Page 1: Information for participants

Why we would like you to take part

We would like you to participate as you are currently writing up a health-related study for publication in a medical journal.  We are testing a new resource designed to help you meet the reporting standards expected by journals which will help you get your work published.

The purpose of the trial

We want to answer the following question 

Does providing an article template with headings and reporting guidance help researchers report their studies more completely than a recommendation to use one or more reporting guidelines?

Who is conducting the trial? 

Investigators at the UK EQUATOR Centre (https://www.equator-network.org/about-us/uk-equator-centre/), part of the internationally recognised EQUATOR Network (https://www.equator-network.org/), are running the trial.

The EQUATOR Network works to promote well-written, complete health research articles through education and training and our freely available, comprehensive, searchable database of reporting guidelines.

This study is supported by the Medical Research Council [grant number MR/S036741/1].

Am I eligible to take part?

You are eligible to take part in the GRReaT trial if:

  • You are currently in the early or planning stages of writing up a healthcare-related research study for publication in a medical journal. 
  • Your study involves the use of descriptive and/or inferential statistics
  • You are the lead author
  • You can commit to submit a publication-ready manuscript to the GRReaT research team within 6-12 months of joining the trial

We are recruiting authors of papers reporting the following study designs

  • cohort study 
  • case-control study 
  • cross sectional study 
  • systematic review of healthcare intervention
  • randomized trial

[Read more about cohort, case-control and cross-sectional studies here]

If you are writing a protocol or a type of study not listed above, such as qualitative research, a systematic review of qualitative or non-interventional research, a case report, or a case series, you are not eligible to take part in this trial. However, guidance on reporting all these and many other types of study can be found on the EQUATOR Network website (https://www.equator-network.org/).

What you can expect if you agree to participate

Before you give your consent, you will be asked to confirm your eligibility by giving a brief (200-500 word) description of your study including characteristics such as the population, type of intervention or exposure, and outcome measures.  

During the consent procedure, you will also be asked to re-confirm your commitment to send us your completed article within 12 months of joining the trial.

You will then be sent an email to confirm your eligibility before being randomized to the intervention or control group.

If you are in the intervention group, you will receive an online article template in Word, containing generic reporting guidance plus items from the appropriate reporting guideline for your study design. 

If you are in the control group, you will receive generic reporting guidance and links to the record of the appropriate reporting guideline for your study design in the EQUATOR database of reporting guidelines.

When you have finished writing your article, and before you submit to a journal or pre-print server, we would like you to email it to the research team, or upload it to the GRReaT study website.

Approximately every month until you upload the final version, we will send a short email reminder of the latest submission date (a maximum of 12 months from enrolment) and encouragement to complete the article.

Once your final manuscript is received, a researcher independent from the GRReaT team will remove all text apart from the title, methods and results sections before assessment and data collection begins.

You will receive an acknowledgement of receipt and an estimate of when your text will be returned to you with the results of the completeness assessment. We will aim to do this within two weeks of receipt.

The GRReaT team will assess the title, methods and results sections for completeness of reporting against the recommended checklist for your study design. Each checklist item will be scored as fully reported, partially reported, or missing. If items in the checklist are clearly irrelevant to your study, they will not be marked as missing.

We will send your manuscript back to you with a copy of our assessment of its completeness.  If items have been assessed as partially reported, the assessors will indicate what information should be added to ensure the item is completely reported.

You are welcome to contact the GRReaT team with any questions you have at any point, and we will establish and maintain a FAQs page on the GRReaT study website.

Do I have to take part?

Participation is completely voluntary. If you change your mind about participating, you can withdraw at any point without giving a reason. We will not use any data we have already collected unless we have your permission to do so.

Will I benefit from taking part?

Both intervention and control group participants will receive an intervention to help them report their study. Whichever group you are allocated to, you will receive more guidance on reporting the scientific content of your study than you would typically receive via a journal’s Guide for Authors.

Your manuscript will be assessed for completeness against a checklist of items from the reporting guideline that applies to your study. The assessment and checklist will be returned to you and comments on what is missing from your manuscript may help you to improve your article before submission to a journal or pre-print server.

How will information about me be kept confidential?

We will always protect your privacy.

Your consent to take part in the study will be recorded electronically alongside identifiers such as your name, email address, and affiliation. This information will be stored on a University of Oxford secure server, separately from the study data.

The sections of your manuscript assessed by the GRReaT researchers will not include any personal identifying details, so researchers working with your text will never know your identity. Your data will be stored using a unique, anonymous study identification number.

A table linking your anonymous study identification number to your personal information will be stored in a separate password-protected location that can only be accessed by the lead investigator.

All study data will be stored in a restricted-access study database unconnected to the table containing your personal details. The study data will be linked to your study identification number, but your personal details will never appear in this database. Access to the study database will be password-protected and will be used only by named researchers working on this study under the direct supervision of the senior investigators.

Can I withdraw?

Yes, you can withdraw from the trial at any time without giving a reason. Any data we have already collected from you, or from the text of your manuscript can be removed from our records and our analysis. However, the trial will be of GRReaT-est use if as few people as possible withdraw. Please feel free to get in touch by email or telephone if you have concerns that mean you are considering withdrawing from the trial.

Who will have access to the data?

We will make the de-identified assessment data and the results of the analyses available to you as participants, and to anyone else who might be interested, on the trial website and the Open Science Framework

Your manuscripts will never be made available to anyone except the assessors and research team.  We will keep these in on a secure site for a year after the publication of the trial results.

We will analyse the data according to the pre-specified analysis plan outlined in our registration and protocol (https://osf.io/d8u76). We will also write an article for journal publication, post it on a pre-print server such as MedRxiv (https://yoda.yale.edu/medrxiv) or Research Square (https://www.researchsquare.com/), and submit it for publication in an open access journal.

What will we do with your data?

Data will be transferred directly to a secure password protected file on an Oxford University secure server. Anonymised data may be used in publicly available project reports and academic publications.  The data and other records from the trial will be kept securely for a minimum of three years after publication, according to the Oxford Univesity policy on the preservation of research data (https://researchdata.ox.ac.uk/preserving-your-data/)

Data protection statement

The University of Oxford is the data controller with respect to your personal data, and as such will determine how your personal data is used in the study. The University will process your personal data for the purpose of the research outlined above.

Research is a task that is performed in the public interest. Further information
about your rights with respect to your personal data is available from:
http://www.admin.ox.ac.uk/councilsec/compliance/gdpr/individualrights/

Who do I contact if I have a concern about the conduct of the trial or I wish to complain? 

If you have a concern about any aspect of taking part in the trial, please email Caroline Struthers (caroline.struthers@csm.ox.ac.uk) or her supervisor Gary Collins (gary.collins@csm.ox.ac.uk), and they will do their best to answer your query. We will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with.

If you remain unhappy or wish to make a formal complaint, please contact the Chair of the Medical Sciences Interdivisional Research Ethics Committee at the University of Oxford (contact details below) who will seek to resolve the matter as soon as possible.

Chair, Medical Sciences Inter-Divisional Research Ethics Committee; Email: ethics@medsci.ox.ac.uk; Address: Research Services, University of Oxford, Wellington Square, Oxford OX1 2JD

Who has approved the trial?

The trial has been reviewed by, and received ethics clearance through, the University of Oxford Central University Research Ethics Committee [Reference number: R60907/RE001]

I still have some questions; how do I get in touch?

If you want to know any more about the project, please email us at: goodreports@csm.ox.ac.uk. Alternatively, you are welcome to contact the lead investigator Caroline Struthers direct (caroline.struthers@csm.ox.ac.uk). You can also read more about the GoodReports project here

If you would like Caroline to call you, please send your telephone number to one of the email addresses above.

Please note that you may only participate if you are 18 years of age or over