Effectiveness of a comprehensive package based on electronic medication monitors at improving treatment outcomes among tuberculosis patients in Tibet: a multicentre randomised controlled trial.

BACKGROUND: WHO recommends that electronic medication monitors, a form of digital adherence technology, be used as a complement to directly observed treatment (DOT) for tuberculosis, as DOT is inconvenient and costly. However, existing evidence about the effectiveness of these monitors is inconclusive. Therefore, we evaluated the effectiveness of a comprehensive package based on electronic medication monitors among patients with tuberculosis in Tibet Autonomous Region (hereafter Tibet), China. METHODS: This multicentre, randomised controlled trial recruited patients from six counties in Shigatse, Tibet. Eligible participants had drug-susceptible tuberculosis and were aged 15 years or older when starting standard tuberculosis treatment. Tuberculosis doctors recruited patients from the public tuberculosis dispensary in each county and the study statistician randomly assigned them to the intervention or control group based on the predetermined randomised allocation sequence. Intervention patients received an electronic medication monitor box. The box included audio medication-adherence reminders and recorded box-opening data, which were transmitted to a cloud-based server and were accessible to health-care providers to allow remote adherence monitoring. A linked smartphone app enabled text, audio, and video communication between patients and health-care providers. Patients were also provided with a free data plan. Patients selected a treatment supporter (often a family member) who was trained to support patients with using the electronic medication monitor and app. Patients in the control group received usual care plus a deactivated electronic medication monitor, which only recorded and transmitted box-opening data that was not made available to health-care providers. The control group also had no access to the app or trained treatment supporters. The primary outcome was a binary indicator of poor monthly adherence, defined as missing 20% or more of planned doses in the treatment month, measured using electronic medication monitor opening data, and verified by counting used medication blister packages during consultations. We recorded other secondary treatment outcomes based on national tuberculosis reporting data. We analysed the primary outcome based on the intention-to-treat population. This trial is registered at ISRCTN, 52132803. FINDINGS: Between Nov 17, 2018, and April 5, 2021, 278 patients were enrolled into the study. 143 patients were randomly assigned to the intervention group and 135 patients to the control group. Follow-up ended when the final patient completed treatment on Oct 4, 2021. In the intervention group, 87 (10%) of the 854 treatment months showed poor adherence compared with 290 (37%) of the 795 months in the control group. The corresponding adjusted risk difference for the intervention versus control was -29·2 percentage points (95% CI -35·3 to -22·2; p<0·0001). Five of the six secondary treatment outcomes also showed clear improvements, including treatment success, which was found for 133 (94%) of the 142 individuals in the intervention arm and 98 (73%) of the 134 individuals in the control arm, with an adjusted risk difference of 21 percentage points (95% CI 12·4-29·4); p<0·0001. INTERPRETATION: The interventions were effective at improving tuberculosis treatment adherence and outcomes, and the trial suggests that a comprehensive package involving electronic medication monitors might positively affect tuberculosis programmes in high-burden and low-resource settings. FUNDING: TB REACH.

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.

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.

Learning from implementation of a COVID case management desk guide and training: a pilot study in Sierra Leone.

BACKGROUND: When the COVID pandemic hit the world, there was need for applied guides and training materials to support frontline health care staff to manage patients effectively and safely and to educate themselves and communities. This article reports on the development and piloting of such a set of materials in Sierra Leone, which were based on international evidence but adapted to the local context. Reflecting on this experience, including community and health system barriers and enablers, is important to prepare for future regional shocks. METHODS: This study, in Bombali district in 2020, piloted user-friendly COVID guides for frontline health workers (the intervention), which was evaluated using facility checklists (pre and post training), routine data analysis and 32 key informant interviews. RESULTS: Key informants at district, hospital and community health centre levels identified gains from the training and desk guides, including improved diagnosis, triaging, infection prevention and management of patients. They also reported greater confidence to share messages on protection with colleagues and community members, which was needed to encourage continued use of essential services during the pandemic. However, important barriers were also revealed, including the lack of testing facilities, which reduced the sense of urgency, as few cases were identified. Actions based on the Ebola experience, such as setting up testing and isolation centres, which the community avoided, were not appropriate to COVID. Stigma and fear were important factors, although these were reduced with outreach activities. Supplies of essential medicines and personal protective equipment were also lacking. CONCLUSION: This pilot study demonstrated the relevance and importance of guides adapted to the context, which were able to improve the confidence of health staff to manage their own and the community's fears in the face of a new pandemic and improve their skills. Previous epidemics, particularly Ebola, complicated this by both creating structures that could be revitalised but also assumptions and behaviours that were not adapted to the new disease. Our study documents positive adaptations and resilience by health staff but also chronic system weaknesses (particularly for medicines, supplies and equipment) which must be urgently addressed before the next shock arrives.

Developing a social mobilisation intervention for salt reduction: participatory action research in Bombali district, Sierra Leone.

BACKGROUND: High salt intake is a major risk factor for hypertension, which in turn contributes to cardiovascular diseases, the major cause of death from non communicable diseases (NCDs). Research is limited on social mobilisation interventions to tackle NCDs, including in fragile health settings such as Sierra Leone. METHODS: Participatory action research methods were used to develop a social mobilisation intervention for salt reduction in Bombali District, Sierra Leone. A team of 20 local stakeholders were recruited to develop and deliver the intervention. Stakeholder workshop reports and interviews were used to record outcomes, enablers, and barriers to the intervention. Focus group discussions were used to observe knowledge, attitudes, and behaviours of community members pre- and post- the intervention. RESULTS: Stakeholders showed enthusiasm and were well engaged in the social mobilisation process around salt reduction. They developed radio jingles, radio show talks, organised community awareness raising meetings, school sensitisation outreaches, and door to door engagements. Stakeholders reported benefiting personally through developing their own skills and confidence in communication and felt positive about their role in educating their community. The interventions led to reported increased awareness of risks of high salt intake and NCDs, resulting in a reduction of salt use in the community, leading to perceived health gains. However, salt reduction was also met with some resistance due to social factors. Local community structures were also reactivated to work on the interventions and connect the community to the local health facility, which saw an increase in patients having their blood pressure checked. The comparison villages also experienced an increase in awareness and perceived reductions in salt intake behaviours. This was as messages had cascaded via the radio and initial focus group discussions. The social mobilisation stakeholders also agreed on future activities that could continue at no or low cost. CONCLUSION: Social mobilisation interventions can provide low-cost strategies to tackle NCDs in fragile settings such as Sierra Leone through the utilisation of community structures. However, more research is required to ascertain the key enablers for replicability and if such successes can be sustained over a longer follow up period.

Evaluation of a Depression Intervention in People With HIV and/or TB in Eswatini Primary Care Facilities: Implications for Southern Africa.

INTRODUCTION: Depression associated with chronic illnesses is common in Southern Africa, yet there are major treatment gaps. This study assesses the feasibility and acceptability of the Healthy Activity Program intervention for depression among people with HIV and/or TB. The intervention involves training nonspecialist nurses in depression, including identification, counseling based on behavioral activation theory, and structured referral. METHODS: This is a mixed methods evaluation of a pilot counseling service integrated within routine HIV and TB care from 2018 to 2019. Participants included people living with HIV and/or patients with TB in rural Eswatini. RESULTS: A total of 324 people living with HIV and/or TB were screened for depression, with 19% (62/324) screening positive. The median number of sessions attended was 3 (interquartile range: 1-5), with 16/60 (26%) attending the minimum 5 sessions. Qualitative results indicated acceptability, but there were concerns about feasibility. CONCLUSIONS: The Healthy Activity Program is a promising option to manage the treatment gap for depression in people with HIV and/or TB. However, task-shifting to nonspecialist health care professionals without increasing staff capacity is a barrier to implementation. Realistic and pragmatic assessments of capacity and workforce are essential.

mHealth guideline training for non-communicable diseases in primary care facilities in Nigeria: a mixed methods pilot study.

OBJECTIVE: To pilot the use of a scalable innovative mobile health (mHealth) non-communicable diseases (NCDs) training application for nurses at the primary care level. DESIGN: Mixed methods pilot of mHealth training on NCD care for nurses at primary healthcare (PHC) facilities. We provide a descriptive analysis of mHealth training test scores, with trend analysis of blood pressure (BP) control using paired t-test for quantitative data and thematic analysis for qualitative data. SETTING: PHC facilities in rural and urban communities in Cross River State, south eastern Nigeria. NCDs were not part of routine training previously. As in most low-and-middle-income settings, funding for scale-up using conventional classroom in-service training for NCDs is not available in Nigeria, and onsite supervision poses challenges. PARTICIPANTS: Twenty-four health workers in 19 PHC facilities. INTERVENTION: A self-paced mHealth training module on an NCD desk guide was adapted to be applicable within the Nigerian context in collaboration with the Federal Ministry of Health. The training which focused on hypertension, diabetes and sickle cell disease was delivered via Android tablet devices, supplemented by quarterly onsite supervision and group support via WhatsApp. The training was evaluated with pre/post-course tests, structured observations and focus group discussions. This was an implementation pilot assessing the feasibility and potential effectiveness of mHealth training on NCD in primary care delivery. RESULTS: Nurses who received mHealth training recorded a statistically significant difference (p<0.001) in average pretest and post-test training scores of 65.2 (±12.2) and 86.5 (±7.9), respectively. Recordings on treatment cards indicated appropriate diagnosis and follow-up of patients with hypertension with significant improvements in systolic BP (t=5.09, p<0.001) and diastolic BP (t=5.07, p<0.001). The mHealth nurse training and WhatsApp support groups were perceived as valuable experiences and obviated the need for face-to-face training. Increased workload, non-availability of medications, facility-level conflicts and poor task shifting were identified challenges. CONCLUSIONS: This initiative provides evidence of the feasibility of implementing an NCD care package supported by mHealth training for health workers in PHCs and the strong possibility of successful scale-up nationally.

Training health workers at scale in Nigeria to fight COVID-19 using the InStrat COVID-19 tutorial app: an e-health interventional study.

BACKGROUND: Health worker training is an essential component of epidemic control; rapid delivery of such training is possible in low-middle income countries with digital platforms. METHODS: Based on prior experience with the Ebola outbreak, we developed and deployed a bespoke InStrat COVID-19 tutorial app, to deliver accurate and regularly updated information about COVID-19 to frontline health workers and epidemic response officers across 25 states of Nigeria. The potential effectiveness of this app in training frontline health workers was assessed through online pre- and post-tests and a survey. RESULTS: A total of 1051 health workers from 25 states across Nigeria undertook the e-learning on the InStrat COVID-19 training app. Of these, 627 (57%) completed both the pre- and post-tests in addition to completing the training modules. Overall, there were statistically significant differences between pre- and post-tests knowledge scores (54 increasing to 74). There were also differences in the subcategories of sex, region and cadre. There were higher post-test scores in males compared with females, younger versus older and southern compared with northern Nigeria. A total of 65 (50%) of the participants reported that the app increased their understanding of COVID-19, while 69 (53%) stated that they had applied the knowledge and skills learnt at work. Overall, the functionality and usability of the app were satisfactory. CONCLUSION: Capacity building for epidemic control using e-health applications is potentially effective, can be delivered at minimal cost and service disruption and can serve as a tool for capacity building in similar contexts.

Codevelopment of COVID-19 infection prevention and control guidelines in lower-middle-income countries: the 'SPRINT' principles.

INTRODUCTION: The COVID-19 pandemic has required the rapid development of comprehensive guidelines to direct health service organisation and delivery. However, most guidelines are based on resources found in high-income settings, with fewer examples that can be implemented in resource-constrained settings. This study describes the process of adapting and developing role-specific guidelines for comprehensive COVID-19 infection prevention and control in low-income and middle-income countries (LMICs). METHODS: We used a collaborative autoethnographic approach to explore the process of developing COVID-19 guidelines. In this approach, multiple researchers contributed their reflections, conducted joint analysis through dialogue, reflection and with consideration of experiential knowledge and multidisciplinary perspectives to identify and synthesise enablers, challenges and key lessons learnt. RESULTS: We describe the guideline development process in the Philippines and the adaptation process in Sri Lanka. We offer key enablers identified through this work, including flexible leadership that aimed to empower the team to bring their expertise to the process; shared responsibility through equitable ownership; an interdisciplinary team; and collaboration with local experts. We then elaborate on challenges including interpreting other guidelines to the country context; tensions between the ideal compared with the feasible and user-friendly; adapting and updating with evolving information; and coping with pandemic-related challenges. Based on key lessons learnt, we synthesise a novel set of principles for developing guidelines during a public health emergency. The SPRINT principles are grounded in situational awareness, prioritisation and balance, which are responsive to change, created by an interdisciplinary team navigating shared responsibility and transparency. CONCLUSIONS: Guideline development during a pandemic requires a robust and time sensitive paradigm. We summarise the learning in the 'SPRINT principles' for adapting guidelines in an epidemic context in LMICs. We emphasise that these principles must be grounded in a collaborative or codesign process and add value to existing national responses.

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.

Governance of community health worker programs in a decentralized health system: a qualitative study in the Philippines.

BACKGROUND: Community health worker (CHW) programs are an important resource in the implementation of universal health coverage (UHC) in many low- and middle-income countries (LMICs). However, in countries with decentralized health systems like the Philippines, the quality and effectiveness of CHW programs may differ across settings due to variations in resource allocation and local politics. In the context of health system decentralization and the push toward UHC in the Philippines, the objective of this study was to explore how the experiences of CHWs across different settings were shaped by the governance and administration of CHW programs. METHODS: We conducted 85 semi-structured interviews with CHWs (n = 74) and CHW administrators (n = 11) in six cities across two provinces (Negros Occidental and Negros Oriental) in the Philippines. Thematic analysis was used to analyze the qualitative data with specific attention to how the experiences of participants differed within and across geographic settings. RESULTS: Health system decentralization contributed to a number of variations across settings including differences in the quality of human resources and the amount of financial resources allocated to CHW programs. In addition, the quality and provider of CHW training differed across settings, with implications for the capacity of CHWs to address specific health needs in their community. Local politics influenced the governance of CHW programs, with CHWs often feeling pressure to align themselves politically with local leaders in order to maintain their employment. CONCLUSIONS: The functioning of CHW programs can be challenged by health system decentralization through the uneven operationalization of national health priorities at the local level. Building capacity within local governments to adequately resource CHWs and CHW programs will enhance the potential of these programs to act as a bridge between the local health needs of communities and the public health system.

National primary care responses to COVID-19: a rapid review of the literature.

OBJECTIVE: The aim of this review, conducted in April 2020, is to examine available national primary care guidelines for COVID-19 and to explore the ways in which these guidelines support primary care facilities in responding to the demands of the COVID-19 pandemic. DESIGN: Rapid review and narrative synthesis. DATA SOURCES: PubMed, Embase and Google, as well as the websites of relevant national health departments, were searched from 1 January 2020 to 24 April 2020. ELIGIBILITY CRITERIA: Documents included must be issued by a national health authority, must be specific to COVID-19 care, directed at healthcare workers or managers, and must refer to the role of primary care in the COVID-19 response. RESULTS: We identified 17 documents from 14 countries. An adapted framework on primary care challenges and responses to pandemic influenza framed our analysis. Guidelines generally reported on COVID-19 service delivery and mostly made specific recommendations for ensuring continued delivery of essential primary care services through telehealth or other virtual care modalities. Few offered guidance to support surveillance as a public health function. All offered guidance on implementing outbreak control measures, largely through flexible and coordinated organisational models with partners from various sectors. There was a lack of guidance to support supply chain management and practice resilience in primary care, and lack of personal protective equipment represents a serious threat to the provision of quality care during the pandemic. CONCLUSIONS: Current national primary care guidelines for COVID-19 provide guidance on infection control and minimising the risk of spread in primary care practices, while supporting the use of new technology and coordinated partnerships. However, to ensure primary care practice resilience and quality of care are upheld, guidelines must offer recommendations on supply chain management and operational continuity, supported by adequate resources.

Adapting and implementing training, guidelines and treatment cards to improve primary care-based hypertension and diabetes management in a fragile context: results of a feasibility study in Sierra Leone.

BACKGROUND: Sierra Leone, a fragile country, is facing an increasingly significant burden of non-communicable diseases (NCDs). Facilitated by an international partnership, a project was developed to adapt and pilot desktop guidelines and other clinical support tools to strengthen primary care-based hypertension and diabetes diagnosis and management in Bombali district, Sierra Leone between 2018 and 2019. This study assesses the feasibility of the project through analysis of the processes of intervention adaptation and development, delivery of training and implementation of a care improvement package and preliminary outcomes of the intervention. METHODS: A mixed-method approach was used for the assessment, including 51 semi-structured interviews, review of routine treatment cards (retrieved for newly registered hypertensive and diabetic patients from June 2018 to March 2019 followed up for three months) and mentoring data, and observation of training. Thematic analysis was used for qualitative data and descriptive trend analysis and t-test was used for quantitative data, wherever appropriate. RESULTS: A Technical Working Group, established at district and national level, helped to adapt and develop the context-specific desktop guidelines for clinical management and lifestyle interventions and associated training curriculum and modules for community health officers (CHOs). Following a four-day training of CHOs, focusing on communication skills, diagnosis and management of hypertension and diabetes, and thanks to a CHO-based mentorship strategy, there was observed improvement of NCD knowledge and care processes regarding diagnosis, treatment, lifestyle education and follow up. The intervention significantly improved the average diastolic blood pressure of hypertensive patients (n = 50) three months into treatment (98 mmHg at baseline vs. 86 mmHg in Month 3, P = 0.001). However, health systems barriers typical of fragile settings, such as cost of transport and medication for patients and lack of supply of medications and treatment equipment in facilities, hindered the optimal delivery of care for hypertensive and diabetic patients. CONCLUSION: Our study suggests the potential feasibility of this approach to strengthening primary care delivery of NCDs in fragile contexts. However, the approach needs to be built into routine supervision and pre-service training to be sustained. Key barriers in the health system and at community level also need to be addressed.

Process Evaluation of a Clustered Randomized Control Trial of a Comprehensive Intervention to Reduce the Risk of Cardiovascular Events in Primary Health Care in Rural China.

BACKGROUND: Cardiovascular disease (CVD) is a major public health challenge in China. This study aims to understand the processes of implementing a comprehensive intervention to reduce CVD events in areas of drug therapy, lifestyle changes, and adherence support in a clustered randomized controlled trial (cRCT). This trial consisted of 67 clusters spanning over 3 years in Zhejiang Province, China. METHOD: A qualitative process evaluation was nested within the cRCT conducted in 9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm. RESULTS: Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills. However, the awareness of patients remained limited, thus compromising their use of CVD preventive drugs and adoption of healthy lifestyles. Health system factors further constrained providers' and patients' responses to the intervention. Financial barrier was a major concern because of the low coverage of health insurance. Other barriers included limited doctor-patient trust and suboptimal staff motivation. CONCLUSION: Our study suggests the feasibility of implementing a comprehensive CVD risk reduction strategy in China's rural primary care facilities. However, health system barriers need to be addressed to ensure the success and sustainability of the intervention.

An antibiotic stewardship programme to reduce inappropriate antibiotic prescribing for acute respiratory infections in rural Chinese primary care facilities: study protocol for a clustered randomised controlled trial.

BACKGROUND: Inappropriate prescribing of antibiotics for acute respiratory infections at the primary care level represents the major source of antibiotic misuse in healthcare, and is a major driver for antimicrobial resistance worldwide. In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages. METHODS: We will use a parallel-group, cluster-randomised, controlled, superiority trial with blinded outcome evaluation but unblinded treatment (providers and patients). We will randomise 34 primary care hospitals from two counties within Guangdong province into the intervention and control arm (1:1 overall ratio) stratified by county (8:9 within-county ratio). In the control arm, antibiotic prescribing and management will continue through usual care. In the intervention arm, we will implement an antibiotic stewardship programme targeting family physicians and patients/caregivers. The family physician components include: (1) training using new operational guidelines, (2) improved management and peer-review of antibiotic prescribing, (3) improved electronic medical records and smart phone app facilitation. The patient/caregiver component involves patient education via family physicians, leaflets and videos. The primary outcome is the proportion of prescriptions for acute respiratory infections (excluding pneumonia) that contain any antibiotic(s). Secondary outcomes will address how frequently specific classes of antibiotics are prescribed, how frequently key non-antibiotic alternatives are prescribed and the costs of consultations. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and a long-term benefit evaluation. The duration of the intervention will be 12 months, with another 24 months' post-trial long-term follow-up. DISCUSSION: Our study is one of the first trials to evaluate the effect of an antibiotic stewardship programme in primary care settings in a low- or middle-income country (LMIC). All interventional activities will be designed to be embedded into routine primary care with strong local ownership. Through the trial we intend to impact on clinical practice and national policy in antibiotic prescription for primary care facilities in rural China and other LMICs. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN96892547. Registered on 18 August 2019.