Abstract:
OBJECTIVES:The Fragility Index, which represents the number of patients responsible for a statistically significant finding, has been suggested as an aid for interpreting the robustness of results from clinical trials. A small Fragility Index indicates that the statistical significance of a trial depends on only a few events. Our objectives were to calculate the Fragility Index of statistically significant results from randomized controlled trials of anesthesia and critical care interventions and to determine the frequency of distorted presentation of results or "spin". DATA SOURCES:We systematically searched MEDLINE from January 01, 2007, to February 22, 2017, to identify randomized controlled trials exploring the effect of critical care medicine or anesthesia interventions. STUDY SELECTION:Studies were included if they randomized patients 1:1 into two parallel arms and reported at least one statistically significant (p < 0.05) binary outcome (primary or secondary). DATA EXTRACTION:Two reviewers independently assessed eligibility and extracted data. The Fragility Index was determined for the chosen outcome. We assessed the level of spin in negative trials and the presence of recommendations for clinical practice in positive trials. DATA SYNTHESIS:We identified 166 eligible randomized controlled trials with a median sample size of 207 patients (interquartile range, 109-497). The median Fragility Index was 3 (interquartile range, 1-7), which means that adding three events to one of the trials treatment arms eliminated its statistical significance. High spin was identified in 42% (n = 30) of negative randomized controlled trials, whereas 21% (n = 20) of positive randomized controlled trials provided recommendations. Lower levels of spin and recommendations were associated with publication in journals with high impact factors (p < 0.001 for both). CONCLUSIONS:Statistically significant results in anesthesia and critical care randomized controlled trials are often fragile, and study conclusions are frequently affected by spin. Routine calculation of the Fragility Index in medical literature may allow for better understanding of trials and therefore enhance the quality of reporting.
journal_name
Crit Care Medjournal_title
Critical care medicineauthors
Grolleau F,Collins GS,Smarandache A,Pirracchio R,Gakuba C,Boutron I,Busse JW,Devereaux PJ,Le Manach Ydoi
10.1097/CCM.0000000000003527subject
Has Abstractpub_date
2019-03-01 00:00:00pages
456-462issue
3eissn
0090-3493issn
1530-0293journal_volume
47pub_type
杂志文章abstract:RATIONALE:Life and death triage decisions are made daily by intensive care unit physicians. Admission to an intensive care unit is denied when intensive care unit resources are constrained, especially for the elderly. OBJECTIVE:To determine the effect of intensive care unit triage decisions on mortality and intensive ...
journal_title:Critical care medicine
pub_type: 杂志文章,多中心研究
doi:10.1097/CCM.0b013e318232d6b0
更新日期:2012-01-01 00:00:00
abstract:OBJECTIVES:To evaluate the ability of central venous-to-arterial carbon dioxide pressure difference, central venous oxygen saturation, and the combination of these two parameters to detect extubation failure in critically ill patients. DESIGN:Multicentric, prospective, observational study. SETTING:Three ICUs. PATIEN...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0000000000004446
更新日期:2020-10-01 00:00:00
abstract:OBJECTIVES:To review the difficulties associated with defining sepsis and its complications and to characterize the role of the proinflammatory cytokines in the development of human septic shock, adult respiratory distress syndrome, and the systemic inflammatory response syndrome. DATA SOURCES:Information presented at...
journal_title:Critical care medicine
pub_type: 杂志文章,评审
doi:
更新日期:1994-07-01 00:00:00
abstract:OBJECTIVE:Addressing the quality gap in ICU-based palliative care is limited by uncertainty about acceptable models of collaborative specialist and generalist care. Therefore, we characterized the attitudes of physicians and nurses about palliative care delivery in an ICU environment. DESIGN:Mixed-methods study. SETT...
journal_title:Critical care medicine
pub_type: 杂志文章,多中心研究
doi:10.1097/CCM.0000000000002099
更新日期:2017-04-01 00:00:00
abstract:OBJECTIVE:To investigate whether inhibition of cyclooxygenase-2, a critical component of the inflammatory pathway, is neuroprotective in a neonatal rat model of cerebral hypoxia-ischemia. The development of brain inflammation largely contributes to neonatal brain injury that may lead to a lifetime of neurologic deficit...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e3181cb1158
更新日期:2010-02-01 00:00:00
abstract:OBJECTIVE:The emergency department (ED) often serves as the first site for the recognition and treatment of patients with suspected severe sepsis. However, few evaluations of the national epidemiology and distribution of severe sepsis in the ED exist. We sought to determine national estimates of the number, timing, ED ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.CCM.0000277043.85378.C1
更新日期:2007-08-01 00:00:00
abstract:BACKGROUND:Extravascular lung water is a quantitative marker of the amount of fluid in the thoracic cavity besides the vasculature. Indexing to both predicted and actual body weight have been proposed to compare different individuals and provide a uniform range of normal. OBJECTIVE:We explored extravascular lung water...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e318275cd75
更新日期:2013-04-01 00:00:00
abstract::Thirty-three patients underwent extensive cardiorespiratory monitoring during cardiac surgery. Recordings of measurements, with derived variables, were made preoperatively, postoperatively, and after extubation approximately 3 h after operation. The data provide a reference that allows decisions on whether the conditi...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:
更新日期:1981-07-01 00:00:00
abstract:OBJECTIVES:To determine whether excessive alcohol consumption increases the risk for intensive care unit (ICU)-acquired bacterial infection, especially ventilator-associated pneumonia (VAP), in nontrauma patients. DESIGN:Prospective observational cohort study. SETTING:A 21-bed polyvalent ICU in a university hospital....
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e318174dd75
更新日期:2008-06-01 00:00:00
abstract::Checklists have been recently promulgated as a method to enhance patient safety and improve outcomes for critically ill patients. Specifically, recent work performed by researchers from the Johns Hopkins Medical Institutions has demonstrated that the addition of checklists to usual care in the intensive care unit is a...
journal_title:Critical care medicine
pub_type: 杂志文章,评审
doi:10.1097/CCM.0b013e31819541f8
更新日期:2009-02-01 00:00:00
abstract:OBJECTIVE:To study whether noninvasive pressure support ventilation (NIPSV) with helium/oxygen (He/oxygen), which can reduce dyspnea, PaCO2, and work of breathing more than NIPSV with air/oxygen in decompensated chronic obstructive pulmonary disease, could have beneficial consequences on outcome and hospitalization cos...
journal_title:Critical care medicine
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1097/01.CCM.0000055369.37620.EE
更新日期:2003-03-01 00:00:00
abstract:OBJECTIVE:To determine the blood discard volume, as a multiple of deadspace, that is required for accurate arterial blood gas and electrolyte testing from arterial catheters. DESIGN:Prospective, controlled, crossover trial. SETTING:Eighteen-bed intensive care unit of a metropolitan teaching hospital. PATIENTS:A tota...
journal_title:Critical care medicine
pub_type: 临床试验,杂志文章
doi:10.1097/01.CCM.0000063448.98777.EF
更新日期:2003-06-01 00:00:00
abstract:OBJECTIVE:To study the impact of a clinical pharmacist in a pediatric intensive care unit. The goals of the study were to determine the type and quantity of patient care interventions recommended by a clinical pharmacist and to specifically examine cost savings (or loss) that resulted from clinical pharmacist recommend...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-200204000-00035
更新日期:2002-04-01 00:00:00
abstract::The records of 101 drowning or near-drowning victims admitted to Children's Hospital of Los Angeles (CHLA) between January 1975 and June 1978 were reviewed. The admission Glasgow coma score could be assigned retrospectively to 94 patients. A low score (less than 5) predicted a high risk group of patients with 80% mort...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:
更新日期:1981-07-01 00:00:00
abstract:OBJECTIVE:The Cardiac Arrhythmia Suppression Trial II showed that moricizine acutely increases the occurrence of sudden cardiac death. Thus the objective of this investigation was to evaluate the antifibrillatory properties of moricizine (a new antiarrhythmic agent) alone and in combination with lidocaine (an establish...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199310000-00029
更新日期:1993-10-01 00:00:00
abstract:OBJECTIVE:Our intent was to evolve a prognosticator that would predict the likelihood that an electrical shock would restore a perfusing rhythm. Such a prognosticator was to be based on conventional electrocardiographic signals but without constraints caused by artifacts resulting from precordial compression. The adver...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-200112000-00019
更新日期:2001-12-01 00:00:00
abstract:OBJECTIVE:To evaluate the in vivo production of prostacyclin and thromboxane A2 during the initial phase of experimental fat embolism as assessed, respectively, by determinations of urine 2,3-dinor-6-ketoprostaglandin F1alpha and 11-dehydrothromboxane B2 excretion. DESIGN:Randomized, controlled trial. SETTING:Animal ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199707000-00025
更新日期:1997-07-01 00:00:00
abstract::A new iridium/iridium-oxide electrode heated to 42 degrees C was used to monitor transcutaneous carbon dioxide levels during surgery in 27 adult patients. The purpose of this study was to compare arterial and transcutaneous CO2 values. This metal electrode performed similarly to glass CO2 electrodes. In addition, its ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198510000-00015
更新日期:1985-10-01 00:00:00
abstract:OBJECTIVE:Catheter-associated infections are common, costly, and potentially lethal. The impact of catheter insertion site on infection risk remains controversial. We aimed to establish whether nontunneled central venous catheters inserted in the subclavian vein are associated with lower risk of catheter-associated inf...
journal_title:Critical care medicine
pub_type: 杂志文章,meta分析
doi:10.1097/CCM.0b013e31823e99cb
更新日期:2012-05-01 00:00:00
abstract:OBJECTIVE:Although it is established that septic shock induces immunosuppression, the mechanisms for this phenomenon remain poorly understood. Human leukocyte antigen-G exerts strong inhibitory effects that are directed at different arms of the immune system. The main objective of the current study was to measure human...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.CCM.0000277039.84372.1C
更新日期:2007-08-01 00:00:00
abstract:OBJECTIVE:To determine whether blood lactate, base deficit, or oxygen-derived hemodynamic variables correlate with morbidity and mortality rates in a clinically-relevant LD50 model of penetrating trauma. DESIGN:Prospective, controlled study. SETTING:University research laboratory. SUBJECTS:Anesthetized, mechanically...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199901000-00044
更新日期:1999-01-01 00:00:00
abstract:OBJECTIVE:To determine the number of adult or pediatric intensive care unit patients without documented invasive fungal infection who receive systemic antifungal therapy. DESIGN:A 1-day cross-sectional cohort study. SETTING:One hundred sixty-nine intensive care units in France and Belgium. PATIENTS:All patients stay...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e318236f297
更新日期:2012-03-01 00:00:00
abstract:OBJECTIVE:Pressure inflating the lung during mechanical ventilation is the difference between pressure applied at the airway opening (Pao) and pleural pressure (Ppl). Depending on the chest wall's contribution to respiratory mechanics, a given positive end-expiratory and/or end-inspiratory plateau pressure may be appro...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.CCM.0000215515.49001.A2
更新日期:2006-05-01 00:00:00
abstract:BACKGROUND AND METHODS:The purpose of this study was twofold: the development of a chronic model of leukocyte-mediated pulmonary injury and the evaluation of the protective effects of methylprednisolone. Rabbits were inoculated ip with zymosan. Blood gases and circulating leukocytes were evaluated. Survivors were kille...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199102000-00023
更新日期:1991-02-01 00:00:00
abstract:OBJECTIVES:Controversy exists regarding the ideal injectate temperature for measuring cardiac output. Iced temperature injectate gives a higher signal/noise ratio and less variability in the measured cardiac output. Thus, less volume and fewer measurements are required. Advocates of room temperature injectate have sugg...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199603000-00021
更新日期:1996-03-01 00:00:00
abstract::Standard techniques for measuring pulmonary resistance (RP) to gas flow in newborn infants yield results that are widely dispersed and difficult to interpret. The purpose of this study is to describe and evaluate a new improved method for determining RP which utilizes a sinusoidal pressure wave generator. Measurements...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198307000-00015
更新日期:1983-07-01 00:00:00
abstract:OBJECTIVE:To compare the scales and predictive power for hospital mortality of three recent multiple organ dysfunction scores. DESIGN:Prospective, observational, validation cohort study. SETTING:A ten-bed medical-surgical intensive care unit in a Finnish tertiary care hospital. PATIENTS:Among the 591 consecutive pat...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-200208000-00005
更新日期:2002-08-01 00:00:00
abstract:OBJECTIVE:To compare the impact of two different customization strategies in the performance of the admission Mortality Probability Model II (MPM II0) using formal statistical assessment. DESIGN:Analysis of the database of a multicenter, multinational, prospective cohort study, EURICUS-1, involving 89 intensive care u...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199712000-00017
更新日期:1997-12-01 00:00:00
abstract:OBJECTIVE:Carbon monoxide (CO), an endogenous byproduct of heme metabolism, is produced at high levels in injured tissue via induction of heme-oxygenase-1 activity, where it contributes to the modulation of proinflammatory processes. Alone, CO has potent anti-inflammatory effects in models of acute and chronic inflamma...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.ccm.0000166349.76514.40
更新日期:2005-06-01 00:00:00
abstract:OBJECTIVES:Clinical applications of inhaled nitric oxide (NO) therapy resulted in the development of delivery systems and monitoring devices applicable to routine clinical care. This article presents the various components necessary for an adequate clinical use of inhaled NO, and discusses the NO gas mixture cylinders,...
journal_title:Critical care medicine
pub_type: 杂志文章,评审
doi:10.1097/00003246-199804000-00033
更新日期:1998-04-01 00:00:00