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[Research methods in clinical cardiology (VII). Experimental studies in cardiology].

Authors :
Muñiz J
Labarthe DR
Juane R
Castro Beiras A
Source :
Revista espanola de cardiologia [Rev Esp Cardiol] 1997 Apr; Vol. 50 (4), pp. 268-77.
Publication Year :
1997

Abstract

Experimental designs in clinical investigation are discussed in this article. Guideline examples have been used in the area of Cardiology using always the same one only one whenever possible. We have looked for a different perspective from what is generally used in the discussion of the general characteristics of experimental designs, and more specifically of clinical trials and we deal with the aspects of clinical trials which are usually ignored due to their marginal character. We also discuss those characteristics which differentiate clinical trials in respect to other designs and types of questions which are answered by clinical trials. And we finally discuss various aspects such as randomization and its various types (simple, block, stratified, pre-randomized) and variable types of evaluating the answers, masking and the problems in its maintenance, with certain kinds of designs, sample size, etc. There is a brief mention of two particular cases: factorial and cross over designs are both discussed, mentioning their strong and weak points. Likewise, we discuss community trials as another experimental design and examples are provided. Finally, we discuss aspects of criteria: such as, When to stop the trials? or Who are the results applicable to?, and we suggest points to take into consideration when these decisions are made.

Details

Language :
Spanish; Castilian
ISSN :
0300-8932
Volume :
50
Issue :
4
Database :
MEDLINE
Journal :
Revista espanola de cardiologia
Publication Type :
Academic Journal
Accession number :
9235611
Full Text :
https://doi.org/10.1016/s0300-8932(97)73217-2