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WAS THE SAMPLE SIZE ADEQUATE TO DETECT A CLINICALLY OR SOCIALLY SIGNIFICANT RESULT?

WAS THE SAMPLE SIZE ADEQUATE TO DETECT A CLINICALLY OR SOCIALLY SIGNIFICANT RESULT?

Published in The new England journal of medicine, 356;7 February 15, 2007, pp 663-675, www.nejm.org
Submit a formal written critical appraisal of the article by Newburger J W et al. using the following questions:
1.i) What is the research question? ii) Is it concerned with the impact of an intervention, causality, or determining the magnitude of a health problem?
2.i) What is the study type? ii) Is the study type appropriate to the research question?
3.i) What is the reference population and source population? ii) Is there any selection bias? iii) If yes, does this threaten the external validity of the study?
4.i) Was the assignment of patients to treatments randomised? ii) Do you think the randomisation process was adequate?
5.Was blinding done in this study? If yes, who were blinded?
6.What are the outcome measures and how are they measured?
7.i)Are statistical tests considered? ii)Were the tests appropriate for the data? iii)Were patients analysed in the groups to which they were randomised? iv)Do the conclusions drawn follow logically from the results of the analyses?
8.Are the results clinically or socially significant? Was the sample size adequate to detect a clinically or socially significant result?
9.What conclusions did the authors reach about the study questions? Do you accept the results of this study?

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