Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials
Author Information
Author(s): Huić Mirjana, Marušić Matko, Marušić Ana
Primary Institution: Agency for Quality and Accreditation in Health Care, Zagreb, Croatia
Hypothesis
How well do ICMJE journals follow their own registration requirement policy for randomized controlled trials?
Conclusion
ICMJE journals published RCTs with proper registration, but the registration data were often inadequate and underwent substantial changes over time.
Supporting Evidence
- 66.4% of RCTs were registered before the ICMJE deadline.
- 77.6% of RCTs started recruitment before registration.
- 44.1% of RCTs had missing key secondary outcomes.
- 38.8% of RCTs had missing primary outcomes.
- Major changes were found in 25.2% of RCTs.
Takeaway
The study looked at clinical trials to see if they were registered properly and found that many had missing or changed information, which can make it hard to trust the results.
Methodology
The study evaluated 152 RCTs published in ICMJE journals, assessing the completeness of registration data and changes made to that data over time.
Potential Biases
Potential bias due to the retrospective nature of the study and the small number of RCTs registered after the ICMJE deadline.
Limitations
The study only assessed one registry, ClinicalTrials.gov, and had a retrospective design.
Participant Demographics
The majority of RCTs included both genders as participants.
Statistical Information
P-Value
0.007
Confidence Interval
95% CI 3–5
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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