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Missing Outcome Data in Recent Perinatal and Neonatal Clinical Trials
Guowei Li1,2, Yingxin Liu1, Jingyi Zhang1
1Center for Clinical Epidemiology and Methodology.
Pediatrics
|February 23, 2024
Summary
Missing outcome data is common in neonatal trials, often inadequately handled. Prevention through careful study design is crucial for reliable clinical trial results.
Area of Science:
- Clinical Trials Methodology
- Neonatal Research
- Biostatistics
Background:
- Missing outcome data in clinical trials can compromise results and clinical practice.
- Neonatal intensive care unit (NICU) patients have high attrition risk for long-term outcome ascertainment post-discharge.
Purpose of the Study:
- To review the handling of missing primary outcome data in perinatal and neonatal randomized trials.
- To assess the use of imputation methods in these trials.
Main Methods:
- Survey of recently published perinatal and neonatal randomized trials in 7 high-impact journals.
- Analysis of reporting on missing primary outcome data and imputation techniques.
Main Results:
- 89% of 87 eligible trials had incomplete primary outcome data.
- Only 49% of trials with missing data performed sensitivity analyses using imputation methods.
- Most analyses (79%) were restricted to participants with complete data.
Conclusions:
- Handling of missing primary outcome data in neonatal trials is frequently inadequate.
- Prevention via careful study design and monitoring is the best strategy to reduce bias.
- Improved approaches include discussing imputation methods, sample size estimation, and data withdrawal management.
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