Authors

Find out if you're eligible for a waiver or discount

Peer review of study protocols

ORCID

• At what stage in the research process were patients/the public first involved in the research and how?
• How were the research question(s) and outcome measures developed and informed by their priorities, experience, and preferences?
• How were patients/the public involved in the design of this study?
• How were they involved in the recruitment to and conduct of the study?
• Were they asked to assess the burden of the intervention and time required to participate in the research?
• How were (or will) they be involved in your plans to disseminate the study results to participants and relevant wider patient communities (e.g. by choosing what information/results to share, when, and in what format)?

How can I maximise my chances of being published?

1. Does my research fall within BMJ Open's aims and scope?
2. Is the research question clear?
3. Is the study design appropriate?
4. Is the study valid?
5. Is the research presented correctly?

Where can I find more general advice?

Resources for data management and sharing

• Original research
• Protocol
• Cohort profile
• Communication
• Supplement

• The article title should include the research question and the study design. Titles should not declare the results of the study.
• A structured abstract including all the following where appropriate (please note that for RCTs there is a specific CONSORT extension for abstracts):
  • objectives: clear statement of main study aim and major hypothesis/research question
  • design: e.g. prospective, randomised, blinded, case control
  • setting: level of care e.g. primary, secondary; number of participating centres. Generalise; don't use the name of a specific centre, but give geographical location if important
  • participants: numbers entering and completing the study; sex and ethnic group if appropriate. Clear definitions of selection, entry and exclusion criteria
  • interventions: what, how, when and how long (this can be deleted if there were no interventions)
  • primary and secondary outcome measures: planned (i.e. in the protocol) and those finally measured (if different, explain why) - for quantitative studies only
  • results: main results with (for quantitative studies) 95% confidence intervals and, where appropriate, the exact level of statistical significance and the number need to treat/harm. Whenever possible, state absolute rather than relative risks
  • conclusions: primary conclusions and their implications, suggest areas for further research if appropriate. Do not go beyond the data in the article
  • where applicable, trial registration: registry and number (for clinical trials and, if available, for observational studies and systematic reviews)
• Please include a ‘Strengths and limitations of this study’ section after the abstract. This section should be no more than 5 bullet points relating specifically to the methods - not the results of the study. This will be published as a summary box after the abstract in the final published article.
• The original protocol for the study, as a supplementary file.
• A funding statement, preferably worded as follows. Either: 'This work was supported by [name of funder] grant number [xxx]' or 'This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors'. You must ensure that the full, correct details of your funder(s) and any relevant grant numbers are included.
• A competing interests statement. See the BMJ Author Hub for details on what to include as competing interests.

• Articles should list each author's contribution individually at the end; this section may also include contributors who do not qualify as authors. Please visit the ICMJE website for more information on authorship.
• Any checklist and flow diagram for the appropriate reporting statement, e.g. STROBE (see below).
• A patient consent form: any article that contains personal medical information about an identifiable living individual requires the patient's explicit consent before we can publish it. We will need the patient to sign our consent form, which requires the patient to have read the article. This form is available in multiple languages.
• A data sharing statement, such as: "Technical appendix, statistical code, and dataset available from the Dryad repository, DOI: [include DOI for dataset here].
• Tables and Figures, we ask that your article does not exceed up to eight figures and tables. Exceeding this will impact upon the paper's 'readability'. Authors are encouraged to submit figures and images in colour - there are no colour charges. Table headers should be provided at the top of each table in the manuscript. We require that you upload your figures as separate files rather than embedding them in the manuscript.
• Supplementary and raw data can be placed online alongside the article although we prefer raw data to be made publicly available and linked to in a suitable repository (e.g. Dryad, FigShare). We may request that you separate out some material into supplementary data files to make the main manuscript clearer for readers.

Pilot studies

• trialling a new procedure intended for use in a larger programme of research
• establishing power calculations required for a full-scale study
• establishing how many patients and/or healthcare professionals can be recruited
• evaluating the financial, technical, administrative or logistic feasibility of a full-scale study, including issues of data collection, protocol adherence, and questionnaire design.

Reporting guidelines

• Protocol papers should report planned or ongoing studies. Manuscripts that report work already carried out will not be considered as protocols. The dates of the study must be included in the manuscript and cover letter.
• Protocols for studies that will require ethical approval, such as trials, are unlikely to be considered without having received that approval
• Title: this should include the specific study type, e.g. randomised controlled trial.
• Abstract: this should be structured with the following sections. Introduction; Methods and analysis; Ethics and dissemination. Registration details should be included as a final section, if appropriate.
• Please include a ‘Strengths and limitations of this study’ section after the abstract. This section should be no more than 5 bullet points relating specifically to the methods - not the results of the study. This will be published as a summary box after the abstract in the final published article.
• Introduction: explain the rationale for the study and what evidence gap it may fill. Appropriate previous literature should be referenced, including relevant systematic reviews.
• Methods and analysis: provide a full description of the study design, including the following. How the sample will be selected; interventions to be measured; the sample size calculation (drawing on previous literature) with an estimate of how many participants will be needed for the primary outcome to be statistically, clinically and/or politically significant; what outcomes will be measured, when and how; a data analysis plan.
• Ethics and dissemination: ethical and safety considerations and any dissemination plan (publications, data deposition and curation) should be covered here.
• Full references.
• Authors' contributions: state how each author was involved in writing the protocol.
• Funding statement: preferably worded as follows. Either: 'This work was supported by [name of funder] grant number [xxx]' or 'This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors'.
• Competing interests statement.

• Purpose: describe why the cohort was set up
• Participants: describe who is in the cohort
• Findings to date: what data has been collected so far and any major results
• Future plans: how will the cohort be used in future, including any date for completion of data collection
• Registration: if your Cohort Profile is linked to a clinical trial, we require the registry and trial registration number to be included. In line with the recommendations of the International Committee of Medical Journal Editors, we require prospective registration of all clinical trials. For Cohort Profiles not linked to a clinical trial, registration is not required.

• Encouraging patient and public involvement
• Improving research transparency and reproducibility
• Reducing research waste through collaboration
• Improving best practice in publishing and peer review

• Title: a clear, concise description of the article’s content.
• Abstract: we recommend a structured abstract that states the objective of the piece along with a summary of the key data or arguments and an overall conclusion.
• Full References
• Authors’ Contributions: state how each author was involved in writing the article.
• Funding statement: preferably worded as follows. Either: ‘This work was supported by [name of funder] grant number [xxx]’ or ‘This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors’.
• Competing Interests statement. see the BMJ Author Hub for details.

• The journal editor, an editorial board member or a learned society may wish to organise a meeting, sponsorship may be sought and the proceedings published as a supplement.
• The journal editor, editorial board member or learned society may wish to commission a supplement on a particular theme or topic. Again, sponsorship may be sought.
• BMJ itself may have proposals for supplements where sponsorship may be necessary.
• A sponsoring organisation, often a pharmaceutical company or a charitable foundation, that wishes to arrange a meeting, the proceedings of which will be published as a supplement.

• Journal in which you would like the supplement published
• Title of supplement and/or meeting on which it is based
• Date of meeting on which it is based
• Proposed table of contents with provisional article titles and proposed authors
• An indication of whether authors have agreed to participate
• Sponsor information including any relevant deadlines
• An indication of the expected length of each paper Guest Editor proposals if appropriate