Article type spotlight: Study Protocols and Registered Reports

Over recent years, many researchers have alluded to a ‘reproducibility crisis’, where many studies are difficult or impossible to reproduce. 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 HRB Open Research also offer a solution to this challenge.

In this blog post, we discuss Study Protocols and Registered Reports, and how they can be utilised to provide a permanent and detailed record of methods so others can better evaluate, assess, and reproduce their research.

What is a Study Protocol?

Study Protocols are an article type available to authors publishing with HRB Open Research 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 that 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 provides a permanent and detailed record of methods, allowing others to evaluate and reproduce your research.

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.

How are Registered Reports related to Study Protocols?

Registered Reports follow on from the published Study Protocol and ensure that there is consistency between the Study Protocol and the full Research Article, with no manipulation of the results (such as the exclusion of negative or null results) or changes to the hypothesis to fit the results. Any changes or additions are clearly outlined for readers to see, 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 preventing the analysis and outcomes from being manipulated to obtain the desired results.

Study Protocols and Registered Reports on HRB Open Research

HRB Open Research’s approach to Registered Reports means that both stages of the Registered Report are available as citable publications, as well as the peer review reports and any changes, either between versions or stages.

Below, we’ve highlighted some examples of Study Protocols and Registered Reports on HRB Open Research.

Exploring diabetic foot screening programs with integrated consolidated framework for implementation: Rapid review protocol

Background Diabetic foot ulcers (DFU)s pose significant challenges for individuals with diabetes, leading to severe consequences, such as lower extremity amputations (LEA)s, reduced quality of life, and increased mortality. Disorganized diabetic foot care services contribute to health inequities worldwide, highlighting the need for structured preventive measures, which require an understanding of organizational and systemic components of the implementation of foot screening programs.

Research, published as part of the Public and Patient Involvement collection, aims to analyse diabetic foot screening programs for individuals at risk of diabetic foot ulcers and lower extremity amputations, using the Consolidated Framework for Implementation Research (CFIR) to identify key components, implementation determinants, barriers, facilitators, and effective strategies in primary care by conducting a rapid review of existing literature and data.

Read the full Study Protocol here.

Healthcare and recreational sector collaboration strategies to support community-based physical activity participation among young people with childhood-onset physical disability: A scoping review protocol

Most young people with physical disabilities do not engage in enough physical activity, which can significantly impact their future health. Although healthcare professionals, families, recreational workers, and the young people themselves recognize the benefits and share the desire to increase participation, many obstacles still remain.

The objective of the scoping review is to identify evidence of collaboration between healthcare and recreational sectors aimed at supporting community-based physical activity participation among young people with childhood-onset physical disability.

Read the full Study Protocol here.

Join the hundreds of authors already publishing Study Protocols, submit yours to HRB Open Research today.