One of the key distinctions between medical publications and scholarly works in other fields is the existence of specialised standards for reporting research findings. In this field, there are several guidelines used depending on the type of article the author is preparing. One of the most important among them is the CONSORT standard. What does it entail? Which aspects of clinical research does it regulate? We will discuss this in more detail in today’s article.
What is CONSORT?
CONSORT (Consolidated Standards of Reporting Trials) – is an international reporting standard for randomised controlled trials (RCTs), developed by a group of researchers, journal editors, and methodologists. First published in 1996, it has undergone several revisions, with the most up-to-date version currently being CONSORT 2025.
The primary aim of the standard is to ensure transparency, reproducibility, and completeness in the reporting of clinical research, enabling readers and reviewers to objectively assess the quality and applicability of the obtained results.
Main components of CONSORT
The standard consists of two key elements: a checklist and a flow diagram. Let us consider each of these components separately.
The checklist contains 30 items grouped according to the structure of a scientific article. It covers sections such as the title and abstract, introduction, methods, results, discussion, and additional information. Each of these sections is divided into several sub-items specifying the type of data that must be included.
Let us examine how this works using the “Methods” section as an example. It contains the following list of items:
- Trial design.
- Participants.
- Interventions.
- Outcomes.
- Sample size.
- Randomisation.
- Allocation.
- Implementation.
- Blinding methodology.
- Statistical methods.
Accordingly, during the writing process, the author must provide key information for each of these aspects.
In the CONSORT 2025 version, particular attention is also given to the principles of open science. The checklist includes requirements regarding clinical trial registration, the availability of the protocol and statistical analysis plan, the possibility of access to de-identified participant data, as well as disclosure of funding sources and potential conflicts of interest. In addition, the updated version includes clarifications concerning the assessment of adverse effects, the handling of missing data, and the description of the actual implementation of interventions.
The participant flow diagram is another equally important element of this standard. It visually demonstrates the progression of patients through all stages of the study, from the initial screening to the final analysis. The diagram indicates how many individuals were assessed, how many were randomised, how many received the assigned treatment, how many withdrew and for what reasons, and how many were ultimately included in the analysis.
What CONSORT regulates: key aspects
Randomisation and allocation
The standard requires a detailed description of the method used to generate the random sequence (for example, computer-generated randomisation or a table of random numbers), the mechanism of allocation concealment, and the implementation of the randomisation process – specifically, who informed participants about their assigned groups and how this was done.
Blinding (Masking)
Authors are required to specify whether the study was blinded and to whom this applied – participants, researchers, or outcome assessors. This refers to a research method in which participants do not know who is receiving the experimental treatment and who belongs to the control group.
Sample size calculation
The article must include a justification of how many participants were required to achieve a statistically significant result with sufficient statistical power. This enables readers to assess whether the study is sufficiently large to detect a clinically meaningful effect.
Statistical methods
A detailed description of the analytical methods is required – including whether the intention-to-treat principle was used, how missing data were handled, and which statistical criteria were applied.
Adverse events
Unlike many other reporting formats, CONSORT explicitly requires authors to report all recorded adverse events, regardless of whether they are considered related to the intervention or not.
CONSORT extensions
Since clinical studies can take many different forms, the basic standard is supplemented by specialised extensions. These have been developed for cluster randomised controlled trials, studies of non-pharmacological interventions, pragmatic trials, pilot and feasibility studies, as well as for specific types of outcomes. Each extension adapts the checklist requirements to the specifics of the respective study design. You can find the full list via this link.
Why is CONSORT important for publication?
Most leading medical journals, such as the Journal of International Medical Research, International Journal of Oral Medicine, and many others, officially require compliance with CONSORT when submitting manuscripts of randomised trials. Authors are generally required to provide a completed checklist indicating the page numbers where each item is addressed. This facilitates the peer-review process and significantly increases the chances of the article being accepted for publication.
Although at first glance the CONSORT standard may appear complex due to the large number of items and reporting requirements, it is precisely this framework that helps authors avoid common mistakes, ensure research transparency, and comprehensively present the results of their scientific work. Its use is an essential requirement for anyone seeking to publish the results of clinical research in peer-reviewed international medical journals.
To avoid potential mistakes, structure your manuscript properly, and ensure the successful publication of your medical article, contact the Scientific Publications company. Our specialists have extensive experience and will help you select an appropriate journal, prepare your manuscript correctly, and successfully navigate all stages of the publication process. Would you like to receive a free consultation? Then fill in the form below, and one of our managers will contact you shortly. Together towards new scientific achievements!
