Use of L’Abbé and pooled calibration plots to assess the relationship between severity of illness and effectiveness in studies of corticosteroids for severe sepsis
British Journal of AnaesthesiaPublished 19 February 2011
Kwok M. Ho, J.A. Tan
Citations18
SJR quartileQ1
SJR score2.36
SNIP2.85
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
The pooled calibration plot suggested that there were excessive deaths in the placebo groups of some RCTs that could explain the apparent benefit of corticosteroids on mortality of patients with severe sepsis.
Abstract
The pooled calibration plot suggested that there were excessive deaths in the placebo groups of some RCTs that could explain the apparent benefit of corticosteroids on mortality of patients with severe sepsis. L'Abbé and pooled calibration plots might be useful as adjuncts to assess interactions between severity of illness and effectiveness of an intervention.
Keywords
Medicine
New England Journal of MedicineIntensive Insulin Therapy in Critically Ill Patients
10,029 Citations2001Greet Van den Berghe, Pieter Wouters +8 more
Intensive insulin therapy to maintain blood glucose at or below 110 mg per deciliter reduces morbidity and mortality among critically ill patients in the surgical intensive care unit.
New England Journal of MedicineEfficacy and Safety of Recombinant Human Activated Protein C for Severe Sepsis
6,122 Citations2001Gordon R. Bernard, Jean‐Louis Vincent +9 more
Treatment with drotrecogin alfa activated significantly reduces mortality in patients with severe sepsis and may be associated with an increased risk of bleeding.
New England Journal of MedicineIntensive versus Conventional Glucose Control in Critically Ill Patients
5,097 Citations2009Nice-Sugar Study Investigators
In this large, international, randomized trial, it was found that intensive glucose control increased mortality among adults in the ICU: a blood glucose target of 180 mg or less per deciliter resulted in lower mortality than did a target of 81 to 108 mg perDeciliter.
JAMAEffect of Treatment With Low Doses of Hydrocortisone and Fludrocortisone on Mortality in Patients With Septic Shock
3,081 Citations2002Djillali Annane
Systematic Reviews in Health Care : Meta-Analysis in Context
2,321 Citations2000Matthias Egger, George Davey Smith +1 more
The second edition of this best-selling book has been thoroughly revised and expanded to reflect the significant changes and advances made in systematic reviewing.
New England Journal of MedicineHydrocortisone Therapy for Patients with Septic Shock
2,092 Citations2008Charles L. Sprung, Djillali Annane +13 more
Hydrocortisone did not improve survival or reversal of shock in patients with septic shock, either overall or in patients who did not have a response to corticotropin, although hydroc Cortisone hastened reversal ofshock in patients in whom shock was reversed.
Annals of Internal MedicineMeta-Analysis in Clinical Research
1,280 Citations1987Kristan A. L'Abbé, ALLAN S. DETSKY +1 more
Important design and statistical issues of this process of combining study results that can be used to draw conclusions about therapeutic effectiveness or to plan new studies are reviewed.
Critical Care MedicineStress doses of hydrocortisone reverse hyperdynamic septic shock
896 Citations1999Josef Briegel, H. Forst +10 more
Infusion of stress doses of hydrocortisone reduced the time to cessation of vasopressor therapy in human septic shock and was associated with a trend to earlier resolution of sepsis-induced organ dysfunctions.
New England Journal of MedicineDrotrecogin Alfa (Activated) for Adults with Severe Sepsis and a Low Risk of Death
882 Citations2005Edward Abraham, Pierre‐François Laterre +14 more
The absence of a beneficial treatment effect, coupled with an increased incidence of serious bleeding complications, indicates that DrotAA should not be used in patients with severe sepsis who are at low risk for death, such as those with single-organ failure or an APACHE II score less than 25.
American Journal of Respiratory and Critical Care MedicineHydrocortisone Infusion for Severe Community-acquired Pneumonia
865 Citations2004Marco Confalonieri, Rosario Urbino +9 more
It is hypothesize that hydrocortisone infusion in severe community-acquired pneumonia attenuates systemic inflammation and leads to earlier resolution of pneumonia and a reduction in sepsis-related complications.
JAMACorticosteroids in the Treatment of Severe Sepsis and Septic Shock in Adults
554 Citations2009Djillali Annane, Éric Bellissant +8 more
The benefits and risks of corticosteroid treatment in severe sepsis and septic shock and the influence of dose and duration are examined and analysis of this subgroup suggests a beneficial drug effect on short-term mortality.
Critical Care MedicineLow-dose hydrocortisone improves shock reversal and reduces cytokine levels in early hyperdynamic septic shock*
329 Citations2005Michael Oppert, Ralf Schindler +7 more
Hemodynamic improvement seemed to be related to endogenous cortisol levels, whereas immune effects appeared to be independent of adrenal reserve, suggesting both hemodynamic and immunomodulatory effects of steroid treatment.
Critical Care MedicineWe should abandon randomized controlled trials in the intensive care unit
183 Citations2010Jean‐Louis Vincent
The limitations of randomized controlled trials in the intensive care unit population are discussed and the importance of considering other study designs in the challengingintensive care unit environment is highlighted.
Critical CarePhysiological-dose steroid therapy in sepsis [ISRCTN36253388]
164 Citations2002Orhan Yıldız, Mehmet Doğanay +4 more
Only Sequential Organ Failure Assessment (SOFA) score was found related to mortality, independent from other factors in multivariate analysis, and there was a trend towards a decrease in the mortality rates of the patients with sepsis who received physiological-dose steroid therapy.
LungEfficacy of Corticosteroids in the Treatment of Community-Acquired Pneumonia Requiring Hospitalization
148 Citations2007Katsunaka Mikami, Masaru Suzuki +11 more
In moderate–severe CAP, administration of corticosteroids promotes resolution of clinical symptoms and reduces the duration of intravenous antibiotic therapy.
PLoS ONEEstimating Long-Term Survival of Critically Ill Patients: The PREDICT Model
114 Citations2008Kwok M. Ho, Matthew Knuiman +2 more
Age and co-morbidity are the most important determinants of long-term prognosis of critically ill patients.
Critical CareUpdating the evidence for the role of corticosteroids in severe sepsis and septic shock: a Bayesian meta-analytic perspective
113 Citations2010John L. Moran, Petra L. Graham +2 more
Although a null effect for mortality treatment efficacy of low dose corticosteroid therapy in severe sepsis and septic shock was not excluded, there remained a high probability of treatment efficacy, more so with outlier exclusion.
Critical Care MedicineLow-dose hydrocortisone during severe sepsis: Effects on microalbuminuria
89 Citations2006Simone Rinaldi, Chiara Adembri +2 more
Low-dose hydrocortisone seems to reduce MACR and serum C-reactive protein but not procalcitonin in patients with severe sepsis, and further studies are needed to confirm these results and to understand the underlying molecular mechanisms.
Sao Paulo Medical JournalEarly dexamethasone treatment for septic shock patients: a prospective randomized clinical trial
75 Citations2007Domingos Dias Cicarelli, Joaquim Edson Vieira +1 more
Early treatment with dexamethasone reduced the seven-day mortality among septic shock patients and showed a trend towards reduction of 28-day mortality.
Statistical Methods in Medical ResearchMulticentre trials: a US regulatory perspective
46 Citations2005Charles Anello, Robert T. O’Neill +1 more
A conceptual framework for the use of multicentre trials in the context of drug development, from the perspective of drug regulation in the United States is provided.
Anesthesia & AnalgesiaPractice Misalignments in Randomized Controlled Trials
44 Citations2010Katherine J. Deans, Peter C. Minneci +3 more
How practice misalignments can affect the safety, results, and conclusions of RCTs is demonstrated and methods to prospectively identify potentially important relationships between therapy titration and patient- and disease-specific characteristics are discussed.
Intensive Care MedicineRisk of death does not alter the efficacy of hydrocortisone therapy in a mouse E. coli pneumonia model
39 Citations2007Yan Li, Xizhong Cui +8 more
The findings suggest that factors other than risk of death may underlie the differing effects of corticosteroids in recent sepsis trials.
Journal of Clinical EpidemiologyForest and funnel plots illustrated the calibration of a prognostic model: a descriptive study
24 Citations2007Kwok M. Ho
Forest and funnel plots could facilitate visual interpretation of the calibration of a prognostic model across different subgroups of critically ill patients across different risk strata and diagnostic subgroups.
Journal of Critical CareImportant issues in the design and reporting of clinical trials in severe sepsis and acute lung injury
23 Citations2008R. Phillip Dellinger, Jean‐Louis Vincent +2 more
This article reviews many of the problems encountered in clinical trial design and reporting and offers a perspective on dealing with them to the betterment of a clinical trial.
Critical CareSteroid use in PROWESS severe sepsis patients treated with drotrecogin alfa (activated)
15 Citations2005Howard Levy, Pierre‐François Laterre +2 more
Patients with severe sepsis from the PROWESS trial who were likely to respond to low-dose steroids according to the AEC were those patients at a high risk for death, however, when using the A EC, regardless of steroid use, patients exhibited a survival benefit from treatment with drotrecogin alfa (activated).
Critical CareCorticosteroids for community-acquired pneumonia: time to act!
10 Citations2008Djillali Annane, G. Umberto Meduri
There is little doubt that a prolonged administration of a moderate dose of corticosteroids may alleviate the systemic inflammatory response and subsequent organ dysfunction in severe infection.
PubMedHemofiltrastion does not influence early S-100B serum levels in septic shock patients receiving stress doses of hydrocortisone or placebo.
6 Citations2005Thomas Mussack, Josef Briegel +2 more
Early S-100B serum levels in septic shock patients receiving either stress doses of hydrocortisone or placebo were not influenced by CVVH, and for the first time, the effect of continuous veno-venous hemofiltration (CVVH) on early S- 100B serum values was analyzed, as reported for out-of-hospital cardiac arrest or severe traumatic brain injury.