Dataset Information

Low quality evidence of epidemiological observational studies on leishmaniasis in Brazil.

ABSTRACT:

Background

Brazil has implemented systematic control methods for leishmaniasis for the past 30 years, despite an increase in cases and continued spread of the disease to new regions. A lack high quality evidence from epidemiological observational studies impedes the development of novel control methods to prevent disease transmission among the population. Here, we have evaluated the quality of observational studies on leishmaniasis conducted in Brazil to highlight this issue.

Methods/principal findings

For this systematic review, all publications on leishmaniasis conducted in Brazil from January 1st, 2002 to December 31st, 2012 were screened via Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist to select observational studies involving human subjects. The 283 included studies, representing only 14.1% of articles screened, were then further evaluated for quality of epidemiological methods and study design based on the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) checklists. Over half of these studies were descriptive or case reports (53.4%, 151), followed by cross-sectional (20.8%, n = 59), case-control (8.5%, n = 24), and cohort (6.0%, n = 17). Study design was not stated in 46.6% (n = 181) and incorrectly stated in 17.5% (n = 24). Comparison groups were utilized in just 39.6% (n = 112) of the publications, and only 13.4% (n = 38) employed healthy controls. Majority of studies were performed at the city-level (62.9%, n = 178), in contrast with two (0.7%) studies performed at the national-level. Coauthorship networks showed the number of author collaborations rapidly decreased after three collaborations, with 70.9% (n = 659/929) of coauthors publishing only one article during the study period.

Conclusions/significance

A review of epidemiological research in Brazil revealed a major lack of quality and evidence. While certain indicators suggested research methods may have improved in the last two years, an emphasis on observational research which employs comparison groups and representative samples is urgently needed.

SUBMITTER: Trentini B

PROVIDER: S-EPMC4157786 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Low quality evidence of epidemiological observational studies on leishmaniasis in Brazil.

Trentini Bruno B Steindel Mário M Marlow Mariel A MA

PloS one 20140908 9

<h4>Background</h4>Brazil has implemented systematic control methods for leishmaniasis for the past 30 years, despite an increase in cases and continued spread of the disease to new regions. A lack high quality evidence from epidemiological observational studies impedes the development of novel control methods to prevent disease transmission among the population. Here, we have evaluated the quality of observational studies on leishmaniasis conducted in Brazil to highlight this issue.<h4>Methods/ ...[more]

PMID: 25197965

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Project description:BackgroundThis meta-epidemiological study aimed to assess methodological quality of a sample of contemporary non-randomised clinical studies of clinical interventions.MethodsThis was a cross-sectional study of observational studies published between January 1, 2012 and December 31, 2018. Studies were identified in PubMed using search terms 'association', 'observational,' 'non-randomised' 'comparative effectiveness' within titles or abstracts. Each study was appraised against 35 quality criteria by two authors independently, with each criterion rated fully, partially or not satisfied. These quality criteria were grouped into 6 categories: justification for observational design (n = 2); minimisation of bias in study design and data collection (n = 11); use of appropriate methods to create comparable groups (n = 6); appropriate adjustment of observed effects (n = 5); validation of observed effects (n = 9); and authors interpretations (n = 2).ResultsOf 50 unique studies, 49 (98%) were published in two US general medical journals. No study fully satisfied all applicable criteria; the mean (+/-SD) proportion of applicable criteria fully satisfied across all studies was 72% (+/- 10%). The categories of quality criteria demonstrating the lowest proportions of fully satisfied criteria were measures used to adjust observed effects (criteria 20, 23, 24) and validate observed effects (criteria 25, 27, 33). Criteria associated with ≤50% of full satisfaction across studies, where applicable, comprised: imputation methods to account for missing data (50%); justification for not performing an RCT (42%); interaction analyses in identifying independent prognostic factors potentially influencing intervention effects (42%); use of statistical correction to minimise type 1 error in multiple outcome analyses (33%); clinically significant effect sizes (30%); residual bias analyses for unmeasured or unknown confounders (14%); and falsification tests for residual confounding (8%). The proportions of fully satisfied criteria did not change over time.ConclusionsRecently published observational studies fail to fully satisfy more than one in four quality criteria. Criteria that were not or only partially satisfied were identified which serve as remediable targets for researchers and journal editors.

Project description:Rationale, aims, and objectivesIt is generally believed that evidence from low quality of evidence generate inaccurate estimates about treatment effects more often than evidence from high (certainty) quality evidence (CoE). As a result, we would expect that (a) estimates of effects of health interventions initially based on high CoE change less frequently than the effects estimated by lower CoE (b) the estimates of magnitude of effect size differ between high and low CoE. Empirical assessment of these foundational principles of evidence-based medicine has been lacking.MethodsWe reviewed the Cochrane Database of Systematic Reviews from January 2016 through May 2021 for pairs of original and updated reviews for change in CoE assessments based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. We assessed the difference in effect sizes between the original versus updated reviews as a function of change in CoE, which we report as a ratio of odds ratio (ROR). We compared ROR generated in the studies in which CoE changed from very low/low (VL/L) to moderate/high (M/H) versus M/H to VL/L. Heterogeneity and inconsistency were assessed using the tau and I2 statistic. We also assessed the change in precision of effect estimates (by calculating the ratio of standard errors) (seR), and the absolute deviation in estimates of treatment effects (aROR).ResultsFour hundred and nineteen pairs of reviews were included of which 414 (207 × 2) informed the CoE appraisal and 384 (192 × 2) the assessment of effect size. We found that CoE originally appraised as VL/L had 2.1 [95% confidence interval (CI): 1.19-4.12; p = 0.0091] times higher odds to be changed in the future studies than M/H CoE. However, the effect size was not different (p = 1) when CoE changed from VL/L → M/H [ROR = 1.02 (95% CI: 0.74-1.39)] compared with M/H → VL/L (ROR = 1.02 [95% CI: 0.44-2.37]). Similar overlap in aROR between the VL/L → M/H versus M/H → VL/L subgroups was observed [median (IQR): 1.12 (1.07-1.57) vs. 1.21 (1.12-2.43)]. We observed large inconsistency across ROR estimates (I2 = 99%). There was larger imprecision in treatment effects when CoE changed from VL/L → M/H (seR = 1.46) than when it changed from M/H → VL/L (seR = 0.72).ConclusionsWe found that low-quality evidence changes more often than high CoE. However, the effect size did not systematically differ between the studies with low versus high CoE. The finding that the effect size did not differ between low and high CoE indicate urgent need to refine current EBM critical appraisal methods.

Project description:BackgroundCutaneous leishmaniasis (CL) is a vector-borne disease classified by the World Health Organization as one of the most neglected tropical diseases. Brazil has the highest incidence of CL in America and is one of the ten countries in the world with the highest number of cases. Understanding the spatiotemporal dynamics of CL is essential to provide guidelines for public health policies in Brazil. In the present study we used a spatial and temporal statistical approach to evaluate the dynamics of CL in Brazil.MethodsWe used data of cutaneous leishmaniasis cases provided by the Ministry of Health of Brazil from 2001 to 2017. We calculated incidence rates and used the Mann-Kendall trend test to evaluate the temporal trend of CL in each municipality. In addition, we used Kuldorff scan method to identify spatiotemporal clusters and emerging hotspots test to evaluate hotspot areas and their temporal trends.ResultsWe found a general decrease in the number of CL cases in Brazil (from 15.3 to 8.4 cases per 100 000 habitants), although 3.2% of municipalities still have an increasing tendency of CL incidence and 72.5% showed no tendency at all. The scan analysis identified a primary cluster in northern and central regions and 21 secondary clusters located mainly in south and southeast regions. The emerging hotspots analysis detected a high spatial and temporal variability of hotspots inside the main cluster area, diminishing hotspots in eastern Amazon and permanent, emerging, and new hotspots in the states of Amapá and parts of Pará, Roraima, Acre and Mato Grosso. The central coast the state of Bahia is one of the most critical areas due to the detection of a cluster of the highest rank in a secondary cluster, and because it is the only area identified as an intensifying hotspot.ConclusionsUsing a combination of statistical methods we were able to detect areas of higher incidence of CL and understand how it changed over time. We suggest that these areas, especially those identified as permanent, new, emerging and intensifying hotspots, should be targeted for future research, surveillance, and implementation of vector control measures.

Dataset Information

Low quality evidence of epidemiological observational studies on leishmaniasis in Brazil.

Background

Methods/principal findings

Conclusions/significance

Publications

Low quality evidence of epidemiological observational studies on leishmaniasis in Brazil.

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