CONSORT

CONSORT Statement

What Is the CONSORT Statement?

The CONSORT (Consolidated Standards of Reporting Trials) statement is a set of evidence-based guidelines designed to improve the reporting of randomized controlled trials (RCTs). It ensures that trials are transparent, reproducible, and interpretable, reducing bias and improving research quality.

The CONSORT 2010 statement consists of:

A 25-item checklist covering trial design, participant flow, outcomes, and statistical analysis.
A flow diagram that illustrates participant enrollment, allocation, follow-up, and analysis.

CONSORT is widely endorsed by journals, regulatory bodies, and ethics committees to enhance the quality of clinical trial reporting.

CONSORT Extensions

Several CONSORT extensions exist to address specific trial designs, types of interventions, outcomes, populations, and alternative reporting formats.

1. Extensions for Different Trial Designs

Cluster Randomized Trials – For trials where groups (e.g., schools, hospitals) are randomized instead of individuals.
Crossover Trials – For trials where participants receive multiple interventions in sequence.
Non-Inferiority and Equivalence Trials – For trials testing whether a new treatment is not worse than or similar to a standard treatment.
Stepped-Wedge Trials – For trials with phased implementation of the intervention across clusters.
Adaptive Trials – For trials that modify the study design based on interim results.

2. Extensions for Different Types of Interventions

Herbal Medicine Trials – For plant-based therapeutic interventions.
Acupuncture Trials – For traditional acupuncture and related interventions.
Psychological and Behavioral Trials – For non-pharmacological behavioral health interventions.
Complex Interventions – For interventions involving multiple components (e.g., community or public health programs).

3. Extensions for Different Outcomes or Populations

Harms (Adverse Events) – Ensures transparent and complete reporting of side effects and safety data.
Patient-Reported Outcomes (PROs) – Focuses on participant-experienced outcomes such as quality of life and symptom burden.
Social and Psychological Interventions – For trials evaluating social, behavioral, and educational interventions.
Children-Specific Trials – Addresses considerations unique to pediatric research.

4. Extensions for Alternative Reporting Methods

Abstracts – Guidance for reporting trials concisely in structured journal abstracts.
Individual Participant Data (IPD) Meta-Analysis – For trials contributing data to IPD-based meta-analyses.

Conclusion

The CONSORT statement and its extensions enhance the clarity, completeness, and reliability of RCT reporting across diverse designs, interventions, and populations. Adoption of CONSORT improves scientific rigor, ethical standards, and usability of trial findings for clinical practice and policy.

For more information and access to CONSORT checklists and flow diagrams, visit the official CONSORT website.