Publications

Background

The limited impact of increased access to care on improvements in health outcomes during the Millennium Development Goal era has been attributed, in part, to inadequate quality of care. We identified regional factors associated with health service quality for sick child care in low-income countries and examined whether provider factors interact with regional factors to affect the quality of care.

Methods

We conducted cross-sectional random intercept four-level linear regression using the most recent Service Provision Assessment and Demographic Health Survey data from four countries (467 from the Democratic Republic of Congo 2018, 2425 from Afghanistan 2018, 2072 from Nepal 2015, and 813 from Senegal 2017). The outcome variable was the service quality score for sick child care, which was measured as the percentage of clinically recommended tasks completed in the integrated management of childhood illness (ranging from 0 to 100). Regional factors were selected based on the High-Quality Health System Framework.

Results

The service quality score was found to be positively associated with the proportion of large facilities (β = 8.61; P = 0.004) and the proportion of providers ranked in the top fifth for service quality score (β = 30.15; P < 0.001) in the region. We identified significant cross-level interactions between provider qualifications (β = −16.6; P < 0.001) or job descriptions (β = 12.01; P = 0.002) and the proportion of providers in the top fifth for service quality scores within the region. As the proportion of top-performing providers in a region increased, the increase in the service quality score was more pronounced among providers who were nonmedical doctors or did not have job descriptions than among their counterparts.

Conclusions

Our findings indicate that the quality of care for sick children in a region improves with a greater proportion of high-performing providers or larger facilities. Providers who are not medical doctors, or those who have specific job descriptions, tend to benefit more from the presence of these top-performing providers.

BACKGROUND: Due to low care utilization, a complex intervention was done for two years to optimize the Ethiopian Health Extension Program. Improved quality of the integrated community case management services was an intermediate outcome of this intervention through community education and mobilization, capacity building of health workers, and strengthening of district ownership and accountability of sick child services. We evaluated the association between the intervention and the health extension workers' ability to correctly classify common childhood illnesses in four regions of Ethiopia. METHODS: Baseline and endline assessments were done in 2016 and 2018 in intervention and comparison areas in four regions of Ethiopia. Ill children aged 2 to 59 months were mobilized to visit health posts for an assessment that was followed by re-examination. We analyzed sensitivity, specificity, and difference-in-difference of correct classification with multilevel mixed logistic regression in intervention and comparison areas at baseline and endline. RESULTS: Health extensions workers' consultations with ill children were observed in intervention (n = 710) and comparison areas (n = 615). At baseline, re-examination of the children showed that in intervention areas, health extension workers' sensitivity for fever or malaria was 54%, 68% for respiratory infections, 90% for diarrheal diseases, and 34% for malnutrition. At endline, it was 40% for fever or malaria, 49% for respiratory infections, 85% for diarrheal diseases, and 48% for malnutrition. Specificity was higher (89-100%) for all childhood illnesses. Difference-in-differences was 6% for correct classification of fever or malaria [aOR = 1.45 95% CI: 0.81-2.60], 4% for respiratory tract infection [aOR = 1.49 95% CI: 0.81-2.74], and 5% for diarrheal diseases [aOR = 1.74 95% CI: 0.77-3.92]. CONCLUSION: This study revealed that the Optimization of Health Extension Program intervention, which included training, supportive supervision, and performance reviews of health extension workers, was not associated with an improved classification of childhood illnesses by these Ethiopian primary health care workers. TRIAL REGISTRATION: ISRCTN12040912, http://www.isrctn.com/ISRCTN12040912.

The Covid-19 and other recent pandemics has highlighted existing weakness in health systems across the Latin-America and the Caribbean (LAC) region to effectively prepare for and respond to Public Health Emergencies. It has been stated that quality of care will be among the most influential factors on Covid 19 mortality rates and low systems performance is the common case in these countries. More comprehensive and system level strategies are required to address the challenges. These must focus on redesigning and strengthening health systems to make them more resilient to the changing needs of populations and based on quality improvement methods that have shown rigorously evaluated positive effects in previous local and regional experiences. A call to action is being made by the Latin American Consortium for Quality, Patient Safety and Innovation (CLICSS) and they provide specific recommendations for decision makers.

INTRODUCTION: The COVID-19 pandemic has disrupted health systems around the world. The objectives of this study are to estimate the overall effect of the pandemic on essential health service use and outcomes in Mexico, describe observed and predicted trends in services over 24 months, and to estimate the number of visits lost through December 2020. METHODS: We used health information system data for January 2019 to December 2020 from the Mexican Institute of Social Security (IMSS), which provides health services for more than half of Mexico's population-65 million people. Our analysis includes nine indicators of service use and three outcome indicators for reproductive, maternal and child health and non-communicable disease services. We used an interrupted time series design and linear generalised estimating equation models to estimate the change in service use and outcomes from April to December 2020. Estimates were expressed using average marginal effects on the risk ratio scale. RESULTS: The study found that across nine health services, an estimated 8.74 million patient visits were lost in Mexico. This included a decline of over two thirds for breast and cervical cancer screenings (79% and 68%, respectively), over half for sick child visits and female contraceptive services, approximately one-third for childhood vaccinations, diabetes, hypertension and antenatal care consultations, and a decline of 10% for deliveries performed at IMSS. In terms of patient outcomes, the proportion of patients with diabetes and hypertension with controlled conditions declined by 22% and 17%, respectively. Caesarean section rate did not change. CONCLUSION: Significant disruptions in health services show that the pandemic has strained the resilience of the Mexican health system and calls for urgent efforts to resume essential services and plan for catching up on missed preventive care even as the COVID-19 crisis continues in Mexico.

BACKGROUND: In Peru, a majority of individuals bypass primary care facilities even for routine services. Efforts to strengthen primary care must be informed by understanding of current practice. We conducted a time motion assessment in primary care facilities in Lima with the goals of assessing the feasibility of this method in an urban health care setting in Latin America and of providing policy makers with empirical evidence on the use of health care provider time in primary care. METHODS: This cross-sectional continuous observation time motion study took place from July - September 2019. We used two-stage sampling to draw a sample of shifts for doctors, nurses, and midwives in primary health facilities and applied the Work Observation Method by Activity Timing tool to capture type and duration of provider activities over a 6-h shift. We summarized time spent on patient care, paper and electronic record-keeping, and non-work (personal and inactive) activities across provider cadres. Observations are weighted by inverse probability of selection. RESULTS: Two hundred seventy-five providers were sampled from 60 facilities; 20% could not be observed due to provider absence (2% schedule error, 8% schedule change, 10% failure to appear). One hundred seventy-four of the 220 identified providers consented (79.1%) and were observed for a total of 898 h of provider time comprising 30,312 unique tasks. Outpatient shifts included substantial time on patient interaction (110, 82, and 130 min for doctors, nurses, and midwives respectively) and on paper records (132, 97, and 141 min) on average. Across all shifts, 1 in 6 h was spent inactive or on personal activities. Two thirds of midwives used computers compared to half of nurses and one third of doctors. CONCLUSIONS: The time motion study is a feasible method to capture primary care operations in Latin American countries and inform health system strengthening. In the case of Lima, absenteeism undermines health worker availability in primary care facilities, and inactive time further erodes health workforce availability. Productive time is divided between patient-facing activities and a substantial burden of paper-based record keeping for clinical and administrative purposes. Electronic health records remain incompletely integrated within routine care, particularly beyond midwifery.

Key FindingsMaternal and newborn health service delivery redesign (MNH redesign) is a policy to shift all deliveries to or close to hospitals.Current system assets that support MNH redesign in Kakamega County are the adequate geographic spread of hospitals, close proximity of women to these hospitals, and high provider and user support for the concept.Before MNH redesign is implemented in Kakamega County, prevailing health system deficits, like health provider shortages and transportation challenges for mothers, would need to be addressed.Key ImplicationsThe county, in partnership with health system researchers, should rigorously evaluate the process of implementing MNH redesign and its impact on health, to learn and test the model and to serve as a base for generalizing uptake across the country.Countries that seek to implement MNH redesign would need to similarly assess feasibility to determine the assets and gaps for implementation.Maternal and newborn health (MNH) service delivery redesign aims to improve maternal and newborn survival by shifting deliveries from poorly equipped primary care facilities to adequately prepared designated delivery hospitals. We assess the feasibility of such a model in Kakamega County, Kenya, by determining the capacity of hospitals to provide services under the redesigned model and the acceptability of the concept to providers and users. We find many existing system assets to implement redesign, including political will to improve MNH outcomes, a strong base of support among providers and users, and a good geographic spread of facilities to support implementation. There are nonetheless health workforce gaps, infrastructure deficits, and transportation challenges that would need to be addressed ahead of policy rollout. Implementing MNH redesign would require careful planning to limit unintended consequences and rigorous evaluation to assess impact and inform scale-up.

Background Widespread increases in facility delivery have not substantially reduced neonatal mortality in sub-Saharan Africa and South Asia over the past 2 decades. This may be due to poor quality care available in widely used primary care clinics. In this study, we examine the association between hospital delivery and neonatal mortality. Methods and findings We used an ecological study design to assess cross-sectional associations between the share of hospital delivery and neonatal mortality across country regions. Data were from the Demographic and Health Surveys from 2009 to 2018, covering 682,239 births across all regions. We assess the association between the share of facility births in a region that occurred in hospitals (versus lower-level clinics) and early (0 to 7 days) neonatal mortality per 1,000 births, controlling for potential confounders including the share of facility births, small at birth, maternal age, maternal education, urbanicity, antenatal care visits, income, region, and survey year. We examined changes in this association in different contexts of country income, global region, and urbanicity using interaction models. Across the 1,143 regions from 37 countries in sub-Saharan Africa and South Asia, 42%, 29%, and 28% of births took place in a hospital, clinic, and at home, respectively. A 10-percentage point higher share of facility deliveries occurring in hospitals was associated with 1.2 per 1,000 fewer deaths (p-value < 0.01; 95% CI: 0.82 to 1.60), relative to mean mortality of 22. Associations were strongest in South Asian countries, middle-income countries, and urban regions. The study’s limitations include the inability to control for all confounding factors given the ecological and cross-sectional design and potential misclassification of facility levels in our data. Conclusions Regions with more hospital deliveries than clinic deliveries have reduced neonatal mortality. Increasing delivery in hospitals while improving quality across the health system may help to reduce high neonatal mortality.

The COVID-19 pandemic has made vivid the need for resilient, high-quality health systems and presents an opportunity to reconsider how to build such systems. Although even well resourced, well performing health systems have struggled at various points to cope with surges of COVID-19, experience suggests that establishing health system foundations based on clear aims, adequate resources, and effective constraints and incentives is crucial for consistent provision of high-quality care, and that these cannot be replaced by piecemeal quality improvement interventions. We identify four mutually reinforcing structural investments that could transform health system performance in resource-constrained countries: revamping health provider education, redesigning platforms for care delivery, instituting strategic purchasing and management strategies, and developing patient-level data systems. Countries should seize the political and moral energy provided by the COVID-19 pandemic to build health systems fit for the future.

This commentary article addresses a critical issue facing Kenya and other Low- and Middle-Income Countries (LMIC): how to remedy deficits in hospitals' nursing workforce. Would employing health care assistants (HCAs) provide a partial solution? This article first gives a brief introduction to the Kenyan context and then explores the development of workforce roles to support nurses in Europe to highlight the diversity of these roles. Our introduction pinpoints that pressures to maintain or restrict costs have led to a wide variety of formal and informal task shifting from nurses to some form of HCA in the EU with differences noted in issues of appropriate skill mix, training, accountability, and regulation of HCA. Next, we draw from a suite of recent studies in hospitals in Kenya which illustrate nursing practices in a highly pressurized context. The studies took place in neo-natal wards in Kenyan hospitals between 2015 and 2018 and in a system with no legal or regulatory basis for task shifting to HCAs. We proffer data on why and how nurses informally delegate tasks to others in the public sector and the decision-making processes of nurses and frame this evidence in the specific contextual conditions. In the conclusion, the paper aims to deepen the debates on developing human resources for health. We argue that despite the urgent pressures to address glaring workforce deficits in Kenya and other LMIC, caution needs to be exercised in implementing changes to nursing practices through the introduction of HCAs. The evidence from EU suggests that the rapid growth in the employment of HCA has created crucial issues which need addressing. These include clearly defining the scope of practice and developing the appropriate skill mix between nurses and HCAs to match the specific health system context. Moreover, we suggest efforts to develop and implement such roles should be carefully designed and rigorously evaluated to inform continuing policy development.

BACKGROUND: Quality of care depends on system, facility, provider, and client-level factors. We aimed at examining structural and process quality of services for sick children and its association with client satisfaction at health facilities in Ethiopia. METHODS: Data from the Ethiopia Service Provision Assessment Plus (SPA+) survey 2014 were used. Measures of quality were assessed based on the Donabedian framework: structure, process, and outcome. A total of 1908 mothers or caretakers were interviewed and their child consultations were observed. Principal component analysis was used to construct quality of care indices including a structural composite score, a process composite score, and a client satisfaction score. Multilevel mixed linear regression was used to analyze the association between structural and process factors with client satisfaction. RESULT: Among children diagnosed with suspected pneumonia, respiratory rate was counted in 56% and temperature was checked in 77% of the cases. A majority of children (92%) diagnosed with fever had their temperature taken. Only 3% of children with fever were either referred or admitted, and 60% received antibiotics. Among children diagnosed with malaria, 51% were assessed for all three Integrated Management of Childhood Illnesses (IMCI) main symptoms, and 4% were assessed for all three general danger signs. Providers assessed dehydration in 54% of children with diarrhea with dehydration, 17% of these children were admitted or referred to another facility, and Oral Rehydration Solution was prescribed for 67% while none received intravenous fluids. The number of basic amenities in the facility was negatively associated with the clients' satisfaction. Private facilities, when the providers had got training for care of sick children in the past 2 years, had higher client satisfaction. There was no statistical association between structure, process composite indicators and client satisfaction. CONCLUSION: The assessment of sick children was of low quality, with many missing procedures when comparing with IMCI guidelines. In spite of this, most clients were satisfied with the services they received. Structural and process composite indicators were not associated with client's satisfaction. These findings highlight the need to assess other dimensions of quality of care besides structure and process that may influence client satisfaction.

CONTEXT AND OBJECTIVES: Non-communicable diseases and injuries (NCDIs) comprise a large share of mortality and morbidity in low-income countries (LICs), many of which occur earlier in life and with greater severity than in higher income settings. Our objective was to assess availability of essential equipment and medications required for a broad range of acute and chronic NCDI conditions. DESIGN: Secondary analysis of existing cross-sectional survey data. SETTING: We used data from Service Provision Assessment surveys in Bangladesh, the Democratic Republic of the Congo, Ethiopia, Haiti, Malawi, Nepal, Senegal and Tanzania, focusing on public first-referral level hospitals in each country. OUTCOME MEASURES: We defined sets of equipment and medications required for diagnosis and management of four acute and nine chronic NCDI conditions and determined availability of these items at the health facilities. RESULTS: Overall, 797 hospitals were included. Medication and equipment availability was highest for acute epilepsy (country estimates ranging from 40% to 95%) and stage 1-2 hypertension (28%-83%). Availability was low for type 1 diabetes (1%-70%), type 2 diabetes (3%-57%), asthma (0%-7%) and acute presentations of diabetes (0%-26%) and asthma (0%-4%). Few hospitals had equipment or medications for heart failure (0%-32%), rheumatic heart disease (0%-23%), hypertensive emergencies (0%-64%) or acute minor surgical conditions (0%-5%). Data for chronic pain were limited to only two countries. Availability of essential medications and equipment was lower than previous facility-reported service availability. CONCLUSIONS: Our findings demonstrate low availability of essential equipment and medications for diverse NCDIs at first-referral level hospitals in eight LICs. There is a need for decentralisation and integration of NCDI services in existing care platforms and improved assessment and monitoring to fully achieve universal health coverage.

BACKGROUND: The use of appropriate and relevant nurse-sensitive indicators provides an opportunity to demonstrate the unique contributions of nurses to patient outcomes. The aim of this work was to develop relevant metrics to assess the quality of nursing care in low- and middle-income countries (LMICs) where they are scarce. MAIN BODY: We conducted a scoping review using EMBASE, CINAHL and MEDLINE databases of studies published in English focused on quality nursing care and with identified measurement methods. Indicators identified were reviewed by a diverse panel of nursing stakeholders in Kenya to develop a contextually appropriate set of nurse-sensitive indicators for Kenyan hospitals specific to the five major inpatient disciplines. We extracted data on study characteristics, nursing indicators reported, location and the tools used. A total of 23 articles quantifying the quality of nursing care services met the inclusion criteria. All studies identified were from high-income countries. Pooled together, 159 indicators were reported in the reviewed studies with 25 identified as the most commonly reported. Through the stakeholder consultative process, 52 nurse-sensitive indicators were recommended for Kenyan hospitals. CONCLUSIONS: Although nurse-sensitive indicators are increasingly used in high-income countries to improve quality of care, there is a wide heterogeneity in the way indicators are defined and interpreted. Whilst some indicators were regarded as useful by a Kenyan expert panel, contextual differences prompted them to recommend additional new indicators to improve the evaluations of nursing care provision in Kenyan hospitals and potentially similar LMIC settings. Taken forward through implementation, refinement and adaptation, the proposed indicators could be more standardised and may provide a common base to establish national or regional professional learning networks with the common goal of achieving high-quality care through quality improvement and learning.

INTRODUCTION: Ethiopia successfully reduced mortality in children below 5 years of age during the past few decades, but the utilisation of child health services was still low. Optimising the Health Extension Programme was a 2-year intervention in 26 districts, focusing on community engagement, capacity strengthening of primary care workers and reinforcement of district accountability of child health services. We report the intervention's effectiveness on care utilisation for common childhood illnesses. METHODS: We included a representative sample of 5773 households with 2874 under-five children at baseline (December 2016 to February 2017) and 10 788 households and 5639 under-five children at endline surveys (December 2018 to February 2019) in intervention and comparison areas. Health facilities were also included. We assessed the effect of the intervention using difference-in-differences analyses. RESULTS: There were 31 intervention activities; many were one-off and implemented late. In eight districts, activities were interrupted for 4 months. Care-seeking for any illness in the 2 weeks before the survey for children aged 2-59 months at baseline was 58% (95% CI 47 to 68) in intervention and 49% (95% CI 39 to 60) in comparison areas. At end-line it was 39% (95% CI 32 to 45) in intervention and 34% (95% CI 27 to 41) in comparison areas (difference-in-differences -4 percentage points, adjusted OR 0.49, 95% CI 0.12 to 1.95). The intervention neither had an effect on care-seeking among sick neonates, nor on household participation in community engagement forums, supportive supervision of primary care workers, nor on indicators of district accountability for child health services. CONCLUSION: We found no evidence to suggest that the intervention increased the utilisation of care for sick children. The lack of effect could partly be attributed to the short implementation period of a complex intervention and implementation interruption. Future funding schemes should take into consideration that complex interventions that include behaviour change may need an extended implementation period. TRIAL REGISTRATION NUMBER: ISRCTN12040912.

Large disparities in maternal and neonatal mortality exist between low- and high-income countries. Mothers and babies continue to die at high rates in many countries despite substantial increases in facility birth. One reason for this may be the current design of health systems in most low-income countries where, unlike in high-income countries, a substantial proportion of births occur in primary care facilities that cannot offer definitive care for complications. We argue that the current inequity in care for childbirth is a global double standard that limits progress on maternal and newborn survival. We propose that health systems need to be redesigned to shift all deliveries to hospitals or other advanced care facilities to bring care in line with global best practice. Health system redesign will require investing in high-quality hospitals with excellent midwifery and obstetric care, boosting quality of primary care clinics for antenatal, postnatal, and newborn care, decreasing access and financial barriers, and mobilizing populations to demand high-quality care. Redesign is a structural reform that is contingent on political leadership that envisions a health system designed to deliver high-quality, respectful care to all women giving birth. Getting redesign right will require focused investments, local design and adaptation, and robust evaluation.

BACKGROUND: As more countries progress towards malaria elimination, a better understanding of the most critical health system features for enabling and supporting malaria control and elimination is needed. METHODS: All available health systems data relevant for malaria control were collated from 23 online data repositories. Principal component analysis was used to create domain specific health system performance measures. Multiple regression model selection approaches were used to identify key health systems predictors of progress in malaria control in the 2000-2016 period among 105 countries. Additional analysis was performed within malaria burden groups. RESULTS: There was large heterogeneity in progress in malaria control in the 2000-2016 period. In univariate analysis, several health systems factors displayed a strong positive correlation with reductions in malaria burden between 2000 and 2016. In multivariable models, delivery of routine services and hospital capacity were strongly predictive of reductions in malaria cases, especially in high burden countries. In low-burden countries approaching elimination, primary health center density appeared negatively associated with progress while hospital capacity was positively correlated with eliminating malaria. CONCLUSIONS: The findings presented in this manuscript suggest that strengthening health systems can be an effective strategy for reducing malaria cases, especially in countries with high malaria burden. Potential returns appear particularly high in the area of service delivery.

Objective: To estimate the use of hospitals for four essential primary care services offered in health centres in low- and middle-income countries and to explore differences in quality between hospitals and health centres. Methods: We extracted data from all demographic and health surveys conducted since 2010 on the type of facilities used for obtaining contraceptives, routine antenatal care and care for minor childhood diarrhoea and cough or fever. Using mixed-effects logistic regression models we assessed associations between hospital use and individual and country-level covariates. We assessed competence of care based on the receipt of essential clinical actions during visits. We also analysed three indicators of user experience from countries with available service provision assessment survey data. Findings: On average across 56 countries, public hospitals were used as the sole source of care by 16.9% of 126 012 women who obtained contraceptives, 23.1% of 418 236 women who received routine antenatal care, 19.9% of 47 677 children with diarrhoea and 18.5% of 82 082 children with fever or cough. Hospital use was more common in richer countries with higher expenditures on health per capita and among urban residents and wealthier, better-educated women. Antenatal care quality was higher in hospitals in 44 countries. In a subset of eight countries, people using hospitals tended to spend more, report more problems and be somewhat less satisfied with the care received. Conclusion: As countries work towards achieving ambitious health goals, they will need to assess care quality and user preferences to deliver effective primary care services that people want to use.

BACKGROUND: Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa. METHODS AND FINDINGS: We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic-time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention. CONCLUSIONS: We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov under registration number NCT02626351.

BACKGROUND: The true burden of tuberculosis in children remains unknown, but approximately 65% go undetected each year. Guidelines for tuberculosis clinical decision-making are in place in Kenya, and the National Tuberculosis programme conducts several trainings on them yearly. By 2018, there were 183 GeneXpert® machines in Kenyan public hospitals. Despite these efforts, diagnostic tests are underused and there is observed under detection of tuberculosis in children. We describe the process of designing a contextually appropriate, theory-informed intervention to improve case detection of TB in children and implementation guided by the Behaviour Change Wheel. METHODS: We used an iterative process, going back and forth from quantitative and qualitative empiric data to reviewing literature, and applying the Behaviour Change Wheel guide. The key questions reflected on included (i) what is the problem we are trying to solve; (ii) what behaviours are we trying to change and in what way; (iii) what will it take to bring about desired change; (iv) what types of interventions are likely to bring about desired change; (v) what should be the specific intervention content and how should this be implemented? RESULTS: The following behaviour change intervention functions were identified as follows: (i) training: imparting practical skills; (ii) modelling: providing an example for people to aspire/imitate; (iii) persuasion: using communication to induce positive or negative feelings or stimulate action; (iv) environmental restructuring: changing the physical or social context; and (v) education: increasing knowledge or understanding. The process resulted in a multi-faceted intervention package composed of redesigning of child tuberculosis training; careful selection of champions; use of audit and feedback linked to group problem solving; and workflow restructuring with role specification. CONCLUSION: The intervention components were selected for their effectiveness (from literature), affordability, acceptability, and practicability and designed so that TB programme officers and hospital managers can be supported to implement them with relative ease, alongside their daily duties. This work contributes to the field of implementation science by utilising clear definitions and descriptions of underlying mechanisms of interventions that will guide others to do likewise in their settings for similar problems.