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101. Health-related quality of life in survivors of septic shock:6-month follow-up from the ADRENAL trial

Author

Hammond, Naomi E., Finfer, Simon R., Li, Qiang, Taylor, Colman, Cohen, Jeremy, Arabi, Yaseen, Bellomo, Rinaldo, Billot, Laurent, Harward, Meg, Joyce, Christopher, McArthur, Colin, Myburgh, John, Perner, Anders, Rajbhandari, Dorrilyn, Rhodes, Andrew, Thompson, Kelly, Webb, Steve, Venkatesh, Balasubramanian, Cowdrey, Keri Anne, Gilder, Eileen, Long, Stephanie, McCarthy, Lianne, McGuinness, Shay, Parke, Rachael, Benefield, Kristen, Chen, Yan, McConnochie, Rachael, Newby, Lynette, Eastwood, Glenn, Jones, Daryl, Peck, Leah, Young, Helen, Boschert, Catherine, Edington, John, Fletcher, Jason, Smith, Julie, Ghelani, Dhaval, Nand, Kiran, Reece, Graham, Sara, Treena, Bewley, Jeremy, Cole, Libby, Kjær, Maj Brit Nørregaard, Madsen, Martin Bruun, Møller, Morten Hylander, Müller, Rasmus, Nielsen, Jonas, Quist, Lars, Thorsen-Meyer, Hans Christian, White, Jonathan, Hammond, Naomi E., Finfer, Simon R., Li, Qiang, Taylor, Colman, Cohen, Jeremy, Arabi, Yaseen, Bellomo, Rinaldo, Billot, Laurent, Harward, Meg, Joyce, Christopher, McArthur, Colin, Myburgh, John, Perner, Anders, Rajbhandari, Dorrilyn, Rhodes, Andrew, Thompson, Kelly, Webb, Steve, Venkatesh, Balasubramanian, Cowdrey, Keri Anne, Gilder, Eileen, Long, Stephanie, McCarthy, Lianne, McGuinness, Shay, Parke, Rachael, Benefield, Kristen, Chen, Yan, McConnochie, Rachael, Newby, Lynette, Eastwood, Glenn, Jones, Daryl, Peck, Leah, Young, Helen, Boschert, Catherine, Edington, John, Fletcher, Jason, Smith, Julie, Ghelani, Dhaval, Nand, Kiran, Reece, Graham, Sara, Treena, Bewley, Jeremy, Cole, Libby, Kjær, Maj Brit Nørregaard, Madsen, Martin Bruun, Møller, Morten Hylander, Müller, Rasmus, Nielsen, Jonas, Quist, Lars, Thorsen-Meyer, Hans Christian, and White, Jonathan

Abstract

Purpose: To investigate the impact of hydrocortisone treatment and illness severity on health-related quality of life (HRQoL) at 6 months in septic shock survivors from the ADRENAL trial. Methods: Using the EuroQol questionnaire (EQ-5D-5L) at 6 months after randomization we assessed HRQoL in patient subgroups defined by hydrocortisone or placebo treatment, gender, illness severity (APACHE II < or ≥ 25), and severity of shock (baseline peak catecholamine doses < or ≥ 15 mcg/min). Additionally, in subgroups defined by post-randomisation variables; time to shock reversal (days), treatment with renal replacement therapy (RRT), and presence of bacteremia. Results: At 6 months, there were 2521 survivors. Of these 2151 patients (85.3%-1080 hydrocortisone and 1071 placebo) completed 6-month follow-up. Overall, at 6 months the mean EQ-5D-5L visual analogue scale (VAS) was 70.8, mean utility score 59.4. Between 15% and 30% of patients reported moderate to severe problems in any given HRQoL domain. There were no differences in any EQ-5D-5L domain in patients who received hydrocortisone vs. placebo, nor in the mean VAS (p = 0.6161), or mean utility score (p = 0.7611). In all patients combined, males experienced lower pain levels compared to females [p = 0.0002). Neither higher severity of illness or shock impacted reported HRQoL. In post-randomisation subgroups, longer time to shock reversal was associated with increased problems with mobility (p = < 0.0001]; self-care (p = 0.0.0142), usual activities (p = <0.0001] and pain (p = 0.0384). Amongst those treated with RRT, more patients reported increased problems with mobility (p = 0.0307) and usual activities (p = 0.0048) compared to those not treated. Bacteraemia was not associated with worse HRQoL in any domains of the EQ-5D-5L. Conclusions: Approximately one fifth of septic shock survivors report moderate to extreme problems in HRQoL domains at 6 months. Hydrocortisone treatment for septic shock was not associat

Published
2020

104. An international comparison of the cost of fluid resuscitation therapies

Author

Taylor, Colman, primary, Yang, Li, additional, Finfer, Simon, additional, Machado, Flavia R., additional, YouZhong, An, additional, Billot, Laurent, additional, Bloos, Frank, additional, Bozza, Fernando, additional, Cavalcanti, Alexandre Biasi, additional, Correa, Maryam, additional, Du, Bin, additional, Hjortrup, Peter B., additional, McIntyre, Lauralyn, additional, Saxena, Manoj, additional, Schortgen, Frédérique, additional, Watts, Nicola R., additional, Myburgh, John, additional, Thompson, Kelly, additional, and Hammond, Naomi E., additional

Published
2021
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105. Plasma Cortisol, Aldosterone, and Ascorbic Acid Concentrations in Patients with Septic Shock Do Not Predict Treatment Effect of Hydrocortisone on Mortality. A Nested Cohort Study

Author

Cohen, Jeremy, primary, Bellomo, Rinaldo, additional, Billot, Laurent, additional, Burrell, Louise M., additional, Evans, David M., additional, Finfer, Simon, additional, Hammond, Naomi E., additional, Li, Qiang, additional, Liu, David, additional, McArthur, Colin, additional, McWhinney, Brett, additional, Moore, John, additional, Myburgh, John, additional, Peake, Sandra, additional, Pretorius, Carel, additional, Rajbhandari, Dorrilyn, additional, Rhodes, Andrew, additional, Saxena, Manoj, additional, Ungerer, Jacobus P. J., additional, Young, Morag J., additional, and Venkatesh, Balasubramanian, additional

Published
2020
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108. Procalcitonin for diagnosis of bacterial pneumonia in critically ill patients during 2009 H1N1 influenza pandemic: a prospective cohort study, systematic review and individual patient data meta-analysis

Author

Pfister, Roman, Kochanek, Matthias, Leygeber, Timo, Brun-Buisson, Christian, Cuquemelle, Elise, Paiva Machado, Mariana Benevides, Piacentini, Enrique, Hammond, Naomi E., Ingram, Paul R., Michels, Guido, Pfister, Roman, Kochanek, Matthias, Leygeber, Timo, Brun-Buisson, Christian, Cuquemelle, Elise, Paiva Machado, Mariana Benevides, Piacentini, Enrique, Hammond, Naomi E., Ingram, Paul R., and Michels, Guido

Abstract

Introduction: Procalcitonin (PCT) is helpful for diagnosing bacterial infections. The diagnostic utility of PCT has not been examined thoroughly in critically ill patients with suspected H1N1 influenza. Methods: Clinical characteristics and PCT were prospectively assessed in 46 patients with pneumonia admitted to medical ICUs during the 2009 and 2010 influenza seasons. An individual patient data meta-analysis was performed by combining our data with data from five other studies on the diagnostic utility of PCT in ICU patients with suspected 2009 pandemic influenza A(H1N1) virus infection identified by performing a systematic literature search. Results: PCT levels, measured within 24 hours of ICU admission, were significantly elevated in patients with bacterial pneumonia (isolated or coinfection with H1N1; n = 77) (median = 6.2 g/L, interquartile range (IQR) = 0.9 to 20) than in patients with isolated H1N1 influenza pneumonia (n = 84; median = 0.56 g/L, IQR = 0.18 to 3.33). The area under the curve of the receiver operating characteristic curve of PCT was 0.72 (95% confidence interval (CI) = 0.64 to 0.80; P < 0.0001) for diagnosis of bacterial pneumonia, but increased to 0.76 (95% CI = 0.68 to 0.85; P < 0.0001) when patients with hospital-acquired pneumonia and immune-compromising disorders were excluded. PCT at a cut-off of 0.5 g/L had a sensitivity (95% CI) and a negative predictive value of 80.5% (69.9 to 88.7) and 73.2% (59.7 to 84.2) for diagnosis of bacterial pneumonia, respectively, which increased to 85.5% (73.3 to 93.5) and 82.2% (68.0 to 92.0) in patients without hospital acquired pneumonia or immune-compromising disorder. Conclusions: In critically ill patients with pneumonia during the influenza season, PCT is a reasonably accurate marker for detection of bacterial pneumonia, particularly in patients with community-acquired disease and without immune-compromising disorders, but it might not be sufficient as a stand-alone marker for withholding antibiotic

Published
2014

109. Individual patient data meta-analysis of hydroxyethyl starch 130/0.4-0.42 versus crystalloid for fluid resuscitation in patients with severe sepsis:a statistical analysis plan

Author

Hammond, Naomi E, Haase, Nicolai, Billot, Laurent, Wetterslev, Jørn, Saxena, Manoj K, Finfer, Simon, Perner, Anders, Myburgh, John, Hammond, Naomi E, Haase, Nicolai, Billot, Laurent, Wetterslev, Jørn, Saxena, Manoj K, Finfer, Simon, Perner, Anders, and Myburgh, John

Abstract

BACKGROUND: The Crystalloid versus Hydroxyethyl Starch Trial (CHEST) and the Scandinavian Starch in Severe Sepsis/ Septic Shock (6S) trial reported that 6% hydroxyethyl starch (HES) is associated with increased use of renal replacement therapy and death in critically ill patients. Data collection was harmonised between the two trials in order to facilitate a preplanned individual patient data meta-analysis (IPDMA) of patients with severe sepsis.OBJECTIVES AND RATIONALE: To publish a statistical analysis plan (SAP) for an IPDMA of patients with severe sepsis enrolled in the 6S trial and the CHEST.METHODS AND OUTCOMES: The SAP is described in broad detail with specific information regarding baseline characteristics and process of care. The outcomes for the trial have been described and are presented as primary, secondary and exploratory outcomes with appropriate comparisons between groups detailed. Subgroups have been defined based on pre-randomisation variables.CONCLUSION: We developed a preanalysis SAP to combine data on patients with severe sepsis from the 6S trial and the CHEST. Prepublication of our SAP will reduce the risk of bias in the reporting of the results and improve confidence in the estimates of effects, allowing comparisons with conventional meta-analyses and assisting in the translation of research findings into clinical practice.

Published
2014

110. Patterns of intravenous fluid resuscitation use in adult intensive care patients between 2007 and 2014: An international cross-sectional study.

Author

Hammond, Naomi E., Taylor, Colman, Finfer, Simon, Machado, Flavia R., An, YouZhong, Billot, Laurent, Bloos, Frank, Bozza, Fernando, Cavalcanti, Alexandre Biasi, Correa, Maryam, Du, Bin, Hjortrup, Peter B., Li, Yang, McIntryre, Lauralyn, Saxena, Manoj, Schortgen, Frédérique, Watts, Nicola R., Myburgh, John, and null, null

Subjects
*RESUSCITATION, *INTENSIVE care units, *SALT, *HYDROXYETHYL starch, *REGRESSION analysis
Abstract

Background: In 2007, the Saline versus Albumin Fluid Evaluation—Translation of Research Into Practice Study (SAFE-TRIPS) reported that 0.9% sodium chloride (saline) and hydroxyethyl starch (HES) were the most commonly used resuscitation fluids in intensive care unit (ICU) patients. Evidence has emerged since 2007 that these fluids are associated with adverse patient-centred outcomes. Based on the published evidence since 2007, we sought to determine the current type of fluid resuscitation used in clinical practice and the predictors of fluid choice and determine whether these have changed between 2007 and 2014. Methods: In 2014, an international, cross-sectional study was conducted (Fluid-TRIPS) to document current patterns of intravenous resuscitation fluid use and determine factors associated with fluid choice. We examined univariate and multivariate associations between patients and prescriber characteristics, geographical region and fluid type. Additionally, we report secular trends of resuscitation fluid use in a cohort of ICUs that participated in both the 2007 and 2014 studies. Regression analysis were conducted to determine changes in the administration of crystalloid or colloid between 2007 and 2014. Findings: In 2014, a total of 426 ICUs in 27 countries participated. Over the 24 hour study day, 1456/6707 (21.7%) patients received resuscitation fluid during 2716 resuscitation episodes. Crystalloids were administered to 1227/1456 (84.3%) patients during 2208/2716 (81.3%) episodes and colloids to 394/1456 (27.1%) patients during 581/2716 (21.4%) episodes. In multivariate analyses, practice significantly varied between geographical regions. Additionally, patients with a traumatic brain injury were less likely to receive colloid when compared to patients with no trauma (adjusted OR 0.24; 95% CI 0.1 to 0.62; p = 0.003). Patients in the ICU for one or more days where more likely to receive colloid compared to patients in the ICU on their admission date (adjusted OR 1.75; 95% CI 1.27 to 2.41; p = <0.001). For secular trends in fluid resuscitation, 84 ICUs in 17 countries contributed data. In 2007, 527/1663 (31.7%) patients received fluid resuscitation during 1167 episodes compared to 491/1763 (27.9%) patients during 960 episodes in 2014. The use of crystalloids increased from 498/1167 (42.7%) in 2007 to 694/960 (72.3%) in 2014 (odds ratio (OR) 3.75, 95% confidence interval (CI) 2.95 to 4.77; p = <0.001), primarily due to a significant increase in the use of buffered salt solutions. The use of colloids decreased from 724/1167 (62.0%) in 2007 to 297/960 (30.9%) in 2014 (OR 0.29, 95% CI 0.19 to 0.43; p = <0.001), primarily due to a decrease in the use of HES, but an overall increase in the use of albumin. Conclusions: Clinical practices of intravenous fluid resuscitation have changed between 2007 and 2014. Geographical location remains a strong predictor of the type of fluid administered for fluid resuscitation. Overall, there is a preferential use of crystalloids, specifically buffered salt solutions, over colloids. There is now an imperative to conduct a trial determining the safety and efficacy of these fluids on patient-centred outcomes. Trial registration: Clinicaltrials.gov: Fluid-Translation of research into practice study (Fluid-TRIPS) [ABSTRACT FROM AUTHOR]

Published
2017
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111. Procalcitonin for diagnosis of bacterial pneumonia in critically ill patients during 2009 H1N1 influenza pandemic: a prospective cohort study, systematic review and individual patient data meta-analysis

Author

Pfister, Roman, primary, Kochanek, Matthias, additional, Leygeber, Timo, additional, Brun-Buisson, Christian, additional, Cuquemelle, Elise, additional, Machado, Mariana Benevides, additional, Piacentini, Enrique, additional, Hammond, Naomi E, additional, Ingram, Paul R, additional, and Michels, Guido, additional

Published
2014
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114. How often are infusion sets for central venous catheters changed in Australian and New Zealand Intensive Care Units? A point prevalence survey

Author

Anstey, Matthew H., Maxwell, Nicky, Rickard, Claire M., Hammond, Naomi E., Knowles, Serena, McGain, Forbes, Hammond, Naomi, Knowles, Serena, Freeman-Sanderson, Amy, Ganu, Subodh, Howe, Belinda, Litton, Ed, Mackle, Diane, Saxena, Manoj, Seppelt, Ian, Towns, Miriam, Yarad, Elizabeth, Hammond, Naomi, Knowles, Serena, Gao, Annie, Li, Yang, Myburgh, John, Seppelt, Ian, Nangla, Conrad, Butt, Fatima, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Thomas, Blessy, Gilder, Eileen, Robertson, Melissa, McMahon, Ellie, Ali, Farisha, Cowdrey, Keri-Anne, McArthur, Colin, Chen, Yan, Simmonds, Catherine, McConnochie, Rachael, O’Connor, Caroline, El-Khawas, Khaled, Hill, Dianne, Cattigan, Claire, Horton, Michelle, Trickey, Jemma, Knott, Cameron, Smith, Julie, Boschert, Catherine, Sara, Treena, Nand, Kiran, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Thomas, Blessy, Ramanan, Mahesh, Marella, Prashanti, Affleck, Julia, Simpson, Shannon, Ellem, Katrina, McKenna, Toni, Nourse, Mary, Leung, Kristine, Edmunds, Tash, McDonald, Bree, Mehrtens, Jan, Cross, Rosalba, Wong, Helen, Twardowski, Pawel, France, Dawn, Hanlon, Gabrielle, Barrett, Jonathan, Palermo, Annamaria, Pellicano, Susan, Eroglu, Ege, Bihari, Shailesh, Brown, Julia, Grear, Laura, Jin, Xia, French, Craig, Bates, Samantha, Towns, Miriam, Marshall, Fiona, McEldrew, Rebecca, McCullough, James, Tallott, Mandy, Gough, Maimoonbe, Nalos, Marek, Younger, Laura, Krishnamurphy, Ravi, Trent, Louise, How, Janet, Stuart, Anne, Chadwick, Llesley, Bhadange, Neeraj, Tyler, Steven, Sosnowski, Kellie, Morrison, Lynette, Sutton, Joanne, Soar, Natalie, Lee, David, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Doyle, Marina, Jongebloed, Katherine, Finnis, Mackenzie, Wilson, Jane, Williams, Tony, Song, Rima, Lai, Vivian, Girijadevi, Dinu, Habraken, Hannah, Browne, Alex, Koelle, Jette, McNab, Charlotte, Masters, Kristy, Gresham, Rebecca, Lowrey, Julie, Whitehead, Christina, Liang, Janet, Harward, Meg, Jones, Cassie, Peake, Sandra, Williams, Tricia, Kurenda, Catherine, Tabah, Alexis, Duroux, Maree, Warhurst, Timothy, Ratcliffe, Megan, Pollock, Hamish, Baker, Stuart, Sonawane, Ravikiran, O'Connor, Stephanie, Brown, Nerissa, Glasby, Kathleen, Rivett, Justine, Campbell, Lewis, Tabuzo, Vera, Smyth, Kirsty, Yarad, Elizabeth, Bass, Frances, Hammond, Naomi, O'Connor, Anne, Leonard, Anton, Waterson, Sharon, Coles, Jennifer, Buhr, Heidi, Newman, Duncan, Boorawong, Piyaporn, Bregolin, Vanessa, Yun, Ji-Hyun, Anstey, Matthew, Rock, Lara, Endemann, Anthadene, Lo, Wei, Ferrier, Janet, Palermo, Annamaria, Reynolds, Claire, Santamaria, John, Holmes, Jennifer, Beca, John, Sherring, Claire, Garrett, Peter, Murray, Lauren, Brailsford, Jane, French, Craig, Bates, Samantha, Towns, Miriam, Marshall, Fiona, McEldrew, Rebecca, Browne, Troy, Goodson, Jennifer, Udy, Andrew, Young, Meredith, Board, Jasmin, McCracken, Phoebe, Martin, Emma-Leah, Martynoga, Robert, Butler, Amelia, Trask, Kara, Olatunji, Shaanti, Cruz, Rhoze Sol, Cruz, Raulle Sol, Navarra, Leanlove, Delaney, Kirsha, Lesona, Eden, Young, Chelsea, Spring, Amelia, Aguilar, April, Young, Paul, and Law, Erin

Abstract

Infusion sets (comprising the tubing, measuring burettes, fluid containers, transducers) that are connected to invasive vascular devices are changed on a regular basis in an effort to reduce bacterial colonisation and bloodstream infection. There is a balance between reducing infection and creating unnecessary waste. Current evidence suggests that for central venous catheters, changing infusion sets at 7 days does not increase infection risks.

Published
2023
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115. Depression Screening in Aneurysmal Subarachnoid Haemorrhage patients and their caregivers: A Systematic Review

Author

Leung, Kwan Yee (Queenie), Cartoon, Jodi, and Hammond, Naomi E.

Abstract

Depression commonly occurs after aneurysmal subarachnoid haemorrhage (aSAH) which can negatively impact patients and their caregivers. Identification and validation of depression screening instruments specifically for patients with aSAH and their caregivers has not been performed.

Published
2023
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116. Head-of-Bed Elevation Improves End-Expiratory Lung Volumes in Mechanically Ventilated Subjects: A Prospective Observational Study.

Author

Spooner, Amy J., Corley, Amanda, Sharpe, Nicola A., Barnett, Adrian G., Caruana, Lawrence R., Hammond, Naomi E., and Fraser, John F.

Subjects
BIOELECTRIC impedance, PATIENT positioning, ARTIFICIAL respiration, CONFIDENCE intervals, LONGITUDINAL method, SCIENTIFIC observation, SUPINE position, DESCRIPTIVE statistics, LUNG volume measurements
Abstract

BACKGROUND: Head-of-bed elevation (HOBE) has been shown to assist in reducing respiratory complications associated with mechanical ventilation; however, there is minimal research describing changes in end-expiratory lung volume. This study aims to investigate changes in end-expiratory lung volume in a supine position and 2 levels of HOBE. METHODS: Twenty postoperative cardiac surgery subjects were examined using electrical impedance tomography. End-expiratory lung impedance (EELI) was recorded as a surrogate measurement of end-expiratory lung volume in a supine position and at 20° and then 30°. RESULTS: Significant increases in end-expiratory lung volume were seen at both 20° and 30° HOBE in all lung regions, except the anterior, with the largest changes from baseline (supine) seen at 30°. From baseline to 30° HOBE, global EELI increased by 1,327 impedance units (95% CI 1,080-1,573, P < .001). EELI increased by 1,007 units (95% CI 880-1,134, P < .001) in the left lung region and by 320 impedance units (95% CI 188-451, P < .001) in the right lung. Posterior increases of 1,544 impedance units (95% CI 1,405-1,682, P < .001) were also seen. EELI decreased anteriorly, with the largest decreases occurring at 30° (−3 3 5 impedance units, 95% CI −486 to −183, P < .001). CONCLUSIONS: HOBE significantly increases global and regional end-expiratory lung volume; therefore, unless contraindicated, all mechanically ventilated patients should be positioned with HOBE. [ABSTRACT FROM AUTHOR]

Published
2014
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117. Quantifying the Impact of Alternative Definitions of Sepsis-Associated Acute Kidney Injury on its Incidence and Outcomes: A Systematic Review and Meta-Analysis.

Author

Donaldson, Lachlan H., Vlok, Ruan, Ken Sakurai, Burrows, Morgan, McDonald, Gabrielle, Venkatesh, Karthik, Bagshaw, Sean M., Bellomo, Rinaldo, Delaney, Anthony, Myburgh, John, Hammond, Naomi E., and Venkatesh, Balasubramanian

Subjects
*ACUTE kidney failure, *RENAL replacement therapy, *CLINICAL trials, *DEFINITIONS, *DATA extraction
Abstract

OBJECTIVES: To derive a pooled estimate of the incidence and outcomes of sepsis-associated acute kidney injury (SA-AKI) in ICU patients and to explore the impact of differing definitions of SA-AKI on these estimates. DATA SOURCES: Medline, Medline Epub, EMBASE, and Cochrane CENTRAL between 1990 and 2023. STUDY SELECTION: Randomized clinical trials and prospective cohort studies of adults admitted to the ICU with either sepsis and/or SA-AKI. DATA EXTRACTION: Data were extracted in duplicate. Risk of bias was assessed using adapted standard tools. Data were pooled using a random-effects model. Heterogeneity was assessed by using a single covariate logistic regression model. The primary outcome was the proportion of participants in ICU with sepsis who developed AKI. DATA SYNTHESIS: A total of 189 studies met inclusion criteria. One hundred fifty-four reported an incidence of SA-AKI, including 150,978 participants. The pooled proportion of patients who developed SA-AKI across all definitions was 0.40 (95% CI, 0.37--0.42) and 0.52 (95% CI, 0.48--0.56) when only the Risk Injury Failure Loss End-Stage, Acute Kidney Injury Network, and Improving Global Outcomes definitions were used to define SA-AKI. There was significant variation in the incidence of SA-AKI depending on the definition of AKI used and whether AKI defined by urine output criteria was included; the incidence was lowest when receipt of renal replacement therapy was used to define AKI (0.26; 95% CI, 0.24--0.28), and highest when the Acute Kidney Injury Network score was used (0.57; 95% CI, 0.45--0.69; p < 0.01). Sixty-seven studies including 29,455 participants reported at least one SA-AKI outcome. At final follow-up, the proportion of patients with SA-AKI who had died was 0.48 (95% CI, 0.43-0.53), and the proportion of surviving patients who remained on dialysis was 0.10 (95% CI, 0.04-0.17). CONCLUSIONS: SA-AKI is common in ICU patients with sepsis and carries a high risk of death and persisting kidney impairment. The incidence and outcomes of SA-AKI vary significantly depending on the definition of AKI used. [ABSTRACT FROM AUTHOR]

Published
2024
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118. Critical care health professionals’ self-reported needs for wellbeing during the COVID-19 pandemic: A thematic analysis of survey responses

Author

Elliott, Rosalind, Crowe, Liz, Abbenbroek, Brett, Grattan, Sarah, and Hammond, Naomi E.

Abstract

Critical care healthcare professionals are a key part of any pandemic response and are at an increased risk for physical and psychological harm, yet their self-reported suggestions to ameliorate the negative effects of pandemics on their wellbeing have rarely been sought.

Published
2021
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120. Additional file 6 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 6. Funnel plot.

121. Additional file 4 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 4. Identified potentially eligible trials not included in the analysis.

122. Additional file 1 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
Data_FILES, 3. Good health
Abstract

Additional file 1. Search strategy.

123. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M, Van't Hooft, Janneke, Smith, Emily R, Haber, Noah A, Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M, Alfonso, Rachelle N, Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C, Aomar, Ismael F, Argumanis, Luis E, Averyanov, Alexander, Baklaushev, Vladimir P, Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B, Bowen, Asha C, Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H, Cardesa, Ana, Carnate, Jose M, Castillo, German Jr J, Cavallo, Rossana, Chowdhury, Fazle R, Chowdhury, Forhad UH, Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M, Compernolle, Veerle, Cortez, Carlo Francisco N, Costa Neto, Abel, D'Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S, De Rosa, Francesco Giuseppe, Denholm, Justin T, Denkinger, Claudia M, Desmecht, Daniel, Díaz-Coronado, Juan C, Díaz Ponce-Medrano, Juan A, Donneau, Anne-Françoise, Dumagay, Teresita E, Dunachie, Susanna, Dungog, Cecile C, Erinoso, Olufemi, Escasa, Ivy Mae S, Estcourt, Lise J, Evans, Amy, Evasan, Agnes LM, Fareli, Christian J, Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E, Garcia, Patricia J, Garcia, Patricia L, Garcia, Jesus A, Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V, Gaviria García, Paula A, Giron-Gonzalez, Jose-Antonio, Gómez-Almaguer, David, Gordon, Anthony C, Gothot, André, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E, Harvala, Heli, Heralde, Francisco M, Herrick, Jesica, Higgins, Alisa M, Hills, Thomas E, Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M, Ivanov, Alexander V, Janssen, Maike, Jennings, Jeffrey H, Jha, Vivekanand, King, Ruby Anne N, Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-François, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-Díaz, Jorge M, López-Robles, Concepción, López-Cárdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C, Lundgren, Maria, Macías, Juan, Maganito, Sandy C, Malundo, Anna Flor G, Manrique, Rubén D, Manzini, Paola M, Marcos, Miguel, Marquez, Ignacio, Martínez-Marcos, Francisco Javier, Mata, Ana M, McArthur, Colin J, McQuilten, Zoe K, McVerry, Bryan J, Menon, David K, Meyfroidt, Geert, Mirasol, Ma Angelina L, Misset, Benoît, Molton, James S, Mondragon, Alric V, Monsalve, Diana M, Moradi Choghakabodi, Parastoo, Morpeth, Susan C, Mouncey, Paul R, Moutschen, Michel, Müller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D, Nielsen, Henrik, Novak, Richard M, O'Sullivan, Matthew VN, Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M, Patel, Mahesh C, Paterson, David L, Peña-Perez, Carlos A, Perez-Calatayud, Angel A, Pérez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J, Quero, Anne Kristine H, Rahman, Md M, Rahman, Md S, Ramesh, Mayur, Ramírez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A, Rego, Eduardo, Roberts, Jason A, Roberts, David J, Rodríguez, Yhojan, Rodríguez-Baño, Jesús, Rogers, Benjamin A, Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M, Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M, Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y, Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven YC, Turgeon, Alexis F, Veloso, Januario D, Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A, Wiese, Lothar, Wikén, Christian, Wood, Erica M, Yusubalieva, Gaukhar M, Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N, Ioannidis, John PA, and Hemkens, Lars G

Subjects
Meta-analysis, Convalescent plasma, Treatment Outcome, SARS-CoV-2, Immunization, Passive, COVID-19, Humans, COVID-19 Serotherapy, 3. Good health, Randomized Controlled Trials as Topic
Abstract

Funder: laura and john arnold foundation, BACKGROUND: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). METHODS: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. RESULTS: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. CONCLUSIONS: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.

124. Additional file 5 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 5. Risk of bias.

125. The Plasma-Lyte 148 versus Saline (PLUS) study protocol amendment

Author

Hammond, Naomi E., Rinaldo Bellomo, Martin Gallagher, David Gattas, Parisa Glass, Diane Mackie, Sharon Micallef, John Myburgh, Manoj Saxena, Colman Taylor, Paul Young, and Simon Finfer

Subjects
Clinical Protocols, Sodium Acetate, Critical Illness, Magnesium Chloride, Fluid Therapy, Humans, Sodium Chloride, Gluconates, Potassium Chloride

126. Additional file 6 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 6. Funnel plot.

127. Additional file 5 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 5. Risk of bias.

128. Additional file 2 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
TheoryofComputation_MISCELLANEOUS, InformationSystems_INFORMATIONSYSTEMSAPPLICATIONS, Data_FILES, GeneralLiterature_MISCELLANEOUS, ComputingMilieux_MISCELLANEOUS, 3. Good health
Abstract

Additional file 2. Email invitation.

130. Additional file 7 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 7. Sensitivity analyses: various meta-analytic approaches.

131. Additional file 4 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 4. Identified potentially eligible trials not included in the analysis.

132. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial (vol 326, pg 1807, 2021)

Author

Munch, Marie W., Myatra, Sheila N., Vijayaraghavan, Bharath Kumar Tirupakuzhi, Saseedharan, Sanjith, Benfield, Thomas, Wahlin, Rebecka R., Rasmussen, Bodil S., Andreasen, Anne Sofie, Poulsen, Lone M., Cioccari, Luca, Khan, Mohd S., Kapadia, Farhad, Divatia, Jigeeshu V., Brochner, Anne C., Bestle, Morten H., Helleberg, Marie, Michelsen, Jens, Padmanaban, Ajay, Bose, Neeta, Moller, Anders, Borawake, Kapil, Kristiansen, Klaus T., Shukla, Urvi, Chew, Michelle S., Dixit, Subhal, Ulrik, Charlotte S., Amin, Pravin R., Chawla, Rajesh, Wamberg, Christian A., Shah, Mehul S., Darfelt, Iben S., Jorgensen, Vibeke L., Smitt, Margit, Granholm, Anders, Kjaer, Maj-Brit N., Moller, Morten H., Meyhoff, Tine S., Vesterlund, Gitte K., Hammond, Naomi E., Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Anubhuti, Cronhjort, Maria, Jakob, Stephan M., Christian Gluud, Lange, Theis, Kadam, Vaijayanti, Marcussen, Klaus V., Hollenberg, Jacob, Hedman, Anders, Nielsen, Henrik, Schjorring, Olav L., Jensen, Marie Q., Leistner, Jens W., Jonassen, Trine B., Kristensen, Camilla M., Clapp, Esben C., Hjortso, Carl J. S., Jensen, Thomas S., Halstad, Liv S., Bak, Emilie R. B., Zaabalawi, Reem, Metcalf-Clausen, Matias, Abdi, Suhayb, Hatley, Emma V., Aksnes, Tobias S., Gleipner-Andersen, Emil, Alarcon, Arif F., Yamin, Gabriel, Heymowski, Adam, Berggren, Anton, La Cour, Kirstine, Weihe, Sarah, Pind, Alison H., Engstrom, Janus, Jha, Vivekanand, Venkatesh, Balasubramanian, and Perner, Anders

133. Additional file 3 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
GeneralLiterature_INTRODUCTORYANDSURVEY, ComputerSystemsOrganization_COMPUTER-COMMUNICATIONNETWORKS, Data_FILES, ComputingMilieux_LEGALASPECTSOFCOMPUTING, 3. Good health
Abstract

Additional file 3. Amendments to the protocol.

134. Additional file 2 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
TheoryofComputation_MISCELLANEOUS, InformationSystems_INFORMATIONSYSTEMSAPPLICATIONS, Data_FILES, GeneralLiterature_MISCELLANEOUS, ComputingMilieux_MISCELLANEOUS, 3. Good health
Abstract

Additional file 2. Email invitation.

135. Individual patient data meta-analysis of hydroxyethyl starch 130/0.4-0.42 versus crystalloid for fluid resuscitation in patients with severe sepsis: a statistical analysis plan

Author

Hammond, Naomi E., Nicolai Haase, Laurent Billot, Jorn Wetterslev, Saxena, Manoj K., Simon Finfer, Anders Perner, and John Myburgh

Subjects
Hydroxyethyl Starch Derivatives, Outcome and Process Assessment, Health Care, Critical Care, Critical Illness, Resuscitation, Sepsis, Plasma Substitutes, Fluid Therapy, Humans, Crystalloid Solutions, Isotonic Solutions
Abstract

The Crystalloid versus Hydroxyethyl Starch Trial (CHEST) and the Scandinavian Starch in Severe Sepsis/ Septic Shock (6S) trial reported that 6% hydroxyethyl starch (HES) is associated with increased use of renal replacement therapy and death in critically ill patients. Data collection was harmonised between the two trials in order to facilitate a preplanned individual patient data meta-analysis (IPDMA) of patients with severe sepsis.To publish a statistical analysis plan (SAP) for an IPDMA of patients with severe sepsis enrolled in the 6S trial and the CHEST.The SAP is described in broad detail with specific information regarding baseline characteristics and process of care. The outcomes for the trial have been described and are presented as primary, secondary and exploratory outcomes with appropriate comparisons between groups detailed. Subgroups have been defined based on pre-randomisation variables.We developed a preanalysis SAP to combine data on patients with severe sepsis from the 6S trial and the CHEST. Prepublication of our SAP will reduce the risk of bias in the reporting of the results and improve confidence in the estimates of effects, allowing comparisons with conventional meta-analyses and assisting in the translation of research findings into clinical practice.

136. Additional file 7 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 7. Sensitivity analyses: various meta-analytic approaches.

137. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M, Van't Hooft, Janneke, Smith, Emily R, Haber, Noah A, Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M, Alfonso, Rachelle N, Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C, Aomar, Ismael F, Argumanis, Luis E, Averyanov, Alexander, Baklaushev, Vladimir P, Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B, Bowen, Asha C, Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H, Cardesa, Ana, Carnate, Jose M, Castillo, German Jr J, Cavallo, Rossana, Chowdhury, Fazle R, Chowdhury, Forhad UH, Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M, Compernolle, Veerle, Cortez, Carlo Francisco N, Costa Neto, Abel, D'Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S, De Rosa, Francesco Giuseppe, Denholm, Justin T, Denkinger, Claudia M, Desmecht, Daniel, D��az-Coronado, Juan C, D��az Ponce-Medrano, Juan A, Donneau, Anne-Fran��oise, Dumagay, Teresita E, Dunachie, Susanna, Dungog, Cecile C, Erinoso, Olufemi, Escasa, Ivy Mae S, Estcourt, Lise J, Evans, Amy, Evasan, Agnes LM, Fareli, Christian J, Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E, Garcia, Patricia J, Garcia, Patricia L, Garcia, Jesus A, Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V, Gaviria Garc��a, Paula A, Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C, Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E, Harvala, Heli, Heralde, Francisco M, Herrick, Jesica, Higgins, Alisa M, Hills, Thomas E, Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M, Ivanov, Alexander V, Janssen, Maike, Jennings, Jeffrey H, Jha, Vivekanand, King, Ruby Anne N, Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M, L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C, Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C, Malundo, Anna Flor G, Manrique, Rub��n D, Manzini, Paola M, Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M, McArthur, Colin J, McQuilten, Zoe K, McVerry, Bryan J, Menon, David K, Meyfroidt, Geert, Mirasol, Ma Angelina L, Misset, Beno��t, Molton, James S, Mondragon, Alric V, Monsalve, Diana M, Moradi Choghakabodi, Parastoo, Morpeth, Susan C, Mouncey, Paul R, Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D, Nielsen, Henrik, Novak, Richard M, O'Sullivan, Matthew VN, Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M, Patel, Mahesh C, Paterson, David L, Pe��a-Perez, Carlos A, Perez-Calatayud, Angel A, P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J, Quero, Anne Kristine H, Rahman, Md M, Rahman, Md S, Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A, Rego, Eduardo, Roberts, Jason A, Roberts, David J, Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A, Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M, Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M, Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y, Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven YC, Turgeon, Alexis F, Veloso, Januario D, Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A, Wiese, Lothar, Wik��n, Christian, Wood, Erica M, Yusubalieva, Gaukhar M, Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N, Ioannidis, John PA, and Hemkens, Lars G

Subjects
Meta-analysis, Convalescent plasma, SARS-CoV-2, COVID-19, 3. Good health, Research Article
Abstract

Funder: laura and john arnold foundation; doi: http://dx.doi.org/10.13039/100009827, BACKGROUND: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). METHODS: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. RESULTS: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. CONCLUSIONS: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.

138. The Plasma-Lyte 148 v Saline (PLUS) study protocol: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality

Author

Hammond, Naomi E., Rinaldo Bellomo, Martin Gallagher, David Gattas, Parisa Glass, Diane Mackie, Sharon Micallef, John Myburgh, Manoj Saxena, Colman Taylor, Paul Young, and Simon Finfer

Subjects
Time Factors, Sodium Acetate, Critical Illness, Resuscitation, Vasodilator Agents, Australia, Magnesium Chloride, Health Services, Length of Stay, Sodium Chloride, Gluconates, Respiration, Artificial, Potassium Chloride, Renal Replacement Therapy, Intensive Care Units, Creatinine, Quality of Life, Fluid Therapy, Humans, Vasoconstrictor Agents, Mortality, New Zealand
Abstract

0.9% sodium chloride (saline) is the most commonly administered resuscitation fluid on a global basis but emerging evidence suggests that its high chloride content may have important adverse effects.To describe the study protocol for the Plasma- Lyte 148 v Saline study, which will test the hypothesis that in critically ill adult patients the use of Plasma-Lyte 148 (a buffered crystalloid solution) for fluid therapy results in different 90-day all-cause mortality when compared with saline.We will conduct this multicentre, blinded, randomised controlled trial in approximately 50 intensive care units in Australia and New Zealand. We will randomly assign 8800 patients to either Plasma-Lyte 148 or saline for all resuscitation fluid, maintenance fluid and compatible drug dilution therapy while in the ICU for up to 90 days after randomisation.The primary outcome is 90-day all-cause mortality; secondary outcomes include mean and peak creatinine concentration, incidence of renal replacement therapy, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, ICU and hospital length of stay, and quality of life and health services use at 6 months.The PLUS study will provide high-quality data on the comparative safety and efficacy of Plasma-Lyte 148 compared with saline for resuscitation and compatible crystalloid fluid therapy in critically ill adult patients.

139. Additional file 3 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
GeneralLiterature_INTRODUCTORYANDSURVEY, ComputerSystemsOrganization_COMPUTER-COMMUNICATIONNETWORKS, Data_FILES, ComputingMilieux_LEGALASPECTSOFCOMPUTING, 3. Good health
Abstract

Additional file 3. Amendments to the protocol.

140. 2024 Focused Update: Guidelines on Use of Corticosteroids in Sepsis, Acute Respiratory Distress Syndrome, and Community-Acquired Pneumonia.

Author

Chaudhuri, Dipayan, Nei, Andrea M., Rochwerg, Bram, Balk, Robert A., Asehnoune, Karim, Cadena, Rhonda, Carcillo, Joseph A., Correa, Ricardo, Drover, Katherine, Esper, Annette M., Gershengorn, Hayley B., Hammond, Naomi E., Jayaprakash, Namita, Menon, Kusum, Nazer, Lama, Pitre, Tyler, Qasim, Zaffer A., Russell, James A., Santos, Ariel P., and Sarwal, Aarti

Subjects
*ADULT respiratory distress syndrome, *COMMUNITY-acquired pneumonia, *PEDIATRIC nursing, *PULMONOLOGISTS, *SEPSIS, *CORTICOSTEROIDS, *SEPTIC shock
Abstract

RATIONALE: New evidence is available examining the use of corticosteroids in sepsis, acute respiratory distress syndrome (ARDS) and community-acquired pneumonia (CAP), warranting a focused update of the 2017 guideline on critical illness-related corticosteroid insufficiency. OBJECTIVES: To develop evidence-based recommendations for use of corticosteroids in hospitalized adults and children with sepsis, ARDS, and CAP. PANEL DESIGN: The 22-member panel included diverse representation from medicine, including adult and pediatric intensivists, pulmonologists, endocrinologists, nurses, pharmacists, and clinician-methodologists with expertise in developing evidence-based Clinical Practice Guidelines. We followed Society of Critical Care Medicine conflict of interest policies in all phases of the guideline development, including task force selection and voting. METHODS: After development of five focused Population, Intervention, Control, and Outcomes (PICO) questions, we conducted systematic reviews to identify the best available evidence addressing each question. We evaluated the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach and formulated recommendations using the evidence-to-decision framework. RESULTS: In response to the five PICOs, the panel issued four recommendations addressing the use of corticosteroids in patients with sepsis, ARDS, and CAP. These included a conditional recommendation to administer corticosteroids for patients with septic shock and critically ill patients with ARDS and a strong recommendation for use in hospitalized patients with severe CAP. The panel also recommended against high dose/short duration administration of corticosteroids for septic shock. In response to the final PICO regarding type of corticosteroid molecule in ARDS, the panel was unable to provide specific recommendations addressing corticosteroid molecule, dose, and duration of therapy, based on currently available evidence. CONCLUSIONS: The panel provided updated recommendations based on current evidence to inform clinicians, patients, and other stakeholders on the use of corticosteroids for sepsis, ARDS, and CAP. [ABSTRACT FROM AUTHOR]

Published
2024
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141. Selective digestive tract decontamination in critically ill adults with acute brain injuries: a post hoc analysis of a randomized clinical trial.

Author

Young, Paul J., Devaux, Anthony, Li, Qiang, Billot, Laurent, Davis, Joshua S., Delaney, Anthony, Finfer, Simon R., Hammond, Naomi E., Micallef, Sharon, Seppelt, Ian M., Venkatesh, Balasubramanian, Myburgh, John A., Gordon, Anthony, Cuthbertson, Brian, Fowler, Robert, Murthy, Srinivas, Pattison, Natalie, Iredell, Jon, Taylor, Colman, and Young, Duncan

Subjects
*CRITICALLY ill patient care, *HOSPITAL mortality, *BRAIN injuries, *CLINICAL trials, *ALIMENTARY canal, *CRITICALLY ill, *CLUSTER randomized controlled trials
Abstract

Purpose: The aim of this study was to determine whether selective decontamination of the digestive tract (SDD) reduces in-hospital mortality in mechanically ventilated critically ill adults admitted to the intensive care unit (ICU) with acute brain injuries or conditions. Methods: We carried out a post hoc analysis from a crossover, cluster randomized clinical trial. ICUs were randomly assigned to adopt or not to adopt a SDD strategy for two alternating 12-month periods, separated by a 3-month inter-period gap. Patients in the SDD group (n = 2791; 968 admitted to the ICU with an acute brain injury) received a 6-hourly application of an oral paste and administration of a gastric suspension containing colistin, tobramycin, and nystatin for the duration of mechanical ventilation, plus a 4-day course of an intravenous antibiotic with a suitable antimicrobial spectrum. Patients in the control group (n = 3191; 1093 admitted to the ICU with an acute brain injury) received standard care. The primary outcome was in-hospital mortality within 90 days. There were four secondary clinical outcomes: death in ICU, ventilator-, ICU- and hospital-free days to day 90. Results: Of 2061 patients with acute brain injuries (mean age, 55.8 years; 36.4% women), all completed the trial. In patients with acute brain injuries, there were 313/968 (32.3%) and 415/1093 (38%) in-hospital deaths in the SDD and standard care groups (unadjusted odds ratio [OR], 0.76, 95% confidence interval [CI] 0.63–0.92; p = 0.004). The use of SDD was associated with statistically significant improvements in the four clinical secondary outcomes compared to standard care. There was no significant heterogeneity of treatment effect between patients with and without acute brain injuries (interaction p = 0.22). Conclusions: In this post hoc analysis of a randomized clinical trial in critically ill patients with acute brain injuries receiving mechanical ventilation, the use of SDD significantly reduced in-hospital mortality in patients compared to standard care without SDD. These findings require confirmation. [ABSTRACT FROM AUTHOR]

Published
2024
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142. Critically ill patients having time outdoors: prevalence and resources in Australia and New Zealand.

Author

Maiden, Matthew J., Horton, Michelle, Power, Paul, Knowles, Serena, Hammond, Naomi E., Hammond, Naomi, Freeman-Anderson, Amy, Howe, Belinda, Mackle, Diane, Saxena, Manoj, Yarad, Elizabeth, Litton, Ed, Ganu, Subodh, Seppelt, Ian, Towns, Miriam, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, and Loughnan, Clare

Subjects
*CRITICALLY ill, *PUBLIC health infrastructure
Abstract

A point prevalence study was conducted in Australia and New Zealand to determine the number of critically ill patients in intensive care units (ICUs) who would benefit from spending time outdoors, the number of patients actually taken outdoors, and the availability of outdoor facilities. The study found that 24% of ICU patients were believed to benefit from time outdoors, but only 1.1% actually spent time outside. Reasons for not taking patients outdoors included unsuitable weather, patient clinical condition, and inadequate staffing resources. The study suggests that more attention should be given to enabling patient-centered care that incorporates the possibility of time outdoors. [Extracted from the article]

Published
2024
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143. Pilot Randomized Clinical Trial of a Passive Non-invasive Positive End-Expiratory Pressure (PEEP) Device for Delivering Positive Pressure Therapy Compared to Standard Care in Non-critically Ill Patients With COVID-19.

Author

Gupta L, Bassi A, Tirupakuzhi Vijayaraghavan BK, Bains L, Saxena KN, Hammond NE, Myatra S, Divatia J, Rajagopal S, Tanna GLD, Liu X, Knowles S, Bathla N, Jha V, and Venkatesh B

Abstract

Background: During the COVID-19 pandemic, there were reports of a shortage of ventilators and oxygen supply, particularly in resource-limited settings. We report the preliminary evaluation of a non-invasive positive end-expiratory pressure (PEEP) mask in hospitalized non-critically ill patients with COVID-19., Methods: We randomly assigned hospitalized adult patients with confirmed COVID-19 infection and requiring greater than 40% supplemental oxygen to either standard care oxygen delivery (control) or via Materialise passive non-invasive PEEP device mask (intervention; Belgium). The primary outcome was a change in mean respiratory rate from baseline over the first three hours after the commencement of the intervention. Secondary outcomes included dyspnea score, need for escalation of respiratory or cardiovascular support, days alive and free of ICU, and day-28 mortality., Results: Between April 30, 2021, and October 10, 2021, we enrolled 132 (65 control, 67 intervention) patients in the study. The mean respiratory rates at baseline were 23 ± 3 and 23 ± 3 in the control and intervention groups, with no significant differences at three hours (23 ± 2.3 vs. 23 ± 2.1, p=0.14). The control group had a higher mean dyspnea score compared to the intervention group (day 5: 5.4 ± 1.6 vs. 4.7 ± 1.4, p=0.015; day 6: 4.7 ± 1.7 vs. 4.0 ± 0.7, p=0.008). A higher proportion of patients in the control group required escalation of respiratory support (38%), as compared to intervention (12%) (p=0.0004). The two groups had no significant differences across other secondary outcomes or with respect to adverse events (barotrauma, aspiration pneumonia, need for vasopressor support)., Conclusions: The use of the novel mask compared to standard care in hospitalized non-critically ill patients with COVID-19 was not associated with reductions in the respiratory rate but was associated with a reduction in the need for escalation of respiratory support without an increase in adverse effects. Large-scale clinical trials of this device are warranted., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. The George Institute for Global Health Institutional Ethics Committee issued approval 15/2020. The study was registered in April 2021 with the Clinical Trial Registry - India (CTRI registration number: CTRI/2021/04/0331750). Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: The trial was supported by internal research funds from The George Institute for Global Health. The masks used in the intervention arm of the trial were supplied by Materialise, Belgium. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Gupta et al.)

Published
2024
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144. REVISE: R e- Ev aluating the I nhibition of S tress E rosions in the ICU: a randomised trial protocol.

Author

Deane AM, Alhazzani W, Guyatt G, Finfer S, Marshall JC, Myburgh J, Zytaruk N, Hardie M, Saunders L, Knowles S, Lauzier F, Chapman MJ, English S, Muscedere J, Arabi Y, Ostermann M, Venkatesh B, Young P, Thabane L, Billot L, Heels-Ansdell D, Al-Fares AA, Hammond NE, Hall R, Rajbhandari D, Poole A, Johnson D, Iqbal M, Reis G, Xie F, and Cook DJ

Subjects
Adolescent, Adult, Humans, Gastrointestinal Hemorrhage therapy, Intensive Care Units, Pantoprazole, Respiration, Artificial, Randomized Controlled Trials as Topic, Pneumonia, Ventilator-Associated, Proton Pump Inhibitors therapeutic use
Abstract

Introduction: The R e- Ev aluating the I nhibition of S tress E rosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE., Methods and Analysis: REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial., Ethics and Dissemination: All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to - Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide., Trial Registration Number: NCT03374800., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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145. Protocol for balanced versus saline trialists: living systematic review and individual patient data meta-analysis of randomised controlled trials (BEST-Living study).

Author

Zampieri FG, Cavalcanti AB, Di Tanna GL, Damiani LP, Hammond NE, Machado FR, Micallef S, Myburgh J, Rice TW, Semler MW, Young PJ, and Finfer S

Abstract

Objective: It remains unclear whether balanced solutions improve patient-centred outcomes in critically ill patients overall and whether the treatment effect is heterogeneous, with evidence that some populations of patients may be helped and others harmed. To provide the most up-to-date and comprehensive assessment of the totality of the evidence, we will perform an ongoing living systematic review with aggregated and individual patient data meta-analysis (IPDMA) comparing the use of balanced solutions with saline in critically ill adults. Design: Living systematic review using aggregated and individual patient data from randomised controlled trials. Data sources: We will conduct annual searches of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials. gov, the Australian New Zealand Clinical Trials Registry (ANZCTR), Japan's University Hospital Medical Information Network (UMIN) Center, and the Brazilian Registry of Clinical Trials (ReBEC). The first search was completed on 1 March 2022 and will be repeated annually. Authors of eligible trials will be invited to provide individual data for the IPDMA. The initial analysis will use all data received up to 30 June 2022. Review methods: We will include randomised controlled trials in adults treated in an intensive care unit that allocated individuals or clusters of patients to a balanced crystalloid solution or 0.9% saline for intravenous fluid therapy. Studies that used colloids as part of the intervention or that recruited only elective surgical patients will be excluded. The primary endpoint will be in-hospital mortality. The key secondary endpoint will be survival at longest follow-up for each trial. Data will be synthesised using both a random effect Bayesian meta-analysis and using hierarchical Bayesian models for individual patient data. Discussion: The use of balanced crystalloid solutions may reduce mortality and improve other outcomes in some critically ill patients. We will assess the totality of current and future evidence by performing an ongoing living systematic review with aggregated data and IPDMA. Protocol registration: CRD42022299282., Competing Interests: FGZ reports receiving grants for investigator-initiated trial from Ionis Pharmaceuticals (USA) and logistics support from Baxter Hospitalar (Brazil) for the BaSICS trial. SF / JM / NH / SM received unrestricted grants from Baxter and CSL (Paid to their institution)., (© 2022 College of Intensive Care Medicine of Australia and New Zealand.)

Published
2023
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146. Statistical analysis plan for the BLING III study: a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis.

Author

Billot L, Lipman J, Brett SJ, De Waele JJ, Cotta MO, Davis JS, Finfer S, Hammond NE, Knowles S, McGuinness S, Myburgh J, Paterson DL, Peake S, Rajbhandari D, Rhodes A, Roberts JA, Roger C, Shirwadkar C, Starr T, Taylor C, and Dulhunty JM

Abstract

Background: The β-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 randomised controlled trial comparing continuous infusion with intermittent infusion of β-lactam antibiotics in 7000 critically ill patients with sepsis. Objective: To describe a statistical analysis plan for the BLING III study. Methods: The statistical analysis plan was designed by the trial statistician and chief investigators and approved by the BLING III management committee before the completion of data collection. Statistical analyses for primary, secondary and tertiary outcomes and planned subgroup analyses are described in detail. Interim analysis by the Data Safety and Monitoring Committee (DSMC) has been conducted in accordance with a pre-specified DSMC charter. Results and conclusions: The statistical analysis plan for the BLING III study is published before completion of data collection and unblinding to minimise analysis bias and facilitate public access and transparent analysis and reporting of study findings. Trial registration: ClinicalTrials.gov Registry NCT03212990., Competing Interests: Jeffrey Lipman has served as a board member for the Bayer ESICM and MSD Antibacterials Advisory Boards and given lectures with honoraria from Pfizer and MSD. Stephen Brett has received a speaker’s fee and attended an Advisory Board from Orion Pharma. Jan De Waele has attended Advisory Boards, acted as a consultant to, or given lectures with honoraria from Accelerate, Bayer Healthcare, Grifols, MSD and Pfizer. David Paterson has received research grants from AstraZeneca and has attended Advisory Boards, acted as a consultant to, or given lectures with honoraria from Three Rivers Pharmaceuticals, Merck, AstraZeneca, SanofiAventis, Pfizer, Johnson and Johnson, Shionogi, Sumitomo and Leo Pharmaceuticals. Jason Roberts has served as a consultant for MSD, Bayer, Astellas, bioMerieux and Accelerate Diagnostics and has received research grants from MSD, The Medicines Company, Pfizer, Astellas and Cardeas Pharma. Claire Roger has received speaker’s fees from Pfizer and MSD. Colman Taylor owns a company, Health Technology Analysts, which provides consulting services to pharmaceutical companies, medical device companies and the Australian Government., (© 2021 College of Intensive Care Medicine of Australia and New Zealand.)

Published
2023
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147. Outcomes following severe septic shock in a cohort of Aboriginal and Torres Strait Islander people: a nested cohort study from the ADRENAL trial.

Author

Donaldson LH, Hammond NE, Agarwal S, Taylor S, Bompoint S, Coombes J, Bennett-Brook K, Bellomo R, Myburgh J, and Venkatesh B

Abstract

Objective: To describe the pattern of acute illness and 6-month mortality and health-related quality-of-life outcomes for a cohort of Aboriginal and Torres Strait Islander patients presenting with septic shock. Design: Nested cohort study of Aboriginal and Torres Strait Islander participants recruited to a large randomised controlled trial of corticosteroid treatment in patients with septic shock. Setting: Royal Darwin Hospital, Northern Territory. Participants: All Aboriginal and Torres Strait Islander patients recruited to the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial at Royal Darwin Hospital were compared with a non-Indigenous cohort drawn from the same site, and a cohort matched for age, sex and severity of disease. Main outcome measures: Mortality at 90 days and 6 months, time to shock resolution, mechanical ventilation requirement, renal replacement therapy requirement, and five-domain, five-level EuroQol questionnaire (EQ-5D-5L) score at 6 months. Results: Aboriginal and Torres Strait Islander patients had significantly reduced risk of death at 90 days when compared with non-Indigenous patients recruited to ADRENAL at Royal Darwin Hospital (12/60 v 23/62; adjusted odds ratio, 0.40 [95% CI, 0.17 to 0.94]) which was robust to additional adjustment for baseline covariates (odds ratio, 0.35 [95% CI, 0.14 to 0.90]). When compared with the matched population drawn from the broader ADRENAL cohort, there was no significant difference in 90-day mortality (12/60 v 16/61; adjusted odds ratio, 1.43 [95% CI, 0.60 to 3.39]; P = 0.42). Only nine Aboriginal and Torres Strait Islander patients provided 6-month health-related quality-of-life data. Conclusions: Aboriginal and Torres Strait Islander patients had reduced risk of death at 90 days when compared with non- Indigenous patients recruited to the ADRENAL trial at Royal Darwin Hospital, which was robust to adjustment for covariates, but similar outcomes when compared with a cohort matched for age, sex and severity of disease., Competing Interests: All authors declare that they do not have any potential conflict of interest in relation to this manuscript., (© 2022 College of Intensive Care Medicine of Australia and New Zealand.)

Published
2023
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149. The Plasma-Lyte 148 versus Saline (PLUS) statistical analysis plan: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality.

Author

Billot L, Bellomo R, Gallagher M, Gattas D, Hammond NE, Mackle D, Micallef S, Myburgh J, Navarra L, Saxena M, Taylor C, Young PJ, and Finfer S

Abstract

Background and objective: The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. Methods: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. Results and conclusions: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias., Competing Interests: None declared., (© 2021 College of Intensive Care Medicine of Australia and New Zealand.)

Published
2023
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