Press Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study.

IMPORTANCE: Results from high-profile randomized controlled trials (RCTs) are routinely reported through press release months prior to peer-reviewed publication. There are potential benefits to press releases (e.g., knowledge dissemination, ensuring regulatory compliance), but also potential drawbacks (e.g., selective reporting, positive "spin"). OBJECTIVE: To characterize the practice of press release predating the publication of a drug-related RCT in a peer-reviewed journal ("preemptive press release"), including factors associated with this practice. DESIGN, SETTING, AND PARTICIPANTS: We systematically reviewed all RCTs of medications published between 2015 and 2019 in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), and Lancet. Press releases were identified using a systematic search of the grey literature (e.g., press release databases, study sponsor websites). An RCT was considered to have a preemptive press release if the press release was published at least three months (90 days) prior to the date of publication in a peer-reviewed journal. MAIN OUTCOMES AND MEASURES: Presence of preemptive press release, defined as a press-release at least 90 days prior to the date of publication in a peer-reviewed journal. As secondary measures for dissemination, we also assessed citation count and Altmetric score. RESULTS: We identified 988 RCTs, of which 172 (17%) had a press release published at least 90 days before the date of peer-reviewed publication. Press releases were published a median of 246 days (interquartile range [IQR] 169-366 days) before publication in a peer-reviewed journal. In the multivariable logistic regression model, the strongest predictor of having a preemptive press release was funding by a pharmaceutical company (odds ratio 13, 95% CI 7, 25). Approximately 85% of RCTs with preemptive press releases had a positive primary outcome and, concordantly, 81% of the corresponding press releases had a positive headline. Multivariable regression models identified studies with a preemptive press release had a similar Altmetric score (median - 15, 95% CI - 33, 12) and higher median citation count (median 22 [95% CI 10 to 33] compared to studies without a preemptive press release. CONCLUSIONS AND RELEVANCE: Preemptive press releases were common, most often issued for trials funded by a pharmaceutical company, and typically preceded publication in a peer-reviewed journal by approximately eight months.

Impact of presentation at conference with timed release of academic publication.

Fast-tracking publication of original research to coincide with a conference presentation ("coordinated publication") is a mechanism of rapidly disseminating new data. How often this occurs, whether its frequency is changing, and the impact of this approach on information dissemination, is unknown. Our objective was to describe the characteristics of coordinated publications, how the practice has changed over time, and evaluate its potential impact on dissemination of study results. We conducted a cross-sectional study of randomized controlled trials published in NEJM, Lancet, and JAMA between January 1, 2015, and December 31, 2019. Among the 1533 included randomized controlled trials, 502 (33%) had coordinated publications. Coordinated publications increased from 30% [n = 94] in 2015 to 37% [n = 136] in 2019. Coordinated publications were more likely to be unblinded (61% [n = 305] vs. 52% [n = 532]) and more likely to be funded by industry (50% [n = 249] vs. 30% [n = 311]). The strongest predictor of a coordinated publication was cardiovascular disease subspecialty (OR = 3.96, 95% CI [2.95, 5.36]). The median number of citations (188 vs. 98) and the median Altmetric score (318 vs. 182) were higher for coordinated publications than non-coordinated publications. These differences persisted in a multivariable regression model. Coordinated publication is increasingly common. While coordinated publications may generate greater attention, they were observed to be more likely to be unblinded and more likely to be funded by industry, raising questions about the value and intentions of such promotion.

Potentially avoidable admissions to general internal medicine at an academic teaching hospital: an observational study.

BACKGROUND: Identifying potentially avoidable admissions to Canadian hospitals is an important health system goal. With general internal medicine (GIM) accounting for 40% of hospital admissions, we sought to develop a method to identify potentially avoidable admissions and characterize patient, provider and health system factors. METHODS: We conducted an observational study of GIM admissions at our institution from August 2019 to February 2020. We defined potentially avoidable admissions as admissions that could be managed in an appropriate and safe manner in the emergency department or ambulatory setting and asked staff physicians to screen admissions daily and flag candidates as potentially avoidable admissions. For each candidate, we prepared a case review and debriefed with members of the admitting team. We then reviewed each candidate with our research team, assigned an avoidability score (1 [low] to 4 [high]) and identified contributing factors for those with scores of 3 or more. RESULTS: We screened 601 total admissions and staff physicians flagged 117 (19.5%) of these as candidate potential avoidable admissions. Consensus review identified 67 candidates as potentially avoidable admissions (11.1%, 95% confidence interval 8.8%-13.9%); these patients were younger (mean age 65 yr v. 72 yr), had fewer comorbidities (Canadian Institute for Health Information Case Mix Group+ 0.42 v. 1.14), had lower resource-intensity weighting scores (0.72 v. 1.50) and shorter hospital lengths of stay (29 h v. 105 h) (p < 0.01). Common factors included diagnostic and therapeutic uncertainty, perceived need for short-term monitoring, government directive of a 4-hour limit for admission decision-making and subspecialist request to admit. INTERPRETATION: Our prospective method of screening, flagging and case review showed that 1 in 9 GIM admissions were potentially avoidable. Other institutions could consider adapting this methodology to ascertain their rate of potentially avoidable admissions and to understand contributing factors to inform improvement endeavours.

Chronic exposure of Brown (Hydra oligactis) and green Hydra (Hydra viridissima) to environmentally relevant concentrations of pharmaceuticals.

Low concentrations of pharmaceuticals in the environment (ng/L to µg/L) are an environmental concern. We used the invertebrates, Hydra oligactis and Hydra viridissima, as freshwater models for primary toxicity testing to study effects of chronic low concentrations of pharmaceuticals in the environment. H. oligactis were exposed to three concentrations (0.1, 1.0 and 10 µg/L) of either fluoxetine, carbamazepine, or triclosan; H. viridissima were exposed to three concentrations (0.1, 1.0 and 10 µg/L) of triclosan. Ecologically relevant endpoints including morphology, budding rate, feeding behaviour, and regenerative capacity were examined during the 14 days exposure period. The interstitial:epithelial stem cell ratios was also examined in H. oligactis. There were no significant effects on the morphology, budding rate and feeding behaviour of the H. oligactis across all concentrations of fluoxetine, carbamazepine, and triclosan. However, regenerative capacity significantly decreased in comparison to the controls when H. oligactis was exposed to 10 µg/L of triclosan and fluoxetine, although there was no significant difference when exposed to carbamazepine. Neither fluoxetine nor carbamazepine treatment altered stem cell ratios. Exposure to triclosan at any concentration did not impact H. viridissima morphology, budding rate, regeneration or feeding behaviour. These results show there are limited effects in Hydra after exposure to chronic, low concentrations of fluoxetine, carbamazepine, and triclosan, except for regeneration in H. oligactis. These endpoints can be used effectively (and cost effectively) to study the effects of environmentally relevant concentrations of pharmaceuticals in Hydra species.