Related Experiment Video
Updated: Jul 11, 2026
09:07
Techniques of Endoscopic Ossiculoplasty
Published on: January 26, 2024
Randomized controlled trials in otolaryngology journals
Francisca Yao1, Michael Singer, Richard M Rosenfeld
1Department of Otolaryngology, State University of New York, Downstate Medical Center, Brooklyn, NY, USA. fbyao@msn.com
Summary
Randomized controlled trials (RCTs) are infrequent in otolaryngology journals. However, these studies often use intent-to-treat analysis and show no publication bias or low power issues.
Area of Science:
- Otolaryngology
- Clinical Research
- Evidence-Based Medicine
Background:
- Randomized controlled trials (RCTs) are crucial for establishing treatment efficacy.
- Understanding trends in RCTs within specialized fields like otolaryngology is important for research design and clinical interpretation.
Purpose of the Study:
- To identify trends in the publication of randomized controlled trials (RCTs) focusing on treatment efficacy in major otolaryngology journals.
- To analyze the characteristics and methodological quality of these RCTs.
Main Methods:
- A comprehensive review of all articles published between 2000 and 2005 in four leading otolaryngology journals was conducted.
- Data extracted included study design, quality, author conclusions, adverse events, and funding sources.
Main Results:
- Only 3.7% of the 5467 articles reviewed were RCTs of treatment efficacy.
- Over half of the RCTs received funding from for-profit, not-for-profit organizations, or both.
- Intent-to-treat analysis was employed in 58% of trials, P values in 88%, and confidence intervals in only 11%.
Conclusions:
- RCTs remain uncommon in otolaryngology literature.
- The use of intent-to-treat analysis is prevalent.
- No evidence of publication bias related to study funding or low statistical power in equivalence-claiming studies was found.
Related Concept Videos
01:13Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:11Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.