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Table of Contents   
LETTER TO THE EDITOR  
Year : 2011  |  Volume : 17  |  Issue : 5  |  Page : 369
Primary outcome in a randomized controlled trial: A critical issue


1 Department of Obstetrics and Gynaecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, University of Delhi, Delhi, India
2 Department of Surgery, University College of Medical Sciences and Guru Teg Bahadur Hospital, University of Delhi, Delhi, India

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Date of Web Publication6-Sep-2011
 

How to cite this article:
Choudhary D, Garg PK. Primary outcome in a randomized controlled trial: A critical issue. Saudi J Gastroenterol 2011;17:369

How to cite this URL:
Choudhary D, Garg PK. Primary outcome in a randomized controlled trial: A critical issue. Saudi J Gastroenterol [serial online] 2011 [cited 2019 Jul 15];17:369. Available from: http://www.saudijgastro.com/text.asp?2011/17/5/369/84504


Sir

We read the original article titled "Laparoscopic versus open appendectomy: a comparison of primary outcome measures" by Khalil et al., [1] with great interest.

Randomized controlled trials (RCTs) are principal tools to identify effectiveness of one treatment over another as they bestow least biased estimates of treatment effects. [2] Absence of selection bias and random distribution of confounding factors among different groups make these scientifically rigorous RCTs a preferred choice over case controlled studies. [3] Unfortunately, design of RCTs usually gets less attention than what it deserves. An RCT may involve a number of outcomes. It is of utmost importance to differentiate a primary outcome from a secondary outcome. Primary outcome (end point) is a very critical issue in the design of RCTs. A primary outcome is one which will be used to arrive at a decision on the overall result of the study. [4] Moreover, a primary outcome will also serve the basis to calculate the sample size for a particular RCT. So, a RCT must have only one primary outcome, which should be decided at the outset of the study.

Khalil et al., [1] involved a number of primary outcomes including operative duration, length of hospital stay, and postoperative complications. They have also not mentioned how sample size was calculated. In a review of 42 RCTs comparing open versus laparoscopic appendectomy, Sadr-Azodi et al. concluded that most of these RCTs had low quality. [5] They recommended that adherence to the CONSORT statement [6] and registration of the trial protocol are important tools to improve the quality of trials in the field of surgery.

 
   References Top

1.Khalil J, Muqim R, Rafique M, Khan M. Laparoscopic versus open appendectomy: A comparison of primary outcome measures. Saudi J Gastroenterol 2011;17:236-40.  Back to cited text no. 1
[PUBMED]  Medknow Journal  
2.Puhan MA, Schünemann HJ. How to increase the value of randomised trials in COPD research. Eur Respir J 2009;34:552-8.  Back to cited text no. 2
    
3.Fung EK, Loré JM Jr. Randomized controlled trials for evaluating surgical questions. Arch Otolaryngol Head Neck Surg 2002;128:631-4.  Back to cited text no. 3
    
4.Stanley K. Design of randomized controlled trials. Circulation 2007;115:1164-9.  Back to cited text no. 4
[PUBMED]  [FULLTEXT]  
5.Sadr-Azodi O, Andrén-Sandberg A. The quality of randomized clinical trials in the field of surgery: Studies on laparoscopic versus open appendectomy as an example. Dig Surg 2009;26:351-7.  Back to cited text no. 5
    
6.Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987-91.  Back to cited text no. 6
[PUBMED]  [FULLTEXT]  

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Correspondence Address:
Pankaj K Garg
Department of Surgery, University College of Medical Sciences and Guru Teg Bahadur Hospital, University of Delhi, Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1319-3767.84504

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