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Tutorial on Biostatistics: Sample Size and Power Calculation for Ophthalmic Studies With Correlated Binary Eye
Gui-Shuang Ying1, Robert J Glynn2, Bernard Rosner2
1Center for Preventive Ophthalmology and Biostatistics, Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States.
Accurate sample size and power calculations are crucial for ophthalmic studies. Accounting for intereye correlation in designs using both eyes improves efficiency and ensures reliable results.
Area of Science:
- Ophthalmology
- Biostatistics
- Clinical Trials
Background:
- Ophthalmic research frequently involves studies with binary outcomes.
- Different study designs utilize one or both eyes per subject, impacting statistical approaches.
Purpose of the Study:
- To detail and illustrate sample size and power calculations for ophthalmic studies.
- To address various common eye designs used in clinical research.
Main Methods:
- Described four eye designs: one-eye, paired, two-eye, and mixture designs.
- Demonstrated sample size and power calculations using formulas and statistical software (SAS, STATA, R, PS).
Main Results:
- Different statistical packages yield similar, though not identical, results, requiring specific parameters.
- Including both eyes per subject offers efficiency gains over one-eye designs.
- Intereye correlation must be considered for accurate calculations when using data from two eyes.
Conclusions:
- Ophthalmic study designs vary in their inclusion of one or both eyes.
- Correct sample size and power calculations are design-dependent and necessitate accounting for intereye correlation.
- Formulas and statistical software facilitate these essential calculations.
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