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Review
. 2020 Sep;24(Suppl 4):S215-S222.
doi: 10.5005/jp-journals-10071-23638.

Critical Analysis of a Randomized Controlled Trial

Balkrishna D Nimavat  1 , Kapil G Zirpe  2 , Sushma K Gurav  2
Affiliations
Review

Critical Analysis of a Randomized Controlled Trial

Balkrishna D Nimavat et al. Indian J Crit Care Med. 2020 Sep.

Abstract

In the era of evidence-based medicine, healthcare professionals are bombarded with plenty of trials and articles of which randomized control trial is considered as the epitome of all in terms of level of evidence. It is very crucial to learn the skill of balancing knowledge of randomized control trial and to avoid misinterpretation of trial result in clinical practice. There are various methods and steps to critically appraise the randomized control trial, but those are overly complex to interpret. There should be more simplified and pragmatic approach for analysis of randomized controlled trial. In this article, we like to summarize few of the practical points under 5 headings: "5 'Rs' of critical analysis of randomized control trial" which encompass Right Question, Right Population, Right Study Design, Right Data, and Right Interpretation. This article gives us insight that analysis of randomized control trial should not only based on statistical findings or results but also on systematically reviewing its core question, relevant population selection, robustness of study design, and right interpretation of outcome. How to cite this article: Nimavat BD, Zirpe KG, Gurav SK. Critical Analysis of a Randomized Controlled Trial. Indian J Crit Care Med 2020;24(Suppl 4):S215-S222.

Keywords: Critical analysis; Evidence based medicine; Randomized control trial.

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Conflict of interest statement

Source of support: Nil Conflict of interest: None

Figures

Flowchart 1
Flowchart 1
Presentation of “critical analysis of RCT”
Fig. 1
Fig. 1
Types of endpoint and their pros and cons
See this image and copyright information in PMC

References

    1. Aslam S, Emmanuel P. Formulating a researchable question: a critical step for facilitating good clinical research. Indian J Sex Transm Dis. 2010;31(1):47–50. doi: 10.4103/0253-7184.69003. DOI: - DOI - PMC - PubMed
    1. Veldhoen RA, Howes D, Maslove DM. Is mortality a useful primary end point for critical care trials? Chest, Elsevier Inc. 2020;158(1):206–211. - PubMed
    1. “Endpoints used for Relative Effectiveness Assessment of pharmaceuticals: Clinical Endpoints”-February 2013 GUIDELINE Endpoints used for Relative Effectiveness Assessment: Clinical Endpoints cki.
    1. fda. Clinical Trial Endpoints.
    1. Farland LV, Correia KF, Wise LA, Williams PL, Ginsburg ES, Missmer SA. p-values and reproductive health: what can clinical researchers learn from the American Statistical Association? Hum Reprod. 2016;31(11):2406–2410. doi: 10.1093/humrep/dew192. DOI: - DOI - PMC - PubMed

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