Related Experiment Video
Updated: May 28, 2026
08:36
The Adjuvant Efficacy of Angong Niuhuang Pill in the Treatment of Viral Encephalitis: A Meta-Analysis of Randomized Controlled Trials
Published on: April 19, 2024
CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.
David Moher1, Sally Hopewell, Kenneth F Schulz
1Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada. dmoher@ohri.ca
International Journal of Surgery (London, England)
|November 1, 2011
Summary
The CONSORT 2010 Statement enhances reporting quality for randomised controlled trials (RCTs). This updated guideline improves clarity and addresses issues like selective outcome reporting bias for better trial validity.
Area of Science:
- Clinical Trials Methodology
- Evidence-Based Medicine
- Scientific Reporting Standards
Background:
- Inconsistent reporting of randomised controlled trials (RCTs) hinders assessment of findings' reliability and validity.
- Inadequate trial design and reporting are linked to biased treatment effect estimates, compromising the integrity of research.
- The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to address these quality issues in RCT reporting.
Purpose of the Study:
- To present the revised CONSORT 2010 Statement, an update aimed at improving the quality of RCT reporting.
- To provide an updated explanation and elaboration document to enhance understanding and application of the CONSORT statement.
- To incorporate recent advancements and recognized issues, such as selective outcome reporting bias, into reporting guidelines.
Main Methods:
- Revision of the CONSORT checklist based on expert meetings and scientific evidence.
- Development of an updated explanatory and elaboration document detailing the rationale and examples for each checklist item.
- Inclusion of guidance on flow diagrams and addressing emerging reporting concerns.
Main Results:
- The CONSORT 2010 Statement offers improved wording and clarity over previous versions.
- The updated guidelines incorporate recommendations for newly recognized reporting issues like selective outcome reporting bias.
- The accompanying explanation and elaboration document provides practical examples and references to support good reporting practices.
Conclusions:
- The CONSORT 2010 Statement and its supporting documents serve as crucial resources for improving the reporting of randomised controlled trials.
- Enhanced transparency in RCT reporting facilitates critical appraisal, interpretation, and the extraction of reliable data for systematic reviews.
- Adherence to CONSORT 2010 guidelines promotes higher standards in clinical trial reporting, ultimately benefiting scientific validity and patient care.
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...
01:12Hazard Ratio
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial evaluating a...
For example, in a clinical trial evaluating a...
01:11Clinical Trials: Overview
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...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
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, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
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.
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...