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| Year : 2011 | Volume
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| Issue : 5 | Page : 369 |
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| Primary outcome in a randomized controlled trial: A critical issue |
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Deepti Choudhary1, Pankaj K Garg2
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 Publication | 6-Sep-2011 |
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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 |
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 | |  |
| 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. 
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| 2. | Puhan MA, Schünemann HJ. How to increase the value of randomised trials in COPD research. Eur Respir J 2009;34:552-8.
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| 3. | Fung EK, Loré JM Jr. Randomized controlled trials for evaluating surgical questions. Arch Otolaryngol Head Neck Surg 2002;128:631-4.
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| 4. | Stanley K. Design of randomized controlled trials. Circulation 2007;115:1164-9.
[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.
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| 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.
[PUBMED] [FULLTEXT] |
Correspondence Address:
Pankaj K Garg
Department of Surgery, University College of Medical Sciences and Guru Teg Bahadur Hospital, University of Delhi, Delhi
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/1319-3767.84504
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| This article has been cited by | | 1 |
Randomized clinical trial of bilateral subtotal thyroidectomy versus total thyroidectomy for Gravesę disease with a 5-year follow-up (Br J Surg 2012; 99: 515-522) |
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| Garg, P.K. | | British Journal of Surgery. 2012; 99(7): 1022-1023 | | [Pubmed] | |
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