The Impact of a Line Probe Assay Based Diagnostic Algorithm on Time to Treatment Initiation and Treatment Outcomes for Multidrug Resistant TB Patients in Arkhangelsk Region, Russia.

BACKGROUND: In the Arkhangelsk region of Northern Russia, multidrug-resistant (MDR) tuberculosis (TB) rates in new cases are amongst the highest in the world. In 2014, MDR-TB rates reached 31.7% among new cases and 56.9% among retreatment cases. The development of new diagnostic tools allows for faster detection of both TB and MDR-TB and should lead to reduced transmission by earlier initiation of anti-TB therapy. STUDY AIM: The PROVE-IT (Policy Relevant Outcomes from Validating Evidence on Impact) Russia study aimed to assess the impact of the implementation of line probe assay (LPA) as part of an LPA-based diagnostic algorithm for patients with presumptive MDR-TB focusing on time to treatment initiation with time from first-care seeking visit to the initiation of MDR-TB treatment rather than diagnostic accuracy as the primary outcome, and to assess treatment outcomes. We hypothesized that the implementation of LPA would result in faster time to treatment initiation and better treatment outcomes. METHODS: A culture-based diagnostic algorithm used prior to LPA implementation was compared to an LPA-based algorithm that replaced BacTAlert and Löwenstein Jensen (LJ) for drug sensitivity testing. A total of 295 MDR-TB patients were included in the study, 163 diagnosed with the culture-based algorithm, 132 with the LPA-based algorithm. RESULTS: Among smear positive patients, the implementation of the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 50 and 66 days compared to the culture-based algorithm (BacTAlert and LJ respectively, p<0.001). In smear negative patients, the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 78 days when compared to the culture-based algorithm (LJ, p<0.001). However, several weeks were still needed for treatment initiation in LPA-based algorithm, 24 days in smear positive, and 62 days in smear negative patients. Overall treatment outcomes were better in LPA-based algorithm compared to culture-based algorithm (p = 0.003). Treatment success rates at 20 months of treatment were higher in patients diagnosed with the LPA-based algorithm (65.2%) as compared to those diagnosed with the culture-based algorithm (44.8%). Mortality was also lower in the LPA-based algorithm group (7.6%) compared to the culture-based algorithm group (15.9%). There was no statistically significant difference in smear and culture conversion rates between the two algorithms. CONCLUSION: The results of the study suggest that the introduction of LPA leads to faster time to MDR diagnosis and earlier treatment initiation as well as better treatment outcomes for patients with MDR-TB. These findings also highlight the need for further improvements within the health system to reduce both patient and diagnostic delays to truly optimize the impact of new, rapid diagnostics.

User cost of Caesarean section: case study of Bunia, Democratic Republic of Congo.

The study estimated the user cost of Caesarean section (CS), a major component of emergency obstetric care (EmOC), in a post conflict situation in Bunia, DR Congo, 2008. A case control study used a structured questionnaire to compare women who had a CS (cases) with women who had a vaginal delivery (controls). Service information was recorded in 20 facilities providing obstetric care. Maternal and perinatal deaths, including those outside health facilities, were recorded and verified. The user cost of CS was estimated at four hospitals, one of them managed by an international non-governmental organization offering EmOC free of charge, compared to the user cost of women who had a vaginal delivery. Among paying users, the mean healthcare cost was $US68.0 for CS and $US12.1 for vaginal delivery; mean transport cost to and from the hospital was $US11.7 for cases and $US3.2 for controls. The mean monthly family income was $US75.5. The user cost of CS placed an important financial burden on patients and their families. During transition from humanitarian to developmental assistance, donors and the State should shore up the EmOC budget to avoid an increase in maternal and perinatal mortality.

From evidence to action to deliver a healthy start for the next generation.

Remarkable progress has been made towards halving of maternal deaths and deaths of children aged 1-59 months, although the task is incomplete. Newborn deaths and stillbirths were largely invisible in the Millennium Development Goals, and have continued to fall between maternal and child health efforts, with much slower reduction. This Series and the Every Newborn Action Plan outline mortality goals for newborn babies (ten or fewer per 1000 livebirths) and stillbirths (ten or fewer per 1000 total births) by 2035, aligning with A Promise Renewed target for children and the vision of Every Woman Every Child. To focus political attention and improve performance, goals for newborn babies and stillbirths must be recognised in the post-2015 framework, with corresponding accountability mechanisms. The four previous papers in this Every Newborn Series show the potential for a triple return on investment around the time of birth: averting maternal and newborn deaths and preventing stillbirths. Beyond survival, being counted and optimum nutrition and development is a human right for all children, including those with disabilities. Improved human capital brings economic productivity. Efforts to reach every woman and every newborn baby, close gaps in coverage, and improve equity and quality for antenatal, intrapartum, and postnatal care, especially in the poorest countries and for underserved populations, need urgent attention. We have prioritised what needs to be done differently on the basis of learning from the past decade about what has worked, and what has not. Needed now are four most important shifts: (1) intensification of political attention and leadership; (2) promotion of parent voice, supporting women, families, and communities to speak up for their newborn babies and to challenge social norms that accept these deaths as inevitable; (3) investment for effect on mortality outcome as well as harmonisation of funding; (4) implementation at scale, with particular attention to increasing of health worker numbers and skills with attention to high-quality childbirth care for newborn babies as well as mothers and children; and (5) evaluation, tracking coverage of priority interventions and packages of care with clear accountability to accelerate progress and reach the poorest groups. The Every Newborn Action Plan provides an evidence-based roadmap towards care for every woman, and a healthy start for every newborn baby, with a right to be counted, survive, and thrive wherever they are born.

Cost-effectiveness of caesarean sections in a post-conflict environment: a case study of Bunia, Democratic Republic of the Congo.

This paper demonstrates the feasibility of health services research in an unstable environment during the transition from crisis to development and its importance for future planning. Effectiveness and the cost of caesarean sections (CSs) were investigated in Bunia, a town affected by conflict and insecurity, in the Democratic Republic of the Congo (DRC) in 2008. The CS rate was 9.7 per cent of expected deliveries. All CSs in the study sample were emergency procedures. A humanitarian non-governmental organisation (NGO) hospital, offering free services, performed 75 per cent of all CSs. The estimated provider cost for CS in 2008 at this hospital was USD 103,514 (that is, USD 144 per CS). With a cost of between USD 3.8 and 9.2 per year of health adjusted life expectancy (HALE) gained, CSs at the NGO hospital were very cost-effective. The estimates give an indication of funding requirements to maintain adequate access to CS after the departure of the humanitarian organisation.

Determinants and consequences of failure of linkage to antiretroviral therapy at primary care level in Blantyre, Malawi: a prospective cohort study.

BACKGROUND: Poor rates of linkage from HIV diagnosis to ART initiation are a major barrier to universal coverage of ART in sub-Saharan Africa, with reasons for failure poorly understood. In the first study of this kind at primary care level, we investigated the pathway to care in the Malawian National Programme, one of the strongest in Africa. METHODS AND FINDINGS: A prospective cohort study was undertaken at two primary care clinics in Blantyre, Malawi. Newly diagnosed HIV-positive adults (>15 years) were followed for 6-months to assess completion of eligibility assessments, initiation of ART and death. Two hundred and eighty participants were followed for 82.6 patient-years. ART eligibility assessments were problematic: only 134 (47.9%) received same day WHO staging and 121 (53.2%) completed assessments by 6-months. Completion of CD4 measurement (stage 1/2 only) was 81/153 (52.9%). By 6-months, 87/280 (31.1%) had initiated ART with higher uptake in participants who were ART eligible (68/91, 74.7%), and among participants who received same-day staging (52/134 [38.8%] vs. 35/146 [24.0%] p = 0.007). Non-completion of ART eligibility assessments (adjusted hazard ratio: 0.11, 95% CI: 0.06-0.21) was associated with failure to initiate ART. Retention in pre-ART care for non-ART initiators was low (55/193 [28.5%]). Of the 15 (5.4%) deaths, 11 (73.3%) occurred after ART initiation. CONCLUSIONS: Although uptake of ART was high and prompt for patients with known eligibility, there was frequent failure to complete eligibility assessment and poor retention in pre-ART care. HIV care programmes should urgently evaluate the way patients are linked to ART. In particular, there is a critical need for simplified, same-day ART eligibility assessments, reduced requirements for hospital visits, and active defaulter follow-up.

Suboptimal patterns of provider initiated HIV testing and counselling, antiretroviral therapy eligibility assessment and referral in primary health clinic attendees in Blantyre, Malawi.

OBJECTIVE: To understand reasons for suboptimal and delayed uptake of antiretroviral therapy (ART) by describing the patterns of HIV testing and counselling (HTC) and outcomes of ART eligibility assessments in primary clinic attendees. METHODS: All clinic attendances and episodes of HTC were recorded at two clinics in Blantyre. A cohort of newly diagnosed HIV-positive adults (>15 years) was recruited and exit interviews undertaken. Logistic regression models were constructed to investigate factors associated with referral to start ART. Qualitative interviews were conducted with providers and patients. RESULTS: There were 2398 episodes of HTC during 18,021 clinic attendances (13.3%) between January and April 2011. The proportion of clinic attendees undergoing HTC was lowest in non-pregnant women (6.3%) and men (8.5%), compared with pregnant women (47.2%). Men had more advanced HIV infection than women (79.7% WHO stage 3 or 4 vs. 56.4%). Problems with WHO staging and access to CD4 counts affected ART eligibility assessments; only 48% completed ART eligibility assessment, and 54% of those reporting WHO stage 3/4 illnesses were not referred to start ART promptly. On multivariate analysis, HIV-positive pregnant women were significantly less likely to be referred directly for ART initiation (adjusted OR: 0.29, 95% CI: 0.13-0.63). CONCLUSIONS: These data show that provider-initiated testing and counselling (PITC) has not yet been fully implemented at primary care clinics. Suboptimal ART eligibility assessments and referral (reflecting the difficulties of WHO staging in primary care) mean that simplified eligibility assessment tools are required to reduce unnecessary delay and attrition in the pre-ART period. Simplified initiation criteria for pregnant women, as being introduced in Malawi, should improve linkage to ART.

A systematic assessment of the concept and practice of public-private mix for tuberculosis care and control.

INTRODUCTION: The STOP TB Partnership aims to improve global tuberculosis (TB) control through expanding access to the directly observed treatment short course (DOTS) strategy. One approach to this is 'Engaging all Care Providers', which evolved from 'Public-Private Mix (PPM) DOTS'. The overall aim of this study was to systematically assess whether and to what degree the STOP TB Partnership's four global objectives of engaging all care providers are met through existing PPM interventions. These four objectives are; 1) Increase TB case detection; 2) Improve TB treatment outcomes; 3) Enhance access and equity; 4) Reduce financial burden on patients. The specific objectives of this assessment were to 1) Understand what PPM means to the STOP TB Partnership's PPM Subgroup and to National Tuberculosis Programme managers; 2) Scope the nature of existing country-level PPM interventions and 3) Review PPM practice against the global PPM objectives. METHODS: We undertook a systematic, multi-facetted assessment. The methods included interviews with National Tuberculosis Programme managers from high burden countries, clarification of key issues with the STOP TB Partnership PPM secretariat and a review of publicly accessible reports and published articles on PPM projects. Both the literature review and interviews with the National Tuberculosis Programme managers yielded data on project characteristics; PPM models at country level; National Tuberculosis Programme partners; and mechanisms for engagement. Matrices were developed from the literature review and the interviews to show the relationship between services and service providers for different PPM projects. Data from the literature were assessed against each of the four global PPM objectives. RESULTS: Twelve National Tuberculosis Programme managers from high burden countries were interviewed about the scope of PPM partnerships. Understanding of PPM and types of engaged providers varied considerably; 'private-for-profit qualified clinical providers' were the dominant category. The literature review yielded information on 22 projects in which 'private-for-profit qualified clinical providers' were again the dominant category. The contributions made by 'private-for-profit qualified clinical providers' and 'Non Governmental Organisation qualified clinical providers', were assessed against the four global PPM objectives. Reporting on tuberculosis case detection and treatment outcomes was generally good and demonstrated important PPM contributions in these areas. Reporting on equity, access and reduced patient costs was often lacking or inconclusive. CONCLUSIONS: PPM has improved case detection and treatment outcomes among patients seeking care with private providers. Evidence on reducing patient costs is inconclusive, and there is scope for increasing equity in access to care by systematically engaging those providers who are the primary agents for poor people seeking health care. Guidelines outlining which types of providers best contribute to achieving the four global objectives, along with the resources required by National Tuberculosis Programs for such engagement is needed.

Can Malawi's poor afford free tuberculosis services? Patient and household costs associated with a tuberculosis diagnosis in Lilongwe.

OBJECTIVE: To assess the relative costs of accessing a TB diagnosis for the poor and for women in urban Lilongwe, Malawi, a setting where public health services are accessible within 6 kilometers and provided free of charge. METHODS: Patient and household direct and opportunity costs were assessed from a survey of 179 TB patients, systematically sampled from all public and mission health facilities in Lilongwe. Poverty status was determined from the 1998 Malawi Integrated Household Survey (MIHS). FINDINGS: On average, patients spent US$ 13 (MK 996 or 18 days' income) and lost 22 days from work while accessing a TB diagnosis. For non-poor patients, the total costs amounted to 129% of total monthly income, or 184% after food expenditures. For the poor, this cost rose to 248% of monthly income or 574% after food. When a woman or when the poor are sick, the opportunity costs faced by their households are greater. CONCLUSION: Patient and household costs of TB diagnosis are prohibitively high even where services are provided free of charge. In scaling up TB services to reach the Millennium Development Goals, there is an urgent need to identify strategies for diagnosing TB that are cost-effective for the poor and their households.

Can public-private collaboration promote tuberculosis case detection among the poor and vulnerable?

Private-public mix (PPM) DOTS is widely advocated as a DOTS adaptation for promoting progress towards the international tuberculosis (TB) control targets of detecting 70% of TB cases and successfully treating 85% of these. Private health care plays a central role in health-care provision in many developing countries that have a high burden of TB. It is therefore encouraging that PPM projects are being set up in various countries around the world to explore possible interaction between the national TB programmes and other partners in the fight against TB. The objective of this review was to use the published literature to assess the range of providers included in PPMs for their ability to provide case-detection services for the vulnerable. From a case-detection perspective, we identify the essential elements of a pro-poor PPM model, namely, cost-effectiveness from a patient perspective, accessibility, acceptability and quality. The review revealed that a very large part of the total spectrum of potential PPM-participating partners has not yet been explored; current models focus on private-for-profit health-care providers and non-governmental organizations. We conclude that it is important to think critically about the type of private providers who are best suited to meeting the needs of the poor, and that more should be done to document the socioeconomic status of patients accessing services through PPM pilots.