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Updated: Oct 29, 2025

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
What outcomes should be evaluated in critically ill patients?
Cassiano Teixeira1, Marcelo Kern2, Regis Goulart Rosa3
1Departamento de Clínica Médica, Programa de Pós-Graduação de Ciências da Reabilitação, Universidade Federal de Ciências da Saúde de Porto Alegre - Porto Alegre (RS), Brasil.
Randomized clinical trials in intensive care need to shift focus from disease outcomes to patient-centered measures like quality of life and symptoms. Overcoming barriers to implementing these patient-centered outcomes is crucial for better reflecting patient and family wishes.
Area of Science:
- Critical care medicine
- Clinical trial design
- Patient-centered outcomes research
Background:
- Randomized clinical trials in intensive care predominantly focus on disease-specific outcomes.
- There is a growing need to incorporate patient-centered outcomes that reflect patients' and families' priorities.
Purpose of the Study:
- To advocate for a paradigm shift in intensive care research towards patient-centered outcomes.
- To highlight the importance of post-discharge measures, quality of life, and symptom assessment (e.g., pain, dyspnea).
Main Methods:
- This study is a conceptual review and discussion of current practices in intensive care clinical trials.
- It analyzes barriers hindering the adoption of patient-centered outcomes.
Main Results:
- Current intensive care trial methodologies prioritize disease-focused outcomes over patient-centered ones.
- Significant barriers exist, including challenges in outcome interpretation, diverse measurement tools, and study complexity.
Conclusions:
- A transition to patient-centered outcomes in intensive care research is essential to align with patient and family values.
- Addressing methodological and systemic barriers, and fostering collaborative outcome definition are necessary for this shift.
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