Although the infographic format was perceived as more enjoyable for reading, it was not better than a traditional, text-based PLS in the translation of knowledge about findings from a Cochrane systematic review.
ObjectiveDissemination of research findings is central to research integrity and promoting discussion of new knowledge and its potential for translation into practice and policy. We investigated the frequency and format of dissemination to trial participants and patient groups.DesignSurvey of authors of clinical trials indexed in PubMed in 2014–2015.ResultsQuestionnaire emailed to 19 321 authors; 3127 responses received (16%). Of these 3127 trials, 2690 had human participants and 1818 enrolled individual patients. Among the 1818, 498 authors (27%) reported having disseminated results to participants, 238 (13%) planned to do so, 600 (33%) did not plan to, 176 (10%) were unsure and 306 (17%) indicated ‘other’ or did not answer. Of the 498 authors who had disseminated, 198 (40%) shared academic reports, 252 (51%) shared lay reports, 111 (22%) shared both and 164 (33%) provided individualised study results. Of the 1818 trials, 577 authors (32%) shared/planned to share results with patients outside their trial by direct contact with charities/patient groups, 401 (22%) via patient communities, 845 (46%) via presentations at conferences with patient representation, 494 (27%) via mainstream media and 708 (39%) by online lay summaries. Relatively few of the 1818 authors reported dissemination was suggested by institutional bodies: 314 (17%) of funders reportedly suggested dissemination to trial participants, 252 (14%) to patient groups; 333 (18%) of ethical review boards reportedly suggested dissemination to trial participants, 148 (8%) to patient groups. Authors described many barriers to dissemination.ConclusionFewer than half the respondents had disseminated to participants (or planned to) and only half of those who had disseminated shared lay reports. Motivation to disseminate results to participants appears to arise within research teams rather than being incentivised by institutional bodies. Multiple factors need to be considered and various steps taken to facilitate wide dissemination of research to participants.
Background: Never before have clinical trials drawn as much public attention as those testing interventions for COVID-19. We aimed to describe the worldwide COVID-19 clinical research response and its evolution over the first 100 days of the pandemic. Methods: Descriptive analysis of planned, ongoing or completed trials by April 9, 2020 testing any intervention to treat or prevent COVID-19, systematically identified in trial registries, preprint servers, and literature databases. A survey was conducted of all trials to assess their recruitment status up to July 6, 2020. Results: Most of the 689 trials (overall target sample size 396,366) were small (median sample size 120; interquartile range [IQR] 60-300) but randomized (75.8%; n=522) and were often conducted in China (51.1%; n=352) or the USA (11%; n=76). 525 trials (76.2%) planned to include 155,571 hospitalized patients, and 25 (3.6%) planned to include 96,821 health-care workers. Treatments were evaluated in 607 trials (88.1%), frequently antivirals (n=144) or antimalarials (n=112); 78 trials (11.3%) focused on prevention, including 14 vaccine trials. No trial investigated social distancing. Interventions tested in 11 trials with >5,000 participants were also tested in 169 smaller trials (median sample size 273; IQR 90-700). Hydroxychloroquine alone was investigated in 110 trials. While 414 trials (60.0%) expected completion in 2020, only 35 trials (4.1%; 3,071 participants) were completed by July 6. Of 112 trials with detailed recruitment information, 55 had recruited <20% of the targeted sample; 27 between 20-50%; and 30 over 50% (median 14.8% [IQR 2.0-62.0%]). Conclusions: The size and speed of the COVID-19 clinical trials agenda is unprecedented. However, most trials were small investigating a small fraction of treatment options. The feasibility of this research agenda is questionable, and many trials may end in futility, wasting research resources. Much better coordination is needed to respond to global health threats.
with and without COVID-19, respectively, and the percentage of males was 66.5% and 54.9%, respectively. Ninety-two patients with COVID-19 and ARDS were propensity score matched to 92 patients with non-COVID-19 ARDS (Table). The etiologies for ARDS among the non-COVID-19-matched cohort were bacterial pneumonia (60%), aspiration (27%), influenza (7%), respiratory syncytial virus infection (2%), and Pneumocystis jiroveci pneumonia (2%). Patients with COVID-19 were more likely to develop gastrointestinal complications compared with those without COVID-19 (74% vs 37%; P < .001; incidence rate ratio, 2.33 [95% CI, 1.52-3.63]). The difference in incidence was more evident after the third day of critical illness (Figure). Specifically, patients with COVID-19 developed more transaminitis (55% vs 27%; P < .001), severe ileus (48% vs 22%; P < .001), and bowel ischemia (4% vs 0%; P = .04). Three of the 4 patients with COVID-19 and bowel ischemia were taken to the operating room and had intraoperative findings consistent with COVID-19 bowel as previously described in different patients. 3 Pathology findings demonstrated fibrin thrombi in the microvasculature underlying areas of necrosis. Discussion | This study found a higher rate of gastrointestinal complications, including mesenteric ischemia, in critically ill patients with COVID-19 compared with propensity scorematched patients without COVID-19, suggesting a distinct phenotype for COVID-19 compared with conventional ARDS. High expression of angiotensin-converting enzyme 2 receptors along the epithelial lining of the gut that act as host-cell receptors for SARS-CoV-2 could explain involvement of abdominal organs. 5 Higher opioid requirements and COVID-19-induced coagulopathy may also explain the disproportionately high rate of ileus and ischemic bowel disease. 2 Differences in duration of illness did not seem to explain the differences in gastrointestinal complications. Limitations of this study include the single center and the unavailability of inflammatory markers to use for matching. Further translational studies are warranted to examine the pathophysiology of these findings.
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