Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification.

The exclusion of people with disabilities from clinical research without appropriate justification is discriminatory, is counter to federal regulations and research guidelines, and limits study generalizability. This matter is understudied, and data on the disability status of trial participants are rarely collected or reported. We analyzed ninety-seven recent interventional protocols in four therapeutic areas registered on ClinicalTrials.gov. Eighty-five percent of protocols allowed broad investigator discretion to determine eligibility, whereas only 18 percent explicitly permitted people with disabilities to use forms of support (such as supported decision making or assistive devices) to facilitate study participation. Eligibility criteria affecting people with disabilities included exclusions for psychiatric (68 percent), substance use (62 percent), HIV or hepatitis (53 percent), cognitive or intellectual (42 percent), visual (34 percent), hearing (10 percent), mobility (9 percent), long-term care (6 percent), and speech and communication (3 percent) disability-related domains. Documented justification was provided for only 24 percent of these exclusions. We recommend greater scrutiny of study eligibility criteria, scientific or ethical justification of exclusions, and accessible study design.

A Systematic Review of Methodological Variation in Healthcare Provider Perspective Tuberculosis Costing Papers Conducted in Low- and Middle-Income Settings, Using An Intervention-Standardised Unit Cost Typology.

BACKGROUND: There is a need for easily accessible tuberculosis unit cost data, as well as an understanding of the variability of methods used and reporting standards of that data. OBJECTIVE: The aim of this systematic review was to descriptively review papers reporting tuberculosis unit costs from a healthcare provider perspective looking at methodological variation; to assess quality using a study quality rating system and machine learning to investigate the indicators of reporting quality; and to identify the data gaps to inform standardised tuberculosis unit cost collection and consistent principles for reporting going forward. METHODS: We searched grey and published literature in five sources and eight databases, respectively, using search terms linked to cost, tuberculosis and tuberculosis health services including tuberculosis treatment and prevention. For inclusion, the papers needed to contain empirical unit cost estimates for tuberculosis interventions from low- and middle-income countries, with reference years between 1990 and 2018. A total of 21,691 papers were found and screened in a phased manner. Data were extracted from the eligible papers into a detailed Microsoft Excel tool, extensively cleaned and analysed with R software (R Project, Vienna, Austria) using the user interface of RStudio. A study quality rating was applied to the reviewed papers based on the inclusion or omission of a selection of variables and their relative importance. Following this, machine learning using a recursive partitioning method was utilised to construct a classification tree to assess the reporting quality. RESULTS: This systematic review included 103 provider perspective papers with 627 unit costs (costs not presented here) for tuberculosis interventions among a total of 140 variables. The interventions covered were active, passive and intensified case finding; tuberculosis treatment; above-service costs; and tuberculosis prevention. Passive case finding is the detection of tuberculosis cases where individuals self-identify at health facilities; active case finding is detection of cases of those not in health facilities, such as through outreach; and intensified case finding is detection of cases in high-risk populations. There was heterogeneity in some of the reported methods used such cost allocation, amortisation and the use of top-down, bottom-up or mixed approaches to the costing. Uncertainty checking through sensitivity analysis was only reported on by half of the papers (54%), while purposive and convenience sampling was reported by 72% of papers. Machine learning indicated that reporting on 'Intervention' (in particular), 'Urbanicity' and 'Site Sampling', were the most likely indicators of quality of reporting. The largest data gap identified was for tuberculosis vaccination cost data, the Bacillus Calmette-Guérin (BCG) vaccine in particular. There is a gap in available unit costs for 12 of 30 high tuberculosis burden countries, as well as for the interventions of above-service costs, tuberculosis prevention, and active and intensified case finding. CONCLUSION: Variability in the methods and reporting used makes comparison difficult and makes it hard for decision makers to know which unit costs they can trust. The study quality rating system used in this review as well as the classification tree enable focus on specific reporting aspects that should improve variability and increase confidence in unit costs. Researchers should endeavour to be explicit and transparent in how they cost interventions following the principles as laid out in the Global Health Cost Consortium's Reference Case for Estimating the Costs of Global Health Services and Interventions, which in turn will lead to repeatability, comparability and enhanced learning from others.

Correction to: A Systematic Review of Methodological Variation in Healthcare Provider Perspective Tuberculosis Costing Papers Conducted in Low- and Middle-Income Settings, Using An Intervention-Standardised Unit Cost Typology.

In the original version of this article, Fig. 3 was published in an incorrect format. The correct figure is published with this correction.

The state of costing research for HIV interventions in sub-Saharan Africa.

The past decade has seen a growing emphasis on the production of high-quality costing data to improve the efficiency and cost-effectiveness of global health interventions. The need for such data is especially important for decision making and priority setting across HIV services from prevention and testing to treatment and care. To help address this critical need, the Global Health Cost Consortium was created in 2016, in part to conduct a systematic search and screening of the costing literature for HIV and TB interventions in low- and middle-income countries (LMIC). The purpose of this portion of the remit was to compile, standardise, and make publicly available published cost data (peer-reviewed and gray) for public use. We limit our analysis to a review of the quantity and characteristics of published cost data from HIV interventions in sub-Saharan Africa. First, we document the production of cost data over 25 years, including density over time, geography, publication venue, authorship and type of intervention. Second, we explore key methods and reporting for characteristics including urbanicity, platform type, ownership and scale. Although the volume of HIV costing data has increased substantially on the continent, cost reporting is lacking across several dimensions. We find a dearth of cost estimates from HIV interventions in west Africa, as well as inconsistent reporting of key dimensions of cost including platform type, ownership and urbanicity. Further, we find clear evidence of a need for renewed focus on the consistent reporting of scale by authors of costing and cost-effectiveness analyses.

Developing the Global Health Cost Consortium Unit Cost Study Repository for HIV and TB: methodology and lessons learned.

Consistently defined, accurate, and easily accessible cost data are a valuable resource to inform efficiency analyses, budget preparation, and sustainability planning in global health. The Global Health Cost Consortium (GHCC) designed the Unit Cost Study Repository (UCSR) to be a resource for standardised HIV and TB intervention cost data displayed by key characteristics such as intervention type, country, and target population. To develop the UCSR, the GHCC defined a typology of interventions for each disease; aligned interventions according to the standardised principles, methods, and cost and activity categories from the GHCC Reference Case for Estimating the Costs of Global Health Services and Interventions; completed a systematic literature review; conducted extensive data extraction; performed quality assurance; grappled with complex methodological issues such as the proper approach to the inflation and conversion of costs; developed and implemented a study quality rating system; and designed a web-based user interface that flexibly displays large amounts of data in a user-friendly way. Key lessons learned from the extraction process include the importance of assessing the multiple uses of extracted data; the critical role of standardising definitions (particularly units of measurement); using appropriate classifications of interventions and components of costs; the efficiency derived from programming data checks; and the necessity of extraction quality monitoring by senior analysts. For the web interface, lessons were: understanding the target audiences, including consulting them regarding critical characteristics; designing the display of data in "levels"; and incorporating alert and unique trait descriptions to further clarify differences in the data.

'He always thinks he is nothing': The psychosocial impact of discrimination on adolescent refugees in urban Uganda.

Armed conflict causes massive displacement, erodes the social fabric of communities, and threatens the healthy development of a nation's future - its youth. Although more than half of the world's registered refugees under the age of eighteen currently reside in urban areas, research on the unique needs of and realities experienced by this population remain limited. In Uganda, as in many refugee-receiving countries, most regulated refugee protections and entitlements fail to extend beyond the confines of official settlements or camps. This dearth of support, in combination with few material resources, uncertain local connections, and little knowledge of the language, leaves refugee families vulnerable to the added burden of an unwelcome reception in cities. Drawing on qualitative data from a study conducted in March and April 2013 with Congolese and Somali adolescents, caregivers, and service providers in refugee settlements in Kampala, this manuscript explores the pervasive nature of discrimination against urban refugees and its effects upon adolescent well-being. Findings suggest that discrimination not only negatively impacts acculturation as youth pursue social recognition in the classroom and among neighborhood peers, but it also impedes help-seeking behavior by caregivers and restricts their ability to ameliorate protection concerns, thereby lowering adolescents' psychosocial well-being. Youth reported low self-worth, withdrawal from school, and an adverse turn toward street connections. Targeted and innovative strategies along with reformed policies that address the unique challenges facing urban refugees are paramount to ensuring that young people in this population experience greater protection, well-being, and future success.

Linking high parity and maternal and child mortality: what is the impact of lower health services coverage among higher order births?

BACKGROUND: A number of data sets show that high parity births are associated with higher child mortality than low parity births. The reasons for this relationship are not clear. In this paper we investigate whether high parity is associated with lower coverage of key health interventions that might lead to increased mortality. METHODS: We used DHS data from 10 high fertility countries to examine the relationship between parity and coverage for 8 child health intervention and 9 maternal health interventions. We also used the LiST model to estimate the effect on maternal and child mortality of the lower coverage associated with high parity births. RESULTS: Our results show a significant relationship between coverage of maternal and child health services and birth order, even when controlling for poverty. The association between coverage and parity for maternal health interventions was more consistently significant across countries all countries, while for child health interventions there were fewer overall significant relationships and more variation both between and within countries. The differences in coverage between children of parity 3 and those of parity 6 are large enough to account for a 12% difference in the under-five mortality rate and a 22% difference in maternal mortality ratio in the countries studied. CONCLUSIONS: This study shows that coverage of key health interventions is lower for high parity children and the pattern is consistent across countries. This could be a partial explanation for the higher mortality rates associated with high parity. Actions to address this gap could help reduce the higher mortality experienced by high parity birth.