Meet the 6 Essential Guides for Publications in Clinical Research
Clinical Research is a particular case in Medical Research, and specifically, within Biomedical Research. These are those studies in which people participate, as patients and / or volunteers, and which are aimed at different purposes, such as developing new treatments or identifying and studying diseases. Thus, there are specific characteristics that must be taken into consideration when working with data from Clinical Research and, of course, when preparing and publishing reports. Publication of clinical research guidelines
The main peculiarity of Clinical Research is the strict ethics and transparency that must always be maintained, in addition to the monitoring of the scientific method, common to any other type of Research. There is strong legislation aimed at the protection of patients who, in addition, must be informed at all times of the situation, and can leave the study if they wish.
Therefore, it is essential that Clinical Research, as well as its publication, be of quality and have a guarantee of transparency and ethics. Furthermore, the concept of accuracy is essential in this context. In those studies that involve work with human beings, ethics requires us to be impeccable in terms of the precision of the observations, the data and the conclusions of those studies. For this, experts have developed a series of guides or guidelines, which are very useful to ensure these principles. In this article we are going to review the 6 most frequently used.
Guidelines for the publication of Clinical Research
The guidelines that we are going to propose here include a series of recommendations for clinical investigators, which will help them to verify all the important points when developing their investigations and especially when reporting them, always based on ethics, transparency and precision. . These are checklists for a number of specific experimental designs. Publication of clinical research guidelines
- PRISMA: Preferred Reporting Elements for Systematic Reviews and Meta-Analysis (for its acronym in English)
- CONSORT: Consolidated Standards for Test Reports
- STROBE: Strengthening the Presentation of Reports of Obstetric Studies in Epidemiology
- MOOSE: Meta-Analysis of Observational Studies in Epidemiology
- STAARD: Standards for the Presentation of Diagnostic Accuracy Study Reports
- SPIRIT: Elements of the Standard Protocol: Recommendations for Interventional Trials
It is necessary to know perfectly the study to which you want to apply these guidelines, therefore, the experimental design is of vital importance. We will select one or the other depending on the type of study. Let’s analice each one of them.
Systematic reviews and meta-analyzes are considered very valuable today for the possibility of generating, transmitting and implementing knowledge. The PRISMA group has been in charge of periodically updating QUORUM (Quality of Reporting of Meta-analyzes), in order to provide the necessary information to write, analyze, interpret and use the results obtained in a Meta-Analysis appropriately. Publication of clinical research guidelines
- STUDIES: in systematic reviews and meta-analysis
- SECTIONS: Title, Summary, Introduction, Method, Results, Discussion and Backgrounds.
- NUMBER OF ITEMS / CONTROL POINTS: 27
CONSORT is an emerging guide to improve the reporting of randomized controlled trials. It was developed in 1996 and was updated in 2010.
- STUDIES: randomized controlled trials
- SECTIONS: Title and Summary, Introduction, Methods, Results, Discussion and Additional Information
- NUMBER OF ITEMS / CONTROL POINTS: 25
STROBE is currently used for observational studies, and was created in 2004.
- STUDIES: observational studies, particularly cohort, case-control, and cross-sectional studies. It is currently being studied whether it could be applied to other types of research , such as those related to the study of genes associated with disease
- SECTIONS: Title, Summary, Introduction, Methodology, Results and Discussion
- NUMBER OF ITEMS / CONTROL POINTS: 18 Publication of clinical research guidelines
MOOSE arose in 1997 with the aim of improving the usefulness of epidemiological analyzes showing the information in a clearer way.
- STUDIES: for systematic reviews and meta-analysis of observational studies
- SECTIONS: Introduction, Search Strategy, Methodology, Results, Discussion, Conclusion
- NUMBER OF ITEMS / CONTROL POINTS: 35
STARD was developed in 2000 with the aim of reducing the difficulty in evaluating diagnostic studies, since elements such as experimental design or analysis method were often absent in these publications.
- STUDIES: diagnostic studies
- SECTIONS: Title, Abstract, Keywords, Introduction, Methodology, Results, Discussion
- NUMBER OF ITEMS / CONTROL POINTS: 25 Publication of clinical research guidelines
SPIRIT was created in 2007. In this case, it was found that there was information that was not usually included in the publications of this type of clinical trial, such as the methods of assigning treatment and masking. This could lead to problems when interpreting the results.
- STUDIES: for intervention studies
- SECTIONS: Administrative Information, Introduction, Methodology, Ethics and Dissemination, Appendices
- NUMBER OF ITEMS / CONTROL POINTS: 33
These guides grew out of mistakes that were made previously. In many cases, important information did not appear in the reports, which, as mentioned above, could lead to a lack of accuracy and transparency, which has no place in this type of investigation.
The biggest advantage of using these guides is that all the information appears in the publications. In addition, this makes it possible to assess the quality of the studies, as well as to compare them with each other. Publication of clinical research guidelines
However, the use of these guidelines does not fully ensure transparency, which ultimately depends on the researcher himself. At this point, it is worth asking who should be responsible for verifying that the control points are met in each case: the editor of the journal? The reviewers? An outsider? In addition, sometimes assuming these guides implies including a lot of information in the articles, and it must be remembered that their extension is limited, so that space problems may arise. Additionally, some authors may decide not to publish because their manuscripts show deficiencies when applying the recommendations, which would lead to a bias when publishing clinical research. At the moment, there are journals that admit manuscripts that do not follow these guidelines,
In summary, while there has been a great improvement in the Clinical Investigations publications in terms of transparency and accuracy, there is still much work to be done.