Literature DB >> 21912071

Primary outcome in a randomized controlled trial: a critical issue.

Deepti Choudhary, Pankaj K Garg.   

Abstract

Mesh:

Year:  2011        PMID: 21912071      PMCID: PMC3178931          DOI: 10.4103/1319-3767.84504

Source DB:  PubMed          Journal:  Saudi J Gastroenterol        ISSN: 1319-3767            Impact factor:   2.485


× No keyword cloud information.
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.
  6 in total

Review 1.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

Authors:  D Moher; K F Schulz; D Altman
Journal:  JAMA       Date:  2001-04-18       Impact factor: 56.272

Review 2.  Design of randomized controlled trials.

Authors:  Kenneth Stanley
Journal:  Circulation       Date:  2007-03-06       Impact factor: 29.690

3.  How to increase the value of randomised trials in COPD research.

Authors:  M A Puhan; H J Schünemann
Journal:  Eur Respir J       Date:  2009-09       Impact factor: 16.671

Review 4.  The quality of randomized clinical trials in the field of surgery: studies on laparoscopic versus open appendectomy as an example.

Authors:  O Sadr-Azodi; A Andrén-Sandberg
Journal:  Dig Surg       Date:  2009-10-30       Impact factor: 2.588

5.  Randomized controlled trials for evaluating surgical questions.

Authors:  Eric K Fung; John M Loré
Journal:  Arch Otolaryngol Head Neck Surg       Date:  2002-06

6.  Laparoscopic versus open appendectomy: a comparison of primary outcome measures.

Authors:  Jawad Khalil; Roohul Muqim; Mohammad Rafique; Mansoor Khan
Journal:  Saudi J Gastroenterol       Date:  2011 Jul-Aug       Impact factor: 2.485

  6 in total
  1 in total

1.  The strength of a randomized controlled trial lies in its design-randomization.

Authors:  Pallvi Kaul; Bodhisattva Bose; Rahul Kumar; Ipsit Ilahi; Pankaj Kumar Garg
Journal:  Support Care Cancer       Date:  2021-03-19       Impact factor: 3.603

  1 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.