Related Experiment Video
Updated: Jun 26, 2025

Psychophysically-anchored, Robust Thresholding in Studying Pain-related Lateralization of Oscillatory Prestimulus Activity
Published on: January 21, 2017
Application of the Estimand Framework to Anesthesia Trials
Anurika P De Silva1, Kate Leslie2, Sabine Braat3
1Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia; Methods and Implementation Support for Clinical and Health (MISCH) research Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia.
The estimand framework helps anesthesia trials precisely define treatment effects, addressing post-randomization events like medication changes or death. Clear estimand definition is vital for relevant and understandable clinical trial results.
Area of Science:
- Anesthesiology
- Clinical Trials
- Biostatistics
Background:
- Intercurrent events (e.g., rescue medication, discontinuation, death) are common in randomized trials.
- These events can complicate the interpretation of trial outcomes.
- Standard methods for handling intercurrent events are often unclear.
Purpose of the Study:
- To describe the application of the estimand framework in anesthesia trials.
- To explain how the estimand framework precisely defines treatment effects.
- To illustrate handling intercurrent events in anesthesia research.
Main Methods:
- Utilizing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E9(R1) addendum.
- Applying the estimand framework to define treatment effects.
- Illustrating with a hypothetical trial on postoperative delirium.
Main Results:
- The estimand framework aligns trial objectives with design, conduct, analysis, and interpretation.
- It provides strategies for managing common intercurrent events in anesthesia trials.
- Facilitates precise definition of the treatment effect of interest.
Conclusions:
- Clear estimand definition is crucial for planning anesthesia trials.
- Ensures that the estimated treatment effect is clearly understood and clinically relevant.
- Aids in answering key clinical questions effectively.
More Related Videos
08:49Assessing Changes in Volatile General Anesthetic Sensitivity of Mice after Local or Systemic Pharmacological Intervention
Published on: October 16, 2013
14:52Recording Brain Electromagnetic Activity During the Administration of the Gaseous Anesthetic Agents Xenon and Nitrous Oxide in Healthy Volunteers
Published on: January 13, 2018
Related Concept Videos
Local Anesthetics: Clinical Application as Epidural Anesthesia
Since epidural anesthetics can be infused through an epidural catheter, all types of drugs, including short-acting ones, can be administered. Chloroprocaine and lidocaine are examples of short and long-duration anesthetics, respectively. Bupivacaine...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
What are Estimates?
The estimate for the mean of a sample is denoted by ͞x, whereas the mean of the population is designated as μ. Further, parameters such...
Stages of General Anesthesia
Inhalational Anesthetics: Overview
Kaplan-Meier Approach