"Even though they insult us, the delivery they give us is the greatest thing": a qualitative study contextualizing women's experiences with facility-based maternal health care in Ethiopia.

BACKGROUND: Globally, amidst increased utilization of facility-based maternal care services, there is continued need to better understand women's experience of care in places of birth. Quantitative surveys may not sufficiently characterize satisfaction with maternal healthcare (MHC) in local context, limiting their interpretation and applicability. The purpose of this study is to untangle how contextual and cultural expectations shape women's care experience and what women mean by satisfaction in two Ethiopian regions. METHODS: Health center and hospital childbirth care registries were used to identify and interview 41 women who had delivered a live newborn within a six-month period. We used a semi-structured interview guide informed by the Donabedian framework to elicit women's experiences with MHC and delivery, any prior delivery experiences, and recommendations to improve MHC. We used an inductive analytical approach to compare and contrast MHC processes, experiences, and satisfaction. RESULTS: Maternal and newborn survival and safety were central to women's descriptions of their MHC experiences. Women nearly exclusively described healthy and safe deliveries with healthy outcomes as 'satisfactory'. The texture behind this 'satisfaction', however, was shaped by what mothers bring to their delivery experiences, creating expectations from events including past births, experiences with antenatal care, and social and community influences. Secondary to the absence of adverse outcomes, health provider's interpersonal behaviors (e.g., supportive communication and behavioral demonstrations of commitment to their births) and the facility's amenities (e.g., bathing, cleaning, water, coffee, etc) enhanced women's experiences. Finally, at the social and community levels, we found that family support and material resources may significantly buffer against negative experiences and facilitate women's overall satisfaction, even in the context of poor-quality facilities and limited resources. CONCLUSION: Our findings highlight the importance of understanding contextual factors including past experiences, expectations, and social support that influence perceived quality of MHC and the agency a woman has to negotiate her care experience. Our finding that newborn and maternal survival primarily drove women's satisfaction suggests that quantitative assessments conducted shortly following delivery may be overly influenced by these outcomes and not fully capture the complexity of women's care experience.

Prioritizing people and rapid learning in times of crisis: A virtual learning initiative to support health workers during the COVID-19 pandemic.

The Western Cape province was the early epicentre of the coronavirus disease 2019 pandemic in South Africa and on the African continent. In this short article we report on an initiative set up within the provincial Department of Health early in the pandemic to facilitate collective learning and support for health workers and managers across the health system, emphasising the importance of leadership, systems resilience, nonhierarchical learning and connectedness. These strategies included regular and systematic engagement with organised labour, different ways of gauging and responding to staff morale, and daily 'huddles' for raid learning and responsive action. We propose three transformational actions that could deliver health systems that protect staff during good times and in times of system shocks. (a) Continuously invest in building the foundations of system resilience in good times, to draw on in an acute crisis situation. (b) Provide consistent leadership for an explicit commitment to supporting health workers through decisive action across the system. (c) Optimise available resources and partners, act on improvement ideas and obstacles. Build trusting relationships amongst and across actors.

Evaluation of the effectiveness of a quality improvement intervention to support integration of maternal, child and HIV care in primary health care facilities in South Africa.

BACKGROUND: Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement (QI) intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa. METHODS: A three-month intervention comprised of six QI mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1. RESULTS: Improvements in some growth monitoring indicators were achieved in intervention clinics compared to control clinics, including measuring the length of the baby (77% vs 63%; p = 0.001) and health workers asking mothers about the child's feeding (74% vs 67%; p = 0.003), but the proportion of mothers who received feeding advice remained unchanged (38% vs 35%; p = 0.48). Significantly more mothers in the intervention group were asked about their baby's health (44% vs 36%; p = 0.001), and completeness of record keeping improved (40% vs 26%; I = < 0.0001). Discussions with the mother about some maternal health services improved: significantly more mothers in the intervention group were asked about HIV (26.5% vs 19.5%; p = 0.009) and family planning (33.5% vs 19.5%; p <  0.001), but this did not result in additional services being provided to mothers at the clinic visit. CONCLUSION: This robust evaluation shows significant improvements in coverage of some services, but the QI intervention was unable to achieve the substantial changes required to provide a comprehensive package of services to all mothers and children. We suggest the QI process be adapted to complex under-resourced health systems, building on the strengths of this approach, to provide workable health systems strengthening solutions for scalable implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04278612. Date of Registration: February 19, 2020. Retrospectively registered.

The Ethiopia healthcare quality initiative: design and initial lessons learned.

OBJECTIVE: To describe the development, implementation and initial outcomes of a national quality improvement (QI) intervention in Ethiopia. DESIGN: Retrospective descriptive study of initial prototype phase implementation outcomes. SETTING: All public facilities in one selected prototype district in each of four agrarian regions. PARTICIPANTS: Facility QI teams composed of managers, healthcare workers and health extension workers. INTERVENTIONS: The Ethiopian Federal Ministry of Health (FMoH) and the Institute for Healthcare Improvement co-designed a three-pronged approach to accelerate health system improvement nationally, which included developing a national healthcare quality strategy (NHQS); building QI capability at all health system levels and introducing scalable district MNH QI collaboratives across four regions, involving healthcare providers and managers. OUTCOME MEASURES: Implementation outcomes including fidelity, acceptability, adoption and program effectiveness. RESULTS: The NHQS was launched in 2016 and governance structures were established at the federal, regional and sub-regional levels to oversee implementation. A total of 212 federal, regional and woreda managers have been trained in context-specific QI methods, and a national FMoH-owned in-service curriculum has been developed. Four prototype improvement collaboratives have been completed with high fidelity and acceptability. About 102 MNH change ideas were tested and a change package was developed with 83 successfully tested ideas. CONCLUSION: The initial successes observed are attributable to the FMoH's commitment in implementing the initiative, the active engagement of all stakeholders and the district-wide approach utilized. Challenges included weak data systems and security concerns. The second phase-in 26 district-level collaboratives-is now underway.

Evaluating the impact of a hospital scale-up phase of a quality improvement intervention in Ghana on mortality for children under five.

OBJECTIVE: To evaluate the scale-up phase of a national quality improvement initiative across hospitals in Southern Ghana. DESIGN: This evaluation used a comparison of pre- and post-intervention means to assess changes in outcomes over time. Multivariable interrupted time series analyses were performed to determine whether change categories (interventions) tested were associated with improvements in the outcomes. SETTING: Hospitals in Southern Ghana. PARTICIPANTS: The data sources were monthly outcome data from intervention hospitals along with program records. INTERVENTION: The project used a quality improvement approach whereby process failures were identified by health staff and process changes were implemented in hospitals and their corresponding communities. The three change categories were: timely care-seeking, prompt provision of care and adherence to protocols. MAIN OUTCOME MEASURES: Facility-level neonatal mortality, facility-level postneonatal infant mortality and facility-level postneonatal under-five mortality. RESULTS: There were significant improvements for two outcomes from the pre-intervention to the post-intervention phase. Postneonatal infant mortality dropped from 44.3 to 21.1 postneonatal infant deaths per 1000 admissions, while postneonatal under-five mortality fell from 23.1 to 11.8 postneonatal under-five deaths per 1000 admissions. The multivariable interrupted time series analysis indicated that over the long-term the prompt provision of care change category was significantly associated with reduced postneonatal under five mortality (ß = -0.0024, 95% CI -0.0051, 0.0003, P < 0.10). CONCLUSIONS: The reduced postneonatal under-five mortality achieved in this project gives support to the promotion of quality improvement as a means to achieve health impacts at scale.

A continuous quality improvement intervention to improve the effectiveness of community health workers providing care to mothers and children: a cluster randomised controlled trial in South Africa.

BACKGROUND: Community health workers (CHWs) play key roles in delivering health programmes in many countries worldwide. CHW programmes can improve coverage of maternal and child health services for the most disadvantaged and remote communities, leading to substantial benefits for mothers and children. However, there is limited evidence of effective mentoring and supervision approaches for CHWs. METHODS: This is a cluster randomised controlled trial to investigate the effectiveness of a continuous quality improvement (CQI) intervention amongst CHWs providing home-based education and support to pregnant women and mothers. Thirty CHW supervisors were randomly allocated to intervention (n = 15) and control (n = 15) arms. Four CHWs were randomly selected from those routinely supported by each supervisor (n = 60 per arm). In the intervention arm, these four CHWs and their supervisor formed a quality improvement team. Intervention CHWs received a 2-week training in WHO Community Case Management followed by CQI mentoring for 12 months (preceded by 3 months lead-in to establish QI processes). Baseline and follow-up surveys were conducted with mothers of infants <12 months old living in households served by participating CHWs. RESULTS: Interviews were conducted with 736 and 606 mothers at baseline and follow-up respectively; socio-demographic characteristics were similar in both study arms and at each time point. At follow-up, compared to mothers served by control CHWs, mothers served by intervention CHWs were more likely to have received a CHW visit during pregnancy (75.7 vs 29.0%, p < 0.0001) and the postnatal period (72.6 vs 30.3%, p < 0.0001). Intervention mothers had higher maternal and child health knowledge scores (49 vs 43%, p = 0.02) and reported higher exclusive breastfeeding rates to 6 weeks (76.7 vs 65.1%, p = 0.02). HIV-positive mothers served by intervention CHWs were more likely to have disclosed their HIV status to the CHW (78.7 vs 50.0%, p = 0.007). Uptake of facility-based interventions were not significantly different. CONCLUSIONS: Improved training and CQI-based mentoring of CHWs can improve quantity and quality of CHW-mother interactions at household level, leading to improvements in mothers' knowledge and infant feeding practices. TRIAL REGISTRATION: ClinicalTrials.Gov NCT01774136.

Can a quality improvement project impact maternal and child health outcomes at scale in northern Ghana?

BACKGROUND: Quality improvement (QI) interventions are becoming more common in low- and middle-income countries, yet few studies have presented impact evaluations of these approaches. In this paper, we present an impact evaluation of a scale-up phase of 'Project Fives Alive!', a QI intervention in Ghana that aims to improve maternal and child health outcomes. 'Project Fives Alive!' employed a QI methodology to recognize barriers to care-seeking and care provision at the facility level and then to identify, test and implement simple and low-cost local solutions that address the barriers. METHODS: A quasi-experimental design, multivariable interrupted time series analysis, with data coming from 744 health facilities and controlling for potential confounding factors, was used to study the effect of the project. The key independent variables were the change categories (interventions implemented) and implementation phase - Wave 2a (early phase) versus Wave 2b (later phase). The outcomes studied were early antenatal care (ANC), skilled delivery, facility-level under-five mortality and attendance of underweight infants at child welfare clinics. We stratified the analysis by facility type, namely health posts, health centres and hospitals. RESULTS: Several of the specific change categories were significantly associated with improved outcomes. For example, three of five change categories (early ANC, four or more ANC visits and skilled delivery/immediate postnatal care (PNC)) for health posts and two of five change categories (health education and triage) for hospitals were associated with increased skilled delivery. These change categories were associated with increases in skilled delivery varying from 28% to 58%. PNC changes for health posts and health centres were associated with greater attendance of underweight infants at child welfare clinics. The triage change category was associated with increased early antenatal care in hospitals. Intensity, the number of change categories tested, was associated with increased skilled delivery in health centres and reduced under-five mortality in hospitals. CONCLUSIONS: Using an innovative evaluation technique we determined that 'Project Fives Alive!' demonstrated impact at scale for the outcomes studied. The QI approach used by this project should be considered by other low- and middle-income countries in their efforts to improve maternal and child health.

Antenatal corticosteroids for management of preterm birth: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth complications are the leading cause of deaths for children under five years. Antenatal corticosteroids (ACS) are effective at reducing mortality and serious morbidity amongst infants born at <34 weeks gestation. WHO guidelines strongly recommend use of ACS for women at risk of imminent preterm birth where gestational age, imminent preterm birth, and risk of maternal infection can be assessed, and appropriate maternal/newborn care provided. However, coverage remains low in high-burden countries for reasons not previously systematically investigated. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks", factors that hinder the scale up, of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for ACS. RESULTS: Eleven out of twelve countries provided data in response to the ACS questionnaire. Health system building blocks most frequently reported as having significant or very major bottlenecks were health information systems (11 countries), essential medical products and technologies (9 out of 11 countries) and health service delivery (9 out of 11 countries). Bottlenecks included absence of coverage data, poor gestational age metrics, lack of national essential medicines listing, discrepancies between prescribing authority and provider cadres managing care, delays due to referral, and lack of supervision, mentoring and quality improvement systems. CONCLUSIONS: Analysis centred on health system building blocks in which 9 or more countries (>75%) reported very major or significant bottlenecks. Health information systems should include improved gestational age assessment and track ACS coverage, use and outcomes. Better health service delivery requires clarified policy assigning roles by level of care and cadre of provider, dependent on capability to assess gestational age and risk of preterm birth, and the implementation of guidelines with adequate supervision, mentoring and quality improvement systems, including audit and feedback. National essential medicines lists should include dexamethasone for antenatal use, and dexamethasone should be integrated into supply logistics.

Method to share learning in real time at scientific meetings: lessons from the IHI-BMJ International Conference on Quality and Safety.

BACKGROUND: Capturing and disseminating key learnings on emerging themes for conference participants is challenging, yet also presents a significant opportunity to distill, share and discuss learning in real time with conference organisers and attendees. The Institute for Healthcare Improvement (IHI) and British Medical Journal (BMJ) collaborate annually to convene a Health Quality and Safety conference attracting 1000 to 3000 attendees each year. AIM: To test a learning system that harvested and synthesised the key lessons shared by conference participants at the 2022 IHI-BMJ Gothenburg Forum, and to disseminate this content. METHODS: Twelve invited Forum attendees collected and shared their 'breakthrough learnings' via electronic survey. Three IHI team members synthesised the participants' responses into themes that were shared and refined in real time at an in-person Forum session including 35 additional participants. RESULTS: Participants shared four learning themes: collaboration and co-production, trust, meaningful communication about data, and broadening the scope of the Science of Improvement field to multi-disciplinary and multi-system approaches. CONCLUSIONS: Collection of key learning on emerging topics of interest to the health system improvement community is feasible and yielded information both for dissemination and real-time learning. While not representing the full scope of the conference learnings, the content resonated with an additional group of reviewers at the conclusion of the conference and has guided planning for the next annual meeting. This approach may be helpful in capturing key themes for discussion and planning by similar improvement communities.

Learning from an equitable, data-informed response to COVID-19: Translating knowledge into future action and preparation.

Introduction: The COVID-19 pandemic revealed numerous barriers to effectively managing public health crises, including difficulties in using publicly available, community-level data to create learning systems in support of local public health decision responses. Early in the COVID-19 pandemic, a group of health care partners began meeting to learn from their collective experiences. We identified key tools and processes for using data and learning system structures to drive equitable public health decision making throughout different phases of the pandemic. Methods: In fall of 2021, the team developed an initial theory of change directed at achieving herd immunity for COVID-19. The theoretical drivers were explored qualitatively through a series of nine 45-min telephonic interviews conducted with 16 public health and community leaders across the United States. Interview responses were analyzed into key themes to inform potential future practices, tools, and systems. In addition to the interviews, partners in Dallas and Cincinnati reflected on their own COVID-19 experiences. Results: Interview responses fell broadly into four themes that contribute to effective, community driven responses to COVID-19: real-time, accessible data that are mindful of the tension between community transparency and individual privacy; a continued fostering of public trust; adaptable infrastructures and systems; and creating cohesive community coalitions with shared alignment and goals. These themes and partner experiences helped us revise our preliminary theory of change around the importance of community collaboration and trust building and also helped refine the development of the Community Protection Dashboard tool. Conclusions: There was broad agreement amongst public health and community leaders about the key elements of the data and learning systems required to manage public health responses to COVID-19. These findings may be informative for guiding the use of data and learning in the management of future public health crises or population health initiatives.

A quality improvement model for the rapid scale-up of a program to prevent mother-to-child HIV transmission in South Africa.

UNLABELLED: QUALITY PROBLEM AND ASSESSMENT: In South Africa (SA), non-governmental organizations (NGOs) have a major role in the provision of health services, but they often compete for funding and influence rather than collaborate. The National Department of Health (NDOH) sought to coordinate existing non-governmental organizations (NGOs) to optimize the prevention of mother-to-child HIV transmission (PMTCT) at scale. SOLUTION: We describe how a group of NGO and government partners were brought together to jointly develop the 'Accelerated Plan' (A-Plan) to improve PMTCT services at health-care facilities in SA. The A-Plan used four main principles of large-scale change to align the network of NGO partners and NDOH: setting targets and improving data, simplifying processes and facilitating local execution, building networks and enabling coordination. IMPLEMENTATION: In the first 6 months of the project, six NGO partners were engaged and the program reached 161 facilities. The program spontaneously spread from five planned subdistricts to nine subdistricts and produced a package of tested interventions to assist in scale-up of the PMTCT program elsewhere. EVALUATION: Districts reported high levels of provider engagement in the initiative. In the 6-month project period, a total of 676 health-care workers and managers were trained in quality improvement methods and tools. Coverage of seven key processes in the PMTCT program was tracked on a monthly basis within each subdistrict. LESSONS LEARNED: We found that a network model for the A-plan could successfully recruit key stakeholders into a strong partnership leading to rapid scale-up of a life-saving public health intervention.

Improving health system quality in low- and middle-income countries that are expanding health coverage: a framework for insurance.

PURPOSE: Low- and middle-income countries are increasingly pursuing health financing reforms aimed at achieving universal health coverage. As these countries rapidly expand access to care, overburdened health systems may fail to deliver high-quality care, resulting in poor health outcomes. Public insurers responsible for financing coverage expansions have the financial leverage to influence the quality of care and can benefit from guidance to execute a cohesive health-care quality strategy. DATA SOURCES: and selection Following a literature review, we used a cascading expert consultation and validation process to develop a conceptual framework for insurance-driven quality improvements in health care. RESULTS OF DATA SYNTHESIS: The framework presents the strategies available to insurers to influence the quality of care within three domains: ensuring a basic standard of quality, motivating providers and professionals to improve, and activating patient and public demand for quality. By being sensitive to the local context, building will among key stakeholders and selecting context-appropriate ideas for improvement, insurers can influence the quality through four possible mechanisms: selective contracting; provider payment systems; benefit package design and investments in systems, patients and providers. CONCLUSION: This framework is a resource for public insurers that are responsible for rapidly expanding access to care, as it places the mechanisms that insurers directly control within the context of broader strategies of improving health-care quality. The framework bridges the existing gap in the literature between broad frameworks for strategy design for system improvement and narrower discussions of the technical methods by which payers directly influence the quality.

Impact evaluation of a quality improvement intervention on maternal and child health outcomes in Northern Ghana: early assessment of a national scale-up project.

OBJECTIVE: To evaluate the influence of the early phase of Project Fives Alive!, a national child survival improvement project, on key maternal and child health outcomes. DESIGN: The evaluation used multivariable interrupted time series analyses to determine whether change categories tested were associated with improvements in the outcomes of interest. PARTICIPANTS: The evaluation used program and outcome data from interventions focused on health-care staff in 27 facilities. SETTING: Northern Ghana. INTERVENTION: The project uses a quality improvement (QI) approach whereby process failures are identified by health staff and process changes are tested in the health facilities and corresponding communities to address those failures. MAIN OUTCOME MEASURES: The maternal health outcomes were early antenatal care attendance and skilled delivery, and the child health outcomes were underweight infants attending child wellness clinics, facility-level neonatal mortality and facility-level infant mortality. RESULTS: Postnatal care changes for the first 1-2 days of life (ß= 0.10, P = 0.07) and the first 6-7 days of life (ß = 0.10, P = 0.07) were associated with a higher rate of visits by underweight infants to child wellness clinics. There was an association between the early pregnancy identification change category with increased skilled delivery (ß = 1.36 P = 0.07). In addition, a greater number of change categories tested was associated with increased skilled delivery (ß = 0.05, P = 0.01). CONCLUSION: The QI approach of testing and implementing simple and low cost locally inspired changes has the potential to lead to improved health outcomes at scale both in Ghana and other low- and middle-income countries.

Macrolide antibiotics for cystic fibrosis.

BACKGROUND: Macrolide antibiotics may have a modifying role in diseases which involve airway infection and inflammation, like cystic fibrosis. OBJECTIVES: To test the hypotheses that, in people with cystic fibrosis, macrolide antibiotics: 1. improve clinical status compared to placebo or another antibiotic; 2. do not have unacceptable adverse effects. If benefit was demonstrated, we aimed to assess the optimal type, dose and duration of macrolide therapy. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings.We contacted investigators known to work in the field, previous authors and pharmaceutical companies manufacturing macrolide antibiotics for unpublished or follow-up data (May 2010).Latest search of the Group's Cystic Fibrosis Trials Register: 29 February 2012. SELECTION CRITERIA: Randomised controlled trials of macrolide antibiotics compared to: placebo; another class of antibiotic; another macrolide antibiotic; or the same macrolide antibiotic at a different dose. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed risk of bias. Seven groups were contacted and provided additional data which were incorporated into the review. MAIN RESULTS: Ten of 31 studies identified were included (959 patients). Five studies with a low risk of bias examined azithromycin versus placebo and demonstrated consistent improvement in forced expiratory volume in one second over six months (mean difference at six months 3.97% (95% confidence interval 1.74% to 6.19%; n = 549, from four studies)). Patients treated with azithromycin were approximately twice as likely to be free of pulmonary exacerbation at six months, odds ratio 1.96 (95% confidence interval 1.15 to 3.33). With respect to secondary outcomes, there was a significant reduction in need for oral antibiotics and greater weight gain in those taking azithromycin. Adverse events were uncommon and not obviously associated with azithromycin, although a once-weekly high dose regimen was associated with more frequent gastrointestinal adverse events. Treatment with azithromycin was associated with reduced identification of Staphylococcus aureus on respiratory culture, but also a significant increase in macrolide resistance. AUTHORS' CONCLUSIONS: This review provides evidence of improved respiratory function after six months of azithromycin. Data beyond six months were less clear, although reduction in pulmonary exacerbation was sustained. Treatment appeared safe over a six-month period; however, emergence of macrolide resistance was a concern. A multi-centre trial examining long-term effects of this antibiotic treatment is needed, especially for infants recognised through newborn screening.

Charting the way forward to better quality health care: how do we get there and what are the next steps? Recommendations from the Salzburg Global Seminar on making health care better in low- and middle-income economies.

OBJECTIVE: In April 2012, the Salzburg Global Seminar (SGS) brought together 58 health leaders from 33 countries to review experiences in improving the quality and safety of health-care services in low- and middle-income countries, synthesize lessons learned from those experiences, discuss challenges and opportunities and recommend next steps to stimulate improvement in such countries. This work summarizes the seminar's key results, expressed as five shared challenges and five lessons learned. DESIGN: The seminar featured a series of interactive sessions with an all-teach, all-learn approach. Session topics were: introduction to the seminar, journey to date, challenges that lie ahead, overcoming the issues of confusion, sustaining execution, strengthening leadership and policy, the role of quality improvement in health systems strengthening and setting the agenda for learning and next steps. RESULTS: Key lessons from the SGS include reducing terminology and methodology confusion, strengthening the learning agenda, embracing improvement science as a means for strengthening health-care systems, developing leadership in improving health care and ensuring that health-care systems focus on patients and communities. A call to action was developed by SGS participants and presented at the 65th World Health Assembly in Geneva. CONCLUSION: There is an inarguable need to move improvement in health care to a new level to attain and exceed the Millennium Development Goals. The challenges can be overcome through concerted action of key stakeholders and the application of scientifically grounded management methods to enable the reliable implementation of high-impact interventions for every patient every time needed.

A nationwide quality improvement project to accelerate Ghana's progress toward Millennium Development Goal Four: design and implementation progress.

QUALITY PROBLEM: The gap between evidence-based guidelines and practice of care is reflected, in low- and middle-income countries, by high rates of maternal and child mortality and limited effectiveness of large-scale programing to decrease those rates. CHOICE OF SOLUTION: We designed a phased, rapid, national scale-up quality improvement (QI) intervention to accelerate the achievement of Millennium Development Goal Four in Ghana. Our intervention promoted systems thinking, active participation of managers and frontline providers, generation and testing of local change ideas using iterative learning from transparent district and local data, local ownership and sustainability. IMPLEMENTATION: After 50 months of implementation, we have completed two prototype learning phases and have begun regional spread phases to all health facilities in all 38 districts of the three northernmost regions and all 29 Catholic hospitals in the remaining regions of the country. To accelerate the spread of improvement, we developed 'change packages' of rigorously tested process changes along the continuum of care from pregnancy to age 5 in both inpatient and outpatient settings. LESSONS LEARNED: The primary successes for the project so far include broad and deep adoption of QI by local stakeholders for improving system performance, widespread capacitation of leaders, managers and frontline providers in QI methods, incorporation of local ideas into change packages and successful scale-up to approximately 25% of the country's districts in 3 years. Implementation challenges include variable leadership uptake and commitment at the district level, delays due to recruiting and scheduling barriers, weak data systems and repeated QI training due to high staff turnover.

Mortality in HIV and tuberculosis patients following implementation of integrated HIV-TB treatment: Results from an open-label cluster-randomized trial.

BACKGROUND: HIV-TB treatment integration reduces mortality. Operational implementation of integrated services is challenging. This study assessed the impact of quality improvement (QI) for HIV-TB integration on mortality within primary healthcare (PHC) clinics in South Africa. METHODS: An open-label cluster randomized controlled study was conducted between 2016 and 2018 in 40 rural clinics in South Africa. The study statistician randomized PHC nurse-supervisors 1:1 into 16 clusters (eight nurse-supervisors supporting 20 clinics per arm) to receive QI, supported HIV-TB integration intervention or standard of care (control). Nurse supervisors and clinics under their supervision, based in the study health districts were eligible for inclusion in this study. Nurse supervisors were excluded if their clinics were managed by municipal health (different resource allocation), did not offer co-located antiretroviral therapy (ART) and TB services, services were performed by a single nurse, did not receive non-governmental organisation (NGO) support, patient data was not available for > 50% of attendees. The analysis population consists of all patients newly diagnosed with (i) both TB and HIV (ii) HIV only (among patients previously treated for TB or those who never had TB before) and (iii) TB only (among patients already diagnosed with HIV or those who were never diagnosed with HIV) after QI implementation in the intervention arm, or enrolment in the control arm. Mortality rates was assessed 12 months post enrolment, using unpaired t-tests and cox-proportional hazards model. (Clinicaltrials.gov, NCT02654613, registered 01 June 2015, trial closed). FINDINGS: Overall, 21 379 participants were enrolled between December 2016 and December 2018 in intervention and control arm clinics: 1329 and 841 HIV-TB co-infected (10·2%); 10 799 and 6 611 people living with Human Immunodeficiency Virus (HIV)/ acquired immunodeficiency syndrome (AIDS) (PLWHA) only (81·4%); 1 131 and 668 patients with TB only (8·4%), respectively. Average cluster sizes were 1657 (range 170-5782) and 1015 (range 33-2027) in intervention and control arms. By 12 months, 6529 (68·7%) and 4074 (70·4%) were alive and in care, 568 (6·0%) and 321 (5·6%) had completed TB treatment, 1078 (11·3%) and 694 (12·0%) were lost to follow-up, with 245 and 156 deaths occurring in intervention and control arms, respectively. Mortality rates overall [95% confidence interval (CI)] was 4·5 (3·4-5·9) in intervention arm, and 3·8 (2·6-5·4) per 100 person-years in control arm clusters [mortality rate ratio (MRR): 1·19 (95% CI 0·79-1·80)]. Mortality rates among HIV-TB co-infected patients was 10·1 (6·7-15·3) and 9·8 (5·0-18·9) per 100 person-years, [MRR: 1·04 (95% CI 0·51-2·10)], in intervention and control arm clusters, respectively. INTERPRETATION: HIV-TB integration supported by a QI intervention did not reduce mortality in HIV-TB co-infected patients. Demonstrating mortality benefit from health systems process improvements in real-world operational settings remains challenging. Despite the study being potentially underpowered to demonstrate the effect size, integration interventions were implemented using existing facility staff and infrastructure reflecting the real-world context where most patients in similar settings access care, thereby improving generalizability and scalability of study findings. FUNDING: Research reported in this publication was supported by South African Medical Research Council (SAMRC), and UK Government's Newton Fund through United Kingdom Medical Research Council (UKMRC).

Macrolide antibiotics for cystic fibrosis.

BACKGROUND: Macrolide antibiotics may have a modifying role in diseases which involve airway infection and inflammation, like cystic fibrosis. OBJECTIVES: To test the hypotheses that, in people with cystic fibrosis, macrolide antibiotics: 1. improve clinical status compared to placebo or another antibiotic; 2. do not have unacceptable adverse effects. If benefit was demonstrated, we aimed to assess the optimal type, dose and duration of macrolide therapy. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings.We contacted investigators known to work in the field, previous authors and pharmaceutical companies manufacturing macrolide antibiotics for unpublished or follow-up data (May 2010).Latest search of the Group's Cystic Fibrosis Trials Register: 09 February 2011. SELECTION CRITERIA: Randomised controlled trials of macrolide antibiotics compared to: placebo; another class of antibiotic; another macrolide antibiotic; or the same macrolide antibiotic at a different dose. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed risk of bias. Seven groups were contacted and provided additional data which were incorporated into the review. MAIN RESULTS: Ten of 31 studies identified were included (959 patients). Five studies with a low risk of bias examined azithromycin versus placebo and demonstrated consistent improvement in forced expiratory volume in one second over six months (mean difference at six months 3.97% (95% confidence interval 1.74% to 6.19%; n = 549, from four studies)). Patients treated with azithromycin were approximately twice as likely to be free of pulmonary exacerbation at six months, odds ratio 1.96 (95% confidence interval 1.15 to 3.33). With respect to secondary outcomes, there was a significant reduction in need for oral antibiotics and greater weight gain in those taking azithromycin. Adverse events were uncommon and not obviously associated with azithromycin, although a once-weekly high dose regimen was associated with more frequent gastrointestinal adverse events. Treatment with azithromycin was associated with reduced identification of Staphylococcus aureus on respiratory culture, but also a significant increase in macrolide resistance. AUTHORS' CONCLUSIONS: This review provides evidence of improved respiratory function after six months of azithromycin. Data beyond six months were less clear, although reduction in pulmonary exacerbation was sustained. Treatment appeared safe over a six-month period; however, emergence of macrolide resistance was a concern. A multi-centre trial examining long-term effects of this antibiotic treatment is needed, especially for infants recognised through newborn screening.

Organizational contextual factors that predict success of a quality improvement collaborative approach to enhance integrated HIV-tuberculosis services: a sub-study of the Scaling up TB/HIV Integration trial.

BACKGROUND: A quality improvement (QI) collaborative approach to enhancing integrated HIV-Tuberculosis (TB) services may be effective in scaling up and improving the quality of service delivery. Little is known of the role of organizational contextual factors (OCFs) in influencing the success of QI collaboratives. This study aims to determine which OCFs were associated with improvement in a QI collaborative intervention to enhance integrated HIV-TB services delivery. METHODS: This is a nested sub-study embedded in a cluster-randomized controlled trial. Sixteen nurse supervisors (clusters) overseeing 40 clinics were randomized (1:1) to receive QI training and mentorship, or standard of care support (SOC). In the QI arm, eight nurse supervisors and 20 clinics formed a "collaborative" which aimed to improve HIV-TB process indicators, namely HIV testing, TB screening, isoniazid preventive therapy (IPT) initiations, viral load testing, and antiretroviral therapy for TB patients. OCFs measured at baseline were physical infrastructure, key staff, flexibility of clinic hours, monitoring data for improvement (MDI), and leadership support. Surveys were administered to clinic staff at baseline and month 12 to assess perceptions of supportiveness of contexts for change, and clinic organization for delivering integrated HIV-TB services. Linear mixed modelling was used to test for associations between OCFs and HIV-TB process indicators. RESULTS: A total of 209 clinic staff participated in the study; 97 (46.4%) and 112 (53.6%) from QI and SOC arms, respectively. There were no differences between the QI and SOC arms scores achieved for physical infrastructure (78.9% vs 64.7%; p = 0.058), key staff (95.8 vs 92; p = 0.270), clinic hours (66.9 vs 65.5; p = 0.900), MDI (63.3 vs 65; p = 0.875, leadership support (46.0 vs 57.4; p = 0.265), and perceptions of supportiveness of contexts for change (76.2 vs 79.7; p = 0.128 and clinic organization for delivering integrated HIV-TB services (74.1 vs 80.1; p = 0.916). IPT initiation was the only indicator that was significantly improved in the parent study. MDI was a significantly associated with increasing IPT initiation rates [beta coefficient (ß) = 0.004; p = 0.004]. DISCUSSION: MDI is a practice that should be fostered in public health facilities to increase the likelihood of success of future QI collaboratives to improve HIV-TB service delivery. TRIAL REGISTRATION: Clinicaltrials.gov , NCT02654613 . Registered 01 June 2015.