[VIII: Statistics in medical publications: check lists for authors].
The "Material and Methods" section of clinical research papers should reference major aspects concerning statistical planning and evaluation of the study design and the resulting clinical data. Particular focus is laid on the listing of methods for description and significance evaluation of the trial data, as well as on design-associated study determinants (randomisation and masking strategy, response rate evaluation, primary endpoints, power and sample size determination, multiple testing, software and methods for statistical analysis). Suggestions for the minimum content to be mentioned in a trial publication are listed in author check lists and are illustrated by means of the study synopsis of a randomised clinical trial on the rotation stability of two lens haptics.
Krummenauer
Frank
F
Institut für Medizinische Biometrie, Epidemiologie und Informatik der Universität Mainz. krummi@imsd.uni-mainz.de
D001319:Authorship; D001699:Biometry; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D006801:Humans; D008374:Manuscripts, Medical as Topic; D008432:Mathematical Computing; D011642:Publications / Q000706:statistics & numerical data*; D012107:Research Design