative care booklet was limited. Conclusion Palliative care remains necessary for HIV despite the increasing availability of ART. However, it is currently significantly lacking in Lesotho and many other sub-Saharan African countries. Greater understanding of palliative care amongst health workers is required, as well as strong political will from the Ministry of Health. The IMAI guidelines are a useful tool for holistic HIV care, including palliative care, but they need to be used more effectively. As ART is becoming increasingly available worldwide, the complex chronic care issues for patients with HIV/AIDS should not be neglected.

Abstract Background Delays seeking care increase transmission of pulmonary tuberculosis and hence the burden of tuberculosis, which remains high in developing countries. This study investigates patterns of health seeking behavior and determines risk factors for delayed patient consultation at public health facilities in 10 districts of Ethiopia. Methods New pulmonary TB patients ≥ 15 years old were recruited at 18 diagnostic centres. Patients were asked about their health care seeking behaviour and the time from onset of symptoms to first consultation at a public health facility. First consultation at a public health facility 30 days or longer after onset of symptoms was regarded as prolonged patient delay. Results Interviews were held with 924 pulmonary patients. Of these, 537 (58%) were smear positive and 387 (42%) were smear negative; 413 (45%) were female; 451 (49%) were rural residents; and the median age was 34 years. Prior to their first consultation at a public health facility, patients received treatment from a variety of informal sources: the Orthodox Church, where they were treated with holy water (24%); private practitioners (13%); rural drug vendors (7%); and traditional healers (3%). The overall median patient delay was 30 days (mean = 60 days). Fifty three percent [95% Confidence Intervals (CI) (50%, 56%)] of patients had delayed their first consultation for ≥ 30 days. Patient delay for women was 54%; 95% CI (54%, 58%) and men 51%; 95% CI (47%, 55%). The delay was higher for patients who used informal treatment (median 31 days) than those who did not (15 days). Prolonged patient delay (≥ 30 days) was significantly associated with both patient-related and treatment-related factors. Significant patient-related factors were smear positive pulmonary disease [Adjusted Odds Ratio (AOR) 1.4; 95% CI (1.1 to 1.9)], rural residence [AOR 1.4; 95% CI (1.1 to 1.9)], illiteracy [AOR 1.7; 95% CI (1.2 to 2.4)], and lack of awareness/misperceptions of causes of pulmonary TB. Significant informal treatment-related factors were prior treatment with holy water [AOR 3.5; 95% CI (2.4 to 5)], treatment by private practitioners [AOR 1.7; 95% CI (1.1 to 2.6)] and treatment by drug vendors [AOR 1.9; 95% CI (1.1 to 3.5)]. Conclusion Nearly half of pulmonary tuberculosis patients delayed seeking health care at a public health facility while getting treatment from informal sources. The involvement of religious institutions and private practitioners in early referral of patients with pulmonary symptoms and creating public awareness about tuberculosis could help reduce delays in starting modern treatment.

Abstract Background The TB operational guideline (the deskguide) is a detailed action guide for county TB doctors aiming to improve the quality of DOTS, while the China national TB policy guide is a guide to TB control that is comprehensive but lacks operational usability for frontline TB doctors. This study reports the process of deskguide adaptation, its scale-up and lessons learnt for policy implications. Methods The deskguide was translated, reviewed, and revised in a working group process. Details of the eight adaptation steps are reported here. An operational study was embedded in the adaptation process. Two comparable prefectures were chosen as pilot and control sites in each of two participating provinces. In the pilot sites, the deskguide was used with the national policy guide in routine in-service training and supervisory trips; while in the control sites, only the national policy guide was used. In-depth interviews and focus groups were conducted with 16 county TB doctors, 16 township doctors, 17 village doctors, 63 TB patients and 57 patient family members. Following piloting, the deskguide was incorporated into the national TB guidelines for county TB dispensary use. Results Qualitative research identified that the deskguide was useful in the daily practice of county TB doctors. Patients in the pilot sites had a better knowledge of TB and better treatment support compared with those in the control sites. Conclusion The adaptation process highlighted a number of general strategies to adapt generic guidelines into country specific ones: 1) local policy-makers and practitioners should have a leading role; 2) a systematic working process should be employed with capable focal persons; and 3) the guideline should be embedded within the current programmes so it is sustainable and replicable for further scale-up.

Background: In Pakistan, the estimated prevalence of chronic obstructive pulmonary disease (COPD) and asthma are 2.1% and 4.3% respectively, and existing care is grossly lacking both in coverage and quality. An integrated approach is recommended for delivering COPD and asthma care at public health facilities. Aim: To understand how an integrated care package was experienced by care providers and patients, and to inform modifications prior to scaling up. Design & setting: The mixed-methods study was conducted as part of cluster randomised trials on integrated COPD and asthma care at 30 public health facilities. Method: The care practices were assessed by analysing the clinical records of n = 451 asthma and n = 313 COPD patients. Semi-structured interviews with service providers and patients were used to understand their care experiences. A framework approach was applied to analyse and interpret qualitative data. Results: Utilisation of public health facilities for chronic lung conditions was low, mainly because of the non-availability of inhalers. When diagnosed, around two-thirds (69%) of male and more than half (55%) of female patients had severe airway obstruction. The practice of prescribing inhalers differed between intervention and control arms. Patient non-adherence to follow-up visits remained a major treatment challenge (though attrition was lower and slower in the intervention arm). Around half of the male responders who smoked at baseline reported having quit smoking. Conclusion: The integrated care of chronic lung conditions at public health facilities is feasible and leads to improved diagnosis and treatment in a low-income country setting. The authors recommend scaling of the intervention with continued implementation research, especially on improving patient adherence to treatment. [ABSTRACT FROM AUTHOR]

Background TB and HIV interaction increases TB incidence and HIV adverse outcomes. Integration improves patients' access to comprehensive care. This paper compares the impact of increasing integration on TB/HIV service delivery. Methods Three hospitals with different delivery models were identified and a survey of TB cases registered between June 2007 and December 2008 conducted. HIV screening, co-trimoxazole preventive therapy (CPT) and antiretroviral therapy (ART) uptake for HIV-positive TB patients were compared. Results Of the 590 TB patients, 85.9% (507/590) knew their HIV status. HIV screening was highest (98.6% [95%CI: 97.6–99.5%]) at the one-stop shop (OSS) and lowest (72.5% [71.9–73.9%]) at the referral site (RS). CPT was highest [(93.8% [91.0–96.7%]) at the RS and least (74.7% [72.8–76.5%]) at the partially-integrated site (PIS). At the OSS it was 82.3% (80.6–84.0%). ART was highest (59.5% [58.0–61.0%]) at the PIS, and 10.8% (10.4–11.1%) at the RS. No ART records existed at the OSS. Conclusions Increasing integration improved HIV screening but not CPT or ART uptake. There was insufficient evidence to identify the most effective model due to design limitations and health system barriers. More research and training is needed to improve uptake, data completeness and accuracy. [ABSTRACT FROM AUTHOR]

Background: In 2004, the Ministry of Health issued the policy of decentralising microscopy services (MCs) to one third of all township hospitals in China. The study was conducted in Gansu Province, a poor western one in China. Ganzhou was one county in Gansu Province. Ganzhou County was identified as a unique case of further decentralisation of tuberculosis (TB) treatment services in township hospitals. The study evaluated the impact of the MC policy on providers and patients in Gansu Province. The second objective was to assess the unique case of Ganzhou County compared with other counties in the province. Methods: Both quantitative and qualitative methods were used. All 523 MCs in the province completed an institutional survey regarding their performance. Four counties were selected for in-depth investigation, where 169 TB suspects were randomly selected from the MC and county TB dispensary registers for questionnaire surveys. Informant interviews were conducted with 38 health staff at the township and county levels in the four counties. Results: Gansu established MCs in 39% of its township hospitals. From January 2006 to June 2007, 8% of MCs identified more than 10 TB sputum smear positive patients while 54% did not find any. MCs identified 1546 TB sputum smear positive patients, accounting for 9% of the total in the province. The throughputs of MCs in Ganzhou County were eight times of those in other counties. Interviews identified several barriers to implement the MC policy, such as inadequate health financing, low laboratory capacity, lack of human resources, poor treatment and management capacities, and lack of supervisions from county TB dispensaries. Conclusion: Microscopy centre throughputs were generally low in Gansu Province, and the contribution of MCs to TB case detection was insignificant taking account the number of MCs established. As a unique case of full decentralisation of TB service, Ganzhou County presented better results. However, standards and quality of TB care needed to be improved. The MC policy needs to be reviewed in light of evidence from this study. [ABSTRACT FROM AUTHOR]

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Background: The TB operational guideline (the deskguide) is a detailed action guide for county TB doctors aiming to improve the quality of DOTS, while the China national TB policy guide is a guide to TB control that is comprehensive but lacks operational usability for frontline TB doctors. This study reports the process of deskguide adaptation, its scale-up and lessons learnt for policy implications. Methods: The deskguide was translated, reviewed, and revised in a working group process. Details of the eight adaptation steps are reported here. An operational study was embedded in the adaptation process. Two comparable prefectures were chosen as pilot and control sites in each of two participating provinces. In the pilot sites, the deskguide was used with the national policy guide in routine in-service training and supervisory trips; while in the control sites, only the national policy guide was used. In-depth interviews and focus groups were conducted with 16 county TB doctors, 16 township doctors, 17 village doctors, 63 TB patients and 57 patient family members. Following piloting, the deskguide was incorporated into the national TB guidelines for county TB dispensary use. Results: Qualitative research identified that the deskguide was useful in the daily practice of county TB doctors. Patients in the pilot sites had a better knowledge of TB and better treatment support compared with those in the control sites. Conclusion: The adaptation process highlighted a number of general strategies to adapt generic guidelines into country specific ones: 1) local policy-makers and practitioners should have a leading role; 2) a systematic working process should be employed with capable focal persons; and 3) the guideline should be embedded within the current programmes so it is sustainable and replicable for further scale-up. [ABSTRACT FROM AUTHOR]