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Objective To evaluate the extent of non-publication or delayed publication of registered randomized trials on vaccines, and to investigate potential determinants of delay to publication. Design Survey.Data sources Trials registry websites, Scopus, PubMed, Google. Main outcome measures Publication status of trial results and time from completion to publication in peer reviewed journals. Study selectionData synthesis Cox proportional hazards regression was used to evaluate potential predictors of publication delay. ResultsWe analysed 384 trials (85% sponsored by industry). Of 355 trials (404 758 participants) that were completed, 176 (n=151 379) had been published in peer reviewed journals. Another 42 trials (total sample 62 765) remained unpublished but reported results in ClinicalTrials.gov. The proportion of trials published 12, 24, 36, and 48 months after completion was 12%, 29%, 53%, and 73%, respectively. Including results posted in ClinicalTrials.gov, 48 months after study completion results were available for 82% of the trials and 90% of the participants. Delay to publication between non-industry and industry sponsored trials did not differ, but non-industry sponsored trials were 4.42-fold (P=0.008) more likely to report negative or mixed findings. Negative results were reported by only 2% of the published trials.Conclusions Most vaccine trials are published eventually or the results posted in ClinicalTrials.gov, but delays to publication of several years are common. Actions should focus on the timely dissemination of data from vaccine trials to the public.

ObjectiveTo evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes), directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both. DesignProspective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up. Data SourcesDirect contact and structured questionnaires by phone or via internet. MethodsAdults (30-75 years) were included if they were smokers of 1 tobacco cigarette/day (tobacco smokers), users of any type of e-cigarettes, inhaling 50 puffs weekly (e-smokers), or smokers of both tobacco and e-cigarettes (dual smokers). Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence. edu).Funding: The authors have no support or funding to report.Competing Interests: The authors have declared that no competing interests exist. Main Outcome MeasuresSustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily. Data SynthesisWe used linear and logistic regression, with region as cluster unit. ResultsFollow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%). All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19;), whereas adding ecigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall). ConclusionsAdding e-cigarettes to tobacco smoking did not facilitate smoking cessation or reduction. If e-cigarette safety will be confirmed, however, the use of e-cigarettes alone may facilitate quitters remaining so. Registration NumberNCT01785537.

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and 555MBq (15mCi) fixed dose regimens respectively. The data on demographic (age, gender), clinical (presence of eye disease, the size/type of goiter) and biochemical variables (serum Thyroid Stimulating Hormone -TSH) were obtained. Primary outcome is to cure hyperthyroidism by rendering the patient either euthyroid or hypothyroid within 6months of single dose RAI therapy. Statistical analysis was carried out with SPSS version 15.0 and the level of statistical significance was taken as P Ͻ 0.05. RESULTS: Three (3) males (15%) and 17 females (85%) received RAI therapy for Graves' hyperthyroidism. Their mean age was 49.4 years (range of 25-75years). Fixed doses of 370MBq (10mCi) and 555MBq (15mCi) both produced a response or cure rate of 100%. Overall, 65% and 35% were made hypothyroid (TSHϾ6.1mIU/L) and euthyroid (TSHϭ0.21-6.0mIU/L) respectively. The incidence of hypothyroidism was 66.6% with fixed dose of 370MBq (10mCi) and 62.5% with fixed dose of 555MBq (15mCi) within 6months post RAI therapy. There was no significant difference in the incidence of hypothyroidism produced by the two fixed doses of RAI therapy. CONCLUSIONS: Radioactive iodine at fixed doses of 370MBq (10mCi) and 555MBq (15mCi) was highly effective for the treatment of Graves' hyperthyroidism, with a cure rate of 100%. Fixed doses of 370MBq (10mCi) and 555MBq (15mCi) produced incidences of hypothyroidism of 66.6% and 62.5% respectively within 6 months of RAI therapy which are not statistically different.

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To study the efficacy and safety of a specific first line antiretroviral (ART) regimen composed of tenofovir (TDF), lamivudine (3TC) and efavirenz (EFV), which was used until recently as the preferred first line treatment for adults in Brazil and is still amongst the recommended by the World Health Organization. Methods: In April, 2017, we conducted a systematic search of the literature in MEDLINE via Pubmed, Cochrane CENTRAL, EMBASE and Lilacs for cohorts that reported on toxicity or CD4 lymphocyte count or viral load among HIV-1 infected adults on first line ART. Only reports on naïve patients were considered. One arm of treatment must have consisted of TDF+3TC+EFV. Results: Our search yielded 441 abstracts, of which 36 registries were read in full, resulting in 5 papers that met all eligibility criterion. The cohorts included comprised 7275 patients mostly from African countries. The most frequent backbone comparators were zidovudine+lamivudine and stavudine+lamivudine, and as for 3º agents, nevirapine and ritonavir boosted lopinavir were most common. The average follow-up was 1 year from the start of treatment. The median age at treatment initiation was 43.6 years and the median CD4 count at baseline was 179.6 cells/mm3. Only one study disclosed effects on viral load, just as only another one reported on CD4 final count. Regarding toxicity, adverse events associated to efavirenz were reported in 4 of 5 studies, mainly associated to the central nervous system and rash. Zidovudine based regimens appear to be safer compared to tenofovir based treatment. ConClusions: Recently, the preferred first line regimen in Brazil traded the 3º agent efavirenz to dolutegravir, which appears to be wise, considering the adverse events associated to the former. Nonetheless, efavirenz is still widely used. It is difficult to study the efficacy and safety of one regimen specifically, however, it is of importance in order to optimize therapy.

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