Over recent years, many researchers have alluded to a ‘reproducibility crisis’, where many studies are difficult or impossible to reproduce, raising questions about the findings. So, how can researchers make their work more reproducible? We’ve covered some methods in a previous blog post; however, the diverse article types available to authors publishing on Open Research Europe also offer a solution to this challenge.
In this blog post, we discuss Study Protocols, and how they can be utilised to ensure trustworthiness of results and increase the repeatability of published studies.
What is a Study Protocol?
Study Protocols are an article type available to authors publishing with Open Research Europe that describe in detail any study design. This includes the experimental design of basic and applied research, systematic reviews, or protocols defining research questions and empirical methods.
Study Protocols typically contain the introduction and methods sections of a standard Research Article (or other article types, such as Systematic Reviews), without including the results and discussion sections. In most cases, this is because the authors have not yet begun collecting their data; however, there are exceptions, such as when cohort data is to be analysed as part of the research.
Why should I publish my research as a Study Protocol?
One of the main advantages of publishing your research as a Study Protocol is that the methods can be peer reviewed before undertaking the work described within it. Reviewers will evaluate the outlined Protocol, including any statistical analyses you plan to perform on the collected data, and provide feedback which you can consider when performing the methods outlined in the Study Protocol.
It’s not just you, as the author, who benefits from publishing your work as a Study Protocol; the wider research community also benefits, as it encourages methods of data collection and analysis are consistent from planning to implementation. The ‘reproducibility crisis’ has been recognised for several years now and is believed to be, in part, caused by the publication of research where changes have been made to the planned methods and analysis. By publishing the methods in advance, it can improve the trustworthiness of results.
Publishing a Study Protocol doesn’t mean you have to publish the results in the same journal or even publish them at all. Your circumstances may change between publishing the Study Protocol and performing the work outlined in the Protocol. Any methods published are still a useful contribution to academic literature, allowing the work to be used and cited by other groups with similar ideas in the future.
Study Protocols on Open Research Europe
Investigating the dynamics of Plasmodium falciparum gametocyte carriage in expectant women under intermittent preventive treatment with sulfadoxine-pyrimethamine in Kilifi, study protocol
Malaria during pregnancy poses significant risks to both maternal and fetal health, increasing the likelihood of maternal anemia, low birth weight, and premature delivery. In regions with high malaria transmission, such as Kilifi, Kenya, intermittent preventive treatment with sulfadoxine- pyrimethamine (IPTp-SP) is used to prevent malaria in pregnant women. Although IPTp-SP is generally regarded as safe and effective, recent evidence indicates that its performance may be suboptimal.
This study aims to determine the prevalence of malaria parasitemia among pregnant women attending antenatal care (ANC) clinics in Kilifi. It will evaluate the IPTp-SP efficacy by determining parasite prevalence and gametocyte carriage in pregnant women. Additionally, the study will identify factors that influence IPTp-SP uptake by analyzing data from a previous larger study, the Kilifi Perinatal and Maternal (KIPMAT) study, which investigated the impact of various risk factors—such as HIV infection, maternal nutrition, malaria, and anemia—on maternal and infant morbidity and mortality. The findings from this research will help inform strategies to optimize malaria prevention and treatment during pregnancy, ultimately improving maternal and child health outcomes.
Read the Study Protocol here.
The STROGHAT study protocol: An intervention study to evaluate safety, effectiveness and feasibility of treating gambiense HAT seropositive subjects with acoziborole.
The number of people getting sleeping sickness in central and western Africa has been going down in recent years. Since the trypanosome species causing the disease in these countries has a human reservoir, the World Health Organization hopes, by 2030, to eliminate its transmission. Simple screening tests exist but diagnostic confirmation is challenging. This hampers treatment coverage but was always considered necessary in view of complexity and toxicity of the older treatment regimens. Now a new oral medication becomes available. It has minimal side effects, and only requires one dose to cure sleeping sickness. This could allow introducing presumptive treatment, based on a positive screening test only.
In the STROGHAT study, researchers will evaluate if giving this new drug to everyone who tests positive to a serological screening test for sleeping sickness, without need for further confirmation, could help getting rid of the disease. The study will take place in a region in the north of the Democratic Republic of the Congo. Researchers will also check for any side effects of the new drug. Additionally, they will evaluate new diagnostic tests that would enable confirmation of the disease in a remote laboratory at a later timepoint, and look at the cost of this approach.
If the study is successful, this innovative approach could be applied to eliminate sleeping sickness transmission in other affected regions and countries.
Read the Study Protocol here.
How are Registered Reports related to Study Protocols?
Registered Reports follow on from the published Study Protocol and ensure consistency between the Study Protocol and the full Research Article, with all results reported (including negative or null results). Any changes or additions are clearly outlined for readers, which helps mitigate publication bias.
As such, Registered Reports are carried out in 2 stages:
- Stage 1: Study Protocol submission, publication and peer review
- Stage 2: Research Article submission, publication and peer review
Submitting your work as a Stage 2 Registered Report is very similar to a traditional Research Article submission, with the following additions:
- “Stage 2 Registered Report” included in the title
- Abstract links to the Approved Study Protocol
If any additional analyses not outlined in the Study Protocol were carried out when preparing the Research Article, these should be outlined in a separate section within the results titled “Exploratory analyses”. The same peer reviewers who reviewed the Study Protocol will be invited to review the full Registered Report. This approach is best for transparency, ensuring that readers can trust the methods have been followed as described in the initial Protocol (unless a justification has been provided) and ensuring consistency between the Stage 1 and Stage 2 Registered Reports.
Join the hundreds of authors already publishing Study Protocols, submit yours to Open Research Europe today.
