Year : 2019 | Volume
| Issue : 5 | Page : 27-30
The CONSORT statement
Department of Anatomy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
Dr. Sarah Cuschieri
Department of Anatomy, Faculty of Medicine and Surgery, Biomedical Building, University of Malta, Msida MSD 2080
Source of Support: None, Conflict of Interest: None
|Date of Web Publication||21-Feb-2019|
Randomized control trials (RCT's) are the gold standard in evaluating and efficiently translating research data into clinical practice. The CONSORT statement was conceptualized in order to help ascertain standardization and reproducibility of RCT's. The articles publishing the CONSORT 2010 statement along with their bibliographies were identified and thoroughly reviewed. The CONSORT statement is made up of a 25-item checklist that provides the author with a solid backbone around which to construct and present an RCT. It sets standards on the trial's design, analysis, and interpretation of the results.
Keywords: Data reporting; epidemiology; publishing; research; research design
|How to cite this article:|
Cuschieri S. The CONSORT statement. Saudi J Anaesth 2019;13, Suppl S1:27-30
| Introduction|| |
Different epidemiological study designs are available, one of which is the randomized control trial (RCT). RCTs are the gold standard in evaluating and efficiently translating research data into clinical practice. In fact, this type of study provides the fundamentals of evidence-based medicine and is the most reliable research design out of all of the epidemiological studies available. Therefore reporting of these invaluable interventions require high-quality reporting techniques, which allow transparency while enabling the readers to critically appraise the trial findings. In order to avoid systematic reporting errors while ascertaining the high-quality reporting standards of RCTs, the CONSORT statement was coined in 1996. The CONSORT was revised over the years to provide clearer explanations and elaborations of the CONSORT principles. The last version was established in 2010 (available at www.consort-statement.org), on which this article will be based. In fact, the original articles publishing the CONSORT 2010 statement together with their bibliographies were identified and thoroughly reviewed.
| The CONSORT Statement|| |
The CONSORT stands for “Consolidated Standards of Reporting Trails” and was developed to aid authors to present the RCTs in a clean, transparent and complete manner, and not to act as a quality assessment tool. The CONSORT is composed of a 25-item checklist, which focuses on the reporting of the trial design, analysis, and interpretation, as seen in [Table 1].[2–4] A CONSORT flowchart is also available, which displays the progress of all participants through the trail, as seen in [Figure 1].
| The CONSORT Checklist|| |
A brief description of each checklist item is provided below.,
Item 1: Title and abstract
The manuscript title should include the words “randomized trial” in order to ensure correct indexing of the manuscript in electronic databases. Indexing of the published manuscript is of utmost importance to ensure identification of the manuscript as describing a trial. Furthermore, correct indexing also enhances the visibility of a researcher's work and increases the citation potential of the published manuscript. Citation of published manuscripts is imperative for the enhancement of the researcher's research metrics and for increasing the prestigious acknowledgment of the researcher and his/her work within the scientific community.
The abstract should include a structured, brief, and clear summary of the study while presenting information found within the actual body of the manuscript. The abstract needs to be well written, since readers tend to assess the overall quality of the trial just by reading the abstract. Furthermore, since not all trial reports are fully freely available for readers, the abstract may be the only source of initial information accessible to readers.
Item 2: Introduction
The Introduction section sets the scientific scene and rational as to why the trial was essential. Trials involving human subjects should have an ethical clearance and exhibit substantial benefit toward mankind.
The objective and hypothesis set out to be investigated in the trial should be reported clearly in this section.
Item 3 to 12: Methods
The Methods section should include a detailed report of how the trial was conducted including the type of design followed and the description of the protocol followed. The type of trial conducted needs to be noted clearly i.e., whether it consisted of a parallel group design or a factorial design. The most common trial design followed is a randomized parallel group design, and in fact the CONSORT statement focuses mainly on such a trial design. It is essential that all the eligibility criteria utilized in the trial protocol are clearly defined since this will enable the reader to interpret the study results adequately. Furthermore, the setting and location (county, city, hospital, and clinic) of the trial needs to be reported, since such information impacts on the study's validity.
Sufficient detail on the intervention and the control groups are required to enable the reproducibility of the trial. When a drug intervention trial is being reported, it is essential that the drug name, dose, mode of administration, timing, and duration details are provided.
The outcome measures, be it primary or secondary outcome, should be identified and defined as part of the Methods section in order to allow readers to use the same outcomes for their own setting. It is not uncommon that the initial objective and protocol are amended throughout the course of the trial. In which case, this change should be reported.
The process of establishing an ethically and scientifically approved trial sample size needs to be noted and justified. Such information needs to provide evidence of the statistical power of the sample population under study. Furthermore, the randomization protocol of the sample population into the intervention and the control groups must be noted. Trials that follow a blinding protocol need to ensure the following: how such blinding was done, who knew about the blinding, was blinding initiated from the start of the trial, among other details. This is to ensure that any potential bias in the results is identified and accounted for.
A detailed description of all the statistical analyses of the data obtained from all stages of the trial needs to be reported.
Item 13 to 19: Results
The CONSORT flowchart, as seen in [Figure 1], is provided to guide the author to the details required in the Results section. It is strongly recommended that the author utilizes the CONSORT flowchart to illustrate the trial outcomes. A detailed account of the intervention and the control groups are required including any loss of follow-up and any individual exclusion that occurred during the trial. If the trial ended prematurely, the reasons contributing to this need to be reported. It is suggestible to illustrate the baseline characteristics of the population under study followed by the primary and secondary outcomes of the study. Furthermore, any harms or unintended effects originating from the trial need to be reported.
Item 20 to 22: Discussion
The Discussion section should include supporting evidence to the trial's findings along with the pros and cons of the results obtained. Any external validation performed needs to be reported and discussed.
Item 23: Other information
The clinical trial should be registered at the very beginning in order to avoid any patency or infringement issues. Such details are required to be included in the manuscript reporting the clinical trial. The details of where a reader can access the full trial protocol needs to be included as well. Clinical trials are very expensive to conduct and funding will be required for it to be successful. All funding sources and the role of the funders in the trial's protocol are imperative to be stated in manuscripts.
| Conclusion|| |
The CONSORT statement is a constantly updated guideline developed to aid RCTs authors in adequately reporting any trial. A 25-checklist and a flowchart comprise the CONSORT statement. Reporting and publishing trials in any journal require the authors to follow the CONSORT statement while writing their manuscript to ensure publication consideration.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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