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The methods for handling missing data in clinical trials influence sample size requirements.
- Source :
-
Journal of clinical epidemiology [J Clin Epidemiol] 2004 May; Vol. 57 (5), pp. 447-53. - Publication Year :
- 2004
-
Abstract
- Objective: Results of studies estimating osteoarthritis progression may be affected by missing values. In clinical trials assessing disease-modifying osteoarthritis drugs, sample sizes should be calculated using close estimates of outcome variables.<br />Study Design and Setting: Supposing a two-parallel group design in hip osteoarthritis clinical trials, we estimated sample sizes using the joint space width (JSW), number of patients with JSW progression >0.5 mm (JSN), time to total hip arthroplasty (THA), and time to JSN or THA using several approaches to deal with missing data.<br />Results: Three-year clinical trials testing a treatment effect of 50%, with a power of 80%, could require sample sizes of 121 patients for JSW, 57 for JS progression using multiple imputation for handling missing values; 200 for THA; and 47 for JSN or THA. These numbers vary greatly depending on the approach chosen for handling missing data.<br />Conclusions: These results can help investigators plan clinical trials to select the primary outcome and a priori specify the way missing data will be handled.
- Subjects :
- Aged
Data Interpretation, Statistical
Disease Progression
Female
Humans
Male
Middle Aged
Multicenter Studies as Topic methods
Osteoarthritis, Hip pathology
Research Design
Sample Size
Treatment Outcome
Antirheumatic Agents therapeutic use
Osteoarthritis, Hip drug therapy
Randomized Controlled Trials as Topic methods
Subjects
Details
- Language :
- English
- ISSN :
- 0895-4356
- Volume :
- 57
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Journal of clinical epidemiology
- Publication Type :
- Academic Journal
- Accession number :
- 15196614
- Full Text :
- https://doi.org/10.1016/j.jclinepi.2003.09.012