"I'll take them another day": A qualitative study exploring the socio-behavioral complexities of childhood vaccination in urban poor settlements.

Despite improvement over recent decades, childhood vaccination uptake remains a concern across countries. The World Health Organization observed that over 25 million children missed out on one or more vaccines in 2021, with urban poor and other marginalized groups being the most affected. Given the higher risk of disease transmission and vaccine-preventable diseases (VPD) outbreaks across densely populated urban slums, identifying effective interventions to improve childhood vaccination in this vulnerable population is crucial. This study explored the behavioral and social factors influencing childhood vaccination uptake in urban informal settlements in Nairobi, Kenya. A grounded theory approach was employed to develop a theoretical account of the socio-behavioral determinants of childhood vaccination. Five focus group discussions (FGDs) were conducted with purposively sampled caregivers of children under five years of age residing in informal settlements. The Theory of Planned Behavior guided the structuring of the FGD questions. An iterative process was used to analyze and identify emerging themes. Thirty-nine caregivers (median age 29 years) participated in the FGDs. From the analysis, four main thematic categories were derived. These included attitude factors such as perceived vaccine benefits, cultural beliefs, and emotional factors including parental love. Additionally, subjective norms, like fear of social judgment, and perceived behavioral control factors, such as self-control and gender-based influences, were identified. Furthermore, a number of practical factors, including the cost of vaccines and healthcare providers attitude, also affected the uptake of vaccination. Various social, behavioral, cultural, and contextual factors influence caregiver vaccination decisions in urban poor settings. Community-derived and context-specific approaches that address the complex interaction between socio-behavioral and other contextual factors need to be tested and applied to improve the timely uptake of childhood vaccinations among marginalized populations.

Assessing the influence of the health system on access to cervical cancer prevention, screening, and treatment services at public health centers in Addis Ababa, Ethiopia.

BACKGROUND: Cervical cancer is the second leading cause of cancer death among Ethiopian women. This study aimed to assess the influence of the health system on access to cervical cancer prevention, screening, and treatment services at public health centers in Addis Ababa, Ethiopia. METHODS: This study used a cross-sectional survey design and collected data from 51 randomly selected public health centers in Addis Ababa. Open Data Kit was used to administer a semi-structured questionnaire on Android tablets, and SPSS version 26 was used to analyze the descriptive data. RESULTS: In the study conducted at 51 health centers, cervical cancer prevention and control services achieved 61% HPV vaccination for girls, 79% for cervical cancer awareness messages, 80% for precancer lesion treatment, and 71% for cervical screening of women. All health centers were performing cervical screening mostly through visual inspection with acetic acid due to the inconsistent availability of HPV DNA tests and the lack of Pap smear tests. In 94% of health centers, adequate human resources were available. However, only 78% of nurses, 75% of midwives, 35% of health officers, and 49% of health extension workers received cervical cancer training in the 24 months preceding the study. Women had provider choices in only 65% of health centers, and 86% of the centers lacked electronic health records. In 41% of the health centers, the waiting time was 30 minutes or longer. About 88% and 90% of the facilities lacked audio and video cervical cancer messages, respectively. CONCLUSION: This study revealed that the annual cervical cancer screening achievement was on track to fulfill the WHO's 90-70-90 targets by 2030. We recommend that decision-makers prioritize increasing HPV vaccination rates, enhancing messaging, reducing wait times, and implementing electronic health records to improve access to cervical cancer services in Addis Ababa.

Deconcentrating regulation in low- and middle-income country health systems: a proposed ambidextrous solution to problems with professional regulation for doctors and nurses in Kenya and Uganda.

BACKGROUND: Regulation can improve professional practice and patient care, but is often weakly implemented and enforced in health systems in low- and middle-income countries (LMICs). Taking a de-centred and frontline perspective, we examine national regulatory actors' and health professionals' views and experiences of health professional regulation in Kenya and Uganda and discuss how it might be improved in LMICs more generally. METHODS: We conducted large-scale research on professional regulation for doctors and nurses (including midwives) in Uganda and Kenya during 2019-2021. We interviewed 29 national regulatory stakeholders and 47 subnational regulatory actors, doctors, and nurses. We then ran a national survey of Kenyan and Ugandan doctors and nurses, which received 3466 responses. We thematically analysed qualitative data, conducted an exploratory factor analysis of survey data, and validated findings in four focus group discussions. RESULTS: Kenyan and Ugandan regulators were generally perceived as resource-constrained, remote, and out of touch with health professionals. This resulted in weak regulation that did little to prevent malpractice and inadequate professional education and training. However, interviewees were positive about online licencing and regulation where they had relationships with accessible regulators. Building on these positive findings, we propose an ambidextrous approach to improving regulation in LMIC health systems, which we term deconcentrating regulation. This involves developing online licencing and streamlining regulatory administration to make efficiency savings, freeing regulatory resources. These resources should then be used to develop connected subnational regulatory offices, enhance relations between regulators and health professionals, and address problems at local level. CONCLUSION: Professional regulation for doctors and nurses in Kenya and Uganda is generally perceived as weak. Yet these professionals are more positive about online licencing and regulation where they have relationships with regulators. Building on these positive findings, we propose deconcentrating regulation as a solution to regulatory problems in LMICs. However, we note resource, cultural and political barriers to its effective implementation.

Factors influencing the uptake and utilization of cervical cancer screening services among women attending public health centers in Addis Ababa, Ethiopia: mixed methods study.

BACKGROUND: Cervical cancer is the second cause of cancer deaths among Ethiopian women. Despite multifaceted government efforts, the uptake and utilization of cervical cancer screening remain very low. This study aimed to assess factors influencing the uptake and utilization of cervical cancer screening at public health centers in Addis Ababa. METHODS: A convergent parallel mixed-method study was employed to collect data through eight focus group discussions with 66 women purposively recruited from outpatient clinics, and cross-sectional face-to-face exit interviews with 80 women attending cervical cancer clinics in four high-patient volume health centers. The group interviews were tape-recorded, transcribed in Amharic, translated into English, and a thematic analysis approach was used in the analysis. Exit interview data were collected using a structured questionnaire in the Open Data Kit tool on an android tablet. STATA version 17 was used for descriptive and inferential data analyses. Statistical significance was set at p < 0.05. RESULTS: The majority of focus group discussion participants had lack of knowledge of cervical cancer and its screening services. The major barriers to the uptake of screening were inadequate public awareness, fear of the procedure, embarrassment, provider's gender, lack of male partner support, and childcare. Women aged 40 years and above were 13.9 times more likely to utilize cervical cancer screening than those under 30 years (AOR = 13.85; 95% CI: 1.40, 136.74). There was a strong preference for a female provider (AOR = 7.07; 95% CI: 1.53, 32.75) among women screened after attending antiretroviral therapy clinics and those screened due to abnormal vaginal bleeding than women referred from family planning clinics (AOR = 6.87; 95% CI: 1.02, 46.44). Safety of screening was negatively associated with women aged 30-39 (AOR = 0.045; 95% CI: 0.003, 0.696), and those who attended primary education, and secondary education and above, (AOR = 0.016; 95% CI: 0.001, 0.262), and (AOR = 0.054; 95% CI: 0.004, 0.724), respectively. CONCLUSIONS: The study identified low public awareness, inadequate provider preference, safety concerns, and poor male partner support for cervical cancer screening. We recommend the decision-makers enhance public messages, maintain provider choices, ensure safety, and engage males to improve the uptake and utilization of cervical cancer screening.

Health practitioner regulation and national health goals.

The role of health practitioner regulation in ensuring patient safety is well recognized. Less recognized is the role of regulation in addressing broader health system priorities. These goals include managing the costs, capacities and distribution of health professional education institutions; ensuring the competence and equitable distribution of health workers; informing workforce planning and mobilization; enabling the use of digital technologies; and addressing challenges related to the international mobility of health workers. Even where health practitioner regulation is designed to advance these goals, important gaps exist between the potential of regulatory systems and their performance. The response to the coronavirus disease 2019 (COVID-19) pandemic led many countries to introduce regulatory changes to allow more flexibility and innovations in the mobilization of health practitioners. Building on this experience, we need to critically re-examine health practitioner regulatory systems to ensure that these systems support rather than impede progress towards national health goals. We discuss the role of health practitioner regulation in contemporary health systems, highlighting recent regulatory reforms in selected countries, including during the COVID-19 pandemic. We identify the importance of dynamic, effective and flexible health practitioner regulatory systems in progress towards universal health coverage and health security.

Le rôle qu'exerce la réglementation relative aux professionnels de la santé pour la sécurité du patient est bien connu. En revanche, celui qu'elle joue dans la définition des grandes priorités du système de santé l'est moins. Elle comporte ainsi plusieurs objectifs, notamment: assurer la gestion des coûts, des capacités et de la distribution des établissements de formation des professionnels de la santé; garantir une répartition équitable d'agents de santé compétents; guider la planification et la mobilisation de la main-d'œuvre; permettre l'intégration des technologies numériques; et enfin, relever les défis liés à la mobilité internationale des acteurs du secteur. Même dans les endroits où une telle réglementation est conçue pour atteindre ces objectifs, des écarts considérables subsistent entre le potentiel des systèmes de réglementation et leurs performances réelles. La lutte contre la pandémie de maladie à coronavirus 2019 (COVID-19) a encouragé de nombreux pays à modifier les règles en vigueur en vue d'offrir une plus grande flexibilité et davantage d'innovations en matière de mobilisation des agents de santé. En nous fondant sur cette expérience, nous devons impérativement réexaminer les systèmes de réglementation propres aux praticiens afin qu'ils constituent un moteur, et non un frein, à la poursuite des objectifs nationaux en matière de santé. Dans le présent document, nous évoquons le rôle de la réglementation relative aux professionnels de la santé dans les systèmes de santé actuels, en mentionnant les récentes réformes entreprises par une série de pays dans ce domaine, y compris durant la pandémie de COVID-19. Nous soulignons également l'importance d'instaurer des systèmes de réglementation dynamiques, efficaces et flexibles pour les praticiens sur la voie menant à la sécurité sanitaire et à une couverture sanitaire universelle.

La función de la reglamentación de los profesionales sanitarios para garantizar la seguridad de los pacientes es bien conocida. Sin embargo, se reconoce menos la función de la reglamentación para atender prioridades más amplias del sistema sanitario. Estos objetivos incluyen: gestionar los costes, las capacidades y la distribución de las instituciones de formación de profesionales sanitarios; asegurar la competencia y la distribución equitativa de los trabajadores sanitarios; informar la planificación y movilización del personal; permitir el uso de tecnologías digitales; y abordar los retos relacionados con la movilidad internacional de los trabajadores sanitarios. Incluso en los casos en que la reglamentación de los profesionales sanitarios está concebida para promover estos objetivos, existen diferencias considerables entre el potencial de los sistemas de reglamentación y sus resultados. La respuesta a la pandemia de enfermedad por coronavirus de 2019 (COVID-19) llevó a muchos países a introducir cambios en la reglamentación para permitir una mayor flexibilidad e innovaciones en la movilización de los profesionales sanitarios. A partir de esta experiencia, es necesario volver a examinar de forma crítica los sistemas de reglamentación de los profesionales sanitarios para garantizar que estos sistemas apoyen y no impidan el progreso hacia los objetivos sanitarios nacionales. En este artículo se analiza la función de la reglamentación de los profesionales de la salud en los sistemas sanitarios contemporáneos y se destacan las recientes reformas reglamentarias introducidas en algunos países, en particular durante la pandemia de COVID-19. Asimismo, se destaca la importancia de que los sistemas de reglamentación de los profesionales sanitarios sean dinámicos, eficaces y flexibles para avanzar hacia la cobertura sanitaria universal y la seguridad sanitaria.

How much does effective health facility inspection cost? An analysis of the economic costs of Kenya's Joint Health Inspection innovations.

BACKGROUND: In most low- and middle-income countries, health facility regulation is fragmented, ineffective and under-resourced. The Kenyan Government piloted an innovative regulatory regime involving Joint Health Inspections (JHI) which synthesized requirements across multiple regulatory agencies; increased inspection frequency; digitized inspection tools; and introduced public display of regulatory results. The pilot significantly improved regulatory compliance. We calculated the costs of the development and implementation of the JHI pilot and modelled the costs of national scale-up in Kenya. METHODS: We calculated the economic costs of three phases: JHI checklist development, start-up activities, and first year of implementation, from the providers' perspective in three pilot counties. Data collection involved extraction from expenditure records and key informant interviews. The annualized costs of JHI were calculated by adding annualized development and start-up costs to annual implementation costs. National level scale-up costs were also modelled and compared to those of current standard inspections. RESULTS: The total economic cost of the JHI pilot was USD 1,125,600 (2017 USD), with the development phase accounting for 19%, start-up 43% and the first year of implementation 38%. The annualized economic cost was USD 519,287, equivalent to USD 206 per health facility visit and USD 311 per inspection completed. Scale up to the national level, while replacing international advisors with local staff, was estimated to cost approximately USD 4,823,728, equivalent to USD 103 per health facility visit and USD 155 per inspection completed. This compares to an estimated USD 86,997 per year (USD 113 per inspection completed) spent on a limited number of inspections prior to JHI. CONCLUSION: Information on costs is essential to consider affordability and value for money of regulatory interventions. This is the first study we are aware of costing health facility inspections in sub-Saharan Africa. It has informed debates on appropriate inspection design and potential efficiency gains. It will also serve as an important benchmark for future studies, and a key input into cost-effectiveness analyses.

Healthcare clinic and pharmacy chains in Kenya and Nigeria: A qualitative exploration of the opportunities and risks they present for healthcare regulatory systems.

BACKGROUND: Regulating fragmented healthcare markets is a major challenge in low- and middle-income countries. Although a recent transformation towards consolidation could improve regulatory efficiency, there are concerns over risks to client safety and market functioning. We investigated market consolidation through the emergence of clinic and pharmacy chains in Kenya and Nigeria and explored resultant regulatory opportunities and risks. METHODS: The study was conducted in Nairobi Kenya and Abuja Nigeria. Data were collected through document reviews and 26 interviews with chain operators, professional associations and regulators between September and December 2018. A thematic analysis was conducted. RESULTS: We characterised two broad types of chains: organic chains that started as single business locations and expanded gradually, and investor-driven chains that expanded rapidly following external capital injection. In both countries, chains and independents were regulated similarly, with regulators failing to both capitalize on opportunities and guard against risks. For instance, chains' brand visibility and centralised management systems made them easier to regulate and more suitable for self-regulation. On the other hand, chains were perceived to pose the risks of market dominance, commercialisation of healthcare, and regulatory capture. CONCLUSION: As healthcare chains expand, regulators should build on opportunities presented and guard against emerging risks.

What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya's Health Facility Inspection Reforms.

BACKGROUND: Health facility regulation in low- and middle-income countries (LMICs) is generally weak, with potentially serious consequences for safety and quality. Innovative regulatory reforms were piloted in three Kenyan counties including: a Joint Health Inspection Checklist (JHIC) synthesizing requirements across multiple regulatory agencies; increased inspection frequency; allocating facilities to compliance categories which determined warnings, sanctions and/or time to re-inspection; and public display of regulatory results. The reforms substantially increased inspection scores compared with control facilities. We developed lessons for future regulatory policy from this pilot by identifying key factors that facilitated or hindered its implementation. METHODS: We conducted a qualitative study to understand views and experiences of actors involved in the one-year pilot. We interviewed 77 purposively selected staff from the national, county and facility levels. Data were analyzed using the framework approach, identifying facilitating/hindering factors at the facility, inspection system, and health system levels. RESULTS: The joint health inspections (JHIs) were generally viewed as fair, objective and transparent, which enhanced their perceived legitimacy. Interactions with inspectors were described as friendly and supportive, in contrast to the punitive culture of previous inspections when bribery had been common. Inspector training and use of an electronic checklist were strongly praised. However, practical challenges with transport, route planning and budgets highlighted the critical nature of strong logistical management. The effectiveness of inspection in improving compliance was hampered by limitations in related systems, particularly facility licensing, enforcement of closures and, in the public sector, control of funds. However, an inclusive reform development process had led to high buy-in across regulatory agencies which was key to the system's success. CONCLUSION: Effective facility inspection involves more than "hardware" such as checklists, protocols and training. Cultural, relational and institutional "software" are also crucial for legitimacy, feasibility of implementation and enforceability, and should be carefully integrated into regulatory reforms.

Understanding Women's Choices: How Women's Perceptions of Quality of Care Influences Place of Delivery in a Rural Sub-County in Kenya. A Qualitative Study.

BACKGROUND: Maternal mortality is still unacceptably high in Kenya. The Kenyan Government introduced a free maternity service to overcome financial barriers to access. This policy led to a substantial increase in women's delivery options. This increase in coverage might have led to a reduction in quality of care. This study explores women's perceptions of quality of delivery services in the context of the free policy and how the perceptions lead to the choice of a place for delivery. METHODS: Our study site was Naivasha sub-County in Kenya, a rural context, whose geography encompasses pastoralists, rural agrarian, and high population density informal settlements near flower farms. Women from this area are from the lowest wealth quintile in Kenya. We conducted a qualitative study to explore the women's perceptions of quality of care based on their experiences during maternity care. The participants were women of reproductive age (18-49 years) attending antenatal care clinics at six health facilities in the sub-county. Six focus group discussions with 55 respondents were used. For inclusion, the women needed to have delivered a baby within the six months preceding the study. Interviews were recorded with consent, translated and transcribed. The interviews were analyzed using a thematic content approach. RESULTS: Four broad themes that determined the choice of health facility for delivery were identified: women's perceptions of clinical quality of care; the cost of delivery; distance to the health facility and management of primary health facilities. An unexpected theme was the presence of home deliveries amongst pastoralist women. These findings suggest that in this setting both process and structural dimensions of quality of care and financial and physical accessibility influence women's choices for place of delivery. CONCLUSION: This study expands our understanding of how women make choices regarding place of delivery. Understanding women's perceptions can provide useful insights to policy makers and facility managers on providing high quality patient centered maternity care necessary to sustain the increased utilization of maternity services at health facilities under the free maternity policy and further reductions in maternal mortality.

When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries.

The recent growth of medicine sales online represents a major disruption to pharmacy markets, with COVID-19 encouraging this trend further. While e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in low-income and middle-income countries (LMICs). Public health concerns associated with e-pharmacy include the sale of prescription-only medicines without a prescription and the sale of substandard and falsified medicines. There are also non-health-related risks such as consumer fraud and lack of data privacy. However, e-pharmacy may also have the potential to improve access to medicines. Drawing on existing literature and a set of key informant interviews in Kenya, Nigeria and India, we examine the e-pharmacy regulatory systems in LMICs. None of the study countries had yet enacted a regulatory framework specific to e-pharmacy. Key regulatory challenges included the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders and risks of over-regulation. However, e-pharmacy also presents opportunities to enhance medicine regulation-through consolidation in the sector, and the traceability and transparency that online records offer. The regulatory process needs to be adapted to keep pace with this dynamic landscape and exploit these possibilities. This will require exploration of a range of innovative regulatory options, collaboration with larger, more compliant businesses, and engagement with global regulatory bodies. A key first step must be ensuring that national regulators are equipped with the necessary awareness and technical expertise to actively oversee this e-pharmacy activity.

Eliciting women's preferences for place of child birth at a peri-urban setting in Nairobi, Kenya: A discrete choice experiment.

OBJECTIVE: Maternal and newborn mortality rates are high in peri-urban areas in cities in Kenya, yet little is known about what drives women's decisions on where to deliver. This study aimed at understanding women's preferences on place of childbirth and how sociodemographic factors shape these preferences. METHODS: This study used a Discrete Choice Experiment (DCE) to quantify the relative importance of attributes on women's choice of place of childbirth within a peri-urban setting in Nairobi, Kenya. Participants were women aged 18-49 years, who had delivered at six health facilities. The DCE consisted of six attributes: cleanliness, availability of medical equipment and drug supplies, attitude of healthcare worker, cost of delivery services, the quality of clinical services, distance and an opt-out alternative. Each woman received eight questions. A conditional logit model established the relative strength of preferences. A mixed logit model was used to assess how women's preferences for selected attributes changed based on their sociodemographic characteristics. RESULTS: 411 women participated in the Discrete Choice Experiment, a response rate of 97.6% and completed 20,080 choice tasks. Health facility cleanliness was found to have the strongest association with choice of health facility (ß = 1.488 p<0.001) followed respectively by medical equipment and supplies availability (ß = 1.435 p<0.001). The opt-out alternative (ß = 1.424 p<0.001) came third. The attitude of the health care workers (ß = 1.347, p<0.001), quality of clinical services (ß = 0.385, p<0.001), distance (ß = 0.339, p<0.001) and cost (ß = 0.0002 p<0.001) were ranked 4th to 7th respectively. Women who were younger and were the main income earners having a stronger preference for clean health facilities. Older married women had stronger preference for availability of medical equipment and kind healthcare workers. CONCLUSIONS: Women preferred both technical and process indicators of quality of care. DCE's can lead to the development of person-centered strategies that take into account the preferences of women to improve maternal and newborn health outcomes.

Understanding what women want: eliciting preference for delivery health facility in a rural subcounty in Kenya, a discrete choice experiment.

OBJECTIVE: To identify what women want in a delivery health facility and how they rank the attributes that influence the choice of a place of delivery. DESIGN: A discrete choice experiment (DCE) was conducted to elicit rural women's preferences for choice of delivery health facility. Data were analysed using a conditional logit model to evaluate the relative importance of the selected attributes. A mixed multinomial model evaluated how interactions with sociodemographic variables influence the choice of the selected attributes. SETTING: Six health facilities in a rural subcounty. PARTICIPANTS: Women aged 18-49 years who had delivered within 6 weeks. PRIMARY OUTCOME: The DCE required women to select from hypothetical health facility A or B or opt-out alternative. RESULTS: A total of 474 participants were sampled, 466 participants completed the survey (response rate 98%). The attribute with the strongest association with health facility preference was having a kind and supportive healthcare worker (ß=1.184, p<0.001), second availability of medical equipment and drug supplies (ß=1.073, p<0.001) and third quality of clinical services (ß=0.826, p<0.001). Distance, availability of referral services and costs were ranked fourth, fifth and sixth, respectively (ß=0.457, p<0.001; ß=0.266, p<0.001; and ß=0.000018, p<0.001). The opt-out alternative ranked last suggesting a disutility for home delivery (ß=-0.849, p<0.001). CONCLUSION: The most highly valued attribute was a process indicator of quality of care followed by technical indicators. Policymakers need to consider women's preferences to inform strategies that are person centred and lead to improvements in quality of care during delivery.

'We just look at the well-being of the baby and not the money required': a qualitative study exploring experiences of quality of maternity care among women in Nairobi's informal settlements in Kenya.

OBJECTIVE: To examine how women living in an informal settlement in Nairobi perceive the quality of maternity care and how it influences their choice of a delivery health facility. DESIGN: Qualitative study. SETTINGS: Dandora, an informal settlement, Nairobi City in Kenya. PARTICIPANTS: Six focus group discussions with 40 purposively selected women aged 18-49 years at six health facilities. RESULTS: Four broad themes were identified: (1) perceived quality of the delivery services, (2) financial access to delivery service, (3) physical amenities at the health facility, and (4) the 2017 health workers' strike.The four facilitators that influenced women to choose a private health facility were: (1) interpersonal treatment at health facilities, (2) perceived quality of clinical services, (3) financial access to health services at the facility, and (4) the physical amenities at the health facility. The three barriers to choosing a private facility were: (1) poor quality clinical services at low-cost health facilities, (2) shortage of specialist doctors, and (3) referral to public health facilities during emergencies.The facilitators that influenced women to choose a public facility were: (1) physical amenities for dealing with obstetric emergencies and (2) early referral to public maternity during antenatal care services. Barriers to choosing a public facility were: (1) perception of poor quality clinical services, (2) concerns over security for newborns at tertiary health facilities, (3) fear of mistreatment during delivery, (4) use of unsupervised trainee doctors for deliveries, (5) poor quality of physical amenities, and (6) inadequate staffing. CONCLUSION: The study provides insights into decision-making processes for women when choosing a delivery facility by identifying critical attributes that they value and how perceptions of quality influence their choices.

Use of standardised patients to assess quality of healthcare in Nairobi, Kenya: a pilot, cross-sectional study with international comparisons.

INTRODUCTION: The quality of clinical care can be reliably measured in multiple settings using standardised patients (SPs), but this methodology has not been extensively used in Sub-Saharan Africa. This study validates the use of SPs for a variety of tracer conditions in Nairobi, Kenya, and provides new results on the quality of care in sampled primary care clinics. METHODS: We deployed 14 SPs in private and public clinics presenting either asthma, child diarrhoea, tuberculosis or unstable angina. Case management guidelines and checklists were jointly developed with the Ministry of Health. We validated the SP method based on the ability of SPs to avoid detection or dangerous situations, without imposing a substantial time burden on providers. We also evaluated the sensitivity of quality measures to SP characteristics. We assessed quality of practice through adherence to guidelines and checklists for the entire sample, stratified by case and stratified by sector, and in comparison with previously published results from urban India, rural India and rural China. RESULTS: Across 166 interactions in 42 facilities, detection rates and exposure to unsafe conditions were both zero. There were no detected outcome correlations with SP characteristics that would bias the results. Across all four conditions, 53% of SPs were correctly managed with wide variation across tracer conditions. SPs paid 76% less in public clinics, but proportions of correct management were similar to private clinics for three conditions and higher for the fourth. Kenyan outcomes compared favourably with India and China in all but the angina case. CONCLUSIONS: The SP method is safe and effective in the urban Kenyan setting for the assessment of clinical practice. The pilot results suggest that public providers in this setting provide similar rates of correct management to private providers at significantly lower out-of-pocket costs for patients. However, comparisons across countries are sensitive to the tracer condition considered.

Observations of infection prevention and control practices in primary health care, Kenya.

OBJECTIVE: To assess compliance with infection prevention and control practices in primary health care in Kenya. METHODS: We used an observational, patient-tracking tool to assess compliance with infection prevention and control practices by 1680 health-care workers during outpatient interactions with 14 328 patients at 935 health-care facilities in 2015. Compliance was assessed in five domains: hand hygiene; protective glove use; injections and blood sampling; disinfection of reusable equipment; and waste segregation. We calculated compliance by dividing the number of correct actions performed by the number of indications and evaluated associations between compliance and the health-care worker's and facility's characteristics. FINDINGS: Across 106 464 observed indications for an infection prevention and control practice, the mean compliance was 0.318 (95% confidence interval, CI: 0.315 to 0.321). The compliance ranged from 0.023 (95% CI: 0.021 to 0.024) for hand hygiene to 0.871 (95% CI: 0.866 to 0.876) for injection and blood sampling safety. Compliance was weakly associated with the facility's characteristics (e.g. public or private, or level of specialization) and the health-care worker's knowledge of, and training in, infection prevention and control practices. CONCLUSION: The observational tool was effective for assessing compliance with infection prevention and control practices across multiple domains in primary health care in a low-income country. Compliance varied widely across infection prevention and control domains. The weak associations observed between compliance and the characteristics of health-care workers and facilities, such as knowledge and the availability of supplies, suggest that a broader focus on behavioural change is required.

Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients.

BACKGROUND: Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available. OBJECTIVE: The aim of this study was to validate an alternative post-market surveillance model to complement existing models. METHODS: The study used standardized patients or mystery clients (people recruited from the local community and trained to pose as real patients) to collect medicine samples after presenting a pre-specified condition. The patients presented four standardized conditions to 42 blinded facilities in Nairobi, Kenya, resulting in 166 patient-clinician interactions and dispensing of 300 medicines at facilities or nearby retail pharmacies. The medicine samples obtained thus resemble those that would be given to real patients. RESULTS: Sixty samples were selected from the 300, and sent for analysis at the Kenya National Quality Control Laboratory. Of these, ten (17%) did not comply with monograph specifications (three ibuprofen, two cetirizine, two amoxicillin/clavulanic acid combinations, and one each for prednisone, salbutamol and zinc). Five of the ten samples that failed had been inappropriately prescribed to patients who had presented symptoms of unstable angina. There was no association between medicine quality and ownership, size or location of the facilities. CONCLUSION: The study shows that the standardized patient model can provide insights into multiple dimensions of care, thus helping to link primary care encounters with medicine quality. Furthermore, it makes it possible to obtain medicines from blinded sellers, thus minimizing the risk of obtaining biased samples.