Related Experiment Video
Updated: Oct 13, 2025
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
10.8K
Innovation and Tribulation in the History of Randomized Controlled Trials in Surgery
Laura E Bothwell1, David S Jones2
1Health Sciences Department, Worcester State University, Worcester, Massachusetts.
Annals of Surgery
|November 17, 2021
Summary
Surgeons have a long history of conducting rigorous empirical studies, contributing significantly to evidence-based medicine and the development of randomized controlled trials (RCTs). Despite challenges, strengthening trial support can advance surgical research.
Area of Science:
- Medical research methodology
- Surgical innovation and evidence-based practice
Background:
- Surgeons have historically contributed to empirical research and evidence-based medicine.
- Innovative trial designs and methods, including randomized controlled trials (RCTs), have been embraced by surgeons.
- The development of surgical research methods parallels advancements in evidence-based medicine.
Observation:
- Surgical trials have unique historical contexts, differing from pharmaceutical research.
- New surgical procedures have often been adopted without prior RCTs.
- RCTs in surgery are frequently initiated in response to controversy surrounding established procedures.
Findings:
- RCTs in surgery have historically supported, rather than dictated, changes in surgical judgment.
- Surgeons face distinct methodological and ethical challenges in blinded and sham-controlled trials.
- Surgical trialists have made significant contributions to evidence-based medicine despite persistent challenges.
Implications:
- Enhanced and systematic support is crucial for the future advancement of surgical RCTs.
- Addressing methodological and ethical complexities in surgical trials is essential.
- Continued surgeon engagement in rigorous research will further refine evidence-based surgical practices.
Related Concept Videos
01:13Randomized Experiments
8.2K
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...
8.2K
01:16Clinical Trials
9.7K
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...
9.7K
01:11Blinding
3.5K
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.
3.5K
01:11Clinical Trials: Overview
3.7K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.7K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
197
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
197
01:21Inflammatory Bowel Disease V: Surgical Management
246
Surgical interventions for inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn's disease, are essential in managing symptoms and addressing complications. The selection of surgical procedures is contingent upon the specific conditions and complications that stem from these illnesses.
Here are some common surgical interventions for IBD:
Here are some common surgical interventions for IBD:
246