Author
Cecilie Bauer Derby
Bio: Cecilie Bauer Derby is an academic researcher. The author has contributed to research in topics: Placebo & Randomized controlled trial. The author has an hindex of 1, co-authored 2 publications receiving 8 citations.
Papers
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University of Copenhagen1, Copenhagen University Hospital2, Aalborg University3, Aarhus University Hospital4, Odense University Hospital5, Karolinska Institutet6, University of Bern7, University of New South Wales8, The George Institute for Global Health9, Manipal University10, Imperial College London11, Homi Bhabha National Institute12, Aarhus University13, University of Southern Denmark14
TL;DR: The COVID STEROID trial as discussed by the authors evaluated the effects of low-dose hydrocortisone on patient-centred outcomes in adults with COVID-19 and severe hypoxia.
Abstract: Background In the early phase of the pandemic, some guidelines recommended the use of corticosteroids for critically ill patients with COVID-19, whereas others recommended against the use despite lack of firm evidence of either benefit or harm. In the COVID STEROID trial, we aimed to assess the effects of low-dose hydrocortisone on patient-centred outcomes in adults with COVID-19 and severe hypoxia. Methods In this multicentre, parallel-group, placebo-controlled, blinded, centrally randomised, stratified clinical trial, we randomly assigned adults with confirmed COVID-19 and severe hypoxia (use of mechanical ventilation or supplementary oxygen with a flow of at least 10 L/min) to either hydrocortisone (200 mg/d) vs a matching placebo for 7 days or until hospital discharge. The primary outcome was the number of days alive without life support at day 28 after randomisation. Results The trial was terminated early when 30 out of 1000 participants had been enrolled because of external evidence indicating benefit from corticosteroids in severe COVID-19. At day 28, the median number of days alive without life support in the hydrocortisone vs placebo group were 7 vs 10 (adjusted mean difference: -1.1 days, 95% CI -9.5 to 7.3, P = .79); mortality was 6/16 vs 2/14; and the number of serious adverse reactions 1/16 vs 0/14. Conclusions In this trial of adults with COVID-19 and severe hypoxia, we were unable to provide precise estimates of the benefits and harms of hydrocortisone as compared with placebo as only 3% of the planned sample size were enrolled. Trial registration ClinicalTrials.gov: NCT04348305. European Union Drug Regulation Authorities Clinical Trials (EudraCT) Database: 2020-001395-15.
29 citations
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TL;DR: In this article, the authors performed a systematic review to assess benefits and harms of adding glucocorticoids to paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) for postoperative analgesia.
Abstract: BACKGROUND: Multimodal analgesia is the leading principle for managing postoperative pain. Recent guidelines recommend combinations of paracetamol and a non-steroidal anti-inflammatory drug (NSAID) for most surgeries. Glucocorticoids have been used for decades due to their potent anti-inflammatory and antipyretic properties. Subsequently, glucocorticoids may improve postoperative analgesia. We will perform a systematic review to assess benefits and harms of adding glucocorticoids to paracetamol and NSAIDs. We expect to uncover pros and cons of the addition of glucocorticoid to the basic standard regimen of paracetamol and NSAIDs for postoperative analgesia. METHOD: This protocol for a systematic review was written according to the The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search for trials in the following electronic databases: Medline, CENTRAL, CDSR and Embase. Two authors will independently screen trials for inclusion using Covidence, extract data and assess risk of bias using Cochrane's ROB 2 tool. We will analyse data using Review Manager and Trial Sequential Analysis. Meta-analysis will be performed according to the Cochrane guidelines and results will be validated according to the eight-step procedure suggested by Jakobsen et al We will present our primary findings in a 'summary of findings' table. We will evaluate the overall certainty of evidence using the GRADE approach. DISCUSSION: This review will aim to explore the combination of glucocorticoids together with paracetamol and NSAIDs for postoperative pain. We will attempt to provide reliable evidence regarding the role of glucocorticoids as part of a multimodal analgesic regimen in combination with paracetamol and NSAID.
3 citations
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TL;DR: This article assessed the benefit and harm of adding glucocorticoids to a combination of paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) for post-operative pain management.
Abstract: Paracetamol and non‐steroidal anti‐inflammatory drugs (NSAIDs) are recommended as the basic pain treatment regimen for most surgeries. Glucocorticoids have well‐known anti‐inflammatory and anti‐emetic properties and may also demonstrate analgesic effects. We assessed benefit and harm of adding glucocorticoids to a combination of paracetamol and NSAIDs for post‐operative pain management.
Cited by
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Copenhagen University Hospital1, Homi Bhabha National Institute2, Apollo Hospitals3, Karolinska Institutet4, Aalborg University5, University of Bern6, Rajendra Institute of Medical Sciences7, Odense University Hospital8, Linköping University9, Bombay Hospital, Indore10, Apollo Hospital, Indraprastha11, Frederiksberg Hospital12, Sir H.N. Reliance Foundation Hospital and Research Centre13, Royal North Shore Hospital14, The George Institute for Global Health15, Academy of Medical Sciences, United Kingdom16, University of Southern Denmark17, University of Copenhagen18
TL;DR: In this article, the effects of 12 mg vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia were evaluated in a randomized clinical trial at 26 hospitals in Europe and India.
Abstract: Importance: A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective: To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions: Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days). Results: Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). Conclusions and Relevance: Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.
119 citations
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University of Bologna1, Başkent University2, University of Belgrade3, Koç University4, Medical University of Graz5, Ciba Specialty Chemicals6, Royal College of Physicians of Ireland7, University of Verona8, Semmelweis University9, National and Kapodistrian University of Athens10, Radboud University Nijmegen11, University of Seville12
TL;DR: The ESCMID COVID-19 guidelines task force was established by the ESCMIDs Executive Committee in 2019 and a small group was established, half appointed by the chair, and the remaining selected with an open call as discussed by the authors.
74 citations
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TL;DR: The ESCMID COVID-19 guidelines task force was established by the ESCMIDS Executive Committee as mentioned in this paper , and a small group was established, half appointed by the chair, and the remaining selected with an open call.
74 citations
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Copenhagen University Hospital1, Homi Bhabha National Institute2, The George Institute for Global Health3, Apollo Hospitals4, Karolinska Institutet5, University of Bern6, University of Copenhagen7, Royal North Shore Hospital8, University of New South Wales9, Manipal University10, Imperial College London11, Aalborg University12, University of Southern Denmark13, Odense University Hospital14, Rajendra Institute of Medical Sciences15, Apollo Hospital, Indraprastha16, Bombay Hospital, Indore17, Linköping University18, Bispebjerg Hospital19
TL;DR: In this article, the authors compared dexamethasone 12 versus 6mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial.
Abstract: We compared dexamethasone 12 versus 6 mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial. In the primary, conventional analyses, the predefined statistical significance thresholds were not reached. We conducted a pre-planned Bayesian analysis to facilitate probabilistic interpretation. We analysed outcome data within 90 days in the intention-to-treat population (data available in 967 to 982 patients) using Bayesian models with various sensitivity analyses. Results are presented as median posterior probabilities with 95% credible intervals (CrIs) and probabilities of different effect sizes with 12 mg dexamethasone. The adjusted mean difference on days alive without life support at day 28 (primary outcome) was 1.3 days (95% CrI −0.3 to 2.9; 94.2% probability of benefit). Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90. Probabilities of benefit on days alive without life support and days alive out of hospital at day 90 were 85 and 95.7%, respectively. Results were largely consistent across sensitivity analyses, with relatively low probabilities of clinically important harm with 12 mg on all outcomes in all analyses. We found high probabilities of benefit and low probabilities of clinically important harm with dexamethasone 12 mg versus 6 mg daily in patients with COVID-19 and severe hypoxaemia on all outcomes up to 90 days.
51 citations
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TL;DR: Paracetamol has been assessed in different conditions and demonstrated therapeutic efficacy on both acute and chronic pain this article, however, a lack of significant efficacy and hepatic toxicity have also been reported.
Abstract: Musculoskeletal pain conditions are age-related, leading contributors to chronic pain and pain-related disability, which are expected to rise with the rapid global population aging. Current medical treatments provide only partial relief. Furthermore, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids are effective in young and otherwise healthy individuals but are often contraindicated in elderly and frail patients. As a result of its favorable safety and tolerability record, paracetamol has long been the most common drug for treating pain. Strikingly, recent reports questioned its therapeutic value and safety. This review aims to present guideline recommendations. Paracetamol has been assessed in different conditions and demonstrated therapeutic efficacy on both acute and chronic pain. It is active as a single agent and is additive or synergistic with NSAIDs and opioids, improving their efficacy and safety. However, a lack of significant efficacy and hepatic toxicity have also been reported. Fast dissolving formulations of paracetamol provide superior and more extended pain relief that is similar to intravenous paracetamol. A dose reduction is recommended in patients with liver disease or malnourished. Genotyping may improve efficacy and safety. Within the current trend toward the minimization of opioid analgesia, it is consistently included in multimodal, non-opioid, or opioid-sparing therapies. Paracetamol is being recommended by guidelines as a first or second-line drug for acute pain and chronic pain, especially for patients with limited therapeutic options and for the elderly.
40 citations