SDU researchers contribute to ensuring good reporting of research
Good research is not just about what is discovered; it’s equally about how the findings are reached and described. Three researchers from the University of Southern Denmark have assisted in updating the key reporting guidelines in health research.
Reporting is describing what you do and why. To ensure the research is credible, it is necessary to account for what was done, the findings and how the experiment was conducted in practice. This is where the guidelines come into the picture as the researchers’ checklists.
‘The reporting guidelines for protocols and randomised trials are important because they help to ensure that the trials can be read and understood by the users. These include the clinicians who use the research to provide patients with the best possible treatment,’ explains Asbjørn Hróbjartsson, Professor at the Department of Clinical Research, University of Southern Denmark. He elaborates:
'The guidelines help making the relations between the research and its application as transparent as possible.’
The updated guidelines for good reporting of protocols (SPIRIT 2025) and completed randomised clinical trials (CONSORT 2025) are now being published. Researchers can use them to ensure that their experiments and presentation of the results are as fully and clearly described as possible.
Protocol and Randomised Clinical Trial
Protocol
A protocol can be described as the recipe of the experiment. The protocol describes how the experiment should be carried out and helps to ensure that things are done correctly, safely and consistently every time. This helps to ensure the credibility of the research and that others can repeat the experiment in the same way, e.g. with multiple patients.
SPIRIT is a checklist tool for reporting protocols.
Randomised Clinical Trial
A randomised clinical or controlled trial is a scientific method of testing whether a treatment works.
‘Clinical’ refers to the fact that the trial takes place in a clinical context, i.e. with patients and treatment, while ‘randomisation’ refers to ‘random distribution’ – typically a draw. This makes it possible to follow two similar groups of patients who are offered two different treatments, such as a new treatment and a standard treatment, and compare the results.
Randomised clinical trials are considered the most reliable method to determine whether a drug, treatment or intervention is actually making a difference.
CONSORT is a checklist tool for reporting randomised clinical trials.
CONSORT is considered one of the ten biggest milestones in health research, and the current update is so significant that the most recognised medical journals have joined forces to publish them simultaneously. The updated guidelines are published in BMJ, JAMA, Lancet, Nature Medicine and PLOS Medicine.
Good research is systematic and planned in detail
The researchers must ensure that the experiment is systematic and planned in detail. This means, among other things, that there must be a protocol – a kind of recipe for how you want to carry out your experiment. This also helps to ensure that other researchers conducting the same experiment will achieve comparable results.
Reporting
Reporting means presenting and documenting the results of the experiment. The purpose is to showcase:
- What you have done
- What you have found
- How the experiment was carried out in practice
Reporting of clinical randomised trials is typically done by peer-reviewed publication in scientific journals. ‘Peer-reviewed’ means that other researchers read and evaluate the work before it is published. They assess whether the research has been carried out properly, whether the results are credible and whether the conclusions make sense.
When the experiment is finished, the researchers must honestly and clearly explain what they have done, how they have done it and what they have found. This reporting takes place in a scientific journal, where peer researchers assess whether the experiment has been conducted properly.
‘We have looked back on the references, criticisms and assessments of SPIRIT and CONSORT that have been made over the past ten years, as well as suggestions in the literature. This has been used to update them, so that they continue to be based on the latest and best knowledge in the field, explains Lasse Østengaard, PhD student at the Department of Clinical Research:
‘During this update, we have also revised the two reporting guidelines in context to ensure they align with each other to a greater extent. This means that the elements from the protocols are carried over to the reporting, which will make it easier to assess the quality of the full research work.
About the update
The guidelines are updated to include the latest knowledge and methods. For example, there is an increased involvement of patients and their relatives in research, and there is a rapid development in the sharing of data. The use and handling of this is now described in the updated guidelines.
SPIRIT and CONSORT have been prepared based on the literature in the field, the latest knowledge and a group of experts who are most knowledgeable about research methods. SDU has been well represented in the preparation of both SPIRIT and CONSORT.
Asbjørn Hróbjartsson is a member of the project’s steering committee and a driving force of SPIRIT 2025. In addition, articles supporting the update have been contributed by Camilla Hansen Nejstgaard, Associate professor at the Department of Clinical Research, and Lasse Østengaard, PhD student at the Department of Clinical Research.
Meet the researcher
For the past three years, he has been among Clarivate’s Highly Cited Researchers in interdisciplinary research. His research focuses on the quality of clinical research, especially systematic reviews and clinical trials. Asbjørn Hróbjartsson is a clinical professor at the Department of Clinical Medicine, Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark.
Meet the researcher
Camilla Hansen Nejstgaard is an associate professor at the Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark. Her research focuses on conflicts of interest in clinical research.
Meet the researcher
Lasse Østengaard is a PhD student at the Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark. His research concentrates on citations in clinical research.