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How to Report Data on Bilateral Procedures and Other Issues with Clustered Data: The CLUDA Reporting Guidelines
Mathilde N Hemmingsen1, Caroline M T Nygaard1, Anna Kaufmann1
1From the Departments of Plastic Surgery and Burns Treatment and Cardiology, Copenhagen University Hospital, Rigshospitalet; and Section of Biostatistics, Department of Public Health, and Department of Immunology and Microbiology, University of Copenhagen.
Plastic surgery studies often have clustered data from bilateral procedures. New guidelines help identify and report this clustered data to improve statistical accuracy in research.
Area of Science:
- Plastic Surgery Research
- Biostatistics
- Scientific Methodology
Background:
- Bilateral procedures in plastic surgery research frequently result in clustered data.
- Failure to account for data clustering can lead to erroneous statistical conclusions.
- Clustered data is prevalent in plastic surgery literature.
Purpose of the Study:
- To investigate the prevalence of reporting issues related to clustered data in bilateral breast procedures.
- To develop guidelines for identifying and addressing clustered data in plastic surgery research.
- To improve the statistical validity of studies involving bilateral procedures.
Main Methods:
- A PubMed search was conducted in February 2020 to identify relevant literature.
- A multidisciplinary team, including biostatisticians and medical doctors, refined the reporting guidelines.
- The review focused on breast surgery literature due to its common use of bilateral procedures.
Main Results:
- Out of 113 studies reviewed, 75 (66%) contained clustered data.
- Only 8 studies (11%) statistically accounted for the clustered data.
- The Clustered Data (CLUDA) reporting guidelines were developed.
Conclusions:
- Clustered data is common in plastic surgery publications.
- The CLUDA guidelines offer a framework for identifying and reporting clustered data.
- Consultation with biostatisticians is recommended for study design involving clustered data.
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