Medical Journal of the Islamic Republic Of Iran
مجله پزشکی جمهوری اسلامی ایران
Med J Islam Repub Iran
Medical Sciences
http://mjiri.iums.ac.ir
2
journal2
1016-1430
2251-6840
8
10.18869/mjiri
14
8888
13
en
jalali
1395
10
1
gregorian
2017
1
1
31
1
online
1
fulltext
en
Important considerations in calculating and reporting of sample size in randomized controlled trials
Biostatistics and Epidemiology
Biostatistics and Epidemiology
Debate Article
Debate Article
<strong>Background: </strong>The calculation of the sample size is one of the most important steps in designing a randomized controlled trial. The purpose of this study is drawing the attention of researchers to the importance of calculating and reporting the sample size in randomized controlled trials.<br>
<strong> Methods:</strong> We reviewed related literature and guidelines and discussed some important issues in sample size calculation and reporting in randomized controlled trials.<br>
<strong> Conclusion:</strong> The calculation of the sample size is one of the most important steps in designing a randomized controlled trial. According to the CONSORT (Consolidated Standards of Reporting Trials) guideline and other standard guidelines for designing and reporting of RCTs, sample size calculations should be reported and justified in all published RCTs. Because sample size calculations are prone to bias and because of the high ethical and financial costs related to conducting an RCT, we recommend involving a biostatistician at the designing stage of the study and to ask for statistical advice for sample size calculations.
Randomized controlled trials (RCTs), Sample size, Post hoc power
843
846
http://mjiri.iums.ac.ir/browse.php?a_code=A-10-2158-3&slc_lang=en&sid=1
Ameneh
Ebrahim Valojerdi
ebrahimi.am@tak.iums.ac.ir
200319475328460035586
200319475328460035586
No
Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Kiarash
Tanha
tanha.kiarash@gmail.com
200319475328460035587
200319475328460035587
No
Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Leila
Janani
leila_janani@yahoo.com
200319475328460035588
200319475328460035588
Yes
Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.