Randomized Controlled Trials

Vol 2 | Issue 2 | July-December 2021 | Page 107-110 | Nidhi Bhatia, Anju Grewal
DOI: 10.13107/ijra.2021.v02i02.037


Authors: Nidhi Bhatia [1], Anju Grewal [2]

[1]  Department of Anaesthesiology & Intensive Care, PGIMER, Chandigarh, India.
[2]  Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.

Address of Correspondence
Dr. Anju Grewal, Professor & Head,
Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
E-mail: dranjugrewal@gmail.com


Abstract


A randomized controlled trial (RCT) is a prospective, comparative, quantitative experiment/study that is performed under controlled conditions with random allocation of interventions to comparison groups. Among all the clinical study designs, evidence generated from RCTs is considered to be at top of the evidence pyramid. There are many different RCT designs and they can be classified on the basis of interventions evaluated, participants’ exposure and level of blinding. All RCTs should be planned prospectively, a research question should be formulated, sample population approached and informed consent obtained from participants of the trial. These consented subjects are randomly assigned to any of the study arms and the changes are then measured over time. The basic principles to designing an RCT include formulating a research question, developing a protocol, randomization, allocation concealment, blinding, sample size calculation and registering of RCTs. Appropriate guidelines for reporting RCTs should be followed and RCTs should only be conducted if they are ethically viable, economical and clinically worthwhile.
Keywords: Randomised Control Trial (RCT)


References


1. Zabor EC, Kaizer AM, Hobbs BP. Randomized Controlled Trials. Chest 2020; 158: S79-S87.
2. Bhide A, Shah PS, Acharya G. A simplified guide to randomized controlled trials. Acta Obstet Gynecol Scand 2018;97:380-387.
3. White H, Sabarwal S, De Hoop T. Randomized Controlled Trials (RCTs): Methodological Briefs 2014 ; Impact Evaluation No. 7, Methodological Briefs no. 7.
4. Stolberg HO, Norman G, Trop I. Randomized controlled trials. AJR Am J Roentgenol 2004;183:1539-44.
5. Thiruvenkatachari B. Randomized controlled trials: The technique and challenges. J Indian Orthod Soc 2015;49:42-7.
6. World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191–2194. doi:10.1001/jama.2013.281053.
7. Elliott TR. Registering randomized clinical trials and the case for CONSORT. Exp Clin Psychopharmacol. 2007 Dec;15(6):511-8. doi: 10.1037/1064-1297.15.6.511. PMID: 18179303; PMCID: PMC2518067.
8. Akobeng AK. Understanding randomised controlled trials. Arch Dis Child 2005 ;90:840-4.


How to Cite this Article: Bhatia N, Grewal A | Randomized Controlled Trials | International Journal of Regional Anaesthesia | July-December 2021; 2(2): 107-110.



(Abstract Text HTML) (Download PDF)


20 replies
  1. Christie
    Christie says:

    I was suggested this blog by way of my cousin. I’m no longer positive whether this put up is written by
    way of him as nobody else know such designated
    approximately my difficulty. You’re amazing! Thanks!

    Reply
  2. Allan
    Allan says:

    It is appropriate time to make some plans forthe longer term and it’s time to be happy. I’ve read this put up and if Imay just I want to recommend you few fascinating issues or advice.Perhaps you can write subsequent articles relating to this article.I desire to read even more issues approximately it!

    Reply

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply

Your email address will not be published. Required fields are marked *