Understanding key drivers and barriers to implementation of the WHO recommendations for the case management of childhood pneumonia and possible serious bacterial infection with amoxicillin dispersible tablets (DT) in Bangladesh: a qualitative study.

BACKGROUND: Pneumonia and possible serious bacterial infection (PSBI) are leading causes of death among under-five children. The World Health Organization (WHO) issued global recommendations for the case management of childhood pneumonia and PSBI when referral is not feasible with oral amoxicillin. However, few governments to date have incorporated child-friendly amoxicillin dispersible tablets (DT) into their national treatment guidelines and policies. We aimed to understand the key drivers to the implementation of WHO recommendations for childhood pneumonia and PSBI using amoxicillin DT in Bangladesh. METHODS: A qualitative study was conducted from October 2017 to March 2018 in two districts of Bangladesh. Interviews were completed with 67 participants consisting of government officials and key stakeholders, international development agencies, health service providers (HSPs), and caregivers of young children diagnosed and treated with amoxicillin for pneumonia or PSBI. Data were analyzed thematically. RESULTS: Policies and operational planning emerged as paramount to ensuring access to essential medicines for childhood pneumonia and PSBI. Though amoxicillin DT is included for National Newborn Health Programme and Integrated Management of Childhood Illnesses in the Operational Plan of the Directorate General of Health Services, inclusion in Community-Based Healthcare Project and Directorate General of Family Planning policies is imperative to securing national supply, access, and uptake. At the sub-national level, training on the use of amoxicillin DT as a first line intervention is lacking, resulting in inadequate management of childhood pneumonia by HSPs. Advocacy activities are needed to create community-wide demand among key stakeholders, HSPs, and caregivers not yet convinced that amoxicillin DT is the preferred formulation for the management of childhood pneumonia and PSBI. CONCLUSION: Challenges in policy and supply at the national level and HSP preparedness at the sub-national levels contribute to the slow adoption of WHO recommendations for amoxicillin DT in Bangladesh. A consultation meeting to disseminate study findings was instrumental in driving the development of recommendations by key stakeholders to address these challenges. A comprehensive and inclusive evidence-based strategy involving all divisions of the Ministry of Health and Family Welfare will be required to achieve national adoption of WHO recommendations and country-wide introduction of amoxicillin DT in Bangladesh.

A low-cost uterine balloon tamponade for management of postpartum hemorrhage: modeling the potential impact on maternal mortality and morbidity in sub-Saharan Africa.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide. This study sought to quantify the potential health impact (morbidity and mortality reductions) that a low-cost uterine balloon tamponade (UBT) could have on women suffering from uncontrolled PPH due to uterine atony in sub-Saharan Africa. METHODS: The Maternal and Neonatal Directed Assessment of Technology (MANDATE) model was used to estimate maternal deaths, surgeries averted, and cases of severe anemia prevented through UBT use among women with PPH who receive a uterotonic drug but fail this therapy in a health facility. Estimates were generated for the year 2018. The main outcome measures were lives saved, surgeries averted, and severe anemia prevented. RESULTS: The base case model estimated that widespread use of a low-cost UBT in clinics and hospitals could save 6547 lives (an 11% reduction in maternal deaths), avert 10,823 surgeries, and prevent 634 severe anemia cases in sub-Saharan Africa annually. CONCLUSIONS: A low-cost UBT has a strong potential to save lives and reduce morbidity. It can also potentially reduce costly downstream interventions for women who give birth in a health care facility. This technology may be especially useful for meeting global targets for reducing maternal mortality as identified in Sustainable Development Goal 3.

Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study.

OBJECTIVES: Use of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH. DESIGN: A mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months. SETTING: Three Ghanaian (district, regional) and three Kenyan (levels 4-6) healthcare facilities. PARTICIPANTS: Obstetric staff (n=451) working within participating facilities. INTERVENTION: PPH management training courses were conducted with obstetric staff. PRIMARY AND SECONDARY OUTCOME MEASURES: Facility measures of adoption, sustainability and fidelity and individual measures of acceptability and feasibility. RESULTS: All participating hospitals adopted the device during the study period and the majority (52%-62%) of the employed obstetric staff were trained on the Ellavi; sustainability and fidelity to training content were moderate. The Ellavi was suited for this context due to high delivery and PPH burden. Dynamic training curriculums led by local UBT champions and clear instructions on the packaging yielded positive attitudes and perceptions, and high user confidence, resulting in overall high acceptability. Post-training and post-use, ≥79% of the trainees reported that the Ellavi was easy to use. Potential barriers to use included the lack of adjustable drip stands and difficulties calculating bag height according to blood pressure. Overall, the Ellavi can be feasibly integrated into PPH care and was preferred over condom catheters. CONCLUSIONS: The training package and time saving Ellavi design facilitated its adoption, acceptability and feasibility. The Ellavi is appropriate and feasible for use among obstetric staff and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package. TRIAL REGISTRATION NUMBERS: NCT04502173; NCT05340777.

User-Centered Design: Developing the RELI Delivery System - a Low-Cost, Non-Electric, Pneumatic Infusion Pump.

PURPOSE: Infusion pumps are the preferred method for intravenous delivery of drugs and fluids, and an essential tool in health facilities. Their high cost, complexity and reliance on electricity pose serious challenges to wide-spread use, availability and access in low- and middle-income countries. PATH developed the RELI Delivery System (RELI), a low cost, non-electric infusion pump to address these challenges. Input collected from fifty-nine newborn and maternal care providers and from seven national level decision makers in Uganda was used to guide product development, further informing product design requirements, and optimal design features to best serve their needs. METHODS: A formative evaluation following a mixed methods approach including focus group discussions (FGDs), stakeholder interviews, and observations was used to collect data from end users. RESULTS: Stakeholders provided critical input on the RELI prototype design features, safety criteria, and contexts of use of infusion pumps, as well as recommendations for design refinements. Infusion systems are greatly needed but not readily available and their use is limited to well-resourced higher level facilities, even though the need is high in non-tertiary care hospital where patient volume is high, resources are scarce, power is inconsistent, and facilities are understaffed and overcrowded. Users expressed a need for an affordable and simple device with an intuitive user interface, clear instructions for use, and basic safety features. CONCLUSION: The study provided important guidance for further design refinements based on input from respondents and confirmed the need for robust, affordable, infusion pumps that meet the requirements for use in low-resource settings.

Evaluating the use of job aids and user instructions to improve adherence for the treatment of childhood pneumonia using amoxicillin dispersible tablets in a low-income setting: a mixed-method study.

OBJECTIVES: We conducted a study to evaluate the use of job aids and simple user instructions to improve adherence for the treatment of childhood pneumonia with amoxicillin dispersible tablet (DT). DESIGN: A mixed-method study implemented in three phases between October 2015 and February 2016. SETTINGS: The study was implemented in two subdistricts of Bangladesh. PARTICIPANTS: Caregivers of children aged 2-59 months, health service providers and key stakeholders at national and district level. INTERVENTIONS: An intervention including training and job aids and user-friendly instructions was introduced in one subdistrict while standard amoxicillin DT packaging and instructions with no training served as the control in the comparison subdistrict. PRIMARY OUTCOME: Adherence behaviour of caregivers of children aged 2-59 months for the treatment of childhood pneumonia with amoxicillin DT. METHODS: We conducted a survey with 56 caregivers in the intervention subdistrict and 38 caregivers in the comparison subdistrict. We also conducted 44 in-depth interviews to evaluate the job aids and user-friendly instructions with healthcare providers and caregivers to assess the feasibility, usability and acceptability of the tools in intervention subdistrict. RESULTS: For 5-day treatment course, 32.1% (95% CI 23.1% to 41.1%) of caregivers in the intervention subdistrict and 2.6% (95% CI 0.3% to 7.8%) in the comparison subdistrict maintained full adherence to the amoxicillin DT treatment for pneumonia. More children under 12 months were given age-appropriate treatment than older children. Key stakeholders and healthcare providers considered the use and integration of the tools into the health system to be feasible and acceptable. CONCLUSIONS: The provision of tools for the treatment of childhood pneumonia with amoxicillin DT had a positive influence on adherence behaviours. These tools can help close information gaps and overcome the barriers posed by medical illiteracy and remembering instructions from providers.

An evaluation of hemoglobin measurement tools and their accuracy and reliability when screening for child anemia in Rwanda: A randomized study.

Blood hemoglobin (Hb) is a common indicator for diagnosing anemia and is often determined through laboratory analysis of venous samples. One alternative to laboratory-based methods is the handheld HemoCue® Hb 201+ device, which requires a finger prick and wicking of blood into a pretreated cuvette for analysis. An alternative HemoCue® gravity method is being investigated for improved accuracy. Further, recent developments in noninvasive technologies could provide an accurate, rapid, safe, point-of-care option for hemoglobin estimation while addressing some limitations of current tools, but device performance must be assessed in low-resource settings. This study evaluated the performance of two HemoCue® Hb 201+ blood sampling methods and a noninvasive device (Pronto® with DCI-mini™ sensors) in a Rwandan pediatric clinic. Reference hemoglobin values were determined in 132 children 6 to 59 months of age by using a standard hematology analyzer (Sysmex KN21TM). Half were tested using the HemoCue® wicking method; half were tested using the HemoCue® gravity method; and 112 had successful hemoglobin readings with Pronto® DCI-mini™. Statistical analysis was used to assess the level of bias generated by each method and the key drivers of bias. The HemoCue® gravity method was the least biased. The HemoCue® wicking and Pronto® methods biases were inversely related to the Sysmex KN21TM results. Both HemoCue® sampling methods correctly classified patients' anemic status in 80% or more of instances, whereas the Pronto® device had a correct classification rate of only 69%. The HemoCue® gravity method was more accurate than the traditional HemoCue® wicking method in this study, but its accuracy and operational feasibility should be confirmed by future studies. The Pronto® DCI-mini™ devices showed considerable promise but require further improvements in sensitivity and specificity before wider adoption.

Cost-effectiveness of condom uterine balloon tamponade to control severe postpartum hemorrhage in Kenya.

OBJECTIVE: To evaluate the cost-effectiveness of condom uterine balloon tamponade (UBT) for control of severe postpartum hemorrhage (PPH) due to uterine atony versus standard PPH care in Kenya. METHODS: A cross-sectional analysis was conducted using cost data collected from 30 facilities in Western Kenya from April 15 to July 16, 2015. Effectiveness data were derived from the published literature. The modeling analysis was performed from the health-system perspective for a cohort of women who gave birth in 2015. Sensitivity analyses tested the robustness of model estimates. Costs were in 2015 US dollars. RESULTS: Compared with standard care with no uterine packing, condom UBT could prevent 1255 hospital transfers, 430 hysterectomies, and 44 maternal deaths. At $5 or $15 per UBT device, the incremental cost per disability-adjusted life year (DALY) averted was $26 or $40, respectively. If uterine packing was assumed to be done with standard care, the cost per DALY averted was $164 when the UBT price was $5 and $199 when the price was $15. CONCLUSION: Condom UBT was a highly cost-effective intervention for controlling severe PPH. This finding remained robust even when key model inputs were varied by wide margins.