Comparison of Publication of Pediatric Probiotic vs Antibiotic Trials Registered on ClinicalTrials.gov.

Importance: The published evidence in support of probiotic use is conflicting, which may be a result of selective publication of probiotic trials. Objectives: To compare the proportion of registered trials that evaluate pediatric probiotics vs those that evaluate antibiotics that are published and to identify study-related factors associated with publication status. Design, Setting, and Participants: This cross-sectional study evaluated eligible trials registered in ClinicalTrials.gov, an online clinical trials registry, from July 1, 2005, to June 30, 2016. Eligible studies included participants younger than 18 years, evaluated a probiotic or 1 of the 5 most commonly prescribed antibiotics in children and adolescents, and randomized study participants. All searches were updated and finalized as of September 9, 2020. Exposures: Probiotic or antibiotic. Main Outcomes and Measures: The primary outcome was study publication status. In addition, exposure status (probiotic vs antibiotic), trial result, and funding source were assessed for independent association with publication status. Whether study design elements, publication journal impact factor, and the interval from study completion to publication differed by exposure status were also evaluated. Results: A total of 401 unique trials (265 probiotic and 136 antibiotic) met eligibility criteria. A greater proportion of antibiotic compared with probiotic studies were published (83 [61.0%] vs 119 [44.9%]; difference, 16.1% [95% CI, 5.8%-25.9%]). After adjustment for funding source, blinding, and purpose, studies evaluating an antibiotic were more likely to be published (odds ratio, 2.1 [95% CI, 1.3-3.4]). No other covariates included in the model were independently associated with publication status. Antibiotic trials, compared with probiotic trials, were more likely to have a therapeutic purpose (114 [83.8%] vs 117 [44.2%]; difference, 39.6% [95% CI, 31.1%-48.3%]) and to be multicenter (46 [33.8%] vs 46 [17.4%]; difference, 16.5% [95% CI, 7.5%-25.7%]). The median impact factor of the journals in which the studies were published was higher for the antibiotic trials (7.2 [IQR, 2.8-20.5] vs 3.0 [IQR, 2.3-4.2]; P < .001). The median number of days to publication did not differ between the probiotic and antibiotic trials (683 [IQR, 441-1036] vs 801 [IQR, 550-1183]; P = .24). Conclusions and Relevance: The findings of this cross-sectional study suggest that probiotic studies are less likely to be published than antibiotic trials. No other study characteristics were associated with publication status. This finding raises concerns regarding the results of meta-analyses of probiotic trials.

Evaluation of intervention reporting in published emergency medicine clinical trials.

OBJECTIVE: The extent of intervention reporting in emergency medicine journals remains unclear. The primary objective is to assess overall completion of the Template for Intervention Description and Replication (TIDieR) checklist described in emergency medicine randomized clinical trials (RCTs). The secondary outcomes were to (1) compare reporting before and after TIDieR publication; (2) evaluate factors associated with intervention reporting. METHODS: Our cross-sectional study used Google Scholar's metrics to identify seven emergency medicine journals; of which, we randomly sampled 300 articles. Using two PubMed searches, we extracted 150 RCTs before and after publications of TIDieR. Two investigators independently extracted data. The primary analysis to measure overall completion included descriptive statistics for each checklist item. Our secondary analysis used an interrupted time series analysis and generalized estimating equations to determine the effect of TIDieR publication on intervention reporting. RESULTS: Our initial search yielded 635 articles; from which, we randomly sampled 300 articles. We excluded 67 articles, leaving 233 for analysis. The mean number of TIDieR items reported was 5.4 (standard deviation = 1.18). Of the 233 trials, 42.9% provided information about materials, 67% provided intervention procedures, and 99.1% provided intervention delivery. The least reported items were intervention modifications (2.6%), intervention adherence assessment methods (3.4%), and intervention adherence assessment outcomes (2.2%). CONCLUSIONS: The completeness of intervention reporting is suboptimal in emergency medicine journals, necessitating improvement. The current state of adherence could be improved through the combined efforts of journal editors, major editorial organizations, and authors.

El espacio de los editores: anuario de Anales de Pediatría / Editors' Corner: anales de Pediatria Annual Report

No disponible

Sugarscience.

Sugarscience was developed by health scientists from the University of California to provide an authoritative, evidence-based resource about sugar and its effects on health.

Communicating chemistry.

New web-based models of scholarly communication have made a significant impact in some scientific disciplines, but chemistry is not one of them. What has prevented the widespread adoption of these developments by chemists­and what are the prospects for adoption over time?