CONSORT: Difference between revisions

Latest revision as of 18:44, 27 June 2025

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.

For more information on CONSORT extensions, visit the EQUATOR Network Website.

Bibliography

Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.
Schulz KF, Altman DG, Moher D; for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Annals of Internal Medicine. 2010;152(11):726–732.
Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database of Systematic Reviews. 2012;11:MR000030.
Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomised trials in journal and conference abstracts. The Lancet. 2008;371(9609):281–283.
Ioannidis JPA, Evans SJW, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Annals of Internal Medicine. 2004;141(10):781–788.

Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.

@@ Line 16: / Line 16: @@
 ==== 1. Extensions for Different Trial Designs ====
-* '''Cluster Randomized Trials''' – For trials where groups (e.g., schools, hospitals) are randomized instead of individuals.
+* '''[[Cluster randomized trials|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.
@@ Line 30: / Line 30: @@
 ==== 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.
+* '''[[Patient-reported outcomes|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.
@@ Line 45: / Line 45: @@
 ''For more information and access to CONSORT checklists and flow diagrams, visit the official [https://www.consort-statement.org CONSORT website].''
+''For more information on CONSORT extensions, visit the [https://www.equator-network.org/?post_type=eq_guidelines&eq_guidelines_study_design=experimental-studies&eq_guidelines_clinical_specialty=0&eq_guidelines_report_section=0&s= EQUATOR Network Website]. ''
 === Bibliography ===