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Video and image data are regularly used in the field of benthic ecology to document biodiversity. However, their use is subject to a number of challenges, principally the identification of taxa within the images without associated physical specimens. The challenge of applying traditional taxonomic keys to the identification of fauna from images has led to the development of personal, group, or institution level reference image catalogues of operational taxonomic units (OTUs) or morphospecies. Lack of standardisation among these reference catalogues has led to problems with observer bias and the inability to combine datasets across studies. In addition, lack of a common reference standard is stifling efforts in the application of artificial intelligence to taxon identification. Using the North Atlantic deep sea as a case study, we propose a database structure to facilitate standardisation of morphospecies image catalogues between research groups and support future use in multiple front-end applications. We also propose a framework for coordination of international efforts to develop reference guides for the identification of marine species from images. The proposed structure maps to the Darwin Core standard to allow integration with existing databases. We suggest a management framework where high-level taxonomic groups are curated by a regional team, consisting of both end users and taxonomic experts. We identify a mechanism by which overall quality of data within a common reference guide could be raised over the next decade. Finally, we discuss the role of a common reference standard in advancing marine ecology and supporting sustainable use of this ecosystem.

Video and image data are regularly used in the field of benthic ecology to document biodiversity. However, their use is subject to a number of challenges, principally the identification of taxa within the images without associated physical specimens. The challenge of applying traditional taxonomic keys to the identification of fauna from images has led to the development of personal, group, or institution level reference image catalogues of operational taxonomic units (OTUs) or morphospecies. Lack of standardisation among these reference catalogues has led to problems with observer bias and the inability to combine datasets across studies. In addition, lack of a common reference standard is stifling efforts in the application of artificial intelligence to taxon identification. Using the North Atlantic deep sea as a case study, we propose a database structure to facilitate standardisation of morphospecies image catalogues between research groups and support future use in multiple front-end applications. We also propose a framework for coordination of international efforts to develop reference guides for the identification of marine species from images. The proposed structure maps to the Darwin Core standard to allow integration with existing databases. We suggest a management framework where high-level taxonomic groups are curated by a regional team, consisting of both end users and taxonomic experts. We identify a mechanism by which overall quality of data within a common reference guide could be raised over the next decade. Finally, we discuss the role of a common reference standard in advancing marine ecology and supporting sustainable use of this ecosystem.

Purpose To quantify costs to patients of accessing HIV care prior to ART initiation. Materials and methods Using a cross-sectional study design, costs incurred by HIV-positive patients prior to ART initiation were estimated at urban primary healthcare facilities in South Africa. Costs included direct costs, indirect (productivity) costs, carer and coping costs (value of assets sold and money borrowed). The percentage of individual income spent on healthcare was calculated and compared by patient income tertiles and CD4 count strata. Results 289 patients (69% female, mean age 37 (SD: 10) years, median CD4 317 (IQR: 138–494) cells/mm3) were interviewed. The total mean monthly cost of pre-ART care was US$15.71. Indirect costs accounted for $2.59 (16.49%) of this when time was valued using the patient’s reported income. The mean monthly patient costs were $31.61, $12.78, $12.65 and $11.93 for those with a CD4 count <100, 101–350, 351–500 and >500 cells/mm3 respectively. The percentage of individual income spent on healthcare was 7.25% for those with a CD4 count <100 cells/mm3 and 4.05% for those with a CD4 count >500 cells/mm3. Conclusions Despite the provision of charge-free services at public clinics, care prior to ART initiation can be costly, particularly for the poor and unemployed. Our study adds to the growing body of evidence that highlights the need to consider policies to reduce the economic barriers to HIV service access, particularly for low income or unwell patient groups, such as improving access to disability grants.

Video and image data are regularly used in the field of benthic ecology to document biodiversity. However, their use is subject to a number of challenges, principally the identification of taxa within the images without associated physical specimens. The challenge of applying traditional taxonomic keys to the identification of fauna from images has led to the development of personal, group, or institution level reference image catalogues of operational taxonomic units (OTUs) or morphospecies. Lack of standardisation among these reference catalogues has led to problems with observer bias and the inability to combine datasets across studies. In addition, lack of a common reference standard is stifling efforts in the application of artificial intelligence to taxon identification. Using the North Atlantic deep sea as a case study, we propose a database structure to facilitate standardisation of morphospecies image catalogues between research groups and support future use in multiple front-end applications. We also propose a framework for coordination of international efforts to develop reference guides for the identification of marine species from images. The proposed structure maps to the Darwin Core standard to allow integration with existing databases. We suggest a management framework where high-level taxonomic groups are curated by a regional team, consisting of both end users and taxonomic experts. We identify a mechanism by which overall quality of data within a common reference guide could be raised over the next decade. Finally, we discuss the role of a common reference standard in advancing marine ecology and supporting sustainable use of this ecosystem.

Purpose To quantify costs to patients of accessing HIV care prior to ART initiation. Materials and methods Using a cross-sectional study design, costs incurred by HIV-positive patients prior to ART initiation were estimated at urban primary healthcare facilities in South Africa. Costs included direct costs, indirect (productivity) costs, carer and coping costs (value of assets sold and money borrowed). The percentage of individual income spent on healthcare was calculated and compared by patient income tertiles and CD4 count strata. Results 289 patients (69% female, mean age 37 (SD: 10) years, median CD4 317 (IQR: 138–494) cells/mm3) were interviewed. The total mean monthly cost of pre-ART care was US$15.71. Indirect costs accounted for $2.59 (16.49%) of this when time was valued using the patient’s reported income. The mean monthly patient costs were $31.61, $12.78, $12.65 and $11.93 for those with a CD4 count <100, 101–350, 351–500 and >500 cells/mm3 respectively. The percentage of individual income spent on healthcare was 7.25% for those with a CD4 count <100 cells/mm3 and 4.05% for those with a CD4 count >500 cells/mm3. Conclusions Despite the provision of charge-free services at public clinics, care prior to ART initiation can be costly, particularly for the poor and unemployed. Our study adds to the growing body of evidence that highlights the need to consider policies to reduce the economic barriers to HIV service access, particularly for low income or unwell patient groups, such as improving access to disability grants.

Video and image data are regularly used in the field of benthic ecology to document biodiversity. However, their use is subject to a number of challenges, principally the identification of taxa within the images without associated physical specimens. The challenge of applying traditional taxonomic keys to the identification of fauna from images has led to the development of personal, group, or institution level reference image catalogues of operational taxonomic units (OTUs) or morphospecies. Lack of standardisation among these reference catalogues has led to problems with observer bias and the inability to combine datasets across studies. In addition, lack of a common reference standard is stifling efforts in the application of artificial intelligence to taxon identification. Using the North Atlantic deep sea as a case study, we propose a database structure to facilitate standardisation of morphospecies image catalogues between research groups and support future use in multiple front-end applications. We also propose a framework for coordination of international efforts to develop reference guides for the identification of marine species from images. The proposed structure maps to the Darwin Core standard to allow integration with existing databases. We suggest a management framework where high-level taxonomic groups are curated by a regional team, consisting of both end users and taxonomic experts. We identify a mechanism by which overall quality of data within a common reference guide could be raised over the next decade. Finally, we discuss the role of a common reference standard in advancing marine ecology and supporting sustainable use of this ecosystem.

Video and image data are regularly used in the field of benthic ecology to document biodiversity. However, their use is subject to a number of challenges, principally the identification of taxa within the images without associated physical specimens. The challenge of applying traditional taxonomic keys to the identification of fauna from images has led to the development of personal, group, or institution level reference image catalogues of operational taxonomic units (OTUs) or morphospecies. Lack of standardisation among these reference catalogues has led to problems with observer bias and the inability to combine datasets across studies. In addition, lack of a common reference standard is stifling efforts in the application of artificial intelligence to taxon identification. Using the North Atlantic deep sea as a case study, we propose a database structure to facilitate standardisation of morphospecies image catalogues between research groups and support future use in multiple front-end applications. We also propose a framework for coordination of international efforts to develop reference guides for the identification of marine species from images. The proposed structure maps to the Darwin Core standard to allow integration with existing databases. We suggest a management framework where high-level taxonomic groups are curated by a regional team, consisting of both end users and taxonomic experts. We identify a mechanism by which overall quality of data within a common reference guide could be raised over the next decade. Finally, we discuss the role of a common reference standard in advancing marine ecology and supporting sustainable use of this ecosystem.

Video and image data are regularly used in the field of benthic ecology to document biodiversity. However, their use is subject to a number of challenges, principally the identification of taxa within the images without associated physical specimens. The challenge of applying traditional taxonomic keys to the identification of fauna from images has led to the development of personal, group, or institution level reference image catalogues of operational taxonomic units (OTUs) or morphospecies. Lack of standardisation among these reference catalogues has led to problems with observer bias and the inability to combine datasets across studies. In addition, lack of a common reference standard is stifling efforts in the application of artificial intelligence to taxon identification. Using the North Atlantic deep sea as a case study, we propose a database structure to facilitate standardisation of morphospecies image catalogues between research groups and support future use in multiple front-end applications. We also propose a framework for coordination of international efforts to develop reference guides for the identification of marine species from images. The proposed structure maps to the Darwin Core standard to allow integration with existing databases. We suggest a management framework where high-level taxonomic groups are curated by a regional team, consisting of both end users and taxonomic experts. We identify a mechanism by which overall quality of data within a common reference guide could be raised over the next decade. Finally, we discuss the role of a common reference standard in advancing marine ecology and supporting sustainable use of this ecosystem.

Background: Amongst HIV-positive adults in South Africa with initial negative Xpert results, we compared the yield from repeating Xpert MTB/RIF (“Xpert”) on sputum to guideline-recommended investigation for tuberculosis (TB). Methods: A systematic sample of adults attending for HIV care were enrolled in a cohort exploring TB investigation pathways. This substudy was restricted to those at highest risk of TB (CD4<200 cells/mm3 or unknown) who had a negative initial Xpert result. At attendance for the Xpert result, a repeat sputum sample was stored, and further investigations facilitated per national guidelines. Participants were reviewed monthly, with reinvestigation if indicated, for at least three months, when sputum and blood were cultured for mycobacteria, and the stored sputum tested using Xpert. We defined TB as “confirmed” if Xpert, line probe assay or Mycobacterium tuberculosis culture within six months of enrolment were positive, and “clinical” if TB treatment was started without microbiological confirmation. Results: Amongst 227 participants with an initial negative Xpert result (63% female, median age 37 years, median CD4 count 100 cells/mm3), 28 (12%) participants had TB diagnosed during study follow-up (16 confirmed, 12 clinical); stored sputum tested positive on Xpert in 5/227 (2%). Amongst 27 participants who started TB treatment, the basis was bacteriological confirmation 11/27 (41%); compatible imaging 11/27 (41%); compatible symptoms 2/27 (7%); and unknown 3/27 (11%). Conclusions: Amongst HIV-positive individuals at high risk of active TB with a negative Xpert result, further investigation using appropriate diagnostic modalities is more likely to lead to TB treatment than immediately repeating sputum for Xpert. TB diagnostic tests with improved sensitivity are needed.

Background: Amongst HIV-positive adults in South Africa with initial negative Xpert results, we compared the yield from repeating Xpert MTB/RIF (“Xpert”) on sputum to guideline-recommended investigation for tuberculosis (TB). Methods: A systematic sample of adults attending for HIV care were enrolled in a cohort exploring TB investigation pathways. This substudy was restricted to those at highest risk of TB (CD4<200 cells/mm3 or unknown) who had a negative initial Xpert result. At attendance for the Xpert result, a repeat sputum sample was stored, and further investigations facilitated per national guidelines. Participants were reviewed monthly, with reinvestigation if indicated, for at least three months, when sputum and blood were cultured for mycobacteria, and the stored sputum tested using Xpert. We defined TB as “confirmed” if Xpert, line probe assay or Mycobacterium tuberculosis culture within six months of enrolment were positive, and “clinical” if TB treatment was started without microbiological confirmation. Results: Amongst 227 participants with an initial negative Xpert result (63% female, median age 37 years, median CD4 count 100 cells/mm3), 28 (12%) participants had TB diagnosed during study follow-up (16 confirmed, 12 clinical); stored sputum tested positive on Xpert in 5/227 (2%). Amongst 27 participants who started TB treatment, the basis was bacteriological confirmation 11/27 (41%); compatible imaging 11/27 (41%); compatible symptoms 2/27 (7%); and unknown 3/27 (11%). Conclusions: Amongst HIV-positive individuals at high risk of active TB with a negative Xpert result, further investigation using appropriate diagnostic modalities is more likely to lead to TB treatment than immediately repeating sputum for Xpert. TB diagnostic tests with improved sensitivity are needed.

Background In 2010 a new diagnostic test for tuberculosis, Xpert MTB/RIF, received a conditional programmatic recommendation from WHO. Several model-based economic evaluations predicted that Xpert would be cost-effective across sub-Saharan Africa. We investigated the cost-effectiveness of Xpert in the real world during national roll-out in South Africa. Methods For this real-world cost analysis and economic evaluation, we applied extensive primary cost and patient event data from the XTEND study, a pragmatic trial examining Xpert introduction for people investigated for tuberculosis in 40 primary health facilities (20 clusters) in South Africa enrolled between June 8, and Nov 16, 2012, to estimate the costs and cost per disability-adjusted life-year averted of introducing Xpert as the initial diagnostic test for tuberculosis, compared with sputum smear microscopy (the standard of care). Findings The mean total cost per study participant for tuberculosis investigation and treatment was US$312·58 (95% CI 252·46–372·70) in the Xpert group and $298·58 (246·35–350·82) in the microscopy group. The mean health service (provider) cost per study participant was $168·79 (149·16–188·42) for the Xpert group and $160·46 (143·24–177·68) for the microscopy group of the study. Considering uncertainty in both cost and effect using a wide range of willingness to pay thresholds, we found less than 3% probability that Xpert introduction improved the cost-effectiveness of tuberculosis diagnostics. Interpretation After analysing extensive primary data collection during roll-out, we found that Xpert introduction in South Africa was cost-neutral, but found no evidence that Xpert improved the cost-effectiveness of tuberculosis diagnosis. Our study highlights the importance of considering implementation constraints, when predicting and evaluating the cost-effectiveness of new tuberculosis diagnostics in South Africa. Funding Bill & Melinda Gates Foundation.

BackgroundThe World Health Organization (WHO) recommendation for regular tuberculosis (TB) screening of HIV-positive individuals with Xpert MTB/RIF as the first diagnostic test has major resource implications.ObjectiveTo develop a diagnostic prediction model for TB, for symptomatic adults attending for routine HIV care, to prioritise TB investigation.DesignCohort study exploring a TB testing algorithm.SettingHIV clinics, South Africa.ParticipantsRepresentative sample of adult HIV clinic attendees; data from participants reporting ≥1 symptom on the WHO screening tool were split 50:50 to derive, then internally validate, a prediction model.OutcomeTB, defined as “confirmed” if Xpert MTB/RIF, line probe assay or M. tuberculosis culture were positive; and “clinical” if TB treatment started without microbiological confirmation, within six months of enrolment.ResultsOverall, 79/2602 (3.0%) participants on ART fulfilled TB case definitions, compared to 65/906 (7.2%) pre-ART. Among 1133/3508 (32.3%) participants screening positive on the WHO tool, 1048 met inclusion criteria for this analysis: 52/515 (10.1%) in the derivation and 58/533 (10.9%) in the validation dataset had TB. Our final model comprised ART status (on ART > 3 months vs. pre-ART or ART < 3 months); body mass index (continuous); CD4 (continuous); number of WHO symptoms (1 vs. >1 symptom). We converted this to a clinical score, using clinically-relevant CD4 and BMI categories. A cut-off score of ≥3 identified those with TB with sensitivity and specificity of 91.8% and 34.3% respectively. If investigation was prioritised for individuals with score of ≥3, 68% (717/1048) symptomatic individuals would be tested, among whom the prevalence of TB would be 14.1% (101/717); 32% (331/1048) of tests would be avoided, but 3% (9/331) with TB would be missed amongst those not tested.ConclusionOur clinical score may help prioritise TB investigation among symptomatic individuals.

BackgroundThe economic burden on households affected by tuberculosis through costs to patients can be catastrophic. WHO's End TB Strategy recognises and aims to eliminate these potentially devastating economic effects. We assessed whether aggressive expansion of tuberculosis services might reduce catastrophic costs.MethodsWe estimated the reduction in tuberculosis-related catastrophic costs with an aggressive expansion of tuberculosis services in India and South Africa from 2016 to 2035, in line with the End TB Strategy. Using modelled incidence and mortality for tuberculosis and patient-incurred cost estimates, we investigated three intervention scenarios: improved treatment of drug-sensitive tuberculosis; improved treatment of multidrug-resistant tuberculosis; and expansion of access to tuberculosis care through intensified case finding (South Africa only). We defined tuberculosis-related catastrophic costs as the sum of direct medical, direct non-medical, and indirect costs to patients exceeding 20% of total annual household income. Intervention effects were quantified as changes in the number of households incurring catastrophic costs and were assessed by quintiles of household income.FindingsIn India and South Africa, improvements in treatment for drug-sensitive and multidrug-resistant tuberculosis could reduce the number of households incurring tuberculosis-related catastrophic costs by 6–19%. The benefits would be greatest for the poorest households. In South Africa, expanded access to care could decrease household tuberculosis-related catastrophic costs by 5–20%, but gains would be seen largely after 5–10 years.InterpretationAggressive expansion of tuberculosis services in India and South Africa could lessen, although not eliminate, the catastrophic financial burden on affected households.FundingBill & Melinda Gates Foundation.

BackgroundThe World Health Organization (WHO) recommendation for regular tuberculosis (TB) screening of HIV-positive individuals with Xpert MTB/RIF as the first diagnostic test has major resource implications.ObjectiveTo develop a diagnostic prediction model for TB, for symptomatic adults attending for routine HIV care, to prioritise TB investigation.DesignCohort study exploring a TB testing algorithm.SettingHIV clinics, South Africa.ParticipantsRepresentative sample of adult HIV clinic attendees; data from participants reporting ≥1 symptom on the WHO screening tool were split 50:50 to derive, then internally validate, a prediction model.OutcomeTB, defined as “confirmed” if Xpert MTB/RIF, line probe assay or M. tuberculosis culture were positive; and “clinical” if TB treatment started without microbiological confirmation, within six months of enrolment.ResultsOverall, 79/2602 (3.0%) participants on ART fulfilled TB case definitions, compared to 65/906 (7.2%) pre-ART. Among 1133/3508 (32.3%) participants screening positive on the WHO tool, 1048 met inclusion criteria for this analysis: 52/515 (10.1%) in the derivation and 58/533 (10.9%) in the validation dataset had TB. Our final model comprised ART status (on ART > 3 months vs. pre-ART or ART < 3 months); body mass index (continuous); CD4 (continuous); number of WHO symptoms (1 vs. >1 symptom). We converted this to a clinical score, using clinically-relevant CD4 and BMI categories. A cut-off score of ≥3 identified those with TB with sensitivity and specificity of 91.8% and 34.3% respectively. If investigation was prioritised for individuals with score of ≥3, 68% (717/1048) symptomatic individuals would be tested, among whom the prevalence of TB would be 14.1% (101/717); 32% (331/1048) of tests would be avoided, but 3% (9/331) with TB would be missed amongst those not tested.ConclusionOur clinical score may help prioritise TB investigation among symptomatic individuals.

Background In 2010 a new diagnostic test for tuberculosis, Xpert MTB/RIF, received a conditional programmatic recommendation from WHO. Several model-based economic evaluations predicted that Xpert would be cost-effective across sub-Saharan Africa. We investigated the cost-effectiveness of Xpert in the real world during national roll-out in South Africa. Methods For this real-world cost analysis and economic evaluation, we applied extensive primary cost and patient event data from the XTEND study, a pragmatic trial examining Xpert introduction for people investigated for tuberculosis in 40 primary health facilities (20 clusters) in South Africa enrolled between June 8, and Nov 16, 2012, to estimate the costs and cost per disability-adjusted life-year averted of introducing Xpert as the initial diagnostic test for tuberculosis, compared with sputum smear microscopy (the standard of care). Findings The mean total cost per study participant for tuberculosis investigation and treatment was US$312·58 (95% CI 252·46–372·70) in the Xpert group and $298·58 (246·35–350·82) in the microscopy group. The mean health service (provider) cost per study participant was $168·79 (149·16–188·42) for the Xpert group and $160·46 (143·24–177·68) for the microscopy group of the study. Considering uncertainty in both cost and effect using a wide range of willingness to pay thresholds, we found less than 3% probability that Xpert introduction improved the cost-effectiveness of tuberculosis diagnostics. Interpretation After analysing extensive primary data collection during roll-out, we found that Xpert introduction in South Africa was cost-neutral, but found no evidence that Xpert improved the cost-effectiveness of tuberculosis diagnosis. Our study highlights the importance of considering implementation constraints, when predicting and evaluating the cost-effectiveness of new tuberculosis diagnostics in South Africa. Funding Bill & Melinda Gates Foundation.

BackgroundThe economic burden on households affected by tuberculosis through costs to patients can be catastrophic. WHO's End TB Strategy recognises and aims to eliminate these potentially devastating economic effects. We assessed whether aggressive expansion of tuberculosis services might reduce catastrophic costs.MethodsWe estimated the reduction in tuberculosis-related catastrophic costs with an aggressive expansion of tuberculosis services in India and South Africa from 2016 to 2035, in line with the End TB Strategy. Using modelled incidence and mortality for tuberculosis and patient-incurred cost estimates, we investigated three intervention scenarios: improved treatment of drug-sensitive tuberculosis; improved treatment of multidrug-resistant tuberculosis; and expansion of access to tuberculosis care through intensified case finding (South Africa only). We defined tuberculosis-related catastrophic costs as the sum of direct medical, direct non-medical, and indirect costs to patients exceeding 20% of total annual household income. Intervention effects were quantified as changes in the number of households incurring catastrophic costs and were assessed by quintiles of household income.FindingsIn India and South Africa, improvements in treatment for drug-sensitive and multidrug-resistant tuberculosis could reduce the number of households incurring tuberculosis-related catastrophic costs by 6–19%. The benefits would be greatest for the poorest households. In South Africa, expanded access to care could decrease household tuberculosis-related catastrophic costs by 5–20%, but gains would be seen largely after 5–10 years.InterpretationAggressive expansion of tuberculosis services in India and South Africa could lessen, although not eliminate, the catastrophic financial burden on affected households.FundingBill & Melinda Gates Foundation.

Managing ecological systems, which operate over large spatial scales, is inherently difficult and often requires sourcing data from different countries and organizations. The assumption might be made that data collected using similar methodologies are comparable, but this is rarely tested. Here, benthic video data recorded using different towed underwater video systems (TUVSs) were experimentally compared. Three technically different TUVSs were compared on different seabed types (rocky, mixed ground and sandy) in Kingmere Marine Conservation Zone, off the south coast of England. For each TUVS, species metrics (forward facing camera), seabed impact (backward facing camera) and operational performance (strengths and limitations of equipment and video footage) were compared with the aim of providing recommendations on their future use and comparability of data between different systems. Statistically significant differences between species richness, density, cover and assemblage composition were detected amongst devices and were believed to be mostly due to their optical specifications. As a result of their high image definition and large field of vision both the benthic contacting heavy and benthic tending TUVS provided good quality footage and ecological measurements. However, the heaviest TUVS proved difficult to operate on irregular ground and was found to cause the most impact to the seabed. The lightest TUVS (benthic contacting light) struggled to maintain contact with the seabed. The benthic tending TUVS was able to fly over variable seabed relief and was comparably the least destructive. Results from this study highlight that particular care should be given to sled and optic specifications when developing a medium- or long-term marine protected area monitoring programme. Furthermore, when using data gathered from multiple sources to test ecological questions, different equipment specifications may confound observed ecological differences. A benthic tending TUVS

Background: The severe shortage of pharmacists is an important limitation to providing antiretroviral treatment (ART) in resource-limited countries. Two task-shifting pharmaceutical care models have been developed to address this in South Africa, namely indirectly supervised pharmacist assistant (ISPA) and nurse-managed models. This study compared pharmaceutical care quality, patient clinical outcomes, and provider staff costs between these models. Methods: An analysis of pharmaceutical quality audits, patient clinical data, and staff costing data collected at 7 ISPA and 8 nurse-managed facilities was undertaken. Pharmaceutical audits were conducted by pharmacists using a standardized tool. Routine clinical data were collected prospectively at patient visits, and staff human resources costs were analyzed. Results: Overall pharmaceutical care quality scores were higher at ISPA sites than nurse-managed sites; 88.8% vs. 79.9%, respectively; risk ratio (ISPA vs. nurse) = 1.11 (95% confidence interval: 1.09 to 1.13; P < 0.0001). Mean provider pharmaceutical-related human resources costs per patient visit and per item dispensed were 29% and 49% lower, respectively, at ISPA facilities. At ISPA facilities, patient attrition was observed to be lower and viral suppression higher than at nurse-managed sites. Conclusion: The ISPA model had a higher quality of pharmaceutical care and was less costly to implement. Further expansion of this model or integrating it with nurse-managed ART may enhance the cost-efficient scale-up of ART programs in Sub-Saharan Africa.

Out‐of‐pocket spending is increasingly recognized as an important barrier to accessing health care, particularly in low‐income and middle‐income countries (LMICs) where a large portion of health expenditure comes from out‐of‐pocket payments. Emerging universal healthcare policies prioritize reduction of poverty impact such as catastrophic and impoverishing healthcare expenditure. Poverty impact is therefore increasingly evaluated alongside and within economic evaluations to estimate the impact of specific health interventions on poverty. However, data collection for these metrics can be challenging in intervention‐based contexts in LMICs because of study design and practical limitations. Using a set of case studies, this letter identifies methodological challenges in collecting patient cost data in LMIC contexts. These components are presented in a framework to encourage researchers to consider the implications of differing approaches in data collection and to report their approach in a standardized and transparent way. © 2016 The Authors. Health Economics published by John Wiley & Sons Ltd.

Purpose Estimating the incremental costs of scaling‐up novel technologies in low‐income and middle‐income countries is a methodologically challenging and substantial empirical undertaking, in the absence of routine cost data collection. We demonstrate a best practice pragmatic approach to estimate the incremental costs of new technologies in low‐income and middle‐income countries, using the example of costing the scale‐up of Xpert Mycobacterium tuberculosis (MTB)/resistance to riframpicin (RIF) in South Africa. Materials and methods We estimate costs, by applying two distinct approaches of bottom‐up and top‐down costing, together with an assessment of processes and capacity. Results The unit costs measured using the different methods of bottom‐up and top‐down costing, respectively, are $US16.9 and $US33.5 for Xpert MTB/RIF, and $US6.3 and $US8.5 for microscopy. The incremental cost of Xpert MTB/RIF is estimated to be between $US14.7 and $US17.7. While the average cost of Xpert MTB/RIF was higher than previous studies using standard methods, the incremental cost of Xpert MTB/RIF was found to be lower. Conclusion Costs estimates are highly dependent on the method used, so an approach, which clearly identifies resource‐use data collected from a bottom‐up or top‐down perspective, together with capacity measurement, is recommended as a pragmatic approach to capture true incremental cost where routine cost data are scarce.

Global guidelines for new technologies are based on cost and efficacy data from a limited number of trial locations. Country‐level decision makers need to consider whether cost‐effectiveness analysis used to inform global guidelines are sufficient for their situation or whether to use models that adjust cost‐effectiveness results taking into account setting‐specific epidemiological and cost heterogeneity. However, demand and supply constraints will also impact cost‐effectiveness by influencing the standard of care and the use and implementation of any new technology. These constraints may also vary substantially by setting. We present two case studies of economic evaluations of the introduction of new diagnostics for malaria and tuberculosis control. These case studies are used to analyse how the scope of economic evaluations of each technology expanded to account for and then address demand and supply constraints over time. We use these case studies to inform a conceptual framework that can be used to explore the characteristics of intervention complexity and the influence of demand and supply constraints. Finally, we describe a number of feasible steps that researchers who wish to apply our framework in cost‐effectiveness analyses.

BackgroundThe post-2015 End TB Strategy sets global targets of reducing tuberculosis incidence by 50% and mortality by 75% by 2025. We aimed to assess resource requirements and cost-effectiveness of strategies to achieve these targets in China, India, and South Africa.MethodsWe examined intervention scenarios developed in consultation with country stakeholders, which scaled up existing interventions to high but feasible coverage by 2025. Nine independent modelling groups collaborated to estimate policy outcomes, and we estimated the cost of each scenario by synthesising service use estimates, empirical cost data, and expert opinion on implementation strategies. We estimated health effects (ie, disability-adjusted life-years averted) and resource implications for 2016–35, including patient-incurred costs. To assess resource requirements and cost-effectiveness, we compared scenarios with a base case representing continued current practice.FindingsIncremental tuberculosis service costs differed by scenario and country, and in some cases they more than doubled existing funding needs. In general, expansion of tuberculosis services substantially reduced patient-incurred costs and, in India and China, produced net cost savings for most interventions under a societal perspective. In all three countries, expansion of access to care produced substantial health gains. Compared with current practice and conventional cost-effectiveness thresholds, most intervention approaches seemed highly cost-effective.InterpretationExpansion of tuberculosis services seems cost-effective for high-burden countries and could generate substantial health and economic benefits for patients, although substantial new funding would be required. Further work to determine the optimal intervention mix for each country is necessary.FundingBill & Melinda Gates Foundation.

Managing ecological systems, which operate over large spatial scales, is inherently difficult and often requires sourcing data from different countries and organizations. The assumption might be made that data collected using similar methodologies are comparable, but this is rarely tested. Here, benthic video data recorded using different towed underwater video systems (TUVSs) were experimentally compared. Three technically different TUVSs were compared on different seabed types (rocky, mixed ground and sandy) in Kingmere Marine Conservation Zone, off the south coast of England. For each TUVS, species metrics (forward facing camera), seabed impact (backward facing camera) and operational performance (strengths and limitations of equipment and video footage) were compared with the aim of providing recommendations on their future use and comparability of data between different systems. Statistically significant differences between species richness, density, cover and assemblage composition were detected amongst devices and were believed to be mostly due to their optical specifications. As a result of their high image definition and large field of vision both the benthic contacting heavy and benthic tending TUVS provided good quality footage and ecological measurements. However, the heaviest TUVS proved difficult to operate on irregular ground and was found to cause the most impact to the seabed. The lightest TUVS (benthic contacting light) struggled to maintain contact with the seabed. The benthic tending TUVS was able to fly over variable seabed relief and was comparably the least destructive. Results from this study highlight that particular care should be given to sled and optic specifications when developing a medium- or long-term marine protected area monitoring programme. Furthermore, when using data gathered from multiple sources to test ecological questions, different equipment specifications may confound observed ecological differences. A benthic tending TUVS

Background: The severe shortage of pharmacists is an important limitation to providing antiretroviral treatment (ART) in resource-limited countries. Two task-shifting pharmaceutical care models have been developed to address this in South Africa, namely indirectly supervised pharmacist assistant (ISPA) and nurse-managed models. This study compared pharmaceutical care quality, patient clinical outcomes, and provider staff costs between these models. Methods: An analysis of pharmaceutical quality audits, patient clinical data, and staff costing data collected at 7 ISPA and 8 nurse-managed facilities was undertaken. Pharmaceutical audits were conducted by pharmacists using a standardized tool. Routine clinical data were collected prospectively at patient visits, and staff human resources costs were analyzed. Results: Overall pharmaceutical care quality scores were higher at ISPA sites than nurse-managed sites; 88.8% vs. 79.9%, respectively; risk ratio (ISPA vs. nurse) = 1.11 (95% confidence interval: 1.09 to 1.13; P < 0.0001). Mean provider pharmaceutical-related human resources costs per patient visit and per item dispensed were 29% and 49% lower, respectively, at ISPA facilities. At ISPA facilities, patient attrition was observed to be lower and viral suppression higher than at nurse-managed sites. Conclusion: The ISPA model had a higher quality of pharmaceutical care and was less costly to implement. Further expansion of this model or integrating it with nurse-managed ART may enhance the cost-efficient scale-up of ART programs in Sub-Saharan Africa.

BackgroundThe post-2015 End TB Strategy sets global targets of reducing tuberculosis incidence by 50% and mortality by 75% by 2025. We aimed to assess resource requirements and cost-effectiveness of strategies to achieve these targets in China, India, and South Africa.MethodsWe examined intervention scenarios developed in consultation with country stakeholders, which scaled up existing interventions to high but feasible coverage by 2025. Nine independent modelling groups collaborated to estimate policy outcomes, and we estimated the cost of each scenario by synthesising service use estimates, empirical cost data, and expert opinion on implementation strategies. We estimated health effects (ie, disability-adjusted life-years averted) and resource implications for 2016–35, including patient-incurred costs. To assess resource requirements and cost-effectiveness, we compared scenarios with a base case representing continued current practice.FindingsIncremental tuberculosis service costs differed by scenario and country, and in some cases they more than doubled existing funding needs. In general, expansion of tuberculosis services substantially reduced patient-incurred costs and, in India and China, produced net cost savings for most interventions under a societal perspective. In all three countries, expansion of access to care produced substantial health gains. Compared with current practice and conventional cost-effectiveness thresholds, most intervention approaches seemed highly cost-effective.InterpretationExpansion of tuberculosis services seems cost-effective for high-burden countries and could generate substantial health and economic benefits for patients, although substantial new funding would be required. Further work to determine the optimal intervention mix for each country is necessary.FundingBill & Melinda Gates Foundation.

Purpose Estimating the incremental costs of scaling‐up novel technologies in low‐income and middle‐income countries is a methodologically challenging and substantial empirical undertaking, in the absence of routine cost data collection. We demonstrate a best practice pragmatic approach to estimate the incremental costs of new technologies in low‐income and middle‐income countries, using the example of costing the scale‐up of Xpert Mycobacterium tuberculosis (MTB)/resistance to riframpicin (RIF) in South Africa. Materials and methods We estimate costs, by applying two distinct approaches of bottom‐up and top‐down costing, together with an assessment of processes and capacity. Results The unit costs measured using the different methods of bottom‐up and top‐down costing, respectively, are $US16.9 and $US33.5 for Xpert MTB/RIF, and $US6.3 and $US8.5 for microscopy. The incremental cost of Xpert MTB/RIF is estimated to be between $US14.7 and $US17.7. While the average cost of Xpert MTB/RIF was higher than previous studies using standard methods, the incremental cost of Xpert MTB/RIF was found to be lower. Conclusion Costs estimates are highly dependent on the method used, so an approach, which clearly identifies resource‐use data collected from a bottom‐up or top‐down perspective, together with capacity measurement, is recommended as a pragmatic approach to capture true incremental cost where routine cost data are scarce.

Global guidelines for new technologies are based on cost and efficacy data from a limited number of trial locations. Country‐level decision makers need to consider whether cost‐effectiveness analysis used to inform global guidelines are sufficient for their situation or whether to use models that adjust cost‐effectiveness results taking into account setting‐specific epidemiological and cost heterogeneity. However, demand and supply constraints will also impact cost‐effectiveness by influencing the standard of care and the use and implementation of any new technology. These constraints may also vary substantially by setting. We present two case studies of economic evaluations of the introduction of new diagnostics for malaria and tuberculosis control. These case studies are used to analyse how the scope of economic evaluations of each technology expanded to account for and then address demand and supply constraints over time. We use these case studies to inform a conceptual framework that can be used to explore the characteristics of intervention complexity and the influence of demand and supply constraints. Finally, we describe a number of feasible steps that researchers who wish to apply our framework in cost‐effectiveness analyses.

Out‐of‐pocket spending is increasingly recognized as an important barrier to accessing health care, particularly in low‐income and middle‐income countries (LMICs) where a large portion of health expenditure comes from out‐of‐pocket payments. Emerging universal healthcare policies prioritize reduction of poverty impact such as catastrophic and impoverishing healthcare expenditure. Poverty impact is therefore increasingly evaluated alongside and within economic evaluations to estimate the impact of specific health interventions on poverty. However, data collection for these metrics can be challenging in intervention‐based contexts in LMICs because of study design and practical limitations. Using a set of case studies, this letter identifies methodological challenges in collecting patient cost data in LMIC contexts. These components are presented in a framework to encourage researchers to consider the implications of differing approaches in data collection and to report their approach in a standardized and transparent way. © 2016 The Authors. Health Economics published by John Wiley & Sons Ltd.

Managing ecological systems, which operate over large spatial scales, is inherently difficult and often requires sourcing data from different countries and organizations. The assumption might be made that data collected using similar methodologies are comparable, but this is rarely tested. Here, benthic video data recorded using different towed underwater video systems (TUVSs) were experimentally compared. Three technically different TUVSs were compared on different seabed types (rocky, mixed ground and sandy) in Kingmere Marine Conservation Zone, off the south coast of England. For each TUVS, species metrics (forward facing camera), seabed impact (backward facing camera) and operational performance (strengths and limitations of equipment and video footage) were compared with the aim of providing recommendations on their future use and comparability of data between different systems. Statistically significant differences between species richness, density, cover and assemblage composition were detected amongst devices and were believed to be mostly due to their optical specifications. As a result of their high image definition and large field of vision both the benthic contacting heavy and benthic tending TUVS provided good quality footage and ecological measurements. However, the heaviest TUVS proved difficult to operate on irregular ground and was found to cause the most impact to the seabed. The lightest TUVS (benthic contacting light) struggled to maintain contact with the seabed. The benthic tending TUVS was able to fly over variable seabed relief and was comparably the least destructive. Results from this study highlight that particular care should be given to sled and optic specifications when developing a medium- or long-term marine protected area monitoring programme. Furthermore, when using data gathered from multiple sources to test ecological questions, different equipment specifications may confound observed ecological differences. A benthic tending TUVS

Background A pragmatic three-tiered approach to monitor the world’s largest antiretroviral treatment (ART) programme was adopted by the South African National Department of Health in 2010. With the rapid expansion of the programme, the limitations of the paper-based register (tier 1) were the catalyst for implementation of the stand-alone electronic register (tier 2), which offers simple digitisation of the paper-based register. This article engages with theory on implementation to identify and contextualise enabling and constraining factors for implementation of the electronic register, to describe experiences and use of the register, and to make recommendations for implementation in similar settings where standardisation of ART monitoring and evaluation has not been achieved. Methods We conducted a qualitative evaluation of the roll-out of the register. This comprised twenty in-depth interviews with a diverse sample of stakeholders at facility, sub-district, and district levels of the health system. Facility-level participants were selected across five sub-districts, including one facility per sub-district. Responses were coded and analysed using a thematic approach. An implementation science framework guided interpretation of the data. Results & Discussion We identified the following seven themes: 1) ease of implementation, 2) perceived value of an electronic M&E system, 3) importance of stakeholder engagement, 4) influence of a data champion, 5) operational and logistical factors, 6) workload and role clarity, and 7) importance of integrating the electronic register with routine facility monitoring and evaluation. Interpreting our findings through an implementation theory enabled us to construct the scaffolding for implementation across the five facility-settings. This approach illustrated that implementation was not a linear process but occurred at two nodes: at the adoption of the register for roll-out, and at implementation at facility-level. Conclusion In th

Background While the Nigerian government has made progress towards the Millennium Development Goals, further investments are needed to achieve the targets of post-2015 Sustainable Development Goals, including Universal Health Coverage. Economic evaluations of innovative interventions can help inform investment decisions in resource-constrained settings. We aim to assess the cost and cost-effectiveness of maternal care provided within the new Kwara State Health Insurance program (KSHI) in rural Nigeria. Methods and Findings We used a decision analytic model to simulate a cohort of pregnant women. The primary outcome is the incremental cost effectiveness ratio (ICER) of the KSHI scenario compared to the current standard of care. Intervention cost from a healthcare provider perspective included service delivery costs and above-service level costs; these were evaluated in a participating hospital and using financial records from the managing organisations, respectively. Standard of care costs from a provider perspective were derived from the literature using an ingredient approach. We generated 95% credibility intervals around the primary outcome through probabilistic sensitivity analysis (PSA) based on a Monte Carlo simulation. We conducted one-way sensitivity analyses across key model parameters and assessed the sensitivity of our results to the performance of the base case separately through a scenario analysis. Finally, we assessed the sustainability and feasibility of this program’s scale up within the State’s healthcare financing structure through a budget impact analysis. The KSHI scenario results in a health benefit to patients at a higher cost compared to the base case. The mean ICER (US$46.4/disability-adjusted life year averted) is considered very cost-effective compared to a willingness-to-pay threshold of one gross domestic product per capita (Nigeria, US$ 2012, 2,730). Our conclusion was robust to uncertainty in parameters estimates (PSA: median US$49.1, 9

Social protection against the cost of illness is a central policy objective of Universal Health Coverage and the post-2015 Global strategy for Tuberculosis (TB). Understanding the economic burden associated with TB illness and care is key to identifying appropriate interventions towards achieving this target. The aims of this study were to identify points in patient pathways from start of TB symptoms to treatment completion where interventions could be targeted to reduce the economic impact on patients and households, and to identify those most vulnerable to these costs. Two cohorts of patients accessing TB services from ten clinics in four provinces in South Africa were surveyed between July 2012 and June 2013. One cohort of 351 people with suspected TB were interviewed at the point of receiving a TB diagnostic and followed up six months later. Another cohort of 168 patients on TB treatment, at the same ten facilities, was interviewed at two-months and five-months on treatment. Patients were asked about their health-seeking behaviour, associated costs, income loss, and coping strategies used. Patients incurred the greatest share of TB episode costs (41%) prior to starting treatment, with the largest portion of these costs being due to income loss. Poorer patients incurred higher direct costs during treatment than those who were less poor but only 5% of those interviewed were accessing cash-transfers during treatment. Indirect costs accounted for 52% of total episode cost. Despite free TB diagnosis and care in South Africa, patients incur substantial direct and indirect costs particularly prior to starting treatment. The poorest group of patients were incurring higher costs, with fewer resources to pay for it. Both the direct and indirect cost of illness should be taken into account when setting levels of financial protection and social support, to prevent TB illness from pushing the poor further into poverty.

Background A pragmatic three-tiered approach to monitor the world’s largest antiretroviral treatment (ART) programme was adopted by the South African National Department of Health in 2010. With the rapid expansion of the programme, the limitations of the paper-based register (tier 1) were the catalyst for implementation of the stand-alone electronic register (tier 2), which offers simple digitisation of the paper-based register. This article engages with theory on implementation to identify and contextualise enabling and constraining factors for implementation of the electronic register, to describe experiences and use of the register, and to make recommendations for implementation in similar settings where standardisation of ART monitoring and evaluation has not been achieved. Methods We conducted a qualitative evaluation of the roll-out of the register. This comprised twenty in-depth interviews with a diverse sample of stakeholders at facility, sub-district, and district levels of the health system. Facility-level participants were selected across five sub-districts, including one facility per sub-district. Responses were coded and analysed using a thematic approach. An implementation science framework guided interpretation of the data. Results & Discussion We identified the following seven themes: 1) ease of implementation, 2) perceived value of an electronic M&E system, 3) importance of stakeholder engagement, 4) influence of a data champion, 5) operational and logistical factors, 6) workload and role clarity, and 7) importance of integrating the electronic register with routine facility monitoring and evaluation. Interpreting our findings through an implementation theory enabled us to construct the scaffolding for implementation across the five facility-settings. This approach illustrated that implementation was not a linear process but occurred at two nodes: at the adoption of the register for roll-out, and at implementation at facility-level. Conclusion In th

Background While the Nigerian government has made progress towards the Millennium Development Goals, further investments are needed to achieve the targets of post-2015 Sustainable Development Goals, including Universal Health Coverage. Economic evaluations of innovative interventions can help inform investment decisions in resource-constrained settings. We aim to assess the cost and cost-effectiveness of maternal care provided within the new Kwara State Health Insurance program (KSHI) in rural Nigeria. Methods and Findings We used a decision analytic model to simulate a cohort of pregnant women. The primary outcome is the incremental cost effectiveness ratio (ICER) of the KSHI scenario compared to the current standard of care. Intervention cost from a healthcare provider perspective included service delivery costs and above-service level costs; these were evaluated in a participating hospital and using financial records from the managing organisations, respectively. Standard of care costs from a provider perspective were derived from the literature using an ingredient approach. We generated 95% credibility intervals around the primary outcome through probabilistic sensitivity analysis (PSA) based on a Monte Carlo simulation. We conducted one-way sensitivity analyses across key model parameters and assessed the sensitivity of our results to the performance of the base case separately through a scenario analysis. Finally, we assessed the sustainability and feasibility of this program’s scale up within the State’s healthcare financing structure through a budget impact analysis. The KSHI scenario results in a health benefit to patients at a higher cost compared to the base case. The mean ICER (US$46.4/disability-adjusted life year averted) is considered very cost-effective compared to a willingness-to-pay threshold of one gross domestic product per capita (Nigeria, US$ 2012, 2,730). Our conclusion was robust to uncertainty in parameters estimates (PSA: median US$49.1, 9

Social protection against the cost of illness is a central policy objective of Universal Health Coverage and the post-2015 Global strategy for Tuberculosis (TB). Understanding the economic burden associated with TB illness and care is key to identifying appropriate interventions towards achieving this target. The aims of this study were to identify points in patient pathways from start of TB symptoms to treatment completion where interventions could be targeted to reduce the economic impact on patients and households, and to identify those most vulnerable to these costs. Two cohorts of patients accessing TB services from ten clinics in four provinces in South Africa were surveyed between July 2012 and June 2013. One cohort of 351 people with suspected TB were interviewed at the point of receiving a TB diagnostic and followed up six months later. Another cohort of 168 patients on TB treatment, at the same ten facilities, was interviewed at two-months and five-months on treatment. Patients were asked about their health-seeking behaviour, associated costs, income loss, and coping strategies used. Patients incurred the greatest share of TB episode costs (41%) prior to starting treatment, with the largest portion of these costs being due to income loss. Poorer patients incurred higher direct costs during treatment than those who were less poor but only 5% of those interviewed were accessing cash-transfers during treatment. Indirect costs accounted for 52% of total episode cost. Despite free TB diagnosis and care in South Africa, patients incur substantial direct and indirect costs particularly prior to starting treatment. The poorest group of patients were incurring higher costs, with fewer resources to pay for it. Both the direct and indirect cost of illness should be taken into account when setting levels of financial protection and social support, to prevent TB illness from pushing the poor further into poverty.

Background A scarcity of human resources for health has been identified as one of the primary constraints to the scale-up of the provision of Anti-Retroviral Treatment (ART). In South Africa there is a particularly severe lack of pharmacists. The study aims to compare two task-shifting approaches to the dispensing of ART: Indirectly Supervised Pharmacist’s Assistants (ISPA) and Nurse-based pharmaceutical care models against the standard of care which involves a pharmacist dispensing ART. Methods A cross-sectional mixed methods study design was used. Patient exit interviews, time and motion studies, expert interviews and staff costs were used to conduct a costing from the societal perspective. Six facilities were sampled in the Western Cape province of South Africa, and 230 patient interviews conducted. Results The ISPA model was found to be the least costly task-shifting pharmaceutical model. However, patients preferred receiving medication from the nurse. This related to a fear of stigma and being identified by virtue of receiving ART at the pharmacy. Conclusions While these models are not mutually exclusive, and a variety of pharmaceutical care models will be necessary for scale up, it is useful to consider the impact of implementing these models on the provider, patient access to treatment and difficulties in implementation.

Background A scarcity of human resources for health has been identified as one of the primary constraints to the scale-up of the provision of Anti-Retroviral Treatment (ART). In South Africa there is a particularly severe lack of pharmacists. The study aims to compare two task-shifting approaches to the dispensing of ART: Indirectly Supervised Pharmacist’s Assistants (ISPA) and Nurse-based pharmaceutical care models against the standard of care which involves a pharmacist dispensing ART. Methods A cross-sectional mixed methods study design was used. Patient exit interviews, time and motion studies, expert interviews and staff costs were used to conduct a costing from the societal perspective. Six facilities were sampled in the Western Cape province of South Africa, and 230 patient interviews conducted. Results The ISPA model was found to be the least costly task-shifting pharmaceutical model. However, patients preferred receiving medication from the nurse. This related to a fear of stigma and being identified by virtue of receiving ART at the pharmacy. Conclusions While these models are not mutually exclusive, and a variety of pharmaceutical care models will be necessary for scale up, it is useful to consider the impact of implementing these models on the provider, patient access to treatment and difficulties in implementation.