Registered Reports: A new way to publish medical research

Registered Reports are an exciting preregistration initiative and publication format that has the potential to substantially increase the transparency and quality of medical and health research, and that is becoming more prominent in journals. clinical trials


HOW DOES IT WORK?


Publishing your research as a Registered Report requires submitting your study to a journal in two stages.


· STAGE 1. First, you submit your protocol to a journal for peer review. The manuscript is then reviewed based on the quality of the introduction, research question/hypothesis, and methodological design. If the study is accepted by the journal at this stage, it is given in-principle acceptance and you can begin data collection.


· STAGE 2. Once the study is complete, you submit the full manuscript to the journal for second stage review. At this point, the peer-reviewers will assess if the full paper adheres to the submitted protocol. If there are any deviations, these should be justified and fully transparent.


To date, over 300 journals offer this publication format.

Image from: https://www.cos.io/initiatives/registered-reports



WHAT ARE THE BENEFITS?


Reporting biases are one factor affecting the transparency and quality of medical research. These biases include questionable practices such as HARKing (Hypothesising After Results are Known), p-hacking (misusing statistical tests to generate a significant result), and selective reporting of results.


Registered Reports are a particularly useful approach to minimising reporting biases:

  • Peer reviewers check the Stage 2 submission against the Stage 1 manuscript for any deviations in the hypothesis and statistical tests.

  • Whether the findings are statistically significant is irrelevant to acceptance of the Stage 2 manuscript as the study has already been granted in-principle acceptance. This reduces the incentive for authors to report a significant result in order to be able to publish their findings.


Research has found that Registered Reports are much more likely to report null findings than those published through the traditional route (61% null findings in RRs vs. 5-20% in traditional journal publications).

Graph developed using the results from Allen & Mehler, 2018


MY PERSONAL EXPERIENCE


I am a third year PhD student in the Leeds Institute of Health Sciences, and a keen advocate for open research practices. Early on, I knew that I wanted to submit my final PhD study, a factorial randomised trial, as a Registered Report.


However, despite my enthusiasm for Registered Reports, there were several challenges.


Medicine has been much slower to adopt Registered Reports than other disciplines.


Currently, few medical journals offer the option to publish a manuscript as a Registered Report.


As a PhD student, I was also initially worried that submitting a Registered Report would cause significant delays in study set up and recruitment. However, I have found the process very quick.


I first submitted a Stage 1 Registered Report to the British Journal of General Practice in October 2021. By the end of January 2022, I had in-principle acceptance.


One piece of advice to anyone considering a Registered Report is to plan ahead as early as possible. I initially started designing and setting up my study in January 2021. By the time I had submitted my Stage 1 Registered Report, all approvals, such as ethics approval, were in place for the study to start immediately.


I have found two key benefits to the process of developing a Registered Report:


  • First, I believe my study will be published much earlier than if I had gone down the traditional publication route. Therefore, this publication format may be particularly valuable for students submitting their PhD by publication.

  • Second, submitting my study as a Registered Report has improved its methodological quality. For example, Registered Reports typically require a priori sample size/power calculations, which are reviewed in Stage 1 before data collection commences. It was much more helpful to receive feedback from the peer reviewers on the protocol whilst changes to the study design and methods could still be implemented.


WHICH MEDICAL JOURNALS OFFER THIS FORMAT?


Several medical and health journals offer the option of publishing through the Registered Report format, including the British Journal of General Practice, BMJ Open Science, and BMC Medicine.


For the full list of journals accepting Registered Reports across all disciplines, please see here: https://www.cos.io/initiatives/registered-reports


You can see my Stage 1 Registered Report manuscript here:

https://osf.io/b5sfh



This guest blog was written by Kelly Lloyd. She is a PhD student at the University of Leeds, supported by an Economic and Social Research Council studentship and Cancer Research UK programme funding. Kelly is also a steering group member of the Declaration to Improve Health Research. She can be contacted by email or on Twitter.


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