Reporting: the publication of scientific studies’ results in the literature

[reading time: 5 minutes]

Since the quality and relevance of the articles found in the literature are judged mainly on the basis of the published report, the importance of respecting the good practice, the ethical standards and the spreading of reliable, clear and reproducible material in the field of the biomedic publications is obvious. A not very clear description of the methodology and of the results could influence negatively their correct distribution and integration in the health care guidelines.

Various initiatives have issued criteria and recommendations to adhere with, stressing that it is the researchers’ responsibility to draft the manuscripts in an honest, clear, accurate and complete manner.

In 2015, the International Society for Medical Publication Professionals, ISMPP, issued the GGP3, an update of the Good Publication Practice Guidelines developed in 2003 and already revised in 2009.

They are a series of recommendations intended for those who write articles for magazines, or prepare presentations for scientific conferences. Different subjects are addressed, including first of all the importance of writing complete, accurate, balanced, transparent and timely reports; of respecting the norms and laws in force and to abide by the guidelines. The responsibility of the authors is also of great importance and so are the need for each of them to fully understand the study, the need to declare the contributions of each of them, the role of the sponsors and the conflict of interest¹.

The International Committee of Medical Journal Editors, ICMJE (a limited working group of generalistic medical journals and not an open organization with free access) has elaborated a document called ICMJE Recommendations, updated in December 2019. These recommendations address the uniformity requirements for manuscripts to be submitted to biomedical journals for publication. And not only do they define the ethical principles related to the conduct and reporting of biomedical research, but also the specific aspects of the writing.

They provide precise criteria for assigning roles, recognitions and responsibilities to authors, contributors and publishers; they highlight the importance of the peer review and of the declaration of the conflict of interest (which may concern both financial relations and other aspects, such as academic competition or intellectual passion); they address the issues of confidentiality and protection of humans subjects and animals. With regard to the publication, they point out the obligation to publish also studies that have not obtained the desired results, to include clinical trials in a public register and to avoid redundant publications².

The EQUATOR Network (Enhancing the QUAlity and Transparency Of Health Research) is also available; a project initially financed by the UK NHS National Knowledge Service in 2006 in order to analyze the state of the art for the creation and circulation of the guidelines for health research reporting.

The EQUATOR Network self-defines itself as “an umbrella organization which brings together researchers, medical journal editors, peer reviewers, developers of reporting guidelines, research funding bodies and other partners who share an interest in improving the quality of research publications and of the research itself”. For further details on the EQUATOR activities please refer to this article of 2008³ which describes the needs to harmonize the accuracy and reliability of the scientific reports and to find the tools to promote its implementation and evaluation.

In 2013, another article on the same subject reiterated the ethical obligation to conduct and publish the research studies in a responsible manner, highlighting several problems associated with the risk of distorting the body of evidence.

There are numerous possible errors, among which the following are mentioned by way of example:

• late publication or non publication of the studies;
• the omission of crucial information in the description of the methodology and in the inclusion and exclusion criteria;
• the inadequate description of the statistical methods and related analyses;
• the selective reporting referred only to some of the outcomes;
• the inadequate presentation of the adverse events, the incompleteness of the data that prevents the study from being included in subsequent systematic reviews;
• the misleading interpretation of the results within the text of the article⁴.

In the EQUATOR Network webpage there are 471 guidelines which identify the standards for the writing of the manuscripts aimed for publication, classified according to the different types of study. The website also offers an algorithm to identify the most appropriate guideline to write the report of the study carried out.

According to the study carried out, the researchers will be able to choose the appropriate guideline, for example, generally the CONSORT guidelines are preferred for the randomized controlled studies (RCT), the PRISMA guidelines for the systematic reviews, the SPIRIT ones for the writing of the study protocols, the PRISMA-P the protocols of the systematic reviews, etc.

For each guideline the EQUATOR Network indicates the article of origin, which explains both its origin and its rationale and the possible checklist, the extensions and the official translations. Each guideline provides the necessary elements to structure the presentation in a standardized manner, in order to provide readers with all the appropriate information – it should be borne in mind that these guidelines are periodically reviewed and that the new versions replace the old ones. Therefore, it is always appropriate to refer to their most recent update.

Bibliography

1. Anand G, Joshi M. Good publication practice guideline 3: Evolving standards for medical writers. Perspect Clin Res. 2019 Jan-Mar;10(1):4-8.
2. http://www.icmje.org/recommendations/browse/
   Simera I, Altman DG, Moher D, Schulz KF, Hoey J. Guidelines for reporting health research: the EQUATOR network’s survey of guideline authors. PLoS Med. 2008 Jun 24;5(6):e139.
3. Simera I, Altman DG. Reporting medical research. Int J Clin Pract. 2013 Aug;67(8):710-6.