Abstract:
OBJECTIVE:To review trial design issues related to control groups. DESIGN:Review of the literature with specific reference to critical care trials. MAIN RESULTS AND CONCLUSIONS:Performing randomized controlled trials in the critical care setting presents specific problems: studies include patients with rapidly lethal conditions, the majority of intensive care patients suffer from syndromes rather than from well-definable diseases, the severity of such syndromes cannot be precisely assessed, and the treatment consists of interacting therapies. Interactions between physiology, pathophysiology, and therapies are at best marginally understood and may have a major impact on study design and interpretation of results. Selection of the right control group is crucial for the interpretation and clinical implementation of results. Studies comparing new interventions with current ones or different levels of current treatments have the problem of the necessity of defining "usual care." Usual care controls without any constraints typically include substantial heterogeneity. Constraints in the usual therapy may help to reduce some variation. Inclusion of unrestricted usual care groups may help to enhance safety. Practice misalignment is a novel problem in which patients receive a treatment that is the direct opposite of usual care, and occurs when fixed-dose interventions are used in situations where care is normally titrated. Practice misalignment should be considered in the design and interpretation of studies on titrated therapies.
journal_name
Crit Care Medjournal_title
Critical care medicineauthors
Takala Jdoi
10.1097/CCM.0b013e3181922bf4subject
Has Abstractpub_date
2009-01-01 00:00:00pages
S80-90issue
1 Suppleissn
0090-3493issn
1530-0293pii
00003246-200901001-00012journal_volume
37pub_type
杂志文章abstract:OBJECTIVE:To evaluate the performance at admission to the pediatric intensive care unit (PICU) of five severity scores, two general (the Pediatric Risk of Mortality [PRISM] II and III scores) and three specific for meningococcal septic shock (Leclerc, Glasgow Meningococcal Septicemia Prognostic Score [GMSPS], and Gedde...
journal_title:Critical care medicine
pub_type: 杂志文章,多中心研究
doi:10.1097/00003246-200008000-00047
更新日期:2000-08-01 00:00:00
abstract:OBJECTIVE:This pilot study was designed to identify which contextual factors facilitate/hinder the implementation of the awakening, breathing, coordination, delirium, and early mobility (ABCDE) bundle for guidance in future studies. DESIGN:The sources of data for this study included document review, planned site visit...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e3182a2c2b1
更新日期:2013-09-01 00:00:00
abstract:OBJECTIVE:Acute renal failure can be treated with continuous renal replacement therapy (CRRT) or intermittent hemodialysis. There is no difference in mortality, although patients treated with CRRT may have a higher rate of renal recovery. Given these considerations, an estimate of the costs by modality may help in choo...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.CCM.0000045182.90302.B3
更新日期:2003-02-01 00:00:00
abstract::Little is known about the structure and objectives of various hospital ethics committees due to their need to preserve confidentiality, their reluctance to reveal internal hospital problems, and their concern about becoming involved in the developing debate about the appropriate role and value of such committees. The ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198211000-00018
更新日期:1982-11-01 00:00:00
abstract:OBJECTIVE:Inotropic and vasopressor drugs are routinely used in critically ill patients to maintain adequate blood pressure and cardiac output in patients with cardiogenic shock although potentially at the expense of increasing myocardial oxygen demand. Pacing optimization has been demonstrated as effective in reducing...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0000000000001655
更新日期:2016-08-01 00:00:00
abstract:OBJECTIVE:To investigate the cardiorespiratory effects of graded bilateral pleural effusions in the anesthetized pig. DESIGN:Prospective, randomized, controlled, laboratory study. SETTING:Animal laboratory. SUBJECTS:Eleven male Yorkshire pigs. INTERVENTIONS:Animals were anesthetized using inhaled isoflurane. Orotra...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199903000-00040
更新日期:1999-03-01 00:00:00
abstract:OBJECTIVES:To evaluate the timing of foregoing life-sustaining treatments in patients enrolled in a sepsis trial and to determine their influence on patient outcome and trial results. DESIGN:Subset of patients in a prospective, randomized, double-blind, placebo-controlled study. SETTING:Twenty-three academic medical ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199703000-00002
更新日期:1997-03-01 00:00:00
abstract:OBJECTIVE:To examine the association between the performance of a tracheostomy and intensive care unit and postintensive care unit mortality, controlling for treatment selection bias and confounding variables. DESIGN:Prospective, observational, cohort study. SETTING:Twelve French medical or surgical intensive care un...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.CCM.0000251134.96055.A6
更新日期:2007-01-01 00:00:00
abstract:OBJECTIVE:To determine whether mechanical ventilation using high tidal volume is associated with nonpulmonary organ dysfunction that can be attenuated by dexamethasone. DESIGN:Prospective randomized animal intervention study. SETTING:Animal care facility in a university hospital. SUBJECTS:Sedated and tracheostomized...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.CCM.0000205663.92384.E7
更新日期:2006-04-01 00:00:00
abstract:OBJECTIVE:To assess whether clinical variables might be useful in selecting patients who will have an acute intracranial abnormality seen in head computed tomographic scans (HCT). DESIGN:Retrospective study. SETTING:Medical intensive care unit (MICU) in a tertiary teaching hospital. MEASUREMENTS:Medical records of p...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-200005000-00008
更新日期:2000-05-01 00:00:00
abstract::Newer pulmonary function instruments make measurement of small airway function possible as a routine, inexpensive part of preoperative preparation of patients with obstructive lung disease. Patients with early stages of chronic obstructive lung disease have maldistribution of ventilation and perfusion producing an inc...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-197507000-00001
更新日期:1975-07-01 00:00:00
abstract:OBJECTIVES:Radial artery pressure is known to differ from central arterial pressure in normal patients (distal pulse amplification) and in the early postcardiopulmonary bypass period. The adequacy of the radial artery as a site for blood pressure monitoring in critically ill patients receiving high-dose vasopressors ha...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199810000-00014
更新日期:1998-10-01 00:00:00
abstract::Many clinical conditions are associated with an increase in abdominal pressure. While the effects on venous return have been studied in the past, little attention has been given to the effect of abdominal pressure on left-sided hemodynamic events. The effects of acute changes in abdominal pressure (Pab) on left ventri...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198510000-00006
更新日期:1985-10-01 00:00:00
abstract:OBJECTIVE:To determine whether chest wall vibration with tracheal gas insufflation during bronchoconstriction maintains gas exchange at lower airway and intrathoracic pressures than those that occur during positive pressure ventilation. DESIGN:Prospective study. SETTING:Experimental laboratory. SUBJECTS:Six anesthet...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-200007000-00057
更新日期:2000-07-01 00:00:00
abstract::A small, double-blind crossover study compared the efficacy of aminophylline and doxapram in ventilator weaning of eight premature infants recovering from respiratory distress syndrome (RDS). Although neither drug was significantly better than the other, four infants were weaned from mechanical ventilation after drug ...
journal_title:Critical care medicine
pub_type: 临床试验,杂志文章
doi:10.1097/00003246-198502000-00016
更新日期:1985-02-01 00:00:00
abstract::Hemodynamic effects of controlled mechanical ventilation (CMV), intermittent mandatory ventilation (IMV), and intermittent mandatory ventilation with 5 cm H20 PEEP (IMV 5 peep) were studied in 20 patients after aortocoronary bypass surgery. Significant increases in cardiac index (CI) and stroke volume index (SI) (p le...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198207000-00001
更新日期:1982-07-01 00:00:00
abstract:OBJECTIVE:To compare four different methods of endotracheal lidocaine administration with respect to the site of administration. DESIGN:Randomized controlled trial. SETTING:University hospital. PATIENTS:Thirty-two female patients (43.6 +/- 11.5 years old) undergoing elective gynecologic operations with an anesthesio...
journal_title:Critical care medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1097/00003246-199107000-00015
更新日期:1991-07-01 00:00:00
abstract::Hemodynamic effects of iso-oncotic 3% dextran-60, 6% dextran-70, and Ringer's acetate were compared in 28 male pigs (25 to 30 kg) subjected to experimental trauma and hemorrhage. The animals were kept anesthetized with 75% N2O/25% O2, 0.8% halothane. Hemodynamic and respiratory conditions were allowed to stabilize for...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198804000-00008
更新日期:1988-04-01 00:00:00
abstract::Subcutaneous, transcutaneous, and conjunctival oxygen tensions (PscO2, PtcO2, and PcjO2, respectively) were measured in anesthetized dogs subjected sequentially to normoxia, hyperoxia, and hypoxia. Intravascular pressure, hemodynamic and oxygen transport variables were measured simultaneously. PtcO2 and PcjO2 closely ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198812000-00011
更新日期:1988-12-01 00:00:00
abstract:OBJECTIVES:Measurement of blood lactate concentration in the early management of sepsis is an important step in severity assessment. High blood lactate levels in the early phase of sepsis have classically been thought to be related to tissue hypoxia, but other factors could intervene. We hypothesized that the activatio...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0000000000001308
更新日期:2015-12-01 00:00:00
abstract:OBJECTIVE:To assess the effect of a helium-oxygen mixture on intubation rate and clinical outcomes during noninvasive ventilation in acute exacerbation of chronic obstructive pulmonary disease. DESIGN:Multicenter, prospective, randomized, controlled trial. SETTING:Seven intensive care units. PATIENTS:A total of 204 ...
journal_title:Critical care medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1097/CCM.0b013e3181b78abe
更新日期:2010-01-01 00:00:00
abstract:OBJECTIVE:To explore the hypothesis that beta-1 adrenoreceptor blockade may be protective through the attenuation of sympathetic hyperactivity and catecholaminergic inflammatory effects on cardiac and hepatic function. DESIGN:Prospective, randomized, controlled study. SETTING:Animal laboratory in a university medical...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e3181c03dfa
更新日期:2010-02-01 00:00:00
abstract:OBJECTIVE:To assess clinician perceptions of a machine learning-based early warning system to predict severe sepsis and septic shock (Early Warning System 2.0). DESIGN:Prospective observational study. SETTING:Tertiary teaching hospital in Philadelphia, PA. PATIENTS:Non-ICU admissions November-December 2016. INTERVE...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0000000000003803
更新日期:2019-11-01 00:00:00
abstract:OBJECTIVE:In the pathogenesis of disseminated intravascular coagulation, dysfunctional natural anticoagulant pathways appear to play a pivotal role. In this article, we will address the mechanisms that contribute to this defect in the regulation of coagulation activation. Furthermore, we will explore the experimental a...
journal_title:Critical care medicine
pub_type: 杂志文章,评审
doi:10.1097/00003246-200107001-00028
更新日期:2001-07-01 00:00:00
abstract::Varying concentrations of lipopolysaccharide (LPS) and mannan suspensions were mixed with either saline or plasma from normal volunteers, heated to 100 degrees C for 10 min, and then subjected to the limulus amebocyte lysate test (LAL). A positive LAL in saline required minimum LPS and mannan concentrations of 10(-11)...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198512000-00016
更新日期:1985-12-01 00:00:00
abstract:OBJECTIVE:To discuss the potential therapeutic value of intraluminal oxygenation of the gut in critical illness. DATA SOURCES:Relevant articles published in the English language literature. STUDY SELECTION:No special study has been carried out for the present presentation. DATA EXTRACTION:Information from the litera...
journal_title:Critical care medicine
pub_type: 杂志文章,评审
doi:10.1097/00003246-199302001-00012
更新日期:1993-02-01 00:00:00
abstract:BACKGROUND:Increased intracranial pressure (ICP) worsens the outcome of acute liver failure (ALF). This study investigates the underlying pathophysiological mechanisms and evaluates the therapeutic effect of albumin dialysis in ALF with use of the Molecular Adsorbents Recirculating System without hemofiltration/dialysi...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.ccm.0000196203.39832.3c
更新日期:2006-01-01 00:00:00
abstract:OBJECTIVES:To investigate attitudes and practices regarding oxygen therapy in intensive care units (ICUs) and to devise quantitative descriptive indices. SETTING:Canadian university-affiliated adult ICUs. PARTICIPANTS:Fifty-two medical directors of ICUs in 48 institutions. INTERVENTION:Structured postal questionnair...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199912000-00033
更新日期:1999-12-01 00:00:00
abstract:OBJECTIVES:Fever is common and associated with increased mortality among patients admitted to adult ICUs, yet recent literature suggests that the incidence of fever may be decreasing. The objective of this study was to determine whether the incidence of fever in adult ICUs changed over time and the factors responsible ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e31828a43b2
更新日期:2013-08-01 00:00:00
abstract::Reproducibility of thermal-dye extravascular lung water (EVLW) estimation by a lung water computer was studied by performing ten consecutive measurements in 45 critically ill patients. EVLW ranged over a wide spectrum from 187 to 1163 ml (2.4 to 18.6 ml/kg). The mean coefficient of variation of ten consecutive measure...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198706000-00014
更新日期:1987-06-01 00:00:00