scholarly journals Antithrombotic Therapy in COVID-19: Systematic Summary of Ongoing or Completed Randomized Trials

2021 ◽  
Author(s):  
Azita H. Talasaz ◽  
Parham Sadeghipour ◽  
Hessam Kakavand ◽  
Maryam Aghakouchakzadeh ◽  
Elaheh Kordzadeh-Kermani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Antithrombotic Therapy ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Antithrombotic Agents ◽  
Randomized Controlled ◽  
Data Gaps ◽  
Medical Wards

ABSTRACTEndothelial injury and microvascular/macrovascular thrombosis are common pathophysiologic features of coronavirus disease-2019 (COVID-19). However, the optimal thromboprophylactic regimens remain unknown across the spectrum of illness severity of COVID-19. A variety of antithrombotic agents, doses and durations of therapy are being assessed in ongoing randomized controlled trials (RCTs) that focus on outpatients, hospitalized patients in medical wards, and critically-ill patients with COVID-19. This manuscript provides a perspective of the ongoing or completed RCTs related to antithrombotic strategies used in COVID-19, the opportunities and challenges for the clinical trial enterprise, and areas of existing knowledge, as well as data gaps that may motivate the design of future RCTs.

scholarly journals Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiao-Li Chen ◽  
Bei-Lei Zhang ◽  
Chang Meng ◽  
Hui-Bin Huang ◽  
Bin Du
Keyword(s):  
Sensitivity Analysis ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Oxygen Therapy ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Icu Patients ◽  
Randomized Controlled

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.

scholarly journals High-cited favorable studies for COVID-19 treatments ineffective in large trials

2022 ◽  
Author(s):  
John P.A. Ioannidis
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Clinical Studies ◽  
Observational Studies ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Wide Dissemination ◽  
Highly Cited Articles ◽  
Highly Cited

Importance. COVID-19 has resulted in massive production, publication and wide dissemination of clinical studies trying to identify effective treatments. However, several widely touted treatments failed to show effectiveness in large well-done randomized controlled trials (RCTs). Objective. To evaluate for COVID-19 treatments that showed no benefits in subsequent large RCTs how many of their most-cited clinical studies had declared favorable results for these interventions. Methods. Scopus (last update December 23, 2021) identified articles on lopinavir-ritonavir, hydroxycholoroquine/azithromycin, remdesivir, convalescent plasma, colchicine or interferon (index interventions) that represented clinical trials and that had received >150 citations. Their conclusions were assessed and correlated with study design features. The ten most recent citations for the most-cited article on each index intervention were examined on whether they were critical to the highly-cited study. Altmetric scores were also obtained. Findings. 40 articles of clinical studies on these index interventions had received >150 citations (7 exceeded 1,000 citations). 20/40 (50%) had favorable conclusions and 4 were equivocal. Highly-cited articles with favorable conclusions were rarely RCTs while those without favorable conclusions were mostly RCTs (3/20 vs 15/20, p=0.0003). Only 1 RCT with favorable conclusions had sample size >160. Citation counts correlated strongly with Altmetric scores, in particular news items. Only 9 (15%) of 60 recent citations to the most highly-cited studies with favorable or equivocal conclusions were critical to the highly-cited study. Conclusion. Many clinical studies with favorable conclusions for largely ineffective COVID-19 treatments are uncritically heavily cited and disseminated. Early observational studies and small randomized trials may cause spurious claims of effectiveness that get perpetuated.

Randomized controlled trials

2020 ◽  
pp. 187-218
Author(s):  
Sube Banerjee ◽  
Rod S. Taylor ◽  
Jennifer Hellier
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trials ◽  
Complex Interventions ◽  
Controlled Trials ◽  
Key Factors ◽  
Randomized Controlled ◽  
Study Population ◽  
Primary Hypothesis ◽  
Definition Of

This chapter on randomized controlled trials (RCTs) considers some of the key factors in the design, conduct, analysis, and interpretation of RCTs. The chapter provides an overview of what constitutes an RCT and why they are needed. The chapter also provides an overview of the major practical elements of the design and conduct of RCTs, including undertaking a background review of literature, the need for formulation of a clear primary hypothesis and objective, selection and definition of the study population, collecting outcomes at baseline and follow-up, and appropriate methods of statistical analysis and inference. The chapter concludes with a consideration of the need for clinical trial units, complex interventions, and alternative RCT designs.

Rotational Bed Therapy to Prevent and Treat Respiratory Complications: A Review and Meta-Analysis

2007 ◽  
Vol 16 (1) ◽  
pp. 50-61 ◽  
Author(s):  
David R. Goldhill ◽  
Michael Imhoff ◽  
Barbara McLean ◽  
Carl Waldmann
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Controlled Trials ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Meta Analysis ◽  
Convincing Evidence ◽  
Controlled Trials ◽  
Respiratory Complications ◽  
Randomized Controlled ◽  
Meta Analyses

• Background Immobility is associated with complications involving many body systems. • Objective To review the effect of rotational therapy (use of therapeutic surfaces that turn on their longitudinal axes) on prevention and/or treatment of respiratory complications in critically ill patients. • Methods Published articles evaluating prophylaxis and/or treatment were reviewed. Prospective randomized controlled trials were assessed for quality and included in meta-analyses. • Results A literature search yielded 15 nonrandomized, uncontrolled, or retrospective studies. Twenty prospective randomized controlled trials on rotational therapy were published between 1987 and 2004. Various types of beds were studied, but few details on the rotational parameters were reported. The usual control was manual turning of patients by nurses every 2 hours. One animal investigation and 12 clinical trials addressed the effectiveness of rotational therapy in preventing respiratory complications. Significant benefits were reported in the animal study and 4 of the trials. Significant benefits to patients were reported in 2 of another 4 studies focused on treatment of established complications. Researchers have examined the effects of rotational therapy on mucus transport, intrapulmonary shunt, hemodynamic effects, urine output, and intracranial pressure. Little convincing evidence is available, however, on the most effective rotation parameters (eg, degree, pause time, and amount of time per day). Meta-analysis suggests that rotational therapy decreases the incidence of pneumonia but has no effect on duration of mechanical ventilation, number of days in intensive care, or hospital mortality. • Conclusions Rotational therapy may be useful for preventing and treating respiratory complications in selected critically ill patients receiving mechanical ventilation.

scholarly journals The effect of glutamine therapy on outcomes in critically ill patients: a meta-analysis of randomized controlled trials

Critical Care ◽  
2014 ◽  
Vol 18 (1) ◽  
pp. R8 ◽  
Author(s):  
Qi-Hong Chen ◽  
Yi Yang ◽  
Hong-Li He ◽  
Jian-Feng Xie ◽  
Shi-Xia Cai ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled
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