Objectives: It has been shown that human clinical trials that lack randomization (RND) or blinding (BLD) often overestimate the magnitude of treatment effects. However, no studies have evaluated the effect of RND and BLD on animal research. The authors' objectives were to determine the proportion of animal studies presented at a national academic emergency medicine meeting that utilize randomization, blinding, or both; and to determine whether failure to employ these techniques changes the likelihood of observing a difference between treatment groups. Methods: Two trained researchers reviewed abstracts presented at the 1997-2001 Society for Academic Emergency Medicine (SAEM) annual meetings using a standard data collection sheet. Studies that used an animal or cell line, compared two or more study groups, and measured an effect caused by the intervention or drugs were included. Studies were classified as randomized (RNDþ) if any part of the experiment involved random assignment of subjects to treatment groups, blinded (BLDþ) if any assessment of the outcome was made by an investigator blinded to treatment group, and outcome-positive (Outcomeþ) if any difference between the study groups met the author's definition of significant. Following the initial review, differences in classification were resolved by consensus. The association between outcome and study methodology (RND, BLD or both) was measured using odds ratios (ORs) with 95% confidence intervals (95% CIs). Results: A total of 2,592 studies were published as abstracts. Three hundred eighty-nine were animal studies, and 290 of these studies had two or more study groups. RNDÿ and BLDÿ studies were more likely to be Outcomeþ than RNDþ or BLDþ studies (OR ¼ 3.4; 95% CI ¼ 1.7 to 6.9 and OR ¼ 3.2; 95% CI ¼ 1.3 to 7.7, respectively). When studies that used both RND and BND were compared with studies that used neither, the OR for a positive study was 5.2 (95% CI ¼ 2.0 to 13.5). Conclusions: These results suggest that animal studies that do not utilize RND and BLD are more likely to report a difference between study groups than studies that employ these methods.
The Toxicology Investigators Consortium (ToxIC) Core Registry was established by the American College of Medical Toxicology in 2010. The Core Registry collects data from participating sites with the agreement that all bedside and telehealth medical toxicology consultations will be entered. This twelfth annual report summarizes the registry’s 2021 data and activity with its additional 8552 cases. Cases were identified for inclusion in this report by a query of the ToxIC database for any case entered from January 1 to December 31, 2021. Detailed data was collected from these cases and aggregated to provide information, which included demographics, reason for medical toxicology evaluation, agent and agent class, clinical signs and symptoms, treatments and antidotes administered, mortality, and whether life support was withdrawn. Gender distribution included 50.4% of cases in females, 48.2% of cases in males, and 1.4% of cases in transgender or gender non-conforming individuals. Non-opioid analgesics were the most commonly reported agent class (14.9%), followed by opioids (13.1%). Acetaminophen was the most common agent reported. Fentanyl was the most common opioid reported and was responsible for the greatest number of fatalities. There were 120 fatalities, comprising 1.4% of all cases. Major trends in demographics and exposure characteristics remained similar to past years’ reports. Sub-analyses were conducted to describe new demographic characteristics, including marital status, housing status and military service, the continued COVID-19 pandemic and related toxicologic exposures, and novel substances of exposure.
Supplementary Information
The online version contains supplementary material available at 10.1007/s13181-022-00910-6.
This study demonstrated potential efficacy for the novel approach of supplying substrate for non-rhodanese mediated sulfur transferase pathways for CN detoxification via intramuscular injection in a moderate size animal model and showed that DOS was useful for optimizing the DMTS treatment.
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