Abstract

Researchers designing pragmatic, multi-centre randomised controlled trials (RCTs) in critical care are faced with numerous potential methodological challenges. These challenges can be outlined using PICO terminology:

Highlights

  • Researchers designing pragmatic, multi-centre randomised controlled trials (RCTs) in critical care are faced with numerous potential methodological challenges

  • These challenges can be outlined using PICO terminology: Population Unlike many other clinical areas, patients admitted to intensive care units (ICUs) do not have identifiable diseases, but are classified as having syndromes with hazy definitions that may be inconsistently applied both within and between centres

  • Control and experimental care are complex interventions with minimal differences between treatment protocols and there is a risk of treatment contamination due to creep from control to intervention treatment, when blinding is not feasible

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Summary

Introduction

Researchers designing pragmatic, multi-centre randomised controlled trials (RCTs) in critical care are faced with numerous potential methodological challenges. Methodological challenges designing pragmatic, multi-centre randomised controlled trials in critical care From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK.

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