Reporting of observational studies is often inadequate, hampering the assessment of their strengths and weaknesses and, consequently, the generalization of study results. The initiative named Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) developed a checklist of 22 items, the STROBE Statement, with recommendations about what should be included in a more accurate and complete description of observational studies. Between June and December 2008, a group of Brazilian researchers was dedicated to the translation and adaptation of the STROBE Statement into Portuguese. The present study aimed to show the translation into Portuguese, introduce the discussion on the context of use, the potential and limitations of the STROBE initiative. Clinical trials and observational studies in the context of modern biomedical researchRandomized clinical trials have been described as the gold standard for biomedical research as they show high internal validity and, consequently, greater accuracy in the effi cacy and effectiveness evaluation of several therapeutic and preventive health practices. 4 However, public health studies have frequently dealt with problems where this study design is not adequate and/or ethical, or, yet, for which the translation of randomized controlled trial fi ndings into concrete intervention and/or treatment conditions faces great diffi culties due to the lack of external validity of fi ndings obtained in a clinical trial context. According to Victora et al,26 randomized clinical trials frequently represent an inadequate choice to assess the performance and impact of large scale interventions, especially in contexts of heterogeneity, whether they are social, economic and/or geographic in nature. In addition, there are operational aspects that can hinder or even preclude the implementation of clinical trials: individuals may not want to be randomized for a given intervention group, randomized selection may not be possible or ethically acceptable in the research context, or, yet, only participants with certain characteristics might accept to be selected. 31 In view of the impossibility or inadequacy of implementation of randomized clinical trials, whether due to ethical or operational questions, observational studies appear as a more feasible solution and, in cohort studies, are relevant alternatives to evaluate the impact of interventions throughout time. 22Observational studies are more adequate to evaluate rare or late side effects associated with certain treatments and they often provide a more accurate indication of what can be achieved in routine clinical practice, once they take The adverse effects of non-steroidal anti-infl ammatory drugs on cardiovascular morbi-mortality has been documented in studies with large sample sizes and longterm follow-up. Until then, these side effects had been imperceptible in the context of clinical trials and even of pharmacovigilance, involving a small number of cases and/or having a relatively short follow-up period. 10Previous...

While lower than other populations-especially among users of stimulants, incarcerated DU and patients with psychiatric comorbidities-adherence to HAART among HIV-positive DU can be achieved. Better adherence was identified among those engaged in comprehensive services providing HIV and addiction treatment with psychosocial support.

We conducted a meta-analysis of studies assessing adherence to highly active antiretroviral therapy (HAART) and a qualitative systematic review of factors associated with better HAART outcomes among HIV+ drug users (DU). Thirty-eight studies were considered, which analyzed 14,960 patients (11,394 HIV+ DU, 76.2%). Overall adherence (pooled percent of DU classified as adherent in each study) was 0.60 (95% CI: 0.52-0.68), similar to levels identified by studies conducted with HIV+ patients who are not drug users. Time frame used to measure adherence was an independent predictor of inter-study heterogeneity. The systematic review identified better HAART outcomes among former DU, those with less severe psychiatric conditions, those receiving opioid substitution therapy and/or psychosocial support. Patients initiating HAART with lower viral load and higher CD4 counts, and those without co-infections also had better treatment outcomes. Our findings suggest that HIV+ DU tend to be inappropriately assumed to be less adherent and unlikely to achieve desirable treatment outcomes, when compared to their non-DU cohort.

BackgroundThe Brazilian response towards AIDS epidemic is well known, but the absence of a systematic review of vulnerable populations ─ men who have sex with men (MSM), female sex workers (FSW), and drug users (DU) remains a main gap in the available literature. Our goal was to conduct a systematic review and meta-analysis of studies assessing HIV prevalence among MSM, FSW and DU, calculating a combined pooled prevalence and summarizing factors associated the pooled prevalence for each group.MethodsNine electronic databases (MEDLINE via PubMed, EMBASE, Cochrane CENTRAL, AIDSLINE, AMED, CINAHL, TOXNET, SciELO, and ISI-Web of Science) were searched for peer-reviewed papers published in English, French, Spanish or Portuguese, from 1999 to 2009. To be included in the review, studies had to measure HIV prevalence and/or incidence as the primary outcome among at least one specific population under analysis.ResultsThe studies targeting the three populations analyzed mostly young participants aged 30 years or less. Among FSW, eight studies were selected (3,625 participants), consistently identifying higher condom use with sexual clients than with occasional and stable partners. The combined HIV prevalence for FSW was 6.2 (95% CI: 4.4-8.3). Ten studies targeting MSM were identified (6,475 participants). Unprotected anal intercourse was commonly reported on those studies, but with great variability according to the nature of the relationship - stable vs. occasional sex partners - and sexual practice - receptive vs. insertive anal sex. Pooled HIV prevalence for MSM was 13.6 (95% CI: 8.2-20.2). Twenty nine studies targeting DU were identified (13,063 participants). Those studies consistently identified injection drug use and syringe/needle sharing as key predictors of HIV-infection, as well as engagement in sex work and male-to-male sex. The combined HIV prevalence across studies targeting DU was 23.1 (95% CI: 16.7-30.2).ConclusionsFSW, MSM and DU from Brazil have a much risk of acquiring HIV infection compared to the general population, among which HIV prevalence has been relatively low (~0.6%). Those vulnerable populations should be targeted by focused prevention strategies that provide accurate information, counseling and testing, as well as concrete means to foster behavior change (e.g. access to condoms, drug abuse treatment, and clean syringes in the case of active injecting drug users), tailored to gender and culture-specific needs. Programs that provide these services need to be implemented on public health services throughout the country, in order to decrease the vulnerability of those populations to HIV infection.

h Skin biopsy samples from 145 relapse leprosy cases and from five different regions in Brazil were submitted for sequence analysis of part of the genes associated with Mycobacterium leprae drug resistance. Single nucleotide polymorphisms (SNPs) in these genes were observed in M. leprae from 4 out of 92 cases with positive amplification (4.3%) and included a case with a mutation in rpoB only, another sample with SNPs in both folP1 and rpoB, and two cases showing mutations in folP1, rpoB, and gyrA, suggesting the existence of multidrug resistance (MDR). The nature of the mutations was as reported in earlier studies, being CCC to CGC in codon 55 in folP (Pro to Arg), while in the case of rpoB, all mutations occurred at codon 531, with two being a transition of TCG to ATG (Ser to Met), one TCG to TTC (Ser to Phe), and one TCG to TTG (Ser to Leu). The two cases with mutations in gyrA changed from GCA to GTA (Ala to Val) in codon 91. The median time from cure to relapse diagnosis was 9.45 years but was significantly shorter in patients with mutations (3.26 years; P ‫؍‬ 0.0038). More than 70% of the relapses were multibacillary, including three of the mutation-carrying cases; one MDR relapse patient was paucibacillary. There is no doubt about the efficiency of the currently used multidrug therapy (MDT) scheme for treatment of leprosy, as demonstrated by the strong decrease in disease prevalence since its implementation and the low number of reported relapse cases (18). However, there has been a scarcity of in-depth studies of relapse occurrences in recent decades (27). As is known, differentiating diagnosis of relapse and reactional states poses some difficulties in the field, being responsible for under-or overdiagnosis of both disease stages. This is important because undiagnosed relapse cases could contribute to continuing disease transmission. In addition, hardly any data on the contribution of emergence of drug-resistant strains of Mycobacterium leprae to leprosy relapses exist.Diaminodiphenylsulfone (DDS), also called dapsone, was the first drug to be effective against leprosy worldwide, and the first cases of resistance to dapsone were detected in 1964 and involved two single nucleotide polymorphisms (SNPs) in the gene folP1, located in codons 53 and 55 (8, 9, 14, 29). Rifampin is the key component of the standard multidrug regimen used for treatment of leprosy, and it has been shown that PCR-based DNA sequence analysis of the rpoB gene of M. leprae was in full concordance with rifampin susceptibility testing in the mouse footpad system (17, 30). In addition to dapsone and rifampin, ofloxacin is also used for leprosy treatment and is a quinolone with an action mechanism based on interaction with DNA gyrase (2); SNPs in gyrA and gyrB confer resistance or hypersensitivity to quinolones (15). Although there is not yet an official definition of multidrug resistance (MDR) in leprosy, in parallel with tuberculosis, we adopt this terminology when we encounter resistance to rifampin and one other drug of the standard M...