Writing for BJGP: Registered Reports
Registered Reports are articles in which the methods and proposed analyses are pre-registered and reviewed prior to the research being conducted. This format is designed to minimise bias while also allowing flexibility to conduct exploratory analyses and report serendipitous findings in the final manuscript. The BJGP is open to the submission of Registered Reports of trials.
Information for authors
This is a two stage process. The Stage 1 submission (the protocol) should include a description of the research question and background literature, hypotheses, experimental procedures, and planned analyses, including a sample size/power calculation. Pilot data, such as recruitment and follow-up rates to confirm feasibility, can be included. Accepted submissions will be given an ‘in-principle acceptance’ (IPA). A submission deadline for the full paper (submitted at Stage 2), based on the information provided in the Stage 1 submission, will be agreed between the authors and the editorial office. Once the study is complete, authors prepare and submit the full paper for review.
Stage 1: Initial manuscript submission and review
Stage 1 submissions should include the manuscript and a brief cover letter, which should include:
- A brief scientific case for consideration.
- A statement confirming that all necessary support (e.g. funding, facilities) and approvals (e.g. ethics) are in place for the proposed research to start immediately.
- An anticipated timeline for completing the study if the initial submission is accepted.
- A statement confirming that, following Stage 1 IPA, the authors agree to register their approved protocol on the Open Science Framework or another recognised public repository. Accepted protocols can be quickly and easily registered using a tailored mechanism for Registered Reports on the Open Science Framework.
Stage 1 submissions (protocols) should include the following sections:
Introduction
A succinct and up-to-date review of the key publications informing the intellectual background to the study. It does not need to be a systematic review, but should avoid obviously selective citation of the literature. The introduction should lead to the framing of the research question being asked, and this should be clearly stated. Please note that following IPA, the Introduction section cannot be altered apart from correction of factual errors, typographic errors and altering of tense from future to past.
Method
A description of the planned setting, patients, intervention, timelines, instruments to be used to measure outcomes, statistical tests to be applied, and software to be used for analysis. It should also include any arrangements for data oversight.
Stage 1 submissions that are judged to be of sufficient quality and within the scope of the Journal will be sent for peer review. Following peer review, manuscripts will be rejected outright, offered the opportunity to revise, or accepted. Accepted proposals will be issued an IPA, indicating that the final (Stage 2) article will be published pending completion of the study, using the approved methods and analysis, passing any pre-specified quality checks, and a defensible interpretation of the results. Stage 1 protocols are not published by the Journal following IPA. Instead they are registered by the authors in a recognised public repository and then integrated into a single completed article following approval of the final Stage 2 manuscript.
Authors must not deviate from the accepted proposal: doing so may lead to rejection of the final manuscript. In cases where the pre-registered protocol is altered after IPA due to unforeseen circumstances the authors must consult the editorial team immediately for advice, and prior to the completion of data collection. Minor changes to the protocol may be permitted by editorial discretion. In such cases, IPA would be preserved and the deviation reported in the Stage 2 submission. If the authors wish to alter the experimental procedures more substantially following IPA but still wish to publish their article as a Registered Report then the manuscript must be withdrawn and resubmitted as a new Stage 1 submission. Note that registered analyses must be undertaken, but additional unregistered analyses can also be included in a final manuscript (see below).
Stage 2: Full manuscript review
Once the study is complete, authors prepare and resubmit their manuscript for full review, with the following additions:
Cover letter
The Stage 2 cover letter must confirm:
- That the manuscript includes a link to the approved Stage 1 protocol on the Open Science Framework or other recognised repository.
- That, for primary Registered Reports, no data for any pre-registered study (other than pilot data included at Stage 1) were collected prior to the date of IPA.
Submission of anonymised raw data, digital study materials
- Anonymised raw data and digital study materials must be made freely available in a public repository/archive with a link provided within the Stage 2 manuscript. Authors are free to use any repository that renders data and materials freely and publicly accessible and provides a digital object identifier (DOI) to ensure that the data remain persistent, unique and citable. Potential repositories include (but are not limited to) Figshare, Harvard Dataverse, and Dryad. For a comprehensive list of available data repositories, see the Registry of Research Data Repositories.
- Raw data must be accompanied by guidance notes, where required, to assist other scientists in replicating the analysis pipeline. Authors are required to upload any relevant analysis scripts and other digital experimental materials that would assist in replication.
- Any supplementary figures, tables, or other text (such as supplementary methods) can either be included as standard supplementary data that accompanies the paper, or they can be archived together with the data. Please note that the raw data itself should be archived (see above) rather than submitted to the journal as supplementary material.
- The Stage 2 manuscript must also contain a link to the registered protocol (deposited following IPA) on the Open Science Framework or other recognised repository.
Background, Rationale and Method
Apart from minor stylistic revisions, the Introduction cannot be altered from the approved Stage 1 submission, and the stated research question or hypothesis cannot be amended or appended. Any textual changes to the Introduction or Method (e.g. correction of typographic errors) must be clearly marked in the Stage 2 submission. Any relevant literature that appeared following the date of IPA should be covered in the Discussion.
Results & Discussion
- The outcome of all registered analyses must be reported in the manuscript, except in rare instances where a registered and approved analysis is subsequently shown to be logically flawed or unfounded. In such cases, the authors, reviewers, and editor must agree that a collective error of judgment was made and that the analysis is inappropriate. In such cases the analysis would still be mentioned in the Method but omitted with justification from the Results.
- It is reasonable that authors may wish to include additional analyses that were not included in the registered submission. For instance, a new analytic approach might become available between IPA and Stage 2 review, or a particularly interesting and unexpected finding may emerge. Such analyses are admissible but must be clearly justified in the text, appropriately caveated, and reported in a separate section of the Results titled ‘Exploratory analyses’. Authors should be careful not to base their conclusions entirely on the outcome of statistically significant post hoc analyses.
- Authors are required to report effect sizes with confidence intervals for inferential analyses. Where results of hypothesis tests are reported, exact P-values should be presented.
The full Stage 2 submission is likely be considered by the same reviewers as in Stage 1, but could also be assessed by new reviewers.
Manuscript withdrawal
It is possible that authors with IPA may wish to withdraw their manuscript following or during data collection. Studies that are not completed by the agreed Stage 2 submission deadline (which can be extended in negotiation with the editorial office) will be considered withdrawn.
Possible reasons for withdrawal include major technical error, an inability to complete the study due to other unforeseen circumstances, or the desire to submit the results to a different journal. In all such cases, manuscripts can be withdrawn at the authors’ discretion.
Information for reviewers
The review process for Registered Reports is divided into two stages. In Stage 1, reviewers assess study protocols before data are collected. In Stage 2, reviewers consider the full paper, including results and interpretation.
Stage 1 manuscripts will include only an Introduction, Methods (including proposed analyses), and pilot data (where applicable). In considering papers at Stage 1, reviewers will be asked to assess:
- The importance of the research question(s).
- The logic, rationale, and plausibility of the proposed hypotheses.
- The soundness and feasibility of the methodology and analysis, including statistical power.
- Whether the clarity and degree of methodological detail is sufficient to exactly replicate the proposed experimental procedures and analysis.
- Whether the authors have pre-specified sufficient outcome-neutral tests for ensuring that the results obtained can test the stated hypotheses.
Following Stage 1 peer review, manuscripts will be accepted, offered the opportunity to revise, or rejected outright. Manuscripts that pass peer review will be issued an ‘in-principle acceptance’ (IPA), indicating that the full article will be published pending successful completion of the study according to the exact methods and analytic procedures outlined, as well as a defensible and evidence-bound interpretation of the results. A submission deadline will be agreed between the authors and the editorial office.
Following completion of the study, authors will complete the manuscript, including the Results and Discussion sections. These Stage 2 manuscripts will more closely resemble a regular article format. The manuscript will then be returned to the reviewers for appraisal of:
- Whether the data are able to test the authors’ proposed hypotheses.
- Whether the Introduction, rationale, and stated hypotheses are the same as the approved Stage 1 submission (required).
- Whether the authors adhered precisely to the registered experimental procedures.
- Whether any unregistered post hoc analyses added by the authors are justified, methodologically sound, and informative.
- Whether the authors’ conclusions and their statement of Implications for Practice are justified given the data.