Eligibility criteria and outcome measures adopted in clinical trials of treatments of cutaneous leishmaniasis: systematic literature review covering the period 1991-2015

OBJECTIVE:To document the sources of heterogeneity in outcomes and shortcomings in trial designs reported by previous systematic reviews. METHODS:Systematic review of clinical trials of CL treatments published since 1991, to assess and compare eligibility criteria and outcome measures in trials (any type of treatment) of CL (any form) reported before and after the publication of the CONSORT statement. RESULTS:We identified 106 eligible trials published between 1991 and 2015, 74% after the 2001 CONSORT statement; 58% (n = 63) were on Old-World CL and 37% (n = 40) in New-World CL; overall, 11 531 patients enrolled in 243 treatment groups on 30 different treatments. Both requirements and definitions for eligibility and outcome criteria varied. Compliance with CONSORT requirements increased for studies published after the 2010 update. As for entry criteria, 94% of studies had a requirement for sex (74% of those enrolling also women excluded those who were pregnant or lactating), 69% for age (variable age ranges), 99% parasitological confirmation, 43% prior duration of illness (14% excluded cases with previous episodes), 46% defined the number, 28% the size and 13% the type of lesions (27% with restrictions as to their anatomical location). Follow-up ranged 1-24 months, with 14% and 91% of studies, respectively, having defined initial and final cure. CONCLUSIONS:This review documents changes in reporting before and after the publication of the CONSORT statement. Lack of standardisation, compounded with the small number of trials relative to the magnitude of the disease in its multiple forms, and with the range of treatments tested explains why evidence to inform treatment guidelines is generally weak for CL. Adopting standardised methodologies will improve the quality and consistency of clinical trials, and ultimately yield better treatments for CL

Tuberculin Skin Test and CD4+/CD8+ T Cell Counts in Adults Infected with the Human Immunodeficiency Virus in Medellín, Colombia

To evaluate the effect of BCG vaccination and T lymphocyte subpopulations on the reactivity to the tuberculin skin test, 113 asymtomatic HIV+ individuals were tuberculin tested by intradermal injection of 5TU of purified protein derivative and the levels of circulating lymphocyte (CD3, CD4 and CD8) subpopulations determined by indirect immunofluorescence. Ninety-two percent of the subjects included in the study were males. The mean age of the group was 32.1±7.4 years. Sixty-two percent presented a BCG scar. However, only 22% exhibited positive tuberculin reactions (³5mm) irrespective of the presence of the BCG scar. Tuberculin positive individuals exhibited higher CD4+ cell counts (p=0.004) and CD4+/CD8+ ratios (p=0.006) than tuberculin negative (<5mm) HIV+ individuals. The number of individuals with positive tuberculin reactions was significantly higher in subjects with more than 500 CD4+ lymphocytes/ml (p=0.02) or CD4+/CD8+ ratios ³1.12 (p=0.002). These results suggest that a prior BCG vaccination does not influence the reactivity to the tuberculin skin test in HIV+ asymptomatic individuals and that the number of CD4+ lymphocytes and the CD4+/CD8+ ratio positively correlate with the tuberculin reactivit

Modelling and projecting the response of local assemblage composition to land use change across Colombia

Understanding the impact of land use change within assemblages is fundamental to mitigation policies at local and regional scale. Here, we aim to quantify how site-level terrestrial assemblages are responding to land use change in Colombia a mega-diverse country and to project future biodiversity under different scenarios of land use change associated with climate change policies. Location: Colombia (northern South America). Methods: We collated original biodiversity data from 17 publications (285 sites) that examined how human impact affects terrestrial biodiversity in Colombia. From each site we estimated compositional intactness (i.e. compositional similarity to undisturbed sites). We fitted generalized linear mixed-effects models to estimate how these measures of local biodiversity vary across land use habitats. Using space-for-time substitution, we applied our estimates to hindcast biodiversity changes since 1500 and project future changes under climate change policies of the four representative concentration pathways (RCPs). Results: Assemblages in urban, cropland and pasture sites were compositionally very different from those in primary vegetation. We infer that average compositional intactness has been reduced by 18% across Colombia to date, with strong regional variation. The best RCP scenario for future biodiversity is GCAM-RCP4.5, a path that favours the expansion of secondary forests under a strong carbon market; while the worst is MESSAGE-RCP8.5, ‘the business-as-usual’ scenario. Main conclusions: Land use change has driven an increasing change in the composition of ecological assemblages in Colombia. By 2095, the implementation of carbon markets policy of climate change from GCAM-RCP4.5 could mitigate these changes in community composition. In contrast, the business-as-usual scenario MESSAGE-RCP8.5 predicts a steep community change placing the quality of ecosystems at risk

The database of the PREDICTS (Projecting Responses of Ecological Diversity In Changing Terrestrial Systems) project

The PREDICTS project-Projecting Responses of Ecological Diversity In Changing Terrestrial Systems (www.predicts.org.uk)-has collated from published studies a large, reasonably representative database of comparable samples of biodiversity from multiple sites that differ in the nature or intensity of human impacts relating to land use. We have used this evidence base to develop global and regional statistical models of how local biodiversity responds to these measures. We describe and make freely available this 2016 release of the database, containing more than 3.2 million records sampled at over 26,000 locations and representing over 47,000 species. We outline how the database can help in answering a range of questions in ecology and conservation biology. To our knowledge, this is the largest and most geographically and taxonomically representative database of spatial comparisons of biodiversity that has been collated to date; it will be useful to researchers and international efforts wishing to model and understand the global status of biodiversity