Abstract:ObjectivesTo assess the effectiveness of prone positioning to reduce the risk of death or respiratory failure in non-critically ill patients hospitalized with COVID-19DesignPragmatic randomized clinical trial of prone positioning of patients hospitalized with COVID-19 across 15 hospitals in Canada and the United States from May 2020 until May 2021.SettingsPatients were eligible is they had a laboratory-confirmed or a clinically highly suspected diagnosis of COVID-19, required supplemental oxygen (up to 50% fra… Show more
“…We excluded 112 full-text articles; therefore, 29 studies were included in the study ( figure 1 ). We included ten RCTs 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 (NCT04853979) that included a total of 1985 patients, and 19 observational studies that included a total of 2669 patients (the reference list for observational studies [non-RCTs] is available in the appendix pp 6–7 ). Figure 1 Study flow diagram …”
Section: Resultsmentioning
confidence: 99%
“…Among the 29 included studies, the awake prone positioning procedures were variable, and the targeted daily proning duration varied between 1 h and 16 h, or as long as the patients could tolerate. Different types of initial respiratory support were used in the ten RCTs, of which seven studies 12 , 13 , 15 , 16 , 17 , 18 , 19 included patients with a lower level of respiratory support (ie, conventional oxygen therapy), two studies 11 , 14 used advanced respiratory support (ie, high-flow nasal cannula or NIV), and one study ( NCT04853979 ) applied all the types of respiratory support. Patients were exclusively in an ICU setting in two RCTs, 16 , 17 exclusively in a general ward setting in six RCTs 12 , 13 , 15 , 18 , 19 ( NCT04853979 ), and in both settings in two RCTs.…”
Section: Resultsmentioning
confidence: 99%
“…Different types of initial respiratory support were used in the ten RCTs, of which seven studies 12 , 13 , 15 , 16 , 17 , 18 , 19 included patients with a lower level of respiratory support (ie, conventional oxygen therapy), two studies 11 , 14 used advanced respiratory support (ie, high-flow nasal cannula or NIV), and one study ( NCT04853979 ) applied all the types of respiratory support. Patients were exclusively in an ICU setting in two RCTs, 16 , 17 exclusively in a general ward setting in six RCTs 12 , 13 , 15 , 18 , 19 ( NCT04853979 ), and in both settings in two RCTs. 11 , 14 Further demographic details of each RCT are shown in the table and in the appendix for observational studies ( appendix pp 8–11 ).…”
Section: Resultsmentioning
confidence: 99%
“…The primary outcome was the cumulative intubation risk across RCTs; the measure of effect was risk ratio (RR; 95% CI). Secondary outcomes included the reported all-cause mortality; the need for escalating respiratory support, which was defined as progression to a higher level of oxygen or respiratory support (room air<conventional oxygen therapy<high-flow nasal cannula<non-invasive ventilation [NIV]<invasive ventilation) according to the included studies; 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 the duration of ICU and hospital stay; and safety outcomes, including cardiac arrest, vomiting, and central or arterial line dislodgement. We also performed a post-hoc analysis on ICU admission among patients who were not admitted to the ICU at enrolment and added it as a secondary outcome.…”
Section: Methodsmentioning
confidence: 99%
“…10 In August, 2021, an international randomised controlled meta-trial with more than 1100 patients found that awake prone positioning significantly reduced intubation need and treatment failure for patients with COVID-19-related acute hypoxaemic respiratory failure requiring support with high-flow nasal cannula. 11 However, before this publication, six randomised controlled trials (RCTs) with a smaller sample size than the meta-trial, 12 , 13 , 14 , 15 , 16 , 17 and two completed but unpublished multi-centre RCTs that enrolled 248 patients 18 and 293 patients, 19 respectively, did not find that awake prone positioning reduced the intubation need for patients with COVID-19; and, three RCTs 12 , 13 , 18 found that patients' adherence to awake prone positioning was low. In the two most recent meta-analyses that included RCTs, 20 , 21 Fazzini and colleagues included two RCTs 11 , 14 and 12 observational studies, and they reported uncertainty regarding the effects of awake prone positioning on intubation and survival, 20 whereas Beran and colleagues included five RCTs 11 , 12 , 13 , 14 , 16 and nine observational studies, and they reported that awake prone positioning has a benefit on mortality.…”
“…We excluded 112 full-text articles; therefore, 29 studies were included in the study ( figure 1 ). We included ten RCTs 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 (NCT04853979) that included a total of 1985 patients, and 19 observational studies that included a total of 2669 patients (the reference list for observational studies [non-RCTs] is available in the appendix pp 6–7 ). Figure 1 Study flow diagram …”
Section: Resultsmentioning
confidence: 99%
“…Among the 29 included studies, the awake prone positioning procedures were variable, and the targeted daily proning duration varied between 1 h and 16 h, or as long as the patients could tolerate. Different types of initial respiratory support were used in the ten RCTs, of which seven studies 12 , 13 , 15 , 16 , 17 , 18 , 19 included patients with a lower level of respiratory support (ie, conventional oxygen therapy), two studies 11 , 14 used advanced respiratory support (ie, high-flow nasal cannula or NIV), and one study ( NCT04853979 ) applied all the types of respiratory support. Patients were exclusively in an ICU setting in two RCTs, 16 , 17 exclusively in a general ward setting in six RCTs 12 , 13 , 15 , 18 , 19 ( NCT04853979 ), and in both settings in two RCTs.…”
Section: Resultsmentioning
confidence: 99%
“…Different types of initial respiratory support were used in the ten RCTs, of which seven studies 12 , 13 , 15 , 16 , 17 , 18 , 19 included patients with a lower level of respiratory support (ie, conventional oxygen therapy), two studies 11 , 14 used advanced respiratory support (ie, high-flow nasal cannula or NIV), and one study ( NCT04853979 ) applied all the types of respiratory support. Patients were exclusively in an ICU setting in two RCTs, 16 , 17 exclusively in a general ward setting in six RCTs 12 , 13 , 15 , 18 , 19 ( NCT04853979 ), and in both settings in two RCTs. 11 , 14 Further demographic details of each RCT are shown in the table and in the appendix for observational studies ( appendix pp 8–11 ).…”
Section: Resultsmentioning
confidence: 99%
“…The primary outcome was the cumulative intubation risk across RCTs; the measure of effect was risk ratio (RR; 95% CI). Secondary outcomes included the reported all-cause mortality; the need for escalating respiratory support, which was defined as progression to a higher level of oxygen or respiratory support (room air<conventional oxygen therapy<high-flow nasal cannula<non-invasive ventilation [NIV]<invasive ventilation) according to the included studies; 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 the duration of ICU and hospital stay; and safety outcomes, including cardiac arrest, vomiting, and central or arterial line dislodgement. We also performed a post-hoc analysis on ICU admission among patients who were not admitted to the ICU at enrolment and added it as a secondary outcome.…”
Section: Methodsmentioning
confidence: 99%
“…10 In August, 2021, an international randomised controlled meta-trial with more than 1100 patients found that awake prone positioning significantly reduced intubation need and treatment failure for patients with COVID-19-related acute hypoxaemic respiratory failure requiring support with high-flow nasal cannula. 11 However, before this publication, six randomised controlled trials (RCTs) with a smaller sample size than the meta-trial, 12 , 13 , 14 , 15 , 16 , 17 and two completed but unpublished multi-centre RCTs that enrolled 248 patients 18 and 293 patients, 19 respectively, did not find that awake prone positioning reduced the intubation need for patients with COVID-19; and, three RCTs 12 , 13 , 18 found that patients' adherence to awake prone positioning was low. In the two most recent meta-analyses that included RCTs, 20 , 21 Fazzini and colleagues included two RCTs 11 , 14 and 12 observational studies, and they reported uncertainty regarding the effects of awake prone positioning on intubation and survival, 20 whereas Beran and colleagues included five RCTs 11 , 12 , 13 , 14 , 16 and nine observational studies, and they reported that awake prone positioning has a benefit on mortality.…”
ImportanceRandomized clinical trials (RCTs) on COVID-19 are increasingly being posted as preprints before publication in a scientific, peer-reviewed journal.ObjectiveTo assess time to journal publication for COVID-19 RCT preprints and to compare differences between pairs of preprints and corresponding journal articles.Evidence ReviewThis systematic review used a meta-epidemiologic approach to conduct a literature search using the World Health Organization COVID-19 database and Embase to identify preprints published between January 1 and December 31, 2021. This review included RCTs with human participants and research questions regarding the treatment or prevention of COVID-19. For each preprint, a literature search was done to locate the corresponding journal article. Two independent reviewers read the full text, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. Time to publication was analyzed using a Cox proportional hazards regression model. Differences between preprint and journal article pairs in terms of outcomes, analyses, results, or conclusions were described. Statistical analysis was performed on October 17, 2022.FindingsThis study included 152 preprints. As of October 1, 2022, 119 of 152 preprints (78.3%) had been published in journals. The median time to publication was 186 days (range, 17-407 days). In a multivariable model, larger sample size and low risk of bias were associated with journal publication. With a sample size of less than 200 as the reference, sample sizes of 201 to 1000 and greater than 1000 had hazard ratios (HRs) of 1.23 (95% CI, 0.80-1.91) and 2.19 (95% CI, 1.36-3.53) for publication, respectively. With high risk of bias as the reference, medium-risk articles with some concerns for bias had an HR of 1.77 (95% CI, 1.02-3.09); those with a low risk of bias had an HR of 3.01 (95% CI, 1.71-5.30). Of the 119 published preprints, there were differences in terms of outcomes, analyses, results, or conclusions in 65 studies (54.6%). The main conclusion in the preprint contradicted the conclusion in the journal article for 2 studies (1.7%).Conclusions and RelevanceThese findings suggest that there is a substantial time lag from preprint posting to journal publication. Preprints with smaller sample sizes and high risk of bias were less likely to be published. Finally, although differences in terms of outcomes, analyses, results, or conclusions were observed for preprint and journal article pairs in most studies, the main conclusion remained consistent for the majority of studies.
ImportanceDiabetes has been reported to be associated with an increased risk of death among patients with COVID-19. However, available studies lack detail on COVID illness severity and measurement of relevant comorbidities.Design, Setting, and ParticipantsWe conducted a multicenter, retrospective cohort study of patients over the age of 18 years who were hospitalized with COVID-19 between January 1, 2020 and November 30, 2020 in Ontario, Canada and Copenhagen, Denmark. Chart abstraction emphasizing co-morbidities and disease severity was performed by trained research personnel. The association between diabetes and death was measured using Poissson regression.Main Outcomes and Measureswithin hospital 30-day risk of death.ResultsOur study included 1018 hospitalized patients with COVID-19 in Ontario and 305 in Denmark, of whom 405 and 75 patients respectively had pre-existing diabetes. In both Ontario and Denmark, patients with diabetes were more likely to be older, have chronic kidney disease, cardiovascular disease, higher troponin levels, and to receive antibiotics compared with adults who did not have diabetes. In Ontario, the crude mortality rate ratio among patients with diabetes was 1.60 [1.24 – 2.07 95% CI] and in the adjusted regression model was 1.19 [0.86 – 1.66 95% CI]. In Denmark, the crude mortality rate ratio among patients with diabetes was 1.27 (0.68 – 2.36 95% CI) and in the adjusted model was 0.87 (0.49 – 1.54 95% CI)]. Meta-analyzing the two rate ratios from each region resulted in a crude mortality rate ratio of 1.55 (95% CI 1.22,1.96) and an adjusted mortality rate ratio of 1.11 (95% CI 0.84, 1.47).ConclusionsPresence of diabetes was not strongly associated with in-hospital COVID mortality independent of illness severity and other comorbidities.
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