On the need for observational studies to design and interpret randomized trials in ICU patients: a case study in stress ulcer prophylaxis

Cook, Deborah J.; Heyland, Daren K.; Marshall, John C.

doi:10.1007/s001340000828

Cited by 25 publications

(13 citation statements)

References 38 publications

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“…Although providing the highest form of evidence, the RCT is not the only form, and qualitative and observational studies also have their place in the evidence base for or against any intervention (96,97). Many of the therapeutic interventions in the ICU are, in fact, life-saving and therefore cannot be studied by an RCT as it would not be feasible or ethically permissible to have a control group (e.g., use of pacemakers in advanced heart block, administration of vasopressor agents in fluid-resistant hypotension, use of mechanical ventilation in acute respiratory failure).…”

Section: Discussionmentioning

confidence: 99%

Multicenter, randomized, controlled trials evaluating mortality in intensive care: Doomed to fail?

Ospina-Tascón

Büchele

Vincent

2008

Critical Care Medicine

157

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This literature search demonstrates that relatively few of the randomized controlled trials conducted in intensive care units and using mortality as a primary outcome show a beneficial impact of the intervention on the survival of critically ill patients. Methodological limitations of some of the randomized controlled trials may have prevented positive results. Other forms of evidence and end points other than mortality need to be considered when evaluating interventions in critically ill patients.

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Section: Discussionmentioning

confidence: 99%

Multicenter, randomized, controlled trials evaluating mortality in intensive care: Doomed to fail?

Ospina-Tascón

Büchele

Vincent

2008

Critical Care Medicine

157

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“…This approach typically involves descriptive, epidemiologic, and observational studies (64). Systematic reviews and meta-analyses provide key RCT epidemiologic data, including incidence and risk factors (65, 66).…”

Section: Approachmentioning

confidence: 99%

Research as a Standard of Care in the PICU*

Zimmerman

Anand

Meert

et al. 2016

Pediatric Critical Care Medicine

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Background Excellence in clinical care coupled with basic and applied research reflects the maturation of a medical subspecialty, advances that field, and provides objective data for identifying best practices. Pediatric intensive care units (PICU) are uniquely suited for conducting translational and clinical research. Moreover, multiple investigations have reported that a majority of parents are interested in their children’s participation in clinical research, even when the research offers no direct benefit to their child. However, such activity may generate ethical conflict with bedside care providers trying to acutely identify the best approach for an individual critically ill child. Ultimately, this conflict may diminish enthusiasm for the generation of scientific evidence that supports application of evidence-based medicine into PICU clinical standard work. Objective Provide an overview of current state PICU clinical research strengths, liabilities, opportunities, and barriers, and contrast this with an established pediatric hematology-oncology iterative research model that constitutes a learning healthcare system. Design Narrative review of medical literature published in English. Conclusions Currently most PICU therapy is not evidence-based. Developing a learning healthcare system in the PICU integrates clinical research into usual practice and fosters a culture of evidence-based learning and continual care improvement. As PICU mortality has significantly decreased, identification and validation of patient-centered, clinically relevant research outcome measures other than mortality is essential for future clinical trial design. Because most pediatric critical illness may be classified as rare diseases, participation in research networks will facilitate iterative, collaborative, multi-institutional investigations that over time identify best practices to improve PICU outcomes. Despite real ethical challenges, critically ill children and their families should have the opportunity to participate in translational/clinical research whenever feasible.

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“…S tudies of service and therapy provision in critical care frequently use observational designs (1,2). These rely on robust, valid risk adjustment to reduce bias and ensure highquality methodology (3)(4)(5).…”

mentioning

confidence: 99%

A new risk prediction model for critical care: The Intensive Care National Audit & Research Centre (ICNARC) model*

Harrison

Parry

Carpenter

et al. 2007

Critical Care Medicine

191

167

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On the need for observational studies to design and interpret randomized trials in ICU patients: a case study in stress ulcer prophylaxis

Cited by 25 publications

References 38 publications

Multicenter, randomized, controlled trials evaluating mortality in intensive care: Doomed to fail?

Multicenter, randomized, controlled trials evaluating mortality in intensive care: Doomed to fail?

Research as a Standard of Care in the PICU*

A new risk prediction model for critical care: The Intensive Care National Audit & Research Centre (ICNARC) model*

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