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.

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.

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.

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.

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.

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.

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.

Delivering integrated hypertension care at private health facilities in urban Pakistan: a process evaluation.

BACKGROUND: In Pakistan about 18% of all adults are affected by hypertension, and only one in eight of the prevalent cases have their hypertension controlled. As in many other low-middle income countries, a public-private partnership approach is being considered for delivering non-communicable disease care in urban areas. AIM: This process evaluation was undertaken to understand how an integrated care intervention was experienced by the care providers and patients, and to inform modifications before possible scaling. DESIGN & SETTING: The mixed-methods study was conducted as part of a cluster randomised trial on integrated hypertension care at 26 private clinics. METHOD: The care practices were assessed by analysing the clinical records of 1138 registered patients with hypertension. 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: District-led objective selection and context-sensitive staff training helped to get the clinics engaged in partnership working. About one-third of patients with hypertension had associated diabetes or renal compromise. The prescription of drugs is influenced by multiple non-clinical considerations of providers and patients. Many doctors allowed the use of home-based remedies as supplements to the prescribed allopathic drugs. Female patients faced more challenges in managing lifestyle changes. The intervention improved adherence to follow-up visits, but patient attrition remained a challenge. CONCLUSION: The integrated hypertension care intervention at private clinics is feasible, and leads to improved diagnosis and treatment in low-income country urban setting. The authors recommend continued implementation research and informed scaling of hypertension care at private clinics.

Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan.

BACKGROUND: There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030. AIM: To assess if an integrated care package can achieve better control of diabetes. DESIGN & SETTING: The pragmatic cluster randomised controlled trial (cRCT) was conducted from December 2014-June 2016 at 14 primary healthcare facilities in Sargodha district. Opportunistic screening, diagnostic testing, and patient recording processes were introduced in both the control 'testing, treating, and recording' (TTR) arm, and the intervention 'additional case management' (ACM) arm, which also included a clinical care guide and pictorial flipbook for lifestyle education, associated clinician training, and mobile phone follow-up. METHOD: Clinics were randomised on a 1:1 basis (sealed envelope lottery method) and 250 patients recruited in the ACM arm and 245 in the TTR-only arm (age ≥25 years and HbA1c >7%). The primary outcome was mean change in HbA1c (%) from baseline to 9-month follow-up. Patients and staff were not blinded. RESULTS: The primary outcome was available for n = 238/250 (95.2%) participants in the ACM arm and n = 219/245 (89.4%) participants in the TTR-only arm (all clusters). Cluster level mean outcome was -2.26 pp (95% confidence intervals [CI] = -2.99 to -1.53) for the ACM arm, and -1.44 pp (95% CI = -2.34 to -0.54) for the TTR-only arm. Cluster level mean ACM-TTR difference (covariate-unadjusted) was -0.82 pp (95% CI = -1.86 to 0.21; P = 0.11). CONCLUSION: The ACM intervention in public healthcare facilities did not show a statistically significant effect on HbA1c reduction compared to the control (TTR-only) arm. Future evaluation should assess changes after a longer follow-up period, and minimal care enhancement in the comparator (control) arm.

Effect of a training and educational intervention for physicians and caregivers on antibiotic prescribing for upper respiratory tract infections in children at primary care facilities in rural China: a cluster-randomised controlled trial.

BACKGROUND: Inappropriate antibiotic prescribing contributes to the generation of drug resistance worldwide, and is particularly common in China. We assessed the effectiveness of an antimicrobial stewardship programme aiming to reduce inappropriate antibiotic prescribing in paediatric outpatients by targeting providers and caregivers in primary care hospitals in rural China. METHODS: We did a pragmatic, cluster-randomised controlled trial with a 6-month intervention period. Clusters were primary care township hospitals in two counties of Guangxi province in China, which were randomly allocated to the intervention group or the control group (in a 1:1 ratio in Rong county and in a 5:6 ratio in Liujiang county). Randomisation was stratified by county. Eligible participants were children aged 2-14 years who attended a township hospital as an outpatient and were given a prescription following a primary diagnosis of an upper respiratory tract infection. The intervention included clinician guidelines and training on appropriate prescribing, monthly prescribing peer-review meetings, and brief caregiver education. In hospitals allocated to the control group, usual care was provided, with antibiotics prescribed at the individual clinician's discretion. Patients were masked to their allocated treatment group but doctors were not. The primary outcome was the antibiotic prescription rate in children attending the hospitals, defined as the cluster-level proportion of prescriptions for upper respiratory tract infections in 2-14-year-old outpatients, issued during the final 3 months of the 6-month intervention period (endline), that included one or more antibiotics. The outcome was based on prescription records and analysed by modified intention-to-treat. This study is registered with the ISRCTN registry, number ISRCTN14340536. FINDINGS: We recruited all 25 eligible township hospitals in the two counties (14 hospitals in Rong county and 11 in Liujiang county), and randomly allocated 12 to the intervention group and 13 to the control group. We implemented the intervention in three internal pilot clusters between July 1, 2015, and Dec 31, 2015, and in the remaining nine intervention clusters between Oct 1, 2016 and March 31, 2016. Between baseline (the 3 months before implementation of the intervention) and endline (the final 3 months of the 6-month intervention period) the antibiotic prescription rate at the individual level decreased from 82% (1936/2349) to 40% (943/2351) in the intervention group, and from 75% (1922/2548) to 70% (1782/2552) in the control group. After adjusting for the baseline antibiotic prescription rate, stratum (county), and potentially confounding patient and prescribing doctor covariates, this endline difference between the groups represented an intervention effect (absolute risk reduction in antibiotic prescribing) of -29% (95% CI -42 to -16; p=0·0002). INTERPRETATION: In China's primary care setting, pragmatic interventions on antimicrobial stewardship targeting providers and caregivers substantially reduced prescribing of antibiotics for childhood upper respiratory tract infections. FUNDING: Department of International Development (UKAID) through Communicable Diseases Health Service Delivery.

Implementation of a comprehensive intervention for patients at high risk of cardiovascular disease in rural China: A pragmatic cluster randomized controlled trial.

OBJECTIVE: This study aims to assess whether a standard intervention package of cardiovascular disease (CVD) care was being delivered effectively, and if it was associated with improved lifestyle and biomedical indicators. METHODS: In rural China, we implemented a pragmatic cluster randomized controlled trial for 12 months, randomized at the township hospital level, and compared with usual care. Intervention case management guideline, training and performance monitoring meeting and patient support activities were designed to fit within the job description of family doctors in the township hospitals and comprised: 1) prescription of a standardised package of medicines targeted at those with hypertension or diabetes; 2) advice about specific lifestyle interventions; and 3) advice about medication adherence. Participants were 50-74 years old, had hypertension and CVD risk scores >20% or diabetes, but were excluded if a history of severe CVD events. We also randomly selected 100 participants from six selected clusters per arm as a panel to collect intermediate biomedical indicators over time. RESULTS: A total of 28,130 participants, in 33 intervention and 34 control township hospitals, were recruited. Compared with the control arm, participants in the intervention arm had substantially improved prescribing rates of anti-hypertensives, statins and aspirin (P<0.001), and had higher medication taking rates of aspirin and statins (P<0.001). Mean systolic and diastolic blood pressures were similar across both arms (0.15 mmHg, P = 0.79, and 0.52 mmHg, P = 0.05, respectively). In the panel, (950) rates of smoking (OR = 0.23, P = 0.02) and salt intake (OR = 2.85, P = 0.03) were significantly reduced in the intervention versus control arms, but there were no statistically significant improvement over the 12 month follow-up period in biomedical indicators (P>0.05). CONCLUSION: Implementation of the package by family doctors was feasible and improved prescribing and some lifestyle changes. Additional measures such as reducing medication costs and patient education are required. TRIAL REGISTRATION: Current Controlled Trials ISRCTN58988083.

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.

Delivering TB/HIV services in Ghana: a comparative study of service delivery models.

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.

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.