Evaluation of a package of risk-based pharmaceutical and lifestyle interventions in patients with hypertension and/or diabetes in rural China: A pragmatic cluster randomised controlled trial.

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.

Long-term outcomes of an educational intervention to reduce antibiotic prescribing for childhood upper respiratory tract infections in rural China: Follow-up of a cluster-randomised controlled trial.

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.

Cost-effectiveness analysis of a multi-dimensional intervention to reduce inappropriate antibiotic prescribing for children with upper respiratory tract infections in China.

BACKGROUND: We developed a multifaceted intervention to reduce antibiotic prescription rate for children with upper respiratory tract infections (URTIs) among primary care doctors in township hospitals in China. The intervention achieved a 29% (95% CI 16-42) absolute risk reduction in antibiotic prescribing. This study was to assess the cost-effectiveness of our intervention at reducing antibiotic prescribing in rural primary care facilities as measured by the intervention's effect on the antibiotic prescription rates for childhood URTIs. METHODS: We took a healthcare provider perspective, measuring costs of consultation (time cost of doctor), prescription monitoring process and peer-review meetings (time cost of participants) and medication costs. Costs on provider side were collected through a bespoke questionnaire from all 25 township hospitals in December 2016, while medication costs were collected prospectively in the trial. Incremental cost-effectiveness ratios were calculated by dividing the mean difference in cost of the two trial arms by the mean difference in antibiotic prescribing rate. RESULTS: This showed an incremental cost of $0.03 per percentage point reduction in antibiotic prescribing. In addition to this incremental cost, the cost of implementing the intervention, including training and materials delivered by township hospitals, was $390.65 (SD $145.68) per healthcare facility. CONCLUSIONS: This study shows that a multifaceted intervention programme, when embedded into routine practice, is very cost-effective at reducing antibiotic prescribing in primary care facilities and has the potential of scale up in similar resource limited settings.

Impact of China's essential medicines scheme and zero-mark-up policy on antibiotic prescriptions in county hospitals: a mixed methods study.

OBJECTIVE: To evaluate the impact of the national essential medicines scheme and zero-mark-up policy on antibiotic prescribing behaviour. METHODS: In rural Guangxi, a natural experiment compared one county hospital which implemented the policy with a comparison hospital which did not. All outpatient and inpatient records in 2011 and 2014 were extracted from the two hospitals. Primary outcome indicator was antibiotic prescribing rate (APR) among children aged 2-14 presenting in outpatients with a primary diagnosis of upper respiratory tract infection (URTI). We organised independent physician reviews to determine inappropriate prescribing for inpatients. Difference-in-difference analyses based on multivariate regressions were used to compare APR over time after adjusting potential confounders. We conducted 12 in-depth interviews with paediatricians, hospital directors and health officials. RESULTS: A total of 8219 and 4142 outpatient prescriptions of childhood URTIs were included in the intervention and comparison hospitals, respectively. In 2011, APR was 30% in the intervention and 88% in the comparison hospital. In 2014, the intervention hospital significantly reduced outpatient APR by 21% (95% CI:-23%, -18%), intravenous infusion by 58% (95% CI: -64%, -52%) and prescription cost by 31 USD (95% CI: -35, -28), compared with the controls. We collected 251 inpatient records, but did not find reductions in inappropriate antibiotic use. Interviews revealed that the intervention hospital implemented a thorough antibiotics stewardship programme containing training, peer review of prescriptions and restrictions for overprescribing. CONCLUSION: The national essential medicines scheme and zero-mark-up policy, when implemented with an antimicrobial stewardship programme, may be associated with reductions in outpatient antibiotic prescribing and intravenous infusions.

Is Early Childhood Development Care at Public Health Facilities in Pakistan Effective? A Cluster Randomized Controlled Trial.

BACKGROUND: Significant brain development in children occurs from birth to 2 years, with environment playing an important role. Stimulation interventions are widely known to be effective in enhancing early childhood development (ECD). This study aims to assess the feasibility and effectiveness of integrating ECD care delivered by lady health visitors (LHVs) at public health facilities in rural Pakistan. METHOD: A cluster randomized controlled trial was conducted through public health facilities in 2 districts of Punjab, Pakistan. A total of 22 clusters (rural health centers and subdistrict hospitals) were randomly allocated to receive routine care (control: n=11 clusters, 406 mother-child pairs) or counseling (intervention: n=11 clusters, 398 mother-child pairs). All children aged 11-12 months without any congenital abnormality were eligible for enrollment. The intervention was delivered by the LHVs to mothers with children aged 12-24 months in 3 quarterly sessions. RESULTS: The primary outcome was the prevention of ECD delays in children aged 24 months (assessed with the Ages and Stages Questionnaire-3). Analysis was done on an intention-to-treat basis. A total of 804 mother-child pairs were registered in the study, of which 26 (3.3%) pairs were lost to follow-up at the endpoint. The proportion of children with 2 or more developmental delays was significantly less in the intervention arm (13%) as compared to the control arm (41%) at an endpoint (odds ratio=0.21; 95% confidence interval=0.11, 0.42). Children in the intervention arm also had significantly better anthropometric measurements when aged 24 months than the children in the control arm. CONCLUSION: The integrated ECD care intervention for children aged 12-24 months at public health facilities was found to be effective in enhancing ECD and reducing the proportion of children with global development delays.

Protocol for a pragmatic cluster randomised controlled trial to evaluate the effectiveness of digital health interventions in improving non-communicable disease management during the pandemic in rural Pakistan.

BACKGROUND: The COVID-19 pandemic has revealed gaps in global health systems, especially in the low- and middle-income countries (LMICs). Evidence shows that patients with non-communicable diseases (NCDs) are at higher risk of contracting COVID-19 and suffering direct and indirect health consequences. Considering the future challenges such as environmental disasters and pandemics to the LMICs health systems, digital health interventions (DHI) are well poised to strengthen health care resilience. This study aims to implement and evaluate a comprehensive package of DHIs of integrated COVID-NCD care to manage NCDs in primary care facilities in rural Pakistan. METHODS: The study is designed as a pragmatic, parallel two-arm, multi-centre, mix-methods cluster randomised controlled trial. We will randomise 30 primary care facilities in three districts of Punjab, where basic hypertension and diabetes diagnosis and treatment are provided, with a ratio of 1:1 between intervention and control. In each facility, we will recruit 50 patients who have uncontrolled hypertension. The intervention arm will receive training on an integrated COVID-NCD guideline, and will use a smartphone app-based telemedicine platform where patients can communicate with health providers and peer-supporters, along with a remote training and supervision system. Usual care will be provided in the control arm. Patients will be followed up for 10 months. Our primary indicator is systolic blood pressure measured at 10 months. A process evaluation guided by implementation science frameworks will be conducted to explore implementation questions. A cost-effectiveness evaluation will be conducted to inform future scale up in Pakistan and other LMICs. DISCUSSION: Our study is one of the first randomised controlled trials to evaluate the effectiveness of DHIs to manage NCDs to strengthen health system resilience in LMICs. We will also evaluate the implementation process and cost-effectiveness to inform future scale-up in similar resource constrained settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier-NCT05699369.

Factors influencing integration of TB services in general hospitals in two regions of China: a qualitative study.

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.

District level external quality assurance (EQA) of malaria microscopy in Pakistan: pilot implementation and feasibility.

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) on site 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 between 1.6% 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.

Evaluating the impact of decentralising tuberculosis microscopy services to rural township hospitals in Gansu Province, China.

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.

Cost implications of delays to tuberculosis diagnosis among pulmonary tuberculosis patients in Ethiopia.

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 > or = 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.

Barriers to TB care for rural-to-urban migrant TB patients in Shanghai: a qualitative study.

OBJECTIVE: To understand barriers to tuberculosis (TB) care among migrant TB patients in Shanghai after the introduction of the TB-free treatment policy which has applied to migrants since 2003, and to provide policy recommendations to improve TB control in migrant populations in big cities. METHODS: In-depth interviews were conducted with 34 migrant patients who registered on the Shanghai TB programme as new bacteria positive pulmonary TB cases. Patients were purposively selected across six districts of Shanghai to give a balance of gender and TB treatment phase. RESULTS: Financial constraints were reported as the biggest barriers to TB service among migrant patients. Many migrant patients experienced high medical costs both before and after their TB diagnosis. The government free treatment policy only covered a small fraction of patients' total costs. However, respondents tended to stay in Shanghai for treatment because their families were in Shanghai, they were more confident with the quality of medical care there or they felt they could not earn cash at home. Migrant patients had a limited knowledge of TB and the free TB treatment policy, and reported being laid off from work or avoided after having TB. CONCLUSIONS: Health system problems caused the biggest barrier to migrant patients' access to TB care. The free treatment policy alone has little, if any, effect in reducing migrant patients' financial stress: it is also essential to provide social welfare, including living subsidies, for poor migrant TB patients.

Delayed consultation among pulmonary tuberculosis patients: a cross sectional study of 10 DOTS districts of Ethiopia.

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 >or= 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 >or= 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 (>or= 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.

Palliative care for HIV in the era of antiretroviral therapy availability: perspectives of nurses in Lesotho.

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.

Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial.

BACKGROUND: Hypertension in Pakistan affects 33% of people aged ≥45 years, and in urban areas around 70% of basic health care occurs in private facilities. AIM: To assess whether enhanced care at urban private clinics resulted in better control of hypertension, cardiovascular disease (CVD) risk factors, and treatment adherence. DESIGN & SETTING: A two-arm cluster randomised controlled trial was conducted at 26 private clinics (in three districts of Punjab) between January 2015-September 2016. Both arms had enhanced screening and diagnosis of hypertension and related conditions, and patient recording processes. Intervention facilities also had a clinical care guide, additional drugs for hypertension, a patient lifestyle education flipchart, associated training, and mobile phone follow-up. METHOD: Clinics were randomised in a 1:1 ratio (sealed envelope lottery method). A total of 574 intervention and 564 control patients in 13 clusters in each arm were recruited (male and female, aged ≥25 years, systolic blood pressure [SBP] >140 mmHg, and/or diastolic blood pressure [DBP] >90 mmHg). The primary outcome was change in SBP from baseline to 9-month follow-up.Staff and patients were not blinded, but outcome assessors were blinded. RESULTS: Nine-month primary outcomes were available for 522/574 (90.9%) intervention and 484/564 (85.8%) control participants (all clusters). The unadjusted cluster-level analysis results were as follows: mean intervention outcome was -25.2 mmHg (95% confidence intervals [CI] = -29.9 to-20.6); mean control outcome was -9.4 mmHg (95% CI = 21.2 to 2.2); and mean control-intervention difference was 15.8 (95% CI = 3.6 to 28.0; P = 0.01). CONCLUSION: The findings and separate process evaluation support the scaling of an integrated CVD-hypertension care intervention in urban private clinics in areas lacking public primary care in Pakistan.

Feasibility of delivering integrated COPD-asthma care at primary and secondary level public healthcare facilities in Pakistan: a process evaluation.

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.

Effectiveness of delivering integrated COPD care at public healthcare facilities: a cluster randomised trial in Pakistan.

BACKGROUND: In Pakistan chronic obstructive pulmonary disease (COPD) prevalence is 2.1% in adults aged >40 years. Despite being a health policy focus, integrated COPD care has remained neglected, with wide variation in practice. AIM: To assess whether enhanced care at public health facilities resulted in better control of COPD, treatment adherence, and smoking cessation. DESIGN & SETTING: A two-arm cluster randomised controlled trial was undertaken in 30 public health facilities (23 primary and 7 secondary), across three districts of Punjab, between October 2014-December 2016. Both arms had enhanced diagnosis and patient recording processes. Intervention facilities also had clinical care guides; drugs for COPD; patient education flipcharts; associated staff training; and mobile phone follow-up. METHOD: Facilities were randomised in a 1:1 ratio (sealed envelope independent lottery method), and 159 intervention and 154 control patients were recruited. The eligibility criteria were as follows: diagnosed with COPD, aged ≥18 years, and living in the catchment area. The primary outcome was change in BODE (Body mass index, airway Obstruction, Dyspnoea, Exercise capacity) index score from baseline to final follow-up visit. Staff and patients were not blinded. RESULTS: Six-month primary outcomes were available for 147/159 (92.5%) intervention and 141/154 (91.6%) control participants (all clusters). The primary outcome results cluster-level analysis were as follows: mean intervention outcome = -1.67 (95% confidence intervals [CI] = -2.18 to -1.16); mean control outcome = -0.66 (95% CI = -1.09 to -0.22); and covariate-adjusted mean intervention-control difference = -0.96 (95% CI = -1.49 to -0.44; P = 0.001). CONCLUSION: The findings of this trial and a separate process evaluation study support the scaling of this integrated COPD care package at primary and secondary level public health facilities in Pakistan and similar settings.

Adapting a generic tuberculosis control operational guideline and scaling it up in China: a qualitative case study.

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.

Is integrated private-clinic based early child development care effective? A clustered randomised trial in Pakistan.

BACKGROUND: In Pakistan, high prevalence of delays in early child development (ECD) is associated with poverty and lack of mothers' caregiving skills. GP clinics, the main sources of care in poor urban localities, lack quality ECD care delivery. A contextualised intervention was developed and tested to enable GPs to deliver clinic-based, tool-assisted ECD counselling of mothers on a quarterly basis. AIM: To assess the effectiveness of delivering a contextualised ECD mother-counselling intervention. DESIGN & SETTING: Clustered randomised controlled trial, in poor urban localities of Pakistan. Locality clusters were allocated to intervention and control arm using simple randomisation. METHOD: A total of 2327 mother-child pairs were recruited at 32 GP clinics, one from each cluster-locality; 16 GP clinics per arm. The clinic-based counselling intervention covering child stimulation, nutrition, and maternal mental health was delivered mainly by clinic assistants to mothers at ≤6 weeks, and 3, 6, and 9 months of child age. At 12 months of child age, each mother-child pair was assessed for the primary outcome, that is, delays in the five development domains (determined by Ages and Stages Questionnaire-3 [ASQ-3] score); and secondary outcomes, namely the prevalence of stunting and maternal depression (determined by Patient Health Questionnaire-9 [PHQ-9] score). The outcome assessors were blinded to the cluster-arm allocation. Outcome analyses were calculated on cluster-level. RESULTS: At 12 months, the number of children with delay in two or more development domains was significantly lower in the intervention arm (-0.17 [95% confidence interval {CI} = -0.26 to -0.09]; P<0.001) compared to the control arm. The difference in the prevalence of child stunting and maternal depression were also significant at -0.21% (95% CI = -0.30 to -0.13; P<0.001) and -0.23% (95% CI = -0.29 to -0.18; P = 0.000) respectively. CONCLUSION: Contextualised ECD care, when delivered at GP clinics in poor urban localities, can effectively reduce the developmental delays during the first 12 months of the child's life.

Process evaluation of integrated diabetes management at primary healthcare facilities in Pakistan: a mixed-methods study.

BACKGROUND: Integrated care for diabetes and associated conditions at primary level health facilities can make care available to a much larger population, especially in rural areas. AIM: This process evaluation was to understand how the authors' integrated care was implemented and experienced by the care providers and patients, and to inform modifications prior to province-wide scale-up. DESIGN & SETTING: The mixed-method study was conducted as part of a cluster randomised trial on integrated diabetes care at 14 public health facilities. METHOD: The care practices were assessed by analysing the routine clinical records of 495 registered patients with diabetes. Then semi-structured interviews with service providers and patients were used to understand their respective care experiences. A framework approach was applied to analyse and interpret the qualitative data. RESULTS: The intervention and the study were implemented as intended under routine conditions in rural health centres. Key service processes effectively delivered included: skill-based training; screening and diagnostic tests; treatment card records; and the additional case management as per desk guide, including monitoring progress in glucose and weight at follow-up consultations, and mobile phone calls to help adherence. However, social and cultural factors affected clients' ability to change lifestyles, especially for women. The intervention effect was limited by the short study follow-up of only 9 months. CONCLUSION: Integrated diabetes care was feasible, both for providers and patients, and potentially scalable at primary care facilities under routine conditions in Pakistan. Additional operational interventions are required for sustained drug supplies, supervision, in-service training, and to address the social challenges to healthy activity and eating, especially for women.